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目的:研究2种阿奇霉素分散片的生物等效性。方法:20名男性健康志愿者随机交叉口服阿奇霉素分散片受试制剂或参比制剂500mg,用微生物琼脂平板扩散法测定血药浓度。采用3p97程序计算主要药动学参数及相对生物利用度,以评价生物等效性。结果:受试制剂与参比制剂的药-时曲线基本一致,Cmax分别为(407.672±36.025)、(413.903±36.945)ng.mL-1,tmax分别为(1.950±0.510)、(1.850±0.366)h,t1/2分别为(50.757±18.919)、(48.926±16.402)h,AUC0～120分别为(4998.110±721.271)、(4853.564±539.555)ng.h.mL-1,AUC0～∞分别为(5793.932±700.138)、(5570.704±614.011)ng.h.mL-1。阿奇霉素受试制剂的相对生物利用度为(99.0±17.6)%。结论:2种制剂具有生物等效性。
Objective: To study the bioequivalence of two azithromycin dispersible tablets. Methods: Twenty healthy male volunteers were randomized to receive azithromycin dispersible tablets (500mg) or reference preparations (500mg). The concentration of plasma was determined by microbiological agar plate diffusion method. The 3p97 program was used to calculate the main pharmacokinetic parameters and relative bioavailability to evaluate bioequivalence. Results: The drug-time curves of test and reference preparations were basically the same with Cmax of (407.672 ± 36.025), (413.903 ± 36.945) ng.mL-1 and tmax of 1.950 ± 0.510 and 1.850 ± 0.366 ), t1 / 2 were (50.757 ± 18.919) and (48.926 ± 16.402) h, respectively. The AUC0 ~ 120 were (4998.110 ± 721.271) and (4853.564 ± 539.555) ng.h.mL- (5793.932 ± 700.138), (5570.704 ± 614.011) ng.h.mL-1. The relative bioavailability of the azithromycin test preparation was (99.0 ± 17.6)%. Conclusion: The two preparations are bioequivalent.