阿奇霉素分散片的人体相对生物利用度

10名健康男性受试者 ,分别单次空腹口服两种国产阿奇霉素分散片 5 0 0mg后 ,测定不同时间血中阿奇霉素的浓度 ,绘制了血药浓度 时间曲线 .结果表明 :两种制剂中阿奇霉素的药物动力学过程均符合二室模型 ,阿奇霉素分散片 (被试制剂 )的Cmax=(0 6 5± 0 18) μg/mL ;tmax=(1 80±0 79)h ;t1/ 2 (ke) =(0 5 6± 0 39)h ;AUC0～∞ =(9 6 9± 1 6 6 ) μg/mL·h .阿奇霉素分散片 (参比制剂 )的Cmax=(0 6 4± 0 2 1) μg/mL ;tmax=(1 80± 0 6 3)h ;t1/ 2 (ke) =(0 48± 0 2 9)h ;AUC0～∞ =(9 5 2± 2 0 8)μg/mL·h .比较两种制剂动力学参数 ,两种制剂间阿奇霉素的Cmax、tmax和AUC0→∞ 均无显著差异 ,P>0 0 5 .阿奇霉素分散片的平均相对生物利用度为 (10 3 38± 12 94) % ,根据双单侧检验可以认为两种制剂在人体内具有生物等效性

A Study on Bioavailability of Azithromycin Dispersive Tablets in Healthy Volunteers

To study the pharmacokinetics and relative bioavailability of azithromycin dispersive tablets, the bioavailabilities of the tablets were studied in 10 normal male volunteers.A dose of 500 mg of azithromycin dispersive tablets was given according to a crossover design. The concentrations in plasma were determind by microbiological analysis.The concentration time curves of azithromycin dispersive tablets fitted to a two compartment open model. t max were(1 80±0 79)and(1 80±0 63)h; C max were(0 65± 0 18)μg/mL and(0 64±0 21)μg/mL;The AUC were(9 69±1 66)and(9 52± 2 08)μg/mL·h respectively. The pharmacokinetic parameters obtained from the study showed no significant difference between the two products ( P >0 05).The relative bioavailability of azithromycin dispersive tablets were(103 38± 12 94)% . According to the two one sided t tests, the two formulations were bioequivalent.