特异性鲎试剂分析甘露聚糖肽氯化钠注射液的细菌内毒素

Analysis of endotoxin-specific TAL reagent on bacterial endotoxins in mannatide sodium chloride injection

目的 考察甘露聚糖肽氯化钠注射液进行细菌内毒素检查的可行性。方法 应用普通鲎试剂及特异性鲎试剂对样品进行内毒素的定性及定量检查。结果 甘露聚糖肽氯化钠注射液经 6倍稀释后对普通鲎试剂的细菌内毒素检查有明显的干扰作用 ,而对特异性鲎试剂无干扰作用 ;以特异性鲎试剂检查 6批样品其细菌内毒素含量均小于 15 0 0EU·L-1,凝胶法和动态浊度法鲎试验均证实了这一点。

AIM To investigate the feasibility of bacterial endotoxins test for mannatide sodium chloride injection(MSCI). METHODS The common and endotoxin specific tachypleus amebocyte lysate (TAL) reagents were applied to detect endotoxins in MSCI qualitatively and quantitatively. RESULTS The six fold dilution of MSCI obviously interfered with the test for bacterial endotoxins when using common TAL reagent;while not by using endotoxin specific TAL reagent, and the content of bacterial endotoxins in six batches of MSCI didn't surpass 1 500 EU·L -1 , gel clot and kinetic turbidimetric limulus tests all verified this. CONCLUSION The bacterial endotoxins in MSCI should be detected with endotoxin specific TAL reagent to avoid false positive reaction on routine test.