光纤传感在线监测格列齐特缓释片的释放度

On-line analysis with fiber-optical sensor on dissolution rate of glicalzide sustained-release tablets

目的利用六通道光纤药物溶出度测定仪,建立一种光纤实时在线监测格列齐特缓释片体外释放度的方法。方法分别采用FODT-601型光纤药物溶出度实时监测仪和2005年版中国药典的紫外分光光度法在226 nm波长处测定格列齐特缓释片的释放度。结果方法回收率为98.9%100.8%,2种测定方法之间差异无显著性（P〉0.05）。格列齐特缓释片的释药曲线可用Peppas方程拟合,释药机制为非Fickian扩散。结论光纤药物溶出度过程监测法能有效地测定缓释制剂的体外释放度,并能真实地反映药物释放的全过程,可替代繁琐的传统方法。

Objective To establish an on-line analysis method for the release rate of glicalzide sustained-release tablets by six channels fiber-optical chemical sensor dissolution test（FOCSDT） system.Methods The drug dissolution concentration was detected respectively using the FOCSDT system and UV（CHP 2005） in 226 nm respectively.Results The recoveries of glicalzide was 98.9%～100.8%,and the parameters obtained by FOCSDT had no significant difference compared with UV（P〉0.05）.The curve of drug release was fitted with the Peppas equation,and the release mechanism of the glicalzide sustained-release tablets was unfickian diffusion.Conclusion As an on-line analysis,real information about the release of drug can be obtained effectively by FOCSDT system,which can take the place of trivial convential methods.