CN108888798A - A kind of flexible foldable biomembrane and preparation method thereof - Google Patents

A kind of flexible foldable biomembrane and preparation method thereof Download PDF

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Publication number
CN108888798A
CN108888798A CN201811061465.2A CN201811061465A CN108888798A CN 108888798 A CN108888798 A CN 108888798A CN 201811061465 A CN201811061465 A CN 201811061465A CN 108888798 A CN108888798 A CN 108888798A
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biomembrane
polyurethane
flexible foldable
chitosan
diaphragm
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不公告发明人
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Circle Holds Biological Medicine Wuxi Co Ltd
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Circle Holds Biological Medicine Wuxi Co Ltd
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Priority to CN201811061465.2A priority Critical patent/CN108888798A/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/22—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
    • A61L15/26—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/22—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
    • A61L15/28—Polysaccharides or their derivatives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42—Use of materials characterised by their function or physical properties
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42—Use of materials characterised by their function or physical properties
    • A61L15/44—Medicaments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04—Macromolecular materials
    • A61L31/042—Polysaccharides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04—Macromolecular materials
    • A61L31/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/16—Biologically active materials, e.g. therapeutic substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L2400/00—Materials characterised by their function or physical properties
    • A61L2400/04—Materials for stopping bleeding

Abstract

The present invention provides a kind of flexible foldable biomembrane and preparation method thereof,The flexible foldable biomembrane is formed by inside and outside two layers,Wherein,Outer layer be absorb liquid after can fragmentation medical polyurethane diaphragm,Internal layer is surface of a wound coating,For example it is made of the mixture dressing of chitosan and its derivative or alginates or both,It can be individually used for wound repair,It can also be carried on medicine adsorption layer using preceding be adsorbed on therapeutic agent,Play the role for the treatment of,Wherein the surface of a wound includes skin,Mucous membrane or in-vivo tissue,It is particularly suitable for uterine neck reparation,Foldable flexible biomembrane is manufactured into mushroom shaped,There is a protrusion in centre,Before use,Therapeutic agent is adsorbed in chitosan and its derivative or alginate dressing,When use,With dedicated vagina folder or dedicated pushing tool,Push is covered on uterine neck discharge surface,Protrusion is fixed in introitus,Continue local administration to realize uterus neck,Increase and treats chronic cervical disease such as cervical erosion,The effect of HPV.

Description

A kind of flexible foldable biomembrane and preparation method thereof
Technical field
The invention belongs to field of medical accessory, and in particular to a kind of flexible foldable biomembrane and preparation method thereof is used for Skin, the adherency of mucous membrane and organ surface, load medicine and repairing and treating.
Background technique
With the development of material science, the biomaterial that can be used as dressing is increasing.The advantages of biological dressing, is main Be with human compatibility is good, toxic side effect is small, antigenicity is low, has certain water penetration, can reduce the surface of a wound dressing change frequency, reduce bacterium It falls density and is conducive to the control surface of a wound and further infects, the physical damnification of new granulation tissue can also be effectively reduced.Not by structure Together, film-type, foam sponge type, gel-type and compound etc. can be divided into.
Film-type is usually the film material made of a kind of material, with homogeneous structural, mainly as short-term dressing For II degree of burn and thickness skin donor wound.Experiments have shown that (such as nylon, polypropylene fibre, polyurethane, polyvinyl alcohol, gathers polyvinyl many materials Acrylonitrile, polycaprolactone, polylactic acid, polyaminoacid, polytetrafluoroethylene (PTFE), silicone elastomer etc.) it can be used as dressing use.It draws The adhesiveness of the porosity for the polytetrafluoroethylene film stretched about 70%~80%, gas permeability and the surface of a wound is good, but use when intensity and Performance is still undesirable.To adapt to bonding and fixation with body tissue, the inner surface of general film-type dressing is velvet-like.
Compound dressing is generally obtained by two or more Material claddings, mainly as the substitute of long-term covering skin, is used In the treatment of deep II degree and III degree burn wound, such as PU foam devises one kind for internal layer and porous PTFE composite membrane, silicon rubber The double-layer artificial skin that human body is easily accepted by, epidermis are the silicon rubber to shield, and internal layer is porous collagen chondroitin sulfate, Clinic shows to can be used for burn and dermatoplasty have certain biological function.
Since organization engineering skin usually supplies nutrition without vascular system, the epithelium on surface is easy necrosis and falls off, therefore, The extracellular three dimensional matrix of material requirements as dermal scaffold is easier to induce the generation of capillary and blood vessel, and blood vessel and Capillary will not change its shape and size after growing into matrix.Desired skin repair membrane should be with some strength, and Biocompatibility and the good natural polymer of cellular affinity are preferably capable of the growth factor that release promotes cell development, or The growth that can inhibit bacterium, after timbering material machine-shaping have porous three-dimensional structure be easy to cell grow into, nutrients Matter and the exchange of metabolin etc..
