摘要
目的建立注射用唑来膦酸细菌内毒素检查方法。方法根据2010年版《中国药典》(二部)附录收载的细菌内毒素检查方法进行试验。结果注射用唑来膦酸稀释至0.0033mg.mL-1溶液,用标示灵敏度0.25EU.mL-1的鲎试剂检测细菌内毒素,无干扰因素影响。结论注射用唑来膦酸可应用鲎试剂进行细菌内毒素法检查,细菌内毒素限度确定为75Eu.mg-1。
OBJECTIVE To establish a method of application of bacterial endotoxin test to Zoledronic acid for Injection.METHODS Bacterial endotoxin test was carried out according to Chinese Pharmacopoeia 2010 edition.RESUTLS It was proved that the maximum non-interference concentration of Zoledronic acid for Injection was 0.0033mg·mL-1 and the sensitivity of tachypleus amebocyte lysate was 0.25EU·mL-1.CONCLUSION The results suggested that the bacterial endotoxin test is suitable for the detection of endotoxin in Zoledronic acid for Injection and the bacterial endotoxin limit is 75EU·mg-1.
出处
《海峡药学》
2012年第3期63-64,共2页
Strait Pharmaceutical Journal
关键词
注射用唑来膦酸
细菌内毒素
干扰实验
Zoledronic acid for Injection
Bacterial endotoxin test
Interfere factors test
