制药工程专业英语单词

A: antibiotic 抗生的；抗生素antibody 抗体adverse 不利的相反的antitumour 抗癌的asymmetric 不对称的acute 急性的administration 管理,（药的）服法availability 有效性,效力antagonize 拮抗aroma 芳香化合物anticancer 抗癌的a steady-state blood or tissue level稳定态的血液或组织水平B: benzene 苯bioavailability 生物利用度biotechnologic 生物技术的bioengineered 生物工程的C: Caffeine 咖啡因clinical 临床的capsule 胶囊chronic 慢性的chromogenic 发色的colorimetric 比色的coagulate 凝结chirality 手性的controlled release 控释D: dimeric 二聚的dosage 配药剂量digestion 消化力degradation 降解,退化degradation 退化,降级demineralize 去离子E: enzyme 酶extraction 萃取提取ether 醚excretion 排泄分泌efficacy 效用,效验expiration 截止enantiomer 对应异构体F: fermentation 发酵fractionation 分馏G: glucose 葡萄糖glycoside 苷,配糖类gastrointestinal 肠胃道的GMP 药品生产质量管理规范GI tract 肠胃系统H: hormone 激素hypotension 低血压heparin 肝素I: insulin 胰岛素interferon 干扰素intermediate 中间体interdependent 互相依赖的impurity 杂质intestinal 肠的interact 相互作用in vivo/in vitro environment在体内的/体外的环境L: lactone 内酯leach 滤取N: nitrate 硝酸盐nutrient 营养的M：Morphine 吗啡O: optimize 优化onset 开始反应P: pharmaceutical 制药的plasma 血浆pharmacokinetics 药物动力学penicillin 青霉素preclinical 潜伏期的prescription 处方,规定pharmacologically 药理的preservation 保存precipitation 沉淀phosphate 磷酸盐peroral 经口的preservative 防腐的；防腐剂pharmacognosist 生药学家pathology 病理学R: recrystallization 重结晶residue 渣滓racemate 外消旋体rational 理性的S: serum 血浆sterile 无细菌的syrup 糖浆suspension 悬浊液sustain 维持synergies 药的协同作用steroid 甾体化合物sedimentary 沉积的stoichiometric 化学计量的sustained release 缓释systemic effects 系统效应T: therapeutical 治疗学的Toluene 甲苯tumour 肿瘤topical （医）局部的tablet 药片,片剂turbidity 浊度V：valid expiration dates 有效截止日期W: World Health Organization 世界卫生组织（WTO）X: xylene 二甲苯A: antibiotic 抗生的；抗生素antibody 抗体adverse 不利的相反的antitumour 抗癌的asymmetric 不对称的acute 急性的administration 管理,（药的）服法availability 有效性,效力antagonize 拮抗aroma 芳香化合物anticancer 抗癌的a steady-state blood or tissue level稳定态的血液或组织水平B: benzene 苯bioavailability 生物利用度biotechnologic 生物技术的bioengineered 生物工程的C: Caffeine 咖啡因clinical 临床的capsule 胶囊chronic 慢性的chromogenic 发色的colorimetric 比色的coagulate 凝结chirality 手性的controlled release 控释D: dimeric 二聚的dosage 配药剂量digestion 消化力degradation 降解,退化degradation 退化,降级demineralize 去离子E: enzyme 酶extraction 萃取提取ether 醚excretion 排泄分泌efficacy 效用,效验expiration 截止enantiomer 对应异构体F: fermentation 发酵fractionation 分馏G: glucose 葡萄糖glycoside 苷,配糖类gastrointestinal 肠胃道的GMP 药品生产质量管理规范GI tract 肠胃系统H: hormone 激素hypotension 低血压heparin 肝素I: insulin 胰岛素interferon 干扰素intermediate 中间体interdependent 互相依赖的impurity 杂质intestinal 肠的interact 相互作用in vivo/in vitro environment在体内的/体外的环境L: lactone 内酯leach 滤取N: nitrate 硝酸盐nutrient 营养的M：Morphine 吗啡O: optimize 优化onset 开始反应P: pharmaceutical 制药的plasma 血浆pharmacokinetics 药物动力学penicillin 青霉素preclinical 潜伏期的prescription 处方,规定pharmacologically 药理的preservation 保存precipitation 沉淀phosphate 磷酸盐peroral 经口的preservative 防腐的；防腐剂pharmacognosist 生药学家pathology 病理学R: recrystallization 重结晶residue 渣滓racemate 外消旋体rational 理性的S: serum 