In recent years, many natural, synthesis high molecular polymers are attempted applied to field of tissue engineering technology, are organizer The reconstruction of official provides three-dimensional porous cytoskeleton.Chitosan and its derivative is a kind of Natural polycations biological polyoses, tool There are special physical chemistry and biological characteristics.
Chitosan and its derivative is a kind of biomaterial that source is very wide, has good biocompatibility, does not exempt from Epidemic focus also has preferable biocidal property, can act on other electronegative macromolecules, form the branch of very strong mechanical performance Frame material meets the performance requirement of tissue engineering bracket and dressing for skin.It is separately added into chitosan and its derivative solution Hyaluronic acid or sodium alginate, it is possible to reduce wound scar, hemostasis and blood coagulation, enhance wound healing the effect of.
Cervical disease mainly has inflammation and HPV viruse infection etc., is common gynecological disease, frequently-occurring disease, can cause uterus, defeated ovum Pipe and pelvic inflammatory disease, it is refractory more, high recurrence rate, physical isolation combines appropriate drug or therapeutic equipments to be presently the most effective means One of, wherein comparing typically chitosan and its derivative uterine neck reparation patch, although chitosan and its derivative uterine neck reparation It is attached to cervicitis affected area (columnar epithelial cell of uterine neck and cervical gland pipe surface), the work of biological barrier is played to wound and mucous membrane With, but the organized compatibility of chitin (or chitosan and its derivative) class dressing is good, hemostatic function is good, anti-infective energy Power is strong, but adhesiveness and compliance are all poor, and the drug of appendix is easy to fall off with secretion, is unable to ensure the drug of continued administration Concentration, therapeutic effect are also restricted because of the property of material itself.Seaweed acids dressing moisture pick-up properties is high, can maintain the surface of a wound One wet environment, it is at low cost, but easily harden, cause the surface of a wound to damage again.Fibroin albumen class dressing has good cell and group It is good to knit compatibility, oxygen flow permeability, but its water imbibition, toughness, mechanicalness and anti-microbial property are to be improved.Bacteria cellulose Class dressing non-immunogenicity, good permeable breathable, with surface of a wound close adhesion, mechanical strength and plasticity are strong, but lack one A effective fermentation system produces with carrying out large-scale low-cost.There is collagen class dressing good biocompatibility hemostasis to promote solidifying, promotion Cell division differentiation, but stability is weaker, poor flexibility, matter are crisp, not resistant to water, and derives from animal, and there are the danger of infection Danger.
For this purpose, we use special technological design, using company exclusively can industrialization degradable medical polyurethane New material has developed the present invention for the better composite repairing material of wound repair, can apply by testing and studying repeatedly In the reparation of a variety of surface of a wound, wherein the drug of cervical disease can be treated with appendix, so that drug concentration is reached treatment concentration, show The clinic expection of better clinical advantage, polyurethane uterine neck flexible foldable biomembrane of the invention is worthy of expecting.
Summary of the invention
Present invention aim to address above-mentioned technical problem, a kind of flexible foldable biomembrane and its preparation side are provided Method can be applied to the reparation of a variety of surface of a wound, improve wound repair effect.
In order to solve the above technical problems, the embodiment of the present invention provides a kind of flexible foldable biomembrane, by inside and outside two layers Composition, wherein outer layer be absorb liquid after can fragmentation medical polyurethane diaphragm, internal layer be surface of a wound coating.
The shape of the flexible foldable biomembrane can need to design according to the adherency of implant site, such as：For The shape of skin surface reparation can be two layers of diaphragm composition；Diaphragm for gastric ulcer can be easy to swallow it is spherical；With It can be tubulose in cavity disease；It can be mushroom for cervical disease；It is spongy for can be for hemostasis.
Wherein, the surface of a wound coating is to carry medicine adsorption layer.Such as by chitosan and its derivative, alginates or both Mixture dressing composition, can be individually used for wound repair, therapeutic activity Drug absorbability can also carried medicine absorption using preceding On layer, wherein the surface of a wound includes skin, mucous membrane or in-vivo tissue.
Further, the load medicine adsorption layer includes alginate dressing layer and chitosan and its derivative dressing layer, the shell Poly- carbohydrates and their derivative dressing layer is adhered on alginate dressing layer, is contacted with the surface of a wound, and playing wound repairing includes skin, mucous membrane Or the effect of in-vivo tissue.
Wherein, the weight percent of the alginates coating and chitosan and its derivative dressing layer is：
Alginate dressing layer 50-100%
Chitosan and its derivative dressing layer 1-49%.
