CN104606722A - Degradable gasket with anti-bacterial anti-adhesion performance - Google Patents
Degradable gasket with anti-bacterial anti-adhesion performance Download PDFInfo
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- CN104606722A CN104606722A CN201310536353.9A CN201310536353A CN104606722A CN 104606722 A CN104606722 A CN 104606722A CN 201310536353 A CN201310536353 A CN 201310536353A CN 104606722 A CN104606722 A CN 104606722A
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Abstract
The invention provides a degradable gasket with anti-bacterial anti-adhesion performance. The degradable gasket is prepared via weaving or knitting of a plurality of bundles of magnesium-based metal wire, or via punching of magnesium-based metal sheets. The magnesium-based metal wire can be made of pure magnesium or a magnesium-based alloy of different elements based on disease characteristics and treatment requirements. The degradable gasket possesses excellent biocompatibility; in vivo degradation and absorption can be realized; degradation speed can be controlled; the degradable gasket is capable of preventing postoperative adhesion and infection, and promoting wound healing, can be used for preventing epidural adhesion after orthopedic surgery laminectomy, adhesion after tendon rupture repairing operation, adhesion after knee surgery, dura adhesion after transcranial surgery, eye socket soft tissue adhesion, intestinal adhesion after abdominal surgery, and intrauterine adhesion, is capable of reducing infection risk of the above surgeries, and possesses significant clinical application value.
Description
Technical field
The present invention relates to biomaterial for medical purpose field, particularly relate to and a kind ofly have the antibacterial and anti-degradable pad being adhered function concurrently.
Background technology
Prevention of postoperative tissue adhesion in surgical operation, it is the ubiquitous difficult problem of surgery every field, more serious tissue adhesion can cause corresponding clinical complication, as in orthopaedics operation on joint, postoperative long-term immobilization or periarticular tissue fibering can cause ankylosis, affect the recovery of postoperative motor function, tendon injury such as the adhesion of tendon after rupture of Achilles tendon prothesis is also common clinical problem, lumbar intervertebral disc posterior excision often needs cut-out or whole vertebral plate, but postoperatively easily there is fibrous scar hypertrophy, the compressing to both is caused with spinal dura mater and adhesion of nerver root, can nervous symptoms be caused thus affect surgical effect, the adhesion of operation of opening cranium generation cerebral tissue can cause posttraumatic epilepsy, orbital void is less but easily be there is postoperative soft tissue adhesion and affects motion and the function of eyeball, in abdominal cavity, operation on pelvis, tissue adhesion is then more common, can cause adhesive ileus time serious, infertile, and paroxysmal abdominal pain etc. bring great misery to patient.Therefore, how effectively prevention of postoperative adhesion thus the incidence rate reducing clinical complication is the important topic that in clinical treatment, letter is to be solved.
In order to prevent above-mentioned tissue adhesion complication, need surgical technic be improved on the one hand, avoiding the anthropic factor of tissue adhesion; On the other hand, along with the development of biomaterial for medical purpose, the local organization that we more easily can stick together in art uses adherence preventing material, as Antiadhesive film, form one deck physical barriers clump and intervene the nature process of tissue adhesion, this is also very effective anti measure at present, and correlation technique and Antiadhesive film material are just obtaining investigation and application widely.Desirable Antiadhesive film material require possesses good biocompatibility, can be continuously present in anti position within a certain period of time, be degraded and absorbed afterwards, while effective prevention of postoperative adhesion, have hemostasis concurrently, prevention of inflammation reaction and anti-infective effect.Pellosil, Chitosan membrane, hyaluronic acid membrane, polylactic acid membrane, oxidized cellulose film is current several research Antiadhesive film material the most widely.Do not cause foreign body reaction after silica gel implant in-vivo tissue, but pellosil can not degradation in vivo, needing second operation to take out, therefore there is aseptic inflammation in some patients, affects functional rehabilitation.Chitosan have avirulence, nonirritant, without challeng, without pyrogenicity, not haemolysis, be the et al. Ke biomaterial of the good absorbable and degradable of a kind of histocompatibility, absorbable and degradable.But Chitosan membrane and body adhesion poor, be difficult to during operation technique wrap, suture strength is obviously not enough, and degradation speed is wayward.Hyaluronic acid membrane has extremely excellent biocompatibility and good biological degradability, the viscoelasticity of height, nontoxic, no antigen, but hyaluronate sodium in vivo retention time is shorter, often degraded before organizing reparation completely, cause adhesion to occur, and haemostatic effect is not good enough.Poly-DL-lactic acid Absorbable rod is anti-is adhered film degradable lactic acid in vivo, carbon dioxide and water is decomposed into again through tricarboxylic acid cycle, can be absorbed by body and get rid of external, it is without toxicity, side effect, but pliability is inadequate, quality is partially hard, defective tightness when parcel is organized, easy slippage, does not have micropore, is unfavorable for secretions or blood penetration, relatively poor to the nutrition supply of tissue, and there are not other auxiliaring effects such as special hemostasis in it, the sour environment particularly produced after polylactic acid degraded is larger to surrounding tissue zest.Oxidized cellulose film is met hemorrhage meeting and is obviously reduced its anti effect, cannot apply during local hemorrhage.Visible, above material all cannot while having anti-stick continuous cropping, possess both anti-inflammatory, anti-infective function.For solving the problem, design is just needed a kind ofly to have the antibacterial and anti-degradable pad being adhered function concurrently.
