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美国药典凡例中英文USPNFGeneralNoticeUSP32-NF27General Notices 凡例USP32 (2)Introduction 简介 (2)4. MONOGRAPHS AND GENERAL CHAPTERS 正文和附录 (3)5. MONOGRAPH COMPONENTS 专论构成 (7)6. TESTING PRACTICES AND PROCEDURES 试验规范和过程(18)7. TEST RESULTS 测试结果 (28)8. TERMS AND DEFINITIONS 术语及定义 (31)9. PRESCRIBING AND DISPENSING 开方和配方 (41)10. PRESERV ATION, PACKAGING, STORAGE, AND LABELING 防腐，包装，贮藏和标签 (42)NF27 (66)Introduction 简介 (66)TITLE 标题 (67)“OFFICIAL” AND “OFFICIAL ARTICLES” “药典的”和“药典药物” (68)STORAGE UNDER NONSPECIFIC CONDITIONS 非特定条件下的贮存 (70)OTHER GENERAL NOTICES 其他凡例 (71)USP32Introduction 简介GENERAL NOTICES AND REQUIREMENTS凡例和要求Change to read:The General Notices and Requirements section (the General Notices) presents the basic assumptions, definitions, and defaultconditions for the interpretation and application of the United States Pharmacopeia (USP) and the National Formulary (NF).凡例和要求部分（凡例）给出对USP和NF中假设、定义、默认条件的解释和应用。
药物分析英语词汇Abbe refractometer 阿贝折射仪absorbance 吸收度absorbance ratio 吸收度比值absorption 吸收absorption curve 吸收曲线absorption spectrum 吸收光谱absorptivity 吸收系数accuracy 准确度acid-dye colorimetry 酸性染料比色法acidimetry 酸量法acid-insoluble ash 酸不溶性灰分acidity 酸度activity 活度additive 添加剂additivity 加和性adjusted retention time 调整保留时间adsorbent 吸附剂adsorption 吸附affinity chromatography 亲和色谱法aliquot （一）份alkalinity 碱度alumina 氧化铝ambient temperature 室温ammonium thiocyanate 硫氰酸铵analytical quality control（AQC）分析质量控制anhydrous substance 干燥品anionic surfactant titration 阴离子表面活性剂滴定法antibiotics-microbial test 抗生素微生物检定法antioxidant 抗氧剂appendix 附录application of sample 点样area normalization method 面积归一化法argentimetry 银量法arsenic 砷arsenic stain 砷斑ascending development 上行展开ash-free filter paper 无灰滤纸（定量滤纸）assay 含量测定assay tolerance 含量限度atmospheric pressure ionization(API) 大气压离子化attenuation 衰减back extraction 反萃取back titration 回滴法bacterial endotoxins test 细菌内毒素检查法band absorption 谱带吸收baseline correction 基线校正baseline drift 基线漂移batch, lot 批batch(lot) number 批号Benttendorff method 白田道夫（检砷）法between day (day to day, inter-day) precision 日间精密度between run (inter-run) precision 批间精密度biotransformation 生物转化bioavailability test 生物利用度试验bioequivalence test 生物等效试验biopharmaceutical analysis 体内药物分析，生物药物分析blank test 空白试验boiling range 沸程British Pharmacopeia (BP) 英国药典bromate titration 溴酸盐滴定法bromimetry 溴量法bromocresol green 溴甲酚绿bromocresol purple 溴甲酚紫bromophenol blue 溴酚蓝bromothymol blue 溴麝香草酚蓝bulk drug, pharmaceutical product 原料药buret 滴定管by-product 副产物calibration curve 校正曲线calomel electrode 甘汞电极calorimetry 量热分析capacity factor 容量因子capillary zone electrophoresis (CZE) 毛细管区带电泳capillary gas chromatography 毛细管气相色谱法carrier gas 载气cation-exchange resin 阳离子交换树脂ceri(o)metry 铈量法characteristics, description 性状check valve 单向阀chemical shift 化学位移chelate compound 鳌合物chemically bonded phase 化学键合相chemical equivalent 化学当量Chinese Pharmacopeia (ChP) 中国药典Chinese material medicine 中成药Chinese materia medica 中药学Chinese materia medica preparation 中药制剂Chinese Pharmaceutical Association (CPA) 中国药学会chiral 手性的chiral stationary phase (CSP) 手性固定相chiral separation 手性分离chirality 手性chiral carbon atom 手性碳原子chromatogram 色谱图chromatography 色谱法chromatographic column 色谱柱chromatographic condition 色谱条件chromatographic data processor 色谱数据处理机chromatographic work station 色谱工作站clarity 澄清度clathrate, inclusion compound 包合物clearance 清除率clinical