目的 建立地榆皂苷自乳化药物传递系统的制备方法并对其进行质量评价。方法 通过溶解度试验、辅料配伍、三元相图中形成乳剂区域面积的大小和D-最优混料实验设计来筛选地榆皂苷自乳化药物传递系统的处方组成和比例，以载药量、粒径和多分散系数为评价指标，对油相、表面活性剂和助表面活性剂的用量进行考察。最后以成乳的外观形态、粒径、多分散系数、Zeta电位和体外溶出度为评价指标，评价其质量。结果 得到地榆皂苷自乳化药物传递系统最优处方为Obleique CC497-聚山梨酯20-Transcutol P（0.25：0.45：0.30），载药量23.93 mg/g，平均粒径为（207.92±2.13）nm，Zeta电位为（38.84±0.18）mV。体外释放结果表明，地榆皂苷自乳化药物传递系统的释药速率极显著地高于地榆皂苷原料药。结论 首次建立了地榆皂苷自乳化药物传递系统，工艺合理可行，质量稳定。

Objective To optimize the formulation of the self-emulsifying drug delivery system of total saponins of Sanguisorba officinalis and evaluate its characteristics. Methods The formulation and its proportion of the self-emulsifying drug delivery system of total saponins of S. officinalis were optimized based on the solubility tests, formula compatibility, microemulsion area in the ternary phase diagram and D-optimal mixing experiment design. The dosage of oil phase, surfactant and co-surfactant were investigated by drug loading, particle size, and polydispersity index. The appearance, particle size, polydispersity index, Zeta potential, and in vitro release of preparation were finally evaluated. Results The ratio of oil phase, surfactant, and co-surfactant was 0.25:0.45:0.30. The drug loading was 23.93 mg/g, the average particle size was (207.92 ±2.13) nm and the zeta potential was (38.84 ±0.18) mV. The release of SEDDS was superior to the bulk drug apparently. Conclusion The self-emulsifying drug delivery system of total saponins of S. officinalis was established. The technology was feasible and the quality was stable.

遵义医学院博士启动基金（F808）；贵州省中医药管理局项目（Q2YY-2016-016）；2017年遵义医学院大学生创新计划项目