Vaccine and emulsification process and application thereof

A process and vaccine technology, applied in vaccines, vaccine emulsification process and application fields, can solve problems such as uneven composition, poor viscosity and stability, unstable vaccine quality, etc., achieve uniform composition and performance, reduce equipment requirements, immunity Effect of effect improvement

Active Publication Date: 2018-05-29
天康生物制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The first object of the present invention is to provide a vaccine emulsification process to alleviate the technical problems in the prior art that the product components are not uniform after emulsification, the viscosity and stability are poor, and the immune effect of the prepared vaccine is not ideal.
[0007] The second purpose of the present invention is to provide a vaccine to alleviate the technical problems of unstable vaccine quality and unsatisfactory immune effect in the prior art

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] This embodiment provides a vaccine emulsification process, comprising the following steps:

[0047] Step a): filter the 206 adjuvant with a nylon filter membrane at 18°C, and heat the adjuvant to 32°C after filtration;

[0048] Step b): adding the 2°C foot-and-mouth disease inactivated vaccine antigen dropwise into the adjuvant, and the temperature of the adjuvant is always maintained at 32°C;

[0049] Step c): after the dropwise addition, the stirring was continued, and the temperature was lowered to 2° C., and the emulsified inactivated foot-and-mouth disease vaccine was prepared.

Embodiment 2

[0051] This embodiment provides a vaccine emulsification process, comprising the following steps:

[0052] Step a): filter the 206 adjuvant with PVDF membrane at 25°C, and heat the adjuvant to 34°C after filtration;

[0053] Step b): adding the 8°C foot-and-mouth disease inactivated vaccine antigen dropwise into the adjuvant, and the temperature of the adjuvant is always maintained at 34°C;

[0054] Step c): After the dropwise addition, the stirring was continued, and the temperature was lowered to 8° C. to prepare the emulsified inactivated foot-and-mouth disease vaccine.

Embodiment 3

[0056] This embodiment provides a vaccine emulsification process, comprising the following steps:

[0057] Step a): at 22°C, filter the 206 adjuvant with a tetrafluoroethylene filter membrane, and heat the adjuvant to 35°C after filtration;

[0058] Step b): adding the 6°C foot-and-mouth disease inactivated vaccine antigen dropwise into the adjuvant, and the temperature of the adjuvant is always maintained at 35°C;

[0059] Step c): After the dropwise addition, the stirring was continued, and the temperature was lowered to 6° C. to prepare the emulsified inactivated foot-and-mouth disease vaccine.

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Abstract

The invention relates to the field of vaccine processing, and particularly provides a vaccine and an emulsification process and application thereof. According to the emulsification process of the vaccine provided by the invention, an antigen is dripped into an adjuvant filtered and sterilized by a filtering and sterilizing device, so that the emulsified vaccine is prepared. The sterilization of the adjuvant adopts a filtering and sterilizing process to replace a conventional high-temperature sterilizing manner, the method is simple and easy to operate, ingredients and properties of the prepared product are uniform, the stability is good, and the immune effect is remarkably increased. The vaccine provided by the invention is prepared by applying the emulsification process for the vaccine. Ingredients and properties of the vaccine are uniform, the stability is good, the immune effect is remarkably increased, and the vaccine can be industrially produced and applied in production and life.

Description

technical field [0001] The invention relates to the field of vaccine processing, in particular to a vaccine, an emulsification process and application of the vaccine. Background technique [0002] Biological products such as vaccines are an important means for humans to fight against viral diseases, and the safety and quality stability of vaccine production are getting more and more attention. Some vaccine production processes include medium preparation, cell cultivation, mixing, buffer preparation, terminal filtration and other processes, followed by processes such as emulsification, sub-packaging, and finished product inspection. Among them, emulsification is a key step in vaccine production, and the quality of the emulsification process directly determines the quality of the vaccine. [0003] The process and technical conditions of oil, emulsifier, and water from the initial entry into the production equipment to the output of the finished emulsion are usually called the...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/135A61P31/14A61L2/02
CPCA61K39/12A61L2/02C12N2770/32134A61L2202/21A61K2039/5252
Inventor 廖勇王涛刘苡佑唐磊邹鲁张忠
Owner 天康生物制药有限公司
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