三七总皂苷肠溶微丸的制备及处方工艺优化  

Preparation and prescription of enteric coated pellets of panax notoginseng saponins pellets

作　　者：赖春花[1] 郑琴[1] 杨明[1] 胡鹏翼[1] 潘俊杰[1] 彭常春[1] 

机构地区：[1]江西中医学院现代中药制剂教育部重点实验室,江西南昌330004

出　　处：《中国中药杂志》2009年第11期1359-1363,共5页China Journal of Chinese Materia Medica

基　　金：国家"十一五"科技支撑计划项目(2006BAI09B08-01);江西省卫生厅中医药科研基金(2007A026)

摘　　要：目的:通过工艺优化,制备释放度符合肠溶制剂要求的三七总皂苷微丸。方法:采用挤出滚圆技术,首先制备三七总皂苷载药丸芯,然后采用流化床底喷包衣设备,以丙烯酸树脂类包衣材料Eudragit L30D-55对载药丸芯进行包衣并用中心复合设计优化肠溶包衣处方。结果:所得三七总皂苷肠溶微丸在人工胃液中2 h内累积释放百分数小于5%,在模拟人体胃肠道环境中3 h内累积释放85%以上。结论:制得的三七总皂苷肠溶微丸抗酸性好,具备较理想的肠溶特征,避免了三七总皂苷类成分在胃液中的降解。Objective： To prepare enteric coated pellets containing panax notoginseng saponins. Method： panax notoginseng saponins loaded pellets were prepared by Extrusion-Spheronization method, and coated by Eudragit L30D-55 using Glatt fluid bed with the bottom spray process, central composite design was used to optimize the coating prescription. Result： The drug release of enteric coated pellets of panax notoginseng saponins pellets would be lower than 5% in 2 h in simulated gastric fluid, but reach above 85% in 3 h in simulated human gastroenterie environment. Conclusion： The enteric coated pellets of panax notoginseng saponins have good acid residence to avoid panax notoginseng saponins from degrading in gastric acid.

关 键 词：三七总皂苷 肠溶微丸 丙烯酸树脂 中心复合设计 

分 类 号：TQ461[化学工程—制药化工]