Hib comprehensive culture medium, Haemophilus influenzae type b conjugate vaccine and preparation method thereof

A Haemophilus influenzae-conjugated vaccine technology, applied in the field of vaccine production and preparation technology, can solve the problems of unstable Haemophilus influenzae type b conjugated vaccine, prone to allergic reactions, high endotoxin content, etc., to achieve stable strain generation, The effect of easy operation and simplified process steps

Active Publication Date: 2016-06-29
ZHONGYI ANKE BIOTECH CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In order to solve the problem that the existing medium for cultivating Haemophilus influenzae type b has many components, high cost, blood-derived components and macromolecular allergenic components, and the production process of the existing Haemophilus influenzae type b conjugate vaccine The key steps have the problems of complicated process and high cost, and the obtained Haemophilus influenzae type b conjugate vaccine is unstable, contains blood-derived components and is prone to allergic reactions, and has high content of nucleic acid, protein and endotoxin. The present invention Provided is a comprehensive HIB culture medium free of blood-derived components and macromolecular allergenic components, a Haemophilus influenzae type B conjugate vaccine and a preparation method thereof

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] Embodiment 1 prepares HIB comprehensive culture medium

[0052] The components and their final concentrations in the medium are: yeast extract powder 10g / l, glucose 10g / l, MgCl 2 ·6H 2 O2.03g / l, β-coenzyme A0.02g / l, hemin 0.01g / l, Na 2 HPO 4 12H 2 O28.65g / l, NaH 2 PO 4 2H 2 O3.12g / l; weigh the above substances according to the above proportions, fully dissolve them in an appropriate amount of sterilized water for injection, then constant volume, and adjust the pH value in the range of 7.2 to 7.4 to obtain the HIB comprehensive culture medium. The medium does not contain blood-derived components and macromolecular allergenic components.

Embodiment 2

[0053] Embodiment 2 prepares HIB comprehensive culture medium

[0054] The components and their final concentrations in the medium are: yeast extract powder 5g / l, glucose 15g / l, MgCl 2 ·6H 2 O3g / l, β-coenzyme A0.01g / l, hemin 0.02g / l, Na 2 HPO 4 12H 2 O22g / l, NaH 2 PO 4 2H 2 05g / l; Take the above substances according to the above ratio, fully dissolve in an appropriate amount of sterilized water for injection, then constant volume, adjust the pH value in the range of 7.2 to 7.4 to obtain the HIB comprehensive culture medium. The medium does not contain blood-derived components and macromolecular allergenic components.

Embodiment 3

[0055] Embodiment 3 prepares HIB comprehensive culture medium

[0056] The components and their final concentrations in the medium are: yeast extract powder 15g / l, glucose 5g / l, MgCl 2 ·6H 2 O1g / l, β-coenzyme A0.03g / l, hemin 0.005g / l, Na 2 HPO 4 12H 2 O32g / l, NaH 2 PO 4 2H 2 O2g / l; Take the above substances according to the above ratio, fully dissolve in an appropriate amount of sterile water for injection, then constant volume, adjust the pH value in the range of 7.2 to 7.4, to obtain the HIB comprehensive culture medium. The medium does not contain blood-derived components and macromolecular allergenic components.

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PUM

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Abstract

The invention provides a HIB (Haemophilus influenzae type B) synthetic medium, a HIB conjugate vaccine and a preparation method of the HIB conjugate vaccine, relates to the field of a vaccine production preparation technology and solves the problems that the HIB conjugate vaccine contains haematogenous components, is likely to have an anaphylactic reaction, is unstable and high in cost and has high content of nucleic acid, egg white and endotoxin. The HIB synthetic medium comprises following components in terms of final concentration: 5-15 g / l of yeast extract powder, 5-15 g / l of glucose, 1-3 g / l of MgCl2*6H2O, 0.01-0.03 g / l of beta-coenzyme, 0.005-0.02 g / l of hemin, 22-32 g / l of Na2HPO4*12H2O and 2-5 g / l of NaH2PO4*2H2O. The medium does not contain the haematogenous components and macromolecular allergen components, so that strain passage is more stable, safer and more reliable, and the prepared HIB conjugate vaccine has low endotoxin content and good stability and is safe and effective.

Description

technical field [0001] The invention relates to the technical field of vaccine production and preparation technology, in particular to an HIB comprehensive culture medium, Haemophilus influenzae type B conjugate vaccine and a preparation method thereof. Background technique [0002] Haemophilus influenzae (Haemophilus Influenzae, HI) is a Gram-negative short bacillus, which is an important pathogenic bacteria that causes primary infection of respiratory system and secondary infection of viral diseases in children. There are usually two types of capsular and non-capsular. According to the specificity of its capsular polysaccharide antigen, it can be divided into six serotypes a-f and a group of non-typeable Haemophilus influenzae. Among them, Haemophilus influenzae type b is the most pathogenic, followed by f, which can cause invasive infection of multiple organs and tissues. According to the epidemiological data of developed countries, meningitis caused by Haemophilus infl...

Claims

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Application Information

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Patent Type & AuthorityPatents(China)
IPC IPC(8): C12N1/20A61K39/102A61P31/04C12R1/21
Inventor李新旺毛倩孙惠君许一鞠长军段琼王云非李雪娇孙婷婷于莉莉
OwnerZHONGYI ANKE BIOTECH CO LTD