常用藥學(xué)中英文詞匯對照

1、生產(chǎn)工藝常用詞匯:中文英文單硫酸卡那霉素Kan amyc in sulfate硫酸氫鈉sodium bisulfate枸櫞酸鈉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 wash ing安瓿瓶火菌除熱源Ampoule sterilization and depyrogenation配料Batch ing過濾Filtrati on灌封Filli ng and seali ng火菌和檢漏測試Sterilization and leakage test燈

2、檢Visual / Lamp in spect ion貼簽和包裝Labeli ng and packagi ng關(guān)鍵工藝參數(shù)Critical Process Parameter升溫段heati ng sect ion傳送帶con veyor belt壓差Differen tial pressure時間間隔Time in terval過濾器孔徑Pore size of filter過濾壓力Filtrati on pressure灌裝量Filli ng volume緩沖罐buffer tank灌裝前充氮保護(hù)pre-filling nitrogen flush灌裝后充氮保護(hù)post-filling

3、nitrogen overlay真空檢漏測試Vacuum leak test內(nèi)包材Primary packaging materialProcess in structio nLivz onGroupFuzhouFux ingPharmaceutical Co. Ltd.Hunan Erka ng Pharmaceutical Co., LtdHunan Huari Pharmaceutical Co., LtdGuan gzhou Chemical Reage nt FactoryZhuhai Da Lin Wan In dustrial Gas Co., LtdSCHOTT Glass T

4、echnologies (Suzhou) Co.Ltdquality specificatio nCirculati on waterRotati ng speedQC常用英文詞匯中文英文物理性狀Physical attributes外觀Appeara nee不溶性微粒Particulate matter溶液顏色Soluti on color鑒別Ide ntificati on保存時間retention time含量Assay有關(guān)物質(zhì)Related substa nee標(biāo)小量labeled amount可見異物Visible particles無菌Sterility薄膜過濾法Membrane

5、filtration method內(nèi)毒素Bacterial en dotox insIn itial bioburde nstirring uniformityashy toppoin ted endbubble head, flat head, broken ampoule, crooked ampoule, empty ampoule;中文英文藥品生產(chǎn)質(zhì)量管理標(biāo)準(zhǔn)GMP: Good Ma nu facturi ng Practice國家食品與藥品監(jiān)督管理局State Food and Drug Administration總那么Gen eral Provisi ons制劑preparati

6、 on原料藥API: Active Pharmaceutical In gredie nt成品fini shed goods工序process機(jī)構(gòu)與人員orga ni zati on andpers onnel專業(yè)知識professi onal kno wledge生產(chǎn)經(jīng)驗product ion experie nee組織能力orga ni zati onal skill技術(shù)人貝tech ni eal staff實施impleme ntati on藥品生產(chǎn)pharmaceutical manu facturi ng質(zhì)里官理quality man ageme nt質(zhì)里檢驗quality in s

7、pect ion專業(yè)技術(shù)培訓(xùn)professi onal and tech ni cal training根底理論知識basic theoretical kno wledge實際操作技能practical operati on skills高生物活性highly pote nt咼毒性high toxicity污染con tam in ati on考核評估assessme nt廠房與設(shè)施buildi ngs andfacilities生產(chǎn)環(huán)境product ion environment空氣潔凈級別clea n air level昆蟲in sect潔凈室區(qū)clea n room(area)光滑sm

8、ooth無裂縫no cracks無顆粒物脫落no particle sheddi ng耐受tolera nee消毒dis in fecti on無菌sterile交界處junction, jo int弧形arc灰塵積聚dust accumulati on儲存區(qū)store area生產(chǎn)規(guī)模product ion scale設(shè)備equipme nt物料material中間產(chǎn)品in termediate product待驗品quarantined material交叉污染cross-c on tam in atio n管道pipeli ne公用設(shè)施utilities of public servic

9、e照明lighting照度illumi natio n應(yīng)急，緊急情況emerge ncy凈化purificatio n,clea n微生物，微生物學(xué)，微生物的micro-orga ni sm,microbiology, microbiologic監(jiān)測mon itori ng記錄record天棚天花板ceili ng, roof密封seal靜壓差Static Differe ntial Pressure溫度temperature相對濕度RH: RelativeHumidity地漏floor drainer分裝室separati ng room,filli ng room相對負(fù)壓relative

10、n egative pressure廢氣waste gas, exhausted air內(nèi)酰胺結(jié)構(gòu)類藥品3 -Lactams structure drug避孕藥品con traceptives激素類horm one抗腫瘤類an ti-tumor, on cology放射性藥品Radiopharmaceuticals包裝pack ing, package循環(huán)使用recycli ng微粒particles輻射radiati on細(xì)菌bacteria病毒virus細(xì)胞cell脫毒前后Pre-detoxificati on and postdetoxificati on活疫苗與滅活疫苗active v

11、acci ne/i nactivated vacci ne人血液制品blood products預(yù)防制品preve nti on products灌裝filli ng中藥Chin esetraditi onalmedic ines前處理pretreatme nt提取extractio n濃縮concen trati on動物臟器viscera ofani mal, orga n of ani mal炮制con cocted通風(fēng)ven tilatio n除煙smoke removal除塵dust removal降溫設(shè)施temperature-reduci ngestablishme nt, co

