常用药学中英文词汇对照

1、生产工艺常用词汇:中文英文硫酸氢钠中性硼玻璃安瓿瓶安瓿瓶清洗Kan amyci n sulfate sodium bisulfate sodium citrate Sulfuric acid solutiNeutral borosilicate glass ampoule Ampoule washi ng安瓿瓶火菌除热源配料过滤灌封Ampoule depyroge natiBatch ingFiltrati onFilli ng and seali sterilizati onand火菌和检漏测试灯检贴签和包装 升温段传送带压差时间间隔 Sterilization and leakage te

2、st Visual / Lamp in spect ion Labeli ng and packag ing Critical Process Parameter heati ng sect ioncon veyor belt Differen tial pressure Time in tervalPore size of filter过滤压力灌 装 量 缓冲罐灌装前充氮保护真空检漏测试 内包材Filtrati on pressure Filli ng volume buffer tankpre-fill ing n itroge n flush post-fillingnitrogenov

3、erlay Vacuum leaktestPrimary packaging materialProcess in structio nLivzonGroupFuzhouFux Pharmaceutical Co.Ltd.HunanErkangPharmaceuticalCo.,HunanHuariPharmaceuticalCo.,LtdGuangzhouChemicalReagentFactory ZhuhaiDaLinWanIndustrialGasCo.,LtdSCHOTT Glass Tech nologies (Suzhou)Co. Ltdquality specificati C

4、irculati on water Rotati ngspeedQC 常用英文词汇中文外观溶液颜色 鉴别含量标 小 量 无菌薄膜过滤法内毒素英文Physical attributes Appeara nee Particulate matter Soluti on colorIdentificatiretentiontime AssayRelated substa nee labeled amount Visible particles SterilityMembrane filtration Bacterial en dotox insIn itial bioburde n stirring

5、 uniformity ashy toppoin ted endbubble head, flat head, broke n ampoule, crooked ampoule, empty ampoule;中文中文英文药品生产质量管理规范GMP: GoodManufacturingPractice国家食品与药品监督管理局State Food and DrugAdministration总则Gen eral Provisi ons制剂preparati on原料药API: Active PharmaceuticalIn gredie nt成品finishedgoods工序process机构与人

6、员orga ni zatio nandpers onnel专业知识professi onalknowledge生产经验producti onexperie nee组织能力orga ni zati onalskill技术人员tech ni calstaff实施药品生产质里官理质里检验impleme ntati onpharmaceuticalmanu facturi quality man ageme ntqualityin spect ion专业技术培训professionalandtechnicaltraining基础理论知识basictheoreticalknowledge高生物活性 咼毒

7、性污染考核评估 生产环境昆虫洁净室（区光滑无裂缝耐受消毒practical operati on highlypote nthigh toxicitycon tam in atiassessme ntbuildi ngs and facilities producti onen viro clean air levelin sectclean room(area) smoothno cracksno particle shedding tolera needis in fecti on无 菌 弧形储 存 区 设备物料待 验 品 管道公用设施照明照度应急，紧急情况净化sterile juncti

8、on, joint arcdust store area producti on scale equipme nt materialin termediate product quara nti ned material cross-c on tam in ati on pipeli neutilities of public servicelighting illumi natio emerge ncypurificati on, clea n微生物微生物学监测记录micro-orga nism, mon itori ng recordmicrobiology,microbiologic天棚

9、天花板ceili ng, roof密封seal温度地漏Static Differential temperatureRH: Relative Humidity floor dra inerPressure分装室相对负压废气separati ngroom,filli ng roomrelativen egativewaste gas, exhausted airB避孕药品激 素 类 包装微粒脱毒前后3 -Lactams structure drug con traceptiveshorm oneanti-tumor,on Radiopharmaceuticals pack ing, packag

10、e recycli ngparticles radiati on bacteria viruscellPre-detoxificationand postdetoxification活疫苗与灭活疫苗人血液制品预防制品灌装active vacci ne/in activated blood productspreve nti onproductsfilli ngvacc ine中 药 前处理提 取 浓缩Chin esetraditipretreatme nt extractio nconcen trati onmedici nes炮制viscera of animal, organ of ani

11、mal con coctedven tilatio n smoke removal dust removal降温设施取样称量室temperature-reduc ingscree ning slici ng grindingcompressed air n oble gas sampli ng weighi ng roomestablishment,cooli ng中药标本Chinese herbal sample, exemplar of TCM检定鉴定verificati on,ide ntificati on同位素Isotope设备equipme nt选型吸附model/typesele

