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Novel vaccine adjuvant and preparation method thereof

A vaccine adjuvant and vaccine technology, applied in antiviral agents, pharmaceutical formulations, medical preparations containing active ingredients, etc., can solve the problems of complex preparation and poor immune effect of vaccine adjuvants, achieve good stability, improve capture effect of ability

Inactive Publication Date: 2014-09-17
SHANGHAI INST OF PHARMA IND +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] The technical problem to be solved in the present invention is to provide a novel vaccine adjuvant composition and its freeze-dried preparation and preparation method for the existing vaccine adjuvant with poor immune effect and complicated preparation. Immune response of the body, reducing the dosage of vaccines, enhancing the immune effect, simple preparation, no need to use high-pressure homogenization or nano-cracking steps, easy for industrial production, and conducive to the maintenance of vaccine activity

Method used

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  • Novel vaccine adjuvant and preparation method thereof
  • Novel vaccine adjuvant and preparation method thereof
  • Novel vaccine adjuvant and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0076] Weigh 1g of squalene, 1g of medium-chain triglyceride, 1.5g of Solutol HS15, 0.5g of lecithin, mix and heat to 70°C, stir to obtain the oil phase; weigh 2g of glycerin, 0.132g of citric acid, add In 60mL water for injection, stir to dissolve, adjust the pH to 7 with sodium hydroxide solution as the water phase; under 500rpm magnetic stirring, add the water phase to the oil phase to obtain an opalescent solution, add water to 100mL, stir evenly, Filter through a 0.22μm filter membrane, fill and seal into ampoules, and obtain the product.

Embodiment 2

[0078] Weigh 2.5g of squalene, 2.5g of medium-chain triglyceride, 154g of Solutol HS, and 1g of lecithin, mix and heat to 60°C, stir to obtain the oil phase; weigh 2g of glycerin, add to 60mL water for injection, stir, As the water phase; under 300rpm mechanical stirring, add the water phase to the oil phase to obtain an opalescent solution, add water to 100mL, stir evenly, filter through a 0.45μm filter membrane, fill and seal into an ampoule, and sterilize by autoclaving, that is have to.

Embodiment 3

[0080] Weigh 0.5g of squalene, 0.5g of medium chain triglyceride, 152g of Solutol HS, 0.5g of lecithin, mix and heat to 50°C, stir to obtain the oil phase; weigh 0.01g of thimerosal, 0.132g of citric acid, Add 60mL of water for injection, stir to dissolve, adjust the pH to 7.4 with sodium hydroxide solution as the water phase; under 700rpm magnetic stirring, add the water phase to the oil phase to obtain an opalescent solution, add trivalent influenza vaccine ( The hemagglutinin content is 6mg each), add water to 100mL, stir evenly, filter through a 0.22μm filter membrane, fill and seal into ampoules, and obtain.

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Abstract

The invention discloses a vaccine adjuvant composition and its freeze-dried preparation and preparation method. The vaccine adjuvant composition comprises, by massic volume, 0.1-15% of an oil phase containing one or more of squalene, squalane and median-chain triglyceride oil, 0.1-15% of one or more emulsifiers selected from polyethylene glycol-12-hydroxystearate, phosphatide and Twain, and 70-99.5% of water. The novel vaccine adjuvant composition has good stability and can be preserved at a temperature of 2-8 DEG C and a temperature of 20-25 DEG C for a long time. The vaccine adjuvant composition can be used as an adjuvant of different vaccines such as an inactivated vaccine, an attenuated vaccine, a split vaccine, a DNA vaccine, a recombinant vaccine, a subunit vaccine and a polypeptide protein vaccine.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a vaccine adjuvant composition, a freeze-dried preparation and a preparation method thereof. Background technique [0002] Vaccine is a special drug, as a biological product produced by the joint development of immunology experience, theory and biotechnology, it prevents the threat of many infectious diseases to the body from the perspective of prevention, and has made great contributions to human beings . The basic components of vaccines often include antigens, adjuvants, preservatives, stabilizers, inactivators and other active ingredients. [0003] With the rapid development of modern biotechnology, new vaccine antigens have high purity, relatively small molecular weight, and low adverse reactions to vaccines. However, the immunogenicity of these antigens is generally weak. In order to improve the effectiveness of the antigen, it is necessary to add adjuvant to the antigen. agents to...

Claims

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Application Information

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IPC IPC(8): A61K39/39A61K9/107A61K9/19A61P37/04A61P31/20A61P31/16A61P31/14A61K39/29A61K39/145A61K39/13A61K39/205
Inventor 金方蔡伟惠
Owner SHANGHAI INST OF PHARMA IND