美国药典 国家处方集 USPNF

1、1 usp-nf 美国药典美国药典/国家处方集国家处方集 august 2009 2 outline nintroduction简介 nmajor sections主要章节 nrevision修订 nsummary小结 3 introduction nusp organization standards development the revision process nusp mission to improve the health of people around the world through public standards and related programs that h

2、elp 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。 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

3、 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 begin 5 how did the u.s. pharmacopeia begin 6 1820 - usp founded: usp standards for 217 d

4、rugs 1848 - drug import act: usp legislatively mandated 1906 -federal pure food 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

5、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。 20 monographs 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

6、to find monographs? usp: drug substances and products, including combinations nf: excipients dietary 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 21 monographs monograph components (in alphabetical order) molecular formula descript

7、ion 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 22 dietary supplements chapters in twice-yearly supplements; in interim revision announcements, whi

8、ch appear six times a year in pharmacopeial forum (pf); and as needed in revision bulletins, which are posted on the usp website. go to /uspnf/notices usp-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。 /uspnf/notices revision

9、 28 interested parties submit comments regarding compendial revisions scientific staff liaison sends to expert committee for review/approval revision proposal in pharmacopeial forum for public review and comment comments on pf reviewed by expert committee expert committee or appropriate executive co

10、mmittee approves for official adoption board 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 process 29 pharmacopeial forum the jour

11、nal of standards development and official compendia 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 announcements/meetings/ highlights in pf reference standard catalog scientific issues contact scientific liaison listed in staff directory in pf phone: (301) 8

12、16-8345 fax: (301) 816-8373 customer service phone: (800) 227-8772 fax: (301) 816-8148 usp store: general usp phone : (301) 881-0666 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： usp总机：001-301-881-0666 some sources for information/assistance 31 usp convention headquarters 32 nusp-nf is a book of standards and information. nmonographs are legal sta