盐酸地芬尼多双层渗透泵片的制备及体外释放研究-中国药房

盐酸地芬尼多双层渗透泵片的制备及体外释放研究

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篇名：	盐酸地芬尼多双层渗透泵片的制备及体外释放研究
TITLE：
摘要：	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K30 6 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。
ABSTRACT：	OBJECTIVE： To prepare Diphenidol hydrochloride double-layer osmotic pump tablets， and study its in vitro release characteristics. METHODS： Double-layer compressing technique and film coating technology were conducted to prepare Diphenidol hydrochloride double-layer osmotic pump tablets. The in vitro releases of it， Difenidol hydrochloride tablets in market， self-made Difenidol hydrochloride single-layer osmotic pump tablets were compared. RESULTS： The formulation was as follow as diphenidol hydrochloride 75 mg， sodium chloride 10 mg， low-molecular-weight polyoxyethylene 15 mg and right amounts of 5％ PVP K30 ethanol solution. Booster layer was high-molecular-weight polyoxyethylene 60 mg， sodium chloride 20 mg， PVP K30 6 mg， right amounts of magnesium stearate. 12 h cumulative release （Q） of prepared double-layer osmotic pump tablets reached 80％， and the release was in line with zero-order kinetic equation. Q15 min of Difenidol hydrochloride tablets had reached 90％； Q12 h of Difenidol hydrochloride single-layer osmotic pump tablets was only 51.14％. CONCLUSIONS： The prepared Difenidol hydrochloride double-layer osmotic pump tablets have sustained release effect， with more complete drug release within 12 h than single-layer one.
期刊：	2017年第28卷第13期
作者：	朱兰琼，刘辉，廖诗琴，段婷
AUTHORS：	ZHU Lanqiong，LIU Hui，LIAO Shiqin，DUAN Ting
关键字：	盐酸地芬尼多；双层渗透泵片；制备；处方；累积释放度
KEYWORDS：	Diphenidol hydrochloride； Double-layer osmotic pump tablets； Preparation； Formulation； Cumulative release
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本月下载数：	10 次

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