中药注射剂热原检查家兔热原法和动态浊度法的比较  

Comparison between Rabbit Pyrogen Test and the Kinetic-turdimetric Assay in the Traditional Chinese Medicine Pyrogen Test Injection

作　　者：周年 郑洋滨 熊明朋 洪燕 刘宁 刘波 ZHOU Nian;ZHENG Yang-bin;XIONG Ming-peng;HONG Yan;LIU Ning;LIU Bo(Jiangxi Institute for Drug Control,NMPA Key Laboratory of Quality Evaluation of Traditional Chinese Patent Medicine,Jiangxi Province Engineering Research Center of Drug and Medical Device Quality,Jiangxi Nanchang 330029,China)

机构地区：[1]江西省药品检验检测研究院,国家药品监督管理局中成药质量评价重点实验室,江西省药品与医疗器械质量工程技术研究中心,江西南昌330029

出　　处：《中国药物评价》2022年第3期204-208,共5页Chinese Journal of Drug Evaluation

摘　　要：目的:对中药注射剂热原检查家兔热原法和鲎试剂动态浊度法进行比较。方法:以随机抽取的10批次中药注射剂为研究对象,分别采用家兔热原法和动态浊度法进行热原检查。结果:10批中药注射剂的家兔热原法热原检查均符合规定,动态浊度法能定量检测中药注射剂中细菌内毒素含量且结果与家兔热原法一致。结论:动态浊度法能定量检测中药注射剂中细菌内毒素的含量,在快速检测中优于家兔热原法,可作为中药注射剂热原检查的补充方法。Objective:To compare the pyrogen test of traditional Chinese medicine injection with rabbit pyrogen test and kinetic-turbidimetric assay of tachypleus amebocyte lysate.Methods:10 batches of traditional Chinese medicine injections randomly selected as the research object were examined by rabbit pyrogen test and kinetic-turbidimetric assay.Results:The rabbit pyrogen test of 10 batches of traditional Chinese medicine injections met the requirements.The kinetic-turbidimetric assay could quantitatively detect the content of bacterial endotoxin in traditional Chinese medicine injections,and the results were consistent with the rabbit pyrogen test.Conclusion:The kinetic-turbidimetric assay can quantitatively detect the content of bacterial endotoxin in traditional Chinese medicine injection,which is better than rabbit pyrogen test in rapid detection.It can be used as a supplementary method for pyrogen test of traditional Chinese medicine injection.

关 键 词：中药注射剂 家兔热原法 动态浊度法 热原 

分 类 号：R927.12[医药卫生—药学]