盐酸地芬尼多双层渗透泵片的制备及体外释放研究

发布时间：2018-07-03 08:28

本文选题：盐酸地芬尼多 + 双层渗透泵片　；参考：《中国药房》2017年13期

【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]:Aim: to prepare difenidol hydrochloride double-layer osmotic pump tablets and to study its release characteristics in vitro. Methods: Difenido hydrochloride bilayer osmotic pump tablets were prepared by double layer pressing technique and film coating process. The in vitro release of difenidol hydrochloride osmotic pump tablets was compared with that of ordinary difenidol hydrochloride tablets and difenidol hydrochloride osmotic pump tablets made by ourselves in vitro. Results: Difenido hydrochloride double-layer osmotic pump tablets were formulated as follows: difenido hydrochloride 75 mg sodium chloride 10 mg low molecular weight polyoxyethylene 15 mg 5% polyvinylpyrrolidone K30 alcohol solution. The booster layer consists of high molecular weight polyoxyethylene 60 mg, sodium chloride 20 mg, polyvinylpyrrolidone K306 mg and magnesium stearate proper amount. The cumulative release (Q) of the bilayer osmotic pump was 80 and the release was in accordance with the zero order kinetic equation, the Q15 min of Difenido hydrochloride ordinary tablet was 90 and the Q12 h of Difenido hydrochloride was only 51.14. Conclusion: Difenidol hydrochloride bilayer osmotic pump tablet has a sustained release effect and is more complete than that of single layer osmotic pump tablet in 12 h.
【作者单位】：南方医科大学药学院;广州军区武汉总医院药剂科;湖北中医药大学药学院;
【基金】：国家“十二五”重大新药创制科技重大专项经费资助课题(No.2013ZX09J13109-05C)
【分类号】：R943

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