Process for purifying prothrombin compound

Abstract

The invention provides a process for purifying a prothrombin compound. The process comprises the following steps: subjecting qualified detected plasma of a healthy person to centrifugation for removal of sediments so as to a raw plasma material; subjecting the raw plasma material to adsorption with DEAE-Sephadex A-50 gel and carrying out washing and elution so as to obtain crude extract of the prothrombin compound; and subjecting the crude extract of the prothrombin compound to further adsorption by using Capto DEAE gel column chromatography and carrying out washing and elution so as to obtain the liquid prothrombin compound. According to the invention, the prothrombin compound is prepared through two-step operations via the DEAE-Sephadex A-50 gel and Capto DEAE gel; and under the designed process conditions, the prepared prothrombin compound has a purity far higher than the purity of a prothrombin compound product prepared by using a traditional process, and blood coagulation factors II, IX and X are good in equalization.

Description

technical field [0001] The invention relates to the technical field of biomedicine, and more specifically, relates to a process for purifying a prothrombin complex. Background technique [0002] Human prothrombin complex concentrates (PCC) is a blood product isolated from human healthy mixed plasma, mainly containing coagulation factors (Coagulation factors, F) II, VII, IX, and X that rely on vitamin K synthesis. PCC products were used clinically in the 1970s, and were widely used in the treatment of hemophilia B, hemophilia A with anticoagulant factor VIII, hemorrhagic disorders caused by low levels of coagulation factors caused by vitamin K deficiency, and as a substitute Fresh frozen plasma reverses various bleeding disorders caused by overdose of vitamin antagonists or coumarin-type anticoagulants. At present, the production of PCC at home and abroad mainly adopts DEAE-SephadexA-50 adsorption for large-scale preparation. The traditional process of producing PCC in my c...

AI Technical Summary

Problems solved by technology

The traditional process of producing PCC in my country uses DEAE-SephadexA-50 gel for two-step batch adsorption. The adsorption medium DEAE-SephadexA-50 gel used in this method has poor mechanical strength and is easily broken after equilibrium, so it is not suitable for columns. Chromatography technology; in addition, DEAE-SephadexA-50 gel has a series of problems such as difficult to estimate and control the supplementary amount in repeated applications, resulting in unstable product quality

[0003] At present, PCC prepared by DEAE-SephadexA-50 gel two-step batch adsorption method at home and abroad has relatively high FII and X content and relatively low purity.

Too high FII, X content, especially too high FII and low purity increase the thrombogenicity of the product

With the development of plasma protein separation technology, there have been reports in recent years that PCC was prepared by expanded bed adsorption technology, but it is still in the stage of laboratory exploration.

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