1.Whatispharmaceutics?Howmanybranchesofpharmaceutics?2.Whatisadrug?GivesomeexamplesAdrugisdefinedasanagentintendedforuseinthediagnosis,mitigation,treatment,cure,orpreventionofdiseaseinhumansorinotheranimals.药物是有目的地用于诊断、缓解、治疗、治愈或预防人类或动物疾病的物质。Emetic(inducevomiting催吐剂)andantiemetic(preventvomiting止吐剂)drugsDiureticdrugs(increasetheflowofurine利尿剂)Expectorantdrugs(increaserespiratorytractfluid除痰剂)Catharticsorlaxatives(evacuatethebowel泻药)Otherdrugsdecreasetheflowofurine,diminishbodysecretions,orinduceconstipation(便秘)DrugstandardsTheunitedstatespharmacopeia(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-ISO9004usedinthepharmaceuticalindustryISOincludedstandardspertainingtodevelopment,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.Prodrugsisatermusedtodescribeacompoundthatrequiresmetabolicbiotransformationafteradministrationtoproducethedesiredpharmacologicallyactivecompound.(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。)aleadcompoundisaprototype(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。)agoaldrugIntheory,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.AtreatmentINDoratreatmentprotocolpermitstheuseofaninvestigationaldruginthetrentmentofpatientsnotenrolledintheclinicalstudybutwhohaveaseriousorimmediatelylife-threateningdiseaseforwhichthereisnonsatisfactoryalternativetherapy.1药剂学定义Thegeneralareaofstudyconcernedwiththeformulationmanufacturestabilityeffectivenessofpharmaceuticaldosageformsistermedpharmaceutics.Biopharmaceuticsistheareaofstudyembracingtherelationshipbetweenthephysical,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.Activetransportdenotesaprocessofthesoluteordrugbeingmovedacrossthemembraneagainstaconcentrationgradient,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.Thebioavailabilitydescribestherateandextenttowhichanactivedrugingredientortherapeuticmoietyisabsorbedfromadrugproductandbecomesavailableatthesiteofdrugaction.Thebioequivalencereferstothecomparisonofbioavailabilitiesofdifferentformulations,drugproducts,orbatchesofthesamedrugproduct.Peakheight(Cmax)concentrationisthemaximumdrugconcentrationobservedinthebloodplasmaorserumfollowingadoseofthedrug.Forconventionaldosageforms,astabletsandcapsules,theCmaxwillusuallyoccuratonlyasingletimepoint,referredtoasTmax.Timeofpeak(Tmax),maximumlevelofdruginthebloodThisparameterreflectstherateofdrugabsorptionfromaformulation.Itistherateofdrugabsorptionthatdeterminesthetimeneededfortheminimumeffectiveconcentrationtobereach