Adsorbed acellular DTP-Sabin strain polio vaccine and preparation method thereof

A cell-free DPT and poliomyelitis technology, applied in the field of biomedicine, can solve the problems of frequent vaccinations and complicated vaccination procedures, and achieve the effects of reducing the number of vaccinations, simplifying the immunization procedures, and saving costs

Inactive Publication Date: 2014-07-09
INST OF MEDICAL BIOLOGY CHINESE ACAD OF MEDICAL SCI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In order to solve the problems of many vaccination times and complicated vaccination procedures in the existing vaccines, the present invention provides a convenient, safe and effective adsorption of acellular DPT-Sabin strain poliomyelitis combined vaccine (DTaP-sIPV) and its preparation method, To completely eradicate polio and prevent diphtheria to ensure the healthy growth of children

Method used

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  • Adsorbed acellular DTP-Sabin strain polio vaccine and preparation method thereof
  • Adsorbed acellular DTP-Sabin strain polio vaccine and preparation method thereof
  • Adsorbed acellular DTP-Sabin strain polio vaccine and preparation method thereof

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Experimental program
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Effect test

Embodiment 1

[0045] (1) According to the requirements of the 2010 edition of the Pharmacopoeia of the People's Republic of China, acellular pertussis antigens (PT, FHA, PRN), tetanus toxoid (TT) and diphtheria toxoid (DT), and Ⅰ, Ⅱ, and Ⅲ Sabin were prepared respectively. Strain poliovirus inactivation solution sIPV type Ⅰ, sIPV type Ⅱ, sIPV type Ⅲ ； Wherein the pertussis used for the preparation of pertussis toxin PT, filamentous hemagglutinin FHA and pertussis adhesin PRN Ⅰ The bacterial number of the corresponding CS bacterial strain is 58003-3; the bacterial number of Clostridium tetani used for the preparation of tetanus toxoid TT is 64008; the bacterial number of the diphtheria bacillus PW8 strain used for the preparation of diphtheria toxoid DT is 38007. From the serum laboratory of China National Institutes for Food and Drug Control; the polioviruses used to prepare type I, II and III poliovirus inactivation solutions of Sabin strains were respectively Ⅰ type is SabinSO+2, Ⅱ type...

Embodiment 2

[0061] (1) According to the requirements of the 2010 edition of the Pharmacopoeia of the People's Republic of China, acellular pertussis antigens (PT, FHA, PRN), tetanus toxoid (TT) and diphtheria toxoid (DT), and Ⅰ, Ⅱ, and Ⅲ Sabin were prepared respectively. Strain poliovirus inactivation solution sIPV type Ⅰ, sIPV type Ⅱ, sIPV type Ⅲ ； Wherein the pertussis used for the preparation of pertussis toxin PT, filamentous hemagglutinin FHA and pertussis adhesin PRN Ⅰ The bacterial number of the corresponding CS bacterial strain is 58003-3; the bacterial number of Clostridium tetani used for the preparation of tetanus toxoid TT is 64008; the bacterial number of the diphtheria bacillus PW8 strain used for the preparation of diphtheria toxoid DT is 38007. From the serum laboratory of China National Institutes for Food and Drug Control; the polioviruses used to prepare type I, II and III poliovirus inactivation solutions of Sabin strains were respectively Ⅰ type is SabinSO+2, Ⅱ type...

Embodiment 3

[0076] (1) According to the requirements of the 2010 edition of the Pharmacopoeia of the People's Republic of China, acellular pertussis antigens (PT, FHA, PRN), tetanus toxoid (TT) and diphtheria toxoid (DT), and Ⅰ, Ⅱ, and Ⅲ Sabin were prepared respectively. Strain poliovirus inactivation solution sIPV type Ⅰ, sIPV type Ⅱ, sIPV type Ⅲ ； Wherein the pertussis used for the preparation of pertussis toxin PT, filamentous hemagglutinin FHA and pertussis adhesin PRN ⅠThe bacterial number of the corresponding CS bacterial strain is 58003-3; the bacterial number of Clostridium tetani used for the preparation of tetanus toxoid TT is 64008; the bacterial number of the diphtheria bacillus PW8 strain used for the preparation of diphtheria toxoid DT is 38007. From the serum laboratory of China National Institutes for Food and Drug Control; the polioviruses used to prepare type I, II and III poliovirus inactivation solutions of Sabin strains were respectively Ⅰ type is SabinSO+2, Ⅱ type ...

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Abstract

The invention provides adsorbed acellular DTP-Sabin strain polio vaccine and a preparation method thereof. Every 100 ml of polio vaccine contains the following components: 3000-6000ugPN of whooping cough toxin, 3000-6000ugPN of filamentous hemagglutinin,1000-2000ugPN of pertactin, 1000-3000Lf of tetanus toxoid, 3000-6000Lf of diphtheria toxoid, 126-154mg of Al(OH)3, 3000-6000DU of sIPVI type, 5700-7100DU of sIPVII type, 4500-9000DU of sIPVIII type, 765-935mg of NaCl, 0-600mg of -2 phenoxyethanol and the balance of H2O. The vaccine can be used for preventing various target diseases, reducing the vaccination frequency, simplifying the immune procedure, improving the inoculation rate and reducing the risk of cross infection.

Description

technical field [0001] The invention relates to an adsorbed acellular pertussis, diphtheria, tetanus and Sabin strain poliomyelitis combined vaccine and a preparation method thereof, belonging to the technical field of biomedicine. Background technique [0002] Whooping cough is a respiratory infectious disease in children caused by Bordetella pertussis, which is highly contagious. The clinical feature is that the cough gradually worsens, showing paroxysmal spasmodic cough. For untreated patients, the course of the disease can last for 2 to 3 months. Pertussis is one of the main diseases that affect children's health and cause death. Before the implementation of immunization programs, the incidence rate of children under 5 years old reached 20-60%. The vaccines that were first applied were based on whole bacterial cells treated with formaldehyde to kill the bacteria and inactivate the toxic substances. Since the implementation of planned immunization in the late 1970s, the...

Claims

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Application Information

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IPC IPC(8): A61K39/295A61P31/04A61P31/14
CPCY02A50/30
Inventor 孙明波姜述德杨净思廖国阳姜莉衡燮马艳高娜奚光跃姬光宋霞陈洪波梁疆莉周健
Owner INST OF MEDICAL BIOLOGY CHINESE ACAD OF MEDICAL SCI
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