辛伐他汀肠黏附型脉冲片的制备工艺研究

Study on preparation of simvastatin intestinal adhesion pulsed tablets

为确定辛伐他汀肠黏附型脉冲片的制备工艺及最优工艺处方,通过单因素和正交试验,以时滞时间及累计释放度为考察因素,优化辛伐他汀肠黏附型脉冲片的最优工艺处方.结果表明,确定辛伐他汀肠黏附型脉冲片的最佳工艺处方为丙烯酸树脂与乙基纤维素比例为65∶35,15%的PEG6000,包衣增重7%.本实验所得处方重现型良好,通过对肠黏附性脉冲片片芯包衣使制剂达到了迟释的效果.

To determine the preparation process and optimal formulation of simvastatin intesti- nal adhesion pulsed tablets, the optimal formulation of simvastatin intestinal patch was opti- mized by single factor and orthogonal test, with time delay and cumulative release as the fac- tors. The results indicated that the optimal formulation of simvastatin intestinal adhesion pulsed tablets was that the ratio of acrylic resin to ethyl cellulose was 65 ： 35, 15% PEG6000, coating weight gain of 7%. The prescription reproducibility of this experiment was good, and the effect of late release was achieved by coating the intestinal adhesive pulsed core.