琥珀酸美托洛尔缓释片的制备及体外释放度考察

Preparation and in vivo release comparation of Metoprolol Succinate Extended-release Tablets

目的制备与倍他乐克释放行为一致的琥珀酸美托洛尔缓释片。方法采用正交试验优化琥珀酸美托洛尔缓释片的处方工艺,通过高效液相色谱法测定体外释放度,并考察处方工艺的重复性,并与市售片进行F2相似因子比较。结果自制片3批次各取样点释放度的SD值均小于2%,F2值分别为92.6、91.5、87.2。结论本处方工艺稳定且释放行为与市售片相似。

Objective To prepare Metoprolol Succinate Extended-release Tablets that release profile is similar with Betaloc. MetHods Using orthogonal test to optimize the prescription of Metoprolol Succinate Extended-release Tablets;Drawing the in-vitro release profile by HPLC,and calculating the value of F2 . Results The SD value of each sampling time of the three batches was less than 2%,the values of F2 were 92. 6,91. 5,87. 2,respectively. CoNclusioN The results showed that the prescription was stability and release profile was similar to the commercially available tablets.