关于构建符合中医药特点中药标准的思考与建议  

Suggestions on Establishment of Standard System Conforming to the Characteristics of Traditional Chinese Medicine

作　　者：赵宇新[1,5] 顾杰 汪祺 何轶[1,5] 于江泳 王海南 马双成 赵军宁 ZHAO Yuxin;GU Jie;WANG Qi;HE Yi;YU Jiangyong;WANG Hainan;MA Shuangcheng;ZHAO Junning(Chinese Pharmacopeia Commission,Beijing 100061,China;Center for Drug Evaluation NMPA,Beijing 100076,China;National Institutes for Food and Drug Control,Beijing 102629,China;National Medical Products Administration,Beijing 100037,China;State Key Laboratory of Drug Regulation Science,Beijing 10061,China)

机构地区：[1]国家药典委员会,北京100061 [2]国家药品监督管理局药品审评中心,北京100076 [3]中国食品药品检定研究院,北京102629 [4]国家药品监督管理局,北京100037 [5]药品监管科学全国重点实验室,北京100061

出　　处：《中国药学杂志》2025年第2期130-137,共8页Chinese Pharmaceutical Journal

摘　　要：目的 基于《中药标准管理专门规定》的分析,提出构建符合中医药特点中药标准体系的建议,强化中药标准在保障药品质量方面的作用。方法 对符合中医药特点标准体系的科学内涵进行分析,提出符合中医药特点标准体系的基本考量。结果 符合中医药特点标准体系科学内涵主要包括尊重中医药传统,遵循中医药理论和尊重中医药规律。结论 在符合中医药特点标准体系构建过程中,应坚持整体评价和关键影响因素相结合的质量控制理念,坚持传承和创新相结合的质量控制理念,中药标准中体现中医药传统思维。OBJECTIVE To strengthen the role of Chinese medicine standards in ensuring drug quality,based on the analysis of Special Regulations on the Management of Traditional Chinese Medicine Standards,propose the suggestions on establishment of standard system conforming to the characteristics of traditional Chinese medicine.METHODS The scientific connotation of standard system conforming to the characteristics of traditional Chinese medicine was analyzed,the basic considerations for construction of traditional Chinese medicine standard system were proposed.RESULTS The scientific connotation of standard system conforming to the characteristics of traditional Chinese medicine mainly includes respecting the tradition of Chinese medicine,complying with the theory of traditional Chinese medicine and observing the objective laws of traditional Chinese medicine.CONCLUSION In the process of establishment of standard system conforming to the characteristics of traditional Chinese medicine,the quality control strategies of comprehensive quality evaluation and key quality factors should be persisted,the quality control strategies of inheritance and innovation should be persisted.Moreover,the traditional thinking of Chinese medicine should be reflected in Chinese medicine standards.

关 键 词：中药标准 中药标准管理专门规定 中医药特点 中医药理论 

分 类 号：R282[医药卫生—中药学]