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

A human immunoglobulin and protein technology, which is applied in the preparation methods, chemical instruments and methods of anti-animal/human immunoglobulins and peptides to achieve the effects of simple process, pollution prevention and advanced methods.

Active Publication Date: 2011-09-28
BANGHE PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

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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Experimental program
Comparison scheme
Effect test

Embodiment 1

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

[0023] ① Dissolution of component Ⅰ+Ⅲ precipitate (material), 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 with pH value of 4.0, cool down to 0-1°C, add 95% ethanol until the ethanol concentration is 8.5%, and re-measure the pH value at 4.90 Between ~5.10, the stirring reaction is cooled to -1.8~2.2 ℃, and the stirring reaction time is 2.5 hours. After that, 4Kg of diatomite and 4Kg of perlite are added to each thousand liters of reaction solution, stirred for 30 minutes, and then use 8.5% balance solution 500L, add 4kg of diatomaceous earth to cyclically clean the filter plate on the filter press, press filtration after equilibration, the liquid temperature is -1.0℃~-2.0℃, after the pressure filtration, ...

Embodiment 2

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

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

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

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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 recipient's blood and enhance the body's anti-infection ability and immune regulation function. The traditional separation process of human immunoglobulin is the low-temperature ethanol fractional precipitation technology founded by Professor E.J.Cohn. This technology 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 albumin from...

Claims

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Application Information

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Patent Type & Authority Patents(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