小鼠口服普拉沙星的急性毒性试验研究

Acute toxicity test of pradofloxacin in mice by oral administration

为初步评价普拉沙星的安全性,进行了小鼠急性毒性试验。采用递加法进行预试验,测得最小致死剂量(LD100)和最大耐受剂量(LD0),确定正式试验给药剂量范围、组数和组间剂量比。正式试验采用寇氏法,观察小鼠口服普拉沙星后的体征变化,记录死亡时间和每组死亡率,对死亡小鼠进行剖检和组织病理学观察,确定普拉沙星对主要脏器的毒性作用。结果显示,小鼠口服普拉沙星的半数致死剂量(LD50)为1606.9 mg/kg,95%可信限为1342.8~1923.1 mg/kg。在给药剂量大于1562 mg/kg时,普拉沙星对小鼠的肺脏、肝脏、脾脏和肾脏均可造成明显损伤。根据化学物质的急性毒性剂量分级,可将普拉沙星判定为低毒化学物。

In order to preliminarily evaluate the safety of pradofloxacin,the studies on acute toxicity in mice were conducted.The minimum lethal dose(LD100)and the maximum tolerated dose(LD0)were measured using the incremental method of pre-testing.The dose range,number of groups,and intergroup dose ratios of formal trial were determined by pre-testing.The formal trial used the modified Karber’s method to observe the change of signs after oral administration of pradofloxacin in mice,record the time of death and mortality in each group,and perform a general autopsy and histopathological examination of the dead mice to determine the toxic effect of pradofloxacin on the main organs.The results showed that half of the lethal dose(LD50)of pradofloxacin in mice was 1606.9 mg·kg-1and 95%confidence interval was 1342.8-1923.1 mg·kg-1,and at doses greater than 1562 mg·kg-1,it caused significant damage to the lung,liver,spleen and kidney of mice.Based on the acute toxic dose classification of the chemical,pradofloxacin can be judged as a low toxicity chemical.