GB2625207A - An antibacterial and procoagulant chest seal and a preparation method thereof - Google Patents

An antibacterial and procoagulant chest seal and a preparation method thereof Download PDF

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Publication number
GB2625207A
GB2625207A GB2317328.9A GB202317328A GB2625207A GB 2625207 A GB2625207 A GB 2625207A GB 202317328 A GB202317328 A GB 202317328A GB 2625207 A GB2625207 A GB 2625207A
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antibacterial
procoagulant
carboxymethyl chitosan
chest seal
preparation
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GB202317328D0 (en
Inventor
Fang Ke
Ren Jie
Lu Zhou
Zhang Yongshun
Hu Haijuan
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Purui Lifesaving Equipment Hebei Co Ltd
Univ Pla Air Force Medical
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Purui Lifesaving Equipment Hebei Co Ltd
Univ Pla Air Force Medical
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Publication of GB202317328D0 publication Critical patent/GB202317328D0/en
Publication of GB2625207A publication Critical patent/GB2625207A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/22Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
    • A61L15/28Polysaccharides or their derivatives
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    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08JWORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
    • C08J3/00Processes of treating or compounding macromolecular substances
    • C08J3/24Crosslinking, e.g. vulcanising, of macromolecules
    • C08J3/246Intercrosslinking of at least two polymers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/716Glucans
    • A61K31/722Chitin, chitosan
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/06Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42Use of materials characterised by their function or physical properties
    • A61L15/64Use of materials characterised by their function or physical properties specially adapted to be resorbable inside the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L26/00Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
    • A61L26/0009Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form containing macromolecular materials
    • A61L26/0023Polysaccharides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L26/00Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
    • A61L26/0061Use of materials characterised by their function or physical properties
    • A61L26/008Hydrogels or hydrocolloids
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08BPOLYSACCHARIDES; DERIVATIVES THEREOF
    • C08B37/00Preparation of polysaccharides not provided for in groups C08B1/00 - C08B35/00; Derivatives thereof
    • C08B37/0006Homoglycans, i.e. polysaccharides having a main chain consisting of one single sugar, e.g. colominic acid
    • C08B37/0024Homoglycans, i.e. polysaccharides having a main chain consisting of one single sugar, e.g. colominic acid beta-D-Glucans; (beta-1,3)-D-Glucans, e.g. paramylon, coriolan, sclerotan, pachyman, callose, scleroglucan, schizophyllan, laminaran, lentinan or curdlan; (beta-1,6)-D-Glucans, e.g. pustulan; (beta-1,4)-D-Glucans; (beta-1,3)(beta-1,4)-D-Glucans, e.g. lichenan; Derivatives thereof
    • C08B37/00272-Acetamido-2-deoxy-beta-glucans; Derivatives thereof
    • C08B37/003Chitin, i.e. 2-acetamido-2-deoxy-(beta-1,4)-D-glucan or N-acetyl-beta-1,4-D-glucosamine; Chitosan, i.e. deacetylated product of chitin or (beta-1,4)-D-glucosamine; Derivatives thereof
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    • C08JWORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
    • C08J3/00Processes of treating or compounding macromolecular substances
    • C08J3/02Making solutions, dispersions, lattices or gels by other methods than by solution, emulsion or suspension polymerisation techniques
    • C08J3/03Making solutions, dispersions, lattices or gels by other methods than by solution, emulsion or suspension polymerisation techniques in aqueous media
    • C08J3/075Macromolecular gels
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    • C08LCOMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L51/00Compositions of graft polymers in which the grafted component is obtained by reactions only involving carbon-to-carbon unsaturated bonds; Compositions of derivatives of such polymers
    • C08L51/02Compositions of graft polymers in which the grafted component is obtained by reactions only involving carbon-to-carbon unsaturated bonds; Compositions of derivatives of such polymers grafted on to polysaccharides
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    • C08LCOMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L97/00Compositions of lignin-containing materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2400/00Materials characterised by their function or physical properties
    • A61L2400/04Materials for stopping bleeding
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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Abstract

Disclosed is an antibacterial and procoagulant chest seal and method of preparation thereof, the chest seal comprising an outer protective layer, a dressing layer, and a sealing adhesive layer from top to bottom; the dressing layer is obtained by preparing a complex of dialdehyde carboxymethyl chitosan and tannic acid, then grafting the dialdehyde carboxymethyl chitosan in the composite with acrylic acid, and then cross-linking to form a hydrogel. The outer protective layer is preferably a release paper, and the sealing adhesive layer is preferably PE, EVA, PEVA, polyurethane, or a natural rubber with anti-permeability. A method for producing the dialdehyde carboxymethyl chitosan is further disclosed.

