百年乐口服液安全性实验研究

目的探讨百年乐口服液的安全性毒性实验研究。方法采用小鼠急性经口毒性试验、Ames试验、小鼠骨髓嗜多染红细胞微核试验和小鼠精子畸形试验及大鼠90天喂养试验。结果百年乐口服液对小鼠急性经口毒性实验结果大于75ml/kg,体内和体外致突变试验均为阴性 ,亚慢性试验3个剂量组的(56.3、112.5、225.0ml/kgBW ,相当成人日用量的75、150、300倍)动物体重和进食量及食物利用率组间相比无差异 ,与阴性对照组比较 ,差异均无显著性 (P>0.05) ;各剂量组血常规和生化检测指标与阴性对照组比较 ,差异均无显著性 (P>0.05) ;病理组织学检查结果 ,各实验组大鼠肝、肾、胃肠、脾和睾丸等组织均未见有病理改变。结论本试验提示百年乐对大鼠亚慢性毒性试验及小鼠毒性试验未产生不良影响。

Safety study of Bainianle dietetic liquid

Objective These tests were aimed at the safety study of Bainianle dietetic liquid.Methods The acute oral toxicity test,Ames test,polychromatic erythrocytes micronucleus test and sperm malformation test of mice and90-day feeding study of rats were adopted in this study.Results The acute toxicity of Bainianle dietetic liquid in mice exceeded75ml/kg.bw.Mutagenicity was negative in vivo and in vitro.Bainianle dietetic liquid was administered to3groups of rats by oral administration daily for90days at56.3,112.5and225ml/kg.bw re-spectively.At the end of the experimental period,there were no significant differences in body weight and food utilization among the dose and control groups.Compared with the control group,there were no significant differ-ences in blood routine examination and biochemical criterion too.We did not observed histopathological changes of liver,kidney,stomach,intestines,spleen and testicle in each group.Conclusion No adverse effects of Bainianle dietetic liquid were observed on subchronic toxicity test of rats and toxicity test of mice.