注射用氨基糖苷类抗生素细菌内毒素定量法的研究

Quantitative Method for the Bacterial Endotoxin in Aminoglycoside Antibiotics for Injection

目的:建立检查注射用氨基糖苷类抗生素细菌内毒素的方法。方法:采用动态比浊法鲎试验,通过对样本中定量添加标准内毒素的干扰预试验,测得回收率,并筛选出最佳检测浓度,再对4种样品进行干扰试验。结果:标准内毒素使用5.000、0.500、0.050EU·mL-1浓度时,氨基糖苷类抗生素在0.5mg·mL-1浓度下对试验无干扰。结论:动态比浊法鲎试验可用于测定注射用氨基糖苷类抗生素的细菌内毒素含量。

OBJECTIVE： To establish a method for endotoxin assay in aminoglycoside antibiotics for injection. METHODS： Kinetic turbidimctric limulus test was used for endotoxin assay in aminoglycoside antibiotics for injection. The recovery rate of bacterial endotoxin was determined though pre -- interference experiments in which quantitative endotoxin was added to different concentrations of aminogtycosides with the concentration optimized, then an interference test on 4 different samples was conducted. RESULTS： At a concentration of 0.5 mg · mL^-1, aminoglycosides didn＇t interfere with the limulus test if the amount of standard endotoxin was at 5.000, 0.500, and 0.050 EU · mL^-1, respectively. CONCLUSIONS： The kinetic turbidimetric limulus test could be used /or endotoxin assay in aminoglycoside antibiotics for injection.