马波沙星注射液在牛体内的生物等效性研究  

Bioequivalence study of marbofloxacin injection in cattle

作　　者：贾兴[1,2] 王玉欣 耿智霞 刘静[1,2] 瞿红颖 宋婷婷[1,2] 郭李珉 邓彦宏 Jia Xing;Wang Yuxin;Geng Zhixia;Liu Jing;Qu Hongying;Song Tingting;Guo Limin;Deng Yanhong(Hebei Yuanzhoang Phamaceutical Co.,Ltd.,Hebei Shijiazhuang 050041;Hebei Technology Innovation Center of Veterinary Drugs,Hebei Shijiazhuang 050041;College of Veterinary Medicine,Jilin University,Jilin Changchun 130000)

机构地区：[1]河北远征药业有限公司,河北石家庄050041 [2]河北省兽药技术创新中心,河北石家庄050041 [3]吉林大学动物医学学院,吉林长春130000

出　　处：《现代畜牧兽医》2023年第5期24-27,共4页Modern Journal of Animal Husbandry and Veterinary Medicine

摘　　要：试验旨在研究马波沙星注射液在牛体内的药代动力学特征和生物等效性,将24只健康成年牛随机分成2组,采用单剂量双周期两处理随机交叉对照盲法设计,按2 mg/kg体重分别皮下注射受试制剂和参比制剂。采用UPLC-MS/MS法测定牛血浆中马波沙星的浓度,DAS 3.0软件对药代动力学参数进行分析,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中马波沙星达峰时间(T_(max))分别为(0.73±0.10) h和(0.78±0.20) h;达峰浓度(C_(max))分别为(1.94±1.21) mg/L和(1.89±1.06) mg/L;药-时曲线面积(AUC_(0-t))分别为(6.33±1.51) h·mg/L和(6.14±1.56) h·mg/L;药-时曲线面积(AUC_(0-∞))分别为(6.82±1.74) h·mg/L和(6.52±1.59) h·mg/L;受试产品和参比产品的T_(max)、C_(max)、AUC_(0-t)和AUC_(0-∞)均无显著性差异(P>0.05)。双单侧t检验及90%置信区间结果均提示两种制剂生物等效,临床中可相互替代。The aim of the study was to investigate the pharmacokinetic characteristics and bioequivalence of maploxacin injection in cattle.Twenty-four healthy adult cattle were randomly divided into two groups,and the test product and the reference product were injected subcutaneously at 2 mg/kg body weight in a single-dose,double-cycle,two-treatment randomized cross-control blind design.Maploxacin concentration in plasma was determined by UPLC-MS/MS method.DAS 3.0 software was used to analyze the pharmacokinetic parameters and evaluate the bioequivalence of the two products.The results showed that the T_(max) of maploxacin was(0.73±0.10)h and(0.78±0.20)h in the test product and the reference product,respectively.The C_(max) was(1.94±1.21)mg/L and(1.89±1.06)mg/L,respectively.The AUC_(0-t) were(6.33±1.51)h·mg/L and(6.14±1.56)h·mg/L,respectively.The AUC_(0-∞) was(6.82±1.74)h·mg/L and(6.52±1.59)h·mg/L,respectively.There were no significant differences in T_(max),C_(max),AUC_(0-t) and AUC_(0-∞) between test products and reference products(P>0.05).The results of double unilateral t test and 90%confidence interval indicated that the two preparations were bioequivalent and could be substituted in clinic.

关 键 词：马波沙星注射液 牛 生物等效性 超高效液相色谱串联质谱 

分 类 号：S859[农业科学—临床兽医学]