中药品质传递过程评价技术与方法研究进展

中药品质的优劣直接关系着中药临床的疗效,是保证中药有效性、安全性、可控性的基础。中药从种植开始形成高品质药材到临床能否发挥应有疗效,品质传递过程是重要保障,而其过程有无完整传递,需要符合中药自身特点的科学评价方法。目前中药评价方法多以化学成分含量作为评价指标,且大多是针对中药材、中药饮片、中药提取物、中药制剂等某单个环节进行质量评价,对中药在生产全产业链的各环节传递过程中的品质整体性变化缺乏关注,对中药品质从药材到制剂直至临床传递过程中的整体性评价方法还未有系统论述。针对中药品质传递过程的规律和特点,对可用于中药品质传递过程的评价技术和方法进行综述,为中药品质传递过程评价及制定符合中药本身特色的质量标准提供参考。

Research progress on evaluation technology and method of quality delivery process of traditional Chinese medicine

The quality of traditional Chinese medicine (TCM) is directly related to the clinical efficacy of TCM, which is the basis for ensuring the effectiveness, safety and controllability of TCM. From the beginning of cultivation of high-quality medicinal materials to the clinical efficacy of Chinese medicine, the quality transmission process is an important guarantee, and whether the process is completely transmitted requires a scientific evaluation method that conforms to the characteristics of Chinese medicine. At present, the evaluation methods of TCM mostly use the content of chemical components as the evaluation index, and mostly focus on the quality evaluation of a single link, such as Chinese medicinal materials, Chinese medicinal pieces, Chinese medicinal extracts, and Chinese medicinal preparations and so on. There is a lack of attention to the overall changes in the quality of TCM in the delivery process of each link in the entire production chain, and there is no systematic discussion on the overall evaluation methods of the quality transmission of TCM from medicinal materials to preparations to clinical. The evaluation techniques and methods that can be used in the quality delivery process of TCM according to the rules and characteristics of the quality delivery process of TCM are summarized in this paper, which provide a reference for the evaluation of quality delivery process of TCM and the formulation of quality standards that conform to the characteristics of TCM.