洛伐烟酸双层缓释片的制备及释放度考察

Investigation of preparation and release in vitro of double-layer sustained-release lovastatin and niacin tablets

目的分别采用进口与国产羟丙基甲基纤维素 (HPMC)作为骨架材料制备洛伐烟酸缓释双层片 ,并比较国内外HPMC的缓释作用。方法用紫外分光光度法测定该制剂缓释层中烟酸的释放度 ,并用相似因子法和Chow′s法对溶出试验数据进行统计分析。结果使用国产HPMC制得的缓释片及进口HPMC制得的缓释片与国外市售片Niaspan的释放行为完全相似 ,相似因子分别为F2 =87 6和F2 =89 2 (5 0≤F2 ≤ 10 0 )。结论缓释片处方设计合理 ,工艺简单 。

Objective To prepare the lovastatin and niacin sustained-release double-layer tablets and compare the sustained-release action of the abroad and homemade HPMC.Methods The release of the niacin in the formulation was determined by the UV method.The stat analyze was studied by the resemble gene method and Chow's method.Results The release action of the self-regulated tablet with homemade HPMC and Niaspan with the abroad HPMC is completely similar.The resemble genes are that F 2=87.6 and F 2=89.2 (50≤F 2≤100).Conclusions The sustained-release tablets are with reason and process is simple and convenient.It is completely feasible that the homemade HPMC replace the abroad HPMC as gel matrix materials.