摘要
目的:为正确理解和准确执行2025年版《中国药典》四部理化分析通用技术要求提供参考。方法:介绍2025年版《中国药典》四部理化分析通用技术要求的主要特点和增修订内容。结果:2025年版《中国药典》四部理化分析通用技术要求与ICH Q系列相关指导原则更加协调,先进成熟的仪器分析技术标准和与药品安全性、有效性和质量可控性有关的分析方法标准的收载进一步增加。结论:2025年版《中国药典》四部理化分析通用技术要求为我国药品走向国际搭建了更便捷的新桥梁,为实现全过程质量控制提供了规范的检测技术支撑,更好满足了我国药品研发、生产、质控和监管的需要。
Objective:To provide reference for the correct understanding and accurate implementation of the general chapters of physical and chemical analysis in the Chinese Pharmacopoeia 2025 Edition VolumeⅣ.Methods:Introduce the main characteristics and content of the additions and revisions of the general chapters of physical and chemical analysis in the Chinese Pharmacopoeia 2025 Edition VolumeⅣ.Results:The general chapters of physical and chemical analysis in the Chinese Pharmacopoeia 2025 Edition are more harmonized with the relevant guidelines of the ICH Q series,and the inclusion of advanced and mature instrument analysis technology standards and analysis method standards related to drug safety,efficacy,and quality controllability is further increased.Conclusion:The general chapters of physical and chemical analysis in the Chinese Pharmacopoeia 2025 Edition have provided a more convenient new bridge for China′s drugs to go international,standardized testing technology support for achieving full process quality control,and better meet the needs of drug research and development,production,quality control,and supervision in China.
作者
徐昕怡
韦石凤
张启明
贺浪冲
张军
马双成
XU Xinyi;WEI Shifeng;ZHANG Qiming;HE Langchong;ZHANG Jun;MA Shuangcheng(Chinese Pharmacopoeia Commission,State Key Laboratory of Drug Regulatory Science,Beijing 102629,China;School of Pharmaceutical Sciences,Capital Medical University,Beijing 100069,China;National Institutes for Food and Drug Control,Beijing 1000504,China;Health Science Center,Xi′an Jiaotong University,Xi′an 710061,China)
出处
《中国药品标准》
2025年第1期45-50,共6页
Drug Standards of China
关键词
中国药典
理化分析
通用技术要求
增修订
Chinese Pharmacopoeia
physical and chemical analysis
general chapter
additions and revisions
作者简介
第一作者:徐昕怡,博士研究生,副主任药师,研究方向:药品标准研究。Tel:010-67079522,E-mail:xuxinyi@chp.org.cn;通信作者:马双成,博士研究生,研究员,博士生导师,研究方向:药物分析与药品标准研究。Tel:010-67079501,E-mail:masc@chp.org.cn;贺浪冲,男,教授,研究方向:药物分析。Tel:029-82655392;张军,男,主任药师,研究方向:药品标准。Tel:(010)67079583。
