美国药典 国家处方集 USPNF.ppt

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1、1,USP-NF美国药典/国家处方集,2,Outline,Introduction简介Major Sections主要章节Revision修订Summary小结,3,Introduction,USP Organization Standards DevelopmentThe Revision ProcessUSP Mission To improve the health of people around the world through public standards and related programs that help ensure the quality and safety

2、 of medicines and foods.,USP组织药典标准的制定修订程序 USP使命通过提供公共标准及其它相关项目以确保优质安全的药品与食品，促进全人类的健康。,4,Lyman Spalding surveyed physicians nationwide between 1817 and 1819 Spalding and 10 fellow physicians met in the U.S.Capitol January 1-7,1820 and the groundwork was laid for establishing the first Pharmacopeia of

3、 the United States of America,1817年至1819年，医学博士Lyman Spalding对全国的内科医师进行了调查 1820年1月1-7日，Spalding 和10名内科医师在美国国会大厦会面，完成了第一部美国药典的基础工作,How did the U.S.Pharmacopeia begin,5,How did the U.S.Pharmacopeia begin,6,1820-USP Founded:USP standards for 217 drugs 1848-Drug Import Act:USP legislatively mandated 1906

4、-Federal Pure Food&Drugs Act:USP and NF standards recognized 1938-Federal Food,Drug&Cosmetic Act:USP and NF standards enforceable by FDA 1990-OBRA recognized USP-DI for off-label uses 1994-DSHEA“official compendium”conformity for dietary supplements(voluntary),1820年USP成立：为217种药物制订了USP标准 1848年进口药品法：U

5、SP获得法律授权 1906年联邦洁净食品和药品法：美国药典(USP)和国家处方集(NF)标准得到认可 1938年联邦食品、药品和化妆品法：美国药典和国家处方集标准由食品和药品管理局(FDA)强制执行 1990年联邦综合预算调节法(OBRA)认可美国药典/药品信息，供用药参考用 1994年被食品补充剂健康和教育法(DSHEA)认可为食品补充剂的“法定标准”（自愿执行）,USPs Legal Recognition,7,USP：独立的非盈利组织从事药典标准的制定及修订公共标准、规格、纯度、质量、包装和标签全球唯一独立药典机构客观、独立的组织更高效的标准制定程序不能使用政府(FDA)机密数据，例如新

6、药标准,USP:Private Not-For-Profit Organization Compendial Standards development and revision Public Standards,strength,purity,quality,packaging,labelingThe only non-governmental Pharmacopeia in the world Objective,independentorganization Faster process for standards development No access to confidentia

7、l government(FDA)data such as acceptance criteria,USPs Legal Recognition,8,USP is made up of over 1,000volunteers Over 400 members of the USPConvention Council of Experts-56 electedexperts who chair expertcommittees representingstandards and information Over 600 volunteers serve onExpert Committees

8、Board of Trustees-11 electedvoting members,USP由1,000多名志愿专家组成 USP委员会有400多名会员 专家主任委员会由56名当选的专家组成，他们分别担任相应标准和信息专家委员会的主席 专家委员会包括600多名专家 理事会由11名有投票权的当选委员组成,USPs Volunteer Decision Makers,9,USP:United States PharmacopeiaNF:National FormularyAvailable formats:Print CD-ROM Online,USP-NF Introduction,Publish

9、ed annually since 2002,USP：美国药典(United States Pharmacopeia)NF:国家处方集(National Formulary)格式：印行本 光盘 在线网络版,自2002年起每年一版,10,A compilation of standards andinformation for pharmaceuticals Standards for drug substances,drug products,excipients,dietary supplements General test methods anddefinitions Informati

10、on about relevanttopics,美国医药产品标准和信息汇编 原料药、制剂、辅料、食品补充剂的质量标准 一般测试方法和定义 相关主题的信息,USP-NF Introduction,11,How USP Establishes Standards,12,Major Sections,Front Matter General Notices General Chapters Reagents Reference Tables Dietary Supplements NF Monographs USP Monographs Glossary,前言 凡例 通则 试剂 参考表 食品补充剂

11、国家处方集(NF)各论 USP各论 术语,By-laws,changes from previous USPDefinitions and assumptionsGeneral test methods,information Materials used in monographsDescription,solubility,etc.Dietary Supplements standardsExcipientsDrug substance,product standardsGlossary references,细则，修订定义和统计学假设一般测试方法、信息各论中使用的材料溶解度等质量标准辅料

12、质量标准原料药、制剂质量标准术语索引,13,Front Matter,Mission and Preface Mission,History,Rules and Procedures（Appendices）People Convention,Council of ExpertsAdmissions Inclusions,omissions and changesCommentary Committees response to comments received about proposal that is official in this aditionAppendices A:Articl

