Poliovirus vaccine for oral administration

A polio and virus vaccine technology, applied in the biological field, can solve the problems that affect the effectiveness and safety of vaccines, are not as good as liquid preparations for young children, vaccine storage conditions and validity period restrictions, etc. Effects of immune response stimulation capacity, effectiveness and active protection

Active Publication Date: 2013-09-25
SINOVAC BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

First, they are potentially biologically hazardous, such as proteins or protein hydrolysates of animal or human origin with uncertain chemical composition
In addition, these existing compositions in this technical field fail to make the attenuated live vaccine have sufficient stability and acid resistance, so that the storage conditions and validity period of the vaccine are greatly limited, and even further affect the effectiveness and safety of the vaccine.
[0006] The live attenuated polio vaccine currently in use in our country is the familiar "sugar pill". It is made of a live virus with reduced pathogenicity, and the preparation is in solid form. It is not easy to use when children take it. It is not as easy as liquid preparations for children to take, and the stability of the sugar pill is not good enough when it is transported between areas with large temperature differences.

Method used

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  • Poliovirus vaccine for oral administration
  • Poliovirus vaccine for oral administration
  • Poliovirus vaccine for oral administration

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] The preparation of embodiment 1 poliovirus antigen

[0039] Poliovirus (hereinafter referred to as poliovirus) strains sabin type I, sabin type II, and sabin type III provided by ATCC of the United States to Beijing Kexing Zhongwei Biotechnology Co., Ltd. were adapted to grow in Vero cells and serially passaged , put it in an incubator at 37.5±1.0°C for 3-5 days to harvest the virus liquid, clarify and filter it with CCID 50 The virus titer value was detected by the method. The above three types of poliovirus harvested in 10 7 -10 8 CCID 50 / ml range.

[0040] The stock solutions of various types of monovalent polioviruses were prepared for the antigenic components of vaccine preparations.

Embodiment 2

[0041] Preparation of Example 2 Poliovirus Vaccine

[0042] (1) Prepare 3M phosphate buffer solution (in which the molar concentration ratio of potassium dihydrogen phosphate and dipotassium hydrogen phosphate is 1:2) and 4M sodium succinate solution stock solution, filter and sterilize, and store at 4°C for later use;

[0043] (2) Mix 10ml of phosphate buffer prepared in step (1) with 15ml of sodium succinate solution;

[0044] (3) Add 150ml of 60% sucrose solution to (2);

[0045] (4) Add 100ml of the antigen solution in Example 1 to (3), the antigen solution is a mixture of sabin type I, type II and type III;

[0046] (5) Use virus-free MEM culture medium to supplement the volume to 300ml; the pH of the vaccine is 7;

[0047] (6) Filter and dispense, 3ml per dose, 100 doses in total.

[0048] Each dose of the vaccine prepared in this embodiment contains the following ingredients: each of the above three serotype polioviruses contains 10 7 -10 8 CCID 50 , 30% sucrose, ...

Embodiment 3

[0049] Example 3 Antacid Effect of Poliovirus Vaccine Containing Different Concentrations of Sucrose

[0050] (1) Preparation of vaccine preparations

[0051] Prepare 4 groups of vaccines containing different sucrose concentrations: Prepare 4 groups of 10ml 3M phosphate buffer solution (the molar concentration ratio of potassium dihydrogen phosphate and dipotassium hydrogen phosphate is 1:2) and 15ml 4M sodium succinate solution, and add to the 4 groups Sucrose solutions containing 30g, 90g, 150g, and 180g of sucrose were added to the mixed solution to prepare 4 kinds of protective agents containing different concentrations of sucrose (phosphate solution + sodium succinate solution + sucrose solution), and added to the 4 groups of protective agents The 100ml antigenic component in Example 1 (same as Example 2, mixed with 3 serotypes) was filled up to 300ml with virus-free MEM culture solution, filtered and sterilized, and divided into 3ml per dose to prepare 100 doses of vacc...

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Abstract

The invention provides a poliovirus vaccine for oral administration. The poliovirus vaccine contains poliovirus antigen, carbohydrate, phosphate and carboxylate. The oral poliovirus vaccine provided by the invention can be adopted to raise stability of the vaccine antigen component, has good stability at temperatures of 37 DEG C, 2-8 DEG C and 25 DEG C, has stable antigen activity, can be used to enhance gastric acid resistance after oral administration of the vaccine finished product, and has good immune response stimulation capability and good safety. The poliovirus vaccine for oral administration contains no other humanized or animal-based protein and has better safety. Meanwhile, the poliovirus vaccine requires low cost, and is suitable for industrial production of the product.

Description

technical field [0001] The invention relates to the field of biotechnology, in particular to a poliovirus vaccine formulation suitable for oral administration. Background technique [0002] Poliomyelitis is a highly contagious disease caused by poliovirus infection in humans. The polio virus can infect the nervous system of the human body, and can cause paralysis of the patient's limbs within a few hours, resulting in permanent disability. Poliomyelitis can occur in people of all ages, but it is more common in infants and young children under 5 years old, so the disease is also called "poliomyelitis". Polioviruses belong to the Enterovirus genus of the Picornaviridae family. The virus is observed under an electron microscope as a small spherical shape with a diameter of 24-30nm, in the form of round particles. Poliovirus contains single-stranded positive-strand RNA, which is wrapped by three coat proteins, namely VP1-3, and the other VP4 protein is the inner coat protein....

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/13A61K47/36A61K47/26A61K47/04A61K47/12A61P31/14
CPCY02A50/30
Inventor 王一丁戈小琴王楠张晓军张博韩星高强董珊珊尹卫东
Owner SINOVAC BIOTECH
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