摘要
以浙江海正生产的硫酸头孢喹诺注射液为受试药物,英特威生产的硫酸头孢喹诺注射液为参比药物,采用双处理、两周期随机交叉设计,第二周期两组交换药物,进行了药代动力学研究。药-时数据采用3P97药代动力学软件进行处理。结果显示,猪肌肉注射受试药物和参比药物(2mg/kg)均表现为二室开放模型,受试药物和参比药物的t1/2a分别为0.315h和0.476h,t1/2β分别为1.429h和1.444h,AUC分别为12.342(μg/mL).h和13.745(μg/mL).h。采用3P97软件对AUC进行了生物等效性分析,结果显示,两药AUC生物等效的90%置信区间为82.1%～100.2%,在80%～120%范围内,符合农业部兽药生物等效性研究规范的要求。结果表明,受试药物与参比药物具有生物等效性。
The pharmacokinetics and bioequivalence of cefquinome sulfate injection in swine were investigated.The testing drug was cefquinome sulfate injection which was made by Zhejiang Hai zheng Animal Pharmaceutical Company,and the control drug was also cefquinome sul fate injection which was made by Intervet Company.The experiment was carried out by using a cross-over method with random two gro ups and two-period and the test drugs of two groups were interchanged at the se cond period.The drug concentration-time data of both groups,processed by 3P97 S oftware,were fitted most suitably with two-compartment open model.The main para meters for the testing and control drugs（2 mg/kg）were as follows：the half life of distribution phase was 0.315 h and 0.476 h,respectively.The half life of elimination phase was 1.429 h and 1.444 h,respectively.Areas under curve was 12.342（μg/mL）·h and 13.745（μg/mL）·h,respectively.Bioequivalence analysis for the parameters AUC was performed by the 3P97 Software.The 90% of confidence interval of AUC for bioequivalence analy sis was 82.1% to 100.2%,within the required range of the Ministry of Agriculture of the People＇s Republic of China（80% to 120%）,indicating that the testing dru g and control drug were bioequivalent in pharmacokinetics.
出处
《中国兽医科学》
CAS
CSCD
北大核心
2010年第9期975-977,共3页
Chinese Veterinary Science
基金
国家"十一五"科技支撑计划项目(2006BAD31B08)
