摘要
目的研究阿奇霉素胶囊在正常人体内的药物动力学,评价两种制剂的生物等效性。方法采用双交叉设计,24名健康志愿受试者交叉口服阿奇霉素供试制剂与参比制剂。采用HPLC法测定阿奇霉素的血药浓度。用DAS药动学程序处理试验数据,并对试验结果进行方差分析和双单侧t检验。结果阿奇霉素的相对生物利用度为104.06%±11.15%;两种制剂的AUC0→t分别为23.98±7.42、23.35±7.70μg.h.ml-1;AUC0→∞分别是31.59±10.57、28.94±10.62μg.h.ml-1;Tmax分别为2.63±0.42、2.46±0.25 h;Cmax分别是1.08±0.22、1.13±0.23μg.ml-1。结论对空腹口服两种制剂后的lnAUC0→∞、lnAUC0→t、lnCmax经双单侧t检验,Tmax经秩和检验,表明二者为生物等效制剂。
OBJECTIVE To investigate the pharmacokinetics and bioequivalence of Azithromycin capsules in healthy volunteers. METHODS A randomized crossover design was performed in 24 healthy male volunteers. In the two study periods, a single lg dose of either test or reference preparation was administered to each volunteer. Azithromycin concentration in plasma was detected by HPLC. The experiment data were calculated with DAS program. The results were analyzed by ANOVA and two one - way test. RESULTS The relative bioavailability of azithromycin in the test was 104. 06% ± 11.15% ;AUC0-t of azithromycin of test and reference preparations were 23. 98 ± 7.42,23.35 ± 7.70 μg· h· ml^ - 1 ;Tmax were 2.63 ± 0.42,2.46 ± 0. 25 h; Cmax were 1.08 ± 0. 22,1.13 ± 0. 23 μg·ml ^- 1. CONCLUSION Bioequivalent evaluation of two preparations by analyzing with two one - way test and rank sum test shows that the two preparations are bioequivalent.
出处
《华西药学杂志》
CAS
CSCD
北大核心
2008年第1期63-65,共3页
West China Journal of Pharmaceutical Sciences
