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［摘 要］目的 研制冻干甲肝减毒活疫苗，提高疫苗的稳定性，便于保存及运输，保证疫苗的接种效果。方法 采用CA－9冻干保护剂，制备冻干疫苗，疫苗液与保护剂之比为3．5∶1。结果 冻干甲肝减毒活疫苗具有与液体疫苗相同的安全性及免疫原性。在2～8℃保存的有效期较液体疫苗的3～5个月提高到18个月。在室温和37℃保存的稳定性也明显提高。结论 冻干甲肝疫苗的稳定性良好，无需低温保存、冷链运输，便于甲肝疫苗的大规模推广应用。
[Abstract] Objective To develop a live attenuated attenuated hepatitis A vaccine, to improve the stability of the vaccine, to facilitate the preservation and transportation, and to ensure the vaccination effect. Methods Lyophilized CA-9 protectant was used to prepare lyophilized vaccine. The ratio of vaccine solution to preservative was 3.5:1. Results Lyophilized live attenuated hepatitis A vaccine has the same safety and immunogenicity as liquid vaccine. The shelf life of 2-8 ° C is increased to 18 months from 3 to 5 months of liquid vaccine. Storage stability at room temperature and 37 ℃ also significantly improved. Conclusion The stability of the freeze-dried hepatitis A vaccine is good, without the need of cryopreservation and cold chain transportation, which facilitates the large-scale popularization and application of hepatitis A vaccine.