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Heat-resistant freeze-drying protectant for live vaccine and its preparation method and application

A heat-resistant freeze-dried, live vaccine technology, applied in the direction of antiviral agents, inactive components of polymer compounds, virus antigen components, etc. The problem of latent heat protection agent, etc., can protect the viability of the virus, reduce the temperature and storage conditions, and achieve the effect of rapid antibody production.

Active Publication Date: 2016-12-07
HUNAN SINOLAND BIOLOGICAL PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Domestic research on heat-resistant protective agents for veterinary biological products started relatively late. In recent years, research reports on this aspect mainly include chicken Newcastle disease, chicken infectious bursa, chicken Marek's disease, chicken infectious bronchitis, chicken pox and swine fever Research on heat-resistant freeze-drying protective agents for live vaccines, but there is no report on heat-resistant freeze-drying protective agents for porcine Japanese encephalitis live vaccines

Method used

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  • Heat-resistant freeze-drying protectant for live vaccine and its preparation method and application
  • Heat-resistant freeze-drying protectant for live vaccine and its preparation method and application
  • Heat-resistant freeze-drying protectant for live vaccine and its preparation method and application

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Effect test

Embodiment 1

[0037] The heat-resistant lyoprotectant of the live vaccine provided by the invention consists of the following raw materials in proportion by weight:

[0038] Gelatin 4%,

[0039] Sucrose 6%,

[0040] Trolox 0.05%,

[0041] Arginine 1.5%,

[0042] Polyvinylpyrrolidone 1%,

[0043] The balance is water for injection.

Embodiment 2

[0045] The heat-resistant lyoprotectant of the live vaccine provided by the invention consists of the following raw materials in proportion by weight:

[0046] Gelatin 5%,

[0047] Sucrose 5%,

[0048] Trolox 0.1%,

[0049] Arginine 1.0%,

[0050] Polyvinylpyrrolidone 2%,

[0051] The balance is water for injection.

Embodiment 3

[0053] The heat-resistant lyoprotectant of the live vaccine provided by the invention consists of the following raw materials in proportion by weight:

[0054] Gelatin 7%,

[0055] Sucrose 4%,

[0056] Trolox 0.15%,

[0057] Arginine 0.5%,

[0058] Polyvinylpyrrolidone 1.5%,

[0059] The balance is water for injection.

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Abstract

The invention discloses a heat-resistant freeze-drying protective agent for live vaccines and a preparation method thereof. The heat-resistant freeze-drying protective agent for live vaccines is composed of the following raw materials in proportion by weight: 1-10% gelatin, 2-10% sucrose %, Trolox 0.01-0.2%, arginine 0.1-2%, polyvinylpyrrolidone 0.5-8%, and the balance is water for injection. Compared with conventional protective agents, the heat-resistant freeze-dried protective agent of live vaccines provided by the invention can more effectively protect the virus activity in porcine Japanese encephalitis vaccines, and can withstand heat for more than 20 days at 37°C. It can be stored for more than 2 years, which reduces the requirements of vaccines on temperature storage conditions, and facilitates vaccine storage and cold chain transportation. Moreover, the invention improves the immune effect of the vaccine, and the antibody of the immunized pig body is produced faster and lasts longer. The preparation method of the heat-resistant lyoprotectant for live vaccines provided by the invention is simple and suitable for large-scale production.

Description

technical field [0001] The invention relates to the technical field of biopharmaceuticals, in particular to a heat-resistant lyoprotectant for live vaccines, a preparation method and application thereof. Background technique [0002] The heat sensitivity of viruses and other biologically active substances and their related products has always been the bottleneck of long-term storage of live vaccines. my country has a vast territory and great differences in economic levels. The phenomenon of short-term exposure of vaccines to high temperature environments (even above 45°C) still exists during transportation and use. Therefore, higher requirements are put forward for the heat resistance of live vaccines. [0003] The heat-resistant lyoprotectant considers the impact of the physical and chemical changes that may occur in the lyophilized substance on the survival of the live vaccine when the live vaccine is stored at a higher temperature and for a longer storage time. At presen...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/42A61K39/12A61P31/14
Inventor 巢伟张桂红王和平徐雷黄岚芬
Owner HUNAN SINOLAND BIOLOGICAL PHARMA
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