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Method for preparing human fibrinogen preparation and preparation prepared by method

A technology of human fibrinogen and preparations, applied in the direction of fibrinogen, animal/human protein, peptide/protein components, etc., to achieve the effect of reducing impurity content, reducing side effects, and high virus safety

Inactive Publication Date: 2015-03-25
HUALAN BIOLOGICAL ENG INC +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] This shows that the above-mentioned existing method for preparing human fibrinogen preparation obviously still has deficiencies, and needs to be improved urgently

Method used

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  • Method for preparing human fibrinogen preparation and preparation prepared by method
  • Method for preparing human fibrinogen preparation and preparation prepared by method
  • Method for preparing human fibrinogen preparation and preparation prepared by method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] (1) Separation of component I: the frozen raw plasma that has passed the virus test and meets the national quarantine period regulations, disinfects the surface of the plasma bag with 75% alcohol, breaks the bag, and collects the plasma in a special plasma collection tank with interlayer In the process, circulating water is used for circulating heating. After the plasma is melted, the cryoprecipitate is removed by centrifugation, and then the plasma from which the cryoprecipitation has been removed is removed by the adsorption method to remove the prothrombin complex. , under the condition of pH 7.0±0.20, stir for 3 hours, then use a filter plate with a nominal pore size of 0.8 μm to 1.5 μm to separate the precipitate by pressure filtration, and use 50 L of -2 ° C to -3 ° C 10% ethanol The solution was top-washed on the precipitate to obtain 9.00Kg of the component I precipitate.

[0029](2) Washing / dissolving Component I: Precipitate 9.00Kg of Component I stored in a c...

Embodiment 2

[0038] (1) Separation of component I: the frozen raw plasma that has passed the virus test and meets the national quarantine period regulations, disinfects the surface of the plasma bag with 75% alcohol, breaks the bag, and collects the plasma in a special plasma collection tank with interlayer In the process, circulating water is used for circulating heating. After the plasma is melted, the cryoprecipitate is removed by centrifugation, and then the prothrombin complex is removed from the cryoprecipitate-removed plasma by adsorption method. , under the condition of pH 7.0±0.20, stir for 1 hour, then use a filter plate with a nominal pore size of 0.8 μm to 1.5 μm to separate the precipitate by pressure filtration, and use 50 L of 10% ethanol at -2°C to -3°C The solution was top-washed for the precipitate to obtain 11.90 Kg of the component I precipitate.

[0039] (2) Washing / dissolving Component I: Precipitate 11.90Kg of Component I stored in a cold storage below -30°C and leav...

Embodiment 3

[0048] (1) Separation of component I: the frozen raw plasma that has passed the virus test and meets the national quarantine period regulations, disinfects the surface of the plasma bag with 75% alcohol, breaks the bag, and collects the plasma in a special plasma collection tank with interlayer In the process, circulating water is used for circulating heating. After the plasma is melted, the cryoprecipitate is removed by centrifugation, and then the plasma from which the cryoprecipitation has been removed is removed by the adsorption method to remove the prothrombin complex. , under the condition of pH 7.0±0.20, stir for 2 hours, then use a filter plate with a nominal pore size of 0.8 μm to 1.5 μm to separate the precipitate by pressure filtration, and use 50 L of -2 ° C to -3 ° C 10% ethanol The solution was top-washed for the precipitate to obtain 14.60 Kg of the component I precipitate.

[0049] (2) Washing / dissolving Component I: Precipitate 14.60Kg of Component I stored i...

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Abstract

The invention discloses a method for preparing a human fibrinogen preparation. The method comprises the following step: with healthy human plasma as raw material, separating and purifying by a low-temperature ethanol protein separation method, wherein a centrifugal method is replaced with a mild filter press method; top washing is carried out on sediments by using a low-temperature ethanol solution; a multi-stage deep filtration is added; a freeze-dry process is improved; the freeze-dry cycle is shortened to 2-3 days from 4-8 days; and inactivation treatment is carried out on viruses by combining an S / D method, a UVC radiation method and a dry heat process, so that the removal effect on lipid envelop viruses and non-lipid envelope viruses, especially heat-resistant parvovirus is ensured. The invention also discloses a fibrinogen preparation prepared by the method. The fibrinogen preparation produced by the method has the advantages of relatively stable quality, relatively low impurity content, and relatively high virus safety; the safety risk which can be brought for a patient by the infusion of the preparation can be reduced to the maximal extent; side reaction during clinical application is reduced; and medication is relatively safe.

Description

technical field [0001] The invention relates to the field of blood products, in particular to a method for preparing a human fibrinogen preparation and the prepared preparation. Background technique [0002] Fibrinogen (Fibrinogen, Fg), that is, coagulation factor Ⅰ (FI), is one of the "central" proteins in the coagulation system, with a relative molecular weight of 340kDa, 2964 (6) amino acid residues, and a molecular length of about 45nm. The maximum diameter is 4.8nm, the half-life is 96-144 hours, the isoelectric point is 5.1-5.5, and the sedimentation coefficient is 7.7-7.9. Fg is mainly synthesized by the liver. It is a glycoprotein containing 3% to 5% carbohydrates. It consists of two identical parts, each of which contains 3 peptide chains, namely Aα, Bβ and γ chains, which are composed of 610 and 461 and 410 amino acid residues. Each part is connected by 12 disulfide bonds, and the two parts are connected at the amino terminal by three disulfide bonds formed by tw...

Claims

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Application Information

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IPC IPC(8): A61K38/36A61P7/04C07K14/75C07K1/36C07K1/34C07K1/30
Inventor 马小伟梁雪爽张学成谢来峰李冠军王学位
Owner HUALAN BIOLOGICAL ENG INC
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