Method for preparing intravenous injection human immune globulin from plasma component FI + III precipitates

Abstract

The invention discloses a method for preparing intravenous injection human immune globulin from plasma component FI + III precipitates. The method comprises the following steps: dissolving the precipitate of the components I + III, adding caprylic acid to precipitate lipid protein, adsorbing miscellaneous proteins such as blood coagulation factors and ceruloplasmin in the supernatant after caprylic acid precipitation by using A50 gel, and performing one-step ion exchange chromatography, ultrafiltration preparation, nano-membrane virus removal and split charging. According to the method, IgG isextracted from precipitates of waste components FI + III, the comprehensive utilization rate of plasma is greatly increased, after a part of impure proteins such as lipoprotein and fibrinogen are precipitated with octanoic acid, a step of A50 gel is added to adsorb various blood coagulation factors in advance, various blood coagulation factors in the product are prevented from being activated inthe subsequent chromatography step, the controllability and smoothness of the process are improved, and the product has high yield and purity.

Description

technical field [0001] The invention relates to the technical field of blood products, in particular to a method for preparing intravenous human immunoglobulin from the precipitation of plasma components FI+III. Background technique [0002] Intravenous human immunoglobulin (pH4, hereinafter referred to as IVIG) is an immunoglobulin isolated and extracted from healthy human plasma. IVIG has dual therapeutic effects of immune replacement and immune regulation, and is widely used in clinical practice. It has significant effects in the treatment of primary or acquired immunoglobulin deficiency, bacterial infections, viral infections, hematological diseases, and Kawasaki disease. At present, the separation method of intravenous human immunoglobulin basically adopts the low temperature ethanol process. In the 1940s, Professor E.J.Cohn of Harvard University invented the process of separating plasma proteins with low-temperature ethanol, which is by systematically changing the fiv...

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Problems solved by technology

Although this process guarantees the quality of the product to a certain extent and reduces energy consumption, the process only has one-step anion exchange chromatography, and it is a flow-through method. The gel needs to absorb 60% of the impurities in the sample, which is doomed to require a large amount of gelation. Gel needs to be filled with a large-scale chromatographic column, which increases the production cost and the complexity of the operation, and because there are many impurities in the sample, mainly there are various coagulation factors that are easily activated or activated coagulation factors, so the upper chromatographic column The former sample is extremely unstable, it is easy to produce protein precipitation, clog the chromatographic column, and the pressure of the sample on the column is high, which increases the complexity of the production process, and the high content of activated coagulation factors in the final product cannot guarantee product quality

In terms of virus inactivation, the patent uses caprylic acid plus two different pore size nanofiltration membranes to filter out viruses in series. Although it is a virus inactivation method with two mechanisms, two different pore size nanofiltration membranes are connected in series. High, resulting in high sample filtration pressure and long filtration time, increasing the risk of product contamination

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