动态显色法定量检测磺达肝癸钠注射液中的细菌内毒素  

Determination of bacterial endotoxin in fondaparinux sodium injection by kinetic chromogenic assay

作　　者：王巨才[1] 王雪[2] WANG Ju-cai;WANG xue(Hainan Drug Inspection Institute,Hainan 570216,China;Henan Provincial People’s Hospital,Zhengzhou 450003,China)

机构地区：[1]海南省药品检验所,海口570216 [2]河南省人民医院,郑州450003

出　　处：《药物分析杂志》2021年第1期180-184,共5页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立动态显色法测定磺达肝癸钠注射液中细菌内毒素含量。方法:依据2020年版《中华人民共和国药典》(通则1143细菌内毒素检查法)的要求,应用Pyros Kinetix^(■)Flex(PKF)细菌内毒素定量检测系统,使用动态显色法鲎试剂,建立细菌内毒素标准曲线,通过干扰预试验确定稀释倍数,测定供试品溶液中外加内毒素的回收率进行干扰试验,完成供试品中细菌内毒素含量的定量检测试验。Pyros^(■)EQS软件自动绘制并出具标准曲线,计算溶液中内毒素的绝对含量,生成报告储存在Oracle数据库中。结果:标准曲线的线性范围为0.001~0.125 EU·mL^(-1)(r=-0.9991),回归方程为lgT=-0.2658 lgC+2.818,供试品在稀释5000、10000、15000、16500倍时均对反应无干扰作用,细菌内毒素回收率在50%~200%范围内,4批供试品的内毒素定量检测结果均符合规定。结论:在Pyros Kinetix^(■)Flex(PKF)细菌内毒素定量检测系统平台,本法可用于磺达肝癸钠注射液中细菌内毒素含量的测定,可定量检测供试品中内毒素的含量。Objective:To establish a kinetic chromogenic assay for the determination of bacterial endotoxin in fondaparinux sodium injection.Methods:According to the requirements of the 2020 edition of the Pharmacopoeia of the People’s Republic of China(General Chapter 1143 Bacterial Endotoxin Inspection Method),the Pyros Kinetix^(■)Flex(PKF)quantitative detection system for bacterial endotoxin was used,and the dynamic color method of Limulus reagent was used to establish a bacterial endotoxin standard curve.The dilution factor was determined through interference pre-experiment,the recovery rate of the endotoxin added to the test solution was determined,and the interference test to complete the quantitative detection test of the bacterial endotoxin content in the test product was performed.A standard curve was automatically drawn and produced through pyros^(■)EQS software,the absolute content of endotoxin in the solution was calculated,and a report was generated and stored in the oracle database.Results:The linear range of the concentration of the standard curve was 0.001 to 0.125 EU·mL^(-1)(r=-0.9991),and the regression equation of the standard curve was lgT=-0.2658 lgC+2.818,which was average when the test product was diluted 5000,10000,15000,16500.There was no interference effect on the reaction,the recovery rate of bacterial endotoxin was in the range of 50%to 200%,and the endotoxin quantitative detection results of the 4 batches of test products all met the regulations.Conclusion:On the Pyros Kinetix^(■)Flex(PKF)bacterial endotoxin quantitative detection system platform,a kinetic chromogenic assay can be established for the determination of bacterial endotoxin content in fondaparinux sodium injection.This method can quickly and quantitatively detect endotoxin content in samples.

关 键 词：动态显色法 磺达肝癸钠注射液 细菌内毒素 干扰试验 美洲鲎试剂 

分 类 号：R917[医药卫生—药物分析学]