抗人T淋巴细胞猪免疫球蛋白急性毒性实验研究

Acute Toxicity Empirical Study on Anti-human T Lymphocyte Porcine Immunoglobulin

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 effect on a kind of preliminary manufacture medcine of anti-human T lymphocyte porcine immunoglobulin（ALG） carried in the mice.Methods According to the randomization principle,ICR mice that weight 18～22 g were equally divided into two groups by the sexuality.The limit and the max dosage experiments were adopted.After a 14-days observation,the mice were sacrificed and postmortem was carried out,then,the abnormal tissue and organ were checked by examining pathological section.Results The mice were all alive after both the 2 tests,and the LD505 g/kg for the investigational drug.But the general state of vena caudalis injection mice was not so perfect during the first 2 days,few mice were infected in liver and kidney.Conclusion LD505g/kg for the ALG that is 250～333 times of the clinical dosages.The result shows that the drug is relatively safe,but the toxicity is still to exist in a short term when the drug is administered at overdose by intravenous injection.