离心造粒法制备罗红霉素缓释小丸

Preparation of Sustained-release Pellets of Roxithromycin Using Centrifugal Granulation Method

目的:制备罗红霉素缓释小丸,并对其体外释药情况进行研究。方法:采用离心造粒技术制备微晶纤维素空白丸核和罗红霉素含药丸芯,以聚丙烯酸树脂Eudragit NE30D为包衣液制成膜控缓释小丸,考察包衣增重、致孔剂用量等因素对缓释小丸释放度的影响。结果:通过单因素考察确定了包衣液处方,所制备的小丸具有明显的缓释特征,体外释药过程符合一级动力学模型。结论:制备的罗红霉素缓释小丸符合12 h缓释要求。

Objective： To prepare roxithromyein sustained-release pellets and investigate the drug release mechanism in vitro. Method： Roxithromycin pellets were prepared by means of powder layering with the centrifugal granulation equipment. Roxithromycin pellets were coated in the same equipment with Eudragit NE30D as coating material. The effects of the coating level and the amount of pore-forming agent on the drug release rate from the sustained-release pellets were studied. Result： The formulation of coating material was determined under single-factor investigation. The coated pellets had a remarkable sustained-release property, the drug release profile in vitro followed first order kinetics. Conclusion： The prepared pellets meet the release standard of 12 h sustained release formulation.