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Adsorbed inactivated influenza vaccine and preparation method thereof

An influenza vaccine and inactivation technology, applied in biochemical equipment and methods, pharmaceutical formulations, medical preparations containing active ingredients, etc., can solve the problem of difficult immune response to whole virus vaccines, achieve effective immune response induction, and ensure supply. Quantity, the effect of good antigenicity

Active Publication Date: 2017-07-21
KM生物医药股份公司 +3
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in the case of the H5N1 subtype, it has been reported that it is difficult to induce a good immune response in humans even with this whole virus vaccine, so it is necessary to consider a plan to further improve the immunogenicity

Method used

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  • Adsorbed inactivated influenza vaccine and preparation method thereof
  • Adsorbed inactivated influenza vaccine and preparation method thereof
  • Adsorbed inactivated influenza vaccine and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0109] Example 1 Preparation of virus stock solution and preparation of trial vaccine (Step A method)

[0110] Prepare virus stock solution and trial vaccine according to the common method of Bacterial Preparation Association. The outline is as follows figure 1 Shown.

Embodiment 2

[0113] Example 2 Preparation of aluminum hydroxide gel

[0114] 143.1 g of sodium carbonate was dissolved in 9L of physiological saline and filtered to prepare a sodium carbonate solution. 316.0 g of aluminum potassium sulfate 12 hydrate (potassium alum) was dissolved in 9 L of physiological saline and filtered to prepare a potassium aluminum sulfate solution. The resulting sodium carbonate solution and potassium aluminum sulfate solution were mixed and stirred. The obtained aluminum hydroxide gel is washed and used as the adjuvant of the present invention.

Embodiment 3

[0117] Example 3 Preparation of adsorption and inactivated whole virus vaccine

[0118] The virus stock solution obtained in Example 1 and the aluminum hydroxide gel obtained in Example 2 were mixed to obtain an adsorbed inactivated whole virus vaccine.

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PUM

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Abstract

The invention discloses: for novel influenza viruses, especially novel viruses with low immunogenicity, an adsorption-inactivated whole-virus influenza vaccine capable of being effective with a low antigen level and causing few side effects and a preparation method thereof. The present invention particularly discloses: an adsorption inactivated influenza vaccine containing aluminum hydroxide gel prepared from sodium carbonate and aluminum potassium sulfate and isolated whole virion influenza virus as active ingredients, and a preparation method of the above adsorption inactivated influenza vaccine, the The method is characterized in that each step is performed using a solvent that does not contain surfactants and ethers.

Description

Technical field [0001] The invention relates to an adsorbed and inactivated whole virus influenza vaccine and a preparation method thereof. Background technique [0002] Influenza viruses belong to the Orthomyxoviridae family (Orthomyxoviridae) and have an RNA enveloped virus with a particle size of about 100 nm in diameter. They are classified into A, B, and C types according to the antigenicity of their internal proteins. Influenza viruses contain a core of ribonucleic acid (RNA) associated with an inner nucleocapsid or nucleoprotein surrounded by a viral envelope with a lipid bilayer structure, and an outer glycoprotein. The inner layer of the virus envelope is mainly composed of matrix proteins, and the outer layer is mostly composed of lipids from the host. The RNA of influenza virus has a segmented structure. The influenza pandemic currently in the world is caused by influenza A viruses. Type A has two envelope glycoproteins: hemagglutinin (HA) and neuraminidase (NA). Ac...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K39/145A61K39/39A61P31/16
CPCA61K39/12A61K39/145A61K39/39A61K2039/5252A61K2039/55505A61P31/16C12N2760/16134A61K9/06A61K39/155A61K47/02
Inventor 后藤修郎城野洋一郎五反田亨荒井节夫细井和男泷泽和幸福家功多田善一
Owner KM生物医药股份公司
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