The application relates to the technical field of vaccine preparation, and discloses an oil-in-water
squalene-containing
adjuvant as well as a preparation method and application thereof. The
adjuvant comprises the following components:
squalene,
polysorbate 80,
sorbitan trioleate, a temperature-sensitive nonionic block
copolymer, an
amino acid CMT
regulator, a polyhydric
alcohol CMT
regulator,
citric acid,
sodium citrate, and the rest is injection water. The preparation method comprises the following steps: preparing an
oil phase; dissolving the temperature-sensitive nonionic block
copolymer, the CMT
regulator, the
citric acid and the
sodium citrate in low-temperature injection water, then pre-treating by temperature rising to obtain an aqueous phase; shearing and emulsifying the aqueous phase and the
oil phase at a specific temperature; and finally, controlling the
cooling speed of the hot
emulsion and filtering. Through the composite formula and the specific process, the long-term storage stability of the
adjuvant is remarkably improved, the
immunocompetence of the vaccine is guaranteed, the process reproducibility is good, and the production cost is reduced.