Summary of the invention
The object of the invention is to overcome above-mentioned deficiency, there is provided a kind of and have the antibacterial and anti-degradable pad being adhered function concurrently, there is good biocompatibility, can degraded and absorbed and degradation rate is controlled in vivo, the basis of prevention of postoperative adhesion has the ilities such as comparatively ideal infection and wound healing simultaneously.
The invention provides a kind of degradable pad with antiseptic anti-adhesion function, described degradable pad is weaved by multiply magnesium-base metal silk thread or braiding forms, or is formed by the punching of magnesium-base metal thin slice.
According to disease character and treatment needs, described magnesium-base metal silk thread or magnesium-base metal thin slice can select pure magnesium or the magnesium base alloy with other element combinations.
Preferably, in described magnesium-base metal silk thread or magnesium-base metal thin slice, the content of magnesium elements is > 90wt%, is more preferably >=92wt%, is more preferably >=94wt%, be more preferably >=96wt% is more preferably >=97wt%, is more preferably >=98wt%.
In described magnesium base alloy except magnesium elements, can also contain in copper, zinc, manganese, selenium, strontium, calcium, ferrum, zirconium, stannum, nickel, aluminum, silver etc. one or more, and/or one or more in rare earth metal.
Described rare earth metal comprises scandium, yttrium, lanthanum, cerium, praseodymium, neodymium, hard iron, samarium, europium, gadolinium, terbium, dysprosium, holmium, erbium, thulium, ytterbium, lutecium.
The diameter of described magnesium-base metal silk thread is preferably 0.01-2mm, is more preferably 0.02-1.5mm, is more preferably 0.03-1mm, be more preferably 0.04-0.5mm, be more preferably 0.05-0.1mm, such as 0.06mm, 0.07mm, 0.08mm or 0.09mm.
The diameter of described magnesium-base metal thin slice is preferably 0.01-2mm, is more preferably 0.01-1.5mm, is more preferably 0.01-1mm, be more preferably 0.02-0.5mm.
Preferably, the surface-coated of described magnesium-base metal silk thread or magnesium-base metal thin slice has medicine, and described medicine can need to select according to practical application, such as, can be antibacterials, anti-inflammation drugs etc.
Preferably, the surface of described magnesium-base metal silk thread or magnesium-base metal thin slice is provided with biodegradable coating.
Further preferably, described biodegradable coating load has medicine, and described medicine can need to select according to practical application, such as, can be antibacterials, anti-inflammation drugs etc.
Wherein, described biodegradable coating comprises and preferably consists of degradable macromolecule coating and/or degradable ceramic coating.
The constituent of described degradable macromolecule coating is preferably polyglycolic acid, polylactic acid, PLLA, polycaprolactone, poly-hydroxy acrylate, gathers one or more combination in any in dioxane ketone, condensing model, poly phosphazene, polymer-amino-acid, poly-B-butyric ester and hydroxypentanoic acid fat and copolymer thereof.
The constituent of described degradable ceramic coating is preferably one or more combination in any of hydroxyapatite, strontium containing hydroxyapatite, Silicon-Substituted Hydroxyapatite, B-trialcium phosphate and phosphoric acid oxygen four calcium.
Described degradable macromolecule coating layer thickness is preferably 0.01-5mm, is more preferably 0.05-4.5mm, is more preferably 0.1-4mm, be more preferably 0.1-3mm, be more preferably 0.1-2.5mm.
