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HIB (Haemophilus influenzae type B) synthetic medium, HIB conjugate vaccine and preparation method of HIB conjugate vaccine

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

Active Publication Date: 2015-12-30
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] Example 1 Preparation of HIB comprehensive medium

[0052] The components in the medium and their final concentration are: yeast extract powder 10g / l, glucose 10g / l, MgCl 2 ·6H 2 O2.03g / l, β-Coenzyme A 0.02g / 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 ratio, fully dissolve them in an appropriate amount of sterile water for injection, and then make the volume constant, adjust the pH value within the range of 7.2 to 7.4, and obtain the HIB comprehensive medium. The medium does not contain blood-derived components and macromolecular allergic components.

Embodiment 2

[0053] Example 2 Preparation of HIB comprehensive medium

[0054] The components in the medium and their final concentration are: yeast extract powder 5g / l, glucose 15g / l, MgCl 2 ·6H 2 O3g / l, β-Coenzyme A 0.01g / l, hemin 0.02g / l, Na 2 HPO 4 ·12H 2 O22g / l, NaH 2 PO 4 ·2H 2 O5g / l; Weigh the above substances according to the above ratio, fully dissolve them in an appropriate amount of sterile water for injection, and then make the volume constant, adjust the pH value within the range of 7.2 to 7.4, and obtain the HIB comprehensive medium. The medium does not contain blood-derived components and macromolecular allergic components.

Embodiment 3

[0055] Example 3 Preparation of HIB comprehensive medium

[0056] The components in the medium and their final concentration are: yeast extract powder 15g / l, glucose 5g / l, MgCl 2 ·6H 2 O1g / l, β-Coenzyme A 0.03g / l, Hemin 0.005g / l, Na 2 HPO 4 ·12H 2 O32g / l, NaH 2 PO 4 ·2H 2 O2g / l; Weigh the above substances according to the above ratio, fully dissolve them in an appropriate amount of sterile water for injection, and then make the volume constant, adjust the pH value within the range of 7.2 to 7.4, and obtain the HIB comprehensive medium. The medium does not contain blood-derived components and macromolecular allergic 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 a HIB comprehensive medium, a type B Haemophilus influenzae conjugate vaccine and a preparation method thereof. Background technique [0002] Haemophilus influenza (Haemophilus Influenzae, HI) is a gram-negative, short bacterium, an important pathogenic bacterium that causes primary infections of the respiratory system in children and secondary infections in viral diseases. Usually there are two major categories of capsule type and non-capsular type. 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 epidemiological data in developed countries, meningitis caused by Haemophilus i...

Claims

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Application Information

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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
Owner ZHONGYI ANKE BIOTECH CO LTD
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