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目的:改进注射用磷霉素钠含量测定的方法。方法:在原有检测方法基础上采用不同温度培养,考察培养温度对微生物检定法测定磷霉素含量的影响。结果:注射用磷霉素钠的微生物检定法测定含量采用培养温度为37～39℃时,在其他检定条件不变的情况下,各项测定指标均可达到要求,优于现行标准检验下的检定指标。结论:该方法操作结果准确,建议今后修订标准时可考虑改进培养温度。
Objective: To improve the method of determination of fosfomycin sodium for injection. Methods: On the basis of the original detection methods, different temperature culture was used to investigate the effect of culture temperature on the determination of fosfomycin by microbial test. Results: When the content of fosfomycin sodium for injection was determined by microbiological assay, all the determination indexes could reach the requirements under the condition of other test conditions unchanged when the culture temperature was 37-39 ℃, which was better than the standard test Test indicators. Conclusion: The results of this method are accurate. It is suggested that the cultivation temperature should be considered in the future revision of the standard.