摘要
目的对注射用法莫替丁进行细菌内毒素检查法研究,建立其细菌内毒素检查方法,并且提高药品检验标准。方法按《中国药典》2005年版二部附录ⅪE细菌内毒素检查法,用不同厂家不同规格的鲎试剂对不同批号的注射用法莫替丁进行了干扰试验和细菌内毒素检查。结果本品稀释到0.5mg.mL-1浓度对细菌内毒素检查法无干扰作用,按拟定标准,12个厂家生产的25批该品种均符合规定。结论本品按限值L=0.25EU.mg-1进行细菌内毒素检查是可行的。
Objective To set up a bacterial endotoxin test for exmiantion of famotidine for injection. Methods Different products of taehypleus amebocyte lysate were used in the test according to the bacterial endotoxin test approved by Chinese Pharmacopeia 2005 edition. Results The interference between the sample and the relative taehypleus amebocyte lysate was eliminable when the sample was diluted below 0.5mg.mL-1.The results of bacterial endotoxin test in twenty-five lots all accorded with the standard of the quality control. Conclusion It is feasible for bacterial endotoxin test of Famotidine for injection in a limit value of 0.25 EU.mg-1
出处
《中国热带医学》
CAS
2009年第12期2308-2310,共3页
China Tropical Medicine
关键词
注射用法莫替丁
细菌内毒素检查法
干扰试验
标准提高
Famofidine for injection
Bacterial endotoxins test
Interference test
Improve test standard
