药材英国药典标准1(中文)

关于颁布儿茶等43种进口药材质量标准的通知国食药监注[2004]144号各省、自治区、直辖市食品药品监督管理局(药品监督管理局），各口岸食品药品监督管理局（药品监督管理局）,各口岸药品检验所：为加强进口药材的监督管理，我局修（制）订了儿茶、方儿茶、西洋参、高丽红参、西红花、牛黄、羚羊角、泰国安息香、苏合香、乳香、没药、血竭、藤黄、沉香、檀香、丁香、母丁香、小茴香、荜茇、广天仙子、豆蔻、槟榔、肉豆蔻、大腹皮、大风子、西青果、诃子、胖大海、芦荟、猴枣、弗朗鼠李皮、胡黄连、肉桂、番泻叶、马钱子、玳瑁、石决明、天竺黄、穿山甲、海狗肾、海马、哈蚧、海龙等43种进口药材的质量标准（见附件），现予颁布.上述质量标准自颁布之日起执行.国家食品药品监督管理局二○○四年五月八日中药材质量标准中文名儿茶汉语拼音Ercha英文名CA TECHU来源儿茶为豆科植物儿茶Acacia catechu（L。

f.）Willd。

的去皮后的枝、干的干燥煎膏.冬季采收枝、干，除去外皮,砍成大块，加水煎煮，浓缩，干燥。

性状本品呈方形或不规则块状，大小不一。

表面棕褐色或黑褐色，光滑而略有光泽。

质硬，易碎，断面不整齐,具光泽，有细孔,遇潮有黏性.无臭,味涩、苦，略回甜。

鉴别（1)本品粉末棕褐色。

可见针状结晶及黄褐色块状物。

（2）取火柴杆浸于本品水溶液中，使轻微着色，待干燥后，再浸入盐酸中立即取出，置火焰附近烘烤,杆上即显深红色。

（3）取本品粉末约0.5g，加乙醚30ml，超声处理10分钟,滤过,滤液蒸干，残渣用甲醇5ml使溶解，作为供试品溶液。

另取儿茶素和表儿茶素对照品，加甲醇制成每1ml各含0.2mg的混合溶液，作为对照品溶液。

照薄层色谱法(中国药典2000年版一部附录ⅥB)试验，吸取供试品溶液5？l，对照品溶液2？l，分别点于同一纤维素预制板上，以正丁醇—醋酸-水（3:2：1，上层）(实验室室内相对湿度要求在40%以下）为展开剂,展开，取出，晾干，喷以10%硫酸乙醇溶液，热风吹至斑点显色清晰。

英国药典于 1864年在英国成立,是英国制药标准的重要来源。

该药典由三卷本组成。

其中两卷为英国药典、一卷为英国兽药典（兽医药品部分）。

各条目均以药品名称字母顺序排列，内容包括药品性质、制法、血产品、免疫产品、电磁药品制法及外科材料等部分.公司一直在为药学方面提供权威的官方标准品，它在药品和保健品方面做出了重大贡献，英国药典不仅为我们提供了药用和成药配方标准以及公式配药标准，而且也向我们展示了许多明确分类并可参照的欧洲药典专著。

广州优瓦仪器有限公司是从事提供实验室分析领域内产品的专业公司；目前公司已是集研发、生产与销售为一体的综合性企业；在行业内具有良好的声誉；主要产品包括色谱产品、化学试剂、标准品、实验室用品、分析仪器配件及耗材等,总部位于香港。

