铁皮枫斗胶囊的毒性研究及安全性评价

A toxicological security study of dendrobium candidum capsule

目的:对铁皮枫斗胶囊的食用安全性进行毒理学评价。方法:采用急性毒性试验、遗传毒性试验(Am es试验、小鼠骨髓微核试验、小鼠精子畸形试验)和30d喂养试验进行评价。结果:雌雄小鼠经口MTD均大于20.0 g/kg体重,A-m es试验、小鼠骨髓微核试验、小鼠精子畸形试验三项遗传毒性试验结果均为阴性。30 d喂养试验未见大鼠的生长发育、血液学、生化、脏体比及组织病理学有异常变化。结论:铁皮枫斗胶囊急性毒性分级属无毒级、无遗传毒性,最大无损害作用剂量大于4.0 g/kg体重,相当于人体推荐摄入量的100倍。在本实验剂量范围内,铁皮枫斗胶囊属安全性保健食品。

Objective：To provide the toxicological evaluation for safety of Dendrobium Candidum capsule.Methods： 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 in this study.Results： The oral MTD in both male and female mice were more than 20.0 g/kg.BW,the results of Ames test,micronucleus test of born marrow in mice,sperm shape abnormality in mice were negative.The thirty-day feeding test in rats demonstrated that it had no obvious toxic effects on growth and development,routine blood,biochemical index,VSI and histopathological changes.Conclusion： Dendrobium Candidum capsule test results showed non-toxic and non-genetic toxicity in acute toxicity test.The largest dose of this sample for no obvious adverse effects was 4.0 g/kg.BW,which is equivalent to 100 times of the recommended amount for human body.Within the scope of this test dose,Dendrobium Candidum capsule is a kind of health food products and was safe for edibility.