三七红曲复方制剂遗传毒性评价

目的评价三七红曲复方制剂的遗传毒性。方法通过细菌回复突变试验(Ames试验)、小鼠骨髓细胞微核试验和小鼠睾丸染色体畸变试验组合的方式评价三七红曲复方制剂的遗传毒性。结果Ames试验中,在8~5000μg/皿剂量范围内,TA97a,TA98,TA100,TA102和TA1535的回复突变菌落数与溶媒对照组比较无统计学差异(P>0.05);小鼠微核试验和睾丸染色体畸变试验中,2,4,8 g/(kg·d)^-1剂量组的微核率和细胞畸变率与溶媒对照组比较未见升高趋势(P>0.05)。3项遗传毒性试验结果均为阴性。结论在本试验条件下,三七红曲复方制剂未见遗传毒性作用。

Genotoxicity Evaluation of Sanqi and Hongqu Compound Preparation

Objective To evaluate the genetic toxicity of Sanqi and Hongqu Compound Preparation.Methods The genotoxicity of Sanqi and Hongqu Compound Preparation was evaluated by the combination of bacterial recovery mutation test(Ames test),micronucleus test of mouse bone marrow cells and chromosome aberration test of mouse testis.Results In Ames test,there was no significant difference in the number of mutant colonies of TA97a,TA98,TA100,TA102 and TA1535 in the dose range of 8-5000μg/plate compared with the solvent control group(P>0.05).In the micronucleus test and testicular chromosome aberration test in mice,the micronucleus rate and cell aberration rate in 2g/(kg·d)^-1,4g/(kg·d)^-1 and 8g/(kg·d)^-1 groups showed no increasing trend compared with the solvent control group(P>0.05).All three genotoxicity tests were negative.Conclusion Under the condition of this experiment,no genotoxicity is observed in Sanqi and Hongqu Compound Preparation.