克拉霉素缓释片在不同释放介质中的释放度研究

Dissolution of clarithromycin sustained release tablets in different media

目的研究自制与市售克拉霉素缓释片在不同释放介质中的释放度,分析其在体外的释放行为。方法参考中国药典和美国药典两种释放度的方法,用HPLC测定自制与市售克拉霉素缓释片释放度,并对其释放模型和f2相似因子进行比较。结果以BIAXIN-XL为参比制剂,自制缓释片在两种释放条件下,f2值均大于50;以KLACID MR为参比制剂,自制缓释片在两种释放条件下,f2值均小于50。结论自制缓释片与市售的BIAXIN-XL的体外释放行为相似。

Objective To study the dissolution of clarithromycin sustained release tablets in different media and analyze their dissolution behavior in vitro. Methods Comparison of CHP2005 and USP31 two different dissolution methods, the dissolution of self-prepared and imported clarithromycin sustained release tablets were determined by HPLC, their kinetics model and similarity factor （f2 value） were compared. Results BIAXIN-XL was used as reference preparation, f2 value of self-prepared sustained release tablets was more than 50 in two different dissolution conditions. When KLACID MR was used as reference preparation, f2 value was less than 50 in two different dissolution conditions. Conclusion The dissolution behavior of BIAXIN-XL of self-prepared and imported clarithromycin sustained release tablets was consistent in vitro.