中草药来源细胞外囊泡样颗粒/中草药囊泡（Chinese herbal medicine-derived EV-like particles，CHM-EVLP）是源于《中国药典》2025年版收载药用植物的天然纳米递送系统，具有生物相容性佳、免疫原性低、跨生物屏障能力突出及多成分协同发挥作用等优势，能有效突破传统药物在神经退行性疾病（neurodegenerative diseases，NDDs）治疗中血脑屏障（blood-brain barrier，BBB）穿透难、单靶点干预效果有限等瓶颈。系统梳理了CHM-EVLP的生物学特征与物质基础，明确其核心粒径集中在30～150 nm，由脂质、蛋白质、核酸及次生代谢物构成复合体系；总结了差速超速离心法、密度梯度离心法、超滤/尺寸排阻色谱法等分离纯化技术及多维度表征方法。重点阐述了CHM-EVLP防治NDDs的核心机制，即通过“抑制蛋白聚集-调控神经炎症-修复线粒体-保护神经元”四重通路协同作用，针对阿尔茨海默病（Alzheimer’s disease，AD）、帕金森病（Parkinson’s disease，PD）形成特异性体内作用路径，并分析了口服、鼻腔、注射等给药途径的适配场景。同时指出当前CHM-EVLP研究存在提取纯化缺乏统一规范、质量控制体系不完善、体内递送效率与长期安全性需深入验证等问题，提出建立标准化制备流程、构建“组合标志体系”、深化关键活性成分-靶点-效应关联验证等未来研究方向。为CHM-EVLP的工程化开发及中医药纳米制剂在NDDs防治中的临床转化提供理论支撑与技术参考，凸显其在中医药现代化领域的应用价值。

Chinese herbal medicine-derived EV-like particles (CHM-EVLP) constitute a natural nanoscale delivery system sourced from medicinal plants listed in the Chinese Pharmacopoeia. Exhibiting excellent biocompatibility, low immunogenicity, outstanding ability to traverse biological barriers, and synergistic effects from multiple components. They effectively overcome limitations in traditional drug therapies for neurodegenerative diseases (NDDs), such as difficulty in penetrating the blood-brain barrier (BBB) and the limited efficacy of single-target interventions. This paper systematically reviews the biological characteristics and material basis of CHM-EVLP, confirming its core particle size distribution between 30—150 nm and its composite structure comprising lipids, proteins, nucleic acids, and secondary metabolites. It summarises separation and purification techniques—including differential ultracentrifugation, density gradient centrifugation, and ultrafiltration/size exclusion chromatography—alongside multidimensional characterisation methods. It emphasises the core mechanism of CHM-EVLP in preventing and treating NDDs, which involves the synergistic action of four pathways: “inhibiting protein aggregation, regulating neuroinflammation, repairing mitochondria, and protecting neurons”. This approach establishes specific in vivo action pathways for Alzheimer’s disease (AD) and Parkinson’s disease (PD), while analysing suitable scenarios for oral, intranasal, and injectable administration routes. Concurrently, it identifies current limitations in CHM-EVLP research, including the absence of standardised extraction and purification protocols, incomplete quality control systems, and the need for further validation of in vivo delivery efficiency and long-term safety. Future research directions proposed include establishing standardised preparation workflows, constructing a “combined marker system”, and deepening the validation of key bioactive component-target-effect relationships. This work provides theoretical underpinnings and technical references for the engineered development of CHM-EVLPs and the clinical translation of TCM nanomedicines in NDDs prevention and treatment, highlighting their application value in modernising traditional Chinese medicine.

R283.6

广东省普通高校特色创新项目（2023KTSCX025）；广东省中医药局科研项目（20254084）；国家重点研发计划“中医药现代化”重点专项（2022YFC3501402）