CN106178089A - A kind of medical toughness closes hemostatic material and compositions - Google Patents

A kind of medical toughness closes hemostatic material and compositions Download PDF

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Publication number
CN106178089A
CN106178089A CN201610574391.7A CN201610574391A CN106178089A CN 106178089 A CN106178089 A CN 106178089A CN 201610574391 A CN201610574391 A CN 201610574391A CN 106178089 A CN106178089 A CN 106178089A
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CN
China
Prior art keywords
medical
toughness
hemostatic material
group
closes
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Pending
Application number
CN201610574391.7A
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Chinese (zh)
Inventor
金海明
李洪波
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QINGDAO ZHONGTENG BIOTECHNOLOGY Co Ltd
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QINGDAO ZHONGTENG BIOTECHNOLOGY Co Ltd
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Priority to CN201610574391.7A priority Critical patent/CN106178089A/en
Publication of CN106178089A publication Critical patent/CN106178089A/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
    • A61L24/00Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/04Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials
    • A61L24/08Polysaccharides
    • 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
    • A61L24/00Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/0005Ingredients of undetermined constitution or reaction products thereof
    • 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
    • A61L24/00Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/001Use of materials characterised by their function or physical properties
    • A61L24/0015Medicaments; Biocides
    • 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/20Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
    • A61L2300/252Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
    • A61L2300/254Enzymes, proenzymes
    • 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/418Agents promoting blood coagulation, blood-clotting agents, embolising agents
    • 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

Abstract

The invention belongs to field of medical article technology, more specifically a kind of medical hemostatic closed material and compositions.A kind of medical toughness closes hemostatic material, the polymerization or condensation with one of A R A or B R1 B structure form, or the mixture of substances of two kinds of structures is condensed or is polymerized.The medical toughness of the present invention closes hemostatic material and compositions, by connecing a reactive group that polymerization or condensation reaction can be occurred to interconnect, form film forming or there is the material of liquid absorption capacity, when it uses, being applied position, film forming or absorbent material can be combined by high energy band and form high tenacity membrane material or absorbent material, to reach preferably to close the effect of wound or hemostasis, prevent occult blood or the hemorrhage probability of secondary.

