Method for extracting human serum albumin from plasma and increasing yield

A technology for human albumin and plasma, which is applied in the field of extracting human albumin to improve the yield, and achieves the effects of smooth and concise production process, reduction of one-step losses, and huge economic and social benefits.

Inactive Publication Date: 2015-04-29
BANGHE PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In view of the above situation, in order to overcome the defects of the prior art, the purpose of the present invention is to provide a method for extracting human albumin from blood plasma and improving the yield, which can effectively solve the problem of extracting and recovering human albumin from plasma and improving the yield. rate problem

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  • Method for extracting human serum albumin from plasma and increasing yield

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Embodiment 1

[0030] The present invention in concrete implementation, comprises the following steps:

[0031] (1) Merging and melting of plasma: After breaking the bag, put it into a clean melting tank, open the melting tank, stir and melt the temperature controller, and make the plasma in the melting tank melt when the water temperature is less than 35°C. Keep it at 2℃~3℃;

[0032](2) Preparation of components I+II+III and pressure filtration separation: measure the volume of the combined plasma, adjust the pH of the mixed plasma to 6.85-6.95 with pH 4.0 acetate buffer, turn on the circulating cooling system to cool down the plasma, wait for the plasma to After cooling down to 0°C, add 95% ethanol (v / v) at -16°C; add ethanol at a rate of 55L / h, so that the final ethanol concentration of the product reaches 20% by volume (v / v). During the process of adding ethanol, the temperature Never higher than 0°C, the final plasma temperature is controlled at -5.2~-5.3°C, continue to stir for 2.5 ho...

Embodiment 2

[0046] The present invention can also be realized by the following steps in implementation:

[0047] (1) Merging and melting of plasma: After breaking the bag, put it into a clean melting tank, open the melting tank, stir and melt the temperature controller, and make the plasma in the melting tank melt when the water temperature is less than 35°C. Keep it at 0℃~4℃;

[0048] (2) Production of components I+II+III and pressure filtration separation: Measure the volume of the combined plasma, adjust the pH of the mixed plasma to 6.85 with pH 4.0 acetate buffer, turn on the circulating cooling system to cool the plasma, wait until the plasma is cooled to After 0°C, add ethanol with a mass concentration of 95% below -15°C; add ethanol at a rate of ≤60L / h, so that the final ethanol concentration of the product reaches a volume ratio of 20% (v / v). During the process of adding ethanol, the temperature remains constant It should not be higher than 0°C, and the final plasma temperature ...

Embodiment 3

[0062] In specific implementation, the present invention can also be realized by the following steps:

[0063] (1) Merging and melting of plasma: After breaking the bag, put it into a clean melting tank, open the melting tank, stir and melt the temperature controller, and make the plasma in the melting tank melt when the water temperature is less than 35°C. Keep it at 2~3℃;

[0064] (2) Production of components I+II+III and pressure filtration separation: measure the volume of the combined plasma, adjust the pH of the mixed plasma to 6.9 with pH 4.0 acetate buffer, turn on the circulating cooling system to cool the plasma, and wait until the plasma is cooled to After 0°C, add ethanol with a mass concentration of 95% at -17°C; add ethanol at a rate of 60L / h, so that the final ethanol concentration of the product reaches a volume ratio of 20% (v / v). During the process of adding ethanol, the temperature should not be higher than 0°C, the final plasma temperature is controlled at...

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Abstract

The invention relates to a method for extracting human serum albumin from plasma and increasing the yield. By adoption of the method, the problems of extracting recovered human serum albumin from the plasma and increasing the yield can be effectively solved. The adopted technical scheme is as follows: the method comprises the following steps of: combination and melting of the plasma, preparation and pressing filtration of components I, II and III, preparation and pressing filtration of a component IV, preparation and pressing filtration of a component V, precipitation, dissolving and filtration of the component V, refined purification of the component V, ultrafiltration dialysis and concentration, preparation, pasteur inactivation, bacteria removal and filling, incubation and verification; the preparation and pressing filtration of the component IV comprise the following steps of: adding physiological saline with the temperature of 0 DEG C and the volume of 1/10 of that of the supernatant of the prepared components I, II and III, using acetate buffer solution with pH of 4.0 to adjust the pH value of the solution to 5.80-5.90, adding alcohol with the temperature of minus 15 DEG C and the volume concentration of 95%, and enabling the final volume concentration of the alcohol to reach 40%. The method has the advantages that the production process is smoother and simple, the yield of the human serum albumin is increased and the economic and social benefits are large.

Description

technical field [0001] The invention relates to biopharmaceuticals, in particular to a method for extracting human serum albumin from blood plasma and increasing the yield. Background technique [0002] Human albumin is the most important functional protein in human blood. Its main physiological function is to regulate the osmotic pressure of the human body and the transport of substances in the metabolism. It plays a very important role in the treatment of a large amount of body fluid loss caused by burns and other reasons. , In addition, human albumin also plays a role in nutrient supply, transportation and detoxification, as well as colloidal protection and stability of other plasma proteins. [0003] At present, most manufacturers of blood products in the world use low-temperature ethanol method to produce human serum albumin. This kind of technology is low-temperature ethanol fractional precipitation technology, which effectively controls five factors of protein precipi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07K14/765C07K1/34
CPCC07K14/765
Inventor 雷文成吕勇时凯陈惠珍
Owner BANGHE PHARMA CO LTD
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