百日咳疫苗的技术演进与质量研究进展

Technical Evolution and Research Advances in Quality of Pertussis Vaccines

关键词:  百日咳疫苗  脱毒工艺  质量控制  结构表征

Key words:  Pertussis vaccine  Detoxification process  Quality control  Structural characterization

摘要:

百日咳是由百日咳鲍特菌（Bordetella pertussis）引发的急性呼吸道传染病，具有高度传染性，对婴幼儿健康构成严重威胁。尽管疫苗已实现广泛接种，近年来全球“百日咳再现”现象，凸显了现有疫苗的局限性。本文系统梳理了百日咳疫苗从全细胞疫苗到无细胞疫苗的发展历史，聚焦当前疫苗研发的核心策略，详细阐述了抗原选择与配伍的科学基础、精制工艺的优化路径，并重点探讨了脱毒工艺这一关键环节及新形势下的质量研究体系构建的关键技术要点。进一步，结合国内外研发经验，从有效性评价、杂质控制、结构表征与批间一致性等维度，系统论述了新形势下以“一致性评价”为核心的质量研究体系，旨在为我国百日咳疫苗的药学研究、工艺升级与质量提升提供参考依据。

Abstract:

Pertussis is an acute respiratory infectious disease caused by Bordetella pertussis, characterized by high transmissibility and posing a serious threat to the health of infants and young children. Despite widespread vaccination, the global resurgence of pertussis in recent years has highlighted the limitations of current vaccines. This review outlines the development of pertussis vaccines from whole-cell to acellular pertussis vaccines, focuses on current core strategies in vaccine research, elaborates on antigen selection and formulation, describes the optimization path for purification processes, and critically discusses detoxification along with the key technical points for establishing a quality research system under the new situation. Furthermore, drawing on global research experience, this review discusses the "consistency evaluation"-centered quality system covering potency assessment, impurity control, structural characterization, and lot-to-lot consistency, aiming to support pharmaceutical research, process optimization, and quality improvement of pertussis vaccines in China.