常用药学中英文词汇对照

1、生产工艺常用词汇中文英文单硫酸卡那霉素Kan amyci n sulfate硫酸氢钠sodium bisulfate枸橼酸钠sodium citrate硫酸溶液Sulfuric acid soluti on中性硼玻璃安瓿瓶Neutral borosilicate glass ampoule安瓿瓶清洗Ampoule washi ng安瓿瓶火菌除热源Ampoulesterilizati onanddepyroge n ati on配料Batch ing过滤Filtrati on灌封Filli ng and seali ng火菌和检漏测试Sterilization and leakage test灯

2、检Visual / Lamp in spect ion贴签和包装Labeli ng and packag ing关键工艺参数Critical Process Parameter升温段heati ng sect ion传送带con veyor belt压差Differe n tial pressure时间间隔Time in terval过滤器孔径Pore size of filter过滤压力Filtrati on pressure灌装量Filli ng volume缓冲罐buffer tank灌装前充氮保护pre-fill ing n itroge n flush灌装后充氮保护post-fill

3、i ng n itroge n overlay真空检漏测试Vacuum leak test内包材Primary packag ing materialProcess in structio nLivz onGroupFuzhouFux ingPharmaceutical Co. Ltd.Hunan Erka ng Pharmaceutical Co., LtdHunan Huari Pharmaceutical Co., LtdGua n gzhou Chemical Reage nt FactoryZhuhai Da Lin Wan In dustrial Gas Co.,LtdSCHOTT

4、GIass Tech nologies (Suzhou) Co.Ltdquality specificati onCirculati on waterRotati ng speedQC常用英文词汇中文英文物理性状Physical attributes外观Appeara nee不溶性微粒Particulate matter溶液颜色Soluti on color鉴别Ide n tificati on保留时间retention time含量Assay有关物质Related substa nee标小量labeled amount可见异物Visible particles无菌Sterility薄膜过滤法

5、Membrane filtration method内毒素Bacterial en dotox insIn itial bioburde nstirri ng uni formityashy toppoin ted endbubble head, flat head, broke n ampoule, crooked ampoule, empty ampoule;中文英文药品生产质量管理规范GMP: Good Manufacturing Practice国家食品与药品监督管理局State Food and Drug Admi nistrati on总则Gen eral Provisi ons制

6、剂preparati on原料药API: Active Pharmaceutical In gredie nt成品fini shed goods工序process机构与人员orga ni zatio n andpers onnel专业知识professi onal kno wledge生产经验producti on experie nee组织能力orga ni zati onal skill技术人员tech ni eal staff实施impleme n tati on药品生产pharmaceutical manu facturi ng质里官理quality man ageme nt质里检验q

7、uality in spect ion专业技术培训professi onal and tech n ical trai ning基础理论知识basic theoretical kno wledge实际操作技能practical operati on skills高生物活性highly pote nt咼毒性high toxicity污染con tam in ati on考核评估assessme nt厂房与设施buildi ngs andfacilities生产环境producti on en vir onment空气洁净级别clea n air level昆虫in sect洁净室（区）clea

8、n room(area)光滑smooth无裂缝no cracks无颗粒物脱落no particle sheddi ng耐受tolera nee消毒dis in fecti on无菌sterile交界处jun cti on, jo int弧形arc灰尘积聚dust accumulati on储存区store area生产规模producti on scale设备equipme nt物料material中间产品in termediate product待验品quara ntined material交叉污染cross-c on tam in ati on管道pipeli ne公用设施utiliti

9、es of public service照明light ing照度illumi n atio n应急，紧急情况emerge ncy净化purificati on,clea n微生物，微生物学，微生物的micro-orga ni sm,microbiology, microbiologic监测mon itori ng记录record天棚天花板ceili n g, roof密封seal静压差Static Differe n tial Pressure温度temperature相对湿度RH: RelativeHumidity地漏floor drainer分装室separati ng room,fil

10、li ng room相对负压relative n egative pressure废气waste gas, exhausted air内酰胺结构类药品3 -Lactams structure drug避孕药品con traceptives激素类horm one抗肿瘤类an ti-tumor, on cology放射性药品Radiopharmaceuticals包装pack ing, package循环使用recycli ng微粒particles辐射radiati on细菌bacteria病毒virus细胞cell脱毒前后Pre-detoxificati on and postdetoxifi

11、cati on活疫苗与火活疫苗active vacci ne/i n activated vacci ne人血液制品blood products预防制品preve nti on products灌装filli ng中药Chin ese traditi onalmedici nes前处理pretreatme nt提取extractio n浓缩concen trati on动物脏器viscera ofani mal, orga n of ani mal炮制con cocted通风ven tilatio n除烟smoke removal除尘dust removal降温设施temperature-re

