Process for preparing human prothrombin complex concentrate by adopting flow adsorption method

Abstract

The invention discloses a process for preparing a human prothrombin complex concentrate by adopting a flow adsorption method. The process is characterized in that a plurality of cylindrical containerswith stirrers are connected in series to form a natural flowing way; gels which are balanced in advance are placed in the various containers; a certain batch of to-be-processed blood plasma is storedabove the first container; the gels are injected quantitatively firstly in the first container, then the gels are stirred and adsorbed for a unit time, and the adsorbed blood plasma is discharged into the second container at a certain flow speed; simultaneously, other to-be-processed blood plasma flows into a first adsorption tank at the same flow speed, so that dynamic balance of the blood plasma quantity in the first container is kept, and at this time, adsorption and separation of the blood plasma in the first container are carried out simultaneously; by analogy, after the all blood plasmapasses through, outlets of the various containers are closed, and washing and elution on the gels are carried out. The blood plasma quantity is not limited by the volume of the containers, the process is easily controlled, an FIX activety recycling ratio is higher, and the risks of leakage of the gels and crossed pollution are avoided.

Description

technical field [0001] The invention relates to a preparation process of a human prothrombin complex, which belongs to the field of biopharmaceuticals, in particular to a process for preparing a human prothrombin complex by a flow adsorption method. Background technique [0002] Human prothrombin complex (Prothrombin Complex Concentrate, PCC) is an intravenous plasma protein preparation that can promote blood coagulation, which is isolated from the mixed plasma of healthy people. It is generally called factor IX concentrated preparation. PCC mainly contains vitamin K-dependent prothrombin (FII), stable factor (FVII), plasma thromboplastin component (FIX) and Stuart-Prower factor (FX). The plasma concentration of various coagulation factor proteins in PCC is between 1 and 200 mg / L, and they all belong to serine proteases, which exist in the form of inactive zymogens in the blood circulation. Since these factors belong to glycoproteins, are synthesized in the liver, and are m...

AI Technical Summary

Problems solved by technology

The batch adsorption method must be adsorbed in a stirred tank, which is easily broken due to poor mechanical strength of the gel; washing and elution must be transferred to a chromatography column to complete, which is cumbersome to operate, labor-intensive, prone to cross-contamination, and has a longer cycle time. Long; limited plasma throughput

[0005] Although the existing technology has made some progress, it is still difficult to break away from the traditional separation and purification technology, and it is only optimized in individual processes such as:

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