定量检测茵栀黄注射液细菌内毒素方法的建立及应用  

Method establishment for quantitative determination of bacterial endotoxin in Yinzhihuang Injection

作　　者：朱昱[1] 郭姣梅 张军霞[2] 周继春[2] 李振国[2] ZHU Yu;GUO Jiao-mei;ZHANG Jun-xia;ZHOU Ji-chun;LI Zhen-guo(Henan University of Chinese Medicine, Zhengzhou, Henan 450046, China)

机构地区：[1]河南中医药大学,河南郑州450046 [2]河南省食品药品检验所,河南郑州450003

出　　处：《中国卫生检验杂志》2019年第5期525-528,共4页Chinese Journal of Health Laboratory Technology

基　　金：河南省科技攻关计划项目(162102310067)

摘　　要：目的建立茵栀黄注射液中细菌内毒素的定量检测方法,与家兔法热原检测结果相比较,以确定动态显色基质法用于茵栀黄注射液中细菌内毒素定量检测的可行性。方法采用光度法中的动态显色基质法对茵栀黄注射液进行干扰试验,以明确供试品对动态显色法鲎试剂是否有干扰作用,确立不干扰浓度,并与家兔法热原检测结果相比较。结果使用动态显色法鲎试剂对茵栀黄注射液稀释至37.5倍时无干扰作用,回收率为50%～200%;家兔法检查3批茵栀黄注射液热原结果均符合规定,动态显色法与家兔法检查结果一致。结论动态显色基质法用于茵栀黄注射液中细菌内毒素含量的定量检测是可行的,相较于家兔法热原检查,其结果更稳定可靠,操作方便快捷,灵敏度高。Objective To establish a quantitative detection method for bacterial endotoxin in Yinzhihuang Injection, which was compared with the rabbit pyrogen test results, so as to determine the feasibility of dynamic chromogenic matrix method for quantitative detection of bacterial endotoxin in Yinzhihuang Injection. Methods Dynamic chromogenic matrix reagent in spectrophotometry was used to interfere Yinzhihuang Injection, determine whether the test article had a disturbing effect on horseshoe crab agent of dynamic chromogenic matrix method, also used to determine non-interference concentration and compared with rabbit pyrogen test results. Results Dynamic chromogenic matrix method was used to detect the endotoxin in Yinzhihuang Injection with 37.5-fold diluted concentration, the recovery rates was within 50%-200%, and pyrogenous results of 3 batches of Yinzhihuang Injection by rabbit method test were in line with the provisions. Dynamic chromogenic matrix method was consistent with the inspection result of rabbit method. Conclusion It is feasible for the quantitative detection of bacterial endotoxin content in Yinzhihuang Injection by dynamic chromogenic matrix method. Compared to the rabbit pyrogen test, the result is more stable and reliable, with the advantages of convenient operation and high sensitivity.

关 键 词：动态显色基质法 茵栀黄注射液 细菌内毒素 干扰试验 家兔法 

分 类 号：R286[医药卫生—中药学]