Method for controlling prekallikrein activator in human serum albumin product

A technology of human albumin and kallikrein, which is applied in the field of preparation of human albumin products, can solve the problems of high prokallikrein activator, etc., and achieve the effect of reducing PKA content and ensuring reliable

Active Publication Date: 2014-04-02
SHANXI KANGBAO BIOLOGICAL PROD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The purpose of the present invention is to provide a method for controlling the prokallikrein activator in human albumin products in view of the problem that the prokallikrein activator is prone to be too high in the current separation process of human albumin products

Method used

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  • Method for controlling prekallikrein activator in human serum albumin product
  • Method for controlling prekallikrein activator in human serum albumin product

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] 1. Diatomite activation pretreatment

[0025] Dissolve 100g of sodium citrate in 50L of water for injection at 20-30°C, add 5kg of diatomaceous earth, stir for 5 minutes, suspend, and let stand for 5 minutes to remove suspended matter and supernatant;

[0026] Repeat the above operation with water for injection without sodium citrate and drain it repeatedly until the pH of the lotion is neutral;

[0027] Dissolve 25 mL of glacial acetic acid in 10L of 20-30°C water for injection, add the above-mentioned drained solid, stir for 5 minutes, suspend, stand for 3 minutes, drain to obtain a solid;

[0028] Wash the solid repeatedly with water for injection until the pH of the washing solution is neutral, drain it to obtain activated diatomaceous earth, and place it in a cold operating room for later use.

[0029] 2. Adsorption of coagulation factor Ⅻ

[0030] Take 100L of the fraction Ⅰ+Ⅱ+Ⅲ supernatant obtained in the process of separating and preparing human albumin by the low-temperat...

Embodiment 2

[0035] 1. Diatomite activation pretreatment

[0036] Dissolve 100g of sodium citrate in 50L of water for injection at 20-30°C, add 5kg of diatomaceous earth, stir for 8 minutes, suspend, and let stand for 4 minutes to remove suspended matter and supernatant;

[0037] Repeat the above operation with water for injection without sodium citrate and drain it repeatedly until the pH of the lotion is neutral;

[0038] Dissolve 25mL of glacial acetic acid in 10L of 20-30°C water for injection, add the above-mentioned drained solid, stir for 8 minutes, suspend, stand for 4 minutes, drain to obtain a solid;

[0039] Wash the solid repeatedly with water for injection until the pH of the washing solution is neutral, drain it to obtain activated diatomaceous earth, and place it in a cold operating room for later use.

[0040] 2. Adsorption of coagulation factor Ⅻ

[0041] Take 100L of component Ⅰ+Ⅱ+Ⅲ supernatant obtained in the process of separating and preparing human albumin by low-temperature etha...

Embodiment 3

[0046] 1. Diatomite activation pretreatment

[0047] Dissolve 100g of sodium citrate in 50L of water for injection at 20-30°C, add 5kg of diatomaceous earth, stir for 10 minutes, suspend, and let stand for 5 minutes to remove suspended matter and supernatant;

[0048] Repeat the above operation with water for injection without sodium citrate and drain it repeatedly until the pH of the lotion is neutral;

[0049] Dissolve 25 mL of glacial acetic acid in 10L of 20-30°C water for injection, add the above-mentioned drained solid, stir for 10 minutes, suspend, let stand for 5 minutes, drain to obtain a solid;

[0050] Wash the solid repeatedly with water for injection until the pH of the washing solution is neutral, drain it to obtain activated diatomaceous earth, and place it in a cold operating room for later use.

[0051] 2. Adsorption of coagulation factor Ⅻ

[0052] Take 100L of the fraction Ⅰ+Ⅱ+Ⅲ supernatant obtained in the process of separating and preparing human albumin by the low-te...

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Abstract

The invention relates to a method for controlling prekallikrein activator in a human serum albumin product. The method comprises the following steps of in the process of separating and preparing human serum albumin through a low-temperature alcohol method: 1) adding activated kieselguhr subjected to sodium citrate pretreatment in a step of separating the component IV from the supernatant of components I+II+III, and adsorbing a blood coagulation factor XII so as to reduce the content of the blood coagulation factor XII; and 2) allowing the component V subjected to ultrafiltration and dialysis and purification to pass through a grease-removing filter element with positive charges, and adsorbing to remove the residual activation factor XIIa fragment in the human serum albumin solution. According to the two steps, the content of the prekallikrein activator in the human serum albumin product is reduced, the protein molecule activity, various physical and chemical indicators and protein yield are not influenced, and a reliable guarantee is provided for safe medication of a user.

Description

Technical field [0001] The present invention relates to a method for preparing human albumin products, in particular to a method for controlling the content of prokallikrein activator (PKA) in the production process of human albumin. Background technique [0002] Human albumin is made from healthy human plasma immunized with hepatitis B vaccine as raw material and separated by low-temperature ethanol. Healthy human plasma is an extremely complex protein mixture. Among them, coagulation factor XII in plasma is in the form of inactive zymogen. When vascular endothelial cells are damaged, the exposed negatively charged collagen fibers can activate coagulation factors. Ⅻ becomes activator Ⅻɑ, activator Ⅻɑ can activate prokallikrein (PK) to produce kallikrein (K K ), K K The kininogen releases bradykinin, and these activated factor fragments are called prokallikrein activators (PKA). Repeated thawing and freezing of human albumin products will lead to denaturation of the protein comp...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07K14/765C07K1/22
Inventor 周满祥杨向有申云飞张慧兰
Owner SHANXI KANGBAO BIOLOGICAL PROD
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