Wherein, the material for carrying medicine adsorption layer is selected from hydrophilic polymer material, specifically includes：Carbomer, poly- card wave Phenanthrene, Sodium Hyaluronate, sodium alginate, chitosan and its derivative, polyaminoacid, polypeptide, povidone, hydroxypropyl cellulose, hydroxyl Propyl methocel, hydroxyethyl cellulose, sodium carboxymethyl starch, polyvinyl alcohol, xanthan gum, modified alginates and its degradation At the alginate of aminohexose and N-acetylglucosamine, starch-grafted acrylonitrile, starch-grafted hydrophilic monomer, poly- third Olefin(e) acid salt, vinyl acetate co-polymer, modified poly ethylene alcohols, modified cellulose (such as cellulose graft acrylonitrile, fiber Ring after plain grafted propylene hydrochlorate, cellulose xanthogenation grafted propylene hydrochlorate, cellulose graft acrylamide, carboxymethyl cellulose Oxygen chloropropane intersect crosslinking) one of or multiple combinations.
In the present invention, the chitosan and its derivative is specially：
Chitosan and its derivative mainly include acylation, carboxylated, alkylation, esterification, Schiff 's base formed and be crosslinked with And pass through diisocyanate (IPDI, BDI, LDI, HDI etc.) and modified obtained chitosan derivatives (the PU- shell of polymer diol Glycan).For example we are chemically reacted to obtain one end with isocyanic acid using polymer diol and lysine diisocyanate The intermediate of root, intermediate are grafted with the amino on chitosan again, have obtained having elasticity and toughness good.
Wherein, absorb liquid after can fragmentation the medical polyurethane diaphragm be selected from degradable medical polyurethane, specifically Including：Polyether-type, polyester-polyether type, natural polymer subtype and the biodegradable PU of plant oil type, aliphatic polyether ammonia Ester, polyurethane-acrylate hydrogel, fatty poly-ester carbonate urethane, polyurethane-urea elastomers, polyurethane-poly dimethyl silicon Oxygen alkane block copolymer, one or both of polyether thermoplastic polyurethane.It is preferred that degradable polyurethane, specifically includes to rely Propylhomoserin diisocyanate does the polyurethane of hard section, and soft segment can be with polyalcohol, polyethylene glycol 200, polyethylene glycol 400, poly- second One of glycol 600 or it is a variety of be initiator, one of LA, GA, CL, PDO, adipic anhydride or a variety of obtain polymer two Alcohol, chain extension selecting are chosen in particular from ethylene glycol, diethylene glycol (DEG), tetraethylene glycol, 1,3- from chain extender diol or diamine or class diamine Propylene glycol, 1,4-butanediol, 1,6- hexylene glycol, 1,7- heptandiol, 1,8- ethohexadiol, 1,9- nonanediol, 1,10- decanediol, second One or both of diamines, propane diamine, butanediamine, pentanediamine, class diamine.
The more preferable soft segment raw material of medical polyurethane diaphragm is selected from one of polyurethane, polyester, polyethers, polyaminoacid Or two kinds of combinations, it is chosen in particular from poly- valerolactone, poly- ε-decalactone, polylactide, polyglycolide, polylactide and polyglycolide Copolymer, polylactide-co-glycolide copolymer, poly- 6-caprolactone, polyhydroxybutyrate, poly butyric ester, poly- hydroxyl penta Acid esters, poly butyric ester -co- valerate, poly- (- dioxane -2,3- diketone of Isosorbide-5-Nitrae), poly- (1,3- dioxane -2- ketone), poly- P-dioxanone, polyanhydride, polymaleic anhydride, poly- hydroxyl-metacrylate, fibrin, polybutylcyanoacrylate, Polycaprolactone propylene dimethyl phthalate, poly- β-maleic acid, polycaprolactone butyl acrylate, by castor oil, the poly- hydroxyl of microbial fermentation Base butyric acid valerate (PHBV) and chemically synthesized polyvinyl alcohol (PVA), the bio-based polyurethane material of preparation, more block polymerizations Object is such as：From oligomerization caprolactone diol, oligomerization dioxanone glycol, polyether ester multi-block polymer, poly- pivalolactone, Polyglycolic acid trimethyl carbonate, polycaprolactone-glycolide, poly- (g- ethyl glutamate), polyglycine, polyalanine, poly- figured silk fabrics ammonia Sour, poly- leucine, poly- isoleucine, polyphenylalanine and polyproline, poly- tryptophan, polyserine, polytyrosine, poly- half Guang Propylhomoserin, poly- methionine, poly-asparagine, polyglutamine and poly- threonine, poly-aspartate and polyglutamic acid, polylysine, Poly arginine and polyhistidyl or be different aminoacids polymer polypeptide, preferably with free amine group by basic amino acid Such as one or both of poly arginine, polylysine and the polyhistidyl combination being polymerized.
Further, the flexible foldable biomembrane prepare material further include promote wound healing high molecular material, Small-molecule drug with biological anti-inflammatory activity, wherein the high molecular material be Sodium Hyaluronate, zinc hyaluronate, PVA, PVP, polylysine, polyglutamic acid, chondroitin sulfate, sodium carboxymethylcellulose, chitosan and its derivative, alginate, change Property the combination of one or both of alginate and its alginate that is degraded into aminohexose and N-acetylglucosamine；Institute State one or two kinds of combinations that small-molecule drug is polypeptide, amino acid and various anti-inflammatory drugs.
