细菌内毒素_____动态比浊法鲎试验;

动态比浊法用于检测生脉注射液中细菌内毒素的研究

http://www.100md.com 《广东药学院学报》 2002年第1期

细菌内毒素,,动态比浊法鲎试验;,生脉;,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,4结论,参考文献

     摘要目的:应用动态比浊法鲎试验定量测定生脉注射液中的细菌内毒素。方法:应用动态比浊法鲎试验，通过对样品中定量添加标准内毒素的干扰预试验，将生脉原液(Lot.No.001007)及1∶4、1∶8、1∶12、1∶16稀释液5个浓度系列，定量添加标准内毒素，其回收率分别为1.09%、48.21%、74.22%、83.68%、96.38%；从中筛选出最佳的检测浓度1∶16稀释液，进行3个批号生脉注射液正式干扰试验，样品中定量添加标准内毒素，其回收率分别为86.11%、88.45%、65.05%。结果:标准内毒素使用5.00、0.500、0.0500 EU/mL，将生脉进行1∶16稀释，样品中定量添加标准内毒素，回收率均为50%～200%，无干扰作用，可用于有效的日常检查。结论:动态比浊法鲎试验可以高效地测定生脉注射液的细菌内毒素。

    关键词动态比浊法鲎试验; 生脉; 细菌内毒素; 干扰试验

    Application of the kinetic turbidimetric limulus test in the endotoxin assay of Shengmai injection

    LAO Haiyan， Luo Yufen， Lin Qiuxiao

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

    Abstract Objective:To apply the kinetic turbidimetric limulus test in the endotoxin assay of Shengmai injection. Methods:The validation test was fulfiled with the recoveries of the amount of endotoxin spiked in Shengmai injection sample and its 4、8、12 and 16-fold dilution being 1.09%、48.21%、74.22%、83.68% and 96.38% respectively. The 16-fold dilution of Shengmai injection was screened as the optimal test concentration and the inhibition enhancement test was conducted in three batches of Shengmai injection, with the recoveries of 86.11%、88.45% and 65.05% respectively. Results: With standard endotoxin working curve of 5.00,0.500 and 0.0500 EU/mL, the 16-fold dilution of Shengmai injection was effective to eliminate the interference in limulus test with the recovery of 50%～200%. Conclution:The kinetict turbidimetric Limulus test is effective in the detection of bacterial endotoxin in Shengmai injection. ......

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