药剂英文课件

Chpter1Introductiontodrugsandpharmacy

Teachinggoal:Graspoftheheritageofpharmacy,drugstandards,drugregulationandcontrol,thepharmacy’scontemporaryrole.

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Aconcepts(1)drug

Itisdefinedasanagentintendedforuseinthediagnosis,mitigation,treatment,cure,orpreventionofdiseaseinhumansorinotheranimals.1Concepts

andtasks2/28(2)

pharmaceuticsbasictheoryformulationdesigndrugproductpreparationtechniquesqualityevaluationcorrectapplication3/28(3)

dosageformsformsofadministratione.g.tablet,capsule,injection,granule…(abstract)4/28(4)

pharmaceuticalpreparationsdrug+forme.g.aspirintablets,0.5%glucoseinfusion…(objective)5/28(5)

pharmaceuticalmanufacturingtheprocessofresearchandpreparationofdrugproduct(verb.)6/28(6)

drugdeliverysystems(DDS)moderndosageformse.g.sustainedorcontrolled;targeting;transdermal;soliddispersion;liposomes;microencapsulation…7/28BTasks

topreparesafe,effective,stableandconvenientpharmaceuticalpreparations(1)basictheory(2)dosageforms(esp.Chinesetraditionalmedicineandbiomedicine)

newpreparationtechniques

excipients

equipment(sealed,effective,multifunction,automationandcontinuity)8/282BranchesindustrialP.—essentialphysicalP.biopharmaceuticspharmacokineticsbasicP.polymersinP.clinicalP.hospitalP.dispensingP.9/283DosageformsAImportance(1)Changetheapplicativepropertiesofdrug(2)Adjusteffectivetime(3)Decreasethesideeffectsofdrug(4)Improvetargetingability(5)Affecteffectiveness10/28BTypes(1)Accordingtoadministrationroutesgastrointestinaltract(GIT):oral

injection(IM,IV,SC…)inhaleparenteraltransdermaltransmucousmembrane(buccal,sublingual…)cavity(rectal,ear,nose,vaginal…)

11/28(2)accordingtodispersionsystemssolution(moleculeorion)colloid(D:1~100nm)emulsion(insolubleliquids)suspension(insolublesolidandliquid)gasdispersion(aerosol)soliddispersion(solidpreparations)microparticledispersion12/28(3)accordingtodrugstatesliquidgassolidsemi-solid13/28CDevelopment1stgeneration:traditional2ndgeneration:sustainedorprolonged3rdgeneration:controlled4thgeneration:targeting14/284RelatedstatutesAPharmacopoeia:standardofmedicineChp2023edition(threeparts)BPrescriptiondrug:prescriptedbydoctorsNonprescriptiondrug(over-the-counter,OTC):mainlychosenandboughtbypatientsthemselves15/28CSeven“G”sGMP(goodmanufacturingpractice)--enterpriseGLP(goodlaboratorypractice)--researchinstituteGCP(goodclinicalpractice)--hospital16/28GSP(goodsupplypractice)--pharmaceuticalcompanyGPP(goodpreparationpractice)--hospitalGAP(goodagriculturalpractice)--ChinesetraditionalmedicineGUP(goodusingpractice)--usingprocessinhospital(pharmacy,storeroom)17/285Gapbetweendomesticandabroad

AbasictheoryBnewpreparationandtechniqueCpromisingexcipientsDadvancedequipmentchallengebutalotofroomforimprovement!18/286TheheritageofpharmacyAThefirstapothecaryPriestcraftwasinthepreparationofthemedicinalmaterialsthattheartoftheapothecaryoriginated.19/28BEarlydrugs

(1)Numerousancienttablets,scrolls,andotherrelics（3000BC）(2)Egyptians:suppositories,gargles,pills,inhal-ations,troches,lotions,ointments,plasters,andenemas.20/28CIntroductionofthescientificviewpoint

Hippocrates(460-377,BC)(2)Dioscorides(1stcentury,AD)(3)ClaudiusGalen(130-200,AD)21/28DEarlyresearch(1)SwedeKarlWilhelmScheele(1742-1786)lacticacidcitricacidoxalicacidtartaricacidarsenicacid22/28(2)Friedrich

Serturner(1783-1841)isolationofmorphinefromopiumin1805(3)Joseph

Caventou(1795-1877)andJosephPelletier(1788-1842)quinineandcinchoninefromcinchonatrychnineandbrucinefromnuxvomica23/28

(4)thePhiladelphiaCollegeofPharmacy

(thenation’sfristschoolofpharmacy,in1821).24/287Drugstandards

Atheunitedstatespharmacopeia(USP)Bthenationalformulary(NF)Cotherpharmacopeiasinternationalpharmacopeia(IP)theunitedkingdom(EP)japan(JP)china(CP)25/28DstandardssetforthinFDA-approvednew-drugapplicationsEinternationalorganizationforstandardization(ISO)26/288DrugregulationandcontrolAFoodandDrugAct(in1906)BManufacturuer’sclaimoftherapeuticbenefitwere