各国药典理化检验方法通则(附录)概况分析

Overview and Analysis of General Chapters( Appendices) of Physical and Chemical Testing Methods in Pharmacopoeias

目的为《中国药典》四部理化检验方法通则引入新方法新技术提供借鉴。方法通过查阅各国新版药典中收载的药品理化检验方法通则(附录)、药典讨论组(PDG)的协调结果和国际人用药品注册技术协调会(ICH)指导原则,总结归纳了理化检验方法的概况、增修订及协调情况,并与2015年版《中国药典》四部相关检验方法收载情况进行初步对比。结果各国新版药典对理化检验方法的增修订主要集中在元素杂质、光谱法和化学计量学,《中国药典》在鉴别试验、光谱及色谱法、杂质检查法、辅料功能性指标检测法等有可借鉴的方法技术。结论《中国药典》应基于我国制药工业现状,遵循渐进和可持续发展原则引入药品检验新技术新方法,加强对药品的质量控制,提升药品可控性。

OBJECTIVE To provide reference for introducing new methods and technologies to the physical and chemical testing methods general chapters in Chinese Pharmacopoeia Volume IV. METHODS By reviewing the general chapters of drug physical and chemical testing methods （appendices） in the new editions of European, US, Japanese and British Pharmacopoeias, the harmonization results of the Pharmacopoeia Discussion Group （PDG） and the guidelines of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use （ICH） , the authors summarized the overview and new, revised and harmonized texts of physical and chemical testing methods, and made a preliminary comparison with the related testing methods in Chinese Pharmacopoeia （2015 edition） Volume IV. RESULTS The new and revised text on the physical and chemical testing methods in the new editions of European, US, Japanese and British Pharmacopoeias are mainly concentrated in elements impurities, spectrometry and chemometrics. Chinese Pharmacopoeia can learn from the technology of identification tests, spectrometry and chromatography, impurities analysis and functionality-related characteristics of pharmaceutical excipients. CONCLUSION Chinese Pharmacopoeia should be based on the actual level of China＇s pharmaceutical industry, follow the principles of progressive and sustainable development, introducing new drug testing technologies and methods to strengthen the quality control of drugs and improve drug controllability.