大豆肽胶囊的安全性毒理学评价

Toxicological and Safety Assessment of Soybean Peptide Capsules

为探讨大豆肽胶囊的安全性,根据我国卫生部《保健食品检验与评价技术规范(2003年版)》进行了大豆肽胶囊的急性毒性试验、遗传毒性试验和30天喂养试验。结果表明:大豆肽胶囊对雌雄性小鼠急性经口毒性试验的LD50均大于20 g/kg·BW,属无毒级。遗传毒性试验中的小鼠骨髓细胞微核试验、小鼠精子畸变试验、小鼠Ames试验结果均为阴性。30 d喂养试验结果表明:采用受试样品1.25、2.5、5.0 g/kg·BW剂量分别对大鼠连续喂养30 d,大鼠未见中毒症状和死亡,各剂量组大鼠体重、摄食量、增重、食物利用率、脏器绝对重量、脏体比、血液学、生化学及组织病理学等指标与对照组比较,均无显著性差异(P>0.05)。通过以上实验可以判定大豆肽胶囊无任何毒副作用。

In order to explore the safety of soybean peptide capsules,according to the Technical Standards forTesting and Assessment of Health Food （2003）by Healthy Ministry, the experiments of acute toxicity,genetictoxicology and thirty days feeding experiment were carried. The results showed that the LD50,which was a non-toxic level,was greater than 20 g/kg· BW for the acute oral toxicity test of male and female mice. In the genetictoxicology test,the bone marrow cell micronuclear test,sperm aberration test and Ames test were all negative.The results of 30-days test showed that the animals of control group and each dose group were well,withoutdeath and abnormal clinical sign. The body weight,food intake,food utilization rate,organ weight,organ/body ratios,hematological parameters and blood biochemical indexes had no significant difference （P〉0.05）between the control group and dose groups. There are no abnormal pathological changes in liver,kidney,stomach, intestine,spleen,testicle and ovary of rats in treatment group. The conclusion is that soybean peptidecapsules are safe with no evident toxic effect.