药物分析-诸论-XXXX

PharmaceuticalAnalysis药物分析王彦Phone:34205673(O);E-mail:[e-mail]:6-304IntroductionDrugsarespecialproductsusedforpreventionandtherapyofdiseases,andforpromotionofthefunctionalityofhumanbody.DefinitionSafetyEffectivenessparticularityofdrugTheDualcharacterspecificityExtremeimportance-qualitycontrolProfessionalPharmaceuticalAnalysisPharmaceuticalanalysisisanappliedsciencedealingwiththeestablishmentanddevelopmentofqualitycontrolmethodsofdrugsandtheirpreparations.ImportanceAnalysisofdrugsandQualitycontrolareveryimportantmeanstoguaranteetheirsafeandeffectiveuse.TherelationshipbetweenPharmaceuticalAnalysisandAnalyticalChmistry.Thekeyisanalysis.Duties1.TotalQualityControlofDrugs—thebaseduties:•Startingmaterials,intermediates,andproducts•productionprocess:qualitycontrolstorageprocess:qualityinvestigationDuties2.Thenewdrugdevelopment-theimportantdutiesestablishinganddevelopingmethodsofqualitycontrolofdrugsthestudiesofstalibitythestudiesofpharmacokineticthestudiesofbioavailabilityDuties3.Clinicaluses—providehelpfortherelatedstudiesTherapeuticDrugMonitoring（治疗药物监测）Clinicalpharmacology（临床药理学）Biopharmaceutics（生物药剂学）2019/8/17Pharma-ceuticalAnalysisChemicalanalysisInstrumentalanalysisacid-basetitrationscomplexmetrictitrationoxidation-reductiontitrationprecipitationtitrationelectrochemicalanalysisphotochemicalanalysisChromatographicanalysisSpectrumanalysisgravimetricanalysisvolumetricanalysisConductometry（电导）、potentiometry（电位），electrolyticanalysis（电解）、coulometricanalysis（库仑）、polarography（极谱）、voltammetry（伏安）.UV,IR,FIGC、LC、TLCNMR、MSDifficulitiesComplicatedingredient：ChinesetratidionalmedicineTheamountisverysmall（microamount,traceamount)。Thetendencyofmodernpharmaceuticalanalysis药品管理理念检验控制质量生产控制质量设计控制质量分析对象静态分析体外分析小样本品质分析简单成分动态分析体内分析高通量生物活性分析复杂体系分析技术单一技术人工分析常量分析联用技术自动化分析、计算机辅助设计超微量分析DrugStandardization•PharmacopoeiaofthePeople’sRepublicofChina(，ChinesePharmacopoeia,Ch.P)（中华人民共和国药典，简称中国药典）-Nationaldrugstandards•MinisterialDrugStandards（国家药品标准，简称为局标准）-assupplementstothenationalpharmacopoeiaChinesePharmacopoeiaAlegaltechnologicalspecification。NineHistoryofCh.PSincethefoundingofChina,eightedition:1953、1963、1977、1985、1990、1995、2000,2005and2010.Thenintheditionis2005。ChinesePharmacopoeiaCommission。HistoryofChp1953年531monographsofdrugs19631310monographs(VolumeIandII)19771925monographs19851489monographs（Englishversion)19901751monographs（临床用稿须知，药品红外光谱集）19952375monographs（中药彩图）20002691monographs（首次收载指导原则）20053214monographs,with525newadmissions（VolumeI,IIandIII）20104567monographs(volumeI:2165;volumeII:2271;volumeIII:131)《中国药典》（2010版）Ch.P.(2010版）2010年1月出版，10月1日正式实施。Otherseparatevolumes:《theAtlasofInfraredSpectraofDrugs》（《药品红外光谱集》）《ChinesePharmacopoeia,Englishedition》（《中国药典英文版》）《AGuidetoClinicalUseofDrugs》(《临床用药需知》)MainmethodsofsevenCh.P01020304050607080容量分析法重量分析法紫外分析法色谱分析法其它1953196319771985199019952000历版药典含量测定中HPLC的使用情况药典版次1977版1985版1990版1995版2000版2005版2010采用次数0856113268491694增加数84857155223203每年增长率（％）1.0％9.6％11.4％31.0％44.6％40.6%USPThePharmacopoeiaoftheUnitedStatesofAmerican(USP)ThenewesteditionisUSP(34)-NF(29)(TheNationalFormulary(NF)Publicationdate:November1,2010Officialdate:May1,2011TheBritishPharmacopoeiaTheBritishPharmacopoeiahasprovidedauthoritativestandardsforthequalityofsubstances,preparationsandarticlesusedinmedicineandpharmacyforalmost140years.Thenewestedition：BP2011（2011-1）EuropeanPharmacopoeiaPh.Eup（EuropeanPharmacopoeia）Thenewestedition：Seventhedtion(EP7)（2011）.JapanesePharmacopoeiaJapanesePharmacopoeia（JP）Thenewestedition:JP(15)(2006)TheInternationalPharmacopoeiaPh.Int（TheInternationalPharmacopoeia）thenewest:fouthedition(2006)《GoodLaboratoryPractice》GLP《GoodManufacturePractice》GMP《GoodSupplyPractice》GSP《GoodClinicalPractice》GCP《GoodAgriculturePracticeforChineseRudedrugs》GAPICH(InternationalConferenceonHarmonisationofTechnicalrequirementsforregistrationofPharmaceuticalsforHumanUse,ICH)(人用药品注册技术国际协调会）S()、Q()、E（)、M（)safetymultidisciplinaryqualityefficacyBooks安登魁主编，药物分析，济南出版社，1992安登魁主编，现代药物分析选论，中国医药科技出版社2001马广慈主编，药物分析方法与应用，科学出版社2000许瑞庭编著，实用药物分析化学，浙江科学技术出版社1992Schirmer，R．E．，ModernMethodsofPharmaceuticalAnalysis，CRCPress，1982Florey，K．，AnalyticalProfilesofDrugSubstances，Vo1．1-18，AcademicPress，1972-1989Journals药物分析杂志(ChineseJournalofPharmaceuticalAnalysis)中国医药工业杂志(ChineseJournalofPharmaceuticals)中国药学杂志(ChinesePharmaceuticJournal)药学学报(ActaPharmaceuticaSinica)分析化学(AnalyticalChemistry)AnalyticalChemistryAnalyticaChimicaActaTheAnalystJournalofpharmaceuticalScienceTalantaRequirementsofthecourse1.Pharmacopoeia2.Identification,Test,Assay3.Taketwelvecategoriesoftypicaldrugasexample,studytherulesandmethodofpharmaceuticalanalysis4.Analysisofpharmaceuticalpreparation5.Learnhowtoestablishthedrugstandard6.ModerntechnologyandmethodChapter1IntroduceofCh.P§1-1Ch.PGeneralNotices（凡例）Monographs（正文）Appendices（附录）Index（索引）GenralNoticesserveasthebasicguidelinesfortheproperinterpretationandapplicationoftheChinesePharmacopoeiainqualitycontrol.Itappliestoanyarticles,appendices