血浆sterile 无细菌的syrup 糖浆suspension 悬浊液sustain 维持synergies 药的协同作用steroid 甾体化合物sedimentary 沉积的stoichiometric 化学计量的sustained release 缓释systemic effects 系统效应T: therapeutical 治疗学的Toluene 甲苯tumour 肿瘤topical （医）局部的tablet 药片,片剂turbidity 浊度V：valid expiration dates 有效截止日期W: World Health Organization 世界卫生组织（WTO）X: xylene 二甲苯A: antibiotic 抗生的；抗生素antibody 抗体adverse 不利的相反的antitumour 抗癌的asymmetric 不对称的acute 急性的administration 管理,（药的）服法availability 有效性,效力antagonize 拮抗aroma 芳香化合物anticancer 抗癌的a steady-state blood or tissue level稳定态的血液或组织水平B: benzene 苯bioavailability 生物利用度biotechnologic 生物技术的bioengineered 生物工程的C: Caffeine 咖啡因clinical 临床的capsule 胶囊chronic 慢性的chromogenic 发色的colorimetric 比色的coagulate 凝结chirality 手性的controlled release 控释D: dimeric 二聚的dosage 配药剂量digestion 消化力degradation 降解,退化degradation 退化,降级demineralize 去离子E: enzyme 酶extraction 萃取提取ether 醚excretion 排泄分泌efficacy 效用,效验expiration 截止enantiomer 对应异构体F: fermentation 发酵fractionation 分馏G: glucose 葡萄糖glycoside 苷,配糖类gastrointestinal 肠胃道的GMP 药品生产质量管理规范GI tract 肠胃系统H: hormone 激素hypotension 低血压heparin 肝素I: insulin 胰岛素interferon 干扰素intermediate 中间体interdependent 互相依赖的impurity 杂质intestinal 肠的interact 相互作用in vivo/in vitro environment在体内的/体外的环境L: lactone 内酯leach 滤取N: nitrate 硝酸盐nutrient 营养的M：Morphine 吗啡O: optimize 优化onset 开始反应P: pharmaceutical 制药的plasma 血浆pharmacokinetics 药物动力学penicillin 青霉素preclinical 潜伏期的prescription 处方,规定pharmacologically 药理的preservation 保存precipitation 沉淀phosphate 磷酸盐peroral 经口的preservative 防腐的；防腐剂pharmacognosist 生药学家pathology 病理学R: recrystallization 重结晶residue 渣滓racemate 外消旋体rational 理性的S: serum 血浆sterile 无细菌的syrup 糖浆suspension 悬浊液sustain 维持synergies 药的协同作用steroid 甾体化合物sedimentary 沉积的stoichiometric 化学计量的sustained release 缓释systemic effects 系统效应T: therapeutical 治疗学的Toluene 甲苯tumour 肿瘤topical （医）局部的tablet 药片,片剂turbidity 浊度V：valid expiration dates 有效截止日期W: World Health Organization 世界卫生组织（WTO）X: xylene 二甲苯知识改变命运1 / 1。

制药行业一些英语词汇总结FDA（Food and drug administration ）：（美国国家）食品药品管理局IND（Investigation new drug）：临床研究申请（指申报阶段，相对于NDA而言）；研究中的新药（指新药开发阶段，相对于新药而言，即临床前研究结束）NDA（New drug application）：新药申请ANDA（Abbreviated New drug application）：简化新药申请EP诉（Export application）：出口药申请（申请出口不被批准在美国销售的药品）Treatment IND：研究中的新药用于治疗Abbreviated New drug：简化申请的新药DMF（Drug master file）：药物主文件（持有者为谨慎起见而准备的保密资料，可以包括一个或多个人用药物在制备、加工、包装和贮存过程中所及的设备、生产过程或物品。

只有在DMF持有者或授权代表以授权书的形式授权给FDA，FDA在审查IND、NDA、ANDA时才能参考其内容）Holder：DMF持有者CFR（Code of federal regulation）：（美国）联邦法规Panel：专家小组Batch production：批量生产；分批生产Batch production records：生产批号记录Post-or Pre- market surveillance：销售前或销售后监督Informed consent：知情同意（患者对治疗或受试者对医疗试验了解后表示同意接受治疗或试验）Prescription drug：处方药OTC drug（over—the—counter drug）：非处方药U．S．