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Lipid microsphere composition

A technology of lipid microspheres and compositions, applied in the directions of oil/fat/wax inactive ingredients, inactive medical preparations, antibody medical ingredients, etc., can solve problems such as difficulty in increasing the supply of vaccines

Active Publication Date: 2013-09-18
LIAONING CHENGDA BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0026] Influenza vaccines are needed in large quantities during flu outbreaks, but it is difficult to increase vaccine supply to meet such a huge demand

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0177] Preparation of Lipid Microsphere Emulsion Adjuvant

[0178] (1) Weigh 20g of soybean oil, 50g of medium-chain oil, 18g of soybean lecithin, and 0.1g of vitamin E, heat and stir in a water bath to mix evenly, and keep the temperature at 70°C as the oil phase; (2) weigh polysorbate 80 (Tween80 ) 2g was added to an appropriate amount of water for injection, heated and stirred to dissolve it, and kept at a temperature of 70°C as the water phase.

[0179] Mix the two phases of oil and water under stirring, and continue to stir to form colostrum; (3) the volume of colostrum is adjusted to 1000mL with water for injection, homogenized by 750bar high-pressure milk for 6 times, and the pH is adjusted to 7.5 with sodium hydroxide to obtain fat A microsphere emulsion type adjuvant.

Embodiment 2

[0181] Preparation of Lipid Microsphere Emulsion Adjuvant

[0182] (1) Weigh 60 g of medium-chain oil, 10 g of soybean lecithin, 3 g of hydrogenated lysophospholipid, and 0.5 g of oleic acid, heat and stir in a water bath to mix evenly, and keep the temperature at 75 ° C to form the oil phase; (2) weigh poloxamer 1881.5 g, 2.25 g of glycerol was added into the citrate buffer solution with a pH of 7.8, heated and stirred to dissolve, and the temperature was maintained at 75° C. as the water phase.

[0183] Mix the two phases of oil and water under stirring, and continue to stir to form colostrum; (3) the colostrum is adjusted to 1000mL with buffer solution, and the lipid microsphere emulsion type adjuvant can be obtained by 800bar high-pressure emulsion for 4 times.

Embodiment 3

[0185] Preparation of Lipid Microsphere Emulsion Adjuvant

[0186] (1) Weigh 60g of peanut oil and 15g of egg yolk phospholipid, heat and stir in a water bath until the phospholipid dissolves, and keep the temperature at 70°C as the oil phase; (2) Weigh 5.0g of sodium deoxycholate and add it to an appropriate amount of water for injection, heat Stir to dissolve and keep the temperature at 70°C as the water phase. Mix the two phases of oil and water under stirring, and continue to stir to form colostrum; (3) The volume of colostrum is adjusted to 1000mL with water for injection, homogenized by 1000bar high-pressure emulsification for 5 times, and the pH is adjusted to 7.0 with sodium bicarbonate. The lipid microsphere emulsion type adjuvant can be obtained.

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Abstract

The invention relates to a lipid microsphere composition. The lipid microsphere composition is characterized by comprising a lipid microsphere emulsifying agent and an immunogenic composition, wherein the lipid microsphere emulsifying agent comprises 1 to 30 weight percent of pharmaceutical grade grease, 0.1 to 10 weight percent of zwitterionic / non-ionic surfactant composition, 0.01 to 5 weight percent of stabilizing agent and the balance of aqueous solution; and the immunogenic composition is a univalent to multivalent composition and usually a trivalent composition, and contains a virus antigen or antigenic preparation from one or more pandemic influenza epidemic related influenza virus strains or with one or more pandemic influenza epidemic related influenza virus strains. The lipid microsphere composition not only can serve as an excellent aid of a vaccine, but also can serve as a conveying system of the vaccine. The lipid microsphere composition is applicable to different administration routes of the vaccine, improves compliance, diversity and selectivity of clinical application, and achieves wide, safe and effective immune effect.

Description

technical field [0001] The present invention relates to a biological product, in particular to a lipid microsphere composition containing a vaccine that can be safely used in humans or other animals. As a novel vaccine adjuvant and delivery system, it is particularly important that the present invention The lipid microsphere composition can well enhance the immune response of the human body to various antigens, has an excellent immune regulation function so as to achieve the effect of cross protection, and belongs to the technical field of biomedicine. Background technique [0002] The vaccine currently used in the European version of the pandemic H1N1 flu vaccine can completely alter the body's immune response to the flu vaccine and enhance The body's ability to produce an antibody response to many types of flu. [0003] Adjuvants are substances that people often add to vaccines to boost the immune response, but are ineffective on their own; the exact reason for this pheno...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/107A61K39/39A61K39/145A61K39/295A61K47/44A61K47/34A61K47/28A61K47/24A61P31/16
Inventor 高军李淑斌段鹏杰魏晓莹周荔葆殷建文万艾玲
Owner LIAONING CHENGDA BIOTECH
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