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引用本文:李娅,张霞,郑传莉,侯延辉,张立明.挤出滚圆-流化床包衣法制备决明子微丸的研究[J].中国现代应用药学,2011,28(11):1010-1013.
LI Ya, ZHANG Xia, ZHEN Chuanli, HOU Yanhui, ZHANG Liming.Study on the Preparation of Cassiac torae Pellets by Extrusion-Spheronization and Fluid Bed Coating Technology[J].Chin J Mod Appl Pharm(中国现代应用药学),2011,28(11):1010-1013.
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挤出滚圆-流化床包衣法制备决明子微丸的研究
李娅,张霞,郑传莉,侯延辉,张立明1,2
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
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。
关键词:  决明子微丸  挤出滚圆法  流化床包衣  溶出度
DOI:
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基金项目:宁夏回族自治区科技攻关项目(宁科计字[2009]232-15)
Study on the Preparation of Cassiac torae Pellets by Extrusion-Spheronization and Fluid Bed Coating Technology
LI Ya, ZHANG Xia, ZHEN Chuanli, HOU Yanhui, ZHANG Liming1,2
1.College of Pharmacy, Ning Xia Medical University, Yinchuan 750004, China;2.Affiliated Hospital Ning Xia Medical University, Yinchuan 750004, China
Abstract:
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.
Key words:  Cassiac torae pellets  extrusion-spheronization  fluid bed coating technology  dissolution in vitro
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