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目的研究头孢克洛2种干混悬剂的药动学及生物等效性。方法采用随机交叉试验设计,20名健康男性志愿者单剂量口服2种头孢克洛干混悬剂各250mg,用液相色谱-串联质谱法测定血浆中头孢克洛的浓度,将20名受试者的经时血药浓度录入DAS(Ver1.0)程序,进行统计分析。结果单剂量口服试验与参比制剂后头孢克洛的ρmax分别为(9.0±s1.7)和(9.6±1.6)mg·L-1,tmax分别为(0.37±0.12)和(0.35±0.05)h,t1/2分别为(0.88±0.16)和(0.87±0.11)h,AUC0～5h分别为(7.9±1.0)和(7.9±1.1)mg·h·L-1,AUC0～∞分别为(8.0±1.0)和(8.0±1.1)mg·h·L-1。2种制剂的tmax、ρmax、AUC0～5h、AUC0～∞均无显著差异。试验制剂的相对生物利用度为(101±12)%。结论试验制剂与参比制剂具有生物等效性。
Objective To study the pharmacokinetics and bioequivalence of cefaclor 2 dry suspensions. Methods Randomized crossover design was used in this study. Twenty healthy male volunteers were given 250 mg oral doses of two cefaclor dry suspensions respectively. The concentrations of cefaclor in plasma were determined by liquid chromatography-tandem mass spectrometry. Twenty Who over time plasma concentration input DAS (Ver1.0) program for statistical analysis. Results The pmax of cefaclor after single-dose oral administration and reference formulation were (9.0 ± s1.7) and (9.6 ± 1.6) mg · L-1, respectively, and the tmax were (0.37 ± 0.12) and (0.35 ± 0.05) h and t1 / 2 were (0.88 ± 0.16) and (0.87 ± 0.11) h respectively, AUC0 ~ 5h were (7.9 ± 1.0) and (7.9 ± 1.1) mg · h · L-1, 8.0 ± 1.0) and (8.0 ± 1.1) mg · h · L-1.2. There was no significant difference in tmax, pmax, AUC0 ~ 5h and AUC0 ~ ∞ between the two formulations. The relative bioavailability of the test formulation was (101 ± 12)%. Conclusion The test preparation and the reference preparation are bioequivalent.