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Influenza vaccine immunization preparation for nasal administration and preparation method thereof

A technology for influenza vaccines and immune preparations, which is applied in the field of human influenza vaccine preparations and its preparation, and can solve the problems that the nasal immunization preparations of influenza vaccines have not yet seen clinical application.

Active Publication Date: 2018-08-28
SHANGHAI MODERN PHARMA ENG INVESTIGATION CENT
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

To date, nasal immunization formulations of inactivated influenza vaccines have not seen clinical application

Method used

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  • Influenza vaccine immunization preparation for nasal administration and preparation method thereof
  • Influenza vaccine immunization preparation for nasal administration and preparation method thereof
  • Influenza vaccine immunization preparation for nasal administration and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] prescription:

[0042]

[0043] The immune enhancer is dodecyl / tetradecyl-glucoside, the pH regulator is phosphate buffer saline (0.01mM, pH=7.2); the osmotic pressure regulator is sodium chloride.

[0044] Preparation:

[0045] Adding the alkyl glycoside to the phosphate buffer solution to dissolve to obtain an alkyl glycoside solution;

[0046] The inactivated influenza vaccine is mixed with the alkyl glycoside solution, and other components are added to obtain the nasally administered influenza vaccine immune preparation. Store at 2-8°C.

Embodiment 2

[0048] prescription:

[0049]

[0050] Described immunopotentiator is chitosan (500,000 molecular weight, deacetylation degree 90%);

[0051] Described pH adjusting agent is glacial acetic acid-sodium acetate buffer solution (pH4.5)

[0052] Preparation:

[0053] Chitosan and glacial acetic acid-sodium acetate buffer solution (pH4.5) are mixed and dissolved, and then inactivated influenza vaccine is added to obtain the influenza vaccine immune preparation for nasal administration;

[0054] Then add 50 g of mannitol, and freeze-dry at -40° C. to obtain an immune freeze-dried preparation of influenza vaccine for nasal administration.

Embodiment 3

[0056] prescription:

[0057] Calculated as HA, inactivated influenza vaccine 75mg for each subtype

[0058] Low Acyl Gellan Gum 5g

[0059] water 1000mL

[0060] The immune enhancer is low acyl gellan gum;

[0061] Preparation:

[0062] The low acyl gellan gum is added to water, stirred and dissolved at 80-100° C., allowed to cool, and then mixed with the inactivated influenza vaccine to obtain the nasally administered influenza vaccine immune preparation.

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Abstract

The invention discloses an influenza vaccine immune preparation for nasal administration and a preparation method thereof. The influenza vaccine immune preparation for nasal administration contains the following ingredients: weighed according to HA, 50-150 mg of valent inactivated influenza vaccine, 1-50 g of an immunopotentiator, 0-9 g of an osmotic pressure regulator, 0-30 g of a pH regulator and 1000 mL of water. The immunopotentiator is selected from alkyl glycoside, chitosan, low-acyl gellan gum or lipidosome. The invention has the following advantages: the developed influenza vaccine immune composition for nasal administration doesn't require injection administration, and immune effect of the influenza vaccine immune composition is similar to intramuscular injection effect.

Description

technical field [0001] The invention relates to human influenza vaccine preparation and preparation method thereof. Background technique [0002] Influenza is an acute respiratory infectious disease caused by influenza virus. Influenza virus is easy to mutate, highly contagious, and spreads quickly. Influenza epidemics have brought serious disasters to humans and seriously affected the development of poultry farming. Influenza viruses are pleomorphic, with spheroids and filaments, and are single-stranded negative-sense RNA viruses. In the spherical virus particle, the helical nucleocapsid is the core of the virus, which is composed of nucleoprotein (NP) and polymerase protein (RNA polymerase components: PB1, PB2, PA). Nucleoprotein (RNP), and RNA connect. The middle layer is protein shell, which contains matrix protein (matrix, M1) and membrane protein (membrane protein, M2). The outer layer comes from the double-layered lipid vesicle membrane of the host cell, and ther...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/00A61K9/127A61K9/10A61K9/19A61K39/39A61K39/145A61P31/16
Inventor 吴闻哲侯惠民吴慧张琪
Owner SHANGHAI MODERN PHARMA ENG INVESTIGATION CENT