Description

DESCRIPTION
An Antibacterial And Procoagulant Chest Seal And A Preparation Method Thereof
Technical Field
[0001] The invention relates to the technical field of medical supplies, in particular to an antibacterial and procoagulant chest seal and a preparation method thereof
Background
[0002] Traumatic pneumothorax is often caused by the puncture of the lung by fractured rib ends, or by bronchial or lung tissue contusion and laceration due to violent acts, or by bronchial or lung rupture caused by a sudden increase in airway pressure. Sharp or firearm injuries that penetrate the chest wall and affect the lungs, bronchi and trachea or esophagus can also cause pneumothorax, and are often hemopneumothorax or pyopneumothorax. In modern warfare, injuries caused by fragments, shrapnel, and other projectiles often occur in the chest and abdomen, resulting in penetrating wounds or deep blind wounds, these injuries can easily lead to open pneumothorax, accompanied by traumatic hemothorax. This poses a serious threat to the life safety of the wounded personnel and is also a significant cause of the reduction of combat personnel.
[0003] In clinical practice, pneumothorax is generally treated by closing chest drainage opening. The existing method ia generally as follow: covering the wound with Vaseline gauze that provides a certain level of sealing, then wrapping with gauze or cotton pad, and finally securing with medical adhesive tape or a thin film patch. However, due to its complex process and the needed materials and devices that are not easily portable, as well as the multiple steps involved, it is difficult to apply in modern warfare. Therefore, portable chest seals have emerged on the market for ease of use.
[0004] Chest seals are convenient to carry and easy to use. By sealing the wound with a chest seal, pneumothorax can be prevented. Chest seals typically use polyurethane composite films, with one side sealed with medical hot melt adhesive. This type of chest seal can quickly close wounds and prevent the formation of pneumothorax. However, in the battlefield, the medical environment is poor and there are a lot of bacteria, and wounds are often accompanied by
DESCRIPTION
heavy bleeding. Failure to stop bleeding in time can cause blood to flow into the chest cavity and form hemothorax, and wound healing is slow, is prone to rupture during the process of the transfer of the wounded, worsening their condition.
[0005] In summary, there is an urgent need for a chest seal that can stop bleeding in time, resist bacterial infection, and promote wound healing in poor medical environments on the battlefield.
Summary of the invention
[0006] Object of the invention: in view of the shortcomings of the prior art, the object of the invention is to provide an antibacterial and procoagulant chest seal and a preparation method thereof to solve the problems of difficulty in stopping bleeding of wounds, susceptibility to bacterial infection and slow wound healing in the prior art.
[0007] Technical scheme: [0008] An antibacterial and procoagulant chest seal comprises an outer protective layer, a dressing layer and a sealing adhesive layer from top to bottom; [0009] the dressing layer is obtained as follows: preparing a complex of dialdehyde carboxymethyl chitosan and tannic acid, then grafting the dialdehyde carboxymethyl chitosan in the composite with acrylic acid, and then cross-linking to form a hydrogel.
[0010] The invention uses carboxymethyl chitosan, utilizing its hydroxyl group to provide grafting sites for further modification, at the same time, as an amphoteric polyelectrolyte, it has good water solubility, film-forming properties and water-absorbing and water retention properties, and can be used as raw material for hydrogel.
[001]] Tannic acid, due to the large number of phenolic hydroxyl groups in its structure, can hinder bacteria from absorbing iron, polysaccharides, amino acids, etc. It can also disrupt bacterial cell walls and membranes, inhibit the formation of biolilms, and thus exhibits strong antibacterial capabilities; at the same time, tannic acid can act as an astringent, stimulating the secretion of basic fibroblast growth factor, and accelerating the healing of internal and external wounds.
[0012] The hydrogel formed by cross-linking in the invention has good biosafety and histocompatibility, and is an excellent hemostatic material. By grafting acrylic acid onto the
DESCRIPTION
hydroxyl sites of dialdehyde carboxymethyl chitosan, and then using a cross-linking agent to form a three-dimensional mesh structure, then a hydrogel dressing layer is formed.
[0013] Further, the outer protective layer is the release paper outer protective layer.
