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目的 对比研究环境内毒素与精制内毒素的热稳定性 ,考察热压灭菌前后细菌内毒素水平的相关性 ,为静脉输液相关医疗器具及药品生产过程的质量控制和医院感染工作提供定量参考依据。方法 分别制备环境内毒素与精制内毒素溶液 ,经两次热压灭菌处理 ,EDS99内毒素测定系统动态浊度法定量测定不同处理后样品的细菌内毒素水平 ,对测定结果进行统计分析和相关回归分析。结果 经单次热压处理后 ,环境内毒素和精制内毒素的对数衰减分别为 (0 .73± 0 .2 3)、(0 .97± 0 .5 8) ,经第二次热压处理后 ,两者分别继续衰减 (0 .6 8± 0 .14)、(0 .86± 0 .5 2 )。结论 环境内毒素与精制内毒素的热稳定性差异无显著性 (P>0 .0 5 ) ,热压处理后的细菌内毒素水平与起始水平有显著的相关性 [r>r0 .0 1 (4 ) ],推广应用细菌内毒素定量检查法具有重要的实践意义。
Objective To compare the thermal stability of environmental endotoxin and purified endotoxin, and to investigate the correlation of bacterial endotoxin levels before and after autoclaving, to provide quantitative reference for the quality control and nosocomial infection of intravenous infusion-related medical devices and pharmaceuticals . Methods The environmental endotoxin and purified endotoxin solution were separately prepared and sterilized twice by autoclaving. The endotoxin level was determined by dynamic nephelometry with EDS99 endotoxin assay system. The results were statistically analyzed and correlated regression analysis. Results After a single hot pressing treatment, the logarithmic decay of endotoxin and endotoxin were (0. 73 ± 0. 23) and (0 .97 ± 0. 58), respectively, After treatment, the two groups continued to decline (0.66 ± 0.14) and (0.86 ± 0.52) respectively. Conclusion There is no significant difference in the thermal stability between environmental endotoxin and refined endotoxin (P> 0.05), and the bacterial endotoxin level after hot pressing has a significant correlation with the initial level [r> r0.0 01 (4)], popularization and application of bacterial endotoxin quantitative test method has important practical significance.