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B-type hepatitis vaccine

A hepatitis B, hepatitis B virus technology, applied in the digestive system, antibody medical ingredients, antiviral agents, etc., can solve the problem of not combining hepatitis B vaccine, and achieve the effect of improving humoral immunity/cellular immunity

Inactive Publication Date: 2003-03-26
BEIJING LUZHU BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] There is no report on the combination of HbsAg and muramyl dipeptide to make hepatitis B vaccine

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] The preparation method of embodiment 1 hepatitis B vaccine injection

[0033] Raw material and source:

[0034] Muramyl dipeptide (MDP): 2 mg / ml was prepared with pure water, sterilized by filtration with a 0.22 μm sterile filter membrane, and frozen at -20°C.

[0035] CHO cells express hepatitis B virus surface antigen (vaccine), 112 μg / ml, which is a product of North China Pharmaceutical Co., Ltd.

[0036] Aluminum phosphate adjuvant: 1.0 mg / ml (calculated as aluminum ions).

[0037] The preparation method of the vaccine: take 9.0ml of the surface antigen of hepatitis B virus expressed by CHO cells in a sterile glass bottle, add 10ml of aluminum phosphate adjuvant, mix well, add 1.0ml of MDP solution, and place it in 2 -8°C. Prepare 20ml of vaccine solution, the prepared vaccine solution contains 50μg of hepatitis B surface antigen, 0.5mg of aluminum adjuvant (calculated according to aluminum ion), and 100μg of MDP per milliliter of the prepared vaccine solution. ...

Embodiment 2

[0037] The preparation method of the vaccine: take 9.0ml of the surface antigen of hepatitis B virus expressed by CHO cells in a sterile glass bottle, add 10ml of aluminum phosphate adjuvant, mix well, add 1.0ml of MDP solution, and place it in 2 -8°C. Prepare 20ml of vaccine solution, the prepared vaccine solution contains 50μg of hepatitis B surface antigen, 0.5mg of aluminum adjuvant (calculated according to aluminum ion), and 100μg of MDP per milliliter of the prepared vaccine solution. Vaccine shot. The preparation method of embodiment 2 hepatitis B vaccine injection

[0038] Raw material and source:

[0039] Muramyl dipeptide (MDP): 2 mg / ml was prepared with pure water, sterilized by filtration with a 0.22 μm sterile filter membrane, and frozen at -20°C.

[0040] CHO cells express hepatitis B virus surface antigen (vaccine), 112 μg / ml, which is a product of North China Pharmaceutical Co., Ltd.

[0041] Aluminum hydroxide adjuvant: 1.0 mg / ml (calculated as aluminum io...

Embodiment 3

[0043] Embodiment 3 has carried out comparative research to vaccine of the present invention and other vaccines, and experiment is as follows:

[0044] The raw materials and sources for preparing the vaccine are as follows:

[0045] Muramyl dipeptide (MDP): 2 mg / ml was prepared with pure water, sterilized by filtration with a 0.22 μm sterile filter membrane, and frozen at -20°C.

[0046] Monophospholipid A (MPL): purchased from SIGMA, USA. Prepare 2 mg / ml with pure water, filter and sterilize with a 0.22 μm sterile filter membrane after ultrasonic treatment, and freeze at -20°C.

[0047] CHO cells express hepatitis B virus surface antigen (CHOHB), 100 μg / ml, and are products of North China Pharmaceutical Co., Ltd.

[0048] Hepatitis B surface antigen (YHB) expressed by yeast, 200 μg / ml, product of Beijing Tiantan Biological Products Co., Ltd.

[0049] Aluminum hydroxide adjuvant: 1.0 mg / ml (calculated as aluminum ions).

[0050] Aluminum phosphate adjuvant: 1.0 mg / ml (calc...

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PUM

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Abstract

The present invention relates to a hepatitis B vaccine, the main composition of said vaccine comprises gene engineering hepatitis B virus surface antigen, muramyl dipeptide (MDP) and aluminium adjuvant. Said hepatitis B vaccine can be used for immunity of adult, renal transplanted patient and patient with renal dialysis therapy and for preventing infection of hepatitis B virus, and said hepatitis B vaccine also can be used for immunotherapy of chronic hepatitis B patient, and the immunogenicity of said vaccine is superior to that of existent aluminium adjuvant hepatitis B vaccine.

Description

Technical field: [0001] The invention relates to a hepatitis B vaccine, in particular to a hepatitis B vaccine containing muramyl dipeptide. Background technique: [0002] Hepatitis B virus (HBV) is a hepadnavirus with a double-shell structure. The shell contains hepatitis B surface antigen (HBsAg), pre-S1 protein (PreS1) and pre-S2 protein (PreS2), and the surface of the core is B Hepatitis core antigen (HBcAg) and e antigen (HBeAg), the inner core contains double-stranded circular DNA and DNA polymerase (DNA-P). [0003] Since China launched hepatitis B vaccination in 1985, the carrier rate of hepatitis B virus among immunized children has been reduced from about 10% to about 1%. In Beijing, Shanghai and other places, due to the high vaccination rate of hepatitis B vaccine among newborns, the carrier rate of hepatitis B virus among preschool children has been reduced to less than 0.5%. Practice has proved that, like other vaccine-preventable diseases, hepatitis B vaccina...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/29A61P1/16A61P31/12
Inventor 孔健蒋先敏
Owner BEIJING LUZHU BIOTECH
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