Clinical metabolic analysis combined with traceability of biosynthetic pathway:a new approach to quality marker of Chinese materia medica

Quality marker(Q-marker)of Chinese materia medica(CMM)plays an important role in quality control of CMM products.However,its research strategy and technique remain unclear.Based on the fact that quality standard of CMM should be associated with clinical efficacy,taking Jinqi Jiangtang tablet treating type 2 diabetes as an example,the Q-marker related to activity via the reverse analysis of drug metabolism in clinic and traceability of botanic biosynthetic pathways is discovered and validated.Therefore,we proposed a new research strategy of Q-marker of CMM with"Discovery of clinical active constituents as guidance,Reverse analysis of metabolic transformations as link,and Traceability of biosynthesis pathways as key",to improve quality control of CMM products.

中药质量标志物在中药质量控制中具有重要作用,然而中药质量标志物研究策略与技术尚不明确。立足于“中药质量标准应关联临床疗效”,以临床疗效确切(治疗2型糖尿病)的金芪降糖片为例,通过临床代谢逆向解析和植物生源合成途径追溯研究思路,发现并确认关联活性的金芪降糖片质量标志物,旨在构建“以临床活性成分发现为导向、代谢转化逆向解析为纽带、生源合成途径追溯为关键”的中药质量标志物研究新路径,推动中药质量标志物理论创新与技术突破。