目的 制备共载人参皂苷Rg₃和五味子乙素脂质体（co-loaded ginsenoside Rg₃ and schisandrin B liposomes，RS-LPs），并对其进行质量评价。方法 采用薄膜超声法制备共载脂质体RS-LPs，以包封率为指标，通过单因素考察和正交试验设计优化共载脂质体处方工艺；并对其表面特征、粒径、多分散系数（polydispersity index，PDI）、ζ电位、体外释放度及稳定性进行考察。结果 优选RS-LPs的制备处方工艺为胆固醇-磷脂质量比1∶5、成膜温度45 ℃、水化剂体积10 mL、超声时间15 min。制得的RS-LPs的平均包封率为（93.31±2.45）%，平均粒径为（121.4±2.6）nm，PDI为0.261±0.024，ζ电位为（−46.8±1.1）mV。体外释放研究表明，RS-LPs在4 h释放了60%，达到释放平衡；RS-LPs在12 h时的累积释放率为80%，24 h内持续缓慢释放。稳定性实验结果表明，RS-LPs在30 d内粒径、PDI、ζ电位无明显变化。并通过初步体外细胞实验对所制备的脂质体的抗肿瘤活性进行测定，表明所制备的脂质体对HepG2细胞拥有明显的抑制作用。结论 优选的RS-LPs制备处方工艺重现性好、包封率高、粒径小，具有明显的缓释效果和良好的抗肿瘤活性，且质量稳定，为人参-五味子药对分子配伍药的应用提供了参考。

Objective To prepare co-loaded ginsenoside Rg₃ and schisandrin B liposomes (RS-LPs) and evaluate their quality. Methods The co-loaded liposomes were prepared by thin film ultrasonic method. The formulation and process of co-loaded liposomes were optimized by single factor investigation and orthogonal experimental design with encapsulation efficiency as the index. The surface characteristics, particle size, polydispersity index (PDI), ζ potential, in vitro release and stability were investigated. Results The optimal preparation process of RS-LPs was as follows: the ratio of cholesterol to phospholipid was 1:5, the film forming temperature was 45 ℃, the volume of hydration agent was 10 mL, and the ultrasonic time was 15 min. The average encapsulation efficiency of the prepared RS-LPs was (93.31 ± 2.45)%, The average particle size was (121.4 ± 2.6) nm, the PDI was 0.261 ± 0.024, and the ζ potential was (−46.8 ± 1.1) mV. In vitro release studies showed that RS-LPs released 60% at 4 h, reaching a release balance. The cumulative release rate of RS-LPs was 80% at 12 h, and sustained slow release within 24 h. The results of stability experiments showed that there was no significant change in particle size, PDI and ζ potential of RS-LPs within 30 d. The anti-tumor activity of the prepared liposomes was determined by preliminary in vitro cell experiments, indicating that the prepared liposomes had a significant inhibitory effect on HepG2 cells. Conclusion The optimized RS-LPs preparation prescription process has good reproducibility, high encapsulation efficiency, small particle size, obvious sustained release effect and good anti-tumor activity, and the quality is stable, which provides a reference for the application of Renshen (Ginseng Radix et Rhizoma)-Wuweizi (Schisandrae Chinensis Fructus) drug pair molecular compatibility.

R283.6

国家自然科学基金资助项目（22301020）；吉林省现代农业产业技术体系项目（JLARS-2025-040210）；吉林省科技发展计划项目（YDZJ202401657ZYTS）