美國(guó)藥典-國(guó)家處方集-USP-NF課件

USP-NF

《美國(guó)藥典/國(guó)家處方集》August20091OutlineIntroduction

簡(jiǎn)介MajorSections 主要章節(jié)Revision

修訂Summary 小結(jié)2IntroductionUSPOrganization StandardsDevelopment TheRevisionProcessUSPMissionToimprovethehealthofpeoplearoundtheworldthroughpublicstandardsandrelatedprogramsthathelpensurethequalityandsafetyofmedicinesandfoods.USP組織藥典標(biāo)準(zhǔn)的制定修訂程序USP使命通過(guò)提供公共標(biāo)準(zhǔn)及其它相關(guān)項(xiàng)目以確保優(yōu)質(zhì)安全的藥品與食品，促進(jìn)全人類(lèi)的健康。3?LymanSpaldingsurveyedphysiciansnationwidebetween1817and1819?Spaldingand10fellowphysiciansmetintheU.S.CapitolJanuary1-7,1820andthegroundworkwaslaidforestablishingthefirstPharmacopeiaoftheUnitedStatesofAmerica?1817年至1819年，醫(yī)學(xué)博士LymanSpalding對(duì)全國(guó)的內(nèi)科醫(yī)師進(jìn)行了調(diào)查?1820年1月1-7日，Spalding和10名內(nèi)科醫(yī)師在美國(guó)國(guó)會(huì)大廈會(huì)面，完成了第一部《美國(guó)藥典》的基礎(chǔ)工作HowdidtheU.S.Pharmacopeiabegin4HowdidtheU.S.Pharmacopeiabegin5?1820-USPFounded:USPstandardsfor217drugs?1848-DrugImportAct:USPlegislativelymandated?1906-FederalPureFood&DrugsAct:USPandNFstandardsrecognized?1938-FederalFood,Drug&CosmeticAct:USPandNFstandardsenforceablebyFDA?1990-OBRArecognizedUSP-DIforoff-labeluses?1994-DSHEA“officialcompendium”conformityfordietarysupplements(voluntary)?1820年—USP成立：為217種藥物制訂了USP標(biāo)準(zhǔn)?1848年—進(jìn)口藥品法：USP獲得法律授權(quán)?1906年—聯(lián)邦潔凈食品和藥品法：《美國(guó)藥典》(USP)和《國(guó)家處方集》(NF)標(biāo)準(zhǔn)得到認(rèn)可?1938年—聯(lián)邦食品、藥品和化妝品法：《美國(guó)藥典》和《國(guó)家處方集》標(biāo)準(zhǔn)由食品和藥品管理局(FDA)強(qiáng)制執(zhí)行?1990年—聯(lián)邦綜合預(yù)算調(diào)節(jié)法(OBRA)認(rèn)可《美國(guó)藥典/藥品信息》，供用藥參考用?1994年—被食品補(bǔ)充劑健康和教育法(DSHEA)認(rèn)可為食品補(bǔ)充劑的“法定標(biāo)準(zhǔn)”（自愿執(zhí)行）USP’sLegalRecognition6USP：獨(dú)立的非盈利組織–從事藥典標(biāo)準(zhǔn)的制定及修訂–公共標(biāo)準(zhǔn)、規(guī)格、純度、質(zhì)量、包裝和標(biāo)簽全球唯一獨(dú)立藥典機(jī)構(gòu)–客觀、獨(dú)立的組織–更高效的標(biāo)準(zhǔn)制定程序–不能使用政府(FDA)機(jī)密數(shù)據(jù)，例如新藥標(biāo)準(zhǔn)USP:PrivateNot-For-ProfitOrganization–CompendialStandardsdevelopmentandrevision–PublicStandards,strength,purity,quality,packaging,labelingTheonlynon-governmentalPharmacopeiaintheworld–Objective,independentorganization–Fasterprocessforstandardsdevelopment–Noaccesstoconfidentialgovernment(FDA)datasuchasacceptancecriteriaUSP’sLegalRecognition7?USPismadeupofover1,000volunteers?Over400membersoftheUSPConvention?CouncilofExperts-56electedexpertswhochairexpertcommitteesrepresentingstandardsandinformation?Over600volunteersserveonExpertCommittees?BoardofTrustees-11electedvotingmembers?USP由1,000多名志愿專(zhuān)家組成?USP委員會(huì)有400多名會(huì)員?專(zhuān)家主任委員會(huì)—由56名當(dāng)選的專(zhuān)家組成，他們分別擔(dān)任相應(yīng)標(biāo)準(zhǔn)和信息專(zhuān)家委員會(huì)的主席?專(zhuān)家委員會(huì)包括600多名專(zhuān)家?理事會(huì)—由11名有投票權(quán)的當(dāng)選委員組成USP’sVolunteerDecisionMakers8USP:UnitedStatesPharmacopeiaNF:NationalFormularyAvailableformats:PrintCD-ROMOnlineUSP-NFIntroductionPublishedannuallysince2002USP：《美國(guó)藥典》(UnitedStatesPharmacopeia)NF:《國(guó)家處方集》(NationalFormulary)格式：印行本光盤(pán)在線網(wǎng)絡(luò)版自2002年起每年一版9?Acompilationofstandardsandinformationforpharmaceuticals?Standardsfordrugsubstances,drugproducts,excipients,dietarysupplements?Generaltestmethodsanddefinitions?Informationaboutrelevanttopics?美國(guó)醫(yī)藥產(chǎn)品標(biāo)準(zhǔn)和信息匯編?原料藥、制劑、輔料、食品補(bǔ)充劑的質(zhì)量標(biāo)準(zhǔn)?一般測(cè)試方法和定義?相關(guān)主題的信息USP-NFIntroduction10?Theprocessisopen.USPstrivesforinputfromvariousstakeholders:?CommentsoninformationfoundintheUSP-NForPharmacopeialForum?AnnualScienceMeeting?RegionalCompendialGroups?StakeholdersForums?IndustryForum?標(biāo)準(zhǔn)的制定程序是開(kāi)放的。USP努力征求所有利益相關(guān)人員的意見(jiàn)：?關(guān)于《美國(guó)藥典/國(guó)家處方集》或《藥典論壇》信息的意見(jiàn)?年度學(xué)術(shù)會(huì)議?區(qū)域性藥典團(tuán)體?利益關(guān)系人論壇?制藥工業(yè)論壇HowUSPEstablishesStandards11MajorSections ?FrontMatter?

