甲氟哌酸的致突变和致畸试验  

THE MUTAGENICITY AND TERATOGENICITY OF PEFLOXACIN

作　　者：孙曼琴[1] 关丽云[1] 李天云[1] 

机构地区：[1]北京医科大学临床药理研究所

出　　处：《中国临床药理学杂志》1989年第4期211-215,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：甲氟哌酸是一种喹诺酮类衍生物,本品具有强大广谱抗菌活性。本实验根据我国新药审批要求来检测国产甲氟哌酸的致突变和致畸作用。甲氟哌酸的致突变作用试验是通过体内、体外两条途径来检测,实验结果表明:不同剂量的甲氟哌酸均无效突作用;用wistar大鼠作致畸试验,实验结果表明:甲氟哌酸不同剂量组对胎鼠的发育无明显影响,活体外观和内脏、骨骼检查均未见异常。Pefloxacin is one of the quinolone derivatives, which hasstrong antibacterial activity against most pathogenic bacteria. The aim ofpresent study was to test the mutagenicity and teratogenicity of home madepefloxacin according to the requirement of the provisions For New DrugApproval of the Country. The Mutagenic effect of pefloxacin was examined in vitro by using indu-ction of micronucleus in the PCEs of mice bone marrow and induction ofchromosomal abrration in human ambilical cord blood. LACA mice wereused in the micronucleus test, animals were divided into 5 groups. Peflo-xacin was (ip) at the dosages of 200, 300 and 400mg/kg, cyclophosphamide(60mg/kg) was used as positive control and the fifth group given solvenonly was used as negative control. The results showed that there were noremarkble difference among different dosage groups of pefloxacin comparedwith the negative control (P>0. 05). The dosaages of pefloxacin used in the chromosomal aberration test were100, 200 and 400μg/ml, The results also showed that there were no obviousdifference between tbe test groups and the negetive control group. The teratogenicity test of pefloxacin was performed in pragnant ratsdivided randomly into 5 groups. In two control groups (negative and posi-tive control), with 5% glucose and concentrated cod-liver were givenorally in a dose of 0.5ml/rat and 0. 6ml/rat, and the dosage of three testgroups were 50, 100 and 150mg/kg respectively. The results showed thatthese were no obvious changes in growth external forms, viscera and ske-letons of the survived fetuses in the three test groups with pefloxacin.

关 键 词：甲氟哌酸 致突变 致畸 安全性 

分 类 号：R965.3[医药卫生—药理学]