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研究头孢克洛分散片在健康人体内的药物动力学及相对生物利用度。采用高效液相色谱法测定8 名志愿者单剂量口服500 m g 头孢克洛分散片和胶囊后的血液浓度。药动学参数经3P87 软件处理计算。头孢克洛分散片的主要药动学参数:Cm ax(1532±242) m g/L,Tpeak(057±015) h,T1/2ke(076±025) h,AUC(2407±447) m g/(h·L);头孢克洛胶囊的主要药动学参数:Cm ax(15.63±2.32) m g/L,Tpeak(0.60±0.13) h,T1/2ke(067±018) h,AUC(2313±337)m g/(h·L)。经统计学处理,两种剂型的药动学参数之间差异均无显著性(P> 005)。头孢克洛分散片的相对生物利用度为(10375±1136)% ,双单测t检验(NDST程序)的结果表明,两种制剂生物等效。
To study the pharmacokinetics and relative bioavailability of cefaclor dispersible tablets in healthy volunteers. The plasma concentrations of cefaclor 500 mg cefaclor dispersible tablets and capsules after oral administration of a single dose to eight volunteers were determined by high performance liquid chromatography. Pharmacokinetic parameters calculated by 3P87 software. The main pharmacokinetic parameters of cefaclor dispersible tablets were Cm ax (1532 ± 242) m g / L, Tpeak (057 ± 015) h, T1 / 2ke (076 ± 0 25 h), AUC (240 ± 447) m g / (h · L). The main pharmacokinetic parameters of cefaclor capsule were Cm ax (15.63 ± 2.32) m g / L, Tpeak (0.60 ± 0.13) h, T1 / 2ke (067 ± 018) h, AUC (2313 ± 337) m g / (h · L). Statistically, there was no significant difference in the pharmacokinetic parameters between the two formulations (P> 005). The relative bioavailability of cefaclor dispersible tablets was (10375 ± 1136)%. The results of the two-test t test (NDST program) showed that both formulations were bioequivalent.