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目的:建立定量检测注射用头孢哌酮钠/舒巴坦钠细菌内毒素的实验方法。方法:采用《中国药典》2005年版二部附录中细菌内毒素的动态浊度法。结果:注射用头孢哌酮钠/舒巴坦钠用细菌内毒素定量法检测无干扰因素影响,内毒素回收率在50%～200%之间,符合《中国药典》规定。结论:使用动态浊度法定量检测注射用头孢哌酮钠/舒巴坦钠中细菌内毒素含量是可行的。
Objective: To establish a method for the quantitative detection of bacterial endotoxin in cefoperazone sodium / sulbactam sodium for injection. Methods: The dynamic turbidity method of bacterial endotoxin in the appendix of 2005 edition of Chinese Pharmacopoeia was used. Results: Cefoperazone sodium / sulbactam sodium for injection was detected by bacterial endotoxin quantification method without interfering factors, and the recovery rate of endotoxin was between 50% and 200%, which accorded with “Chinese Pharmacopoeia”. Conclusion: It is feasible to use dynamic nephelometry to quantitatively detect bacterial endotoxin in cefoperazone sodium / sulbactam sodium for injection.