摘要
建立盐酸法舒地尔注射液细菌内毒素检查法,保证检测结果符合质量标准要求。采用《中国药典》2010年版附录ⅪE细菌内毒素检查法要求进行试验,结果表明,将盐酸法舒地尔注射液稀释至0.5 mg/mL,用灵敏度为0.25 EU/mL的鲎试剂做干扰试验,无干扰影响;确定盐酸法舒地尔注射液细菌内毒素限值为5.0 EU/mg,应用鲎试剂可以进行细菌内毒素法的检查。
In order to ensure that test results meet quality standards,a method for testing bacterial endotoxin in fasudil hydrochloride injection using tachypleus amebocyte lysate （TAL）was established.The tests were conducted according to appendix Ⅺ E of Chp 2010. Results showed when the maximum concentration of fasudil hydrochloride injection was 0.5 mg/mL,there was non-interference using TAL which sensitivity was 0.25 EU/mL in the interference test. It was pointed out that the limit of bacterial endotoxin was 5.0 EU/mg and bacterial endotoxin test could be used for the detection of endotoxin in fasudil hydrochloride injection.
出处
《煤炭与化工》
CAS
2013年第4期100-103,共4页
Coal and Chemical Industry
关键词
盐酸法舒地尔注射液
细菌内毒素
干扰试验
鲎试剂
fasudil hydrochloride injection
bacterial endotoxin
interference test
tachypleus amebocyte lysate
