目的 對人工培植的蟬花孢梗束進行毒理學研究，評價其口服安全性。方法 利用急性毒性試驗、體外中國倉鼠肺細胞染色體畸變試驗、骨髓細胞微核試驗、鼠傷寒沙門氏菌回復突變試驗和孕鼠致畸試驗進行毒理學評價。結(jié)果 急性毒性試驗結(jié)果表明蟬花孢梗束對雌、雄大鼠急性經(jīng)口最大耐受量（MTD）均>10 g/kg，屬于無毒級；中國倉鼠肺細胞染色體畸變試驗、骨髓細胞微核試驗、鼠傷寒沙門氏菌回復突變試驗以及3項遺傳毒性試驗的結(jié)果皆為陰性，未顯示致突變性；蟬花孢梗束各劑量組在大鼠孕期體質(zhì)量、死胎率、吸收胎率與陰性對照組比較差異無顯著性（P>0.05），各劑量組胎鼠質(zhì)量、胎鼠身長、前囟寬度與陰性對照組比較差異無顯著性（P>0.05）；各劑量組在胎鼠外觀、內(nèi)臟發(fā)育、骨骼發(fā)育檢查上與陰性對照組比較差異無顯著性（P>0.05）。結(jié)論 在本研究條件下，未見蟬花孢梗束有急性毒性、遺傳毒性，對孕鼠無致畸作用，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

國家星火計劃（2015GA700011）