盐酸地芬尼多双层渗透泵片的制备及体外释放研究

China Pharmacy(2017)

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Abstract
目的:制备盐酸地芬尼多双层渗透泵片并研究其体外释放特性.方法:采用双层压片技术和薄膜包衣工艺制备盐酸地芬尼多双层渗透泵片,比较其与市售盐酸地芬尼多普通片、自制盐酸地芬尼多单层渗透泵片的体外释放度.结果:盐酸地芬尼多双层渗透泵片处方为盐酸地芬尼多75 mg、氯化钠10 mg、低分子量聚氧乙烯15 mg、5%聚乙烯吡咯烷酮K30乙醇溶液适量;助推层为高分子量聚氧乙烯60 mg、氯化钠20 mg、聚乙烯吡咯烷酮K306 mg、硬脂酸镁适量.所制双层渗透泵片12 h累积释放度(Q)达80%,且释放符合零级动力学方程;盐酸地芬尼多普通片的Q15 min达90%,盐酸地芬尼多单层渗透泵片的Q12 h仅为51.14%.结论:所制盐酸地芬尼多双层渗透泵片具有缓释作用,且较单层渗透泵片12 h内释药更完全.
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Key words
Diphenidol hydrochloride,Double-layer osmotic pump tablets,Preparation,Formulation,Cumulative release
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