Sabin株脊髓灰质炎灭活疫苗D抗原国家标准品的建立Establishment of national standard for D antigen of inactivated poliomyelitis vaccine from Sabin strain
英志芳;江征;蔡玮;周健;王剑锋;徐康维;李长贵;
摘要(Abstract):
目的制备Sabin株脊髓灰质炎灭活疫苗D抗原国家标准品,并进行协作标定及稳定性检测。方法委托中国医学科学院医学生物学研究所按照国家批准工艺制备分装三价候选国家标准品,并考察其均匀性;组织5家实验室采用统一的D抗原ELISA检测方法对候选标准品协作标定,确定D抗原标示值,并对其稳定性进行初步检测。结果候选标准品分装精度变异系数(CV)为0.21%;Ⅰ、Ⅱ、Ⅲ型CV值分别为7.39%、6.21%、7.75%;Ⅰ、Ⅱ、Ⅲ型在不同实验室间D抗原含量的CV值分别为4.03%5.90%、3.48%5.90%、3.48%4.00%、3.03%4.00%、3.03%4.53%,抗原含量均一性良好;确定Ⅰ、Ⅱ、Ⅲ型最终标准品效价分别为180、191、243 DU/m L。将标准品于4及-20℃放置4个月,3个血清型的D抗原含量均未发生较大变化;25℃放置约7周时,各血清型D抗原含量才出现下降趋势;37℃放置1周时开始下降,尤以Ⅰ型最为明显。结论制备的候选标准品满足国家生物标准物质的要求,可应用于Sabin株脊髓灰质炎灭活疫苗体外效力检测。
关键词(KeyWords): Sabin株脊髓灰质炎灭活疫苗;D抗原;标准品
基金项目(Foundation):
作者(Authors): 英志芳;江征;蔡玮;周健;王剑锋;徐康维;李长贵;
DOI: 10.13200/j.cnki.cjb.002053
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