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A kind of Igm-rich human immunoglobulin preparation and preparation method thereof

A human immunoglobulin and preparation technology, which is applied in the preparation methods of peptides, derived from serum immunoglobulins, chemical instruments and methods, etc., can solve the problems of allergies, difficult separation, and large side effects in patients, and achieves low IgA content, High safety and less side effects

Active Publication Date: 2021-01-26
CHENGDU RONGSHENG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the high content of IgA in human plasma and the similarity of many physicochemical properties between IgM and IgA, the separation of the two is very difficult, resulting in IgM-enriched immunoglobulin preparations containing large amounts of IgA, and the presence of large amounts of IgA can lead to selective IgA deficiency Hypersensitivity in patients, severe shock or death may occur
[0003] At present, the most commonly used IgM-rich human immunoglobulin preparation is composed of 12% IgM, 12% IgA, and 76% IgG. The IgA content is as high as 12%, which is equivalent to the IgM content, and there are serious safety hazards , side effects

Method used

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  • A kind of Igm-rich human immunoglobulin preparation and preparation method thereof
  • A kind of Igm-rich human immunoglobulin preparation and preparation method thereof
  • A kind of Igm-rich human immunoglobulin preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Embodiment 1 uses the preparation of the immunoglobulin preparation rich in IgM of the present invention

[0037] 1. Experimental materials

[0038] Cohn fraction I+I+I or fraction I+I: prepared according to the low-temperature ethanol precipitation method described in "Medical Biological Products" (People's Health Publishing House), second edition, page 1194.

[0039] Hydrochloric acid, caprylic acid, Capto Q filler, Gigacap Q filler, Unosphere Q filler, Macrocap Q, diatomaceous earth and Beckman IMMAGE IgA detection kit are all commercially available.

[0040] 2. Experimental method

[0041] Flowchart such as figure 1 Shown:

[0042] 2.1 Separation and purification method:

[0043] Dissolve 4kg of component I+II+III precipitates in 40L 5°C water for injection, stir for 1 hour, use 0.5M acetic acid to adjust the pH to 4.20, heat and stir in a 25°C water bath for 2 hours to increase the solubility of the required IgG and fully dissolve.

[0044] Add octanoic acid d...

Embodiment 2

[0057] Embodiment 2 uses the preparation of the immunoglobulin preparation rich in IgM of the present invention

[0058] 1. Experimental materials

[0059] Cohn fraction I+I+I or fraction I+I: prepared according to the low-temperature ethanol precipitation method described in "Medical Biological Products" (People's Health Publishing House), second edition, page 1194.

[0060] Hydrochloric acid, caprylic acid, Capto Q filler, Gigacap Q filler, Unosphere Q filler, Macrocap Q, diatomaceous earth and Beckman IMMAGE IgA detection kit are all commercially available.

[0061] 2. Experimental method

[0062] Flowchart such as figure 1 Shown:

[0063] 2.1 Separation and purification method:

[0064] Dissolve 4kg of component I+II+III precipitates in 40L 5°C water for injection, stir for 1 hour, use 0.5M acetic acid to adjust the pH to 4.20, heat and stir in a 25°C water bath for 2 hours to increase the solubility of the required IgG and fully dissolve.

[0065] Add octanoic acid d...

Embodiment 3

[0078] Embodiment 3 uses the preparation of the immunoglobulin preparation rich in IgM of the present invention

[0079] 1. Experimental materials

[0080] Cohn fraction I+I+I or fraction I+I: prepared according to the low-temperature ethanol precipitation method described in "Medical Biological Products" (People's Health Publishing House), second edition, page 1194.

[0081] Glacial acetic acid, sodium octanoate, Capto Q filler, Gigacap Q filler, Unosphere Q filler, Macrocap Q, diatomaceous earth and Beckman IMMAGE IgA detection kit are all commercially available.

[0082] 2. Experimental method

[0083] Flowchart such as figure 1 Shown:

[0084] 2.1 Separation and purification method:

[0085] Dissolve 4kg of component I+II+III precipitates in 40L 5°C water for injection, stir for 1 hour, use 0.5M acetic acid to adjust the pH to 4.20, heat and stir in a 25°C water bath for 2 hours to increase the solubility of the required IgG and fully dissolve.

[0086] Add 1mol / L sod...

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Abstract

The invention discloses an IgM component of human immunoglobulin and a preparation method of the IgM component of the human immunoglobulin, and further discloses an IgM-rich human immunoglobulin preparation and a preparation method thereof. According to the methods provided by the invention, IgA and IgM can be effectively separated, and the content of the IgA in the obtained IgM component is low, so that the content of the IgA in the IgM-rich human immunoglobulin preparation prepared by using the IgM component is also extremely low, the side effect is small, the safety is high and the clinical application prospect is good.

Description

technical field [0001] The invention relates to a preparation method of blood products, in particular to an IgM-rich human immunoglobulin preparation and a preparation method thereof. Background technique [0002] IgM-rich human immunoglobulin preparation, the main component is composed of IgG and IgM, used for anti-bacterial infection and treatment of autoimmune diseases, prepared by separating human plasma. Due to the high content of IgA in human plasma and the similarity of many physicochemical properties between IgM and IgA, the separation of the two is very difficult, resulting in IgM-enriched immunoglobulin preparations containing large amounts of IgA, and the presence of large amounts of IgA can lead to selective IgA deficiency The patient is allergic, which can cause shock or death in severe cases. [0003] At present, the most commonly used IgM-rich human immunoglobulin preparation is composed of 12% IgM, 12% IgA, and 76% IgG. The IgA content is as high as 12%, whi...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K39/395A61K35/16A61K9/19A61P31/04A61P37/02C07K16/06C07K1/36C07K1/34C07K1/30C07K1/18
Inventor 王焰吕家成梁洪卢杨利李泽林武鹏胡晓东张月星
Owner CHENGDU RONGSHENG PHARMA