叶黄素咀嚼片毒理学安全性评价

Toxicology and safety assessment of lutein chewable tablets

目的:评价叶黄素咀嚼片作为功能性食品食用的毒理学安全性。方法:按照我国卫生部《食品安全毒理学评价程序和检验方法规范》进行急性毒性试验、遗传毒性试验(Ames试验、小鼠骨髓细胞微核试验、小鼠精子畸形试验)和30 d喂养试验进行毒理学研究。结果:叶黄素咀嚼片对两种性别的ICR小鼠急性经口最大耐受剂量>20.0g/kgbw,按照急性毒性分级标准规定,该受试物属无毒级;遗传毒性试验(Ames试验、骨髓细胞微核试验、小鼠精子畸形试验)均为阴性;30d喂养试验表明,该受试物在0.19、0.38、0.75g/kgbw(分别相当于推荐人群日摄入量的25、50、100倍)剂量时,对SD大鼠的临床检查、血液学、血生化学和脏器重量和系数以及病理组织形态等指标均无明显不良影响。结论:叶黄素咀嚼片具有较好的食用安全性。

Objective ： To evaluate the toxicological safety of lutein chewable tablets. Methods ： according to the nation- al standards of Food toxicological assessment issued by Healthy Ministry of PRC, theacute toxicity, genotoxicity tests （Ames test, bone marrow cell micronucleus, sperm shape abnormality） and thirty days feeding test were carried out. Results： The acute toxicity result shows that the biggest tolerance dose of lutein chewable tabletson different sex ICR mice was more than 20.0g/kgbw. The results fell into the scale of non - toxicity. Three genotoxicity tests （ Ames test, bone marrow cell micronucleus, sperm shape abnormality） were all negative. The results of test on feeding for 30 days showed that there were no evident influence on the clinic experiment, hematology, biochemistry, the weight and coeffi- cient of visceral organ and several indexes of pathological organization under the experiment dosage range of O. 19,0. 38、O. 75g/kg bw （which were 20, 50 and 100 times separately of recommended absorption for human groups a day）. Conclusion： lutein chewable tablets is very safe.