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盐酸二甲双胍胃漂浮片的制备及体外释放研究

Study on preparation of the metformin hydrochloride floating tablets and releasing character in vitro

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【作者】 夏清荣张维博李绪奇何红波姚日生

【Author】 XIA Qing-rong1,2,ZHANG Wei-bo1,LI Xu-qi1,et al(1.School of Medical Engineering,Hefei University of Technology,Hefei,Anhui 230009; 2.Hefei Fourth People’s Hospital,Hefei,Anhui 230022)

【机构】 合肥工业大学医学工程学院安徽省合肥市第四人民医院

【摘要】 目的探讨盐酸二甲双胍胃漂浮片的制备及体外释放。方法采用干法直接压片法,以羟丙甲纤维素为主要骨架材料,以十八醇和碳酸氢钠作助漂剂制备盐酸二甲双胍胃漂浮缓释片。对影响释药的因素如骨架材料、碳酸氢钠含量、释放介质等进行考察,并在此基础上采用正交试验设计筛选出最优处方。结果片剂具有良好的漂浮特性,药物释放时间可达6 h以上。最优处方:每片含盐酸二甲双胍60 mg,HPMC 108 mg,十八醇10 mg,NaHCO35.2 mg,乙基纤维素14 mg,聚乙二醇(PEG6000)0.1mg。结论药物通过扩散和凝胶骨架溶蚀共同作用释放,释药曲线较好地符合单指数加Higuchi平方根律方程。

【Abstract】 Objective To explore the preparation of the metformin hydrochloride floating tablets and releasing character in vitro.Methods Metformin hydrochloride stomach floating sustained release tablets have been prepared by employing the dry powder of direct pressure method,with HPMC main skeleton materials,stearyl alcohol and NaHCO3 help-bleaching agent.This experiment investigates the influence of the drug release factors such as skeleton materials,NaHCO3 content,release medium.On that basis we use the orthogonal design to confirm the best prescription.Results They have a good floating characteristics and the drug release time can reach 6 h more.The best prescription:metformin hydrochloride 60 mg,HPMC 108 mg,stearyl alcohol 10 mg,NaHCO3 5.2 mg,ethyl cellulose 14 mg,polyethylene glycol(PEG6000) 0.1 mg.Conclusion The drug through the diffusion and gel skeleton dissolution common function release,drug release curve is suitable for single index and Higuchi square root law equation.

  • 【文献出处】 安徽医药 ,Anhui Medical and Pharmaceutical Journal , 编辑部邮箱 ,2012年06期
  • 【分类号】TQ463.2;R927
  • 【被引频次】11
  • 【下载频次】407
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