基于《中国药典》中药片剂质量控制项目变化趋势分析  

Analysis of trends in quality control measures for traditional Chinese medicine tablets based on Chinese Pharmacopoeia

作　　者：吴琼 谢君 张轶欧 杨钤 郝振明 康娅 张玲 WU Qiong;XIE Jun;ZHANG Yi'ou;YANG Qian;HAO Zhenming;KANG Ya;ZHANG Ling(Manufacture Laboratory,The Hospital of Shanxi University of Chinese Medicine(Shanxi Provincial Traditional Chinese Medicine Hospital),Taiyuan 030045,China)

机构地区：[1]山西省中医药研究院(山西省中医院)制剂室,山西太原030045

出　　处：《药物评价研究》2024年第7期1645-1652,共8页Drug Evaluation Research

基　　金：山西省应用基础研究青年项目(201901D211525);山西省中医药研究院院级课题(ZJ-202231)。

摘　　要：基于《中国药典》2015年版与2020年版,系统性分析比较2版《中国药典》收载的中药片剂质量控制项目的相关内容,详细梳理性状、鉴别、检查项、含量测定、浸出物检测、特征图谱与指纹图谱等中药片剂的质量控制项目的差异。在2015年版的基础上,2020年版中对多项质量控制项目进行了完善和细节补充,提升了《中国药典》的科学性、规范性、权威性和实用性。同时针对目前《中国药典》在中药片剂质量控制项目方面的不足,对中药片剂的未来发展和质量管理提出了具体的思考和建议,为提高中药片剂的质量控制水平提供重要参考,也为新版《中国药典》中药片剂的编写和修订提供科学依据。This study conducts a comprehensive analysis and comparison of the quality control parameters for traditional Chinese medicine(TCM)tablets as stipulated in the 2015 and 2020 editions of Chinese Pharmacopoeia.It meticulously documents various quality control measures,including physical characterizations,identification tests,inspection protocols,content determination,extract testing,and both characteristic and fingerprint spectral analyses.Building on the framework established by the 2015 edition,the 2020 revision has introduced refinements and additions to numerous quality control metrics,thereby enhancing the scientific rigor,standardization,authoritative nature,and usability of Chinese Pharmacopoeia.At the same time,specific thoughts and suggestions have been put forward for the future development and quality management of traditional Chinese medicine tablets in response to the shortcomings of the current Chinese Pharmacopoeia in the quality control project of traditional Chinese medicine tablets,Moreover,these improvements provide an essential reference for advancing the quality control practices of TCM tablets and offer a solid scientific foundation for the ongoing development and revision of the TCM tablets section in future editions of Chinese Pharmacopoeia.

关 键 词：《中国药典》 中药片剂 质量控制 质量标准 质量管理 

分 类 号：R286[医药卫生—中药学]