干扰试验__

动态比浊法鲎试验定量测定盐酸川芎嗪注射液中细菌内毒素含量

http://www.100md.com 《广东药学院学报》 2001年第2期

干扰试验,,动态比浊法鲎试验;盐酸川芎嗪;细菌内毒素;干扰试验,1试验材料及仪器,2方法与结果,3讨论,参考文献

     摘要目的:应用动态比浊法鲎试验定量测定盐酸川芎嗪注射液中的细菌内毒素含量。方法:通过对样品中定量添加标准内毒素的干扰试验，检测其回收率应在50%～200%范围。结果:将样品进行1/100稀释可以有效地消除其对鲎试验的干扰。结论:EDS99细菌内毒素检测仪可以高效地测定样品中的细菌内毒素含量。

    关键词动态比浊法鲎试验;盐酸川芎嗪;细菌内毒素;干扰试验

    Application of the kinetic turbidimetric Limulus test to Ligustrazin Hydrochloride injection

    LIN Qiuxiao,LAO Haiyan,LI Zhihui

    (Pharmaceutical Department of Guangdong Provincial People's Hospital,Guangzhou,Guangdong 510080)

    Abstract Objective:The kinetic turbidimetric Limulus test was used in the endotoxin assay of Ligustrazin Hydrochloride injection. Methods: The validation test was fulfiled,when the amount of endotoxin spiked in Ligustrazin Hydrochloride injection sample was recovered in the range of 50%～200% .Results: A 100fold dilution to Ligustrazin Hydrochloride injection was effective to eliminate the interference in Limulus test.Conclusion: The EDS99 kinetic tube reader provides a new way for the detection of endotoxin in Ligustrazin Hydrochloride injection. ......

百拇医药网 http://www.100md.com/html/DirDu/2006/06/20/01/30/60.htm

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