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目的:建立氟罗沙星葡萄糖注射液的细菌内毒素检查法。方法:根据中国药典2000年版二部收载的细菌内毒素检查法的要求进行实验。结果:将氟罗沙星葡萄糖注射液经8倍稀释可消除干扰因素,用标示灵敏度为0.25 EU·ml~(-1)的鲎试剂检测细菌内毒素是有效的。结论:可用鲎试验法取代家兔法对氟罗沙星葡萄糖注射液进行热原检查。
Objective: To establish a bacterial endotoxin test for fleroxacin and glucose injection. Methods: According to the Chinese Pharmacopoeia 2000 edition of the two contained bacterial endotoxin test requirements of the experiment. Results: Eight times dilution of fleroxacin and glucose injection could eliminate the interference factors. It is effective to detect bacterial endotoxin by using limulus reagent with a sensitivity of 0.25 EU · ml -1. CONCLUSION: The pyrivorine glucose injection can be replaced by rabbit test with pyrogen test.