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目的建立定量检测注射用磷霉素钠细菌内毒素试验方法。方法采用《中国药典》2000年版附录检测细菌内毒素的动态浊度法。结果注射用磷霉素钠用细菌内毒素定量法检测无干扰因素影响,内毒素回收率在50%～200%范围内。结论使用细菌内毒素动态浊度法定量检测注射用磷霉素钠的细菌内毒素是可行的,可用细菌内毒素定量法代替家兔热原检查法。
Objective To establish a method for the quantitative determination of bacterial endotoxin in fosfomycin sodium for injection. Methods The dynamic turbidity method was used to detect bacterial endotoxin in the Appendix of Chinese Pharmacopoeia 2000 edition. Results Fosfomycin sodium for injection was determined by bacterial endotoxin quantification without interfering factors. The recovery of endotoxin was in the range of 50% ~ 200%. Conclusion Bacterial endotoxin dynamic nephelometry is a feasible method for the quantitative determination of bacterial endotoxin in fosfomycin sodium for injection. Bacterial endotoxin quantification can be used instead of pyrogen test in rabbits.