常用藥學(xué)中英文詞匯對(duì)照

1、生產(chǎn)工藝常用詞匯中文英文單硫酸卡那霉素Kan amyci n 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 washi ng安瓿瓶火菌除熱源Ampoulesterilizati onanddepyroge n ati on配料Batch ing過(guò)濾Filtrati on灌封Filli ng and seali ng火菌和檢漏測(cè)試Sterilization and leakage test燈

2、檢Visual / Lamp in spect ion貼簽和包裝Labeli ng and packag ing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Differe n tial pressure時(shí)間間隔Time in terval過(guò)濾器孔徑Pore size of filter過(guò)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-fill ing n itroge n flush灌裝后充氮保護(hù)post-fill

3、i ng n itroge n overlay真空檢漏測(cè)試Vacuum leak test內(nèi)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 n tificati on保留時(shí)間retention time含量Assay有關(guān)物質(zhì)Related substa nee標(biāo)小量labeled amount可見(jiàn)異物Visible particles無(wú)菌Sterility薄膜過(guò)濾法

5、Membrane filtration method內(nèi)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;中文英文藥品生產(chǎn)質(zhì)量管理規(guī)范GMP: Good Manufacturing Practice國(guó)家食品與藥品監(jiān)督管理局State Food and Drug Admi nistrati on總則Gen eral Provisi ons制

6、劑preparati 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 zatio n andpers onnel專(zhuān)業(yè)知識(shí)professi onal kno wledge生產(chǎn)經(jīng)驗(yàn)producti on experie nee組織能力orga ni zati onal skill技術(shù)人員tech ni eal staff實(shí)施impleme n tati on藥品生產(chǎn)pharmaceutical manu facturi ng質(zhì)里官理quality man ageme nt質(zhì)里檢驗(yàn)q

7、uality in spect ion專(zhuān)業(yè)技術(shù)培訓(xùn)professi onal and tech n ical trai ning基礎(chǔ)理論知識(shí)basic theoretical kno wledge實(shí)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(píng)估assessme nt廠(chǎng)房與設(shè)施buildi ngs andfacilities生產(chǎn)環(huán)境producti on en vir onment空氣潔凈級(jí)別clea n air level昆蟲(chóng)in sect潔凈室（區(qū)）clea

8、n room(area)光滑smooth無(wú)裂縫no cracks無(wú)顆粒物脫落no particle sheddi ng耐受tolera nee消毒dis in fecti on無(wú)菌sterile交界處jun cti on, jo int弧形arc灰塵積聚dust accumulati on儲(chǔ)存區(qū)store area生產(chǎn)規(guī)模producti on scale設(shè)備equipme nt物料material中間產(chǎn)品in termediate product待驗(yàn)品quara ntined material交叉污染cross-c on tam in ati on管道pipeli ne公用設(shè)施utiliti

9、es of public service照明light ing照度illumi n atio n應(yīng)急，緊急情況emerge ncy凈化purificati on,clea n微生物，微生物學(xué)，微生物的micro-orga ni sm,microbiology, microbiologic監(jiān)測(cè)mon itori ng記錄record天棚天花板ceili n g, roof密封seal靜壓差Static Differe n tial Pressure溫度temperature相對(duì)濕度RH: RelativeHumidity地漏floor drainer分裝室separati ng room,fil

10、li ng room相對(duì)負(fù)壓relative n egative pressure廢氣waste gas, exhausted air內(nèi)酰胺結(jié)構(gòu)類(lèi)藥品3 -Lactams structure drug避孕藥品con traceptives激素類(lèi)horm one抗腫瘤類(lèi)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 postdetoxifi

11、cati on活疫苗與火活疫苗active vacci ne/i n activated 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 ese traditi onalmedici nes前處理pretreatme nt提取extractio n濃縮concen trati on動(dòng)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-re

12、duc ingestablishme nt, cooli ng篩選scree ning切片slici ng粉碎grinding壓縮空氣compressed air惰性氣體n oble gas取樣sampli ng稱(chēng)量室weighi ng room中藥標(biāo)本Chin ese herbal sample, exemplar of TCM檢定鑒定verificati on,ide n tificatio n同位素Isotope設(shè)備equipme nt選型model/typeselecti on耐腐蝕an ticorrosi on吸附adsorpti on, absorptio n潤(rùn)滑劑，潤(rùn)滑lubri

