硝苯吡啶水凝胶型骨架片剂的研制

STUDIES ON HYDROPHILIC GEL MATRIX TABLET OF NIFEDIPINE

摘要: 根据水凝胶骨架释放机制,研制了硝苯吡啶溶蚀型骨架片剂A。其体外溶出行为符合一级动力学过程。体外环境如介质、桨速不影响其溶出行为。片剂A的体内血浓用气相色谱法测定,其体内配置状态以二室模型描述较为适宜,经计算机模型嵌合程序迭代处理求得动力学参数。生物等效性研究表明:片A与国外长效片B无显著差异,而与市售普通片C有显著差异。A相对于B和C的生物利用度分别为97.66%和281.80%。稳定性试验表明片剂A对光不稳定,温度、湿度对其基本无影响。薄膜包衣延缓了药物的光解。

Abstract: A nifedipine matrix tablet (A) was prepared by using hydrophilic polymer. The dissolution behaviors of nifedipine formulation were tested by the paddle method. It was found that the dissolution behavior of A was little affected by in vitro environment, i.