雪蛤颗粒的安全性毒理学研究

Study on the safety and toxicity of Hashima Granules

目的考察雪蛤颗粒的安全性。方法以SD大鼠和昆明种小鼠为受试动物,对雪蛤颗粒进行了急性毒性试验、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)、大鼠30 d喂养试验的研究。结果 SD大鼠急性毒性试验经口最大耐受量(MTD)大于15 g/kg,判断雪蛤颗粒属无毒类;Ames试验、骨髓细胞微核试验、小鼠精子畸形试验3项遗传毒性试验结果均为阴性;大鼠30 d喂养试验:最高剂量为人体推荐摄入量的100倍,未引起大鼠整体健康状况、生理生化功能和器官组织形态学等各项重要指标的异常变化。结论雪蛤颗粒无明显毒副作用,为其安全性评价提供了一定的依据。

Objective To study the safety and toxicity of the Hashima Granules. Methods SD rat and Kunming mice were as test subjects, Acute oral toxicity test, genetic toxicity test（including Ames test, bone marrow micronucleus test and mouse sperm abnormality test）, 30 days feeding study in rats of Hashima Granules were carried on. Results MTD of acute oral toxicity test on SD rats was greater than 15 g/kg, and three genetic toxicity tests including Ames test, bone marrow micronucleus test, mice sperm abnormality test were all negative; 30 days rat feeding test showed that the highest dose was 100 times of recommended human intake, which did not cause abnormal changes in the key indicators of the overall health status, physiological and biochemical function and morphology and other organs and tissues of rats.Conclusion No obvious toxic and side effects of the Hashima granules are provided for the safety evaluation of the Hashima Granules.