注射用奥美拉唑钠细菌内毒素检查法

目的:对注射用奥美拉唑钠进行凝胶法干扰试验,建立注射用奥美拉唑钠细菌内毒素检查的试验方法。方法:采用2005年版中国药典二部附录细菌内毒素检查法。结果:注射用奥美拉唑钠稀释5倍(2 mg·mL~(-1))时对细菌内毒素检查法无干扰作用。结论:使用细菌内毒素检查法检查注射用奥美拉唑钠中的细菌内毒素是可行的,可用细菌内毒素检查法代替家兔热原检查法。

Study on determination of bacterial endotoxin of omeprazole sodium for injection

Objective:To establish a method for the determination of bacterial endotoxin of omeprazole sodium for injection;Method:According to the method of determination of bacterial endotoxin approved by Chinese Pharmaco- poeia 2005 edition.Results:The interference on the determination of bacterial endotoxin can be excluded when omeprazole sodium for injection was diluted 5 times.Conclusion:It is feasible to detect the bacterial endotoxin of omeprazole sodium for injection by the method of determination of bacterial endotoxin and the method may replace pyrogen test.