基于中药质量标志物的中药质量追溯系统建设

中药质量标志物从概念到理论的发展过程中,得到我国中药科研与产业界的重视。中药质量是影响产业发展和民生需求的重大问题,确定影响中药质量的标志物,并综合信息分析、风险评估,确定并控制影响产品质量所有因素。特别是通过从药材源头到成品全过程的质量、标准和控制研究,构建全程可溯源的控制和基于中药质量标志物的中药产品质量追溯系统,应是保证中药质量和产业过程全程控制的关键,以期对中药产业健康发展产生新的影响。

Construction of traceability system of Chinese materia medica product quality based on quality marker of Chinese materia medica

In the development process of quality markers of Chinese materia medica (CMM) from the concept to the theory of the development process, quality markers of CMM have attracted the national CMM research and industry attention. Focusing on the factors that affect the quality of CMM, the author analyzed the markers which affect the quality to identify the quality markers, analyzed the comprehensive information, performed risk assessment, and identified and controlled all factors that affect the product quality. Especially the author presented the concept on whole process of quality control, standards and control research to build a full range of traceable control to build a new system, product quality traceability system, to ensure the quality of CMM products and industrial process control. The system will have a new impact on the healthy development of traditional Chinese medicine industry.