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Preparation process of intravenous injection human immune globulin with high purity and low IgA content

A human immunoglobulin and preparation technology, which is applied in the field of preparation technology of intravenous injection of human immunoglobulin with high purity and low IgA content. problem, to achieve good inactivation effect, reduce content and increase content

Pending Publication Date: 2022-05-10
新疆德源生物工程有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

For example, Zhang Zhan published the document "The Effects of Different Virus Inactivation Processes on the Quality and Yield of Intravenous Immunoglobulin", which used low pH incubation, nano-membrane filtration, pasteurization and S / D virus inactivation processes to treat static Injection of human immunoglobulin stock solution, however, has a certain impact on the quality of intravenous immunoglobulin, and will affect the yield of intravenous immunoglobulin

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  • Preparation process of intravenous injection human immune globulin with high purity and low IgA content

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Example 1 The preparation process of intravenous human immunoglobulin 1

[0031] (1) Separation of component I+II+III precipitation from plasma

[0032] (2) Production and separation of components I+III

[0033] Use 8 times the precipitated weight of component I+II+III, dissolve the precipitated component I+II+III with 0.01mol / L sodium chloride solution at 0°C, and start stirring to 30rpm. After complete dissolution, add pH4.0 acetate buffer solution, adjust the pH value to 5.10, cool down to below 0°C, spray 95% ethanol at -15°C, so that the final ethanol concentration reaches 17% v / v, and the ethanol injection speed 80kg / h. Control the temperature of the final reaction solution at -5.5°C. After the addition of ethanol, continue to stir for 2 hours, let it stand for 6 hours, turn on the stirring speed at 30 rpm, and carry out pressure filtration separation after 15 minutes.

[0034] (3) S / D inactivation

[0035] Add the S / D solution slowly (stirring speed 20rpm) b...

Embodiment 2

[0054] Embodiment 2 Preparation process 2 of intravenous injection of human immunoglobulin

[0055] (1) Separation of component I+II+III precipitation from plasma

[0056] (2) Production and separation of components I+III

[0057] Dissolve the precipitate of component I+II+III with 0.01mol / L sodium chloride solution at 1°C, which is 10 times the weight of the precipitate of component I+II+III, and start stirring to 70rpm. Add pH 4.0 acetate buffer solution after complete dissolution, adjust the pH value to 5.0, cool down to below 0°C, spray 95% ethanol at -20°C to make the final ethanol concentration reach 17% v / v, ethanol injection speed 70kg / h. Control the temperature of the final reaction solution to -5.0°C. After the addition of ethanol, continue to stir for 2 hours, let stand for 6 hours, turn on the stirring speed of 35rpm, and carry out pressure filtration separation after 15 minutes.

[0058] (3) S / D inactivation

[0059] Add S / D solution slowly (stirring speed 30...

Embodiment 3

[0078] Example 3 The preparation process of intravenous human immunoglobulin 3

[0079] (1) Separation of component I+II+III precipitation from plasma

[0080] (2) Production and separation of components I+III

[0081] Dissolve the precipitate of component I+II+III with 0.01 mol / L sodium chloride solution at 2°C, which is 12 times the weight of the precipitate of component I+II+III, and start stirring to 30rpm. After complete dissolution, add pH4.0 acetate buffer solution, adjust the pH value to 5.15, cool down to below 0°C, and spray 95% ethanol at -20°C to make the final ethanol concentration reach 17% v / v, ethanol injection speed 50kg / h. Control the temperature of the final reaction solution at -5.5°C. After the addition of ethanol, continue to stir for 2 hours, let stand for 6 hours, turn on the stirring speed at 50 rpm, and carry out pressure filtration separation after 15 minutes.

[0082] (3) S / D inactivation

[0083] Add the S / D solution slowly (stirring speed 40r...

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Abstract

The invention belongs to the field of blood products, and particularly relates to a preparation process of intravenous injection human immune globulin with high purity and low IgA content. The preparation process of the human immunoglobulin for intravenous injection mainly comprises the following steps: preparation of a component I and a component III or a component III, S / D inactivation, first ultrafiltration, chromatography, second ultrafiltration, preparation of an intermediate product, pasteurization, third ultrafiltration, virus removal and filtration with a nano-film, preparation of a semi-finished product, sterilization and filling and the like. The prepared human immunoglobulin for intravenous injection is high in yield, high in purity and low in IgA content. Meanwhile, a virus inactivation process combining S / D inactivation and pasteurization is adopted, so that the aim of inactivating lipid-enveloped and non-lipid-enveloped viruses is fulfilled, and the product safety is further ensured.

Description

technical field [0001] The invention belongs to the field of blood products, in particular to a preparation process for intravenous injection of human immunoglobulin with high purity and low IgA content. Background technique [0002] Intravenous injection of human immunoglobulin is made of immunoglobulin components separated and extracted from healthy human plasma, and refined through steps such as virus inactivation and removal. Intravenous injection of human immunoglobulin has dual therapeutic effects of immune replacement and immune regulation, and is widely used clinically in the treatment of primary or acquired immunoglobulin deficiency, bacterial infection, viral infection, blood system disease, Kawasaki disease, etc. There are significant effects. [0003] Intravenous human immunoglobulin as a blood product requires strict quality control in order to better control the clinical effect. The pharmacopoeias of various countries have corresponding regulations on the qua...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07K16/06C07K1/36C07K1/34C07K1/18A61K39/395A61K9/00A61K47/26
CPCC07K16/06C07K16/065C07K1/36C07K1/34C07K1/18A61K9/0019A61K47/26C07K2317/21A61K2039/505
Inventor 吕献忠苏峰崔婷婷孙书秒王雅琴陈远洋
Owner 新疆德源生物工程有限公司