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A method for extracting human serum albumin from component iv-2 precipitation

A human albumin, IV-2 technology, applied in the field of extracting human albumin, can solve problems such as waste

Active Publication Date: 2016-10-12
SHENZHEN WEIGUANG BIOLOGICAL PROD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The precipitate of component IV-2 separated in the above steps is usually discarded as waste after high-pressure sterilization. Due to many factors affecting the process of separation and precipitation, a certain amount of albumin co-precipitates in the precipitate of component IV-2 And they are discarded together, resulting in waste, and there is also a long-term tight supply and demand situation in the albumin market

Method used

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  • A method for extracting human serum albumin from component iv-2 precipitation
  • A method for extracting human serum albumin from component iv-2 precipitation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0060] This embodiment provides a method for extracting human serum albumin from component IV-2 precipitation, comprising the following steps:

[0061] Step 1: Dissolving Component IV-2 Precipitation

[0062] 105kg of the component IV-2 precipitate was stirred with 945kg of an aqueous solution containing 8.03kg of sodium chloride and 6.62kg of sodium citrate at 1.5°C for more than 6 hours until completely dissolved;

[0063] Step 2: Separation of Component IV-1 Precipitation

[0064] Use acetic acid-sodium acetate buffer solution of pH 4.0 (the preparation method of acetic acid-sodium acetate buffer solution is: take 1088.6g sodium acetate trihydrate, pour it into a 10L large vertical bottle, dissolve it with an appropriate amount of water for injection, shake it, and measure Get 2288ml of glacial acetic acid, join in the solution, add water for injection to 10 L, mix well and get it, the same below) 1.6kg Adjust the pH value of the solution solution of component IV-2 precip...

Embodiment 2

[0084] This embodiment provides a method for extracting human serum albumin from component IV-2 precipitation, comprising the following steps:

[0085] Step 1: Dissolving Component IV-2 Precipitation

[0086]Precipitate 102kg of component IV-2 with 918kg of aqueous solution containing 7.80kg of sodium chloride and 6.43kg of sodium citrate at 1.7°C and stir for more than 6 hours until completely dissolved;

[0087] Step 2: Separation of Component IV-1 Precipitation

[0088] Use 1.6 kg of acetic acid-sodium acetate buffer solution with pH 4.0 to adjust the pH value of the solution solution of component IV-2 precipitation in step 1 to 6.08, use -15 ° C refrigerant to lower the temperature to -0.9 ° C, add -20.5 ° C 95 % (v / v) ethanol 487.4kg, adjust the pH value to 6.23 with 0.5mol / L sodium hydroxide solution, adjust the suspension temperature to -4.7°C with -15°C refrigerant, and stir for 2.2 hours at a stirring speed of 80rpm , use 923Kg of 40% balance liquid to balance and c...

Embodiment 3

[0108] This embodiment provides a method for extracting human serum albumin from component IV-2 precipitation, comprising the following steps:

[0109] Step 1: Dissolving Component IV-2 Precipitation

[0110] Component IV-2 precipitation of 106 kg was stirred with 954 kg of an aqueous solution containing 8.11 kg of sodium chloride and 6.68 kg of sodium citrate at 2.8 ° C for more than 6 hours until completely dissolved;

[0111] Step 2: Separation of Component IV-1 Precipitation

[0112]Use 1.6 kg of acetic acid-sodium acetate buffer solution with pH 4.0 to adjust the pH value of the solution solution of component IV-2 precipitation in step 1 to 6.01, use -15 °C refrigerant to lower the temperature to -0.8 °C, add -21.7 °C 95 % (v / v) ethanol 506.5kg, adjust the pH value to 6.28 with 0.5mol / L sodium hydroxide solution, adjust the suspension temperature to -5.4°C with -15°C refrigerant, and stir the reaction for 2.9 hours at a stirring speed of 87rpm , use 979Kg of 40% balance...

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Abstract

The invention discloses a method for extracting human albumin from component IV-2 sediment. The human albumin is prepared by the steps of dissolving component IV-2 sediment, separating component IV-1 sediment, separating the component IV-2 sediment, separating component V sediment, dissolving the component V sediment, filtering, performing ultra-filtration dialysis, concentrating, heating, purifying, filtering, performing ultra-filtration dialysis, concentrating and preparing. The steps are closely linked with each other, so that in the semi-finished human albumin product, the protein content is more than 20.1%, the purity is not less than 98.0% of the total amount of the protein, the pH value is 6.5-7.3, and the residual ethanol content is not more than 0.025g / 100ml.

Description

technical field [0001] The invention relates to the field of biopharmaceuticals, in particular to a method for extracting human serum albumin from component IV-2 precipitation. Background technique [0002] Albumin is the protein with the most content in human plasma, about 45g / L, accounting for 60% of the total plasma protein. It is one of the blood volume expanders commonly used in clinical practice. Plasma albumin mainly has two physiological functions: ① Maintain plasma colloid osmotic pressure, ② combine with various ligands (ligands), and play a transport function. [0003] The human albumin separation process is a low-temperature ethanol plasma fractionation technology developed by Professor Cohn of Harvard University in the United States. This technology adjusts the five elements of the low-temperature ethanol method through multiple steps: pH value, temperature, ethanol concentration, protein concentration, and ionic strength. To achieve step-by-step separation of ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07K14/765C07K1/34
CPCC07K14/765
Inventor 吕东升张战骆远艺郑庭均王锦才黄岳彬谢思艺
Owner SHENZHEN WEIGUANG BIOLOGICAL PROD