[0014] Further, the sealing adhesive layer is selected from one of PE, EVA, PEVA, polyurethane or natural rubber that has anti-permeability.
[0015] Further, the preparation method of the dialdehyde carboxymethyl chitosan comprises the following steps: [0016] (1) Adding deionized water to the reactor, then adding carboxymethyl chitosan and stirring to dissolve, then adding oxidant and adjusting the system pH to 3.5-4; [0017] (2) Heating the reactor in step (1) to 40-45°C and stirring for 4-5 hours under light-shielding conditions; [0018] (3) Adding ethylene glycol solution to the reactor in step (2), stirring at room temperature for 0.5-1 hour, centrifuging and washing the product, and freeze-drying under vacuum for 20-24 hours to obtain the dialdehyde carboxymethyl chitosan [0019] On the basis of carboxymethyl chitosan, a new active group-aldehyde group is generated through selective oxidation, which can act as part of the cross-linking effect by itself and reduce the use of toxic cross-linking agents.
[0020] Further, the oxidant in step (1) is sodium periodate.
[0021] Further, the tannic acid is pharmaceutical tannic acid. It complies with the national industry standards LY-T 1300, LY-T1640 and LY-T1641. It has high purity and low heavy metal content and can be used in the pharmaceutical field.
[0022] The preparation method of the antibacterial and procoagulant chest seal comprises the following steps: [0023] (1) Adding deionized water to the reactor, then adding dialdehyde carboxymethyl chitosan and stirring to dissolve, then adding biological buffer to adjust the system pH to 88.5, adding tannic acid and mixing evenly, reacting at room temperature for 6-8 hours; [0024] (2) Continuously flowing protective gas into the reactor in step (1), then adding initiator and acrylic acid and stirring evenly, reacting at room temperature for 4-5 hours, then letting it stand for 10-12 hours;
DESCRIPTION
[0025] (3) Adding the cross-linking agent to the reactor in step (2), stirring evenly, sealing, and then letting it stand at room temperature for 10-12 hours to prepare the dressing layer; [0026] (4) Placing the dressing layer in step (3) on top of the sealing adhesive layer, and covering the outer protective layer on the outside of the sealing adhesive layer and dressing layer to prepare the antibacterial and procoagulant chest seal.
[0027] Step (1) Preparing a complex of dialdehyde carboxymethyl chitosan and tannic acid. [0028] Step (2) Grafting acrylic acid on the hydroxyl site of dialdehyde carboxymethyl chitosan, [0029] Step (3) cross-linking to form a hydrogel.
[0030] Further, the mass ratio of the dialdehyde carboxymethyl chitosan, tannic acid and acrylic acid is (1-1.5): (3-5): (10-15).
[0031] Further, the biological buffer in step (1) is selected from one of tris(hydroxyme thyl)aminomethane, N,N-dihydroxyethylglycine or 2-[4-(2-hydroxyethyl)piperazin-1 -yl]eth anesulfoni c acid.
[0032] The buffer selected in the invention is a biological buffer, which has good buffering capacity, has little interference with biochemical processes and has no toxicity to cells.
[0033] Further, the initiator in step (2) is selected from one of 2,2'-azobis[2-(2-imidazo lin-2-yl)propane] dihydrochloride or Dimethyl 2,2'-azobis(2-methylpropionate).
[0034] The initiator selected in the invention is selected from the initiator that does not contain cyano groups. Compared with other initiators, its decomposition products are non-toxic, less harmful to the body, decompose smoothly, and have a high conversion rate. [0035] Further, the cross-linking agent in step (3) is selected from one of 1-Ethy1-3 -0 -dimethylaminopropyl)carbodiim de or N-hydroxysuccinimide.
[0036] The cross-linking agent selected in the invention is non-toxic and has good biocompatibility. Used in combination with dialdehyde carboxymethyl chitosan which has a certain self-cross-linking ability, it has the characteristics of non-toxic and good biocompatibility while ensuring sufficient cross-linking degree.
[0037] Advantageous effects: [0038] 1. The chest seal provided by the invention uses dialdehyde carboxymethyl chitosan.
DESCRIPTION
Chitosan is a natural linear polyaminopolysaccharide linear polymer compound with broad-spectrum antibacterial properties and good biocompatibility, and it has no toxic and side effects on the human body. Hemostasis can be achieved through an electrostatic reaction between the cathode of erythrocyte membrane and the anode of the chitosan surface.
