注射剂中常用4种抗氧剂的细菌内毒素检查方法研究

Methodology Study on Bacterial Endotoxin Test of Four Antioxidants Used in Injections

关键词:  无水亚硫酸钠  亚硫酸氢钠  焦亚硫酸钠  硫代硫酸钠  细菌内毒素

Key words:  anhydrous sodium sulfite  sodium bisulfite  sodium pyrosulfite  sodium thiosulfate  bacterial endotoxin

摘要:

目的建立4种抗氧剂（无水亚硫酸钠、亚硫酸氢钠、焦亚硫酸钠和硫代硫酸钠）的细菌内毒素检查方法。方法按中国药典2005年版二部附录收载的细菌内毒素检查方法进行实验。结果4种抗氧剂在200 μg·mL-1浓度以下对鲎试剂无干扰作用。细菌内毒素限值订为2.5 EU·mg-1。结论这4种抗氧剂采用细菌内毒素检查方法是可行的。

Abstract:

OBJECTIVE To establish the quality standard for the bacterial endotoxins test of four antioxidants(anhydrous sodium sulfite,sodium bisulfite,sodium pyrosulfite and sodium thiosulfate).METHODS The test was operated according to the method for examination of bacterial endotoxin test in Ch.P(2005)Vol II.RESULTS The four antioxidants did not interfere with TAL reagent under the concentration of 200 μg·mL-1.The appropriate limit of endotoxin was 2.5 EU·mg-1.CONCLUSION It was feasible to use this method in the examination of the four antioxidants.