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动态浊度法定量检测复方苦参注射液中细菌内毒素
引用本文:刘源,孔玮.动态浊度法定量检测复方苦参注射液中细菌内毒素[J].时珍国医国药,2007,18(2):412-413.
作者姓名:刘源  孔玮
作者单位:1. 江苏省镇江市药品检验所,212003
2. 江苏省镇江市第一人民医院,212003
摘    要:目的建立定量检测复方苦参注射液中细菌内毒素实验方法。方法采用《中国药典》2005年版(Ⅲ部)附录检测细菌内毒素的动态浊度法。结果复方苦参注射液用细菌内毒素定量法检测无干扰因素影响,内毒素回收率在50%~200%范围内。结论使用动态浊度法定量检测复方苦参注射液的细菌内毒素是可行的,可用细菌内毒素方法代替兔热原检查法,同时又避免了限量法内毒素检测时的干扰。

关 键 词:复方苦参注射液  细菌内毒素  动态浊度法  干扰实验
文章编号:1008-0805(2007)02-0412-02
修稿时间:2006年8月4日

Application of the Turbidimetric -Kinetic Method for the Measurement of Endotoxin in Composite Radix Sophora Flavescentis Injection
LIU Yuan,KONG Wei.Application of the Turbidimetric -Kinetic Method for the Measurement of Endotoxin in Composite Radix Sophora Flavescentis Injection[J].Lishizhen Medicine and Materia Medica Research,2007,18(2):412-413.
Authors:LIU Yuan  KONG Wei
Abstract:Objective To develop an assay for determination of bacterial endotoxin(BET) in Composite Radix Sophora Flavescentis Injection.Methods BET was determined by turbidimetric-kinetic method.Results The content in Composite Radix Sophora Flavescentis Injection did not interfere with the quantitation of BET.The recovery of BET was between 50% and 200%.Conclusion The method is proved to be suitable for determination of the BET in Composite Radix Sophora Flavescentis Injection and could be used as an alternative for the rabbit pyrogen test to the injection.
Keywords:Composite Radix Sophora Flavescentis Injection  Bacterial endotoxin  Turbidimetric-Kinetic method  Interfere factors test
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