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A kind of lyoprotectant and its application in lyophilized live attenuated hepatitis A vaccine

A technology of freeze-dried protective agent and live attenuated vaccine, which is applied in the field of biological products, can solve the problems of long preparation time and slow dissolution speed of freeze-dried protective agent, and achieve improved dissolution speed, good clinical safety and immunogenicity, Recipe Simple Effects

Active Publication Date: 2019-01-08
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

[0005] In order to solve the problems of slow dissolution rate and long preparation time of existing lyoprotectants, the present invention provides a lyoprotectant and its application in freeze-dried live attenuated hepatitis A vaccines to It achieves good effects of reducing costs and shortening the preparation cycle, and can be used as a substitute for existing freeze-drying protective agents

Method used

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  • A kind of lyoprotectant and its application in lyophilized live attenuated hepatitis A vaccine
  • A kind of lyoprotectant and its application in lyophilized live attenuated hepatitis A vaccine
  • A kind of lyoprotectant and its application in lyophilized live attenuated hepatitis A vaccine

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Effect test

Embodiment 1

[0027] A. Human embryonic lung diploid cells KMB 17 For passage 30, use 0.04% trypsin + 0.03% ethylenediaminetetraacetic acid to disperse and suspend the monolayer cells in the culture medium at a speed of 8-12 rpm and a temperature of 37±0.5°C Culture for 3-6 days to make the cells grow into a dense monolayer;

[0028] B. KMB that will grow into a dense monolayer 17 Discard the nutrient solution for the cells, and after digestion, collect the cells with MEM medium containing 3% serum, and add live attenuated hepatitis A vaccine virus seeds to the cells according to the ratio of the number of viruses to the number of cells at 1:40-60 , Stir for 1 hour at 37°C with a speed of 100 rpm to suspend and adsorb the virus, add maintenance solution containing 8% serum to the final volume of each spinner bottle to 180ml, keep the temperature at 35±0.5°C and continue to rotate After culturing for 14 days, replace with fresh nutrient solution, and co-cultivate for 26-28 days;

[0029] ...

Embodiment 2

[0037] A. Human embryonic lung diploid cells KMB 17 For the 20th generation, use 0.03% trypsin + 0.02% ethylenediaminetetraacetic acid to disperse and suspend the monolayer cells in the culture medium at a speed of 8-12 rpm and a temperature of 37±0.5°C Culture for 3-6 days to make the cells grow into a dense monolayer;

[0038] B. KMB that will grow into a dense monolayer 17 Discard the nutrient solution for the cells, and after digestion, collect the cells with MEM medium containing 2% serum, and add live attenuated hepatitis A vaccine virus seeds to the cells according to the ratio of the number of viruses to the number of cells at 1:40-60 Stir for 2 hours at 37°C with a speed of 20 rpm to suspend and adsorb the virus, add maintenance solution containing 5% serum to the final volume of each spinner bottle to 180ml, keep the temperature at 35±0.5°C and continue to rotate After culturing for 14 days, replace with fresh nutrient solution, and co-cultivate for 26-28 days;

...

Embodiment 3

[0047] A. Human embryonic lung diploid cells KMB 17 For passage 40, use 0.05% trypsin + 0.04% ethylenediaminetetraacetic acid to disperse and suspend the monolayer cells in the culture medium at a speed of 8-12 rpm and a temperature of 37±0.5°C Culture for 3-6 days to make the cells grow into a dense monolayer;

[0048] B. KMB that will grow into a dense monolayer 17 Discard the nutrient solution for the cells, and after digestion, collect the cells with MEM medium containing 5% serum, and add live attenuated hepatitis A vaccine virus seeds to the cells according to the ratio of the number of viruses to the number of cells at 1:40-60 Stir for 0.5 hours at a temperature of 37°C and a speed of 120 rpm to suspend and adsorb the virus, add maintenance solution containing 10% serum to the final volume of each spinner bottle to 180ml, keep the temperature at 35±0.5°C and continue to rotate After culturing for 14 days, replace with fresh nutrient solution, and co-cultivate for 26-2...

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Abstract

The invention discloses a lyophilized protectant and application thereof in a lyophilized live attenuated hepatitis A vaccine. The lyophilized protectant is prepared from the following components: 2-10g / 100ml of trehalose, 2.93-5.87mu g / 100ml of N-octyl-D-glucamine, 2.21-4.42mu g / 100ml of N-acetyl-D-glucosamine and water serving as a solvent. When the lyophilized protectant is applied, the lyophilized protectant is added into a live attenuated hepatitis A vaccine virus bulk in a volume ratio of 1:(0.7-1.2). According to the lyophilized protectant, the titer of the lyophilized protectant is invariant, the thermal stability is remarkably improved, and the lyophilized vaccine has excellent safety and immunogenicity. The lyophilized protectant has specific formula ingredients and simple formula; the preparation method is simple and feasible, is easy to implement, has strong step operability, and is beneficial to standard large-scale production of products.

Description

technical field [0001] The invention relates to a freeze-drying protective agent and its application in a freeze-dried live attenuated hepatitis A vaccine, belonging to the technical field of biological products. Background technique [0002] Hepatitis A vaccine is an effective means of preventing hepatitis A. At present, the live attenuated hepatitis A vaccine has been made into a freeze-dried dosage form by using freeze-drying technology, which can more effectively guarantee the thermal stability and immunogenicity of the vaccine. [0003] At present, the lyophilized live attenuated hepatitis A vaccine is made by adding a lyoprotectant, which plays a very important role in maintaining the activity of the antigen in the vaccine. However, the current freeze-drying protective agent still has problems such as high cost, slow dissolution rate of the freeze-drying protective agent, and long preparation time. [0004] Therefore, it is necessary to research and develop new freez...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/26A61K39/29A61K9/19A61P1/16A61P31/14
CPCA61K9/19A61K39/12A61K47/26A61K2039/5254C12N2770/32434Y02A50/30
Inventor 王海漩胡云章胡凝珠
Owner INST OF MEDICAL BIOLOGY CHINESE ACAD OF MEDICAL SCI
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