现行中药配方颗粒国家标准的探讨  

Discussion on Current National Standards for Traditional Chinese Medicine Dispensing Granules

作　　者：郝亚冬 马堃[2] 温瑞卿 李东辉 HAO Yadong;MA Kun;WEN Ruiqing;LI Donghui(Haidian District Food and Drug Safety Monitoring Center,Beijing 100094,China;China Academy of Chinese Medical Sciences,Beijing 100700,China)

机构地区：[1]北京市海淀区食品药品安全监控中心,北京100094 [2]中国中医科学院,北京100700

出　　处：《中国实验方剂学杂志》2023年第15期158-164,共7页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：国家中医药传承与创新“百千万”人才工程(岐黄工程)岐黄学者专项;中国中医科学院科技创新工程项目(CI2021A02406)。

摘　　要：强化中药配方颗粒的标准制定与质量管理,是我国中医药发展战略规划的重要组成部分。为检验现行中药配方颗粒国家标准在临床应用与质量控制整体性的实践情况,笔者对现行标准收载品种进行分类归纳,分析其临床适用性,并探讨鉴别、含量测定、特征图谱/指纹图谱等项目检验方法的特点。结果发现现行标准在数量上覆盖度不足,在主治功效、药材科属、炮制方法、制备方式等层面覆盖度更显薄弱;总结出国家标准在检验方法中的特点为以临床应用为导向,以参照物系统为基础,以特征图谱检验为突破,进而提升了中药配方颗粒质量控制的整体性。建议后续应扩大国家标准覆盖度,以满足市场发展需求。为提升临床适用性,应增加国家质量标准内容,包括增加品种多样性,满足临床使用需求;提高标准要求,改善临床服用感受;加强有效性研究,突出临床药效。同时,提升监管检验的可及性,出台无国家标准品种的管理细则,为中药配方颗粒产业的健康有序发展奠定基础。Strengthening the standard formulation and quality management of traditional Chinese medicine(TCM)dispensing granules is an important part of the strategic planning for the development of TCM in China.In order to examine the clinical application and overall quality control of the existing national standards for TCM dispensing granules,this study classified and summarized the varieties in the existing standards,analyzed their clinical applicability,and discussed the characteristics of the test methods for identification,content determination and specific chromatogram/fingerprint.It was found that the coverage of the existing standards was inadequate in terms of quantity,and it was even weaker in the aspects of therapeutic efficacy,herb family,processing method and preparation method of TCM dispensing granules.It was concluded that the characteristics of national standards in test methods were summarized as follows:guided by clinical application,based on the reference system,taking specific chromatogram as a breakthrough,so as to improve the overall quality control of TCM dispensing granules.It is suggested that the coverage of national standards should be subsequently expanded to meet the needs of market development.In order to enhance clinical applicability,the content of national quality standards should be increased,including increasing variety diversity to meet the needs of clinical application,raising the standard requirements to improve the clinical medication experience,and strengthening effectiveness research to highlight clinical efficacy.At the same time,the accessibility of regulatory inspection is enhanced,the rules for the management of varieties without national standards are promulgated to lay the foundation for the healthy and orderly development of TCM dispening granule industry.

关 键 词：中药配方颗粒 国家标准 质量控制 《中华人民共和国药典》 临床应用 指纹图谱/特征图谱 含量测定 

分 类 号：R22[医药卫生—中医基础理论] R28[医药卫生—中医学] R94