Varicella-zoster human immunoglobulin, method for preparing same and application thereof in pharmacy

A technology of human immunoglobulin and immunoglobulin, which is applied in biological immune products, specific immunoglobulin for chickenpox and treatment of herpes zoster and its preparation, and the application field of pharmaceutical preparations, which can solve the problems of non-specificity and achieve Improve drug efficacy and enhance the effect of concentration

Inactive 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

[0005] The technical problem to be solved by the present invention is to provide a high-titer varicella-zoster virus human immunoglobulin with good curative effect and provide a Simple, convenient and low-cost preparation method, and its application in the preparation of medicines for preventing the occurrence of chickenpox and treating postherpetic neuralgia

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] 1. Immunity of plasma donors:

[0023] From August 1, 2008 to September 7, 2008, 254 healthy plasma donors who met the national blood collection standards were selected, and the same blood donor was inoculated with live attenuated varicella vaccine on days 0 and 25 respectively (the vaccine manufacturer is China Shanghai Institute of Biological Products, Biotechnology Group Corporation, batch number 20080803, 0.5ml / bottle) 1 bottle each. 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.

[0024] 2. Plasma screening and collection of plasma donors:

[0025] From September 21, 2008, solid-phase enzyme-linked immunoassay was used to quantitatively detect varicella-zoste...

Embodiment 2

[0067] prevent chickenpox

[0068] In a primary school in a chickenpox high-incidence area, a total of 262 students were randomly selected from four classes in the third grade. The experimental group consisted of 126 people, with an average age of 9.8 years, including 65 males and 61 females; the varicella-zoster human immunoglobulin prepared in Example 1 was injected intramuscularly with 125 IU / person, only injected once, and observed for 4 months. No case of chickenpox occurred, the incidence rate was 0%. The blank control group consisted of 136 people, with an average age of 10.1 years, including 69 males and 67 females. After 4 months of observation, 31 cases developed chickenpox, and the incidence rate was 22.8%.

Embodiment 3

[0070] Shingles Treatment

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PUM

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Abstract

The invention discloses a varicella-zoster human immunoglobulin, wherein the titer of the neutralizing antibody of the varicella-zoster virus is more than or equal to 50IU/mL, the purity of the immunoglobulin is more than or equal to 90 percent of total protein, and the content of protein is less than or equal to 180g/L. The preparation method of the varicella-zoster human immunoglobulin comprises the following steps: from blood plasma donors meeting the national blood taking standard, selecting the blood plasma of the donors, of which the titer of the neutralizing antibody IgG of the varicella-zoster virus is more than or equal to 2IU/mL and the content of protein is more than or equal to 55g/L as material blood plasmas for preparing the varicella-zoster human immunoglobulin, and mixing the obtained blood plasmas; by low-temperature ethanol or chromatography protein separation process, separating and extracting the immunoglobulin component from the obtained material blood plasmas; and processing the immunoglobulin component by the procedures of pressure filtration, chromatography, centrifuging, ultra-filtration, virus inactivation, blending, sterilization, subpackaging and the like so as to prepare the varicella-zoster human immunoglobulin. The method can be used for preparing medicaments for preventing varicella and treating post herpetic neuralgia.

Description

technical field [0001] The invention belongs to the field of biotechnology, and relates to a biological immune product, in particular to a specific immunoglobulin for treating chickenpox and herpes zoster, a preparation method thereof, and an application thereof in preparing medicines. Background technique [0002] Varicella-zoster virus (English abbreviation: VZV) belongs to human herpes simplex virus type 3, and its primary infection is varicella. Chickenpox is an acute, highly contagious infectious disease that is common in children and can be transmitted through the respiratory tract and contact. Generally, the prognosis is good. The symptoms of adults infected with VZV are very severe. Once varicella patients appear in susceptible groups, it is difficult to prevent the outbreak of varicella in this group. Reactivation of VZV after latency causes herpes zoster. In recent years, the incidence of herpes zoster (English abbreviation: HZ) has increased significantly, and t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07K16/08C07K16/06C07K1/36A61K39/42A61P31/22A61P29/00
Inventor 张振湖孙思才胡辉恒
Owner TONROL BIOLOGICAL PHARM CO LTD
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