基于全程质量控制理念的附子饮片标准化体系研究与构建  

Construction of Standardization System for Aconiti Lateralis Radix Praeparata Decoction Pieces Based on Whole-Process Quality Control

作　　者：兰青山 杜杰 易进海[4] 夏燕莉 王继永 侯强平 周海燕 LAN Qing-shan;DU Jie;YI Jin-hai;XIA Yan-li;WANG Ji-yong;HOU Qiang-ping;ZHOU Hai-yan(Sichuan Jiangyou Zhongba Fuzi Technology Development Co.,Ltd.,Jiangyou 621700,China;Beijing Huamiao Phamaceutical Co.,Ltd.,Sinopharm Group,Beijing 102600,China;China National Traditional Chinese Medicine Co.,Ltd.,Beijing 100195,China;Sichuan Academy of Chinese Medicine Sciences,Chengdu 610041,China;Chengdu University,Chengdu 610106,China)

机构地区：[1]四川江油中坝附子科技发展有限公司,四川江油621700 [2]国药集团北京华邈药业有限公司,北京102600 [3]中国中药有限公司,北京100195 [4]四川省中医药科学院,四川成都610041 [5]成都大学,四川成都610106

出　　处：《中国现代中药》2023年第1期192-201,共10页Modern Chinese Medicine

基　　金：国家中药标准化项目(ZYBZH-Y-ZY-45)。

摘　　要：以实施国家中药标准化项目为契机,结合中药产业自身特点和发展现状,通过基于全程质量控制理念的附子饮片标准化建设研究,制定并验证了从种子种苗、种根繁育到药材生产、饮片生产、追溯系统等覆盖全产业链关键环节的附子技术规程和标准,实现附子饮片“从田地到医院”的全产业链无缝对接。构建了高标准的附子饮片全产业链质量管理体系,实现毒性中药附子产量和质量的稳定,为附子规范化生产起到良好的示范作用,从而推动中药产业发展的规范化、标准化,引导行业的良性健康发展。Amid the national initiative of standardization of traditional Chinese medicine and in view of the characteristics and status quo of the traditional Chinese medicine industry,this study developed and tested the technical regulations and standards for Aconiti Lateralis Radix Praeparata decoction pieces,which covered the key links from field to hospital in the industry,such as selection of seminal roots,seedling breeding,medicinal material production,decoction piece processing,and traceability.A high-standard quality management system involving the whole industry chain of Aconiti Lateralis Radix Praeparata decoction pieces was constructed,which can ensure the stable yield and quality of the medicinal material and guide the development of this industry in a standard and science-based way.

关 键 词：附子 中药标准化 道地药材 江油附子 质量控制 

分 类 号：R286[医药卫生—中药学]