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ProfessionalGlossaryContentFDAGlossaryFOODANDDRUGADMINISTRATIONGMPGlossary(美國)食品藥品管理局GoodManufacturingPractice藥品生產(chǎn)質(zhì)量管理規(guī)范PharmaceuticaltermsEtyma&AffixFDAGlossary臨床實驗標準藥物藥物產(chǎn)品原料藥副作用國家處方集美國藥典ClinicalTrialStandardDrugDrugProductDrugSubstanceAdverseEffectNationalFormularyTheUnitedStatesPharmacopeiaFDAGlossary標示量規(guī)格含量注冊商標不良反應LabeledAmountStrengthProprietaryNameAdverseReactionGMPGlossary原料藥又稱:活性藥物組分API(ActivePharmaceuticalIngredient)批次批號新藥申請批量生產(chǎn)處方藥非處方藥Batch/LotBatchNumber/Lot-NumberNewDrugApplicationBatchProductionPrescriptionDrugOTCDrug(Over-The-CounterDrug)GMPAbbreviateGCPGLPA.A.AADRAQLBOMCIPGoodClinicalPractice藥品臨床研究管理規(guī)范GoodLaboratoryPractice藥品臨床前安全性研究質(zhì)量管理規(guī)范AdditionandAmendments增補和修訂AdverseDrugReaction藥物不良反應AcceptableQualityLevel合格質(zhì)量標準BillofMaterial物料清單CleaninginPlace在線清洗FDAAbbreviateGAPPLAQAQCSDATQCUSPGoodAgriculturePractice藥材生產(chǎn)管理規(guī)范ProductLicenseApplication產(chǎn)品許可申請QualityAssurance質(zhì)量保證QualityControl質(zhì)量控制StateDrugAdministration國家藥品監(jiān)督管理局TotalQualityControl全面質(zhì)量管理UnitedStatesPharmacopeia美國藥典PharmaceuticaltermsPPb濃度partsperbillionconcentration(10-9)PPt濃度partspertrillionconcentration(10-12)ppm濃度partspermillionconcentration(10-6)安全范圍safetyrange安全試驗法innocuitytestmethod安全系統(tǒng)safetycoefficient安慰劑placebo螯合劑chelatingagent靶細胞targetcell百分濃度percentageconcentration半數(shù)致死劑量halflethaldose;medianlethaldose;LD50半衰期half-lifeperiod;halflifetime包衣片coatedtablet薄膜衣film-coatingPharmaceuticalterms飽和溶液saturatedsolution必需脂肪酸essentialfattyacid變態(tài)反應allergy;allergicreaction表面活性surfaceactivity表面張力surfacetension補體complement補體系統(tǒng)complementsystem不良反應adversereaction長期毒性實驗longtermtoxicitytest長效制劑prolongedactionpreparation腸溶控釋片entericcontrolledreleasetablets腸溶衣entericcoatingPharmaceuticalterms處方prescription;recipe穿透促進劑penetrationenhancers磁性藥物制劑magneticmedicinalpreparations大分子macromolecule當量equivalentweight當量定律equivalentlaw當量濃度normality當量溶液normalsolution等張溶液isotonicsolution低聚糖oligosaccharide滴定titration滴定曲線titrationcurve滴丸劑pill遞質(zhì)transmitter電解electrolyzation電解質(zhì)electrolyte定向藥物制劑directedpharmaceuticalpreparationsPharmaceuticalterms毒理學toxicology毒性反應toxicresponse;toxicreaction對癥治療symptomatictreatment多劑量給藥multipledoseadministration二重感染superinfection法定處方officialformula芳族化合物aromaticcompound放射毒理學radiotoxicology放射藥劑學radiopharmaceutics非必需氨基酸nonessentialaminoacid分子病moleculardisease分子溶液molecularsolution分子生物學molecularbiologyPharmaceuticalterms分子藥理學molecularpharmacology輔料excipient副作用sideeffect附加劑additive干燥劑desiccant;dryingagent感受器receptor個體差異性individualdifferences;individualvariation給藥方案或給藥速度dosageregimenordoserate給藥間隔dosinginterval工業(yè)藥劑學industrialpharmacy共價鍵covalentbond廣譜抗生素broad-spectrumantibiotic過濾filtration過敏性藥物反應anaphylacticdrugreaction過氧化物superoxide含量均勻度contentuniformity核糖核酸ribonucleicacid;RNAPharmaceuticalterms合并用藥drugcombination合成藥物syntheticdrugs合劑mixture痕量元素traceelement化學分析chemicalanalysis化學藥物治療chemotherapy基本藥物essentialdrugs基因gene激活劑activator激活作用activation激素hormone急性毒性實驗acutetoxicitytest劑量dosage;dose劑量或濃度的依存性doseorconcentrationdependency劑型dosageformPharmaceuticalterms嚼用片chewabletablets拮抗作用antagonism解毒作用detoxication介質(zhì)mediator;transmitter;medium精神依賴性psychicdependence劇藥powerfuldrug絕對致死劑量absolutelethaldose;LD100抗毒素antitoxin抗體antibody抗血清antiserum抗藥性resistancetodrugs抗原antigen克當量gram-equivalentweight克當量數(shù)gram-equivalentnumber克分子gram-molecule;gram-mol克分子分數(shù)molarfraction克分子量grammolecularweightPharmaceuticalterms克分子濃度molarconcentration克原子gram-atom控釋制劑controlledreleasepreparation口腔內(nèi)給藥oraladministration擴散diffusion擴散系數(shù)coefficientofdiffusion累加效應additiveeffect冷藏cold-storage冷凍freezing;refrigeration量子藥理學quantumpharmacology臨床藥理學clinicalpharmacology臨床藥學clinicalpharmacy慢通道slowpathway慢性毒性實驗chronictoxicitytest;longtermtoxicitytest酶enzymePharmaceuticalterms敏感性sensitivity摩爾分數(shù)濃度molfractionconcentration摩爾濃度molarity耐受性tolerance耐藥性drugtolerance內(nèi)消旋體mesomer皮膚給藥skinadministration片劑硬度tablethardness氣體分析gasanalysis身體依賴性physicaldependence滲透壓osmoticpressure生長曲線growthcurvePharmaceuticalterms生物半衰期biologicalhalflife生物利用度bioavailability生物制品biologicalproduct生藥crudedrugs手性藥物chiraldrug受體receptor體積比濃度volumebyvolumeconcentration體液bodyfluid天然抗體naturalantibody天然抗原naturalantigen天然免疫naturalimmunity天然藥物crudedrugs;naturaldrugs同位素isotope突變mutation外消旋體raceme微量元素traceelement穩(wěn)態(tài)血藥濃度steadystateplasmaconcentrationPharmaceuticalterms消除速率常數(shù)eliminationrateconstant效價potency效價單位potencyunit效價強度potencyintensity效應effect協(xié)同作用synergism興奮性excitability懸浮液suspension選擇性selectivity血管內(nèi)給藥intravascularadministration血管外給藥extravascularadministration血漿plasma血漿蛋白結(jié)合率plasmaproteinbindingratio血清serum血藥濃度bloodconcentration血液制品bloodproducts藥—時曲線drug-timecurve藥峰濃度peakconcentrationofdrug藥峰時間peaktimeofdrug藥劑等效性pharmaceuticalequivalence藥敏試驗drugsensitivetestPharmaceuticalterms藥品批號drugbatchnumber藥品有效期expirydate;dateofexpiration藥品質(zhì)量標準drugstandard藥物代謝drugmetabolism藥物分布drugdistribution藥物分析pharmaceuticalanalysis藥物排泄drugexcretion藥物吸收drugabsorption藥物相互作用druginteraction藥物消除drugelimination藥物蓄積drugaccumulation藥效動力學pharmacodynamics有效半衰期effectivehalt有效率effectiverate有效濃度effectiveconcentration閾劑量thresholddose直腸給藥rectaladministration直線相關linearcorrelationPharmaceuticalterms中華人民共和國衛(wèi)生部藥品標準DrugStandardofMinistryofPublicHealthofthePeople'sRepublicofChina最大耐受劑量maximaltolerabledose;LDO最大無作用劑量maxialnoneffectivedose;EDO最小顯著差數(shù)leastsignificantdifference最小有效量minimaleffectivedose最小致死劑量minimallethaldose;MLDPharmaceuticalterms?