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目的:研究阿奇霉素干混悬剂的人体相对生物利用度和生物等效性。方法:健康志愿者18名,随机双交叉试验方法,单剂量口服试验及对照制剂500mg,间隔期为2周。用微生物法测定血浆中阿奇霉素浓度。计算两者的药代动力学参数及相对生物利用度,并进行生物等效性评价。结果:单剂量口服试验及对照制剂的Cmax分别为(836±219)μg·L-1和(868±210)μg·L-1;tmax分别为(2．3±0．5)h和(2．3±0．6)h;AUC(0-144h)分别为(5 355．3±1 612．2)μg·h·L-1和(5 349．0±916．5)μg·h·L-1。以AUC(0-144h)计算试验制剂的相对生物利用度为(101．4±27．9)％。结论:两制剂在单剂量下具有生物等效性。
Objective: To study the relative bioavailability and bioequivalence of azithromycin in suspension. Methods: Eighteen healthy volunteers were randomly divided into two groups: randomized double-crossover test, single-dose oral test and control 500mg with interval of 2 weeks. Determination of Azithromycin in Plasma by Microbial Method. The pharmacokinetic parameters and relative bioavailability of the two drugs were calculated and the bioequivalence was evaluated. Results: The Cmax values of single oral dose and control group were (836 ± 219) μg · L-1 and (868 ± 210) μg · L-1, respectively; tmax was (2.3 ± 0.5) 2.3 ± 0.6) h and AUC (0-144 h) were (5 355.3 ± 1 612.2) μg · h · L-1 and (5 349.0 ± 916.5) μg · h · L-1. The relative bioavailability of the test formulation calculated as AUC (0-144 h) was (101.4 ± 27.9)%. Conclusions: Both formulations are bioequivalent at a single dose.