周培育;符秀娟;
ZHOU Pei-yu1,FU Xiu-juan2(1.Hainan Chuntch Pharmaceutical Co.Ltd.,Haikou 570216,China;2.Hainan Vocational and Technical Institute of Biological Sciences,Haikou 570216,China)

• 1:海南中化联合制药工业有限公司
• 2:海南职业技术学院生物科学系

摘要(Abstract)：

目的建立注射用头孢地嗪钠的细菌内毒素检查方法。方法采用《中华人民共和国药典》2005年版二部附录XI E收载的细菌内毒素检查法。结果注射用头孢地嗪钠稀释成质量浓度为1.25 g.L-1供试液,用浓度为0.125 EU.mL-1的鲎试剂对细菌内毒素检查无干扰。结论采用细菌内毒素检查法检查注射用头孢地嗪钠的细菌内毒素是可行的。
Objective To establish a bacterial endotoxin test method of cefodizime sodium for injection.Methods The bacterial endotoxin test method in Chinese Pharmacopoeia(Edition 2005,VolumeⅡ) was adopted.Results Cefodizime sodium for injection in concentration of 1.25 g·L-1 had no interference to the bacterial endotoxin test,and the lowest limit of detection of the bacterial endotoxin accorded with the regulation.Conclusions It is feasible to detect the bacterial endotoxin of cefodizime sodium for injection by the method of determination of bacterial endotoxin.

关键词(KeyWords)： 头孢地嗪钠;注射剂;细菌内毒素检查法
cefodizime sodium;injection;bacterial endotoxin inspection

Abstract:

Keywords:

基金项目(Foundation):

作者(Authors): 周培育;符秀娟;
ZHOU Pei-yu1,FU Xiu-juan2(1.Hainan Chuntch Pharmaceutical Co.Ltd.,Haikou 570216,China;2.Hainan Vocational and Technical Institute of Biological Sciences,Haikou 570216,China)

DOI: 10.14066/j.cnki.cn21-1349/r.2010.05.013

参考文献(References)：

• [1]国家药典委员会,中华人民共和国药典:二部[M].北京:化学工业出版社,2005:附录XI E.