GeneralNotices?

GeneralChapters?

Reagents?

ReferenceTables?

DietarySupplements?

NFMonographs?

USPMonographs

?Glossary前言凡例通則試劑參考表食品補(bǔ)充劑國(guó)家處方集(NF)各論USP各論術(shù)語(yǔ)By-laws,changesfrompreviousUSPDefinitionsandassumptionsGeneraltestmethods,information

MaterialsusedinmonographsDescription,solubility,etc.DietarySupplementsstandardsExcipientsDrugsubstance,productstandardsGlossaryreferences細(xì)則，修訂定義和統(tǒng)計(jì)學(xué)假設(shè)一般測(cè)試方法、信息各論中使用的材料溶解度等質(zhì)量標(biāo)準(zhǔn)輔料質(zhì)量標(biāo)準(zhǔn)原料藥、制劑質(zhì)量標(biāo)準(zhǔn)術(shù)語(yǔ)索引12FrontMatterMissionandPrefaceMission,History,RulesandProcedures（Appendices）PeopleConvention,CouncilofExpertsAdmissionsInclusions,omissionsandchangesCommentaryCommittee’sresponsetocommentsreceivedaboutproposalthatisofficialinthisaditionAppendicesA:ArticlesofIncorporation,B:Constitution,C:Rulesandprocedures,D:CommunicationsPolicy,E:DocumentDisclosurePolicy,F:Proceedings,etc.使命和前言

使命、歷史、規(guī)則和程序（附錄）人員USP委員會(huì)、專(zhuān)家主任委員會(huì)、合作者修訂說(shuō)明

收載，刪減和修改注釋專(zhuān)家委員會(huì)對(duì)關(guān)于本版本中正式生效修訂提議意見(jiàn)的反饋附錄A:組織章程,B:章程與細(xì)節(jié),C:規(guī)則與程序,D:通訊政策,E:文件公開(kāi)政策,F:文獻(xiàn)匯編等等13GeneralNotices?

TheGeneralNoticesandRequirementssection(theGeneralNotices)presentsthebasicassumptions,definitions,anddefaultconditionsfortheinterpretationandapplicationoftheUnitedStatesPharmacopeia(USP)andtheNationalFormulary(NF).?

