摘要
目的 :建立复方醋酸钠注射液的细菌内毒素检测法。方法 :参照《中国药典》2 0 0 0年版二部收载的细菌内毒素检测法进行试验。结果 :经干扰试验 ,复方醋酸钠注射液对鲎试剂的凝集反应无干扰作用 ,用标示灵敏度 0 .5 EU/ml的鲎试剂检测细菌内毒素是有效的。结论
Objective: To establish a bacterial endotoxin testing method for monitoring pyrogen of compound sodium acetate injection. Methods: Bacterial endotoxin test method described in the Chinese pharmacopoeia (2000 edition) was used. Results: The test showed that the reaction with amebocyte lysate was not disturbed by compound sodium acetate injection and the sensitivity was 0.5EU/ml. Conclusion: Amebocyte lysate method can be used in place of rabbit method for pyrogen monitoring of compound sodium acetate injetion.
出处
《天津药学》
2001年第6期75-76,共2页
Tianjin Pharmacy
关键词
复方醋酸钠注射液
细菌内毒素
热原检测
compound sodium acetate injection, bacterial endotoxin, pyrogen test