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目的:建立快速检测盐酸左氧氟沙星注射液细菌内毒素检查法以代替热原检查法。方法:用抑制增强试验和对比试验。结果:稀释1→2样品溶液无干扰作用,与家兔法结果一致。结论:将盐酸左氧氟沙星注射液稀释2倍可用灵敏度为0.25 EU·ml~(-1)的鲎试剂作细菌内毒素检查。
Objective: To establish a rapid detection of levofloxacin injection bacterial endotoxin test instead of pyrogen test. Methods: Inhibition enhancement test and comparison test. Results: Dilution 1 → 2 sample solution without interference, consistent with the results of the rabbit. CONCLUSION: The levofloxacin hydrochloride injection is diluted by 2 times and the bacterial endotoxin test can be carried out using the 鲎 reagent with a sensitivity of 0.25 EU · ml -1.