食源性生物活性肽的毒理学安全性评价

Toxicological assessment of food-borne bioactive peptide

目的检测食源性生物活性肽的食用安全性。方法对食源性生物活性肽进行大鼠急性经口毒性试验、遗传毒性试验、30天喂养试验。结果雌、雄大鼠经口最大耐受剂量(MTD)均大于15.0 g/kg.bw,相当于人体推荐用量的750倍。Ames试验、小鼠骨髓细胞微核试验、小鼠精子畸形试验3项遗传毒性试验结果均为阴性,表明该受试物无致突变作用。在大鼠30天喂养试验中,实验动物生长发育良好,血液学、血液生化学、脏器系数及病理学相关指标未见异常变化。结论食源性生物活性肽属无毒物质,未显示有遗传毒性,初步估计其最大无作用剂量为2.0 g/kg.bw。

Aim To evaluate the edible safety of food-borne bioactive peptide.Methods Acute toxicity test,genetic toxicity test and thirty days feeding test were performed.Results It was shown that the oral maximum tolerated dose（MTD） was higher than 15.0 g/kg·bw both in male or female mice,equivalent to 750 times of the recommended dosage.Three genetic toxicity tests included Ames test,Micronucleus test and Sperm shape abnormality test were negative,which means no inducing effect of pathological changes and mutation.During thirty days feeding test,the experimental groups were in good state and hematology,biochemistry,viscera modulus and histology were all in healthy ranges.Conclusion Food-borne bioactive peptide has no acute toxicity,no genotoxicity.The no-observed-adverse-effect level of the product is 2.0 g/（kg·bw）.