藥品行業(yè)詞匯表

1、藥品行業(yè)詞匯表英文中文翻譯英文中文翻譯Accelerated testing加速試驗(yàn)Reproducibility重復(fù)性Climatic zones氣候帶Detection limit檢測限Commitment batches承諾批次Quantitation limit定量限Container closure system包裝容器Linearity線性Drug substance原料藥Range范圍Excipient賦型劑Robustness耐用性Expiration date有效日期Chemical development studies化學(xué)開發(fā)研究Formal stability stud

2、ies正式穩(wěn)定性研究Enantiomeric impurity異構(gòu)體雜質(zhì)Intermediate testing中間試驗(yàn)Extraneous contaminant外源性污染Long term testing長期試驗(yàn)Identified impurity鑒定的雜質(zhì)New molecular entity新分子實(shí)體Identified threshold鑒定闕值（鑒定限）Primary batch申報(bào)批次Impurity雜質(zhì)Production batch大生產(chǎn)批次Impurity profile雜質(zhì)概況Re-test date復(fù)檢日期Intermediate中間體Re-test period復(fù)

3、檢期New drug substance新原料藥Specification質(zhì)量標(biāo)準(zhǔn)Precision精密度Stress testing (drug substance)強(qiáng)降解試驗(yàn)Repeatability重復(fù)性Analytical procedure分析方法Intermediate precision中間精密度Accuracy準(zhǔn)確度Polymorphic form多晶型Potential impurity潛在雜質(zhì)Combination product復(fù)方制劑Qualification threshold界定闕值（界定限）Chiral手性Reagent試劑Degradation product降

4、解產(chǎn)物Reporting threshold報(bào)告闕值（報(bào)告限）Enantiomer異構(gòu)體Solvent溶劑Identified impurity鑒定雜質(zhì)Specified impurity特定雜質(zhì)In-process tests過程中檢測Starting material起始物料Polymorphism多晶型Unidentified impurity未鑒定雜質(zhì)New drug substance新原料藥Acceptance criteria可接受標(biāo)準(zhǔn)Racemate外消旋體Permitted daily exposure每日可接受藥物中殘留溶劑的最大攝入量Quality質(zhì)量Universal

5、test常規(guī)檢測Specification質(zhì)量標(biāo)準(zhǔn)Acceptance criteria可接受標(biāo)準(zhǔn)Solvent溶劑Active pharmaceutical ingredient藥物活性組分（原料藥）Specific test專屬性試驗(yàn)API starting materialAPI起始物料Specified impurity特定雜質(zhì)Batch批Unidentified impurity未鑒定雜質(zhì)Batch number批號Contract manufacturer合同制造商Calibration校驗(yàn)Critical關(guān)鍵Computer system計(jì)算機(jī)系統(tǒng)Cross-contaminat

6、ion交叉污染Computerized system計(jì)算機(jī)化系統(tǒng)Deviation偏差Contamination污染Expiry date失效日期Lot批In-process control生產(chǎn)過程控制Lot number批號Mother liquor母液Packaging material包裝材料Reprocessing再處理Material物料Retest date復(fù)測期Procedure規(guī)程Reworking返工Process aids工藝輔助材料Signature(signed)簽名Process control工藝控制Validation驗(yàn)證Qualification確認(rèn)Valida

7、tion protocol驗(yàn)證方案Quality assurance質(zhì)量保證Yield, Expected預(yù)期產(chǎn)量Quality control質(zhì)量控制Yield, Theoretical理論產(chǎn)量Quality unit質(zhì)量部Design space設(shè)計(jì)空間Production生產(chǎn)Formal experimental design正式實(shí)驗(yàn)設(shè)計(jì)Reference standard, primary一級標(biāo)準(zhǔn)品Quarantine待驗(yàn)Reference standard, secondary二級標(biāo)準(zhǔn)品Raw material原輔料Risk風(fēng)險(xiǎn)Corrective action糾正措施Risk ma

8、nagement風(fēng)險(xiǎn)管理Enabler支持者Risk reduction風(fēng)險(xiǎn)降低Key performance indicators關(guān)鍵性能指標(biāo)Decision maker決策制定者Innovation創(chuàng)新Detectability檢測能力Knowledge management知識管理Product lifecycle產(chǎn)品生命周期Pharmaceutical quality system藥品質(zhì)量體系Quality risk management質(zhì)量風(fēng)險(xiǎn)管理Outsourced activities外包活動Quality system質(zhì)量系統(tǒng)Preventive action預(yù)防措施Requi

9、rements要求Production realisation產(chǎn)品實(shí)現(xiàn)Risk acceptance風(fēng)險(xiǎn)認(rèn)可Quality manual質(zhì)量手冊Risk analysis風(fēng)險(xiǎn)分析Quality planning質(zhì)量計(jì)劃Risk assessment風(fēng)險(xiǎn)評估Quality policy質(zhì)量方針Risk communication風(fēng)險(xiǎn)通報(bào)Quality risk management質(zhì)量風(fēng)險(xiǎn)管理Risk control風(fēng)險(xiǎn)控制Senior management最高管理Risk evaluation風(fēng)險(xiǎn)評價(jià)State of control控制狀態(tài)Risk identification風(fēng)險(xiǎn)鑒定Chan

