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Preparation technology of hepatitis B human immunoglobulin

A human immunoglobulin and preparation technology, applied in the direction of immunoglobulin, antiviral immunoglobulin, peptide, etc., can solve the problems of low purity and potential safety hazards of hepatitis B immunoglobulin, and achieve stable protein separation and purification effect of effect

Inactive Publication Date: 2018-03-06
ZHEJIANG HAIKANG BIOLOGICAL PROD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0003] The Chinese patent with application publication number CN101161232A and application publication date of April 16, 2008 discloses a preparation method for intravenous injection of human hepatitis B immunoglobulin. The purity of globulin is not high (about 93%), which has certain potential safety hazards

Method used

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  • Preparation technology of hepatitis B human immunoglobulin

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Embodiment 1: A kind of preparation technology of hepatitis B human immunoglobulin comprises the following steps:

[0027] (1) Preparation of Component II+III

[0028] According to the three-dose reimmunization immunization program in 0, 1, and 2 months, the plasma donors are immunized with hepatitis B vaccine, and the anti-HBs titer ≥ 8IU / ml of component II+III is obtained, and the anti-HBs titer of high titer raw plasma is ≥ 8IU / ml;

[0029] (2) Preparation of Component II

[0030]i. Separation of component III

[0031] ①Take component II+III prepared from high-titer raw material plasma, add 12 times the volume of water for injection, and dissolve at 5°C;

[0032] ②Adjust the pH to 5.15 with HAc-NaAc buffer;

[0033] ③Add ≤-15°C ethanol solution with a volume concentration of 95%, and adjust the volume concentration of ethanol to 18%;

[0034] ④ Adjust the temperature to -5.0°C to separate component III;

[0035] ⑤Filter the reaction solution using 5 μm and 2 μm...

Embodiment 2

[0054] Embodiment 2: a kind of preparation technology of hepatitis B human immunoglobulin, comprises the following steps:

[0055] (1) Preparation of Component II+III

[0056] According to the three-dose reimmunization immunization program in 0, 1, and 2 months, the plasma donors are immunized with hepatitis B vaccine, and the anti-HBs titer ≥ 8IU / ml of component II+III is obtained, and the anti-HBs titer of high titer raw plasma is ≥ 8IU / ml;

[0057] (2) Preparation of Component II

[0058] i. Separation of component III

[0059] ① Take component II+III prepared from high-titer raw material plasma, add 8 times the volume of water for injection, and dissolve at 3°C;

[0060] ②Adjust the pH to 5.10 with HAc-NaAc buffer;

[0061] ③Add ≤-15°C ethanol solution with a volume concentration of 92%, and adjust the volume concentration of ethanol to 19%;

[0062] ④ Adjust the temperature to -5.5°C to separate component III;

[0063] ⑤Filter the reaction solution using 5 μm and 2 ...

Embodiment 3

[0082] Embodiment 3: a kind of preparation technology of hepatitis B human immunoglobulin, comprises the following steps:

[0083] (1) Preparation of Component II+III

[0084] According to the three-dose reimmunization immunization program in 0, 1, and 2 months, the plasma donors are immunized with hepatitis B vaccine, and the anti-HBs titer ≥ 8IU / ml of component II+III is obtained, and the anti-HBs titer of high titer raw plasma is ≥ 8IU / ml;

[0085] (2) Preparation of Component II

[0086] i. Separation of component III

[0087] ① Take the component II+III prepared from high-titer raw material plasma, add 14 times the volume of water for injection, and dissolve at 7°C;

[0088] ②Adjust the pH to 5.20 with HAc-NaAc buffer;

[0089] ③Add ≤-15°C ethanol solution with a volume concentration of 98%, and adjust the volume concentration of ethanol to 17%;

[0090] ④ Adjust the temperature to -4.5°C to separate component III;

[0091] ⑤Filter the reaction solution using 5 μm a...

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Abstract

The invention discloses a preparation technology of a hepatitis B human immunoglobulin. The preparation technology comprises the following steps: preparing a component II and a component III; separating the component III: taking the component II and the component III that are prepared from a high potency raw material plasma, dissolving the component II and the component III with water for injection at low temperature, regulating the pH value to 5.00-5.30, the concentration of ethanol to 16-20% and the temperature to (-5.8)-(-4.0) DEG C, and filtering; separating the component II: taking filtrate, regulating the pH value to 7.20-7.55, the concentration of ethanol to 0.03-0.06% and the temperature to (-12.0)-(-8.0) DEG C, and filtering; purifying the component II: dissolving the component IIwith water for injection at low temperature, regulating the pH value to 6.45-7.10 and the conductivity to 1.2-1.5ms / cm, and performing chromatographic purification; regulating the pH value to 4.30-4.80, performing equimultiple dialysis and concentrating protein fluid to more than or equal to 60g.L; preparing an intermediate product; preparing a stock solution The preparation technology has an effect of improving the purity.

Description

technical field [0001] The invention relates to a preparation process of hepatitis B human immunoglobulin. Background technique [0002] Hepatitis B immunoglobulin (HBIG) is a specific immune globulin prepared by separating, purifying, and virus inactivating the plasma with high hepatitis B surface antibody titer collected after hepatitis B vaccine immunization by healthy plasma donors. Protein, which has specific passive immunity, can neutralize surface antigens in the body and clear the virus. Hepatitis B human immunoglobulin is an antibody drug against hepatitis B, which has important clinical application value in preventing vertical transmission of hepatitis B from mother to child and preventing accidental infection of hepatitis B. [0003] The Chinese patent with application publication number CN101161232A and application publication date of April 16, 2008 discloses a preparation method for intravenous injection of human hepatitis B immunoglobulin. The purity of globu...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07K16/08C07K1/36C07K1/34C07K1/16
CPCC07K16/082
Inventor 沈荣杰汤浩宇庄建芬李洪桥叶雪维
Owner ZHEJIANG HAIKANG BIOLOGICAL PROD