目的 通过遗传毒性研究，评价冬虫夏草西洋参复合物的毒理学安全性。方法 按照Ames实验、小鼠骨髓细胞微核试验及小鼠精子畸形实验方法进行研究，并对实验结果进行判定。结果 冬虫夏草西洋参复合物对雌、雄小鼠的急性毒性最大耐受剂量均大于12.0 g/kg；Ames实验中5个剂量组回变菌落数均未超过自发回变组的2倍，且无剂量-反应关系；复合物3个剂量组骨髓细胞微核实验中雌鼠微核率分别为0.32%、0.36%、0.40%，雄鼠微核率分别为0.30%、0.32%、0.40%；小鼠精子畸形实验中精子畸形率分别为2.4%、2.3%、2.3%，微核率和精子畸形率与对照组比较均无显著性增加（P＞0.05）。

Objective To evaluate toxicological safety of Cordyceps sinensis and Panax quinquefolium compound according to the genetic toxicity study. Methods Mice acute oral toxicity test, Salmonella typhimurium reverse mutation test, micronucleus test of mice bone marrow and mice sperm shape abnormality test were carried out in the compound. Results The MTD of the compound was greater than 12.0 g/kg BW for both male and female mice in the acute oral toxicity test, which shows non-toxic substance. The reverse mutation number of Salmonella typhimurium reverse mutation test in five dose groups did not exceed 2-fold of the spontaneous revertant colony number, nor was there a dose-response relationship, the result of Ames test was negative. Micronucleus rate of each dose group for female mouse were 0.32%, 0.36%, and 0.40%, respectively. Micronucleus rate of each dose group for male mouse were 0.30%, 0.32%, and 0.40%, respectively. Sperm shape abnormality rate of each dose group were 2.4%, 2.3%, and 2.3%, respectively. Micronucleus rate and sperm shape abnormality rate had no significant increase compared with the negative control. The results of micronucleus test of mice bone marrow and mice sperm shape abnormality test were negative. Conclusion Under this experimental condition, the genetic toxicity of the compound is not found, and it is classified as non-toxic.

湖北省科技支撑计划项目（2014BEC094）