氢氧化铝佐剂细菌内毒素凝胶法检测方法验证

Validation of bacterial endotoxin test for aluminum hydroxide adjuvant by TAL method

目的:建立氢氧化铝佐剂的鲎试剂凝胶法检测方法。方法:按《中国药典》2020版通则1143细菌内毒素检查法,采用3种缓冲液、钙镁离子添加剂正交设计进行干扰预试验;2个厂家的鲎试剂对不同批号氢氧化铝佐剂进行干扰试验、样品处理的有效性验证。结果:通过干扰预试验,筛选到排除干扰条件。在验证条件下,氢氧化铝佐剂以PBS缓冲液、钙镁离子添加剂排除干扰,对细菌内毒素检查法无干扰作用。结论:建立的凝胶法检测方法用于检查氢氧化铝佐剂的细菌内毒素可行。

Objective:To establish a TAL gel-clot bacterial endotoxin test for aluminum hydroxide adjuvant.Methods:According to the bacterial endotoxin test in general chapter 1143 of the Chinese Pharmacopoeia 2020,pre-interference test was performed using 3 types of buffer solutions and Ca-Mg additive by orthogonal design.The interference test and sample preparation validation were carried out using different batches of aluminum hydroxide adjuvant from 2 TAL manufacturers.Results:No interference was obtained through pre-interference test.Under the validated conditions,aluminum hydroxide adjuvant combined with phosphate buffered saline and Ca-Mg additive was employed to remove interference in bacteria endotoxin test.Conclusion:The established TAL gel-clot method is applicable to bacterial endotoxin test for aluminum hydroxide adjuvant.