中药材监督管理现状及全产业链监管模式创新初探  

The supervision and management of Chinese medicinal materials and the innovation of the supervision mode of the whole industry chain

作　　者：蒋敏桃 何畏[2] 赵卫权[2] 王世宇[1] 李毅 JIANG Min-tao;HE Wei;ZHAO Wei-quan;WANG Shi-yu;LI Yi(Chengdu University of Traditional Chinese Medicine,Chengdu 611137,Sichuan;Sichuan Provincial Drug Administration,Chengdu 610031,Sichuan;Sichuan Food and Drug Inspection and Testing Institute,Chengdu 611731,Sichuan)

机构地区：[1]成都中医药大学,四川成都611137 [2]四川省药品监督管理局,四川成都610031 [3]四川省食品药品检验检测院,四川成都611731

出　　处：《中药与临床》2021年第1期1-5,共5页Pharmacy and Clinics of Chinese Materia Medica

摘　　要：中药材是生产中药饮片、中药制剂和中成药的原料,其质量好坏将直接影响中药饮片、中药制剂、中成药的安全性和有效性,对中医药事业的发展影响巨大。文章以现行法律法规为基础,采用文献查阅、个案分析、数据分析等方法对中药材监督管理困境和质量现状进行分析,提出全新的中药材全产业链管理规范及监管模式:一是开展中药材全产业链质量管理模式,研究制定中药材种子种苗标准到建立溯源体系,以此从源头保障中药饮片、中药制剂和中成药的质量;二是充分发挥中药材管理相关职能部门的作用,各司其职,齐抓共治,共同保障中药材质量。Chinese medicinal materials are the raw materials for the production of herbal decoction pieces,Chinese medicine preparation and Chinese patent medicine.Their quality directly affects the safety and effectiveness of herbal decoction pieces,Chinese medicine preparation and Chinese patent medicine,and has a great impact on the development of traditional Chinese medicine.Based on the existing laws and regulations,this paper analyzes the difficulties and quality status of the supervision and management of Chinese medicinal materials by means of literature review,case analysis,data analysis and other methods,and proposes a new management standard and supervision mode for the whole industrial chain of Chinese medicinal materials.Firstly,the whole industrial chain of Chinese medicinal materials quality management mode is put forward including establishment of seed seedling standard of Chinese medicinal materials and traceability system to guarantee the quality of herbal decoction pieces,Chinese medicine preparation and Chinese patent medicine from the source.Secondly,the relevant departments for the management of Chinese medicinal materials should play a full role in jointly ensure the quality of Chinese medicinal materials.

关 键 词：中药材 质量 管理 全产业链 监管模式 

分 类 号：R282[医药卫生—中药学]