海马补肾丸为中药大品种，疗效确切，但其基础研究薄弱，质量控制方法简单，不能科学评价和有效控制该药的质量。基于中药质量标志物的理念和确定原则，对其化学物质组及口服血行成分进行了辨识与表征，进而通过整体动物模型、蛋白组学、代谢组学、网络药理学以及受体结合及酶学检测等方法，评价其有效性、阐释作用机制、确定药效物质基础、提炼质量标志物，为充分发挥该药的临床价值、建立科学的质量评价体系提供了理论和实验依据。

Haima Bushen Pills (HBP) is a kind of major Chinese materia medica varieties, which has been proven to be effective. However, due to its weak research foundation and simple quality control method, the quality of HBP cannot be evaluated scientifically and controlled effectively. In this paper, the chemical components of HBP and components ingested into the blood were identified and characterized based on the concept and determination principle of quality marker (Q-marker). Then, through the animal models, proteomics, metabolomics, network pharmacology, receptor binding and enzyme detection and other methods, its effectiveness was evaluated, the mechanism was explained, the effective components were determined, and the Q-marker was extracted. This paper provides theoretical and experimental evidence for giving full play to the clinical value and establishing a scientific quality evaluation system of HBP.

国家自然科学基金重点项目（81430096）；国家自然科学基金重点项目（81830111）