常用藥學(xué)中英文詞匯對(duì)照

1、學(xué)習(xí)文檔 僅供參考學(xué)習(xí)文檔 僅供參考生產(chǎn)工藝常用詞匯：中文硫酸氫鈉枸櫞酸鈉硫酸溶液中性硼玻璃安瓿瓶安瓿瓶清洗配料燈檢貼簽和包裝 升溫段傳送帶壓差時(shí)間間隔 過濾壓力 灌裝量緩沖罐真空檢漏測試 內(nèi)包材英文Kanamycin sulfate sodium bisulfate sodium citrate Sulfuric acid solutionNeutral borosilicate glass ampoule Ampoule washingAmpoule sterilization and depyrogenation BatchingFiltrationFilling and sealing

2、 Sterilization and leakage test Visual / Lamp inspection Labeling and packaging Critical Process Parameterheating section conveyor belt Differential pressure Time intervalPore size of filter Filtration pressure Filling volume buffer tankpre-filling nitrogen flush post-filling nitrogen overlay Vacuum

3、 leak testPrimary packaging materialProcess instructionLivzonGroupPharmaceutical Co. Ltd.FuxingHunan Erkang Pharmaceutical Co., Ltd Hunan Huari Pharmaceutical Co., Ltd Guangzhou Chemical Reagent Factory Zhuhai Da Lin Wan Industrial Gas Co., Ltd SCHOTT Glass Technologies(Suzhou) Ltdquality specificat

4、ion Circulation water Rotating speedQC中文外觀溶液顏色 鑒別含量標(biāo) 示 量 無菌薄膜過濾法內(nèi)毒素英文Physical attributes Appearance Particulate matter Solution color Identification retention time AssayRelated substance labeled amount Visible particles SterilityMembrane filtration method Bacterial endotoxinsInitial bioburdenstirrin

5、g uniformity ashy toppointed endbubblehead,flathead,brokencrooked ampoule, emptyampoule;中文藥品生產(chǎn)質(zhì)量管理標(biāo)準(zhǔn)總則制 劑 成 品 工序機(jī)構(gòu)與人員專業(yè)知識(shí)英文GMP: Good Manufacturing Practice State Food and Drug Administration General ProvisionspreparationAPI: Active Pharmaceutical Ingredient finished goodsprocessorganization and pers

6、onnel professional knowledge生產(chǎn)經(jīng)驗(yàn)組織能力技術(shù)人員實(shí)施藥品生產(chǎn)質(zhì)量管理質(zhì)量檢驗(yàn)高生物活性 高毒性污染考核評(píng)估 生產(chǎn)環(huán)境昆蟲光滑無裂縫耐受消 毒 無 菌 弧形儲(chǔ) 存 區(qū) 設(shè)備物料中間產(chǎn)品待驗(yàn)品production experience organizational skill technical staff implementation pharmaceutical quality managementquality inspectionprofessional and technical training basic theoretical knowledge p

7、ractical operation skillshighly potent high toxicity contamination assessmentbuildings and facilities production environment clean air levelinsectclean room(area) smoothno cracksno particle shedding tolerance disinfectionsterile junction, joint arcdust store area production scale equipment materiali

8、ntermediate quarantined 管道照明照度凈化監(jiān)測記錄天棚天花密封溫度地漏分 裝 室 廢氣避孕藥品激 素 類 包裝微粒脫毒前后活疫苗與滅活疫苗人血液制品cross-contamination pipelineutilities of public lightingillumination emergency purification, micro-organism, microbiology, microbiologic monitoringrecord ceiling, roof sealStatic Differential Pressure temperatureRH:

9、 Relative Humidity floor drainerseparating room, filling room relative negative pressure waste gas, exhausted air-Lactams structure drug contraceptiveshormoneanti-tumor, oncology Radiopharmaceuticals packing, package recyclingparticles radiation bacteria virus cellPre-detoxification and post detoxif

10、ication active vaccine/inactivated vaccineblood products灌裝中藥prevention products fillingChinese traditional medicines前處理動(dòng)物臟器炮制降溫設(shè)施篩選壓縮空氣惰性氣體取樣稱 量 室 中藥標(biāo)本檢定設(shè) 備 選 型 吸附潤滑劑,鑒定潤滑pretreatmentextraction concentrationviscera of animal, organ of animal concoctedventilation smoke removal dust removaltemperature

