文章摘要
徐昕怡,刘贞,洪小栩.美国药典光谱法修订规划及对《中华人民共和国药典》的启示[J].中国药事,2019,33(2):202-207
美国药典光谱法修订规划及对《中华人民共和国药典》的启示
Revision Plan of Spectrometry General Chapters of USP and Enlightenment to the Chinese Pharmacopoeia
投稿时间:2018-09-11  
DOI:10.16153/j.1002-7777.2019.02.014
中文关键词: 美国药典  光谱法  中国药典  修订
英文关键词: United States Pharmacopoeia  spectrometry  Chinese Pharmacopoeia  revision
基金项目:
作者单位
徐昕怡 国家药典委员会, 北京 100061 
刘贞 江西省药品检验检测研究院, 南昌 330029 
洪小栩 国家药典委员会, 北京 100061 
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中文摘要:
      目的:为2020年版《中华人民共和国药典》(以下简称《中国药典》)四部光谱法通则的制修订提供借鉴和参考。方法:通过查阅美国药典(USP)2010年至2020年修订历史和未来规划,总结归纳了10年间美国药典光谱法通则修订的目的及内容,并探讨《中国药典》四部光谱法通则增修订工作路径。结果:USP在2015年至2020年间将删除光谱法概述性通则,制定具有相同体例结构的各个光谱法通则并配备相应指导原则,修订与之相关的分析仪器确认及验证和确认指导原则。结论:应建立系统整体的修订思路,规范《中国药典》四部光谱法通则的体例结构,增强在各论中的适用性,引入先进方法技术。
英文摘要:
      Objective: To provide references for the revision of spectroscopy general chapters of Chinese Pharmacopoeia volume IV 2020 edition. Methods: By reviewing the revision history and future plans of the United States Pharmacopoeia (USP) from 2010 to 2020, the revision purpose and content of spectroscopy general chapters in USP during the last ten years were summarized. The revision plan of the spectroscopy general chapters of Chinese Pharmacopoeia four volumes was discussed. Results: The spectroscopy overview general chapter of USP will be deleted from 2015 to 2020. Spectroscopy general chapters with the same system structure will be developed and corresponding guidelines will also be provided. The relevant qualification, validation and verification guidelines for analytical instruments will be revised. Conclusion: A systematic and holistic revision plan should be established. The structure of spectroscopy general chapters of Chinese Pharmacopoeia four volumes should be standardized. Suitability in the monograph should be improved and advanced methods and techniques should be introduced.
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