测定b型流感嗜血杆菌结合疫苗游离多糖的脱氧胆酸钠沉淀法的建立

 目的  建立测定b型流感嗜血杆菌（Haemophilus influenzae type b，Hib）结合疫苗游离多糖的脱氧胆酸钠（sodium deoxycholate，DOC）沉淀法。 方法   在一定的酸性条件下，用1%DOC沉淀分离Hib结合疫苗中的结合多糖和游离多糖，测定上清和沉淀的多糖含量，并对该法进行验证。 结果   DOC沉淀法的标准曲线具有可靠的线性，决定系数＞0.999。该法的准确性和精密度良好，多糖加样回收率为103%~108%，相对标准差均<10%。 结论   建立的DOC沉淀法可用于Hib结合疫苗中的游离多糖测定。

Establishment of a sodium deoxycholate precipitation method for determination of the free polysaccharide in Haemophilus influenzae type b conjugate vaccine

Objective To establish a sodium deoxycholate precipitation method for determination of the free polysaccharide in Haemophilus influenzae type b （Hib） conjugate vaccine.Methods The conjugated and the free polysaccharides were separated using 1 % sodium deoxycholate （DOC） under certain conditions.The contents of free polysaccharide in supernatant and precipitate were detected.The DOC precipitation method was validated.Results The standard curve of the DOC precipitation method had good linearity and the coefficient of determination was 〉0.999.The DOC precipitation method had good accuracy and precision.Recoveries and relative standard deviations of the establish method were 103%-108% and 〈10%,respectively.Conclusion The established DOC precipitation method can be used to detect the free polysaccharide in Hib conjugate vaccine.