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目的:研究5%甘露醇注射液的细菌内毒素检查方法。方法:通过干扰试验证明5%甘露醇注射液对λ=0.5EU/ml的鲎试剂无抑制和增强作用。结果:使用λ=0.5EU/ml的鲎试剂可直接取样进行检测。结论:5%甘露醇注射液可以用细菌内毒素检查法取代热原检查法。
Objective: To study the bacterial endotoxin test of 5% mannitol injection. Methods: Interference test showed that 5% mannitol injection had no inhibitory and enhancing effects on the limulus reagent with λ = 0.5EU / ml. Results: The lambda = 0.5EU / ml of 鲎 reagent can be directly sampled for testing. Conclusion: 5% mannitol injection can replace the pyrogen test with bacterial endotoxin test.