2025年版《中国药典》凡例的变化与特点  

The development and characteristics of general noticein Chinese Pharmacopoeia 2025 Edition

作　　者：王绯[1] 宋宗华[1] 马双成 舒融 WANG Fei;SONG Zonghua;MA Shuangcheng;SHU Rong(Chinese Pharmacopoeia Commission,State Key Laboratory of Drug Regulatory Science,Beijing 100061,China)

机构地区：[1]国家药典委员会,药品监管科学全国重点实验室,北京100061

出　　处：《中国药品标准》2025年第1期11-16,共6页Drug Standards of China

基　　金：国家药品标准提高课题(2023Y18)。

摘　　要：目的:介绍和简述2025年版《中国药典》凡例地位、特点和编写思路,为更好地理解和执行2025年版《中国药典》提供参考和建议。方法:从总体布局和主要内容两个方面,阐述了2025年版《中国药典》凡例内容和修订的基本情况。结果:《中国药典》与其他各国药典相比,同时收载了中药、化学药、生物制品和辅料、药包材等标准,《中国药典》各部均有凡例,分别有34至48项条款,以11至12个章节内容编排,根据收载品种类别不同,发展历史不同,各部的凡例在体例和内容上呈现差异。鉴于凡例对于《中国药典》的重要性和重要地位,将《中国药典》各部凡例进行协调和统一是行业发展需要。随着法规的出台、调整和药典收载内容的变化,以及药品质量控制新技术新方法新理念的应用,考虑到各类药品在质量控制和监管上都各具特殊性,《中国药典》凡例全面规范了相关要求,在兼顾药典一部、二部、三部和四部特点的基础上,既保留相对统一又兼具各部收载内容的特色,实现了《中国药典》各部凡例体例的统一规范和共性内容的协调一致。结论:2025年版《中国药典》凡例无论从形式上和内容上都有了明显的变化和提升。通过对2025年版《中国药典》凡例整体情况和修订内容的介绍,让药典使用者更加深入的理解《中国药典》,正确使用《中国药典》。Objective:Introduce and briefly describe the status,characteristics,and writing ideas of general notice in the Chinese Pharmacopoeia 2025 edition,providing reference and suggestions for better understanding and implementation of the Chinese Pharmacopoeia 2025 edition.Methods:This article elaborates on the content and revision of general notice in the Chinese Pharmacopoeia 2025 edition from the perspective of frame structure and main contents.Results:Compared with other pharmacopoeias of various countries,Chinese Pharmacopoeia includes standards for traditional Chinese medicine,chemical drugs,biological products and excipients,pharmaceutical packaging materials,etc.Each section of Chinese Pharmacopoeia has its own general notice,with 34 to 48 items arranged in 11 to 12 chapters.Depending on the type of products included and the development history,the general notice in each section present differences in format and content.Given the importance and significance of the standards in Chinese Pharmacopoeia,it is necessary for the industry to coordinate and unify the general notice in various parts of Chinese Pharmacopoeia.With the introduction and revision of regulations,changes in the content of pharmacopoeias,and the application of new technologies,methods,and concepts in drug quality control,considering the unique characteristics of various drugs in quality control and supervision,Chinese Pharmacopoeia has comprehensively standardized relevant requirements.While taking into account the characteristics of the first,second,third,and fourth parts of the pharmacopoeia,it retains the characteristics of relative uniformity and the content of each part,achieving the unified standardization of the general rules of each general notice in the Chinese Pharmacopoeia 2025 edition and the coordination and consistency of common content.Conclusion:The current version of Chinese Pharmacopoeia has undergone significant changes and improvements in both form and content.By introducing the overall situation and revised content of genera

关 键 词：中国药典 凡例 药品标准 质量控制 

分 类 号：R921.2[医药卫生—药学]