CN1168503C - Veterinarian virus kind biological product heat resisting freeze drying protective agent and its preparation technique - Google Patents
Veterinarian virus kind biological product heat resisting freeze drying protective agent and its preparation technique Download PDFInfo
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- CN1168503C CN1168503C CNB011388714A CN01138871A CN1168503C CN 1168503 C CN1168503 C CN 1168503C CN B011388714 A CNB011388714 A CN B011388714A CN 01138871 A CN01138871 A CN 01138871A CN 1168503 C CN1168503 C CN 1168503C
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Abstract
The present invention relates to a heat-resistance freeze-drying protecting agent for veterinarian virus biological products, and a preparation process thereof. Various kinds of protecting agents are respectively mixed with each other according to ingredients and proportions. The present invention is characterized in that effective ingredients of each protecting agent are respectively sterilized, the effective ingredients which can be sterilized at high pressure are dissolved in distilled water in a preparation proportion and are sterilized at 116 DEG C for 30 to 40 minutes, and ingredients which can not resist high temperature are also dissolved in distilled water in a preparation proportion and are filtered by a filter film with a hole diameter of 0.22 mum for sterilization; then, the two kinds of ingredients are mixed with each other so as to obtain the freeze-drying heat-resistance protecting agent; when used, the freeze-drying heat-resistance protecting agent is added to virus antigen liquid in a proportion of 1:1; then, a mixed solution of the protecting agent and the virus antigen liquid is packaged and freeze-dried. Freeze-dried shapes of products of the present invention can still be maintained after the products are preserved for 24 months at 2 to 8 DEG C, and the virus content is lower than standard content specified for veterinarian biological products in China. The present invention relates to a product with the advantages of low cost and long effect, and a preparation method thereof, and the present invention solves the long existing problem of high cost for transporting and preserving veterinarian biological products.
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 weak malicious freeze dried vaccine heat-resisting lyophilized protecting agent of a kind of newcastle disease and preparation technology, reduce protective condition, extend using period and reduce use cost.
The preparation technology of the weak malicious freeze dried vaccine heat-resisting lyophilized protecting agent of newcastle disease, press component, mixed, it is characterized in that protectant active substance 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 malicious freeze dried vaccine heat-resisting lyophilized protecting agent of newcastle disease, comprise gelatin commonly used, sucrose, dextrin, it is characterized in that the material component proportioning of heat-resisting lyophilized protecting agent is: gelatin 1.5-2%, sucrose 5-6%, dextrin 5-10%, PVP (K90) 2-5%, sorbitol 2%, sodium glutamate 1-2%; Be the dry component in the preparation, percentage ratio residue part is distilled water.
The preparation technology of the weak malicious freeze dried vaccine heat-resisting lyophilized protecting agent of newcastle disease, 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: gelatin, sucrose, dextrin, PVP (90), 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 also are dissolved in the distilled water, in proportion with the membrane filtration degerming of aperture 0.22 μ m; 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:
A. make 10 times of serial dilutions by the real tissue mass that contains with sterile saline, get 3 suitable dilution factors, inoculate 5 of 10 age in days SPF Embryo Gallus domesticus in the allantoic cavity respectively, every embryo 0.1mL puts 37 ℃ and continues to hatch, the dead in the past Embryo Gallus domesticus of 48h discards to be disregarded, at the Embryo Gallus domesticus of 48-120h death, take out results Embryo Gallus domesticus liquid at any time, with same dilution Embryo Gallus domesticus liquid mixed in equal amounts, measure the red cell agglutination valency respectively.To 120h, get all embryos of living, gather in the crops Embryo Gallus domesticus liquid one by one, measure the red cell agglutination valency respectively, agglutination titer 〉=160 are judged to infection, calculate EID
50
B. press label and indicate plumage part, vaccine is diluted to 1 plumage part/0.1mL with sterile saline, remake 10 times of serial dilutions, other method is the same, calculates every plumage part EID at last
50Content.
(2) reach standard
Viral loss rate is less than 0.4 titre after A, the lyophilizing.
B. every plumage part viral level 〉=10 after the lyophilizing
6.7EID
50
C. the product after the lyophilizing is put 37 ℃ and is preserved 10d and 30d and carry out viral level and measure, the viral level rate of descent the former within 1 titre, the latter is within 2 titres.
D. product is put 25 ℃ of preservation 30d after the lyophilizing, and the viral level rate of descent is within 0.6 titre.
E. product is put 2-8 ℃ of preservation 24 months, every plumage part viral level 〉=10
6.17EID
50
Claims (2)
1, the weak malicious freeze dried vaccine heat-resisting lyophilized protecting agent of a kind of newcastle disease, comprise gelatin commonly used, sucrose, dextrin, it is characterized in that the material component proportioning of heat-resisting lyophilized protecting agent is: gelatin 1.5-2%, sucrose 5-6%, dextrin 5-10%, PVP (K90) 2-5%, sorbitol 2%, sodium glutamate 1-2%; Be the dry component in the preparation, percentage ratio residue part is distilled water.
2 one kinds of technologies that prepare the weak malicious freeze dried vaccine heat-resisting lyophilized protecting agent of the described newcastle disease of claim 1, 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 is carried out degerming to be handled: (1) is to can autoclaved material: gelatin, sucrose, dextrin, PVP (90), 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; 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.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB011388714A CN1168503C (en) | 2001-12-21 | 2001-12-21 | Veterinarian virus kind biological product heat resisting freeze drying protective agent and its preparation technique |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB011388714A CN1168503C (en) | 2001-12-21 | 2001-12-21 | Veterinarian virus kind biological product heat resisting freeze drying protective agent and its preparation technique |
Related Child Applications (7)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB2004100295860A Division CN1253209C (en) | 2001-12-21 | 2001-12-21 | Heat-resistant lyophilized protectant of lyophilized vaccine for henpox and preparing process thereof |
| CNB2004100295837A Division CN1223375C (en) | 2001-12-21 | 2001-12-21 | Heat resisting lyophilized protectant for chicken infectious bronchitis (H120, H52, Kidney infectious bronchitis W93) lyophilized vaccine and preparing process thereof |
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| CNB2004100295822A Division CN1233418C (en) | 2001-12-21 | 2001-12-21 | Heat-resisting lyophilized protectant for chicken newcastle disease, chicken infectious bronchitis (H120, H52) dual lyophilized vaccine and preparing process thereof |
| CNB2004100295841A Division CN1222320C (en) | 2001-12-21 | 2001-12-21 | Heat-resistant lyophilized protectant of lyophilized vaccine for chicken infectious laryngotracheitis and preparing process thereof |
| CN 200410029587 Division CN1222314C (en) | 2001-12-21 | 2001-12-21 | Heat resisting lyophilized protectant for chicken Marek's disense turkey herpes virus lyophilized vaccine and preparing process thereof |
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Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1426816A CN1426816A (en) | 2003-07-02 |
| CN1168503C true CN1168503C (en) | 2004-09-29 |
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| Application Number | Title | Priority Date | Filing Date |
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| CNB011388714A Expired - Fee Related 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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| CN102671209B (en) * | 2012-05-30 | 2013-06-05 | 青岛农业大学 | Heat-resistant freeze-drying protective agent for newcastle disease live vaccines and preparation method |
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