中药传统质量控制中单一指标成分评价模式存在局限性，难以体现中药“多成分-多靶点-整体调节”的作用特征。中药质量标志物（quality marker，Q-Marker）理论是驱动质控范式从单一成分向整合评价转化的核心。构建中药Q-Marker多维度评价体系，通过效应成分指数、生物效价等临床可验证的量化指标，强化质控标准对药品安全性/有效性的保障能力，推动质控理念从“唯成分论”向临床功效关联导向转化，为建立符合国际监管要求的科学评价体系、加速中医药现代化进程开辟新视域。

The single component evaluation model in traditional Chinese medicine (TCM) quality control has limitations, failing to fully reflect the characteristic mechanism of “multiple components-multiple targets-holistic regulation” inherent in TCM. The theory of quality marker (Q-Marker) for TCM serves as the core driver for transforming quality control paradigms from single component to integrated evaluation. Establishing a multidimensional evaluation system for TCM Q-Marker, using clinically verifiable quantitative indicators such as effect component indices and bioassays, enhances the ability of quality control standards to ensure drug safety and efficacy. This shift propels quality control philosophy from a “single component focus” toward a clinically efficacy oriented approach, opening new perspectives for establishing a scientifically sound evaluation system compliant with international regulatory requirements and accelerating the modernization of TCM.

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国家中医药管理局全国名老中医药专家传承工作室建设项目(国中医药人教函[2018] 134号); 河南省中医药科学研究专项重点课题(20-21ZY1024)