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IgM component of human immunoglobulin and preparation method thereof

A technology of human immunoglobulin and weight percentage, applied in the field of IgM component of human immunoglobulin and preparation thereof, can solve the problems of allergies in patients, large side effects, difficulty in separation, etc., and achieves low IgA content, small side effects, and safety. high sex effect

Pending Publication Date: 2015-12-30
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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  • IgM component of human immunoglobulin and preparation method thereof
  • IgM component of human immunoglobulin and preparation method thereof
  • IgM component of human immunoglobulin and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Embodiment 1 uses the preparation of the IgM component of human immunoglobulin of the present invention

[0041] 1. Experimental materials

[0042] Cohn component I+II+III or component II+III: prepared according to the low-temperature ethanol precipitation method recorded in "Medical Biological Products" (People's Health Publishing House), second edition, page 1194.

[0043] Hydrochloric acid, octanoic acid, CaptoQ filler, GigacapQ filler, UnosphereQ filler, MacrocapQ, diatomaceous earth and Beckman IMMAGE IgA detection kit are all commercially available.

[0044] 2. Experimental method

[0045] Flowchart such as figure 1 Shown:

[0046] 2.1 Separation and purification method:

[0047] Dissolve 4kg of component I+II+III precipitate in 40L of 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 required IgG solubility and fully dissolve.

[0048] Add octanoic acid dire...

Embodiment 2

[0061] Embodiment 2 uses the preparation of the IgM component of human immunoglobulin of the present invention

[0062] 1. Experimental materials

[0063] Cohn component I+II+III or component II+III: prepared according to the low-temperature ethanol precipitation method recorded in "Medical Biological Products" (People's Health Publishing House), second edition, page 1194.

[0064] Hydrochloric acid, octanoic acid, CaptoQ filler, GigacapQ filler, UnosphereQ filler, MacrocapQ, diatomaceous earth and Beckman IMMAGE IgA detection kit are all commercially available.

[0065] 2. Experimental method

[0066] Flowchart such as figure 1 Shown:

[0067] 2.1 Separation and purification method:

[0068] Dissolve 4kg of component I+II+III precipitate in 40L of 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 required IgG solubility and fully dissolve.

[0069] Add octanoic acid dire...

Embodiment 3

[0082] Embodiment 3 uses the preparation of the IgM component of human immunoglobulin of the present invention

[0083] 1. Experimental materials

[0084] Cohn component I+II+III or component II+III: prepared according to the low-temperature ethanol precipitation method recorded in "Medical Biological Products" (People's Health Publishing House), second edition, page 1194.

[0085] Glacial acetic acid, sodium octanoate, CaptoQ filler, GigacapQ filler, UnosphereQ filler, MacrocapQ, diatomaceous earth, and Beckman IMMAGE IgA detection kit are all commercially available.

[0086] 2. Experimental method

[0087] Flowchart such as figure 1 Shown:

[0088] 2.1 Separation and purification method:

[0089] Dissolve 4kg of component I+II+III precipitate in 40L of 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 required IgG solubility and fully dissolve.

[0090] Add 1mol / L sodiu...

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Abstract

The invention discloses an IgM component of human immunoglobulin and a preparation method thereof. The IgA content in the IgM component is low, the IgA content in an IgM-rich human immunoglobulin preparation prepared from the IgM component is also very low, and the IgM component has small side effects, high safety and good clinical application prospects.

Description

technical field [0001] The invention relates to a preparation method of blood products, in particular to an IgM component of human immunoglobulin 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%, which i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07K16/18C07K1/36C07K1/30C07K1/18
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