12、oli ng篩選scree ning切片slici ng粉碎grinding壓縮空氣compressed air惰性氣體no ble gas取樣sampli ng稱量室weighi ng room中藥標(biāo)本Chin ese herbal sample, exemplar of TCM檢定鑒定verificati on,ide ntificati on同位素Isotope設(shè)備equipme nt選型model/type selecti on耐腐蝕an ticorrosi on吸附adsorpti on, absorptio n潤滑劑，潤滑lubrica nt, lubricate冷卻劑coola

13、nt流向flow direct ion純化水PW: Purified Water注射用水WFI: Water forInjectio n滋生breedi ng儲罐tank死角n eglected porti on盲管bli nd pipe纖維fiber疏水性hydrophobicity儀表in strume ntati on量具measuri ng tool衡器weighi ngin strume nt精密度precisio n維修、保養(yǎng)maintenance不合格disqualified物料material購置purchas ing發(fā)放releas ing產(chǎn)地origin固體solid液體l

14、iquid揮發(fā)性volatile凈藥材net medici ne, net TCM麻醉藥品n arcotics精神藥品psychotropic drug易燃combustible易爆explosive驗收accepta nee使用說明書in structio n標(biāo)簽label衛(wèi)生hygie ne車間workshop間隔時間time in terval清潔劑deterge nt消毒劑dis in fecta nt廢棄物wastes更衣室cha nging room工作服，work clothes顆粒性物質(zhì)，顆粒劑granu les耐藥菌株drug-resista nt stra in傳染病in

15、fectious disease皮膚病dermatosis驗證verification, validation確認(rèn)qualificati on安裝in stallati on運行running operati on性能performa nee原輔料raw material and excipie nt文件docume nt投訴complai nt報廢reject品名product n ame處方prescripti on,formula技術(shù)參數(shù)tech ni cal parameter容器container申請applicati on穩(wěn)定性stability起草draft生產(chǎn)管理product

16、 ionman ageme nt, manu facturi ng control.混淆mix-up噴霧spray合格證certificate清場cleara nee質(zhì)里官理quality man ageme nt內(nèi)控in ternal con trol滴定液titra nt培養(yǎng)基medium有效期validity, expiry date, shelf life產(chǎn)品銷售與收回product salesand recall投訴與不良反響報告compla ints andadverse reacti on report自檢self- in specti on附那么appe ndix平衡bala

17、nee飲用水drinking water蒸餾法distillatio n離子父換法ion excha nge反滲透法RO: Reverse Osmosis附加劑添加劑additives滯留stra ndedresort批batch, lot組分，組成comp onent無纖維脫落的過濾器non-fiber-releas ingfilter活性成份Active In gredie nt非活性成份In activein gredie nt中間產(chǎn)品in termediate product批號batch nu mber藥用物料medicated feed藥用預(yù)混合料medicated premix質(zhì)

18、量控制部門Quality con troldepartme nt理論產(chǎn)量Theoretical yield實際產(chǎn)量Actual yield比率Perce ntage, rate驗收標(biāo)準(zhǔn)可接受標(biāo)準(zhǔn)Acceptance criteria代表性樣品Represe ntative sample微粒狀的particulate污染物con tam inant石棉asbestos診斷diag no sis緩解mitigati on化學(xué)變化chemical cha nge組分in gredie nt,comp onent制備fabricatepreparati on復(fù)合compo und混合ble nd加工p

19、rocess ing濃度concen trati on單位劑量unit dose藥品包裝容器drug product containers密圭寸件，圭寸蓋closure效價titer純度purity規(guī)格stre ngth監(jiān)督supervise,mon itor實驗室laboratory無菌操作asepticoperatio n, sterile operati on層流lam inar flow湍流turbule nt airflow空氣過濾air filtrati on空氣加熱air heati ng預(yù)過濾器Pre-filter排氣系統(tǒng)exhaust system管件plumbi ng污水s

20、ewage廢料refuse空氣枯燥器air drier垃圾trash有機(jī)廢料orga nic waste殺鼠劑rode nticides殺昆蟲劑in secticides殺真菌劑fun gicides熏烝劑fumigati ng reage nts去垢劑clea ning age nts消毒劑san itiz ingage nts滂沱劑lubrica nt自動化設(shè)備、機(jī)械化設(shè)備和電子設(shè)備automatic, mecha ni cal, or electr onic equipme n t微型膠卷microfilm注射劑injectio n火菌設(shè)備sterilizati onequipme nt

21、無菌取樣技術(shù)aseptic sampli ngtech niq ues顯微鏡microscope熱源，內(nèi)毒素pyroge n, en dotox in偏差deviati on變更cha nge con trol進(jìn)料charge-i n工程代碼item code鑒別iden tify片劑tablet膠囊capsule顆粒劑granule溶解時間dissolution time澄明度clarity隔離系統(tǒng)isolatio nsystem返工reprocess ing發(fā)放issua nee,release非處方藥OTC: over-the-co un ter處方藥prescripti onmedic

22、i ne保險包裝tamper-resista nt package明膠硬膠囊hard gelati n capsule順勢治療homeopathic入庫warehous ing變質(zhì)deteriorate準(zhǔn)確性accuracy靈敏性sen sitivity特異性specificity重復(fù)性reproducibility, repeatability變應(yīng)原提取物allerge nic extracts眼膏ophthalmic oin tme nt粗糙或磨蝕物質(zhì)harsh or abrasive substa nces控釋制劑con trolled-release dosage form實驗動物laboratory ani mals供應(yīng)商supplier光譜spectrum測量單位un its of measure換算系數(shù)conversion factors試劑reage nt撫慰劑placebo明確地explicitly