A process for preparing human prothrombin complex by flow adsorption method

A technology of human prothrombin and complex, which is applied in the field of preparation of human prothrombin complex, can solve the problems of difficult separation and purification technology, poor mechanical strength of gel, and limitation of plasma processing volume, and achieve simple operation and no Gel leakage, effective removal of impurities
CN108441490BActive Publication Date: 2021-11-30华润博雅生物制药集团股份有限公司
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
华润博雅生物制药集团股份有限公司
Publication Date
2021-11-30

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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.
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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...

Claims

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