动态浊度法定量检测注射用氨苄西林钠中细菌内毒素含量

Quantitative Determination of Bacterial Endotoxin in Ampicillin Sodium for Injection by Kinetic Turbidimetric Assay

目的建立注射用氨苄西林钠中细菌内毒素含量的定量测定方法。方法采用稀释法排除氨苄西林钠对细菌内毒素含量测定的干扰。结果将注射用氨苄西林钠液稀释100倍,可排除其对细菌内毒素含量测定的干扰。结论使用动态浊度法检测注射用氨苄西林钠中的细菌内毒素含量是可行的,此方法可替代家兔热原检查法。

Objective To establish a method for the determination of bacterial endotoxin of ampicillin sodium for injection. Methods To exclude the interference of ampicillin sodium for injection to the determination of bacterial endotoxin through dilution method. Results The ampicillin sodium for injection did not interfere the determination of bacterial endotoxin when they were diluted for 100 times. Conclusion The determination of bacterial endotoxin may be used to ampicillin sodium for injection, and the method may replace the pyrogen test.