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Hepatitis B vaccine preparation

A technology for hepatitis B and hepatitis B virus, applied to medical preparations containing active ingredients, antiviral agents, digestive system, etc., can solve problems such as difficult high-level humoral immunity

Inactive Publication Date: 2003-03-12
BEIJING LUZHU BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The currently used hepatitis B vaccines are all vaccines containing aluminum hydroxide adjuvant, which can induce humoral immunity well, but it is difficult to induce high-level humoral immunity

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] One of the preparation methods of embodiment 1 hepatitis B vaccine

[0031] Detoxified monophospholipid A was purchased from Avanti Polar Lipids, Inc, USA, hepatitis B virus surface antigen (vaccine) was purchased from Beijing Institute of Biological Products, and human anti-HBs immunoglobulin (HBIG) was purchased from Shanghai Institute of Biological Products. Aluminum hydroxide and aluminum phosphate adjuvants are self-made products of our company.

[0032] Dissolve detoxified MPL with water for injection to a final concentration of 1.0 mg / ml, and ultrasonically assist in dissolution (control temperature 2-20°C).

[0033] Adjust genetically engineered hepatitis B surface antigen (HBsAg) with phosphate buffer to a final concentration of 100 μg / ml. 1 μg of HBsAg was reacted with different amounts of HBIG, and then the amount of remaining HBsAg and HBIG in the reaction system was measured with an EIA kit. The results showed that the amount of antibody that allowed more ...

Embodiment 2

[0035] Embodiment two hepatitis B vaccine preparation method two

[0036] Detoxified monophospholipid A was purchased from Avanti Polar Lipids, Inc, USA, hepatitis B virus surface antigen (vaccine) was purchased from Beijing Institute of Biological Products, and HBIG was purchased from Shanghai Institute of Biological Products. Aluminum hydroxide and aluminum phosphate adjuvants are self-made products of our company.

[0037] Dissolve detoxified MPL with water for injection to a final concentration of 1.0 mg / ml, and ultrasonically assist in dissolution.

[0038] Adjust genetically engineered hepatitis B surface antigen (HBsAg) with phosphate buffer to a final concentration of 100 μg / ml. Add 4.0ml HBIG (see Example 1) to 10ml HBsAg solution, react at room temperature for 24 hours (or react at 2-8°C for 22 hours after reacting at 37°C for 2 hours), shake once every hour; add 10ml aluminum Adjuvant (1mg / ml according to Al 3+ Calculation), placed at room temperature for 24 hour...

Embodiment 3

[0039] The third of the preparation method of embodiment three hepatitis B vaccine

[0040] Detoxified monophospholipid A was purchased from Avanti Polar Lipids, Inc, USA, hepatitis B virus surface antigen (vaccine) was purchased from Beijing Institute of Biological Products, and HBIG was purchased from Shanghai Institute of Biological Products. Aluminum hydroxide and aluminum phosphate adjuvants are self-made products of our company.

[0041] Dissolve detoxified MPL with water for injection to a final concentration of 1.0 mg / ml, and ultrasonically assist in dissolution.

[0042] The genetically engineered hepatitis B surface antigen (HBsAg) was adjusted with phosphate buffer to a final concentration of 200 μg / ml. Take 10 ml of HBsAg solution, then add 8.5 ml of HBIG (6% excess, see Example 1), and react at room temperature for 24 hours, during which time shake once every hour. Add 3.7ml of 18% PEG 6000 solution, discard the supernatant after centrifugation, wash the precipi...

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Abstract

A novel hepatitis B vaccine contains the genetically engineered surface antigen of hepatitis B virus, human surface antigen antibody of heptitis B, Al adjuvant and A(MPL). Its advantage is high immunogenicity.

Description

Technical field: [0001] The present invention relates to a new vaccine preparation, especially the hepatitis B vaccine preparation. The formula adopted in the preparation can induce strong immune response in the body. It can be used for the immunization of adults, those who fail to immunize with other types of hepatitis B vaccines, kidney dialysis patients, organ transplant patients, and immunotherapy of chronic hepatitis B patients. 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%. ...

Claims

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Application Information

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IPC IPC(8): A61K39/29A61P1/16A61P31/12
Inventor 孔健蒋先敏
Owner BEIJING LUZHU BIOTECH
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