尼麦角林缓释片制备工艺研究

Study on Preparation Technology of Nicergoline Sustained Release Tablets

目的研究尼麦角林缓释片的制备工艺。方法以羟丙基甲基纤维素(HPMC)和聚乙二醇6000(PEG6000)为基本骨架材料,乳糖和微晶纤维素为稀释剂,采用湿法制粒制备尼麦角林缓释片。通过正交设计优化出尼麦角林缓释片的处方,按2005年版《中国药典(二部)》附录溶出度测定法第一法测其释放度。结果所制备的缓释片在12h内呈现良好的一级释放特征。结论通过正交设计优化的尼麦角林缓释片处方为最优处方,体外释放与进口的尼麦角林缓释片相比无显著性差异。

Objective To study the preparation method of Nicergoline Sustained Release Tablets.Methods With HPMC and PEG 6000 as the basic skeleton materials,lactose and microcrystalline cellulose as diluent,the wet granulation was used to prepare Nicergoline Sustained Release Tablets.The prescription of Nicergoline Sustained Release Tablets was optimized by orthogonal design.According to the first method of dissolution assays in the appendix of the Chinese Pharmacopoeia（2005 version）,the release was measured.Results The sustained release tablets prepared by this method showed the better first-order release characteristics within 12 h.Conclusion The prescription of Nicergoline Sustained Release Tablets optimized by orthogonal design is optimal,which in vitro release has no significant difference compared with the imported Nicergoline Sustained Release Tablets.