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Heat-resisting protective agent and application thereof

A technology of heat-resistant protective agent and protective agent, which is applied in the direction of anti-viral agents, medical preparations with non-active ingredients, and viral antigen components to achieve the effect of reducing physical damage and enhancing heat-resistant performance.

Active Publication Date: 2013-04-17
南京国创生物技术研究院有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, existing heat-resistant lyoprotectants can only preserve live vaccines for 24 months at 2-8°C and 30 days at 37°C.

Method used

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  • Heat-resisting protective agent and application thereof
  • Heat-resisting protective agent and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Example 1 Preparation of heat-resistant protective agent

[0027] In this embodiment, unless otherwise specified, percentages refer to percentages by weight.

[0028] Among them, casein hydrolyzate was purchased from ShanHai Richu Bioscience Co..Ltd, batch number 090901; polyvinylpyrrolidone (K-30) was purchased from Sinopharm Chemical Reagent Co., Ltd., batch number F20111009; Pluronic F 68 was purchased from From Shanghai Sangon Biotechnology Co., Ltd., batch number HJ0522B2012.

[0029] Heat-resistant protectant 1 recipe:

[0030] Trehalose 68%,

[0031] Glycine 6%,

[0032] Gelatin 3%,

[0033] Casein Hydrolyzate 6%,

[0034] Polyvinylpyrrolidone 6%,

[0035] Glycerin 5%,

[0036] Plunik 68 6%.

[0037] Heat Resistant Protectant 2 Recipe:

[0038] Trehalose 38%, Sucrose 20%,

[0039] 2% each of arginine, glycine, methionine, glutamic acid and isoleucine,

[0040] Gelatin 6%,

[0041] Casein Hydrolyzate 10%,

[0042] Polyvinylpyrrolidone 3%,

[0043] G...

Embodiment 2

[0079] Example 2 Preparation and Heat Resistance of Newcastle Disease Live Vaccine Freeze-dried Powder

[0080] (1) Preparation of heat-resistant protective agent

[0081] Prepare heat-resistant protective agent 1-6 by the method of embodiment 1.

[0082] (2) Preparation of chicken Newcastle disease virus liquid (live virus liquid)

[0083]Chicken Newcastle disease virus solution was provided by Nanjing Tianbang Biotechnology Co., Ltd. Specific preparation method: According to the relevant requirements of "Compilation of Quality Standards for Veterinary Biology" (2006-2008), chicken Newcastle disease virus liquid (La Sota strain) was prepared, and the virus content of each virus liquid was 10 7.5 EID 50 (chicken embryo test method).

[0084] (3) Preparation of freeze-dried powder of Newcastle disease live vaccine

[0085] Dissolving the heat-resistant protective agent with a solvent to obtain a protective agent solution;

[0086] Mix heat-resistant protective agent...

Embodiment 3

[0102] Example 3 Freeze-dried powder of porcine reproductive and respiratory syndrome live vaccine and its heat resistance

[0103] (1) Preparation of heat-resistant protective agent

[0104] Prepare heat-resistant protective agent 1-6 by the method of embodiment 1.

[0105] (2) Preparation of porcine reproductive and respiratory syndrome virus liquid (live virus liquid)

[0106] The porcine reproductive and respiratory syndrome virus liquid (live virus liquid) was provided by Nannong Hi-Tech Biological Products Co., Ltd. Specific method: According to the relevant requirements of the "Compilation of Quality Standards for Veterinary Biology" (2006-2008), the porcine reproductive and respiratory syndrome virus liquid (R98 strain) was prepared, and the virus content of each virus liquid was 10 5.5 TCID 50 (cytometry).

[0107] (3) Preparation of lyophilized powder of porcine reproductive and respiratory syndrome live vaccine

[0108] The corresponding porcine reproductive ...

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Abstract

The invention provides a heat-resisting protective agent and an application thereof, and relates to the field of live microorganism deposit. The heat-resisting protective agent comprises the following substances: 40-80% of oligosaccharide, 3-12% of amino acid, 3-12% of gelatin, 3-12% of casein hydrolysate, 3-12% of polyvinyl pyrrolidone, 3-12% of glycerol, and 3-12% of poloxamer-68. The invention further provides the application of the heat-resisting protective agent in preparation of live vaccine freeze-dried powder. The heat-resisting protective agent is dissolved with a solvent; a protective agent solution is obtained; the protective agent solution is mixed with live virus liquid; a live vaccine is obtained; the live vaccine is freeze-dried; and then the live vaccine freeze-dried powder is obtained. The heat-resisting protective agent can improve heat resistance of the live vaccine, and the live vaccine freeze-dried powder prepared by the heat-resisting protective agent is stored for 2 months at 37 DEG C, and stored for 24 months at 15 DEG C.

Description

technical field [0001] The invention relates to the field of preservation of living microorganisms, in particular to a heat-resistant protective agent and its application. Background technique [0002] The heat sensitivity of viruses and other biologically active substances and their related products has always been the bottleneck of long-term storage of live vaccines. my country has a vast territory and great differences in economic levels. The phenomenon of short-term exposure of vaccines to high temperature environments (even above 45°C) still exists during transportation and use. Therefore, higher requirements are put forward for the heat resistance of live vaccines. [0003] The heat-resistant lyoprotectant considers the impact of the physical and chemical changes that may occur in the lyophilized substance on the survival of the live vaccine when the live vaccine is stored at a higher temperature and for a longer storage time. However, the existing heat-resistant lyop...

Claims

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Application Information

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IPC IPC(8): A61K47/42A61K47/32A61K47/26A61K47/18A61K47/10A61P31/12A61P31/14A61K9/19A61K39/17A61K39/12
Inventor 卢宇吕芳邓碧华张金秋侯继波
Owner 南京国创生物技术研究院有限公司
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