CN1528453A - 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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- CN1528453A CN1528453A CNA2004100295818A CN200410029581A CN1528453A CN 1528453 A CN1528453 A CN 1528453A CN A2004100295818 A CNA2004100295818 A CN A2004100295818A CN 200410029581 A CN200410029581 A CN 200410029581A CN 1528453 A CN1528453 A CN 1528453A
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Abstract
The present invention relates to a heat-resisting freeze-dried protection agent for chicken infectious Fabricius bursa disease low virulent strain (B87) freeze-dried vaccine and its preparation method. All the components of said protection agent are mixed according to a certain mixing ratio; and it is characterized by that all the effective components of said protection agent must be respectively undergone the process of sterilization treatment. For the components which can be sterilized at high-pressure they can be dissolved in distilled water, and sterilized for 30-40 min. at 116 deg.C; and for the components which are not resistant to high temp. they are dissolved in distilled water, and can be filtered by means of filtration membrane whose pore diameter is 0.22 microns and sterilized, then the said two portions are mixed.
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 component proportioning 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, protectant material component comprises sucrose commonly used, defatted milk powder, dextrin, it is characterized in that the component proportioning 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 that the dry component with above-mentioned heat-resisting lyophilized protecting agent is mixed in proportion, 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, 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 poison of a kind of infectious bursal disease (B87) freeze dried vaccine heat-resisting lyophilized protecting agent, protectant material comprises sucrose commonly used, defatted milk powder, dextrin, it is characterized in that the material component proportioning 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 poison of the described infectious bursal disease of preparation claim 1 (B87) freeze dried vaccine heat-resisting lyophilized protecting agent, comprise that the dry component with above-mentioned heat-resisting lyophilized protecting agent is mixed in proportion, 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 in the virus antigen liquid in 1: 1 ratio during use, carry out lyophilization after the packing.
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Application Number | Priority Date | Filing Date | Title |
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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 |
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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 |
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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 |
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CN1528453A true CN1528453A (en) | 2004-09-15 |
CN1251762C CN1251762C (en) | 2006-04-19 |
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Cited By (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 |
CN102258537A (en) * | 2011-07-15 | 2011-11-30 | 骆延波 | Preparation method for chicken infectious bursal disease specific transfer factor |
CN103550770A (en) * | 2013-11-19 | 2014-02-05 | 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 |
-
2001
- 2001-12-21 CN CN 200410029581 patent/CN1251762C/en not_active Expired - Fee Related
Cited By (6)
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 |
CN102258537A (en) * | 2011-07-15 | 2011-11-30 | 骆延波 | Preparation method for chicken infectious bursal disease specific transfer factor |
CN102258537B (en) * | 2011-07-15 | 2012-07-04 | 骆延波 | Preparation method for chicken infectious bursal disease specific transfer factor |
CN103550770A (en) * | 2013-11-19 | 2014-02-05 | 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 |
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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Publication number | Publication date |
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CN1251762C (en) | 2006-04-19 |
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