越橘叶黄素片的毒理学安全性评价研究

The Toxicological Safety Evaluation Study on Bilberry Lutein Tablets

对越橘叶黄素片的食用安全性进行毒理学评价。依据食品安全性毒理学评价程序和方法进行急性毒性试验、遗传毒性试验(Ames试验、骨髓细胞微核试验和精子畸形试验)、大鼠30 d喂养试验。小鼠急性毒性试验经口最大耐受剂量(MTD)均>20.0 g/kg·BW,属无毒级。Ames试验、骨髓细胞微核试验和精子畸形试验结果均为阴性,表明受试物无致突变作用。大鼠30 d喂养试验,试验动物均生长发育良好,体重、摄食量、血液学、血液生化学、脏器系数及病理组织学相关指标均未见异常变化。越橘叶黄素片急性毒理分级属无毒级,无遗传毒性,在本实验剂量范围内。越橘叶黄素片属于安全性保健食品。

Toxicological evaluation was conducted on the edible safety of bilberry lutein tablets.Acute toxicity test,genetic toxicity test(Ames test,bone marrow cell micronucleus test and sperm deformities test)and rat 30 d feeding test were conducted according to food safety toxicology evaluation procedure and method.The acute toxicity test in mice through the mouth maximum tolerated dose(MTD)>20.0 g/kg bw,belongs to the non-toxic level.The results of Ames test,bone marrow cell micronucleus test and sperm malformation were all negative,indicating that the subjects had no mutation effect.In rat 30 d feeding test,the animals were all well developed,and no abnormal changes were observed in the indexes of weight,food intake,hematology,blood biochemistry,organ coefficient and histopathology.Acute toxicology classification of bilberry lutein tablets was non-toxic and has no genetic toxicity,within the scope of this experimental dosage.Bilberry lutein tablets are safe health foods.