测定过氧化氢酶活性的分光光度法的建立及验证

发布时间：2018-11-18 09:42

【摘要】：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(P0.05),样品日间和人员间检测结果的RSD均5%;在20~30℃温度范围内该方法耐用性良好,在p H 7.0~7.5范围内耐用性良好;该方法在样品浓度为0.2~1.6μl/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。
[Abstract]:Objective to establish a method for the determination of catalase activity of 23 valent pneumococcal polysaccharide vaccine. Methods the activity of catalase was determined by potassium permanganate titration and ultraviolet spectrophotometry, and the repeatability, day precision, durability and linearity of ultraviolet spectrophotometry were tested. Results the RSD of the two batches of samples were determined 6 times repeatedly. There was no significant difference in the results of the two batches of samples within 3 days and the two batches of samples between different working days (P0.05). The RSD of the test results of the two batches of samples during the day and between the people were 5. The method has good durability in the temperature range of 20 鈩，

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