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目的筛选布洛伪麻自微乳化释药系统处方,并考察其溶出度。方法通过绘制假三元相图、乳化后的外观及粒径的测定筛选最佳处方;以市售软胶囊为参比制剂测定自微乳化胶囊在不同溶出介质中的溶出度;考察自微乳化后药液的稳定性。结果最优处方为1,2-丙二醇、Tween80、油酸乙酯3种物质的质量比为15∶40∶45。自微乳化制剂中布洛芬在3种溶出介质中溶出无差异,45 min时溶出度均达80%以上,而市售软胶囊在蒸馏水、0.1 mol.L-1盐酸中,60 min布洛芬的溶出度不到40%。结论自微乳化制剂中布洛芬的溶出不受介质的影响。
Objective To screen the formulation of self-microemulsifying drug delivery system of budesprazole and study its dissolution. Methods The best formulation was screened by measuring the pseudo-ternary phase diagram, the appearance and the particle size after emulsification. The dissolution rate of self-microemulsifying capsules in different dissolution mediums was measured with commercially available soft capsules as reference preparation. After the liquid stability. Results The optimal prescription was 1,2-propanediol, Tween80 and ethyl oleate in mass ratio of 15:40:45. The self-microemulsifying formulations of ibuprofen dissolution in the three dissolution medium no difference, 45 min dissolution rate reached more than 80%, while commercially available soft capsules in distilled water, 0.1 mol.L-1 hydrochloric acid, 60 min Buluo Fen dissolution less than 40%. Conclusion The dissolution of ibuprofen in self-microemulsifying formulations is unaffected by the medium.