Sheet preparation for tissue adhesion

A preparation and freeze-dried tablet technology, applied in the field of tablet preparation and its preparation, can solve the problems of low tensile strength, insufficient tissue adhesion, poor tissue sealing ability, etc., achieve excellent flexibility and elasticity, and improve physical strength and stability effects

Inactive Publication Date: 2013-05-08
JURIDICAL FOUND THE CHEMO SERO THERAPEUTIC RES INST
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, since said invention is not a tablet formulation, it is difficult to use the composition with pressure
In addition, the composition has low tensile strength and poor tissue sealing ability
In addition, its operation is troublesome because an applicator is necessary to apply to the affected part
In addition, due to the immobilization of solid fibrinogen and solid thrombin on the carrier, the two components can instantaneously react with each other to form fibrin, thus resulting in insufficient adhesion to the tissue to be applied

Method used

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  • Sheet preparation for tissue adhesion
  • Sheet preparation for tissue adhesion
  • Sheet preparation for tissue adhesion

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0077] Embodiment 1: the method for preparing tablet preparation

[0078] For sheet-shaped carriers, bioabsorbable sheets are used. Specifically, for the bioabsorbable sheet, Neoveil 015G (registered trademark) (Gunze; composition: polyglycolic acid; thickness 0.15 mm), Neoveil 03G (registered trademark) (Gunze; composition: polyglycolic acid; thickness 0.3 mm) were used and Neoveil 05G (registered trademark) (Gunze; composition: polyglycolic acid; thickness 0.5 mm).

[0079]Prepare fibrinogen solution I to contain about 12.0% (w / v) fibrinogen, about 90 IU / mL coagulation factor XIII, 1.5% (w / v) human serum albumin, 2.6 %(w / v) Sodium Chloride, 1.8%(w / v) Trisodium Citrate, 0.5%(w / v) Isoleucine, 0.7%(w / v) Glycine, 1.6%(w / v) Arginine Hydrochloride, 1.2% (w / v) Monosodium Glutamate, 0.03% (w / v) Polysorbate 80, 1.0% Glycerin. Fibrinogen solution II is a solution obtained by doubly diluting fibrinogen solution I with water for injection to obtain a solution of about 6.0% (w / v) fi...

Embodiment 2

[0092] Embodiment 2: Evaluation test of tablet preparation adhesive force

[0093] For saline, saline of the Japanese Pharmacopoeia (Otsuka Pharmaceutical Co., Ltd., ). For water for injection, water for injection of the Japanese Pharmacopoeia (The Chemo-Sero-Therapeutic Research Institute, ). As a control of the tablet preparation, TachoComb (registered trademark) (CSL Behring) was used.

[0094] Fix two pieces of porcine dermis (adhesive area: 2.5×2.5cm) with a fixing device, and put 50μL / cm 2 Saline was applied to these tablets, and the tablet formulation was placed on top. Immediately after pressing for 5 minutes, one of the fixtures was pulled horizontally, the maximum tensile strength (N: Newton) was measured, and the obtained value was recorded as the adhesive force of the tablet preparation. For TachoComb, the N value is 22, for Invention E / G, the N value is 5, for the Invention A / B / D / F / J / K / L, the N value is 6, for the Invention D, the N value is 8. The resu...

Embodiment 3

[0097] Embodiment 3: SDS-PAGE of tablet preparation

[0098] [Sample preparation before gelling: 0 minutes]

[0099] TachoComb and Invention B prepared in Example 1 were tested. Prepare 0.5×0.8cm=0.4cm 2 slices and placed in sample tubes. Add the reducing solution to the sample tube. The tablets were allowed to dissolve at room temperature for 48 hours while stirring the solution containing the tablets appropriately. After boiling, electrophoresis, staining (CBB) and destaining were performed.

[0100] [Sample preparation after gelling: 5, 60 minutes]

[0101] TachoComb and Invention A prepared in Example 1 were tested. Prepare 0.5×0.8cm=0.4cm 2 slices and placed in sample tubes. Saline (40 μL) was added to the sample tube to dissolve and undergo gelation. 5 minutes or 60 minutes after the addition of saline and gelation, the reducing solution was added to end the gelation. While stirring the solution containing the gel flakes appropriately, the flakes were allowed...

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Abstract

Provided is a sheet preparation in which a fibrinogen component and a thrombin component are separately immobilized by immobilizing the fibrinogen component to one face of a sheet-like support and immobilizing the thrombin component to the other face to which the fibrinogen component is not immobilized, and also provided is a method for producing the sheet preparation.

Description

technical field [0001] The present invention relates to a sheet preparation consisting of a sheet-shaped carrier containing fibrinogen and thrombin as active ingredients and a method for preparing the same. More specifically, the present invention relates to a sheet preparation for tissue adhesion, which is characterized in that fibrinogen is held on one surface of a sheet-shaped carrier, and thrombin is held on a sheet-shaped carrier, and a method for producing the same. on the other surface of the carrier. Background technique [0002] Fibrinogen is a very important coagulation factor that acts in the final stage of the coagulation cascade. Fibrinogen, for example, is converted from its soluble form by thrombin upon activation of the coagulation system after injury to insoluble fibrin, which plays an important role in hemostasis and wound healing. [0003] Fibrinogen plays an important role in hemostasis and wound healing. For example, clinically, fibrinogen has been us...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L24/00A61K9/70A61K38/43A61K38/48A61K47/34A61L26/00
CPCA61L26/0042A61L15/26A61L2400/04A61K38/363A61L15/32A61F13/00063A61L26/0019A61P7/04C08L67/04A61L24/10A61K9/70A61K38/48A61L26/00
Inventor 嵯峨秀树羽室强
Owner JURIDICAL FOUND THE CHEMO SERO THERAPEUTIC RES INST
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