氟比洛芬分散片的制备及质量控制

目的 制备氟比洛芬分散片以提高其崩解和溶出性能，并建立质量控制标准。方法 通过崩解剂、表面活性剂的考察和正交设计筛选出最佳处方：崩解剂CMS—Na的用量为7％，加入方法为内加和外加相结合，十二烷基硫酸钠(SDS)用量为1％。紫外分光光度法测定片剂含量。结果 优选处方的分散片崩解时间小于1min，分散均匀，通过2号筛网；体外溶出试验表明：分散片15min即可完全溶出，远快于普通片剂。结论 本设计的氟比洛芬分散片符合中国药典要求，制备工艺简单，有较好的应用前景。

Preparation and Quality Control of Flurbiprofen Dispersible Tablet

Aim To prepare flurbiprofen dispersible tablet for the elevation of disintergration and dissolution properties Methods After factor inspect of disintergration agent and surfactant,orthogonal design was used to optimize the formulation:CMS-Na and SDS were selected as disintergrating agent and surfactant,with the amount of 7%,1% in the formultion,respectively.Result The optimized dispersible tablet can disintergrate in 1 min and screen through No.2 screen.It can dissolute thoroughly in 15min, which is much faster than normal market tablet.Conclusion The quality of the dispersible tablet conforms to the standard of CHP2000 and the formulation is simple for the industry application.