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盐酸伊托必利胃漂浮延迟缓释片的研制

Preparation of itopride hydrochloride intragastric floating delayed-onset sustained-release tablets

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【作者】 金岩; 李嫄; 段旭;

【Author】 JIN Yan,LI Yuan,DUAN Xu(Department of Pharmacy,Shengjing Hospital of China Medical University,Shenyang 110004,China)

【机构】 中国医科大学附属盛京医院药剂科;

【摘要】 目的:筛选盐酸伊托必利胃漂浮延迟缓释片的处方,并评价其漂浮和体外释放特性。方法:单因素考察对片剂处方进行筛选与优化,制备盐酸伊托必利胃漂浮缓释片,测定其体外释药与漂浮特性。在单因素考察的基础上通过正交设计试验确定了最优处方。结果:优选的处方为每片含HPMC K100M为100mg,碳酸氢钠为150 mg,羧甲基淀粉钠100 mg。该片剂能在3 min内起漂,持续漂浮时间达8 h以上,12 h累计释放达90%,符合零级方程。结论:该片剂具漂浮、缓释作用,制备工艺简单。

【Abstract】 Objective:To optimize the formula of itopride hydrochloride intragastric floating delayed-onset sustained-release tablets and to evaluate its buoyant and drug release property in vitro.Methods:Monofactorial experiment was used to select the optimal formula of the tablet.The buoyant and drug release property in vitro were also observed.The optimum formulation of the tablet was chosen based on an orthogonal experiment.Results:The optimal formula included HPMC K100M 100 mg,NaHCO3 150 mg,CMC-Na 100 mg.The tablets began to float in 3 min,and floating time was over 8 h.The drug was delayed to release in vitro over 12 h.Conclusion:The tablet has a floating and sustained-release effect,and the preparation is simple.

  • 【文献出处】 中国新药杂志 ,Chinese Journal of New Drugs , 编辑部邮箱 ,2009年07期
  • 【分类号】R943.41
  • 【被引频次】7
  • 【下载频次】257
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