甲鱼肽粉安全性的初步评价研究

目的 对甲鱼肽粉的安全性进行初步评价研究。方法 采用大、小鼠急性毒性试验、Ames 试验、小 鼠骨髓嗜多染红细胞微核试验、小鼠精子畸形试验和大鼠 30 d 喂养试验对甲鱼肽粉进行急性毒性、遗传毒性 和亚慢性毒性研究。结果 甲鱼肽粉对大、小鼠经口最大耐受量(MTD)均大于 20.0 g/(kg.bw); Ames 试验显示 在加与不加 S9 时各剂量组回变菌落数与自发回变对照组比较差异无统计学意义(P>0.05); 小鼠骨髓嗜多染红 细胞微核试验和精子畸形试验结果显示, 各剂量组的微核率和精子畸形率与阴性对照组比较差异均无统计学 意义(P>0.05); 30 d 喂养试验表明甲鱼肽粉未见明显毒性反应, 最大未观察到有害作用的剂量为 8.4 g/(kg.bw)。 结论 在本次实验条件下, 甲鱼肽粉经口 MTD>20.0 g/(kg.bw), 属实际无毒级, 并且未见遗传毒性, 30 d 喂养 试验未见其对受试动物有毒性损害作用。

Evaluation study on the safety of the turtle peptide powder

Objective To study the safety of the turtle peptide powder. Methods Acute toxicity tests in mice and rats, Ames test, micronucleus test, sperm abnormality test and 30 d feeding test were conducted to examine the safety of the turtle peptide powder. Results The MTD of the turtle peptide powder in mice and rats were both more than 20.0 g/(kg.bw). No increase in the number of revertant colonies was found in the Ames test with and without S9. The micronucleus rates and sperm abnormality rates in all dosages were not significantly different from the negative control (P>0.05). There was no treatment-related adverse effects on rats treated with the turtle peptide powder and the no-observed-adverse-effect-level (NOAEL) was 8.4 g/(kg.bw). Conclusion The turtle peptide powder showed no acute toxicity, mutagenicity and subchronic toxicity under these test conditions.