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Method for extracting human TIG (Tetanus Immune Globulin) based on chromatography

A technology of human immunoglobulin and tetanus, applied in the direction of antibacterial immunoglobulin and peptide preparation methods, chemical instruments and methods, etc., can solve the problem of low purity of tetanus human immunoglobulin, and achieve mild inactivation conditions , improve the yield, improve the effect of purity

Active Publication Date: 2011-09-14
哈尔滨派斯菲科生物制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It is produced by a low-temperature ethanol process, and the virus is inactivated by one-step heating, and the purity of the tetanus human immunoglobulin produced according to this process is low

Method used

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  • Method for extracting human TIG (Tetanus Immune Globulin) based on chromatography
  • Method for extracting human TIG (Tetanus Immune Globulin) based on chromatography

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] A: Rough separation:

[0020] After thawing and mixing 1000L plasma, add acetic acid buffer to adjust its pH value to 5.80, add pre-cooled 95% ethanol to make the ethanol concentration of the reaction solution reach 18%, adjust the temperature at -4°C, add 0.5% (g / ml) diatomaceous earth filter aid, filter with a filter press to obtain the precipitate of component I+II+III, and dissolve the precipitate of component I+II+III in 0 ℃ water for injection of 5 times the amount, and stir for 3 hour, turn on the refrigeration to maintain the temperature of the reaction solution at 0°C, add acetic acid buffer, adjust the pH value of the reaction solution to 5.15, add pre-cooled 95% ethanol, and make the ethanol concentration of the reaction solution reach 17%. , cooling the reaction solution, so that the final temperature of the reaction solution is -4.5 ° C, after adding ethanol, add 0.5% (g / ml) diatomite filter aid and filter with a filter press, collect and filter the supern...

Embodiment 2

[0028] A: Rough separation:

[0029]After thawing and mixing 1000L plasma, add acetic acid buffer to adjust its pH value to 6.00, add pre-cooled 95% ethanol to make the ethanol concentration of the reaction solution reach 20%, adjust the temperature at -5°C, add 1.0% (g / ml) diatomaceous earth filter aid, filter with a filter press to obtain the precipitate of component I+II+III, and dissolve the precipitate of component I+II+III in 6 times the amount of water for injection at 0°C, and stir for 3 hour, turn on refrigeration to keep the temperature of the reaction solution at 0°C, add acetic acid buffer solution, adjust the pH value of the reaction solution to 5.25, add pre-cooled 95% ethanol, and make the ethanol concentration of the reaction solution reach 18%. , cooling the reaction solution, so that the final temperature of the reaction solution is -5.0 ° C, after adding ethanol, add 1.0% (g / ml) diatomite filter aid and filter with a filter press, collect and filter the sup...

Embodiment 3

[0037] A: Rough separation:

[0038] After thawing and mixing 1000L plasma, add acetic acid buffer solution to adjust its pH value to 6.20, add pre-cooled 95% ethanol to make the ethanol concentration of the reaction solution reach 22%, adjust the temperature at -6°C, add 1.5% (g / ml) diatomaceous earth filter aid, filter with a filter press to obtain the precipitate of component I+II+III, and dissolve the precipitate of component I+II+III in 8 times the amount of water for injection at 0°C, and stir for 3 hour, turn on refrigeration to keep the temperature of the reaction solution at 0°C, add acetic acid buffer, adjust the pH value of the reaction solution to 5.35, add pre-cooled 95% ethanol, and make the ethanol concentration of the reaction solution reach 19%. , cooling the reaction solution so that the final temperature of the reaction solution is -5.5 ° C, after adding ethanol, add 1.5% (g / ml) diatomite filter aid and filter with a filter press, collect and filter the sup...

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Abstract

The invention belongs to the field of blood products in biological products, in particular relates to a method for extracting human TIG (Tetanus Immune Globulin) based on chromatography. The method comprises the following three steps: 1, primary separation; 2, purification by chromatography; and 3, virus inactivation. When the chromatography process provided by the invention is used for further purifying products, the purity of the products is improved greatly, the purity of human TIC in the products can be improved to above 98%, which is not only far higher than the standard specified in Chinese Pharmacopoeia version 2010, but also higher than the standard specified in European Pharmacopoeia; in addition, the contents of other impurities causing anaphylactic reaction are reduced greatly, for instance, two major anaphylactic substances, namely anticomplement active substance (ACA) and depressor substance (PKA), are both reduced remarkably. Two different virus inactivation processes, namely low-pH incubation and nano-film filtering, are adopted in the invention and can be used for effectively inactivating and removing both lipid-enveloped viruses and non lipid-enveloped viruses.

Description

technical field [0001] The invention belongs to the category of blood products in biological products, in particular to a method for extracting tetanus human immunoglobulin by chromatography. Background technique [0002] Tetanus is a disease that seriously threatens human health. It is caused by the invasion of the human body by the tetanus bacilli through wounds. It is common in open wounds and newborns delivered unscientifically. Because the treatment of the disease is relatively difficult, its case fatality rate is as high as 20% to 50%, and there are tetanus cases all over the world. Therefore, it is very important to develop effective drugs for the prevention and treatment of tetanus. For a long time, humans have mainly used horse tetanus antiserum (TAT) to prevent and treat tetanus. Because a large number of horse proteins in horse serum often cause allergic reactions or even shock in patients, the clinical application is greatly limited. Tetanus human immunoglobuli...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/395A61P31/04C07K16/12C07K1/18C07K1/14
Inventor 陈凤珠孙晓东魏舒李常禄杨金平于洋郭晶
Owner 哈尔滨派斯菲科生物制药有限公司
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