Squalene-containing oil-in-water adjuvant, and methods of making and using same

By using a composite stabilizing system of squalene, small molecule surfactants, and thermosensitive nonionic block copolymers in oil-in-water adjuvants, the problems of storage instability and insufficient immune activity of existing adjuvants are solved, achieving efficient storage and immune activation effects of adjuvants.

CN121944103BActive Publication Date: 2026-07-03HUANUOTAI BIOMEDICAL TECHNOLOGY (CHENGDU) CO LTD
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Patent Information

Application Number
CN202610433622.6
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2026-04-03
Publication Date
2026-07-03
Estimated Expiration
2046-04-03

AI Technical Summary

Technical Problem

Existing oil-in-water adjuvants suffer from increased droplet size and wider distribution during long-term storage, resulting in insufficient physical stability, affecting immunogenicity and reproducibility of the preparation process, and increasing production costs.

Method used

Using squalene-based oil-in-water adjuvants, a dense steric hindrance layer is formed through a composite stabilization system of small molecule surfactants and temperature-sensitive nonionic block copolymers, combined with amino acids and polyol modifiers, to ensure the thermodynamic and chemical stability of the emulsion.

Benefits of technology

It significantly improved the long-term storage stability and immunomodulatory activity of the adjuvant, ensuring the high efficacy and batch-to-batch consistency of the vaccine, and reducing production costs.

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Abstract

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.
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