酮洛芬自乳化制剂处方及化学稳定性研究

目的建立酮洛芬自乳化制剂处方 ,并考察其稳定性。方法通过溶解度实验和三元相图的建立 ,筛选酮洛芬自乳化制剂处方。用HPLC法测定处方经高低温循环和光照加速实验前后药物的含量 ,考察其化学稳定性。结果酮洛芬自乳化制剂处方中油相、表面活性剂和助表面活性剂分别为油酸乙酯、Tween 80和乙二醇单乙基醚 (Transcutol)。处方经高低温循环后酮洛芬平均含量由 99 8% (w)变为 99 0 % (w) ,光照 5d和 10d后 ,平均含量分别降为 85 7% (w )和 6 8 7%(w )。结论酮洛芬自乳化制剂处方比例为酮洛芬 油酸乙酯 Tween 80 Transcutol(w∶w∶w∶w =5 0∶4 0 0∶4 3 5 0∶11 5 )。制剂对热稳定 ,对光不稳定 ,需避光保存

Self-emulsifying preparation and chemical stability studying of ketoprofen

Objective To develop the formula for self-emulsifying of ketoprofen and study stability of ketoprofen in the self-emulsifying drug delivery systems (SEDDS).Methods Through solubility experiments and constructing pseudo-ternary phase diagrams,the formula was screened.The chemical stability of the SEDDS formulations after temperature cycling and illumination was evaluated utilizing an HPLC assay.Results In the formula of ketoprofen,the oil,surfactant and cosurfactant were ethyl oleate,Tween 80 and Transcutol respectively.The average content of ketoprofen in the SEDDS after the temperature cycling was 99.0%,while they were 87.5% and 68.7% after 5 days and 10 days under illumination.Conclusion The formula for self-emulsifying of ketoprofen is ketoprofen,ethyl oleate,Tween 80 and Trandcutol,and the proportion of them is (w∶w∶w∶w=5.0∶40.0∶43.5∶11.5).The ketoprofen SEDDS need to be preserved without illumination.