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Heat-resistant freeze-drying protectant for porcine Japanese encephalitis live vaccine, preparation method and application thereof

A porcine Japanese encephalitis, heat-resistant freeze-drying technology, applied in the directions of freeze-drying delivery, antiviral agents, pharmaceutical formulations, etc. The formula ingredients and preparation method are simple, solve the problem of refrigerated transportation, and have good heat resistance performance

Active Publication Date: 2018-04-24
CHINA ANIMAL HUSBANDRY IND
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, there is no research report on the heat-resistant lyoprotectant for porcine Japanese encephalitis

Method used

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  • Heat-resistant freeze-drying protectant for porcine Japanese encephalitis live vaccine, preparation method and application thereof
  • Heat-resistant freeze-drying protectant for porcine Japanese encephalitis live vaccine, preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-3

[0024] Example 1-3 Heat-resistant freeze-drying protectant for porcine Japanese encephalitis live vaccine and its preparation

[0025] (1) Formula of lyoprotectant

[0026] The formulation of the lyoprotectant is shown in Table 1, the pH value is 7.5, and it is prepared with water.

[0027] Table 1 The formula of the live porcine encephalitis Japanese encephalitis vaccine heat-resistant lyoprotectant of the present invention

[0028]

[0029] (2) Preparation method

[0030] Weigh the above ingredients in proportion, dissolve them in water, adjust the pH value to 7.5 with hydrochloric acid solution, and sterilize at 110°C for 30 minutes to obtain the heat-resistant freeze-drying protective agent for porcine Japanese encephalitis live vaccine.

Embodiment 4

[0031] Example 4 Application of heat-resistant freeze-drying protectant for porcine Japanese encephalitis live vaccine in preparation of porcine Japanese encephalitis live vaccine

[0032] Three batches of the heat-resistant lyoprotectant prepared in Example 1-3 and the qualified virus antigen (SA14-14-2) solution were shaken thoroughly according to the volume ratio of 1:1, and immediately carried out after quantitative distribution Freeze dried. At the same time, 0.5% gelatin and 2.5% sucrose vaccine were used as the control group. The freeze-drying method is as follows:

[0033] Put the subpackaged vaccine into the freeze dryer box. The minimum temperature of the vaccine in the pre-freezing stage is +40°C, and maintain it for 2 hours after reaching the minimum temperature; the final temperature of the vaccine in the sublimation drying stage is -20°C, and the time to reach the final temperature is 17 hours. The vacuum control pressure of the freeze-drying box is 0.18mbar; t...

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PUM

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Abstract

The invention provides a porcine Japanese encephalitis live vaccine heat-resistant lyophilized protective agent. The protective agent comprises the following components in percentage by weight: 1.0-1.4% of gelatin, 9-11% of sucrose, 9-11% of trehalose, 0.15-0.35% of polyvinylpyrrolidone, 0 .3-0.8% of sorbitol, 0.3-0.8% of mannitol, 0.1-0.2% of PEG-6000, and 0.01-0.02% of tween-80, the pH value of the protective agent is 7.5, and the components are added with water to be dissolved and sterilized at high temperature to obtain the protective agent.The lyophilized protective agent disclosed by the invention is mixed with a porcine Japanese encephalitis live vaccine virus solution, and freeze-drying is carried out to obtain a lyophilized vaccine. The heat-resistant lyophilized protective agent disclosed by invention is simple in formulation, easy in preparation, suitable for large-scale production, has good protection efficacy for vaccines, and can ensure that the vaccines can be preserved for 10 days effectively at the normal temperature, even at the temperature of 37 DEG C, and preserved for 24 months at the temperature of 2-8 DEG C.

Description

technical field [0001] The invention relates to the field of veterinary biological products, in particular to a heat-resistant freeze-drying protective agent for porcine Japanese encephalitis live vaccine, its preparation method and application. Background technique [0002] Japanese encephalitis virus, also known as Japanese Encephalitis Virus (JEV), referred to as JEV, belongs to the Flaviridae (Flaviridae) genus, and the disease caused by it is referred to as JE. Viral encephalitis, which is mainly transmitted by Culex rhinorrhea, is an acute infectious disease of the central nervous system that seriously threatens the health of humans and animals. Pig is an important storage host and amplification host of Japanese encephalitis virus, the main source of infection of Japanese encephalitis, and one of the main pathogens that cause reproductive disorders in sows. The attenuated live vaccine is one of the main vaccines to prevent this infectious disease. But porcine Japanese...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/42A61K47/26A61K47/32A61K47/10A61K39/12A61K9/19A61P31/14
CPCY02A50/30
Inventor 潘春刚姜国华郝霖雨段伟韩伟张岐蜀周建民胡小元尹立明
Owner CHINA ANIMAL HUSBANDRY IND
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