阿奇霉素分散片的研究

Study on the Dispersible Azithromycin Tablets

研究阿奇霉素分散片的分散性能和体内生物利用度测定。本品分散时间<3min(20℃水中),10min内溶出度>95％(标示量);相对生物利用度为99.73％,t_(max)为1.7±0.5 h,C_(max)为0.527±0.042μg/mL,本品满足英国药典分散片质量要求;与对照制剂比较AUC等效(P>0.05),但达峰时间提前,体现了分散片快速起效之特性。

To study on dispersible Azithromycin tablets. Methods: The dispersible property and bioavailability of the tablets were determined. Results: Less than three minutes of dispersible time of the tablets were determined in 20℃ water. More than 95% of the labled amount were dissolved in ten minutes in 37℃ water. The mean relative bioavailability of the tablets was 99.73% . Mean tmax and Cmax were 1.7±0.5h and 0.527±0.042)μg/ml respectively. Conclusion; The dispersible Azithromycin tablets have a good dispersible property and more rapid in effect.