细菌内毒素的热压稳定性研究

Thermostablity of Bacterial Endotoxin

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 comparatively study the thermostability of natural endotoxin and fined endotoxin, search for the correlation of endotoxin levels in final products and the initial concentration before sterilization as quantitative reference for control of production and intrahospital infection. METHODS Samples of both kinds of endotoxin were prepared, autoclaved twice and determined by kinetic-turbidimetry with EDS99 system. Analysis of statistics and linear regression was carried out. RESULTS The log reduction of natural endotoxin and fined endotoxin after first autoclaving were(0.73±0.23) and (0.97±0.58), respectively. The reduction caused by the second autoclaving were (0.68±0.14) and (0.86±0.52), respectively.CONCLUSIONS No significant difference of thermostability was seen between natural endotoxin and fined one (P>0.05). Significant linearity of endotoxin levels can be found between the final products and the initialr>r 0.01(4) ]. Quantitative bacterial endotoxin test (BET) is practically necessary for production control of injection, single-use syringe . Quantitative bacterial endotoxin test (BET) is practically necessary for production control of injection, single-use syringe etc.