单硝酸异山梨酯缓释胶囊处方工艺研究

Study on the Formulation and Technology of Isosorbide Mononitrate Sustained-Release Capsules

目的:研究单硝酸异山梨酯胶囊的处方工艺。方法:采用挤出滚圆机制备单硝酸异山梨酯含药丸芯,采用包衣机进行缓释包衣,将丸芯填充入空心胶囊壳中。测定缓释胶囊体外释放度,考察丸芯制备参数、包衣材料和包衣增重对释放度的影响。结果:缓释包衣材料选择乙基纤维素,包衣增重8%释放效果最好。筛选出微丸最佳制备条件:挤出速度15 r/min,滚圆时间5 min,滚圆速度400 r/min。最优条件下,缓释胶囊释放效果批间重复性较好。结论:该处方条件下,单硝酸异山梨酯缓释胶囊的工艺简单可行,重现性好,缓释效果良好。

Objective:To study the formulation and technology of isosorbide mononitrate capsules.Method:Use an extrusion spheronizer to prepare isosorbide mononitrate-containing pellet cores,use a coating machine for slow-release coating,and fill the pellet cores into hollow capsule shells.The in vitro release rate of sustained-release capsules was determined,and the effects of pellet core preparation parameters,coating materials and coating weight gain on the release rate were investigated.Results:Ethyl cellulose was selected as the slow-release coating material,and the coating weight gain 8%had the best release effect.The best pellet preparation conditions were selected:extrusion speed 15 r·min^(-1),spheronization time 5 min,spheronization speed 400 r·min^(-1).Under the optimal conditions,the release effect of sustained-release capsules has good inter-batch reproducibility.Conclusion:Under the conditions of this prescription,the process of isosorbide mononitrate sustained-release capsules is simple and feasible,with good reproducibility,and achieves a better sustained-release effect.