10、ge management變更管理Risk review風(fēng)險(xiǎn)回顧Trend趨勢Severity嚴(yán)重性Continual improvement持續(xù)改進(jìn)Stakeholder利益相關(guān)者Control strategy控制策略Air lock氣鎖D valueD值A(chǔ)lert level警戒標(biāo)準(zhǔn)Dynamic動態(tài)的Action level糾偏標(biāo)準(zhǔn)Endotoxin內(nèi)毒素Aseptic manufacturing area無菌生產(chǎn)區(qū)Gowning qualification更衣確認(rèn)Aseptic processing facility無菌生產(chǎn)廠房HEPA filter高效過濾器Aseptic proc

11、essing room無菌操作間HVAC空調(diào)凈化系統(tǒng)Asepsis無菌（狀態(tài)）Intervention干預(yù)Bioburden含氧菌（生物負(fù)荷）Isolator隔離操作器Barrier屏障Laminar flow層流Biological indicator BI生物指示劑Operator操作人員Clean area潔凈區(qū)Overkill sterilization process過度殺滅滅菌程序Component組分Pyrogen熱原Colony Forming Unit(CFU)菌落形成單位（菌落數(shù)）Sterile product無菌產(chǎn)品Critical surface關(guān)鍵區(qū)域Steriliz

12、ing filter除菌過濾器Decontamination去污染Quality control unit質(zhì)量部門Disinfection消毒Unidirectional flow單向流Depyrogenation去熱原Terminal sterilization最終滅菌Validation驗(yàn)證ULPA filter超低穿透過濾器Worse case最差條件Vessel管道Reaction反應(yīng)Vent排氣口Tank桶罐Tare皮重Flush沖洗Purified water純化水Gross weight毛重Dry干燥Unload缷料centrifuge離心機(jī)crystallize結(jié)晶Rinse漂

13、洗Filtrate過濾Precipitation沉淀Separate分離Adjust pH to調(diào)節(jié)pH至Solvent溶劑Transport container周轉(zhuǎn)桶Intermediate中間體Organic layer有機(jī)層Aqueous layer水層Extraction萃取Cleaning agent清潔劑Vacuum distill減壓蒸餾Contamination污染Hydrolyze水解Residual殘留Time complete終止時間搪玻璃反應(yīng)器Time started起始時間The stainless steel reactor不銹鋼反應(yīng)器Condenser冷凝器Rea

14、ctor反應(yīng)釜Reflux回流batch number批號Heat加熱Preparation制備Temperature溫度Charge投料Net weight凈重Stir攪拌Jacket夾套Take a sample取樣Bottom valve底閥Suck吸入Sample retention留樣Recrystallization重結(jié)晶Pressure壓力Spin dry旋轉(zhuǎn)干燥Purification精制，提純Monitor監(jiān)測Blending混合Sponsor 主辦者（指負(fù)責(zé)并著手臨床研究者）Labeled amount標(biāo)示量Agency 審理部門（指FDA）Identity 真?zhèn)?；鑒別；特

15、性NF（美國）國家藥品集USP美國藥典INN國際非專有名稱Protocol 方案Established name確定的名稱Adverse effect副作用Preparing and submitting起草和申報(bào)Benefit 受益Animal trial動物試驗(yàn)Accelerated approval加速批準(zhǔn)Batch production record生產(chǎn)批號記錄POST-OR PRE- MARKET SURVEILLANCE銷售前或銷售后監(jiān)督Batch production批量生產(chǎn)DMF holderDMF 持有者CFR（美國）聯(lián)邦法規(guī)Panel專家小組A

16、NDA簡化新藥申請DMF藥物主文件FDA（美國）食品藥品管理局NDA新藥申請Adapter接液管Air condenser空氣冷凝管Beaker燒杯Crucible tongs坩堝鉗Boiling flask燒瓶Condenser-Allihn type球型冷凝管boiling flask-3-neck三口燒瓶Condenser-west tube直型冷凝管Burette clamp滴定管夾Claisen distilling head減壓蒸餾頭Burette stand滴定架臺Busher funnel布氏漏斗Crucible with cover帶蓋的坩堝Distilling head蒸餾

17、頭Distilling tube蒸餾管Erlenmeyer flask錐型瓶Evaporating dish (porcelain)瓷蒸發(fā)皿Filter flask(suction flask)抽濾瓶Florence flask平底燒瓶Fractionating column分餾柱Geiser burette (stopcock)酸氏滴定管graduated cylinder量筒Hirsch funnel赫氏漏斗Long-stem funnel長頸漏斗Medicine dropper滴管Mohr burette for use with pinchcock堿氏滴定管Mohr measuring pipette量液管Mortar研缽Pestle研杵Pinch clamp彈簧節(jié)流夾Plastic squeeze bottle塑料洗瓶Rubber pipette bulb吸耳球Wide-mouth bottle廣口瓶Tripod三角架Transfer pipette移液管Watch glass表皿volumetric flask容