粉葛氨糖复方毒理学安全性评价

Assessment on Safety of Kduzu-glucosamine Formula

摘要:

按照保健食品安全性毒理学评价程序，采用急性毒性试验、遗传毒性试验（Ames试验、小鼠骨髓微核试验、小鼠精子畸形试验）和30 d喂养试验进行粉葛氨糖复方的安全性评价。结果粉葛氨糖复方对雌、雄昆明种小鼠的最大耐受剂量（MTD）均大于20.0 g/(kg?bw)；三项遗传毒性试验（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）结果均为阴性；30 d喂养试验未见大鼠的生长发育、血液学、生化及组织病理学有异常变化。粉葛氨糖复方急性毒性分级属无毒级、无遗传毒性，在本实验剂量范围内，属安全性保健食品。

Abstract:

According to procedures for toxicological assessment of supplement food, acute toxicity test, genetic toxicity test (Ames test，micronucleus test of born marrow in mice，sperm shape abnormality test in mice) and thirty-day feeding test in rats were conducted to assess toxicological safety of mice and rats fed with Kduzu-glucosamine formula. The results showed that mouse oral LD50 was above 20.0 g/(kg?bw). Ames test and micronucleus test of bone marrow cells and sperm shape abnormality test in mice were all negative. Rats after being fed Kduzu -glucosamine Formula for 30 d with three different doses groups grew well. Hematology and hematology biochemistry index were all normal. No abnormal symptoms were observed after gross anatomy. Kduzu-glucosamine formula belongs to the actual innocuous level and no-genetic toxicity, being used according to recommending amounts is safe.