CN102671207A - Newcastle disease and avian infectious bronchitis bigeminal live vaccine heat-resisting freeze-drying protective agent and preparation method - Google Patents
Newcastle disease and avian infectious bronchitis bigeminal live vaccine heat-resisting freeze-drying protective agent and preparation method Download PDFInfo
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- CN102671207A CN102671207A CN2012101730553A CN201210173055A CN102671207A CN 102671207 A CN102671207 A CN 102671207A CN 2012101730553 A CN2012101730553 A CN 2012101730553A CN 201210173055 A CN201210173055 A CN 201210173055A CN 102671207 A CN102671207 A CN 102671207A
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Abstract
The invention relates to a newcastle disease and avian infectious bronchitis bigeminal live vaccine heat-resisting freeze-drying protective agent and a preparation method. The newcastle disease and avian infectious bronchitis bigeminal live vaccine heat-resisting freeze-drying protective agent provided by the invention comprises the following components: 1-2% of sodium carboxymethylcellulose, 2-8% of xylo-oligosaccharide, 1-3% of sorbitol, 0.5-0.8% of sodium glutamate, 0.1-0.5% of sodium selenite and the balance of water for injection. The heat-resisting freeze-drying protective agent provided by the invention solves the problem that the newcastle disease and avian infectious bronchitis bigeminal live vaccine can not be stored for a long time and transported at 2-8 DEG C.
Description
Technical field
The present invention relates to a kind of newcastle disease and infectious bronchitis of chicken bigeminal live vaccine heat-resisting lyophilized protecting agent, and preparation method thereof, belong to animal and use the production of vaccine field.
Background technology
Freeze Drying Technique is a biological important application technology, is usually used in the research and production of biological product, to keep the biological characteristics of bacterium, seed culture of viruses, stabilate raw material and half-finished biological activity, the effect duration of prolongation finished product.Freeze drying protectant is the key technology during live vaccine is produced, and has very big influence for preservation, transportation and the use of vaccine.
External live vaccine freeze-dried products is more than 15 months 2～8 ℃ storage life; But the protective agent prescription holds in close confidence; China animal with vaccine in, the freeze dried vaccine of living accounts for sizable ratio, domestic protective agent commonly used is mainly milk, sucrose, gelatin etc.; Prescription is simple, and is poor to the defencive function of vaccine.If under 2 ℃～8 ℃ conditions, storage life has only for 4～June, how need preserve below-15 ℃.Add that the protectant development of domestic traditional biological product relatively lags behind, make the long preservation of finished product limited with transportation.So the research of heat-resisting lyophilized protecting agent is badly in need of very much, in the eighties in 20th century, developed country just begins to carry out the research of heat-resisting lyophilized protecting agent.The research of China aspect heat-resisting lyophilized protecting agent is started late, and adds that Chinese market is huge, and the foreign biomolecule goods pour in, market competition aggravation.For the survival and development of national biological product industry, it is particularly urgent that the research of novel and effective heat-resisting lyophilized protecting agent and application seem.
Sodium carboxymethyl cellulose sodium (CMC) as colloid and binding agent, can be used as safe food additive usually.Last century, the seventies China began to adopt, and the nineties begins generally to use.It is the widest, the maximum cellulose kind of consumption of the scope of application in the world today.CMC is not only good emulsifying stabilizing agent, thickening agent in food applications; And have excellent freeze, melt stable; Particularly very excellent to the emulsifiability of animal and vegetable oil, protein and aqueous solution, can make it form the even matter emulsion of stable performance.In medical industry, can make the emulsion stabilizer of injection, the binding agent of tablet and film former.Someone through the basis and zoopery proof CMC be safe and reliable anticarcinogen carrier.
Oligomeric xylose claims that again xylooligosaccharide is by the functional polymerization sugar of 2-7 xylose molecule with β-1,4 glycosidic bond be combined into.Acid, Heat stability is good, difficult fermentation is compared with other oligosaccharide, and the outstanding feature of oligomeric xylose is that stability is very good.Even (PH=2.5-7) is heated to 100 ℃ and also do not decompose basically under acid condition, according to document, the xylotriose in the oligomeric xylose, 1,4-.beta.-Xylobiose and xylose all have reproducibility, do not have more than the Xylotetrose..
