基于"质量-药效-代谢"关联的中药质量评价方法研究

Under the direction of theory of traditional Chinese medicine, this project which would begin from the integrity of traditional Chinese medicine and synthesize the traditional quality control methods, discussed the relationship between Chinese herbal medicinal ingredients and curative effects by combining the quality evaluation with the early research of curative effect and metabolism. Then, the project built the quality evaluation system which consisted with the curative effects and could reflect the inherent quality of traditional Chinese medicine, and hence proposed the new method for quality evaluation associated in "quality，curative effect and metabolism". This project which guided by the curative effects determined the therapeutic material basis of Radix Angelicae, Radix Astragali and Danggui Buxue Decoction by the data and results of quality evaluated experiments, pharmacodynamic experiments and pharmacokinetics experiments. We calculated the principal components by PK-PD mathematical model and measured the quantity of them by many analytical methods. and made the quality evaluated methods really reflected the curative effects.

本课题在中医药理论指导下，从中药的整体性出发，整合传统质控方法，将质量评价与疗效和代谢的早期研究相结合，探讨中药成分与药效的相关关系，建立以化学成分药效动态为线索的、与药效一致的、能反映中药内在质量的质量评价体系，提出"质-效-代"关联的质量评价新方法。本课题以当归、黄芪及其复方当归补血汤为研究载体，整个研究过程始终以体现药效为指导，以仿生提取、人工胃液、人工肠液温孵和化学分析等技术为手段，确定和制备消化道吸收组分，然后通过"质-效-代"实验将质量评价与药效和代谢相关联，锁定饮片和复方生血的药效物质基础，明确质量评价目标。采用多成分定量分析技术质控饮片的质量，以"多成分PK-PD数学分析模型"分析计算复方中主要成分的效应贡献大小，确定"质-效-代"关联的首选质控成分，通过控制最优组分的量与比例关系达到质量评价的目的,建立能体现疗效的质量评价方法。

本课题在中医药理论指导下，从中药的整体性出发，整合传统质控方法，将质量评价与疗效和代谢的早期研究相结合，探讨中药成分与药效的相关关系，建立以化学成分药效动态为线索的、与药效一致的、能反映中药内在质量的质量评价体系，提出“质-效-代”关联的质量评价新方法。本课题以当归、黄芪及其复方当归补血汤为研究载体，整个研究过程始终以体现药效为指导，以仿生提取、人工胃肠液温孵和大鼠离体实验探讨中药多成分体内动态代谢情况，采用化学成分指纹图谱技术全程检测对比分析多成分代谢过程，形象地反映出多成分体内吸收代谢轮廓，锁定饮片和复方生血的药效物质基础，明确质量评价目标。整个研究过程始终以体现药效为核心，将多成分药物代谢学术思想与中药学体系结合应用，开创一种流程化“质量-药效-代谢”关联的方法学路线。确定“质-效-代”关联的首选质控成分，以期建立能体现疗效的质量评价方法。