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Heat-resisting lyophilized protecting agent of live vaccine for animal and preparation method thereof

A heat-resistant freeze-drying and protective agent technology, which is applied in the field of cryobiology, can solve the problems that have not been fully promoted and applied, and have not been reported in detail, and achieve the effect of promoting antigen promotion, improving immunity level, and improving humoral immunity.

Inactive Publication Date: 2009-07-08
RINGPU (BAODING) BIOLOGICAL PHARMACEUTICAL CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Wang Dong et al. (2002) have developed a heat-resistant freeze-drying protective agent. The vaccines freeze-dried with this protective agent are stored at 2°C-8°C for 24 months. Not fully promoted
[0008] However, almost all veterinary biological freeze-dried products in developed countries in the world are stored at 2-8°C for more than 24 months, but there is no detailed report on the method.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Embodiment 1: Preparation of heat-resistant lyoprotectant

[0025] A heat-resistant freeze-drying protection immune enhancer for freeze-dried live vaccines for animals, including commonly used gelatin, lactose, etc., is characterized in that the material composition ratio of the heat-resistant freeze-drying protectant is changed: gelatin 1-3%, lactose 1-8% and so on; each substance is a dry matter component, and the remainder of the percentage is distilled water.

[0026] The preparation process is as follows:

[0027] It includes mixing the dry matter components of the above-mentioned heat-resistant protective immune enhancer in proportion, and is characterized in that the effective material components of the heat-resistant freeze-drying protective agent are sterilized respectively: (1) gelatin, which can be autoclaved, Components such as lactose were dissolved in 1 / 2 distilled water of the total amount of heat-resistant freeze-drying protective agent according to the...

Embodiment 2

[0028] Embodiment 2: the sterility test of heat-resistant lyoprotectant

[0029]The conventional culture medium was sterilized by high-pressure steam at 121°C for 15 minutes, and then cooled at room temperature. On the aseptic operating table, inoculate the heat-resistant freeze-drying protective agent according to a series of gradients such as 1:1, 1:10, and 1:100, and then put all the culture medium into a 36±1°C incubator for overnight cultivation, and set up at the same time control.

[0030] After 24-72 hours, no colonies were produced in the medium of each gradient, but a large number of colonies appeared on the control medium, indicating that the sterility test of the prepared heat-resistant lyoprotectant was negative after sterilization.

Embodiment 3

[0031] Embodiment 3: Toxicological test of heat-resistant lyoprotectant

[0032] According to 10 times the amount of heat-resistant freeze-drying protective agent contained in the product, 7 days old healthy chicks were respectively given drinking water, nasal drops, eye drops and 10 subcutaneous injections, and observed for 21 days. The results are shown in Table 1.

[0033] Chicks (7d), 40 in total death or illness normal fatality rate Drinking water / 10pcs 0 10 0％ Nasal drops / 10pcs 0 10 0％ Dotted eyes / 10pcs 0 10 0％ Subcutaneous injection / 10 pcs 0 10 0％

[0034] It was found that all the chicks were healthy and alive without any adverse reactions.

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PUM

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Abstract

The invention provides a heat-resistant freeze-drying protective agent applied to animal freeze-dried live vaccine. The heat-resistant freeze-drying protective agent comprises 1%-3% of glutin, 1%-8% of lactose and the like, wherein, all substances are dry components, and distilled water takes all the rest percentage. The invention also provides a method for preparing the protective agent. ND live vaccine prepared by the protective agent of the invention can be conserved for more than 24 months at the temperature of 2 DEG C to 8 DEG C. Immunity test shows that the average antibody level of immunized chicken is 1 to 2 titers higher than the average antibody level of tested chicken immunized by the ND live vaccine which is freeze-dried by ordinary protective agent, and the antibody level is uniform. Therefore, the freeze-drying protective agent can be widely applied to the production and conservation of various animal live vaccines and has wide application prospect.

Description

technical field [0001] The invention relates to the field of cryobiology, in particular to a heat-resistant freeze-drying protective agent for freeze-dried live vaccines for animals and a preparation method thereof. Background technique [0002] Research on lyoprotectants is concentrated in the fields of medicine and biology, and is one of the main contents of the branch of cryobiology. However, the research and application of heat-resistant lyoprotectant belongs to patent information and is in a confidential state. Foreign research on this aspect is far ahead of our country. [0003] In the field of medical biological products, Fry reported in 1951 that using 5-10% glucose as a protective agent for Escherichia coli resulted in a higher number of live bacteria. Moreover, the survival rate in the preservation process is high, which is mainly because the glucose contains crystal water, and the living bacteria are not easy to die. Grerff's freeze-drying research on multiple ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/42A61K9/19
Inventor 郁宏伟杨保收
Owner RINGPU (BAODING) BIOLOGICAL PHARMACEUTICAL CO LTD
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