用不同鲎试剂检查细菌内毒素的结果比较

Comparison of Results of the Bacterial Endotoxins Test Using Different LAL Reagent

目的 :比较两种鲎试剂的细菌内毒素检查结果 ,避免判断误差。方法 :中国药典九五版细菌内毒素检查法。结果 :鲎试剂灵敏度测定值λc由于与标示灵敏度λb 存在 0 .5～ 2 .0倍的差别 ,导致对某些样品进行检查时出现一阴一阳的结果。结论 :只要阴性结果的鲎试剂λc 在 0 .5～ 2 .0λb(包括 0 .5λb 和 2 .0λb)之间 。

OBJECTIVE:To compare the results of the bacterial endotoxins test between two Limulus Amebocyte Lysate (LAL) reagents. METHOD:The test was carried out as per China pharmacopoeia (ChP) method.RESULTS:The determinations of the LAL reagent sensitivity(λ c) were different,The results were the negative and positive combinations.CONCLUSION:The method indicated that the experimental values met the requirement of ChP,as if the result showed negative between 0.5λ b and 2.0λ b.