pharmacy 临床药学coefficient of distribution 分配系数coefficient of variation 变异系数color change interval （指示剂）变色范围color reaction 显色反应colorimetric analysis 比色分析colorimetry 比色法column capacity 柱容量column dead volume 柱死体积column efficiency 柱效column interstitial volume 柱隙体积column outlet pressure 柱出口压column temperature 柱温column pressure 柱压column volume 柱体积column overload 柱超载column switching 柱切换committee of drug evaluation 药品审评委员会comparative test 比较试验completeness of solution 溶液的澄清度compound medicines 复方药computer-aided pharmaceutical analysis 计算机辅助药物分析concentration-time curve 浓度－时间曲线confidence interval 置信区间confidence level 置信水平confidence limit 置信限congealing point 凝点congo red 刚果红（指示剂）content uniformity 装量差异controlled trial 对照试验correlation coefficient 相关系数contrast test 对照试验counter ion 反离子（平衡离子）cresol red 甲酚红（指示剂）crucible 坩埚crude drug 生药crystal violet 结晶紫（指示剂）cuvette, cell 比色池cyanide 氰化物cyclodextrin 环糊精cylinder, graduate cylinder, measuring cylinder 量筒cylinder-plate assay 管碟测定法daughter ion （质谱）子离子dead space 死体积dead-stop titration 永停滴定法dead time 死时间decolorization 脱色decomposition point 分解点deflection 偏差deflection point 拐点degassing 脱气deionized water 去离子水deliquescence 潮解depressor substances test 降压物质检查法derivative spectrophotometry 导数分光光度法derivatization 衍生化descending development 下行展开desiccant 干燥剂detection 检查detector 检测器developer, developing reagent 展开剂developing chamber 展开室deviation 偏差dextrose 右旋糖，葡萄糖diastereoisomer 非对映异构体diazotization 重氮化2,6-dichlorindophenol titration 2,6-二氯靛酚滴定法differential scanning calorimetry (DSC) 差示扫描热量法differential spectrophotometry 差示分光光度法differential thermal analysis (DTA) 差示热分析differentiating solvent 区分性溶剂diffusion 扩散digestion 消化diphastic titration 双相滴定disintegration test 崩解试验dispersion 分散度dissolubility 溶解度dissolution test 溶出度检查distilling range 馏程distribution chromatography 分配色谱distribution coefficient 分配系数dose 剂量drug control institutions 药检机构drug quality control 药品质量控制drug release 药物释放度drug standard 药品标准drying to constant weight 干燥至恒重dual wavelength spectrophotometry 双波长分光光度法duplicate test 重复试验effective constituent 有效成分effective plate number 有效板数efficiency of column 柱效electron capture detector 电子捕获检测器electron impact ionization 电子轰击离子化electrophoresis 电泳electrospray interface 电喷雾接口electromigration injection 电迁移进样elimination 消除eluate 洗脱液elution 洗脱emission spectrochemical analysis 发射光谱分析enantiomer 对映体end absorption 末端吸收end point correction 终点校正endogenous substances 内源性物质enzyme immunoassay(EIA) 酶免疫分析enzyme drug 酶类药物enzyme induction 酶诱导enzyme inhibition 酶抑制eosin sodium 曙红钠（指示剂）epimer 差向异构体equilibrium constant 平衡常数equivalence point 等当点error in volumetric analysis 容量分析误差excitation spectrum 激发光谱exclusion chromatography 排阻色谱法expiration date 失效期external standard method 外标法extract 提取物extraction gravimetry 提取重量法extraction titration 提取容量法extrapolated method 外插法，外推法factor 系数，因数，因子feature 特征Fehling’s reaction 费林反应field disorption ionization 场解吸离子化field ionization 场致离子化filter 过滤，滤光片filtration 过滤fineness of the particles 颗粒细度flame ionization detector(FID) 火焰离子化检测器flame emission spectrum 火焰发射光谱flask 烧瓶flow cell 流通池flow injection analysis 流动注射分析flow rate 流速fluorescamine 荧胺fluorescence immunoassay(FIA) 荧光免疫分析fluorescence polarization immunoassay(FPIA) 荧光偏振免疫分析fluorescent agent 荧光剂fluorescence spectrophotometry 荧光分光光度法fluorescence detection 荧光检测器fluorimetyr 荧光分析法foreign