中药质量控制与评价创新方法研究进展及应用

中药质量是保证中药功效稳定性及应用安全性的基础，其规范化、标准化、现代化，是推动中药走向国际化的重要前提。近年来，围绕中药质量控制和评价体系建设及模式创新取得了突破，中药整合质量观、中药质量标志物等新思路、新模式的提出，引领了中药质控发展的新方向，涌现出了一系列中药质量评价创新技术与创新方法。拟从化学基准、化学基准与药理效应基准相结合、化学基准与生物效应基准相结合3个角度，从中药评价方面梳理近年来中药质控方法方面最新研究，系统阐述中药质量评价创新方法及其应用现状，探讨其未来发展趋势，以期为建立符合中药特色理论的质量控制体系提供拓展思路。

Research progress and application of innovative methods for quality control and evaluation of traditional Chinese medicine

The quality of traditional Chinese medicine is the basis to its efficacy stability and application safety. Thenormalization, standardization and modernization of quality is an important premise to promote the internationalization of traditional Chinese medicine. In recent years, breakthroughs have been made in the system and model of quality control and evaluation in traditional Chinese medicine. The proposal of new ideas such as intergrated quality control of TCMs and quality markers can guide new direction of the development of quality control in traditional Chinese medicine. Subsequently, a series of innovative technologies and innovative methods of quality evaluation in traditional Chinese medicine have emerged. This study inventoried the latest research on quality control methods in traditional Chinese medicine, systematically expounded the innovative methods and its application status from three perspectives of chemical benchmark, the combination of chemical benchmark and pharmacological effect benchmark, and the combination of chemical benchmark and biological effect benchmark, and discussed its future development trend. This paper provides an expanding idea for establishing a quality control system in line with the characteristic theory of traditional Chinese medicine.