摘要
为研究国产和进口托芬那酸注射液在犬体内的药代动力学和生物等效性,采用双处理、双周期随机交叉试验设计,将20头健康比格犬随机分成2组,按0.1 m L/kg体重肌肉分别单剂量注射受试制剂和参比制剂,采用高效液相色谱法测定血浆中托芬那酸的浓度,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(0.2±0.1)h和(0.3±0.2)h;Cmax分别为(5.12±1.55)μg/m L和(5.38±2.04)μg/m L;AUC0-t分别为(12.1±2.97)μg·h·m L^(-1)和(12.28±3.24)μg·h·m L^(-1);AUC_(0-∞)分别为(13.38±3.10)μg·h·m L^(-1)和(13.85±3.40)μg·h·m L^(-1)。托芬那酸注射液受试制剂和参比制剂的AUC_(0-t)、AUC_(0-∞)、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。该试验为兽医临床给药方案的制定以及合理用药提供参考。
To evaluate the pharmacokinetics and bioequivalence of tolfenamic acid injection in dogs,in arandomized two-way self-crossover study,20 healthy dogs were randomly divided into two groups,and were given respectively a single dose of test or reference preparations by intramuscular injection（ 0. 1m L / kg）. Plasma concentrations of tolfenamic acid were measured by HPLC. The pharmacokinetic parameters were calculated by Win Nonlin6. 3 software,and the bioequivalence were evaluated. The main pharmacokinetic parameters of the test and reference preparations were asfollows： Tmaxwere（ 0. 2 ± 0. 1） h,（ 0. 3 ± 0. 2） h; Cmaxwere（ 5. 12 ± 1. 55）μg /m L,（ 5. 38 ± 2. 04） μg /m L; AUC0-twere（ 12. 1 ± 2. 97） μg·h·m L^（-1）,（ 12. 28 ± 3. 24） μg·h·m L-1;AUC0-∞were（ 13. 38 ± 3. 10） μg·h·m L^（-1）,（ 13. 85 ± 3. 40） μg·h·m L^（-1）. The pharmacokinetic parameters（ AUC_（0-t）,AUC_（0-∞）,C_（max）,T_（max）） showed no significant difference between test and reference preparations of tolfenamic acid suspension injections（ P〉0. 05）. The test and reference formulations are bioequivalent after two one-side t-test. Two kinds of injection can replace each otherclinically. This study will provide theoretical basis formaking of veterinary clinical dosage regimen and clinical rational administration.
出处
《中国兽药杂志》
北大核心
2016年第8期53-57,共5页
Chinese Journal of Veterinary Drug
基金
江苏高校优势学科建设工程资助项目(PAPD)
扬州大学"新世纪人才工程"资助
