和辉胶囊的毒理学安全性评价

本研究了评价保健食品和辉胶囊的食用安全性。依据国家卫生和计划生育委员会《保健食品检验与评价技术规范》(2003年版)和《食品安全性毒理学评价程序》(GB 15193.1-2014),开展大鼠急性毒性试验、遗传毒性试验(小鼠骨髓细胞微核试验、小鼠精子畸形试验、Ames试验)和大鼠30 d喂养试验,对和辉胶囊进行毒理学研究,观察其有无毒性反应。结果表明,急性毒性实验中,雌、雄大鼠对和辉胶囊的最大耐受剂量(MTD)均大于15.0 g/kg·bw,和辉胶囊属无毒级;小鼠骨髓细胞微核试验、小鼠精子畸形试验、Ames试验三项结果均为阴性,和辉胶囊无遗传毒性;大鼠30 d喂养试验中,和辉胶囊试验剂量在1.20 g/kg·bw~4.80 g/kg·bw范围内(最高剂量相当于人体推荐用量的100倍),大鼠的生长发育、血液学、血液生化学及病理学方面各项相关指标的检验均未发现明显不良影响。说明和辉胶囊无急性毒性、遗传毒性和亚急性毒性,具有较高的食用安全性。

Toxicological Safety Evaluation of Hehui Capsule

This study evaluated the edible safety of health food Hehui capsule. According to the National Health and Family Planning Commission''s (2003 edition) and (GB15193.1-2014), the rat acute toxicity test, genotoxicity test (micronucleus test of bone marrow cells, sperm abnormality test and Ames test in mice) and feeding test of 30 days in rats were carried out to observe if there was toxic reaction. The results showed that the maximum tolerated dose (MTD) of male and female rats to Hehui capsule was higher than 15.0 g/kg?bw in acute toxicity test, so the Hehui capsule was nontoxic; The results of micronucleus test of bone marrow cells, sperm malformation test and Ames test in mice were all negative, Hehui capsule had no genotoxicity; In the 30-day feeding test of rats, the dose of Hehui capsule was within the range of 1.20 g/kg?bw ~ 4.80 g/kg?bw (the maximum dose was equal to 100 times the recommended dose of the human body). There were no significant adverse effects on the test of relevant indicators in the growth, development, hematology, blood biochemistry and pathology of rats. It showed that Hehui capsule had no acute toxicity, genetic toxicity and subacute toxicity, and had high food safety.