Method for extracting intravenous injection human immunoglobulin from plasma separation component I and plasma separation component III

A technology for separation of human immunoglobulin and plasma, applied in the field of extraction of human immunoglobulin for intravenous injection, which can solve the problems of unstable components and difficult to remove

Active Publication Date: 2019-10-15
国药集团武汉血液制品有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

All kinds of blood coagulation stabilizing factors in Component I + III are easily activated during the separation process, resulting in unstable components during the separation process, resulting in a large amount of precipitates or flocs, which are difficult to remove

Method used

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  • Method for extracting intravenous injection human immunoglobulin from plasma separation component I and plasma separation component III
  • Method for extracting intravenous injection human immunoglobulin from plasma separation component I and plasma separation component III
  • Method for extracting intravenous injection human immunoglobulin from plasma separation component I and plasma separation component III

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Example 1, Sodium Octanoate Precipitation F Ⅰ+Ⅲ Removal of Miscellaneous Protein Technology Research

[0031] The purpose of this step is to optimize the octanoic acid precipitation conditions: not only meet the requirement of removing the impurity proteins in F Ⅰ+III as much as possible, but also meet the requirement of high IgG content when loading on the column.

[0032] Experimental reagents and equipment:

[0033] 1. Reagent: 100ml of 1M sodium octanoate mother liquor; half-diluted hydrochloric acid; F Ⅰ + Ⅲ precipitation.

[0034] 2. Equipment: 6 200ml and 500ml beakers each; 36 50ml molded bottles; 2 glass rods; 1 PH meter; 1 balance; 6 magnetic stirrers, 1 electric bacteria collector; tower.

[0035] Experimental program:

[0036] 1. Dissolving amount of F Ⅰ+Ⅲ precipitate:

[0037] (1) Dissolving amount of normal sodium caprylate precipitate 5g F Ⅰ+III precipitate is dissolved in 200ml water for injection;

[0038] (2) Dissolve 20g of F Ⅰ+III precipitate in...

Embodiment 2

[0053] Embodiment 2, ion exchange chromatography

[0054] Equipment used: AKTA Purifier 100

[0055] Software: Unicorn 5.3

[0056] Reagents and solutions:

[0057] Buffer A: 200mM NaAC-HAC buffer, pH5.4;

[0058] Buffer B: 10mM NaAC-HAC buffer, pH5.4;

[0059] Buffer D: 200mM NaAC-HAC buffer, pH6.0;

[0060] Buffer E: 10mM NaAC-HAC buffer, pH6.0;

[0061] Buffer C: 1M NaOH;

[0062] 2M acetic acid;

[0063] 0.5M NaOH;

[0064] 1, pretreatment (carry out according to embodiment 1 optimization result)

[0065] (1) Dissolution of F Ⅰ+III precipitate: F Ⅰ+III precipitate was dissolved in water for injection at 20% (wt).

[0066] (2) Dosage of sodium octanoate: 50mM.

[0067] (3) Adjust pH: 4.9.

[0068] 2. Precipitation process:

[0069](1) Completely stir and dissolve the F Ⅰ+III precipitate with water for injection at room temperature according to the set amount, then slowly add 1M octanoic acid to the set concentration while stirring;

[0070] (2) After stirring f...

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Abstract

The invention relates to a method for extracting intravenous injection human immunoglobulin from a plasma separation component I and a plasma separation component III. The method comprises the steps of (1) precipitating F I+III components: dissolving F I+III precipitate in water for injection according to the concentration of 20%(wt), and precipitating impurity protein in F I+III components underthe condition of 50mM sodium caprylate and pH being 4.9; and (2) further refining IgG components by using ion exchange chromatography, wherein the step of further refining IgG components by using ionexchange chromatography comprises substeps of (a): performing Capto Q chromatography pretreatment on an IgG solution obtained in the step (1) to obtain an IgG solution 1; (b) performing Capto Q XP chromatography treatment on the IgG solution 1 so as to obtain an IgG solution 2; and (c) performing ultrafiltration and concentration on the IgG solution 2 so as to obtain IgG refined liquid.

Description

technical field [0001] The invention belongs to the field of biotechnology, and in particular relates to a method for extracting intravenous human immunoglobulin from plasma fractions I and III. Background technique [0002] The active ingredient of intravenous human immunoglobulin is mainly protein, and more than 95% of it is immunoglobulin. Immunoglobulin is mainly purified and extracted from plasma fraction II, and the most important method is to purify and prepare by low-temperature ethanol method. The precipitate of component I + III (F I + III) produced after the extraction of immunoglobulin is usually disposed of as waste, and IgG is rarely purified from this component, the main reason being that it contains complex components. The main components of Component I+III precipitation are lipoprotein, blood coagulation factor VIII (FVIII), IgG, IgM, fibrinogen, fibronectin and other trace proteins. All kinds of coagulation stabilizing factors in components I+III are easi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07K16/06
CPCC07K16/065
Inventor 王月方斌彭良俊韩韧喻剑虹李策生刘莹胡勇刘琦董天保龚钦岳胜兰郑宵蓓罗红张云杨丹丹左林梅峰
Owner 国药集团武汉血液制品有限公司
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