对乙酰氨基酚注射液细菌内毒素检查方法实验研究

Study on bacterial endotoxins test of acetaminophen injection

目的建立对乙酰氨基酚注射液细菌内毒素检查法。方法参照《中国药典》2005年版二部附录ⅪE中细菌内毒素检查法干扰实验及中国药品检验标准操作规范中细菌内毒素检查法的要求用不同厂家的鲎试剂对3批供试品进行干扰实验。结果对乙酰氨基酚注射液在4.17mg.mL-1稀释浓度时对细菌内毒素检查法无干扰作用,其细菌内毒素限值L=0.12EU.mg-1。结论对乙酰氨基酚注射液采用细菌内毒素检查法是可行的。

OBJECTIVE To study the bacterial endotoxins test of acetaminophen injection. METHODS Take 3 groups of acetaminophen injection progress inhibition and enhancement test to use TAL from different factory. According to the bacterial endotoxins test and inhibition or enhancement test approved by Chinese pharmacopoeia of 2005 edition. RESULTS 4.17mg·mL^-1 solution of acetaminophen injection don＇t inhibit or enhance the test L = 0.12 EU·mg^-1. CONCLUSION These results suggest that the bacterial endotoxins test can be used for the detection of endotoxin in acetaminophen injection.