Technological process for improving stable FVII yield of human prothrombin complexes

A human prothrombin complex technology, applied in the field of medicine and biology, can solve the problem of low yield of human prothrombin complex factor IX, and achieve the effect of improving the adsorption rate and increasing the binding force

Active Publication Date: 2009-05-27
SHANDONG TAIBANG BIOLOGICAL PROD CO LTD +1
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  • Description
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Problems solved by technology

However, the yields of human prothrombin complex factors...

Method used

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  • Technological process for improving stable FVII yield of human prothrombin complexes
  • Technological process for improving stable FVII yield of human prothrombin complexes

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Embodiment 1

[0024] The manufacturing process of freeze-dried human prothrombin complex comprises the following steps:

[0025] (1) 400kg of human plasma was frozen at -30°C, after the surface of the plasma bag was sterilized with alcohol, the hydrated slurry was injected, and the mixing temperature was 0-5°C;

[0026] (2) Centrifuge to remove cryoprecipitate, and the supernatant is clarified and filtered to obtain a liquid volume of 395L;

[0027] (3) Adjust its ionic strength: Stir the supernatant at a low speed of 10-50 rpm, add 10-25°C water for injection at a flow rate not higher than 5L / min, and adjust its ionic strength so that the conductance is controlled at 2- 12ms / cm;

[0028] (4) Gel adsorption: Add 12kg of swollen DEAE-Sephadex A-50 wet glue to absorb for 45-60 minutes;

[0029] (5) Wash 2-5 volumes of the gel with 40-60 L of sodium chloride with a concentration of 0.15-0.25 mol / L and 40-60 L of sodium citrate with a concentration of 0.01-0.02 mol / L, and collect the eluate; ...

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Abstract

The invention relates to the field of bio-pharmaceutical technology, in particular to a technical method for improving stable F VII yield rate of human thrombogen complex. The following procedures are included: freshly freezing blood plasma of a healthy person at a low temperature; removing cryoprecipitate; carrying out clarification filtration; adjusting ionic strength; carrying out gel absorption; carrying out wash and elution; carrying out ultrafiltration; killing S/D virus; carrying out gel absorption; carrying out wash and elution; carrying out ultrafiltration; carrying out aseptic filtration and subpackage; carrying out freeze-drying; and carrying out hot-air sterilization.

Description

technical field [0001] The invention belongs to the field of medical biotechnology, in particular to a production process of freeze-dried human prothrombin complex. Background technique [0002] The existing manufacturing method of human prothrombin complex includes the following steps: fresh plasma of low-temperature frozen healthy people→removal of cryoprecipitate→clarification and filtration→gel adsorption→washing, elution→ultrafiltration→S / D virus inactivation→ Gel adsorption→washing, elution→ultrafiltration→sterilizing filtration, aliquoting→lyophilization→dry heat inactivation. [0003] In the manufacturing stage, the process undergoes two-step virus inactivation of S / D and dry heat. The virus inactivation is relatively thorough, and all indicators meet the standards of the Pharmacopoeia of the People's Republic of China. However, the yields of human prothrombin complex factors VII, II, X and IX produced by this process are relatively low. Contents of the invention ...

Claims

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Application Information

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IPC IPC(8): A61K35/14A61K38/48A61K9/19C12N9/74A61P7/04
Inventor 刘欣晏张顺龙吴春涛菅长永师秀梅孙永长杜济良
Owner SHANDONG TAIBANG BIOLOGICAL PROD CO LTD
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