尼美舒利缓释胶囊的研究

Preparation of Nimesulide Sustained-release Capsules

目的研究尼美舒利缓释胶囊的制备方法,筛选最佳制备工艺条件。方法采用淀粉和糊精为赋形剂制备尼美舒利含药微丸,乙基纤维素为包衣材料,采用悬浮包衣法制备了尼美舒利缓释微丸,用正交实验表的安排进行试验,并确定其最佳工艺条件,按优化后的结果选择实验条件进行重复实验,测定体外释放度以考察缓释效果。结果制备的缓释胶囊在12h内释药符合Higuchi模型动力学过程。结论按优化结果选择的制备工艺条件所制备的尼美舒利缓释胶囊其缓释效果好,达到设计要求。

Objective To investigate the preparation method of sustained-release nimesulide capsules. Methods The formulation of coating of nimesulide pellets was studied by orthogonal design with the drug accumulated release rate as the evaluation criterion. Using starch and dextrin as the excipients of the bead core with nimesulide and ethylcellulose as coating material, sustained-release pellets were prepared by suspension coating technology. Three batches of the optimum formulation were prepared, and the release profile of the sustained release drug delivery system containing nimesulide was determined in vitro. Results The result showed that the accumulated release of the nimesulide sustained release capsules complied with the Higuchi model. Conclusion The sustained-release nimesulide capsules prepared with the optimized preparation methods are up to standard and meet design specification with good sustained-release profile.