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THE HISTORY OF USP-NF《美国药典/国家处方集》的历史

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2018年10月13日

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THE HISTORY OF USP-NF《美国药典/国家处方集》的历史

On January 1, 1820, 11 physicians met in the Senate Chamber of the U.S. Capitol building to establish a pharmacopoeia for the United States. These practitioners sought to create a compendium of the best therapeutic products, give them useful names, and provide recipes for their preparation. Nearly a year later, on December 15, 1820, the first edition of The Pharmacopoeia of the United States was published. Over time, the nature of the United States Pharmacopeia (USP) changed from being a compendium of recipes to a compendium of documentary standards that increasingly are allied with reference materials, which together establish the identity of an article through tests for strength, quality, and purity. The publishing schedule of the USP also changed over time. From 1820 to 1942, the USP was published at 10-year intervals; from 1942 to 2000, at 5-year intervals; and beginning in 2002, annually.

1820年1月1日,11位医生在美国国会大厦参议院会议厅召开会议制定美国药典。这些医师们试图制定一部最好治疗产品的手册,给出它们有效名称,提供制剂处方。大概—年以后,1820年12月15日,《美国药典》第一版出版了。经过一段时间,《美国药典》的性质从一部处方手册转变成了不断增加参照材料的文献标准手册,通过检査手段共同建立品种规格、质量和纯度等标准。后来,《美国药典》出版周期也发生了改变。从1820年到1942年,《美国药典》每隔十年出版一版;从1942年到2000年,每五年出版一版;从2002年开始,每年出版一版。

In 1888, the American Pharmaceutical Association published the first national formulary under the title The National Formulary of Unofficial Preparations (NF). Both the USP and the NF were recognized in the Federal Food and Drugs Act of 1906 and again in the Federal Food, Drug, and Cosmetic Act 1938. In 1975, USP acquired the National Formulary (NF), which now contains excipients standards with references to allied reference materials. Today, USP continues to develop USP and NF through the work of the Council of Experts into compendia that provide standards for articles based on advances in analytical and metrological science. As these and allied sciences evolve, so do USP and NF. 1

1888年,美国药学会出版了第一部国家处方集,名称为《非正式制剂的国家处方集》。《美国药典》(USP)和《国家处方集》(NF)都得到1906年《联邦食品药品法案》的认可。1975年USP合并了NF,现在NF通过引用相关参考材料收录了辅料的标准。如今,UPS不断通过专家委员会的工作,把USP和NF观发展成为提供以分析和计量科学进步为基础的品种标准手册。有了这些工作和科学的进展,USP和NF确实得到发展。

医学英语


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