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Porcine Japanese encephalitis live vaccine heat-resistant lyophilized protective agent as well as 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: 2014-03-26
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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  • Porcine Japanese encephalitis live vaccine heat-resistant lyophilized protective agent as well as preparation method and application thereof
  • Porcine Japanese encephalitis live vaccine heat-resistant lyophilized protective agent as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-3

[0024] Example 1-3 Heat-resistant freeze-dried protective agent for porcine Japanese encephalitis live vaccine and its preparation

[0025] (1) Formula of freeze-dried protective agent

[0026] The formulation of the freeze-dried protective agent is shown in Table 1, and the pH value is 7.5, prepared with water.

[0027] Table 1 The formula of the heat-resistant freeze-dried protective agent of the porcine Japanese encephalitis vaccine

[0028]

[0029] (2) Preparation method

[0030] The above components are weighed in proportion, dissolved in water, adjusted to pH 7.5 with hydrochloric acid solution, and sterilized at 110°C for 30 minutes to obtain a heat-resistant lyophilized protective agent for porcine Japanese encephalitis live vaccine.

Embodiment 4

[0031] Example 4 Application of the heat-resistant freeze-dried protective agent of porcine Japanese encephalitis live vaccine in preparing porcine Japanese encephalitis live vaccine

[0032] Three batches of the heat-resistant freeze-dried protective agent prepared in Example 1-3 and the virus antigen (SA14-14-2) that have passed the test were shaken thoroughly at a volume ratio of 1:1, and then immediately after the quantitative aliquot Freeze dry. At the same time, 0.5% gelatin and 2.5% sucrose protectant vaccine were set as the control group. The freeze-drying method is as follows:

[0033] Put the aliquoted vaccine into a freeze-dried cabinet. The minimum temperature of the vaccine in the pre-freezing stage is +40°C, and it is maintained for 2 hours after reaching the lowest 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 i...

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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-dried protective agent for porcine Japanese encephalitis live vaccine, its preparation method and application. Background technique [0002] Japanese encephalitis virus is also known as Japanese Encephalitis Virus (JEV), referred to as Japanese encephalitis virus, belonging to the Flaviridae (Flaviridae) flavivirus genus, the disease caused by it is referred to as Japanese encephalitis, the most common is the three-band Viral encephalitis in which Culex raptorans is the main vector is an acute infectious disease of the central nervous system that seriously threatens the health of humans and animals. Pigs are 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. Attenuated live vaccines are one of...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/42A61K47/26A61K47/32A61K47/10A61K47/34A61K39/12A61K9/19A61P31/14
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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