栀子西红花甙对Beagle犬静脉给药的长期毒性研究

Thirteen week Veinal Toxicity Study of Crocins in Beagle Dogs

目的 :观察栀子西红花甙对Beagle犬的各种毒性反应 ,以评价栀子西红花甙的安全性。方法 :栀子西红花甙以 0、5 0、112、2 5 0mg/kg每天静脉注射给药一次 ,每周 6d ,连续给药 13周。 结果 :静脉注射栀子西红花甙后 ,犬主要表现为皮肤搔痒 ,皮肤、粘膜、巩膜等染成黄色 ,尿液、粪便颜色加深 ,且总胆红素和白细胞显著升高 ,而红细胞计数、血红蛋白及红细胞压积明显降低 ,活动减少等。对犬的血清生化、尿、粪常规、体重增长、心电图等均未发现明显的与药物作用有关的异常变化。组织切片检查表明 ,在所有受检脏器中 ,均未见明显的病理改变。结论 :在此试验条件下 ,栀子西红花甙静脉注射给药 13周对犬的无毒剂量为 5 0mg/kg。

Purpose:The toxicity study of crocins, which were isolated from the fruits of Gardenia jasminoides Ellis, was conducted in beagle dogs to evaluate its safety. Methods: The 13 week repeated doses of 0, 50, 112, 250 mg/kg were injected intravenously once daily. Results: No deaths occurred in any group. As main clinical signs or changes due to the drug treatment, cutaneous pruritus, yellowed skin, mucosa, sclera, increased TBIL and WBA, decreased RBC, HGB, HCT, and reduced locomotor activity were noted in the 250 mg/kg dose group. There were no drug related changes in food intake, urinalysis, fecal occult blood test, body weight, electrocardiogram, blood chemistry, hepatic and renal function tests, organ weight and autopsy. Conclusion: From these results, the non toxic dose of crocins was estimated to be 50 mg/kg under the present conditions.