兰索拉唑双相释药微丸胶囊的制备

Preparation of lansoprazole biphasic release pellet capsules

目的 研究兰索拉唑双相释药微丸胶囊剂的制备方法。方法 采用离心造粒法制备兰索拉唑含药微丸,用流化床包衣法分别制备兰索拉唑肠溶微丸和肠溶脉冲微丸,然后将两种微丸按固定比例填充至空心胶囊内。用体外释放度法观察肠溶微丸累计释放量。结果 优化处方：载药丸心中碳酸镁用量15%,低取代羟丙纤维素（L-HPC）用量20%;肠溶微丸中隔离衣层增重9%~10%,肠溶衣层增重〉41%;肠溶脉冲微丸溶胀层包衣增重50%~60%,控释层包衣增重50%,肠溶衣层增重〉41%,后干燥时间为4 h。结论 以肠溶微丸技术制备兰索拉唑双相释药微丸胶囊,工艺可行,重复性良好,质量稳定可靠。

Objective To prepare lansoprazole biphasic release pellet capsules. Methods The pellets carrying lansoprazole were directly prepared by centrifugal making-pill method,and the pellets of enteric coating and enteric pulsatile coating were adopted by fluidized bed coating method. Then the two kinds of pellets were filled by a fixed proportion to hollow capsules. In vitro dissolution method was used for the observation of the drug release behavior. Results The optimized formulation was as follows：the magnesium carbonate level was 15%,the L-HPC level was 20% in pellets carried drug,the isolation gown level was 9%-10%,the enteric coating level was above 41% in enteric coated pellets,the swelling agent level was 50-60%,the controlled layer level was 50%,the enteric coating level was above 41% in pulsatile enteric coated pellets,and the drying time was 4 h in the end. Conclusion The method is feasible for preparation of lansoprazole biphasic release pellet capsules by encapsulating enteric-coated pellets,and able to obtain good repeatability and stable quality.