Description

A kind of medical toughness closes hemostatic material and compositions
Technical field
The invention belongs to field of medical article technology, more specifically a kind of medical hemostatic closed material and compositions.
Background technology
Hemostasis is one of core of essential surgical skills technology, and the surgical procedures at any position of human body is the most bar none Relate to hemorrhage with hemostasis, hemostatic technique by the apparatus haemostatic measures that the past is simple develop under the conditions of modern surgery numerous and complicated Complicated technical system.The part that wherein application of hemostatic material is important during becoming this.Traditional ligation, stitching, Coagulation, the method such as tamp have again new development on the basis of inheriting, as intraperitoneal fills hemostasis because easily inducing infection, abdomen inner cavity chamber Syndrome, secondary hemorrhage etc. and be once abandoned, but only handle aptly, be still effective life saving measure in early days.Good Biological dressing can directly facilitate coagulation process, cannot be only used for extensive oozing of blood wound surface, and can have in some conventional surgery arts Effect reduces oozing of blood rate.Novel wound first aid hemostatic material often from wound hemostatic material in the application in emergency care of trauma field and Can effectively be combined with human body wound.Preferably biological hemostatic material should possess following characteristics: hemostasis is rapid, avirulence, nothing Antigenicity, easily it is absorbed by the body, do not increases Infection probability, do not affects organization healing, low price etc..Have been developed at present perhaps The wound surface Absorbable hemostatic material of multiple types, mainly has: Fibrin Glue, collagen protein, starch, chitosan, many micropores class without Machine material such as zeolite etc., carboxymethyl cellulose (soluble hemostyptic powder cloth), a-cyanoacrylate class loading glue etc..
Powder or liquid medical hemostatic closed material, owing to it is suitable for irregular wound surface, application is simple, always in clinic In widely used, but there is also some problems simultaneously, the blood clot intensity difference formed such as powder hemostatic material, be easily broken product The problems such as raw secondary is hemorrhage, and sealer needs wound bed fluid to dry, and liquid absorption capacity is poor, the toughness of material difference of formation.So Strengthening closing the toughness of hemostatic material, the tensile strength improving product is imperative.
Summary of the invention
In order to make up the drawbacks described above that existing hemostatic material exists, the present invention provides a kind of new hemostatic material, should be only Blood toughness of material is excellent, and liquid absorption capacity is good.
The technical solution adopted in the present invention is: a kind of medical toughness closes hemostatic material, by having A-R-A or B-R1-B Polymerization or the condensation of one of structure form, or the mixture of substances of two kinds of structures is condensed or is polymerized.
A group is selected from metal ion, halide ion, amino, hydroxyl, carboxyl, succinamide imido grpup, maleimide Base, sulfonic group, phosphate-based, polyphosphoric acids ester group, nitro, itrile group, aldehyde radical, fragrance aldehyde radical, anhydride, fatty acid anhydride, ketone group, carboxylic In perester radical, sulfydryl any one.
B group be metal ion, halide ion, amino, hydroxyl, carboxyl, succinamide imido grpup, dimaleoyl imino, Sulfonic group, phosphate-based, polyphosphoric acids ester group, nitro, itrile group, aldehyde radical, fragrance aldehyde radical, anhydride, fatty acid anhydride, ketone group, carboxylic acid Any one in ester group, sulfydryl.
R is peptide, albumen, polysaccharide, fat, nucleic acid monomer or polymer and connects by-reaction product or derivant, and Microsphere that above material is formed by crosslinking method and microsphere are again through the structure of modification reaction;The A group of the upper connection of R Quantity is more than or equal to 2.
R1 is peptide, albumen, polysaccharide, fat, lactic acid, hydroxyacetic acid, nucleic acid monomer or polymer and connects by-reaction product Thing or derivant, and the microsphere that formed by crosslinking method of above material and microsphere are again through the knot of modification reaction Structure;The B group quantity of the upper connection of R1 is more than or equal to 2.
A can be identical with B structure, R with R1 structure can also be identical.
A group is preferably, polyphosphoric acids base, succinimido or dimaleoyl imino.
B group is preferably, sodium ion, succinimido or dimaleoyl imino.
R is preferably oxidized cellulose, regenerated oxidised cellulose, hetastarch, crosslinked starch, dextran, fiber egg In vain, any one in chitosan.
R1 is preferably, oxidized cellulose, regenerated oxidised cellulose, hetastarch, crosslinked starch, glucosan, fiber egg Any one in Bai.
Comprising described medical toughness and close the compositions of hemostatic material, it comprises hemorrhage further.Wherein said Hemorrhage is thrombin.
The medical toughness of the present invention closes hemostatic material and compositions, polymerization or condensation reaction can be occurred mutual by connecing to prop up The reactive group connected, forms film forming or has the material of liquid absorption capacity, when it uses, will be able to become being applied position Film or absorbent material are compound and form high tenacity membrane material or absorbent material by high energy band, with reach preferably to close wound or The effect of hemostasis, prevents occult blood or the hemorrhage probability of secondary.
Detailed description of the invention
Example 1, the medical toughness of the present embodiment close hemostatic material, by two kinds of materials that structure is A-R-A and B-R1-B Condensation forms.Wherein R and R1 is crosslinked starch microspheres;A is sodium ion;B is phosphate-based.
Concrete preparation process is:
(1) using carboxymethyl starch sodium and starch, respectively is raw material, prepares crosslinked starch microspheres by reverse crosslinking method.
(2), use starch be crosslinked starch microspheres prepared by raw material, with sodium dihydrogen phosphate, deionized water is according to 1:1:5 ratio Example mixes, and under the conditions of 40 DEG C, reacts 24h, then uses deionized water repeatedly to clean, and precipitation obtains starch phosphate after drying Crosslinked microsphere.
(3), carboxymethyl starch sodium crosslinked starch microspheres and starch phosphate crosslinked microsphere, mix according to according to 1:1 ratio Uniformly, fill carry out irradiation aseptic process.Obtain the medical toughness of powdery and close hemostatic material.
(4), when being operated, meet the non-splash type bleeding wounds such as oozing of blood, this material is sprayed in wound surface, form sediment In the blood of powder microsphere absorption wound position between moisture, and spherex, by chemical bonding reaction, it is condensed into starch gel, and phosphorus Hydrochlorate, the moisture that spherex absorbs in blood causes Blood cell accumulation, quickly forms high intensity blood clot, block hemorrhage portion Position, completes hemostasis, and owing to starch microparticles is connected to become an entirety by chemical bond, the intensity of blood clot obtains than loose condition (of surface) To improving, can effectively reduce the secondary that wound causes due to reasons such as carryings hemorrhage.
Example 2, the medical toughness of the present embodiment close hemostatic material, by the polymerization that structure is A-R-A or B-R1-B Forming, wherein R or R1 is chain fatty;A or B is hydroxyl ethyl acrylate.
Concrete preparation process is:
(1), use medical grade soybean oil material, use chemistry to meet Zhi Fangfa on grease material, connect a hydroxyl ethyl acrylate, Use petroleum ether extraction purified material.Obtain the medical toughness of liquid and close hemostatic material.
(2), carry out operation stitching operation time, this material is sprayed in stitching thread site of puncture, hydroxyl ethyl acrylate material The moisture initiated polymerization in body fluid, blood met by material, forms the membranaceous closed material with certain toughness.Due to chain fatty The introducing of structure, improve the Alpha-hydroxy ethyl acrylate glue product used on the market at present can produce bigger polymerization heat, The shortcomings such as the film toughness produced after, solidification strong to tissue irritation is not enough, fragility is big.
Example 3, the present embodiment are to comprise the medical toughness of the present invention to close hemostatic material and the compositions of thrombin, preparation side Method is:
(1), using polysaccharide material glucosan, by controlling material rate, every unit glucosan connects a 4-8 maleimide respectively Amine groups, obtains hemostatic material 1.This hemostatic material is formed by the polymerization that structure is A-R-A, and wherein R is glucosan, and A is horse Carry out imide group.
(2), using polysaccharide material glucosan, by controlling material rate, every unit glucosan connects a 4-8 succinum respectively Imide group, obtains hemostatic material 2.This hemostatic material is formed by the polymerization that structure is B-R1-B, and wherein R1 is glucosan, B is butanimide group.
(3), Clinical practice time, use matching while using mode, by fast to equivalent hemostatic material 1, hemostatic material 2 and thrombin Speed mixing, i.e. joins and i.e. uses.Thrombin and blood quickly form little blood clot, and are wrapped in by hemostatic material 1 and hemostatic material 2 In the fine and close network structure that polymerization is formed, block rapidly bleeding part, can use as tissue sealant.

