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A heat-resistant freeze-drying protectant for recombinant pseudorabies virus vaccine and its preparation method

A technology for recombinant pseudorabies and virus vaccines, which can be applied in pharmaceutical formulations, medical preparations with non-active ingredients, non-active ingredients of polymer compounds, etc., and can solve the problems of short storage time, long-term storage of vaccines and long-distance transportation restrictions, and poor protection performance. and other problems, to achieve the effect of high aging resistance, good appearance and strong support

Active Publication Date: 2018-10-23
ZHAOQING DAHUANONG BIOLOGIC PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the above formula is simple and the cost is low, its protection performance is poor and the storage time is short. At 2°C-8°C, the storage period is only 3-6 months, and most of them need to be stored below -15°C. The long-term storage and long-distance transportation of vaccines are greatly restricted

Method used

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  • A heat-resistant freeze-drying protectant for recombinant pseudorabies virus vaccine and its preparation method
  • A heat-resistant freeze-drying protectant for recombinant pseudorabies virus vaccine and its preparation method
  • A heat-resistant freeze-drying protectant for recombinant pseudorabies virus vaccine and its preparation method

Examples

Experimental program
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preparation example Construction

[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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Abstract

The invention relates to a heat-resistant freeze-drying protective agent for a recombinant pseudorabies virus vaccine, which is made of the following components in terms of weight percentage: 2-3% gelatin, 1-2% polyvinylpyrrolidone K-301-2%, and 0-0 trehalose 4%, sucrose 2-5%, mannitol 0.1-0.5%, astragalus polysaccharide 0-0.5%, glycine 1-1.5%, arginine 0-1%, bovine serum albumin 0-1%, and the balance is injection use water. The invention also provides a preparation method of the recombinant pseudorabies virus vaccine heat-resistant freeze-drying protectant. The heat-resistant freeze-drying protective agent for recombinant pseudorabies virus vaccine of the invention can prolong the storage time of the vaccine in a relatively high temperature environment, and its preparation method is simple, which is convenient for production and application.

Description

technical field [0001] The invention relates to the field of vaccine adjuvants, in particular to a heat-resistant freeze-drying protectant for recombinant pseudorabies virus vaccine and a preparation method thereof. Background technique [0002] Recombinant pseudorabies virus, such as the recombinant pseudorabies virus preserved in the Chinese Type Culture Culture Center with the preservation number: CCTCC-V201408, is used to prepare vaccines for the prevention and treatment of porcine pseudorabies; among the existing vaccines, attenuated live vaccines are used to prevent One of the main vaccines for livestock and poultry infectious diseases, live vaccines account for a considerable proportion of animal vaccines in my country. Freeze-drying and storing live vaccines provides a lot of convenience for the transportation, storage and use of vaccines. At present, the existing heat-resistant lyoprotectant for live vaccines, such as the commonly used lyophilized live vaccine heat-...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/42A61K47/32A61K47/36A61K47/16A61K47/26
Inventor 谢小雨黄红亮陈瑞爱任常宝佘峥邓小雄
Owner ZHAOQING DAHUANONG BIOLOGIC PHARMA
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