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Thrombin-loaded microsphere-expanded sponge composite hemostatic material and preparation method and application thereof

A technology of hemostatic material and thrombin, which is applied in the field of medical devices, can solve problems such as difficulty in bonding wound surfaces, decreased hemostatic effect, and difficulty in exerting the effect of thrombin, achieving good clinical application prospects, avoiding vascular embolism, and rich sources of raw materials Effect

Active Publication Date: 2020-04-24
安徽中科迈德医疗科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This method directly contacts thrombin with a cross-linking agent, and there is a risk of thrombin inactivation resulting in a decrease in the hemostatic effect; patent 200480007509.3 immobilizes thrombin on a bioabsorbable synthetic nonwoven fabric, and the bioabsorbable synthetic nonwoven fabric Polyglycolic acid, polylactic acid, and copolymers of glycolic acid and lactic acid are all hydrophobic materials, which have the disadvantages of being difficult to adhere to the wound surface and exerting the effect of thrombin

Method used

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  • Thrombin-loaded microsphere-expanded sponge composite hemostatic material and preparation method and application thereof
  • Thrombin-loaded microsphere-expanded sponge composite hemostatic material and preparation method and application thereof
  • Thrombin-loaded microsphere-expanded sponge composite hemostatic material and preparation method and application thereof

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Experimental program
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Effect test

Embodiment 1

[0029] A preparation method for carrying thrombin microspheres-expandable sponge composite hemostatic material, comprising the following steps:

[0030] (1) Preparation of sodium alginate-loaded thrombin microspheres, after mixing sodium alginate solution with a mass concentration of 2% and thrombin solution (enzyme activity is 20 iu / mL) for electrostatic spraying and collecting a mass concentration of 0.5 % calcium chloride solution, followed by washing with ultrapure water and freeze-drying to obtain sodium alginate-loaded thrombin microspheres. The working parameters of the electrostatic spray are: voltage 5KV, flow rate 1 mL / h, distance from needle to receiver 8cm.

[0031] (2) Using PBS buffer as a solvent, prepare a carboxymethyl chitosan grafted methacrylic acid solution with a mass concentration of 1%.

[0032] (3) Add 50% cystine and 0.05% sodium alginate-loaded thrombin microspheres to the carboxymethyl chitosan-grafted methacrylic acid solution.

[0033] (4) Add p...

Embodiment 2

[0035] A preparation method for carrying thrombin microspheres-expandable sponge composite hemostatic material, comprising the following steps:

[0036] (1) Preparation of sodium hyaluronate-loaded thrombin microspheres, mix sodium hyaluronate solution with a mass concentration of 5% and thrombin solution (enzyme activity is 50 iu / mL) for electrostatic spraying and collect the mass concentration 5% glutaraldehyde solution, followed by washing with ultrapure water and freeze-drying to obtain sodium hyaluronate-loaded thrombin microspheres. The working parameters of the electrostatic spray are: voltage 10KV, flow rate 2 mL / h, distance from needle to receiver 12cm.

[0037] (2) Using PBS buffer as a solvent, prepare a sodium alginate grafted maleimide solution with a mass concentration of 50%.

[0038] (3) Add 10% cystine and 5% sodium hyaluronate-loaded thrombin microspheres to the above-mentioned sodium alginate-grafted maleimide solution.

[0039] (4) Add photoinitiator 1173...

Embodiment 3

[0041] A preparation method for carrying thrombin microspheres-expandable sponge composite hemostatic material, comprising the following steps:

[0042] (1) Preparation of dextran-loaded thrombin microspheres. Mix 3% dextran solution with thrombin solution (enzyme activity: 100 iu / mL) for electrostatic spraying and collect a concentration of 1 % genipin solution, followed by washing with ultrapure water and freeze-drying to obtain dextran-loaded thrombin microspheres. The working parameters of the electrostatic spray are: voltage 12KV, flow rate 8 mL / h, distance from needle to receiver 15cm.

[0043](2) Using PBS buffer as a solvent, prepare a hyaluronic acid grafted isocyanate solution with a mass concentration of 10%.

[0044] (3) Add 5% mercapto-polyethylene glycol-mercapto (weight average molecular weight 2000-10000) and 5% dextran-loaded thrombin microspheres to the above hyaluronic acid-grafted isocyanate solution.

[0045] (4) Add photoinitiator 2959 with a mass conce...

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Abstract

A thrombin-loaded microsphere-expanded sponge composite hemostatic material and a preparation method and application thereof are disclosed. According to the prepared thrombin-loaded microsphere-expanded sponge composite hemostatic material, thrombin with hemostatic activity is loaded in microspheres, and the thrombin-loaded microspheres are loaded on the sponge with good swelling rate and swellingproperty. Through synergistic exertion of advantages of three ingredients, the expanded sponge with a good swelling rate can rapidly absorb moisture in blood so as to concentrate blood coagulation factors and accelerate hemostasis; the expanded sponge can generate physical compression on damaged tissues and promote hemostasis; thrombin is loaded through the microspheres, so that thrombin can be prevented from leaking and entering blood vessels to cause vascular embolism, and thrombin activity can be retained; and thrombin loaded with hemostatic active ingredients can activate a blood coagulation path to accelerate hemostasis. In addition, the microsphere-sponge composite hemostatic material has good biocompatibility, raw material sources are abundant, and the cost is controllable. Therefore, the microsphere-sponge composite hemostatic material has good clinical application prospects.

Description

technical field [0001] The invention specifically relates to the technical field of medical devices, in particular to a composite hemostatic material loaded with thrombin microspheres-swellable sponge and its preparation method and application. Background technique [0002] Uncontrollable bleeding is one of the main causes of death in battlefield trauma, traffic accidents, and surgical operations. Traditional hemostatic materials such as gauze, bandages, and cotton balls can only stop bleeding by pure physical pressure. Capillary bleeding in wounds; new hemostatic materials such as hydrogel, microspheres, and sponges have greatly improved their ability to absorb water in blood, and can achieve hemostasis by concentrating coagulation factors or blocking wounds, compared with traditional hemostatic materials. There is a certain improvement, but for the case of a large amount of bleeding, there is still a risk that the hemostatic material will be washed away by the blood, and t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L24/00A61L24/08
CPCA61L24/001A61L24/0015A61L24/0036A61L24/08A61L2300/254A61L2300/418A61L2400/04A61L2400/12C08L5/04C08L5/08C08L5/02C08L1/284
Inventor 石长灿席光辉刘雯杨啸李徐坚季志孝
Owner 安徽中科迈德医疗科技有限公司
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