摘要
目的为医疗器械的细菌内毒素检测确定合适的浸提时间。方法依据《中华人民共和国药典》2010年版附录XIE细菌内毒素检查法的动态浊度法,在不同浸提时间下测定细菌内毒素溶液中细菌内毒素的含量。结果溶液中的细菌内毒素含量在37℃24小时和72小时的浸提条件下会大大减少,在37℃1小时、2小时和4小时的浸提条件下不会发生明显改变。结论医疗器械细菌内毒素检测的最佳浸提时间不宜超过4小时。
Objective To determine the suitable immersed time for bacterial endotoxin test of medical devices. Methods The bacterial endotoxin test was performed to detect bacterial endotoxin concentration of different immersed time according to the Chinese Pharmacopoeia 2010 Edition. Results The bacterial endotoxin concentration of the solution was reduced when the immersed time was 24 hours or 72 hours. There was no significant change when the immersed time was 1 h, 2 h or 4 h. Conclusion The most suitable immersed time is 4 h or shorter for bacterial endotoxin test of medical devices.
出处
《中国药事》
CAS
2014年第2期172-173,184,共3页
Chinese Pharmaceutical Affairs
关键词
细菌内毒素
动态浊度法
浸提时间
bacterial endotoxin
kinetic turbidity method
immersed time
