药品监管制度下中药材与中药饮片的管理现状与建议  

Current status and suggestions on regulation of traditional Chinese medicine raw materials and preparations under regulatory system of drugs

作　　者：瞿礼萍[1,2] 徐永丹 何韦静 张定堃 杨男[4] 宋民宪 闵志强[1,2] 张廷模 QU Li-ping;XU Yong-dan;HE Wei-jing;ZHANG Ding-kun;YANG Nan;SONG Min-xian;MIN Zhi-qiang;ZHANG Ting-mo(State Key Laboratory of Southwestern Chinese Medicine Resources,Chengdu University of Traditional Chinese Medicine,Chengdu 611137,China;Sichuan Center for Regulatory Sciences in Traditional Chinese Medicine,Chengdu 611137,China;Sichuan Academy of Chinese Medicine Sciences,Chengdu 610041,China;West China School of Pharmacy,Sichuan University,Chengdu 610065,China;Bejing Dongwei(Chengdu)Law Firms,Chengdu 610065,China)

机构地区：[1]成都中医药大学西南特色中药资源国家重点实验室,四川成都611137 [2]四川省中药监管科学研究基地,四川成都611137 [3]四川省中医药科学院,四川成都610041 [4]四川大学华西药学院,四川成都610065 [5]北京东卫(成都)律师事务所,四川成都610065

出　　处：《中国中药杂志》2025年第3期824-832,共9页China Journal of Chinese Materia Medica

基　　金：第七批全国老中医药专家学术经验继承工作项目;第四届四川省十大名中医张廷模工作室项目;四川省社会科学重点研究基地·四川中医药发展研究中心项目(STDYB202411);四川省科技计划项目(2023JDR0242)。

摘　　要：当前我国中医药事业迈入高质量发展的新阶段,如何从源头上夯实中药产业基础,是主管部门、产业界和学术界共同关注的焦点议题。该研究系统分析了中药材与中药饮片监管法律法规体系,并以中药产业链和药品生命周期为线索,从中药资源保护及种植(养殖)源头、中药材和中药饮片生产与质量监管、市场准入与流通等环节,解析了药品监管制度下药材和中药饮片的管理现状,剖析了存在的主要问题,并提出相应建议。研究结果对于未来进一步完善构建符合中药特点的药品监管体制和中药卓越监管体系具有良好参考价值。At present, the cause of traditional Chinese medicine(TCM) in China has entered a new period of high-quality development. How to strengthen the foundation for the TCM industry from the source is an important issue that deserves the attention of the authorities, industry, and academia. This study systematically analyzed the regulatory system of TCM raw materials and preparations. The study took the TCM industry chain and the product life cycle as a clue and focused on the dimensions of TCM resource protection and plant cultivation(farming), production and quality supervision of TCM raw materials and preparations, and their market access and distribution. It analyzed the current situation of the regulation of TCM raw materials and preparations under the regulatory system of drugs, discussed the main problems, and put forward corresponding suggestions. The results can provide an important reference value for the subsequent improvement of the regulatory system of drugs and the construction of a prominent regulatory system of drugs in accordance with TCM characteristics.

关 键 词：中药材和中药饮片 野生资源 种植(养殖) 流通 炮制规范 质量 

分 类 号：R288[医药卫生—中药学]