CN102526751B - Heat-resistant freeze-dried protective agent for swine fever spleen and lymph tissue origin live vaccine and preparation method for heat-resistant freeze-dried protective agent - Google Patents
Heat-resistant freeze-dried protective agent for swine fever spleen and lymph tissue origin live vaccine and preparation method for heat-resistant freeze-dried protective agent Download PDFInfo
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- CN102526751B CN102526751B CN2012100401099A CN201210040109A CN102526751B CN 102526751 B CN102526751 B CN 102526751B CN 2012100401099 A CN2012100401099 A CN 2012100401099A CN 201210040109 A CN201210040109 A CN 201210040109A CN 102526751 B CN102526751 B CN 102526751B
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Abstract
The invention discloses a heat-resistant freeze-dried protective agent for a swine fever spleen and lymph tissue origin live vaccine. A solution is prepared by using water for injection as a solvent and comprises the following components in percentage by mass: 3 percent of gelatin, 5 percent of polyvinylpyrrolidone, 1 percent of fructosan, 3 percent of trehalose, 3 percent of glycine, 3 percent of sorbierite and 2 percent of sodium glutamate which are dry substances. The preparation method comprises the following steps of: (1) dissolving the gelatin and the polyvinylpyrrolidone (K90) which can be sterilized under high pressure into the water for injection according to the ratio and sterilizing at the temperature of 121 DEG C for 15 minutes; (2) dissolving the sorbierite, the sodium glutamate, the fructosan, the glycine and the trehalose which cannot resist high temperature into the water for injection according to the ratio and filtering and sterilizing by using a filter membrane with the aperture of 0.22 mu m; and (3) mixing the solution obtained in the step (1) and the solution obtained in the step (2) to obtain the heat-resistant freeze-dried protective agent. The invention relates to a low-cost and long-acting product and a preparation method thereof, which solves the problem of high transportation and storage cost for veterinary biological products for a long time.
Description
Technical field
The present invention relates to a kind of swine fever spleen and drench source heat-resisting lyophilized protecting agent of live vaccine and preparation method, belong to animal and manufacture field with viral lived vaccine.
Background technology
In the field of vaccine product, freeze drying protectant and preparation technology thereof are key technologies during live vaccine is produced, and preservation, transportation and the use of vaccine had a significant impact.At present, in China's live vaccine, the freeze dried vaccine of living accounts for sizable ratio, and domestic protective agent commonly used is mainly milk, sucrose, gelatin etc., and prescription is simple, and defencive function is poor.If under 2 ℃ of-8 ℃ of conditions, storage life only has 4-6 month, how need to below-15 ℃, preserve.Add that the protectant development of domestic traditional veterinary biologics relatively lags behind, make the long preservation of finished product vaccine and transportation limited.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 starts to carry out the research of heat-resisting lyophilized protecting agent.The research of China aspect heat-resisting lyophilized protecting agent is started late; but present research has in this respect obtained certain achievement; Fu Dexia etc. (1997) by gelatin sucrose protective agent for malicious freeze-dried vaccine a little less than newcastle disease and infectious bronchitis of chicken a little less than malicious freeze-dried vaccine, its immune effect and milk sucrose protective agent are basic identical.The research that Wang Rengeng etc. (1989) are the heat resisting protective of freeze-dried vaccine to newcastle disease I shows, preserves for 2-8 ℃ and can reach " rules " standard in 24 months, is mainly milk, sucrose, sodium glutamate, mannitol etc.Shen Ming waits by force (1990) to be studied rabies freeze-dried vaccine heat resisting protective, and take materials such as sucrose, milk, EDTA, mannitol as main, through 2-8 ℃, preserving effect duration is 1 year.Li Daoyi etc. (1996) have carried out the protectant research of swine fever freeze-dried vaccine; main component is CHO, sodium glutamate, Ox blood serum, skim milk etc.; preserved 15-24 month for 4-8 ℃; 25 ℃ 100 days; 37 ℃ 7 days; through check, the mensuration such as physical behavior, vacuum, moisture, safe effect reach ministry standard.Wang Dong etc. (2002) have developed a kind of heat-resisting lyophilized protecting agent, with the vaccine of this protective agent lyophilizing, under 2 ℃ of-8 ℃ of conditions, preserve after 24 months, and virus titer, without obvious decline, is popularized application in an all-round way but reach yet.
