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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 investigate and optimize the process conditions of extrusion-spheronization-fluidized bed coating method for preparation of cassia seed alcohol pellets. Methods The optimum preparation conditions of L9 (34) orthogonal design were used to prepare the microspheres of cassia seed extract. The powder properties of the pellets were investigated. The pellets were coated with a fluidized granulation coating machine and the dissolution rate in vitro was determined. Results MCC as the main excipients, drug loading 40%, extrusion frequency of 30 Hz, spheronization frequency of 50 Hz, spheronization time 4 min, the fluidized bed coating made of cassia seed alcohol pellets, roundness, flow Sexual, in vitro release are more ideal. Conclusion The preparation of extrusion-spheronization - fluidized bed coating method cassia seed alcohol pellets, the process is simple, the finished product of good quality.