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Meningococcus capsular polysaccharide polyvalent multivalent conjugate vaccine, preparation method and application thereof

A meningococcal and capsular polysaccharide technology, which is applied in the direction of carrier-binding antigen/hapten components, pharmaceutical formulations, nitro compound active ingredients, etc. and protein content to reduce costs, improve yield and purity

Inactive Publication Date: 2011-06-01
BEIJING MINHAI BIOTECH +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The disadvantage of this process is that it is difficult to control the nucleic acid content and protein content in the extract, and it is difficult to obtain a meningococcal polysaccharide extract that meets the specifications. Therefore, it is of practical significance to improve this process to obtain a product with higher purity.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Example 1 Extraction of crude polysaccharides from meningococcal group A, C, Y, and W135

[0024] Open the freeze-dried strains of groups A, C, Y, and W135 stored at low temperature, and resuscitate them with ordinary meat water, inoculate them on 10% sheep blood ordinary agar medium, and place them in 8% CO 2 Environment, cultured at 37°C for 24h. Transfer to modified semi-comprehensive solid medium, set 8% CO 2 Environment, cultivated at 37°C for 12h. Continue to inoculate into 300ml of improved semi-comprehensive liquid medium, and cultivate for 4 hours at 37°C in a shaker with a rotation speed of 200rpm. The culture was transferred to a fermenter that had been added with a semi-comprehensive liquid medium, and cultured at 37°C for 6-9 hours under the conditions of pressure 0.03Mpa, ventilation 10L / min, stirring speed 100rpm, and pH 7.0. In the late logarithmic phase of growth, add formaldehyde with a final concentration of 1% to sterilize. The fermenter culture ...

Embodiment 2

[0025] Example 2 Extraction of crude polysaccharides from meningococcal group A, C, Y, and W135

[0026] The supernatant is obtained in Example 1, and the method and steps for extracting the capsular polysaccharides of meningococcus group A, C, Y, and W135 are the same as in Example 1, except that the addition of the main flocculant is 400ppm, without adding Auxiliary flocculant, the flocculation extraction temperature is 18°C, adjust the pH to 6.5, the electric field strength in the stirring container is 20v / cm, and the action time is 30min. First stir rapidly at 1000rpm for 5min, and then stir at 30rpm for 10min. The recoveries of capsular polysaccharides were 78.3% (Group A), 75.9% (Group C), 71.8% (Group Y), and 60.2% (Group W135).

Embodiment 3

[0027] Example 3 Extraction of crude polysaccharides from meningococcal group A, C, Y, and W135

[0028] The supernatant is obtained in Example 1, and the method and steps for extracting the capsular polysaccharides of meningococcus group A, C, Y, and W135 are the same as in Example 1, except that the main flocculant is dodecylbenzenesulfonic acid Sodium, the addition amount is 50ppm, the addition amount of co-flocculation agent is 50ppm, the flocculation extraction temperature is 32°C, adjust the pH to 6.0, the electric field strength in the stirring container is 30v / cm, the action time is 20min, first stir rapidly at 1000rpm for 5min, Stir again at 30 rpm for 10 min. The recoveries of capsular polysaccharides were 59.9% (Group A), 52.1% (Group C), 50.3% (Group Y), and 43.6% (Group W135).

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PUM

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Abstract

The invention discloses a meningococcus capsular polysaccharide polyvalent multivalent conjugate vaccine, a preparation method and application thereof. The polyvalent multivalent conjugate vaccine comprises at least two conjugates of group A, group C, group Y or Group W135 meningococcus capsular polysaccharide and cholera toxin B-subunit. The invention improves the method for extracting the meningococcus capsular polysaccharide, and improves the yield and purity of the capsular polysaccharide by adopting a flocculation extraction method under an electric field.

Description

technical field [0001] The invention relates to a meningococcal capsular polysaccharide multivalent conjugated vaccine, its preparation method and application. Background technique [0002] Meningococcus is one of the most common causes of bacterial meningitis in the world and is the only bacterium capable of causing large-scale epidemics of meningitis. The rapid progression of meningococcal disease often kills the patient within 1 or 2 days of onset or causes severe sequelae, even in the best medically treated cases. Chemoprophylaxis can prevent secondary cases among close contacts, but because secondary cases account for only 1% to 2% of all meningococcal disease, chemoprevention is of little value in controlling most endemic and epidemic diseases. Therefore, immunization with a safe and effective vaccine is the only reasonable way to control meningococcal disease. [0003] Among the 13 serogroups of meningococcus, group A, group B, group C, group W135 and group Y can ca...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/095A61K47/48A61K31/04A61K39/385
Inventor 张明华魏文进郝倩张美香曹欣胡鹏韩菲王婷婷何家琦任涛唐秀丽
Owner BEIJING MINHAI BIOTECH
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