注射用头孢呋辛钠杂质谱研究

Study on the impurity profile of cefuroxime sodium for injection

目的对两个国内厂家生产的注射用头孢呋辛钠和原研品的杂质谱进行对比分析,并对检出主要杂质的结构和来源进行分析。方法采用中国药典有关物质方法对注射用头孢呋辛钠的杂质情况进行对比分析,采用高分辨质谱对检出的主要杂质进行结构鉴定。结果两个国内厂家产品的杂质谱与原研品相当,检出的主要杂质的结构一致。结论注射用头孢呋辛钠中检出的杂质主要为降解杂质,为保证临床用药的安全性,建议在中国药典中增加对已知降解杂质的控制。

Objective To compare the impurity profiles of cefuroxime sodium for injection produced by two domestic pharmaceutical manufactures and the original drugs,and study the sources and structures of major impurities.Methods To detect and analyze the impurity profiles of cefuroxime sodium for injection by the related substances method in the Chinese Pharmacopoeia.To identify the structures of major impurities,high resolution mass spectrometry was used.Results The impurity profiles of cefuroxime sodium for injection produced by two domestic pharmaceutical manufactures are similar to that of the original drugs,and the structures of the majorimpurities were the same.Conclusion In order to ensure the safety of clinical medication,it is recommended that the control of known degradable impurities in Chinese Pharmacopoeia should be increased,because the major impurities detected in cefuroxime sodium for injection are mainly come from degradation.