Public Health Service：美国卫生福利部NIH（NATIONAL INSTITUTE OF HEALTH）：（美国）全国卫生研究所Clinical trial：临床试验Animal trial：动物试验Accelerated approval：加速批准Standard drug：标准药物Investigator：研究人员；调研人员Preparing and Submitting：起草和申报Submission：申报；递交Benefit（S）：受益Risk (S）：受害Drug substance：原料药Established name：确定的名称Generic name：非专利名称Proprietary name：专有名称；INN（international nonproprietary name）：国际非专有名称Narrative summary记叙体概要Adverse effect：副作用Adverse reaction：不良反应Archival copy：存档用副本Review copy：审查用副本Official compendium：法定药典（主要指USP、NF）．USP（The united states Pharmacopeia）：美国药典（现已和NF合并一起出版）NF（National formulary）：（美国）国家药品集OFFICIAL＝Pharmacopeia = COMPENDIAL：药典的；法定的；官方的Agency：审理部门（指FDA等）Sponsor：主办者（指负责并着手临床研究者）Identity：真伪；鉴别；特性Strength：规格；规格含量（每一剂量单位所含有效成分的量）Labeled amount：标示量Regulatory specification：质量管理规格标准（NDA 提供）Regulatory methodology：质量管理方法（FDA用于考核原料药或药物产品是否符合批准了的质量管理规格标准的整套步骤）Regulatory methods validation：管理用分析方法的验证（FDA对NDA提供的方法进行验证）Dietary supplement：食用补充品COS/CEP 欧洲药典符合性认证ICH （International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals forHuman Use)人用药物注册技术要求国际协调会议Acceptance Criteria: 接收标准(接收测试结果的数字限度、范围或其它合适的量度标准) Active Pharmaceutical Ingredient (API) (or Drug Substance): 活性药用成分(原料药)旨在用于药品制造中的任何一种物质或物质的混合物，而且在用于制药时，成为药品的一种活性成分。

medicinal药品,药物, 药的,药用的，治疗的medical 医学的，医术的pharmaceutical 药学的，制药的，药品be split into 分成，分为alkaloid 生物碱enzyme 酶polysaccharide 多糖，多聚糖precursor 前体steroid甾体peptide 肽hormone 激素gall 胆汁insulin 胰岛素pancreas胰腺serum/sera血清，浆液vaccine 疫苗cholesterol 胆固醇gelatine 骨胶，明胶antibiotic 抗生素，抗菌的interferon 干扰素antibody 抗体fermentation 发酵therapy 治疗/ therapeutic治疗的therapeutic margin caffeine咖啡因dopamine多巴胺yeast 酵母mucous membrane粘液的，分泌粘液的plasma 血浆，淋巴液，等离子体penicillin 青霉素penicillium 青霉菌derivative衍生物sterile无菌的，不能生育的aerobic 需氧的oxygen feedstuff 饲料lymph淋巴，淋巴液starch 淀粉regiospecific reaction区域专一性反应stereospecific reaction立体专一性反应glucose葡萄糖immobilize 固定heterogeneous 不均匀的，多相的contamination污染genetic 创始的，遗传学的hygienic 卫生学的，卫生的intermediate中间体extraction 萃取recrystallization 重结晶/ crystal 晶体，晶体的xylene 二甲苯toluene 甲苯ether 醚synthesize 综合，合成benzene苯/ chlorobenzene氯苯synthetic, 合成的，人造的；化学合成品synthesis [复syntheses] 综合,综合物，合成(法)semisynthetic, lead structure先导结构preparation 制备，制剂isolate使分离，使离析/ isolation heart glycoside tocopherol 生育酚hydrolysis水解/hydrolysate水解产物/hydrolyze水解hydroxylation 羟基化dextran 葡聚糖，代血浆wool 羊毛 ーlactamβ-内酰胺amino acid 氨基酸/ amino 氨基的penicilamine 青霉胺ammonia 氨ammonium 铵/ ammonium sulfate硫酸铵amine 胺amide酰胺microorganism 微生物microbiological微生物学的mutant 变异的；突变型，突变体starting material 起始原料natural source天然来源organ器官/target organ 靶器官pancreas 胰腺natural product 天然产物mould 霉，霉菌；发霉high performance 高效bacterial 细菌的protein 蛋白质degradation 降解metabolism新陈代谢/ metabolize metabolite代谢物molecule /molecular weight food additive organiclactic acid乳酸citric acid 柠檬酸tetracycline 四环素carbon dioxide 二氧化碳carbohydrate 碳水化合物saccharide 糖/多糖polysaccharide nitrogen 氮urea 尿素phosphate 磷酸盐optimal 优化的，最佳的separate vt 分离absorption 吸收absorb vt. 吸收filtration 过滤filtrate 滤液filte 过滤（vt），过滤器（n）recombinant 重组的，重组子purification 纯化encode把(电文等)译成电码(或密码), 编码calcium 钙chromatographic procedure 色谱操作步骤isomerization异构化/isomeric phenol 酚fructose 果糖fumaric acid 富马酸countless test 非计数的diagnose诊断diagnostic analysis分析/analyze 分析vt / analyst分析家/ analytical分析的protease 蛋白酶Ingredient 成分in combination with 结合Digestion 消化。

