Method for preparing immune globulin against lymphocyte of human

A technology of immunoglobulin and lymphocytes, which is applied in the field of preparation of anti-human T cell pig immunoglobulin, can solve the problems of ammonium sulfate salting-out method backward technology, difficulty for ordinary staff to master, and various chemical reagents, etc., and achieve reduction Effects of red blood cell hemolysis reaction, shortened production cycle, and easy control of reaction conditions

Active Publication Date: 2008-11-26
武汉中生毓晋生物医药有限责任公司
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Problems solved by technology

[0003] The current technology for producing anti-human T cell porcine immunoglobulin is the ammonium sulfate salting out method. The problems in this method are: 1. It is difficult to produce on a large scale and the yield is low; 2. There is a lot of waste in the production process; 3. The products in the production process 4. The production cost is high; 5. The process of ammonium sulfate salting out method is relatively backward, the production process is relatively complicated, and there are many chemical reagents to be used, which are difficult for ordinary workers to master in a short time ; 6. Long production cycle and high equipment occupancy rate

Method used

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  • Method for preparing immune globulin against lymphocyte of human

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Embodiment 1

[0038] Embodiment 1 prepares anti-human T cell pig immunoglobulin according to the following process:

[0039] 1. Prepare immune plasma: Use human peripheral blood T lymphocytes or human thymocytes to immunize healthy pigs, collect and separate pig plasma after passing the inspection.

[0040]2. Production of 20% ethanol: Accurately weigh the amount of pig plasma, pour it into a large stainless steel tank, start the stirring paddle to stir slowly, add 20% to 30% of 0.85% physiological sodium chloride solution according to the amount of plasma, stir evenly, and add pH4. 0 acetate buffer solution to adjust the pH value of the mixed solution to 6.0±0.50, then lower the temperature of the mixed solution to -4.0°C±-1.0°C, add 95% ethanol, the temperature of ethanol should not be lower than -25°C, add Complete ethanol, after continuing to stir for 2 hours, stop stirring and stand still for 8 hours.

[0041] 3. Precipitation and separation of components I+II+III: Use a low-temperatu...

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Abstract

The invention provides a preparation method for anti-lymphocyte immunoglobulin, which has the steps that human peripheral blood T lymphocytes or human thymocyte is used for immunizing healthy pigs for collecting and separating porcine plasma; after the manufacturing with 20 percent of ethanol, components I plus II plus III deposit is separated by a low-temperature high-speed centrifuge or a filter press; after the manufacturing with 14 percent of ethanol, supernatant fluid is separated and collected; after the manufacturing with 25 percent of ethanol and component II deposit is separated; subsequently, anti-T cell porcine immunoglobulin is obtained after the steps of refinement, configuration and virus inactivation of immunoglobulin, etc. Compared with the currently used ammonium sulfate precipitation method, the technology of the invention has the advantages of mass production, simple operation, easy command, short production period, little reagent usage, low cost, no pollution, and the like, which overcomes the disadvantages of the existing technology of hard realization of large-scale production, low yield, serious waste, environment pollution, high production cost, complex production process, various service chemical agents, long production period, high equipment occupation rate, etc.

Description

technical field [0001] The invention relates to a preparation method of immunoglobulin, in particular to a preparation method of anti-human T cell pig immunoglobulin (ALG-P). Background technique [0002] Anti-human T-cell porcine immunoglobulin is a specific biological immunosuppressant for lymphocytes and their functions. This product is a specific immunoglobulin extracted from human lymphocytes immunized pigs and its plasma. It is mainly used for the prevention and treatment of immune rejection in clinical organ transplantation, the prevention of graft-versus-host reaction in bone marrow transplantation, and the treatment of aplastic anemia and other diseases; autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura and other immune disease can also be tried. [0003] The current technology for producing anti-human T cell porcine immunoglobulin is the ammonium sulfate salting out method. The problems in this method are: 1. It is difficult to produce on a large sc...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07K16/42A61K39/395A61P37/06
Inventor 余健吴笛宰家敏张伟华徐江峰
Owner 武汉中生毓晋生物医药有限责任公司
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