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Hydrophobia-tetanus double titer human immunoglobulin, method for preparing same and application thereof in pharmacy

A technology of human immunoglobulin and immunoglobulin, which is applied in the direction of antiviral immunoglobulin, antibacterial immunoglobulin, immunoglobulin from serum, etc., can solve the problems of inconvenient clinical use, single potency, and high cost, and achieve Large social and economic benefits, simple and convenient use

Active Publication Date: 2009-12-02
TONROL BIOLOGICAL PHARM CO LTD
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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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  • Hydrophobia-tetanus double titer human immunoglobulin, method for preparing same and application thereof in pharmacy
  • Hydrophobia-tetanus double titer human immunoglobulin, method for preparing same and application thereof in pharmacy
  • Hydrophobia-tetanus double titer human immunoglobulin, method for preparing same and application thereof in pharmacy

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] 1. Immunity of plasma donors:

[0024] 263 plasma donors who met the national blood donation standards were selected, and they were inoculated with rabies vaccine (produced by Liaoning Chengda Biology Co., Ltd., batch number: 20081001, dose: 0.5 ml / branch) 1ml, 0.5ml, 0.5ml, 0.5ml, 1ml. 15 days after the completion of rabies vaccination, apply the adsorbed tetanus vaccine (produced by Wuhan Institute of Biological Products, batch number 20081002, dose 0.5mL / bottle), according to the dosage of 0.5mL on days 0, 14±2, and 28±5 Immunization, and establish detailed immunization records. The national blood collection standard includes the following items: the protein content detected by the biuret method is greater than or equal to 55g / L, the alanine aminotransferase (Lai's method) is not higher than 25 units, the hepatitis B surface antigen is negative, and the syphilis is negative , HIV-1 / HIV-2 antibody negative, HCV antibody negative.

[0025]

[0026]

[0027] ...

Embodiment 2

[0081] Clinical application evaluation: (1) 120 patients in the experimental group were bitten or scratched by rabies or other mad animals, aged 2-61 years, with an average of 23.7 years; Immunoglobulin is used to prevent the occurrence of rabies and tetanus. The dosage is calculated according to the titer of rabies neutralizing antibody 20IU / kg body weight, and it is applied once. Results: No adverse reactions occurred; no rabies and tetanus occurred in continuous observation for 1 year. (2) In the control group, 47 patients who were bitten or scratched by rabies or other mad animals were exposed, aged 3-65 years, with an average of 21.4 years old; rabies patient immunoglobulin produced by Hualan Biotechnology (batch number: 200803001, specification: 200IU / 2.0ml / bottle) is used to prevent the occurrence of rabies, and the dosage is calculated according to the rabies neutralizing antibody titer 20IU / kg body weight, once applied; simultaneously use the tetanus human immunoglob...

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Abstract

The invention discloses a hydrophobia-tetanus double titer human immunoglobulin, wherein the purity of the immunoglobulin is more than or equal to 90 percent of total protein, the titer of the hydrophobia neutralizing antibody is more than or equal to 100IU / mL, the titer of the tetanus neutralizing antibody is more than or equal to 40IU / mL, and the content of protein is less than or equal to 180g / L. In addition, the invention also discloses a method for preparing the hydrophobia-tetanus double titer human immunoglobulin and application of the hydrophobia-tetanus double titer human immunoglobulin in preparing medicaments for preventing hydrophobia and tetanus.

Description

technical field [0001] The invention belongs to the field of biotechnology, and relates to a biological immune product, in particular to a rabies and tetanus bivalent human immunoglobulin, a preparation method thereof, and an application thereof in preparing medicines. 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. ...

Claims

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Application Information

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IPC IPC(8): C07K16/12C07K16/10C07K16/06C07K1/36A61K39/42A61K39/40A61P31/14A61P31/04
Inventor 张振湖孙思才胡辉恒
Owner TONROL BIOLOGICAL PHARM CO LTD
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