摘要
建立检测复方电解质注射液中细菌内毒素的动态浊度法。确定样品细菌内毒素限值(L)为0.5 EU/mL,建立细菌内毒素的标准曲线,考察供试品对细菌内毒素检查的干扰情况,分析不同稀释倍数下细菌内毒素的回收率,并进行验证。结果显示,细菌内毒素浓度线性范围为0.01042~2.0000 EU/mL;供试品稀释20~40倍时,细菌内毒素回收率均50%~200%范围内;方法准确性及精密度试验的变异系数均小于10%;3批样品的细菌内毒素含量均小于检测限,回收率在64%~75%范围内。该方法快速简便,灵敏度高,抗干扰性强,可用于复方电解质注射液中细菌内毒素的定量检测。
To establish a kinetic turbidimetric assay(KTA)for the detection of bacterial endotoxin in compound electrolyte injection.The limit(L)of bacterial endotoxin was determined to be 0.5 EU/mL,the standard curve for detection of bacterial endotoxin by KTA was plotted,the interference of samples on the detection of bacterial endotoxin was investigated,the recovery rate of the bacterial endotoxin at different dilution multiples was analyzed,and the validation test was carried out.The results showed that the linear range of bacterial endotoxin concentration was 0.01042-2.0000 EU/mL.When the test sample was diluted by 20-40 multiples,the recovery rate of bacterial endotoxin was in the range of 50%-200%,the coefficients of variation(CV)of accuracy test and precision test were less than 10%.The content of bacterial endotoxin in three batches of samples was less than the limited value,and the recovery rate was in the range of 64%-75%.The method is rapid,simple,sensitive and anti-interference,which can be used for the quantitative detection of bacterial endotoxin in compound electrolyte injection.
作者
黄俊辉
吴建福
张芬
廖霞
潘兴华
陈雪婷
陈勇军
梁晓
刘沐芸
HUANG Junhui;WU Jianfu;ZHANG Fen;LIAO Xia;PAN Xinghua;CHEN Xueting;CHEN Yongjun;LIANG Xiao;LIU Muyun(Shenzhen Beike Bio-Technology Co.,Ltd,Shenzhen Guangdong,518000,China;National Engineering Research Center for Key Common Technologies in the Cell Industry)
出处
《质量安全与检验检测》
2024年第5期23-25,30,共4页
QUALITY SAFETY INSPECTION AND TESTING
关键词
动态浊度法
复方电解质注射液
细菌内毒素
Kinetic turbidimetric assay
Compound electrolyte injection
Bacterial endotoxin
