基于中药质量标志物的中药产业高质量发展技术策略

Technology Strategy for High-quality Development of Traditional Chinese Medicine Industry Based on Quality Markers of Traditional Chinese Medicine

中药质量是中药安全有效的保障,中药质量关乎国民生命健康,也关乎中药产业的健康发展。以往中药质量研究与质量控制模式难以满足中药复杂体系的质量控制要求,需要在理论、模式、技术方法和研究路径上实现质的突破。在对中药复杂体系和产业特点客观分析的基础上,针对中药质量研究与质量控制现实问题,提出基于中药质量标志物的中药产业高质量发展技术策略。以此建立与中药临床效用密切关联、特有专属、整体评价和面向中药全产业链的质量标准和质量控制体系,并为行业监管提供科学、有效的“监管工具”,对于提高我国中药质量标准和质量控制水平具有一定的参考意义。

The quality of traditional Chinese medicine(TCM)is the safe and effective guarantee of TCM,which is related to the health of national life and the healthy development of TCM industry.The previous quality research and quality control mode of TCM was difficult to meet the quality requirements of the complex system of TCM,and it was necessary to achieve a qualitative breakthrough in theory,mode,technical method and research path.On the basis of objective analysis of the complex system and industrial characteristics of TCM,this paper proposes the technology strategy of high-quality development of TCM industry based on the quality markers(Q-markers)of TCM in view of the practical problems of quality research and quality control of TCM.Therefore,it is necessary to establish a quality standard and quality control system that is closely related to the clinical efficacy of TCM,unique and exclusive,overall evaluation and oriented to the whole industrial chain of TCM,so as to provide scientific and effective'regulatory tools'for industry supervision,which has certain reference value for improving the quality standard and quality control level of TCM in China.