odor 异臭foreign pigment 有色杂质formulary 处方集fraction 馏分freezing test 结冻试验funnel 漏斗fused peaks, overlapped peaks 重叠峰fused silica 熔融石英gas chromatography(GC) 气相色谱法gas-liquid chromatography(GLC) 气液色谱法gas purifier 气体净化器gel filtration chromatography 凝胶过滤色谱法gel permeation chromatography 凝胶渗透色谱法general identification test 一般鉴别试验general notices （药典）凡例general requirements （药典）通则good clinical practices(GCP) 药品临床管理规范good laboratory practices(GLP) 药品实验室管理规范good manufacturing practices(GMP) 药品生产质量管理规范good supply practices(GSP) 药品供应管理规范gradient elution 梯度洗脱grating 光栅gravimetric method 重量法Gutzeit test 古蔡（检砷）法half peak width 半峰宽[halide] disk method, wafer method, pellet method 压片法head-space concentrating injector 顶空浓缩进样器heavy metal 重金属heat conductivity 热导率height equivalent to a theoretical plate 理论塔板高度height of an effective plate 有效塔板高度high-performance liquid chromatography (HPLC) 高效液相色谱法high-performance thin-layer chromatography (HPTLC) 高效薄层色谱法hydrate 水合物hydrolysis 水解hydrophilicity 亲水性hydrophobicity 疏水性hydroscopic 吸湿的hydroxyl value 羟值hyperchromic effect 浓色效应hypochromic effect 淡色效应identification 鉴别ignition to constant weight 灼烧至恒重immobile phase 固定相immunoassay 免疫测定impurity 杂质inactivation 失活index 索引indicator 指示剂indicator electrode 指示电极inhibitor 抑制剂injecting septum 进样隔膜胶垫injection valve 进样阀instrumental analysis 仪器分析insulin assay 胰岛素生物检定法integrator 积分仪intercept 截距interface 接口interference filter 干涉滤光片intermediate 中间体internal standard substance 内标物质international unit(IU) 国际单位in vitro 体外in vivo 体内iodide 碘化物iodoform reaction 碘仿反应iodometry 碘量法ion-exchange cellulose 离子交换纤维素ion pair chromatography 离子对色谱ion suppression 离子抑制ionic strength 离子强度ion-pairing agent 离子对试剂ionization 电离，离子化ionization region 离子化区irreversible indicator 不可逆指示剂irreversible potential 不可逆电位isoabsorptive point 等吸收点isocratic elution 等溶剂组成洗脱isoelectric point 等电点isoosmotic solution 等渗溶液isotherm 等温线Karl Fischer titration 卡尔·费歇尔滴定kinematic viscosity 运动黏度Kjeldahl method for nitrogen 凯氏定氮法Kober reagent 科伯试剂Kovats retention index 科瓦茨保留指数labelled amount 标示量leading peak 前延峰least square method 最小二乘法leveling effect 均化效应licensed pharmacist 执业药师limit control 限量控制limit of detection(LOD) 检测限limit of quantitation(LOQ) 定量限limit test （杂质）限度（或限量）试验limutus amebocyte lysate(LAL) 鲎试验linearity and range 线性及范围linearity scanning 线性扫描liquid chromatograph/mass spectrometer (LC/MS) 液质联用仪litmus paper 石蕊试纸loss on drying 干燥失重low pressure gradient pump 低压梯度泵luminescence 发光lyophilization 冷冻干燥main constituent 主成分make-up gas 尾吹气maltol reaction 麦牙酚试验Marquis test 马奎斯试验mass analyzer detector 质量分析检测器mass spectrometric analysis 质谱分析mass spectrum 质谱图mean deviation 平均偏差measuring flask, volumetric flask 量瓶measuring pipet(te) 刻度吸量管medicinal herb 草药melting point 熔点melting range 熔距metabolite 代谢物metastable ion 亚稳离子methyl orange 甲基橙methyl red 甲基红micellar chromatography 胶束色谱法micellar electrokinetic capillary chromatography(MECC, MEKC) 胶束电动毛细管色谱法micelle 胶束microanalysis 微量分析microcrystal 微晶microdialysis 微透析micropacked column 微型填充柱microsome 微粒体microsyringe 微量注射器migration time 迁移时间millipore filtration 微孔过滤minimum fill 最低装量mobile phase 流动相modifier 改性剂，调节剂molecular formula 分子式monitor 检测，监测monochromator 单色器monographs 正文mortar 研钵moving belt interface 传送带接口multidimensional detection 多维检测multiple linear regression 多元线性回归multivariate calibration 多元校正natural product 