雷贝拉唑钠肠溶胶囊处方研究及稳定性考察

目的：筛选雷贝拉唑钠肠溶胶囊处方进行并考察其稳定性。方法：采用挤出滚圆和流化床包衣工艺制备雷贝拉唑钠肠溶微丸,采用L₉(3₄)正交试验设计进行载药微丸处方优化,按选定的处方制备微丸,进行隔离层和肠溶层包衣,包衣后将微丸灌装胶囊,成10mg规格,对制备的胶囊进行加速试验确定其稳定性。结果：制备的雷贝拉唑钠肠溶胶囊含量,有关物质,释放度较好,加速条件下质量稳定,稳定性较好。 结论：本工艺简单可行,样品稳定性良好,可作为雷贝拉唑钠肠溶胶囊的制备工艺。

Preparation and stability of sodium rabeprazole enteric-coated capsules

Objective To study the preparation and stability of sodium rabeprazole enteric-coated capsules.Methods The extrusion-spheronization method and fluid-bed coating technology were used to prepare the sodium rabeprazole enteric-coated capsules.The L₉(3⁴)orthogonal experimental design method was used to optimize the preparation of the sodium rabeprazole pellets. The pellets were coated by an isolation layer and an enteric coating layer,and then capsuled as10 mg formulation. The accelerated test was used to establish the stability of the capsules. Results The prepared capsules showed good reproducibility between batches and good stability after the accelerated test.Conclusions The prepared capsules were feasible in technology,reproducible and reliable in quality and the method can be used for the preparation of sodium rabeprazole enteric-coated capsules.