（完整版）药学英语专业词汇一、药物分类及命名1. 抗生素（Antibiotics）青霉素（Penicillin）头孢菌素（Cephalosporins）大环内酯类（Macrolides）2. 抗病毒药物（Antiviral Drugs）抗流感病毒药物（Antiviral for Influenza）抗艾滋病病毒药物（Antiviral for HIV）3. 抗肿瘤药物（Anticancer Drugs）化疗药物（Chemotherapeutic Agents）靶向治疗药物（Targeted Therapy Drugs）4. 心血管系统药物（Cardiovascular Drugs）抗高血压药物（Antihypertensive Drugs）抗心绞痛药物（Antianginal Drugs）抗心律失常药物（Antiarrhythmic Drugs）5. 消化系统药物（Gastrointestinal Drugs）抗胃溃疡药物（Antigastric Ulcer Drugs）止泻药物（Antidiarrheal Drugs）泻药（Laxatives）6. 中枢神经系统药物（Central Nervous System Drugs）抗抑郁药物（Antidepressants）抗精神病药物（Antipsychotic Drugs）镇痛药物（Analgesics）二、药物剂型及给药途径1. 剂型（Dosage Forms）片剂（Tablets）胶囊（Capsules）注射剂（Injections）2. 给药途径（Routes of Administration）口服（Oral）肌内注射（Intramuscular）静脉注射（Intravenous）三、药物作用及不良反应1. 药物作用（Pharmacological Actions）抗菌作用（Antibacterial Action）抗病毒作用（Antiviral Action）镇痛作用（Analgesic Action）2. 不良反应（Adverse Reactions）过敏反应（Allergic Reactions）胃肠道反应（Gastrointestinal Reactions）肝脏毒性（Hepatotoxicity）四、药学专业英语词汇1. 药理学（Pharmacology）药物代谢（Drug Metabolism）药物动力学（Pharmacokinetics）药效学（Pharmacodynamics）2. 药剂学（Pharmaceutics）制剂工艺（Preparation Technology）药物稳定性（Drug Stability）药物质量控制（Drug Quality Control）3. 药物化学（Medicinal Chemistry）药物合成（Drug Synthesis）药物结构（Drug Structure）药物设计（Drug Design）本文档旨在帮助药学专业学生和从业者掌握药学英语专业词汇，提高专业英语水平，为学术交流和临床实践提供便利。

medicinal药品,药物, 药的,药用的 be split intopharmaceutical 药学的，制药的，药品 starting materialsynthetic, synthetics, synthesis, semisynthetic, synthesize,alkaloid 生物硷lead structure intermediateisolation natural sourceenzyme heart glycosidesteroid 甾体 precursor 前体organ/target organ peptidehormone 激素 insulinpancreas vaccinepolysaccharide serumcholesterol 胆固醇 amino acidgelatine hydrolysis水解/hydrolysate水解产物/hydrolyze水解hydroxylation antibiotic 抗生素，抗菌的antibody interferon 干扰素fermentation 发酵 dextran 葡聚糖ーlactam natural producttherapy/therapeutic治疗的/therapeutic margincaffeine咖啡因 yeastmicro b iological mutantmicroorganism geneticmould high performancebacterial proteinmucous membrane degradationmetabolism新陈代谢 metabolite代谢物plasma 血浆molecule /molecular weightfood additive organiclactic acid乳酸 citric acid 柠檬酸penicillin penicilliumtetracycline derivative衍生物contamination污染sterile无菌的aerobic oxygencarbon dioxide carbohydratestarch saccharide/ polysaccharideglucose葡萄糖 nitrogenureaPhosphate optimalammonium sulfate ammoniaseparate filtrateabsorption extractionrecombinant encodepurification chromatographic procedurecalcium regiospecific reaction区域专一性反应stereospecific reaction 立体专一性反应isomerization/isomeric fructosecountless test diagnose diagnosticanalysis/ analyst/ analytical/ analyze protease Ingredient in combination withDigestion enymatic cleavageBy means of