阿莫西林克拉维酸钾脉冲胶囊的制备

Preparation of Amoxicillin and Clavulanate Potassium Pulsatile Capsules

采用挤出滚圆法制备阿莫西林克拉维酸钾微丸,再分别以Eudragit?L30D-55和Eudragit?S100包衣。将上述3种在不同pH条件下释放的微丸按等比例混匀后装入囊壳,得脉冲胶囊。并进行了体外释放度研究。考察了包衣增重以及pH敏感型材料包衣后添加HPMC隔离层对体外释放度的影响。结果显示,制备的脉冲胶囊在pH 2.0、6.0和7.8的磷酸盐缓冲液中,呈pH依赖型的脉冲释药。

Amoxicillin and clavulanate potassium pellets were prepared by extrude-spheronization method.The pH-dependent pulsatile capsules were prepared by the above pellets uncoated,Eudragit? L30D-55 coated pellets and Eudragit S100 coated pellets with the ratio of 1∶1∶1.The in vitro release of pH dependent pulsatile capsules was discussed.The effects of coating level and HPMC insulation layer on in vitro released were performed.The pulsatile capsules exhibited an excellent pH dependent release profile in pH 2.0,pH 6.0 and pH 7.8 phosphate buffer solution.