天然产物Nessler glasses(tube) 奈斯勒比色管Nessler’s reagent 碱性碘化汞钾试液neutralization 中和nitrogen content 总氮量nonaqueous acid-base titration 非水酸碱滴定nonprescription drug, over the counter drugs (OTC drugs) 非处方药nonproprietary name, generic name 非专有名nonspecific impurity 一般杂质non-volatile matter 不挥发物normal phase 正相normalization 归一化法notice 凡例nujol mull method 石蜡糊法octadecylsilane chemically bonded silica 十八烷基硅烷键合硅胶octylsilane 辛（烷）基硅烷odorless 无臭official name 法定名official specifications 法定标准official test 法定试验on-column detector 柱上检测器on-column injection 柱头进样on-line degasser 在线脱气设备on the dried basis 按干燥品计opalescence 乳浊open tubular column 开管色谱柱optical activity 光学活性optical isomerism 旋光异构optical purity 光学纯度optimization function 优化函数organic volatile impurities 有机挥发性杂质orthogonal function spectrophotometry 正交函数分光光度法orthogonal test 正交试验orthophenanthroline 邻二氮菲outlier 可疑数据，逸出值overtones 倍频峰，泛频峰oxidation-reduction titration 氧化还原滴定oxygen flask combustion 氧瓶燃烧packed column 填充柱packing material 色谱柱填料palladium ion colorimetry 钯离子比色法parallel analysis 平行分析parent ion 母离子particulate matter 不溶性微粒partition coefficient 分配系数parts per million (ppm) 百万分之几pattern recognition 模式识别peak symmetry 峰不对称性peak valley 峰谷peak width at half height 半峰宽percent transmittance 透光百分率pH indicator absorbance ratio method pH指示剂吸光度比值法pharmaceutical analysis 药物分析pharmacopeia 药典pharmacy 药学phenolphthalein 酚酞photodiode array detector(DAD) 光电二极管阵列检测器photometer 光度计pipeclay triangle 泥三角pipet(te) 吸移管，精密量取planar chromatography 平板色谱法plate storage rack 薄层板贮箱polarimeter 旋光计polarimetry 旋光测定法polarity 极性polyacrylamide gel 聚丙酰胺凝胶polydextran gel 葡聚糖凝胶polystyrene gel 聚苯乙烯凝胶polystyrene film 聚苯乙烯薄膜porous polymer beads 高分子多孔小球post-column derivatization 柱后衍生化potentiometer 电位计potentiometric titration 电位滴定法precipitation form 沉淀形式precision 精密度pre-column derivatization 柱前衍生化preparation 制剂prescription drug 处方药pretreatment 预处理primary standard 基准物质principal component analysis 主成分分析programmed temperature gas chromatography 程序升温气相色谱法prototype drug 原型药物provisions for new drug approval 新药审批办法purification 纯化purity 纯度pyrogen 热原pycnometric method 比重瓶法quality control(QC) 质量控制quality evaluation 质量评价quality standard 质量标准quantitative determination 定量测定quantitative analysis 定量分析quasi-molecular ion 准分子离子racemization 消旋化radioimmunoassay 放射免疫分析法random sampling 随机抽样rational use of drug 合理用药readily carbonizable substance 易炭化物reagent sprayer 试剂喷雾器recovery 回收率reference electrode 参比电极refractive index 折光指数related substance 有关物质relative density 相对密度relative intensity 相对强度repeatability 重复性replicate determination 平行测定reproducibility 重现性residual basic hydrolysis method 剩余碱水解法residual liquid junction potential 残余液接电位residual titration 剩余滴定residue on ignition 炽灼残渣resolution 分辨率，分离度response time 响应时间retention 保留reversed phase chromatography 反相色谱法reverse osmosis 反渗透rider peak 驼峰rinse 清洗，淋洗robustness 可靠性，稳定性routine analysis 常规分析round 修约（数字）ruggedness 耐用性safety 安全性Sakaguchi test 坂口试验salt bridge 盐桥salting out 盐析sample applicator 点样器sample application 点样sample on-line pretreatment 试样在线预处理sampling 取样saponification value 皂化值saturated calomel electrode(SCE) 饱和甘汞电极selectivity 选择性separatory funnel 分液漏斗shoulder peak 肩峰signal to noise ratio 信噪比significant difference 显著性差异significant figure 有效数字significant level 显著性水平significant testing 显著性检验silanophilic interaction 亲硅羟基作用silica gel 