注射用卡络磺钠细菌内毒素检查方法研究  

Investigation on the method of bacterial endotoxin test for Carbazochrome Sodium Sulfonate for Injection

作　　者：孙智培 何硕 胡翮 SUN Zhipei;HE Shuo;HU He(Xiangtan Institute of Food and Drug Control,Xiangtan 411100,China)

机构地区：[1]湘潭市食品药品检验所,湘潭411100

出　　处：《中国药品标准》2020年第3期223-226,共4页Drug Standards of China

摘　　要：目的:建立注射用卡络磺钠的细菌内毒素检验方法。方法:按照《中国药典》2015年版四部通则1143细菌内毒素检查法,用两个不同厂家鲎试剂对3批注射用卡络磺钠进行了干扰实验和细菌内毒素检查。结果:注射用卡络磺钠浓度稀释至0.13 mg·mL^-1,使用灵敏度为0.25 EU·mL^-1的鲎试剂,对鲎试剂和细菌内毒素反应无干扰作用,可对注射用卡络磺钠进行细菌内毒素检查。结论:建立的方法可用于注射用卡络磺钠的细菌内毒素检查。Objective:To establish a method of bacterial endotoxin test for Carbazochrome Sodium Sulfonate for Injection.Methods:In accordance with bacterial endotoxin test in general notice 1143 of ChP 2015 VolumeⅣ,the TALs from two manufacturers were used to conduct the interference test and to determine bacterial endotoxin in three batches of Carosulfonate Sodium Sulfonate for Injection.Results:There was no interference on the reaction between TAL and bacterial endotoxin when Carbazochrome Sodium Sulfonate for Injection was diluted to 0.13 mg·mL^-1 and the TAL had the sensitivity of 0.25 EU·mL^-1.Conclusion:The established method can be applicable to bacterial endotoxin in Carbazochrome Sodium Sulfonate for Injection.

关 键 词：注射用卡络磺钠 细菌内毒素 凝胶法 干扰实验 

分 类 号：R921.2[医药卫生—药学]