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目的研究头孢克罗泡腾片在健康志愿者体内的相对生物利用度。方法采用双交叉试验 ,12名健康志愿者口服单剂量头孢克罗泡腾片和胶囊两种制剂0.75g,RP_HPLC法测定人血浆中头孢克罗浓度 ,药_时数据用ATPK拟合 ,按一室模型计算药物动力学参数。结果泡腾片和胶囊Tmax 分别为 (0.58±0.12)和 (0.73±0.17)h,Cmax 分别为 (31.27±5.81)和 (30.56±5.25) μg·ml-1 ,AUC0～4 分别为 (35.5±4.65)和 (35.9±2.90) μg·h·ml-1 。试验品的相对生物利用度为 (98.6±7.5) %。结论头孢克罗泡腾片与胶囊生物等效。
Objective To study the relative bioavailability of cefaclor effervescent tablets in healthy volunteers. Methods Double crossover test was used in this study. Twelve healthy volunteers were given oral single dose of cefaclor effervescent tablets and capsule 0.75g, and the concentration of cefaclor in human plasma was determined by RP-HPLC. Pharmacokinetic parameters for the compartment model. Results The Tmax of effervescent tablets and capsules were (0.58 ± 0.12) and (0.73 ± 0.17) h, respectively, with Cmax of (31.27 ± 5.81) and (30.56 ± 5.25) μg · ml- 4.65) and (35.9 ± 2.90) μg · h · ml-1. The relative bioavailability of the test product was (98.6 ± 7.5)%. Conclusions Cefaclor effervescent tablets are bioequivalent to capsules.