CN1251762C - Heat resisting lyophilized protectant for chicken infections Fabianite bursa hypotpxicity (B87) lyophilized vaccine and preparing process thereof - Google Patents
Heat resisting lyophilized protectant for chicken infections Fabianite bursa hypotpxicity (B87) lyophilized vaccine and preparing process thereof Download PDFInfo
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- CN1251762C CN1251762C CN 200410029581 CN200410029581A CN1251762C CN 1251762 C CN1251762 C CN 1251762C CN 200410029581 CN200410029581 CN 200410029581 CN 200410029581 A CN200410029581 A CN 200410029581A CN 1251762 C CN1251762 C CN 1251762C
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Abstract
The present invention relates to a heat resistant freeze dried protective agent of infectious bursal disease attenuated virus (B87) freeze dried vaccines and a preparation technology thereof. The protective agent is prepared by mixing components according to a certain proportion, and is characterized in that the effective components of the protective agent are treated for sterilization by the following steps: the effective components sterilized under high pressure are dissolved in distilled water for sterilization according to a preparation proportion for 30 to 40 minutes at a temperature of 116 DEG C; the effective components which can not resist high temperature are also dissolved in distilled water for filtration sterilization according to a preparation proportion by a filter membrane with a hole diameter of 0.22 mum; the effective components in the first two steps are mixed to obtain the heat resistant freeze dried protective agent which can be added to virus antigen liquids according to the proportion of 1 to 1 when used, and can be freeze dried after respectively packed. The prepared heat resistant freeze dried protective agent can maintain the freeze dried shape after preserved at a temperature of 2 to 8 DEG C for 24 months, and all of the virus contents surpass the specified standards of veterinary biopreparation in China. The present invention is a preparation with low cost and long action and a preparation method thereof, which solves the problems of high transportation cost and high storage cost through the ages for veterinary biopreparation.
Description
Technical field
The present invention relates to the Freeze Drying Technique of biological product, preservation adjuvant and manufacture method thereof.
Background technology
China's veterinary biological product protective agent commonly used at present is mainly 5% sucrose skim milk and 5-10% sucrose, the 1.5-3% gelatin, and goods require cryopreservation (below 15 ℃), and the storage life of 2-8 ℃ of condition only 3-9 month must use up at normal temperatures as early as possible.This is just for the preservation of veterinary biological product, transportation, use etc. bring many difficulties and inconvenience, simultaneously owing to must cryopreservation causing energy resource consumption and storage cost big.
At present, the flourishing in the world biological freeze-dried products of national veterinary almost all is that 2-8 ℃ of preservation is more than 24 months.But the not play-by-play of square method.Chinese patent CN1176827A " a kind of manufacture method of freeze-dried live vaccine for animal use " proposes to adopt with polyvinylpyrrolidone, sodium carboxymethyl cellulose; tamarind gum; sodium glutamate; trehaloses etc. are the freeze drying protectant that the formulated of main matrix freeze drying protectant becomes; the method that freeze-drying curve that employing adapts with it and newcastle disease vaccine virus antigen are made the newcastle disease freeze-dried live vaccine, but this Seedling long preservation under 2-8 ℃ of condition.
Summary of the invention
The purpose of this invention is to provide a kind of infectious bursal disease weak poison (B87) freeze dried vaccine heat-resisting lyophilized protecting agent and preparation technology, reduce protective condition, extend using period and reduce use cost.
The weak poison of infectious bursal disease (B87) freeze dried vaccine heat-resisting lyophilized protecting agent is characterized in that the material weight percentages of heat-resisting lyophilized protecting agent is: defatted milk powder 5%, sucrose 5-6%, dextrin 5%, Vc 0.1%, sorbitol 2%, sodium glutamate 1-3%, beef peptone 1-3%; Be the dry component in the preparation, percentage ratio residue part is distilled water.
Above-mentioned protectant preparation technology presses component, mixed, it is characterized in that protectant active substance component is handled degerming respectively: sterilized 30-40 minute for 116 ℃ to being dissolved in the distilled water in the preparation ratio by autoclaved material (1); (2) material with non-refractory also is dissolved in the distilled water in the preparation ratio, with aperture 0.22 μ m membrane filtration degerming; After finishing degerming respectively (1), (2) two kinds of compositions are mixed, be the lyophilizing heat resisting protective, add in the virus antigen liquid in 1: 1 ratio during use, carry out lyophilization after the packing.
The preparation of preparation technology's preparation of the present invention can be preserved more than 24 months under 2-8 ℃ of condition, can reach every index of regulation in " People's Republic of China's veterinary biological product quality standard ".
The specific embodiment
The weak poison of infectious bursal disease (B87) freeze dried vaccine heat-resisting lyophilized protecting agent is characterized in that the weight percentages of heat-resisting lyophilized protecting agent is: defatted milk powder 5%, sucrose 5-6%, dextrin 5%, Vc 0.1%, sorbitol 2%, sodium glutamate 1-3%, beef peptone 1-3%; Be the dry component in the preparation, percentage ratio residue part is distilled water.
