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Method for preparing intravenous immunoglobulin

A technology of intravenous injection of human immunoglobulin, which is applied in the field of preparation of intravenous human immunoglobulin, can solve the problems of low purity, increased risk, and adverse reactions of intravenous injection of human immunoglobulin, so as to reduce the risk of medication and ensure medication safe effect

Active Publication Date: 2015-04-01
SHENZHEN WEIGUANG BIOLOGICAL PROD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This traditional production process uses a two-step method to extract intravenous human immunoglobulin. The biggest defect is that the produced intravenous human immunoglobulin has low purity and high polymer content, which is easy to cause adverse reactions after infusion. reaction
Because the molecular weight of the polymer is large, it can cause anaphylactoid reaction, anti-complement activity and blood pressure drop. With the deepening of research, its treatment range is increasing, such as skin diseases, organ transplantation, tumors, leukemia, etc. Some patients need Long-term use or single bolus infusion, where the risk is greatly increased

Method used

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  • Method for preparing intravenous immunoglobulin
  • Method for preparing intravenous immunoglobulin
  • Method for preparing intravenous immunoglobulin

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0088] Step 1: Dissolution of Component I+II+III Precipitate

[0089] 56.3 kg of components I+II+III were stirred with 394.54 kg of 0.7°C aqueous solution containing 0.54 kg of sodium dihydrogen phosphate (containing 0.54 kg of sodium dihydrogen phosphate and 394.0 kg of water for injection) for more than 6 hours until completely dissolved to obtain the composition Divide 450.8kg of I+II+III precipitation solution.

[0090] Step 2: Separation of Component I+III-1 Precipitation

[0091] Use 3.0kg of 1mol / L acetic acid solution to adjust the pH value of the above component I+II+III precipitation solution to 5.03, use -15°C refrigerant to cool down to -0.4°C, and then add -20.8°C 95% (v / v) ethanol Solution 28.2kg, and use 0.5mol / L sodium hydroxide solution to adjust the pH value to 5.12, use -15°C refrigerant to adjust the final suspension temperature to -2.6°C, stir at a stirring speed of 90rpm for 2 hours, add diatomaceous earth after the reaction is complete 1.9kg and 1.2kg ...

Embodiment 2

[0111] Step 1: Dissolution of Component I+II+III Precipitate

[0112] Precipitate 56.0kg of component I+II+III with an aqueous solution containing sodium dihydrogen phosphate at 1.1°C (containing 0.54kg of sodium dihydrogen phosphate, 391.7kg of water for injection) and stir for more than 6 hours until completely dissolved to obtain component I+II +III precipitation solution 448.2kg.

[0113] Step 2: Separation of Component I+III-1 Precipitation

[0114] Use 2.9kg of 1mol / L acetic acid solution to adjust the pH value of the above-mentioned component I+II+III precipitation solution to 5.10, use -15°C refrigerant to cool down to -0.3°C, and then add -20.5°C 95% (v / v) ethanol Solution 28.0kg, and use 0.5mol / L sodium hydroxide solution to adjust the pH value to 5.13, use -15°C refrigerant to adjust the final suspension temperature to -2.9°C, stir at a stirring speed of 82rpm for 2.8 hours, add diatomaceous earth after the reaction is complete 1.9kg and 1.2kg of perlite were stir...

Embodiment 3

[0134] Step 1: Dissolution of Component I+II+III Precipitate

[0135] Precipitate 54.6 kg of component I+II+III with 3.1°C aqueous solution containing sodium dihydrogen phosphate (containing 0.53 kg of sodium dihydrogen phosphate, 382.1 kg of water for injection) and stir for more than 6 hours until completely dissolved to obtain component I+II +III precipitation solution 437.3kg.

[0136] Step 2: Separation of Component I+III-1 Precipitation

[0137] Use 2.9kg of 1mol / L acetic acid solution to adjust the pH value of the above-mentioned component I+II+III precipitation solution to 5.06, use -15°C refrigerant to cool down to -0.2°C, and then add -20.8°C 95% (v / v) ethanol Solution 27.3kg, and adjust the pH value to 5.19 with 0.5mol / L sodium hydroxide solution, adjust the final suspension temperature to -3.0°C with -15°C refrigerant, stir at a stirring speed of 83rpm for 2.1 hours, add diatomaceous earth after the reaction is complete 1.9kg and 1.2kg of perlite, stirred at a st...

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Abstract

The invention provides a method for preparing the intravenous immunoglobulin. The method particularly includes the steps of dissolving component I+II+III or component II+III sediments; separating component I+III-1 or component III-1 sediments; separating component I+III-2 or component III-2 sediments; separating component II sediments; dissolving and filtering the component II sediments; conducting ultrafiltration, dialyzing and concentrating; conducting purification and filtering; conducting ultrafiltration dialysis, concentrating and preparation. By means of the method, steps and step parameters of the traditional process method are improved, specific combinations of the steps and the step parameters can be used for effectively extracting the human immunoglobulin for the intravenous injections from the component I+II+III or component II+III sediments, the technical problems that the human immunoglobulin for the intravenous injections is low in purity, and the content of polymer and the like is slightly high are solved, the pharmacy risk of people is reduced, and the pharmacy safety of people is guaranteed.

Description

technical field [0001] The invention relates to the field of biopharmaceuticals, in particular to a preparation method for intravenous injection of human immunoglobulin. Background technique [0002] Immunoglobulin is a glycoprotein synthesized and secreted by B lymphocytes. It mainly exists in the circulatory system and is also distributed on the cell surface. The main function of immunoglobulin is to resist the infection of various pathogenic microorganisms on the human body. Mainly used for: ① primary and secondary immunodeficiency diseases; ② idiopathic thrombocytopenic purpura; ③ Kawasaki disease; ④ AIDS treatment; ⑤ other indications, such as diabetes, rheumatoid arthritis, myasthenia Weakness, autoimmune anemia, aplastic anemia, etc. The immunoglobulin production process is a low-temperature ethanol protein separation process researched and developed by Professor Cohn of Harvard Medical School. This technology adjusts the five elements of the low-temperature ethanol...

Claims

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Application Information

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IPC IPC(8): C07K16/06C07K1/34
Inventor 张战吕东升骆远艺郑庭均王锦才邹延平谢文杰
Owner SHENZHEN WEIGUANG BIOLOGICAL PROD
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