中药药理与临床2026，Vol.42Issue(1)：2-14,13.
方剂纳米体原理:中药汤剂如何从复杂暗盒到清晰透明
Principle of Formula-Derived Nanoparticles:How TCM Decoctions Transform from a Complex Black Box to Clarity and Transparency
摘要
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 aggre-gates,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 com-plex,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-compo-nent,multi-target,and holistic regulation of TCM treatment,proposing the potential of TCM-Deco in advancing the devel-opment 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 mech-anism,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.关键词
中药汤剂体/方剂纳米体/自组装/纳米递送系统/中药现代化/构效关系/中药监管科学Key words
TCM decoctosome/Formula-derived nanoparticles/Self-assembly/Nano-drug delivery system/Modernization of TCM/Structure-activity relationship/Regulatory science for TCM引用本文复制引用
艾彦伶,华桦,陈春英,孙全梅,赵军宁..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(1):2-14,13.基金项目
国家自然基金委基础科学中心(编号:22388101) （编号:22388101）
新基石项目(编号:NCI202318) （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) （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). （编号:25ZDAZX007）
