Dong Zhen, Xing Shou-Ye, Zhang Ji-Yu, Zhou Xu-Zheng
Lanzhou Institute of Husbandry and Pharmaceutical Sciences, Chinese Academy of Agricultural Sciences (CAAS), Lanzhou, China.
Key Laboratory of Veterinary Pharmaceutical Development, Ministry of Agriculture, Lanzhou, China.
Front Vet Sci. 2020 Dec 16;7:598313. doi: 10.3389/fvets.2020.598313. eCollection 2020.
To evaluate the safety of ivermectin microemulsion injection, 100 Wistar rats were injected intraperitoneally at 0.38 g/kg, 0.19 g/kg, and 0.1 g/kg for 14 days. The 14-day repeated toxicity test of ivermectin microemulsion injection was systematically evaluated by clinical observation, organ coefficient, hematological examination, clinical chemistry examination, and histopathological examination. The results showed that no rats died during the test. At the initial stage of treatment, the rats in the high dose group had mild clinical reaction, which disappeared after 4 days. Clinical chemistry showed that the high dose of ivermectin microemulsion could cause significant changes in ALT and LDH parameters in male rats; high and medium doses could increase the liver coefficients of male and female rats. The toxic target organ may be the liver as indicated by histopathological findings. No significant toxic injury was found in the heart, liver, spleen, lung, kidney, brain, ovary, and testes of all groups of rats. No drug-related toxic effects were found at low doses, and thus the NOVEL of ivermectin microemulsion injection was 0.19 g/kg.
为评价伊维菌素微乳注射液的安全性,将100只Wistar大鼠分别以0.38 g/kg、0.19 g/kg和0.1 g/kg的剂量腹腔注射给药,连续14天。通过临床观察、脏器系数、血液学检查、临床生化检查和组织病理学检查,对伊维菌素微乳注射液进行了14天重复毒性试验系统评价。结果显示,试验期间无大鼠死亡。治疗初期,高剂量组大鼠出现轻度临床反应,4天后消失。临床生化检查表明,高剂量伊维菌素微乳可使雄性大鼠ALT和LDH参数发生显著变化;高、中剂量可使雄性和雌性大鼠肝脏系数升高。组织病理学结果提示,毒性靶器官可能为肝脏。各剂量组大鼠的心、肝、脾、肺、肾、脑、卵巢和睾丸均未发现明显的毒性损伤。低剂量未发现与药物相关的毒性作用,因此伊维菌素微乳注射液的无可见不良反应剂量为0.19 g/kg。