冻干保护剂在活疫苗生产中的应用进展

Progress of application of lyophilization stabilizer in live vaccine production

冻干是疫苗研发及制备过程中的关键技术,在疫苗冻干及储藏过程中疫苗的化学成分、冻结温度和速率、干燥温度及干燥固体中剩余水分、储藏环境的温度和湿度等均会对疫苗的活性产生影响。为防止疫苗在冻干过程中活性组分的变性,需添加合适的冻干保护剂,可尽量减少冻干及储藏过程对疫苗活性造成的损伤。本文就几种常见冻干保护剂的保护机理及应用、筛选方法与面临的挑战及其未来的发展趋势作一综述。

Lyophilization is a key technique for the development and production of vaccines. During lyophization and storage, the activity of vaccine is influenced by various factors, including the chemical composition, temperature and rate for freezing, temperature for drying, residual moisture in dried solid as well as temperature and humidity of environment for storage. In order to prevent the active composition of vaccine from degeneration during lyophilization, it is necessary to add an appropriate stabilizer to minimize the loss of vaccine activity due to lyophization and storage. This paper reviews the action mechanism, methods for screening, challenge and development tendency of various lyophilization stabilizers.