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目的应用动态比浊法定量测定蒲公英注射液中细菌内毒素含量。方法通过对样品中定量添加标准细菌内毒素进行干扰试验。以40倍稀释为最佳的检测浓度,进行三个批号蒲公英注射液干扰试验,其回收率分别为163.1%,188.6%,132.4%。结果回收率均在50%~200%之间,样品对鲎试剂反应无干扰作用,可用于日常检查。结论动态比浊法鲎试剂试验可以有效的测定蒲公英注射液中的细菌内毒素含量。
Objective To apply dynamic turbidimetry to quantitatively determine bacterial endotoxin content in dandelion injection. Methods The interference test was performed by adding standard bacterial endotoxin to the sample. The 40-fold dilution was used as the best detection concentration for three batches of dandelion injection interference test, and the recovery rates were 163.1%, 188.6%, and 132.4%, respectively. Results The recovery rate was between 50% and 200%. The sample did not interfere with the limulus reagent reaction and could be used for daily inspection. Conclusion The dynamic turbidimetric limulus reagent test can effectively determine bacterial endotoxin content in dandelion injection.