Wherein, recoverable characteristic after the medical polyurethane diaphragm has certain thickness and folds, the medical poly- ammonia Ester diaphragm with a thickness of 0.02~1mm, selected from using PCL as the degradable medical polyurethane of soft segment.
The present invention also provides a kind of preparation methods of flexible foldable biomembrane, include the following steps：
(1-1) by polyurethane and promotes the high molecular material of wound healing to be spun into a thickness of 0.02- by electrostatic spinning The medical polyurethane diaphragm of 1mm；
(1-2) chooses, and there is the high molecular material of strong water sorption, adhesive attraction to be prepared into loose porous dressing；
Loose porous dressing prepared by step (1-2) is added suitable quantity of water to be adhered to the medical poly- of step (1-1) preparation by (1-3) It on urethane diaphragm, then dries, dry or is lyophilized, that is, form flexible foldable biomembrane.
The present invention also provides the preparation methods of another flexible foldable biomembrane, include the following steps：
(2-1) polyurethane and PVP are dissolved with organic solvent, pour the medical polyurethane film being made with a thickness of 0.02-1mm Piece；
(2-2) chooses, and there is the high molecular material of strong water sorption, adhesive attraction to be prepared into composite fibre or attractive gel；
Composite fibre prepared by step (2-2) or attractive gel are coated uniformly on the doctor of step (2-1) preparation by (2-3) It with polyurethane film on piece, then dries, dry or is lyophilized, that is, form the flexible foldable biomembrane of different purposes.
The present invention also provides a kind of preparation methods pasted using flexible foldable biology film preparation uterine neck reparation, for treating Cervical disease includes the following steps：
(3-1) polyurethane and PVP are dissolved with organic solvent, pour and the mushroom doctor with a thickness of 0.02-0.5mm is made Use polyurethane diaphragm；
(3-2) chooses alginates or chitosan and its derivative or two kinds of mixture is prepared into composite fibre；
Composite fibre prepared by step (3-2) is adhered to doctor prepared by step (3-1) with a little sodium alginate by (3-3) It with polyurethane film on piece, then dries, dry or is lyophilized, that is, form the flexible foldable uterine neck reparation patch of different purposes.
Flexible foldable biomembrane of the present invention, wherein the side for pasting the surface of a wound can add tool when in use Medicative bioactive molecule, the bioactive molecule include：Biology is anti-inflammatory, antibacterial, the small molecule of antiviral activity, promotes wound Mouthful healing active medicine active constituent, protein, polyaminoacid (such as polylysine, polyglutamic acid etc.), polypeptide, nutrition because The combination of one or both of son and stem cell.Wherein trophic factors is selected from：Nerve growth factor, brain source nerve growth because Son, neural mitogen, ciliary neurotrophic factor, interleukin-6, fibroblast growth factor, leucocyte inhibit because It is son, insulin-like growth factor, insulin starch peptide, epidermal growth factor, glial cell line-derived neurotrophic factor, platelet derived The combination of one or more of growth factor, transforming growth factor β；It is dry thin that the stem cell can be divided into myeloid-lymphoid stem cell, multipotency Born of the same parents and specially one of energy stem cell.
Flexible foldable biomembrane of the present invention can be used as uterine neck patch and use, using preceding by the medical polyurethane Diaphragm is adsorbed on diaphragm adsorption orifice；Medical polyurethane diaphragm is released to docile with dedicated vagina folder or transmitting device when use The protrusion for being equipped with and being embedded in cervix opening is formed, diaphragm can be fixed on palace since diaphragm is mushroom in uterine neck discharge surface Neck mouth position.
