Heat-resisting lyophilized protector for recombinant pseudorabies virus vaccine and preparation method of heat-resisting lyophilized protector
A technology for recombinant pseudorabies and virus vaccines, which can be used in pharmaceutical formulations, medical preparations with non-active ingredients, and non-active components of polymer compounds, which can solve the long-term storage and long-distance transportation limitations of vaccines, short storage time, and poor protection performance. and other problems, to achieve the effect of good appearance, high aging resistance and strong support
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[0022] The preparation method of the recombinant pseudorabies virus vaccine heat-resistant lyoprotectant in the embodiment of the present invention, it comprises the following steps:
[0023] a. Take gelatin, polyvinylpyrrolidone K-30, trehalose, sucrose, mannitol and astragalus polysaccharide, and then dissolve them in part of the water for injection, which accounts for 4 / 5 of the total amount of water for injection. Sterilize at high temperature for 15 minutes to obtain solution A;
[0024] B. get glycine, arginine and bovine serum albumin of formula quantity, be dissolved in the water for injection of remaining part (that is account for 1 / 5 of water for injection total amount), then use the filter membrane filter sterilization that aperture is 0.22 μ m, Obtain solution B;
[0025] c. Mix the solution A obtained in step a with the solution B obtained in step b to obtain the product.
Embodiment 1-5、 comparative example 1-3
[0027] For the heat-resistant lyoprotectant of Examples 1-5 and Comparative Examples 1-3 of the present invention, the specific formula composition is shown in Table 1 below (numbers in the formula table represent mass percentages),
[0028] Table 1: Formula table of heat-resistant lyoprotectant of embodiment and comparative example
[0029]
[0030]
experiment example
[0032] The heat-resistant lyoprotectant of the recombinant pseudorabies virus vaccine prepared by the embodiments of the present invention and the comparative examples is tested for its performance;
[0033] 1.1 Materials
[0034] 1.1.1 Viruses and Cells
[0035] The recombinant virus rPRV-ORF2 was independently constructed and preserved by the inventor. The recombinant virus was preserved in the China Type Culture Center with the preservation number: CCTCC-V201408; the recombinant virus can effectively express the ORF2 gene of PCV2 and can be used to prepare PCV2-PRV Duplex genetic engineering vaccine. ST cells were purchased from China Veterinary Drug Administration.
[0036] 1.1.2 Serum, medium and trypsin reagents
[0037] Fetal bovine serum and DMEM medium were purchased from Gibco, and trypsin was a product of Sigma. Sodium Chloride, Potassium Chloride, Glucose, NaHCO 3 , EDTA is analytical reagent.
[0038] 1.1.3 Experimental animals and antibody detection kits
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