摘要
目的:建立依达拉酮注射液的细菌内毒素检查方法。方法:用凝胶法比较不同浓度的依达拉酮注射液对细菌内毒素检测的干扰情况。结果:采用灵敏度为0.125EU·mL^(-1)的鲎试剂,将本品稀释后,浓度小于或等于0.0375g·L^(-1)时对鲎试剂与内毒素的凝集反应无干扰。结论:本品可用细菌内毒素检查法代替热原检查来控制其质量,其细菌内毒素限期值可定为3.33EU·mg^(-1)。
OBJECTIVE To establish a bacteria endotoxin detection method for monitoring pyrogen in edaravone injection. METHODS Using the gelation assay, interference effects caused by different concentration of edaravone injection in bacteria endotoxin test were studied. RESULTS The test showed that the reactions with tachypleus amebocyte lysate were not disturbed by the diluted sample,which concentration was less than or equal to 0.0375 g.L-1, sensitivity of TAL was 0.125 EU.mL-1. CONCLUSIONS Method of bacteria endotoxin test can be used in place of rabbit method for pgrogen monitoring of edaravone injection, its endotoxin limit concentrartion can be established as to less than 3. 33 EU.mL-1.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2003年第5期270-272,共3页
Chinese Journal of Hospital Pharmacy
关键词
依达拉酮注射液
细菌内毒素
检测
鲎试剂
edaravone injection
bacteria endotoxin test
tachypleus amebocyte lysate(TAL)
reaction of disturbance
