金斛春冲剂安全性毒理学评价

Toxicological assessment of the edible safety of Jinhuchun granule

目的 对金斛春冲剂的食用安全性进行毒理学评价。 方法 采用急性毒性试验、遗传毒性试验(Ames试验、小鼠骨髓微核试验、小鼠精子畸形试验)、30d喂养试验进行检测评价。 结果 雌雄小鼠经口LD50均大于20 0g/kg体重,Ames试验、小鼠骨髓微核试验、小鼠精子畸形试验三项遗传毒性试验结果均为阴性。5 00g/kg体重之剂量30d喂养试验未见明显毒性作用。 结论 金斛春冲剂急性毒性分级属无毒级、无遗传毒性,初步估计最大无损害作用剂量大于5g/kg体重,相当于人体推荐摄入量的100倍。

Objective To evaluate toxicologically the edible saf ty of Jinhuchun granule. Methods Acute toxity test,Ames test,Mi c ronucieus test,Sperm shape abnornality test and thirty days feeding test were pe rformed. Results The oral LD (50) in male or female mice w a s higher than 20.0g/kg.bw.Ames test,micronecleus test and sperm shape abnorma li ty were postive.No synificant toxicity was detected in Thirty days feeding test . Conclusion Jinhuchun granule has no acute toxicity,no genotox icity,maximal-no-observd-adverse-effect level(MNOAEL) is more than one handr ed times proposal daily intake amount in human.