关键词: 安特芬; 精子畸形试验; 微核试验; 安全性评价

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.

Key words: ANTIDEP (Terbinafine); sperm abnormality test; micronucleus test; evaluation of safety