Separated and purified acellular pertussis-diphtheria-tetanus, b-type haemophilus influenzae and A-group and C-group meningococcus combined vaccine and preparation method thereof

A technology for Haemophilus influenzae and meningococcus, which can be applied to medical preparations containing active ingredients, bacteria, antibacterial drugs, etc., can solve the problems of decreased vaccination rate, high side effects, and rebound of pertussis incidence.

Inactive Publication Date: 2015-06-10
CHENGDU OLYMVAX BIOPHARM
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the 1970s, due to serious adverse reactions after inoculation with whole-cell diphtheria pertussis vaccine (DTwP), countries such as Japan and the Netherlands appeared to resist vaccination and stop using it, resulting in a decline in the vaccination rate, resulting in the incidence of pertussis There is a rebound
Although there is a similar product DTP-Hib-AC combination vaccine under development in China, it still uses the traditional formaldehyde sterilization process to prepare whole-cell pertussis vaccine stock solution, which has high side effects

Method used

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  • Separated and purified acellular pertussis-diphtheria-tetanus, b-type haemophilus influenzae and A-group and C-group meningococcus combined vaccine and preparation method thereof
  • Separated and purified acellular pertussis-diphtheria-tetanus, b-type haemophilus influenzae and A-group and C-group meningococcus combined vaccine and preparation method thereof
  • Separated and purified acellular pertussis-diphtheria-tetanus, b-type haemophilus influenzae and A-group and C-group meningococcus combined vaccine and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] Embodiment 1: a kind of combination vaccine, it is made up of A component and B component:

[0045] The A component is a liquid preparation, which consists of the following components:

[0046] Pertussis toxin: 5μg; filamentous hemagglutinin: 5μg; pertussis adhesin: 2μg; diphtheria toxoid: 10LF; tetanus toxoid: 4LF; aluminum hydroxide: 1.0mg / ml; sodium chloride: 7.5g / L;

[0047] The B component is a freeze-dried preparation, which consists of the following components:

[0048]Group A meningitis polysaccharide conjugate: 10 μg; Group C meningitis polysaccharide conjugate: 10 μg; Haemophilus influenzae type B polysaccharide conjugate: 10 μg; Lactose: 5 mg.

[0049] Component A is divided into bottle A, and component B is divided into bottle B. Each bottle of A bottle and B bottle is 0.5ml. Mix A bottle and B bottle before use for intramuscular injection.

Embodiment 2

[0050] Embodiment 2: a kind of combination vaccine, it is made up of A component and B component:

[0051] The A component is a liquid preparation, which consists of the following components:

[0052] Pertussis toxoid: 40μg; filamentous hemagglutinin: 40μg; pertussis adhesin: 10μg; diphtheria toxoid: 25LF; tetanus toxoid: 10LF; aluminum hydroxide: 2.0mg / ml; sodium chloride: 9.5g / L;

[0053] The B component is a freeze-dried preparation, which consists of the following components:

[0054] Group A meningitis polysaccharide conjugate: 30 μg; Group C meningitis polysaccharide conjugate: 30 μg; Haemophilus influenzae type B polysaccharide conjugate: 30 μg; Lactose: 20 mg.

[0055] Component A is divided into bottle A, and component B is divided into bottle B. Each bottle of A bottle and B bottle is 0.5ml. Mix A bottle and B bottle before use for intramuscular injection.

Embodiment 3

[0056] Embodiment 3: a kind of combination vaccine, it is made up of A component and B component:

[0057] The A component is a liquid preparation, which consists of the following components:

[0058] Pertussis toxin: 15μg; filamentous hemagglutinin: 20μg; pertussis adhesin: 4μg; diphtheria toxoid: 16LF; tetanus toxoid: 5LF; aluminum hydroxide: 1.4mg / ml; sodium chloride: 8.0g / L;

[0059] The B component is a freeze-dried preparation, which consists of the following components:

[0060] Group A meningitis polysaccharide conjugate: 16 μg; Group C meningitis polysaccharide conjugate: 18 μg; Haemophilus influenzae type B polysaccharide conjugate: 20 μg; Lactose: 10 mg.

[0061] Component A is divided into bottle A, and component B is divided into bottle B. Each bottle of A bottle and B bottle is 0.5ml. Mix A bottle and B bottle before use for intramuscular injection.

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Abstract

The invention discloses a combined vaccine and a preparation method thereof. The combined vaccine is formed by a component A and a component B, wherein the component A is a liquid preparation and composed of pertussis toxin, filamentous hemagglutinin, pertussis adhesion, diphtheria toxoid, tetanus toxoid, aluminium hydroxide and sodium chloride; the component B is a freeze-drying preparation and composed of A-group meningitis polysaccharide conjugate, C-group meningitis polysaccharide conjugate, b-type haemophilus influenzae polysaccharide conjugate and lactose. The preparation method of the vaccine includes the steps of preparing of acellular pertussis-diphtheria-tetanus vaccine semi-finished products, A-group and C-group meningococcocci and b-type haemophilus influenzae combined vaccine semi-finished products, split charging and packaging. The vaccine has the characteristics of being safe, effective, controllable and capable of preventing diseases through an injection, the preparation method is easy to operate, preparation is facilitated, cost is low, and the combined vaccine is suitable for industrialized mass production.

Description

technical field [0001] The invention belongs to the technical field of vaccine production and preparation, and in particular relates to a separated and purified acellular diphtheria pertussis-type b Haemophilus influenzae-group A group C meningococcal combined vaccine and a preparation method thereof. Background technique [0002] Pertussis, diphtheria, tetanus and other diseases are widespread in our country and cause serious harm. Timely vaccination is an effective preventive and protective measure. Pertussis, diphtheria and tetanus combined vaccine (DTP), as the first vaccine included in the WHO Expanded Immunization Program (EPI), has played an important role in the prevention and control of these three infectious diseases. In the 1970s, due to serious adverse reactions after inoculation with whole-cell diphtheria pertussis vaccine (DTwP), countries such as Japan and the Netherlands appeared to resist vaccination and stop using it, resulting in a decline in the vaccinati...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/10A61K39/102A61K39/08A61K39/05A61K39/095A61P31/04C12N1/20
CPCA61K39/05A61K39/08A61K39/095A61K39/102C12N1/20
Inventor 陈道远李洪光吴强马礼耕陈元芬罗力心李靖
Owner CHENGDU OLYMVAX BIOPHARM
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