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Code中文名称Product001萜烯苯酚的合成树脂Acepromazinemaleate904乙酰唑胺分析标准品Acetazolamide Assay Standard6814-乙酰 2-氟联苯4-Acetyl2-fluorobiphenyl907乙酰半胱氨酸分析标准品AcetylcysteineAssay Standard438阿昔洛韦分析标准品Aciclovir AssayStandard003肾上腺素酸式酒石酸盐分析标准品Adrenaline (epinephrine) acid tartrate Assay Standard763阿苯达唑分析标准品Albendazole AssayStandard436亚历山大番泻叶世果粉分析标准品Alexandrian senna fruit powder Assay Standard006阿法多龙三醋酸分析标准品Alfadoloneacetate Assay Standard007硫酸丁胺卡那霉素分析标准品AlfaxaloneAssay Standard825盐酸阿夫唑嗪分析标准品Alfuzosinhydrochloride Assay Standard415异丁嗪分析标准品Alimemazine tartrateAssay Standard831别嘌呤醇杂质AAllopurinol ImpurityA832别嘌呤醇杂质BAllopurinol ImpurityB843别嘌呤醇杂质CAllopurinol ImpurityC844别嘌呤醇杂质DAllopurinol ImpurityD845别嘌呤醇杂质EAllopurinol ImpurityE560溴苄铵托西酸盐9-Allyl-2-chlorothioxanthen-9-ol725枸橼酸阿尔维林杂质分析标准品Alverinecitrate Assay Standard724枸橼酸阿尔维林杂质标准品Alverine citrate impurity standard solution530盐酸金刚烷胺分析标准品Amantadinehydrochloride Assay Standard853硫酸丁胺卡那霉素分析标准品AmikacinSulphate Assay Standard008盐酸阿米洛利分析标准品Amiloridehydrochloride Assay Standard010头孢洛宁4-Amino-6-chlorobenzene-1-3-disulphonamide374头孢呋辛酯3-Amino-6-chloro-1-methyl-4-phenylquinolin-2-ol839苯丁酸氮芥3-amino-4-(2-chlorophenyl)-6-nitroquinolin-2(1H)-one813氯二甲苯酚2-Amino-5-chloropyridine012盐酸扑尔敏2-Amino-4,6-Dichlorophenolhydrochloride011顺铂7-Aminodesacetoxycephalosporanic acid602盐酸富马酸氯马斯汀(E)-4-Amino-2-ethylidenebutyricacid hydrochloride684氯美噻唑乙二磺酸盐分析标准品AminoglutethimideAssay Standard881甲磺酸二氢麦角碱杂质AAminoglutethimideimpurity A4172-Amino-1-(4-nitrophenyl)propane-1,3-diol2-Amino-1-(4-nitrophenyl)propane-1,3 -diol6013-Aminopent-4-ene-1,1-dicarboxylicacid3-Aminopent-4-ene-1,1-dicarboxylic acid5363-Amino-4-phenoxy-5-sulphamoylbenzoicacid3-Amino-4-phenoxy-5-sulphamoylbenzoicacid014丙氧基苯甲酸3-Amino-4-propoxybenzoicacid532盐酸丙氧基苯甲酸分析标准品Amiodaronehydrochloride Assay Standard785无水的氨苄西林分析标准品AnhydrousAmpicillin Assay Standard021氨苄青霉素Ampicillintrihydrate015双甲脒分析标准品Amitraz AssayStandard016盐酸阿米替林分析标准品Amitriptylinehydrochloride Assay Standard019阿莫西林三水物分析标准品AmoxicillinTrihydrate Assay Standard748阿莫西林杂质标准品Amoxicillinimpurity standard546阿泊拉霉素Apramycin694盐酸马来酸麦角新碱分析标准品Argininehydrochloride Assay Standard461酒石酸麦角胺Ascorbic acid617阿匹司林分析标准品Aspirin AssayStandard492阿替洛尔分析标准品Atenolol AssayStandard370阿替洛尔杂质标准品Atenolol impuritystandard023雌二醇半水合物分析标准品Atropinesulphate Assay Standard366依他尼酸1-(3-Azabicyclo[]oct-3-yl)-3-o-tolylsulphonylurea 024氮杂羟基嘌呤2-Azahypoxanthine025阿扎哌隆分析标准品Azaperone AssayStandard534阿扎丙宗分析标准品AAzapropazone AssayStandard515阿扎丙宗分析标准品BAzapropazoneimpurity A516阿扎丙宗分析标准品CAzapropazoneimpurity B517阿扎丙宗分析标准品Azapropazoneimpurity C527阿扎丙宗分析标准品Azapropazoneimpurity standard028氟比洛芬钠分析标准品Baclofen AssayStandard535膦甲酸钠Baclofen lactam030二丙酸倍氯米松分析标准品Beclometasonedipropionate Assay Standard760灰黄霉素Beclometasone17-propionate761胍乙啶Beclometasone21-propionate685盐酸氢溴酸后马托品分析标准品Benserazide036甲磺酸苯扎托品分析标准品Benzatropinemesilate Assay Standard610盐酸羟丙甲纤维素分析标准品Benzydaminehydrochloride Assay Standard426苯甲酸苄酯分析标准品Benzyl benzoateAssay Standard611单硝酸异山梨酯1-Benzyl-3-(3-diethylamino-propoxy)-1H-indazole037伊维菌素(1S,2R)-1-benzyl-3-dimethylamino-2-methyl-1-phenylpropyl acetate609左薄荷脑1-Benzyl-1-H-indazol-3-ol824盐酸左炔诺孕酮分析标准品Betahistinedihydrochloride Assay Standard575倍他米松分析标准品Betamethasone AssayStandard041倍他米松磷酸钠Betamethasone sodiumphosphate042倍他米松戊酸分析标准品Betamethasonevalerate Assay Standard043倍他米松Betamethasone21-valerate686盐酸倍他洛尔分析标准品Betaxololhydrochloride Assay Standard755苯扎贝特分析标准品Bezafibrate AssayStandard046莫美他松糠酸酯2-(Biphenyl-4-yl)propionicacid047比沙可啶分析标准品Bisacodyl AssayStandard612溴苄铵托西酸盐分析标准品Bretyliumtosilate Assay Standard613盐酸诺氟沙星2-Bromobenzyldimethylaminehydrochloride050甲磺酸溴隐亭分析标准品BromocriptineMesilate Assay Standard440盐酸芍药苷杂质标准品Buclizinehydrochloride impurity standard793布地奈德分析标准品Budesonide AssayStandard537布美他尼分析标准品Bumetanide AssayStandard479盐酸布比卡因定分析标准品Bupivacaine403白消安分析标准品Busulfan AssayStandard192强的松2-tert-Butylamino-1-(4-hydroxy-3-methylphenyl)ethanolsulphate531氢化泼尼松磷酸钠2-Butyl-3-(4-hydroxy-3,5-di-iodobenzoyl)benzofuran766咖啡因分析标准品Caffeine AssayStandard355降血钙素分析标准品Calcitonin (salmon)Assay Standard059硫酸卷曲霉素Capreomycinsulphate538卡托普利分析标准品Captopril AssayStandard500柳氮磺胺吡啶Captoprildisulphide477盐酸舒必利2-Carbamoyl-1-methyl-3-[2-(5-methylimidazol-4-yl-methylthio)ethyl]guanidine dihydrochloride523甲萘威分析标准品Carbaryl AssayStandard060卡比多巴分析标准品Carbidopa AssayStandard749卡比马唑分析标准品Carbimazole AssayStandard711卡帕分析标准品Carboplatin AssayStandard767羧甲基纤维素钠分析标准品Carmellosesodium Assay Standard567盐酸卡替洛尔分析标准品Carteololhydrochloride Assay Standard792头孢克洛分析标准品Cefaclor AssayStandard784头孢羟氨苄分析标准品Cefadroxil AssayStandard061头孢氨苄分析标准品Cefalexin AssayStandard562头孢洛宁分析标准品Cefalonium AssayStandard819头孢唑林钠Cefazolin Sodium820头孢西丁钠分析标准品Cefoxitin SodiumAssay Standard063头孢拉定分析标准品Cefradine AssayStandard976头孢曲松钠分析标准品Ceftriaxone sodiumAssay Standard977头孢曲松钠异构体Ceftriaxone sodiumE-isomer502头孢呋辛酯分析标准品Cefuroxime axetilAssay Standard925头孢呋辛钠分析标准品Cefuroxime sodiumAssay Standard757盐酸塞利洛尔分析标准品Celiprololhydrochloride Assay Standard926鹅去氧胆酸Chenodeoxycholicacid064苯丁酸氮芥分析标准品ChlorambucilAssay Standard854氯霉素分析标准品ChloramphenicolAssay Standard067盐酸氯环嗪Chlorcyclizinehydrochloride068醋酸氯己定分析标准品Chlorhexidineacetate Assay Standard4411,4-bis(4-Chlorobenzhydryl)piperazine1,4-bis(4-Chlorobenzhydryl)piperazine756N-p-chlorobenzoyltyramineN-p-chlorobenzoyltyramine6044-Chlorobenzylphthalazinone4-Chlorobenzylphthalazinone3766-氯-4-(2-氯苯基)喹啉-2-甲醛6-Chloro-4-(2-chlorophenyl)quinazoline-2-carboxaldehyde4426-Chloro-1,4-dihydro-1-methyl-4-phenylquinazolin-4-ol6-Chloro-1,4-dihydro-1-m ethyl-4-phenylquinazolin-4-ol4707-Chloro-1-5-dihydro-5-phenyl-1,5-benzodiazepine-2,4(3H)-dione7-Chloro-1-5-di hydro-5-phenyl-1,5-benzodiazepine-2,4(3H)-dione04917β,17'β-bis(3-[bis-(2-chloroethyl)carbamoyloxy]estra-1,3,5,(10)-trienyl)pyrophosphate17β,17'β-bis(3-[bis-(2-chloroethyl)carbamoyloxy]estra-1,3,5,(10)-trienyl)pyrophosphate4465-(2-Chloroethyl)-4-methyl-3-[2-(4-methylthiazol-5-yl)ethyl]thiazolium chloride5-(2-Chloroethyl)-4-methyl-3-[2-(4-methylthiazol-5-yl)ethyl]thiazolium chloride0714-[2-(5-Chloro-2-methoxybenzamido)ethyl]benzenesulphonamide4-[2-(5-Chloro-2-methoxybenzamido)ethyl]benzenesulphonamide9655-氯-1-甲基-4-硝基咪唑5-Chloro-1-methyl-4-nitroimidazole3785-Chloro-2-methylaminobenzophenone5-Chloro-2-methylaminobenzophenone4436-(2-Chlorophenyl)-2,4-dihydro-2-[(dimethylamino)methylene]8-nitroimidazo[1,2-a][1,4]benzodiazepin-1-one6-(2-Chlorophenyl)-2,4-dihydro-2-[( dimethylamino)methylene]8-nitroimidazo[1,2-a][1,4]benzodiazepin-1-one0744-Chloro-5-sulphamoylanthranilicacid4-Chloro-5-sulphamoylanthranilic acid075二苯甲酸2-(4-Chloro-3-sulphamoylbenzoyl)benzoicacid076氯噻嗪Chlorothiazide5592-氯噻吨酮2-Chlorothioxanthone0772-(6-Chlorothymoxy)ethyldimethylaminehydrochloride2-(6-Chlorothymoxy)ethyldimethylaminehydrochloride0792-Chlorotritanol2-Chlorotritanol080氯二甲苯酚分析标准品ChloroxylenolAssay Standard081扑尔敏分析标准品Chlorphenaminemaleate Assay Standard856盐酸氯丙嗪Chlorpromazinehydrochloride467氧氯丙嗪亚砜Chlorpromazinesulphoxide491氯塞酮分析标准品Chlortalidone AssayStandard783盐酸金霉素分析标准品Chlortetracyclinehydrochloride Assay Standard618胆酸分析标准品Cholic acid AssayStandard475西米替汀分析标准品Cimetidine AssayStandard809顺铂分析标准品Cisplatin AssayStandard833克拉霉素分析标准品ClarithromycinAssay Standard834克拉霉素杂质EClarithromycinimpurity E525富马酸氯马斯汀分析标准品Clemastinefumarate Assay Standard084氯碘羟喹分析标准品Clioquinol AssayStandard507氯巴占分析标准品受控药物Clobazam Assay Standard Controlled Substance522氯倍他索杂质AClobetasol impurityA521丙酸氯倍他索分析标准品Clobetasolpropionate Assay Standard482丁酸氯倍他松分析标准品Clobetasonebutyrate Assay Standard406氯可托龙己酸盐Clocortolonehexanoate663氯苯吩嗪分析标准品Clofazimine Assay Standard543氯美噻唑乙二磺酸盐分析标准品Clomethiazole edisilate Assay Standard980盐酸氯米帕明Clomipraminehydrochloride983氯丙咪嗪杂质FClomipramine ImpurityF981氯丙咪嗪杂质CClomipramine impurityC484氯安定分析标准品受控药物Clonazepam Assay Standard Controlled Substance085盐酸可乐定分析标准品Clonidinehydrochloride Assay Standard565二盐酸化物反式氯哌噻吨醋酸trans-Clopenthixol acetate dihydrochloride566二盐酸化物反氯哌噻吨癸酸酯trans-Clopenthixol decanoate dihydrochloride561盐酸反氯哌噻吨trans-Clopenthixol hydrochloride628氯前列烯醇钠分析标准品Cloprostenolsodium Assay Standard379克霉唑分析标准品Clotrimazole AssayStandard088苄星邻氯青霉素分析标准品Cloxacillin benzathine Assay Standard905氯氮平分析标准品Clozapine AssayStandard091甲磺酸二氢麦角碱分析标准品Co-dergocrine mesilate Assay Standard715盐酸薄片分析标准品受控药物Cocainehydrochloride Assay Standard Controlled Substance514盐酸可待因分析标准品受控药物Codeinehydrochloride Assay Standard Controlled Substance090磷酸可待因分析标准品受控药物CodeinePhosphate Assay Standard Controlled Substance787维生素D3分析标准品ColecalciferolAssay Standard614盐酸考来替泊Colestipolhydrochloride551考来烯胺分析标准品ColestyramineAssay Standard585醋酸可的松分析标准品Cortisone acetateAssay Standard094克罗米同分析标准品Crotamiton AssayStandard466维生素B12分析标准品CyanocobalaminAssay Standard4782-Cyano-1-methyl-3-[2-(5-methylimidazol-4-yl-methylsulphinyl)ethyl]guanidine2 -Cyano-1-methyl-3-[2-(5-methylimidazol-4-yl-methylsulphinyl)ethyl]guanidine096盐酸苯甲嗪分析标准品Cyclizinehydrochloride Assay Standard886盐酸环苯扎林Cyclobenzaprinehydrochloride098环戊噻嗪Cyclopenthiazide380盐酸环喷托酯分析标准品Cyclopentolatehydrochloride Assay Standard688醋酸环丙氯地孕酮分析标准品Cyproteroneacetate Assay Standard383阿糖胞苷分析标准品Cytarabine AssayStandard100达卡巴嗪Dacarbazine771丹曲林分析标准品Dantrolene AssayStandard428二羟蒽醌Dantron429二羟蒽醌杂质标准品Dantron impuritystandard102氨苯砜分析标准品Dapsone AssayStandard103硫酸异喹胍Debrisoquinesulphate104癸氧喹酯Decoquinate791Delta-3-CefaclorDelta-3-Cefaclor572DeltamedraneDeltamedrane631溴氰菊酯分析标准品Deltamethrin AssayStandard632溴氰菊酯杂质标准品Deltamethrinimpurity standard789盐酸去甲金霉素分析标准品Demeclocyclinehydrochloride Assay Standard889N-DemethylerythromycinAN-Demethylerythromycin A504去乙酰韦替洛尔Desacetylmetipranolol730N-DesalkylflurazepamN-Desalkylflurazepam987云铁胺甲磺酸酯Desferrioxaminemesilate931盐酸去郁敏Desipraminehydrochloride689盐酸去甲苯扎托品Desmethylbenzatropine hydrochloride568去氧孕烯分析标准品Desogestrel AssayStandard816去氧孕烯杂质DDesogestrel impurityD817去氧孕烯杂质EDesogestrel impurityE594DesogestrelΔ3-isomerDesogestrel Δ3-isomer578地塞米松分析标准品Dexamethasone AssayStandard108地塞米松磷酸钠Dexamethasone sodiumphosphate646磷酸地塞米松分析标准品Dexamethasonephosphate Assay Standard811地塞米松杂质标准品Dexamethasoneimpurity standard465右旋丙氧芬分析标准品受控药物DextropropoxypheneHCl Assay Standard Controlled Substance549荧光素二乙酸盐分析标准品DiacetylfluoresceinAssay Standard887&nbsp石斛 dongding;盐酸脉石中的矿石，填充料，物料分析标准品受控药物DiamorphineHydrochloride Assay Standard Controlled Substance111地西泮受控药物Diazepam ControlledSubstance1146，11-二氢二苯并[b，e]硫杂卓-11-酮Dibenzo[b,e]thiepin-11(6H)-one1243-(Dibenzo[b,e]thiepin-11(6H)-ylidene)-N,N-dimethylaminopropan-1-amine-S-oxid ehydrochloride3-(Dibenzo[b,e]thiepin-11(6H)-ylidene)-N,N-dimethylaminopropan-1-am ine-S-oxidehydrochloride85810，11-二氢二苯并[a，b]环庚烯-5-酮Dibenzosuberone6083-(1,5-Dibenzyl-1H-indazole-3-yl)oxypropyldimethylaminehydrochloride3-(1,5-Dibenzyl-1H-indazole-3-yl)oxypropyldimethylamine hydrochloride116双氯酚分析标准品Dichlorophen AssayStandard420二氯芬杂质分析标准品Dichlorophenimpurity standard Assay Standard7211-(2,5-Dichlorophenyl)-5-isopropylbiguanidehydrochloride1-(2,5-Dichlorophenyl)-5-isopropylbiguanidehydrochloride619双氯芬酸钠分析标准品Diclofenac sodiumAssay Standard598双氯芬酸二乙胺Diclofenacdiethylamine828双氯芬酸杂质ADiclofenac impurityA810双氯西林钠Dicloxacillinsodium118褐霉酸二乙醇胺分析标准品Diethanolaminefusidate Assay Standard3612-Diethylaminoethyl-3-(1-naphthyl)-2-(1-naphthylmethyl)propionateoxalate2-Diethylaminoethyl-3-(1-naphthyl)-2-(1-naphthylmethyl)propionate oxalate737枸橼酸二乙碳酰嗪Diethylcarbamazinecitrate119Diethyl-4-decyloxy-3-ethoxyanilinomethylenemalonateDiethyl-4-decyloxy-3-ethox yanilinomethylenemalonate859己烯雌酚分析标准品DiethylstilbestrolAssay Standard677DiethylstilbestrolmonophosphateDiethylstilbestrolmonophosphate401戊酸双氟可龙分析标准品Diflucortolonevalerate Assay Standard397戊酸双氟可龙杂质标准品Diflucortolonevalerate impurity standard855洋地黄毒甙分析标准品Digitoxin AssayStandard431酒石酸双氢可待因分析标准品受控药物DihydrocodeineTartrate Assay Standard Controlled Substance120甲磺酸双氢麦角汀Dihydroergocristinemesilate1222,3-二氢-6-苯基咪唑噻唑盐酸盐2,3-Dihydro-6-phenylimidazo[2,1-b] thiazole815bis-(1,7-dihydro-6H-purine)-6,6-disulphidebis-(1,7-dihydro-6H-purine)-6,6-dis ulphide726硫氮酮Diltiazem HCl899地尔硫卓杂质标准品Diltiazem ImpurityStandard5826,6-Dimethoxy-2,2'-binaphthyl6,6-Dimethoxy-2,2'-binaphthyl1954-Dimethylamino-3-methyl-1,2-diphenylbutan-2-olhydrochloride4-Dimethylamino-3-methyl-1,2-diphenylbutan-2-olhydrochloride6073-Dimethylaminopropyl 2-benzylaminobenzoatehydrochloride3-Dimethylaminopropyl2-benzylaminobenzoate hydrochloride4561,5-二甲基己胺1,5-Dimethylhexyl(methyl)amine865Dimethyl-2,6-dimethyl-4-(2-nitrophenyl)pyridine-3,5-dicarboxylateDimethyl-2,6 -dimethyl-4-(2-nitrophenyl)pyridine-3,5-dicarboxylate866Dimethyl-2,6-dimethyl-4-(2-nitrosophenyl)pyridine-3,5-dicarboxylateDimethyl-2 ,6-dimethyl-4-(2-nitrosophenyl)pyridine-3,5-dicarboxylate511Dimethyl{5-[2-(1-methylamino-2-nitrovinylamino)ethylsulphinylmethyl]furfuryl}amineDimethyl{5-[2-(1-methylamino-2-nitrovinylamin o)ethylsulphinylmethyl]furfuryl}amine3642,2-Dimethyl-5(2,4-xylyloxy)valericacid2,2-Dimethyl-5(2,4-xylyloxy)valericacid690敌匹硫磷分析标准品Dimpylate AssayStandard691Dimpylate forchromatographyDimpylate for chromatography902地诺前列酮分析标准品Dinoprostone AssayStandard896盐酸苯海拉明Diphenhydraminehydrochloride128盐酸地匹哌酮分析标准品受控药物Dipipanonehydrochloride Assay Standard Controlled Substance673盐酸地匹福林分析标准品Dipivefrinehydrochloride Assay Standard659地匹福林杂质标准品Dipivefrineimpurity standard589利巴韦林杂质标准品分析标准品DiprenorphineAssay Standard131双嘧达莫分析标准品Dipyridamole AssayStandard384N1,N2-Diquinoxalin-2-ylsulphanilamideN1,N2-Diquinoxalin-2-ylsulphanilamide615帕米膦酸钠分析标准品Disodiumpamidronate Assay Standard132二硫化四乙基秋兰姆分析标准品DisulfiramAssay Standard385蒽三酚分析标准品Dithranol AssayStandard674盐酸多巴酚丁胺分析标准品Dobutaminehydrochloride Assay Standard133多库酯钠分析标准品Docusate sodiumAssay Standard669马来酸多潘立酮分析标准品Domperidonemaleate Assay Standard468盐酸多巴胺分析标准品Dopaminehydrochloride Assay Standard134盐酸度琉平分析标准品Dosulepinhydrochloride Assay Standard135盐酸多沙普仑分析标准品Doxapramhydrochloride Assay Standard136盐酸多虑平分析标准品Doxepinhydrochloride Assay Standard823多塞平杂质标准品Doxepin ImpurityStandard990盐酸阿霉素分析标准品Doxorubicinhydrochloride Assay Standard780盐酸强力霉素分析标准品Doxycyclinehyclate Assay Standard675氟哌利多分析标准品Droperidol Assay Standard138去氢孕酮Dydrogesterone139硝酸益康唑分析标准品Econazole nitrate Assay Standard741马来酸依那普利Enalaprilmaleate742依那普利拉Enalaprilat743依那普利双酮Enalaprildiketopiperazine387盐酸麻黄碱分析标准品毒品Ephedrine hydrochloride Assay Standard Drug Precursor 992盐酸表阿霉素Epirubicinhydrochloride788alpha-骨化醇分析标准品Ergocalciferol Assay Standard405马来酸麦角新碱分析标准品Ergometrine maleate Assay Standard Drug Precursor141酒石酸麦角胺分析标准品Ergotamine tartrate Assay Standard Drug Precursor781红霉素Erythromycin794红霉素A分析标准品Erythromycin AAssay Standard795红霉素B分析标准品Erythromycin BAssay Standard796红霉素C分析标准品Erythromycin CAssay Standard790依托红霉素Erythromycinestolate798琥乙红霉素Erythromycin ethylsuccinate488硬脂酸红霉素分析标准品Erythromycin stearate Assay Standard396苯甲酸雌二醇分析标准品Estradiol benzoate Assay Standard729雌二醇半水合物分析标准品Estradiol hemihydrate Assay Standard142雌莫司汀Estramustine752雌三醇分析标准品Estriol AssayStandard753雌三醇杂质标准品Estriol impurity standard860雌酚酮Estrone616雌酮硫酸酯哌嗪分析标准品EstropipateAssay Standard143依他尼酸分析标准品Etacrynic acidAssay Standard421炔雌醇分析标准品EthinylestradiolAssay Standard145乙氧酰胺苯甲酯分析标准品Ethopabate Assay Standard146乙琥胺分析标准品Ethosuximide AssayStandard150Ethyldimethyl[2-(2-methylbenzhydryloxy)ethyl]ammonium chlorideEthyldimethyl[2-(2-methylbenzhydryloxy)ethyl]ammonium chloride 437N-EthylglucaminehydrochlorideN-Ethylglucamine hydrochloride149甲氯芬那酸Ethylmeclofenamate529依托度酸分析标准品Etodolac AssayStandard533依托度酸二聚体Etodolac aciddimer541依托度酸Etodolac 1-methylanalogue542依托度酸Etodolac 8-methylanalogue885依托泊苷分析标准品Etoposide AssayStandard653法莫替丁分析标准品Famotidine AssayStandard655法莫替丁降解杂质1Famotidinedegradation impurity 1656法莫替丁降解杂质2Famotidinedegradation impurity 2654法莫替丁杂质CFamotidine impurityC6204-联苯乙酸分析标准品Felbinac AssayStandard777非洛地平分析标准品Felodipine AssayStandard758非洛地平杂质标准品Felodipine impurity standard692苯硫咪唑Fenbendazole693达虫净杂质CFenbendazole impurityC {5-(phenylthio)-2-aminobenzimidazole}354联苯丁酮酸分析标准品Fenbufen Assay Standard661非诺特罗降解杂质AFenoteroldegradation impurity A660氢溴酸芬忒醇分析标准品Fenoterol hydrobromide Assay Standard665枸橼酸芬太尼分析标准品受控药物Fentanyl citrate Assay Standard Controlled Substance 666芬太尼杂质AFentanyl impurityA156倍硫磷分析标准品Fenthion AssayStandard740非那雄胺分析标准品Finasteride Assay Standard571盐酸黄酮哌酯分析标准品Flavoxate hydrochloride Assay Standard676醋酸氟卡胺分析标准品Flecainide acetate Assay Standard159醋酸氟氢可的松分析标准品Fludrocortisone acetate Assay Standard840氟硝西泮受控药物FlunitrazepamControlled Substance160醋酸肤轻松分析标准品Fluocinolone acetonide Assay Standard489醋酸氟轻松分析标准品Fluocinonide Assay Standard161氟可龙己酸分析标准品Fluocortolone hexanoate Assay Standard162氟可龙三甲基乙酸分析标准品Fluocortolone pivalate Assay Standard163氯苯丁酮4'-Fluoro-4-chlorobutyrophenone573氟米龙分析标准品FluorometholoneAssay Standard797盐酸氟西汀分析标准品Fluoxetine hydrochloride Assay Standard164氟甲睾酮Fluoxymesterone738氟哌噻吨cis-Flupentixol554二盐酸化物噻吨癸酸酯分析标准品Flupentixol decanoate dihydrochloride Assay Standard556盐酸反噻吨癸酸酯trans-Flupentixol decanoate dihydrochloride597盐酸顺式三氟噻吨丙酸cis-Flupenthixol propionate dihydrochloride167盐酸氟奋乃静分析标准品Fluphenazinehydrochloride Assay Standard574氟比洛芬钠分析标准品Flurbiprofensodium Assay Standard587丙酸氟替卡松分析标准品Fluticasonepropionate Assay Standard588氟及卡松丙酸酯杂质FluticasoneS-methyl impurity600马来酸氟伏沙明分析标准品Fluvoxaminemaleate Assay Standard671氟伏沙明杂质标准品Fluvoxamine maleateimpurity standard627甲酰基利福霉素 SV3-FormylrifamycinSV639Form-2',4'-xylidideForm-2',4'-xylidide623膦甲酸钠分析标准品Foscarnet sodiumAssay Standard678磷雌酚钠Fosfestrol sodium547呋噻米分析标准品Furosemide AssayStandard643加拉明杂质标准品Gallamine impuritystandard363吉非罗齐分析标准品Gemfibrozil AssayStandard303二甲苯氧庚酸杂质AGemfibrozilimpurity A 2,2-dimethyl-5-(4-propen-1-yl)-2,5-xylyloxy)valeric acid365吉非罗齐甲酯Gemfibrozil methylester174硫酸庆大霉素Gentamicinsulphate175格列本脲分析标准品Glibenclamide AssayStandard368格列齐特分析标准品Gliclazide AssayStandard580格列喹酮分析标准品Gliquidone AssayStandard581硫胺格列喹酮Gliquidonesulphonamide652硝酸甘油溶液分析标准品Glyceryltrinitrate solution Assay Standard814戈舍瑞林六胜肽GoserelinHexapeptide180灰黄霉素分析标准品Griseofulvin AssayStandard181胍乙啶分析标准品Guanethidinemonosulphate Assay Standard879鸟嘌呤Guanine407氟哌啶醇分析标准品Haloperidol AssayStandard185氢溴酸后马托品分析标准品Homatropinehydrobromide Assay Standard186双氢氯噻嗪分析标准品HydrochlorothiazideAssay Standard576氢化可的松分析标准品HydrocortisoneAssay Standard584醋酸氢化可的松分析标准品Hydrocortisoneacetate Assay Standard187氢化可的松半琥酯HydrocortisoneHydrogen Succinate188氢化可的松磷酸钠Hydrocortisonesodium phosphate190氢氟噻嗪Hydroflumethiazide770对羟基苯乙酮4'Hydroxyacetophenone197羟基脲分析标准品HydroxycarbamideAssay Standard526N-甲基-2-(2-羟乙基)吡咯烷2-(2-Hydroxyethyl)-1-methylpyrrolidine1965-[1-Hydroxy-2-(1-methyl-3-phenylpropylamino)ethyl]salicylicacidhydrochloride5-[1-Hydroxy-2-(1-methyl-3-phenylpropylamino)ethyl]salicylicacid hydrochloride829D-alpha-(4-hydroxyphenyl)glycineD-alpha-(4-hydroxyphenyl)glycine888(5RS)-3-(2-hydroxyphenyl)-5-phenylcyclohex-2-enone(5RS)-3-(2-hydroxyphenyl)-5 -phenylcyclohex-2-enone1942-(6-Hydroxythymoxy)ethyldimethylaminehydrochloride2-(6-Hydroxythymoxy)ethyldimethylaminehydrochloride198丁溴东莨菪碱分析标准品Hyoscinebutylbromide Assay Standard199东莨菪碱氢溴酸盐分析标准品HyoscineHydrobromide Assay Standard774羟丙甲纤维素分析标准品HypromelloseAssay Standard539布洛芬分析标准品Ibuprofen AssayStandard2025-碘-2'-脱氧尿苷分析标准品IdoxuridineAssay Standard759异环磷酰胺分析标准品Ifosfamide AssayStandard664IminophenazineIminophenazine932盐酸丙咪嗪Imipraminehydrochloride999吲达帕胺分析标准品Indapamide AssayStandard1000吲达帕胺杂质BIndapamide impurityB625异丙托溴铵分析标准品Ipratropiumbromide Assay Standard557异丁基苯乙酮4'-Isobutylacetophenone550硝酸异康唑分析标准品Isoconazolenitrate Assay Standard205盐酸异丙肾上腺素分析标准品Isoprenalinehydrochloride Assay Standard778盐酸异丙美沙嗪Isopromethazinehydrochloride206硝酸异山梨酯Isosorbidedinitrate799异脱二水山梨醇-2-硝酸酯Isosorbide2-nitrate800单硝酸异山梨酯分析标准品Isosorbidemononitrate Assay Standard4994'-(2-Isopropylaminoethyl)methanesulphonanilide hydrochloride4'-(2-Isopropylaminoethyl)methanesulphonanilide hydrochloride626苯酰甲硝唑8s-Isopropyl-3β-hydroxytropaniumbromide621萜烯苯酚的合成树脂分析标准品IsradipineAssay Standard622伊拉地平杂质BIsradipine impurityB624伊拉地平杂质DIsradipine impurityD864伊维菌素分析标准品Ivermectin AssayStandard861KanamycinmonosulpateKanamycin monosulpate736盐酸氯胺酮受控药物KetamineHydrochloride Controlled Substance6681-(2-甲氧苯基)哌嗪分析标准品Ketoprofen Assay Standard667酮基布洛芬乙酯Ketoprofen ethylester707甲基多巴分析标准品Lacidipine Assay Standard647拉西地平杂质标准品Lacidipineimpurity Standard802拉米夫定分析标准品Lamivudine Assay Standard872兰索拉唑分析标准品Lansoprazole Assay Standard873兰索拉唑杂质标准品Lansoprazoleimpurity standard212盐酸左旋咪唑Levamisolehydrochloride356盐酸甲基苯巴比妥分析标准品Levobunolol hydrochloride Assay Standard213甲基强的松龙分析标准品Levodopa Assay Standard772左薄荷脑分析标准品Levomenthol Assay Standard723甲基泼尼松龙醋酸酯分析标准品Levomepromazine maleate Assay Standard634左美丙嗪亚砜Levomepromazinesulphoxide501左炔诺孕酮分析标准品LevonorgestrelAssay Standard215盐酸林可霉素分析标准品Lincomycin hydrochloride Assay Standard727利多卡因分析标准品Lidocaine Assay Standard214盐酸利多卡因Lidocaine (Lignocaine) hydrochloride733亚麻油Linseed oil695赖诺普利分析标准品Lisinoprildihydrate Assay Standard696赖诺普利二酮哌嗪Lisinoprildiketopiperazine433乳酸锂分析标准品Lithium lactateAssay Standard927石胆酸Lithocholic acid697盐酸洛非帕明分析标准品Lofepramine hydrochloride Assay Standard635盐酸米赛林分析标准品Loperamide hydrochloride Assay Standard636洛派丁胺 N-氧化物LoperamideN-oxide874扑米酮分析标准品Loratadine Assay Standard875兰索拉唑杂质标准品LoratadineImpurity Standard447甲磺酸氯普唑仑受控药物Loprazolammesilate Controlled Substance434普鲁卡因青霉素分析标准品受控药物Lorazepam Assay Standard Controlled Substance528丙氯拉嗪分析标准品受控药物Lormetazepam Assay Standard Controlled Substance867环苯咯丙醇分析标准品Losartan Potassium Assay Standard218赖甲环素Lymecycline776利奈孕酮Lynestrenol1008甲苯咪唑Mebendazole220盐酸美克洛嗪片Meclozinehydrochloride221醋酸甲羟孕酮分析标准品Medroxyprogesterone acetate Assay Standard222甲地孕酮Megestrol223醋酸甲地孕酮分析标准品Megestrol acetate Assay Standard629美洛昔康分析标准品Meloxicam Assay Standard630美洛昔康杂质标准品Meloxicam impurity standard391马法兰分析标准品Melphalan AssayStandard699盐酸吡多素分析标准品Mepivacaine hydrochloride Assay Standard583盐酸酒石酸美托洛尔分析标准品Meptazinol hydrochloride Assay Standard7732-羟基丙酸单锂盐分析标准品Mercaptopurine Assay Standard762巯嘌呤杂质标准品Mercaptopurineimpurity standard496美索达嗪苯磺酸Mesoridazinebesilate226酒石酸美拉明Metaraminoltartrate227盐酸伊拉地平分析标准品Metforminhydrochloride Assay Standard552盐酸美沙酮分析标准品受控药物Methadonehydrochloride Assay Standard Controlled Substance232酮基布洛芬1-(2-Methoxyphenyl)piperazine644对乙酰氨基-邻甲氧基苯甲酸甲酯 Methyl4-acetamido-2-hydroxybenzoate6061-Methylazepan-4-onehydrochloride1-Methylazepan-4-onehydrochloride6051-Methyl-4-(2-benzoylhydrazino)azepanhydrochloride1-Methyl-4-(2-benzoylhydrazino)azepanhydrochloride2393-Methyl-2,2-diphenyl-4-piperidinobutyronitrile3-Methyl-2,2-diphenyl-4-piperi dinobutyronitrile240甲基多巴分析标准品Methyldopa AssayStandard241盐酸甲基多巴乙酯分析标准品Methyldopatehydrochloride Assay Standard569拉米夫定3-Methylflavone-8-carboxylicacid5703-Methylflavone-8-carboxylic acid ethylester3-Methylflavone-8-carboxylic acid ethylester4444-methyl-5-(2-hydroxyethyl)thiazole4-methyl-5-(2-hydroxyethyl)thiazole4572-Methyl-6-methylaminoheptan-2-ol2-Methyl-6-methylaminoheptan-2-ol4761-methyl-3-[2-(5-methylimidazol-4-yl-methylthio)ethyl]guanidine dihydrochloride1-methyl-3-[2-(5-methylimidazol-4-yl-methylthio)ethyl]guanidine dihydrochloride237MethylN-4[2-(5-chloro-2-methoxybenzamido)ethyl]benzenesulphonylcarbamateMethylN-4[2-(5-chloro-2-methoxybenzamido)ethyl]benzenesulphonylcarbamate244兰索拉唑2-Methyl-5-Nitroimidazole245(1-Methyl-5-nitroimidazol-2-yl)methanol(1-Methyl-5-nitroimidazol-2-yl)methano l641N-Methyl-N'-(2,4-xylyl)formamidinehydrochlorideN-Methyl-N'-(2,4-xylyl)formamidinehydrochloride662甲苯比妥分析标准品受控药物MethylphenobarbitalAssay Standard Controlled Substance248甲基强的松龙分析标准品MethylprednisoloneAssay Standard249左美丙嗪马来酸盐分析标准品Methylprednisoloneacetate Assay Standard846三盐酸化物左美丙嗪马来酸盐N-methyl-bis[beta-(2-pyridyl)ethyl]amine trihydrochloride4454-Methyl-5-vinylthiazoleedisilate4-Methyl-5-vinylthiazole edisilate409马来酸美西麦角分析标准品Methysergidemaleate Assay Standard642美替洛尔分析标准品Metipranolol AssayStandard357盐酸胃复安分析标准品Metoclopramidehydrochloride Assay Standard540酒石酸美托洛尔分析标准品Metoprololtartrate Assay Standard603甲硝唑分析标准品Metronidazole AssayStandard735苯酰甲硝唑Metronidazolebenzoate251美克西酮Mexenone252盐酸米安色林分析标准品Mianserinhydrochloride Assay Standard253硝酸咪康分析标准品Miconazole nitrateAssay Standard884咪康唑杂质AMiconazole impurityA722咪达唑仑分析标准品受控药物Midazolam AssayStandard Controlled Substance394盐酸米诺环素分析标准品Minocyclinehydrochloride Assay Standard637米诺地尔分析标准品Minoxidil AssayStandard842米氮平分析标准品Mirtazapine AssayStandard768莫美他松糠酸酯分析标准品Mometasone。