[0039] The invention uses carboxymethyl chitosan, utilizing its hydroxyl group to provide grafting sites for further modification, at the same time, as an amphoteric polyelectrolyte, it has good water solubility, film-forming properties and water-absorbing and water retention properties, and can be used as raw material for hydrogel. On the basis of carboxymethyl chitosan, a new active group-aldehyde group is generated through selective oxidation, which can act as part of the cross-linking effect by itself and reduce the use of toxic cross-linking agents.
[0040] 2. Tannic acid is added to the chest seal provided by the invention. Tannic acid has excellent broad-spectrum antibacterial activity and also has the ability to promote wound healing. Tannic acid, due to the large number of phenolic hydroxyl groups in its structure, can hinder bacteria from absorbing iron, polysaccharides, amino acids, etc. It can also disrupt bacterial cell walls and membranes, inhibit the formation of biofilms, and thus exhibits strong antibacterial capabilities; at the same time, tannic acid can act as an astringent, stimulating the secretion of basic fibroblast growth factor, and accelerating the healing of internal and external wounds.
[0041] 3. The chest seal provided by the invention uses the hydrogel structure. Hydrogel is a substance composed of an infinite three-dimensional network and water. It can be exchanged with body fluids and provide nutrients for the growth of cells and tissues, therefore, it has good biosafety and histocompatibility, and is an excellent hemostatic material. By grafting acrylic acid onto the hydroxyl sites of dialdehyde carboxymethyl chitosan, and then using a cross-linking agent to form a three-dimensional mesh structure, the meshes are interconnected, making it have better water absorption; when in contact with blood, it can absorb plasma, concentrate blood, which can facilitate platelet aggregation, and improve hemostatic effect. [0042] 4. The chest seal provided by the invention is non-toxic and has excellent biocompatibility: the buffer selected in the invention is a biological buffer, which has good
DESCRIPTION
buffering capacity, has little interference with biochemical processes and has no toxicity to cells; the initiator selected in the invention is selected from the initiator that does not contain cyano groups. Compared with other initiators, its decomposition products are non-toxic, less harmful to the body, decompose smoothly, and have a high conversion rate; the cross-linking agent selected in the invention is non-toxic and has good biocompatibility. Used in combination with dialdehyde carboxymethyl chitosan which has a certain self-cross-linking ability, it has the characteristics of non-toxic and good biocompatibility while ensuring sufficient cross-linking degree
Description of Embodiments
[0043] The invention will be described below in combination with specific embodiments. It should be noted that the following embodiments are examples of the invention and are only used to illustrate the invention but not to limit the invention. Other combinations and various improvements within the concept of the invention can be made without departing from the object or scope of the invention.
[0044] The carboxymethyl chitosan used in this invention was purchased from Shandong Fengtai Biotechnology Co., Ltd.; the tannic acid was medicinal tannic acid purchased from Zhangjiajie Jiurui Biotechnology Co., Ltd.; the absorbable hemostatic membrane was Datsing Biopaper purchased from Beijing Datsing Biotechnology Co., Ltd; the chest seal is Pengyue PY191 purchased from Shenyang Pengyue Technology Co., Ltd.; the compact chest seal is NAR HyFin purchased from North American Rescue Company in the United States. The remaining reagents and equipment are conventional reagents and equipment in this technical fi el d.
[0045] The preparation method of the dialdehyde carboxymethyl chitosan: [0046] (I) In parts by weight, adding deionized water to the reactor, then adding 5 parts of carboxymethyl chitosan and stirring to dissolve, then adding 5 parts of sodium periodate and adjusting the system pH to 4; [0047] (2) Heating the reactor in step (1) to 45°C and stirring for 4 hours under light-shielding conditions; [0048] (3) Adding ethylene glycol solution to the reactor in step (2), stirring at room
DESCRIPTION
temperature for 1 hour, centrifuging and washing the product 3 times with tert-butanol, and freeze-drying under vacuum for 24 hours to obtain the dialdehyde carboxymethyl chitosan. [0049] Embodiment 1 [0050] (1) In parts by weight, adding 30 parts of deionized water to the reactor, then adding 1 part of dialdehyde carboxymethyl chitosan and stirring to dissolve, then adding tris(hydroxymethyl)aminomethane solution to adjust the system pH to 8.5, adding 3 parts of tannic acid and mixing evenly, reacting at room temperature for 6 hours, [0051] (2) Continuously flowing nitrogen into the reactor in step (1), then adding 0.05 parts of 2,2'-azobis[2-(2-imidazolin-2-yl)propane] dihydrochloride and 10 parts of acrylic acid and stirring evenly, reacting at room temperature for 4 hours, then letting it stand for 12 hours; [0052] (3) Adding 0.05 parts of 1-Ethyl-3-(3-dimethylaminopropyl)carbodiimide to the reactor in step (2), stirring evenly, sealing, and then letting it stand at room temperature for 12 hours to prepare the dressing layer, [0053] (4) Placing the dressing layer in step (3) on top of the sealing adhesive layer, and covering the outer protective layer on the outside of the sealing adhesive layer and dressing layer to prepare the antibacterial and procoagulant chest seal.
