EPR长效注射液对靶动物肉牛的安全性试验

Safety Testing of EPR Long-acting Injection in Target Animal Beef Cattle

试验旨在评价乙酰氨基阿维菌素(Eprinomectin,EPR)长效注射液的安全性,考察安全剂量范围,为临床安全使用提供依据。选用16头健康杂交肉牛,随机分为4组,每组4头(公母各半),分别以推荐剂量(1.0 mg/kg·BW)的0(空白对照组)、1、3、5倍剂量颈部皮下给药1次,给药后观察120 d。观察受试肉牛在试验期间(给药前7天~给药后第120天)的临床表现(精神、行为状况等)、采食、给药局部部位、粪便等,对体温、脉搏、呼吸、采食量、体重等指标进行测量;在给药前一天和给药后(第3天、第28天、第56天、第84天、第112天)采集受试肉牛的尾静脉血,进行血液学和血液生化检查;于给药后第3天和第120天,分别对5倍剂量组和空白对照组试验肉牛各2头(1公1母)进行安乐死,剖检观察心、肝、脾、肺、肾等有无病理变化,计算脏器指数,对主要器官进行组织病理学检查。结果显示,EPR长效注射液对靶动物肉牛的临床表现、粪便和饮食无明显影响,各剂量给药组受试肉牛的体温、脉搏、呼吸频次、体重与空白对照组无显著差异(P>0.05);血液学检查及血液生化分析结果显示,各剂量组试验肉牛指标与空白组均无显著差异(P>0.05);剖检结果显示,5倍剂量组和空白对照组试验肉牛的主要脏器心、肝、脾、肺、肾无肉眼可见的损伤和病变,脏器系数与空白对照组无显著差异(P>0.05);病理组织学检查结果显示,5倍剂量组和空白对照组试验肉牛的主要脏器心、肝、脾、肺、肾无明显的病理变化。综上所述,EPR长效注射液对靶动物肉牛皮下注射给药,即使按5倍推荐剂量单次给药,也无明显的毒副作用和不良反应。因此,EPR长效注射液在靶动物肉牛上按1.0 mg/kg·BW皮下注射给药是安全的。

To evaluate the safety of EPR long-acting injection,investigate the range of safe dosages,and provide a basis for its safe clinical use,sixteen healthy hybrid beef cattle were randomly divided into 4 groups,with 4 cows in each group.They were given subcutaneous administration of EPR injection once at 0,1,3,and 5 times of the recommended dose(1.0 mg/kg·BW).The clinical manifestations(mental and behavioral conditions,etc.),the local parts of feeding,administration and feces of the beef cattle were observed during the experiment(7 days before administration to 120 days after administration).The indexes of body temperature,pulse,respiration,feed intake and body weight were measured.Tail venous blood was collected before and after administration(day 3,day 28,day 56,day 84,day 112)for hematology and blood biochemical examination.After the administration of day 3 and day 120,the beef cattle in the 5-fold dose group and the blank control group were euthanized 50%according to male and female respectively.The pathological changes of the heart,liver,spleen,lung and kidney were observed by autopsies.The coefficients of organs were calculated,and histopathological examinations of major organs were performed.The results showed that EPR long-acting injection had no significant effects on the clinical manifestations,feces and diet of target beef cattle,and there were no significant differences in body temperature,pulse,respiratory frequency and body weight of beef cattle in each dose administration group compared with the blank control group(P>0.05).The results of hematological examination and serum biochemical analysis showed that there were no significant differences in the indexes between the two groups(P>0.05).The results of autopsy showed that the heart,liver,spleen,lung and kidney of beef cattle in the 5-fold dose group and the blank control group had no visible damage and lesions,and the organ coefficients were not significantly different from the blank control group(P>0.05).The results of histopathological examination showed that there were no obvious pathological changes in the heart,liver,spleen,lung and kidney of the main organs of beef cattle in the 5-fold dose group and the blank control group.In summary,EPR long-acting injection had no obvious toxic side effects and adverse reactions when given subcutaneously to target animal beef cattle,even if given at 5 times the recommended dose.Therefore,EPR long-acting injection is safe when administered subcutaneously at 1.0 mg/kg·BW in the target animal beef cattle.