常见中药名中英文对照丹皮酚（paeonol)99%，菊花提取物(Chrysanthemum extract)12:1，益母草提取物(leonurus sibiricas P.E.)10:1葛根提取物(pueraria lobat P.E.)40%，黄芪提取物(Astraglus Extract Polysaccharides)16%Polysaccharides，0.1%,0.3%Astragalosides5 丹参提取物Dan-shen extract 8:1，苦参提取物Lighiyellow Sophora Root P.E 5:1，鱼腥草提取物herba houttuyniae extract 10:1，蛇床子提取物 Common cnidium extract Osthole蛇床子素10%/12:1丹皮提取物 Moutan bark extract 5:1覆盆子提取物 Raspberry extract 12:1杜仲叶提取物 Eucommia bark extract 10:1杜仲皮提取物 Eucommia leaf extract 7:1大枣提取物 Jujube P.E. 5:1/10:1板藍根 Banlangen Isatis Root Radix Isatidis 5：1穿山龍 Chuanshanrong Ningpo Yam Rhizome Rhizoma Dioscoreae Nipponicae 5：1前胡 Qianhu Hogfennel Root Radix Peucedani 5：1太子參 Taizishen Heterophylly Falsestarwort Root Radix Pseudostellariae 5：1夏枯草 Xiakucao Common Selfheal Fruit -spike Spica Prunellae 5：1四季青 Sijiqing Purpleflower Holly Leaf Folium Ilicis Purpureae 5：1金樱子jinyingzi Rosehips extract 7:1桔梗 Jugeng Platycodon Root Radix Platycodi 5∶1山茱萸 Shanzhuyu Asiatic Cornelian Cherry Fruit Fructus Corni 5∶1黄精 Huangjing Solomonseal Rhizome Rhizoma Polygonati 5∶1海金沙 Haijinsha Japanese Climbing Fern Spore Spora Lygodii 5∶1垂盆草 Chuipencao Strngy Stonecrop Herb Herba Sedi 5∶1枸杞提取物Lycium Chinese mill P.E. 8:1银杏提取物Ginkgo biloba P.E. 24%/6%虎杖提取物Giant Knotweed Extract 白藜芦醇Resveratrol 20%/40%熟地黄提取物Rehmannia(cooked) extract 6:1枇杷叶提取物 Loquat leaf extract 8:1粉防己提取物 Radix Stephaniae Tetrandrae extract 10:1五味子提取物 Schisandra Extract 2%Schisandrins 五味子素5%UV 9%UV锯棕榈提取物 Saw Palmetto Berry extract 4:1淫羊藿提取物shortorned epimedium P.E. 10% 20%延胡索提取物Corydalis Yanhusuo P.E. 10:1金樱子提取物 Rosehips extract 4:1茜草 Qiancao Indian Madder Root Radix Rubiae 5：1板兰根提取物 Radix isatidis chrysanthemun flower P.E. 4:1/10:1灵芝提取物 Reishi mushroom P.E 5:1金银花提取物 Honey suckle flower P.E. 7:1/10:1艾叶提取物 Folium artemisiae argri P.E. 4:1山药提取物 Wild yam P.E. 5:1远志提取物：Thinleaf Milkwort Extract 4：1棕榈子提取物 zonglvzi animal extracts 5：1车前草提取物 CHE QIAN CAO Plantago Herb PE, 5:1当归提取物 dong quai P.E. 4:1/3：1/ 1%Ligustilide藁本内酯紫锥菊Echinacea purpurea4% 多酚Polyphenols，1%菊苣酸Chicoricacid/5：1刺五加siberians ginseng0.8%刺五加疳EleutherosideB+E生姜Ginger Extract 10：1卡瓦kava kava30% 卡瓦内酯Kakalactones贯叶连翘st john's wort0.3%,0.33% 金丝桃素Hypericin苹果多酚Apple Polyphenol75%多酚红车轴草red clover8,10,20% 鹰嘴豆芽素辣根Horseradish leaf 5：1灵芝Reishi Mshroom Extract 5：1水飞蓟提取物silymarin80%水飞蓟素，30%水飞蓟宾+异水飞蓟宾28烷醇Octacosanol30% - 90% GC5羟色氨酸5-HTP99%HPLC石杉碱甲Huperzine A99%HPLC漆黄素Fisetin98%HPLC枳实提取物Citrus Aurantium P.E. 辛弗林Synephrine 4%-30%黑升麻提取物Black Cohosh P.E.三萜皂甙Triterpenoides Saponis 2.5%HPLC何首乌提取物Fo-Ti P.E. 10:1HPLC人参提取物Ginseng P.E. 人参总皂甙Ginsenosides 80%UV葡萄籽提取物Grape Seed P.E.前花青素 OPC95%UV绞股蓝提取物Gynostemma Pentaphyllum P.E.绞股蓝总皂甙Gypenosides 80% 、98%UV 问荆提取物Horsetail P.E.有机硅Silica 7%UV千层塔提取物Huperzia Serrate P.E.石杉碱甲Huperzine 1% 5%HPLC山楂提取物Hawthorn P.E. 牧荆素-2"-鼠李糖甙Vitexin-2''-rhamnoside 2.0% HPLC燕麦提取物Oat P.E.10：1松树皮提取物Pine Bark P.E.前花青素OPC 95%UV红景天提取物Rhodiola Rosea P.E. 红景天甙 Salidroside 1% 2%Rosavin 3%HPLC锯叶棕提取物Saw palmetto P.E.脂肪酸Fatty acid 25%GC大豆提取物Soybean Isoflavones P.E.总异黄酮Isoflavones 40%HPLC刺蒺藜提取物Tribulus Terrestris P.E.蒺藜皂甙Saponins 40% 45%UV山药提取物Wild Yam P.E. 薯蓣皂素Diosgenine 6-16%HPLC白柳树皮提取物White Willow Bark P.E水杨甙Salicin 8%-30%HPLC石榴提取物Pomegranate P.E. 鞣花酸Ellagic acid 40%HPLC缬草提取物Valerian Root缬草酸Valerenic Acids 0.3%HPLC石蒜提取物Galanthamine 1%加兰他敏 1% 98% HPLC葫芦巴子提取物Fenugreek PE 15：1。

英国药典二氧化硅含量标准-概述说明以及解释1.引言1.1 概述概述部分的内容可以介绍英国药典和二氧化硅含量标准的背景和重要性。

英国药典（British Pharmacopoeia）是英国政府主导的药典，旨在确保药品的质量和安全，并提供关于药品的规范和标准。

它是全球最古老、最为广泛使用的药典之一，被广泛认可和接受。

二氧化硅是一种常见的化学物质，具有广泛的应用领域。

在医药工业中，二氧化硅常用作药品的填充剂、稳定剂和流变剂。

它不仅可以增加药品的体积，还可以提高药品的稳定性和流动性。

然而，不同的药品需要不同的二氧化硅含量，过多或过少的二氧化硅都可能会影响药品的质量和疗效。

因此，为了确保药品的一致性和质量，制定了二氧化硅含量的标准。

这些标准指定了药品中二氧化硅的最大和最小含量，以及什么样的测试方法可以用于测量二氧化硅含量。

这些标准的制定是基于科学研究和国际共识，旨在保证药品的质量和安全。

了解英国药典中关于二氧化硅含量的标准对于制药行业和药品生产者来说至关重要。

遵循英国药典的要求能够确保药品在生产过程中的质量和稳定性，并且能够满足患者的需要和期望。

对于药学研究者和相关领域的专业人士来说，了解这些标准还能够为他们的研究和开发提供指导和参考。

总而言之，英国药典中关于二氧化硅含量的标准起着至关重要的作用，不仅可以保证药品的质量和安全，还能够为药品生产者和研究人员提供指导和参考。

在药品生产和研究中，遵循这些标准能够确保药品的一致性和有效性，从而更好地满足患者的需求。

1.2 文章结构文章结构部分:文章的结构非常重要，可以帮助读者更好地理解和组织所阐述的内容。

本文将按照以下结构进行组织：第一部分是引言，主要包括概述、文章结构和目的三个方面。

在概述部分，将简要介绍英国药典中的二氧化硅含量标准的重要性和应用背景。

接下来，在文章结构部分，将详细介绍本文按照何种结构进行组织，在本文中的各个部分分别阐述的内容。

最后，明确本文的目的，即为读者提供关于英国药典中二氧化硅含量标准的全面了解。

英国药典2012 有关物质项译文液相色谱法（见2.2.29）供试品溶液：取20mg本品用2mL乙腈溶解之后，用流动相A稀释至10.0mL。

对照溶液(a)：去1.0mL待测溶液用流动相A稀释至100.0mL。

再取该液1.0mL 用流动相A稀释至10.0mL。

对照溶液(b)：取布洛芬杂质B对照品1.0mL用乙腈稀释至10.0mL（溶液A）。

取20mg布洛芬标准品用2mL乙腈溶解，加入1.0mL溶液A，并用流动相A稀释至10.0mL。

对照溶液(c)：用1mL乙腈溶解布洛芬（峰鉴别用）对照品，并用流动相A稀释至5mL。

色谱柱：型号：l = 0.15 m, Ø = 4.6 mm；固定相：十八烷基键合硅胶，直径5µm；流动相：流动相A：将0.5体积的磷酸和340体积的乙腈、600体积的水混合，平衡后用水稀释至1000体积。

流动相B：乙腈时间（min）流动相A（体积百分比）流动相B（体积百分比）0-25 100 0 25-55 100→15 0→85相对保留时间：布洛芬保留时间约为21min，杂质J约为0.2min，杂质N约为0.3，杂质A约为0.9，杂质B约为1.1。

系统适应性：对照溶液（b）峰谷比：最小值1.5；Hp为杂质B的色谱峰顶点至基线的高度，Hv为布洛芬色谱峰和杂质B色谱峰分离的最低点至基线的高度。

根据需要调整流动相A中乙腈的浓度。

限度：杂质A、J、N：每种杂质均不超过对照溶液（a）色谱图中主成分峰面积的1.5倍（0.15%）；非特定杂质：每种杂质均不超过对照溶液（a）色谱图中主成分峰面积的0.5倍（0.05%）；总杂：不超过对照溶液（a）色谱图中主成分峰面积的2倍（0.2%）；忽略限度：对照溶液（a）色谱图中主成分峰面积的0.3倍（0.03%）。

杂质F 气相色谱法（2.2.28）- 使用常规步骤甲基化溶液：取1mLDMF-DMA和1mL吡啶，用乙酸乙酯稀释至10mL。

供试品溶液：取本品50.0mg于密封小瓶中，用1.0mL乙酸乙酯溶解，加入1mL甲基化溶液，密封，置于烘箱100°C高温加热20min。

一枝黄花YizhihuanghuaSOLIDAGINIS HERBA本品为菊科植物一枝黄花SoZWago decMrrens Lour.的干燥全草。

秋季花果期采挖，除去泥沙，晒干。

【性状I本品长30〜100cm。

根茎短粗，簇生淡黄色细根。

茎圆柱形，直径〇. 2〜0. 5cm;表面黄绿色、灰棕色或暗紫红色，有棱线，上部被毛；质脆，易折断，断面纤维性，有髓。

单叶互宽0. 3(2)3030ml酯-甲醇-喷以3%【检查】水分不得过13.0% (通则0832第二法）。

总灰分不得过8.0%(通则2302)。

酸不溶性灰分不得过4.0% (通则2302)。

【浸出物】照水溶性浸出物测定法（通则2201)项下的热浸法测定，不得少于17. 0%。

【含量测定】照高效液相色谱法（通则0512)测定。

色谱条件与系统适用性试验以十八烷基硅烷键合硅胶为填充剂；以乙腈-甲醇-0.4%醋酸溶液（16 : 8 : 76)为流动相；检测波长为360nm。

理论板数按芦丁峰计算应不低于 2500。

对照品溶液的制备取芦丁对照品适量，精密称定，加甲醇制成每lml含0. lmg的溶液，即得。

供试品溶液的制备取本品粉末（过三号筛）约2g，精密称定，置具塞锥形瓶中，精密加人70%乙醇50ml,称定重量，加热回流40分钟，放冷，再称定重量，用70%乙醇补足减失的重量，摇匀，滤过，取续滤液，即得。

测定法分别精密吸取对照品溶液与供试品溶液各l 〇pl,注人液相色谱仪，测定，即得。

本品按干燥品计算，含无水芦丁（C2 7H3。

0, s)不得少于0. 10%。

饮片【炮制】除去杂质，喷淋清水，切段，干燥。

【性味与归经】辛、苦，凉。

归肺、肝经。

【功能与主治】清热解毒，疏散风热。

用于喉痹，乳蛾，咽•或光叶丁公藤cm。

外皮灰黄或龟质坚硬，色，异型维流3小时，莨菪对照品溶液各3^1，烷-乙酸乙酯-干，置紫外色谱相应的位置上，显相同的亮蓝色荧光斑点。

【检查】水分不得过12.0%(通则0832第二法）。

英国药典2009年版罗红霉素C41H76N2O15 837功能和用途抗菌定义（3R,4S,5S,6R,7R,9R,11S,12R,13S,14R）-4-[﹙2,6-二脱氧-3-C-甲基-3-O-甲基-α-L-核-吡喃糖基﹚氧]-14-乙基-7,12,13-三羟基-10-[﹙E﹚-[(2-甲氧基乙氧基)甲氧基]亚氨基]-3,5,7,9,11,13-六甲基-6-[[3,4,6-三脱氧-3-(二甲氨基)-β-D-木-吡喃糖基]氧]氧杂环十四烷-2-酮（红霉素9-﹙E﹚-[O-[(2-甲氧基乙氧基)甲基]肟]）本品系发酵制品中分离得到的半合成产品。

