奥美拉唑肠溶微丸胶囊的制备及质量考察

Preparation and quality inspection of Omeprazole Enteric-coated Pellets Capsules

目的制备奥美拉唑肠溶微丸胶囊。方法用离心制丸法直接制备载药母丸,再用流化床包衣法进行微丸包衣;采用正交试验设计对包衣液处方进行筛选优化,研究玉米朊在隔离层上的应用,采用新的肠溶层包衣处方。结果试验处方制得的奥美拉唑肠溶微丸稳定性好,酸性介质中2 h稳定性良好,耐酸力≥98%,p H 6.8缓冲液中释放达标,45 min体外释放度≥90%。结论采用药丸直接起母的方法简化了操作,降低了成本;选用玉米朊作为隔离层成膜材料,很好地提高了奥美拉唑的稳定性;在肠溶层中采用单硬脂酸甘油酯,既促进了微丸的体外释放,又增强了肠溶衣的稳定性。

objective To prepare omeprazole Enteric-coated Pellets Capsules. Methods Female pills of carried drug were directly prepared by centrifugal pill method,then pellets coating was adopted by fluidized bed coating method. The coating solution formulation was optimized by orthogonal design,to study the application of zein in isolation layer,and new enteric-coated prescription was used. Results The prepared omeprazole Enteric-coated Pellets had good stability,and good stability in acidic medium for 2 h. The acid strength≥98%,the release was up to the standard in buffer solution of pH 6. 8,and the vitro release for 45 min≥90%. Conclusion The method was simple and reduced costs. The stability of ome-prazole was raised with zein as the spacer layer forming material. Using glycerol monostearate in the enteric layer,not only promoted the release of the pellets in vitro,but also enhanced the stability of enteric coating.