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Preparing method of human serum albumin

A human albumin and product technology, applied in the field of human albumin preparation, can solve problems such as inability to apply, and achieve the effects of reducing the load of miscellaneous proteins, shortening the process time, and improving safety

Active Publication Date: 2015-11-11
SHANDONG TAIBANG BIOLOGICAL PROD CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, it is reported that this method can only process 13L supernatant, which cannot be applied in actual production

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] (1) Separation of components FI+II+III

[0037] When feeding slurry, control the circulating water temperature of the slurry tank at 35°C and the plasma temperature at 2°C. Dilute the plasma protein concentration to 4.5% with normal saline, then adjust the plasma pH to 5.90 with 2mol / L acetate buffer, add ethanol until the ethanol concentration of the product is 19.0%, add acetate buffer to pH 5.90, adjust Plasma temperature is -5 ℃, let stand for 10h.

[0038] Add perlite and diatomaceous earth to the blood plasma, stir evenly, and filter in depth. The obtained supernatant is the component FI+II+III supernatant.

[0039] (2) Component FIV separation

[0040] Add water for injection containing 19% ethanol concentration and 0.12mol / L sodium chloride to the supernatant of component FI+II+III, further dilute the protein concentration to 2%, and add ethanol until the ethanol concentration of the finished product is 40.0%. Adjust the pH to 5.90 with 2mol / L acetic acid bu...

Embodiment 2

[0051] (1) Treatment of supernatant after separation of fraction FIV

[0052] The fraction FIV supernatant was dealcoholized with a 10KDa ultrafiltration membrane bag, and the ultrafiltration diluent was sodium citrate 5mmol / L, pH4.6 buffer. Ultrafiltration was performed until the ethanol concentration of the supernatant was 10%, the conductivity was 3.5mS / cm, and the protein content was 25mg / ml. The pH was adjusted to 4.6 with 0.3mol / L hydrochloric acid solution to obtain the refined supernatant after FIV separation.

[0053] (2) Ion exchange chromatography

[0054] Pack the CaptoDEAE gel into the chromatography column. The ratio of column bed volume to sample volume is 1:40. The chromatographic column was equilibrated for 3 column volumes with a buffer solution containing 5 mmol / L sodium citrate and pH 4.6. The refined supernatant after FIV separation is pumped into the chromatographic column after being filtered through a 0.2 μm online membrane. The chromatography colum...

Embodiment 3

[0058] (1) Treatment of supernatant after separation of fraction FIV

[0059] The fraction FIV supernatant was dealcoholized with a 10KDa ultrafiltration membrane bag, and the ultrafiltration diluent was sodium citrate 5mmol / L, pH6.9 buffer. Ultrafiltration was performed until the ethanol concentration of the supernatant was 10%, the conductivity was 3.5mS / cm, and the protein content was 40mg / ml. The pH was adjusted to 6.9 with 0.3mol / L sodium hydroxide solution to obtain the refined supernatant after FIV separation.

[0060] (2) Ion exchange chromatography

[0061] Pack the CaptoDEAE gel into the chromatography column. The ratio of column bed volume to sample loading product volume is 1:20. The chromatographic column was equilibrated for 3 column volumes with a buffer solution containing 5 mmol / L sodium citrate and pH 6.9. The refined supernatant after FIV separation is pumped into the chromatographic column after being filtered through a 0.2 μm online membrane. The chrom...

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Abstract

The invention relates to the technical field of biological product and blood product production, and mainly relates to a separation and purification method of human serum albumin in the blood product production, in particular to a preparing method of human serum albumin. According to the method, healthy plasma supernatant is used as raw materials; a Kistler-Nitchmann low-temperature ethanol method is adopted for precipitating and separating ingredients FI+II+III and ingredients FIV; supernatant after the ingredient FIV separation is subjected to dealcoholization treatment; then, one-step ion exchange chromatography and ultrafiltration are further performed; a proper amount of sodium caprylate is added as a stabilizer; after the Pasteur virus inactivation treatment is performed, the human serum albumin finished product is obtained. Through efficient liquid chromatography detection, the purity of the human serum albumin prepared by the process is higher than 99 percent; the polymer content is lower than or equal to 1 percent; the yield of the plasma reaches 28 to 30g / L. The purity of the product is higher; the impurity protein content is lower, so that the clinical medication is safer.

Description

technical field [0001] The invention relates to the technical field of production of biological products and blood products, and mainly relates to a method for separating and purifying human serum albumin in the production of blood products, in particular to a method for preparing human serum albumin. Background technique [0002] The main physiological function of human serum albumin is to regulate the osmotic pressure of the human body and act as an important material transport carrier in the metabolism. It has a good curative effect on the prevention and treatment of hypoproteinemia, edema or ascites caused by liver cirrhosis or kidney disease. [0003] At present, the method for preparing human serum albumin from human plasma is mainly a low-temperature ethanol process based on the Cohn-Oncley method or the Kistler-Nitschmann method. The low-temperature ethanol process used by most domestic blood product manufacturers to prepare human albumin mainly includes as describe...

Claims

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Application Information

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IPC IPC(8): C07K1/34C07K1/30C07K1/18
Inventor 井金荣范加金周安陈晨刘志远吴菲菲刘文杰刘兆路张翠萍巩艳艳菅长永马山
Owner SHANDONG TAIBANG BIOLOGICAL PROD CO LTD
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