Unlock instant, AI-driven research and patent intelligence for your innovation.

IgM-rich human immunoglobulin preparation and preparation method thereof

A technology for human immunoglobulin and protein preparations, which is applied in the field of preparation of blood products, can solve the problems of allergies, separation difficulties, and large side effects in patients, and achieves the effects of low IgA content, high safety, and small side effects.

Active Publication Date: 2015-12-09
CHENGDU RONGSHENG PHARMA
View PDF4 Cites 2 Cited by
  • 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

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • IgM-rich human immunoglobulin preparation and preparation method thereof
  • IgM-rich human immunoglobulin preparation and preparation method thereof
  • 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, octanoic acid, CaptoQ filler, GigacapQ filler, UnosphereQ filler, MacrocapQ, 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 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.

[0044] Add octanoic acid directly t...

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, octanoic acid, CaptoQ filler, GigacapQ filler, UnosphereQ filler, MacrocapQ, 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 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.

[0065] Add octanoic acid directly t...

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, CaptoQ filler, GigacapQ filler, UnosphereQ filler, MacrocapQ, 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 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.

[0086] Add 1mol / L sodium octa...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

No PUM Login to View More

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

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
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