摘要
目的评价毛蚶提取物的遗传毒性,为评价其安全性提供毒理学依据。方法选用体外细菌回复突变(Ames)试验、中国仓鼠肺细胞(CHL)体外染色体畸变试验、小鼠骨髓嗜多染红细胞微核试验,进行毛蚶提取物的遗传毒性研究。Ames试验设5 000.0、2 500.0、1 250.0、625.0、312.5μg/皿5个剂量;体外CHL细胞染色体畸变试验,设立5.00、2.50、1.25 mg/m L 3个剂量,毛蚶提取物与CHL细胞分别接触6、24 h;小鼠骨髓微核试验,设立5 000、2 500、1 250 mg/kg 3个剂量,给药1次。结果 Ames试验,毛蚶提取物在加与不加S9时各剂量组回变菌落数均未超过自发回变菌落数的2倍,亦无剂量相关性,结果为阴性;CHL染色体畸变试验,毛蚶提取物代谢活化组和非代谢活化组的染色体畸变率均低于5%,染色体畸变试验结果为阴性。小鼠骨髓微核试验,各剂量组的微核率与阴性对照组比较,差异不显著,结果为阴性。结论在本试验条件下,毛蚶提取物未见潜在的遗传毒性。
Objective To assess the genotoxicity of extract from Arca subcrenata, in order to provide toxicological basis for evaluating its safety. Methods Ames test, CHL chromosome aberration assay, and bone marrow micronucleus assay in mice were used. In Ames test, there were five dose groups respectively at follows： 5000.0, 2500.0, 1250.0, 625.0, and 312.5 rag/plate. In CHL chromosome aberration assay, the doses were 5.00, 2.50, and 1.25 mg/mL, exposure time were 6 and 24 h. In vivo micronucleus assay, there were 3 dose groups： 5000, 2500, 1250 mg/kg, for just once. Results In Ames test, in the presence of S9 mixture or not, the number of revertant colonies 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. At the concentration of 1.25--5.00 mg/mL, the extract from A. subcrenata achieved a chromosome aberration of less than 5% with or without S9 mixture, negative response was found. In bone marrow micronucleus assay, compared with negative control group, micronucleus rate of each dose group showed no significant difference, and the result was negative. Conclusion Under this conditions, no genotoxicity was observed in the extract from A. subcrenata.
出处
《药物评价研究》
CAS
2016年第3期357-361,共5页
Drug Evaluation Research