硅胶silver chloride electrode 氯化银电极similarity 相似性simultaneous equations method 解线性方程组法size exclusion chromatography(SEC) 空间排阻色谱法sodium dodecylsulfate, SDS 十二烷基硫酸钠sodium hexanesulfonate 己烷磺酸钠sodium taurocholate 牛璜胆酸钠sodium tetraphenylborate 四苯硼钠sodium thiosulphate 硫代硫酸钠solid-phase extraction 固相萃取solubility 溶解度solvent front 溶剂前沿solvophobic interaction 疏溶剂作用specific absorbance 吸收系数specification 规格specificity 专属性specific rotation 比旋度specific weight 比重spiked 加入标准的split injection 分流进样splitless injection 无分流进样spray reagent （平板色谱中的）显色剂spreader 铺板机stability 稳定性standard color solution 标准比色液standard deviation 标准差standardization 标定standard operating procedure(SOP) 标准操作规程standard substance 标准品stationary phase coating 固定相涂布starch indicator 淀粉指示剂statistical error 统计误差sterility test 无菌试验stirring bar 搅拌棒stock solution 储备液stoichiometric point 化学计量点storage 贮藏stray light 杂散光substituent 取代基substrate 底物sulfate 硫酸盐sulphated ash 硫酸盐灰分supercritical fluid chromatography(SFC) 超临界流体色谱法support 载体（担体）suspension 悬浊液swelling degree 膨胀度symmetry factor 对称因子syringe pump 注射泵systematic error 系统误差system model 系统模型system suitability 系统适用性tablet 片剂tailing factor 拖尾因子tailing peak 拖尾峰tailing-suppressing reagent 扫尾剂test of hypothesis 假设检验test solution(TS) 试液tetrazolium colorimetry 四氮唑比色法therapeutic drug monitoring(TDM) 治疗药物监测thermal analysis 热分析法thermal conductivity detector 热导检测器thermocouple detector 热电偶检测器thermogravimetric analysis(TGA) 热重分析法thermospray interface 热喷雾接口The United States Pharmacopoeia(USP) 美国药典The Pharmacopoeia of Japan(JP) 日本药局方thin layer chromatography(TLC) 薄层色谱法thiochrome reaction 硫色素反应three-dimensional chromatogram 三维色谱图thymol 百里酚（麝香草酚）（指示剂）thymolphthalein 百里酚酞（麝香草酚酞）（指示剂）thymolsulfonphthalein ( thymol blue) 百里酚蓝（麝香草酚蓝）（指示剂）titer, titre 滴定度time-resolved fluoroimmunoassay 时间分辨荧光免疫法titrant 滴定剂titration error 滴定误差titrimetric analysis 滴定分析法tolerance 容许限toluene distillation method 甲苯蒸馏法toluidine blue 甲苯胺蓝（指示剂）total ash 总灰分total quality control(TQC) 全面质量控制traditional drugs 传统药traditional Chinese medicine 中药transfer pipet 移液管turbidance 混浊turbidimetric assay 浊度测定法turbidimetry 比浊法turbidity 浊度ultracentrifugation 超速离心ultrasonic mixer 超生混合器ultraviolet irradiation 紫外线照射undue toxicity 异常毒性uniform design 均匀设计uniformity of dosage units 含量均匀度uniformity of volume 装量均匀性（装量差异）uniformity of weight 重量均匀性（片重差异）validity 可靠性variance 方差versus …对…，…与…的关系曲线viscosity 粘度volatile oil determination apparatus 挥发油测定器volatilization 挥发法volumetric analysis 容量分析volumetric solution(VS) 滴定液vortex mixer 涡旋混合器watch glass 表面皿wave length 波长wave number 波数weighing bottle 称量瓶weighing form 称量形式weights 砝码well-closed container 密闭容器xylene cyanol blue FF 二甲苯蓝FF（指示剂）xylenol orange 二甲酚橙（指示剂）zigzag scanning 锯齿扫描zone electrophoresis 区带电泳zwitterions 两性离子zymolysis 酶解作用。
VALIDATION OF COMPENDIAL PROCEDURES药典方法的验证Test procedures for assessment of the quality levels of pharmaceutical articles are subject to various requirements. According to Section 501 of the Federal Food, Drug, and Cosmetic Act, assays and specifications in monographs of the United States Pharmacopeia and the National Formulary constitute legal standards. The Current Good Manufacturing Practice regulations [21 CFR 211.194(a)] require that test methods, which are used for assessing compliance of pharmaceutical articles with established specifications, must meet proper