Heatproof lyoprotectant for live vaccine against pseudorabies and preparation method thereof, and lyophilized vaccine and preparation method thereof

A heat-resistant freeze-drying and protective agent technology, applied in the preparation of freeze-dried vaccines and freeze-dried vaccines, heat-resistant freeze-dried protective agents for live pseudorabies vaccines, and the preparation of protective agents, can solve the problem of insufficient protective effects of heat-resistant protective agents to improve dehydration protection, promote sublimation, and improve tolerance

Active Publication Date: 2017-10-24
SICHUAN HUAPAI BIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0008] Aiming at the above-mentioned problems existing in the prior art, the present invention provides a heat-resistant freeze-drying protective agent for pseudorabies live vaccine, a preparation method of the protective agent, a freeze-dried vaccine and a preparation method of the freeze-dried vaccine, which can effectively solve the existing pseudorabies live vaccine. The problem of poor protective effect of rabies live vaccine heat-resistant protective agent

Method used

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  • Heatproof lyoprotectant for live vaccine against pseudorabies and preparation method thereof, and lyophilized vaccine and preparation method thereof
  • Heatproof lyoprotectant for live vaccine against pseudorabies and preparation method thereof, and lyophilized vaccine and preparation method thereof
  • Heatproof lyoprotectant for live vaccine against pseudorabies and preparation method thereof, and lyophilized vaccine and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] A heat-resistant freeze-drying protectant for pseudorabies live vaccine, comprising the following components by weight: 30g of gelatin, 10g of trehalose, 50g of sucrose, 1g of bovine serum albumin, 10g of tryptone, 20g of enzymolyzed casein, 10g of thiourea, L-sodium glutamate 8g, arginine 1g, polyvinylpyrrolidone (PVP-K30) 5g and mannitol 1g.

[0027] The preparation method of above-mentioned pseudorabies live vaccine heat-resistant lyoprotectant comprises the following steps:

[0028] (1) Preparation of liquid A

[0029] Weigh trehalose, bovine serum albumin, enzymatic casein, sodium L-glutamate, thiourea, arginine, polyvinylpyrrolidone and mannitol according to the formula, add an appropriate amount of water for injection until completely dissolved, and then make up to volume to 1L, and finally filter and sterilize with a 0.22μm filter membrane;

[0030] (2) Preparation of liquid B

[0031] Weigh gelatin, sucrose and tryptone according to the formula, dissolve in ...

Embodiment 2

[0035] A heat-resistant freeze-drying protectant for pseudorabies live vaccine, comprising the following components by weight: 100g of gelatin, 50g of trehalose, 150g of sucrose, 20g of bovine serum albumin, 80g of tryptone, 100g of enzymolyzed casein, 50g of thiourea, L-sodium glutamate 20g, arginine 30g, polyvinylpyrrolidone (PVP-K30) 50g and mannitol 20g.

[0036] The preparation method of above-mentioned pseudorabies live vaccine heat-resistant lyoprotectant comprises the following steps:

[0037] (1) Preparation of liquid A

[0038] Weigh trehalose, bovine serum albumin, enzymatic casein, sodium L-glutamate, thiourea, arginine, polyvinylpyrrolidone and mannitol according to the formula, add an appropriate amount of water for injection until completely dissolved, and then make up to volume to 1L, and finally filter and sterilize with a 0.22μm filter membrane;

[0039] (2) Preparation of liquid B

[0040] Weigh gelatin, sucrose and tryptone according to the formula, diss...

Embodiment 3

[0044] A heat-resistant freeze-drying protectant for pseudorabies live vaccine, comprising the following components in parts by weight: 50g of gelatin, 15g of trehalose, 96g of sucrose, 2g of bovine serum albumin, 40g of tryptone, 40g of enzymatic hydrolyzed casein, and 16g of thiourea , L-sodium glutamate 12g, arginine 2g, polyvinylpyrrolidone (PVP-K30) 10g and mannitol 1g.

[0045] The preparation method of above-mentioned pseudorabies live vaccine heat-resistant lyoprotectant comprises the following steps:

[0046] (1) Preparation of liquid A

[0047] Weigh trehalose, bovine serum albumin, enzymatic casein, sodium L-glutamate, thiourea, arginine, polyvinylpyrrolidone and mannitol according to the formula, add an appropriate amount of water for injection until completely dissolved, and then make up to volume to 1L, and finally filter and sterilize with a 0.22μm filter membrane;

[0048] (2) Preparation of liquid B

[0049] Weigh gelatin, sucrose and tryptone according to ...

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Abstract

The invention provides a heatproof lyoprotectant for a live vaccine against pseudorabies. The heatproof lyoprotectant comprises, by weight, 3 to 10 parts of gelatin, 1 to 5 parts of trehalose, 5 to 15 parts of sucrose, 0.1 to 2 parts bovine serum albumin, 1 to 8 parts of tryptone, 2 to 10 parts of enzyme-hydrolyzed casein, 1 to 5 parts of thiourea, 0.8 to 2 parts of L-monosodium glutamate, 0.1 to 3 parts of arginine, 0.5 to 5 parts of polyvinylpyrrolidone (PVP-K30) and 0.1 to 2 parts of mannitol. The invention also discloses a preparation method of the heatproof lyoprotectant and a lyophilized vaccine prepared from the heatproof lyoprotectant. When the heatproof lyoprotectant is used for protecting the vaccine and a specific lyophilization process is employed, lyophilization loss of viruses can be effectively reduced, the temperature tolerance of the viruses can be improved, and the vaccine can still maintain good physical properties and titer after long-term storage; i.e., the vaccine has stable characters and has the characteristics of heat resistance and long storage time.

Description

technical field [0001] The invention belongs to the technical field of heat-resistant protective agents for vaccines, and in particular relates to a heat-resistant freeze-dried protectant for pseudorabies live vaccines, a preparation method for the protectant, a freeze-dried vaccine and a preparation method for the freeze-dried vaccine. Background technique [0002] Porcine pseudorabies is an acute infectious disease of pigs caused by porcine pseudorabies virus (PRV). The disease is fulminant in pigs, and can cause abortion and stillbirth in pregnant sows, infertility in boars, mass death of newborn piglets, dyspnea and growth stagnation in fattening pigs. It is one of the major infectious diseases that endanger the global pig industry. Vaccination is the fundamental measure to prevent and control pseudorabies. [0003] The heat sensitivity of viruses and other biologically active substances and their related products has always been the bottleneck of long-term storage of l...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/245A61K47/42A61K47/26A61K47/20A61K47/18A61K47/32A61P31/22
CPCA61K39/12A61K47/183A61K47/20A61K47/26A61K47/32A61K47/42A61K2039/5254A61K2039/552C12N2710/16734
Inventor 万成燕吴越李宇夏宏燕周应辉池波邱梁冻吕亮
Owner SICHUAN HUAPAI BIO PHARMA
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