12、ct an ticorrosi onadsorpti on,absorptio n润滑剂，润滑lubrica nt, lubricate冷却剂coola nt流向flow direct ion纯化水PW: Purified Water注射用水WFI: Water for Injection滋生breed ing储罐tank死角n eglectedporti on盲管bli nd pipe纤维fiber疏水性hydrophobicity仪表in strume ntati on量具measuri ng tool衡器weigh ingin strume nt精密度不合格物 料 购 买 发 放 产 地

13、 固 体 液 体 易燃标签间隔时间precisi on maintenance disqualified material purchas ing releas ing origi nsolid liquid volatilenet medicine, net n arcotics psychotropic drug combustibleexplosive accepta nee in structi on labelhygie ne workshop time in terval清洁剂消毒剂废弃物更衣室工作服，颗粒性物质耐药菌株传染病皮肤病验 证 确 认 安 装 运 行 性 能 原辅料文

14、件 投 诉 报 废 品 名 处方技术参数deterge nt dis in fectawastescha ngingwork clothes granu lesdrug-resistantinfectiousdisease dermatosisverificati on, validati on qualificati onin stallati on running operati on performa neeraw material and excipie nt docume ntcomplai nt rejectproduct n ameprescripti on,tech ni ca

15、lparameter容 器 申 请 稳定性起草生产管理container applicati on stability draftproducti onman ageme nt,manu facturi ngcontrol.混 淆 喷 雾 合格证清场质里官理内 控 滴定液培养基有效期产品销售与收回mix-up spray certificate cleara neequality man ageme ntinternal con trol titra ntmediumvalidity, expiry date, shelf product sales and recall投诉与不良反应报告自

16、检 附 则 平 衡 饮用水compla ints and adverse react ion self- in spect ionappe ndix bala nee drinking report蒸馏法离子交换法反渗透法附加剂添加剂distillatio n ion exchangeRO: Reverse Osmosis additives滞留批组分， 组成stra nded batch, lot comp onentresort无纤维脱落的过滤器活性成份非活性成份non-fiber-releas Active In gredie ntIn activein gredie ntfilter中

17、间产品批号药用物料in termediate batch nu mber medicated product药用预混合料medicated premix质量控制部门理论产量实际产量比率验收标准可接受标准Qualitycontrol Theoretical yield Actual yield Perce ntage, Accepta nee criteriadepartme nt代表性样品微粒状的Represe ntative sample particulate污染物石 棉 诊 断 缓解化学变化con tamasbestos diag no sis mitigationchemicalcha

18、 nge组分in gredie 制备fabricate复合compo und混合ble nd加工process ingcomp onent preparati on浓度单位剂量药品包装容器密圭寸件， 效价concen trati on unit dosedrug product containers closuretiter purity stre 监督实验室supervise, laboratorymon itor无菌操作层流asepticoperati on,sterile operatio lam inar flow湍流空气过滤空气加热预过滤器turbule nt air filtrat

19、ion air heating Pre-filterair flow排气系统垃圾有机废料杀 鼠 剂 杀昆虫剂杀真菌剂熏 烝 剂 去垢剂exhaust system plumbi ng sewagerefuse air drier trashorga nicrode nticidesin secticides fun gicidesfumigati ngreage clea ning age nts消毒剂滂沱剂san itiz ing lubrica ntage nts自动化设备、机械化设备和电子设备微型胶卷automatic, mechanical, or electronic tmicrof

20、ilmequipmen注 射 剂 火菌设备injectio nsterilizatio nequipme nt无菌取样技术显微镜热源， 偏差鉴别片 剂 胶 囊 颗粒剂澄 明 度 返工发放aseptic sampli ng microscopepyroge n,en dotox deviati oncha nge con trol charge-i nitem code identify tablet capsule granuledissoluti onclarityisolationreprocess ingissua nee, releasetech niq ues非处方药处方药OTC:

21、over-the-counter prescripti onmedici 保险包装tamper-resista ntpackage顺势治疗 入库变 质 准确性灵敏性特异性hard gelatin homeopathic warehous ing deteriorate accuracysen sitivityspecificity重复性变应原提取物reproducibility, allerge nicrepeatability眼膏粗糙或磨蚀物质ophthalmicoin tme nt harsh or abrasive substances控释制剂controlled-releasedosage form实验动物供 应 商 光谱laboratory supplier spectrumani mals测量单位试剂取代units of measure con vers ion factors reage ntplacebo