摘要
目的：制备丹参酮ⅡA自微乳化软胶囊，并对其进行体外评价。方法：通过绘制伪三元相图，以外观、乳化时间、乳化后粒径为指标，确定最佳处方；测定丹参酮ⅡA自微乳化软胶囊的溶出度。结果：处方选用聚山梨酯-80为乳化剂，无水乙醇为助乳化剂，油酸乙酯为油相，其比例是2：1：2。所制得的微乳外观均一透明，平均粒径为（25．8±3．9）nm；在pH1．2无酶人工胃液中15min累积溶出率〉85％。结论：通过处方筛选制备出了丹参酮ⅡA自微乳化软胶囊，具有较好的溶出度。
OBJECTIVE：To preparation and in vitro evaluation the self-microemulsifying soft capsule （SMESC）of tanshinone Ⅱ A. METHODS： The-optimum formulations of Tan- Ⅱ A SMESC were screened by pseudo-ternary phase diagrams, with the appearance, the time of mieroemulsion,particle size as parameters,The dissolution of Tan- Ⅱ A SMESC was measured. RESULTS： In the selected formulation,Tween-80,Ethanol,Ethyl oleate were screened respectively as emulsifier,co-emulsifier and oil pluse. The optimized proportion was 45 ： 20： 35. The physical appearance was transparent and uniform, The particle diameter was （ 25.8 ± 3.9）nm . The percent of accumulated dissolution of Tan- Ⅱ A SMESC in pH 1.2 SGF was up to 85 at 15min. CONCLUSION：The optimized Tan-ⅡA SMESC is obtained, and with good dissolution.
关键词
丹参酮ⅡA
自微乳化软胶囊
体外评价
Tanshinone ⅡA, self-microemulsifying soft capsule, In vitro evaluation
