| 硫酸头孢喹肟注射液在猪体内的生物等效性研究 |
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| 引用本文： | 李龙飞,孔梅,郑莉,陈玲,冯言言,常雪,崔进,吴连勇.硫酸头孢喹肟注射液在猪体内的生物等效性研究[J].中国兽药杂志,2019,53(7):61-67. |
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| 作者姓名： | 李龙飞 孔梅 郑莉 陈玲 冯言言 常雪 崔进 吴连勇 |
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| 作者单位： | 齐鲁动物保健品有限公司,,,,,,,齐鲁动物保健品有限公司 |
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| 摘 要： | 为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3mg/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Win Nonlin6.3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±0.73h和2.25±0.55h;Cmax分别为2.37±0.34μg/mL和2.45±0.36μg/mL;AUC0-t分别为26.38±2.30μg·h·mL^-1和24.86±2.19μg·h·mL^-1;AUC0-∞分别为26.74±2.34μg·h·mL^-1和25.07±2.20μg·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-∞、Cmax、Tmax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。该试验可为兽医临床合理用药提供参考。
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| 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 |
| 收稿时间： | 2019/6/2 0:00:00 |
| 修稿时间： | 2019/6/24 0:00:00 |
Bioequivalence of Cefquinome Sulfate Injection in Pigs |
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| LI Long-fei,KONG Mei,ZHENG Li,CHEN Ling,FENG Yan-yan,CHANG Xue,CUI Jin,WU Lian-yong.Bioequivalence of Cefquinome Sulfate Injection in Pigs[J].Chinese Journal of Veterinary Drug,2019,53(7):61-67. |
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| Authors: | LI Long-fei KONG Mei ZHENG Li CHEN Ling FENG Yan-yan CHANG Xue CUI Jin WU Lian-yong |
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| Institution: | Qilu Animal Health,,,,,,, |
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| Abstract: | To evaluate the pharmacokinetics and bioequivalence of domestic and imported cefquinome sulfate injection( 7.5%) in pigs. By a randomized two-way self-crossover study,twenty 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 and the bioequivalence were calculated by WinNonlin 6. 3 software. The main pharmacokinetic parameters of the test and reference were as follows: Tmax were 2.30±0.73 h and 2.25±0.55 h;Cmax were 2.37±0.34 μg/m L and 2.45±0.36 μg/m L;AUC0-twere 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 and 25.07±2.20 μg·h·mL^-1. There was no significant difference in Tmax,Cmax,AUC0-t,AUC0-∞between the two formulations( P>0.05). Double unilateral two one-side t-test results suggest that the two formulations are bioequivalent and clinically interchangeable. This study provides theoretical basis for clinical rational administration. |
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| Keywords: | UPLC-MS/MS Cefquinome Sulfate Injection Pig Bioequivalence |
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