藥物分析專業(yè)詞匯翻譯?釋藥系統(tǒng)(drugdeliverysystem,DDS)?中國藥典(ChinesePharmacopoeia,ChP)?美國藥典(TheUnitedStatesPharmacopoeia,USP)?美國國家處方集(TheNationalFormulary,NF)?英國藥典(BritishPharmacopoeia,BP)?歐洲藥典(EuropeanPharmacopoeia,Ph.Eup)?國際藥典(TheInternationalPharmacopoeia,Ph.Int)?良好藥品實驗研究規(guī)范(GoodLaboratoryPractice,GLP)?良好藥品生產(chǎn)規(guī)范(GoodManufacturePractice,GMP)?良好藥品供應規(guī)范(GoodSupplyPractice,GSP)?良好藥品臨床試驗規(guī)范(GoodClinicalPractice,GCP)?分析質(zhì)量管理(AnalyticalQualityControl,AQC)?藥物的鑒別試驗identificationtest?一般鑒別試驗generalidentificationtest?專屬鑒別試驗specificidentificationtest?靈敏度sensitivity?最低檢出量minimumdetectablequantity?最低檢出濃度minimumdetectableconcentration?藥品標準?質(zhì)量標準?標準品?國際標準品?參比標準?對照品?規(guī)格?藥品質(zhì)量控制?分析質(zhì)量控制?性狀?drugstandard?qualitystandard?standardsubstance?internationalstandardsubstance?referencestandard?referencesubstance?specification?drugqualitycontrol?analyticalqualitycontrol?characteristics?鑒別?限度檢查?吸光度?吸光系數(shù)?吸光度比值?澄清度?氯化物?硫酸鹽?重金屬?identification?limittest?absorbance?specificabsorbance?absorbanceratio?clarity?chloride?sulfate?heavymetal?干燥失重?含量測定?含量均勻度?溶出度?崩解時限?藥物釋放?相對密度?穩(wěn)定性試驗?耐用性?lossondrying?assay?uniformityofdosageunits?dissolution?disintegration?drugrelease?relativedensity?stabilitystudy?ruggedness????????????????熾灼殘渣residueonignition熱重分析法thermogravimetricanalysis,TGA差示熱分析法differentialthermalanalysis,DTA差示掃描量熱法differentialscanningcalorimetry,DSC全血wholeblood治療藥物濃度監(jiān)測therapeuticdrugmonitoring,TDM結(jié)合bound游離free綴合物conjugate液-液提取法liquid-liquidextraction,LLE離子對試劑ionpairreagent離子對提取法ionpairextractionmethod反離子counter液-固提取法liquid-solidextractionLSE半自動樣品制備系統(tǒng)advancedautomatedsampleprocessor,AASP精密度precision???????????????標準差standarddeviation,SDorS相對標準差relativestandarddeviation,RSD變異系數(shù)coefficientofvariation,CV批內(nèi)精密度within-runprecision日內(nèi)精密度within-dayprecision批間精密度between-runprecision日間精密度daytodayprecision準確度accuracy定量限limitofquantitation,LOQ檢測限limitofdetection,LOD選擇性selectivity專屬性specificity線性與范圍linearityandrange重現(xiàn)性reproducibility耐用性robustness?拖尾因子tailingfactor?含量均勻度contentuniformity?溶出度dissolution?離子對高效液相色譜法ion-pair,HPLC?超臨界流體萃取supercriticalfluidextraction,SFE?國際非專利藥名InternationalNamesforPharmaceuticalSubstances,INN?國際理論和應用化學聯(lián)合會InternationalUnionofPureandAppliedChemistry,IUPAC?有機化學命名原則NomenclatureofOrganicChemistry?填充柱packedcolumn?開管柱opentubularcolumn?空心柱capillarycolumn?熔融石英開管柱fusedsilicaopentubularcolumn,F(xiàn)SOT?高分辨率氣相色譜法highresolutiongaschromatography,HRGC?????????????壁涂開管柱wall-coatedopentubularcolumn,WCOT柱固定化相開管柱immobilizedphaseopentubularcolumn,IPOT柱交聯(lián)柱crosslinkingcolumn鍵合相柱bondingphasecolumn擔體涂漬開管柱support-coatedopentubularcolumn,SCOT柱分流進樣splitinjection不分流進樣splitlessinjection柱頭進樣on-columninjection直接進樣directinjection手性分離色譜chiralseparationchromatography,CSC手性固定化chiralstationaryphase,CSP手性衍生試劑chiralderivatizationreagent,CDR非對映異構(gòu)體diastereoisomer,DSTM?????????????????