长效土霉素注射液在猪体内的生物等效性研究

Bioequivalence of Long-acting Oxytetracycline Injection in Swines

关键词:  长效土霉素注射液  猪  药代动力学  生物等效性

Key words:  Long-acting  Swine  Oxytetracycline injectionon  Bioequivalence

摘要:

研究自制长效土霉素注射液与进口土霉素注射液(得米先)在猪体内单剂量注射的药代动力学和生物等效性,为临床应用提供参考和依据。采用双处理、双周期随即交叉试验设计。12头健康猪分为两组,分别先后单剂量肌肉注射自制长效土霉素注射液与得米先注射液,用高效液相色谱法测定血浆中土霉素的浓度,3P97软件计算药代动力学参数。自制长效土霉素注射液与参比制剂的主要药动学参数如下：AUC分别为(145.41?3.59)、(159.28?4.47)((μg/ml)*h),T_1/2β分别为(84.776?2.21) 、(72.740?1.95)h, C_max分别为(3.519?1.66)、(3.924?1.34)( μg/ml), T_max分别为(1.848?0.54) 、(1.760?0.41)h。采用3p97药代动力学软件分析比较AUC和C_max90%置信区间,自制长效土霉素注射液的AUC、C_max的90%置信区间分别为94.7％～105.2％、85.0％-114.6％,分别落在参比制剂的80%-125%、70%-143%范围内,两组参数差异不显著(P>0.05),结果表明二者具有生物等效性。

Abstract:

The characteritics of pharmacokinetics and bioequivalence of home-made and imported long-acting oxytetracycline injectionon in swines injected in a single dose were investigated. A random two-period cross-over bioavailability trial was designed in 12 healthy swines which were divided into 2 groups and injected intramuscularly respectively. The plasma concentration of oxytetracycline was determined by HPLC-UV. The pharmacokinetic parameters were calculated by 3P97 to evaluate the bioequivalence of the test and reference preparations. The main pharmacokinetic parameters of the two formulations were as follows：AUC, (145.41?3.59)、(159.28?4.47)((μg/ml)*h); T_1/2β, (84.776?2.21)、(72.740?1.95)h; C_max,(3.519?1.66)、(3.924?1.34)(μg/ml); T_max, (1.848?0.54)、(1.760?0.41)h; respectively. The 90% of confident interal of AUC and C_max which were processed using 3p97 Software from testing group were 94％～105％、85％-114％,respectively. The 90% of confident interal of AUC was in the range of 80%-125% of the reference preparation _.The 90% of confident interal of C_max was in the range of 75%-143% of the reference preparation. The results showed that there were no statistically significant differences between the main pharmaeokinetic parameters of two formulations(t-test, (P>0.05)). The test and reference preparations had pharmacokinetics bioequivalence.