12、duc ingestablishme nt, cooli ng筛选scree ning切片slici ng粉碎grinding压缩空气compressed air惰性气体n oble gas取样sampli ng称量室weighi ng room中药标本Chin ese herbal sample, exemplar of TCM检定鉴定verificati on,ide n tificatio n同位素Isotope设备equipme nt选型model/typeselecti on耐腐蚀an ticorrosi on吸附adsorpti on, absorptio n润滑剂，润滑lubri

13、ca n t, lubricate冷却剂coola nt流向flow directi on纯化水PW: Purified Water注射用水WFI: Water forIn jectio n滋生breed ing储罐tank死角n eglected porti on盲管bli nd pipe纤维fiber疏水性hydrophobicity仪表in strume n tati on旦曰 量具measuri ng tool衡器weigh ing in strume nt精密度precisi on维修、保养maintenance不合格disqualified物料material购买purchas i

14、ng发放releas ing产地origi n固体solid液体liquid挥发性volatile净药材net medic ine, net TCM麻醉药品n arcotics精神药品psychotropic drug易燃combustible易爆explosive验收accepta nee使用说明书in structi on标签label卫生hygie ne车间workshop间隔时间time in terval清洁剂deterge nt消毒剂dis in fecta nt废弃物wastes更衣室cha nging room工作服，work clothes颗粒性物质,颗粒剂granu les

15、耐药菌株drug-resista nt stra in传染病in fectious disease皮肤病dermatosis验证verificatio n, validati on确认qualificati on安装in stallati on运行running operati on性能performa nee原辅料raw material and excipie nt文件docume nt投诉complai nt报废reject品名product n ame处方prescripti on,formula技术参数tech ni cal parameter容器container申请applica

16、ti on稳定性stability起草draft生产管理producti onman ageme nt, manu facturi ng con trol.混淆mix-up喷雾spray合格证certificate清场cleara nee质里官理quality man ageme nt内控in ternal con trol滴定液titra nt培养基medium有效期validity, expiry date, shelf life产品销售与收回product salesand recall投诉与不良反应报告compla ints andadverse react ion report自检s

17、elf- in spect ion附则appe n dix平衡bala nee饮用水drinking water蒸馏法distillatio n离子交换法ion exeha nge反渗透法RO: Reverse Osmosis附加剂添加剂additives滞留stra n ded resort批batch, lot组分，组成comp onent无纤维脱落的过滤器non -fiber-releas ingfilter活性成份Active In gredie nt非活性成份In activein gredie nt中间产品in termediate product批号batch nu mber药用

18、物料medicated feed药用预混合料medicated premix质量控制部门Quality con troldepartme nt理论产量Theoretical yield实际产量Actual yield比率Perce n tage, rate验收标准可接受标准Accepta nee criteria代表性样品Represe n tative sample微粒状的particulate污染物con tam inant石棉asbestos诊断diag no sis缓解mitigatio n化学变化chemical cha nge组分in gredie nt,comp onent制备f

19、abricatepreparati on复合compo und混合ble nd加工process ing浓度concen trati on单位剂量un it dose药品包装容器drug product containers密圭寸件,圭寸盖closure效价titer纯度purity规格stre n gth监督supervise,mon itor实验室laboratory无菌操作asepticoperati on, sterile operati on层流lam inar flow湍流turbule nt airflow空气过滤air filtrati on空气加热air heati ng预过

20、滤器Pre-filter排气系统exhaust system管件plumbi ng污水sewage废料refuse空气干燥器air drier垃圾trash有机废料orga nic waste杀鼠剂rode n ticides杀昆虫剂in secticides杀真菌剂fun gicides熏烝剂fumigati ng reage nts去垢剂clea ning age nts消毒剂san itiz ingage nts滂沱剂lubrica nt自动化设备、机械化设备和电子设备automatic, mecha ni cal, or electr onic equipme nt微型胶卷microf

21、ilm注射剂in jectio n火菌设备sterilizatio nequipme nt无菌取样技术aseptic sampli ngtech niq ues显微镜microscope热源,内毒素pyroge n, en dotox in偏差deviati on变更cha nge con trol进料charge-i n项目代码item code鉴别ide ntify片剂tablet胶囊capsule颗粒剂granule溶解时间dissolution time澄明度clarity隔离系统isolati onsystem返工reprocess ing发放issua n ee,release非处

22、方药OTC: over-the-co un ter处方药prescripti onmedici ne保险包装tamper-resista nt package明胶硬胶囊hard gelati n capsule顺势治疗homeopathic入库warehous ing变质deteriorate准确性accuracy灵敏性sen sitivity特异性specificity重复性reproducibility, repeatability变应原提取物allerge n ic extracts眼膏ophthalmic oin tme nt粗糙或磨蚀物质harsh or abrasive substa n ces控释制剂con trolled-release dosage form实验动物laboratory ani mals供应商supplier光谱spectrum测量单位un its of measure换算系数con vers ion factors试剂reage nt安慰剂placebo明确地explicitly取代supersede溶液solutio n批准approval（美国）食品药品监督管理局FDA: F