含量按干燥品计算，含C41H76N2O15为96.0%～102.0%。

性状外观白色或类白色结晶性粉末。

溶解度在水中几乎不溶，易溶于丙酮、乙醇和二氯甲烷。

本品在稀盐酸中几乎不溶。

本品具有多态性（5.9）。

鉴别A.红外吸收光谱（2.2.24）与罗红霉素对照品图谱比较。

如果图谱不一致，可取本品适量制成90g/l二氯甲烷溶液测定。

B.见含量测定项下色谱图。

供试品溶液的色谱图中主成分峰的保留时间和峰形与对照溶液（a）的色谱图中主成分峰保持一致。

检查溶液外观本品溶液是澄清的（2.2.1）和无色的（2.2.2方法Ⅱ）取本品0.2g溶于甲醇中，并用甲醇稀释至20ml。

比旋度-93～-96（干燥品）取本品0.500g溶于丙酮中，并用丙酮稀释至50.0ml。

有关物质液相色谱法（2.2.29）。

溶液A将30体积的乙腈和70体积的48.6g/l磷酸二氢铵溶液混合，用稀氢氧化钠溶液调PH至5.3。

供试品溶液取本品50.0mg，精密称定，用溶液A溶解，并用溶液A 稀释至25.0ml。

对照溶液（a）取罗红霉素对照品50.0mg，精密称定，用溶液A溶解，并用溶液A 稀释至25.0ml。

对照溶液（b）精密量取对照溶液（a）1.0ml，用溶液A稀释至100.0ml。

对照溶液（c）取罗红霉素对照品2.0mg，精密称定，用溶液A溶解，并用溶液A 稀释至1.0ml。

中药化学成分中英文对照表(doc 40页)Anagyrine 臭豆碱,安那吉碱,安纳基林, Andrographolide 穿心莲内酯,穿心莲乙素5α-Androstane-3,17-Diol 5α-雄烷-3,17-二醇5α-Androstenediol 5α-雄烯二醇AnetholeAnemonine25-anhydrocimicigenol-3-O--β-D- xylopyranoside gbc-09β-AnhydroicaritinAnisodamine 山莨菪碱Anisodine 樟柳碱Apigenin 芹菜素,芹菜甙元,芹菜(甙)配基,芹黄素Apigenin-7-glucoside 芹菜甙元(芹菜素)-7-葡萄糖甙Apigenin-7-O-glucoside 芹菜甙元(芹菜素)-7-O-葡萄糖甙Apigenin-8-O-glucoside 芹菜甙元(芹菜素)-8-O-葡萄糖甙Apigenin-8-O-β-glucoside 芹菜甙元(芹菜素)-8-O-葡萄糖甙,牡荆素Arbutin 熊果甙Arctiin 牛蒡子甙Aristolochic acid 马兜铃总酸Aristolochic acid A 马兜铃酸 AAristolochic acid B 马兜铃酸 BAristolochic acid C 马兜铃酸 CArmillarisin A 亮菌甲素,假蜜环菌甲素Arteannuic acid 青蒿酸Atraotydin 苍术甙α-Artemether α-蒿甲醚β-Artemether β-蒿甲醚Arteannuin 青蒿素Artemetin 蒿亭Artemisinic acid 青蒿酸Artemisinin 青蒿素Arundoin 芦竹素Asarinin 细辛脂素, 细辛酯素α-Asaron α-细辛醚β-Asaron β-细辛醚AseculinAsiatic acid 积雪草酸Asiaticoside 积雪草甙DL-Asparagine DL-天冬素,DL-天冬碱L-Asparagine L-天冬素,DL-天冬碱(怕热+4℃)DL-Aspartic acid DL-天冬酸L-Aspartic acid L-天冬酸AstragalinAstragaloside II 黄芪皂甙 IIAstragaloside IV 黄芪甲甙Atisine chlorideAtractydin 苍术素Atractylon 苍术酮Atractyloside 苍术甙Atropine SulfateAucubin 桃叶珊瑚甙Avacularin 扁蓄甙Azedarachin(Toosendanin) 川楝素,苦楝素Baicalein 黄芩素,黄芩甙元,黄芩黄素Baicalin 黄芩甙,贝加灵Benzoylene ureaBaptitixine 金雀花碱,野靛碱,金雀儿碱,金莲花碱Barbaloin 芦荟甙Beesioside I[(20S,24S)-15β,16β-iacetoxy-18,24;20,24-diepoxy-9,19-cyclanostane -3β,25-diol-3-O-β-D-xylopyranoside]yl-28-O-α- L-rhamnopyranosyl(1-4)- β-D-glucopyranosyl(1-6)- β-D-glucopyranosyl ester gbc-21Benzoin 安息香Benzoin ethyl ether 安息香乙醚Berbamine hydrochloride 盐酸小檗胺Berberine 小檗碱,黄连素Berberine hydrochloride 盐酸小檗碱，盐酸黄连素Bergapten 佛手柑内酯,5-甲氧基补骨脂素Bergenin 岩白菜素,矮茶素,虎耳草素,岩白菜宁,佛手配质Betaine 甜菜碱Betulin 白桦脂醇Betulinic acid 白桦脂酸2,3- Dihydroxy Betulinic acid 2,3-二羟基白桦脂酸Bicuculline 毕枯枯林Biflorin 双花母草素BIflorine 原阿片碱Bilirubin 胆红素Bilobalide 白果内酯Bilobetin 7-去甲基银杏双黄酮Bronyl acetate 乙酸龙脑酯4-(2-Bronyloxy)-2-butytene-1-ol 4-冰片氧基-2-丁烯-1-醇4-(2-Bronyloxy)-2-butanol 4-冰片氧基-1-丁醇Brervifolincaboxylic acid 天豆叶苏木酚酸,短叶苏木酚酸BrevicorninBritanin 大花旋覆花素Brucealine-glucoside 鸦蛋子苦素 E 葡萄糖甙Bruceine D 鸦蛋子苦素 DBruceine E 鸦蛋子苦素 EBrucine 马钱子碱,布鲁生Brucine sulfate 马钱子碱硫酸盐borneol 龙脑Bornyl acetate 乙酸龙脑酯Bufalin 蟾毒灵γ-Bufotalin γ-日蟾毒配质Bulleyaconitine A 草乌甲素Butenolide A 白术内酯 AButenolide B 白术内酯 Bn-Butyl-p-hydroxybenzoatButylidene 丁烯基太内酯Byakangelicin 比克白芷素Byoscine bulylbromideByoscine hydrobromideCaffeine 咖啡因,咖啡碱,茶碱Calcicalin A 灰岩香茶菜甲素Calycosin 毛蕊异黄酮Calycosin-O-β-D-glucopyranoside 毛蕊异黄酮甙Campanulin 风铃草素Camphol 樟脑Camptothecine 喜树碱Cantharidin 斑蝥素Caohuoside ACaohuoside BCaohuoside CCaohuoside DCaohuoside ECapnoidine 咖喏定Capsaicin 辣椒碱Carboxymethylpachymaran 羧甲基茯苓多糖Cardamonin 小豆蔻明β-Caryophllene alcohol β-石竹烯醇, β-丁香烯醇β-Caryophllene acetate β-乙酸石竹烯醇酯, β-乙酸丁香烯醇酯Caryptoside 山栀子甙Catalpin 梓甙,梓实糖甙Catalpinoside 梓醇,脱对羟基苯甲酸梓甙Catalpol 梓醇Catalposide 梓甙(+)-Catechin hydrate 儿茶素Caudatin(Cauldatin)Celafurine 呋喃南蛇碱Cepharanthine 头花千金藤碱,千金藤素, Cephalomannine 三尖杉宁碱Cephalotaxin 三尖杉碱Chanlmogric acid 大风子酸Chasmanconitine 查斯曼尼亭Chasmanine 查斯曼宁碱ChelerythridimerineChelerythrineChelerythrine hydrochloride 盐酸白屈菜红碱Chelidonic acid 白屈菜酸Chelidonine 白屈菜碱Chenodeoxycholic acid 鹅去氧胆酸L-Chiro-inositolChitin 甲壳素Chloranthalactone C 金粟兰内酯 C4-Chloro-3,5-dimethoxybenzoic-O-arabitol ester 猴菇菌素 IChlorogenic Acid 绿原酸Chlorophyll Cu 叶绿素铜Cholesterol 胆固醇Cholic acid 胆酸6-Choropurine Riboside 6-氯嘌呤核苷Chrysin 5,7-二羟基黄酮,白杨素,白杨黄素Chrysophanic acid 大黄酚Chrysophanol 大黄酚10-(Chrysophanol-7’-yl)-10-hydroxychrysophanol-9-anthrone Cimigenol xyloside 升麻醇木糖甙Cimigenol xyloside gbc-08Cimiside 升麻甙Cinnamaldehyde 肉桂醛Cinnamate sodium 肉桂酸钠Cinnamic aldehyde 桂皮醛Cinnamic acid 桂皮酸6-O-Cinnamoyl CatalpolCinnamon oil 肉桂油Cinnamoyl chloride 肉桂酰氯Cinnamyl alcohol 肉桂醇Cincumol 莪术醇,姜黄醇Cinobufagin 华蟾酥毒基Cis-communic acid 反式璎柏酸Cis-podophyllic acidCistanoside C 角胡麻甙 CCistanoside D 角胡麻甙 DCiwujianoside B 刺五加皂甙BCnidium lactone 蛇床子素Coclaurine 乌药碱Codeine PhosphateColchicinamide 秋水酰胺Colchicine 秋水仙碱Columbin 黄藤内酯Conduritol 牛奶菜醇2-COOH-3OH-4-Isopenyl-5-OCH3-stylbene 木豆芪Cordycepin 冬虫夏草素,蛹虫草菌素,虫草素Corilagin 柯里拉京,鞣(料)云实精,柯子次鞣素Corticosterone 皮质甾酮Corydalis 原阿片碱Corydine 紫堇定Corydaline 延胡索碱甲,紫堇碱Corydinine 原阿片碱CorypallineCostunolide 木香烃内酯P-Coumaric acid 对香豆酸Coumarin 香豆素,香豆精,香豆酮Crassicauline A 粗茎乌头碱Cryptotanshinone 隐丹参酮Cucurbitacin 雪胆甲素Cucurbitacin B 葫芦素 B,葫芦苦素 B Cucurbitacin IIa 葫芦素 IIaCucurbitacin IIb 葫芦素 IibCucurbitacin E 葫芦素 E,葫芦苦素 E Curculigoside 仙茅甙CuhuosideCurcumalactone 莪术内酯Curcumenol 莪术醇,姜黄醇Curcumin 姜黄素Curcumol 莪术醇,姜黄醇Curculigoside 仙茅甙Curgerenone 莪术酮Cyclovirobune D 环常绿黄杨碱 D,黄杨木生物碱 I,环锦热黄杨碱 DCylindrin 白茅素cyclcanoline 轮黄藤酚碱α-Cyperone α-香附酮Cytisine 金雀花碱,野靛碱,金雀儿碱,金莲花碱Daidzein 大豆甙元，黄豆甙元,大豆黄素,大豆黄酮,黄豆黄素Daidzein-4’,7-diglucoside 黄豆甙元-4`,7-二葡萄糖甙Daidzein-8-C-glucoside 黄豆甙元-8-葡萄糖甙Daidzeol 大豆甙元，黄豆甙元,大豆黄素,大豆黄酮Daidzin 大豆甙,黄豆甙Sodium Danshensu 丹参素钠DaphneticinDaphnetin 祖师麻甲素,(白)瑞香素, 瑞香内酯, Daphnin 祖师麻乙素,(白)瑞香甙Daphnoretin 西瑞香素Daucosterol 胡萝卜素,胡萝卜甾醇Dauricine 北豆根碱,蝙蝠葛碱,山豆根碱,北山豆根碱Daurisoline 北豆根苏林碱,蝙蝠葛苏林碱10-Deacetylbaccatin III 10-脱乙酰基巴卡丁 III 14-Debenzoylfranchetine 14-去苯甲酰大度乌碱Decosahedaenoic acid(DHA) 二十二碳烯酸Decursin 日本前胡素,紫花前胡素Dehydrocavidine 去氢紫堇碱Dehydrocorydaline 去氢延胡索素Dehydrocostunolide lactone 脱氢木香内酯13-Dehydroxyindaconintine 13-去羟基印乌碱6,7-Dehydroxyleanone 6,7-去氢罗列酮6-Dehydrozeylenyl 2-isonicotinic ester Delavaconitine 紫草乌碱甲Deltalineα-Deltatinβ-DeltatinDemethoxycurcumin 去甲氧基姜黄素3’-Demethyl etoposide4’-Demethyl epipodophyllotoxin 4`-去甲氧基表鬼臼毒素Demethyl Evodiamin 去甲基吴茱萸碱4’-Demethyl isopicropodophyllone4’-Demethyl podophyllotoxin 4`-去甲氧基鬼臼毒素Dencichine 三七素Denudatine 裸翠雀亭Deoxyandrographoline 去氧穿心莲内酯, 穿心莲甲素Deoxycholic acid 去氧胆酸27-Deoxyla actein Dehydroandrographoline 脱水穿心莲内酯,穿心莲丁素Deoxyaconitine 脱氧乌头碱Deoxyschizandrin 脱氧五味子素,五味子甲素,五味子素 ADephylloside BN-Desmethydauricine Desmethylanhydroicaritin4-Desoxy-coriacinDesoxypodophyllotoxinDeverative of Amethystoidin A 乙酰香茶菜甲素Dianyctrsnlgide 大蒜素L-Dicendrine 左旋荷包牡丹碱D-Dicentrine 右旋荷包牡丹碱Dictamnine 白藓碱Dictamnolactone 吴茱萸内酯,柠檬苦素Didymin 香风草甙(20S,24S)-18,24;20,24-diepoxy-9,19-cyclanostane -3β,15β,16β-25-tetraol-3-O-β-D-xylopyranoside gbc-22aDiffractaic acid 地弗地衣酸Digitogenin 洋地黄毒甙Digoxin 地高辛Dihydroartemisinin 二氢青蒿素Dihydrocucurbitacin F-25-acetate 雪胆甲素1,7-Dihydro-3,4-dimethoxyanthone Dihydrotanshinone I 二氢丹参酮 I1,8-Dihydroxy Anthraquinone 1,8二羟基蒽醌2,5-Dihydroxybenzoic acid6-Dihydroxybenzoic acid3,4-Dihydroxybenzoic acid3,5-Dimethoxybenzoic acid2.5-Dimethoxybenzaldehyde5,8-Dimethoxy-6,7-dimethoxyflavone 5,8-二羟基二甲氧基黄酮β,β-Dimethylacrylalkannin β,β-二甲基丙烯欧紫草素N,N’-Dimethyldauricine IodideO,O-Dimethyldaurisoline3,5-Dimethoxybenzaldehyde2,5-Dimethoxybenzoic acid4’,7-dimethoxyisoflavone 4’,7-二甲基异黄酮7,4’-Di-O-hydroxymethylpuerarin7,4’-Di-o-methylpuerarin4’-methoxy-3’,5,7-trihydroxyflavone 4’-甲氧基-3’,5,7-三羟基黄酮4’-o-methoxycarbonylmethylene-puerarin5-methoxygenistin-7-o-glucoside 5-甲氧基染料木素-7-O-葡甙Diphylloside ADiphylloside BDiphylloside CDipsacus saponin IX 续断皂甙 IXDipsacus saponin X 续断皂甙 XDioscin 薯蓣皂甙Diosgenin 薯蓣皂甙元Docetaxel 多西紫杉醇n-Docosane 正-二十二烷Doesahexaenoic acid (DHA) 二十二碳六烯酸Cis-4,7,10,13,16,19-Doesahexaenoic acid ethyl es ter 二十二碳六烯酸乙酯L-Dopa L-多巴Dracoalban 血竭素高氯酸盐p-Dracorhodin Perochlorate 血竭素高氯酸盐,对二甲氨基苯甲醛Dragamine HbrDulcite 卫矛醇,甜醇Dulcitol 卫矛醇,甜醇Dulcose 卫矛醇,甜醇Eburicoic acid 齿孔酸Eburicolic acid 齿孔酸β-Ecdysone β-脱皮激素Ecdysterone β-脱皮激素Effusanin AEffusanin BEffusanin ECis-5,8,11,14,17-Eicosapentaenoic acid(EPA) 二十五碳烯酸Cis-5,8,11,14,17-Eicosapentaenoic acid ethyl este r 二十五碳烯酸甲酯α-Elemene α-榄香烯β-Elemene β-榄香烯δ-Elemene δ-榄香烯Eleutheroside B 刺五加甙BEllagic acid 鞣花酸,胡颓子酸Emodin 大黄素Emodin monomethyl ether 大黄素甲醚Eonurine 益母草碱L-Ephedrine hydrochloride L-盐酸麻黄碱(-)-Epicatechin （EC）表儿茶素20-Epieratamine(-)-Epigallocatechin (EGC) 表没食子酸儿茶素(-)-Epigallocatechin gallate(EGCG) 表没食子儿茶素没食子酸酯8-Epiloganin 8-表番木鳖碱8-Epiloganic acid 8-表番木鳖酸Epimedin AEpimedin BEpimedin CEpimedosideEpimedoside AEpimedoside BEpimedoside CEpimedoside DEpimedoside E Epimedokoreanoside I Epimedokoreanoside II7-EpiphlomiolEpitriptolideErgometrini Maleats 马来酸麦角新碱Ergonovine Maleats 马来酸麦角新碱Ergosterol 麦角甾醇Erychroside 桂竹糖芥甙Erycib alkaloid II 丁公藤乙素Erythromycin 红霉素Esculetin 七叶树甙元Esculin 七叶树甙Estradiol 雌二醇(炔雌醇?) Etepholiclin 光千金藤定碱4-Ethoxybenzaldehyde2-Ethoxybenzoic acidEthoxychelerthrine 乙氧基白屈菜红碱Ethyl cinnamate 肉桂酸乙酯7-Ethyl camptothecin 7-乙基喜树碱7-Ethyl-10-Hydroxy camptothecin 7-乙基-10-羟基喜树碱Ethyl-p-methoxycinnamate 对甲氧基苯乙酯Etoposide(α-tipe) 足叶乙甙Etoposide 足叶乙甙Eucalyptole 桉油精Eugenol 丁香酚Euhorbiasteroid 续随二萜醇Euonine 雷公藤新碱EuphrosideEvodiamine 吴茱萸碱Evodin 吴茱萸内酯,柠檬苦素Excisanin A 香茶菜甲素Excisanin B 香茶菜乙素EzochasmanineFangchinoline 防己诺林碱Fargesin 辛夷脂素Farrerol 杜鹃素Ferulic acid 阿魏酸Fibrauretin 大黄藤素FlavoneFormononetin 刺芒柄花素Forsythiaside 连翘酯甙Forsythin 连翘甙Forsythingenin 连翘酯素Forsythinol 连翘醇Forsythoside A 连翘甙Forsythoside C 连翘甙 CForsythoside D 连翘甙 DFranchetine 大度乌碱Fucosterol 岩光甾醇Fumalic acid 阿魏酸Fumalic acid methyl etherFumalic acid monosodium saltFumarine 原阿片碱Gallic acid 没食子酸3-O-galloyl-（-）epicatechin(GEC)6’-O-Galloyl-homoarbutin 6’-O-没食子酰基高熊果甙2”-O-Galloyl-hyperin 2”-O-没食子酰基金丝桃甙Gamabufalin 日蟾毒它灵Ganolactone 灵芝内酯Gastrodin 天麻素α-Gastrodin α-天麻素β-Gastrodin β-天麻素Geniposide 栀子甙,京尼平甙,去羟基栀子甙Geniposidic acid 栀子酸Genistein 染料木素,染料木甙元, 染料木质素Genistein-8-c-apiosyl-(1-6)glucoside 大豆甙元 8-c-芹菜糖基(1-6)葡萄糖甙Genistin 染料木甙,GentianidinGentianine 龙胆(宁)碱,秦艽碱甲Gentiopicrin 龙胆苦甙Gentiopicroside 龙胆苦甙Ginkgetin 银杏双黄酮,银杏黄素,白果双黄酮,银杏亭Ginkgolides(90%) 银杏总内酯Ginkgolide A 银杏内酯 AGinkgolide B 银杏内酯 BGinkgolide C 银杏内酯 CGinkgolide J 银杏内酯 JGingerol 姜辣素Ginnalin AGinsenoside Rb1 人参皂甙 Rb1 Ginsenoside Rb2 人参皂甙 Rb2 Ginsenoside Rb3 人参皂甙 Rb3 Ginsenoside Rc 人参皂甙 Rc Ginsenoside Rd 人参皂甙 Rd Ginsenoside Re 人参皂甙 Re Ginsenoside F11 人参皂甙 F11 Ginsenoside Rg1 人参皂甙 Rg1 Ginsenoside Rg2 人参皂甙 Rg2 Ginsenoside Rg3 人参皂甙 