奥美拉唑肠溶片的乙醇诱导剂量倾泻试验

Alcohol-induced Dose Dumping Study of Omeprazole Enteric-coated Tablets

建立了紫外-可见(UV-Vis)光谱法测定奥美拉唑(1)肠溶片在乙醇浓度分别为0、5%、20%、40%的pH 1.2盐酸中的释放行为。结果显示,1在4种释放介质中线性关系良好(r=0.999 8、0.999 9、0.999 8、0.999 8);平均回收率(n=9)分别为100.12%、100.25%、100.37%、100.73%,RSD分别为0.25%、0.36%、0.73%、0.52%。参比制剂在乙醇浓度为20%的pH 1.2盐酸中开始出现倾泻现象,参比制剂与自制制剂均在乙醇浓度为40%的pH 1.2盐酸中出现倾泻现象。由此可见,乙醇能加速1肠溶片中1的释放,在高浓度乙醇的作用下,此现象更明显,为1的临床合理用药以及制剂的开发研究提供了参考。

An ultraviolet-visible(UV-Vis) spectroscopic method was established to determine the release behavior of omeprazole(1) enteric-coated tablets in pH 1.2 hydrochloric acid with different alcohol concentrations (0,5%,20%,and 40%).The results showed that it was linear for 1 in above four media(r=0.999 8,0.999 9,0.999 8,0.999 8).The average recoveries of 1(n=9) were 100.12%,100.25%,100.37%,100.73% respectively,with the RSDs of 0.25%,0.36%,0.73%,0.52%.The reference preparation began to pour in the pH 1.2 hydrochloric acid with an alcohol concentration of 20%,and the dumping appeared in the medium with 40% of alcohol for both the reference and the self-made preparations.It could be concluded that alcohol could accelerate the release of 1 from the title enteric-coated tablets.This phenomenon was more obvious under the action of high concentration of alcohol,which provided a reference for the formulation development and clinical rational use of 1 preparations.