Method for rapidly extracting human immunoglobulin from blood plasma

Abstract

The invention relates to the technical field of biological products, in particular to a method for rapidly extracting human immunoglobulin from blood plasma. According to the invention, plasma is usedas a raw material, octanoic acid with a specific concentration is adopted for direct precipitation, the component reaction steps are reduced, and the final product is good in quality and high in yield and basically does not contain activated blood coagulation factor XI and other impurities, which can effectively avoid the thrombogenic risk in the process of product use, and reduce the athromboticadverse reaction of the product. The production method is simple, the process period is short, component reaction steps in a plasma low-temperature ethanol process are not needed, the immunoglobulincan be rapidly prepared, the method is particularly suitable for preparing specific immunoglobulin for sudden large-scale epidemic infection, and the specific immune antibody preparation with high efficiency and high safety can be quickly provided for patients.

Description

technical field [0001] The invention relates to the technical field of biological products, in particular to a method for rapidly extracting human immunoglobulin from blood plasma. Background technique [0002] Human immunoglobulin (Immunoglobulin, Ig) is the main substance of the human body's immune response to foreign antigens (such as bacteria, viruses and their toxins or foreign substances), also known as antibodies. Immunoglobulins can be divided into 5 categories according to their structures, named IgG, IgA, IgM, IgD and IgE respectively. Among them, IgG has the highest content, accounting for about 70-80% of the total serum immunoglobulins, and is an important plasma immunoglobulin. one of protein. [0003] Human immunoglobulin can be made into injections to supplement various antibodies needed by the human body and improve the body's ability to resist disease and infection. It is mainly divided into ordinary immunoglobulins and specific immunoglobulins. Ordinary i...

AI Technical Summary

Problems solved by technology

The preparation method has complicated process steps, and the required raw material component II needs to be prepared through component I, component II+III, component II reaction and multi-step component separation steps, and component II is further dissolved, chromatographed and virus Only inactivation can make the final product. The product manufacturing cycle is long, and immunoglobulin preparations cannot be prepared quickly, so as to play the important therapeutic role of immunoglobulin, especially specific immunoglobulin, in the case of sudden epidemic infection.

[0005] In addition, according to the research, it is found that in the existing product preparation process, due to the low-temperature ethanol reaction, a certain amount of blood coagulation factors will remain in the plasma protein components, and will enter the final product during the preparation process, especially blood coagulation factor XI, An important reason for the risk of thrombosis in immunoglobulin preparations

Therefore, safe immunoglobulin preparations for clinical use should be products that do not contain coagulation factors. However, the existing low-temperature ethanol process has been used for many years, and there is no specific removal step for coagulation factors. If you want to specifically remove coagulation factors, Special removal steps are required, and new reagents are usually used, which will lead to the introduction of new impurities and prolong the overall preparation time, such as patent CN201210071691.5 (a preparation process for intravenous injection of human immunoglobulin)