CN102526751A - 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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- CN102526751A CN102526751A CN2012100401099A CN201210040109A CN102526751A CN 102526751 A CN102526751 A CN 102526751A CN 2012100401099 A CN2012100401099 A CN 2012100401099A CN 201210040109 A CN201210040109 A CN 201210040109A CN 102526751 A CN102526751 A CN 102526751A
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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 method for preparing, belong to animal and make the 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 very big influence.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 has only 4-6 month, how need preserve below-15 ℃.Add that the protectant development of domestic traditional veterinary biologics relatively lags behind, make the long preservation of finished product vaccine 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; But present research has in this respect obtained certain achievement; Fu Dexia etc. (1997) are used for a little less than the newcastle disease malicious freeze-dried vaccine a little less than the malicious freeze-dried vaccine and infectious bronchitis of chicken with gelatin sucrose protective agent, and its immune effect and milk sucrose protective agent are basic identical.Wang Rengeng etc. (1989) are that the research of the heat resisting protective of freeze-dried vaccine shows to newcastle disease I, preserve for 2-8 ℃ can reach " rules " standard in 24 months, are mainly milk, sucrose, sodium glutamate, mannitol etc.Shen Ming waits (1990) that rabies freeze-dried vaccine heat resisting protective is studied by force, is main with materials such as sucrose, milk, EDTA, mannitol, and preserving effect duration through 2-8 ℃ 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, mensuration such as physical behavior, vacuum, moisture, safety effectiveness reach ministry standard.Wang Dong etc. (2002) have developed a kind of heat-resisting lyophilized protecting agent,, under 2 ℃ of-8 ℃ of conditions, preserve after 24 months with the freeze dried vaccine of this protective agent, and virus titer does not have obvious decline, do not use but reach yet to popularize in an all-round way.
Since 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, and heat-resisting lyophilized protecting agent there is immunocompetence but parmacodynamics-less activity, can keep the stability of vaccine when preserving in lyophilizing; When first dry under 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; With water for injection is the solvent obtain solution, and 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 method for preparing of source heat-resisting lyophilized protecting agent of live vaccine, (1) to can autoclaved gelatin, polyvinylpyrrolidone (K90), be dissolved in water for injection in ratio separately, 121 ℃ of sterilizations 15 minutes; (2) with material component sorbitol, sodium glutamate, anhydrofructose, glycine, the trehalose of non-refractory; All be dissolved in the water for injection membrane filtration degerming with aperture 0.22 μ m in ratio separately; Then (1), (2) are mixed; Be heat-resisting lyophilized protecting agent, each constituent mass percent concentration is in the freeze drying protectant: gelatin 3%, polyvinylpyrrolidone 5%, anhydrofructose 1%, trehalose 3%, glycine 3%, sorbitol 3%, sodium glutamate 2%.Add in the virus antigen liquid by 1: 1 volume ratio during use, carry out lyophilization after the packing.
Heat-resisting lyophilized protecting agent of live vaccine of the present invention reduces preservation condition, prolongs 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 each item index 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 elaborated.
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 method for preparing of source heat-resisting lyophilized protecting agent of live vaccine, (1) to can autoclaved gelatin, polyvinylpyrrolidone (K90), be dissolved in water for injection in ratio separately, 121 ℃ of sterilizations 15 minutes; (2) with material component sorbitol, sodium glutamate, anhydrofructose, glycine, the trehalose of non-refractory; All be dissolved in the water for injection membrane filtration degerming with aperture 0.22 μ m in ratio separately; After accomplishing degerming respectively (1), (2) two kinds of compositions are mixed, be heat-resisting lyophilized protecting agent, add in the virus antigen liquid by 1: 1 volume 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, 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. frozen in the cycle and be no more than 48h.
3. viral level is measured and standard
Imitate inspection with rabbit: press label and indicate head part; Dilute suitable multiple with normal saline with 750 times of every part vaccine dilutions or by the real antigen amount that contains, 2 of ear vein injection rabbit, every 1mL; According to rabbit body temperature change to confirm tiring of vaccine, the effectiveness of product reach 50,000 times qualified.