Flexible foldable biomembrane of the present invention can coat the active constituent for treating various diseases on diaphragm, Specifically include the anti-inflammatory, antibacterial of biology, the small molecule of antiviral activity, the active medicine for promoting wound healing, protein, polypeptide, The combination of one or both of trophic factors and stem cell.Wherein, trophic factors is selected from：Nerve growth factor, brain source property mind Through growth factor, neural mitogen, ciliary neurotrophic factor, interleukin-6, fibroblast growth factor, leucocyte Inhibiting factor, insulin-like growth factor, insulin starch peptide, epidermal growth factor, glial cell line-derived neurotrophic factor, blood are small The combination of one or more of plate source property growth factor, transforming growth factor β；The stem cell can be divided into myeloid-lymphoid stem cell, more Energy stem cell and specially energy stem cell, specifically include：Embryonic stem cell, candidate stem cell, bone marrow interstital stem cell, nerve cord are thin One or both of born of the same parents, muscle stem cell, Osteogenic Stem, endodermal stem cells, retinal stem cells, pancreatic stem cells with On；Biological anti-inflammatory drug specifically includes antibacterial-anti-inflammatory drug, clinically used at present mainly to have following a few classes：Antibiotics, sulphur Amine, metronidazole class, antimycotic, Chinese patent drug class.Such as beta-lactam antibiotic：1, penicillin antibiotics:Such as mould Plain G, ospen, procaine penicillin, Amoxicillin, An Benzyl penicillin, mezlocillin, carbenicillin, Imipenem (safe energy), Meropenem, Panipenem；2, cephalosporins：Such as, cefalexin (pioneer 4), Cefazolin sodium are (first Cutting edge of a knife or a sword 5), Cefradine (pioneer 6), cefadroxil, Ceftriaxone Sodium (ceftriaxone)；3, hydrocarbon mould alkenes and penems:Such as Imipenem；4, monocycle class antibiotic:Such as aztreonam；Fluoroquinolones antibiotic medicine:Such as Ciprofloxacin, Ofloxacin, promise Flucloxacillin, lavo-ofloxacin hydrochloride, gatifloxacin；5, macrolide antibiotics：As roxithromycin, azithromycin, carat are mould Element；6, aminoglycoside antibiotics：Gentamicin, Amikacin, micronomicin；7, other antibiotic etc., there are also it is middle at Medicine class, such as：The common three gold plaques active constituent of Yunnan Baiyao, anti-urinary system infection contamination, the infection of the upper respiratory tract are common double yellow Connect oral solution and its injection, also connect the clear piece active constituent of Pu Shuan, cow-bezoar antitoxic bolus (piece) active constituent, chuanxinlian tablet activity Ingredient, Chlorogenic Acid in Ying Huang Capsules active constituent, anti-inflammation capsule active constituent, interferon formulation, miaow quinoline not moral, cidofovir, send Trane, Oil of zedoary turmeric, borneol, phytic acid ketone, Erhuang dissipate, podophyllin, 5% phthiobuzone creme, 0.25% idoxuridine ointment, 30%~50% Trichloroacetic acid or saturation dichloroacetic acid, 18% Peracetic acid, 10% bigcatkin willow acid+acetic acid, 40% formaldehyde, 2% liquefied phenol, 75% Ethyl alcohol, 20% tincture of iodine, bromogeramine etc..
To improve the performances such as the sticking of flexible foldable biomembrane, indwelling, can medicine be carried in preparation and is inhaled during the preparation process Addition promotes the ingredient of drug absorption, release and disintegration when attached layer.For example addition gas-producing disintegrant, acid source can select lemon Lemon acid, tartaric acid, fumaric acid, adipic acid, malic acid etc.；Alkali source can select sodium carbonate, sodium bicarbonate, saleratus, carbonic acid Potassium, calcium carbonate etc.；PH adjusting agent can select lactic acid, citric acid, potassium hydrogen tartrate, benzoic acid, alginic acid, sorbic acid, rich horse Acid, ascorbic acid, stearic acid, oleic acid, ethylenediamine tetra-acetic acid (EDTA), boric acid, Boratex, triethylamine etc..
Above-mentioned technical proposal of the invention has the beneficial effect that：Flexible foldable biomembrane of the invention can be according to need Various shape is made, outer layer plays the role of that microorganism is isolated, and internal layer mosanom and chitosan and its derivative are covered in wound Facial position plays the role of lasting physical isolation and drug release to appendix drug, guarantees that local mucous membrane is administered continuously, enhancing treatment Effect.
Detailed description of the invention
Fig. 1 is the structural schematic diagram of flexible foldable biomembrane in the present invention；
Fig. 2 is the structural schematic diagram of flexible uterine neck reparation patch in the present invention；
Fig. 3 is the structural schematic diagram in the present invention for the foldable biomembrane of tubular flexible of cavity disease.
Description of symbols：
1, medical polyurethane diaphragm；2, alginate dressing layer；3, chitosan and its derivative dressing layer；4, alginates and shell Poly- carbohydrates and their derivative mixing dressing layer；5, mushroom protrusion.
Specific embodiment
To keep the technical problem to be solved in the present invention, technical solution and advantage clearer, below in conjunction with attached drawing and tool Body embodiment is described in detail.As shown in Figure 1, the present invention provides a kind of flexible foldable biomembrane, formed by inside and outside two layers, Wherein, outer layer be absorb liquid after can fragmentation medical polyurethane diaphragm 1, internal layer be surface of a wound coating.