11、-reducing establishment, cooling screeningslicing grinding compressed air noble gas sampling weighing roomChinese herbal sample, exemplar of TCM verification, identificationIsotope equipmentmodel/type selection anticorrosion adsorption, absorptionlubricant, lubricate冷卻劑流 向 純化水注射用水滋生儲(chǔ)罐死角coolantflow d

12、irectionPW: Purified WaterWFI: Water for Injection breedingtankneglected portion盲管纖 維 儀 表 量 具 衡 器 不合格物 料 購 買 發(fā) 放 產(chǎn) 地 固 體 液 體 易燃標(biāo)簽間隔時(shí)間blind pipefiber hydrophobicity instrumentation measuring tool weighing instrument precision maintenance disqualified materialpurchasing releasing origin solid liquid v

13、olatilenet medicine, net narcotics psychotropic drug combustibleexplosive acceptance instruction label hygiene workshoptime interval清潔劑消毒劑廢棄物更衣室工作服,顆粒性物質(zhì),耐藥菌株顆粒劑detergent disinfectant wastes changing room work clothes granulesdrug-resistant strain傳染病皮膚病驗(yàn) 證 確 認(rèn) 安 裝 運(yùn) 行 性 能 原輔料文 件 投 訴 報(bào) 廢 品 名 處方技術(shù)參數(shù)容

14、器 申 請(qǐng) 穩(wěn)定性起草生產(chǎn)管理混 淆 噴 霧 清場內(nèi)控滴定液培養(yǎng)基有效期產(chǎn)品銷售與收回投訴與不良反應(yīng)報(bào)告自檢附 則 平 衡 飲用水infectious disease dermatosisverification, validation qualification installationrunning operation performanceraw material and excipient documentcomplaint reject product nameprescription, formula technical parameter containerapplication

15、 stability draftproduction management, manufacturing l.mix-up spray certificate clearancequality management internal control titrantmediumvalidity, expiry date, shelf life product sales and recallcomplaints and adverse reaction report self-inspectionappendix balance drinking water蒸餾法離子交換法反滲透法附加劑添加劑滯

16、留批組分, 組成無纖維脫落的過濾器活性成份中間產(chǎn)品 批號(hào)藥用物料理論產(chǎn)量實(shí)際產(chǎn)量比率驗(yàn)收標(biāo)準(zhǔn)可接受標(biāo)準(zhǔn)代表性樣品污 染 物 石棉組分單位劑量藥品包裝容器distillation ion exchangeRO: Reverse additivesstranded batch, lot componentnon-fiber-releasing filter Active IngredientInactive ingredient intermediate product batch number medicated feed medicated premixQuality controlTheor

17、etical yieldActual yield Percentage, rate Acceptance criteria Representative sample particulate contaminantasbestos diagnosis mitigation chemical ingredient, component fabricate preparation compoundblend processing concentration unit dosedrug product containers密封件, 封蓋效價(jià)純 度 規(guī) 格 監(jiān) 督 實(shí)驗(yàn)室層流湍流管件垃圾有機(jī)廢料殺 鼠

18、 劑 殺昆蟲劑殺真菌劑熏 蒸 劑 去 垢 劑 消 毒 劑 滂沱劑自動(dòng)化設(shè)備、機(jī)械化設(shè)備和電子設(shè)備微型膠卷注 射 劑 滅菌設(shè)備無菌取樣技術(shù)顯微鏡熱源, 內(nèi)毒素偏差closure titer purity strengthsupervise, monitor laboratoryaseptic operation, sterile operation laminar flowturbulent air flow air filtrationair heating Pre-filter exhaust plumbing sewagerefuse air trashorganic waste rode

19、nticides insecticides fungicides fumigating reagents cleaning agents sanitizing agents lubricantautomatic, mechanical, or electronic tmicrofilm injectionsterilization equipment aseptic sampling techniques microscopepyrogen, endotoxin deviation鑒別片 劑 膠 囊 顆粒劑澄 明 度 返工發(fā)放非處方藥處 方 藥 保險(xiǎn)包裝順勢治療 入庫變 質(zhì) 準(zhǔn)確性靈敏性特異性

20、重復(fù)性變應(yīng)原提取物眼膏粗糙或磨蝕物質(zhì)控釋制劑供 給 商 光譜試劑撫慰劑change control charge-initem code identify tablet capsule granuledissolution time clarity isolation reprocessingissuance, release OTC: over-the-counter prescription tamper-resistant hard gelatin capsule homeopathicwarehousing deteriorate accuracy sensitivity specificityreproducibility, allergenic extractsophthalmic ointmentharsh or abrasive substances controlled-release dosage form laboratory animalssupplier spectrumunits of measure conversion reage