TO STUDY THE STABILITY OF THE MAIN QUALITY INDICATORS OF AN EMULSION VACCINE AGAINST THE H5N1 INFLUENZA VIRUS

Modern inactivated emulsion vaccine preparations against avian viral diseases are complex multicomponent immunobiological preparations consisting of a dispersed phase represented by inactivated viruses in combination with an oil adjuvant. The dispersed medium is an oil adjuvant containing as a base highly purified mineral oil in combination with an emulsifier, a surfactant having bipolar molecules with a unique ability to dissolve in both oil and aqueous solutions. Obtaining a stable emulsion from a dispersed medium and phase is possible using modern technological techniques, equipment and high-tech methods. Depending on the manufacturing technology, storage and transportation conditions, inactivated vaccine preparations with an emulsion of the reverse type may have different physical states of the emulsion, which significantly affect their immunobiological properties. Physical changes associated with technological processes during the manufacture and storage of the drug in emulsions of the "water-oil" type can be reversible and irreversible. The purpose of the study was to determine compliance with the standards of the SRT, the most significant quality indicators of the developed inactivated emulsion vaccine preparations that are used in the fight against avian influenza, during storage. The article presents the test results of 3 samples of the developed inactivated emulsion vaccines against the H5N1 avian influenza virus. During 24 months of storage, at specified time intervals, the main quality indicators of the developed vaccine preparations were determined. It was found that the stability and viscosity of the developed emulsion preparations practically did not change relative to the initial standard standards for 24 months. There was also no increase in reactogenicity.