廖丹;杨烨;李青耘;谢姗姗;王静;

• 1:成都生物制品研究所有限责任公司

摘要(Abstract)：

目的建立测定23价肺炎球菌多糖疫苗的关键原辅材料—过氧化氢酶活性的方法,并进行验证。方法分别采用高锰酸钾滴定法和紫外分光光度法测定过氧化氢酶活性,并对紫外分光光度法进行重复性、日间精密度、不同人员间精密度、耐用性、线性验证。结果两批样品重复测定6次结果的RSD均<5%;两批样品两名检测人员3日内的检测结果以及两批样品不同工作日间的检测结果差异均无统计学意义(P>0.05),样品日间和人员间检测结果的RSD均<5%;在20³0℃温度范围内该方法耐用性良好,在p H 7.030℃温度范围内该方法耐用性良好,在p H 7.0⁷.5范围内耐用性良好;该方法在样品浓度为0.27.5范围内耐用性良好;该方法在样品浓度为0.2¹.6μl/ml之间的线性关系良好。结论分光光度法重复性、日间精密度、不同人员间精密度良好,且操作简便,结果可靠,适用于过氧化氢酶的质量控制。

关键词(KeyWords)： 过氧化氢酶;酶活性;分光光度法

Abstract:

Keywords:

基金项目(Foundation):

作者(Authors): 廖丹;杨烨;李青耘;谢姗姗;王静;

DOI: 10.13200/j.cnki.cjb.000861

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