Animal lyophilized inactivated vaccine and preparation process thereof

A technology for inactivated vaccines and animals, which can be used in freeze-dried transportation, medical preparations containing active ingredients, drug combinations, etc. It can solve the problems of affecting product quality and immune effect, cumbersome emulsification process, and single adjuvant dosage form. Achieve the effect of solving the difficulty in satisfying the antigen content of the combined vaccine, solving the problem of excessive immunization times, and good emulsifying performance

Active Publication Date: 2014-04-23
SHANGHAI CHUANG HONG BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In the past, the adjuvants used in the production of animal inactivated vaccines were of a single type, mainly water-in-oil, and the main materials were mineral white oil, Siben 80, Tween 80, aluminum stearate, etc.
The emulsification process is cumbersome and requires high-speed shearing equipment. The emulsified inactivated vaccine is called an oil emulsion inactivated vaccine. This inactivated vaccine is easy to layer, affecting product quality and immune effect. Greater stress, such as vomiting, tremors, foaming at the mouth and other side effects

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Preparation of freeze-dried inactivated vaccine against Streptococcus suis

[0029] 1. Antigen preparation Inoculate 5-15% of Streptococcus suis production seeds into buffered modified Martin broth with a pH value of 7.2-7.6. The temperature was 37°C, the culture was carried out with low-speed agitation and without steam. At the beginning of the cultivation, 50% glucose solution was added at a ratio of 0.2%, and 2-5% bovine serum was added for feeding. After culturing for 4-6 hours, add an appropriate amount of buffered modified Martin broth containing 0.2% glucose and 2-5% bovine serum, stop feeding 4 hours before the end of the culture, and the final glucose content does not exceed 0.2%. After culturing for 12-18 hours, harvest the culture fluid to obtain the vaccine antigen bacteria fluid.

[0030] 2. Inactivation Add formaldehyde solution to the antigenic bacteria solution that has passed the antigen content, sterility test, and safety test to make the final conce...

Embodiment 2

[0033] Preparation of porcine circovirus type 2 freeze-dried inactivated vaccine

[0034] 1. Antigen preparation Porcine circovirus type 2 (PCV-2) was inoculated on well-growing PK15 cells, cultured in suspension at 37°C, cultured for 24-72 hours, and the cell culture medium was harvested.

[0035] 2. Inactivation: Add an appropriate inactivator to the cell culture medium that has passed the antigen content and sterility test to make the final concentration 0.1-0.5%, inactivate at 37°C for 48 hours, harvest the antigen solution and put it in a -20°C freezer Save it for later use.

[0036] 3. Freeze-drying. Make the sterile inactivated antigen solution into a homogenate with a 1:1-5 ratio of freeze-drying protective agent, add an appropriate amount of antibiotics, mix thoroughly, and quickly follow the appropriate freeze-drying process curve after quantitative packaging. Freeze and vacuum dry to prepare the finished product of freeze-dried inactivated vaccine.

Embodiment 3

[0038] Preparation of Freeze-dried Inactivated Vaccine of Porcine Pseudorabies

[0039] 1. Antigen preparation Inoculate porcine pseudorabies virus on well-grown monolayer chicken embryo fibroblasts, culture in rotation at 37°C, observe the cell lesion every day, and harvest the cell culture medium when the cell lesion is more than 75%.

[0040] 2. Inactivation: Add an appropriate inactivator to the cell culture medium that has passed the antigen content and sterility test so that the final concentration is 0.1-1%, inactivate at 25-37°C for 24-48 hours, harvest the antigen solution and put it in Store in -20°C freezer for later use.

[0041] 3. Freeze-drying. Make the sterile inactivated antigen solution into a homogenate with a 1:1-5 ratio of freeze-drying protective agent, add an appropriate amount of antibiotics, mix thoroughly, and quickly carry out freeze-vacuum drying after quantitative packaging to prepare a freeze-dried Dry inactivated vaccine products.

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PUM

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Abstract

The invention relates to an animal lyophilized inactivated vaccine and a preparation process thereof. The animal lyophilized inactivated vaccine comprises a separately-packaged immune adjuvant or diluent and a separately-packaged inactivated vaccine produced through vacuum freeze-drying, wherein vaccine antigen is inactivated and then is subjected to a vacuum freeze-drying process to obtain the inactivated vaccine, and the immune adjuvant or diluent has a good emulsifying performance. Compared with the animal lyophilized inactivated vaccine and the preparation process in the prior art, the animal lyophilized inactivated vaccine and the preparation process of the present invention have the following characteristics that: the vaccine can be subjected to freeze-drying to obtain the powdery or massive vaccine according to the immunizing dose of the single variety vaccine, the corresponding immune adjuvant is adopted to carry out preparation and use on site during use, and the fixed formulation is formed in a short time; farmers can selectively combine vaccines according to the requirements so as to well solve the problem of difficultly-achieved combined vaccine antigen content and further solve the defects of multiple immunization and too high immunizing dose of the traditional inactivated vaccine; and the difficult problem of short storage time of the inactivated vaccine is solved.

Description

technical field [0001] The invention relates to the field of vaccine production for animals, in particular to a freeze-dried inactivated vaccine for animals and a preparation process thereof. Background technique [0002] Animal vaccines play a vital role in the prevention of animal diseases. The current types of animal vaccines include freeze-dried live attenuated vaccines and inactivated vaccines (liquid). [0003] At present, inactivated vaccines for animals are inactivated antigens mixed with immune adjuvants in a certain proportion, emulsified (high-speed shearing, grinding), and made into a suspension liquid with a certain dosage form (oil-in-water, oil-in- water, water-in-oil-in-water, hydrophilic type, etc.), and finally packed in bottles. In order to maintain the specific dosage form of the vaccine that has been emulsified, it is required to be stored and transported at 2-8°C. If the emulsification process is not good or the storage temperature changes, the vaccine...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K39/00A61P31/00A61P33/02A61K39/09A61K39/12A61K39/245A61K39/102
Inventor 赖志高俊锋章伟建马晶晶吴碧清
Owner SHANGHAI CHUANG HONG BIOTECH
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