13、es of Incorporation,B:Constitution,C:Rules and procedures,D:Communications Policy,E:Document Disclosure Policy,F:Proceedings,etc.,使命和前言 使命、历史、规则和程序（附录）人员 USP委员会、专家主任委员会、合作者修订说明 收载，删减和修改注释 专家委员会对关于本版本中正式生效修订 提议意见的反馈附录 A:组织章程,B:章程与细节,C:规则与程序,D:通讯政策,E:文件公开政策,F:文献汇编等等,14,General Notices,The General Noti

14、ces and Requirements section(the General Notices)presents the basic assumptions,definitions,and default conditions for the interpretation and application of the United States Pharmacopeia(USP)and the National Formulary(NF).Requirements stated in these General Notices apply to all articles recognized

15、 in the USP and NF(the“compendia”)and to all general chapters unless specifically stated otherwise.,凡例部分为USP和NF的解释、应用提供基本假设、定义，及默认的条件。除另有说明，凡例中的要求适用于USP 和NF（或称“药典”）中的所有产品及所有的通则。,15,You will learn what to do if.在以下情况下，你需要学习 You do not understand a term in USP-NF不理解USP-NF中的术语 You are not sure how to a

16、pply an analytical procedure to your product不确定如何将分析方法应用于你的产品 You need to know how containers and closures are defined(soon to bemoved elsewhere)需要了解容器和密闭的要求 You ever fail a certain USP-NF testUSP-NF检测曾经失败过 A USP-NF chromatographic procedure does not show one of yourimpuritiesUSP-NF的色谱方法不能显示你的某个杂质,G

17、eneral Notices,16,e.g.,definitions:“about=+10%”The use of the word“about”in the USP means+10%of the original value/parameter Yes for weights,volumes,dimensions No for temperatures,times,acceptance criteriaIngredients and Processes“Official drug products and finished devices are prepared from ingredi

18、ents that meet the requirements of the compendial monographs for those individual ingredients for which monographs are provided.”,General Notices,例如规定:“大约=+10%”“大约”在USP中意思是原始值的+10%是 重量,体积,尺寸 否 温度,次数,接受标准药物成分和工艺收入USP各论的药品，必须使用符合USP-NF的原料。,17,General Chapters,Two main purposes for general chapters:Gen

19、eral test procedures for USP and NF monographs Source of information on related industry topicsMain contents Chapter Charts General Tests and Assays General Information,通则的两个主要目标：提供USP-NF药品标准的一般检测方法 提供行业相关主题的信息主要内容：通则图表 一般检测和含量测定 通则说明,18,General ChaptersGeneral chapters(e.g.,Chromatography):Descript

20、ions of tests and procedures forapplication through individual monographs,Descriptions and specifications of conditions and practices for pharmaceutical compounding,General information for the interpretation of the compendial requirements,Descriptions of general pharmaceutical storage,dispensing,and

21、 packaging practices,or General guidance to manufacturers of officialsubstances or official products.Example:As described in Monograph-pH:between 3.0 and 5.5,in a solutioncontaining 100 mg per mL.Water,Method I:between 3.0%and6.0%.,通则(例如：色谱法):各论中应用的测试和方法的描述；配药的条件及操作的描述与标准；对药典要求的通用解释；描述通用的药品贮存、配方和包装操

22、作，以及 对药用原料和制剂生产商的通用指导原则例如：各论中描述-pH:between 3.0 and 5.5,in a solution containing 100 mgper mL.Water,Method I:between 3.0%and 6.0%.,General Chapters,19,Reagents&Reference Tables,20,Monographs,目的：USP-NF 各论作为公共标准，在一般的商业活动中发挥者重要作用。含量测定和限度规定构成法定标准。,范畴：USP：原料药和制剂，包括复方制剂NF:辅料Dietary Supplements:植物药、维生素和矿物质,

23、21,Monographs,22,Dietary Supplements Chapters&Monographs,Designated as part of USP,not NF 6 related general chapters，General Information for dietary supplements(disintegration,dissolution,etc.)monographs(Vitamins,minerals,and botanicals,etc.)：Standards for dietary supplements,属于美国药典（USP）的内容，而不是国家处方集

24、（NF）的内容 六个相关通则，一般信息（崩解、溶出等）各论(维生素、矿物质及植物药)：质量标准,23,NF Monographs,400 Monographs,400多个品种,24,25,26,General Notices:The Most Important Document Youve Never Read General Chapters:General Tests Monographs:Legal Recognition Revision,凡例：可能是你从未看过的最重要的资料 附录：一般测试方法、信息 各论：法律地位 修订,Key points,27,Revision,28,29,P

25、harmacopeial Forum The Journal of StandardsDevelopment and OfficialCompendia Revision Published Bimonthly,药典论坛 关于标准制定和药典修订的期刊 双月刊,Pharmacopeial Forum,30,Some Sources for Information/Assistance,31,USP Convention Headquarters,32,USP-NF is a book of standards and information.Monographs are legal standards in the U.S.General Notices and General ChaptersOften overlooked,but it is important to understand their contents.It is always so essential to pay your attention of the revision.,Summary,33,Thank You!,