烟酸缓释骨架片的制备及体外释放度考察

Preparation and in vitro release of Niacin sustained-release tablets

目的 :制备烟酸缓释骨架片并考察其体外释放度。方法 :以国外上市 Niaspan R○ 作为对照 ,考察了 4种型号的羟丙基甲基纤维素 (HPMC)对释放性能的影响 ,并比较了缓释片在水、0 .1mol/ L 盐酸及 p H6 .8磷酸盐缓冲液三种介质中的释放度。结果 :用 Higuchi方程拟合发现 ,自制片和对照片均具有典型的缓释性能 ,而且自制片和对照片的释放度没有差别。结论 :自制的烟酸缓释骨架片工艺简单易行 ,释放度亦符合要求。

Object: To prepare niacin sustained-release tablets and investigate in vitro release profile of the formulation. Methods: Matrix-based sustained-release niacin tablets were formulated using 4 kinds of HPMC with different viscosity. The effects of different dissolution media (water, 0.1 mol/L HCl and pH 6.8 phosphate buffer) on in vitro release were studied. Results: Our homemade niacin sustained-release tablets met the proposed standards for controlled-release products. Conclusions: The experimental formulation compared well with commercial product Niaspan(r).