The thickness of described degradable ceramic coating is preferably 0.01-5mm, is more preferably 0.05-4.5mm, is more preferably 0.1-4mm, be more preferably 0.1-3mm, be more preferably 0.1-2.5mm.
According to practical application needs, the surface of described degradable pad also can be coated with medicine.
The degradable pad with antiseptic anti-adhesion function provided by the invention has good biocompatibility, can degraded and absorbed and degradation rate is controlled in vivo, the basis of prevention of postoperative adhesion have the ilities such as comparatively ideal infection and wound healing simultaneously, be applicable to being applied to epidural adhesion after bone surgery prevention vertebrae plate resection, the posterior synechiae of tendon rupture prothesis, knee joint posterior synechiae is strong, also be applicable to prevention craniotomy after dura mater adhesions, orbital soft tissue's adhesion, intestinal adhesion after abdominal cavity operation, intrauterine adhesion etc., and the postoperative infection risk of above operation can be reduced simultaneously, there is important clinical value.
Detailed description of the invention
Below in conjunction with specific embodiment, the invention will be further described, to understand the present invention better.
Embodiment 1
The degradable pad of antiseptic anti-adhesion function that what the present embodiment provided have is woven by pure magnesium silk thread and forms, and the diameter of described pure magnesium silk thread is 1mm.
Biological safety
Biological assessment is carried out according to experimental technique described in GB/T16886.Experimental result shows, the degradable pad that the present embodiment provides does not have obvious cytotoxicity and hemagglutinin to 3T3 cell, does not have obvious sensitization, stimulation and genetoxic.
Anti-microbial property
Adopt experimental strain: the S. epdermidis strains (MRSE) of S. epdermidis strains (S.epidermidis), methicillin resistance and the S. epdermidis strains (ATCC35984) in purchased from American normal bacterial storehouse.Bacteriostatic experiment is according to standard regulations such as " JISZ2801-2000 " antibacterial fabricated product-antibiotic property test method and antibacterial effect ", GB/T21510-2008 " nano inorganic material anti-microbial property detection method " ".
Result shows, and the antibiotic rate of the degradable pad that the present embodiment provides is 95%, and the antibiotic rate of matched group (conventional transparent matter sorrel) is 3%.
Et al. Ke is tested:
Prevention of epidural adhesion after laminectomy is tested:
20 New Zealand white rabbit random packet, make L4 vertebral plate damage model.Experimental group epidural adheres to the degradable pad that the present embodiment provides, and matched group adheres to conventional transparent matter sorrel, if blank.12 weeks after operation carries out gross examination of skeletal muscle, histological observation and biochemical analysis to laminectomy site, cicatrization and adhesion situation between more each group.Experimental result shows, the scoring of the improvement Rvdell-Balazs adhesion toughness of experimental group, collagen content and improvement Nussvaum histological score are all better than matched group and blank group.
Prevention knee joint posterior synechiae experiment:
20 New Zealand white rabbit are divided into two groups at random---experimental group and matched group.All animals are row right side synovectomy of knee joint all, and in art, experimental group places the degradable pad that the present embodiment provides in synovectomy region, and matched group places conventional transparent matter sorrel.Art finishes, and right lower extremity Cast fixes 4 weeks.To the kneed gross examination of skeletal muscle in the capable right side of every treated animal, sxemiquantitative score, histological observation, biomechanical analysis and biochemical analysis, all quantitative datas compare through t inspection.Experimental result shows, the degree of experimental group joint accretion is starkly lower than matched group, illustrates that the degradable pad that the present embodiment provides can effectively prevent knee joint posterior synechiae.
Anti-adhesion of tendon experiment:
Adult New Zealand gate rabbit 20, random packet, new two blue White Rabbit left foot three-toed extensor tendon is cut, experimental group wraps up the degradable pad that the present embodiment provides, matched group parcel conventional transparent matter sorrel, sew up, within 2,4,6 weeks, row gross examination of skeletal muscle, histology examine distant and out of sight and inflammatory reaction assessment to Post operation respectively again.Experimental result shows, the anti effect of experimental group is better than matched group.
Embodiment 2
The degradable pad of antiseptic anti-adhesion function that what the present embodiment provided have is woven by Mg-Zn silk thread (content of magnesium is 97wt%) and forms, and the diameter of described Mg-Zn silk thread is 0.8mm.
