克拉霉素缓释片的制备及药动学研究

Pharmaceutical study of extended-release clarithromycin

克拉霉素用水溶性羟丙甲纤维素等药用辅料制成缓释片 ,再包薄膜衣用于改善味觉和减小胃肠道副作用。药动学研究证明 ,该制剂与普通片相比具有统计学上显著较低的Cmax、相同的Cmin和AUC ;与美国AbbottLaboratories上市的Bianxing XL片生物等效。

Clarithromycin extended release tablets were prepared using water soluble HPMC and other pharmaceutically acceptable compositions. In order to improve taste profile of clarithromycin and reduce gastrointestinal side effects, the tablets were then coated with an aqueous coating. Pharmacokinetics study had proved that it induced statistically significant lower C max ? equivalent C min and AUC compared to immediate release tablets and maintained bioavailability substantially equivalent to Biaxin  XL marketed by Abbott Laboratories in USA.