fumaric acidBindimmobilize racemate /racemicacetyl heterogeneouscatalysis mediumester synthetic routeregistration compoundOrganometallic pyridinearomatic toluenexylene phenolrecrystallization/crystal methanol/ethanolacetone ethyl acetatebenzene/ chlorobenzene diethyl ethersodium hydroxide hydrochloric acidsulfuric acid nitric acidacetic acid potassium carbonatechlorine/ chloride iodine/iodidefluorine/ fluoride bromine/bromideimpurity quality certificateGMP hygienicin large amount facilityInspection analogousHygienic be subjected toadminister/administration biologic responsebiologic membrane to a large extentpenetration spatial arrangement pharmacologic stereochemistrythree-dimensional structure lipidstructure-activity relationship stericcorrelation parameterpartition coefficient distribution fuction conformation extraction排泄optical isomerism/optical isomer enantiomorphic/ enantiomorph by no means tartaric acidManually magnificationdrug design polarized light dextrorotatory levorotatory Clokwise countclockwiseAntipode nonsuperimposable mirror image Coincide with glyceraldehydeAbsolute literatureconfiguration crystallographyasymmetric center accessisomeric enantiomerdiastereoisomer atomic numberPrioritymagnification solubilityspatial sequencein vivo/in vitro receptorintravenous injection静脉注射 be susceptible to敏感的With respect to contractSubstrate epoxidationcarcinogen oxidation /oxidasepreparation predominantspecies complexdehydrase/dehydrogenase/decarboxylase/hydrolytic enzymes/isomerase/permease Choline one out of every ten 十分之一clinical 临床的 interactionexcrete/excretion inversionCoordination DelayEfficacy in place相称的，合适的entity drug developmentattrition toxicity/toxic/ toxicology/Anti-infectives Healthcarerepro-toxicology/genotoxicity drug candidateindication pharmacokinetics adverse profileformulary/formulation/fornulor onsetdose/once a day dosing dosage/dosage form/overdosage regulatory interdependentsubacute亚急性的/chronic clinical/preclinicalvital optimum/ optimizeimpurity pilot plantcritical path criteriaupdate in paralleladequate stabilitypotency shelf-lifedermal cardiovascular 心血管的respiratory nervousconcurrently labelsynergies 协同作用 antagonizereversible/irreversible permissiblelifespan diseasetumour inhalercapsule rodentfoetal teratologyexposure patchset-up hazardOn a large scale shelf-lifetannin caffeineIn common vacuum fitrationhomogeneous gallic acidhydroxyl group esterifyphenolic precipitatenon-hydrolyzable carboxyl groupacidic calcium carbonatechloroform flavonoiddistillation sublimationsalicylic acid three neck round bottom flask separatory funnel steam bathdistillation flask 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制药专业英语Accelerated testing 加速试验Reproducibility 重复性Climatic zones 气候带Detection limit 检测限Commitment batches 承诺批次Quantitation limit 定量限Container closure system 