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New scheme of combining cell factor fusion protein (IL 2/FC) and compound Chinese medicine 861 for enhancing immune response of HB vaccine and breaking immune tolerance of HBV

A technology of cytokines and fusion proteins, applied in the direction of viruses, antiviral agents, fusion polypeptides, etc., can solve the problems that are difficult to remove, cannot achieve virus removal, and the removal rate is less than 30%.

Active Publication Date: 2007-06-27
江苏百英生物科技有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] 3. Chronic hepatitis B develops to the third stage, that is, the inactive virus carrier state. During this period, due to the low immunity of the body, the virus is low in replication, and it is difficult to clear it. After a few years, the virus may become active again and cause the condition to worsen. It is also difficult treat;
[0006] 4. The existing antiviral therapy has limited effect, and the clearance rate of interferon on hepatitis B is only 30%
At present, there is no effective and widely used method that can break "immune tolerance", activate the body's protective immune response against hepatitis B virus, and protect liver cells and functions at the same time, so it cannot achieve the purpose of clearing the virus and making the patient recover

Method used

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  • New scheme of combining cell factor fusion protein (IL 2/FC) and compound Chinese medicine 861 for enhancing immune response of HB vaccine and breaking immune tolerance of HBV
  • New scheme of combining cell factor fusion protein (IL 2/FC) and compound Chinese medicine 861 for enhancing immune response of HB vaccine and breaking immune tolerance of HBV
  • New scheme of combining cell factor fusion protein (IL 2/FC) and compound Chinese medicine 861 for enhancing immune response of HB vaccine and breaking immune tolerance of HBV

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Experimental program
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Effect test

Embodiment 1

[0047] Example 1. Interleukin 2 immunoglobulin Fc (also known as IL-2 / Fc fusion protein) expression Body construction and protein expression

[0048] In order to maintain the full biological activity of interleukin 2 and increase its circulating half-life in vivo. We used genetic engineering to fuse interleukin 2 (IL-2) with the Fc gene of immunoglobulin and express it in mammalian cells, thus creating a new type of IL-2 / Fc fusion protein (Figure 1 , structure of IL-2 / Fc fusion protein).

[0049] Build process:

[0050] Using synthetic primers, mouse IL-2 cDNA (GenBank accessionnumber, NM008366) was cloned from the ATCC 37553 plasmid template. N-terminal primer, plus restriction enzyme site NotI. C-terminal primer with restriction site BamHI appended. Mouse Fcr2a cDNA (GenBank accession number, BC108375) was reverse-transcribed from mRNA of MIgG2a-secreting hybridoma cells (ATCC HB129). The Fcr2a fragment was cloned from the Fcr2a cDNA template by adding a restriction...

Embodiment 2

[0057] Example 2.IL-2 / Fc significantly enhances the humoral immune response and enhances the hepatitis B vaccine CD8 against HBV + T cell cellular immunity

[0058] Since IL-2 / Fc has all the biological activities of IL-2 and has a circulating half-life of up to 20 hours, we use IL-2 / Fc as an immunopotentiator to enhance humoral and cellular immune responses susceptible to immune challenge. We first adopted the protocol of intraperitoneal injection of IL-2 / Fc fusion protein. Balb / c mice (commercially purchased from Beijing Weitong Lihua Animal Co., Ltd., certificate number 0060937) received intradermal hepatitis B vaccine immunization (recombinant yeast hepatitis B vaccine, a product of Beijing Tiantan Biotechnology Co., Ltd., batch number 20080304, each Rats were subcutaneously injected with 1 μg on each side of the groin, the total dose was 2 μg / rat), and from the next day, they received a daily intraperitoneal injection of IL-2 / Fc (commercially purchased from Chimerigen C...

Embodiment 3

[0062] Embodiment 3. Chinese medicine compound Danqi mixture (new prescription) (hereinafter referred to as compound recipe 861 (new prescription))

[0063] See references 1 and 2 for the old prescription of Chinese medicine 861. The present invention relates to an improved Fu Fang 861 (Xin Fang), for details, please refer to Reference 3.

[0064] 1. Containing ingredients: Danshen, Astragalus, Cordyceps mycelium, Bupleurum, Radix Paeoniae Rubra, Angelica, Safflower, Rhizoma Cyperi, Tangerine Peel, Millet Spatholobus, Chuanxiong and other eleven herbs.

[0065] 2. Production process: firstly, the crude drugs of each single herb are extracted, concentrated, dried, and granulated to make granules. Then each granule (prepared and provided by Tianjiang Pharmaceutical Factory in Jiangyin City, Jiangsu Province or Beijing Capital Dadi Pharmaceutical Co., Ltd., providing dosage form as granule) is uniformly mixed with the following doses in parts by weight to form Compound 861 (ne...

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Abstract

The present invention is a kind of medicine composition comprising cell factor fusion protein (IL-2 / Fc) and compound Chinese medicine 861, their medicine composition preparation and kit, and their application as immunity potentiator for strengthening HB vaccine immune response and breaking the immune tolerance of HBV.

Description

technical field [0001] The present invention relates to the field of hepatitis B treatment, more specifically, the present invention relates to a cytokine fusion protein IL-2 / Fc and a traditional Chinese medicine compound 861, their pharmaceutical combination, their pharmaceutical composition and kit, and their It is used as an immune enhancer (especially an immune enhancer that enhances the immune response of the hepatitis B vaccine and breaks the immune tolerance of the hepatitis B virus). Background technique [0002] Hepatitis B is a global infectious disease, especially in my country. According to the World Health Organization, about 2 billion people in the world have been infected with HBV, of which 350 million are chronic HBV infections, and 1 million people die every year. In HBV infection. The hepatitis B infection rate in our population is 57%, the HBsAg positive rate is 9.09%, and about 300,000 people die from HBV-related diseases every year. Therefore, hepatitis...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/29A61K38/20A61P31/20A61P1/16A61K36/8905
CPCA61K36/71A61K36/068A61K36/8905A61K2039/55533A61K36/232C07K2319/30A61K36/481C12N2730/10134A61K36/53A61K39/292A61K36/236A61K36/233A61K36/752A61K36/486A61K36/286A61K39/12A61P1/16A61P31/20
Inventor 郑心校王宝恩田燕李新民
Owner 江苏百英生物科技有限公司
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