【摘要】 为了保证多糖蛋白结合疫苗的生产质量,建立了高效离子色谱和电化学检测残余溴化氰(CNBr)的方法。结果显示,该方法用于Hib多糖蛋白结合疫苗的残余氰化物检测时,在10~100μg/L的测定范围内,具有良好的专属性、灵敏度、精密度、线性和准确度。该方法操作简便,检测时间仅需要10 min。该方法也适用于以溴化氰作为多糖活化剂的其他多糖蛋白结合疫苗的质量控制。更多还原

【Abstract】 To keep the quality of Hib vaccine,the method for residual cyanide was established based on high performance anion exchange chromatography and electrochemical detector.The validation result shows that this method is of the good specificity,sensitivity,precision,linearity and accuracy in a detection range between 10μg/L and 100μg/L when it is applied in the testing of residual cyanide of Hib vaccine.It is easy to operate and just needs ten minutes in whole testing.There is the potential to apply it in the quality control of other polysaccharide and protein conjugate vaccines which use cyanogen bromide as activated reagent.更多还原