Biological safety
Biological assessment is carried out according to experimental technique described in GB/T16886.Experimental result shows, the degradable pad that the present embodiment provides does not have obvious cytotoxicity and hemagglutinin to 3T3 cell, does not have obvious sensitization, stimulation and genetoxic.
Anti-microbial property
Adopt experimental strain: the S. epdermidis strains (MRSE) of S. epdermidis strains (S.epidermidis), methicillin resistance and the S. epdermidis strains (ATCC35984) in purchased from American normal bacterial storehouse.Bacteriostatic experiment is according to standard regulations such as " JISZ2801-2000 " antibacterial fabricated product-antibiotic property test method and antibacterial effect ", GB/T21510-2008 " nano inorganic material anti-microbial property detection method " ".
Result shows, and the antibiotic rate of the degradable pad that the present embodiment provides is 98%, and the antibiotic rate of matched group (conventional transparent matter sorrel) is 3%.
Et al. Ke is tested:
Prevention of epidural adhesion after laminectomy is tested:
20 New Zealand white rabbit random packet, make L4 vertebral plate damage model.Experimental group epidural adheres to the degradable pad that the present embodiment provides, and matched group adheres to conventional transparent matter sorrel, if blank.12 weeks after operation carries out gross examination of skeletal muscle, histological observation and biochemical analysis to laminectomy site, cicatrization and adhesion situation between more each group.Experimental result shows, the scoring of the improvement Rvdell-Balazs adhesion toughness of experimental group, collagen content and improvement Nussvaum histological score are all better than matched group and blank group.
Prevention knee joint posterior synechiae experiment:
20 New Zealand white rabbit are divided into two groups at random---experimental group and matched group.All animals are row right side synovectomy of knee joint all, and in art, experimental group places the degradable pad that the present embodiment provides in synovectomy region, and matched group places conventional transparent matter sorrel.Art finishes, and right lower extremity Cast fixes 4 weeks.To the kneed gross examination of skeletal muscle in the capable right side of every treated animal, sxemiquantitative score, histological observation, biomechanical analysis and biochemical analysis, all quantitative datas compare through t inspection.Experimental result shows, the degree of experimental group joint accretion is starkly lower than matched group, illustrates that the degradable pad that the present embodiment provides can effectively prevent knee joint posterior synechiae.
Anti-adhesion of tendon experiment:
Adult New Zealand gate rabbit 20, random packet, new two blue White Rabbit left foot three-toed extensor tendon is cut, experimental group wraps up the degradable pad that the present embodiment provides, matched group parcel conventional transparent matter sorrel, sew up, within 2,4,6 weeks, row gross examination of skeletal muscle, histology examine distant and out of sight and inflammatory reaction assessment to Post operation respectively again.Experimental result shows, the anti effect of experimental group is better than matched group.
Embodiment 3
The degradable pad of antiseptic anti-adhesion function that what the present embodiment provided have is woven by Mg-Zn-Sr silk thread (content of magnesium is 96wt%) and forms, and the diameter of described Mg-Zn-Sr silk thread is 0.7mm.
Biological safety
Biological assessment is carried out according to experimental technique described in GB/T16886.Experimental result shows, the degradable pad that the present embodiment provides does not have obvious cytotoxicity and hemagglutinin to 3T3 cell, does not have obvious sensitization, stimulation and genetoxic.
Anti-microbial property
Adopt experimental strain: the S. epdermidis strains (MRSE) of S. epdermidis strains (S.epidermidis), methicillin resistance and the S. epdermidis strains (ATCC35984) in purchased from American normal bacterial storehouse.Bacteriostatic experiment is according to standard regulations such as " JISZ2801-2000 " antibacterial fabricated product-antibiotic property test method and antibacterial effect ", GB/T21510-2008 " nano inorganic material anti-microbial property detection method " ".
Result shows, and the antibiotic rate of the degradable pad that the present embodiment provides is 93%, and the antibiotic rate of matched group (conventional transparent matter sorrel) is 3%.
Et al. Ke is tested:
Prevention of epidural adhesion after laminectomy is tested:
20 New Zealand white rabbit random packet, make L4 vertebral plate damage model.Experimental group epidural adheres to the degradable pad that the present embodiment provides, and matched group adheres to conventional transparent matter sorrel, if blank.12 weeks after operation carries out gross examination of skeletal muscle, histological observation and biochemical analysis to laminectomy site, cicatrization and adhesion situation between more each group.Experimental result shows, the scoring of the improvement Rvdell-Balazs adhesion toughness of experimental group, collagen content and improvement Nussvaum histological score are all better than matched group and blank group.