Rg3 Ginsenoside Rh1 人参皂甙 Rh1 Ginsenoside Rh2 人参皂甙 Rh2 Ginsenoside Ro 人参皂甙 Ro Ginsenoside RT5 人参皂甙 RT5D-GlucoseGlycine 甘氨酸GlycitinGlycocholate sodium 牛胆酸钠Glycocholic acid 甘胆酸Glycyrrhizic acid 甘草酸,甘草皂甙,甘草甜素Glycyrrhetinic acid 甘草次酸18β-Glycyrrhetinic acid methyl ester 18β-甘草次酸甲酯Glycyrrhizinic acid monoammonium salt 甘草酸单铵盐Glycyrrhizinic acid monopotassium salt 甘草酸单钾盐18β-Glycyrrhetinic acid 18β-甘草次酸Gomisin A(Schisandrol B) 五味子醇乙, 五味子醇BGomisin B(Schisantherin B) 五味子酯乙Gomisin C(Schisantherin A) 五味子酯甲Guanosine 鸟苷Guayewuanine A 瓜叶乌头碱 A Guayewuanine B 瓜叶乌头碱 BGypenoside XLIV 绞股蓝皂甙 XLIV Harmaline 骆驼蓬碱Harmine 哈尔明Harpagoside 玄生甙,钩果草甙Harringtonine 三尖杉酯碱,哈林通碱Harringtonolide 高三尖杉酯碱HederageninHelenin (Alantolactone) 土木香内酯Helicid 豆腐果甙Hematorylin 苏木素Hematin chloride 氯高铁血红素Hemin 血红素HemslegadinumHeparin sodiamHesperidin 橙皮甙Heteratisine 异氢异叶乌头素HetisineHetisinonen-Hexadecane 正-十六烷HomoarbutinHomoharringtonine 高三尖杉酯碱Honokiol 和厚朴酚Houttugnin 鱼腥草素Human chorio gonadofropin (HCG) Human menopausal gonadotropin (HMG) Huperzine A 石杉碱甲Hydrastine 北美黄连碱p- Hydroxyacetophenone 对羟基苯乙酮4’-Hydroxyacetophenone 4’-对羟基苯乙酮5-Hydroxyacetylproponic acid4-HydroxybenzaldehydeP-Hydroxybenzoic acid 对羟基苯甲酸Hydroxyevodiamin 羟基吴茱萸碱3-Hydroxy-4-methoxybenzaldehyde3-Hydroxy-4-methoxybenzoic acid2-Hydroxy-3-methoxybenzoic acid4-Hydroxy-3-methoxybenzoic acid5-Hydroxy-4’-methoxyflavone-7-β-rutinoside 5-羟基-4’甲氧基黄酮-7-芸香甙10-Hydroxy-camptothecin 10-羟基喜树碱ω-Hydroxy-Δ2-decenoic acid ω-羟基-Δ2-葵烯酸,王浆酸10-Hydroxydecenoic acid 10-羟基葵烯酸10-Hydroxydecylenic acid 10-羟基-Δ2-葵烯酸,王浆酸5-hydroxy-7,4’-dimethoxyflavanone1-Hydroxy-3,4-dimethoxyxanthone-O-β-D-glucophranosideHydroxyevodiamine 羟基吴茱萸碱5-Hydroxyflavone7-HydroxyflavoneHydroxyrenifolin2α-Hydroxypanaxidiol 2α-羟基人参二醇12-Hydroxy-6,7-secoabieta-8,11,13-triene-6,7-dia l 12-羟基断松香烷 8,11,13三烯 6,7二醛1-Hydroxy-2,3,4,5-tetramethoxyxanthone1-Hydroxy-2,3,4,7-tetramethoxyxanthone4-Hydroxybenzaldehyde3-Hydroxy-4-methoxybenzaldehyde3-Hydroxy-4-methoxybenzoic acid2-Hydroxy-3-methoxybenzoic acid4-Hydroxy-3-methoxybenzoic acid16-HydroxytriptolideHydroxyursolic acidHyoscin 东莨菪碱HyoscyamineHypaconitine 下乌头碱,次乌头碱, 次乌碱Hypaphorine 下箴刺桐碱Hypericin 金丝桃素Hyperin 金丝桃苷,金丝桃甙,田基黄甙,海棠因,槲皮素-3-半乳糖甙Hyperoside 金丝桃苷,金丝桃甙,田基黄甙,海棠因,槲皮素-3-半乳糖甙HypolideHypocrellin A 竹红菌甲素Icariin 淫羊藿甙IcaritinIcariside IIcariside IIIcariside-3-o-rhamnoside Ikarisoside A Ikarisoside B Ikarisoside C Ikarisoside D Ikarisoside E Ikarisoside F Imperialine 西贝碱Imperatorin 欧前胡素Indaconitone 印乌碱Indigotin 靛兰, 靛蓝Indirubin 靛玉红Inosine 肌苷,肌甙Inositol 肌醇Ipriflavone 伊普黄酮Isatin 靛玉红Isoaconitine 紫草乌碱乙Isoalantolactone 异土木香内酯D-Isoascorbic acid D-异抗坏血酸Isoastragaloside II 异黄芪皂甙 II IsoatisineIsobergaptenIsobiflorin 异双花母草素Isocolumbind-Isocorydine chloride 异紫堇定Isocupressic acid 异柏油酸IsodonalIsoferulic acid 异阿魏酸Isofraxidin 异秦皮定IsoginkgetinIsoimperatorin 异欧前胡素Isoliensinine 异莲心碱Isoliquiritigenin 异甘草素Isoliquiritin 异甘草甙Isomangiferin 异芒果甙Isonicotinoylhydrazine 异烟酰肼Isonicotinic acid 异烟酸Isosafrole 异黄樟油素Isoquinoline 异喹啉IsopicropodophylloneIsopimpinellin 异茴芹内酯Isopsoralen 异补骨酯素Isoquercitrin 异槲皮甙,异槲皮素,罗布麻甲素Isorhamnetin 异鼠李素Isosteviol 异甜菊醇IsotetrandrineIsoneotriptophenolideIsopropyl myristate 肉豆蔻酸异丙酯Istaubulib AJatrorrhizine chloride 盐酸药根碱Jujuboside A 酸枣仁皂甙 AJujuboside B 酸枣仁皂甙 BKadsurinKaempferitrinKaempferol 山奈酚,山奈素,山奈黄素,山奈黄酮醇,四氢基黄酮,崁非醇,猫眼草素I,白蕊草素III, Kaempferol-3-O-β-D-glucopyranosyl-β-D-glucopyranosideKaempferol-4’-methyl etherKaranjin 干华豆晶 4Kirilowproten KopsamineKopsanine Korepimedoside A Kuliansu 苦楝素Kumujian AKumujian BKumujian DKumujian GLamalbidLamiridoside Lappacontine LasiokaurinLathyrol 千金子二萜醇Laurate ethyl 月桂酸乙酯Laurate methyl 月桂酸甲酯Laurate sodium 月桂酸钠Lauric acid 月桂酸LentinanLeurocristine (VCR) Levonorgestrel 左炔诺孕酮Liensinine 莲心碱Ligustilide 藁本内酯Limonin 吴茱萸内酯,柠檬苦素Linoleic acid 亚油酸,r-亚麻酸Liquiritigenin 甘草素Liquiritin 甘草甙Lithocholic acid 石胆酸Liwuaconitine 丽乌碱Lobeline chlorideLoganin 番木鳖甙,马钱素,马钱子甙Longistyline A 木豆芪 ALongtouaconitine ALupenyl acetate 乙酰羽扇豆醇酯Lupeol 羽扇豆醇酯Lupeol palmitale 棕榈酰羽扇豆醇酯Luteolin 木樨草素Luteolin-7-O-glucoside 木樨草素-7-O-葡萄糖甙Lycoctonine 牛扁碱Lycoramine HBr 氢溴酸石蒜胺Lycorine 石蒜碱Lycorine HBr 氢溴酸石蒜碱Lysionotin 岩豆素Macleyine 原阿片碱Macrocalin A 大萼香茶菜甲素Macrocalin B 大萼香茶菜乙素Macrocalin C 大萼香茶菜丙素Madecassoside 羟基积雪草甙Madecassic acid 羟基积雪草酸Magnesium Lithospermate B 丹参酸B镁Magnoflorine 木兰花碱Magnoline 木兰脂素Magnolol 厚朴酚Mangiferin 芒果甙,杧果甙Mannitol 甘露醇D-Mannose 甘露糖Maoecrystal A 毛萼晶甲Maoecrystal B 毛萼晶乙Maoecrystal C 毛萼晶丙Maoecrystal D 毛萼晶丁Maytanperline 美登普林Matrine 苦参碱Menthol 薄荷脑Mesaconitine 中乌碱,中乌头碱,新乌头碱,美沙乌头碱,新乌碱Metallothionein4-Methoxybenzaldehyde3-Methoxybenzoic acidP-Methoxycinnamic acid 对甲氧基肉桂酸10-methoxymedicarpin 10-甲氧基美迪紫檀素8-Methoxypsoralen 8-甲氧基补骨脂素4-Methoxysalicylaldehyde 4-甲氧基水杨醛Methoytanshinone 次甲丹参酮5-Methoxytryptamine6-Methyl-5,7-dimethoxyflavone 6-甲基-5,7-二甲氧基黄酮Methylene tanshinquinone 次甲丹参醌Methyl ferulateMethylophiopogonanone A 麦冬高异黄酮A Methy-3-aminosalicylate 3-氨基水杨酸甲酯Methy-5-aminosalicylate 5-氨基水杨酸甲酯N-Methylcantharidin 甲基斑蟊素O-Methyldauricine 甲基北豆根碱,甲基蝙蝠葛碱, 甲基山豆根碱Methylhesperidine 甲基陈皮甙Methyl linolenate 次亚麻酸甲酯N-Methyl-N-(4-methoxylphenyethyl)-cinnamam ideMethyl Nonyl Ketone（Z-Undecanone）甲基正任酮Methyl Salicylata 水杨酸甲酯3’-Methyoxy-puerarin 3`-甲氧基葛根素Miltirone 次甲丹参醌Mifepristone 米非司酮MiscantuosideMogroside IIE 罗汉果甙 IIEMogroside III 罗汉果甙 IIIMogroside IV 罗汉果甙 IVMogroside V 罗汉果甙 VMonocrotaline 农吉利碱,野百合碱,猪屎豆碱Monolupine(Anagyrine) 臭豆碱,安那吉碱,安纳基林,Monotropein 水晶兰甙Morroniside 莫诺甙MorusinMuscone 麝香酮MycosMyristaldehyde 肉豆蔻醛Myristic acid 肉豆蔻酸NardosinolNardosinonNaringin 柚皮甙Narumicin INeferine 甲基莲心碱NeriifolinNeoandrographolide 新穿心莲内酯,穿心莲丙素，穿心莲新甙, 新穿心莲内酯Neo-houttuyninum 新鱼腥草素NeolineNeotriptophenolideNevadensin 石吊兰素NicotineNimbecetin 山奈酚,山奈素,山奈黄素,山奈黄酮醇,四氢基黄酮,崁非醇,猫眼草素I,白蕊草素III, NitidineNitogenin 薯蓣皂甙元9-Nitrocamptothecin 9-硝基喜树碱9-Nitro-10-Hydroxy camptothecin 9-硝基-10-羟基喜树碱10-NonacosanolNoradranabineNorgestrel 炔诺孕酮Notoginsenoside R1 三七皂甙 R1 Notoginsenoside RC 三七皂甙 COleanolic acid 齐墩果酸,石竹素Olanolic acid-3-O-α-L-rhamnopyran-osyl(1-2)-α-L-arabinopyranosyl-28-O-α- L-rhamnopyranosyl(1-4)- β-D-glucopyranosyl(1-6) - β-D- glucopyranosyl ester gbc-34Olanolic acid-3-O-β-D- glucopyranosyl(1-3)-α-L- rhamnopyran-osyl(1-2)-α-L-arabinopyranosyl-28-O-α- L-rhamnopyranosyl(1-4)- β-D-glucopyranosyl(1-6)- β-D-glucopyranosyl ester gbc-35Ombuoside 商陆甙Ophiopogonin A 麦冬皂苷AOrcinolOridonin 东凌草素Oroxylin A 木蝴蝶素Orthosphenic acid 雷公藤三萜酸Osthol 蛇床子素Oxymatrine 氧化苦参碱Oxysophorcarpine 氧化槐果碱Pachymaran 茯苓多糖Pachymic acid 茯苓酸Paclitaxel 紫杉醇Paeoniflorin 芍药甙Paeonol 丹皮酚Palmitale 棕榈酸Palmatine HCL 盐酸巴马亭,盐酸巴马汀,盐酸掌叶防己碱Panaxadiol 人参二醇Panaxatriol 人参三醇Papaverine HCl 盐酸罂粟碱ParvifolisidePatehouli aleohal 百秋李醇Pedunculoside II 具栖冬青甙β-Peltatin-glucoside β-足叶草脂素甙β-Peltatin-A-methyl ether β-足叶草脂素A早醚Peimine (浙)贝母甲素Peiminine (浙)贝母乙素,贝母宁碱,去氢贝母碱Pentadecanone-2 十五烷酮-2PeruvosidePhadodendrol 杜鹃醇Phaseolin 菜豆甙元1-phenyl-2,4-hexadiyn-1-oneN-Phenyl-2-naphthylamine N-苯基-2-萘胺Piceatannol-3’-O-β-D-glucopyranoside Phillyrin 连翘甙Phloyoside IIPhododendrolPhyscion 大黄素甲醚Phytolaccoside EPhytolaccoside GPiceatannolPiceatannol-3’-0-β-D-glucopyranoside Piceatannol-4’-0-β-D-glucopyranoside PicroetoposidePicroetoposide hydroxy acid PicropodophyllotaxinPilocarpine hydrochloride 毛果云香碱盐酸盐Pimpinollin 虎耳草素Pinitol 松醇Pinostrobin 球松素Piperine 胡椒碱PlantarenalosidePlatypetaloside APlumbagin 矾松素Podocarpusflavone 罗汉松双黄酮 B Podophyllotoxin 鬼臼毒素Podophyllotoxin glucoside PodophyllotoxonePolydatin 虎杖甙,白藜芦醇甙Polystachoside 蓼属甙Ponticin 土大黄甙(素)Populnetin 山奈酚,山奈素,山奈黄素,山奈黄酮醇,四氢基黄酮,崁非醇,猫眼草素I,白蕊草素III,Populin 白杨甙Praeruptorin A 白花前胡甲素Praeruptorin B 白花前胡乙素Praeruptorin C 白花前胡丙素Praeruptorin D 白花前胡丁素Praeruptorin E 白花前胡甲素Praeruptorin F 白花前胡甲素Pregnanediol 孕二醇Progeserone 孕烯醇酮Precasin 相思豆碱ProcesterolProtocatechuic acid 原儿茶酸Protocatechualdehyde 原二茶醛Protopanaxadiol 原人参二醇Protopanaxatriol 原人参三醇Protopine 原阿片碱Pseud aconitine 伪乌碱Pseudo ephedrine 伪麻黄碱d-Pseudu-ephedrine hydrochloride 盐酸伪麻黄碱Pseudo ginsenoside F11 拟人参皂甙 F11 Pseudo ginsenoside Rt5 拟人参皂甙 Rt5 Pseudo laric acid B 土荆皮乙酸Pseudo lycorine 伪石蒜碱PseudophedrinePseudo protopine 伪原阿片碱Psoralen 补骨酯素Puerarin 葛根素Pyrogallic acid 焦性没食子酸PyrogallolQingdanone 青黛酮Qinghaosu I 青蒿甲素Qinghaosu II 青蒿乙素Qinghaosu III 青蒿丙素QingyangshenggeninQuebrachitolQuercetin 槲皮素Quercetin-3-O-xyloglucoside 槲皮素-3-O-木糖葡萄糖甙Quercetin-3- galactoside 槲皮素-3-半乳糖甙,金丝桃甙,田基黄甙,海棠因Quercitrin 槲皮甙4-Quinazolone 4-喹唑酮[4(3H)-quinazolinone] 4(3H)-喹唑酮[2,4[1H,3H］-Quinazolinedione] 2，4（1H，3H）-喹唑二酮Quinic acid 喹啉酸Quinidine 喹啉丁Quinine 喹啉Quinsetrol 炔雌醚Rasthorin A 细锥香茶菜甲素Rabdocetsin B 细锥香茶菜乙素Rabdocetsin C 细锥香茶菜丙素Rabdocetsin D 细锥香茶菜丁素Rabdocetsin E 细锥香茶菜戊素Rabdoforrestin A 紫萼香茶菜甲素Rabdophyllin G 大叶庚Rabdophyllin H 大叶辛Rabdosin C 香茶菜素 CReducing arteannuim 还原青蒿素Renifolin 肾叶驴蹄草甙Reserpine 利血平Resibufogenin 酯蟾毒配基Resveratrol 白藜芦醇Resveratrol-4’-O-β-D-（6’-O-galloyl）glucopyranosideResveratrol 3-O-β-D-glucoside2"-Rhamnosylicarisoside II2"-Rhamnosylikarisoside ARhamnoluteun 山奈酚,山奈素,山奈黄素,山奈黄酮醇,四氢基黄酮,崁非醇,猫眼草素I,白蕊草素III,2"-O-Rhamnosylscoparin 2"-O-鼠李糖扫帚黄酮Rhaponticin 土大黄甙(素)Rhapontin 土大黄甙(素)Rheic acidRhein 大黄酸RheosmineRhodininRhodioloside 红景天甙RhodiosinRhododendrin 白色杜鹃素Rhombinin(Anagyrine) 臭豆碱,安那吉碱,安纳基林,Rhynchophylline 钩藤碱Robigenin 山奈酚,山奈素,山奈黄素,山奈黄酮醇,四氢基黄酮,崁非醇,猫眼草素I,白蕊草素III,Rorifone 焊菜素Rosavin 肉桂醇甙,洛塞维,酪萨维Rosmarinic acid 迷迭香酸, 罗丹酚酸Rotenone 鱼藤酮Rotundinum 延胡索碱乙,罗通定,四氢巴马亭Rubescensin (A) 东凌草素Rutaecarpine 吴茱萸次碱Rutin 芦丁,芸香甙Sagittatoside ASagittatoside BSaikosaponin A 柴胡皂甙 A Saikosaponin b1 柴胡皂甙 b1 Saikosaponin b2 柴胡皂甙 b2 Saikosaponin C 柴胡皂甙 C Saikosaponin D 柴胡皂甙 D Saikogenin a 柴胡皂甙元 a Saikogenin d 柴胡皂甙元 d Saikoside a 柴胡皂甙 aSaikoside c 柴胡皂甙 cSaikoside d 柴胡皂甙 dSalicylic acid methyl esterSalicin 水杨甙,水杨素Salylic acid 水杨酸Salicylate ethyl 水杨酸乙酯Salicylate methyl 水杨酸甲酯;冬青油Salicylate Isomyl 水杨酸异戊酯Salicylate phenyl 水杨酸苯酯Salicylate eserine 水杨酸毒扁豆碱Salicylate sodium 水杨酸钠Salicylate ammonium 水杨酸铵Salicylaldehyde 水杨酸醛Salicylanlide 水杨酰苯胺Salicylamide 水杨酰胺Salidroside 红景天甙Salsolinol 去甲猪毛菜碱Salvianic acid 丹参酸甲Sandaracopimaric acid 山达海松酸Sanguinarine hydrochloride 盐酸血根碱Santonin 山道年Sarsasapogenin 菝契皂甙元,洋菝契皂甙元Sciadopitysin 金松双黄酮Schisantherin A 五味子内酯甲Schisandrin 五味子醇甲,五味子素,五味子醇 A γ-Schisandrin γ-五味子素, 五味子素 B,五味子乙素Schisandrin B γ-五味子素, 五味子素 B,五味子乙素Schizandrin B γ-五味子素, 五味子素 B,五味子乙素Schizandrin 五味子醇甲,五味子素,五味子醇 A Schizandrol 五味子醇。

