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挤出滚圆法制备吲哚美辛缓释微丸
引用本文:宦娣,易涛,刘颖,肖璐,何吉奎,欧阳辉. 挤出滚圆法制备吲哚美辛缓释微丸[J]. 中国药房, 2011, 0(17): 1583-1586
作者姓名:宦娣  易涛  刘颖  肖璐  何吉奎  欧阳辉
作者单位:西南大学药学院;澳门科技大学澳门药物及健康应用研究所;西南大学动物科技学院;
基金项目:重庆市自然科学基金项目(2009BB5106); 重庆高校优秀成果转化资助项目(KJ08B06); 西南大学博士基金项目(SWUB2008032)
摘    要:目的:制备吲哚美辛(IMC)缓释微丸并考察其体外释放行为。方法:采用挤出滚圆法制备微丸,以微丸收率为考察指标,优选挤出速率、滚圆速度和滚圆时间参数水平;以体外释药曲线为考察指标,崩解剂微晶纤维素(MCC)、骨架材料羟丙甲基纤维素(HPMC)和润湿剂水的处方用量为因素,设计单因素试验筛选辅料处方,并进行处方验证试验及其释药机制研究。结果:优选的较佳工艺参数为挤出速度65r.min-1、滚圆速度650r.min-1、滚圆时间3min;优选的处方为MCC19、HPMC20、水6mL;验证试验表明所制得的IMC缓释微丸释放度重现性好且符合缓释制剂的要求,其释药机制为药物扩散和骨架溶蚀的混合型机制。结论:挤出滚圆法制备IMC缓释微丸方法可行,且制剂具有良好的体外缓释效果。

关 键 词:吲哚美辛  挤出滚圆法  缓释微丸  制备  工艺参数  释药机制

Preparation of Indomethacin Sustained-release Pellets by Extrusion-spheronization Method
HUAN Di,YI Tao,LIU Ying,XIAO Lu,OUYANG Hui YI Tao HE Ji-kui. Preparation of Indomethacin Sustained-release Pellets by Extrusion-spheronization Method[J]. China Pharmacy, 2011, 0(17): 1583-1586
Authors:HUAN Di  YI Tao  LIU Ying  XIAO Lu  OUYANG Hui YI Tao HE Ji-kui
Affiliation:HUAN Di,YI Tao,LIU Ying,XIAO Lu,OUYANG Hui(College of Pharmaceutical Sciences,Southwest University,Chongqing 400715,China) YI Tao(Macau Institute for Medicine and Health Application Research,Macau University of Science and Technology,Macau,China) HE Ji-kui(College of Animal Science and Technology,China)
Abstract:OBJECTIVE:To prepare Indomethacin sustained-release pellets and to investigate drug release behavior of it in vitro.METHODS:The pellets were prepared by extrusion-spheronization method.The extrusion velocity,spheronization velocity and spheronization time were optimized with the field of pellets as index.The formula of excipients was optimized by single-factor experiment with drug release curves as index and the amount of MCC,HPMC and water as factors.The validation test of formula was conducted and drug re...
Keywords:Indomethacin  Extrusion-spheronization method  Sustained-release pellet  Preparation  Technology parameters  Drug release mechanism  
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