佐匹克隆及其杂质对斑马鱼胚胎发育毒性的比较研究

目的 对佐匹克隆及其主要杂质的斑马鱼胚胎发育毒性进行比较研究.方法 以斑马鱼胚胎为实验对象,在体视光学显微镜下观察佐匹克隆及其主要杂质(杂质A、B、C和2-氨基-5-氯吡啶)在不同暴露浓度时对斑马鱼胚胎发育情况的影响,包括胚胎致畸、致死情况的检测与统计.结果 佐匹克隆及其4个杂质对斑马鱼胚胎发育的毒性表型类似;毒性作用...

Developmental toxicity of zopiclone and its impurities in zebrafish embryos

Objective To compare the toxicity of zopiclone and its main impurities on embryonic development of zebrafish.Methods Embryonic development of zebrafish was investigated under a stereo microscope at different concentrations of the drug.The teratogenicity and lethality of zebrafish embryos were statistically analyzed in conjunction with microscopic observation.Results Zopiclone and its impurities had a similar toxic phenotype to embryonic development of zebrafish and the toxic effects occurred during the development of embryonic organs.The results showed that both teratogenicity and the mortality rate of embryos were positively correlated with drug concentrations.The embryonic toxicity was the strongest in impurity C,followed by 2-amino-5-chloropyridine,impurity B,impurity A,and zopiclone.Conclusion Based on the impurity spectrum of zopiclone,the contents of impurities in marketed drugs and the experimental toxicity results of zopiclone and its major impurities on embryonic development,it was recommended that 2-amino-5-chloropyridine be controlled as a specified impurity with a strict limit in the quality specifications of zopiclone materials and preparations in order to ensure the safety and quality of this drug.