无细胞百日咳工艺中(PO_4)^(3-)影响DTaP免疫效力分析

Analysis of (PO_4)^(3-) affecting DTaP potencies in different acellular Pertussis preparations

用 0 0 2mol/L磷酸盐缓冲液和不用磷酸盐缓冲液透析生产无细胞百日咳 (aP) ,按《2 0 0 0年版生物制品规程》制备和检定氢氧化铝吸附无细胞百日咳、白喉、破伤风联合疫苗 (DTaP)。发现用磷酸盐缓冲液和不用磷酸盐缓冲液透析生产aP组成DTaP免疫效力差异非常显著 ,后者 10 0 % (10 / 10 )合格 ,前者合格率只有 2 7% (3/ 11) ,用钼兰法测定DTaP中PO4 3 -离子浓度。结果表明后者的PO4 3 -浓度只是前者的 1/ 10。PO4 3 -依次影响白喉、破伤风。

The comparison with and without 0.02 mol/L phosphate in production of acellular Pertussis was investigated,according to the Requirements of Biologics in edition of year 2000,on the purpose of preparation of combined absorbed vaccine for Diphtheria,tetanus and acellular Pertussis(DTaP).The potency of preparation resulted from phophate buffer dialysis was significantly lover than that of without the same treatment.The qualified rate of former was only 27%(3/11),but that of later was 100%(10/10).The concentration of PO 4 3- in DTaP was determined by Melybdenum blue method,results showed that the concentration of later was only 1/10 for that of former.The affecting potencies were in a order of Diphtheria,Tetanus and acellular Pertussis.