Appendix XVI B. Microbiological Examination of Non-sterile Products1. Test for Specified Micro-organisms1(Ph. Eur. method 2.6.13)1 INTRODUCTIONThe tests described hereafter will allow determination of the absence or limited occurrence of specifiedmicro-organisms that may be detected under the conditions described.The tests are designed primarily to determine whether a substance or preparation complies with anestablished specification for microbiological quality. When used for such purposes, follow the instructionsgiven below, including the number of samples to be taken, and interpret the results as stated below.Alternative microbiological procedures, including automated methods, may be used, provided that theirequivalence to the Pharmacopoeia method has been demonstrated.2 GENERAL PROCEDURESThe preparation of samples is carried out as described in general chapter 2.6.12.If the product to be examined has antimicrobial activity, this is insofar as possible removed or neutralisedas described in general chapter 2.6.12.If surface-active substances are used for sample preparation, their absence of toxicity formicro-organisms and their compatibility with inactivators used must be demonstrated as described ingeneral chapter 2.6.12.3 GROWTH-PROMOTING AND INHIBITORY PROPERTIES OF THE MEDIA, SUITABILITY OF THETEST AND NEGATIVE CONTROLSThe ability of the test to detect micro-organisms in the presence of the product to be tested must beestablished. Suitability must be confirmed if a change in testing performance, or the product, which mayaffect the outcome of the test is introduced.3-1 Preparation of test strainsUse standardised stable suspensions of test strains or prepare them as stated below. Seed lot culturemaintenance techniques (seed-lot systems) are used so that the viable micro-organisms used forinoculation are not more than 5 passages removed from the original master seed-lot.3-1-1 Aerobic micro-organisms Grow each of the bacterial test strains separately in casein soya beandigest broth or on casein soya bean digest agar at 30-35 °C for 18-24 h. Grow the test strain for Candidaalbicans separately on Sabouraud-dextrose agar or in Sabouraud-dextrose broth at 20-25 °C for 2-3days.∙—Staphylococcus aureus such as ATCC 6538, NCIMB 9518, CIP 4.83 or NBRC 13276; ∙—Pseudomonas aeruginosa such as ATCC 9027, NCIMB 8626, CIP 82.118 or NBRC 13275; ∙—Escherichia coli such as ATCC 8739, NCIMB 8545, CIP 53.126 or NBRC 3972;∙—Salmonella enterica subsp. enterica serovar Typhimurium, such as ATCC 14028 or, as an alternative, Salmonella enterica subsp. enterica serovar Abony such as NBRC 100797, NCTC 6017 orCIP 80.39;∙—Candida albicans such as ATCC 10231, NCPF 3179, IP 48.72 or NBRC 1594.Use buffered sodium chloride-peptone solution pH 7.0 or phosphate buffer solution pH 7.2 to make test suspensions. Use the suspensions within 2 h or within 24 h if stored at 2-8 °C.3-1-2 Clostridia Use Clostridium sporogenes such as ATCC 11437 (NBRC 14293, NCIMB 12343, CIP 100651) or ATCC 19404 (NCTC 532 or CIP 79.03) or NBRC 14293. Grow the clostridial test strain under anaerobic conditions in reinforced medium for clostridia at 30-35 °C for 24-48 h. As an alternative to preparing and then diluting down a fresh suspension of vegetative cells of Cl. sporogenes, a stable spore suspension is used for test inoculation. The stable spore suspension may be maintained at 2-8 °C for a validated period.3-2 Negative controlTo verify testing conditions, a negative control is performed using the chosen diluent in place of the test preparation. There must be no growth of micro-organisms. A negative control is also performed when testing the products as described in section 4. A failed negative control requires an investigation.3-3 Growth promotion and inhibitory properties of the mediaTest each batch of ready-prepared medium and each batch of medium prepared either from dehydrated medium or from ingredients.Verify suitable properties of relevant media as described in Table 2.6.13.-1.Test for growth promoting properties, liquid mediaInoculate a portion of the appropriate medium with a small number (not more than 100 CFU) of the appropriate micro-organism. Incubate at the specified temperature for not more than the shortest periodof time specified in the test. Clearly visible growth of the micro-organism comparable to that previously obtained with a previously tested and approved batch of medium occurs.Test for growth promoting properties, solid mediaPerform the surface-spread method, inoculating each plate with a small number (not more than 100 CFU) of the appropriate micro-organism. Incubate at the specified temperature for not more than the shortest period of time specified in the test. Growth of the micro-organism comparable to that previously obtained with a previously tested and approved batch of medium occurs.Test for inhibitory properties, liquid or solid mediaInoculate the appropriate medium with at least 100 CFU of the appropriate micro-organism. Incubate at the specified temperature for not less than the longest period of time specified in the test. No growth of the test micro-organism occurs.Test for indicative propertiesPerform the surface-spread method, inoculating each plate with a small number (not more than 100 CFU) of the appropriate micro-organism. Incubate at the specified temperature for a period of time within the range specified in the test. Colonies are comparable in appearance and indication reactions to those previously obtained with a previously tested and approved batch of medium.3-4 Suitability of the test methodFor each product to be tested, perform the sample preparation as described in the relevant paragraph in section 4. Add each test strain at the time of mixing, in the prescribed growth medium. Inoculate the test strains individually. Use a number of micro-organisms equivalent to not more than 100 CFU in the inoculated test preparation.Perform the test as described in the relevant paragraph in section 4 using the shortest incubation period prescribed.The specified micro-organisms must be detected with the indication reactions as described in section 4. Any antimicrobial activity of the product necessitates a modification of the test procedure (see 4-5-3 of general chapter 2.6.12).If for a given product the antimicrobial activity with respect to a micro-organism for which testing is prescribed cannot be neutralised, then it is to be assumed that the inhibited micro-organism will not be present in the product.4 TESTING OF PRODUCTS4-1 Bile-tolerant gram-negative bacteria4-1-1 Sample preparation and pre-incubation Prepare a sample using a 1 in 10 dilution of not less than 1 g of the product to be examined as described in general chapter 2.6.12, but using casein soya bean digest broth as the chosen diluent, mix and incubate at 20-25 °C for a time sufficient to resuscitate the bacteria but not sufficient to encourage multiplication of the organisms (usually 2 h but not more than 5 h).4-1-2 Test for absence Unless otherwise prescribed, use the volume corresponding to 1 g of the product, as prepared in 4-1-1, to inoculate enterobacteria enrichment broth-Mossel. Incubate at 30-35 °C for24-48 h. Subculture on plates of violet red bile glucose agar. Incubate at 30-35 °C for 18-24 h.The product complies with the test if there is no growth of colonies.4-1-3 Quantitative test4-1-3-1 Selection and subculture Inoculate suitable quantities of enterobacteria enrichmentbroth-Mossel with the preparation as described under 4-1-1 and/or dilutions of it containing respectively 0.1 g, 0.01 g and 0.001 g (or 0.1 mL, 0.01 mL and 0.001 mL) of the product to be examined. Incubate at 30-35 °C for 24-48 h. Subculture each of the cultures on a plate of violet red bile glucose agar. Incubate at 30-35 °C for 18-24 h.4-1-3-2 Interpretation Growth of colonies constitutes a positive result. Note the smallest quantity of the product that gives a positive result and the largest quantity that gives a negative result. Determine from Table 2.6.13.-2 the probable number of bacteria.4-2 Escherichia coli4-2-1 Sample preparation and pre-incubation Prepare a sample using a 1 in 10 dilution of not less than 1 g of the product to be examined as described in general chapter 2.6.12, and use 10 mL or the quantity corresponding to 1 g or 1 mL to inoculate a suitable amount (determined as described under 3-4) of casein soya bean digest broth, mix and incubate at 30-35 °C for 18-24 h.4-2-2 Selection and subculture Shake the container, transfer 1 mL of casein soya bean digest broth to 100 mL of MacConkey broth and incubate at 42-44 °C for 24-48 h. Subculture on a plate of MacConkey agar at 30-35 °C for 18-72 h.4-2-3 Interpretation Growth of colonies indicates the possible presence of E. coli. This is confirmed by identification tests.The product complies with the test if no colonies are present or if the identification tests are negative.4-3 Salmonella4-3-1 Sample preparation and pre-incubation Prepare the product to be examined as described in general chapter 2.6.12, and use the quantity corresponding to not less than 10 g or 10 mL to inoculate a suitable amount (determined as described under 3-4) of casein soya bean digest broth, mix and incubate at 30-35 °C for 18-24 h.4-3-2 Selection and subculture Transfer 0.1 mL of casein soya bean digest broth to 10 mL of Rappaport Vassiliadis Salmonella enrichment broth and incubate at 30-35 °C for 18-24 h. Subculture on plates of xylose, lysine, deoxycholate agar. Incubate at 30-35 °C for 18-48 h.4-3-3 Interpretation The possible presence of Salmonella is indicated by the growth of well-developed, red colonies, with or without black centres. This is confirmed by identification tests.The product complies with the test if colonies of the types described are not present or if the confirmatory identification tests are negative.4-4 Pseudomonas aeruginosa4-4-1 Sample preparation and pre-incubation Prepare a sample using a 1 in 10 dilution of not less than 1 g of the product to be examined as described in general chapter 2.6.12, and use 10 mL or the quantity corresponding to 1 g or 1 mL to inoculate a suitable amount (determined as described under 3-4) of casein soya bean digest broth and mix. When testing transdermal patches, filter the volume of sample corresponding to 1 patch of the preparation described under 4-5-1 in general chapter 2.6.12through a sterile filter membrane and place in 100 mL of casein soya bean digest broth. Incubate at 30-35 °C for 18-24 h.4-4-2 Selection and subculture Subculture on a plate of cetrimide agar and incubate at 30-35 °C for 18-72 h.4-4-3 Interpretation Growth of colonies indicates the possible presence of P. aeruginosa. This is confirmed by identification tests.The product complies with the test if colonies are not present or if the confirmatory identification tests are negative.4-5 Staphylococcus aureus4-5-1 Sample preparation and pre-incubation Prepare a sample using a 1 in 10 dilution of not less than 1 g of the product to be examined as described in general chapter 2.6.12, and use 10 mL or the quantity corresponding to 1 g or 1 mL to inoculate a suitable amount (determined as described under 3-4) of casein soya bean digest broth and mix. When testing transdermal patches, filter the volume of sample corresponding to 1 patch of the preparation described under 4-5-1 in general chapter 2.6.12through a sterile filter membrane and place in 100 mL of casein soya bean digest broth. Incubate at 30-35 °C for 18-24 h.4-5-2 Selection and subculture Subculture on a plate of mannitol salt agar and incubate at 30-35 °C for 18-72 h.4-5-3 Interpretation The possible presence of S. aureus is indicated by the growth of yellow/white colonies surrounded by a yellow zone. This is confirmed by identification tests.The product complies with the test if colonies of the types described are not present or if the confirmatory identification tests are negative.4-6 Clostridia4-6-1 Sample preparation and heat treatment Prepare a sample using a 1 in 10 dilution (with a minimum total volume of 20 mL) of not less than 2 g or 2 mL of the product to be examined as described in general chapter 2.6.12. Divide the sample into 2 portions of at least 10 mL. Heat 1 portion at 80 °C for 10 min and cool rapidly. Do not heat the other portion.4-6-2 Selection and subculture Use 10 mL or the quantity corresponding to 1 g or 1 mL of the product to be examined of both portions to inoculate suitable amounts (determined as described under 3-4) of reinforced medium for clostridia. Incubate under anaerobic conditions at 30-35 °C for 48 h. After incubation, make subcultures from each container on Columbia agar and incubate under anaerobic conditions at 30-35 °C for 48-72 h.4-6-3 Interpretation The occurrence of anaerobic growth of rods (with or without endospores) giving a negative catalase reaction indicates the presence of clostridia. This is confirmed by identification tests.The product complies with the test if colonies of the types described are not present or if the confirmatory identification tests are negative.4-7 Candida albicans4-7-1 Sample preparation and pre-incubation Prepare the product to be examined as described in general chapter 2.6.12, and use 10 mL or the quantity corresponding to not less than 1 g or 1 mL to inoculate 100 mL of Sabouraud-dextrose broth and mix. Incubate at 30-35 °C for 3-5 days.4-7-2 Selection and subculture Subculture on a plate of Sabouraud-dextrose agar and incubate at30-35 °C for 24-48 h.4-7-3 Interpretation Growth of white colonies may indicate the presence of C. albicans. This is confirmed by identification tests.The product complies with the test if such colonies are not present or if the confirmatory identification tests are negative.The following section is given for information.5 RECOMMENDED SOLUTIONS AND CULTURE MEDIAThe following solutions and culture media have been found to be satisfactory for the purposes for which they are prescribed in the test for microbial contamination in the Pharmacopoeia. Other media may be used provided that their suitability can be demonstrated.Stock buffer solution Place 34 g of potassium dihydrogen phosphate in a 1000 mL volumetric flask, dissolve in 500 mL of purified water, adjust to pH 7.2 ± 0.2 with sodium hydroxide, dilute to 1000.0 mL with purified water and mix. Dispense into containers and sterilise. Store at 2-8 °C.Phosphate buffer solution pH 7.2 Prepare a mixture of stock buffer solution and purified water(1:800 V/V) and sterilise.Buffered sodium chloride-peptone solution pH 7.0Potassium dihydrogen phosphateDisodium hydrogen phosphate dihydrateSodium chloridePeptone (meat or casein)Purified waterSterilise in an autoclave using a validated cycle.Casein soya bean digest brothPancreatic digest of caseinPapaic digest of soya beanSodium chlorideDipotassium hydrogen phosphateGlucose monohydratePurified waterAdjust the pH so that after sterilisation it is 7.3 ± 0.2 at 25 °C. Sterilise in an autoclave using a validatedcycle.Casein soya bean digest agarPancreatic digest of caseinPapaic digest of soya beanSodium chlorideAgarPurified waterAdjust the pH so that after sterilisation it is 7.3 ± 0.2 at 25 °C. Sterilise in an autoclave using a validatedcycle.Sabouraud-dextrose agarDextroseMixture of peptic digest of animal tissue and pancreatic digest of casein (1:1) AgarPurified waterAdjust the pH so that after sterilisation it is 5.6 ± 0.2 at 25 °C. Sterilise in an autoclave using a validatedcycle.Potato dextrose agarInfusion from potatoesDextroseAgarPurified waterAdjust the pH so that after sterilisation it is 5.6 ± 0.2 at 25 °C. Sterilise in an autoclave using a validatedcycle.Sabouraud-dextrose brothDextroseMixture of peptic digest of animal tissue and pancreatic digest of casein (1:1) Purified waterAdjust the pH so that after sterilisation it is 5.6 ± 0.2 at 25 °C. Sterilise in an autoclave using a validatedcycle.Enterobacteria enrichment broth-MosselPancreatic digest of gelatinGlucose monohydrateDehydrated ox bilePotassium dihydrogen phosphateDisodium hydrogen phosphate dihydrateBrilliant greenPurified waterAdjust the pH so that after heating it is 7.2 ± 0.2 at 25 °C. Heat at 100 °C for 30 min and cool immediately.Violet red bile glucose agarYeast extractPancreatic digest of gelatinBile saltsSodium chlorideGlucose monohydrateAgarNeutral redCrystal violetPurified waterAdjust the pH so that after heating it is 7.4 ± 0.2 at 25 °C. Heat to boiling; do not heat in an autoclave. MacConkey brothPancreatic digest of gelatinLactose monohydrateDehydrated ox bileBromocresol purplePurified waterAdjust the pH so that after sterilisation it is 7.3 ± 0.2 at 25 °C. Sterilise in an autoclave using a validated cycle.MacConkey agarPancreatic digest of gelatinPeptones (meat and casein)Lactose monohydrateSodium chlorideBile saltsAgarNeutral redCrystal violetPurified waterAdjust the pH so that after sterilisation it is 7.1 ± 0.2 at 25 °C. Boil for 1 min with constant shaking then sterilise in an autoclave using a validated cycle.Rappaport Vassiliadis Salmonella enrichment brothSoya peptoneMagnesium chloride hexahydrateSodium chlorideDipotassium phosphatePotassium dihydrogen phosphateMalachite greenPurified waterDissolve, warming gently. Sterilise in an autoclave using a validated cycle, at a temperature not exceeding 115 °C. The pH is to be 5.2 ± 0.2 at 25 °C after heating and autoclaving.Xylose, lysine, deoxycholate agarXyloseL-LysineLactose monohydrateSucroseSodium chlorideYeast extractPhenol redAgarSodium deoxycholateSodium thiosulfateFerric ammonium citratePurified waterAdjust the pH so that after heating it is 7.4 ± 0.2 at 25 °C. Heat to boiling, cool to 50 °C and pour into Petri dishes. Do not heat in an autoclave.Cetrimide agarPancreatic digest of gelatinMagnesium chlorideDipotassium sulfateCetrimideAgarPurified waterGlycerolHeat to boiling for 1 min with shaking. Adjust the pH so that after sterilisation it is 7.2 ± 0.2 at 25 °C. Sterilise in an autoclave using a validated cycle.Mannitol salt agarPancreatic digest of caseinPeptic digest of animal tissueBeef extractD-MannitolSodium chlorideAgarPhenol redPurified waterHeat to boiling for 1 min with shaking. Adjust the pH so that after sterilisation it is 7.4 ± 0.2 at 25 °C. Sterilise in an autoclave using a validated cycle.Reinforced medium for clostridiaBeef extractPeptoneYeast extractSoluble starchGlucose monohydrateCysteine hydrochlorideSodium chlorideSodium acetateAgarPurified waterHydrate the agar, dissolve by heating to boiling with continuous stirring. If necessary, adjust the pH so that after sterilisation it is 6.8 ± 0.2 at 25 °C. Sterilise in an autoclave using a validated cycle. Columbia agarPancreatic digest of caseinMeat peptic digestHeart pancreatic digestYeast extractMaize starchSodium chlorideAgar, according to gelling powerPurified waterHydrate the agar, dissolve by heating to boiling with continuous stirring. If necessary, adjust the pH so that after sterilisation it is 7.3 ± 0.2 at 25 °C. Sterilise in an autoclave using a validated cycle. Allow to cool to 45-50 °C; add, where necessary, gentamicin sulfate corresponding to 20 mg of gentamicin base and pour into Petri dishes.2. Microbial Enumeration Tests2(Ph. Eur. method 2.6.12)1 INTRODUCTIONThe tests described hereafter will allow quantitative enumeration of mesophilic bacteria and fungi that may grow under aerobic conditions.The tests are designed primarily to determine whether a substance or preparation complies with an established specification for microbiological quality. When used for such purposes follow the instructions given below, including the number of samples to be taken, and interpret the results as stated below.The methods are not applicable to products containing viable micro-organisms as active ingredients.Alternative microbiological procedures, including automated methods, may be used, provided that their equivalence to the Pharmacopoeia method has been demonstrated.2 GENERAL PROCEDURESCarry out the determination under conditions designed to avoid extrinsic microbial contamination of the product to be examined. The precautions taken to avoid contamination must be such that they do not affect any micro-organisms that are to be revealed in the test.If the product to be examined has antimicrobial activity, this is insofar as possible removed or neutralised. If inactivators are used for this purpose, their efficacy and their absence of toxicity for micro-organisms must be demonstrated.If surface-active substances are used for sample preparation, their absence of toxicity formicro-organisms and their compatibility with inactivators used must be demonstrated.3 ENUMERATION METHODSUse the membrane filtration method or the plate-count methods, as prescribed. Themost-probable-number (MPN) method is generally the least accurate method for microbial counts, however, for certain product groups with a very low bioburden, it may be the most appropriate method.The choice of method is based on factors such as the nature of the product and the required limit of micro-organisms. The chosen method must allow testing of a sufficient sample size to judge compliance with the specification. The suitability of the method chosen must be established.4 GROWTH PROMOTION TEST, SUITABILITY OF THE COUNTING METHOD AND NEGATIVE CONTROLS4-1 General considerationsThe ability of the test to detect micro-organisms in the presence of product to be tested must be established.Suitability must be confirmed if a change in testing performance, or the product, which may affect the outcome of the test is introduced.4-2 Preparation of test strainsUse standardised stable suspensions of test strains or prepare them as stated below. Seed lot culture maintenance techniques (seed-lot systems) are used so that the viable micro-organisms used for inoculation are not more than 5 passages removed from the original master seed-lot. Grow each of the bacterial and fungal test strains separately as described in Table 2.6.12.-1.Use buffered sodium chloride-peptone solution pH 7.0 or phosphate buffer solution pH 7.2 to make test suspensions; to suspend A. brasiliensis spores, 0.05 per cent of polysorbate 80 may be added to the buffer. Use the suspensions within 2 h or within 24 h if stored at 2-8 °C. As an alternative to preparing and then diluting a fresh suspension of vegetative cells of A.brasiliensis or B. subtilis, a stable spore suspension is prepared and then an appropriate volume of the spore suspension is used for test inoculation. The stable spore suspension may be maintained at 2-8 °C for a validated period of time.4-3 Negative controlTo verify testing conditions, a negative control is performed using the chosen diluent in place of the test preparation. There must be no growth of micro-organisms. A negative control is also performed when testing the products as described in section 5. A failed negative control requires an investigation.4-4 Growth promotion of the mediaTest each batch of ready-prepared medium and each batch of medium, prepared either from dehydrated medium or from the ingredients described.Inoculate portions/plates of casein soya bean digest broth and casein soya bean digest agar with a small number (not more than 100 CFU) of the micro-organisms indicated in Table 2.6.12.-1, using a separate portion/plate of medium for each. Inoculate plates of Sabouraud-dextrose agar with a small number (not more than 100 CFU) of the micro-organisms indicated in Table 2.6.12.-1, using a separate plate of medium for each. Incubate in the conditions described in Table 2.6.12.-1.For solid media, growth obtained must not differ by a factor greater than 2 from the calculated value for a standardised inoculum. For a freshly prepared inoculum, growth of the micro-organisms comparable to that previously obtained with a previously tested and approved batch of medium occurs. Liquid media aresuitable if clearly visible growth of the micro-organisms comparable to that previously obtained with a previously tested and approved batch of medium occurs.4-5 Suitability of the counting method in the presence of product4-5-1 Preparation of the sample The method for sample preparation depends upon the physical characteristics of the product to be tested. If none of the procedures described below can be demonstrated to be satisfactory, an alternative procedure must be developed.Water-soluble products Dissolve or dilute (usually a 1 in 10 dilution is prepared) the product to be examined in buffered sodium chloride-peptone solution pH 7.0, phosphate buffer solution pH 7.2 or casein soya bean digest broth. If necessary, adjust to pH 6-8. Further dilutions, where necessary, are prepared with the same diluent.Non-fatty products insoluble in water Suspend the product to be examined (usually a 1 in 10 dilution is prepared) in buffered sodium chloride-peptone solution pH 7.0, phosphate buffer solution pH 7.2 or casein soya bean digest broth. A surface-active agent such as 1 g/L of polysorbate 80 may be added to assist the suspension of poorly wettable substances. If necessary, adjust to pH 6-8. Further dilutions, where necessary, are prepared with the same diluent.Fatty products Dissolve in isopropyl myristate, sterilised by filtration or mix the product to be examined with the minimum necessary quantity of sterile polysorbate 80 or another non-inhibitory sterilesurface-active agent, heated if necessary to not more than 40 °C, or in exceptional cases to not more than 45 °C. Mix carefully and if necessary maintain the temperature in a water-bath. Add sufficient of the pre-warmed chosen diluent to make a 1 in 10 dilution of the original product. Mix carefully whilst maintaining the temperature for the shortest time necessary for the formation of an emulsion. Further serial tenfold dilutions may be prepared using the chosen diluent containing a suitable concentration of sterile polysorbate 80 or another non-inhibitory sterile surface-active agent.Fluids or solids in aerosol form Aseptically transfer the product into a membrane filter apparatus or a sterile container for further sampling. Use either the total contents or a defined number of metered doses from each of the containers tested.Transdermal patches Remove the protective cover sheets ('release liners') of the transdermal patches and place them, adhesive side upwards, on sterile glass or plastic trays. Cover the adhesive surface with a sterile porous material, for example sterile gauze, to prevent the patches from sticking together, and transfer the patches to a suitable volume of the chosen diluent containing inactivators such as polysorbate 80 and/or lecithin. Shake the preparation vigorously for at least 30 min.4-5-2 Inoculation and dilution Add to the sample prepared as described above (4-5-1) and to a control (with no test material included) a sufficient volume of the microbial suspension to obtain an inoculum of not more than 100 CFU. The volume of the suspension of the inoculum should not exceed 1 per cent of the volume of diluted product.To demonstrate acceptable microbial recovery from the product, the lowest possible dilution factor of the prepared sample must be used for the test. Where this is not possible due to antimicrobial activity or poor solubility, further appropriate protocols must be developed. If inhibition of growth by the sample cannot otherwise be avoided, the aliquot of the microbial suspension may be added after neutralisation, dilution or filtration.4-5-3 Neutralisation/removal of antimicrobial activity The number of micro-organisms recovered from the prepared sample diluted as described in 4-5-2 and incubated following the procedure described in4-5-4, is compared to the number of micro-organisms recovered from the control preparation.。

