张昕,黄文静,张肖群
ZHANG Xin,HUANG Wen-jing,ZHANG Xiao-qun (Guangdong Institute for Drug Control

• 1:广东省药品检验所

摘要(Abstract)：

目的针对4批颜色不合格注射用头孢呋辛钠进行结果分析。方法目测法和紫外-可见分光光度法检查注射用头孢呋辛钠溶液颜色,并采用2种溶剂对样品作不同处理。结果3次目测法结果与1次紫外-可见分光光度法测定结果基本一致,2种溶剂对检查结果没有明显影响。结论紫外-可见分光光度法可与目测法相结合,作为注射用头孢呋辛钠颜色的检查手段之一。
Objective To analyze the results of 4 batch of cefuroxime sodium for injections with solution colour disqualification.Methods The solution colour was determined by visual observation and ultraviolet-visible absorption spectroscopy,and the samples were separately dissolved in 2 solvents.Results Three results of visual observation were accordant with the result by ultraviolet-visible absorption spectroscopy.Two difference solvents had no significant effect on the results.Conclusion The combination method of visual observation and ultraviolet-visible absorption spectroscopy can be used for the determination of colour of cefuroxime sodium for injections.

关键词(KeyWords)： 注射用头孢呋辛钠;颜色;目测法;紫外-可见分光光度法
cefuroxime sodium for injection;solution colour;visual observation;ultraviolet-visible absorption spectroscopy

Abstract:

Keywords:

基金项目(Foundation):

作者(Author): 张昕,黄文静,张肖群
ZHANG Xin,HUANG Wen-jing,ZHANG Xiao-qun (Guangdong Institute for Drug Control

参考文献(References)：

• 1庞青云,柳飞,张洁萍,等.注射用头孢曲松钠溶液颜色与相关杂质的研究.中国药品标准,2009,10(2):101-105.
• 2王乾蕾,陆汉豪,黄冬.一批含量不合格阿莫西林颗粒测定结果分析.中国卫生产业,2007,48:112-113.
• 3中国药典委员会.中国药典.第2部.北京:化学工业出版社,2005.
• 4 JX20000076,注射用头孢呋辛钠进口药品注册标准.