常用藥學(xué)中英文詞匯知識(shí)整合對(duì)照

生產(chǎn)工藝常用詞匯:中文英文單硫酸卡那霉素Kanamycinsulfate硫酸氫鈉sodiumbisulfate枸椽酸鈉sodiumcitrate硫酸溶液Sulfuricacidsolution中性硼玻璃安甑瓶Neutralborosilicateglassampoule安瓿瓶清洗Ampoulewashing安甑瓶滅菌除熱源Ampoule sterilization anddepyrogenation配料Batching過濾Filtration灌封Fillingandsealing滅菌和檢漏測(cè)試Sterilizationandleakagetest燈檢Visual/Lampinspection貼簽和包裝Labelingandpackaging關(guān)鍵工藝參數(shù)CriticalProcessParameter升溫段heatingsection傳送帶conveyorbelt壓差Differentialpressure時(shí)間間隔Timeinterval過濾器孔徑Poresizeoffilter

過濾壓力Filtrationpressure灌裝量Fillingvolume緩沖罐buffertank灌裝前充氮保護(hù)pre-fillingnitrogenflush灌裝后充氮保護(hù)post-fillingnitrogenoverlay真空檢漏測(cè)試Vacuumleaktest內(nèi)包材PrimarypackagingmaterialProcessinstructionLivzonGroupFuzhouFuxingPharmaceuticalCo.Ltd.HunanErkangPharmaceuticalCo.,LtdHunanHuariPharmaceuticalCo.,LtdGuangzhouChemicalReagentFactoryZhuhaiDaLinWanIndustrialGasCo.,LtdSCHOTTGlassTechnologies(Suzhou)Co.LtdqualityspecificationCirculationwaterRotatingspeed

QC常用英文詞匯中文英文物理性狀Physicalattributes外觀Appearance不溶性微粒Particulatematter溶液顏色Solutioncolor鑒別Identification保留時(shí)間retentiontime含量Assay有關(guān)物質(zhì)Relatedsubstance士二一日仞\小量labeledamount可見異物Visibleparticles尢菌Sterility薄膜過濾法Membranefiltrationmethod內(nèi)毒素BacterialendotoxinsInitialbioburdenstirringuniformityashytoppointedendbubblehead,flathead,brokenampoule,crookedampoule,emptyampoule;

中文英文藥品生產(chǎn)質(zhì)量管理規(guī)范GMP:GoodManufacturingPractice國家食品與藥品監(jiān)督管理局StateFoodandDrugAdministration總則GeneralProvisions制劑preparation原料藥API:ActivePharmaceuticalIngredient成品finishedgoods工序process機(jī)構(gòu)與人員organizationandpersonnel專業(yè)知識(shí)professionalknowledge生產(chǎn)經(jīng)驗(yàn)productionexperience組織能力organizationalskill技術(shù)人員technicalstaff

實(shí)施 implementation藥品生產(chǎn)pharmaceuticalmanufacturing質(zhì)量管理qualitymanagement質(zhì)量檢驗(yàn)qualityinspection專業(yè)技術(shù)培訓(xùn)professionalandtechnicaltraining基礎(chǔ)理論知識(shí)basictheoreticalknowledge實(shí)際操作技能practicaloperationskills高生物活性highlypotent高毒性hightoxicity污染contamination考核評(píng)估assessment廠房與設(shè)施buildingsandfacilities生產(chǎn)環(huán)境productionenvironment空氣潔凈級(jí)別cleanairlevel昆蟲insect潔凈室（區(qū)）cleanroom(area)光滑smooth無裂縫nocracks無顆粒物脫落noparticleshedding耐受tolerance消毒disinfection

無菌 sterile交界處junction,joint弧形arc灰塵積聚dustaccumulation儲(chǔ)存區(qū)storearea生產(chǎn)規(guī)模productionscale設(shè)備equipment物料material中間產(chǎn)品intermediateproduct待驗(yàn)品quarantinedmaterial交叉污染cross-contamination管道pipeline公用設(shè)施utilitiesofpublicservice照明lighting照度illumination應(yīng)急，緊急情況emergency凈化purification,clean微生物，微生物學(xué)，微生物的micro-organism,microbiology,microbiologic監(jiān)測(cè)monitoring記錄record天棚天花板ceiling,roof

密封seal靜壓差StaticDifferentialPressure溫度temperature相對(duì)濕度RH:RelativeHumidity地漏floordrainer分裝室separatingroom,fillingroom相對(duì)負(fù)壓relativenegativepressure廢氣wastegas,exhaustedairB-內(nèi)酰胺結(jié)構(gòu)類藥品0-Lactamsstructuredrug避孕藥品contraceptives激素類hormone抗腫瘤類anti-tumor,oncology放射性藥品Radiopharmaceuticals包裝packing,package循環(huán)使用recycling微粒particles輻射radiation細(xì)菌bacteria病毒virus細(xì)胞cell脫毒前后Pre-detoxificationandpostdetoxification

活疫苗與滅活疫苗activevaccine/inactivatedvaccine人血液制品bloodproducts預(yù)防制品preventionproducts灌裝filling中藥Chinesetraditionalmedicines前處理pretreatment提取extraction濃縮concentration動(dòng)物臟器visceraofanimal,organofanimal炮制concocted通風(fēng)ventilation除煙smokeremoval除塵dustremoval降溫設(shè)施temperature-reducingestablishment,cooling篩選screening切片slicing粉碎grinding壓縮空氣compressedair惰性氣體noblegas取樣sampling稱里至weighingroom

