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Method for extracting intravenous injection human immunoglobulin by low temperature ethanol

A technology of human immunoglobulin and low-temperature ethanol, which is applied in the field of preparation of intravenous human immunoglobulin, can solve the problems of long separation period of components, low purity, and the need to improve the yield of human immunoglobulin, so as to shorten the separation period, Effect of improving clarity and improving effectiveness

Inactive Publication Date: 2014-03-26
HUALAN BIOLOGICAL ENG CHONGQING
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The component separation cycle of this method is slightly longer, and the purity is lower, and the yield of human immunoglobulin production needs to be improved

Method used

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  • Method for extracting intravenous injection human immunoglobulin by low temperature ethanol

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Effect test

Embodiment 1

[0027] see figure 1 , the method for extracting intravenously injected human immunoglobulin with low-temperature ethanol, using human plasma as raw material, adopting low-temperature ethanol method and pressure filtration method to produce human immunoglobulin, the production operating pressure is less than 0.25MPa, comprising the following steps:

[0028] Step 1. Separation of FI from plasma:

[0029] Control the temperature of the fused human plasma at 0.0°C, adjust the protein concentration to 40g / l, adjust the conductivity of the solution to 12.0ms / cm, pH to 6.80, ethanol concentration to 7.0% by volume, and control the temperature to -1.0 °C, after the precipitation is complete, use a filter press to filter under pressure, choose a deep layer filter plate with a pore size of no more than 0.9 μm (such as 0.9 μm), control the temperature of the filter press to below -1 °C, and filter to separate The FI precipitate was obtained to obtain the FI supernatant.

[0030] Step 2...

Embodiment 2

[0045] see figure 1 , the method for extracting intravenously injected human immunoglobulin with low-temperature ethanol uses human plasma as raw material, adopts low-temperature ethanol method and pressure filtration method to produce human serum albumin, and the production operating pressure is less than 0.25MPa, comprising the following steps:

[0046] Step 1. Separation of FI from plasma:

[0047] The temperature of the fused human plasma is controlled at 2.0°C, the protein concentration is adjusted to 52.5g / l, the conductivity of the solution is adjusted to 13.1ms / cm, the pH value is adjusted to 7.05, the ethanol concentration is adjusted to 8.5% by volume, and the temperature is controlled to -2.0°C, after the precipitation is complete, use a filter press to filter under pressure, choose a deep layer filter plate with a pore size of no more than 0.9 μm (such as 0.6 μm), and control the temperature of the filter press to below -1°C. The FI precipitate was separated by fi...

Embodiment 3

[0063] see figure 1 , the method for extracting intravenously injected human immunoglobulin with low-temperature ethanol uses human plasma as raw material, adopts low-temperature ethanol method and pressure filtration method to produce human serum albumin, and the production operating pressure is less than 0.25MPa, comprising the following steps:

[0064] Step 1. Separation of FI from plasma:

[0065] Control the temperature of the fused human plasma at 4.0°C, adjust the protein concentration to 65g / l, adjust the conductivity of the solution to 14.0ms / cm, adjust the pH value to 7.30, adjust the ethanol concentration to 10.0% by volume, and control the temperature to - 3.0°C, after the precipitation is complete, use a filter press to filter under pressure, choose a deep layer filter plate with a pore size of no more than 0.9 μm (such as 0.3 μm), control the temperature of the filter press to below -1°C, and filter The FI precipitate was separated, and the FI supernatant was ta...

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Abstract

The invention discloses a method for extracting intravenous injection human immunoglobulin by low temperature ethanol. In the method, FI, FII+III, FIII and FII are sequentially separated; and when FII precipitates are subjected to ultrafiltration and purification, processes of ultrafiltration dealcoholization, Pasteur inactivation, primary precipitation separation, secondary precipitation separation and secondary precipitation ultrafiltration dealcoholization are sequentially adopted. According to the invention, in the filtering process, the temperature of a filter press is controlled in a low-temperature range; the proper electrical conductivity is adopted in the precipitation separation processes; yield of the immunoglobulin is improved; when the immunoglobulin is purified and refined, precipitation separation is carried out for twice; secondary clarification sterilization filtration is adopted in the process of carrying out precipitation separation for twice; and by a four-stage filtering technology, insoluble particles in a product are removed and clarity and yield of the product are improved.

Description

technical field [0001] The invention relates to a method for preparing intravenous human immunoglobulin by using human plasma as a raw material, and more specifically relates to a method for extracting intravenous human immunoglobulin by using a low-temperature ethanol method. Background technique [0002] The low-temperature ethanol method is one of the preparation methods of human plasma protein. This method was invented by Professor Edwin J. Cohn of Harvard Medical School in the United States in 1940, so it is also called "Kong's method". The Kong method was originally used to separate bovine serum albumin and was subsequently applied to the separation of human plasma. The low-temperature ethanol method uses mixed plasma as the raw material to gradually reduce the acidity (from pH7.0 to pH4.0). Increase the concentration of ethanol (from 0 to 40%), while reducing the temperature (from 2°C to -2°C), various proteins are separated from the solution step by step in the form...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07K1/36C07K1/34C07K1/30
Inventor 安康张宝献张其昌王猛滕世超郭心怡
Owner HUALAN BIOLOGICAL ENG CHONGQING
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