微量动态显色法定量检测3种大输液的细菌内毒素

目的：应用微量动态显色法试剂对5％葡萄糖注射液、0.9％氯化钠注射液、替硝唑氯化钠注射液等进行内毒素定量检测,并与凝胶法结果比较.方法：使用微量动态显色法试剂对5％葡萄糖注射液、0.9％氯化钠注射液、替硝唑氯化钠注射液进行干扰初筛试验及干扰试验.使用凝胶法试剂对5％葡萄糖注射液、0.9％氯化钠注射液、替硝唑氯化钠注射液进行细菌内毒素日常检查.结果：使用微量动态显色法试剂对5％葡萄糖注射液、0..9％氯化钠注射液、替硝唑氯化钠注射液在8倍稀释浓度下进行内毒素检测,回收率均在50％～200％之间,检测结果与凝胶法结果一致.结论：微量动态显色法可以应用于大输液及某些药品细菌内毒素检测,尤其是过程监控.

Application of Micro kinetic Chromogenic Method in Endotoxin Quantitative Detection of Three Kinds of Infusions

Objective：To detect the endotoxin in 5% glucose injections,0.9% sodium chloride injections and tinidazole sodium chloride injections by micro-kinetic chromogenic method followed by the comparison with the results of gelclot method.Methods：The interference screening test and interference test for 5% glucose injections,0.9% sodium chloride injections and tinidazole sodium chloride injections were carried out using micro-kinetic chromogenic reagent.The endotoxin in the injections was detected routinely by gel-clot method.Results：The micro-kinetic chromogenic reagents were used to detect the endotoxin in the injections with 8-fold diluted concentration,the recovery was within the range of 50%-200%,and the results were consistent with those of gel-clot method.Conclusion：Micro-kinetic chromogenic method can be applied in the detection of bacterial endotoxin in large infusions and some other drugs,especially in the process monitoring.