西安医科大学学报2001,Vol.22Issue(1):23-24,37,3.
罗红霉素分散片的人体药物动力学 及相对生物利用度
Pharmacokinetics and relative bioavailability of roxithromycin dispersive tablets in healthy volunteers
马小亚 1王美纳 1王玉虎 1梁维薇 1王信隆 2芦燕青2
作者信息
- 1. 西安交通大学第二医院临床药理研究室,
- 2. 医学院微生物学教研室
- 折叠
摘要
Abstract
Objective To study the pharmacokinetics and relativebioavailability of roxithromycin dispersive tablets in healthy volunteers.Methods A single oral dose of 300mg roxithromycin dispersive tablets and capsules were given to 12 healthy male volunteers according to an open randomized crossover design.The concentrations of roxithromycin in serum were determined by microbioassay. The pharmacokinetic parameters of roxithromycin were calculated with 3P97 program.Results The concentration-time curves of roxithromycin dispersive tablets or roxithromycin capsules conformed to a two compartment model. The main pharmacokinetic parameters of the two formulations were as follows: the T1/2β was (14.76±2.77) hand (14.92±3.12) h, the Tmax was (1.38±0.23) h and (1.63±0.23) h, the Cmax was (8.37±0.66) mg/L and (8.23±0.63) mg/L, the AUC0→∞ was (91.84±11.90)hmg/L and (88.55±10.70)hmg/L,respectively.The results of statistical analysis showed that there was no significant difference between the two formulations in the Cmax and AUC0→∞. The relative bioavailability of roxithromycin dispersive tablets to capsules was (103.75±5.58)%.Conclusion The two formulations were bioequivalent.关键词
罗红霉素/分散片/药物动力学/生物利用度分类
医药卫生引用本文复制引用
马小亚,王美纳,王玉虎,梁维薇,王信隆,芦燕青..罗红霉素分散片的人体药物动力学 及相对生物利用度[J].西安医科大学学报,2001,22(1):23-24,37,3.