苯扎贝特分散片溶出度测定条件的研究

Study on the Conditions of Dissolution Determination for Bezafibrate Dispersible Tablets

目的:建立苯扎贝特分散片的溶出度测定条件。方法:采用正交试验法,以转速、取样时间、溶出介质pH为考察因素,采用高效液相色谱法测定含量,筛选出最佳溶出条件。结果:苯扎贝特分散片的最佳溶出条件为转速50 r·min^(-1),取样时间60 min,溶出介质pH为7.6。结论:本方法准确、可靠,可用于苯扎贝特分散片溶出度的测定。

Objective：To establish the conditions of dissolution determination for bezafibrate dispersible tablets.Method：Three factors including the rotating speed,sampling time and pH value of the dissolution medium were screened by orthogonal test,the content of bezafibrate was determined by HPLC.Result：The best dissolution conditions for bezafibrate dispersible tablets were as follows： the rotating speed of 50 r ？ min^（-1）,sample time of 60 min,and pH value of the dissolution medium of 7.6.Conclusion：The method is accurate,reliable and applicable in the dissolution determination of bezafibrate dispersible tablets.