美洛昔康干混悬剂的制备及其处方因素考察

Preparation of Meloxicain dry suspension and study of its prescription quality

目的研究美洛昔康干混悬剂最佳处方及制备工艺。方法以沉降体积比、溶解情况、再分散性为指标,分别考察五种助悬剂对干混悬剂质量的影响;以沉降体积比为指标,正交试验筛选最佳处方。结果选择HPMC(E50)为助悬剂;最佳处方为:美洛昔康0.75%、HPMC(E50)0.8%、SDS0.5%、微粉硅胶0.5%,菠萝香精1%,蔗糖96.45%。结论制备出美洛昔康干混悬剂且质量符合《中国药典》(2010版)的相关要求。

Objective To optimize the preparation of Meloxicain dry suspension and to study its pre- scription quality. Methods The effects of different suspending agents in different proportions on the sedimentation volume ratios, dissolved condition and re - dispersible condition of the suspensions. The best prescription was investigated by orthogonal experiments to optimize the preparation technology. Results HPMC（E50） should be choose as suspending agent. The best prescription was Meloxicain 0.75%, HPMC （E50） 0.8 %, SDS 0.5 %, silica gel 0.5 %, pineapple scent 1%, sucrose 96.45 %. Conclusion The Meloxicain dry suspension is prepared and its quality meets the requirements of Chinese Pharmacopoeia on dry suspension.