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Preparation method of adsorbed diphtheria, tetanus and acellular pertussis and hemophilus influenza type B tetravalent combined vaccine

A cell-free DTP and combined vaccine technology, which is applied in the field of adsorption of acellular DTP and the preparation of a quadrivalent combination vaccine for haemophilic influenza B, can solve the problems of reduced immune response of PRP polysaccharide, etc., and improve reliability. and safety effects

Inactive Publication Date: 2018-05-01
CHENGDU KANGHUA BIOLOGICAL PROD
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  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The purpose of the present invention is to overcome the shortcoming of prior art, provide a kind of preparation method that absorbs acellular diphtheria pertussis and type B hemophilic influenza quadrivalent combined vaccine, to solve the problem of DTaP-Hib quadruple vaccine caused by aluminum hydroxide adjuvant Technical Problems with PRP Polysaccharides for Vaccines to Reduce Immune Response

Method used

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Embodiment 1

[0028] A preparation method for adsorbing acellular diphtheria pertussis and hemophilic influenza type B quadrivalent combined vaccine, comprising the following steps,

[0029] S1, establishment of strain bank

[0030] Establishment of pertussis strain bank: inoculate pertussis strains on Bao-Jinger medium, culture at 35-37°C for no more than 72 hours, and each subsequent generation for no more than 48 hours, pass to the fourth generation, and culture for 24 hours, Scrape off the bacterial lawn, mix it in skimmed milk, subpackage, freeze-dry, vacuum seal, and store at -20°C, as the main generation seed batch strain;

[0031] The establishment of the Corynebacterium diphtheriae strain bank: Inoculate the Corynebacterium diphtheriae strains on Lin's medium, culture them at 34°C for 24-48 hours, and then subculture them on Lin's medium for 4 generations. After centrifugation, the bacteria Place the body in skim milk and mix well, freeze-dry after aliquoting, vacuum seal, and sto...

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Abstract

The invention discloses a preparation method of an adsorbed diphtheria, tetanus and acellular pertussis and hemophilus influenza type B tetravalent combined vaccine. The preparation method comprises the steps of S1, establishment of strain libraries, including establishment of a pertussis strain library, establishment of a corynebacterium diphtheriae strain library, establishment of a tetanus bacillus strain library and establishment of a hemophilus influenza type B strain library; S2, preparation of a pertussis stock solution, including ammonium sulfate salting-out, density gradient centrifugation and glutaraldehyde detoxification; S3, preparation of diphtheria toxins; S4, preparation of tetanus toxins; S5, preparation of hemophilus influenza type B toxins; and S6, preparation of the tetravalent combined vaccine. The pertussis stock solution, the diphtheria toxins, the tetanus toxins and the hemophilus influenza type B toxins are mixed to prepare the tetravalent combined vaccine whichcan effectively prevent and treat pertussis, diphtheria, tetanus and influenza type B; and oil-in-water emulsion MF59 and PLG particles are adopted instead of an aluminum hydroxide adjuvant, so thatthe phenomenon of immune reaction reduction of PRP polysaccharides of DTaP-Hib can be effectively avoided, and the reliability and safety of the DTaP-Hib tetravalent combined vaccine can be improved.

Description

technical field [0001] The invention specifically relates to a preparation method for adsorbing acellular diphtheria pertussis and hemophilic influenza type B quadrivalent combined vaccine. Background technique [0002] Pertussis, diphtheria and tetanus mixed vaccine is called DPT vaccine for short. It is prepared from pertussis vaccine, refined diphtheria and tetanus toxoid in appropriate proportions, and is used to prevent the three diseases of pertussis, diphtheria and tetanus. Currently used are adsorbed pertussis vaccine, diphtheria and tetanus toxoid mixed vaccine (adsorbed DPT) and adsorbed acellular pertussis vaccine, diphtheria and tetanus toxoid mixed vaccine (adsorbed acellular DPT). The acellular diphtheria combined vaccine is made of acellular pertussis vaccine stock solution, diphtheria toxoid stock solution and tetanus toxoid stock solution plus aluminum hydroxide adjuvant. It is a milky white suspension, the adjuvant sinks after standing, and it becomes a un...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/116A61K39/102A61K39/10A61K39/08A61K39/05A61K39/39A61P31/04
CPCA61K39/05A61K39/08A61K39/102A61K39/39A61K2039/55566A61K2039/70
Inventor 冯晓侯文礼
Owner CHENGDU KANGHUA BIOLOGICAL PROD
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