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10名健康男性受试者,分别单次空腹口服国产罗红霉素分散片和国产片剂300mg后,用不同时间血中罗红霉素的浓度绘制了血药浓度时间曲线.结果表明:两种制剂中罗红霉素的药物动力学过程均符合二室模型,Cmax(702±173)μg/mL和(647±12)μg/mL,Tmax为(105±034)h和(150±041)h,t1/2(ke)为(1585±212)h和(1407±207)h,AUC0→∞为(687±143)μg/mL·h和(656±148)μg/mL·h.比较两种制剂动力学参数,两种制剂间罗红霉素的Cmax和AUC0→∞均无显著差异,P>005.罗红霉素分散片的平均相对生物利用率为(1057±1203)%,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.
Ten healthy male subjects were given a single fasting oral roxithromycin dispersible tablets and domestic tablets 300mg, with different levels of blood roxithromycin concentration-time curve of blood concentration-time curve. The results showed that the pharmacokinetics of roxithromycin in both preparations were in accordance with two-compartment model with Cmax (702 ± 173) μg / mL and (647 ± 12) μg / mL, Tmax (105 ± 034) h and (150 ± 041) h, t1 / 2 (ke) were (1585 ± 212) h and (07 ± 207) h, AUC0 → ∞ of (687 ± 143) μg / mL · h and (656 ± 148) μg / mL · h. Comparing the kinetic parameters of the two preparations, there was no significant difference in the Cmax and AUC0 → ∞ of roxithromycin between the two preparations, P> 005. The average relative bioavailability of roxithromycin dispersible tablets was (1057 ± 1203)%. According to the double unilateral test, the two preparations could be considered bioequivalent in human.