摘要
目的:建立注射用兰索拉唑的细菌内毒素检查法。方法:按照2010年版《中国药典》(二部)附录细菌内毒素检查法,采用2个厂家的鲎试剂对5个厂家的5批样品,通过预干扰和干扰试验确定样品最大无干扰质量浓度,并进行细菌内毒素检查。结果:将供试品溶液稀释到质量浓度为0.1 mg/ml时,不干扰细菌内毒素试验,其细菌内毒素限值为5 EU/mg。结论:采用细菌内毒素检查法检查注射用兰索拉唑中的细菌内毒素方法可行。
OBJECTIVE： To establish the method for bacterial endotoxin test of Lansoprazole for injection. METHODS： According to bacterial endotoxin test stated in appendix U of Chinese Pharmacopeia （2010 edition）, maximal non-interference concentrations of 5 bacthes of samples from 5 manufacturers were determined by pre-interference test and interference test by using tachypleus amebocyte lysate （TAL） from 2 manufacturers. And then bacterial endotoxin test was conducted. RESULTS： Lansoprazole for injection which is diluted to 0.1 mg/ml will not interfere with bacteria endotoxin test. The limitation of bacteria endotoxin was 5 EU/mg. CONCLUSIONS： It is feasible to detect the bacterial endotoxin of Lansoprazole for injection by the method of bacterial endotoxin test.
出处
《中国药房》
CAS
CSCD
2014年第25期2379-2380,共2页
China Pharmacy
关键词
注射用兰索拉唑
细菌内毒素
鲎试剂
干扰试验
Lansoprazole for injection
Bacterial endotoxin
Tachypleus amebocyte lysate
Interference test