Surface of a wound coating in the present embodiment is made of alginate dressing layer 2 and chitosan and its derivative dressing layer 3, Contact the surface of a wound is chitosan and its derivative dressing layer 3, and alginate dressing layer 2 is attached on medical polyurethane diaphragm 1, is used When chitosan and its derivative dressing layer 3 is covered on the surface of a wound, chitosan and its derivative dressing layer 3 play antibacterial promote wound The effect that mouth is repaired, alginate dressing layer 2 play the role of absorbing sepage, and the medical polyurethane diaphragm 1 of outside is absorbed in sepage It can be gone to sticks and staves in the case where saturation, be easily peeled off discharge.As shown in Fig. 2, the present invention provides a kind of flexibilities for cervical disease Uterine neck reparation patch, outer layer are medical polyurethane diaphragm 1, and internal layer is that alginates and chitosan and its derivative mix dressing layer 4, institute It states medical polyurethane diaphragm and alginate dressing is equipped with the mushroom protrusion 5 of insertion cervix opening, before use, therapeutic agent is applied It overlays on alginates and chitosan and its derivative mixing dressing layer 4, reparation patch is clamped with dedicated vagina pusher varus, by mushroom Mushroom shape protrusion 5 is embedded in cervix opening, and alginates and chitosan and its derivative mixing 4 docile of dressing layer are in uterine neck discharge surface.
The shape of flexible foldable biomembrane of the present invention can need to design according to the adherency of implant site, than Such as：Shape for skin surface reparation can be two layers of diaphragm composition；Diaphragm for gastric ulcer, which can be, to be easy to swallow It is spherical；For cavity disease to can be tubulose as shown in Figure 3；For cervical disease to can be mushroom as shown in Figure 2；With It is spongy in can be for hemostasis.
The preparation of polyurethane uterine neck flexible foldable biomembrane of the invention is described in further detail below with reference to several embodiments Method.
Embodiment 1
Polyurethane is dissolved in chloroform soln by S1-1, is made into 15% solution, is spun into tool using electrostatic spinning technique Having aperture is 1-15 μm, with a thickness of the diaphragm of 0.1-0.2mm, as medical polyurethane diaphragm；
Alginate fibre and Chitosan powder are uniformly mixed by S1-2, even to be coated in medical polyurethane film obtained by step S1-1 On piece, dry or dry both flexible foldable biomembrane.
Embodiment 2
Polyurethane is dissolved in chloroform soln by S2-1, is made into 15% solution, and PVP is made into 15% solution with ethyl alcohol, Using electrostatic spinning technique to spray, it is spun into weight ratio 1:1 aperture that has is 1-15 μm, with a thickness of the medical poly- of 0.05-0.1mm Urethane diaphragm；
S2-2 uniformly coats alginate dressing on a side surface of medical polyurethane diaphragm prepared by step S2-1, applies Expect that surface coats a strata lysine PU- chitosan derivatives chloroformic solution, that is, forms the flexible foldable biology of the present embodiment Film.
Embodiment 3
Polyurethane is dissolved in chloroform soln by S3-1, is made into 15% chloroformic solution, is formed in concave-convex type grinding tool, It heats solvent flashing and forms medical polyurethane diaphragm；
Sodium alginate and chitosan are matched gelled by S3-2, are coated uniformly on the resulting medical polyurethane film of step S3-1 On piece, dries or dries, that is, forms the polyurethane uterine neck flexible foldable biomembrane of the present embodiment.
Embodiment 4
S4-1 will be using 1,3 propylene glycol as chain extender, and it is soft segment that PEG200, which causes the polymer diol that CL is obtained, and LDI is hard section Polyurethane (molecular weight 7-8 ten thousand), be made into 15% chloroformic solution, form waterproof breathable membrane on grinding tool, form medical poly- ammonia Ester diaphragm；
S4-2 adds 25% tincture of iodine in the gel solution of sodium alginate and chitosan, is coated uniformly on step S4-1 It on resulting medical polyurethane diaphragm, dries or dries, that is, form the polyurethane antibiotic flexible foldable biomembrane of the present embodiment.
Embodiment 5
S5-1 will be using 1,4 butanediamine as chain extender, and it is soft segment that PEG600, which causes the polymer diol that PDO is obtained, and LDI is hard section Polyurethane (molecular weight 5-7 ten thousand), be made into 15% chloroformic solution, PVP is made into 15% ethanol solution, the two ratio 3:1, use is quiet It is 5-20 μm, with a thickness of the porous medical polyurethane diaphragm of 0.1-0.2mm that Electrospinning, which is spun into aperture,；
Zinc hyaluronate and chitosan are matched gelled by S5-2, are coated uniformly on medical polyurethane film obtained by step S5-1 On piece, dry or dry it is spare, that is, formed the present embodiment treatment HPV infection polyurethane uterine neck flexible foldable biomembrane.
Embodiment 6
PU (is the PU of hard section, (molecular weight 5-7 ten thousand), addition by soft segment, lysine diisocyanate of PCL-GA by S6-1 Weight ratio is 3:1 PVP is made into 15% chloroformic solution, is cast in concave-convex type mold, forms the tool with a thickness of 0.05-0.1mm There is the medical polyurethane diaphragm of waterproof and breathable structure；
PU- chitosan and alginate dressing are uniformly mixed by S6-2 with suitable quantity of water, are coated uniformly on doctor obtained by step S6-1 It with polyurethane film on piece, dries, be lyophilized or dry, that is, form the polyurethane uterine neck flexible foldable biomembrane of the present embodiment.
