A process for preparing human prothrombin complex by flow adsorption method

Abstract

The invention discloses a process for preparing human prothrombin complex by flow adsorption method. , a certain batch of plasma to be processed is stored above the first container; it is quantitatively injected into the first container, the gel is stirred and adsorbed for a unit time, and then the adsorbed plasma is released to the second container at a certain flow rate At the same time, other plasma to be processed flows into the first adsorption tank at the same flow rate, that is to maintain the dynamic balance of the amount of plasma in the first container. At this time, the adsorption and separation of plasma in the first container It is carried out at the same time; by analogy, after all the plasma has passed through, the outlet of each container is closed, and the gel is washed and eluted respectively. In this way, the amount of plasma is not limited by the volume of the container, the process is easy to control and the recovery rate of FIX activity is high, and there is no risk of gel leakage and cross-contamination.

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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