摘要
目的建立快速的盐酸异丙嗪注射液中细菌内毒素检查方法。方法按《中国药典》2010年版(二部)附录细菌内毒素检查法,采用2个厂家的鲎试剂对国内9个生产厂家的盐酸异丙嗪注射液进行干扰试验的研究。结果盐酸异丙嗪注射液在1.0 mg.mL-1浓度时对细菌内毒素检查无干扰。结论本法简便、快速、灵敏,可以用作盐酸异丙嗪注射液的细菌内毒素限度检查。
Abstract：Objective To establish a rapid method for bacterial endotoxin test of Promethazine Hydrochloride Injection. Methods Interference tests of Promethazine Hydrochloride Injections which producted by 9 domestic manufacturers were per- formed with TAL from 2 manufacturers according to bacterial endotoxin test method in Appendix of Chinese Pharmacopoeia（ 2010 Edition ）. Results No interference was found when Promethazine Hydrochloride Injection with concentration of 1.0 mg ·mL^-1 Conclution The method was simple, rapid,sensitive, and it can be used for the bacterial endotoxin limit test of Promethazine Hydrochloride Injection.
出处
《齐鲁药事》
2012年第5期277-278,282,共3页
qilu pharmaceutical affairs
关键词
盐酸异丙嗪注射液
细菌内毒素
干扰试验
Promethazine Hydrochloride Injection
Bacterial endotoxin
Interference test