[0054] Embodiment 2 [0055] Basically the same as Embodiment 1, except that the amount of tannic acid is changed to 5 parts [0056] Embodiment 3 [0057] Basically the same as Embodiment 1, except that the amount of acrylic acid is changed to 15 parts.
[0058] Embodiment 4 [0059] Basically the same as Embodiment 1, except that the amount of dialdehyde carboxymethyl chitosan is changed to 1.5 parts [0060] Comparative Example 1 [0061] Basically the same as Embodiment 1, except that the tannic acid is replaced by an equal amount of sodium hyaluronate.
[0062] Comparative Example 2
DESCRIPTION
[0063] Basically the same as Embodiment 1, except that acrylic acid is replaced by an equal amount of methylenesuccinic acid.
[0064] Comparative Example 3 [0065] Basically the same as Embodiment 1, except that dialdehyde carboxymethyl chitosan is replaced by an equal amount of carboxymethyl chitosan.
[0066] Comparative Example 4 [0067] Absorbable hemostatic membrane.
[0068] Comparative Example 5 [0069] Chest seal.
[0070] Comparative Example 6 [0071] Compact chest seal.
[0072] Performance Testing [0073] 1. Water absorption capacity test: placing 0.5g of the product of Embodiment 1-4 and 0.5g of the product of Comparative Example 1-4 in a 1000m1 beaker respectively, adding 500m1 of distilled water, letting them stand at room temperature for six hours, after the water absorption reaches saturation, filtering out the distilled water, weighing the mass, and calculating the water absorption rate. The results are as follows.
[0074] Sample (m/g) Water Absorption (m/g) Comparative Example (gig) Embodiment 1 0.5 60 120 Embodiment 2 0.5 62 124 Embodiment 3 0.5 59 118 Embodiment 4 0.5 60 120 Comparative Example 1 0.5 46 92 Comparative Example 2 0.5 52 104 Comparative Example 3 0.5 53 106 Comparative Example 4 0.5 50 100 [0075] According to the comparison between Embodiment 1-4 and Comparative Example 4,
DESCRIPTION
it can be seen that the chest seal provided by the invention has stronger water absorption ability, and thus has stronger hemostatic ability. According to the comparison between Embodiment 1-4 and Comparative Example 1-3, it can be seen that tannic acid has excellent water absorption capacity, using acrylic acid to graft, modify and the use of dialdehyde carboxymethyl chitosan can make the prepared hydrogel have better water absorption capacity.
[0076] 2. Hemostatic ability test: Japanese white rabbits were randomly divided into 11 groups. Japanese white rabbits were anesthetized and fixed on the operating table. The femoral vein was surgically exposed and cut transversely. After allowing them to spurt blood freely for 10 seconds, the products of Embodiment 1-4 and Comparative Example 1-6 were used to stop bleeding at the wound. Using gauze to squeeze hemostasis as a blank control, observing the hemostasis time.
[0077] Procoagulant ability test: taking pictures of Japanese white rabbits' wound every 2 days after the injury, and using Image-Pro Plus Version 6.0 image analysis software to calculate Japanese white rabbits' wound areas until the wounds heal.
[0078] Healing rate = (original wound area -unhealed wound area)/original wound areas 100%. The results are as follows.
