细菌内毒素凝胶法在疫苗检定中的适应性应用和影响因素排除

Adaptive Application of Bacterial Endotoxin Gel Assay in Vaccine Test and Excluded of Influencing Factors

研究了内毒素凝胶测定法在疫苗及原辅料检定中的适应性及其影响因素.结果显示:(1)各批次疫苗采用凝胶法检测,干扰试验均成立,检测结果均符合标准;(2)水温在下限36℃和上限38℃时凝结效果均有所下降,须严格控制水温.(3)进口牛血清凝胶法适应性差,采取10倍稀释后70℃加热10min的方法可消除干扰,或采取动态浊度法也可解决.

The adaptability and influencing factors of endotoxin gel method in vaccine and its raw and auxiliary materials were analyzed.The results showed that:(1)By using the gel method,all the interference test in the method were passed,and the test results of vaccine batches were compiled with thestandard.The results of the semi-quantitative method were the same as that getting from the gel method.(2)The condensation effect has declined when the water temperature was36℃or38℃,so the water temperature need to be strictly controlled.(3)The imported bovine serum and the self-made aluminum hydroxide adjuvant poorly adapts to the gel method.The interference can be eliminated,when the imported bovine serum was heated at70℃for10minutes after10times diluted.But the problem of poor adaption to the self-made aluminum hydroxide adjuvant remains to be resolved.