Preparation method of human serum albumin and human serum albumin

A technology of human serum albumin and processing method, which is applied in the field of biological products, can solve problems such as dyspnea, patient blood pressure drop, flushing, etc., and achieve the effect of stable process, easy operation, and improved safety and effectiveness

Inactive Publication Date: 2017-09-29
TONROL BIOLOGICAL PHARM CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Clinically, in the process of using blood products containing a large amount of PKA (such as human serum albumin, etc.), it will cause adverse reactions such as blood pressure drop, flushing, dyspnea, etc.

Method used

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  • Preparation method of human serum albumin and human serum albumin
  • Preparation method of human serum albumin and human serum albumin

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] 1. Plasma acquisition

[0024] Collect plasma from healthy people through our company's plasmapheresis station

[0025] 2. Plasma collection

[0026] According to the requirements of the production instructions, the required quantity of 7983.585kg of qualified plasma was extracted.

[0027] 3. Plasma pooling and thawing

[0028] In a Class D clean factory, control the temperature of the dissolving water to <37°C, and use the water bath melting method for plasma melting. The temperature of the thawed plasma was <4°C.

[0029] 4. Ethanol precipitation and filtration separation of components Ⅰ+Ⅱ+Ⅲ

[0030] After accurately measuring the volume of the thawed plasma to 7549L, dilute it to 8305L with 0.9% NaCl solution 0.1 times the plasma volume, adjust the pH to 6.3 with pH4.0 buffer, add 2216L of 95% ethanol below -15°C, and the final temperature Control at -5°C; add diatomaceous earth to the reaction solution at a rate of 20 g / L, and separate the solid and liquid wit...

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Abstract

The invention provides a preparation method of human serum albumin and the human serum albumin. The preparation method of the human serum albumin comprises the following steps: I, extracting supernatant of a component IV from human plasma with a low-temperature ethanol method to serve as a raw material; II, performing fine-filtering treatment on the supernatant of the component IV; III, adjusting the pH of clear liquor obtained by fine-filtering treatment to obtain precipitate of a component V; IV, dissolving the precipitate of the component V and purifying to obtain finished human serum albumin. By adopting the preparation method, the prekallikrein activator content of the finished human serum albumin is lower than or equal to 12IU/ml, and the polymer content is lower than or equal to 2 percent. The preparation method has the advantages of easiness and convenience in operation and stable process in production and application, and the quality of a final product is higher than the national standard.

Description

technical field [0001] The invention belongs to the technical field of biological products, and relates to a preparation method of human serum albumin and human serum albumin prepared by the method. Background technique [0002] Human serum albumin is a protein preparation extracted from the plasma of healthy people. Human serum albumin is mainly used for shock caused by blood loss, trauma and burns, cerebral edema and increased brain pressure caused by brain damage. And edema or ascites caused by liver cirrhosis or nephropathy has a good curative effect, and it is an essential drug for saving lives and healing the wounded. At present, the low-temperature ethanol process is mainly used in China for separation and purification. The parameters and process steps of the low-temperature ethanol process used by different manufacturers are slightly different, so the quality of human albumin products sold in the market is different. Prokallikrein activator (PKA) and multimer conten...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07K14/765C07K1/36C07K1/34C07K1/30
CPCC07K14/765
Inventor 米长明谢长福胡辉恒
Owner TONROL BIOLOGICAL PHARM CO LTD
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