A kind of oil emulsion vaccine and demulsification method of the vaccine

An oil emulsion and vaccine technology, applied in the field of vaccines, can solve the problems of high viscosity, easy delamination and poor stability of vaccines

Active Publication Date: 2020-11-27
吉林冠界生物技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] However, the existing oil emulsion vaccines generally have defects such as high vaccine viscosity, poor stability, and easy delamination.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0061] Embodiment 1 A kind of preparation method of oil emulsion vaccine preparation

[0062] Prepare the oil emulsion vaccine as follows:

[0063] (1) Prepare the oil phase: weigh 94 parts of white oil, 6 parts of Span 80 and 0.5 part of aluminum stearate, first add Span 80 to the white oil, stir evenly, add aluminum stearate, heat to make it fully Mix, then cool down to 20°C;

[0064] (2) Preparation of the water phase: Take an aqueous solution of H5 avian influenza virus antigen (cells infected with H5 avian influenza virus) and mix it evenly with Tween 80, wherein the weight ratio of the H5 avian influenza virus antigen aqueous solution to Tween 80 is Be 96:4, afterwards, the temperature of described aqueous phase is adjusted to 20 degrees centigrade;

[0065] (3) Preparation of water-in-oil vaccine: put the oil phase into the emulsification device and start stirring, and at the same time slowly add the water phase, the rotation speed is 1800r / min, the stirring time is 1...

Embodiment 2

[0066] Embodiment 2 A kind of preparation method of oil emulsion vaccine preparation

[0067] Prepare the oil emulsion vaccine as follows:

[0068] (1) Prepare the oil phase: weigh 93 parts of white oil, 7 parts of Span 80 and 0.3 parts of aluminum stearate, first add Span 80 to the white oil, stir well, then add aluminum stearate, heat to make it fully Mix, then cool down to 15°C;

[0069] (2) Preparation of the water phase: Take an aqueous solution of H5 avian influenza virus antigen (cells infected with H5 avian influenza virus) and mix it evenly with Tween 80, wherein the weight ratio of the H5 avian influenza virus antigen aqueous solution to Tween 80 is is 95:5, after that, the temperature of the aqueous phase is adjusted to 15°C;

[0070] (3) Preparation of water-in-oil vaccine: Put the oil phase into the emulsification device and start stirring, and at the same time slowly add the water phase, the rotation speed is 1500r / min, the stirring time is 7min, and the weight...

Embodiment 3

[0072] Prepare the oil emulsion vaccine as follows:

[0073] (1) Prepare the oil phase: weigh 95 parts of white oil and 5 parts of Span 80, add Span 80 to the white oil, stir evenly, and adjust the temperature of the oil phase to 25°C;

[0074] (2) Preparation of the water phase: Take an aqueous solution of H5 avian influenza virus antigen (cells infected with H5 avian influenza virus) and mix it evenly with Tween 80, wherein the weight ratio of the H5 avian influenza virus antigen aqueous solution to Tween 80 is It is 95.5:4.5, afterwards, the temperature of described aqueous phase is adjusted to 25 ℃;

[0075] (3) Preparation of water-in-oil vaccine: put the oil phase into the emulsification device and start stirring, and at the same time slowly add the water phase, the rotation speed is 2000r / min, the stirring time is 15min, and the weight ratio of the oil phase to the water phase is 2:1 , after the stirring, start the emulsification pump to start emulsification, the time ...

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PUM

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Abstract

The invention relates to an oil emulsion vaccine and a demulsification method of the vaccine. The oil emulsion vaccine comprises an oil phase and a water phase, wherein the oil phase and the water phase in a weight ratio of 1-2:1 are mixed and emulsified, the oil phase comprises the following raw materials in parts by weight: 93-95 parts of white oil, 5-7 parts of a lipophilic surfactant and 0-0.5part of aluminum stearate; the water phase comprises an aqueous vaccine antigen solution and a hydrophilic surfactant in a weight ratio of 95-96:4-5. The oil emulsion vaccine has the advantages of being low in viscosity, good in stability and not prone to layering; meanwhile, the vaccine also has the advantages of low cost and high cost performance. Besides, with adoption of the demulsification method, the oil emulsion vaccine with good stability can be effectively demulsified by repeated freezing and thawing.

Description

technical field [0001] The invention relates to the field of vaccines, in particular to an oil emulsion vaccine and a method for breaking the emulsion of the vaccine. Background technique [0002] Oil emulsion vaccine is a commonly used vaccine dosage form, which plays an irreplaceable role in the application of vaccines due to its characteristics of continuous immune stimulation and long immune protection period. [0003] With the continuous development of the biological vaccine industry, people's understanding of the safety and side effects of vaccines has gradually deepened, and the requirements for the quality of oil emulsion vaccines have also gradually increased. [0004] Oil-emulsion vaccines have a large oil-water interface, which is a thermodynamically unstable system. Its instability is mainly manifested in delamination, rupture, transformation, and corruption. Delamination and rupture are the most common, which is a long-standing problem for vaccine manufacturers....

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K39/145A61K9/107A61K47/12A61P31/16
CPCA61K9/107A61K39/12A61K47/12C12N2760/16134
Inventor 李莉赵海源陈宏朱长动冯玉强蒋晓梅张天舒王玉红宋海岩石莹付春杰张丹孟令伟赵鹤张阔
Owner 吉林冠界生物技术有限公司
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