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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。
Objective To evaluate the safety of turtle peptide powder. Methods The acute toxicity, genotoxicity and subchronic toxicity of soft-shelled turtle powder were investigated by acute toxicity test in mice and mice, Ames test, micronucleus test in mouse bone marrow polychromatic erythrocytes, sperm abnormality test in mice and 30-day rat feeding test the study. The results showed that the maximum tolerated dose (MTD) of the turtle peptide in both large and large mice was more than 20.0 g / (kg bw). The Ames test showed that the number of colonies and the number of spontaneous regression in each dose group with and without S9 (P> 0.05). The results of micronucleus test and sperm abnormality test showed that there was no statistical difference between micronucleus rate and sperm abnormality rate in each dose group and the negative control group Significance (P> 0.05). The feeding test for 30 days showed that no significant toxic reaction was observed in turtle peptide, and the maximum dose of 8.4 g / (kg bw) was not observed. Conclusion Under the experimental conditions, the MTD of turtle peptide powder> 20.0 g / (kg bw) is an actual non-toxic grade, and no genotoxicity was observed. Toxicity to the test animals was not observed in the 30 d feeding test .