Hydrophobia, tetanus double-titer human immunoglobulin and preparation method thereof

A technology of human immunoglobulin and immunoglobulin, applied in antiviral agents, antibacterial drugs, antibodies, etc., can solve the problems of inconvenient clinical use, single potency, high cost, etc., and achieve simple and convenient use, low preparation cost, The effect of simple preparation method

Inactive Publication Date: 2009-08-12
SHANXI KANGBAO BIOLOGICAL PROD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the rabies immunoglobulin and tetanus human immunoglobulin used clinically in our country are both of single potency, and multiple injections are required during use, which is inconvenient for clinical use and high in cost

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] 1. Immunity of plasma donors:

[0019] Select plasma donors who are in good health and meet the requirements of the raw material plasma of blood products, and receive 2, 2, 1, 1, and 2 doses of rabies vaccine on days 0, 3, 7, 14, and 28, respectively. Thirty days after the rabies vaccine was inoculated, the adsorbed tetanus vaccine was applied, and the dose was not less than 0.5 mL on days 0, 14, and 28 for immunization, and detailed immunization records were established.

[0020] 2. Plasma screening and collection of plasma donors:

[0021] Select the solid-phase enzyme-linked immunoassay (ELISA) to quantitatively detect the rabies antibody and tetanus antibody in the serum or plasma of the plasma donor respectively. Protein content (biuret method) not less than 55g / L, alanine aminotransferase (Rei's method) not higher than 25 units, hepatitis B surface antigen negative, syphilis negative, HIV-1 / HIV-2 antibody Negative, HCV antibody-negative and other plasma that mee...

Embodiment 2

[0055] Use the rabies and tetanus bivalent human immunoglobulin prepared in Example 1 to immunize patients, wherein 100 people were injured by dogs, 20 people were bitten by rats, 20 people were injured by cats, and 20 people were bitten by pigs. After continuous observation for 4 years, no morbidity and death cases were found.

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Abstract

The invention relates to a rabies and tetanus double valence human normal immunoglobulin, the rabies valence of antibody is not less than 100IU / mL, the tetanus valence of antibody is not less than 60IU / mL, the content of protein is not more than 175g / L, the immunoglobulin purity is not lower than 92% of the total protein content. The preparation method of source plasma of the protein is to select plasma supplier to be inoculated with rabies vaccine and then with adsorbed tetanus vaccine at least 1-5 days later to obtain the source plasma with rabies valence of antibody being not less than 6IU / mL and the tetanus valence of antibody being not less than 5IU / mL and ensure that the rabies valence of antibody of the source plasma is not less than 10IU / m and the tetanus valence of antibody is not less than 8IU / mL after mixture. The immunoglobulin of the invention can be used to immunize patients suffering exposed wounds caused by biting and scratching of a mad dog or other mad animals.

Description

technical field [0001] The invention belongs to the field of biotechnology and relates to a biological immune product, in particular to a bivalent immunoglobulin capable of simultaneously preventing human rabies and tetanus and a preparation method thereof. Background technique [0002] Rabies is an elastic virus whose pathogen is ribonucleic acid. According to the statistics of the World Health Organization, rabies is prevalent in more than two-thirds of the countries and regions in the world. my country and Southeast Asia are in the high-incidence areas of rabies in the world, and its cases account for more than 70% of the world. Once the onset of rabies, there is currently no cure, and the mortality rate is almost 100%. According to the rabies vaccination program recommended by WHO, the exposed persons are injected with human rabies immunoglobulin (RIg), and then intramuscularly injected with rabies vaccine to ensure the immune effect of the exposed persons. This method...

Claims

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Application Information

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IPC IPC(8): A61K39/40A61K39/42A61P31/04A61P31/14
Inventor 孙思才周凯
Owner SHANXI KANGBAO BIOLOGICAL PROD
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