Embodiment 7
S7-1 by PU (being the PU of hard section, number-average molecular weight 3-4 ten thousand by soft segment, lysine diisocyanate of PCL-GA), Be made into 15% chloroformic solution, use electrostatic spinning technique be spun into aperture for 1-15 μm, with a thickness of the medical of 0.05-0.1mm Polyurethane diaphragm；
Sodium carboxymethylcellulose is coated on alginate dressing by S7-2, is adhered to medical polyurethane film obtained by step S6-1 On piece, dries, is lyophilized or dries, that is, forms the flexible foldable biomembrane of the present embodiment.
Embodiment 8
PU (being the PU of hard section, number-average molecular weight 3-4 ten thousand by soft segment, lysine diisocyanate of PC) is made by S8-1 30% chloroformic solution is coated uniformly on mold, dries the medical polyurethane diaphragm to be formed with a thickness of 0.05-0.1mm；
Poly-D-lysine, chitosan and alginate dressing are made into paste by S8-2, are coated uniformly on obtained by step S8-1 On medical polyurethane diaphragm, dries or dry spare, that is, form the flexible foldable biomembrane of the present embodiment.
Embodiment 9
The polyurethane uterine neck flexible foldable biomembrane of the wound more for sepage, preparation method are：
PU (being the PU of hard section, number-average molecular weight 3-4 ten thousand by soft segment, lysine diisocyanate of PDO) is made by S9-1 25% chloroformic solution, is coated uniformly on that be dried on grinding tool with aperture be 1-15 μm, with a thickness of the medical poly- of 0.05-0.1mm Urethane diaphragm；
The upper surface of the step S9-1 medical polyurethane diaphragm prepared is coated one layer of poly-D-lysine and alginates by S9-2 Dressing mixture dries or dries the polyurethane uterine neck flexible foldable biomembrane for forming the present embodiment.
Embodiment 10
The polylysine PU that S10-1 will be crosslinked with lysine diisocyanate, is made hydrogel with water for injection, is cast in Grinding tool freeze it is drying at aperture be 1-30 μm, with a thickness of the porous medical polyurethane diaphragm of 0.01-0.5mm；
S10-2 uniformly coats 1% carbomer gel on medical polyurethane diaphragm prepared by step S10-1, then shell is gathered Sugared dressing docile is dried or is dried in polyurethane film on piece, that is, forms the polyurethane uterine neck flexible foldable biology of the present embodiment Film.
Embodiment 11
S11-1 by PU (being the PU of hard section, number-average molecular weight 2-3 ten thousand by soft segment, lysine diisocyanate of PCL-GA), Be made into 35% chloroformic solution, pour build up with aperture be 1-10 μm, with a thickness of the porous membrane of 0.05-0.1mm；
Polylysine PU and the poloxamer188 (weight ratio 1 that S11-2 will be crosslinked with lysine diisocyanate:1), Be configured to 1% hydrogel with water for injection, be coated uniformly on diaphragm made from S11-1, in docile alginate dressing dry or Drying, that is, form the flexible foldable biomembrane of the present embodiment.
12 zoopery of embodiment
Female New Zealand White Rabbit 6 are taken, positive test model is made in inoculation albicans strain, is divided into two groups, often Group 3, the inflammatory cell of vaginal washing fluid, data are as follows when testing 7 days：
Group Number of elements PMN Macrophage Lymphocyte
1 3 101±10.2 9.8±4.2 1.8±1.2
2 3 98±11.7 10.8±3.8 2.2±1.7
Wherein give chitosan gel rubber+tincture of iodine for the 1st group, coating is primary daily, and the 2nd group is prepared using the embodiment of the present invention 6 Polyurethane uterine neck flexible foldable biomembrane+tincture of iodine, replacement is primary every three days.Treatment cycle be 15 days, appearance see two groups it is equal Without apparent inflammatory reaction, the inflammatory cell of vaginal washing fluid is tested, data are as follows：
Group Number of elements PMN Macrophage Lymphocyte
1 3 21±1.9 2.1±0.7 It is not detected
2 3 8±1.7 It is not detected It is not detected
Experimental result is shown：Polyurethane uterine neck flexible foldable biomembrane prepared by the present invention has physical isolation well And drug carrying ability, potential applicability in clinical practice are wide.
The above is a preferred embodiment of the present invention, it is noted that for those skilled in the art For, without departing from the principles of the present invention, several improvements and modifications can also be made, these improvements and modifications It should be regarded as protection scope of the present invention.

Claims (10)

1. a kind of flexible foldable biomembrane, which is characterized in that formed by inside and outside two layers, wherein outer layer is can after absorbing liquid The medical polyurethane diaphragm of fragmentation, internal layer are surface of a wound coating.