standards of accuracy and reliability. Also, according to these regulations [21 CFR 211.194(a)(2)], users of analytical methods described in USP NF are not required to validate the accuracy and reliability of these methods, but merely verify their suitability under actual conditions of use. Recognizing the legal status of USP and NF standards, it is essential, therefore, that proposals for adoption of new or revised compendial analytical procedures be supported by sufficient laboratory data to document their validity.用于评估药品质量的检验方法需要满足不同的要求。
2.6.1. STERILITY2.6.1 无菌检查法The test is applied to substances, preparations or articles which, according to the Pharmacopoeia, are required to be sterile. However, a satisfactory result only indicates that no contaminating micro-organism has been found in the sample examined in the conditions of the test.本检查方法适用于按照药典要求应当无菌的原料、制剂或其他物质。
但是，如果按照本无菌检查法的结果符合要求，仅表明在该检查条件下未发现微生物污染。
PRECAUTIONS AGAINST MICROBIAL CONTAMINATION微生物污染防范The test for sterility is carried out under aseptic conditions. In order to achieve such conditions, the test environment has to be adapted to the way in which the sterility test is performed. The precautions taken to avoid contamination are such that they do not affect any micro-organisms which are to be revealed in the test. The working conditions in which the tests are performed are monitored regularly by appropriate sampling of the working area and by carrying out appropriate controls.无菌检测试验应在无菌的条件下进行。
药物分析专业词汇中英文对照绪论释药系统（drug delivery system，DDS）中国药典（Chinese Pharmacopoeia,ChP）美国药典（The United States Pharmacopoeia,USP）美国国家处方集（The National Formulary,NF）英国药典（British Pharmacopoeia,BP）欧洲药典（European Pharmacopoeia,Ph.Eup）国际药典（The International Pharmacopoeia,Ph.Int）良好药品实验研究规范（Good Laboratory Practice,GLP）良好药品生产规范(Good Manufacture Practice,GMP)良好药品供应规范(Good Supply Practice,GSP)良好药品临床试验规范(Good Clinical Practice,GCP)分析质量管理(Analytical Quality Control,AQC)第1章药物的鉴别试验药物的鉴别试验identification test一般鉴别试验general identification test专属鉴别试验specific identification test灵敏度sensitivity最低检出量minimum detectable quantity最低检出浓度minimum detectable concentration第2章药物的杂质检查巯基醋酸mercaptoacetic acid古蔡氏Gutzeit二乙基二硫代氨基甲酸银siliver diethyldithio-carbamate硫酸灰分sulphated ash炽灼残渣residue on ignition热重分析法thermogravimetric analysis,TGA差示热分析法differential thermal analysis,DTA差示扫描量热法differential scanning calorimetry,DSC碱性酒石酸铜试验Fehling’s reagent异红紫酸盐isopurpurate2，3-二氨基萘2,3-diaminonaphthalene4，5-苯并苯硒二唑4，5-benzopiazselenol第3章定量分析样品前处理与测定方法的效能指标汞齐化法amalgamation method氧瓶燃烧法oxygen flask combustion method葡萄糖醛酸甙glucuronides硫酸酯sulphates血浆plasma血清serum全血whole blood治疗药物浓度监测therapeutic drug monitoring,TDM结合bound游离free缀合物conjugate l液-液提取法liquid-liquid extraction,LLE离子对试剂ion pair reagent离子对提取法ion pair extraction method反离子counter液-固提取法liquid-solid extraction LSE半自动样品制备系统advanced automated sample processor,AASP 烷基化alkylations酰基化acylations L硅烷化silylations精密度precision标准差standard deviation,SD orS相对标准差relative standard deviation变异系数coefficient of variation,批内精密度within-run precision日内精密度within-day precision批间精密度between-run precision日间精密度day to day precision准确度accuracy定量限limit of quantitation,LOQ检测限limit of detection,LOD选择性selectivity专属性specificity线性与范围linearity and range重现性ruggedness耐用性robustness散布图scatter diagram+y r:L!z7\9^'T3l'h*M荧光偏振免疫测定法fluorescence