【摘要】 采用小鼠精子畸形试验和微核试验,对安特芬(特比萘芬)进行体内致突变性评价。微核试验:小鼠32只分4组(阴性组、阳性组、治疗量组、2倍治疗量组),连续两次灌胃,间隔24 h,末次灌胃6 h后处死小鼠,取股骨制成骨髓涂片,Gimsa染色,读取微核率;精子畸形试验:雄性小鼠32只分4组(阴性组、阳性组、治疗量组、2倍治疗量组),灌胃5 d,首次给药35 d后处死小鼠,取附睾制片,读取精子畸形率。试验结果显示,安特芬试验组小鼠微核发生率与阴性对照组差异不显著(P>0.05),而阳性对照组微核发生率极显著高于阴性对照组(P<0.01);安特芬试验组小鼠精子畸形率与阴性对照组差异不显著(P>0.05),阳性对照组精子畸形率极显著高于阴性对照组(P<0.01)。研究结果表明,新药安特芬在推荐剂量下无体内致突变作用。更多还原

【Abstract】 Mouse sperm abnormality test and micronucleus test were used to evaluate mutagenicity of ANTIDEP(Terbinafine) in vivo studies.Mouse micronucleus test: 32 mice were divided into 4 groups,include negative group,positive group,the treatment volume group,two times the therapeutic dose group.The drugs was gastric perfused twice to the fasting mice at 24 h interval,6 h after the second perfusion,the mice were put to death.The femur bone marrow smear was made and Gimsa stained,count the MNCF(micronucleus frequency).Sperm abnormality test: 32 male mice were divided into 4 groups,include negative group,positive group,the treatment volume group,two times the therapeutic dose group.The drugs was gastric perfused 5 times to the fasting mice at 24 h interval,35 d after the first perfusion,the mice were put to death.Take the epididymis,and produce the sperm smear,examine the sperm deformity.The results showed that there were no significant difference between the experimental group and the negative group(P>0.05),while the positive control group was significantly higher than the negative control group(P<0.01);there were no significant difference between the experimental group and the negative group(P>0.05),while the positive control group was significantly higher than the negative control group(P<0.01).The results suggest that the new drug ANTIDEP has no mutagenesis in vivo.更多还原