包装容器Linearity 线性Drug substance 原料药Range 范围Excipient 赋型剂Robustness 耐用性Expiration date 有效日期Chemical development studies 化学开发研究Formal stability studies 正式稳定性研究Enantiomeric impurity 异构体杂质Intermediate testing 中间试验Extraneous contaminant 外源性污染Long term testing 长期试验Identified impurity 鉴定的杂质New molecular entity 新分子实体Identified threshold 鉴定阙值（鉴定限）Primary batch 申报批次Impurity 杂质Production batch 大生产批次Impurity profile 杂质概况Re-test date 复检日期Intermediate 中间体Re-test period 复检期New drug substance 新原料药Specification 质量标准Precision 精密度Stress testing (drug substance) 强降解试验Repeatability 重复性Analytical procedure 分析方法Intermediate precision 中间精密度Accuracy 准确度Polymorphic form 多晶型Potential impurity 潜在杂质Combination product 复方制剂Qualification threshold 界定阙值（界定限）Chiral 手性Reagent 试剂Degradation product 降解产物Reporting threshold 报告阙值（报告限）Enantiomer 异构体Solvent 溶剂Identified impurity 鉴定杂质Specified impurity 特定杂质In-process tests 过程中检测Starting material 起始物料Polymorphism 多晶型Unidentified impurity 未鉴定杂质New drug substance 新原料药Acceptance criteria 可接受标准Racemate 外消旋体Permitted daily exposure 每日可接受药物中残留溶剂的最大摄入量Quality 质量Universal test 常规检测Specification 质量标准Acceptance criteria 可接受标准Solvent 溶剂Active pharmaceutical ingredient 药物活性组分（原料药）Specific test 专属性试验API starting material API起始物料 Specified impurity 特定杂质Batch 批Unidentified impurity 未鉴定杂质Batch number 批号Contract manufacturer 合同制造商Calibration 校验Critical 关键Computer system 计算机系统Cross-contamination 交叉污染Computerized system 计算机化系统Deviation 偏差Contamination 污染Expiry date 失效日期Lot 批In-process control 生产过程控制Lot number 批号Mother liquor 母液Packaging material 包装材料Reprocessing 再处理Material 物料Retest date 复测期Procedure 规程Reworking 返工Process aids 工艺辅助材料Signature(signed) 签名Process control 工艺控制Validation 验证Qualification 确认Validation protocol 验证方案Quality assurance 质量保证Yield, Expected 预期产量Quality control 质量控制Yield, Theoretical 理论产量Quality unit 质量部Design space 设计空间Production 生产Formal experimental design 正式实验设计Reference standard, primary 一级标准品Quarantine 待验Reference standard, secondary 二级标准品Raw material 原辅料Risk 风险Corrective action 纠正措施Risk management 风险管理Enabler 支持者Risk reduction 风险降低Key performance indicators 关键性能指标Decision maker 决策制定者Innovation 创新Detectability 检测能力Knowledge management 知识管理Product lifecycle 产品生命周期Pharmaceutical quality system 药品质量体系Quality risk management 质量风险管理Outsourced activities 外包活动Quality system 质量系统Preventive action 预防措施Requirements 要求Production realisation 产品实现Risk acceptance 风险认可Quality manual 质量手册Risk analysis 风险分析Quality planning 质量计划Risk assessment 风险评估Quality policy 质量方针Risk communication 风险通报Quality risk management 质量风险管理Risk control 风险控制Senior management 最高管理Risk evaluation 风险评价State of control 控制状态Risk identification 风险鉴定Change management 变更管理Risk review 风险回顾Trend 趋势Severity 严重性Continual improvement 持续改进Stakeholder 利益相关者Control strategy 控制策略Air lock 气锁 D value D值Alert level 警戒标准Dynamic 