药品行业词汇表

1、药品行业词汇表英文中文翻译英文中文翻译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 stud

2、ies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

3、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

4、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

5、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 materialAPI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-contaminat

6、ion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Valida

7、tion 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 ma

8、nagement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Requi

9、rements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Chan

10、ge 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 valueD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 proc

11、essing 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Steriliz

12、ing 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

13、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Rea

14、ctor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

15、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 holderDMF 持有者CFR（美国）联邦法规Panel专家小组A

16、NDA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

17、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