重组乙肝疫苗纯度高效液相层析(HPLC)测定方法的改进

为建立重组汉逊酵母乙肝疫苗HPLC检定方法，应用TSK－G5000PW检测系统测定汉逊酵母重组乙肝疫苗表面抗原的纯度，对不同样品处理液的配比浓度和处理时间分别进行了探讨，作者选用DTT／Tween-80作为样品处理效果优于DTT＋Tween-20,1:50Tween-80与0.1mol/L等量混合为样品处理液的适宜浓度。样品处理液与等量样品混匀时间介于35s-2min时，HPLC分离效果好，结果稳定。该处理液及处理时间对CHO细胞及Merck酿酒酵母重组乙肝疫苗表面抗原的HPLC纯度测定无影响。结果表明：现有的HPLC检测系统用0.1mol/L DTT与1：50 Tween-80等量混合处理后能有效地检测不同类型重组乙肝疫苗表面抗原的纯度。

A modified method of HPLC to assay the purity of recombinant hepatitis B vaccine(rHBV)

TSK-G5000PW assay system was modified to determine the purity of recombinant hepatitis B vaccine made from Hasnula yeast. The result showed that DTT/Tween-80 was suitable treating solution for sample, and the optimum concentration was the mixture of same volume of 1:50 Tween-80 and 0.1mol/L DTT, While the working time was within 35 seconds to 2 minutes. This modified TSK-G5000PW assay system had no effect on determining the purity of rHBV made from or CHO cell.