盐酸沙格雷酯控释微丸的制备及其质量评价  

Preparation and Quality Evaluation of Sarpogrelate Hydrochloride Controlled-release Pellets

作　　者：陈超[1] 黄春玉 谢俊 周建平[1] 

机构地区：[1]中国药科大学药剂学教研室,南京210009 [2]南京金陵药业股份有限公司,南京210009

出　　处：《药学与临床研究》2012年第6期506-509,共4页Pharmaceutical and Clinical Research

摘　　要：目的:制备盐酸沙格雷酯控释微丸并对其质量进行评价。方法:采用挤出-滚圆工艺制备载药丸芯,以Eurdragit NE30D对丸芯进行流化床包衣,并对影响药物释放的主要因素,如包衣增重,衣膜老化条件等进行考察。结果:所制备的载药丸芯具有较好的圆整度、脆碎度、流动性等;包衣增重7%,50℃老化24 h条件下制得的控释微丸具有较理想的释放行为。结论:制备了适合流化床包衣的盐酸沙格雷酯载药丸芯,以尤特奇水分散体包衣得到了12 h控释微丸。Objective： To prepare sarpogrelate hydrochloride controlled-release pellets and evaluate their quality. Methods： Pellets containing sarpogrelate hydrochloride were produced via extrusion-spheronisation process with quality evaluated. The aqueous coating technique with fluidized bed was used to prepare the controlled-release pellets, with Eurdragit NE30D as the film materials. Factors affecting drug release, including coating weight gaining and film aging conditions, were investigated. Results： The prepared pellets with coating thickness of 7% and aged at 50℃ for 24 h had ideal controlled release and good characteristics. Conclusion： It is possible to prepare sarpogrelate hydrochloride controlled-release pellets by extrusion-spheronization and Eudragit NE30D coating.

关 键 词：盐酸沙格雷酯 控释 微丸 挤出滚圆 质量评价 

分 类 号：R944.9[医药卫生—药剂学]