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Immunoglobulin, and preparation method thereof

An immunoglobulin and human immunoglobulin technology, applied in the field of immunoglobulin and its preparation, can solve the problem of difficult control of opalescence, and achieve the effects of reducing purification time, process duration, and simple and reliable operation process

Active Publication Date: 2017-08-29
HUALAN BIOLOGICAL ENG INC +3
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The purpose of the present invention is to provide an immunoglobulin and its preparation method, which aims to provide a new preparation method of immunoglobulin, which can improve the problem that opalescence is not easy to control in the existing low-temperature ethanol precipitation process

Method used

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Examples

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Effect test

preparation example Construction

[0022] A preparation method of immunoglobulin, comprising: mixing immunoglobulin solution with a pH value of 4.0-8.0 and microcrystalline cellulose, and separating solid and liquid after homogenization.

[0023] Microcrystalline cellulose is a solid product obtained by hydrolyzing natural cellulose with an inorganic acid to a limit degree of polymerization. Microcrystalline cellulose is an odorless, tasteless, very fine white short stick or amorphous crystalline powder. Microcrystalline cellulose is insoluble in water, dilute acid, organic solvent and grease, and partially dissolves and moistens in dilute alkali solution.

[0024] Microcrystalline cellulose has extremely strong water absorption, the degree of polymerization is about 220, and the degree of crystallinity is high. The shape of microcrystalline cellulose is close to spherical, and its specific surface area is relatively large. There are multiple pores distributed inside the microcrystalline cellulose, and the mu...

Embodiment 1

[0055] Embodiment 1 provides a kind of intravenous injection of human immunoglobulin, which is mainly prepared by the following steps:

[0056] Adjust the pH value of the intravenous human immunoglobulin intermediate product after pasteurization with 1mol / L acetic acid to 6.0; The proportion of immunoglobulin is 2g / L. and mixed uniformly for 30 minutes under agitation.

[0057] Put the above mixture in a filter press equipped with a 50P filter plate, pressurize to 1kg / cm 2 Filter and collect the filtered clear solution.

Embodiment 2

[0059] Embodiment 2 provides a kind of intravenous injection of human immunoglobulin, which is mainly prepared by the following steps:

[0060] Take 100 mL of pasteurized intravenous human immunoglobulin solution, and process it in a centrifuge with a centrifugal force of 10,000 g for 10 minutes to remove visible solid precipitates to obtain the supernatant of intravenous immunoglobulin solution with heavy opalescence.

[0061] Take 25 mL of the supernatant of the intravenously injected human immunoglobulin solution obtained above, adjust the pH value of the solution to 4.0 with 1 mol / L acetic acid, add 0.050 g of microcrystalline cellulose, and shake on a rotary shaker to make the microcrystalline cellulose fully mix. Evenly dispersed in the intravenous injection of human immunoglobulin solution, after 30 minutes, the suspension was centrifuged at 10000g for 10 minutes, and the filtrate was taken.

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Abstract

The invention belongs to the field of biological pharmacy, and more specifically relates to an immunoglobulin, and a preparation method thereof. The preparation method comprises following steps: an immunoglobulin solution with a pH value of 4.0 to 8.0 is mixed with microcrystalline cellulose, homogenizing is carried out, and then solid-liquid separation is carried out so as to obtain the immunoglobulin. According to the preparation method, microcrystalline cellulose adsorption and solid-liquid separation are capable of eliminating the opalescence of intravenous injection human immune globulin. In immunoglobulin purification process with microcrystalline cellulose, treatment time period is short, operation process is simple and reliable, immunoglobulin purifying time is shortened, and cost is reduced.

Description

technical field [0001] The invention relates to the field of biopharmaceuticals, in particular to an immunoglobulin and a preparation method thereof. Background technique [0002] Human immunoglobulin is the main substance of the human body's immune response to foreign antigens (such as bacteria, viruses and other toxins or foreign substances), also known as antibodies. At present, the low-temperature ethanol precipitation process (Cohn's method) is mainly used to prepare intravenous immunoglobulin. In the low-temperature ethanol precipitation process, the redissolution operation after protein precipitation can easily lead to incomplete dissolution and dispersion of the protein in the solution, resulting in opalescence in the product. In addition, the virus pasteurization step of intravenous immunoglobulin causes some proteins in the product to be heated, and the protein structure suffers thermal damage, which also makes the product solution produce opalescence. Contents ...

Claims

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Application Information

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IPC IPC(8): C07K16/00C07K1/14
CPCC07K1/14C07K16/00
Inventor 马小伟李光飞梁雪爽张宝献李冠军赵东
Owner HUALAN BIOLOGICAL ENG INC
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