动态的Action level 纠偏标准Endotoxin 内毒素Aseptic manufacturing area 无菌生产区Gowning qualification 更衣确认Aseptic processing facility 无菌生产厂房HEPA filter 高效过滤器Aseptic processing room 无菌操作间HVAC 空调净化系统Asepsis 无菌（状态）Intervention 干预Bioburden 含氧菌（生物负荷）Isolator 隔离操作器Barrier 屏障Laminar flow 层流Biological indicator BI 生物指示剂Operator 操作人员Clean area 洁净区Overkill sterilization process 过度杀灭灭菌程序Component 组分Pyrogen 热原Colony Forming Unit(CFU) 菌落形成单位（菌落数）Sterile product 无菌产品Critical surface 关键区域Sterilizing filter 除菌过滤器Decontamination 去污染Quality control unit 质量部门Disinfection 消毒Unidirectional flow单向流Depyrogenation 去热原Terminal sterilization 最终灭菌Validation 验证ULPA filter 超低穿透过滤器Worse case 最差条件Vessel 管道Reaction 反应Vent排气口Tank 桶罐Tare 皮重Flush 冲洗Purified water 纯化水Gross weight 毛重Dry 干燥Unload 缷料centrifuge 离心机crystallize 结晶Rinse 漂洗Filtrate 过滤Precipitation 沉淀Separate 分离Adjust pH to 调节pH至Solvent 溶剂Transport container 周转桶Intermediate 中间体Organic layer 有机层Aqueous layer 水层Extraction 萃取Cleaning agent 清洁剂Vacuum distill 减压蒸馏Contamination 污染Hydrolyze 水解Residual 残留Time complete 终止时间G.L.R 搪玻璃反应器Time started 起始时间The stainless steel reactor 不锈钢反应器Condenser 冷凝器Reactor 反应釜Reflux 回流batch number 批号Heat 加热Preparation 制备Temperature 温度Charge 投料Net weight 净重Stir 搅拌Jacket 夹套Take a sample 取样Bottom valve 底阀Suck 吸入Sample retention 留样Recrystallization 重结晶Pressure 压力Spin dry 旋转干燥Purification 精制，提纯Monitor 监测Blending 混合Sponsor 主办者（指负责并着手临床研究者）Labeled amount 标示量Agency 审理部门（指FDA）Identity 真伪；鉴别；特性NF （美国）国家药品集USP 美国药典INN 国际非专有名称Protocol 方案Established name 确定的名称Adverse effect 副作用Preparing and submitting 起草和申报Benefit 受益Animal trial 动物试验Accelerated approval 加速批准Batch production record 生产批号记录POST-OR PRE- MARKET SURVEILLANCE 销售前或销售后监督Batch production 批量生产DMF holder DMF 持有者CFR （美国）联邦法规Panel 专家小组ANDA 简化新药申请DMF 药物主文件FDA （美国）食品药品管理局NDA 新药申请Adapter 接液管Air condenser 空气冷凝管Beaker 烧杯Crucible tongs 坩埚钳Boiling flask 烧瓶Condenser-Allihn type 球型冷凝管boiling flask-3-neck 三口烧瓶Condenser-west tube 直型冷凝管Burette clamp 滴定管夹Claisen distilling head 减压蒸馏头Burette stand 滴定架台Busher funnel 布氏漏斗Crucible with cover 带盖的坩埚Distilling head 蒸馏头Distilling tube 蒸馏管Erlenmeyer flask 锥型瓶Evaporating dish (porcelain) 瓷蒸发皿Filter flask(suction flask) 抽滤瓶Florence flask 平底烧瓶Fractionating column 分馏柱Geiser burette (stopcock) 酸氏滴定管graduated cylinder 量筒Hirsch funnel 赫氏漏斗Long-stem funnel 长颈漏斗Medicine dropper 滴管Mohr burette for use with pinchcock 碱氏滴定管Mohr measuring pipette 量液管Mortar 研钵Pestle 研杵Pinch clamp 弹簧节流夹Plastic squeeze bottle 塑料洗瓶Rubber pipette bulb 吸耳球Wide-mouth bottle 广口瓶Tripod 三角架Transfer pipette 移液管Watch glass 表皿volumetric flask 容量瓶Thiele melting point tube 提勒熔点管Test tube 试管Test tube holde 试管夹Separatory funnel 分液漏斗Stemless funnel 无颈漏斗Validation 验证Qualification/Verification 验证Stability 稳定性In compliance with 符合Active ingredients 主药Excipient 辅料Buffering agent 缓冲剂Towards lower limit 偏低限pH value 酸碱度Formulated amount 处方量。