液相层积法制备兰索拉唑肠溶微丸的工艺研究  

Preparation of lansoprazole enteric coated pellets by liquid phase layering

作　　者：李镇[1] 丁平田[1] 郝堂娜[1] 陈黎赟[1] 

机构地区：[1]沈阳药科大学药学院

出　　处：《中国药剂学杂志（网络版）》2008年第4期133-140,共8页Chinese Journal of Pharmaceutics：Online Edition

摘　　要：目的制备兰索拉唑肠溶微丸并考察其体外释放。方法采用流化床包衣技术制备兰索拉唑的载药微丸,采用L9(34)正交实验设计优化上药工艺参数;以OPADRY(YS-1-7006)、EudragitL30D-55为包衣材料,考察不同包衣质量增加对药物释放的影响。结果制得的微丸表面光滑,圆整度高,在人工胃液中耐酸性好,人工肠液中释放迅速,释放度可以达到90%以上。结论该制备工艺简单易行,可以用来制备兰索拉唑肠溶微丸,有望实现工业化。Objective To prepare lansoprazole enteric coated pellets and investigate in vitro drug release.Method Lansoprazole pellets were prepared by liquid phase layering method with a fluidized bed equipment,the optimal processing parameters were obtained by orthogonal experiment design.Thereafter the lansoprazole pellets were coated with OPADRY(YS-1-7006)and Eudragit L30D-55,and effects of coating level on drug release characteristics was studied.Result The optimized enteric-coated pellets was spherical with smooth surface and the pellets were acid resistant.In contrast,drug release in artificial intestinal liquid was rapid and complete.Conclusion The preparation procedure is simple and feasible,which is easy to be scaled up.

关 键 词：药剂学 肠溶微丸 液相层积法 兰索拉唑 流化床 药物释放 

分 类 号：TQ463[化学工程—制药化工]