人用纯化Vero细胞狂犬病疫苗中硫酸鱼精蛋白残留量的测定

RESIDUE DETECTION OF PROTAMINE SULFATE FROM PURIFIED VERO-CELL RABIES VACCINES USED FOR HUMAN

用硫酸鱼精蛋白可去除 vero细胞狂犬病疫苗中残存的细胞基质 DNA,使其残余量小于 10 0 pg/剂量 ,但经一系列处理后的疫苗中硫酸鱼精蛋白应无残留 ,方认为安全可靠。我们采用毛细管电泳法 ,检测该种疫苗中硫酸鱼精蛋白残留量 ,在待检样品中硫酸鱼精蛋白未检出 ,该方法最小检出量为 3ppm。

Aim We can use protamine sulfate to remove residual plasmic DNA in Vero-cell rabies vaccines, at the end, the residue can be less than 100pg/dose.Only when there is no photamine sulfate in final vaccine, can we consider it be safe and reliable. We detect the residue of protamin sulfate in the vaccine with capillary electrophoresis. We can't find any protamine sulfate in test sample, the minimal concentration we can detect with this method is 3ppm.