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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 potassium clavulanate pellets were prepared by extrusion spheronization and then coated with Eudragit® L30D-55 and Eudragit® S100, respectively. The above three kinds of pellets released under different pH conditions are evenly mixed into the capsule shell to obtain a pulse capsule. And in vitro release studies. The effects of coating weight gain and the release of HPMC isolation layer on the in vitro release of pH-sensitive materials were investigated. The results showed that the prepared pulse capsule was pH-dependent pulse-release in pH 2.0, 6.0 and 7.8 phosphate buffer.