目的 制备氧化苦参碱（OMT）磷脂复合物（PC）自乳化释药系统（OMT-PC-SEDDS），并对其进行质量评价及体外释放度考察。方法 通过伪三元相图的绘制，以乳化区域面积为指标，筛选处方中乳化剂、助乳化剂种类及混合乳化剂比值（K_m），以溶解度大小考察油相种类，确定最佳处方；并对OMT-PC-SEDDS的外观、平均粒径、自乳化时间、体外释放特性及稳定性进行评价。结果 OMT-PC-SEDDS最佳处方为乳化剂Kolliphor HS 15与助乳化剂乙醇质量比为2∶1，中链甘油三酯（MCT）与Kolliphor HS 15和乙醇的总质量的质量比为2∶8。制备得到的OMT-PC-SEDDS外观呈澄明液体，稳定性良好，加水稀释后形成浅乳白色并带淡蓝色乳光的乳液，透射电子显微镜（TEM）观察呈类球形，分布均匀；平均粒径为（355.00±19.50）nm，Zeta电位为（-12.80±0.66）mV。在pH 6.8磷酸缓冲液中，OMT、OMT-PC和OMT-PC-SEDDS的体外释放在4 h分别达到93.84%、88.39%、88.61%。结论 考察所得最佳处方制备的OMT-PC-SEDDS粒径适宜，稳定性良好。

Objective To prepare oxymatrine (OMT) phospholipid complex (PC) self-emulsifying drug delivery system (OMT-PC-SEDDS), and evaluate its quality and release in vitro. Methods The emulsifiers, co-emulsifiers and ratio of emulsifier to co-emulsifier (K_m) were selected through the pseudo-ternary phase diagram method, using emulsified area as selection index, investigation of oil phase by solubility was determined to optimize the prescription. The appearance, average particle diameter, self-emulsification time, in vitro release characteristics, and stability of OMT-PC-SEDDS were evaluated. Results The optimum prescription of OMT-PC-SEDDS was emulsifier Kolliphor HS 15 and co-emulsifier ethanol mass ratio of 2:1, the mass ratio of medium chain triglyceride (MCT) to the total mass of Kolliphor HS 15 and ethanol was 2:8. The appearance of OMTPC-SEDDS was translucent clear liquid with good stability. OMT-PC-SEDDS diluted with water to form milky and pale blue emulsion. The emulsion was observed to be spherical by transmission electron microscopy and distributed evenly with average particle size of (355.00 ±19.50) nm and Zeta potential of (-12.80 ±0.66) mV. In pH 6.8 phosphate buffer, the in vitro release, the in vitro release of OMT, OMT-PC, and OMT-PC-SEDDS respectively reached 93.84%, 88.39%, and 88.61% at 4 h. Conclusion The prepared OMT-PC-SEDDS by optimum formulation of this study has a good particle size and good stability.

贵州省高等教育科技创新团队（黔教合人才团队字[2014]31）；贵州省科技创新创新团队（黔科合人才团队[2015]4025号）；贵州省高层次创新型人才百层次人才（贵州科技厅黔科合人才[2015]4029号）；贵州医科大学药学国际科技合作基地（黔科合平台人才[2017]5802）；贵州省科学技术基金重点项目（黔科合JZ字[2015]2002号）；遵义医学院基础药理省部共建教育部重点实验室项目（黔教合KY字[2017]379）；贵阳医学院博士启动基金项目（院博合J字[2017-24]号）