不同规格鲎试剂对人血白蛋白热原进行检测的对比分析  

Comparative analysis on the detection of human albumin pyrogen with diffe rent limulus reagents

作　　者：佘姣姣 张宝献 龚志明 何小锋 刘泽彬 高语 谭娜 刘利 杨柳 SHE Jiaojiao;ZHANG Baoxian;GONG Zhiming;HE Xiaofeng;LIU Zebin;GAO Yu;TAN Na;LIU Li;YANG Liu(Hualan BioEngineering Chongqing Co.,LTD.,Chongqing 408100,China)

机构地区：[1]华兰生物工程重庆有限公司,重庆408100

出　　处：《当代医药论丛》2023年第12期92-94,共3页

摘　　要：目的:比较几种规格鲎试剂检测人血白蛋白热原的结果,选出高灵敏度、少稀释的规格备用。方法:按《中国药典》2020年版通则中的“1143细菌内毒素检查法”进行人血白蛋白热原的检测,采用不同厂家、不同灵敏度的鲎试剂对不同批号的人血白蛋白分别进行干扰试验。结果:在验证条件下,选用0.06 EU·mL^(-1)鲎试剂,供试品以BET水稀释1~27倍(5 g/L)、2~55倍(10 g/L),对细菌内毒素检查法无干扰作用。结论:文中建立的方法用于检查人血白蛋白的热原可行,且稳定性良好。Objective:To compare the results of several specifications of limulus lysate for the detection of human albumin pyrogen,and select the specifications with high sensitivity and less dilution.Methods:According to the“1143 bacterial endotoxin test method”in the General rules of Chinese Pharmacopoeia(2020 Edition),human blood albumin pyrogen was detected,and interference tests were performed on different batches of human blood albumin using limulus reagents of different manufacturers and different sensitivities.Results:Under the conditions of verification,0.06 EU·mL^(-1) limulus reagent was used to dilute the tested products with BE T water 1-27 times(5 g/L)and 2-55 times(10 g/L),which had no interference with bacterial endotoxin test.Conclusion:The method established in this paper is feasible and stable for detecting pyrogen of human blo od albumin.

关 键 词：人血白蛋白 细菌内毒素 凝胶法 鲎试剂 干扰试验 

分 类 号：R97[医药卫生—药品]