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pH非依赖释放型法莫替丁缓释片的研制

Preparation of famotidine pH-independent sustained release tablets

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【作者】 孙天慧聂淑芳彭博刘嘉潘卫三赵光燃徐立元

【Author】 SUN Tian-hui1,NIE Shu-fang1,PENG Bo1,LIU Jia1,PAN Wei-san1,ZHAO Guang-ran2,XU Li-yuan2(1 School of Pharmacy,Shenyang Pharmaceutical University,Shenyang 110016,China;2 Fuxin Red-Crowned-Crane Pharmaceutical Co.,Ltd,Liaoning Fuxin 123000,China)

【机构】 沈阳药科大学药学院阜新市仙鹤制药有限责任公司

【摘要】 目的:制备pH非依赖释放型法莫替丁缓释片,使法莫替丁在体内的释放不因所处胃肠道不同区段的pH值不同而发生变化。方法:混合使用Eudragit S100与羟丙甲纤维素为缓释材料,以枸橼酸为pH缓冲剂,采用直接压片法制备了非pH依赖释放型法莫替丁缓释片。结果:单用HPMC为缓释材料,其体外释放呈pH依赖性;在处方中加入Eudragit S100和枸橼酸,能明显降低缓释片体外释放对pH的敏感性,且当HPMC-Eudragit S100-枸橼酸为一定比例混合使用时,缓释片呈体外pH非依赖性释放的特征。结论:在处方中加入Eudragit S100和枸橼酸,并采用合适的比例可以制备pH非依赖释放型缓释片。

【Abstract】 Objective: To prepare famotidine pH-independent sustained release tablets,with expect that drug release will not be influenced by the pH in different region of gastrointestinal tract.Methods: The famotidine sustained release tablets were prepared by direct powder compression method.HPMC and Eudragit S100 were used as a sustained release matrix material,and citric acid as a release-modifier.Results: The release of famotidine from sustained release tablets was pH-dependent when HPMC was used alone.The sensitivity of drug release to the pH value of dissolution medium was significantly decreased when Eudragit S100 and citric acid were incorporated into sustained-release tablets.Furthermore,the drug release rate was independent on pH when blending HPMC,Eudragit S100 and citric acid in a proper ratio.Conclusion: The famotidine pH-independent sustained release tablets can be prepared by adjusting the ratio of Eudragit S100 and citric acid to a proper point.

  • 【文献出处】 中国新药杂志 ,Chinese Journal of New Drugs , 编辑部邮箱 ,2009年09期
  • 【分类号】R943.41
  • 【被引频次】3
  • 【下载频次】179
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