4,3 batches of trial-productions and are established conventional 5% sucrose skimmed milk protective agent matched group by the freeze dried product of this heat-resisting lyophilized protecting agent, place under 37 ℃, 2-8 ℃ condition to preserve, and viral level and physical behavior thereof etc. are measured in the different time sampling.The result sees table;
Table 1 swine fever spleen of the present invention drenches after the live vaccine lyophilizing of source parametric measurements such as physical behavior
Table 2 swine fever spleen of the present invention drenches 10 days efficacy determinations of 37 ℃ of held of source live vaccine
Table 3 swine fever spleen of the present invention drenches 2～4 ℃ of held different times of source live vaccine efficacy determinations
Table 4 swine fever spleen of the present invention drenches source live vaccine safety testing
Find out from above experimental result; Under the varying environment temperature, heat-resisting lyophilized protecting agent of the present invention is superior to conventional 5% sucrose skimmed milk protective agent to the protection effect that the swine fever spleen drenches the source live vaccine, after the lyophilizing vaccine reach 8.5 ten thousand times qualified; Product is preserved 10d at 37 ℃, the effectiveness of product reach 60,000 times qualified.Product was preserved 24 months at 2-8 ℃, and the effectiveness 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 the excellent protection effect.
Should be understood that, concerning those of ordinary skills, can improve or conversion, and all these improvement and conversion all should belong to the protection domain of accompanying claims of the present invention according to above-mentioned explanation.
Claims (2)
1. a swine fever spleen drenches the source heat-resisting lyophilized protecting agent of live vaccine; It is characterized in that; With water for injection is the solvent obtain solution, and 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 method for preparing of source heat-resisting lyophilized protecting agent of live vaccine, it is characterized in that, (1) to can autoclaved gelatin, polyvinylpyrrolidone (K90), be dissolved in water for injection in ratio separately, 121 ℃ of sterilizations 15 minutes; (2) with material component sorbitol, sodium glutamate, anhydrofructose, glycine, the trehalose of non-refractory; All be dissolved in the water for injection membrane filtration degerming with aperture 0.22 μ m in ratio separately; Then (1), (2) are mixed; Be heat-resisting lyophilized protecting agent, each constituent mass percent concentration is in the freeze drying protectant: gelatin 3%, polyvinylpyrrolidone 5%, anhydrofructose 1%, trehalose 3%, glycine 3%, sorbitol 3%, sodium glutamate 2%.
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Cited By (4)
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|---|---|---|---|---|
| CN102626520A (en) * | 2012-04-23 | 2012-08-08 | 青岛农业大学 | Heat-resisting cryoprotectant of mink canine distemper live vaccine and preparation method thereof |
| CN103041383A (en) * | 2013-01-07 | 2013-04-17 | 江苏省农业科学院 | Heatproof freeze-drying protective agent of live vaccine, live vaccine freeze-drying powder and preparation method and preparation method of live vaccine freeze-drying powder |
| CN105012963A (en) * | 2015-08-19 | 2015-11-04 | 肇庆大华农生物药品有限公司 | Heat-resisting lyophilized protector for recombinant pseudorabies virus vaccine and preparation method of heat-resisting lyophilized protector |
| 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 |
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| 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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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102626520A (en) * | 2012-04-23 | 2012-08-08 | 青岛农业大学 | Heat-resisting cryoprotectant of mink canine distemper live vaccine and preparation method thereof |
| CN103041383A (en) * | 2013-01-07 | 2013-04-17 | 江苏省农业科学院 | Heatproof freeze-drying protective agent of live vaccine, live vaccine freeze-drying powder and preparation method and preparation method of live vaccine freeze-drying powder |
| 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 |
| CN105012963A (en) * | 2015-08-19 | 2015-11-04 | 肇庆大华农生物药品有限公司 | Heat-resisting lyophilized protector for recombinant pseudorabies virus vaccine and preparation method of heat-resisting lyophilized protector |
| 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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| CN102526751B (en) | 2013-11-20 |
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