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Diphtheria, tetanus and acellular pertussis/Haemophilus influenzae type b - group A and C meningococcus combined vaccine

A cell-free DPT and Haemophilus influenzae technology, applied in antibacterial drugs, bacterial antigen components, antibody medical components, etc., can solve the problems of complex vaccine components, interference of detection methods, interference of free polysaccharide detection, etc.

Active Publication Date: 2012-12-12
WUHAN INST OF BIOLOGICAL PROD CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the complex composition of the vaccine, in addition to the active ingredients, other components, such as freeze-dried excipients, will cause certain interference to the detection method
For example, lactose will interfere with the detection of free polysaccharides of various polysaccharides

Method used

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  • Diphtheria, tetanus and acellular pertussis/Haemophilus influenzae type b - group A and C meningococcus combined vaccine
  • Diphtheria, tetanus and acellular pertussis/Haemophilus influenzae type b - group A and C meningococcus combined vaccine
  • Diphtheria, tetanus and acellular pertussis/Haemophilus influenzae type b - group A and C meningococcus combined vaccine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0057] 1. Preparation of Adsorbed Acellular DPT Vaccine:

[0058] (1) Prepare each monovalent vaccine stock solution:

[0059] (1) Pertussis vaccine stock solution is manufactured according to the 2010 edition of "Chinese Pharmacopoeia" "Adsorbed DPT combined vaccine" in Appendix 1 "Pertussis vaccine stock solution manufacturing and verification requirements" working seed batch through serological test, skin necrosis test, toxicity test and Freeze-dried after titer determination. After opening the batch of working seed strains, inoculate them on the culture medium, such as the improved bag-ginger medium or activated carbon semi-comprehensive medium, and cultivate them at 35~37°C for no more than 72 hours. After the pure bacteria inspection, collect the bacteria and suspend them. In PBS of pH7.0~7.4. Use formaldehyde solution with a final concentration of less than 0.1% to sterilize, and after the sterilization test, the pertussis vaccine stock solution is obtained.

[0060]...

Embodiment 2

[0104] 1. Preparation of Adsorbed Acellular DPT Vaccine:

[0105] (1) Prepare each monovalent vaccine stock solution:

[0106] (1) Pertussis vaccine stock solution is manufactured according to the 2010 edition of "Chinese Pharmacopoeia" "Adsorbed DPT combined vaccine" in Appendix 1 "Pertussis vaccine stock solution manufacturing and verification requirements" working seed batch through serological test, skin necrosis test, toxicity test and Freeze-dried after titer determination. After opening the batch of working seed strains, inoculate them on the culture medium, such as the improved bag-ginger medium or activated carbon semi-comprehensive medium, and cultivate them at 35~37°C for no more than 72 hours. After the pure bacteria inspection, collect the bacteria and suspend them. In PBS of pH7.0~7.4. Use formaldehyde solution with a final concentration of less than 0.1% to sterilize, and after the sterilization test, the pertussis vaccine stock solution is obtained.

[0107]...

Embodiment 3

[0152] 1. Preparation of Adsorbed Acellular DPT Vaccine:

[0153] (1) Prepare each monovalent vaccine stock solution:

[0154] (1) Pertussis vaccine stock solution is manufactured according to the 2010 edition of "Chinese Pharmacopoeia" "Adsorbed DPT combined vaccine" in Appendix 1 "Pertussis vaccine stock solution manufacturing and verification requirements" working seed batch through serological test, skin necrosis test, toxicity test and Freeze-dried after titer determination. After opening the batch of working seed strains, inoculate them on the culture medium, such as the improved bag-ginger medium or activated carbon semi-comprehensive medium, and cultivate them at 35~37°C for no more than 72 hours. After the pure bacteria inspection, collect the bacteria and suspend them. In PBS of pH7.0~7.4. Use formaldehyde solution with a final concentration of less than 0.1% to sterilize, and after the sterilization test, the pertussis vaccine stock solution is obtained.

[0155]...

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Abstract

The invention provides a diphtheria, tetanus and acellular pertussis / Haemophilus influenzae type b - group A and C meningococcus combined vaccine, which has the characteristics of high safety, high efficacy, high controllability and prevention of multiple diseases through one injection, satisfies relevant requirements on absorbed diphtheria, tetanus and acellular pertussis combined vaccines, Haemophilus influenzae type b combined vaccines and group A and C meningococcus combined vaccines in the Third Part of Chinese Pharmacopoeia (2010) and proposed Rules on Production and Inspection of Diphtheria, Tetanus and acellular Pertussis / Haemophilus influenzae Type b - Group A and C Meningococcus Combined Vaccines, and achieves an effect of putting into practical application.

Description

Technical field: [0001] The invention provides an adsorbed acellular diphtheria pertussis / type b haemophilus influenzae-group A and C meningococcal combined vaccine. It is a six-vaccination vaccine composed of adsorbed acellular diphtheria combined vaccine, Haemophilus influenzae type b-A, group C meningococcal conjugate vaccine, which is used to prevent pertussis, diphtheria, tetanus and infections caused by groups A and C. The invention relates to vaccines for cerebrospinal meningitis caused by meningococcus, otitis media and meningitis caused by Haemophilus influenzae type b, and belongs to the technical field of vaccine production and preparation. Background technique: [0002] Infectious diseases are still an important cause of infant mortality. There are more than 30 diseases that can be prevented by immunization in the world. According to statistics, children need to receive about 21 vaccinations before entering school. According to the current immunization program, ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/116A61K39/10A61K39/08A61K39/05A61K39/102A61K39/095A61P31/04
Inventor 杨晓明魏树源段凯薛红刚李新国项美娟卢佳丽
Owner WUHAN INST OF BIOLOGICAL PROD CO LTD
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