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Method for preparing highly concentrated fibrinogen solution and method for preparing fibrin sealant by using thereof

A fibrinogen, highly concentrated technology, used in the preparation of highly concentrated fibrinogen solution, fibrin sealant product field

Inactive Publication Date: 2014-10-15
KOREA GREEN CROSS CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] However, in the case of said frozen liquid products, there is the disadvantage of solvent / detergent (S / D) treatment and heat treatment with steam in order to remove any virus originating from the blood (see U.S. Patent No. 5,962,405 and Tisseel data( www.baxter.com) )
[0011] In particular, there is the inconvenience that, in order to use steam for heat treatment, freeze-drying should be carried out in the middle of the process (see European Patent Publication No. 345246 and European Patent Publication No. 159311)
In addition, since the method of using freeze-dried fibrinogen to decompose fibrinogen in order to obtain highly concentrated fibrinogen, there is an inconvenience in that, in order to obtain a fibrin sealant with a high concentration, especially 70mg / ml or higher concentration of fibrinogen solution, the freeze-drying process should be carried out

Method used

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  • Method for preparing highly concentrated fibrinogen solution and method for preparing fibrin sealant by using thereof
  • Method for preparing highly concentrated fibrinogen solution and method for preparing fibrin sealant by using thereof
  • Method for preparing highly concentrated fibrinogen solution and method for preparing fibrin sealant by using thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0075] Example 1: Preparation of highly concentrated fibrinogen solution

[0076] The low concentrated fibrinogen solution and factor XIII in the present invention are isolated and prepared from human plasma. First, after separation of the cryoprecipitate from the human plasma, fibrin was prepared using cryoprecipitation, virus inactivation (using a solvent / detergent (S / D) treatment method), anion chromatography, glycine precipitation The original sediment (see figure 1 ).

[0077] After removal of the cryoprecipitate from human plasma, after the preparation of Factor XIII from fraction I obtained by ethanol precipitation by the citrate precipitation process, the S / D treatment process, the anion chromatography process and the concentration process, the fiber The protein precipitate is dissolved and mixed, and then heat-treated (10 hours at 60°C), which is a virus inactivation process, anion chromatography process, and dialysis concentration process, so that the low-level ...

Embodiment 2

[0085] Example 2: Stability of fibrin sealant component 1 according to temperature storage conditions

[0086] A fibrin sealant component 1 was prepared by mixing 10 mg / mL albumin, 1000 KIU / mL aprotinin, and Tween 80 with the highly concentrated fibrinogen solution prepared according to Example 1.

[0087] The prepared fibrin sealant component 1 was sterilized by filtration using a 0.2 μm filter to be filled in a 1 mL syringe, thus confirming stability according to storage conditions. The fibrin sealant component 1 used in this experiment contained 88 mg / mL of fibrinogen and 65 IU / mL of factor XIII.

[0088] Stability was assessed by measuring the time to clotted fibrinogen protein reduced by 10% as shelf life.

[0089] As a result, it was observed that the fibrin sealant component 1 comprising Factor XIII according to the invention was stable for at least 24 months at -18°C and up to 6 months at 25°C (see Table 3).

[0090] Table 3. Stability of fibrin sealant component 1...

Embodiment 3

[0092] Embodiment 3: the preparation of fibrin sealant product

[0093] The fibrin sealant component 1 prepared in Example 2 was supplied with fibrin sealant component 2 containing thrombin and calcium chloride filled in separate containers to prepare a fibrin sealant product, and finally, the two The two solutions are mixed with each other so that fibrin polymers are formed and can be used for medical purposes etc. In the fibrin sealant component 2 filled in a separate container, 500 IU / mL of thrombin and 40 mM of calcium chloride were contained, and 40 mg / mL of albumin may be additionally added.

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Abstract

Provided are a method for preparing a highly concentrated fibrinogen solution, and a method for preparing a fibrin sealant component 1 containing the highly concentrated fibrinogen solution and Factor ChiIII. More particularly, the method for preparing a highly concentrated fibrinogen solution according to the present invention can be prepared by adding amino acid or amino acid derivatives, and / or salts, etc. to a lowly concentrated fibrinogen solution separated from blood plasma and highly concentrating fibrinogen using an ultra filtration method, and a fibrin sealant component 1 in order to be used in a fibrin sealant product can be prepared by adding Factor ChiIII before or after the ultra filtration in the method for preparing the highly concentrated fibrinogen. The fibrin sealant component 1 prepared by the method according to the present invention may be cryopreserved in a liquid state, be preserved for a long time at room temperature, and be immediately applied to treatment without performing a reconstitution process. In addition, the present invention relates to a fibrin sealant product configured of the fibrin sealant component 1 and a fibrin sealant component 2 which is a solution containing thrombin and calcium chloride filled in a separate container. The fibrin sealant product according to the present invention may be provided in a vial type in which the fibrin sealant component 1 and the fibrin sealant component 2 are filled in separate vials, respectively, or a pre-filled type in which the fibrin sealant component 1 and the fibrin sealant component 2 are filled in separate syringes connected with each other to thereby be immediately used.

Description

technical field [0001] The present invention relates to a method of preparing a highly concentrated fibrinogen solution and a method of preparing a fibrin sealant component 1 comprising said highly concentrated fibrinogen solution and Factor XIII. More specifically, the method for preparing a highly concentrated fibrinogen solution according to the present invention is characterized in that amino acids or amino acid derivatives, salts, etc. are added to the low concentrated fibrinogen solution separated from blood plasma, and then The filtration method thus produces highly concentrated fibrinogen. Process for the preparation of a fibrin sealant component 1 for use in a fibrin sealant product, characterized in that factor XIII is added before or after ultrafiltration in the process for preparing a highly concentrated fibrinogen solution. Here, the fibrin sealant component 1 according to the invention is preferably in a solution state. [0002] The fibrin sealant component 1 p...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/36A61K38/37A61P7/02A61P7/00
CPCA61L24/106C07K14/75A61K38/45A61K38/363C08L89/00A61P7/00A61P7/02A61P7/04A61K38/36A61K38/37
Inventor 金俊植李建术金基镕姜镛孙基桓
Owner KOREA GREEN CROSS CORP
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