polarization immunoassay第4章巴比妥类药物的分析溴化十六烷基三甲基苄铵cetyltrimethylbenzylammonium bromide，CTMA 氯化四癸基二甲基苄铵T etradacyldimethybenzylammonium chloride，TDBA第5章芳酸及其酯类药物的分析苯甲酸及其钠盐benzoic acid and sodium benzoate布美他尼bumetanide羟苯乙酯ethylparoben丙磺舒probenecid酚黄乙胺etamsylate第6章胺类药物的分析第7章杂环类药物的分析二硝基氯苯反应Vongerichten反应戊烯二醛反应反应第8章生物碱类药物的分析生物碱alkaloids阿片gum opium扫尾剂tailing-suppressing reagent蒂巴因thebaine诺司卡品noscapine竞争离子competing ions亲脂性lipophicity拖尾因子tailing factor金刚烷adamantane第9章维生素类药物的分析维生素vitamin去氢维生素A dehydroretinol去水维生素A anhydroretinol鲸醇kitol三氯化锑反应Carr-Price反应维生素B1 thiamine hydrochloride；盐酸硫胺2，3，5-三苯基氯化四氮唑2，3，5-triphenyltetrazolium chlorid，TTC红四氮唑red tetrazoline，RT蓝四氮唑blue tetrazoline，BT3，3’-二甲基氧苯基-双-4，4’-（3，5-二苯基）氯化四氮唑{3，3’-dianisole-bis[4，4’-（3，5-dipheny）tetrazolium chloride]}有色甲……formazan铁-酚试剂iron-phenol reagente铁-柯柏试剂iron-Kober reagent南药07药理复试题一、名词解释（5分*10）1、一级动力学消除；2、非竞争性拮抗剂；3、动作电位时程；4、前致癌物；5、初次接触效应；6、synergism；7、mutation；8、GLP；9、acute toxicity；10、uptake1。
（附录Ⅰ制剂通则）Appendix ⅠGeneral Requirements for Prearations（丸剂）ⅠA Pills丸剂系指药材细粉或药材提取物加适宜的黏合剂或其他辅料制成的珠形或类球形制剂，分为蜜丸、水蜜九、水丸、糊丸、蜡丸和浓缩丸等类型。
Pills are spherical or spherical-like solid dosage forms made of finely powdered crude drugs or crude drug extracts, proper binders or other excipients. They are classified into honeyed pills, water-honeyed pills, watered pills, pasted pills, concentrated pills waxed pills and concentrated pills etc.蜜丸系指药材细粉以蜂蜜为黏合剂制成的丸剂。
其中每丸重量在0.5g( 含0.5g)以上的称大蜜丸，每丸重量在0.5以下的称小蜜丸。
Honeyed pills are made of fine powder of crude drugs, using honey as binder. Among them, pills weighing more than 0.5g (including 0.5g) per pill are big honeyed pills, pills weighing less than 0.5g per pill are small honeyed pills.水蜜丸系指药材细粉以蜂蜜和水为黏合剂制成的丸剂。
Water-honeyed pills are made of fine powder of crude drugs, using honey and water as binders.水丸系指药材细粉以水（或根据制法用黄酒、醋、稀药汁、糖液等）为黏合剂制成的丸剂。
常用药品检验与分析专业英语中国药典：Chinese Pharmacopoeia,ChP美国药典：The United States Pharmacopoeia,USP美国国家处方集：The National Formulary,NF英国药典：British Pharmacopoeia,BP欧洲药典：European Pharmacopoeia,Ph.Eup国际药典：The International Pharmacopoeia,Ph.Int释药系统：drug delivery system，DDS良好药品实验研究规范：Good Laboratory Practice,GLP良好药品生产规范：Good Manufacture Practice,GMP良好药品供应规范：Good Supply Practice,GSP良好药品临床试验规范：Good Clinical Practice,GCP分析质量管理：Analytical Quality Control,AQC药物的鉴别试验identification test一般鉴别试验general identification test专属鉴别试验specific identification test灵敏度sensitivity最低检出量minimum detectable quantity最低检出浓度minimum detectable concentration炽灼残渣residue on ignition定性分析：qualitative analysis定量分析：quantitative analysis质量控制：quality control(QC)容量滴定法：volumetric precipitation method 重量分析法：gravimetric analysis精密度：precision标准偏差：standard deviation,SD orS相对标准偏差：relative standard deviation,RSD 变异系数：coefficient of variation,CV批内精密度：within-run precision日内精密度：within-day precision批间精密度：between-run precision日间精密度：day to day precision准确度：accuracy定量限：limit of quantitation,LOQ检测限：limit of detection,LOD选择性：selectivity专属性：specificity线性与范围：linearity and range重现性：ruggedness耐用性：robustness误差传递：propagation of error空白试验：blank test对照试验：contrast test平行测定：replicate determination继沉淀：postprecipitation共沉淀：coprecipitation化学因数：chemical factor色谱法（层析法）：chromatography固定相：stationary phase流动相：mobile phase差示热分析法：differential thermal analysis,DTA 氧瓶燃烧法：oxygen flask combustion method治疗药物浓度监测：therapeutic drug monitoring,TDM 