[对麻疹疫苗活性使用药典参考材料的经验]
A S Binyatova1, T N Yunasova1, R A Volkova1
1Scientific Centre for Expert Evaluation of Medicinal Products.
Voprosy virusologii
|December 29, 2023
概括
这项研究证实了麻疹疫苗药典参考材料 (PRM) 的稳定活性. 这确保了疫苗中麻疹病毒的准确测量,支持有效的疾病预防工作.
科学领域:
- 免疫学 免疫学 免疫学
- 病毒学 病毒学
- 药理学 药理学是指药理学的学科.
背景情况:
- 全球麻疹发病率不断上升,需要高质量的疫苗.
- 确保麻疹疫苗的有效性是公共卫生政策的一个关键目标.
研究的目的:
- 评估麻疹疫苗药典参考材料 (PRM) 的有用性,以测量麻疹病毒的特定活性.
- 评估PRM在俄罗斯联邦含麻疹疫苗质量控制方面的表现.
主要方法:
- 对一种特定的麻疹疫苗PRM (10系列) 的分析.
- 在各种含麻疹疫苗中测定麻疹病毒特异性活性.
- 审查2021-2022年生产总结协议和实验室数据.
主要成果:
- 在PRM中,麻疹病毒标位始终处于认证范围内 (4.63±0.5毫克TCD50/0.5毫升).
- 平均PRM标位 (4.61 lgTCD50/0.5毫升) 与认证值非常接近,标准偏差最小 (≤0.15 lgTCD50).
- 测试结果符合所有监管接受标准,表明分析性能稳定.
结论:
- 麻疹疫苗PRM表现出稳定的活性.
- 在疫苗中确定麻疹病毒标位的方法是准确的.
- PRM是监测疫苗中麻疹病毒特异性活性的一种有效工具.
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