清热类中药醒脑静注射液热原检测方法的比较  

The comparison of pyrogen tests for heat-clearing Xingnaojing Injection

作　　者：刘群 阮新 阮健 LIU Qun;RUAN Xin;RUAN Jian(Yantai Center for Food and Drug Control and Test,Yantai 264670,China;Technology Center of Yantai Customs,Yantai 264000,China)

机构地区：[1]烟台市食品药品检验检测中心,烟台264670 [2]烟台市海关技术中心,烟台264000

出　　处：《中国新药杂志》2021年第8期760-764,共5页Chinese Journal of New Drugs

摘　　要：目的:清热类中药醒脑静注射液热原检测中,对家兔法和动态浊度法进行比较。方法:选取3批清热类中药注射剂醒脑静注射液为研究对象,实验分为7个组,内毒素组、外加内毒素制成内毒素+供试品组3个、供试品组3个,采用家兔热原检查法进行热原检查,同时采用动态浊度法对醒脑静注射液中内毒素进行定量检测。结果:家兔法测定供试品组3批样品均无热原反应;内毒素组家兔体温升高均达到0.6℃,发生热原反应;内毒素+供试品组与内毒素组比较,2批样品的内毒素+供试品组热原检查呈假阴性。动态浊度法测定3批醒脑静注射液的细菌内毒素含量,内毒素含量<0.01 EU·mL^(-1)。结论:家兔热原检查法对清热类中药醒脑静注射液热原检测出现假阴性,动态浊度法能定量检测其细菌内毒素的含量。Objective:To compare the rabbit method and dynamic turbidity method for pyrogen detection in heat-clearing Xingnaojing injection.Methods:Three batches of heat-clearing type Chinese medicine injection,Xingnaojing injection,were selected as the research object.Animals were divided into seven groups,including endotoxin,3 groups of endotoxin+endotoxin test samples,3 groups of endotoxin test samples.Pyrogen was tested using rabbit pyrogen examination.At the same time,the endotoxin in Xingnaojing Injection was quantitatively detected by dynamic turbidimetry.Results:No pyrogen reaction was found in 3 batches of test sample groups by rabbit method.The body temperature of rabbits in endotoxin group increased by 0.6℃,and the pyrogen reaction occurred.Compared with the endotoxin group,the pyrogen test in endotoxin+test group was false negative.The contents of bacterial endotoxin in 3 batches of Xingnaojing Injection groups were determined by dynamic turbidimetric method,the content of endotoxin was<0.01 EU·mL^(-1).Conclusion:Rabbit pyrogen test is easy to produce false negative results for pyrogen test of heat-clearing Xingnaojing Injection,and dynamic turbidimetry can quantitatively detect the contents of bacterial endotoxin.

关 键 词：醒脑静注射液 细菌内毒素 热原检查法 动态浊度法 

分 类 号：R927.1[医药卫生—药学]