Prevention knee joint posterior synechiae experiment:
20 New Zealand white rabbit are divided into two groups at random---experimental group and matched group.All animals are row right side synovectomy of knee joint all, and in art, experimental group places the degradable pad that the present embodiment provides in synovectomy region, and matched group places conventional transparent matter sorrel.Art finishes, and right lower extremity Cast fixes 4 weeks.To the kneed gross examination of skeletal muscle in the capable right side of every treated animal, sxemiquantitative score, histological observation, biomechanical analysis and biochemical analysis, all quantitative datas compare through t inspection.Experimental result shows, the degree of experimental group joint accretion is starkly lower than matched group, illustrates that the degradable pad that the present embodiment provides can effectively prevent knee joint posterior synechiae.
Anti-adhesion of tendon experiment:
Adult New Zealand gate rabbit 20, random packet, new two blue White Rabbit left foot three-toed extensor tendon is cut, experimental group wraps up the degradable pad that the present embodiment provides, matched group parcel conventional transparent matter sorrel, sew up, within 2,4,6 weeks, row gross examination of skeletal muscle, histology examine distant and out of sight and inflammatory reaction assessment to Post operation respectively again.Experimental result shows, the anti effect of experimental group is better than matched group.
Embodiment 4
The degradable pad of antiseptic anti-adhesion function that what the present embodiment provided have is woven by Mg-Zn-Ca silk thread (content of magnesium is 95wt%) and forms, and the diameter of described Mg-Zn-Ca silk thread is 0.7mm.
Biological safety
Biological assessment is carried out according to experimental technique described in GB/T16886.Experimental result shows, the degradable pad that the present embodiment provides does not have obvious cytotoxicity and hemagglutinin to 3T3 cell, does not have obvious sensitization, stimulation and genetoxic.
Anti-microbial property
Adopt experimental strain: the S. epdermidis strains (MRSE) of S. epdermidis strains (S.epidermidis), methicillin resistance and the S. epdermidis strains (ATCC35984) in purchased from American normal bacterial storehouse.Bacteriostatic experiment is according to standard regulations such as " JISZ2801-2000 " antibacterial fabricated product-antibiotic property test method and antibacterial effect ", GB/T21510-2008 " nano inorganic material anti-microbial property detection method " ".
Result shows, and the antibiotic rate of the degradable pad that the present embodiment provides is 94%, and the antibiotic rate of matched group (conventional transparent matter sorrel) is 3%.
Et al. Ke is tested:
Prevention of epidural adhesion after laminectomy is tested:
20 New Zealand white rabbit random packet, make L4 vertebral plate damage model.Experimental group epidural adheres to the degradable pad that the present embodiment provides, and matched group adheres to conventional transparent matter sorrel, if blank.12 weeks after operation carries out gross examination of skeletal muscle, histological observation and biochemical analysis to laminectomy site, cicatrization and adhesion situation between more each group.Experimental result shows, the scoring of the improvement Rvdell-Balazs adhesion toughness of experimental group, collagen content and improvement Nussvaum histological score are all better than matched group and blank group.
Prevention knee joint posterior synechiae experiment:
20 New Zealand white rabbit are divided into two groups at random---experimental group and matched group.All animals are row right side synovectomy of knee joint all, and in art, experimental group places the degradable pad that the present embodiment provides in synovectomy region, and matched group places conventional transparent matter sorrel.Art finishes, and right lower extremity Cast fixes 4 weeks.To the kneed gross examination of skeletal muscle in the capable right side of every treated animal, sxemiquantitative score, histological observation, biomechanical analysis and biochemical analysis, all quantitative datas compare through t inspection.Experimental result shows, the degree of experimental group joint accretion is starkly lower than matched group, illustrates that the degradable pad that the present embodiment provides can effectively prevent knee joint posterior synechiae.
Anti-adhesion of tendon experiment:
Adult New Zealand gate rabbit 20, random packet, new two blue White Rabbit left foot three-toed extensor tendon is cut, experimental group wraps up the degradable pad that the present embodiment provides, matched group parcel conventional transparent matter sorrel, sew up, within 2,4,6 weeks, row gross examination of skeletal muscle, histology examine distant and out of sight and inflammatory reaction assessment to Post operation respectively again.Experimental result shows, the anti effect of experimental group is better than matched group.
