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8 名健康男性志愿者交叉单剂量口服500 m g 阿奇霉素分散片及片剂,采用微生物法测定不同时间的血药浓度,求得分散片和普通片的药物动力学参数分别如下:ka 为1.28±0.23、1.21±0.18 h- 1;t1/2((β)为46.27±8.16、49.81±8.82 h;Cm ax 为0.62±0.11、0.58±0.11 μg/m l;Tm ax 为1.73±0.15、1.82±0.15 h;AUC为10.16±2.35、10.65±3.43 μg·h/m l。经统计学处理,两制剂的ka、Cm ax、Tmax、t1/2(β)均无显著性差异(P> 0.05)。分散片相对生物利用度F为95.09±4.98% 。经方差分析、配对t检验,均得出两制剂具有生物等效性的结论。
Eight healthy male volunteers were given a crossover single oral dose of 500 mg azithromycin dispersible tablets and tablets. The plasma concentrations of different concentrations of azithromycin tablets were determined by the microbiological method. The pharmacokinetic parameters of the dispersible tablets and ordinary tablets were as follows: ka = 1. 28 ± 0.23,1.21 ± 0.18 h-1; t1 / 2 ((β) 46.27 ± 8.16,49.81 ± 8.82 h; Cm ax was 0.62 ± 0 .11,0.58 ± 0.11 μg / m l; Tm ax was 1.73 ± 0.15 and 1.82 ± 0.15 h; AUC was 10.16 ± 2.35 and 10.65 ± 3 .43 μg · h / m l. There was no significant difference in ka, Cm ax, Tmax and t1 / 2 (β) between the two preparations (P> 0.05) Was 95.09 ± 4.98% .Analysis of variance and paired t-test showed that the two preparations were bioequivalent.