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Extraneous contaminant外源性污染Long term testing長期試驗Identified impurity鑒定的雜質(zhì)New molecular entity新分子實體Identified threshold鑒定闕值（鑒定限）Primary batch申報批次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報告闕值（報告限）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Critical關(guān)鍵Computer system計算機(jī)系統(tǒng)Cross-contaminat

6、ion交叉污染Computerized system計算機(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驗證Qualification確認(rèn)Valida

7、tion protocol驗證方案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)計空間Production生產(chǎn)Formal experimental design正式實驗設(shè)計Reference standard, primary一級標(biāo)準(zhǔn)品Quarantine待驗Reference standard, secondary二級標(biāo)準(zhǔn)品Raw material原輔料Risk風(fēng)險Corrective action糾正措施Risk ma

8、nagement風(fēng)險管理Enabler支持者Risk reduction風(fēng)險降低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)品實現(xiàn)Risk acceptance風(fēng)險認(rèn)可Quality manual質(zhì)量手冊Risk analysis風(fēng)險分析Quality planning質(zhì)量計劃Risk assessment風(fēng)險評估Quality policy質(zhì)量方針Risk communication風(fēng)險通報Quality risk management質(zhì)量風(fēng)險管理Risk control風(fēng)險控制Senior management最高管理Risk evaluation風(fēng)險評價State of control控制狀態(tài)Risk identification風(fēng)險鑒定Chan

10、ge management變更管理Risk review風(fēng)險回顧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)危昏b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Benefit 受益Animal trial動物試驗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