Sodium selenite research shows, whole three kinds of regulatory mechanisms that selenium influences immune system significantly and comprised, i.e. cellular immunization, humoral immunization and nonspecific immunity.Selenium can also promote lymphocyte to produce antibody, the haematogenic immunity globulin levels is increased or keeps normally, gives an amount of selenium supplement of tumor patient in therefore clinical, can effectively improve patient's body's immunity, enhancing body anti-cancer and anti-cancer ability.Selenium has antioxidation as the composition of glutathione peroxidase; Regulate immunity, antitumor action.Selenium has antioxidation, participates in the synthetic of coenzyme Q10, keeps cell membrane integrity, keeps the normal growth of animal organism and grows, and scarce selenium can cause multiple disease and cancer.Selenium is that human immunity is regulated nutrient, can active cell immunity medium-sized lymphocyte, again can the immune stimulatory globulin and antibody produce.Immunoregulation effect is to accomplish through antioxidant ubiquinone, cysteine, vitamin E, and these all will could activate in selenic presence, and scarce selenium must cause immunity degradation, and all kinds of diseases occur in succession.Selenium not only can be kept the normal growth promoter of animal body; Closely related with body antioxidation mechanism; Can also improve humoral immunization and the cellular immune function of animal; Enhancing body is to strengthen one of body immune system and the requisite trace element of anti-infection ability to the resistivity of infectious disease.Selenium supplement can strengthen humoral immunization.Can improve sheep red blood cell antigen for the animal selenium supplement, can also improve the content of immunoglobulin (IgM, IgA).
The research of newcastle disease and infectious bronchitis of chicken bigeminal live vaccine heat-resisting lyophilized protecting agent; Chang Xianyong 5% sucrose defatted milk is protectant freeze dried vaccine; 2 ℃～8 ℃ preservations only 12 months, add the heat-resisting lyophilized protecting agent vaccine, 2 ℃～8 ℃ can preserve 2 years after.Explain that heat-resisting lyophilized protecting agent compares conventional protective agent and more can protect vaccine effectively, the holding time is more permanent.The kind of heat-resisting lyophilized protecting agent and proportioning are to influence the quality of vaccine and the key factor of preservation effect.Freeze drying protectant can influence biological product quality, tire and stability, change the production technology of biological product, improve the product predictive ability and also increase stability among product batches.
Summary of the invention
The invention provides a kind of newcastle disease and infectious bronchitis of chicken bigeminal live vaccine heat-resisting lyophilized protecting agent; Purpose is that the vaccine heat-resisting lyophilized protecting agent is mixed with live vaccine, and solving newcastle disease and infectious bronchitis of chicken bigeminal live vaccine only can not be in the technical problem of 2 ℃～8 ℃ following long preservation and transportation.
The concrete technical scheme that the present invention adopts is following:
A kind of newcastle disease and infectious bronchitis of chicken bigeminal live vaccine heat-resisting lyophilized protecting agent; Concrete composition comprises sodium carboxymethyl cellulose 1～2%, oligomeric xylose 2～8%, sorbitol 1～3%, sodium glutamate 0.5～0.8%, sodium selenite 0.1～0.5%, and surplus is a water for injection.
The compound method of above-mentioned newcastle disease and infectious bronchitis of chicken bigeminal live vaccine heat-resisting lyophilized protecting agent comprises the steps:
1) sodium carboxymethyl cellulose fully is dissolved in water for injection as A liquid;
2) oligomeric xylose, sorbitol fully are dissolved in water for injection, as B liquid;
3) sodium glutamate, sodium selenite fully are dissolved in water for injection, as C liquid;
4), be mixed with heat-resisting lyophilized protecting agent by the volume ratio of 1:1:1 with above-mentioned A liquid, B liquid and C liquid.
The application of above-mentioned newcastle disease and infectious bronchitis of chicken bigeminal live vaccine heat-resisting lyophilized protecting agent; Vaccine freeze-drying protective agent is mixed with newcastle disease and infectious bronchitis of chicken bigeminal live vaccine virus liquid by the volume ratio of 2～6:1, after packing, carry out lyophilization then.
