论文部分内容阅读
目的:观察口服罗红霉素干混悬剂的相对生物利用度。方法:用微生物法测定10名男性健康志愿者分别口服罗红霉素干混悬剂和片剂各150mg后的血药浓度,以观察罗红霉素干混悬剂的相对生物利用度。结果:罗红霉素干混悬剂和片剂的Tmax分别为(1.2±0.4)h及(1.8±0.5)h(P=0.01),Cmax分别为(4.66±0.47)mg/L及(4.06±0.89)mg/L(P>0.05),AUC0~48h分别为(36.35±5.32)mg·h/L及(35.63±4.19)mg·h/L(t检验P>0.05,生物等效性检验P<0.05)。干混悬剂的相对生物利用度(F)为(102±10)%(85%~116%)。Tmax和Cmax两参数经生物等效性检验P>0.05。与罗红霉素片剂比较,干混悬剂的Tmax平均提前30min,Cmax提高15%。两药的t1/2β、V/F和MRT等参数差异无显著性(P>0.05)。结论:以AUC和F衡量口服给药后的吸收程度,两制剂具有生物等效性。以Tmax和Cmax作指标,罗红霉素干混悬剂比片剂吸收快,达峰时间提前,峰浓度提高。两种制剂在消除方面基本一致
Objective: To observe the relative bioavailability of oral roxithromycin suspension. Methods: The plasma concentrations of 150 mg of roxithromycin dry suspensions and tablets were determined by the microbiological method in 10 male healthy volunteers to observe the relative bioavailability of roxithromycin dry suspension. Results: Tmax of roxithromycin in suspension and tablet were (1.2 ± 0.4) h and (1.8 ± 0.5) h respectively (P = 0.01), Cmax were ( 4.66 ± 0.47 mg / L and 4.06 ± 0.89 mg / L respectively (P> 0.05), and the AUC0-48h were (36.35 ± 5.32) mg · h / L and (35.63 ± 4.19) mg · h / L respectively (t test P> 0.05, bioequivalence test P <0.05). The relative bioavailability (F) of the dry suspension was (102 ± 10)% (85% to 116%). Tmax and Cmax two parameters by bioequivalence test P> 0.05. Compared with roxithromycin tablets, the Tmax of the dry suspension was 30 minutes earlier on average and the Cmax increased by 15%. The two drugs t1 / 2β, V / F and MRT parameters such as no significant difference (P> 0.05). CONCLUSIONS: AUC and F measure the extent of absorption after oral administration and both formulations are bioequivalent. Tmax and Cmax as indicators, roxithromycin dry suspension absorbed faster than the tablet, the peak time ahead of time, the peak concentration increased. The two formulations are basically the same elimination