盐酸青藤碱肠溶缓释微丸的制备

摘要

Objective:To develop the sinomenine hydrochloride enteric-coated and sustained-release pellets.Methods:Sinomenine hydrochloride enteric-coated and sustained-release pellets were prepared with Eudragit NE30D,HPMC E5 and Eudragit L30D-55 coating by fluid-bed,then the dissolutions were detected at different coating levels.Results:The accumulative release of the prepared pellets in the artificial gastric juice after 2 hours was lower than 10％ and dissolved slowly in artificial intestinal liquid in 8 hours.Conclusion:This preparation processing is simple and feasible with good reproducibility.And it may be used in industrial production.%目的:制备盐酸青藤碱肠溶缓释微丸.方法:分别以Eudragit NE30D为缓释膜材,HPMC E5为隔离层膜材,Eudragit L30D-55为肠溶层膜材,采用流化床包衣法制备盐酸青藤碱肠溶缓释微丸,并考察缓释层、隔离层和肠溶层包衣增重对药物释放的影响.结果:制备的肠溶缓释微丸在人工胃液中释放度＜10％,人工肠液中缓慢释放8h.结论:该制备工艺简单易行,重现性好,有望应用于工业化生产.