FIELD: chemical; pharmaceutical industry.
SUBSTANCE: invention concerns a new composition for the preparation of a stabilizer used in the production of live dry yellow fever vaccine in bottle form, containing the following components: 8 g of sodium chloride (NaCl); 0.2 g of potassium chloride (KCl); 1.13 g of disodium phosphate dihydrate (Na2HPO4⋅2H2O); 0.2 g of potassium dihydrogen phosphate (KH2PO4); 0.13 g of calcium chloride dihydrate (CaCl2⋅2H2O); 0.076 g of magnesium sulfate heptahydrate (MgSO4⋅7H2O); 61.5 g of lactose; 30.8 g of sorbitol; 2.4 g of l-histidine; 1.37 g of l-alanine; 9–10 g of gelatin. The stabilizer is prepared by dissolving a set of components in water for injection. Providing high stabilizing properties of the composition without creating a high protein load on the body of the patient receiving the vaccine. The proposed stabilizer is characterized by high stabilizing properties and is suitable for creating bottled forms of yellow fever vaccine preparations and their semi-finished products.
EFFECT: preparations containing the stabilizer of the proposed composition remain stable for a long time, including for a long time after opening the package without loss of quality and even at high temperatures due to the climatic zone of the endemic area.
7 cl, 4 tbl
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Authors
Dates
2024-02-08—Published
2022-06-03—Filed