Method for preparing human immunoglobulin for intravenous injection

Abstract

The invention provides a method for preparing human immunoglobulin for intravenous injection. The method comprises the following steps of a, dissolving: taking a Cohn method F II precipitation; dissolving the precipitation in water for injection; performing clarifying filtration; adjusting the pH value to 6.60+ / -0.1; uniformly stirring; adjusting the electrical conductivity to 1.40+ / -0.05ms / cm; adjusting the temperature to 0-5DEG C, and uniformly stirring; b, performing chromatography: purifying by using a chromatographic column of DEAE Sepharose Fast Flow, and collecting human immunoglobulin component liquid; c, performing ultrafiltration: performing ultrafiltration and dialysis on flow penetrating liquid in the step b; when the osmotic pressure is lower than 30mOs mol / kg, concentrating the treated liquid until the protein concentration is 4.0 percent+ / -1 percent (w / v) to obtain concentrated solution; d, inactivating virus: adding sorbitol in the concentrated solution until the concentration is (33+ / -1) percent (w / v), adjusting the pH value to 5.00+ / -0.1; keeping the temperature 60+ / -0.5DEG C constant for 10 hours, cooling and performing clarifying filtration; e, performing ultrafiltration and dialysis and preparing to obtain the human immunoglobulin. The human immunoglobulin prepared by the method disclosed by the invention is high in purity; an Fc segment is high in biological activity and good in quality; IgA and other impurity factors are in low in content; the method has the advantages of few side effects, high yield and good market application prospect.

Description

technical field [0001] The invention belongs to the field of blood products, in particular to a method for preparing intravenous human immunoglobulin. Background technique [0002] Intravenous injection of human immunoglobulin (pH4, hereinafter referred to as IVIG) is the immunoglobulin component extracted from the plasma of healthy people by low-temperature ethanol protein separation, and refined through further processing and virus inactivation. IVIG has dual therapeutic effects of immune replacement and immune regulation, and is widely used clinically, and has remarkable effects in the treatment of primary or acquired immunoglobulin deficiency, bacterial infection, viral infection, blood system disease, Kawasaki disease, etc. [0003] In order to ensure the curative effect of IVIG clinical treatment, it is very important to carry out strict quality control. Pharmacopoeias in Europe, the United States and my country all have corresponding regulations on the quality control...

AI Technical Summary

Problems solved by technology

However, the content of IgA in the immunoglobulin preparation prepared by the current low-temperature ethanol process is relatively high, and patients with congenital selective IgA deficiency are prone to adverse reactions after infusion, which needs to be improved, such as the patent application document with the publication number CN102532307A The method disclosed in, the average IgA content of the prepared human immunoglobulin products is 15.03 μg / ml

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