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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
【摘要】 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。
【Abstract】 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.Theconcentrationsof cefiximein human plasma were determined by HPLC method. The pharmacokinetic 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, t1/2 (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.
- 【文献出处】 中国医药工业杂志 ,Chinese Journal of Pharmaceuticals , 编辑部邮箱 ,2006年07期
- 【分类号】R96
- 【被引频次】6
- 【下载频次】210