中国药业2025，Vol.34Issue(15)：28-33,6.DOI:10.3969/j.issn.1006-4931.2025.15.005
基于科学监管与质量控制的中药全产业链溯源体系构建
Construction of the Whole Industry Chain Traceability System for Traditional Chinese Medicine Based on Scientific Regulation and Quality Control
摘要
Abstract
Objective To enhance the effectiveness of quality control and scientific regulation of traditional Chinese medicine.Methods The application of modern information technologies such as the Internet of Things,blockchain,and coding in the cultivation/breeding,research and development,production,and circulation of traditional Chinese medicine was analyzed,and a whole industry chain traceability system of GAP-GLP-GCP-GMP-GSP-adverse drug reaction(ADR)monitoring and reporting system.Results By utilizing information technology to develop and integrate various software and data,and introducing the drug risk warning mechanism,the whole process traceability and scientific regulation from planting/breeding,research and development,production to market circulation could be realized.However,there were still difficulties in coordinating multiple links,high costs and technical challenges,as well as issues related to data privacy and security.Conclusion The whole industry chain traceability system can effectively improve the safety and regulatory efficiency of various links in the traditional Chinese medicine industry chain,ensure the quality of traditional Chinese medicine,and enhance the competitiveness of the traditional Chinese medicine industry.It is recommended to establish a unified regulatory information platform,and strengthen collaborative cooperation among the government,industry associations,enterprises,and medical institutions to achieve data sharing and real-time supervision.Meanwhile,it is recommended to utilize blockchain technology and hierarchical access control to ensure data transparency and immutability,and protect sensitive information,in order to achieve parallel development of drug scientific regulation and privacy protection.关键词
中药/全产业链溯源体系/科学监管/质量控制Key words
traditional Chinese medicine/whole industry chain traceability system/scientific regulation/quality control分类
医药卫生引用本文复制引用
冯婧,孟杰,胡娟娟..基于科学监管与质量控制的中药全产业链溯源体系构建[J].中国药业,2025,34(15):28-33,6.基金项目
重庆市教育委员会科学技术研究项目[KJQN202102804]. （）
