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目的 染料木素原料药致突变性研究。方法 采用鼠伤寒沙门氏菌回复突变试验 ( Ames试验 )、小鼠骨髓嗜多染红细胞微核试验、小鼠睾丸精母细胞染色体畸变试验。结果 染料木素原料药各剂量组对鼠伤寒沙门氏菌株 TA97,TA98,TA1 0 0 ,TA1 0 2 无诱变性 ;也无诱发小鼠骨髓嗜多染红细胞微核率和睾丸精母细胞染色体畸变率增加的作用 (与溶剂对照组比较 ,P>0 .0 5 )。结论 在本试验条件下 ,染料木素原料药无致突变作用。
Objective To study the mutagenicity of genistein drug substance. Methods Salmonella typhimurium reverse mutation test (Ames test), micronucleus test of bone marrow erythrocyte polychromatic erythrocytes and chromosome aberration test of mouse testicular spermatocytes were used. Results The genistein API had no mutagenic effect on the Salmonella typhimurium strains TA97, TA98, TA100 and TA102 in each dose group; it also did not induce the micronucleus rate of polychromatic RBCs and chromosome aberration of testicular spermatocytes in murine bone marrow. The effect of the rate increase (P>0.05) compared to the solvent control group. Conclusion Under the conditions of this experiment, the genistein drug substance has no mutagenic effect.