液-液提取法：liquid-liquid extraction,LLE液-固提取法：liquid-solid extraction LSE标准溶液：standard solution碘量法：iodimetry溴酸钾法：potassium bromate method重铬酸钾法：potassium dichromate method高锰酸钾法：potassium permanganate method平板色谱法：plane chromatography纸色谱法：paper chromatography薄层色谱法：thin layer chromatography,TLC分配色谱法：partition chromatography吸附色谱法：adsorpion chromaography离子交换色谱法：ion exchange chromatography,IEC 分配系数：distribution cofficient交联度：degree of cross linking交换容量：exchange capacity薄层板：thin layer plate展开剂：developing solvent ,developer相对比移值：relative Rf, Rr。
国际药品注册翻译医药翻译网的国际药品注册翻译译员多毕业于国内外著名医科大学，并在各自的国际药品注册翻译领域有过丰富翻译经验。
国际药品注册翻译人员都经过严格测试，大多有国外留学、工作经历，具有良好的国际药品注册翻译能力。
国际药品注册翻译网项目组成员对国际药品注册翻译的文化背景、语言习惯、专业术语等有深入的把握。
医药翻译网鼎力提供每位国际药品注册翻译客户质量最高、速度最快的国际药品注册翻译。
医药翻译网凭借严格的质量控制体系、规范化的运作流程和独特的审核标准已为各组织机构及来自全球的医药公司提供了高水准的国际药品注册翻译，不少的医药公司还跟我们签定了长期合作协议。
国际药品注册翻译的质量和速度质量是企业生存和发展的根本，为确保国际药品注册翻译的准确性，项目的全过程如下：一、庞大国际药品注册翻译团队保证各类国际药品注册翻译稿件均由专业人士担任。
二、规范化的国际药品注册翻译流程。
从获得资料的开始到交稿全过程进行质量的全面控制，并同时做到高效率，快速度的原则。
三、及时组建若干翻译小组，分析各项要求，统一专业词汇，确定语言风格，译文格式要求。
四、国际药品注册翻译均有严格的语言和专业技术双重校对。
从初稿的完成到统稿，从校对到最终审核定稿，甚至词汇间的细微差别也力求精确。
五、不间断的进行招聘，充足的人力资源不断汇集国际药品注册翻译界的精英和高手。
不断对内部及外聘国际药品注册翻译人员进行系统的再培训工程。
六、曾6 小时翻译4.5 万字的速度客户所需。
七、有效沟通。
国际药品注册翻译大项目组协调各方面工作：高级项目经理项目经理（Project Manager)翻译（Translation）编辑（Editing）校对（Profreading）质量控制（Quality Assurance）国际药品注册翻译技术配备一、制作部配备有先进的计算机处理设备，多台扫描仪、打印机、光盘刻录机、宽带网络接入、公司拥有独立的服务器，各项领先技术确保所有文件系统化处理和全球同步传输。
美国药典USP31-71-⽆菌检查法-双语版美国药典USP31-NF26⽆菌检查法《71》.doc71 STERILITY TESTS ⽆菌检查法Portions of this general chapter have been harmonized with the corresponding texts of the European Pharmacopeia and/or the Japanese Pharmacopeia. Those portions that are not harmonized are marked with symbols () to specify this fact.此通则的各部分已经与欧洲药典和/或⽇本药典的对应部分做了协调。
不⼀致的部分⽤符号（）来标明。
The following procedures are applicable for determining whether a Pharmacopeial article purporting to be sterile complies with the requirements set forth in the individual monograph with respect to the test for sterility. Pharmacopeial articles are to be tested by the Membrane Filtration method under Test for Sterility of the Product to be Examined where the nature of the product permits. If the membrane filtration technique is unsuitable, use the Direct Inoculation of the Culture Medium method under Test for Sterility of the Product to be Examined. All devices, with the exception of Devices with Pathways Labeled Sterile, are tested using the Direct Inoculation of the Culture Medium method. Provisions for retesting are included under Observation and Interpretation of Results.下⾯这些步骤适⽤于测定是否某个⽤于⽆菌⽤途的药品是否符合其具体的各论中关于⽆菌检查的要求。
药典四部通则英文（实用版）目录1.药典四部的概念与组成2.药典四部的英文翻译3.通则的定义及其在药典中的作用4.药典四部通则的英文内容概述正文药典是药品质量标准的重要参考书，其中药典四部是我国药品标准的核心组成部分，包括一部中药、二部化学药品、三部生物制品和四部放射性药品。
药典四部详细规定了各类药品的质量标准、检验方法、生产工艺等内容，对保证药品质量和公众用药安全具有重要意义。
药典四部的英文翻译为 "Pharmacopoeia Four Parts", 其中"Pharmacopoeia" 是药典的意思，"Four Parts" 则表示四部。
英文翻译为 "Chinese Pharmacopoeia" 的是整个中国药典，包括四部在内的所有内容。
通则是药典中的一种章节，主要规定了药品质量评价的一般原则、检验方法、限度等内容。
通则在药典中起到提纲挈领的作用，是各类药品质量标准的基础。
在药典四部中，通则主要集中在第一部中药和第二部化学药品中，对药品的质量评价和检验具有重要指导意义。
药典四部通则的英文内容概述主要包括以下几个方面：一是药品质量评价的一般原则，如纯度、均匀性、稳定性等；二是药品的检验方法，如化学分析、仪器分析、生物检验等；三是药品的质量限度，如含量、杂质、重金属等。
这些内容在药典四部通则中都有详细的英文规定，为药品质量标准的实施提供了重要依据。
综上所述，药典四部是我国药品质量标准的核心组成部分，其中包括中药、化学药品、生物制品和放射性药品的质量标准、检验方法、生产工艺等内容。
通则是药典中的重要章节，对药品质量评价和检验具有重要指导意义。
药典四部通则的英文内容概述主要包括药品质量评价的一般原则、检验方法、质量限度等。