毛細管電泳capillaryelectrophoresis,CE毛細管區(qū)帶電泳capillaryzoneelectrophoresis,CZE膠束動電毛細管色譜micellarelectrokineticcapillarychromatography,MECC膠束動電色譜micellarelectrokineticchromatography,MEKC環(huán)糊精動電色譜cyclodextrinselectrokineticchromatography,CDEKC離子交換動電色譜ion-exchangeelectrokineticchromatography,IEEKC微滴乳狀液動電色譜microemulsionelectrokineticchromatography,MEEKC毛細管凝膠電泳capillarygelelectrophoresis,CGE毛細管等電聚焦capillaryisoelectricfocusing,CIEF毛細管等速電泳capillaryisotachorphoresis,CITP毛細管電色譜capillaryelectrochromatography,CEC色譜響應函數(shù)chromatographicresponsefunction,CRF色譜優(yōu)化函數(shù)chromatographicoptimizationfunction,COF等級色譜響應函數(shù)hierarchicalchromatographicresponsefunction,HCRF差示分光光度法differencespectrophotometry近紅外光譜nearinfra-redspectrum,NIRS中紅外光譜midinfra-redspectrum,MIRS?光譜匹配法spectralmatching?匹配指數(shù)matchindex,M.I.?主成分分析法principalcomponentregression,PCR?人工神經(jīng)網(wǎng)絡方法artificialneuralnetworks,ANN?核磁共振nuclearmagneticresonance,NMR?二維NMRtwodimensionalNMR?色譜聯(lián)用技術hyphenatedtechniqueschromatography,HTC?接口interface?重建色譜圖reconstructivechromatogram?總離子流totalioncarrent,TIC?選擇性離子監(jiān)測selectedionmonitoring,SIM?多離子檢測multipleiondetection,MID?質(zhì)量碎片圖譜法massfragmentography?電子轟擊離子化electronimpactionization,EI?化學離子化chemicalionization,CI?快原子轟擊fastatombombardment,F(xiàn)AB?熱噴霧thermospray,TSP?電噴霧electrospray,ESP?大氣壓離子化atmosphericpressureionization,?粒子束接口particalbeam?動態(tài)快原子轟擊法FAB?離子噴霧接口ISP?電子噴霧法ESP?串聯(lián)質(zhì)譜MS-MSAPIEtyma&AffixesEtyma1.haplo,mono,uni:單,一,獨haploid單倍體monoxide一氧化碳monoatomic單原子的2.bi,di,dipl,twi,du::二,雙,兩,偶biocolor雙色,dichromatic雙色的,diplobacillus雙桿菌dikaryon雙核體,twin:孿生dual雙重的3.tri:三,丙triangle三角triacylglycerol三酰甘油tricarboxylicacidcycle三羧酸循環(huán)4.quadri,quadru,quart,tetr,tetra:四quadrilateral四邊的quadrivalent四價的quadruped四足動物tetrode四極管tetracycline四環(huán)素Etyma&Affixes5.pent,penta,quique五pentose戊糖pentagon五角形pentane戊烷quintuple五倍的pentose戊糖pentomer五鄰粒6.hex,hexa,sex六hexose已糖hexapod六足動物hexapoda昆蟲綱hexamer六聚體7.hepta,sept七heptane庚烷heptose庚糖heptoglobin七珠蛋白Pharmaceuticalterms8.Oct9.enne,nonaoctagon八八角形九octane辛烷octase辛糖10.deca,dekanonapeptide九肽十enneahedron九面體11.deci,decapod十足目動物decahedron十面體li,decimeter十分之一,分分米decigram十分之一克13.micro,millimole千分之一,毫毫摩(爾)milliliter毫升14.nanomicrogram百萬分之一,微,微小,微量微克microogranism微生物nanosecond十億分之一,毫微,納十億分之一秒nanometer納米十克Pharmaceuticalterms15.demi,hemi,semi半demibariel半桶hemicerebrum大腦半球semi-conductor半導體16.holo全,整體,完全holoenzyme全酶holoprotein全蛋白17.macro大,巨大,多macrophage巨噬細胞macrogamete大配子macroelement常量元素macromolecular大分子18.poly,multi,mult多,復合polyacrylate聚丙烯酸酯polymerase聚合酶multinucleate多核的multicistronicmRNA

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