The vaccine of protective agent of the present invention protection was preserved 24～36 months at 2～8 ℃, still kept the profile after the lyophilizing, and viral level is all above the standard of national veterinary biological product rules.Viral loss rate is low before and after the lyophilizing; The ageing-resistant degree of freeze-drying prods is high; Product was preserved 24～36 months at 2～8 ℃; Viral level does not change, thereby has solved newcastle disease and the infectious bronchitis of chicken bigeminal live vaccine only can not be in the technical problem of 2 ℃～8 ℃ following long preservation and transportation.
The specific embodiment
Embodiment 1
The preparation of newcastle disease and infectious bronchitis of chicken bigeminal live vaccine heat resistant freeze drying vaccine
1) sodium carboxymethyl cellulose is mixed with water for injection, under 98～100 ℃ of temperature, heated 10～20 minutes, be cooled to room temperature, be mixed with the A liquid of concentration 3% (concentration involved in the present invention is all mass percent concentration except that specified otherwise is arranged).
2) oligomeric xylose, sorbitol are mixed with water for injection, be mixed with B liquid, oligomeric xylose concentration 8%, sorbitol concentration 3%.
3) with sodium glutamate, sodium selenite mixes with removing water for injection, and stirring and evenly mixing is mixed with C liquid, concentration of sodium glutamate 1.5%, concentration of sodium selenite 1.5%.
4), be mixed with vaccine freeze-drying protective agent by the volume ratio of 1:1:1 with A liquid, B liquid and C liquid.
5) vaccine freeze-drying protective agent being pressed 3:1 (V/V) mixes with newcastle disease and infectious bronchitis of chicken bigeminal live vaccine virus liquid.
6) carry out lyophilization after the packing.
7) sealing, packing can be preserved 36 months for 2 ℃～8 ℃.
Embodiment 2
The preparation of newcastle disease and infectious bronchitis of chicken bigeminal live vaccine heat resistant freeze drying vaccine
1) sodium carboxymethyl cellulose is mixed with water for injection, under 98～100 ℃ of temperature, heated 10～20 minutes, be cooled to room temperature, be mixed with the A liquid of concentration 3%.
2) oligomeric xylose, sorbitol are mixed with water for injection, be mixed with B liquid, oligomeric xylose concentration 6%, sorbitol concentration 3%.
3) with sodium glutamate, sodium selenite mixes with removing water for injection, and stirring and evenly mixing is mixed with C liquid, concentration of sodium glutamate 1.5%, concentration of sodium selenite 0.3%.
4), be mixed with vaccine freeze-drying protective agent by the volume ratio of 1:1:1 with A liquid, B liquid and C liquid.
5) vaccine freeze-drying protective agent being pressed 2:1 (V/V) mixes with newcastle disease and infectious bronchitis of chicken bigeminal live vaccine virus liquid.
6) carry out lyophilization after the packing.
7) sealing, packing can be preserved 28 months for 2 ℃～8 ℃.
Embodiment 3
The preparation of newcastle disease and infectious bronchitis of chicken bigeminal live vaccine heat resistant freeze drying vaccine
1) sodium carboxymethyl cellulose is mixed with water for injection, under 98～100 ℃ of temperature, heated 10～20 minutes, be cooled to room temperature, be mixed with the A liquid of concentration 6%.
2) oligomeric xylose, sorbitol are mixed with water for injection, be mixed with B liquid, oligomeric xylose concentration 10%, sorbitol concentration 6%.
3) with sodium glutamate, sodium selenite mixes with removing water for injection, and stirring and evenly mixing is mixed with C liquid, concentration of sodium glutamate 1.5%, concentration of sodium selenite 0.3%.
4), be mixed with vaccine freeze-drying protective agent by the volume ratio of 1:1:1 with A liquid, B liquid and C liquid.
5) vaccine freeze-drying protective agent being pressed 5:1 (V/V) mixes with newcastle disease and infectious bronchitis of chicken bigeminal live vaccine virus liquid.
6) carry out lyophilization after the packing.
7) sealing, packing can be preserved 32 months for 2 ℃～8 ℃.
Claims (3)
1. newcastle disease and infectious bronchitis of chicken bigeminal live vaccine heat-resisting lyophilized protecting agent; Concrete composition comprises sodium carboxymethyl cellulose 1～2%, oligomeric xylose 2～8%, sorbitol 1～3%, sodium glutamate 0.5～0.8%, sodium selenite 0.1～0.5%, and surplus is a water.
