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目的观察拟生产药物抗人T淋巴细胞猪免疫球蛋白(ALG)对小鼠的急性毒性作用。方法 ICR小鼠,体质量18～22g,雌雄各半,分别采用腹腔注射限度试验和尾静脉注射最大受试药量试验法,连续观察14d后处死全部小鼠,并进行尸体解剖、大体肉眼观察,发现异常的组织或器官进行病理切片送检。结果两种试验方法结果均显示:所有试验动物存活,供试品的LD50>5g/kg,但尾静脉注射最大给药量试验时,发现给药2d内动物的一般情况较差,处死并解剖后发现用药组有少数小鼠出现肝、肾的感染性侵害。结论 ALG的LD50值大于5g/kg,约相当于临床用量的250～333倍,提示该药物比较安全,但在过量静脉注射后短期内对小鼠仍有一定毒性。
Objective To observe the acute toxic effects of anti-human T lymphocyte porcine immunoglobulin (ALG) on mice. Methods ICR mice, weighing 18-22 g, were divided into two groups: the intraperitoneal injection limit test and the maximum dose test with tail vein injection. All mice were sacrificed after 14 days of continuous observation. The autopsy and gross macroscopic observations were performed. , abnormal tissues or organs were found for pathological examination. Results The results of the two test methods showed that all experimental animals survived. The LD50 of the test article was >5 g/kg. However, when the maximum dose was tested with the tail vein injection, it was found that the animals within 2 days of administration were generally worse, were sacrificed and dissected. Afterwards, it was found that a small number of mice in the medication group developed liver and kidney infections. Conclusion The LD50 value of ALG is more than 5g/kg, which is equivalent to 250-333 times of clinical dosage, suggesting that the drug is safe, but it still has certain toxicity to mice in short term after intravenous injection.