【摘要】 目的建立丙泊酚注射液细菌内毒素的检查方法。方法参照《中国药典》2010年版二部附录的细菌内毒素检查方法,采用两个厂家的鲎试剂,对不同稀释倍数的丙泊酚注射液进行干扰试验。结果丙泊酚注射液稀释12倍时对鲎试剂与细菌内毒素之间的凝集反应既无抑制作用,也无增强作用。3个批号的供试品细菌内毒素均符合要求。结论凝胶法可用于检测丙泊酚注射液的细菌内毒素。更多还原

【Abstract】 Objective To establish a method of bacterial endotoxin test for Propofol Injection.Methods According to the appendix of Chinese Pharmacopoeia(2010 edition,vol.Ⅱ),interference test was used to study the influence of different diluted sample by using TAL from two manufacturers.Results The experiment showed that the sample had no inhibitive or enhanced effect on congregating reaction when it was diluted 12 times.Bacterial endotoxins in 3 batches of samples were eligible.Conclusion Gelation assay is suitable for bacterial endotoxin test of Propofol Injection.更多还原