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Technology for preparing hepatitis B human immunoglobulin for intravenous injection

A technology of human immunoglobulin and hepatitis B, which is applied in the direction of antiviral immunoglobulin and peptide preparation methods, medical preparations of non-active ingredients, etc. Hepatitis surface antibody titer impact and other issues, to achieve the effect of broad market application prospects, high virus safety, and high purity

Active Publication Date: 2014-08-27
新疆德源生物工程有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The current manufacturers of intravenous hepatitis B human immunoglobulin use the method of low-temperature ethanol separation of proteins, by changing the solution pH, temperature and ethanol concentration for protein separation and purification, but this method will affect the titer of hepatitis B surface antibodies impact, and when the IgA and IgM in the product are too high, it will affect the curative effect of the product. For example, the IgA content is the primary unsafe factor for patients lacking IgA, and may cause immediate hypersensitivity reactions. It is necessary to reduce the content of such ingredients

Method used

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  • Technology for preparing hepatitis B human immunoglobulin for intravenous injection
  • Technology for preparing hepatitis B human immunoglobulin for intravenous injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Embodiment 1, utilize above-mentioned method to produce intravenous hepatitis B human immunoglobulin:

[0026] (1) Plasma thawing: Thaw raw plasma with hepatitis B surface antibody titer ≥ 8IU / ml at 0-4°C;

[0027] (2) Component separation: Dilute the plasma in step (1) with 0.85% by mass sodium chloride solution to a protein content of 4.5%~5.5%, adjust the pH value to 7.0, add 95% ethanol to The ethanol concentration of the reaction solution is 25%, the temperature of the reaction solution is controlled at -2~-3°C, and pressure filtration is performed to obtain the precipitation of component I;

[0028] (3) Octanoic acid precipitation: Dissolve the component I precipitate in step (2) with 2 times the amount of 0.06M acetate buffer, then adjust the pH to 4.8 with 1mol / L acetic acid, slowly add octanoic acid or caprylate to precipitate, Filtrate is collected by filtration;

[0029] (4) The first step of chromatography: adjust the filtrate in step (3) to pH 6.2 with ph...

Embodiment 2

[0034] Embodiment 2, this preparation method inactivated virus technique compares with low pH hatching put inactivated virus technique:

[0035]

[0036] Therefore, the virus inactivation method used in this process is more effective than the traditional low pH virus inactivation method.

Embodiment 3

[0037] Embodiment 3, preparation technique of the present invention and traditional ethanol separation preparation technique gained product parameter comparison:

[0038]

[0039] Therefore, the quality and yield of the intravenously injected hepatitis B human immunoglobulin prepared by this process are better than those prepared by traditional ethanol separation.

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Abstract

The invention discloses a technology for preparing hepatitis B human immunoglobulin for intravenous injection. The protein is purified through caprylic acid precipitation and chromatography, and meanwhile viruses are removed through the S / D inactivation method and DV50 nanometer films. Compared with a traditional technology, the technology for preparing hepatitis B human immunoglobulin for intravenous injection is high in yield, purity and virus removal rate, safer and more effective.

Description

technical field [0001] The invention relates to a preparation process of hepatitis B human immunoglobulin for intravenous injection, belonging to the field of blood products. Background technique [0002] Hepatitis B immunoglobulin (HBIG) is a specific immune globule prepared by separating, purifying, and virus inactivating the plasma with high hepatitis B surface antibody titer collected after hepatitis B vaccine immunization health donors Protein, with specific passive immunity, can neutralize the hepatitis B surface antigen in the body and clear the virus. As early as the 1970s, France used the HevacB Pasteur vaccine to immunize volunteer blood donors to obtain the immune plasma required for the preparation of HBIG. In addition to France, the United States and other European countries have also developed HBIG and have been widely used in humans. my country began to develop HBIG in the late 1980s, and developed this blood product in the 1990s. It has been clinically prov...

Claims

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Application Information

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IPC IPC(8): A61K39/42A61K47/12C07K16/08C07K1/36C07K1/30C07K1/18C07K1/16A61P31/20
Inventor 吕献忠苏峰
Owner 新疆德源生物工程有限公司
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