Application of Coryebacterium parvum or its composition in preparing medicaments for treating hepatitis B

A technology for Corynebacterium brevis and hepatitis B, which is applied in the preparation of medicaments for the treatment of hepatitis B, and the application field of the preparation of medicaments for the treatment of hepatitis B, can solve the problem of increasing the proportion of virus resistance variation, High mutation rate, aggravation of disease and other problems, to achieve the effect of improved absorption and diffusivity, uniform particle size, and good therapeutic effect

Inactive Publication Date: 2011-11-09
NAT INST FOR THE CONTROL OF PHARMA & BIOLOGICAL PROD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Although lamivudine takes effect quickly, the mutation rate after 1 and 2 years is very high (the level of autoimmunity determines whether there is a mutation)
With the prolongation of medication time, the proportion of virus drug-resistant mutations in patients increased (14%, 38%, 49% and 66% in the first, second, third and f

Method used

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  • Application of Coryebacterium parvum or its composition in preparing medicaments for treating hepatitis B
  • Application of Coryebacterium parvum or its composition in preparing medicaments for treating hepatitis B
  • Application of Coryebacterium parvum or its composition in preparing medicaments for treating hepatitis B

Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0063] Experimental Example 1 Protective effect of NCPP on Beijing shelduck duck hepatitis B infection:

[0064] 1. Materials and methods

[0065] 1. Materials

[0066] 1.1 Animals: 150 1-day-old Peking ducks, male or female, purchased from Beijing Qianjin Duck Factory.

[0067] 1.2 Duck hepatitis B virus positive serum: collected from Shanghai shelduck, donated by Institute of Pharmaceutical Biotechnology, Chinese Academy of Medical Sciences, stored at -20°C.

[0068] 1.3 Plasmid: pUC18-DHBV-DNA (containing the whole genome DNA of DHBV), donated by the Institute of Pharmaceutical Biotechnology, Chinese Academy of Medical Sciences, stored at -20°C.

[0069] 1.4 Test product:

[0070] Test product 1: acellular brevus preparation (NCPP), properties: white homogeneous opaque liquid, provided by China National Institute for the Control of Pharmaceutical and Biological Products.

[0071] Test product 2: Hepatitis B immunoglobulin, provided by China Institute for the Control of ...

Embodiment 2

[0128] The protective effect of embodiment 2CPP on Beijing shelduck duck hepatitis B infection

[0129] 1. Materials and methods

[0130] 1. Materials

[0131] 1.1 Animals: 150 1-day-old Peking ducks, male or female, purchased from Beijing Qianjin Duck Factory.

[0132] 1.2 Duck hepatitis B virus positive serum: collected from Shanghai shelduck, donated by Institute of Pharmaceutical Biotechnology, Chinese Academy of Medical Sciences, stored at -20°C.

[0133] 1.3 Plasmid: pUC18-DHBV-DNA (containing the whole genome DNA of DHBV), donated by the Institute of Pharmaceutical Biotechnology, Chinese Academy of Medical Sciences, stored at -20°C.

[0134] 1.4 Test product:

[0135] Test product 1: Corynebacterium brevis preparation (CPP), properties: white homogeneous opaque liquid, provided by China National Institute for the Control of Pharmaceutical and Biological Products.

[0136] Test product 2: Hepatitis B immunoglobulin, provided by China Institute for the Control of Phar...

Embodiment 3

[0160] Embodiment 3 clinical trials

[0161] 1. Treatment objects and methods

[0162] 1.1 Inclusion criteria: age 12-65 years old, body weight ≥ 33kg, positive serum HBsAg and hepatitis B virus (HBV) DNA > 6 months before screening, positive HBsAg and HBV-DNA during screening (dot blot method) , Serum alanine aminotransferase (alanine aminotransferase, ALT) within 3 months before screening is below 10 times the upper limit of normal (ULN).

[0163] 1.2 Exclusion criteria: anti-HCV, anti-HDV and anti-HIV positive; decompensated chronic liver disease; suspected hepatocellular carcinoma, autoimmune liver disease, genetic liver disease; bone marrow suppression; abnormal renal function; severe organic disease disease, mental illness; alcoholism, drug abuse; used antiviral drugs (including lamivudine), immunomodulators or inhibitors, cytotoxic drugs or steroid hormones 6 months before screening; Those who have not taken effective contraceptive measures and those with a history of...

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Abstract

The invention relates to an application of a Coryebacterium parvum preparation (CPP) or an non-cell Coryebacterium parvum preparation (NCPP) in the pharmaceutical field, and especially relates to the application in preparing medicaments for treating virus hepatitis B infection, and the application of the CPP/NCPP combined with a hepatitis B immunoglobulin (HBIG) or an anti-hepatitis B immunoglobulin (humanized/human anti-HBs) in preparing the medicaments for treating virus hepatitis B infection. The CPP is a preparation which is prepared through inactivating the CP with formaldehyde, and the CPP has the characteristics of nanometer level, uniform particle size, high absorption degree and diffusion degree, low heat source and no formaldehyde residual; and the CPP has a certain effect for resisting virus hepatitis B infection, and the NCPP has an obvious effect, and the CPP/NCPP combined with the HBIG/HBs has a more obvious effect.

Description

technical field [0001] The present invention relates to the application of a short coryneform bacterium preparation (CPP) or a cell-free breve coryneform bacterium preparation (NCPP) in the field of pharmacy, in particular to the application in the preparation of medicaments for the treatment of hepatitis B, or in combination with anti-hepatitis B The application of the hepatitis immunoglobulin in the preparation of a medicament for treating hepatitis B belongs to the field of medicine. Background technique [0002] Viral hepatitis B is a worldwide disease caused by the hepatitis B virus (HBV). The incidence rate is high in developing countries. According to statistics, there are more than 280 million asymptomatic hepatitis B virus carriers (HBsAg carriers) in the world, and my country accounts for about 130 million. Most of them are asymptomatic, and 1 / 3 of them have clinical manifestations of liver damage. At present, there are 30 million hepatitis B patients in our coun...

Claims

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Application Information

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IPC IPC(8): A61K35/74A61K39/395A61P37/02A61P31/20A61P1/16
Inventor 高尚先李守悌
Owner NAT INST FOR THE CONTROL OF PHARMA & BIOLOGICAL PROD
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