2023學(xué)年完整公開課版DrugAnalysisOverviewandBasicTasks

PharmaceuticalAnalysisDrugAnalysisOverviewandBasicTasksDrugAnalysisOverviewandBasicTasksXuYingqianTasksofdruganalysisBasiccontentandrequirementsofdruganalysisQualitymanagementstandardContentsMaster

NatureandtasksofdruganalysisFamiliar

BasiccontentandrequirementsofdruganalysisUnderstand

DrugqualitymanagementstandardkeyanddifficultpointsThefirstsectionNatureandtasksofdruganalysisWhatisdrugDrugsrefertosubstancesthatareusedtoprevent,treat,anddiagnosehumandiseases,purposelyregulatehumanphysiologicalfunctions,andspecifyindicationsorfunctionalindications,usageanddosage,includingChineseherbalmedicines,Chineseherbalmedicines,Chinesepatentmedicines,andchemicalrawmaterials.Anditspreparations,antibiotics,biochemicaldrugs,radioactivedrugs,serum,vaccines,bloodproductsanddiagnosticdrugs.1.Natureandtasksofdruganalysis（1）Druganalysisisamajorprofessionalcoursesetupinpharmacy,drugqualityandsafety,drugproductiontechnology,drugmanagementandmanagement,andotherprofessionalregulations.Itisanimportantpartoftheentirepharmaceuticalsciencefield.（2）NatureofdruganalysisObjective：AdisciplinethatresearchesanddevelopscomprehensivequalitycontrolmethodsfordrugsMethod：Chemistry,physicalchemistryandbiochemistry.Object：Researchthequalitycontrolmethodsofsyntheticdrugs,naturaldrugs,biochemicaldrugsandtheirpreparations.2.ThetaskofdruganalysisProductionqualitycontrolonrawmaterialsandaccessoriesNewcompoundPrecli-nicalstudyNewdrugresea-rchapplic-ationClini-calTrialsNewdrugapplicationsNewdrugproductionListedIntermediatepurity

ProductionpurityAnalysismethodRelatedmaterialsBulkdrugqualitystandardPreparationqualitystandardStabilityinvestigationTreatmentmonitoringStabilitymonitoringDruganalysisisfoundationofalldrugs2.藥物分析的任務(wù)ThetaskofdruganalysisQualitystandardsettingActiveingredientdeterminationpuritytestingChemicalstructureconfirmationDrugdevelopmentDrugproduction

clinicalpharmacyDrugcirculationPharmaceuticalAnalysisPreparationqualityProductionprocessoptimizationIntermediateDrugqualityCounterfeitinspectionDrugstabilityTherapeuticdrugmonitoringmedicineinteractionsClinicaldrugtrialsGuideclinicalmedication2.ThetaskofdruganalysisEnsurethatdrugsaresafe,effective,andqualitycontrollable.TasksChemicalinspectionoffinishedpharmaceuticalproducts;Qualitycontrolofthedrugproductionprocess;Qualityinspectionofthedrugstorageprocess;Clinicaldruganalysiswork;Theformulationofdrugqualitystandardsinnewdrugresearch.ThesecondsectionBasiccontentandrequirementsofdruganalysis1.BasiccontentsofdruganalysisAnalysischaracteristicsandbasicmethodsoftraditionalChinesemedicinepreparationsDrugImpurityInspectionMethodOverviewofdrugqualitystandardsGeneralproceduresandbasicmethodsofdrugbioassayAnalysischaracteristicsandbasicmethodsofpharmaceuticalpreparationsObservationandidentificationofdrugproperties

