复方苦参注射液；_细菌内毒素；_动态浊度法；

动态浊度法定量检测复方苦参注射液中细菌内毒素

http://www.100md.com 《时珍国医国药》 2007年第2期

复方苦参注射液；,细菌内毒素；,动态浊度法；,干扰实验,,复方苦参注射液；,细菌内毒素；,动态浊度法；,干扰实验,1材料与仪器,2方法与结果,3讨论,参考文献：

     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

    Application of the Turbidimetric-Kinetic Method for the Measurement of Endotoxin in Composite Radix Sophora Flavescentis Injection

    LIU Yuan，KONG Wei

    (Zhenjiang Institute for Drug Control, Zhenjiang 212003，China； The First Hospital of Zhenjiang, Zhenjiang 212003,China)

    Abstract：ObjectiveTo develop an assay for determination of bacterial endotoxin(BET) in Composite Radix Sophora Flavescentis Injection.MethodsBET was determined by turbidimetrickinetic method. ResultsThe content in Composite Radix Sophora Flavescentis Injection did not interfere with the quantitation of BET.The recovery of BET was between 50% and 200%.ConclusionThe 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. ......

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