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中药汤剂作为中医临床应用历史最悠久(可追溯至夏末商初伊尹制汤液)、临床使用最广泛的核心剂型，已被证实能有效解决多种临床复杂病证的治疗需求。但中药汤剂药效物质不明白，多药理作用和机制不清楚，长期以来被视为难以明晰的“暗盒”。近年来，研究发现中药汤剂在传统水煎过程中，不仅仅是水溶性小分子成分的提取，更为重要的是在水煎煮热力学驱动下可自组装形成具有纳米尺度结构的有序聚集体，即“中药汤剂体”(TCM decoctosome, TCM-Deco)。作为“方剂纳米体”(formula-derived nanoparticles, FDN)家族中与临床实践最为贴近的成员，TCM-Deco在热诱导与非共价相互作用驱动下形成，其结构复杂而有序，兼具天然来源与功能协同的特性。本文系统综述了TCM-Deco的形成机制、结构特征、成分组成及其多维表征策略，重点探讨了其在增强生物利用度、实现多成分协同与智能递送等方面的生物学功能，探讨了中药“多成分-多靶点-整体调节”治疗理念的纳米科学内涵，提出其在开发新型纳米药物、推动中药现代化、国际化的潜在价值。同时，本文也指出了当前TCM-Deco研究在形成机制解析、质量控制标准化、体内过程阐明及科学监管路径确立等方面面临的挑战，强调需要改变中药监管理念以适应其复杂性。
Abstract：Traditional Chinese medicine(TCM) decoctions, the longest-standing and most widely used core dosage form in the clinical practice of TCM,have been proven effective in the treatment of various complex diseases since their traceable origins at the end of the Xia Dynasty and the beginning of the Shang Dynasty when Yi Yin first prepared them. However, the material basis for their efficacy, along with their multiple pharmacological effects and mechanisms, remains largely undefined, which contribute to the long-standing reputation of TCM decoctions as an elusive “black box”. Recent studies have revealed that the decocting process of TCM decoctions do not solely extract water-soluble small molecules but also promote the self-assembly of ordered nanostructured aggregates under thermodynamic driving forces. These aggregates, termed TCM decoctosomes(TCM-Deco),are the members of the formula-derived nanoparticles(FDNs) family most closely aligned with clinical practice. Driven by heat induction and non-covalent interactions, TCM-Deco forms complex, yet ordered structures that combine natural origins with functional synergy. This review comprehensively summarizes the formation mechanisms, structural characteristics, composition, and multidimensional characterization strategies of TCM-Deco, with focuses on the biological functions, such as enhancing bioavailability, enabling multi-component synergy, and facilitating intelligent delivery. Additionally, this review examines the nanoscientific implications of the multi-component, multi-target, and holistic regulation of TCM treatment, proposing the potential of TCM-Deco in advancing the development of novel nanomedicines and contributing to the modernization and internationalization of TCM. Furthermore, this review highlights the current challenges in TCM-Deco research, including the need for clarification of the formation mechanism, standardization of quality control, understanding of in vivo processes, and establishment of scientific regulatory pathways, stressing the importance of adapting regulatory frameworks to accommodate the inherent complexity of TCM.
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基本信息:
DOI：10.13412/j.cnki.zyyl.20260105.001
中图分类号:R283.6
引用信息:
[1]艾彦伶,华桦,陈春英,等.方剂纳米体原理：中药汤剂如何从复杂暗盒到清晰透明[J].中药药理与临床,2026,42(01):2-14.DOI:10.13412/j.cnki.zyyl.20260105.001.
基金信息:
国家自然基金委基础科学中心(编号：22388101); 新基石项目(编号：NCI202318); 国家纳米科学中心研究所自主部署科研类项目资助(编号：E59651R1); 四川省中医药管理局科学技术研究专项重大项目资助(编号：25ZDAZX007)
2026-01-05
2026-01-05
2026-01-05