摘要
目的研究硫酸氢氯吡格雷左旋异构体的毒性,为控制其限度提供依据。方法通过静脉给药的方式分别对实验动物注射硫酸氢氯吡格雷与硫酸氢氯吡格雷左旋异构体,观察试验动物毒性反应情况,记录实验动物给药后的反应和持续时间,并在给药后连续观察14 d。结果硫酸氢氯吡格雷左旋异构体在50 mg/kg的给药剂量时会产生明显的神经毒性,而硫酸氢氯吡格雷无神经毒性。结论应严格控制片剂中左旋异构体的含量,其限度不超过1.0%可保证硫酸氢氯吡格雷片的足够安全。
Objective Establish a basis on controlled limit of clopidogrel hydrogen sulfate levisomer by investigating the neurotoxicity of clopidogrel hydrogen sulfate levisomer in animails.Methods The animails were intravenously administered a certain amount of clopidogrel hydrogen sulfate and clopidogrel hydrogen sulfate levisomer,respectively.The animal toxic reactions and reaction time were continuously observed and recorded for 14 d.Results Obvious neurotoxicity reactions were observed in animails when a dose of 50 mg/kg of clopidogrel hydrogen sulfate levisomer was administered,while no neurotoxicity reactions were observed for clopidogrel hydrogen sulfate.Conclusion To ensure the safety of clopidogrel hydrogen sulfate tablets,the content of clopidogrel hydrogen sulfate levisomer in clopidogrel hydrogen sulfate tablets should be controlled at a limit of not more than 1.0%.
出处
《今日药学》
CAS
2013年第5期257-260,共4页
Pharmacy Today
基金
国家"十二五"新药创制科技重大专项(编号:2012ZX09201101-006)
