[关键词]
[摘要]
中药饮片炮制是保障临床疗效、实现减毒增效及调控药性的关键环节,其质量评价直接关系中药临床应用的安全性、有效性和稳定性。传统以指标成分含量或化学指纹图谱为核心的质量控制模式,难以全面反映炮制过程中药性、功效与物质基础的动态变化。质量标志物(quality marker,Q-Marker)理论的提出,为中药饮片质量评价提供了新的研究思路,而基于“性-效-物”关联的研究模式进一步强调药性、药效与化学物质基础之间的内在联系。系统综述了Q-Marker理论的发展及其核心内涵,阐述了“性-效-物”关联的理论基础,重点总结了基于化学指纹图谱与模式识别、谱效关系、血清药物化学、代谢组学、肠道微生态等技术的饮片炮制Q-Marker筛选与验证策略,并归纳人工智能、多维组学、空间代谢组学及质谱成像等新技术在饮片Q-Marker辨识中的研究进展。在此基础上,从中药饮片炮制专属性出发,首次将人工智能、多组学技术与“性-效-物”关联框架系统整合于饮片Q-Marker研究中,分析当前饮片Q-Marker研究存在药性量化不足、筛选标准不统一、炮制专属性评价体系缺乏及多源数据融合能力有限等关键问题,并提出构建兼具炮制专属性、功效关联性和全过程可追溯性的中药饮片Q-Marker研究体系,为中药饮片质量标准提升及现代化质量控制提供理论依据与技术参考。
[Key word]
[Abstract]
Processing of traditional Chinese medicine (TCM) decoction pieces is a crucial procedure for ensuring clinical efficacy, reducing toxicity, enhancing therapeutic effects, and regulating medicinal properties. However, conventional quality control methods based mainly on indicator compounds or chromatographic fingerprints are insufficient to comprehensively characterize the dynamic changes in medicinal properties, pharmacological efficacy, and chemical constituents during processing. The quality marker (Q-Marker) theory provides a novel framework for quality evaluation of TCM decoction pieces, while the “property-effect-substance” correlation strategy further emphasizes the intrinsic relationship among medicinal properties, pharmacological effects, and chemical material basis. This review systematically summarizes the theoretical development and core concepts of Q-Marker, elucidates the scientific basis of the “property-effect-substance” correlation, and highlights recent advances in Q-Marker screening and validation strategies based on chemical fingerprinting and pattern recognition, spectrum-effect relationships, serum pharmacochemistry, metabolomics, and gut microbiota studies. Furthermore, emerging technologies, including artificial intelligence, multi-omics integration, spatial metabolomics, and mass spectrometry imaging, are reviewed for their applications in the identification of processing-related Q-Markers. On this basis, from the perspective of the processing specificity of TCM decoction pieces, this review, for the first time, systematically integrates artificial intelligence, multi-omics technologies, and the “property-effect-substance” correlation framework into the study of Q-Markers for TCM decoction pieces. Current challenges, including insufficient quantitative characterization of medicinal properties, lack of standardized screening criteria, absence of processing-specific evaluation systems, and inadequate integration of multidimensional data, are analyzed. A Q-Marker research system characterized by processing specificity, efficacy relevance, and whole-process traceability is further proposed, thereby providing theoretical support and technical guidance for improving quality standards and modern quality control of TCM decoction pieces.
[中图分类号]
R282
[基金项目]
国家自然科学基金资助项目(82274098,8260141165);国家重点研发计划项目(2023YFC3504200);中国博士后科学基金面上项目(2026M794307)