目的 对人工培植的蝉花孢梗束进行毒理学研究，评价其口服安全性。方法 利用急性毒性试验、体外中国仓鼠肺细胞染色体畸变试验、骨髓细胞微核试验、鼠伤寒沙门氏菌回复突变试验和孕鼠致畸试验进行毒理学评价。结果 急性毒性试验结果表明蝉花孢梗束对雌、雄大鼠急性经口最大耐受量（MTD）均>10 g/kg，属于无毒级；中国仓鼠肺细胞染色体畸变试验、骨髓细胞微核试验、鼠伤寒沙门氏菌回复突变试验以及3项遗传毒性试验的结果皆为阴性，未显示致突变性；蝉花孢梗束各剂量组在大鼠孕期体质量、死胎率、吸收胎率与阴性对照组比较差异无显著性（P>0.05），各剂量组胎鼠质量、胎鼠身长、前囟宽度与阴性对照组比较差异无显著性（P>0.05）；各剂量组在胎鼠外观、内脏发育、骨骼发育检查上与阴性对照组比较差异无显著性（P>0.05）。结论 在本研究条件下，未见蝉花孢梗束有急性毒性、遗传毒性，对孕鼠无致畸作用，具有良好的安全性。

Objective To evaluate the toxicological safety of Isaria cicadae synnemata (ICS). Methods The acute toxicity test, genotoxicity test (chromosome aberration of Chinese hamster lung fibroblast cells, micronucleus test of bone marrow cell in mice and Ames test) and teratogenicity test were employed for toxicological research and evaluation of ICS. Results Acute toxicity test showed that the acute oral maximum tolerateddoses (MTD) of ICS to male and female rats were both more than 10 g/kg,indicating that ICS was non-toxicity. The results of genotoxicity tests, including chromosome aberration of Chinese hamster lung fibroblast cells, bone marrow cell micronucleus test,and Ames test, were all negative without mutations. In addition, no obvious adverse effect was observed on the weight, stillbirth rate, fetus rate, weight of fetal rats, the length of the fetus, the width of the anterior tibia, the appearance, visceral development and skeletal development of the fetuses. Conclusion ICS is a non-toxic substance without acute toxicity, genetic toxicity and teratogenic effect on pregnant rats.

R285.5;R996.2

国家星火计划（2015GA700011）