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A safe and efficient freeze-dried fibrin sealant and preparation method thereof

A technology of fibrin and sealing agent, applied in the field of medicine, can solve the problems of inapplicability, inability to guarantee the activity of thrombin, unsatisfactory effect, etc., and achieve the effect of convenient clinical use

Inactive Publication Date: 2011-11-30
SHANGHAI LIKANGRUI BIOLOGICAL ENG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Some stabilizers can reduce the denaturation effect of dry heat on fibrinogen and thrombin, but the effect is still unsatisfactory, especially when the product is reconstituted at 37°C after high concentration of fibrinogen, the time often exceeds 30 Minutes, and the activity is greatly reduced, and the activity of thrombin is still not guaranteed
Therefore existing fibrinogen and thrombin formulations are not suitable for the above-mentioned dry heat inactivated virus treatment

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] formula:

[0034] Freeze-dried fibrinogen powder 13 parts, freeze-dried thrombin powder 3 parts

[0035] The freeze-dried fibrinogen powder comprises the following components in parts by weight:

[0036] 12 parts of fibrinogen, 1 part of stabilizer A;

[0037] The fibrinogen powder comes from inactivated pig plasma;

[0038] Described stabilizer A is glycine, sodium citrate and sodium chloride;

[0039] The freeze-dried thrombin powder comprises the following components in parts by weight:

[0040] 1.5 parts of thrombin, 1.5 parts of stabilizer B;

[0041] The thrombin comes from inactivated pig plasma;

[0042] The stabilizer B is glucose and dextran;

[0043] Preparation:

[0044] (1) Preparation of freeze-dried fibrinogen powder:

[0045] Add fibrinogen and stabilizer A to water, wherein the weight content of fibrinogen is 4%, mix and dissolve, then freeze-dry, and then inactivate at 100°C for 30 minutes to obtain freeze-dried fibrinogen powder;

[0046] (2)...

Embodiment 2

[0053] formula:

[0054] Freeze-dried fibrinogen powder 15 parts, freeze-dried thrombin powder 5 parts

[0055] The freeze-dried fibrinogen powder comprises the following components in parts by weight:

[0056] 13 parts of fibrinogen, 2 parts of stabilizer A;

[0057] The fibrinogen powder comes from inactivated bovine plasma;

[0058] The stabilizer A is arginine hydrochloride, sodium citrate and sodium chloride.

[0059] The freeze-dried thrombin powder comprises the following components in parts by weight:

[0060] 2.5 parts of thrombin, 2.5 parts of stabilizer B;

[0061] The thrombin comes from inactivated bovine plasma;

[0062] The stabilizer B is dextran and sucrose;

[0063] Preparation:

[0064] (1) Preparation of freeze-dried fibrinogen powder:

[0065] Add fibrinogen and stabilizer A to water, wherein the weight content of fibrinogen is 5%, mix and dissolve, then freeze-dry, and inactivate at 100°C for 30 minutes to obtain freeze-dried fibrinogen powder;

...

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PUM

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Abstract

The invention discloses a safe and efficient freeze-dried fibrin sealant and a preparation method thereof. The freeze-dried fibrin sealant is composed of independent components in the following parts by weight: 12-15 parts of freeze-dried fibrinogen powder , 3 to 5 parts of freeze-dried thrombin powder. The invention provides a freeze-dried fibrin sealing agent that can be treated by a heat-resistant method by adopting an effective fibrinogen and thrombin stabilizer and a reasonable formula. The heat treatment of the preparation can not only ensure the inactivation of lipid-enveloped and non-lipid-enveloped viruses, but also allow the preparation to be quickly reconstituted at room temperature, which greatly facilitates clinical use, especially for fibrin glue used in first aid. significance.

Description

technical field [0001] The invention relates to the technical field of medicine, and is a freeze-dried fibrin sealant capable of withstanding high-temperature inactivation virus treatment. Background technique [0002] Fibrin sealant consists of two components: lyophilized fibrinogen and thrombin. Fibrinogen, coagulation factor I, is one of the main components of plasma protein, with a molecular weight of about 340,000. Fibrinogen can form fibrin under the action of thrombin, and then form a stable fibrin thrombus together with platelets. It is clinically used together with thrombin for emergency hemostasis and wound adhesion. [0003] Fibrinogen and thrombin are easily inactivated in liquid form. Therefore, the preparations used clinically are all freeze-dried preparations, which are reconstituted with water for injection when used. There are safety issues in the clinical application of fibrin sealant. The existing fibrin freeze-dried preparations are all blood products...

Claims

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Application Information

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IPC IPC(8): A61K38/48A61P7/04A61K38/36A61L24/10
Inventor 任彩霞刘光万戚平忠雷晓丽冯洁
Owner SHANGHAI LIKANGRUI BIOLOGICAL ENG
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