摘要
目的用细菌内毒素检查法检测奥扎格雷注射液中的热原,减少临床热原反应的发生。方法按照《中国药典》2010版(二部)附录细菌内毒素检查法和细菌内毒素检查指导原则,进行干扰实验,测定注奥扎格雷注射液细菌内毒素限定值。结果本品稀释16倍时对测定无干扰,限值为2.5 EU/mL。结论细菌内毒素法简便、快速、灵敏,能有效检测奥扎格雷注射液中热原。
Objective To detect the limulus in ozagrel injection with a bacterial endotoxin test. Method The interference test was performed according to the bacterial endotoxin method and its guiding principle assigned in ＂Chinese Pharmacopoeia 2010 version＂.Results The ozagrel injection showed no interference aider diluted 16 times with a limit 0f2.5 EU/mL. Conclusion Bacterinal Endotoxin method is simple, rapid, sensitive, and can effectively detect the pyrogen of ozagrel injection.
出处
《中国医药指南》
2013年第16期42-43,共2页
Guide of China Medicine
