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目的 :建立注射用磷霉素钠的细菌内毒素检查法。方法 :按中国药典 2 0 0 0年版二部附录规定进行鲎试剂复核、样品干扰试验和样品测定。结果 :75mg·ml- 1 的样品稀释 4倍后 ,可用标示灵敏度为 0 .2 5EU·ml- 1 的鲎试剂检测其细菌内毒素 ,实验结果与临床应用情况相符。结论 :鲎法检测注射用磷霉素钠的细菌内毒素方法可行、结果可靠 ,可代替兔法检测其热原。
Objective: To establish a bacterial endotoxin test for fosfomycin sodium for injection. Methods: According to the Chinese Pharmacopoeia 2000 edition two appendix 鲎 reagent review, sample interference test and sample determination. Results: After the sample of 75mg · ml-1 was diluted 4-fold, the bacterial endotoxin could be detected by the 标 reagent with a labeling sensitivity of 0.25EU · ml-1. The experimental results are consistent with the clinical application. Conclusion: The method of detecting the bacterial endotoxin of fosfomycin sodium for injection is feasible and the results are reliable. It can replace the rabbit method to detect the pyrogen.