Preparation process of human immunoglobulin for intravenous injection

Abstract

The invention relates to the field of medicine, in particular to a preparation process of human immunoglobulin for intravenous injection. Octanoic acid is used for replacing ethanol as a precipitatingagent, so that acidic protein in blood plasma generates precipitates; IgG molecules with high isoelectric points are reserved on supernate; only through one-step precipitation reaction, the materialscan be transferred to a chromatography working procedure; caprylate is used; lipid envelope viruses are inactivated under the mild condition in short time; even partial non-lipid envelope viruses canbe inactivated; the action time is short; the effect is good; the bioactivity of the immunoglobulin cannot be easily influenced; the product safety is improved; the quality and the yield of the product are ensured; a two-step chromatography working procedure is used; most partial polymers and other impure protein are removed; the pyrogen is reduced; chromoprotein such as ceruloplasmin can be adsorbed; the product appearance is effectively improved; one-step precipitation reaction is used; the loss is reduced; the product yield is improved; the preparation process of human immunoglobulin for intravenous injection has the advantages of high product yield, high purity and high safety.

Description

technical field [0001] The invention relates to the field of biopharmaceuticals, in particular to a preparation process for intravenous injection of human immunoglobulin. 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. The content in plasma is about 6.6-14.5g / L. IgG is mainly synthesized by plasma cells in the spleen and lymph nodes. It is composed of four peptide chain molecules, and the peptide chains are connected by disulfide bonds. The relative molecular mass is 150kD. [0003] The active i...

AI Technical Summary

Problems solved by technology

[0004] At present, in the preparation process of intravenous human immunoglobulin, S / D is often used to inactivate (some foreign blood product companies choose to inactivate the virus for 6 hours at 30°C), or use nano-membrane filtration to remove the virus, However, the S / D inactivation takes a long time and the effect is relatively general, which is likely to affect the biological activity of intravenously injected human immunoglobulin. When using nano-membrane filtration to remove viruses, some viruses cannot be effectively removed, which affects the safety of clinical use of the product.

Images