兰索拉唑肠溶片处方工艺及质量研究

Preparation and Quality Evaluation of Lansoprazole Enteric-coated Tablets

考察了各种辅料与兰索拉唑之间的影响因素,筛选出合适辅料,并采用单因素法优化兰索拉唑肠溶片的处方工艺。结果表明,所研制的兰索拉唑肠溶片经高温、高湿和强光影响因素和加速试验考察,0.1mol/L盐酸2h药物释放量小于10%;在pH6.8磷酸盐缓冲液中45min药物释放度大于80%;有关物质含量小于2%。

The interactions between lansoprazole and several excipients were investigated to screen suitable excipients for lansoprazole enteric-coated tablets. The preparation was optimized by single factor design. The results of the influence factors （including high temperature, high humidity and strong light） test and accelerated test showed that the 2 h accumulative amount of the enteric-coated tablets in 0.1 mol/L HCI was below 10% while the 45 min accumulative amount was above 80 % in pH 6.8 phosphate buffer solution. The related substances of the enteric-coated tablets were below 2 %.