美洛昔康口腔崩解片的质量考察

The Quality Evaluation of Meloxicam Orally Disintegrating Tablet

目的:对自制的美洛昔康口腔崩解片进行质量考察.方法:建立了考察崩解时限的方法并考察了相关影响因素.建立了溶出度测定方法,比较了自制美洛昔康口腔崩解片与市售普通片的溶出度.进行了人体适应度试验.结果:美洛昔康口腔崩解片崩解、溶出迅速,人体适应度良好.结论:自制的美洛昔康口腔崩解片质量良好.所建立的方法可用于口腔崩解片的质量控制.

Objective：To evaluate the quality of new compressed meloxicam tablet which can rapidly disinter grated in the oral cavity. Methods： The factors which influence disintegration were investigated. Methods for evaluation of disintegration,dissolution and acceptability were developed. In addition,dissolution of conventional and new rapidly-disintegrating meloxicam tablets were compared. Results; Disintegration and dissoulution of meloxicam rapidly-disintegrating tablet were quick. The tablet was acceptable to people. Conclusion： The quality of meloxieam rapidly-disintegrating tablet was satisfactory. The developed methods could be applied to the quality control of the new tablet rapidly disintegrating in the oral cavity.