绿茶提取物的安全性分析评价

Safety assessment of extract from green tea

目的 对调节血糖产品-绿茶提取物的安全性进行评价。方法 采用急性经口毒性试验、蓄积毒性试验、小鼠骨髓嗜多染红细胞微核试验、V79细胞基因突变试验对绿茶提取物的急性毒性、蓄积毒性、遗传毒性进行观察。结果 该提取物对雌、雄性小鼠急性经口LD50 均>10 0 0 0mg/ (kg·bw) ,属于实际无毒级;对动物蓄积系数K >5 ,属于弱蓄积性;对小鼠骨髓细胞未产生致畸变作用;对体外培养的中国仓鼠肺细胞(V79) ,无论直接作用和代谢活化后作用,均未呈现致突变性。结论 绿茶提取物是一种安全的调节血糖制剂。

Objective To test the toxicity of an extract from green t ea used for blood glucose regulation.Methods Acute oral toxicity test,cumulative toxicity test ,in vivo mammalian bone marrow cytogenetics test and in vitro mammalian cell gene mutation test were applied on it.Results The median lethal dose (LD_~50) for female an d male mice was more than10?000?mg/kg body weight.It belonged to actual non-t oxic substance.The extract had weak accumulation in mice (accumalation index>5), and it did not show distortion effect on mice marrow cell.It did not have mutati ve effect on V_~79 cell either directly or activated.Conclusion The extract from green tea is a safty agent fo r diabetes mellitus patients.