头孢克洛分散片在人体中的药代动力学和生物利用度

目的： 测试国产头孢克洛分散片在8 名健康男性志愿者体内的药代动力学和相对生物利用度。方法：采用 HPLC 法测定血、尿药浓度, 比较了单剂量口服 500 mg头孢克洛分散片和普通胶囊的体内过程和生物利用度。结果：头孢克洛分散片的药代动力学符合一室开放模型。试验药品和对照药品的cmax分别为（15.87±4.54）和 （13.75±4.54）μg/ml; tmax分别为（0.63±0.19 ）和（0.66±0.19）h; t1/2 分别为（0.54±0.13）和（0.63±0.20）h; AUC0？∞分别为（19.13±2.82）和（18.30±3.62）h*μg/ml。试验药品的相对生物利用度为（106.59±19.13）％。结论：两种制剂的AUC及其对数形式经三因素方差分析和双单侧t检验均无显著性差异,提示两者具有生物等效性。

Pharmacokinetics and bioavailability of cefaclor in healthy volunteers

Objective: To observe the pharmacokinetic process of cefaclor in 8 healthy volunteers and assess the bioequivalence between 2 kinds of its dosage forms. Methods: A randomized crossover and selfcontrol design was used. Eight healthy volunteers were single oral dosed with 250 mg dispersing tablet or capsule, respectively. The plasma and urine concentrations were determined by HPLC method. The pharmacokinetic parameters were calculated by 3P87 program and the bioequivalence was assessed by ANOVA. Results: A onecompartment open pharmacokinetic model was adopted and the cmax, tmax, t1/2 and AUC0 of tablet and capsule were (15.874.54) and (13.754.54) g/ml; (0.630.19) and (0.660.19) h; (0.540.13) and (0.630.20) h; (19.132.82) and (18.303.62) hg/ml. There were no significant differences between the 2 preparations. Conclusion: The 2 kinds of preparations are bioequivalent and the average relative bioavailability of dispersing tablet is (106.5919.13)%.