糙米酵素红曲酒的小鼠口服毒理学安全性评价

Dietary safety evaluation of red koji brown rice wine in rat after oral administration

目的:研究糙米酵素红曲酒的引用安全性。方法:依据《保健食品检验与评价技术规范》,对糙米酵素红曲酒进行了急性毒性试验、小鼠骨髓细胞微核试验、小鼠精子畸形试验、Ames试验、小鼠30d喂养试验。结果:糙米酵素红曲酒对雌雄小鼠的急性经口的最大耐受剂量(MTD)均大于20g/kg体重;小鼠骨髓细胞微核试验、小鼠精子畸形试验、Ames试验均为阴性;小鼠30d喂养试验中,试验动物生长情况良好,体重检查、血清检查、脏体比结果与对照组相比,均无明显差异。结论:糙米酵素红曲酒属实际无毒物质,未显示有遗传毒性,初步估计其未观察到损害作用的剂量(NOAEL)为20g/kg体重。

Objective： To evaluate the dietary safety of the red koji fermented brown rice wine. Method： Acute toxicity test, rat bone marrow cells in rats and micronuclei sperm malformation test, Ames test, 30d in rats fed test are set on the brown rice enzyme red kojic rice wine according to the health food inspection and evaluation of technical specifications. Results： Brown rice enzyme red kojic rice wine for male and female rats acute through the mouth of the maximum tolerated dose （MTD） are both more than 20g/kg .bw; Rat bone marrow cells in rats and micronuclei sperm malformation test, Ames test are negative; the rats in rats fed 30d test are in good condition, and there are no differences in weight inspection, serum examination, organ and body when compared with the control group. Conclusion： Brown rice enzyme red kojic rice wine is an actual non-toxic substances with no genetic toxicity, preliminary estimate the NOAEL is 20g/kg .bw, which is safe up to 1000 fold higher than the recommended human dosage.