抗增液复溶鲎试剂检查参麦注射液的细菌内毒素

The Bacterial Endotoxins Test for Shenmai Injection by TAL Reconstituted with Antienhancement Solution

目的:建立抗增液复溶鲎试剂检测参麦注射液中细菌内毒素的方法。方法:对不同批号的参麦注射液分别进行抑制或增强试验,考察确立其内毒素检查法。结果:用抗增液复溶鲎试剂可以消除参麦注射液(40倍稀释)对细菌内毒素检查的干扰。结论:用抗增液复溶灵敏度0.25EU/mL的鲎试剂对参麦注射液进行细菌内毒素检查是可行的。

Objective:To study the bacterial endotoxins test for Shenmai injection by TAL reconstituted with antienhancement solution. Methods:TAL was reconstitute d with antienhancement solution.Inhibition or enhancement test was conducted for Shenmai injection with different batch number by TAL to establish the endotoxin s examination.Results:When the limulus lysate's sensitivity(λ) is 0.25 EU/mL,th e maximum valid dilution is 1 ∶40,the interference between the sample and the r elative TAL is eliminable.And the result of bacteria lendotoxins test is the sam e as that of pyrogen test with healthy mature rabbits.Conclusion:The result is r eliable,the bacterial endotoxins test for Shenmai injection by TAL reconstituted with antienhancement solution is feasible.