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Combined vaccine for preventing meningitis in children and preparation method of combined vaccine

A combination vaccine and meningitis technology, applied in the direction of medical preparations containing active ingredients, pharmaceutical formulas, carrier-bound antigen/hapten components, etc., can solve the problem of no simultaneous

Inactive Publication Date: 2015-03-04
BEIJING ZHIFEI LVZHU BIOPHARM
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] There are already marketed vaccines against the above pathogenic bacteria in the world, such as "23-valent pneumococcal polysaccharide vaccine", "13-valent pneumococcal conjugate vaccine" and "10-valent pneumococcal conjugate vaccine" against Streptococcus pneumoniae, etc., against Haemophilus influenzae "Haemophilus influenzae type b conjugate vaccine" against meningococcus "ACYW 135 Meningococcal Polysaccharide Vaccine", "ACYW 135 Group meningococcal conjugate vaccine", "AC group meningococcal polysaccharide vaccine", "AC group meningococcal conjugate vaccine", "A group meningococcal polysaccharide vaccine", etc. There are also combined vaccines against two pathogenic bacteria, such as "AC Meningococcal group (conjugate) Haemophilus influenzae type b (conjugate) combined vaccine", "CY group meningococcal Haemophilus influenzae type b conjugate vaccine", etc., but have not yet targeted Streptococcus pneumoniae and Haemophilus influenzae at the same time Combination vaccine of the three pathogenic bacteria of Neisseria meningitidis

Method used

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  • Combined vaccine for preventing meningitis in children and preparation method of combined vaccine
  • Combined vaccine for preventing meningitis in children and preparation method of combined vaccine
  • Combined vaccine for preventing meningitis in children and preparation method of combined vaccine

Examples

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Embodiment 1

[0060] The preparation of embodiment one capsular polysaccharide

[0061] After bacterial fermentation, collect the supernatant by centrifugation, concentrate by 100Kd ultrafiltration, collect the retentate, add ethanol to 25%, collect the supernatant by centrifugation, add ethanol to 75%, collect the precipitate by centrifugation, and reconstitute with water for injection, hydroxyapatite Chromatography, collect the flow-through, concentrate by 100KD ultrafiltration, clarify by centrifugation, and freeze-dry to prepare capsular polysaccharide.

Embodiment 2

[0062] Embodiment diamine reduction method prepares conjugate (direct connection)

[0063] Polysaccharide dissolved to 5-10mg / ml, add sodium periodate to 2.5-10mmol / L, avoid light oxidation, glycerol terminates the reaction, after 30KD ultrafiltration and concentration, add protein at a ratio of 1:0.5-2, and add borocyanide at the same time Sodium to 2mg / ml, react at room temperature for 3 to 7 days, then purify by molecular sieve chromatography, collect V 0 Nearby elution peaks yield conjugates.

Embodiment 3

[0064] Embodiment triamine reduction method prepares conjugate (bridging agent connects)

[0065] Polysaccharide dissolved to 5-10mg / ml, add sodium periodate to 2.5-10mmol / L, avoid light oxidation, glycerol terminates the reaction, after 30KD ultrafiltration and concentration, add adipic dihydrazide (ADH) and sodium borocyanide to The final concentration was 40 mg / ml and 2 mg / ml, and reacted at room temperature for 3 days to prepare derivatives.

[0066] Derivatized polysaccharides and carrier proteins are mixed at a mass ratio of 1:0.5~2, carbodiimide (EDAC) is added to a final concentration of 0.02mol / L, and the pH value is maintained at 5.6 for more than 150 minutes. The prepared conjugate is purified by molecular sieve chromatography. collect V 0 Nearby elution peaks were obtained to obtain the stock solution of the conjugate.

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Abstract

The invention relates to a combined vaccine for preventing meningitis in children and a preparation method of the combined vaccine. The vaccine contains polysaccharide protein conjugates of diplococcus meningitidis, streptococcus pneumoniae and haemophilus influenza, is applied to immunization of children over 6 weeks, and is used for preventing meningitis in children caused by diplococcus meningitidis, streptococcus pneumoniae and haemophilus influenza and simultaneously for preventing other infectious diseases caused by these pathogenic bacteria.

Description

Technical field: [0001] The invention relates to a combined vaccine and a preparation method thereof, which are mainly used for preventing children's meningitis and other infectious diseases caused by related pathogenic bacteria. The combined vaccine of the present invention is particularly related to the prevention of meningitis in children caused by Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae, as well as other infectious diseases caused by these pathogenic bacteria. Background technique: [0002] Acute bacterial meningitis is one of the leading causes of death in children, with 170,000 deaths worldwide each year (Meenakshi R., et al. Sequelae due to bacterial meningitis among African children: a systematic literature review. BMC Medicine 2009, 7:47 ), among the survivors, there is also a high proportion of neurological sequelae, which seriously endanger human health. The main pathogenic bacteria that cause bacterial meningitis include Strep...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/385A61K39/116A61K39/095A61K39/09A61K39/102A61P31/04
Inventor 杜琳朱卫华
Owner BEIJING ZHIFEI LVZHU BIOPHARM
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