Claims (10)

1. a medical toughness closes hemostatic material, it is characterised in that: gathered by the material with one of A-R-A or B-R1-B structure Close or condensation forms, or the mixture of substances of two kinds of structures is condensed or is polymerized.
2. close hemostatic material according to the medical toughness described in claim 1, it is characterised in that: A from B is identical or different;R Identical from R1 or different.
3. close hemostatic material according to the medical toughness described in claim 2, it is characterised in that: A or B group selected from metal from Son, halide ion, amino, hydroxyl, carboxyl, succinamide imido grpup, dimaleoyl imino, sulfonic group, phosphate-based, poly phosphorus Perester radical, nitro, itrile group, aldehyde radical, fragrance aldehyde radical, anhydride, fatty acid anhydride, ketone group, carboxylic acid ester groups, sulfydryl in any one.
4. close hemostatic material according to the medical toughness described in claim 2, it is characterised in that: R or R1 is peptide, albumen, many Sugar, fat, lactic acid, hydroxyacetic acid, nucleic acid monomer, or the polymer that formed for monomer with above material and connect by-reaction product Or derivant, and the microsphere that formed by crosslinking method of above material and microsphere are again through the structure of modification reaction;R Or A or the B group quantity connected on R1 is more than or equal to 2.
Medical toughness the most according to claim 3 closes hemostatic material, it is characterised in that: A group is polyphosphoric acids base, amber Amber imide or dimaleoyl imino.
Medical toughness the most according to claim 3 closes hemostatic material, it is characterised in that: B group is sodium ion, succinyl Imido grpup or dimaleoyl imino.
Medical toughness the most according to claim 4 close hemostatic material, R selected from oxidized cellulose, regenerated oxidised cellulose, Any one in hetastarch, crosslinked starch, dextran, fibrin, chitosan.
Medical toughness the most according to claim 4 closes hemostatic material, and R1 is selected from oxidized cellulose, regenerating oxidation fiber Any one in element, hetastarch, crosslinked starch, glucosan, fiber egg.
9. comprise the medical toughness described in any one of claim 1-8 and close the compositions of hemostatic material, it is characterised in that: this group Compound comprises hemorrhage.
Compositions the most according to claim 9, it is characterised in that: described hemorrhage is thrombin.
CN201610574391.7A 2016-07-21 2016-07-21 A kind of medical toughness closes hemostatic material and compositions Pending CN106178089A (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112957518A (en) * 2018-08-20 2021-06-15 稳得希林(杭州)生物科技有限公司 Polysaccharide-based tissue adhesive medical adhesive and application thereof
CN115721772A (en) * 2022-12-15 2023-03-03 湖南中腾湘岳生物科技有限公司 Absorbable hemostatic material
CN115721772B (en) * 2022-12-15 2024-05-10 湖南中腾湘岳生物科技有限公司 Absorbable hemostatic material

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Publication number Priority date Publication date Assignee Title
CN112957518A (en) * 2018-08-20 2021-06-15 稳得希林(杭州)生物科技有限公司 Polysaccharide-based tissue adhesive medical adhesive and application thereof
CN115721772A (en) * 2022-12-15 2023-03-03 湖南中腾湘岳生物科技有限公司 Absorbable hemostatic material
CN115721772B (en) * 2022-12-15 2024-05-10 湖南中腾湘岳生物科技有限公司 Absorbable hemostatic material

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Application publication date: 20161207