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

A technology for human prothrombin and preparation process, which is applied in the field of preparing human prothrombin complexes by flow adsorption method, can solve the problems of fragility, cross-contamination cycle, poor mechanical strength of gel, etc., so as to reduce the occurrence of thrombus and improve the Product purity, the effect of maintaining original properties

Active Publication Date: 2018-08-24
华润博雅生物制药集团股份有限公司
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  • Claims
  • Application Information

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-contamina

Method used

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

Examples

Experimental program
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Effect test

Embodiment 1

[0074] Embodiment 1: Taking 1000 liters of plasma as an example, the specific preparation process is as follows:

[0075] (1) Preparation of cryoprecipitate-free plasma

[0076] Raw material plasma collected according to the requirements of Part Three of the 2015 edition of the "Chinese Pharmacopoeia" that has passed the re-inspection and passed the quarantine period is sterilized with 75% ethanol in the pre-melting room, and then rinsed with water for injection below 35°C to exhaust the ethanol. , to break the bag. After the bag is broken, it is transported to the melting tank, and the circulating water of 30-35 °C is used for interlayer circulation to melt the slurry; after the plasma is melted, the hot water circulation is stopped in time, and the temperature of the plasma is controlled between 0-4 °C, and the sample is sent for quality inspection. Anti-HIV, HBsAg, anti-HCV, anti-HBs and microbial limit inspection; after filtration or centrifugation, the centrifugation spe...

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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...

Claims

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Application Information

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IPC IPC(8): C12N9/74C12M1/12C12M1/02
CPCC12M21/14C12M23/58C12M27/02C12M33/14C12N9/6429C12Y304/21005
Inventor 梁小明张猛何淑琴张忠兵黄璠刘敏亮
Owner 华润博雅生物制药集团股份有限公司
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