美国药典-国家处方集-USP-NF课件

USP-NF美国药典美国药典/国家处方集国家处方集August 20091OutlinenIntroduction简介nMajor Sections主要章节nRevision修订nSummary小结2IntroductionnUSP Organization Standards DevelopmentThe Revision ProcessnUSP Mission To improve the health of people around the world through public standards and related programs that help ensure the quality and safety of medicines and foods.n USP组织组织药典标准的制定修订程序n USP使命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。3 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 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 begin4How did the U.S.Pharmacopeia begin5 1820-USP Founded:USP standards for 217 drugs 1848-Drug Import Act:USP legislatively mandated 1906-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：USP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 Recognition6USP：独立的非盈利组织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 confidential government(FDA)data such as acceptance criteriaUSPs Legal Recognition7 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 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 Makers8USP:United States PharmacopeiaNF:National FormularyAvailable formats:Print CD-ROM OnlineUSP-NF IntroductionPublished annually since 2002USP：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9 A compilation of standards andinformation for pharmaceuticals Standards for drug substances,drug products,excipients,dietary supplements General test methods anddefinitions Information 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 Introduction10 The process is open.USP strives forinput from various stakeholders:Comments on information found inthe USP-NF or Pharmacopeial Forum Annual Science Meeting Regional Compendial Groups Stakeholders Forums Industry Forum 标准的制定程序是开放的。USP努力征求所有利益相关人员的意见：关于美国药典/国家处方集或药典论坛信息的意见 年度学术会议 区域性药典团体 利益关系人论坛 制药工业论坛How USP Establishes Standards11Major Sections Front Matter General Notices General Chapters Reagents Reference Tables Dietary Supplements NF Monographs USP Monographs Glossaryl 前言l 凡例l 通则l 试剂l 参考表l 食品补充剂l 国家处方集(NF)各论l USP各论l 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质量标准原料药、制剂质量标准术语索引12Front MatterMission 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:Articles 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13General Notices The General Notices 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 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。14You 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 apply 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General Notices15e.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 ingredients that meet the requirements of the compendial monographs for those individual ingredients for which monographs are provided.”General Notices例如规定例如规定:“大约大约=+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。16General ChaptersTwo main purposes for general chapters:General 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：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：主要内容：通则图表 一般检测和含量测定 通则说明17General ChaptersGeneral chapters(e.g.,Chromatography ):Descriptions 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 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%.通则通则(例如：色谱法例如：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 Chapters18Reagents&Reference Tables Reagents:Defines suitable grades for reagents and methods of preparation for solutions in the tests and assays of USP-NF.Reagents,Indicators and Solutions;Indicators and Indicator Test Papers,etc.Reference Tables:Containers for Dispensing Capsules and Tablets;Description and Solubility;Atomic weights,etc.试剂：为美国药典/国家处方集检查和含量测定用溶液提供适当的试剂级别和配制方法；试剂、指示剂及溶液；指示用试纸等；参考表：胶囊和片剂用容器；性状和溶解性；原子质量等物理化学数据。19Monographs 目的：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。Why we have Monographs?USP-NF Monographs play an important role in ordinary commerce as public standards.Assays and specifications constitute legal standards in Monographs of USP-NF.Where to find Monographs?USP:Drug substances and products,including combinationsNF:ExcipientsDietary Supplements:Botanicals,vitamins and minerals 范畴：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20Monographs Monograph components(in alphabetical order)Molecular Formula Description and Solubility Identification Test Physical and Chemical Test Assay Impurities Residual Solvents USP Reference Standards,etc各论的构成各论的构成(按英文字母顺序按英文字母顺序)分子量 性状和溶解性 鉴别试验 理化试验 含量 杂质 残留溶剂 USP 参考物质等等21Dietary 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（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22NF Monographs What is an Excipient?An excipient is any component,other than the active substance(s),intentionally added to the formulation of a dosage form,e.g.,antioxidants,buffers,coating agents and sweetening agents,etc.辅料是有意添加到制剂处方中的处活性物质外的任何成分，如抗氧剂、缓冲剂、包衣材料和甜味剂等。400 Monographs400多个品种23 USP Monographs set forth thearticles name,definition,specification,and otherrequirements related topackaging,storage,andlabeling.The specification consists oftests,procedures,andacceptance criteria that helpensure the identity,strength,quality,and purity of thearticle.USP各论中建立了产品的名称、定义、标准，及与包装、贮存，和标签相关的要求。标准包括测试、方法以及接受范围，以确保产品的一致性、含量、质量和纯度。USP Monographs24USP Monographs A single monograph may includeseveral different tests,procedures,and/or acceptance criteria thatreflect attributes of differentmanufacturers articles.Such alternatives may bepresented for differentpolymorphic forms,impurities,hydrates,and dissolution cases.各论可能包含不同的检测、方法和/或接受范围，这体现了不同厂商产品的特性。这种多样性可能表现在不同的晶型，杂质，水合物以及溶出度的情况。25 General Notices:The Most Important Document Youve Never Read General Chapters:General Tests Monographs:Legal Recognition Revisionl 凡例：可能是你从未看过的最重要的资料l 附录：一般测试方法、信息l 各论：法律地位l 修订Key points26 USP-NF is continuously revised.Revisions are presented：Annually in the USP-NF;In twice-yearly Supplements;In Interim Revision Announcements,which appear six times a year inPharmacopeial Forum(PF);and As needed in Revision Bulletins,which are posted on the USP website.Go tohttp:/www.usp.org/USPNF/noticesUSP-NF 持续修订。修订可通过以下渠道获得：每年的新版USP-NF;一年2次的增补本;一年6期药典论坛(PF)中的“临时修订申明”；以及 修订公告-在USP 网站公布。http:/www.usp.org/USPNF/noticesRevision27Interested parties submit comments regarding compendial revisionsScientific staff liaison sends to Expert Committee for review/approvalRevision proposal in Pharmacopeial Forum for Public Review and CommentComments on PF reviewed by Expert CommitteeExpert Committee or appropriate Executive Committee approves for official adoptionBoard of Trustees approves publication fiduciary responsibility感兴趣的人士提交关于药典修订建议USP学术联系人将建议发送给专家委员会审核/批准在药典论坛(Pharmacopeial Forum)中发布修订提议，供公众审议和评论专家委员会审议关于药典论坛(PF)的建议专家委员会或相关执行委员会批准正式采纳理事会批准发布信托责任USP-NF Revision Process28Pharmacopeial 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 Forum29 www.usp.org Announcements/Meetings/Highlights in PF Reference Standard Catalog Scientific Issues Contact scientific liaison listed instaff directory in PFPhone:(301)816-8345FAX:(301)816-8373 Customer ServicePhone:(800)227-8772FAX:(301)816-8148USP Store:http:/store.usp.org General USP Phone:(301)881-0666 www.usp.org www.usp.org 药典论坛中的声明/会议/摘要 标准物质目录 学术问题 请联系药典论坛(PF)员工目录中列出的学术联系人电话：001-301-816-8345传真：001-301-816-8373 客户服务电话：(800)227-8772传真：001-301-816-8148在线服务：http:/store.usp.org USP总机：001-301-881-0666Some Sources for Information/Assistance30USP Convention Headquarters31nUSP-NF is a book of standards and information.nMonographs are legal standards in the U.S.nGeneral Notices and General ChaptersOften overlooked,but it is important to understand their contents.nIt is always so essential to pay your attention of the revision.Summary3233