基于炮制建立反映中药饮片质量特点的中药标准  

Establishment of Traditional Chinese Medicine Standards Reflecting the Quality Characteristics of Chinese Herbal Pieces Based on Processing

作　　者：汪祺[1] 赵宇新[2] 顾杰 于江泳 王海南 魏锋[1] 赵军宁 马双成 WANG Qi;ZHAO Yuxin;GU Jie;YU Jiangyong;WANG Hainan;WEI Feng;ZHAO Junning;MA Shuangcheng(National Institutes for Food and Drug Control,Beijing 102629,China;Chinese Pharmacopeia Commission,Beijing 100061,China;Center for Drug Evaluation NMPA,Beijing 100076,China;National Medical Products Administration,Beijing 100037,China;State Key Laboratory of Drug Regulatory Science,Beijing 100061,China)

机构地区：[1]中国食品药品检定研究院,北京102629 [2]国家药典委员会,北京100061 [3]国家药品监督管理局药品审评中心,北京100076 [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114-120,共7页Chinese Pharmaceutical Journal

摘　　要：目的 依据《中药标准管理专门规定》,提出基于炮制建立反映中药饮片质量特点的中药标准的建议,为中药饮片质量控制和评价提供依据。方法 以《中药标准管理专门规定》鼓励突出炮制特色,注重传统炮制经验的研究和传承为指导原则,以中药炮制技术作为中药饮片质量标准建立的出发点,通过对炮制经验、技术的总结,综合提出标准制定过程中应关注的项目和指标,并根据现行中药饮片质量标准中存在的问题提出建议。结果 建立符合中药饮片质量特点的中药标准应能阐释炮制的科学内涵,重点关注不同炮制目的导致的化学成分或成分组的变化,此外还应关注指标的科学性、专属性,与药效的关联性,同时兼顾其含量限度。结论 建议在开展全面深入研究的基础上,掌握炮制前后中药饮片物质基础变化规律,建立科学、合理、可行的质控项目和指标,实现对中药材质量的控制和评价。OBJECTIVE To establish a Chinese medicine standard based onprocessing,reflect the quality characteristics of Chinese medicine decoction pieces and provide a basis forquality control andevaluation of Chinese medicine decoction piece.METHODS Encouraged by the Special Regulations on the Management of Traditional Chinese Medicine Standards,highlighting the characteristics of traditional Chinese medicine processing and emphasizing the research and inheritance of traditional processing experience as the guiding principle,taking Chinese medicine processing technology as the starting point for establishing quality standards for Chinese medicine decoction pieces,summarizing processing experience and technology,comprehensively proposing the items and indicators that should be paid attention to in the standard formulation process,and making suggestions based on the problems existing in the current Chinese medicine decoction piece quality standards.RESULTS Establishing Chinese medicine standards that meet the quality characteristics of traditional Chinese medicine decoction pieces should be able to explain the scientific connotation of processing,with a focus on the changes in chemical composition or component groups caused by different processing purposes.In addition,attention should be paid to the scientificity and specificity of indicators,their correlation with drug efficacy,and their content limits.CONCLUSION It is recommended to conduct comprehensive and in-depth research to grasp the changes in the material basis of traditional Chinese medicine decoction pieces before and after processing,establish scientific,reasonable,and feasible quality control projects and indicators,and achieve control and evaluation of the quality of traditional Chinese medicine.

关 键 词：中药标准 中药标准管理专门规定 中药饮片 中药炮制 质量评价 

分 类 号：R282[医药卫生—中药学]