中药质量标志物（quality marker，Q-Marker）创新理念的提出及其方法学体系的建立，为中药物质基础及质量控制研究开辟了新的模式。基于中药Q-Marker理论，对注射用益气复脉（冻干）（Yiqi Fumai Lyophilized Injection，YQFM）的Q-Marker开展了系统性研究，确定了人参皂苷Rb₁、Rg₁、Rf、Rh₁、Rc、Rb₂、Ro、Rg₃及麦冬皂苷C、麦冬苷元-3-O-α-L-吡喃鼠李糖基-（1→2）-β-D-吡喃葡萄糖苷、偏诺皂苷元-3-O-α-L-吡喃鼠李糖基-（1→2）-β-D-吡喃木糖基-（1→4）-β-D-吡喃葡萄糖苷、果糖和五味子醇甲为YQFM的Q-Marker。在前期研究基础上，阐述了YQFM的药理作用和临床应用，进一步解释了Q-Marker的药效机制与YQFM临床疗效之间的内在关系。此外，根据与临床疗效相关的活性研究成果，进一步将人参皂苷Rd及人参皂苷Re纳入YQFM的Q-Marker中，以期完善YQFM的Q-Marker体系，揭示了Q-Marker在YQFM临床治疗疾病中的关键作用，为产品质量的全面评价与控制提供充实的依据。

The establishment of concept of quality marker (Q-Marker) and its methodologies made a new mode for the chemical constituent and quality control researches of traditional Chinese medicines (TCMs). Based on theory of Q-Marker, Q-Markers of Yiqi Fumai Lyophilized Injection (注射用益气复脉, YQFM) was studied systematically. And ginsenosides Rb₁, Rg₁, Rf, Rh₁, Rc, Rb₂, Ro, Rg₃, ophiopojaponin C, phiogenin-3-O-α-L-rhamnopyranosyl-(1→2)-β-D-glucopyranoside, pennogenin-3-O-α-L-rhamnopyranosyl-(1→2)-β-D-xylopyranosyl-(1→4)-β-D-glucopyranosid, fructose, and schisandrin A were determined as Q-Markers of YQFM. Pharmaceutical efficacy and clinical application were presented in the previous studies. The relationship between clinical application of Q-Marker and clinical efficacy of YQFM was elucidated. Furthermore, according to the bioactivity studies relevant to clinical efficacy, ginsenoside Rd and Re were considered into the Q-Marker of YQFM. In order to improve the Q-Marker system of YQFM, which demonstrated that Q-Marker played key roles in the clinical application of YQFM, and provided scientific evidence for quality evaluation and control of the product.

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