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利用生物统计软件对兰州生研所12年间生产的147批百日咳菌苗原液的免疫力进行质反应平行线测定分析(平行线法),并与《中国生物制品规程》95版中WilsonWorcester法(W-W)比较,结果表明,质反应平行线测定法的各剂量反应百分率落在经验区间内;ED50可信限区间为0.016~0.014;相对效价95%可信限区间为0775~0.655。按合格、不合格、复试三个水平对147批百日咳菌苗的免疫力进行了分析与评价。并以中国百日咳菌苗免疫力试验用参考品为对照,对待检菌苗的稳定性及实验一致性进行了质量检测,计得总体回归系数分别为1.5879(x2=60.90)和1.3849(x2=163.24);总体ED50分别为0.014和0.015;待检菌苗总体相对效价0714,两法的ED50值间及相对效价值间存在很好的相关性(r=0.8376及r=0.9940)。
The bioassay software was used to measure the parallel reaction of the immunity of 147 B. pertussis vaccine strains produced by Lanzhou Institute of Health in 12 years (parallel line method) and compared with the WilsonWorcester method W-W). The results showed that the percentages of each dose response in the parallel reaction of mass reaction fell within the empirical range; the ED50 confidence interval was 0.016 ~ 0.014; the relative potency 95% confidence interval was 0 775 ~ 0.655. The immunity of 147 B. pertussis strains was analyzed and evaluated according to the three levels of pass, fail and retest. In order to compare the stability and experimental consistency of the tested vaccine against the pertussis vaccine in China, the overall regression coefficients were 1.5879 (x2 = 60.90) and 1 .3849 (x2 = 163.24). The overall ED50 were 0.014 and 0.015, respectively. The overall relative titer of the vaccine to be tested was 0.73. There was a good correlation between the ED50 values and relative efficacy values (R = 0.8376 and r = 0.9940).