Preparation method of anti-human lymphocyte immunoglobulin
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An immunoglobulin and lymphocyte technology, which is applied in the field of preparation of anti-human T cell porcine immunoglobulin, can solve the problems of backward ammonium sulfate salting-out method, difficult for ordinary staff to grasp, and high equipment occupancy rate, and achieves reduction of Effects of red blood cell hemolysis, shortened production cycle, and easy collection
Active Publication Date: 2011-11-30
武汉中生毓晋生物医药有限责任公司
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[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
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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 the 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-tempe...
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Abstract
The invention provides a preparation method of anti-human lymphocyte immunoglobulin, which comprises the steps of: immunizing healthy pigs with human peripheral blood T lymphocytes or human thymocytes, collecting and separating pig plasma, making it with 20% ethanol, and using A low-temperature high-speed centrifuge or a filter press separates the precipitate of component I+II+III, and after making it with 14% ethanol, separates and collects the supernatant, and then makes it with 25% ethanol, separates the precipitate of component II, and then The anti-human T cell porcine immunoglobulin can be obtained through steps such as immunoglobulin purification, configuration and virus inactivation. Compared with the currently used ammonium sulfate salting-out method, the process of the present invention has the advantages of mass production, simple operation and easy mastery, short production cycle, less reagents used, low cost, no environmental pollution, etc., and overcomes the difficulties existing in the existing process. Large-scale production, low output, large waste, environmental pollution, high production cost, complicated production process, various chemical reagents used, long production cycle, high equipment occupancy 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...
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