THE HISTORY OF USP-NF《美國(guó)藥典/國(guó)家處方集》的歷史

THE HISTORY OF USP-NF《美國(guó)藥典/國(guó)家處方集》的歷史

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位醫(yī)生在美國(guó)國(guó)會(huì)大廈參議院會(huì)議廳召開會(huì)議制定美國(guó)藥典。這些醫(yī)師們?cè)噲D制定一部最好治療產(chǎn)品的手冊(cè)，給出它們有效名稱，提供制劑處方。大概—年以后，1820年12月15日，《美國(guó)藥典》第一版出版了。經(jīng)過一段時(shí)間，《美國(guó)藥典》的性質(zhì)從一部處方手冊(cè)轉(zhuǎn)變成了不斷增加參照材料的文獻(xiàn)標(biāo)準(zhǔn)手冊(cè)，通過檢査手段共同建立品種規(guī)格、質(zhì)量和純度等標(biāo)準(zhǔn)。后來，《美國(guó)藥典》出版周期也發(fā)生了改變。從1820年到1942年，《美國(guó)藥典》每隔十年出版一版;從1942年到2000年，每五年出版一版;從2002年開始，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，美國(guó)藥學(xué)會(huì)出版了第一部國(guó)家處方集，名稱為《非正式制劑的國(guó)家處方集》?！睹绹?guó)藥典》(USP)和《國(guó)家處方集》(NF)都得到1906年《聯(lián)邦食品藥品法案》的認(rèn)可。1975年USP合并了NF，現(xiàn)在NF通過引用相關(guān)參考材料收錄了輔料的標(biāo)準(zhǔn)。如今，UPS不斷通過專家委員會(huì)的工作，把USP和NF觀發(fā)展成為提供以分析和計(jì)量科學(xué)進(jìn)步為基礎(chǔ)的品種標(biāo)準(zhǔn)手冊(cè)。有了這些工作和科學(xué)的進(jìn)展,USP和NF確實(shí)得到發(fā)展。

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