药剂学英文名词解释整理文档格式.docx

药剂学英文名词解释整理文档格式.docx

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●Otherdrugsdecreasetheflowofurine,diminishbodysecretions,orinduceconstipation（便秘）

Drugstandards

●Theunitedstatespharmacopeia（药典）andthenationalformulary（国家药品标准）

●Pharmakon,meaning“drug”;

poiein,meaning“make”;

●Thecombinationindicatesanyrecipeorformulaorotherstandardsrequiredtomakeorprepareadrug.

●Organizedsetsofmonographsorbooksofthesestandardsarecalledpharmacopeiasorformularies.

InternationalOrganizationforstandardization（ISO）

isaninternationalconsortiumofrepresentativebodiesconstitutedtodevelopandpromoteuniformorharmonizedinternationalstandards.

国际标准化组织是一个代表性的国际联合会，其设立是为了发展和增进国际标准的均一性和协调性。

ISO9000-ISO9004usedinthepharmaceuticalindustry

●ISOincludedstandardspertainingtodevelopment,production,qualityassurance,qualitycontrol,detectionofdefectiveproducts,qualitymanagement,andotherissuesasproductsafetyandliability.

●ISO包括标准适合开发、生产、质量保证、质量控制、缺陷产品的检测、质量管理和其他如产品安全性和责任的问题。

●Internationallyrecognizedquality-managementsystem.

Prodrugs

isatermusedtodescribeacompoundthatrequiresmetabolicbiotransformationafteradministrationtoproducethedesiredpharmacologicallyactivecompound.

（前体药物使之能够在给药后经体内代谢性生物转化成具有期望的药理活性化合物的化合物。

）

aleadcompound

isaprototype（原形化学物质）chemicalcompoundthathasafundamentaldesiredbiologicorpharmacologicactivity.

（先导化合物是一种具有生物学和药理学活性基本要求的原型化学物质。

agoaldrug

Intheory,a“goaldrug”

●wouldproducethespecificallydesiredeffect,

●beadministeredbythemostdesiredroute（generallyorally）atminimaldosageanddosingfrequency,

●haveoptimalonsetanddurationofactivity,

理论上，目标药物应能通过最理想的途径（通常为口服）以最小的剂量和给药频率给药，能产生特异的期望疗效，具有最理想的起效和持续时间，

●exhibitnosideeffects,

●followingitsdesiredeffectwouldbeeliminatedfromthebodyefficiently,completely,andwithoutresidualeffect.

●itwouldbeeasilyproducedatlowcost,

●bepharmaceuticallyelegant,

●physicallyandchemicallystableundervariousconditionsofuseandstorage.

●（无副作用，并在发挥疗效后能完全有效地从体内消除，且无残留效应。

它应该易于生产，费用低，制剂产品美观，在不同的使用和贮藏条件下物理和化学上稳定。

5（知）

●Pharmacodynamicsisthestudyofthebiochemicalandphysiologicaleffectsofdrugsandtheirmechanismsofaction.

●Pharmacokineticsdealswiththeabsorption,distribution,metabolismorbiotransformation,andexcretionofdrugs.

●Clinicalpharmacologyappliespharmacologicprinciplestothestudyoftheeffectsandactionsofdrugsinhumans.

AtreatmentIND

oratreatmentprotocolpermitstheuseofaninvestigationaldruginthetrentmentofpatientsnotenrolledintheclinicalstudybutwhohaveaseriousorimmediatelylife-threateningdiseaseforwhichthereisnonsatisfactoryalternativetherapy.

1药剂学定义

Thegeneralareaofstudyconcernedwiththe

formulation

manufacture

stability

effectiveness

ofpharmaceuticaldosageformsistermedpharmaceutics.

Biopharmaceutics

istheareaofstudyembracingtherelationshipbetweenthephysical,chemical,andbiologicalsciencesastheyapplytodrugs,dosageforms,andtodrugaction.

（生物药剂学是围绕物理学、化学和生物科学及它们关于药物、剂型和药物作用相互关系的研究领域。

药物动力学

Theareaofstudywhichelucidatesthetimecourseofdrugconcentrationinthebloodandtissuesistermedpharmacokinetics.

Itisthestudyofthekineticsofabsorption,distribution,metabolismandexcretion（ADME）ofdrugsandtheircorrespondingpharmacologic,therapeutic,ortoxicresponseinanimalsandman.

Pharmacokineticsalsomaybeappliedinthestudyofinteractionsbetweendrugs.

Activetransport

denotesaprocessofthesoluteordrugbeingmovedacrossthemembraneagainstaconcentrationgradient,thatis,fromasolutionoflowerconcentrationtooneofahigherconcentrationor,ifthesoluteisanion,againstanelectrochemicalpotentialgradient

（主动转运是指溶质或药物穿过生物膜的转运的过程是逆浓度梯度进行，即从低浓度向高浓度转运或当溶质是离子时逆电化学电势梯度转运。

endocytosis（内吞）

Manylargemoleculesandparticlescannotentercellsviapassiveoractivemechanisms.However,somemayenter,asyet,byaprocessknownasendocytosis（内吞）

Inphagocytosis（吞噬）（celleating）,

largeparticlessuspendedintheextracellularfluidareengulfedandeithertransportedintocellsoraredestroyedwithinthecell.Thisisaveryimportantprocessforlungphagocytesandcertainliverandspleencells.

Pinocytosis（胞饮）（celldrinking）

isasimilarprocessbutinvolvestheengulfingofliquidsorverysmallparticlesthatareinsuspensionwithintheextracellularfluid.

Thebioavailability

describestherateandextenttowhichanactivedrugingredientortherapeuticmoietyisabsorbedfromadrugproductandbecomesavailableatthesiteofdrugaction.

