影响含铝佐剂疫苗吸附率和解离率的因素分析

Analysis on Factors Affecting Adsorption and Desorption Rates of Aluminum Adjuvant-containing Vaccines

吸附率和解离率作为含铝佐剂疫苗重要的体外质量评价指标,是降低临床试验风险的重要保证。随着含铝佐剂疫苗评价手段的不断升级和工艺研究的日益深化,行业也对可为相关产品提供系统解析和深入分析的参考资料提出了更高层次的需求。该文基于项目实践经验,重点从佐剂特性、抗原特点和工艺特征方面论述分析,辅以评价方法设计的改善建议,系统总结了原辅料、铝佐剂、制剂工艺、检测方法等影响含铝佐剂疫苗吸附率和解离率的因素,旨在为制剂产品的开发提供参考和借鉴。

As a key in vitro quality evaluation index,the adsorption and desorption rates are essential for reducing the risk of clinical tests of aluminum adjuvant-containing vaccines.With the continuous upgrading of the evaluation methods and deepening of process research of aluminum adjuvant-containing vaccines,higher demands for reference materials that can be used for systematic and in-depth analyses of related products have been put forward.Based on the actual development experience of the preparation project,this paper mainly analyzes the characteristics of adjuvant and antigen,and preparation technology.Also,it gives some suggestions for improvement in the evaluation method design.At the same time,it systematically describes the factors affecting the adsorption and desorption rates of aluminum adjuvant-containing vaccines,such as excipients,aluminum adjuvant,preparation process,and determination methods,to provide modest references for the research and development activities of pharmaceutical products.