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Freeze-drying protective agent for vaccines

A technology of freeze-drying protective agent and vaccine, which is applied to medical preparations with non-active ingredients, non-effective ingredients of polymer compounds, and pharmaceutical formulas, etc. It can solve problems such as immune failure, poor protective performance, and discounted potency, and achieve operational Simplicity, low cost, and the effect of extending shelf life

Active Publication Date: 2013-10-09
YEBIO BIOENG OF QINGDAO
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] At present, the attenuated live vaccine is one of the main vaccines for preventing livestock and poultry infectious diseases. In my country's animal vaccines, live vaccines account for a considerable proportion. Stored at 2-8°C, the storage period is only 3-6 months, and most of them need to be stored at -15°C
However, the demand for low-temperature storage greatly restricts the long-term storage and long-distance transportation of vaccines. In addition, grass-roots epidemic prevention departments and users lack necessary freezing and cold storage facilities. immune failure

Method used

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  • Freeze-drying protective agent for vaccines
  • Freeze-drying protective agent for vaccines
  • Freeze-drying protective agent for vaccines

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Formula and preparation method of freeze-dried freeze-dried protective agent: divided into two parts, A liquid and B liquid.

[0023] 1) Preparation of liquid A: Take 3 g of NZ amine, 0.375 g of monopotassium glutamic acid salt, 25 g of sucrose, and 1.875 g of hydrolyzed milk protein. Sterilize by membrane filtration and store at 2-8°C for later use.

[0024] 2) Preparation of liquid B: take 20g of hydrolyzed gelatin, fully dissolve it with 100ml of water for injection at 70-80°C, autoclave at 121°C and 15 pounds for 30 minutes, and store at 37°C after sterilization.

[0025] 3) Mix liquid A and liquid B at a ratio of 4:1, and mix well to obtain a freeze-dried freeze-dried protective agent. The mass and volume percentage concentrations of each component are as follows: 2.4% NZ-amine, 0.3% glutamine Monopotassium acid salt, 20% sucrose, 1.5% hydrolyzed milk protein, 4% hydrolyzed gelatin.

[0026] Preparation of vaccines using the lyoprotectant of the present invention...

Embodiment 2

[0033] 1. Formula and preparation method of freeze-dried freeze-dried protective agent: divided into two parts, A solution and B solution.

[0034] 1) Preparation of liquid A: NZ-amine 4wt%, glutamic acid monopotassium salt 0.5 wt%, sucrose 25 wt%, hydrolyzed milk protein 2.5 wt% (wt means weight to volume ratio g / ml); add the above ingredients in order Put it into water for injection, fully dissolve it, shake it well, filter it with a 0.22μm filter membrane, and store it at 2-8°C for later use.

[0035] 2) Preparation of liquid B: hydrolyzed gelatin 6 wt%, fully dissolved in water for injection at 70-80 °C, 121 °C, 15 lbs high pressure for 30 minutes, sterilized and stored at 37 °C.

[0036] 3) Mix liquid A and liquid B at a ratio of 1:1, mix well and then use it as a freeze-drying protective agent.

[0037] 2. Vaccine preparation

[0038] 1) After the porcine Japanese encephalitis virus is cultured, carry out sterility test and virus content determination, mix the qualifie...

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Abstract

The invention relates to a freeze-drying protective agent which is composed of the following components in percentage by mass or volume: 2.4-4% of NZ-amine, 0.3-0.5% of monopotassium salt of glutamic acid, 20-25% of sucrose, 1.5-2.5% of hydrolyzed lactoprotein, 4-6% of hydrolyzed gelatin and the balance of water. The freeze-drying protective agent provided by the invention is low in raw material cost and simple to operate, and can implement large-scale production. After the vaccines are stored at 2-8 DEG C for 24 months, the titers of the vaccines are respectively greater than or equal to 105.7TCID50 / dose (Chinese Standard), thereby effectively prolonging the storage life of the vaccines.

Description

technical field [0001] The invention belongs to the technical field of vaccine preparation, and in particular relates to a vaccine freeze-drying protectant. Background technique [0002] At present, the attenuated live vaccine is one of the main vaccines for preventing livestock and poultry infectious diseases. In my country's animal vaccines, live vaccines account for a considerable proportion. Stored at 2-8°C, the storage period is only 3-6 months, and most of them need to be stored at -15°C. However, the demand for low-temperature storage greatly restricts the long-term storage and long-distance transportation of vaccines. In addition, grass-roots epidemic prevention departments and users lack necessary freezing and cold storage facilities. Immune failure. . The freeze-dried vaccine of the freeze-drying protective agent provided by the invention can be stored for a long time at 2-8°C, and the storage period can be as long as 24 months. It solves the long-standing probl...

Claims

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Application Information

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IPC IPC(8): A61K47/42A61K47/18A61K47/26
Inventor 管清江邹桂荣郭长文胡潇孙健李平
Owner YEBIO BIOENG OF QINGDAO
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