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Preparing technology for human immune globulin

A technology of human immunoglobulin and preparation process, which is applied in the field of blood products, can solve the problems of immunoglobulin loss and other problems, and achieve the effect of simple steps, reduced loss, 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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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0003] However, compared with developed countries, my country still has a big gap in high-tech research and development or clinical application research.
Most of the production processes currently used in China are the traditional ethanol multi-layer separation method to extract immunoglobulins. Although the purity of immunoglobulins obtained by this process is high, it also inevitably causes the loss of immunoglobulins

Method used

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  • Preparing technology for human immune globulin
  • Preparing technology for human immune globulin

Examples

Experimental program
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Effect test

Embodiment 1

[0019] Embodiment 1: Prepare rabies patient immunoglobulin by the present invention

[0020] (1) Plasma thawing: Melt 100 servings of raw plasma with a rabies surface antibody titer ≥ 8IU / mL at 0-4°C;

[0021] (2) Separation of components Ⅰ+Ⅱ+Ⅲ from plasma: Dilute the plasma with 0.1mol / L NaCl solution, the dilution end point is that the protein content is 4.5%~5.5%, and then adjust the plasma pH with pH 4.0 acetate buffer 5.50~6.00, cool down to below 0°C and start spraying 95% ethanol below -15°C, so that the final ethanol concentration of the reaction solution reaches 25% (v / v), and the final temperature of the product is controlled at -2.0~-3.0°C, continue to stir for 2 After 1 hour, add diatomite and use a filter press to filter under pressure. The maximum liquid inlet pressure should not exceed 0.20Mpa, and press filter to obtain components Ⅰ+Ⅱ+Ⅲ;

[0022] (3) The first step of chromatography: dissolve the components I+II+III obtained in step (2) with NaCl solut...

Embodiment 2

[0028] Example 2: The process steps of preparing hepatitis B human immunoglobulin, tetanus human immunoglobulin and anti-D human immunoglobulin by this method are the same as those in Example 1.

Embodiment 3

[0029] Embodiment 3: Comparison of product parameters between the preparation process of the present invention and the traditional ethanol multi-stage separation preparation process:

[0030] rabies immunoglobulin

[0031]

[0032] Hepatitis B Human Immunoglobulin

[0033]

[0034] It can be seen from the table that the quality and yield of human immunoglobulin prepared by this process are better than those prepared by traditional ethanol multistage separation.

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Abstract

The invention discloses a preparing technology for human immune globulin. The preparing technology includes the steps of (1) separating a component I, a component II and a component III from plasma, (2) primary chromatography, (3) primary separation, (4) secondary chromatography, (5) ultrafiltration, (6) preparing a semi-finished product and (7) preparing a finished product. One-step separation and two-step chromatography are adopted for extracting and purifying the globulin, compared with a traditional ethyl alcohol multi-level separation technology, the preparing technology is simple and convenient and rapid to carry out, and meanwhile the prepared human immune globulin is high in yield and purity and good in quality.

Description

technical field [0001] The invention relates to a preparation process of human immunoglobulin, which belongs to the field of blood products. Background technique [0002] Human plasma protein products are valuable human-derived biological drugs. Since Professor Cohn established the low-temperature ethanol separation process for industrial-scale separation of plasma proteins in the 1940s, the development of blood products, especially clinical applications, market share, product safety and production processes have undergone qualitative leaps. [0003] However, compared with developed countries, my country still has a big gap in high-tech research and development or clinical application research. Most of the production processes currently used in China are the traditional ethanol multi-layer separation method to extract immunoglobulins. Although the purity of immunoglobulins obtained by this process is high, it also inevitably causes the loss of immunoglobulins. [0004] In ...

Claims

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Application Information

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IPC IPC(8): C07K16/08C07K16/10C07K16/12C07K16/18C07K16/06C07K1/36C07K1/30C07K1/16
Inventor 吕献忠苏峰
Owner 新疆德源生物工程有限公司
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