论文部分内容阅读
目的:探讨制备氧化苦参碱缓释微丸的影响因素。方法:以挤出滚圆法制备含药丸芯,采用流化床包衣法,分别以HPMC E5及Eudragit RS 30D作为隔离层及控释层的包衣材料进行包衣,考察隔离层包衣增重,控释层增塑剂的种类、用量,以及包衣增重对微丸释放行为的影响。结果:优选出以2%的HPMC E5作为隔离层包衣液,并加入0.2%的PEG400作为增塑剂,隔离层包衣增重10%;控释层包衣处方为Eudragit RS 30D6%,滑石粉2%,增塑剂邻苯二甲酸二丁酯(DBP)2%,水90%,包衣增重10%。所制备的氧化苦参碱缓释微丸与普通微丸相比,表现出明显的缓释行为。结论:该工艺处方所制备的氧化苦参碱缓释微丸具有良好的缓释特性。
Objective: To explore the influencing factors of preparing oxymatrine sustained-release pellets. Methods: Pellets were prepared by extrusion-spheronization method. The fluidized bed coating method was used to coat HPMC E5 and Eudragit RS 30D respectively as the coating material of the release layer and the controlled release layer. The weight gain of the coating , The type and amount of controlled release plasticizer, and the effect of coating weight gain on the release behavior of pellets. Results: 2% HPMC E5 was selected as the coating solution of the barrier layer, 0.2% PEG400 was added as the plasticizer and the coating weight gain was 10%. The controlled release coating was formulated with Eudragit RS 30D6%, talc Powder 2%, plasticizer dibutyl phthalate (DBP) 2%, water 90%, coating weight gain 10%. The prepared oxymatrine sustained-release pellets showed obvious slow-release behaviors compared with ordinary pellets. Conclusion: Oxymatrine sustained-release pellets prepared by the process prescription have good sustained-release properties.