氟比洛芬自乳化给药系统的制备及体外溶出度考察

Preparation of self-emulsifying drug delivery systems of flurbiprofen and investigation of dissolution

目的:制备氟比洛芬自乳化给药系统(SEDDS)以提高药物的溶出度。方法:通过绘制假三元相图和体外自乳化效率的评价确定最优处方;以氟比洛芬片为参比制剂测定SEDDS的溶出度。结果:最优SEDDS处方中的油相为油酸乙酯,乳化剂为聚山梨醇酯80,助乳化剂为PEG400,其比例为50.0∶35.0∶15.0,药物为辅料总量的5.0%。结论:氟比洛芬SEDDS与片剂相比,药物的溶出度有显著提高。

OBJECTIVE To improve the dissolution of flurbiprofen by self-emulsifying drug delivery systems. METHODS Through drawing pseudo-ternary phase diagrams and self-emulsification in vitro, the optimum formulation was obtained for flurbiprofen. The dissolution of SEDDS was measured, taking the tablets as reference. RESULTS In the optimum formulation, ethyl oleate, Tween 80 and PEG 400 were selected as oil phase, emulsifier and cosolvent, respectively, with the propor tion of 50. 0：35.0： 15.0. The content of flurbiprofen was fixed at 5.0 % w/w of the vehicle. CONCLUSION The in vitro dis solution of flurbiprofen from optimal SEDDS is faster observably than those of flurbiprofen tablets.