[0079] Hemostasis time (t/s) Healing rate in 2 days Healing rate in 4 days Healing rate in 6 days Healing rate in 8 days Healing rate in 10 days Blank Control 85 9.7 21.2 29.5 53.1 80.6 Embodiment 1 19 11.2 28.7 49.2 72.9 97.3 Embodiment 2 20 11.5 29.6 50.1 74.2 98.2 Embodiment 3 18 10.4 28.5 48.7 71.1 96.6 Embodiment 4 21 10.1 28.9 49.0 71.5 96.9 Comparative Example 1 32 10.1 21.7 36.2 58.7 86.4 Comparative 28 10.3 25.4 42.9 67.8 90.6
DESCRIPTION
Example 2
Comparative Example 3 30 10.6 26.1 43.1 68.2 91.3 Comparative Example 4 28 11.3 22.9 30.2 55.1 83.3 Comparative Example 5 69 10.8 22.1 29.8 53.4 82.1 Comparative Example 6 65 10.2 21.7 29.2 52.3 81.4 [0080] According to the comparison between Embodiment 1-4, Comparative Example 4-6 and the blank control, in terms of hemostatic ability, the chest seal provided by the invention has hemostatic ability, and has stronger hemostatic ability than conventional hemostatic membranes, hemostasis can be completed in a shorter time; in terms of procoagulant ability, the chest seal provided by the invention basically healed the wound on the 10th day, and is stronger than Japanese white rabbits' own healing ability, achieving the effect of promoting healing; at the same time, it is also stronger than other chest seals and hemostatic products in procoagulant ability. According to the comparison between Embodiment 1-4 and Comparative Example 1-3, it can be seen that tannic acid has better hemostatic ability and procoagulant ability than sodium hyaluronate, using acrylic acid to graft, modify and the use of dialdehyde carboxymethyl chitosan make the prepared hydrogel to have better hemostatic and procoagulant abilities.
[0081] 3. Antibacterial ability test: according to ASTM 21-96 -Standard Practice for Determining Resistance of Synthetic Polymeric Materials to Fungi, the anti-mold performance of the product is tested by using the petri dish method. The samples prepared in Embodiment 1-4 and Comparative Example 1-4 were made into 50m x5Omm specifications and placed flat on the surface of the solidified inorganic salt culture medium. Then preparing a mixed suspension of fungal spores: 5 kinds of molds (Aspergillus niger, Penicillium funiculosum, Chaetomium globosum, Gliocladium virens, and Aureobasidium pullulans), the prepared spore suspension should use spores (1,000,000 ± 200,000) spores/mL, which can be
DESCRIPTION
calculated with a counter. Spraying the spore suspension evenly and finely on the entire surface of the sample, the pressure of the sprayer should reach 110 kPa. After drying slightly, covering the Petri dish lid. Marking the name, number and date of the sample on the cover, placing it in an incubator, and maintaining it at a temperature of 28°C to 30°C and a relative humidity of no less than 85%. The standard cultivation time for the test is 28 days. After 28 days, the evaluation for anti-mold grade is carried out. The results are in the table below. [0082] Anti-mold Grade Embodiment 1 0 Embodiment 2 0 Embodiment 3 0 Embodiment 4 0 Comparative Example 1 2 Comparative Example 2 1 Comparative Example 3 1 Comparative Example 4 3 Comparative Example 5 3 Comparative Example 6 4 [0083] The evaluation criteria for anti-mold grade are as follows: [0084] Anti-mold Grade Evaluation Criteria for Anti-mold Grade 0 No mold growth 1 Trace growth (less than 10%) 2 Slight growth (10-30%) 3 Moderate growth (30-60%) 4 Heavy growth (60%-full coverage) [0085] According to the comparison between Embodiment 1-4 and Comparative Example 46, it can be seen that the chest seal provided by the invention has strong antibacterial ability,
DESCRIPTION
while the chest seals and hemostatic products currently on the market have very poor antibacterial ability. According to the comparison between Embodiment 1-4 and Comparative Examples 1-3, it can be seen that tannic acid has strong antibacterial ability, using acrylic acid to graft, modify and the use of di al dehyde carboxymethyl chitosan can make the prepared hydrogel have better antibacterial ability.
[0086] The above embodiments are only for illustrating the technical concepts and characteristics of the invention. The object is to allow those familiar with this technology to understand the content of the invention and implement it. This does not limit the scope of protection of the invention. MI equivalent changes or modifications made based on the spirit and essence of the invention shall be included in the protection scope of the invention.

Claims (10)

  1. CLAIMS1. An antibacterial and procoagulant chest seal, wherein it comprises an outer protective layer, a dressing layer and a sealing adhesive layer from top to bottom; the dressing layer is obtained as follows: preparing a complex of dialdehyde carboxymethyl chitosan and tannic acid, then grafting the dialdehyde carboxymethyl chitosan in the composite with acrylic acid, and then cross-linking to form a hydrogel.
