头孢克肟胶囊的药物动力学及生物等效性研究

Pharmacokinetics and Bioequivalence of Cefixime Capsules

18名健康受试者单剂量交叉口服两种头孢克肟胶囊,进行药物动力学和生物等效性研究。采用HPLC法测定人血浆中头孢克肟的浓度。受试制剂和参比制剂的AUC0-∞分别为(18.22±3.79)和(18.68±3.67)μg·ml-1·h,Cmax分别为(2.10±0.36)和(1.98±0.36)μg/ml,t1/2分别为(3.65±0.81)和(3.78±0.66)h。双单侧t检验结果表明,两种头孢克肟胶囊具有生物等效性。

The pharmacokinetics and bioequivalence of single dosage of two brands of cefixime capsules were investigated in 18 healthy volunteers, according to a cross-over design. The concentrations of cefixime in human plasma were determined by HPLC method. The pharmacoldnetic parameters of test and reference preparation were AUC0-∞ （18.22 ± 3.79）and （18.68 ±3.67） μg·ml^-1·h, Cmax （2.10±0.36） and （1.98 ± 0.36） μg·ml^-1, t1/a （3.65±0.81）and （3.78±0.66）h, respectively. The result of two one-side t test showed that two preparations were bioequivalent.