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

作　　者：班付国[1] 吴宁鹏[1] 周红霞[1] 李建正 王丽景 董晓盈 

机构地区：[1]河南省兽药监察所,郑州450008 [2]郑州后羿制药有限公司,郑州450000

出　　处：《中国兽药杂志》2013年第7期38-41,共4页Chinese Journal of Veterinary Drug

基　　金：河南省科技攻关项目(102102110187)

摘　　要：研究自制长效土霉素注射液与进口长效土霉素注射液(得米先注射液)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-1.h,T1/2β分别为(84.776±2.21)、(72.740±1.95)h,Cmax分别为(3.519±1.66)、(3.924±1.34)μg/mL,Tmax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Cmax90%置信区间,自制长效土霉素注射液的AUC、Cmax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. 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-1·h; T1/2β（84.776±2.21）,（72.740±1.95） h; Cmax（3.519±1.66）, （3. 924±1.34） μg/mL ; Tmax（ 1. 848 - 0.54）, （ 1. 760 - 0.41 ） h, respectively. The 90% of confident interal of AUC and Cmax which were processed using 3P97 Software from testing group were 94.7% - 105.2% ,85.0% 114.6% ,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 Cmax was in the range of 70% - 143% of the reference preparation. The results showed that there were no statistically significant differences （P 〉 0. 05 ） between the main pharmaeokinetic parameters of two formulations （t - test ）. The test and reference preparations had pharmacokinetics bioequivalence.

关 键 词：长效土霉素注射液 猪 生物等效性 

分 类 号：S859.796[农业科学—临床兽医学]