FIELD: chemistry; pharmaceuticals.
SUBSTANCE: invention relates to a method of producing a vaccine adjuvant in the form of an emulsion, including the preparation of a hydrophobic phase containing squalene of plant origin and phosphatidylcholines dissolved in squalene, and the preparation of a hydrophilic phase containing a buffer solution and the Tween 80 emulsifier dissolved in it, mixing the hydrophobic and hydrophilic phases and grinding the particles of the hydrophobic phase in the hydrophilic phase by treating the mixture with ultrasound to obtain an emulsion, characterized in that the final content of the components of the mixture before ultrasound treatment is, mass.%: 3.0–10.0 of squalene; 0.5–1.0 of phosphatidylcholines; 0.5–1.0 of Twin 80 emulsifier; the rest is up to 100% — 50 mM buffer solution with pH 7.6, and the content of phosphatidylcholines and emulsifier in the mixture is in a 1:1 ratio, and the mixture of adjuvant components is treated with ultrasound with a wave frequency of 20–60 kHz and a treatment duration of 3 times 40 sec with an interval between treatments of 2–3 minutes; the first and second ultrasonic treatment is carried out at a temperature of the mixture of components of 58–62°C, and the final ultrasonic treatment is carried out at a temperature of the mixture of components of 8–12°C to obtain an emulsion with a particle size in the range of 30–90 nM.
EFFECT: ensuring the possibility of preserving the adjuvant emulsion for over 6 months.
1cl, 2 dwg, 1 tbl, 4 ex
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Authors
Dates
2024-01-16—Published
2022-12-20—Filed