[关键词]
[摘要]
中药质量是保障临床疗效、维系产业发展的核心,更是推动中医药传承创新与高质量发展的国家战略议题。刘昌孝院士从中医药体系特点出发,创造性提出中药质量标志物(quality marker,Q-Marker)理论,系统界定中药质量评价的核心要素,为中药质量服务临床与标准研究提供了全新视域。方证代谢组学遵循方证对应的中医药理论及临床实践,整合系统生物学与中药血清药物化学的技术和方法,一体化实现中医证候诊断与中药方剂效应精准评价,在此基础上发现与临床疗效相关、体现方剂配伍、可追溯体内代谢和制备过程的中药药效物质基础,解决证候生物学本质与中药方剂治疗内涵等关键科学问题,成为Q-Marker发现的重要手段。中药Q-Marker提出10周年之际,系统梳理方证代谢组学理论体系与研究范式,总结其在发掘Q-Marker中的实践应用,展望新技术体系等发展带来的优势并研判未来发展方向,以期推动中药质量评价体系的科学化升级,更好服务于人类卫生健康命运共同体。
[Key word]
[Abstract]
The quality of traditional Chinese medicine (TCM) is fundamental to ensuring consistent clinical efficacy and sustaining the healthy development of the TCM industry, and it also represents a national strategic issue for the inheritance, innovation, and high-quality advancement of TCM. Academician Liu Changxiao, based on the intrinsic characteristics of the TCM system, has innovatively proposed the theory of TCM quality marker (Q-Marker), systematically defining the core elements of TCM quality evaluation and providing a new perspective for quality assessment oriented toward clinical efficacy and standardization research. Chinmedomics, grounded in the theory and clinical practice of formula-syndrome correspondence, integrates systems biology with TCM serum pharmacochemistry to enable the integrated precise evaluation of syndrome differentiation and therapeutic efficacy of TCM prescriptions. On this basis, it facilitates the identification of the pharmacodynamic material basis that are associated with clinical efficacy, reflect formula compatibility, and are traceable to in vivo metabolic processes and preparation procedures. This approach addresses key scientific issues related to the biological essence of syndromes and the therapeutic connotation of TCM formulas, thereby becoming an important methodological strategy in Q-Marker discovery. On the occasion of the 10th anniversary of the Q-Marker concept, this review systematically summarizes the theoretical framework and research paradigm of Chinmedomics, highlights its practical applications in Q-Marker identification, and prospects the advantages brought by new technology systems and discusses future development directions driven by emerging technologies. This work aims to promote the scientific upgrading of TCM quality evaluation systems and to better serve the global community of health for all.
[中图分类号]
R285
[基金项目]
国家自然科学基金区域创新发展联合基金项目(U23A20501);国家自然科学基金青年项目(82505016);黑龙江省自然科学基金青年基金项目(QC2025H022);黑龙江省重点研发计划项目(2022ZX02C04);中国博士后科学基金第18批特别资助项目(2025T180973);黑龙江省博士后资助项目(LBH-Z23272);黑龙江中医药大学青年科技创新能力培养项目(2024-KYYWF-1380,2024XJJ-QNCX011);黑龙江中医药大学大学生科技创新项目(KY2024-05)