中药复方具有多成分、协调整合作用特点，其整体药效的表征不是单一成分药效的简单相加，而是存在着复杂的成分间相互作用，这给中药复方质量控制带来极大挑战。现今，多数复方的质控成分与药效/毒效关联性不强，难以确保临床疗效的稳定、均一。为此，本项目拟以参附注射液为研究载体，融合多学科技术与方法，在充分考虑多成分相互作用的基础上，构建中药复方效应成分“量-效/毒”关联的质量控制新方法，开展如下研究：（1）通过评估“成分组合”对整体药效的贡献，快速发现能够基本代表参附注射液心肌保护作用的“关键效应成分群”；（2）从关键效应成分群的“代谢处置”及对“内源活性分子调控”两个方面，解析成分间的相互作用模式；（3）建立基于成分间相互作用的关键效应成分群“量-效/毒”关系模型，确定适宜的含量波动范围。本项目将为建立科学、合理、可量化的中药复方质量控制模式提供新的思路与方法，为中药现代化、国际化发展提供方法学支撑。

Traditional Chinese medicine (TCM) posesses the characteritics of multiple components and integrative effect. Its holistic effect could not be considered as the simple accumulation of single component effect, a complex interaction among multi-components must be taken into consideration. However, most index components of TCM were not closely interrelated with their effect, which is difficult to ensure their effect and safty. Based on this point, this project would select Shenfu injection as research carrier, combine multi-discipline technique, and fully analyze components interaction to develop a ‘dose-effect/toxicity’ compounds interconnection oriented method for the quality control of TCM. It generally includes three steps: (1) rapidly finding the ‘key effective combinatorial components’ that can represent the myocardial protective effect of Shenfu injection by assessment of contributions of ‘combinatorial compounds’ to the holistic effect of Shenfu injection; (2) comprehensively expounding interaction modes of ‘key effective combinatorial components’ based on the metabolic disposition and endogenous active components regulation effect; (3) developing a ‘multi component-multi concentration’ statistics model to determine the appropriate quantity fluctuation range of ‘key effective combinatorial components’. This study will provide universal strategy and method to develop new quality control mode which can reflect the multicomponent integrative effects and the ‘compound-concentration-effect’ relationship of TCM, and provide methodological support for the modernization and internationalization of TCM.