Due to freeze drying protectant can affect biological product quality, tire and stability; change the production technology of biological product; improve the product prediction ability and increase the stability between product batches; and heat-resisting lyophilized protecting agent has immunocompetence but parmacodynamics-less activity; can when lyophilizing and preservation, remain the stability of vaccine; when first dry at suitable temperature vaccine do not collapse, enterprise's low cost can be obtained.
Summary of the invention
The purpose of this invention is to provide a kind of novel swine fever spleen and drench source heat-resisting lyophilized protecting agent of live vaccine and preparation method thereof, reduce protective condition, extend using period and reduce use cost.
A kind of swine fever spleen drenches the source heat-resisting lyophilized protecting agent of live vaccine, take water for injection as the solvent obtain solution, each constituent mass percent concentration is: gelatin 3%, polyvinylpyrrolidone 5%, anhydrofructose 1%, trehalose 3%, glycine 3%, sorbitol 3%, sodium glutamate 2%; Be the dry component.
Above-mentioned swine fever spleen drenches the preparation method of source heat-resisting lyophilized protecting agent of live vaccine, (1) to can autoclaved gelatin, polyvinylpyrrolidone (K90), in ratio separately, be dissolved in water for injection, 121 ℃ sterilizing 15 minutes; (2) by material component sorbitol, sodium glutamate, anhydrofructose, glycine, the trehalose of non-refractory; All in ratio separately, be dissolved in water for injection the membrane filtration degerming with aperture 0.22 μ m; Then (1), (2) are mixed; be heat-resisting lyophilized protecting agent, in freeze drying protectant, each constituent mass percent concentration is: gelatin 3%, polyvinylpyrrolidone 5%, anhydrofructose 1%, trehalose 3%, glycine 3%, sorbitol 3%, sodium glutamate 2%.During use, by 1: 1 volume ratio, add in virus antigen liquid, after packing, carry out lyophilization.
Heat-resisting lyophilized protecting agent of live vaccine of the present invention, reduce preservation condition, extends storage life, reduces the immune efficacy of use cost and raising vaccine thereof, makes storage, transportation and the use of live vaccine all more convenient, economical.Preparation of the present invention can be preserved more than 24 months under 2-8 ℃ of condition, can reach the indices of regulation in " People's Republic of China's veterinary biological product quality standard ".
The specific embodiment
Below in conjunction with specific embodiment, the present invention is described in detail.
A kind of novel swine fever spleen drenches the source heat-resisting lyophilized protecting agent of live vaccine; proportioning is: gelatin 3g, polyvinylpyrrolidone 5g, anhydrofructose 1g, trehalose 3g, glycine 3g, sorbitol 3g, sodium glutamate 2g; water for injection 80g, can obtain 100g swine fever spleen and drench the source heat-resisting lyophilized protecting agent of live vaccine.
The swine fever spleen drenches the preparation method of source heat-resisting lyophilized protecting agent of live vaccine, (1) to can autoclaved gelatin, polyvinylpyrrolidone (K90), in ratio separately, be dissolved in water for injection, 121 ℃ sterilizing 15 minutes; (2) by material component sorbitol, sodium glutamate, anhydrofructose, glycine, the trehalose of non-refractory; All in ratio separately, be dissolved in water for injection the membrane filtration degerming with aperture 0.22 μ m; After completing respectively degerming, (1), (2) two kinds of compositions are mixed, be heat-resisting lyophilized protecting agent, during use, by 1: 1 volume ratio, add in virus antigen liquid, after packing, carry out lyophilization.
Technical parameter and detection method
1. the physical behavior of product, steriling test, mycoplasma check, exogenous virus check, safety verification, residual moisture mensuration and vacuum are measured by method and the standard of " People's Republic of China's veterinary biological product rules " and are undertaken.
2. frozen in the cycle and be no more than 48h.
3. viral level is measured and standard
With the rabbit effect, examine: press label and indicate head part, with normal saline, by 750 times of every part vaccine dilutions or by the real antigen amount that contains, dilute suitable multiple, 2 of ear vein injection rabbit, every 1mL, according to rabbit body temperature change to determine tiring of vaccine, the effect of product reach 50,000 times qualified.
