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12名健康志愿者随机自身交叉单剂量口服阿奇霉素分散片和阿奇霉素片进行生物利用度研究,用微生物杯碟法测定血清中阿奇霉素浓度。结果表明阿奇霉素两种制剂的体内药时数据符合二室模型,Cmax分别为0.34和0.36μg/ml;tp为1.97和1.90h;t为44.81和42.96h;AUC(0~168)为7.49和7.47mg·h·L-1。阿奇霉素分散片相对生物利用度为101.74±14.56%,表明阿奇霉素分散片与阿奇霉素片具有生物等效性。
Twelve healthy volunteers were randomized to cross oral single doses of azithromycin dispersible tablets and azithromycin tablets bioavailability studies using the method of microbial plate cup azithromycin serum concentration. The results showed that the in vivo pharmacokinetic data of the two preparations of azithromycin accord with the two-compartment model with Cmax of 0.34 and 0.36 μg / ml respectively; tp of 1.97 and 1.90 h; t of 44.81 and 42.96 h; AUC (0 ~ 168) of 7.49 and 7.47 mg · h · L-1. The relative bioavailability of azithromycin dispersible tablets was 101.74 ± 14.56%, indicating that azithromycin dispersible tablets and azithromycin tablets have bioequivalence.