《中国药典》与《日本药典》凡例的比较研究与思考

Comparation and considerations for general notice between the Chinese Pharmacopoeia and the Japanese Pharmacopoeia

目的:比较研究《中国药典》与《日本药典》凡例的特点和差异,为《中国药典》凡例的编撰提供参考和建议。方法:从框架结构和主要内容两个角度,对《中国药典》与《日本药典》凡例进行比较研究。结果:《中国药典》各部均有凡例,分别有34至48项条款,以10至12个章节内容编排,根据收载品种类别不同各部存有差异;《日本药典》凡例共计49项条款,未以章节形式编排。两国药典凡例在框架结构和具体内容上存在名称术语的定义和表述、性状判定、修约规则、风险评估、质控理念等诸多内容上的差异,《中国药典》凡例框架清晰、内容具体,可操作性强;《日本药典》凡例条款描述较为简洁,一些需要在专业知识指导下实施。结论:比较研究得到启示,《中国药典》各部凡例各具特点,可通过融入先进分析技术,结合法律法规要求,优化凡例内容和条目,探索各部凡例的协调统一。

Objective:The characteristics and differences of the general notice between the Chinese Pharmacopoeia and the Japanese Pharmacopoeia were investigated to provide references and suggestions for the compilation of the Chinese Pharmacopoeia.Methods:From the perspective of frame structure and main contents,the general notice between the Chinese Pharmacopoeia and the Japanese Pharmacopoeia was compared.Results:Each volume of the Chinese Pharmacopoeia had its general notice,including 34 to 48 items and 10 to 12 chapters based on different varieties collected in each volume.The Japanese Pharmacopoeia had 49 items not arranged by chapters.There are many differences on the general notice between the Chinese Pharmacopoeia and the Japanese Pharmacopoeia,such as the definitions and expressions of names,determination of appearance,revision rules,risk assessment and quality control conception.The framework of the general notice in the Chinese Pharmacopoeia was clear,the content was specific and the operation was friendly.The term description of the general notice in the Japanese Pharmacopoeia was concise,and some terms need to be implemented under the guidance of professional knowledge.Conclusion:In light of comparative study,every volume′s general notice of the Chinese Pharmacopoeia has its own characteristics.By integrating advanced analytical technique,combining the requirements with laws and regulations,and optimizing content and terms,all volume′s general notice could be explored to be coordinated and unified.