自2016年中药质量标志物（quality markers，Q-Marker）概念提出至今，该领域研究已走过10年的发展历程。系统梳理中药Q-Marker领域的研究进展，围绕理论体系构建、研究策略与技术方法、基础研究实践成果、产业化转化应用及前沿新技术融合等维度展开综述，同时剖析当前研究存在的关键科学问题与现实挑战，并对未来发展趋势进行展望。研究认为，Q-Marker后续研究将进一步锚定方证对应的临床有效性验证核心目标，依托人工智能与多组学联用技术实现Q-Marker的智能筛选与发现；研究对象将由单一活性成分逐步转向多维系统性表征；通过构建全产业链数字化溯源管控体系，推动中药Q-Marker体系纳入国际药品监管标准，实现中药质量与安全的一体化精准管控，为中药Q-Marker的深化研究、产业化落地与国际化推广提供理论依据与实践参考。

Since the concept of quality markers (Q-Marker) for traditional Chinese medicine (TCM) was proposed in 2016, the field has witnessed a decade of development. This review systematically consolidates the research advances in TCM Q-Markers, examining such dimensions as the construction of the theoretical system, research strategies and technical approaches, achievements in basic research, industrial transformation and application, and integration with cutting-edge technologies, while also dissecting the key scientific questions and practical challenges currently confronted and outlining future development trends. The review concludes that future Q-Marker research will be further anchored to its core goal of validating clinical efficacy based on formula-syndrome correspondence; that, underpinned by artificial intelligence and integrated multi-omics technologies, intelligent screening and discovery of Q-Markers will be realized; that the focus of study will gradually shift from single active components toward multi-dimensional, systematic characterization; and that, by establishing a digital traceability and quality-control system spanning the entire industrial chain, the TCM Q-Marker framework will be driven toward incorporation into international drug regulatory standards. In this way, integrated and precise control of the quality and safety of TCM can be achieved, providing both a theoretical basis and a practical reference for deepening Q-Marker research, facilitating its industrial implementation, and advancing its globalization.

R285

国家科技重大专项（2025ZD05497000）