尼可地尔缓释骨架片的制备

Preparation of nicorandil sustained release matrix tablets

目的制备尼可地尔缓释骨架片。方法采用亲水性高分子材料HPMC为骨架,制备尼可地尔缓释片,并用单因素试验考察其释药特征。正交试验优化处方工艺。结果以60%HPMC K100M为骨架材料,磷酸氢钙为填充剂,用10%PVP的乙醇溶液为黏合剂,湿法制粒压片为最佳工艺。结论本品制备工艺简便,药物体外释放接近Higuchi模型,能实现药物24 h内缓慢释放。

Objective To prepare nicorandil sustained release matrix tablets. Methods The tablets were prepared by water soluble HPMC matrix, and the release behaviors were investigated by single factor study. The formulation and preparation procedure were optimized by orthogonal design. Results The optimal technology was as follows： 60%HPMC K100 M was used as the matrix material, calcium hydrogen phosphate as the filler, and 10% PVP of alcohol as the bonding agent to prepare nicorandil sustained release matrix tablets by the wet granule compression technique. Conclusion The release in vitro of the drug accords with Higuchi equation. This preparation technol ogy is simple and drug releases within 24 h.