RequirementsstatedintheseGeneralNoticesapplytoallarticlesrecognizedintheUSPandNF(the“compendia”)andtoallgeneralchaptersunlessspecificallystatedotherwise.?凡例部分為USP和NF的解釋、應(yīng)用提供基本假設(shè)、定義，及默認(rèn)的條件。?除另有說(shuō)明，凡例中的要求適用于USP和NF（或稱(chēng)“藥典”）中的所有產(chǎn)品及所有的通則。14Youwilllearnwhattodoif...在以下情況下，你需要學(xué)習(xí)?YoudonotunderstandaterminUSP-NF不理解USP-NF中的術(shù)語(yǔ)?Youarenotsurehowtoapplyananalyticalproceduretoyourproduct不確定如何將分析方法應(yīng)用于你的產(chǎn)品?Youneedtoknowhowcontainersandclosuresaredefined(soontobemovedelsewhere)需要了解容器和密閉的要求?YoueverfailacertainUSP-NFtestUSP-NF檢測(cè)曾經(jīng)失敗過(guò)?AUSP-NFchromatographicproceduredoesnotshowoneofyourimpuritiesUSP-NF的色譜方法不能顯示你的某個(gè)雜質(zhì)GeneralNotices15e.g.,definitions:“about=+10%”?Theuseoftheword“about”intheUSPmeans+10%oftheoriginalvalue/parameter?Yes–forweights,volumes,dimensions?No–fortemperatures,times,acceptancecriteriaIngredientsandProcesses“Officialdrugproductsandfinisheddevicesarepreparedfromingredientsthatmeettherequirementsofthecompendialmonographsforthoseindividualingredientsforwhichmonographsareprovided.”GeneralNotices例如規(guī)定:“大約=+10%”?“大約”在USP中意思是原始值的+10%?是–重量,體積,尺寸?否–溫度,次數(shù),接受標(biāo)準(zhǔn)藥物成分和工藝收入U(xiǎn)SP各論的藥品，必須使用符合USP-NF的原料。16GeneralChaptersTwomainpurposesforgeneralchapters:?GeneraltestproceduresforUSPandNFmonographs?SourceofinformationonrelatedindustrytopicsMaincontents?ChapterCharts?GeneralTestsandAssays?GeneralInformation通則的兩個(gè)主要目標(biāo)：?提供USP-NF藥品標(biāo)準(zhǔn)的一般檢測(cè)方法?提供行業(yè)相關(guān)主題的信息主要內(nèi)容：?通則圖表?一般檢測(cè)和含量測(cè)定?通則說(shuō)明17GeneralChaptersGeneralchapters(e.g.,Chromatography<621>):?Descriptionsoftestsandproceduresforapplicationthroughindividualmonographs,?Descriptionsandspecificationsofconditionsandpracticesforpharmaceuticalcompounding,?Generalinformationfortheinterpretationofthecompendialrequirements,?Descriptionsofgeneralpharmaceuticalstorage,dispensing,andpackagingpractices,or?Generalguidancetomanufacturersofofficialsubstancesorofficialproducts.Example:AsdescribedinMonograph---?pH<791>:between3.0and5.5,inasolutioncontaining100mgpermL.?Water,MethodI<921>:between3.0%and6.0%.通則(例如：色譜法<621>):?各論中應(yīng)用的測(cè)試和方法的描述；?配藥的條件及操作的描述與標(biāo)準(zhǔn)；?對(duì)藥典要求的通用解釋?zhuān)?描述通用的藥品貯存、配方和包裝操作，以及?對(duì)藥用原料和制劑生產(chǎn)商的通用指導(dǎo)原則例如：各論中描述------?pH<791>:between3.0and5.5,inasolutioncontaining100mgpermL.?Water,MethodI<921>:between3.0%and6.0%.GeneralChapters18Reagents&ReferenceTables?

Reagents:DefinessuitablegradesforreagentsandmethodsofpreparationforsolutionsinthetestsandassaysofUSP-NF.Reagents,IndicatorsandSolutions;IndicatorsandIndicatorTestPapers,etc.?

ReferenceTables:ContainersforDispensingCapsulesandTablets;DescriptionandSolubility;Atomicweights,etc.試劑：為美國(guó)藥典/國(guó)家處方集檢查和含量測(cè)定用溶液提供適當(dāng)?shù)脑噭┘?jí)別和配制方法；試劑、指示劑及溶液；指示用試紙等；參考表：膠囊和片劑用容器；性狀和溶解性；原子質(zhì)量等物理化學(xué)數(shù)據(jù)。

19Monographs目的：USP-NF各論作為公共標(biāo)準(zhǔn)，在一般的商業(yè)活動(dòng)中發(fā)揮者重要作用。含量測(cè)定和限度規(guī)定構(gòu)成法定標(biāo)準(zhǔn)。WhywehaveMonographs?USP-NFMonographsplayanimportantroleinordinarycommerceaspublicstandards.AssaysandspecificationsconstitutelegalstandardsinMonographsofUSP-NF.WheretofindMonographs?USP:Drugsubstancesandproducts,includingcombinationsNF:ExcipientsDietarySupplements:Botanicals,vitaminsandminerals

