中药材追溯体系建设10年回顾与展望
投稿时间:2022-05-18     点此下载全文
引用本文:赵润怀,温川飙,焦炜,曹国钧.中药材追溯体系建设10年回顾与展望[J].中国现代中药,2022,24(10):1823-1829
DOI:10.13313/j.issn.1673-4890.20220518001
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作者中文名作者英文名单位中文名单位英文名E-Mail
赵润怀* ZHAO Run-huai 中国中药协会 中药追溯专业委员会,北京 100061
中国中药有限公司,北京 100195
Committee of Chinese Medicine Traceability, China Association of Traditional Chinese Medicine, Beijing 100061, China
China National Traditional Chinese Medicine Co., Ltd., Beijing 100195, China
 
温川飙 WEN Chuan-biao 中国中药协会 中药追溯专业委员会,北京 100061
成都中医药大学,四川 成都 610072
Committee of Chinese Medicine Traceability, China Association of Traditional Chinese Medicine, Beijing 100061, China
Chengdu University of Traditional Chinese Medicine, Chengdu 610072, China
 
焦炜 JIAO Wei 中国中药协会 中药追溯专业委员会,北京 100061
中国中药有限公司,北京 100195
Committee of Chinese Medicine Traceability, China Association of Traditional Chinese Medicine, Beijing 100061, China
China National Traditional Chinese Medicine Co., Ltd., Beijing 100195, China
 
曹国钧 CAO Guo-jun 中国中药协会 中药追溯专业委员会,北京 100061
广东跑合中药材电子商务有限公司,广东 广州 510385
Committee of Chinese Medicine Traceability, China Association of Traditional Chinese Medicine, Beijing 100061, China
Guangdong Paohe Chinese Herbs E-Commerce Co., Ltd., Guangzhou 510385, China
 
中文摘要:我国开展中药材追溯体系建设至今已10年,期间颁布和修订实施的《中华人民共和国中医药法》《中华人民共和国药品管理法》《中药材生产质量管理规范》等法律法规和发展规划中均提出“建设中药材追溯体系”。中药材全过程追溯包括中药材种子种苗、种植养殖环境、田间管理、采收加工、检验包装、仓储物流等农业生产和商业流通环节,再到中药饮片和中成药生产企业,最后到医疗机构和消费者手中,具有较长的产业链,各级政府监管部门和科研机构也参与其中。总结中药材追溯体系建设10年来的探索和实践经验,从追溯市场需求、企业追溯体系建设和管理政策等方面进行分析,提出建设“三位一体”的中药材追溯体系,包括中药材追溯体系建设、追溯服务平台建设和中药材追溯标准化建设;提出实施追溯的关键是规范化、标准化和信息化;并针对存在的普遍问题提出解决的措施和建议,旨在适应不断发展变化的形势,促进中药质量安全监管和中药产业高质量发展。
中文关键词:中药材追溯体系  依法追溯  信息化  数字化  标准化
 
Construction of Traceability System for Chinese Medicinal Materials in the Past Ten Years
Abstract:After construction of the traceability system for Chinese medicinal materials has lasted for ten years. The Law of the People's Republic of China on Traditional Chinese Medicine, Medicinal Product Administration Law of the People′s Republic of China, and Good Agricultural Practice for Chinese Crude Drugs issued and implemented during this period all proposed to build a traceability system for Chinese medicinal materials. The whole traceability process of Chinese medicinal materials covers the seed/seedling planting, planting/breeding environment, field management, harvesting and processing, inspection, package, storage and circulation. This is a long chain involving agricultural production, commercial circulation, decoction pieces production enterprises, Chinese patent medicine production enterprises, medical institutions, and consumers. Moreover, the national and local government departments and research institutions also participate in this process. This paper summarizes the experience accumulated in the construction of traceability system for Chinese medicinal materials and proposes to build a "trinity" traceability system involving the traceability system, platform, and standardization. Furthermore, we propose that the key to implementing traceability is to achieve informatization, networking, and standardization. In view of the existing problems, we propose practical solutions, aiming to improve the quality and safety supervision of Chinese medicinal materials and step up the high-quality development of Chinese medicine industry.
keywords:traceability system for Chinese medicinal materials  traceability according to law  informatization  networking  standardization
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