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目的:考察甲硝唑葡萄糖注射液鲎法内毒素检查的可行性,建立其常规内毒素检查法。方法:采用内毒素定量技术和二次校正标准加入强化法,试验确定样品原液与1∶1稀释液对鲎试验的干扰行为。结果:样品原液对鲎试验具有近2倍的抑制作用,经1∶1稀释后可消除。30批样品的内毒素检查与热原检查结果相符。结论:甲硝唑葡萄糖注射液经1∶1稀释后,使用灵敏度为0.25EU·ml-1鲎试剂进行内毒素检查可替代其热原检查
Objective: To investigate the feasibility of metronidazole glucose injection 鲎 endotoxin test to establish its routine endotoxin test. Methods: The method of quantification of endotoxin and secondary calibration standard was added to the fortification method to determine the interference behavior of the sample stock solution and 1: 1 dilution on the test. Results: The sample liquid had a nearly 2-fold inhibitory effect on the test, which could be eliminated by 1: 1 dilution. The endotoxin test of 30 batches of samples was consistent with the pyrogen test results. Conclusion: Metronidazole glucose injection by 1: 1 dilution, the use of sensitivity of 0.25EU · ml-1 鲎 reagent endotoxin test can replace the pyrogen test