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.
出处
《中国现代应用药学》
CAS
CSCD
北大核心
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)
关键词
决明子微丸
挤出滚圆法
流化床包衣
溶出度
Cassiac torae pellets
extrusion-spheronization
fluid bed coating technology
dissolution in vitro
作者简介
李娅，女，存读研究生Tel：15296900112 E-mail：liya201206@163．com
通信作者：张立明，男，硕士，副教授Tel：（0951）6980188E—mail：nyzlm@163．com
