沈阳药科大学学报

2011, v.28;No.181(02) 93-98

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盐酸普萘洛尔骨架型缓释微丸的制备及处方工艺优化
Preparation and optimization of propranolol hydrochloride matrix sustained-release pellets

庞茗之,刘强,董江南,聂淑芳,杨星钢,潘卫三
PANG Ming-zhi,LIU Qiang,DONG Jiang-nan,NIE Shu-fang,YANG Xing-gang,PAN Wei-san(School of Pharmacy

摘要(Abstract):

目的制备盐酸普萘洛尔骨架型缓释微丸,并对其体外释药情况进行研究。方法采用挤出-滚圆法制备盐酸普萘洛尔骨架型缓释微丸,研究工艺及处方因素对盐酸普萘洛尔骨架型缓释微丸的制备和释放度的影响,采用星点-效应面优化法确定最优处方。结果确定最优处方的质量分数及工艺参数为:乙基纤维素(EC)9.06%、十八醇(octadecanol)48.03%、微晶纤维素(MCC)22.91%、无水乙醇适量,挤出速度30 r.min-1、滚圆转速1 377 r.min-1、滚圆时间40 min。结论盐酸普萘洛尔骨架型缓释微丸体外释药缓慢、持续、平稳。
Objective To study the preparation of matrix sustained-release pellets containing propranolol hydrochloride and its evaluation in vitro. Methods The pellets were prepared by extrusion-spheronization,central composite design-response surface methodology was applied to optimize the formulation and manufacturing process,which was characterized by cumulative release. Results Optimized formulation and processing parameter were 9.06% EC,48.03% octadecanol,22.91% MCC,absolute ethyl alcohol as wetting agent,extruded at 30 r·min-1 and spheronized at 1 377 r·min-1 for 40 min. Conclusions Drug release of propranolol hydrochloride matrix sustained-release pellets in vitro is sustained and stable.

关键词(KeyWords): 盐酸普萘洛尔;骨架缓释微丸;星点设计;挤出滚圆法
propranolol hydrochloride;matrix sustained-release pellet;central composite design;extrusion-spheronization

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作者(Author): 庞茗之,刘强,董江南,聂淑芳,杨星钢,潘卫三
PANG Ming-zhi,LIU Qiang,DONG Jiang-nan,NIE Shu-fang,YANG Xing-gang,PAN Wei-san(School of Pharmacy

DOI: 10.14066/j.cnki.cn21-1349/r.2011.02.011

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