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Method for extracting human immune globulin from component I+III or component III

A human immunoglobulin and protein technology, applied in the direction of anti-animal/human immunoglobulin and peptide preparation methods, chemical instruments and methods, etc., to achieve the effects of advanced methods, pollution prevention, and simple processes

Active Publication Date: 2010-02-17
BANGHE PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0003] In view of the above situation, in order to overcome the defects of the prior art, the object of the present invention is to provide a method for extracting human immunoglobulin from component I+III or component III, which can effectively solve the problem of extracting human immunoglobulin from component I+III or component III. Extract human immunoglobulin in III to meet people's demand for immunoglobulin, and the technical solution is realized by the following steps:

Method used

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Embodiment 1

[0022] The present invention is realized by the following steps:

[0023] 1. Dissolving of component I+III precipitate (thing), the method is to fully dissolve component I+III with 0.01M disodium hydrogen phosphate solution at 5°C with 15 times the amount of precipitation;

[0024] ②Separation of component I: the method is to adjust the pH value to 4.90-5.00 with acetic acid buffer solution with a pH value of 4.0, cool down to 0-1°C, add 95% ethanol until the ethanol concentration is 8.5%, and retest the pH value at 4.90 Between ~5.10, the stirring reaction is cooled to -1.8~2.2°C, and the stirring reaction time is 2.5 hours. After that, add 4Kg of diatomaceous earth and 4Kg of perlite to each thousand liters of reaction solution, stir for 30 minutes, and then use 8.5% balance solution 500L, add 4kg of diatomite to circularly clean the upper filter plate of the filter press, press filter after balancing, the outlet temperature is -1.0°C~-2.0°C, dry the filter plate with pre-co...

Embodiment 2

[0036] The present invention can also be realized by the following steps:

[0037] ① Dissolution of component III precipitate (substance): fully dissolve component III precipitation (substance) with 0.01M disodium hydrogen phosphate solution at 5°C with 15 times the precipitation amount;

[0038] ②Separation of component III: the method is to measure the volume of the solution in step ①, adjust the pH of the solution to 5.10-5.20 with 1mol / L NaOH, then add 95% ethanol, and adjust the concentration of ethanol to 14% in the solution , after stirring and reacting at a temperature of -2.0°C to -4.0°C for more than 2 hours, add 3Kg of diatomite and 3Kg of perlite to each thousand liters of the reaction solution, stir for 30 minutes, use 500L of 14% balance solution, add 5Kg of diatomite to the The upper filter plate of the filter press is cleaned circularly. After the balance, the filter is pressed. The temperature of the outlet liquid is -2.0℃~-3.0℃. Plate 2 times, recover the wash...

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Abstract

The invention relates to a method for extracting human immune globulin from a component I+III or a component III, which can effectively extract human immune globulin from a component I+III or a component III so as to meet the demands of human immune globulin for people, and comprises the following steps: (1) dissolving the deposits of component I+III or component III; (2) removing the component I;(3) separating the component III; (4) separating a component II; (5) dissolving and filtering the component II; (6) ultrafiltering, dialyzing and concentrating; (7) purifying the component II; (8) purifying; and (9) ultrafiltering and dialyzing. The method is advanced, has simple process and can effectively separate the component II from the component I+III or the component III so as to further make the component II into a finished product of human immune globulin, and has very important realistic significance of relieving the short supply situation of domestic source plasma, not only sufficiently utilize raw materials but also prevent environmental pollution; therefore, the method has huge economic and social benefits.

Description

1. Technical field [0001] The invention relates to the field of biopharmaceuticals, in particular to a method for extracting human immunoglobulin from component I+III or component III. 2. Background technology [0002] Immunoglobulin is a group of proteins with antibody activity. After infusion, it can rapidly increase the IgG level in the blood of the recipient, and enhance the body's anti-infection ability and immune regulation function. The traditional separation process of human immunoglobulin is the low-temperature ethanol fractionation precipitation technique founded by Professor E.J.Cohn. This technique effectively controls the five factors of protein precipitation: pH value, temperature, protein concentration, ionic strength, and ethanol concentration to gradually precipitate plasma Generally, the step of separating human immunoglobulin is to first separate component II from the I+II+III component or II+III component produced in the process of extracting human serum ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07K16/18C07K1/34C07K1/14
Inventor 吕勇时凯刘国荣张志龙陈慧珍
Owner BANGHE PHARMA CO LTD
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