4,3 batches of products by the lyophilizing of this heat-resisting lyophilized protecting agent of trial-production, and establish conventional 5% sucrose skimmed milk protective agent matched group, is placed under 37 ℃, 2-8 ℃ condition and preserves, and the different time sampling, measure viral level and physical behavior thereof etc.The results are shown in Table;
Table 1 swine fever spleen of the present invention drenches after the live vaccine lyophilizing of source the parametric measurements such as physical behavior
Table 2 swine fever spleen of the present invention drenches under 37 ℃ of source live vaccine places 10 days efficacy determinations
Table 3 swine fever spleen of the present invention drenches under 2～4 ℃ of source live vaccine places the different time efficacy determinations
Table 4 swine fever spleen of the present invention drenches source live vaccine safety testing
From above experimental result, find out; at the varying environment temperature, heat-resisting lyophilized protecting agent of the present invention is better than conventional 5% sucrose skimmed milk protective agent to the protection effect that the swine fever spleen drenches the source live vaccine, after lyophilizing vaccine reach 8.5 ten thousand times qualified; product is preserved 10d at 37 ℃, the effect of product reach 60,000 times qualified.Product was preserved 24 months at 2-8 ℃, and the effect of product is all more than 50,000 times.Heat resisting protective of the present invention drenches the source live vaccine to the swine fever spleen and has good protection effect.
Should be understood that, for those of ordinary skills, can be improved according to the above description or conversion, and all these improve and conversion all should belong to the protection domain of claims of the present invention.
Claims (2)
1. a swine fever spleen drenches the source heat-resisting lyophilized protecting agent of live vaccine, it is characterized in that, take water for injection as the solvent obtain solution, each constituent mass percent concentration is: gelatin 3%, polyvinylpyrrolidone 5%, anhydrofructose 1%, trehalose 3%, glycine 3%, sorbitol 3%, sodium glutamate 2%; Be the dry component.
2. swine fever spleen according to claim 1 drenches the preparation method of source heat-resisting lyophilized protecting agent of live vaccine, it is characterized in that, (1) to can autoclaved gelatin, PVP K90, in ratio separately, be dissolved in water for injection, 121 ℃ sterilizing 15 minutes; (2) by material composition sorbitol, sodium glutamate, anhydrofructose, glycine, the trehalose of non-refractory; All in ratio separately, be dissolved in water for injection the membrane filtration degerming with aperture 0.22 μ m; Then (1), (2) are mixed; be heat-resisting lyophilized protecting agent, in freeze drying protectant, each constituent mass percent concentration is: gelatin 3%, polyvinylpyrrolidone 5%, anhydrofructose 1%, trehalose 3%, glycine 3%, sorbitol 3%, sodium glutamate 2%.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102626520B (en) * | 2012-04-23 | 2013-07-03 | 青岛农业大学 | Application of heat-resisting cryoprotectant of mink canine distemper live vaccine |
| CN103041383B (en) * | 2013-01-07 | 2014-02-05 | 江苏省农业科学院 | Heatproof freeze-drying protective agent of live vaccine, live vaccine freeze-drying powder and preparation method thereof |
| CN106310250A (en) * | 2015-06-19 | 2017-01-11 | 上海市农业科学院 | Swine fever oral attenuated freezing-dry vaccine and preparation method thereof and freeze-drying protective agent |
| CN105012963B (en) * | 2015-08-19 | 2018-10-23 | 肇庆大华农生物药品有限公司 | A kind of recombinant pseudorabies virus vaccine heat-resisting lyophilized protecting agent and preparation method thereof |
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| CN101474410A (en) * | 2008-12-11 | 2009-07-08 | 天津瑞普生物技术股份有限公司 | Heat-resisting lyophilized protecting agent of live vaccine for animal and preparation method thereof |
| CN101947321A (en) * | 2010-09-30 | 2011-01-19 | 郑州后羿制药有限公司 | Heat-resisting and freeze-drying protector for live vaccine and preparation method thereof as well as live newcastle disease vaccine |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101474410A (en) * | 2008-12-11 | 2009-07-08 | 天津瑞普生物技术股份有限公司 | Heat-resisting lyophilized protecting agent of live vaccine for animal and preparation method thereof |
| CN101947321A (en) * | 2010-09-30 | 2011-01-19 | 郑州后羿制药有限公司 | Heat-resisting and freeze-drying protector for live vaccine and preparation method thereof as well as live newcastle disease vaccine |
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| 孙东坡等.蛋白质冷冻干燥制品中的保护剂及其保护机制.《药学进展》.2003,第27卷(第4期),第201-205页. |
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