灯盏花素葡萄糖注射液对犬长期毒性试验的研究

Chronic Toxicity Study of Scutellarin Glucose Injection in Dogs

目的:观察犬连续静脉注射灯盏花素葡萄糖注射液(Scutellarin glucose injection,Scu)的长期毒性反应,为临床试验研究提供安全性参考。方法:分别设空白对照及灯盏花素葡萄糖注射液高、中、低(21mg/kg、10.5mg/Kg、5.25mg/Kg)3个剂量组,高剂量相当于拟临床人用量的70倍,静脉注射(容量为1ml/Kg),1次/日,连续3个月。末次给药后24小时活杀4只犬,停药后两周再活杀2只犬,分别测定各组犬的血液学、血液生化学等指标,同时测定主要脏器系数,系统尸检和镜检。结果:在用药期间,中剂量组血清GPT值升高,中、高剂量组血Cr值升高,低、中、高剂量组血BUN值升高(P<0.05),提示有一定程度的肝、肾功能损害,但停药两周后能恢复正常。在给药过程中,动物饮食、活动、排泄均未见明显异常,无一动物死亡。停药后各组动物在饮食、活动、排泄、精神状态等方面均未见明显差异;脏器系数、血液学检测结果均在正常范围;病理组织切片无特异性改变。停药后无迟缓性毒性发生。结论:灯盏花素葡萄糖注射液在给药期间对犬肝、肾功能有一定程度的损伤,但停药后又能恢复正常。

Objective： To investigate the chronic toxicity and the impaired reversibility on target organ after administering iv scutellarin glucose injection（Scu） in dogs. Methods： The toxicity reaction and impaired degree after administering Scu（21mg/kg, 10. 5mg/Kg, 5. 25mg/Kg） were observed by detecting indexes of hematology, hematological biochemics and pathohistology. Results： All dogs survived after administering iv Scu for 90 days. but GPT of dogs treated with middle dosage, Cr of dogs treated with middle and high dosage, BUN of dogs treated with low, middle, high doses were increasing, The injury on renal and liver was observed, But these symptoms were relived or disappeared after withdrawal. No Supervention injury was found after withdrawal. Conclusion： By long-term administering iv SCU in dogs, it can damage renal and liver cells in some animals. The results show that the target organ were renal and liver, but the injury could be recovered.