2种氟苯尼考注射液在鸡体内的药动学和生物等效性研究

Study on the Pharmacokinetics and Bioequivalence of Two Kinds of Florfenicol Injection in Chicken

[目的]比较先灵葆雅动物保健公司生产的氟苯尼考注射剂(参比制剂)和国内某厂家生产的氟苯尼考注射剂(受试制剂)在鸡体内的药代动力学特征,并评价2种制剂间的生物等效性。[方法]选用24只快大型白羽肉鸡,分为2组,按0.067 mL/kg的剂量分别给予受试制剂和参比制剂。采用液质联用法测定血药浓度,使用WinNonlin软件计算2种制剂的药代动力学参数和生物等效性。[结果]受试制剂和参比制剂的峰浓度(C_(max))分别为(4.85±0.57)和(4.83±0.43)μg/mL,达峰时间(T_(max))分别为(39.58±23.68)和(41.67±16.06)min,曲线下面积(AUC_(0-24 h))分别为(1561.32±497.38)和(1529.25±444.88)(μg·min)/mL。双单侧t检验法和置信区间法结果均表明2种制剂生物等效。[结论]国产氟苯尼考注射液与先灵葆雅动物保健公司生产的氟苯尼考注射液生物等效。

[Objective]To compare the pharmacokinetic characteristics and evaluate the bioequivalence of two kinds of florfenicol injections produced by Schering plough animal health company(reference preparation)and a domestic manufacturer(test preparation).[Method]24 fast large white-feathered broilers were randomly divided into two groups.The reference preparation and test preparation were administrated by the dose of 0.067 mL/kg.LC-MS/MS method was used to determine the plasma concentration,and pharmacokinetic parameters and bioequivalence result of the two preparations were calculated by WinNonlin.[Result]The peak concentrations(C_(max))of test preparation and reference preparation were(4.85±0.57)and(4.83±0.43)μg/mL respectively,T_(max) were(39.58±23.68)and(41.67±16.06)min respectively,AUC _(0-24h) were(1561.32±497.38)and(1529.25±444.88)(μg·min)/mL.Analysis of double one-sided t-test and confidence interval showed that the two preparations were bioequivalent.[Conclusion]Two kinds of florfenicol injections from Schering-Plough animal health company and domestic market were bioequivalent.