七叶皂苷钠微乳注射剂的制备及质量评价

Preparation of Sodium Aescinat Micro-emulsion for Injection

摘要: 目的优化七叶皂苷钠微乳的处方，制备稳定的七叶皂苷钠微乳注射剂。方法通过绘制伪三元相图的方法，选择合适的微乳剂组分及配比，制备七叶皂苷钠油／水（O／W）型微乳注射剂（七叶皂苷钠的大豆磷脂+HS15/甘油/中链甘油三酸酯/水）。结果选用中链甘油三酸酯为油相，大豆磷脂和HS15（1∶2）为乳化剂，甘油为助乳化剂，固定乳化剂与助乳化剂比例（Km值）在2.00～3.75之间可获得较为理想的三相图，形成稳定微乳。结论采用本实验处方可制得稳定的七叶皂苷钠微乳注射剂。

Abstract: Objective?To prepare and optimize the conditions of Sodium Aescinat micro-emulsion for injection. Methods?Sodium Aescinat O/W micro-emulsion (soybean phospholipids+HS15/glycerin/medium chain triglycerides/water) was formulated guided by the pseudo-titration ternary phase diagram. Results?Stable Sodium Aescinat micro-emulsion was obtained with medium chain triglycerides as oil, soybean phospholipids+HS15 (1∶2) as emulsifier, glycerin as co-emulsifier, and a ratio of emulsifier and co-emulsifier (Km) between 2.00-3.75. Conclusion?Stable Sodium Aescinat micro-emulsion can be prepared with conditions described in this study.