丁香(CARYOPHMLLI FLOS)的中英药典对比【来源】中国药典：本品为桃金娘科植物丁香Eugenia caryophyllata Thunb.的干燥花蕾。

当花蕾由绿色转红时采摘，晒干。

英国药典：Syzygium aromaticum (L.) Merill et L. M. Perry (Eugenia caryophyllus (C. Spreng.) Bull. et Harr.)干燥红褐色的整个花蕾。

最低150毫升/千克的挥发油。

含有特性、芳香的气味。

评述：中英药典的植物来源相同，但英国药典规定并描述了丁香中挥发油的含量和气味。

【性状】中国药典：本品略呈研棒状，长1-2cm。

花冠圆球形，直径0.3-0.5cm，花瓣4，覆瓦状抱合，棕褐色或褐黄色，花瓣内为雄蕊和花柱，搓碎后可见众多黄色细粒状花药。

萼筒圆柱状，略扁，有的稍弯曲，长0.7-1.4cm，直径0.3-0.6cm，红棕色或褐棕色，上部有4枚三角状的萼片，十字状分开。

质坚实，富油性。

气芳香浓烈，味辛辣、有麻舌感。

英国药典：花蕾红褐色,由一个四棱形的柄状部分,隐头花序, 长10 - 12毫米，直径2 - 3毫米,上覆盖四片裂片的萼片，围绕直径4 - 6毫米的柱头。

含多枚胚珠的双室子房位于隐头花序的上部，柱头球状或圆顶状,由4片覆瓦状花瓣组成,花瓣围绕数枚弯曲的雄蕊和一个底部带有蜜腺盘的短小、直立的中柱。

用指甲挤压花序，渗出挥发油。

粉末深棕色，具有特殊气味。

评述：中英药典对丁香的性状描述大致相同，重点强调其花冠、萼片和芳香气味。

但中国药典中对丁香的味道也有描述，英国药典则详细描述雌蕊的结构。

【鉴别】⑴显微鉴别法：中国药典：本品萼筒中部横切面：表皮细胞1列，有较厚角质层。

皮层外侧散有2-3列径向延长的椭圆形油室，长150-200µm；其下有20-50个小型双韧维管束，断续排列成环，维管束外围有少数中柱鞘纤维，壁厚，木化。

内侧为数列薄壁细胞组成的通气组织，有大形腔隙。

部分国家、地区草药重金属和农药残留限量标准汇总加入WTO后，中药的国际贸易将以国际通行的标准进行。

目前，国际上虽然尚无植物类中药的国际标准，但是FAO和WHO均制定了食品、蔬菜及茶叶重金属的允许摄入量和农药残留限量。

美国、欧盟及传统出口中药的东南亚地区均对中药提出了重金属和农药残留限量的指标，并有提高的趋势。

近年来国际贸易中以环保标准为基础的绿色认证制度日趋盛行，“环保标签”在许多情况下变成贸易壁垒。

在中药材生产过程中，由于对土壤选择不严，以及长期施用农药、化肥和除草剂，加之对农药的盲目选择，施用时间和剂量等达不到技术要求，导致目前药材普遍存在农药残留量和有害重金属含量超标，这是造成中药材质量下降的重要因素，也是制约我国中药及其它农副产品难以走向国际市场的重要原因之一，直接影响了中药在国际市场上的竞争力。

在此情况下，一方面我们要建立适合我国产品质量的标准以适应国际标准。

另一方面中药在中国有数千年的使用历史，世界各国在制定相应的植物药产品质量标准中也多参考我国的中药标准，因此，制定绿色标准也可以影响世界，达到对我中药产品国际贸易相对有利的局面。

由外经贸部制定并颁布的《药用植物及制剂外经贸绿色行业标准》已于2001年07月01日起正式实施。

这是我国中药的第一个进出口质量标准，也是我国中药的第一个绿色标准，对推动我国中药进入国际市场，确保植物药进出口品质，有着重大的历史性意义。

一、中国大陆（一）中国药典（2010版）药典对植物药中重金属和农药残留量的限量要求( ×10- 6)（二）药用植物及制剂外经贸绿色行业标准（WM/T2-2004）适用范围：药用植物原料及制剂的外经贸行业品质检验 重金属及砷盐限量：重金属总量 ≤20.0 mg/kg 。

铅（Pb ） ≤5.0 mg/kg 。

镉（Cd ） ≤0.3 mg/kg 。

汞（Hg ） ≤0.2 mg/kg 。

铜（Cu ） ≤20.0 mg/kg 。

中草药药物中英文名称(P-S) pagodatree flower bud 槐米pagodatree pod 槐角pale butterflybush flower 密蒙花palmleaf raspberry fruit 覆盆子pangolin scales 穿山甲panicled fameflower root 土人参paniculate swallowwort root 徐长卿papaya 番木瓜papermulberry fruit 楮实子parslane herb 马齿苋patience dock root 牛西西peach seed 桃仁pearl 珍珠pedate pinallia jackinthepulpit rhizome 天南星pedunculate acronychia wood 沙塘木peking euphorbia root 京大戟pepper 胡椒pepper wort herb 田字草peppermint 薄荷pepperweed seed / tansymustard seed 葶苈子perfoliote knotweed herb 杠板归perilla fruit 紫苏子perilla leaf 紫苏叶perilla stem 紫苏梗persimmon calyx and receptacle 柿蒂pevuvian apple herb 冰粉pharbitis seed 牵牛子philippine flemingia root 千金拔philippine violet herb 紫花地丁phoenix tree seed 梧桐子pillbug 鼠妇虫pilose asiabell root /moderate asiabell root/szechwon tangshen root 党参pine leaf 松毛pine nodular branch 油松节pine pollen 松花粉pinellia tuber 半夏pink herb 瞿麦pink plumepoppy herb 博落回pink reineckea herb 吉祥草pipe fish海龙plant soot 百草霜plantain herb 车前草plantain seed 车前子platycladi seed 柏子仁platycodon root 桔梗poisonous buttercup herb 石龙芮pokeberry root 商陆pomegranate rind 石榴皮prepared common monkshood daughter root 附子prepared salt 秋石pricklyash peel 花椒prince's-feather fruit 水荭花子prince's-feather herb 荭草puberulous glochidion herb 算盘子pubescent holly root 毛冬青pubescent pepper herb 毛蒟puff-ball 马勃pumice 浮石pummelo peel 化橘红puncturevine caltrop fruit 蒺藜purple lythrum herb 千屈菜purpleflower crotalaria herb 农吉利purpleflower holly leaf四季青purslane speedwell herb 仙桃草pyrite 自然铜pyrolusite 无名异pyrrosia leaf 石韦quartz 白石英radde anemone rhizome 竹节香附radish seed 莱菔子raisin tree seed 枳具子ramie root 苎麻根rangooncreeper fruit 使君子realgar 雄黄red ochre 代赭石red paeony root 赤芍red psychotria leaf 山大颜red-knees herb 辣蓼reed rhizome 芦根rehmannia root 地黄remote lemongrass herb 芸香草rhesus macaque bezoar 猴枣rhubarb 大黄rice bean 赤小豆rice-grain sprout 谷芽ricepaperplant pith 通草rivier giantarum rhizome 魔芋romanet grape root 野葡萄rose 玫瑰花rose mallow root 地桃花rosewood heart wood 降香roughhaired holly root 岗梅根round cardamom fruit /java amomum fruit 白豆蔻rush 灯心草rust-coloured crotalaria herb 假地兰safflower 红花saffron 西红花sago leaf 凤尾蕉叶sal ammoniac 硇砂sampson st. john'swort herb 元宝草sanchi 三七sandalwood 檀香sappan wood 苏木sargentgloryvine stem 大血藤sarmentose pepper herb 假蒟savoury rhododendron leaf 烈香杜鹃sawtooth oak bark 橡木皮saxifraga 虎耳草scabrous doellingeria rhizome and root 东风菜scabrous elephantfoot herb 地胆头scabrous mosla herb 石荠苧scandent schefflera stem and leaf 七叶莲scarlet kadsura root 黑老虎根scorpion 全蝎sea horse 海马sea-ear shell 石决明seaweed 海藻semen nelumbinis 莲子semi-pinnated brake herb 半边旗senna leaf 番泻叶sensitiveplat herb 含羞草serpoletleaf sandwort herb 小无心菜serrate chloranthus root 及己serrate gtorybower herb 三对节sessile stemona root/japanese stemona root/tuber stemona root 百部sessileflower acanthopanax bark 短梗五加sevenlobed yam rhizome / foochow yam rhizome 绵萆解sharpleaf galangal fruit 益智仁sheepear inula herb 羊耳菊shepherdspurse herb 荠菜shiny cinquefoil root 翻白叶shinyleaf pricklyash root 两面针shorthairy antenoron herb 金线草shortleaf kyllinga herb 水蜈蚣shortstalk monkshood root/pendulous monkshood root雪上一只蒿shorttube lycoris bulb 石蒜shouliang yam rhizome 薯莨shrubalthea bark 川槿皮siberian cocklour fruit 苍耳子silktree albizzia bark 合欢皮simple glorybower root 臭茉莉simpleleaf shrub chastetree fruit 蔓荆子sinense knotweed rhizome 蜈蚣七single roxburgh rose fruit 刺梨果sinkiang arnebia root /redroot gromwell root 紫草sinkiang fritillary bulb 伊贝母skyblue broomrape herb 列当slender dutchmanspipe root 青木香slenderstyle acanthopanax bark 五加皮/南small centipeda herb 鹅不食草smallfruit fig aerial root 榕须smallfruit rose root 小果蔷薇snake slough 蛇蜕snakegourd fruit 瓜蒌snakegourd seed 瓜蒌仁snow lotus herb 雪莲花snow of june herb 六月雪snowbell-leaf tickclover herb 广金钱草soda-apple night-shade herb 天茄子songaria cynomorium herb 锁阳south dodder seed / chinese dodder seed 菟丝子sowthistle tasselflower herb 一点红soybean germinated大豆黄卷spanishneedles herb / railway beggarticks herb 鬼针草spiderflower seed 白花菜子spike aletris herb 粉条儿菜spina date seed 酸枣仁spiny amarauth herb or root 刺苋菜spreading hedyotis herb 白花蛇舌草sri lanka pouzolzia herb 雾水葛stalactite 钟乳石star anise 八角茴香starwort root 银柴胡stiff silkworm 僵蚕stone-like omphalia 雷丸stringy stonecrop herb 垂盆草striped crotalaria herb 猪屎豆suberect spatholobus stem 鸡血藤suffrutescent securinega twig 叶底珠sulphur 硫黄sun euphorbia herb 泽漆sunflower receptacle 向日葵sunset abelmoschus root 黄蜀葵swamp mahogany leaf 大叶桉叶sweet basil herb 罗勒sweet broomwort herb 冰糖草sweet osmanthus flower 桂花sweet wormwood herb 青蒿sweetscented oleander leaf 夹竹桃叶sword jackbean seed 刀豆子swordlike atractylodes rhizome / chinese atractylodes rhizome 苍术szechuan lovage rhizome 川芎szechuan melandium root 瓦草szechwan chinaberry fruit 川楝子。

