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目的 :测定国产头孢克洛胶囊的药代动力学及相对生物利用度。方法 :8名受试者随机交叉空腹口服国产和进口头孢克洛 10 0 0mg ,用微生物方法测定药物浓度 ,计算药代动力学参数和国产品的相对生物利用度。 结果 :体内过程符合血管外二室模型 ,国产品Cmax 为 (2 0 .5 1± 3.48)mg/L ,Tmax 为 (0 .84± 0 .13)h ,t1/ 2 β为(1.0 7± 0 .38)h ,AUC为 (2 7.2 7± 2 .88)mg·h/L ,2 4h累积尿排出率为 (6 9.15± 6 .6 6 ) %。国产胶囊剂与进口胶囊剂比较的相对生物利用度为 10 8.43%。结论 :国产头孢克洛胶囊剂的生物利用度与进口胶囊剂相仿 ,两制剂具有生物等效性
Objective: To determine the pharmacokinetics and relative bioavailability of domestic cefaclor capsules. Methods: Eight subjects were randomized to receive 100 mg of domestic and imported cefaclor orally on a fasting cross. The drug concentration was determined by the microbiological method. The pharmacokinetic parameters and the relative bioavailability of the domestic product were calculated. Results: The in vivo process was in accordance with the extravascular 2 compartment model. The Cmax of domestic product was (20.5 ± 3.48) mg / L, Tmax was (0.84 ± 0.13) h, t1 / 2 β was 0. 38) h, the AUC was (2 7.27 ± 2.88) mg · h / L, and the cumulative urinary excretion rate was (24.15 ± 6.66)% at 24 hours. The relative bioavailability of domestic capsules and imported capsules was 10 8.43%. Conclusion: The domestic bioavailability of cefaclor capsules is similar to that of imported capsules. The two preparations have bioequivalence