普乐林注射液的安全性评价

Evaluation of the safety of Puerarin injection

目的 评价普乐林注射液的安全性。方法 观察普乐林注射液对小鼠的急性毒性 ,对人红细胞的体外溶血作用 ,对豚鼠致敏性及免疫性溶血的影响。结果 小鼠静注普乐林的LD5 0为 816.7mg/kg ;在 6h内 ,未见体外溶血和红细胞凝集反应 ;未引起豚鼠明显过敏症状 ,但其红细胞体外溶血分数增加。结论 普乐林注射液对实验动物无明显毒性 ,但部分豚鼠有发生不同程度免疫性溶血的可能。

Objective: To evaluate the safety of Puerarin injection. Methods: The acute toxicity of Puerarin in mice, the haemolytic effect on human erythrocyte in vitro, hypersensitization and immunohaemolytic effect on guinea pigs were studied. Results: When Puerarin was administered intravenously in mice, the median lethal dose was 816.7 mg/kg. The haemolytic effect on human erythrocyte was not observed in 6 hours. The hypersensitive symptoms in guinea pigs were not found, but the haemolytic figures increased in vitro. Conclusion: The toxicity of Puerarin injection is not significant in animals; yet immunohaemolysis in some guinea pigs is possible.