硫酸头孢喹肟注射液在猪体内的生物等效性研究

Bioequivalence of Cefquinome Sulfate Injection in Pigs

关键词:  超高效液相色谱-串联质谱  硫酸头孢喹肟注射液  猪  生物等效性

Key words:  UPLC-MS/MS  Cefquinome Sulfate Injection  Pig  Bioequivalence

摘要:

摘要:为了研究国产和进口硫酸头孢喹肟注射液（7.5%）在猪体内的药代动力学特征和生物等效性，采用双处理、双周期随机交叉试验设计，将20头健康三元杂交猪随机分成2组，按 3 mg/kg 体重分别单剂量肌内注射受试制剂和参比制剂，采用超高效液相色谱-串联质谱法测定血浆中头孢喹肟的浓度，利用 WinNonlin6.3 软件计算主要药动学参数，并评价两种制剂的生物等效性。结果显示，受试制剂和参比制剂的 Tmax 分别为2.30±0.73 h和2.25±0.55 h; Cmax分别为2.37±0.34 μg/ml和2.45±0.36 μg/ml; AUC0－t分别为26.38±2.30 μg/h/mL－1和 24.86±2.19 μg/h.mL－1; AUC0－∞分别为 26.74±2.34 μg/h.mL－1和 25.07±2.20 μg/h.mL－1 。硫酸头孢喹肟注射液受试制剂和参比制剂的AUC0－t、AUC0－∞、C max、T max 均无显著性差异，(p>0.05)。双单侧 t 检验结果显示两种制剂生物等效，临床上可相互替代,试验为兽医临床合理用药提供参考。

Abstract:

Abstract: To evaluate the pharmacokinetics and bioequivalence of domestic and imported Cefquinome Sulfate Injection（7.5%） in pigs. In a randomized two-way self-crossover study, 20 healthy pigs were randomly divided into two groups, and were given respectively a single dose of test or reference preparations by intramuscular injection(3 mg/kg). Plasma concentrations of Cefquinome were measured by UPLC-MS/MS. The pharmacokinetic parameters were calculated by WinNonlin6.3 software, and the bioequivalence were evaluated. The main pharmacokinetic parameters of the test and reference preparations were asfollows: Tmax were 2.30±0.73 h, 2.25±0.55 h; Cmax were 2.37±0.34 μg/ml, 2.45±0.36 μg/ml; AUC0－t were 26.38±2.30 μg/h.mL－1, 27.19±2.19 μg/h.mL－1; AUC0－∞ were 27.35±2.34 μg/h.mL－1, 25.07±2.20 μg/h/mL－1. The pharmacokinetic parameters (AUC0－t, AUC0－∞, Cmax, Tmax) showed no significant difference between test and reference preparations of Cefquinome Sulfate Injection, (p>0.05). The test and reference formulations are bioequivalent after two one-side t-test. Two kinds of injection can replace each other clinically; This study provides theoretical basis for clinical rational administration.