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本文提出了人血蛋白制品样品、鲎试剂以及显色基质鲎三肽,按一定的条件孵育,释放对硝基苯胺(PNA),用分光光度计在545nm处测定OD值的方法。借此可定量地检测样品中的内毒素含量(0.125Eμ/ml～1.0Eμ/ml),其相关系数为r=0.9981。该法避免了人血蛋白制品中蛋白对一般鲎试验的干扰,为研究生产过程中热原分布状况和人血蛋白制品中热原检测,提供了简便、灵敏、定量、稳定、快速可行的方法。经与经典的免法热原检查结果比较,具相关性。
In this paper, a method for the determination of OD value of human blood protein sample, limulus reagent and chromogenic substrate tripeptide, under certain conditions of incubation and release of p-nitroanilide (PNA), using a spectrophotometer at 545 nm was proposed. The content of endotoxin in the sample (0.125Eμ / ml ~ 1.0Eμ / ml) can be quantitatively detected with a correlation coefficient of r = 0.9981. This method avoids the interference of proteins in human blood protein products to the general blood test, and provides a simple, sensitive, quantitative, stable, rapid and feasible method for studying pyrogen distribution and pyrogen detection in human blood protein products in the production process . Compared with the classic pyrogen test results, there is a correlation.