癌变·畸变·突变

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头孢嗪脒钠的遗传毒性研究

陈秀娟,黄俊明*,李 欣,李 庆,陈美芬,梁扬盛   

  1. ( 广东省疾病预防控制中心,广东 广州 511430 )  
  • 收稿日期:2013-06-25 修回日期:2013-09-03 出版日期:2013-09-30 发布日期:2013-09-30
  • 通讯作者: 黄俊明,Tel:020-31051228;E-mail:huang jun ming@ cdcp.org.cn
  • 作者简介:陈秀娟 (1974- ),女,广东人,检验师,研究方向:遗传毒理。 E-mail:clover0815@foxmail.com

The genetic toxicity of cetirizine amidine sodium

CHEN Xiu-juan,HUANG Jun-ming*,LI Xin,LI Qing,CHEN Mei-fen,LIANG Yang-sheng   

  1. (Centre for Disease Control and Prevention of Guangdong Province, Guangzhou 511430, Guangdong, China)
  • Received:2013-06-25 Revised:2013-09-03 Online:2013-09-30 Published:2013-09-30
  • Contact: HUANG Jun-ming,Tel:020-31051228;E-mail:huang jun ming@ cdcp.org.cn

摘要:

目的: 探讨头孢嗪脒钠的遗传毒性,为其作为新药的开发应用提供必要的实验资料。方法:采用哺乳动物骨髓细胞微核试验、哺乳动物骨髓细胞染色体畸变试验和鼠伤寒沙门氏菌回复突变试验 (Ames试验)对头孢嗪脒钠的遗传毒性进行研究。结果:头孢嗪脒钠各剂量组的微核率与阴性对照组比较,差异均无统计学意义 (P>0.05);各剂量组细胞的染色体畸变率与阴性对照组比较,差异均无统计学意义(P>0.05);各剂量组下的TA97、TA98、TA100、TA102菌株的回变菌落数与溶剂对照组比较,回变菌落数均未出现两倍或两倍以上增加。结论:在本实验条件下,未检测到头孢嗪脒钠的遗传毒性。

关键词: 头孢嗪脒钠, 头孢类抗生素, 遗传毒性, 安全性评价

Abstract:

OBJECTIVE: To explore the genetic toxicity of cetirizine amidine sodium and to evaluate whether cetirizine amidine sodium would change the genetic material in the body. Providing necessary experimental data for its development and application as a new drug. METHODSThree tests were used to study the genetic toxicity of cetirizine amidine sodium: bone marrow cell micronucleus test,in vitro mammalian cells chromosome aberration test and salmonella typhimurium typhimurium mammals microsomal enzyme test (Ames test). RESULTSThe rates of micronucleus in each dose group and negative control group showed no significant difference (P>0.05). Cell chromosome aberration frequency in each group and in negative control group revealed no significant difference. Comparing with the solvent control group,the number of revertant colonies of TA97,TA98,TA100,TA102 strains did not increase twice or more times. CONCLUSION: Under this experimental condition,cetirizine amidine sodium did not demonstrate any genetic toxicity.

Key words: cetirizine amidine sodium, cephalosporin, genetic toxicity, safety evaluation