注射用盐酸胺碘酮细菌内毒素检查法研究  

Study on Bacterial endotoxins test for Amiodarone hydrochloride injection

作　　者：陈琪 许姿敏 

机构地区：[1]广东省食品药品检验所药理室,广东广州510180

出　　处：《中国当代医药》2013年第8期72-73,75,共3页China Modern Medicine

摘　　要：目的建立注射用盐酸胺碘酮细菌内毒素检测法。方法按照《中华人民共和国药典》2010年版(二部)附录ⅪE细菌内毒素检查法,对3批样品进行干扰试验和细菌内毒素检查。结果将样品浓度稀释到0.125mg/mL时,不干扰细菌内毒素试验,其细菌内毒素限值定为1.000EU/mg。结论细菌内毒素检查法用于注射用盐酸胺碘酮热原的检查,方法适用、可靠。Objective To eatablish a detecting method for the bacterial endotoxin in the Amiodarone hydrochioride injection. Methods Three batches of samples were used for interference test and bacterial endotoxins test in accor dance with Appendix XI E, Volume 2, 2010 Edition of Chinese Pharmacopoeia Results Samples were diluted to 0.125 mg/mL, which did not interfere with bacteria endotoxin test. The limitation of bacteria endotoxin was 1.0 EU/mg. Conclusion It is reliable and applied for bacterial endotoxin test on pyrogen in dipyridamole For injection.

关 键 词：注射用盐酸胺碘酮 细菌内毒素 干扰试验 热原 

分 类 号：R927[医药卫生—药学]