Embodiment 5
The degradable pad of antiseptic anti-adhesion function that what the present embodiment provided have is woven by Mg-Mo-Zn alloy silk thread (content of magnesium is 92wt%) and forms, and the diameter of described Mg-Mo-Zn alloy silk thread is 0.9mm.
Biological safety
Biological assessment is carried out according to experimental technique described in GB/T16886.Experimental result shows, the degradable pad that the present embodiment provides does not have obvious cytotoxicity and hemagglutinin to 3T3 cell, does not have obvious sensitization, stimulation and genetoxic.
Anti-microbial property
Adopt experimental strain: the S. epdermidis strains (MRSE) of S. epdermidis strains (S.epidermidis), methicillin resistance and the S. epdermidis strains (ATCC35984) in purchased from American normal bacterial storehouse.Bacteriostatic experiment is according to standard regulations such as " JISZ2801-2000 " antibacterial fabricated product-antibiotic property test method and antibacterial effect ", GB/T21510-2008 " nano inorganic material anti-microbial property detection method " ".
Result shows, and the antibiotic rate of the degradable pad that the present embodiment provides is 95.6%, and the antibiotic rate of matched group (conventional transparent matter sorrel) is 3%.
Et al. Ke is tested:
Prevention of epidural adhesion after laminectomy is tested:
20 New Zealand white rabbit random packet, make L4 vertebral plate damage model.Experimental group epidural adheres to the degradable pad that the present embodiment provides, and matched group adheres to conventional transparent matter sorrel, if blank.12 weeks after operation carries out gross examination of skeletal muscle, histological observation and biochemical analysis to laminectomy site, cicatrization and adhesion situation between more each group.Experimental result shows, the scoring of the improvement Rvdell-Balazs adhesion toughness of experimental group, collagen content and improvement Nussvaum histological score are all better than matched group and blank group.
Prevention knee joint posterior synechiae experiment:
20 New Zealand white rabbit are divided into two groups at random---experimental group and matched group.All animals are row right side synovectomy of knee joint all, and in art, experimental group places the degradable pad that the present embodiment provides in synovectomy region, and matched group places conventional transparent matter sorrel.Art finishes, and right lower extremity Cast fixes 4 weeks.To the kneed gross examination of skeletal muscle in the capable right side of every treated animal, sxemiquantitative score, histological observation, biomechanical analysis and biochemical analysis, all quantitative datas compare through t inspection.Experimental result shows, the degree of experimental group joint accretion is starkly lower than matched group, illustrates that the degradable pad that the present embodiment provides can effectively prevent knee joint posterior synechiae.
Anti-adhesion of tendon experiment:
Adult New Zealand gate rabbit 20, random packet, new two blue White Rabbit left foot three-toed extensor tendon is cut, experimental group wraps up the degradable pad that the present embodiment provides, matched group parcel conventional transparent matter sorrel, sew up, within 2,4,6 weeks, row gross examination of skeletal muscle, histology examine distant and out of sight and inflammatory reaction assessment to Post operation respectively again.Experimental result shows, the anti effect of experimental group is better than matched group.
Embodiment 6
The degradable pad of antiseptic anti-adhesion function that what the present embodiment provided have is punched by Mg-Mo-Zn alloy sheet (content of magnesium is 92wt%) and forms, and the thickness of described Mg-Mo-Zn alloy sheet is 0.7mm.
Biological safety
Biological assessment is carried out according to experimental technique described in GB/T16886.Experimental result shows, the degradable pad that the present embodiment provides does not have obvious cytotoxicity and hemagglutinin to 3T3 cell, does not have obvious sensitization, stimulation and genetoxic.
Anti-microbial property
Adopt experimental strain: the S. epdermidis strains (MRSE) of S. epdermidis strains (S.epidermidis), methicillin resistance and the S. epdermidis strains (ATCC35984) in purchased from American normal bacterial storehouse.Bacteriostatic experiment is according to standard regulations such as " JISZ2801-2000 " antibacterial fabricated product-antibiotic property test method and antibacterial effect ", GB/T21510-2008 " nano inorganic material anti-microbial property detection method " ".
Result shows, and the antibiotic rate of the degradable pad that the present embodiment provides is 95.6%, and the antibiotic rate of matched group (conventional transparent matter sorrel) is 3%.