ConceptsandbasicmethodsofinvivodruganalysisAnalysisoftypicaldrugs2.LearningmethodFirstofall,weshouldcomprehensivelyapplywhatwehavelearnedinthepast,focusondrugqualityissues,studytheinternallawsandmethodsofdrugqualitycontrol,andexploreeffectivewaystoimprovedrugquality.Thekeyissueishowtousethenecessarytechnologiesandmethodstoanalyzethequalityofdrugs,tostudyandexploretherelationshipbetweenthechemicalstructure,physicalandchemicalcharacteristics,existenceofthedrugsandthechoiceofanalysismethods,andtochoosethenecessarytechnologiesandmethodsforcomprehensivedrugquality(Identification,inspection,contentdetermination,andresolutionofauthenticity)analysisandcontrolofthewholeprocess(research,production,supply,storageanduseofrawmaterials,intermediates,finishedproducts,preparations)Druganalysisisatoolandeyeforthedevelopmentoftheentirepharmacyprofession,andcandirectlyparticipateinsolvingmajorproblemsinthedevelopmentofpharmacy.Therefore,weshouldlearntolearnbyourselvesandbegoodatindependentthinking,thatis,weshouldpayattentiontothestudyofbasictheoreticalknowledgeofdrugqualityanalysisandtherigoroustrainingofbasicexperimentalskills,soastocontinuouslyimprovetheabilitytosolveproblemsindependentlyThethirdsectionDrugqualitymanagementstandardThecomprehensivecontrolofdrugqualityinvolvesallaspectsofdrugresearch,production,supply,clinicalandtesting.

Drugqualityisnottested

Howtoensurethequalityofdrugs?Fullcontrol(fullandfullprocess)

Howtofullycontrol(scientificmanagement,four-levelstandard)GLPGMPGSPGCPGoodLaboratoryPracticeGoodManufacturePracticeGoodSupplyPracticeGoodClinicalPractice1.GLPNon-clinicalresearch-varioustoxicityteststoevaluatethesafetyofdrugsGLPcertificationmeansthattheStateFoodandDrugAdministration(SFDA)inspectstheorganizationandmanagementsystem,personnel,experimentalfacilities,instrumentsandequipment,andtheoperationandmanagementoftestitemsofdrugnon-clinicalsafetyevaluationresearchinstitutions,andwhethertheycomplyGLPmakesanassessmentGLPismainlyusedfornon-clinicalresearchfordrugregistration2.GMPThebasicguidelinesfordrugproductionandqualitymanagement.Themainspiritistosuperviseandmanagetheentireprocessofdrugproduction.Itsetsclearrequirementsforthepersonnel,plant,equipment,rawmaterials,technology,qualityinspection,andhygienerequiredfortheproductionofdrugs.Payattentiontopriorcontrol,reducepollutionandcross-contaminationduringtheproductionofdrugs,andstrivetoeliminatethehiddendangersofsubstandardproductstoensurethatthedrugsproducedaresafe,effective,andstableandcontrollableinquality3.GSPThebasicprinciplesofdrugqualitymanagementinclude:managementresponsibility,personnelandtraining,facilitiesandequipment,purchase,acceptanceandinspection,storageandmaintenance,deliveryandtransportation,salesandafter-salesservice,etcGSPisastandardthatmustbeimplementedintheprocessofdrugpurchase,storage,transportationandsales4.GCPClinicaltrials-Anysystematicstudyofadruginhumans(patientsorhealthyvolunteers),includingitseffects,adversereactions,absorption,distribution,metabolism,andexcretion,todeterminetheefficacyandsafetyofthedruginquestionGCPisastandardprovisionforthewholeprocessofclinicaltrials,includingprogramdesign,organization,implementation,monitoring,inspection,recording,analysis,summaryandreporting.Toensurethattheclinicaltrialprocessisstandard,theresultsarescientificandreliable,therightsandinterestsofthesubjectareprotectedandthesafetyofthesubjectisensuredTheselectionofclinicaltrialmethodsmustconformtoscientificandethicalrequirementssummary1.Thenatureofpharmaceuticalanalysis:itisadisciplinethatstudiesanddevelopstotalqualitycontrolmethodsforpharmaceuticalproducts.Itmainlyappliesthetechniquesandmethodsofchemistry,physicalchemistryandbiochemistrytostudythequalitycontrolmethodsforsyntheticdrugs,naturald