硫酸头孢喹肟注射液在猪体内的药代动力学及生物等效性研究

Pharmacokinetics and Bioequivalence Evaluation of Cefquinome Sulfate Injection in Pigs

关键词:  硫酸头孢喹肟注射液  药代动力学  生物等效性  猪

Key words:  Cefquinome sulfate injection  Pharmacokinetics  Bioequivalence  Pigs

摘要:

为了研究硫酸头孢喹肟注射液在猪体内的药代动力学及生物等效性,将10头健康猪随机分成两组,按2mg/kg体重肌肉注射两种硫酸头孢喹肟注射液,采用高效液相色谱法测定血浆中硫酸头孢喹肟的浓度,计算主要药代动力学参数,评价两制剂的生物等效性。肌肉注射两种硫酸头孢喹肟注射液后两组的消除半衰期(T_1/2β)、达峰浓度(C_max)、曲线下面积(AUC)等参数差异不显著(P>0.05)。采用双单侧t检验进行判断,受试组AUC90%置信区间为108.2%-115.3%,在对照组均值的80%-120%范围内；C_max90%置信区间为91.9%-115.3%,在对照组均值的70%-130%范围内。两种产品在猪体内具有生物等效性和类似的药代动力学。

Abstract:

To evaluate the pharmacokinetics and bioequivalence of cefquinome sulfate injection in pigs, 10 healthy pigs were randomLy divided into two groups and given two kinds of cefquinome sulfate injection by intramuscular injection (2mg/kg). The high performance liquid chromatography method was used to detect the concentration of cefquinome sulfate in plasma,and the major pharmacokinetic parameters were analyzed and the bioequivalence of two formulations was evaluated. The eliminate half life (T_1/2β), peak concentration (C_max) and area under curve (AUC) of the two groups after given two kinds of cefquinome sulfate injection had no significant difference. Based on analysis of two-sided t-test, the 90% confidential intervals of the test cefquinome sulfate injection in AUC were 108.2%-115.3% and were within the bioequivalent range (80%-120%) of the reference injection, the 90% confidential intervals in C_max were 91.9%-115.3% and were within the range (70%-130%) of the reference injection. The two products are bioequivalent and similar pharmacokinetics in healthy pigs．