范疇：USP：原料藥和制劑，包括復(fù)方制劑NF:輔料DietarySupplements:植物藥、維生素和礦物質(zhì)20MonographsMonographcomponents(inalphabeticalorder)?MolecularFormula?DescriptionandSolubility?IdentificationTest?PhysicalandChemicalTest?Assay?Impurities?ResidualSolvents?USPReferenceStandards,etc各論的構(gòu)成(按英文字母順序)?分子量?性狀和溶解性?鑒別試驗(yàn)?理化試驗(yàn)?含量?雜質(zhì)?殘留溶劑?USP參考物質(zhì)等等21DietarySupplementsChapters&Monographs?

DesignatedaspartofUSP,notNF?6relatedgeneralchapters，GeneralInformationfordietarysupplements(disintegration,dissolution,etc.)?monographs(Vitamins,minerals,andbotanicals,etc.)：Standardsfordietarysupplements?屬于《美國(guó)藥典》（USP）的內(nèi)容，而不是《國(guó)家處方集》（NF）的內(nèi)容?六個(gè)相關(guān)通則，一般信息（崩解、溶出等）?各論(維生素、礦物質(zhì)及植物藥)：質(zhì)量標(biāo)準(zhǔn)22NFMonographsWhatisanExcipient?Anexcipientisanycomponent,otherthantheactivesubstance(s),intentionallyaddedtotheformulationofadosageform,e.g.,antioxidants,buffers,coatingagentsandsweeteningagents,etc..輔料是有意添加到制劑處方中的處活性物質(zhì)外的任何成分，如抗氧劑、緩沖劑、包衣材料和甜味劑等。>400Monographs400多個(gè)品種23?USPMonographssetforththearticle'sname,definition,specification,andotherrequirementsrelatedtopackaging,storage,andlabeling.?Thespecificationconsistsoftests,procedures,andacceptancecriteriathathelpensuretheidentity,strength,quality,andpurityofthearticle.?USP各論中建立了產(chǎn)品的名稱(chēng)、定義、標(biāo)準(zhǔn)，及與包裝、貯存，和標(biāo)簽相關(guān)的要求。?標(biāo)準(zhǔn)包括測(cè)試、方法以及接受范圍，以確保產(chǎn)品的一致性、含量、質(zhì)量和純度。USPMonographs24USPMonographs?Asinglemonographmayincludeseveraldifferenttests,procedures,and/oracceptancecriteriathatreflectattributesofdifferentmanufacturers'articles.?Suchalternativesmaybepresentedfordifferentpolymorphicforms,impurities,hydrates,anddissolutioncases.?各論可能包含不同的檢測(cè)、方法和/或接受范圍，這體現(xiàn)了不同廠商產(chǎn)品的特性。?這種多樣性可能表現(xiàn)在不同的晶型，雜質(zhì)，水合物以及溶出度的情況。25?

GeneralNotices:TheMostImportantDocumentYou’veNeverRead?

GeneralChapters:GeneralTests?

Monographs:LegalRecognition?

Revision凡例：可能是你從未看過(guò)的最重要的資料附錄：一般測(cè)試方法、信息各論：法律地位修訂Keypoints26

USP-NFiscontinuouslyrevised.Revisionsarepresented：?AnnuallyintheUSP-NF;?Intwice-yearlySupplements;?InInterimRevisionAnnouncements,whichappearsixtimesayearinPharmacopeialForum(PF);and?AsneededinRevisionBulletins,whicharepostedontheUSPwebsite.Gotohttp:///USPNF/noticesUSP-NF持續(xù)修訂。修訂可通過(guò)以下渠道獲得：?每年的新版USP-NF;?一年2次的增補(bǔ)本;?一年6期《藥典論壇》(PF)中的“臨時(shí)修訂申明”；以及?修訂公告-在USP網(wǎng)站公布。http:///USPNF/noticesRevision27InterestedpartiessubmitcommentsregardingcompendialrevisionsScientificstaffliaisonsendstoExpertCommitteeforreview/approvalRevisionproposalinPharmacopeialForumforPublicReviewandCommentCommentsonPFreviewedbyExpertCommitteeExpertCommitteeorappropriateExecutiveCommitteeapprovesforofficialadoptionBoardofTrusteesapprovespublicatio