2. the compound method of described newcastle disease of claim 1 and infectious bronchitis of chicken bigeminal live vaccine heat-resisting lyophilized protecting agent comprises the steps:
1) sodium carboxymethyl cellulose is fully water-soluble as A liquid;
2) oligomeric xylose, sorbitol is fully water-soluble, as B liquid;
3) sodium glutamate, sodium selenite are fully water-soluble, as C liquid;
4) with above-mentioned A liquid, B liquid and C liquid, be mixed with heat-resisting lyophilized protecting agent by 1:1:1.
3. the application of said newcastle disease of claim 1 and infectious bronchitis of chicken bigeminal live vaccine heat-resisting lyophilized protecting agent; Protective agent is mixed with newcastle disease and infectious bronchitis of chicken bigeminal live vaccine virus liquid by the volume ratio of 2～6:1, after packing, carry out lyophilization then.
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| CN 201210173055 CN102671207B (en) | 2012-05-30 | 2012-05-30 | Newcastle disease and avian infectious bronchitis bigeminal live vaccine heat-resisting freeze-drying protective agent and preparation method |
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| CN 201210173055 CN102671207B (en) | 2012-05-30 | 2012-05-30 | Newcastle disease and avian infectious bronchitis bigeminal live vaccine heat-resisting freeze-drying protective agent and preparation method |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104208712A (en) * | 2013-09-27 | 2014-12-17 | 郑州后羿制药有限公司 | Chicken infectious bursal disease yolk antibody heatproof freeze-drying protective agent and preparation method thereof |
| CN114042167A (en) * | 2021-12-08 | 2022-02-15 | 山东滨州博莱威生物技术有限公司 | Newcastle disease and infectious bronchitis bivalent live vaccine heat-resistant protective agent and preparation method and application thereof |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1176827A (en) * | 1997-09-24 | 1998-03-25 | 中国兽药监察所 | Method for preparing freeze-dried live vaccine for animal use |
| CN1426816A (en) * | 2001-12-21 | 2003-07-02 | 卫广森 | Veterinarian virus kind biological product heat resisting freeze drying protective agent and its preparation technique |
| CN1772302A (en) * | 2005-11-14 | 2006-05-17 | 中国农业科学院哈尔滨兽医研究所 | Heat resistant freeze drying protectant for chicken Newcastle disease live vaccine and its prepn and application |
| CN1887275A (en) * | 2006-07-20 | 2007-01-03 | 上海交通大学 | Prepn process of polysaccharide vitreous particle carrying active vaccine or antibody |
-
2012
- 2012-05-30 CN CN 201210173055 patent/CN102671207B/en not_active Expired - Fee Related
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1176827A (en) * | 1997-09-24 | 1998-03-25 | 中国兽药监察所 | Method for preparing freeze-dried live vaccine for animal use |
| CN1426816A (en) * | 2001-12-21 | 2003-07-02 | 卫广森 | Veterinarian virus kind biological product heat resisting freeze drying protective agent and its preparation technique |
| CN1772302A (en) * | 2005-11-14 | 2006-05-17 | 中国农业科学院哈尔滨兽医研究所 | Heat resistant freeze drying protectant for chicken Newcastle disease live vaccine and its prepn and application |
| CN1887275A (en) * | 2006-07-20 | 2007-01-03 | 上海交通大学 | Prepn process of polysaccharide vitreous particle carrying active vaccine or antibody |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104208712A (en) * | 2013-09-27 | 2014-12-17 | 郑州后羿制药有限公司 | Chicken infectious bursal disease yolk antibody heatproof freeze-drying protective agent and preparation method thereof |
| CN104208712B (en) * | 2013-09-27 | 2016-08-17 | 郑州后羿制药有限公司 | A kind of infectious bursal disease yolk antibody heat-resisting lyophilized protecting agent and preparation method thereof |
| CN114042167A (en) * | 2021-12-08 | 2022-02-15 | 山东滨州博莱威生物技术有限公司 | Newcastle disease and infectious bronchitis bivalent live vaccine heat-resistant protective agent and preparation method and application thereof |
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| CN102671207B (en) | 2013-06-05 |
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