Freeze-drying hepatitis A attenuated live vaccine and its preparation method

A technology for live attenuated vaccines and hepatitis A, applied in freeze-dried delivery, antiviral agents, pharmaceutical formulations, etc., can solve the problems of large loss of vaccine activity and low virus titer, and achieve good safety and immunogenicity , The effect of stable chemical properties and good stability

Inactive Publication Date: 2006-10-11
INST OF MEDICAL BIOLOGY CHINESE ACAD OF MEDICAL SCI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, when using the prior art to freeze-dry the vaccine, because the hepatitis A virus is relatively sensitive to heat, the activity of the vaccine is greatly lost during the freeze-drying process, and the virus titer is very low after freeze-drying

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] Add a lyoprotectant to the hepatitis A attenuated live vaccine virus liquid at a volume ratio of 1:0.7, and the lyoprotectant consists of the following components:

[0052] Trehalose 2%

[0053] Gelatin 0.1%

[0054] Dextran 1.5%

[0055] Glycine 1.5%

[0056] Through the following methods:

[0057] A. Human embryonic lung diploid cells KMB 17 For the 30th generation, use 0.03% trypsin + 0.04% ethylenediaminetetraacetic acid to disperse and suspend the monolayer cells in the culture medium, and cultivate them at a speed of 8 rpm and a temperature of 37±0.5°C for 6 days, allowing the cells to grow into a dense monolayer;

[0058] B. KMB that will grow into a dense monolayer 17 The cells discard the nutrient solution, after digestion, collect the cells with the MEM medium containing 2% serum, add the hepatitis A live attenuated vaccine virus seed in the amount of 1: 40 according to the ratio of the number of viruses to the number of cells in the cells, Stir at a te...

Embodiment 2

[0062] Add a lyoprotectant to the hepatitis A attenuated live vaccine virus liquid at a volume ratio of 1:1.2, and the lyoprotectant consists of the following components:

[0063] Trehalose 10%

[0064] Gelatin 1%

[0065] Dextran 0.5%

[0066] Glycine 0.5%

[0067] Through the following methods:

[0068] Through the following process steps:

[0069] A. Human embryonic lung diploid cells KMB 17 For the 40th generation, use 0.05% trypsin + 0.02% ethylenediaminetetraacetic acid to disperse and suspend the monolayer cells in the culture medium, and culture at a speed of 12 rpm and a temperature of 37±0.5°C for 3 days, allowing the cells to grow into a dense monolayer;

[0070] B. KMB that will grow into a dense monolayer 17 The cells discard the nutrient solution, after digestion, collect the cells with the MEM medium containing 5% serum, add the hepatitis A live attenuated vaccine virus seeds in the cells according to the ratio of the number of viruses to the number of ce...

Embodiment 3

[0074] Add a lyoprotectant to the hepatitis A attenuated live vaccine virus liquid at a volume ratio of 1:1, and the lyoprotectant consists of the following components:

[0075] Trehalose 5%

[0076] Gelatin 0.6%

[0077] Dextran 1%

[0078] Glycine 0.8%

[0079] The freeze-dried live attenuated hepatitis A vaccine was prepared by the same method as in Example 1.

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[0089] age group (years old)

[0090] reaction

[0091] body temperature

[0092] vaccine

[0093] group

[0094] dosage form

[0095]

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PUM

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Abstract

The invention relates to a freeze-dried live attenuated hepatitis A vaccine and its preparation, which comprises live attenuated hepatitis A vaccine virus liquid and freeze-drying protective agent by the volumetric ratio of 1:0.7-1.2, and the freeze-drying protective agent comprises the following constituents: trehalose 2-10%, gelatin 0.1-1%, dextroglucose glycoside 0.5-1.5%, glycine 0.5-1.5%.

Description

technical field [0001] The invention relates to a freeze-dried live attenuated hepatitis A vaccine and a preparation method thereof, belonging to biological products [0002] technology field. Background technique [0003] Hepatitis A vaccine is an effective means of preventing hepatitis A. At present, the hepatitis A vaccines produced at home and abroad (including inactivated vaccines and live attenuated vaccines) are all in liquid dosage form, and their basic feature is that they must rely on the cold chain system to ensure their quality during storage and transportation. As a developing country with a large population, an underdeveloped economy, a complex geographical environment, and inconvenient transportation, it is difficult for the live attenuated hepatitis A vaccine in liquid dosage form to be kept in a strict cold chain environment during storage and transportation, which often affects the vaccine. the quality of. The use of freeze-drying technology to make the ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K39/29A61K47/42A61P31/14
CPCY02A50/30
Inventor 胡云章胡凝珠刘国栋瞿素
Owner INST OF MEDICAL BIOLOGY CHINESE ACAD OF MEDICAL SCI
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