Et al. Ke is tested:
Prevention of epidural adhesion after laminectomy is tested:
20 New Zealand white rabbit random packet, make L4 vertebral plate damage model.Experimental group epidural adheres to the degradable pad that the present embodiment provides, and matched group adheres to conventional transparent matter sorrel, if blank.12 weeks after operation carries out gross examination of skeletal muscle, histological observation and biochemical analysis to laminectomy site, cicatrization and adhesion situation between more each group.Experimental result shows, the scoring of the improvement Rvdell-Balazs adhesion toughness of experimental group, collagen content and improvement Nussvaum histological score are all better than matched group and blank group.
Prevention knee joint posterior synechiae experiment:
20 New Zealand white rabbit are divided into two groups at random---experimental group and matched group.All animals are row right side synovectomy of knee joint all, and in art, experimental group places the degradable pad that the present embodiment provides in synovectomy region, and matched group places conventional transparent matter sorrel.Art finishes, and right lower extremity Cast fixes 4 weeks.To the kneed gross examination of skeletal muscle in the capable right side of every treated animal, sxemiquantitative score, histological observation, biomechanical analysis and biochemical analysis, all quantitative datas compare through t inspection.Experimental result shows, the degree of experimental group joint accretion is starkly lower than matched group, illustrates that the degradable pad that the present embodiment provides can effectively prevent knee joint posterior synechiae.
Anti-adhesion of tendon experiment:
Adult New Zealand gate rabbit 20, random packet, new two blue White Rabbit left foot three-toed extensor tendon is cut, experimental group wraps up the degradable pad that the present embodiment provides, matched group parcel conventional transparent matter sorrel, sew up, within 2,4,6 weeks, row gross examination of skeletal muscle, histology examine distant and out of sight and inflammatory reaction assessment to Post operation respectively again.Experimental result shows, the anti effect of experimental group is better than matched group.
Be described in detail specific embodiments of the invention above, but it is just as example, the present invention is not restricted to specific embodiment described above.To those skilled in the art, any equivalent modifications that the present invention is carried out and substituting also all among category of the present invention.Therefore, equalization conversion done without departing from the spirit and scope of the invention and amendment, all should contain within the scope of the invention.
Claims (10)
1. have a degradable pad for antiseptic anti-adhesion function, it is characterized in that, described degradable pad is weaved by multiply magnesium-base metal silk thread or braiding forms, or is formed by the punching of magnesium-base metal thin slice.
2. degradable pad according to claim 1, is characterized in that, the content > 90wt% of magnesium in described magnesium-base metal silk thread or magnesium-base metal thin slice.
3. degradable pad according to claim 1, is characterized in that, the diameter of described magnesium-base metal silk thread is 0.01-2mm; Magnesium-base metal sheet thickness is 0.01-2mm.
4. degradable pad according to claim 3, is characterized in that, the diameter of described magnesium-base metal silk thread is 0.05-0.1mm; Magnesium-base metal sheet thickness is 0.01-1mm.
5. degradable pad according to claim 1, is characterized in that, the surface-coated of described magnesium-base metal silk thread or magnesium-base metal thin slice has medicine.
6. degradable pad according to claim 1, is characterized in that, the surface of described magnesium-base metal silk thread or magnesium-base metal thin slice is provided with biodegradable coating.
7. degradable pad according to claim 6, is characterized in that, described biodegradable coating load has medicine.
8. the degradable pad according to claim 6 or 7, is characterized in that, described biodegradable coating comprises degradable macromolecule coating and/or degradable ceramic coating.
9. degradable pad according to claim 8, it is characterized in that, the constituent of described degradable macromolecule coating is polyglycolic acid, polylactic acid, PLLA, polycaprolactone, poly-hydroxy acrylate, poly-to one or more combination in any in dioxane ketone, condensing model, poly phosphazene, polymer-amino-acid, poly-B-butyric ester and hydroxypentanoic acid fat and copolymer thereof.
10. degradable pad according to claim 8, it is characterized in that, the constituent of described degradable ceramic coating is one or more combination in any of hydroxyapatite, strontium containing hydroxyapatite, Silicon-Substituted Hydroxyapatite, B-trialcium phosphate and phosphoric acid oxygen four calcium.
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CN108853603A (en) * | 2017-05-10 | 2018-11-23 | 上海交通大学 | Biodegradable medical kirsite sticking patch of one kind and its preparation method and application |
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