CAJ | 학술논문

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,0.1 mol/L盐酸2 h药物释放量小于10%;在pH 6.8磷酸盐缓冲液中45 min药物释放度大于80%;有关物质含量小于2%.
고찰료각충보료여란색랍서지간적영향인소,사선출합괄보료,병채용단인소법우화란색랍서장용편적처방공예.결과표명,소연제적란색랍서장용편경고온、고습화강광영향인소화가속시험고찰,0.1 mol/L염산2 h약물석방량소우10%;재pH 6.8린산염완충액중45 min약물석방도대우80%;유관물질함량소우2%.
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 HCl 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%.