The preparation technology of the weak poison of infectious bursal disease (B87) freeze dried vaccine heat-resisting lyophilized protecting agent, comprise dry component mixed by weight percentage with above-mentioned heat-resisting lyophilized protecting agent, it is characterized in that protectant active substance component is carried out degerming to be handled: (1) is to can autoclaved material: defatted milk powder, sucrose, dextrin, beef peptone, be dissolved in the distilled water 116 ℃ of sterilizations 30-40 minute in ratio separately; (2) with the material of non-refractory: sorbitol, sodium glutamate, Vc; All be dissolved in the distilled water, with the membrane filtration degerming of aperture 0.22 μ m in ratio separately; After finishing degerming respectively (1), (2) two kinds of compositions are mixed, be the lyophilizing heat resisting protective, add in the virus antigen liquid in 1: 1 ratio during use, carry out lyophilization after the packing.
Technical parameter and detection method
1. the physical behavior of product, steriling test, mycoplasma check, exogenous virus check, specificity check, safety verification, residual moisture mensuration and vacuum are measured by the method and the standard of " People's Republic of China's veterinary biological product rules " and are undertaken.
2. lyophilization cycle is no more than 48h.
3. protectant toxicity test
Bird vaccine carries out each 20 of collunarium, eye dripping, drinking-water and subcutaneous injections by containing 10 times of amounts protecting dosage in the middle of the product respectively to 7 age in days healthy chicks, observes 20d, and chickling is all strong to live; There is not any untoward reaction.
4. viral level is measured and standard
(1) assay method: vaccine is made 10 times of serial dilutions with sterile saline, with the fine hair allantois
(1) assay method: vaccine is made 10 times of serial dilutions with sterile saline, and with allantocherion approach inoculation 10-12 age in days SPF Embryo Gallus domesticus, every embryo 0.2mL observes 168h, calculates ELD
50
(2) reach standard
A. after the lyophilizing viral loss rate less than 0.4 titre.
B. every plumage part viral level 〉=10 after the lyophilizing
3.7ELD
50
C. the product after the lyophilizing is put 37 ℃ and is preserved 10d and 30d and carry out viral level and measure, and the former rate of descent is within 0.2 titre, and the latter is in 0.4 titre.
D. product is put 25 ℃ to preserve 30d viral level rates of descent is within 0.2 titre.
E. product is put 2-8 ℃ of preservation 24 months, every plumage part viral level 〉=10
3.37ELD
50
Claims (2)
1, the weak malicious B87 freeze dried vaccine heat-resisting lyophilized protecting agent of a kind of infectious bursal disease is characterized in that the material weight percentages of heat-resisting lyophilized protecting agent is: defatted milk powder 5%, sucrose 5-6%, dextrin 5%, Vc 0.1%, sorbitol 2%, sodium glutamate 1-3%, beef peptone 1-3%; Be the dry component in the preparation, percentage ratio residue part is distilled water.
2, the technology of the weak malicious B87 freeze dried vaccine heat-resisting lyophilized protecting agent of the described infectious bursal disease of preparation claim 1, comprise dry component mixed by weight percentage with above-mentioned heat-resisting lyophilized protecting agent, it is characterized in that protectant active substance component is carried out degerming respectively to be handled: (1) is to can autoclaved material: defatted milk powder, sucrose, dextrin, beef peptone, be dissolved in the distilled water 116 ℃ of sterilizations 30-40 minute in ratio separately; (2) with the material of non-refractory: sorbitol, sodium glutamate, Vc; All be dissolved in the distilled water, with the membrane filtration degerming of aperture 0.22 μ m in ratio separately; After finishing degerming respectively (1), (2) two kinds of compositions are mixed, be the lyophilizing heat resisting protective, add virus antigen liquid at 1: 1 in proportion, carry out lyophilization after the packing.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410029581 CN1251762C (en) | 2001-12-21 | 2001-12-21 | Heat resisting lyophilized protectant for chicken infections Fabianite bursa hypotpxicity (B87) lyophilized vaccine and preparing process thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410029581 CN1251762C (en) | 2001-12-21 | 2001-12-21 | Heat resisting lyophilized protectant for chicken infections Fabianite bursa hypotpxicity (B87) lyophilized vaccine and preparing process thereof |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB011388714A Division CN1168503C (en) | 2001-12-21 | 2001-12-21 | Veterinarian virus kind biological product heat resisting freeze drying protective agent and its preparation technique |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1528453A CN1528453A (en) | 2004-09-15 |
| CN1251762C true CN1251762C (en) | 2006-04-19 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN 200410029581 Expired - Fee Related CN1251762C (en) | 2001-12-21 | 2001-12-21 | Heat resisting lyophilized protectant for chicken infections Fabianite bursa hypotpxicity (B87) lyophilized vaccine and preparing process thereof |
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Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102160856A (en) * | 2011-03-28 | 2011-08-24 | 南京易海生物科技有限公司 | Neglect-proof drinking immunization tablet for infectious bursal disease (IBD) and preparation method thereof |
| CN102258537B (en) * | 2011-07-15 | 2012-07-04 | 骆延波 | Preparation method for chicken infectious bursal disease specific transfer factor |
| CN103550770B (en) * | 2013-11-19 | 2015-03-04 | 浙江美保龙生物技术有限公司 | Preparation method of compound effervescent tablets for treating chicken infectious bursal disease |
| CN109157657A (en) * | 2018-09-29 | 2019-01-08 | 商丘美兰生物工程有限公司 | Infectious bursal disease live-vaccine heat-proof freeze drying protectant and preparation method thereof |
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