应用皮内多点攻毒法检测吸附精制白喉类毒素效价

The Potency Assay for Purified Adsorbed Diphtheria Toxoid using the Multiple Intradermai Challenge Test

将待检吸白类与参考标准品免疫动物后进行皮内攻毒,记录得分结果进行量反应平行线分析,其可靠性测验结果表明,剂间与回归项变异皆十分显著;偏离平行项、二次曲线、反二次曲线项以及试品间项变异皆不显著。这说明3批待检吸白类与参考标准品的剂量反应回归,是平行直线关系。所检定的3批吸白类效价分别为55.47、56.74和47.06IU/0.5ml,皆超过了WHO规程规定的30IU/0.5 ml的水平。以上事实说明,WHO所推荐的皮内多点攻毒法检测吸白类效价,方法是可靠的和敏感的。

The reliability test of parallel line quantitative analysis based on the intradermal challenge scores of three lots of purified adsorbed diphtheria toxoid (dad) and the standard reference preparation showed that the variations of regression and between doses were significant. However, the deviation of parallelism, second degree curve, anti-second degree curve and between preparations were not significant. This suggested the dose response regression of the three lots of test Dad and standard reference preparation were linear and pa- rallel. According to these findings, we have estimated the potencies of the test Dad and their fiducial limits. They were 55.47, 56.74 and 47.06IU/0.5ml, respectively, and all of them exceeded 30IU/0.5 ml in accordance with WHO requirements.The facts mentioned above proved the method recommended by WHO for the potency assay of the purified adsorbed diphtheria toxoid using the multiple intradermal challenge test was reliable and sensitive.