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Hepatitis B treating vaccine prepn and its prepn process and use

A hepatitis B and hepatitis B vaccine technology, applied in medical preparations containing active ingredients, antiviral agents, pharmaceutical formulations, etc., can solve the problem of not achieving promotion or recovery of immune regulation, inconsistent treatment dose, treatment course, and lack of hepatitis B vaccine. Standardization and other issues to achieve the effect of maintaining concentration, increasing single batch yield, and reducing toxic and side effects

Inactive Publication Date: 2004-11-24
SHENZHEN KANGTAI BIOLOGICAL PROD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the clinical application of hepatitis B vaccine has not been standardized for many years, and the treatment dose and course of treatment are not uniform. Generally speaking, the dose is too small and the course of treatment is too short, which has not achieved the effect of promoting or restoring immune regulation.

Method used

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  • Hepatitis B treating vaccine prepn and its prepn process and use

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0069] This embodiment relates to hepatitis B vaccine (HBsAg) acute toxicity experimental research

[0070] 1 Materials and methods

[0071] 1.1 Instruments and medicines, diluents

[0072] Therapeutic hepatitis B vaccine 1ml each, containing HBsAg 60μg, aluminum 0.5mg, batch number: T010702, aluminum diluent containing aluminum 0.5mg / ml, Hitachi 7020 automatic biochemical analyzer, AC920 EO Hematology analyzer (Sweden), ELISA detector and reagents (HELIX, USA).

[0073] 1.2 Experimental animals

[0074] Clean-grade SD rats and SPF-grade NIH mice were provided by the Experimental Animal Center of Guangzhou University of Traditional Chinese Medicine. Rats weigh 200-240 grams, mice: 20-23 grams for females, 23-27 grams for males. Healthy cynomolgus monkeys were provided by Guangdong Shunde Institute of Experimental Animals, aged 2-3 years.

[0075] 1.3 Acute toxicity test method in mice

[0076] NIH mice were randomly divided into three groups according to sex and body wei...

Embodiment 2

[0120] This example relates to the effect of hepatitis B vaccine (HBsAg) on ​​mouse cellular immune response

[0121] 1.1. Materials:

[0122] Recombinant (yeast) hepatitis B vaccine [Recombinant Hepatitis B Vaccine (yeast), hereinafter referred to as RHBV], each 1ml, mainly containing recombinant (yeast) HBsAg subunit 60μg, all solvents use aluminum diluent 0.5mg / ml (Shenzhen Kangtai Biological Products Co., Ltd. product). As the experimental animals, 6-8 week-old SPF Balb / c mice were used, half male and half female, weighing 16-18 g (purchased from the Department of Experimental Animals, Tongji Hospital, Huazhong University of Science and Technology). The main reagents and instruments are RPMI-1640 medium (Sigma Company), calf serum (Sijiqing Biological Company), tritium-thymidine ( 3 H-TdR, Beijing Institute of Atomic Energy), IL-2, IFN-γ detection kit (Shenzhen Jingmei Bioengineering Company), hepatitis B surface antibody detection kit (Shanghai Industry Kehua Biotechnol...

Embodiment 3

[0179] This embodiment relates to the impact of hepatitis B vaccine (HBsAg) on ​​HBV markers in HBV gene mice

[0180] 1. Materials and Methods

[0181] 1.1 HBsAg vaccine: Provided by Shenzhen Kangtai Biological Products Co., Ltd., batch number: T010702, 1ml each, containing 60 μg of recombinant (yeast) HBsAg subunit, solvents are aluminum diluent (0.5mg / ml), batch number: A010621.

[0182] 1.2 Experimental animals: HBV transgenic mice: SPF grade, certificate of conformity: No. 2002A001, half male and half male, weighing 16-18 grams. The center builds itself, raises and breeds.

[0183] 1.3 Main detection reagents HBsAg EIA detection kit: Shanghai Industrial Kehua Biotechnology Co., Ltd., HBsAg solid-phase rapid method quantitative kit: Institute of Isotopes, China Institute of Atomic Energy, HBsAg immunohistochemical reagents: Dako company, American company HBV DNA fluorescence Quantitative PCR kit: American AmgGen company

[0184] 1.4 Grouping and administration of mice: ...

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Abstract

The hepatitis B treating vaccine preparation includes recombinant hepatitis B vaccine 40-80 microgram / ml and aluminum 0.5 mg / ml. The preparation process, use and composition of the hepatitis B treating vaccine are also disclosed. The preparation can induce cell immune response for body to eliminate HBV, increase the cell immunity of Balb / c mouse, promote the high level expression of Th1 cell factor, raise T proliferation level and raise specific CTL activity.

Description

technical field [0001] The invention relates to a therapeutic hepatitis B vaccine preparation, preparation method and application thereof, specifically refers to a hepatitis B surface antigen preparation fermented by yeast using gene recombination technology, and belongs to the field of biological products. Background technique [0002] Chronic hepatitis B (CHB) is a common and frequently-occurring disease in my country, and the exploration of its treatment methods mainly starts from the following aspects: anti-virus, regulation of immune function, liver protection (promoting liver cell regeneration), anti-hepatic fibrosis , to prevent cancer, etc., but antiviral treatment is the key to overcome this disease, which has formed a consensus. Currently recognized anti-HBV drugs at home and abroad are interferon-α (IFN-α) and lamivudine. The antiviral mechanism of IFN-α includes immune regulation and direct antiviral effect, while lamivudine inhibits the activity of reverse trans...

Claims

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Application Information

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IPC IPC(8): A61K39/29A61P1/16A61P31/12
Inventor 范力汪恩浩曾滢朱征宇甘建辉
Owner SHENZHEN KANGTAI BIOLOGICAL PROD
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