挤出滚圆-流化床包衣法制备决明子微丸的研究  

Study on the Preparation of Cassiac torae Pellets by Extrusion-Spheronization and Fluid Bed Coating Technology

作　　者：李娅[1] 张霞[1] 郑传莉[2] 侯延辉[1] 张立明[1] 

机构地区：[1]宁夏医科大学药学院宁夏回药现代化工程技术研究中心,银川750004 [2]宁夏医科大学附属医院药剂科,银川750004

出　　处：《中国现代应用药学》2011年第11期1010-1013,共4页Chinese Journal of Modern Applied Pharmacy

基　　金：宁夏回族自治区科技攻关项目(宁科计字[2009]232-15)

摘　　要：目的考察并优化挤出滚圆-流化床包衣法制备决明子醇提物微丸的工艺条件。方法采用L9(34)正交设计实验优化制剂工艺条件制备决明子醇提物微丸,考察微丸的粉体学性质,流化制粒包衣机将微丸包衣,并测定体外溶出度。结果以MCC为主要辅料,载药量40%,挤出频率30 Hz,滚圆频率50 Hz,滚圆时间4 min,经流化床包衣制得的决明子醇提物微丸,圆整度、流动性、体外释放度均较理想。结论应用挤出滚圆-流化床包衣法制备决明子醇提物微丸,其工艺简便,成品质量好。OBJECTIVE To optimize the process conditions of Cassiac torae pellets by extrusion-spheronization and fluid bed coating technology.METHODS L9（34）orthogonal design was used to obtain optimal process conditions of Cassiac torae pellets by extrusion-spheronization technology.Micromeritics of the pellets was determined.The pellets were coated by fluid bed coating technology.Their dissolution profiles were tested in vitro.RESULTS The optimal formulation and process condition of Cassiac torae pellets prepared by extrusion-spheronization were as follows： MCC as the main excipient,40% drug loading,spheronization velocity being 50 Hz;spheronization time being 4 minutes,extrusion velocity being 30 Hz.The obtained pellets were round,smooth and even.The cummulative drug release in vitro was more than 99% within 60 minutes.CONCLUSION The process of preparing Cassiac torae pellets by extrusion-spheronization and fluid bed coating machines was simple and quick with excellent quality and yield of pellets.

关 键 词：决明子微丸 挤出滚圆法 流化床包衣 溶出度 

分 类 号：R283.6[医药卫生—中药学]