lac 紫草茸laciniate kalanchoe herb 鸡爪三七ladybell root 南沙参lalang grass rhizome 白茅根lance asiabell root 羊乳lancelesf lily bulb / greenish lily bulb / low lily bulb 百合langdu root 狼毒largeflower jasmine flower 素馨花largehead atractylodesrhizome 白术largeleaf gentian root / 秦艽straw-coloured gentian rootlargetrifoliolious bugbane rhizome 升麻lawn pennywort herb 天胡荽leatherleaf mahonia stem chinese mahonia stem 功劳木leech 水蛭lemonfragrant angelica root 香白芷lemongrass herb 香茅lepidogrammitis herb 鱼鳖草lesser galangal rhizome 高良姜levant cotton root 棉花根lightyellow sophora root 苦参lilac daphne flower bud 芫花lilyofthevalley herb 铃兰limonite 禹余粮lindley butterflybush herb 醉鱼草lindley eupatorium herb 野马追linear leaf speedwell 一支香linear stonecrop herb 佛假草linearstripe rabdosia herb 溪黄草liquoric root 甘草lithargite 密陀僧little multibanded krait 金钱白花蛇littleleaf indianmulberry herb 白眼藤lobed actinostemma herb 盒子草lobedfruit schizocapsarhizome 水田七long pepper 筚茇long stephania herb 粪箕笃longhairy antenoron herb 金钱草long-nosed pit viper 蕲蛇longstamen onion bulb 薤白longtube ground ivy herb 连钱草loquat leaf 枇杷叶lotus leaf 荷叶lotus plumule 莲子心lotus rhizome node 藕节lotus seed pot 莲房lotus stamen 莲须lovely hemsleya root 雪胆lowdaphne stringbush flower and leaf 黄芫花lucid ganoderma 灵芝luckynut thevetia seed 黄花夹竹桃lunate peltate sundew herb 茅膏菜lushan mountain barberry root 刺黄莲lychee seed 荔枝核madagascar periwinkle herb 长春花magnetite 磁石maifanite 麦饭石malaytea scurfpea fruit 补骨脂male fern rhizome 绵马贯众malt 麦芽manchurian lilac bark 暴马子皮manchurian rhododendron leaf 照山白manchurian tubergourd fruit 赤袍子manchurian wildginger 细辛manshurian dutchmanspipe stem 关木通mantis egg-case 桑螵蛸manyflower gueldenstaedtid herb 甜地丁manyflowersolomonsealrhizome / siberian solomonseal rhizome / king solomonseal rhizome 黄精manyprickle acanto-panax root 刺五加mary rhododendron leaf and twig 紫花杜鹃matteuccia fern rhizome 荚果蕨贯众meadowrue root and rhizome 马尾连medcinal evodia fruit 吴茱萸medicated leaven 六神曲medicinal changium root 明党参medicinal cyathula root 川牛膝medicinal indianmulberry root 巴戟天medicine terminalia fruit 诃子membranous milkvetch root / 黄芪mongolian milkcetch rootmexican tea herb 土荆芥mile swertia herb 青叶胆mirabilite 芒硝moellendorf's spidemoss herb 地柏枝mole cricket 蝼蛄mongolian dandelion herb 蒲公英mongolian snakegourd root 天花粉mongollian thyme herb 地椒motherwort fruit 茺蔚子motherwort herb 益母草mountain dragon 古山龙mountain spicy tree fruit 毕澄茄mountain yam rhizome 山萆解mulberry fruit 桑椹mulberry leaf 桑叶mulberry twig 桑枝mullein mightbrier leaf 假烟叶mus covite 云母musk 麝香muskmelon base 甜瓜蒂muskmelon seed 甜瓜子muskroot-like semiaquilegia root 天葵子myrrh 没药nacre 珍珠母nakedflower beautyberry leaf 裸花紫珠nardostachyos root and rhizome 甘松narrowleaf screwtree root 山芝麻natant salvinia herb 槐叶苹natural indigo 青黛negundo chastetree fruit 黄荆子negundo chastetree leaf 黄荆叶ningpo yam rhizome 穿山龙nutgrass galingale rhizome 香附nutmeg 肉豆蔻nux vomica 马钱子obcordate raspberry root 黄锁梅obscured homalomenarhizome 千年健obtuseleaf cinnamon bark 山肉桂officinal asparagus root 石刁柏officinal magnolia bark 厚朴omoto nipponlily rhizome 白河车ophicslcite 花蕊石opium 阿片oriental bittersweet root 南蛇藤根oriental blechnum fern rhizome 乌毛蕨贯众oriental stephania root 白药子oriental waterplantain rhizome 泽泻orpiment 雌黄ovalleaf dutchmanspipe root 通城虎ovateleaf holly bark 救必应ovientvine 青风藤oyster shell 牡蛎。

各国药典比较ChP、USP、Ph.Eur.中药/天然药物质量标准比较及评述—以芦荟为例by14211第一部分中美欧药典简介1.中国药典《中华人民共和国药典》，简称《中国药典》。

是由国家药典委员会（原名卫生部药典委员会成立于1950年），根据《中华人民共和国药品管理法》的规定，负责组织编纂《中华人民共和国药典》及制定、修订国家药品标准，是法定的国家药品标准。

由国家食品药品监督管理部门批准颁布实施。

《中华人民共和国药典》（简称《中国药典》）2010年版，分一部、二部和三部，收载品种总计4567种，其中新增1386种。

药典一部收载药材和饮片、植物油脂和提取物、成方制剂和单味制剂等，品种共计2165种，其中新增1019种（包括439个饮片标准）、修订634种；药典二部收载化学药品、抗生素、生化药品、放射性药品以及药用辅料等，品种共计2271种，其中新增330种、修订1500种；药典三部收载生物制品，品种共计131种，其中新增37种、修订94种。

2010版药典收载的附录亦有变化，其中药典一部新增14个、修订47个；药典二部新增15个、修订69个；药典三部新增18个、修订39个。

一、二、三部共同采用的附录分别在各部中予以收载，并尽可能做到统一协调、求同存异。

中国药典包括凡例、正文及附录，是药品研制、生产、经营、使用和监督管理等均应遵循的法定依据。

所有国家药品标准应当符合中国药典凡例及附录的相关要求。

作为我国保证药品质量的法典，本版药典在保持科学性、先进性、规范性和权威性的基础上，着力解决制约药品质量与安全的突出问题，着力提高药品标准质量控制水平，充分借鉴了国际先进技术和经验，客观反映了中国当前医药工业、临床用药及检验技术的水平，必将在提高药品质量过程中起到积极而重要的作用，并将进一步扩大和提升我国药典在国际上的积极影响。

2.美国药典《美国药典/国家处方集》U.S. Pharmacopeia / National Formulary（简称USP/NF）。

2017年版《英国药典》概述及启示作者：谢茵张静来源：《中国药房》2018年第03期中圖分类号 R921.3 文献标志码 A 文章编号 1001-0408（2018）03-0410-06DOI 10.6039/j.issn.1001-0408.2018.03.29摘要目的：对2017年版《英国药典》进行概述，为药品检验者使用药典提供便利。

方法：通过对2017年版《英国药典》的主要内容和编排结构进行概览，运用文献研究并与2015年版《中国药典》进行比较，描述中、英两国药典的异同，并提出可供我国药典的借鉴之处。

结果与结论：《英国药典》内容包括“介绍”“凡例”“正文品种”“红外对照图谱”等7部分，其分为“医药原料药”“配方制剂”“兽药”等6卷。

与之前版本比较，2017年版新增了69个品种，删除了9个专论，技术修改91个品种；与《中国药典》比较，《英国药典》另纳入了兽药、顺势疗法制剂、手术材料和红外光谱图等。

与《中国药典》5年修订1次比较，英国药典委员会每年都对《英国药典》进行更新和修订，为科学分析方法的建立及时提供了可靠的参考材料；同时，还建立了《英国药典》在线网站，为使用者提供了更加方便、快捷的平台；并特别注重与药品制造商、监管机构、欧洲药品管理局（EMA）以及EMA中的中草药产品委员会保持紧密的联系，以及时修订药品标准；由此为我国药典的修订提供启示和借鉴。

关键词 2017年版；英国药典；中国药典；概述；启示ABSTRACT OBJECTIVE： To summarize 2017 edition of British Pharmacopoeia， and to facilitate the use of it by drug inspectors. METHODS： The main contents and layout of 2017 edition of British Pharmacopoeia were overviewed； the similarities and differences between Chinese Pharmacopoeia and British Pharmacopoeia were described by means of literature research and general comparison with the 2015 edition of Chinese Pharmacopoeia. The reference for Chinese Pharmacopoeia was put forward. RESULTS & CONCLUSIONS： British Pharmacopoeia includes 7 parts as “introduction” “explanatory notes” “text variety” “infrared control chromatogram”， and divided into 6 volumes，such as “pharmaceutical raw materials” “formulated preparations” “veterinary drugs”. Compared with the previous edition， 2017 edition added 69 new varieties，removed 9 monographs and modified 91 varieties technologically. Compared with Chinese Pharmacopoeia， British Pharmacopoeia additionally included veterinary drugs， homeopathic preparations， surgical materials， infrared spectrogram， etc. Compared with the update of Chinese Pharmacopoeia every 5 years， British Pharmacopoeia Commission updated and revised the British Pharmacopoeia every year， and provided reliable reference for the establishment of scientific analysis methods in time. At the same time， British Pharmacopoeia Commission established British Pharmacopoeia online website to provide a more convenient and fastplatform for users； British Pharmacopoeia Commission paid special attention to maintaining close ties with drug manufacturers， regulators， the European Medicines Agency （EMA） and the Chinese Herbal Medicine Products Committee in EMA so as to revise drug standards timely. It provides enlightenment and reference for the revision of Chinese Pharmacopoeia.KEYWORDS 2017 edition； British Pharmacopoeia； Chinese Pharmacopoeia； Outline；Inspiration《英国药典》是英国药典委员会（British Pharmacopoeia Commission）正式出版的英国官方医学法典，是英国药品标准的重要来源，不仅为读者提供了药用和成药配方标准以及配药标准公式，而且也向读者展示了所有明确分类及可参照的《欧洲药典》专论，是药品质量控制、药品生产许可证管理的重要依据，为药物的质量控制提供了法律依据和科学参考[1-2]。

执业药师药学专业知识一（药品质量与药品标准）模拟试卷5(题后含答案及解析)题型有：1. A1型题 2. B1型题 3. X型题1．《英国药典》的全称是( )。

A．Japanese PharmacopoeiaB．Chinese PharmacopoeiaC．European PharmacopoeiaD．British PharmacopoeiaE．The Pharmacopoeia of United States of American 正确答案：D 涉及知识点：药品标准与药典2．《中国药典》规定原料药的含量百分数，如未规定上限时，系指不超过( )。

A．110.00%B．105.00%C．103.30%D．101.00%E．100.50%正确答案：D 涉及知识点：药品标准与药典3．下面哪一项属于均一性检查( )。

A．水分B．粒度C．制酸力D．重金属E．重量差异正确答案：E 涉及知识点：药品标准与药典4．[α]Dt表示( )。

A．黏度B．折光率C．旋光度D．比旋度E．吸光度正确答案：D 涉及知识点：药品质量检验与体内药物检测5．旋光度测定时，配制溶液及测定时，除另有规定外，均应调节温度至( )。

A．10℃～30℃B．15℃～30℃C．20℃～30℃D．20℃±0．5℃E．25℃±2℃正确答案：D 涉及知识点：药品质量检验与体内药物检测6．下列哪种方法最适宜检查药物中的残留溶剂( )。

A．滴定分析法B．薄层色谱法C．气相色谱法D．紫外—可见分光光度法E．高效液相色谱法正确答案：C解析：此题主要考查药物残留溶剂的检查方法。

药物中的残留溶剂主要为有机试剂，有机试剂易挥发，一般采用气相色谱法检查。

知识模块：药品质量检验与体内药物检测7．在紫外—可见分光光度法中，与溶液浓度和液层厚度成正比的是( )。

A．透光率B．狭缝宽度C．测定波长D．吸光度E．吸收系数正确答案：D 涉及知识点：药品质量检验与体内药物检测8．在体内药物分析中最为常用的样本是( )。

2017年版《英国药典》概述及启示目的：对2017年版《英国药典》进行概述，为药品检验者使用药典提供便利。

方法：通过对2017年版《英国药典》的主要内容和编排结构进行概览，运用文献研究并与2015年版《中国药典》进行比较，描述中、英两国药典的异同，并提出可供我国药典的借鉴之处。

结果与结论：《英国药典》内容包括“介绍”“凡例”“正文品种”“红外对照图谱”等7部分，其分为“医药原料药”“配方制剂”“兽药”等6卷。

与之前版本比较，2017年版新增了69个品种，删除了9个专论，技术修改91个品种；与《中国药典》比较，《英国药典》另纳入了兽药、顺势疗法制剂、手术材料和红外光谱图等。

与《中国药典》5年修订1次比较，英国药典委员会每年都对《英国药典》进行更新和修订，为科学分析方法的建立及时提供了可靠的参考材料；同时，还建立了《英国药典》在线网站，为使用者提供了更加方便、快捷的平台；并特别注重与药品制造商、监管机构、欧洲药品管理局（EMA）以及EMA中的中草药产品委员会保持紧密的联系，以及时修订药品标准；由此为我国药典的修订提供启示和借鉴。

ABSTRACT OBJECTIVE：To summarize 2017 edition of British Pharmacopoeia，and to facilitate the use of it by drug inspectors. METHODS：The main contents and layout of 2017 edition of British Pharmacopoeia were overviewed；the similarities and differences between Chinese Pharmacopoeia and British Pharmacopoeia were described by means of literature research and general comparison with the 2015 edition of Chinese Pharmacopoeia. The reference for Chinese Pharmacopoeia was put forward. RESULTS & CONCLUSIONS：British Pharmacopoeia in cludes 7 parts as “introduction” “explanatory notes” “text variety” “infrared control chromatogram”，and divided into 6 volumes，such as “pharmaceutical raw materials” “formulated preparations” “veterinary drugs”. Compared with the previous edition，2017 edition added 69 new varieties，removed 9 monographs and modified 91 varieties technologically. Compared with Chinese Pharmacopoeia，British Pharmacopoeia additionally included veterinary drugs，homeopathic preparations，surgical materials，infrared spectrogram，etc. Compared with the update of Chinese Pharmacopoeia every 5 years，British Pharmacopoeia Commission updated and revised the British Pharmacopoeia every year，and provided reliable reference for the establishment of scientific analysis methods in time. At the same time，British Pharmacopoeia Commission established British Pharmacopoeia online website to provide a more convenient and fast platform for users；British Pharmacopoeia Commission paid special attention to maintaining close ties with drug manufacturers，regulators，the European Medicines Agency （EMA）and the Chinese Herbal Medicine Products Committee in EMA so as to revise drug standards timely. It provides enlightenment and reference for the revision of Chinese Pharmacopoeia.KEYWORDS 2017 edition；British Pharmacopoeia；Chinese Pharmacopoeia；Outline；Inspiration《英国药典》是英国药典委员会（British PharmacopoeiaCommission）正式出版的英国官方医学法典，是英国药品标准的重要来源，不仅为读者提供了药用和成药配方标准以及配药标准公式，而且也向读者展示了所有明确分类及可参照的《欧洲药典》专论，是药品质量控制、药品生产许可证管理的重要依据，为药物的质量控制提供了法律依据和科学参考[1-2]。

卫生部颁药品标准（中药材第一册）(100种)白巨胜拼音名：Baijusheng英文名：SEMEN LACTUCAE书页号：y1-31 标准编号：本品为菊科植物莴苣Lactuca satica L.的干燥成熟果实。

夏秋采收，除去杂质，晒干。

【性状】本品呈长卵形，略扁，长3～4mm，宽1～2mm。

表面灰白色、黄白色或少有棕褐，有光泽，两面具突起的弧形棱线7～8条。

质坚，断面白色，富有油性，无臭，味淡。

【鉴别】(1) 取本品用湿水浸泡约1小时后用手捻之，果皮与种子即分离，种皮为一薄膜，包围整个种子。

子叶两枚，胚乳不发达。

(2) 本品粉末棕黄色。

子叶细胞众多,大小不等,类圆形。

种皮细胞表面观长条形。

果皮细胞淡黄色，长条形，细胞壁呈均匀的连珠状增厚。

油滴散在。

【性味与归经】微甘，温，归肝、肾经。

【功能与主治】通乳、利尿、活血、益肝肾。

用于乳汁不通，大便不利，伤损作痛，肾亏遗精，筋骨痿软。

【用法与用量】5～10g；外用适量。

【贮藏】置阴凉干燥处，防虫蛀。

白药子拼音名：Baiyaozi英文名：RADIX STEPHANIAE CEPHARANTHAE书页号：y1-32 标准编号：本品为防己科植物头花千斤藤Stephania cepharantha Hayata的干燥块根，秋、冬两季采挖，除去次根，洗净，切片，干燥。

【性状】本品为不规则的块状，直径2～7cm，厚0.2～1.5cm。

外皮暗褐色，有皱纹及须根痕。

切面类白色或灰白色，可见筋脉纹（维管束），有的略呈环状排列。

质硬而脆，易折断，断面显粉性。

气微，味苦。

【鉴别】(1) 本品横切面：木栓层为10余列细胞，含棕色物。

外有落皮层。

皮层散有少数石细胞。

维管束外韧型，略呈轮状排列，木质部不发达,中心木质部可见纤维束。

薄壁细胞含草酸钙方晶及细小针晶；并含多数淀粉粒。

(2) 取本品粗粉5g，加乙醇25ml，置水浴上回流10分钟，滤过，滤液蒸干, 残渣加稀盐酸2ml使溶解，滤过。