辛伐他汀缓释片的制备工艺研究

摘要

Using simvastatin as bulk drug,to determine the preparation process and optimal process of simvastatin sustained release tablets.Through single factor analysis and orthogonal experiment to determine the sustained release tablets' best prescription process.The ratio of octadecanol to carbomer 934 was 3:1, the magnesium stearate was 1%, the hardness was 5~6 N.The prescription of the preparation was good, and the expected effect of the experi-mental scheme was reached.%以辛伐他汀为原料药,确定辛伐他汀缓释片的制备工艺及最优工艺处方.通过单因素考察和正交实验来确定缓释片的处方和工艺,以药物的释放度为指标,确定最佳处方工艺.十八醇与卡波姆934比例为3:1,硬脂酸镁用量为1%,硬度5~6 N.所得处方重现型良好,达到了实验方案的预期效果.