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目的建立肺炎链球菌多糖结合物中游离蛋白含量的测定方法。方法采用Lowry法与凝胶色谱法相结合的方法检测结合物中游离蛋白浓度,再计算出结合物中游离蛋白含量,并对建立的方法进行准确性和精密性验证。结果采用本方法测定3个浓度肺炎链球菌多糖结合物中游离蛋白含量的平均回收率分别为98.6%、98.5%和97.0%;检测同一批肺炎链球菌多糖结合物的试验间变异系数CV值为3.0%。结论该方法简便、易行,准确性和精密性较好,可准确检测出肺炎链球菌多糖结合物中游离蛋白的含量。
Objective To establish a method for the determination of free protein in Streptococcus pneumoniae polysaccharide conjugate. Methods The combination of Lowry method and gel chromatography was used to detect the concentration of free protein in the conjugate. Then the free protein content in the conjugate was calculated. The accuracy and precision of the established method were verified. Results The average recoveries of free protein in the three concentrations of S. pneumoniae polysaccharide conjugate were 98.6%, 98.5% and 97.0% respectively. The CV of the same batch of S. pneumoniae polysaccharide conjugates was 3.0%. Conclusion The method is simple, easy, accurate and precise, and can accurately detect the content of free protein in Streptococcus pneumoniae polysaccharide conjugate.