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Combined vaccine for adsorbing Diphtheria, tetanus and acellular pertussis-Sabin inactivated poliovirus and preparation thereof

A cell-free DTP and poliomyelitis technology, applied in the field of medical biology, can solve the problems of increasing the chance of cross-infection, unfavorable planned immunization, and affecting the vaccination rate, so as to reduce the number of vaccinations, prevent various target diseases, and improve the The effect of vaccination rate

Inactive Publication Date: 2011-09-14
INST OF MEDICAL BIOLOGY CHINESE ACAD OF MEDICAL SCI
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  • Summary
  • Abstract
  • Description
  • Claims
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AI Technical Summary

Problems solved by technology

[0005] In the planned immunization of children implemented in our country, acellular diphtheria tetanus vaccine and inactivated polio vaccine are administered separately. More vaccinations and complicated immunization procedures not only bring many troubles to parents, but also It brings pain to children and increases various costs, and it will affect the vaccination rate and increase the chance of cross-infection, which is not conducive to the promotion of planned immunization

Method used

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  • Combined vaccine for adsorbing Diphtheria, tetanus and acellular pertussis-Sabin inactivated poliovirus and preparation thereof
  • Combined vaccine for adsorbing Diphtheria, tetanus and acellular pertussis-Sabin inactivated poliovirus and preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] 1) Phase I pertussis CS strain (bacteria number 58003-3), Clostridium tetani (bacteria number 64008) and diphtheria PW8 strain (bacteria number 38007) purchased from the serum laboratory of China National Institutes for Food and Drug Control ), and poliovirus type I SabinSO+2, type II SabinSO+2, and type III PfizerSOR+1 purchased from the World Health Organization (WHO), respectively, according to the requirements of the Pharmacopoeia of the People's Republic of China in 2010, prepared into acellular pertussis stock solution AP, Tetanus toxoid TT, diphtheria toxoid DT, Ⅰ, Ⅱ, Ⅲ Sabin strain poliovirus inactivation solution sIPV Ⅰ, sIPV Ⅱ, sIPV Ⅲ, spare;

[0043] 2) Take the material according to the following formula:

[0044] Acellular pertussis liquid AP 400ugPN

[0045] Tetanus Toxoid TT 700Lf

[0046] Diphtheria Toxoid DT 2500Lf

[0047] Al(OH) 3 154mg

[0048] sIPVI type 6000DU

[0049] sIPV Ⅱ type 7100DU

[0050] sIPV Ⅲ type 9...

Embodiment 2

[0057] 1) same as step 1 of embodiment 1);

[0058] 2) Take the material according to the following formula:

[0059] Acellular pertussis liquid AP 1800ugPN

[0060] Tetanus Toxoid TT 300Lf

[0061] Diphtheria Toxoid DT 1000Lf

[0062] Al(OH) 3 126mg

[0063] sIPV type Ⅰ 6000DU

[0064] sIPV Ⅱ type 5700DU

[0065] sIPV Ⅲ type 9000DU

[0066] NaCl 765mg

[0067] h 2 O 8.6g;

[0068] 3) Aluminum hydroxide adsorption

[0069] According to the ratio of step 2), take 126mgAl(OH) 3 (final concentration of 1.26mg / ml), 935mgNaCl (final concentration of 9.35mg / ml) and 8.6g of water for injection were mixed and then autoclaved; at room temperature and under continuous stirring, 1000Lf of DT (final concentration of 10Lf / ml), 300Lf of TT (final concentration of 3Lf / ml), 1800ugPN of AP (final concentration of 18ugPN / ml), 6000DU of sIPV I (final concentration of 60DU / ml), 5700DU of sIPV II (antigen concentration of 57 DU / ml), 9000 DU of sIPV II...

Embodiment 3

[0071] 1) same as step 1 of embodiment 1);

[0072] 2) Take the material according to the following formula:

[0073] Acellular pertussis liquid AP 1100ugPN

[0074] Tetanus Toxoid TT 500Lf

[0075] Diphtheria Toxoid DT 1800Lf

[0076] Al(OH) 3 140mg

[0077] sIPVI type 4500DU

[0078] sIPVⅡ 6400DU

[0079] sIPVⅢ type 6600DU

[0080] NaCl 850mg

[0081] 2-Phenoxyethanol 300mg

[0082] h 2 O 27.2g;

[0083] 3) Aluminum hydroxide adsorption

[0084] According to the ratio of step 2), take 140mgAl(OH) 3(final concentration of 1.40mg / ml), 850mgNaCl (final concentration of 8.50mg / ml) and 27.2g of water for injection were mixed and then autoclaved; at room temperature and under continuous stirring, 1800Lf of DT (final concentration of 18Lf / ml), 500Lf of TT (final concentration of 5Lf / ml), 1100ugPN of AP (final concentration of 11ugPN / ml), 4500DU of sIPV I (final concentration of 45DU / ml), 6400DU of sIPV II (final concentration of 64DU / m...

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Abstract

The invention provides combined vaccine for adsorbing Diphtheria, tetanus and acellular pertussis-Sabin (DTaP-sIPV) inactivated poliovirus and preparation thereof. The DTaP-sIPV is characterized in that each 100ml of the combined vaccine comprises the following components: 400-1800ug (PN) of acellular pertussis (AP) stock solution, 300-700Lf of tetanus toxoid (TT), 1000-2500Lf of diphtheria toxoid (DT), 126-154mg of Al(OH)<3>, 3000-6000DU of sIPV I, 5700-7100DU of sIPV II, 4500-9000DU of sIPV III, 765-935mg of NaCl, 0-600mg of 2-phenoxyethanol and the balance of H<2>O. Compared with the existing products, the DTaP-sIPV has the advantages of higher biological safety, better side reaction and the like; and the DTaP-sIPV has the beneficial effects of preventing a plurality of target diseases, reducing inoculating needles, simplifying immunization programs, improving inoculation rate, reducing opportunity of cross infection, being popular with a majority of parents and children, saving various expenses and facilitating smooth promotion of immunization plan.

Description

[0001] technical field [0002] The invention relates to an adsorbed acellular pertussis, diphtheria, tetanus and Sabin strain poliomyelitis combined vaccine and a preparation process thereof, belonging to the field of medical biotechnology. Background technique [0003] Whooping cough is a respiratory infectious disease in children caused by Bacillus pertussis, which is highly contagious. The clinical feature is that the cough gradually worsens and shows 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 planned immunization , the incidence rate of children under 5 years old reaches 20-60%. Diphtheria is an acute respiratory infectious disease caused by diphtheria bacillus. The prominent clinical features are hyperemia and swelling of the mucous membranes in the pharynx and larynx, and the formation of gray...

Claims

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Application Information

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Patent Type & Authority Applications(China)
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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