The present application relates to a vaccine freeze-
drying protective agent, its preparation method and application, and belongs to the technical field of biological
medicine. The vaccine freeze-
drying protective agent comprises the following raw materials:
trehalose,
mannitol,
arginine,
pullulan, 2-hydroxypropyl-beta-
cyclodextrin,
phospholipid,
sodium sulfite and a protective additive; the protective additive is at least one of hydroxyectoin,
betaine, dodecyl dimethyl
betaine and polycarboxylic
betaine. The preparation method comprises the following steps: mixing 2-hydroxypropyl-beta-
cyclodextrin and
phospholipid by high-speed shearing, sequentially adding the remaining components, adjusting pH and
osmotic pressure, and then performing freeze-
drying after
sterile filtration. The protective agent can effectively inhibit phase separation,
sugar recrystallization and interface adsorption during the freeze-drying process, significantly improve the activity
retention rate and
physical stability of the vaccine during freeze-drying and storage, and is suitable for the preparation of freeze-drying preparations of various vaccines such as viral vaccines, bacterial vaccines and recombinant
protein vaccines.