中藥標(biāo)本 Chineseherbalsample,exemplarofTCM檢定鑒定verification,identification同位素Isotope設(shè)備equipment選型model/typeselection耐腐蝕anticorrosion吸附adsorption,absorption潤(rùn)滑劑，潤(rùn)滑lubricant,lubricate冷卻劑coolant流向flowdirection純化水PW:PurifiedWater注射用水WFI:WaterforInjection滋生breeding儲(chǔ)罐tank死角neglectedportion盲管blindpipe纖維fiber疏水性hydrophobicity儀表instrumentation量具measuringtool衡器weighinginstrument

精密度precision維修、保養(yǎng)maintenance不合格disqualified物料material購買purchasing發(fā)放releasing產(chǎn)地origin固體solid液體liquid揮發(fā)性volatile凈藥材netmedicine,netTCM麻醉藥品narcotics精神藥品psychotropicdrug易燃combustible易爆explosive驗(yàn)收acceptance使用說明書instruction標(biāo)簽label衛(wèi)生hygiene車間workshop間隔時(shí)間timeinterval

清潔劑detergent消毒劑disinfectant廢弁物wastes更衣室changingroom工作服，workclothes顆粒性物質(zhì)，顆粒劑granules耐藥菌株drug-resistantstrain傳染病infectiousdisease皮膚病dermatosis驗(yàn)證verification,validation確認(rèn)qualification安裝installation運(yùn)行runningoperation性能performance原輔料rawmaterialandexcipient文件document投訴complaint報(bào)廢reject品名productname處方prescription,formula技術(shù)參數(shù)technicalparameter

容器 container申請(qǐng)application穩(wěn)定性stability起草draft生產(chǎn)管理productionmanagement,manufacturingcontrol.混淆mix-up噴霧spray合格證certificate清場(chǎng)clearance質(zhì)量管理qualitymanagement內(nèi)控internalcontrol滴定液titrant培養(yǎng)基medium有效期validity,expirydate,shelflife產(chǎn)品銷售與收回productsalesandrecall投訴與不良反應(yīng)報(bào)告complaintsandadversereactionreport自檢self-inspection附則appendix平衡balance飲用水drinkingwater

蒸餾法 distillation離子交換法ionexchange反滲透法RO:ReverseOsmosis附加劑添加劑additives滯留strandedresort批batch,lot組分，組成component無纖維脫落的過濾器non-fiber-releasingfilter活性成份ActiveIngredient非活性成份Inactiveingredient中間產(chǎn)品intermediateproduct批號(hào)batchnumber藥用物料medicatedfeed藥用預(yù)混合料medicatedpremix質(zhì)量控制部門Qualitycontroldepartment理論產(chǎn)量Theoreticalyield實(shí)際產(chǎn)量Actualyield比率Percentage,rate驗(yàn)收標(biāo)準(zhǔn)可接受標(biāo)準(zhǔn)Acceptancecriteria代表性樣品Representativesample微粒狀的particulate

污染物 contaminant石棉asbestos診斷diagnosis緩解mitigation化學(xué)變化chemicalchange組分ingredient,component制備fabricatepreparation復(fù)合compound混合blend加工processing濃度concentration單位劑量unitdose藥品包裝容器drugproductcontainers密封件，封蓋closure效價(jià)titer純度purity規(guī)格strength監(jiān)督supervise,monitor實(shí)驗(yàn)室laboratory尢菌操作asepticoperation,sterileoperation層流laminarflow

湍流 turbulentairflow空氣過濾airfiltration空氣加熱airheating預(yù)過濾器Pre-filter排氣系統(tǒng)exhaustsystem管件plumbing污水sewage廢料refuse空氣十燥器airdrier垃圾trash有機(jī)廢料organicwaste殺鼠劑rodenticides殺昆蟲劑insecticides殺真菌劑fungicides熏蒸劑fumigatingreagents去垢劑cleaningagents消毒劑sanitizingagents滂沱劑lubricant自動(dòng)化設(shè)備、機(jī)械化設(shè)備和電子設(shè)備automatic,mechanical,orelectronicequipment微型膠卷microfilm

注射劑injection火菌設(shè)備sterilizationequipment尢菌取樣技術(shù)asepticsamplingtechniques顯微鏡microscope熱源，內(nèi)毒素pyrogen,endotoxin偏差deviation變更c(diǎn)hangecontrol進(jìn)料charge-in項(xiàng)目代碼itemcode鑒別identify片劑tablet膠囊capsule顆粒劑granule溶解時(shí)間dissolutiontime澄明度clarity隔離系統(tǒng)isolationsystem返工reprocessing發(fā)放issuance,release非處方藥OTC:over-the-counter處方藥prescriptionmedicine保險(xiǎn)包裝tamper-resistantpackage

明膠硬膠囊hardgelatincapsule順勢(shì)治療homeopathic入庫warehousing變質(zhì)deteriorate準(zhǔn)確性accuracy靈敏性sensitivity特異性specificity重復(fù)性reproducibility,repeatability變應(yīng)原提取物allergenicextracts眼膏ophthalmicointment粗糙或磨蝕物質(zhì)harshorabrasivesubstances控釋制劑controlled-releasedosageform實(shí)驗(yàn)動(dòng)物laboratoryanimals供應(yīng)商supplier光譜spectrum測(cè)量單位unitsofmeasure換算系數(shù)conversionfactors試劑Ureagent安慰劑placebo明確地explicitly取代supersede

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