  2. 2. An antibacterial and procoagulant chest seal according to claim 1, wherein the outer protective layer is the release paper outer protective layer.
  3. 3. An antibacterial and procoagulant chest seal according to claim 1, wherein: the sealing adhesive layer is selected from one of PE, EVA, PEVA, polyurethane or natural rubber that has anti-permeability.
  4. 4. An antibacterial and procoagulant chest seal according to claim I, wherein: the preparation method of the dialdehyde carboxymethyl chitosan comprises the following steps: (1) Adding deionized water to the reactor, then adding carboxymethyl chitosan and stirring to dissolve, then adding oxidant and adjusting the system pH to 3.5-4; (2) Heating the reactor in step (1) to 40-45°C and stirring for 4-5 hours under light-shielding conditions; (3) Adding ethylene glycol solution to the reactor in step (2), stirring at room temperature for 0.5-1 hour, centrifuging and washing the product, and freeze-drying under vacuum for 20-24 hours to obtain the dialdehyde carboxymethyl chitosan.
  5. 5. An antibacterial and procoagulant chest seal according to claim 4, wherein the oxidant in step (1) is sodium periodate.
  6. 6. A preparation method of the antibacterial and procoagulant chest seal according to any one of claims 1-5, wherein: it comprises the following steps: (1) Adding deionized water to the reactor, then adding dialdehyde carboxymethyl chitosan and stirring to dissolve, then adding biological buffer to adjust the system pH to 88.5, adding tannic acid and mixing evenly, reacting at room temperature for 6-8 hours; (2) Continuously flowing protective gas into the reactor in step (1), then adding initiator and acrylic acid and stirring evenly, reacting at room temperature for 4-5 hours, then letting it stand for 10-12 hours; (3) Adding the cross-linking agent to the reactor in step (2), stirring evenly, sealing, andCLAIMSthen letting it stand at room temperature for 10-12 hours to prepare the dressing layer; (4) Placing the dressing layer in step (3) on top of the sealing adhesive layer, and covering the outer protective layer on the outside of the sealing adhesive layer and dressing layer to prepare the antibacterial and procoagulant chest seal.
  7. 7. A preparation method of the antibacterial and procoagulant chest seal according to claim 6, wherein: the mass ratio of the dialdehyde carboxymethyl chitosan, tannic acid and acrylic acid is (1-1.5): (3-5): (10-15).
  8. 8. A preparation method of the antibacterial and procoagulant chest seal accordin g to claim 6, wherein: the biological buffer in step (1) is selected from one of tris(hy droxymethyDaminomethane, N,N-dihydroxyethylglycine or 2-[4-(2-hydroxyethyl)piperazin - I -yl]eth an esul foni c acid.
  9. 9. A preparation method of the antibacterial and procoagulant chest seal accordin g to claim 6, wherein: the initiator in step (2) is selected from one of 2,2'-azobis[2-(2 -imidazolin-2-yepropane] dihydrochloride or Dimethyl 2,2'-azobis(2-methy-lpropionate).
  10. 10. A preparation method of the antibacterial and procoagulant chest seal according to claim 6, wherein: the cross-linking agent in step (3) is selected from one of 1-Ethy1-3 -(3 -dimethyl aminopropyl)carbodiimi de or N-hydroxysuccinimide.
GB2317328.9A 2022-11-16 2023-11-13 An antibacterial and procoagulant chest seal and a preparation method thereof Pending GB2625207A (en)

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US20040101547A1 (en) * 2002-11-26 2004-05-27 Pendharkar Sanyog Manohar Wound dressing containing aldehyde-modified regenerated polysaccharide
CN113941025A (en) * 2021-10-27 2022-01-18 四川大学华西医院 Tissue-adhesive hydrogel and application thereof
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CN103709267A (en) * 2013-11-28 2014-04-09 江南大学 Preparation method of dialdehyde carboxymethyl chitosan
CN213156978U (en) * 2020-06-30 2021-05-11 泰州市榕兴医疗用品股份有限公司 Thoracic cavity sealing patch
CN113069166A (en) * 2021-03-01 2021-07-06 河南神龙战救医疗装备有限公司 Chest sealing patch with hemostasis function
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CN113941025A (en) * 2021-10-27 2022-01-18 四川大学华西医院 Tissue-adhesive hydrogel and application thereof
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