13、ca n t, lubricate冷卻劑coola nt流向flow directi on純化水PW: Purified Water注射用水WFI: Water forIn jectio n滋生breed ing儲(chǔ)罐tank死角n eglected porti on盲管bli nd pipe纖維fiber疏水性hydrophobicity儀表in strume n tati on旦曰 量具measuri ng tool衡器weigh ing in strume nt精密度precisi on維修、保養(yǎng)maintenance不合格disqualified物料material購(gòu)買(mǎi)purchas i

14、ng發(fā)放releas ing產(chǎn)地origi n固體solid液體liquid揮發(fā)性volatile凈藥材net medic ine, net TCM麻醉藥品n arcotics精神藥品psychotropic drug易燃combustible易爆explosive驗(yàn)收accepta nee使用說(shuō)明書(shū)in structi on標(biāo)簽label衛(wèi)生hygie ne車(chē)間workshop間隔時(shí)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

15、耐藥菌株drug-resista nt stra in傳染病in fectious disease皮膚病dermatosis驗(yàn)證verificatio n, validati on確認(rèn)qualificati on安裝in stallati on運(yùn)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(bào)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(qǐng)applica

16、ti on穩(wěn)定性stability起草draft生產(chǎn)管理producti onman ageme nt, manu facturi ng con trol.混淆mix-up噴霧spray合格證certificate清場(chǎng)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(xiāo)售與收回product salesand recall投訴與不良反應(yīng)報(bào)告compla ints andadverse react ion report自檢s

17、elf- in spect ion附則appe n dix平衡bala nee飲用水drinking water蒸餾法distillatio n離子交換法ion exeha nge反滲透法RO: Reverse Osmosis附加劑添加劑additives滯留stra n ded resort批batch, lot組分，組成comp onent無(wú)纖維脫落的過(guò)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(hào)batch nu mber藥用

18、物料medicated feed藥用預(yù)混合料medicated premix質(zhì)量控制部門(mén)Quality con troldepartme nt理論產(chǎn)量Theoretical yield實(shí)際產(chǎn)量Actual yield比率Perce n tage, rate驗(yàn)收標(biāo)準(zhǔn)可接受標(biāo)準(zhǔn)Accepta nee criteria代表性樣品Represe n tative sample微粒狀的particulate污染物con tam inant石棉asbestos診斷diag no sis緩解mitigatio n化學(xué)變化chemical cha nge組分in gredie nt,comp onent制備f

19、abricatepreparati on復(fù)合compo und混合ble nd加工process ing濃度concen trati on單位劑量un it dose藥品包裝容器drug product containers密圭寸件,圭寸蓋closure效價(jià)titer純度purity規(guī)格stre n gth監(jiān)督supervise,mon itor實(shí)驗(yàn)室laboratory無(wú)菌操作asepticoperati on, sterile operati on層流lam inar flow湍流turbule nt airflow空氣過(guò)濾air filtrati on空氣加熱air heati ng預(yù)過(guò)

20、濾器Pre-filter排氣系統(tǒng)exhaust system管件plumbi ng污水sewage廢料refuse空氣干燥器air drier垃圾trash有機(jī)廢料orga nic waste殺鼠劑rode n ticides殺昆蟲(chóng)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(dòng)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 nt微型膠卷microf

21、ilm注射劑in jectio n火菌設(shè)備sterilizatio nequipme nt無(wú)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c(diǎn)ha nge con trol進(jìn)料charge-i n項(xiàng)目代碼item code鑒別ide ntify片劑tablet膠囊capsule顆粒劑granule溶解時(shí)間dissolution time澄明度clarity隔離系統(tǒng)isolati onsystem返工reprocess ing發(fā)放issua n ee,release非處

22、方藥OTC: over-the-co un ter處方藥prescripti onmedici ne保險(xiǎn)包裝tamper-resista nt package明膠硬膠囊hard gelati n capsule順勢(shì)治療homeopathic入庫(kù)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 n ic extracts眼膏ophthalmic oin tme nt粗糙或磨蝕物質(zhì)harsh or abrasive substa n ces控釋制劑con trolled-release dosage form實(shí)驗(yàn)動(dòng)物laboratory ani mals供應(yīng)商supplier光譜spectrum測(cè)量單位un its of measure換算系數(shù)con vers ion factors試劑reage nt安慰劑placebo明確地explicitly取代supersede溶液solutio n批準(zhǔn)approval（美國(guó)）食品藥品監(jiān)督管理局FDA: F