中药大品种二次开发研究是中药创新研究的重要内容，是继承和发展中医药理论，突破制约中医药理论和中药产业发展瓶颈的重要路径。以疏风解毒胶囊为研究对象，进行了系统的二次开发研究，通过药材、成品以及口服入血成分的辨识和表征，阐释了疏风解毒胶囊的化学物质组，进一步通过UPLC-Q/TOF-MS整合核转录因子-κB（NF-κB）双荧光素酶报告基因系统、G-蛋白偶联受体结合实验以及网络药理学分析和谱-效筛选方法，筛选和明确了主要药效物质基础；基于传统功效，以整体动物模型、基因组学等方法，从抗炎免疫、解热等方面阐释其作用机制，并阐明主要成分的药动学及组织分布规律，阐释了疏风解毒胶囊的作用机制；通过拆方研究并与同类中药以及化学药比较，阐释了该药的组方特点和配伍规律，提炼和发现了其作用特点、比较优势和临床核心价值；通过多批样品、多指标成分的含量测定以及指纹图谱共有模式的建立等方面进行系统研究，建立疏风解毒胶囊的药材与成品的质量控制体系，对原有的质量标准进行了全面提升，保证了产品的质量均一、稳定、可控。为该品种的临床推广应用和指导临床实践提供了重要的理论和实验依据，并为其他中药大品种的二次开发研究提供了可参考的思路与模式。

The study of secondary development of major Chinese materia medica varieties is the important content of Chinese materia medica (CMM) innovation research, and it is also the important approach of inheriting and developing traditional Chinese medine (TCM) theory and breaking the bottleneck restricting of the development of TCM theory and CMM industry. In this paper, the secondary development of Shufeng Jiedu Capsule (SJC) was systematically studied. The chemical components of SJC were elucidated by the identification and characterization of herbs, SJC and components ingested into the blood. The main effective components were further screened and cleared by integrating UPLC-Q/TOF-MS, NF-κB double luciferase reporter gene system, binding experiments of G protein coupled receptors, network pharmacology analysis, and spectrum-efficiency screening method. Based on the traditional efficacy, the mechanism of SJC was explained in terms of anti-inflammatory immunity, antipyretic effect, pharmacokinetics and tissue distribution of the main components based on the methods of animal model and genomics. The formula features, compatibility regularity were clarified and the action properties, comparative advantages and core clinical value were found and refined by the research of decomposed recipes and the comparison with the similar CMM recipes and chemical drugs. The quality control systems of SJC and related herbs were established by content determination of multi-target ingredients and multi-batch samples, and the establishment of the characteristic mode of HPLC fingerprint. The original quality standards were promoted comprehensively to ensure the uniformity, stability and controllability of product quality. This study not only provided important theoretical and experimental basis for clinical application and guidance of clinical practice, but also provided research ideas and modes for the secondary development of other major CMM varieties.

国家中药标准化专项资助项目（ZYBZH-C-AH-02）；国家自然科学基金资助项目（81430096）；国家自然科学基金资助项目（81703802）