常用藥學中英文詞匯對照

1、生產(chǎn)工藝常用詞匯中文英文單硫酸卡那霉素Kan 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 packag ing關鍵工藝參數(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pre-fill ing n itroge n flush灌裝后充氮保護post-fill

3、i ng n itroge n overlay真空檢漏測試Vacuum leak test內包材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保留時間retention time含量Assay有關物質Related substa nee標小量labeled amount可見異物Visible particles無菌Sterility薄膜過濾法

5、Membrane filtration method內毒素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)質量管理規(guī)范GMP: Good Manufacturing Practice國家食品與藥品監(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機構與人員orga ni zatio n andpers onnel專業(yè)知識professi onal kno wledge生產(chǎn)經(jīng)驗producti on experie nee組織能力orga ni zati onal skill技術人員tech ni eal staff實施impleme n tati on藥品生產(chǎn)pharmaceutical manu facturi ng質里官理quality man ageme nt質里檢驗q

7、uality in spect ion專業(yè)技術培訓professi onal and tech n ical trai ning基礎理論知識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廠房與設施buildi ngs andfacilities生產(chǎn)環(huán)境producti on en vir onment空氣潔凈級別clea n air level昆蟲in sect潔凈室（區(qū)）clea

8、n room(area)光滑smooth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jun cti on, jo int弧形arc灰塵積聚dust accumulati on儲存區(qū)store area生產(chǎn)規(guī)模producti on scale設備equipme nt物料material中間產(chǎn)品in termediate product待驗品quara ntined material交叉污染cross-c on tam in ati on管道pipeli ne公用設施utiliti

9、es of public service照明light ing照度illumi n atio n應急，緊急情況emerge ncy凈化purificati on,clea n微生物，微生物學，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 n g, roof密封seal靜壓差Static Differe n tial Pressure溫度temperature相對濕度RH: RelativeHumidity地漏floor drainer分裝室separati ng room,fil

10、li ng room相對負壓relative n egative pressure廢氣waste gas, exhausted air內酰胺結構類藥品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細菌bacteria病毒virus細胞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動物臟器viscera ofani mal, orga n of ani mal炮制con cocted通風ven tilatio n除煙smoke removal除塵dust removal降溫設施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稱量室weighi ng room中藥標本Chin ese herbal sample, exemplar of TCM檢定鑒定verificati on,ide n tificatio n同位素Isotope設備equipme nt選型model/typeselecti on耐腐蝕an ticorrosi on吸附adsorpti on, absorptio n潤滑劑，潤滑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購買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驗收accepta nee使用說明書in structi on標簽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,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驗證verificatio n, validati on確認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技術參數(shù)tech ni cal parameter容器container申請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cleara nee質里官理quality man ageme nt內控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投訴與不良反應報告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

18、物料medicated feed藥用預混合料medicated premix質量控制部門Quality con troldepartme nt理論產(chǎn)量Theoretical yield實際產(chǎn)量Actual yield比率Perce n tage, rate驗收標準可接受標準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化學變化chemical cha nge組分in gredie nt,comp onent制備f

19、abricatepreparati on復合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titer純度purity規(guī)格stre n gth監(jiān)督supervise,mon itor實驗室laboratory無菌操作asepticoperati on, 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預過

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有機廢料orga nic waste殺鼠劑rode n ticides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自動化設備、機械化設備和電子設備automatic, mecha ni cal, or electr onic equipme nt微型膠卷microf

21、ilm注射劑in jectio n火菌設備sterilizatio nequipme nt無菌取樣技術aseptic sampli ngtech niq ues顯微鏡microscope熱源,內毒素pyroge n, en dotox in偏差deviati on變更cha nge con trol進料charge-i n項目代碼item code鑒別ide ntify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)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deteriorate準確性accuracy靈敏性sen sitivity特異性specificity重復性reproducibility, repeatability變應原提取物allerge n ic extracts眼膏ophthalmic oin tme nt粗糙或磨蝕物質harsh or abrasive substa n ces控釋制劑con trolled-release dosage form實驗動物laboratory ani mals供應商supplier光譜spectrum測量單位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approval（美國）食品藥品監(jiān)督管理局FDA: F