【摘 要】
：
目的：建立一种高效大小排阻色谱(HPSEC)方法检测b型流感嗜血杆菌(Hib)结合疫苗分子大小分布.方法：采用TSK G6000PW色谱柱,1.0％(w/v)Na2SO4作为流动相,流速设置为0.4ml/min,紫外检测波长为206nm,并连接激光散射检测器(MALS),对Hib结合疫苗的原液和制剂样品进行分子大小分布的检测;将该结果与CL-4B凝胶柱检测的结果进行比较.同时对一组原液和制剂样品进
【机 构】
：
天津康希诺生物技术有限公司 天津科技大学,天津 300457
【出 处】
：
2013中国药学大会暨第十三届中国药师周
论文部分内容阅读
目的：建立一种高效大小排阻色谱(HPSEC)方法检测b型流感嗜血杆菌(Hib)结合疫苗分子大小分布.方法：采用TSK G6000PW色谱柱,1.0％(w/v)Na2SO4作为流动相,流速设置为0.4ml/min,紫外检测波长为206nm,并连接激光散射检测器(MALS),对Hib结合疫苗的原液和制剂样品进行分子大小分布的检测;将该结果与CL-4B凝胶柱检测的结果进行比较.同时对一组原液和制剂样品进行高温处理,用HPSEC法和CL-4B色谱法分析样品降解趋势.结果：HPSEC法可以对小量的以CRM197为载体的Hib结合疫苗进行分子大小分布的检测,每个样品的检测时间仅需40分钟,其检测结果与CL-4B色谱法的结果有着良好的相关性;HPSEC与激光散射检测器相连可以用来进行Hib结合疫苗的重均分子量的测定;通过对一组高温处理的样品进行分析,HPSEC法能够准确地反映出样品的降解趋势,与CL-4B色谱法的结果有着良好的可比性.结论：HPSEC法是一种比CL-4B色谱法检测更高效的分子大小测定方法.
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