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Haemophilus influenzae type b conjugate vaccine and application thereof

A Haemophilus influenzae and conjugate vaccine technology, applied in the field of Haemophilus influenzae type b conjugate vaccine, can solve problems such as low recovery rate of polysaccharide protein conjugates, and achieve the effects of improving recovery rate, increasing stability and avoiding potential changes

Inactive Publication Date: 2013-04-03
BEIJING MINHAI BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, using 0.2mol / L sodium chloride solution as the mobile phase, the recovery rate of polysaccharide-protein conjugates is low

Method used

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  • Haemophilus influenzae type b conjugate vaccine and application thereof
  • Haemophilus influenzae type b conjugate vaccine and application thereof
  • Haemophilus influenzae type b conjugate vaccine and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0053] The following examples are used to illustrate the present invention, but are not intended to limit the scope of the present invention. Preparation of Example 1b type Haemophilus influenzae conjugate vaccine stock solution

[0054] 1) Prepare the refined polysaccharide of Haemophilus influenzae type b by adopting the process steps of strain culture, fermentation and refined polysaccharide preparation stipulated in the "Haemophilus influenzae type b conjugate vaccine" regulations in the third part of the Pharmacopoeia of the People's Republic of China (2010 edition) . The production strain of Haemophilus influenzae type b (MH200201, independently isolated by Beijing Minhai Biotechnology Co., Ltd.) was used, the strain was rejuvenated, cultivated, and fermented, and the fermentation broth was sterilized by formaldehyde and the culture was harvested;

[0055] 2) The collected culture was centrifuged to remove the bacteria, cetyltrimethylammonium bromide (CTAB) was added to p...

Embodiment 2

[0060] Embodiment 2 Preparation of stock solution of Haemophilus influenzae type b conjugate vaccine

[0061] The method steps are the same as in Example 1, except that the concentration of the TRIS-HCl buffer used is 0.05 mol / L.

[0062] Table 2 The assay results of the same batch of conjugates with different purification media

[0063]

Embodiment 3b

[0064] The preparation of embodiment 3b type Haemophilus influenzae conjugate vaccine stock solution

[0065] The method steps are the same as in Example 1, except that 0.1 mol / L TRIS-HCl buffer solution is used for equilibration.

[0066] Table 3 The assay results of the same batch of conjugates with different purification media

[0067]

[0068] The results show that: the same conjugate uses TRIS-HCl buffer as the mobile phase, and the recovery rate is much higher than that of using 0.2mol / L sodium chloride solution as the mobile phase, and the recovery rate of the former is more than twice that of the latter.

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Abstract

The invention relates to a haemophilus influenzae type b conjugate vaccine and application thereof. The haemophilus influenzae type b conjugate vaccine comprises a haemophilus influenzae type b polysaccharide-tetanus toxoid conjugate, of which the pH value is 7.2 to 7.5. A TRIS-HCI buffer solution system is adopted during the process of purifying a haemophilus influenzae type b polysaccharide protein conjugate, so that the recovery rate of the purifying process of the polysaccharide protein conjugate is remarkably improved, the stability of the products in the subsequent process can be improved, and the pH value of the product is maintained within the neutral range so as to avoid potential change of the product quality due to change of the pH value.

Description

technical field [0001] The invention relates to a Haemophilus influenzae vaccine, in particular to type b Haemophilus influenzae conjugate vaccine and application thereof. Background technique [0002] Haemophilus influenzae is divided into a, b, c, d, e, f and non-type according to the nature of the capsule, among which type b Haemophilus influenzae is the most aggressive. Diseases such as purulent meningitis, pneumonia, arthritis, and epiglottitis caused by Haemophilus influenzae type b (Hib) have become an important public health problem worldwide. The successfully developed Hib polysaccharide vaccine and Hib conjugate vaccine can effectively prevent infection caused by Haemophilus influenzae type b. For children under 5 pairs, especially infants and young children under 2 years old, the protective effect of Hib polysaccharide vaccine is not good. [0003] For strains whose main antigen is capsular polysaccharide, conjugate vaccine is currently an excellent method to im...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/102A61K39/385A61P31/04
Inventor 孙晓东刘建凯
Owner BEIJING MINHAI BIOTECH
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