Thebioequivalence

referstothecomparisonofbioavailabilitiesofdifferentformulations,drugproducts,orbatchesofthesamedrugproduct.

Peakheight（Cmax）

concentrationisthemaximumdrugconcentrationobservedinthebloodplasmaorserumfollowingadoseofthedrug.

Forconventionaldosageforms,astabletsandcapsules,theCmaxwillusuallyoccuratonlyasingletimepoint,referredtoasTmax.

Timeofpeak（Tmax）,

maximumlevelofdrugintheblood

Thisparameterreflectstherateofdrugabsorptionfromaformulation.Itistherateofdrugabsorptionthatdeterminesthetimeneededfortheminimumeffectiveconcentrationtobereachedandthusfortheinitiationofthedesiredpharmacologiceffect.

Areaundertheserumconcentrationtimecurve（AUC）

TheAUCofaconcentration-timeplotisconsideredrepresentativeofthetotalamountofdrugabsorbedintothecirculationfollowingtheadministrationofasingledoseofthatdrug.

ThesmallertheAUC,thelessdrugabsorbed.

Pharmaceuticalequivalents

aredrugproductsthatcontainidenticalamountsoftheidenticalactivedrugingredient,i.e.,thesamesaltoresterofthesametherapeuticmoiety,inidenticaldosageforms,butnotnecessarilycontainingthesameinactiveingredients,andthatmeettheidenticalcompendialorotherapplicablestandardofidentity,strength,quality,andpurity,includingpotencyand,whereapplicable,contentuniformity,disintegrationtimes,and/ordissolutionrates.

（制剂等效指包含等量同种活性药物成分的药品，即：

有相同治疗效应的相同盐或酯的形式，相同剂型。

但并不一定包含相同的非活性成分，具有相同的外观或其他相应的性质如规格、质量、纯度，包括效价、含量均匀性、崩解时间和溶出速率。

Pharmaceuticalalternatives

aredrugproductsthatcontaintheidenticaltherapeuticmoiety,oritsprecursor,butnotnecessarilyinthesameamountordosageformorasthesamesaltorester.Eachsuchproductindividuallymeetseithertheidenticaloritsownrespectivecompendialorotherapplicablestandardofidentity,strength,quality,andpurity,includingpotencyand,whereapplicable,contentuniformity,disintegrationtimes,and/ordissolutionrates.

（制剂替代品指含有相同治疗效果的组成部分或它的前体药物，不需要相同剂量、相同剂型、相同的盐或酯的形式。

每种药品符合同样的或各自的外观和其他相应的性质如规格、质量、纯度，包括效价，含量均匀性、崩解时间和溶出速率。

Bioequivalentdrug

productsarepharmaceuticalequivalentsorpharmaceuticalalternativeswhoserateandextentofabsorptiondonotshowasignificantdifferencewhenadministeredatthesamemolardoseofthetherapeuticmoietyundersimilarexperimentalconditions,eithersingledoseormultipledose.

（生物等效性药品指在相同的试验条件下，单次或多次给予相同治疗剂量的药物，其吸收的速率和程度没有显示显著性差异的制剂等效品或制剂替代品。

Therapeuticequivalents

hasbeenusedtoindicatepharmaceuticalequivalentswhich,whenadministeredtothesameindividualsinthesamedosageregimens,willprovideessentiallythesametherapeuticeffect.

Thehalf-life（T1/2）

ofadrugdescribesthetimerequiredforadrug’sbloodorplasmaconcentrationtodecreasebyonehalf.

4（复）WhatisNoyes-Whitneyequation?

ThedissolutionofasubstancemaybedescribedbythemodifiedNoyes-Whitneyequation:

dc/dt=kS（cs-ct）

inwhichdc/dtistherateofdissolution

kisthedissolutionrateconstant

Sisthesurfaceareaofthedissolvingsolid,

Csisthesaturationconcentrationofdruginthediffusionlayer

Ctistheconcentrationofthedruginthedissolutionmediumattimet

Biotransformation

isatermusedtoindicatethechemicalchangesthatoccurwithdrugswithinthebodyastheyaremetabolizedandalteredbyvariousbiochemicalmechanisms.

Theprocessofbiotransformationiscommonlyreferredtoasthe“detoxification”or“inactivation”process.

8（复）Explainshortlyaboutonecompartmentmodelandtwocompartmentmodel？

●Thesimplestpharmacokineticmodelisthesinglecompartmentopen-modelsystem.

Thismodeldepictsthebodyasonecompartmentcharacterizedbyacertainvolumeofdistribution（Vd）thatremainsconstant.

●Inthetwo-compartmentsystem,adrugentersintoandisinstantaneouslydistributedthroughoutthecentralcompartment.

Itssubsequentdistributionintothesecondorperipheralcompartmentisslower.

8Powders

areintimatemixturesofdry,finelydivideddrugsand/orchemicalsthatmaybeintendedforinternalorexternaluse.e.g.tablets,capsules,liquiddosageforms,ointmentsandcreams.

粘附性（adhesion）

是指不同分子间产生的引力，如粉体粒子与器壁间的粘附。

凝聚性（cohesion，粘着性）

是指同分子间产生的引力，如粉体粒子之间发生粘附而形成聚集体（randomfloc）

6Capsules

aresoliddosageformsinwhichmedicinalagentsand/orinertsubstancesareenclosedinasmallshellofgelatin.Gelatincapsuleshellsmaybehardorsoft,dependingontheircomposition.

1（知）sustained-releasepreparations缓释制剂

系指在规定释放介质中，按要求缓慢地非恒速释放药物，其与相应的普通制剂比较，给药频率比普通制剂减少一半或给药频率比