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
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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.
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