依诺沙星分散片的人体相对生物利用度研究

Relative bioavailability of enoxacin dispersible tablets

目的:研究依诺沙星分散片(受试制剂)和依诺沙星片(参比制剂)的生物等效性。方法:采用双周期随机交叉试验设计。分别予20名男性健康志愿者依诺沙星受试制剂或参比制剂各0.4 g单剂量口服。用HPLC法测定给药后血样中依诺沙星的浓度。用DAS软件计算药动学参数。结果:受试制剂与参比制剂的Cm ax分别为(5 320±1 275)和(5 163±1 241)ng.mL-1;Tm ax(0.88±0.37)和(0.89±0.37)h;AUC0→24 h(23 317±7 187)和(22 904±7 098)ng.h.mL-1;AUC0→∞(24 502±7 396)和(24 085±7 377)ng.h.mL-1。受试制剂的相对生物利用度为(102±9)%。结论:依诺沙星分散片与依诺沙星片生物等效。

Objective： To study the relative bioavailability of enoxacin dispersible tablets. Methods： 20 healthy male volunteers were randomly received with a single crossover dose of enoxacin test or reference tablets. The blood samples from the volunteers were collected to measure plasma enoxacin concentrations by HPLC. The pharmacokinetic parameters were analyzed by DAS Verl. 0 program. Results： The pharmacokinetic parameters of test or reference tablets were as followed： Cmax （5 320 ± 1 275） vs. （5 163 ±1 241）ng·mL^-1 ;Tmax （0.88 ±0.37）vs. （0.89 ±0. 37）h;AUC0-24h（23 317 ±7 187）vs. （22904 ± 7 098） ng· h· mL^ -1 ; AUC0-∞ （ 24 502 ± 7 396 ） vs. （24 085 ± 7 377 ） ng· h· mL ^- 1, respectively ; the P values of these parameters showed no significant difference （P 〉 0.05 ）. The relative bioavailability of enoxacin dispersible tablets was （102 ± 9） %. Conclusion： The enoxacin dispersible tablets were bioequivalent to enoxacin tablets.