复方硫酸铝注射液细菌内毒素检查法的研究

Study on the Bacterial Endotoxin Test of Compound Aluminum Sulphate Injection

目的 探讨建立复方硫酸铝注射液细菌内毒素检查法。方法 用两个厂家的鲎试剂对三批样品进行干扰试验。结果 复方硫酸铝注射液在 6 0 0倍稀释时无干扰作用。结论 本品稀释后可用高灵敏度鲎试剂检查。

Aim To establish the method for testing Bacterial Endotoxin in Compound Aluminum Sulphate Injection.Methods The test of interference was done on 3 batches of Compound Aluminum Sulphate Injection with 2 kinds tachypleus amebocyte lysate (TAL) from different factories.Results There was no interference in 600-fold dilution.Conclusion This method can be used to detect the Bacterial Endotoxin in Compound Aluminum Sulphate Injection.