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Instant lyophilized fibrinogen and fibrin ferment formulation composition, preparation method and use thereof

A fibrinogen and fibrin technology, which is used in drug combinations, peptide/protein components, blood diseases, etc., can solve the problems of not simple and fast operation, slow reconstitution speed, and shortened dissolution time, and achieves protection of biological activity and preservation. The effect of increasing time and increasing stability

Active Publication Date: 2009-02-25
HANBANG MEDICAL SCI & TECH HARBIN CITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This patent shortens the dissolving time by adding a stabilizer, but the disadvantage of this patent is: the fibrinogen and amino acids are made into freeze-dried powder, and reconstituted with water for injection when used, the reconstituted speed is still slow, and the During the process, measure water for injection and reconstitute, the operation is not simple and fast enough

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0063] (1) The preparation method of the fibrinogen in composition 1:

[0064] 1. Add 3.8mg of anticoagulant sodium citrate to each ml of pig whole blood, centrifuge at 3500r / min at 4°C for 30 minutes at low temperature, separate the plasma, and sterilize and filter with a 0.2μm microporous membrane to obtain the filtrate;

[0065] 2. When cooling the obtained filtrate to -5°C, add pre-cooled -20°C ethanol to a concentration of 8%, and centrifuge at 3500r / min to obtain a precipitate rich in fibrinogen;

[0066] 3. Add 2ml of a solution containing 12mg of sodium citrate and 9mg of sodium chloride per mg of the resulting fibrin precipitate to make it completely dissolved, add 10mg of polysorbate-80 and 3mg of tributyl phosphate per ml, and adjust it with 1% NAOH solution. to pH 7.0;

[0067] 4. Stir at 24°C for 8 hours to inactivate lipid-enveloped viruses;

[0068] 5. When the temperature is lowered to -2°C, add ethanol pre-cooled to -20°C to a final concentration of 8% for l...

Embodiment 2

[0088] (1) Preparation of fibrinogen in composition 1:

[0089] 1. Add 3.8mg of anticoagulant sodium citrate to 1ml of pig whole blood, centrifuge at 3500r / min at 8°C for 30 minutes at low temperature, separate the plasma, and sterilize and filter with a 0.2μm microporous membrane to obtain the filtrate;

[0090] 2. When the obtained filtrate is cooled to -5°C, add ethanol pre-cooled to -20°C to a final concentration of 8%, precipitate with ethanol at low temperature, and centrifuge at 3500r / min to obtain a precipitate rich in fibrinogen;

[0091] 3. Add 2ml of a solution containing 12mg of sodium citrate and 9mg of sodium chloride per mg of the obtained fibrinogen precipitate to make it completely dissolved, add 10mg of polysorbate-80 and 3mg of tributyl phosphate per ml, and oxidize with 1% hydroxide The pH value of the sodium solution is 7.0;

[0092] 4. Stir at 24-28°C for 8 hours to inactivate lipid-enveloped viruses,

[0093] 5. When the temperature is lowered to -2°C,...

Embodiment 3

[0112] Embodiment 3: comparative test of fibrinogen lysate

[0113] The fibrinogen prepared in Example 2 was dissolved with the following solvent system, and the dissolution time of the fibrinogen was observed, and the experimental conditions were uniformly controlled at 37°C.

[0114]

Numbering

solvent system

pH value

Dissolving time (minutes) 60 days

Solute properties 60 days

coagulation vitality 1 distilled water 6.8 10min precipitation —— 2 Normal saline 9mg / ml 6.8 8min flocculent —— 3 Physiological saline-NaOH9mg / ml 7.5 11min flocculent —— 4 NaOH-HCl 2mg / ml 7.5 7min 30second flocculent —— 5 NaOH-HCl 6mg / ml 7.5 7min flocculent —— 6 NaOH-HCl 12mg / ml 7.5 7min flocculent —— 7 Arginine-acetic acid 8mg / ml 7.5 6min slightly turbid 56sec. 8 Arginine-acetic acid 24mg / ml 7.5 7min slightly turbid 50sec. 9 Arginine-acetic acid 48mg / ml 7.5 8mi...

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PUM

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Abstract

The invention provides a composition of instant freeze-dried fibrinogen and thrombin preparation, a preparation method and a use thereof, and the composition comprises composition 1 composed of 35-70mg / ml of fibrinogen, 9-15mg / ml of sodium citrate, 7-12mg / ml of sodium chloride, 0.3-0.6mg / ml of polysorbate-80, 10-15mg / ml of mannitol, 4 -8mg / ml of arginine and 3.5-5.5mg / ml of glutamic acid by mg / ml and composition 2 composed of 700-1,200 mg / ml of thrombin, 3-6mg / ml of dextran 20, 15-25mg / ml of glycine, 5-7mg / ml of sodium chloride and 4-7mg / ml of calcium chloride by mg / ml. A sealant avoids the risk of spreading of AIDS virus, and the like, increases the drug stability, reduces the degeneration during the virus inactivation process by dry-heat method, protects biological activity, avoids local liquid storage of the using part caused by high permeability and the irritation of a large amount of inorganic salts to tissues, is conductive to the healing of trauma sites and ensures product safety and independent package to the maximum extent, thereby increasing storage time, facilitating use and meeting the clinical and field first-aid needs.

Description

technical field [0001] The invention relates to a freeze-dried fibrinogen preparation and a thrombin preparation, in particular to a fibrinogen preparation and a thrombin preparation composition, a preparation method and an application thereof. Background technique [0002] 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, so It is clinically used together with thrombin for emergency hemostasis and wound adhesion. Thrombin, coagulation factor II, is a rapid hemostatic drug that directly acts on the last step in the coagulation process. Under the joint action of calcium ions and coagulation factor XIII, it finally converts fibrinogen into a stable fibrin network to exert hemostasis effect. Therefore, the composition of fibrinogen and thrombin has hemostatic speed and action intensi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/48A61P7/04A61K38/36
Inventor 余美伦
Owner HANBANG MEDICAL SCI & TECH HARBIN CITY
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