微量动态显色法定量检测胎牛血清中细菌内毒素含量  

Quantitative detcetion of bacterial endotoxin content in fetal bovine serum by micro-kinetic chromogenic method

作　　者：方韵 屠哲玮 黄依雯 季文君 FANG Yun;TU Zhe-wei;HUANG Yi-wen;JI Wen-jun(Suzhou Institute for Drug Control,Suzhou Jiangsu 215000)

机构地区：[1]苏州市药品检验检测研究中心,江苏苏州215000

出　　处：《中南药学》2024年第5期1350-1353,共4页Central South Pharmacy

摘　　要：目的 探讨微量动态显色法定量检测胎牛血清中的细菌内毒素的可行性,并与凝胶法结果比较。方法 采用微量动态显色法鲎试剂,建立标准曲线,通过预干扰试验确定稀释倍数,测定供试品外加内毒素回收率进行干扰试验,对供试品进行定量检测,并与凝胶法试验结果进行比较。结果 标准曲线的线性范围为0.02~20 EU·mL^(-1),回归方程为lgT=2.9334-0.2883 lgC,相关系数| r |=0.9992,供试品在稀释200倍时无干扰作用,细菌内毒素回收率在50%~200%内,其中3批供试品的内毒素定量检测结果小于规定限值,1批高于限值,检测结果与凝胶法一致。结论 本品可采用微量动态显色法定量检测细菌内毒素含量,进行质量控制。Objective To determine the feasibility of quantitatively detecting the bacterial endotoxin in fetal bovine serum by micro-kinetic chromogenic method and compare the results with those of gel-clot method.Methods The micro-kinetic chromogenic method of limulus reagent was used to establish a bacterial endoxtoxin standard curve.The dilution factor was determined through interference pre-experiment,and the recovery rate of the endotoxin added to the test solution was determined.The interference test was performed to quantitatively detected the bacterial endotoxin content in the test product,and the results were compared with those of the gel-clot method.Results-The linear range of the standard curve was 0.02 to 20 EU·mL^(-1),the regression equation was lgT=2.9334-0.2883 lgC,and the correlation coefficient|r|=0.9992.The samples had no interference when being diluted 200 times,the recovery rate of bacterial endotoxin ranged from 50%to 200%.The result of endotoxin quantitative detection for 3 batches of samples was lower than the specified limit,and that of 1 batch was higher than the limit.Conclusion Micro-kinetic chromogenic method for quantitative detection of the bacterial endotoxin can be used for the quality control of fetal bovine serum.

关 键 词：微量动态显色法 胎牛血清 细菌内毒素 定量检测 

分 类 号：R927[医药卫生—药学]