摘要
目的为正确理解和准确执行2020年版《中国药典》四部理化分析通则提供参考。方法介绍2020年版《中国药典》四部理化分析通则的编制原则、过程和主要考虑,总结分析增修订内容和主要特点。结果根据2020年版《中国药典》编制大纲的指导思想、目标和重点工作任务,秉承科学性、通用性、可操作性、渐进和可持续发展、与国际标准统一协调的原则,国家药典委员会理化分析专业委员会开展2020年版《中国药典》四部理化分析通则的编制工作。进一步扩大先进成熟分析技术的应用,加强分析方法适用性要求和中药材外源性污染控制方法的制定,提高杂质控制要求与国际通用技术要求的协调统一性。结论2020年版《中国药典》四部理化分析通则为保障我国药品安全、有效和质量可控提供方法和技术上的支持,在鼓励先进检测技术应用、强化药品监管手段和增强《中国药典》国际影响力方面发挥重要和积极的作用。
OBJECTIVE To provide references for the correct understanding and accurate implementation of the physical and chemical analysis general chapters of the Chinese Pharmacopoeia 2020 Edition volumeⅣ.METHODSE The pinciples,processes,and main considerations of the development of the physical and chemical analysis general chapters of the Chinese Pharmacopoeia 2020 edition volume IV are introduced,and the content and main characteristics are summarized and analyzed.RESULTS According to the goals and key tasks of the Chinese Pharmacopoeia 2020 edition,the principles of scientificity,versatility,operability,gradual and sustainable development,and harmonization with international standards,the physical and chemical analysis committee of the Chinese Pharmacopoeia commission carry out the development of the physical and chemical analysis general chapters of the Chinese Pharmacopoeia 2020 edition volumeⅣ.Further expand the application of advanced and mature analytical techniques,strengthen the applicability of analytical methods and the development of the external pollution control methods for Chinese medicinal materials,and improve the harmonization of analytical techniques and impurity control requirements with international technical requirements.CONCLUSION The physical and chemical analysis general chapters of Chinese Pharmacopoeia 2020 edition volumeⅣprovide method and technical support to ensure the safety,effectiveness and controllable quality of China′s pharmaceuticals,and play an important and positive role in encouraging the application of advanced analytical technology,strengthening drug regulatory measures,and enhancing the international influence of the Chinese Pharmacopoeia.
作者
徐昕怡
宋宗华
贺浪冲
杨昭鹏
XU Xin-yi;SONG Zong-hua;HE Lang-chong;YANG Zhao-peng(Chinese Pharmacopoeia Commission,Beijing 100061,China;Health Science Center,Xi′an Jiaotong University,Xi′an 710061,China)
出处
《中国药学杂志》
CAS
CSCD
北大核心
2020年第14期1172-1176,共5页
Chinese Pharmaceutical Journal
关键词
中国药典
四部
理化分析
通则
Chinese Pharmacopoeia
volume IV
physical and chemical analysis
general chapter
