摘要
目的研究高渗氯化钠右旋糖酐70注射液细菌内毒素检查的可行性,为制定细菌内毒素检查法质量标准提供依据。方法按中国药典2005年版二部中细菌内毒素检查法进行操作,并与热原检查法进行对比试验。结果高渗氯化钠右旋糖酐70注射液对鲎试剂的凝集反应无干扰作用。内毒素的限值定为0.5 EU/mL。结论高渗氯化钠右旋糖酐70注射液采用细菌内毒素检测方法是可行的。
OBJECTIVE To examine the feasibility for bacterial endotoxin test of hypertonic sodium chloride dextran70 injection, and provide bases for establishing the quality standard of method for bacterial endotoxin test. METHODS Bacterial endotoxin test in the Chinese Pharmacopoeia 2005 was applied, and was compared with pyrogen test. RESULTS Hypertonic sodium chloride dextran 70 injection did not interfere the congregating reactivity of tachypleus amebocyte lysate. The appropriate limit of endotoxin was 0.5 EU/ mL. CONCLUSION It is feasible to use this method in the examination of hypertonic sodium chloride dextran70 injection.
出处
《中国现代应用药学》
CAS
CSCD
北大核心
2007年第2期141-143,共3页
Chinese Journal of Modern Applied Pharmacy
基金
军队"十五"指令性课题(010L43)
关键词
高渗氯化钠右旋糖酐70注射液
鲎试剂
细菌内毒素
hypertonic sodium chloride dextran 70 injection
tachypleus amebocyte lysate
bacterial endotoxin
