中药质量控制长期以少数指标性成分的定性定量分析为主，难以充分表征多成分共同作用所决定的整体质量属性，也难以解释化学质量差异与临床有效性、安全性之间的关系。中药质量标志物（quality marker，Q-Marker）理论将有效性纳入质量标志物的基本属性，为建立物质基础、功能效应与临床价值相衔接的质量评价体系提供了理论框架。生物效应评价可为候选Q-Marker的功效相关性、效应贡献及质量区分能力提供功能证据。围绕Q-Marker的发现、验证与应用，梳理不同层级的生物效应指标，比较直接活性测定、生物效价/生物毒价测定、效应成分指数（effect-constituent index，ECI）、生物效应表达谱和效应当量（effect equivalent，EE）等方法的特点、适用范围及局限，并讨论评价标准化、多功效Q-Marker整合、临床相关性验证及效应量值转化等问题。总体来看，生物效应评价并非替代化学检测，而是增强候选Q-Marker功效代表性和质量区分能力的重要手段。未来应以特定功效和临床定位为导向，完善候选Q-Marker从物质识别、效应验证到临床关联的证据链，推动中药质量控制由成分合格判定向与功效和临床价值相衔接的质量保障转变。

Quality control of traditional Chinese medicine (TCM) has long relied on the qualitative and quantitative analysis of a limited number of marker constituents, which is insufficient to fully characterize the overall quality arising from the combined actions of multiple constituents or to explain the relationship between chemical quality variation and clinical efficacy and safety. The quality marker (Q-Marker) theory incorporates efficacy as an essential attribute of quality markers and provides a theoretical framework for linking the material basis, functional effects and clinical value of TCM. Bioeffect evaluation can provide functional evidence for the efficacy relevance, effect contribution and quality-discriminative capacity of candidate Q-Markers. Focusing on the discovery, validation and application of Q-Marker, this review summarizes bioeffect indicators at different levels and compares the characteristics, applicability and limitations of direct activity assays, biopotency/biotoxicity assays, the effect-constituent index (ECI), bioeffect profiling and effect equivalent (EE). Key issues, including standardization of bioeffect evaluation, integration of Q-Marker for multiple therapeutic effects, validation of clinical relevance and translation of bioeffect measurements into quantitative quality indicators, are also discussed. Overall, bioeffect evaluation is not intended to replace chemical analysis, but rather to strengthen the efficacy representativeness and quality-discriminative capacity of candidate Q-Marker. Future studies should be guided by specific therapeutic effects and intended clinical applications, with an emphasis on strengthening the evidence chain linking material identification, effect validation and clinical relevance of candidate Q-Markers, thereby promoting the transition of TCM quality control from constituent-based compliance testing toward quality assurance aligned with therapeutic effects and clinical value.

R282;R285

天津市教委科研计划项目（2024KJ038）；天津市教委科研计划项目（2024KJ035）；天津中医药大学第一附属医院“拓新工程”基金科研项目（院ZZ2024009）