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目的:建立浓氯化钠注射液的细菌内毒素检查法。方法:利用细菌内毒素检查法与热原检查法对比实验及样品的干扰试验。结果:干扰试验结果表明:本品在原液,1∶2,1∶4及最大有效稀释倍数(MVD=5倍)时,对TAL均无干扰作用,对比试验表明细菌内毒素检查法与热原检查法结果一致。结论:浓氯化钠注射液可用细菌内毒素检查法代替家兔热原检查。
Objective: To establish a bacterial endotoxin test for concentrated sodium chloride injection. Methods: Bacterial endotoxin test and pyrogen test were used to compare experiments and sample interference test. Results: The results of the interference test showed that the product did not interfere with TAL in the stock solution, 1: 2, 1: 4 and the maximum effective dilution factor (MVD = 5 times). The comparative tests showed that the bacterial endotoxin test was similar to pyrogen Check the results of the same. Conclusion: Bacterial endotoxin test can be used instead of pyrogen test in concentrated sodium chloride injection.