摘要
目的:建立枸橼酸焦磷酸铁溶液的细菌内毒素检测方法。方法:按《中国药典》2015年版四部通则1143细菌内毒素检查法进行试验和结果判断,采用凝胶法,用不同厂家的鲎试剂对枸橼酸焦磷酸铁溶液3批样品进行干扰试验和细菌内毒素检查。结果:根据生产单位药品标准和临床实际应用情况,确定枸橼酸焦磷酸铁溶液的细菌内毒素限值为2EU·mL^(-1)。其最大不干扰浓度为0.17 mg·mL^(-1),可用灵敏度为0.06 EU·mL^(-1)及以上的鲎试剂检测其中的细菌内毒素。结论:枸橼酸焦磷酸铁溶液可进行细菌内毒素检测。
Objective:To establish a method for determination of bacterial endotoxin in ferric pyrophosphate citrate solution.Methods:The interference test and bacterial endotoxin test of three batch samples of ferric pyrophosphate citrate solution were performed with the TALs from different manufacturers according to the gel method of bacterial endotoxin test in the Chinese Pharmacopeia 2015 VolumeⅣ.Results:The limit of bacterial endotoxin in ferric pyrophosphate citrate solution was set as 2 EU·mL^(-1)based on the criteria in house and clinical practice.The maximum non-interference concentration was 0.17 mg·mL^(-1),and the bacterial endotoxin could be tested with the 0.06 EU·mL^(-1)or higher sensitivity.Conclusion:The TAL can be used in bacterial endotoxin test for ferric pyrophosphate citrate solution.
作者
洪颖
盖雅婷
翁鹭娜
林丽花
张真
李玲玲
HONG Ying;GAI Yating;WENG Luna;LIN Lihua;ZHANG Zhen;LI Lingling(Xiamen Institute for Food and Drug Quality Control,361000,China)
出处
《中国药品标准》
CAS
2021年第1期15-18,共4页
Drug Standards of China
关键词
枸橼酸焦磷酸铁
细菌内毒素检查
干扰试验
ferric pyrophosphate citrate solution
bacterial endotoxin test
interference test
