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目的:甲磺酸培氟沙星注射液热原试验存在降温现象,依法不能作出判定,从而考虑建立甲磺酸培氟沙星注射液细菌内毒素检查方法控制热原。方法:采用联合药液的内毒素总量确定其细菌内毒素限值,通过干扰试验确定最大不干扰稀释浓度。结果:甲磺酸培氟沙星注射液经过80倍稀释后,选用标示灵敏度为0.SEU·ml~(-1)的鲎试剂检测细菌内毒素是有效的。结论:甲磺酸培氟沙星注射液可用细菌内毒素检查方法取代热原检查法。
OBJECTIVE: There is cooling phenomenon in the pyrogen test of pefloxacin mesylate injection, which can not be judged according to the law, so as to establish the bacterial endotoxin test method of pefloxacin mesylate injection to control the pyrogen. Methods: The limit of bacterial endotoxin was determined by the total amount of endotoxin in the combined liquid and the maximum non-interfering dilution was determined by interference test. Results: After the 80-fold dilution of pefloxacin mesylate injection, the detection of bacterial endotoxin by using the limulus reagent with the sensitivity of 0.SEU · ml -1 was effective. Conclusion: Pefloxacin mesylate injection can replace the pyrogen test by bacterial endotoxin test.