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羟氯扎胺盐酸左旋咪唑复方混悬液对靶动物牛的安全性试验

Target Animal Safety Testing of Oxyclozanide Levamisole Compound Suspension in Cattle
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摘要 为评价羟氯扎胺盐酸左旋咪唑复方混悬液的安全性,确定该药对靶动物牛的毒性风险,选用32头健康西门塔尔肉牛(10~12月龄),随机分为4组,每组8头,分别以推荐剂量的0、1、3、5倍剂量连续口服给药3 d,给药后观察14 d。在试验开始前(第0天)、给药结束后(第4天)及试验结束后(第18天)抽取试验牛血液进行血液学检查及血清生化检查。试验第4天,于0剂量组和5倍剂量组内随机选择4头牛进行安乐死(雌雄各半),试验结束后安乐死0剂量组及5倍剂量组剩余牛,进行组织病理学观察。综合体重、临床毒性观察、血液学检查、血清生化检查和组织病理学观察结果,评估药物的安全性。试验结果显示,1、3、5倍剂量组给药后12 h内多数牛均出现腹泻反应,5倍剂量组个别牛有短暂的表现呆滞、食欲减退,停药后副作用逐渐减弱或消失,试验第5天时临床各项观测结果均正常;其他剂量组未出现采食、饮水及精神状态异常,未观测到明显临床病理表现。试验结束后,0剂量组及1倍剂量组试验牛体重均有增加,但3倍剂量组及5倍剂量组试验牛体重下降;血液学检查及血清生化分析结果显示,与0剂量组相比,3倍剂量组及5倍剂量组试验牛部分指标存在显著差异(P<0.05);对试验牛剖检,组织病理学观察未发现肉眼可见明显病变。综上所述,连续3 d每天口服5倍推荐剂量的羟氯扎胺盐酸左旋咪唑复方混悬液靶动物牛仍可耐受,故临床按推荐剂量为0.25 mL/kg口服羟氯扎胺盐酸左旋咪唑复方混悬液具有安全性。 To evaluate the safety of oxyclozanide levamisole compound suspension and to determine the potential risk of toxicity to the target animals,32 healthy Simmental beef cattle(10-12 months of age)were randomly divided into 4 groups of 8 cattle each and administered orally at 0,1,3 and 5 times the recommended dose for 3 consecutive days and observed for 14 days after administration.Blood was taken from the test cattle for haematological and serum biochemical examinations before(day 0),after(day 4)and at the end of(day 18)the trial.On day 4,four cows were randomly selected for euthanasia(half male and half female)in the 0x and 5x dose groups,and at the end of the trial,the remaining cows in the 0x and 5x dose groups were euthanised for histopathological examination.The safety of the drug was assessed by combining weight,clinical toxicity observations,haematological examination,serum biochemical examination and histopathological examination.The results showed that most of the cattle in the 1,3 and 5 times dose groups showed diarrhoeal reactions within 12h after administration,while some cattle in the 5 times dose group showed transient sluggishness and poor appetite,which gradually diminished or disappeared after stopping the drug.The results of haematological examination and serum biochemical analysis showed that there were significant differences in some indicators between the 3x and 5x dose groups compared to the 0x dose group(P<0.05).The histopathological examination of the test cattle did not reveal any significant lesions visible to the naked eye.In conclusion,the oral administration of 5 times the recommended dose of oxyclozanide levamisole compound suspension for 3 consecutive days was still tolerated by the target animals,and therefore the oral administration of oxyclozanide levamisole compound suspension at the recommended dose(0.25 mL/kg)has a good safety profile for clinical use.
作者 高馨儿 陈玲玲 姚学强 周凯仁 王娟 周绪正 朱晓鹏 张继瑜 GAO Xin-er;CHEN Ling-ling;YAO Xue-qiang;ZHOU Kai-ren;WANG Juan;ZHOU Xu-zheng;ZHU Xiao-peng;ZHANG Ji-yu(College of Veterinary Medicine,Gansu Agricultural University,Lanzhou,Gansu,730070,China;Lanzhou Institute of Animal Husbandry and Pharmaceutical Sciences,Lanzhou,Gansu,730050,China;Wanhe Grass and Animal Industry Technology Development Co,Zhangye,Gansu,734312,China)
出处 《动物医学进展》 北大核心 2024年第2期84-89,共6页 Progress In Veterinary Medicine
基金 国家肉牛牦牛产业技术体系项目(CARS-37) 甘肃省科技计划项目(20JR10RA023)。
关键词 羟氯扎胺 盐酸左旋咪唑 靶动物安全 oxyclozanide levamisole cattle target animal safety
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