2. a kind of flexible foldable biomembrane according to claim 1, which is characterized in that the surface of a wound coating can be Carry medicine adsorption layer.
3. a kind of flexible foldable biomembrane according to claim 1 or 2 and its application, which is characterized in that the load medicine Adsorption layer includes alginate dressing layer and chitosan and its derivative dressing layer, the chitosan and its derivative dressing layer adherency On alginate dressing layer.
4. a kind of flexible foldable biomembrane according to claim 3 and its application, which is characterized in that the alginates apply Layer and the weight percent of chitosan and its derivative dressing layer are：
Alginate dressing layer 50-100%
Chitosan and its derivative dressing layer 1-49%.
5. a kind of flexible foldable biomembrane according to claim 1 or 3, which is characterized in that the load medicine adsorption layer Material is selected from hydrophilic polymer material, specifically includes：Carbomer, Polycarbophil, Sodium Hyaluronate, sodium alginate, chitosan And its derivative, polyaminoacid, polypeptide, povidone, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, hydroxyethyl cellulose, carboxylic Methyl starch sodium, polyvinyl alcohol, xanthan gum, modified alginates and its it is degraded into aminohexose and N- acetylglucosamine Alginate, starch-grafted acrylonitrile, starch-grafted hydrophilic monomer, polyacrylate, vinyl acetate co-polymer, change One of property polyvinyl alcohol, modified cellulose or multiple combinations.
6. a kind of flexible foldable biomembrane according to claim 1 and its application, which is characterized in that the medical poly- ammonia Ester diaphragm is selected from degradable polyurethane, specifically includes：Polyether-type, polyester-polyether type, natural polymer subtype and plant oil type Biodegradable PU, aliphatic poly ether urethane, polyurethane-acrylate hydrogel, fatty poly-ester carbonate urethane, polyurethane- Urea elastomers, polyurethane-polydimethylsiloxaneblock block copolymers, one or both of polyether thermoplastic polyurethane.
7. a kind of flexible foldable biomembrane according to claim 1 or 2, which is characterized in that the medical polyurethane film Piece with a thickness of 0.02 ~ 1mm, the medical polyurethane diaphragm is selected from using PCL as the degradable medical polyurethane of soft segment.
8. the preparation method of flexible foldable biomembrane described in a kind of any one of claim 1 ~ 7, which is characterized in that packet Include following steps：
（1-1）By electrostatic spinning, by polyurethane and the high molecular material of wound healing is promoted to be spun into a thickness of 0.02-1mm's Medical polyurethane diaphragm；
（1-2）Choosing, there is the high molecular material of strong water sorption, adhesive attraction to be prepared into loose porous dressing；
（1-3）By step（1-2）The loose porous dressing of preparation adds suitable quantity of water to be adhered to step（1-1）The medical polyurethane of preparation It on diaphragm, then dries, dry or is lyophilized, that is, form flexible foldable biomembrane.
9. the preparation method of flexible foldable biomembrane described in a kind of any one of claim 1 ~ 7, which is characterized in that including Following steps：
（2-1）Polyurethane and PVP are dissolved with organic solvent, pour and different shape and the medical poly- ammonia with a thickness of 0.02-1mm is made Ester diaphragm；
（2-2）Choosing, there is the high molecular material of strong water sorption, adhesive attraction to be prepared into attractive gel；
（2-3）By step（2-2）The attractive gel of preparation is coated uniformly on step（2-1）On the medical polyurethane diaphragm of preparation, Then it dries, dry or is lyophilized, that is, form flexible foldable biomembrane.
10. the preparation method of flexible foldable biomembrane described in a kind of any one of claim 1 ~ 7, which is characterized in that packet Include following steps：
（3-1）Polyurethane and PVP are dissolved with organic solvent, pour and the mushroom medical poly- ammonia with a thickness of 0.02-0.5mm is made Ester diaphragm；
（3-2）It chooses alginates or chitosan and its derivative or two kinds of mixture is prepared into composite fibre；
（3-3）By step（3-2）The composite fibre of preparation is with sodium alginate gel uniform fold in step（3-1）The doctor of preparation It with polyurethane film on piece, dries, dry or is lyophilized, that is, form flexible foldable biomembrane.
CN201811061465.2A 2018-09-12 2018-09-12 A kind of flexible foldable biomembrane and preparation method thereof Pending CN108888798A (en)

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CN112516378A (en) * 2020-12-02 2021-03-19 浙江工业大学 Preparation method of phytic acid/silk fibroin/calcined dolomite bone adhesive
CN112663344A (en) * 2020-12-29 2021-04-16 泉州市伊呗思谷化妆品科技有限公司 Waterproof moisture-permeable film and preparation method thereof
CN114214750A (en) * 2022-01-13 2022-03-22 天津工业大学 Flame-retardant polyacrylonitrile composite fiber and preparation method and application thereof
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