基于“药材基原-物质基础-质量标志物-质控方法”层级递进的中药质量标准模式研究

A pattern of hierarchical progression for quality standard of Chinese materia medica based on “herbal origin-material basis-quality markers-quality control method”

中药质量控制是保证中药临床用药安全性和有效性的重要措施,也是制约中药现代化进程的瓶颈。针对当前中药质量标准评价模式,从中药真伪鉴别和优劣评价两方面综述现阶段中药质量控制方法的研究策略,阐述中药质量标准研究现状,探讨中药质量标准的发展趋势。提出以"药材基原为基础、物质基础研究为支撑,质量标志物(Q-markers)辨析为核心,质控方法为手段"的中药质量控制新模式。基于正品药材,深入研究物质基础,辨析Q-markers,构建质控方法,控制中药质量,制定符合中药特色的质量控制标准。

Quality control of Chinese materia medica （CMM） is an effective measure to ensure the safety and effectiveness of CMM in clinical practice,which is also a bottleneck to restrict the modernization process of CMM.Regarding the current quality evaluation model of CMM,we reviewed the research strategies of quality control for CMM at the present stage from the perspectives of ＂discrimination of authenticity＂ and ＂assessment of superiority＂ to state the research status and development tendency of quality standard of CMM.What＇s more,we put forward a new quality control pattern of CMM based on ＂identification of herbal origin,study on material basis,discrimination of quality markers （Q-markers）,and development of quality control method＂.An in-depth study of material basis based on authentic CMM was implemented to discriminate ＂Q-markers＂,and further developed a quality control method to control the quality of CMM.Finally,a quality control standard has been established to meet the characteristic of CMM.