CN104511057A - Degradable and absorbable postoperative anti-adhesion material with anti-infection function - Google Patents
Degradable and absorbable postoperative anti-adhesion material with anti-infection function Download PDFInfo
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- CN104511057A CN104511057A CN201310451070.4A CN201310451070A CN104511057A CN 104511057 A CN104511057 A CN 104511057A CN 201310451070 A CN201310451070 A CN 201310451070A CN 104511057 A CN104511057 A CN 104511057A
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- magnesium
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- adhesion preventing
- postoperative
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- 230000002980 postoperative effect Effects 0.000 title abstract description 32
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- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 claims abstract description 32
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- KIUKXJAPPMFGSW-DNGZLQJQSA-N (2S,3S,4S,5R,6R)-6-[(2S,3R,4R,5S,6R)-3-Acetamido-2-[(2S,3S,4R,5R,6R)-6-[(2R,3R,4R,5S,6R)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2-carboxylic acid Chemical compound CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 KIUKXJAPPMFGSW-DNGZLQJQSA-N 0.000 claims abstract description 9
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- WCDDVEOXEIYWFB-VXORFPGASA-N (2s,3s,4r,5r,6r)-3-[(2s,3r,5s,6r)-3-acetamido-5-hydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-4,5,6-trihydroxyoxane-2-carboxylic acid Chemical compound CC(=O)N[C@@H]1C[C@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](C(O)=O)O[C@@H](O)[C@H](O)[C@H]1O WCDDVEOXEIYWFB-VXORFPGASA-N 0.000 claims abstract description 8
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Landscapes
- Materials For Medical Uses (AREA)
Abstract
The invention provides a degradable and absorbable postoperative anti-adhesion material with an anti-infection function. The material includes: 40-95wt% of an anti-adhesion host material, and the balance magnesium based metal. The anti-adhesion host material is one of hyaluronic acid, hyaluronate and polylactic acid or a mixture of several of the substances. The degradable and absorbable postoperative anti-adhesion material with an anti-infection function provided by the invention has good biosecurity, and can realize controllable degradation behavior through regulation of the composition design and structure, thereby adapting to the needs of different clinical treatment cycles. A magnesium based metal can degrade in vivo to generate metal ions, can effectively prevent peripheral infection of anti-adhesion membrane material peripheral tissues, reduces postoperative infective rate, simultaneously can promote wound healing, and well meets the treatment demands of different surgical operations for prevention of postoperative adhesions. According to the invention, the magnesium based metal is added into the material to replace part of hyaluronate to reduce the use amount, thereby saving the production cost.
Description
Technical field
The present invention relates to biomaterial for medical purpose field, particularly relate to the post-operation adhesion preventing material that a kind of degradable with infection function absorbs.
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, the above material of single application all cannot avoid respective application limitation, and often not there is antiinflammatory, anti-infective miscellaneous function, the requirement of desirable Antiadhesive film material can not be reached, for solving the problem, just needing that the processing modified thus degradable of development of new is carried out to existing Antiadhesive film material and absorbing Antiadhesive film material to adapt to the actual needs of clinical treatment.
Summary of the invention
The object of the invention is to overcome above-mentioned deficiency, a kind of novel post-operation adhesion preventing material is provided, there is 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.
The post-operation adhesion preventing material that the degradable with infection function provided by the invention absorbs, by weight percentage, the component of described post-operation adhesion preventing material comprises:
Anti material of main part 40-95wt%, is preferably 48-90wt%, is more preferably 55-85wt%, is more preferably 60-80wt%, be more preferably 65-75wt%,
Magnesium-base metal surplus;
Wherein, described anti material of main part is one or more the mixture in hyaluronic acid, hyaluronate, polylactic acid.
According to disease character and treatment needs, described magnesium-base metal material can select pure magnesium or the magnesium base alloy with other element combinations.
Preferably, in described magnesium base alloy, the content of magnesium is >=90wt%, is more preferably >=94wt%, is more preferably >=95wt%, 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.
Preferably, often kind of content≤5wt% in other elements in described magnesium base alloy, is more preferably≤3wt%, is more preferably≤2wt%, be more preferably≤1wt%.
Further preferably, containing silver in described magnesium base alloy, and in described magnesium base alloy, silver content is more preferably≤3wt% for≤5wt%(, is more preferably≤2wt%, is more preferably≤1wt%), surplus is magnesium.
Further preferably, containing copper in described magnesium base alloy, and in described magnesium base alloy, copper content is more preferably≤3wt% for≤5wt%(, is more preferably≤2wt%, is more preferably≤1wt%), surplus is magnesium.
Preferably, described post-operation adhesion preventing material is diaphragm.
The thickness of described diaphragm is preferably 0.01-5mm, is more preferably 0.02-3mm, is more preferably 0.03-3mm, is more preferably 0.03-1mm, is more preferably 0.035-0.5mm.
Described hyaluronate is pharmaceutically acceptable hyaluronate, such as, can be hyaluronate sodium, potassium hyaluronate etc.
The post-operation adhesion preventing material that the degradable with infection function provided by the invention absorbs, there is good biological safety, by Composition Design and organizational structure regulation and control, realize its degradation behavior controlled, its degradation cycle is adjustable as 15 days-2 months, thus adapts to the needs of clinical different treatment cycle.Magnesium-base metal degradation in vivo produces metal ion, can effectively prevent to infect around Antiadhesive film surrounding materials tissue, reduce infection rate after abortion operation, there is wound healing simultaneously, different surgical field can be met preferably as the treatment needs of the operations such as orthopaedics, department of general surgery, department of obstetrics and gynecology to prevention of postoperative adhesion.Hyaluronic acid and hyaluronate sodium or polylactic acid cost higher, the present invention adds magnesium-base metal wherein, instead of a part of hyaluronate, can reduce its use amount thus save production cost.
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
Present embodiments provide the postoperative anti-adhesion membrane that a kind of degradable with infection function absorbs, by weight percentage, the composition material of described postoperative anti-adhesion membrane contains: hyaluronic acid 85wt%, and surplus is magnesium.
Biological safety
Biological assessment is carried out according to experimental technique described in GB/T16886.Experimental result shows, the postoperative anti-adhesion membrane 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 postoperative anti-adhesion membrane 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 postoperative anti-adhesion membrane 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 postoperative anti-adhesion membrane 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 postoperative anti-adhesion membrane 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 postoperative anti-adhesion membrane 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
Present embodiments provide the postoperative anti-adhesion membrane that a kind of degradable with infection function absorbs, by weight percentage, the composition material of described postoperative anti-adhesion membrane contains: hyaluronic acid 80wt% and surplus magnesium copper alloy; Wherein, in described magnesium copper alloy, the content of copper is 0.5wt%, and surplus is magnesium.
Biological safety
Biological assessment is carried out according to experimental technique described in GB/T16886.Experimental result shows, the postoperative anti-adhesion membrane 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 postoperative anti-adhesion membrane 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 postoperative anti-adhesion membrane 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 postoperative anti-adhesion membrane 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 postoperative anti-adhesion membrane 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 postoperative anti-adhesion membrane 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
Present embodiments provide the postoperative anti-adhesion membrane that a kind of degradable with infection function absorbs, by weight percentage, the composition material of described postoperative anti-adhesion membrane contains: hyaluronic acid 78wt% and surplus magnesium silver alloy; Wherein, in described magnesium silver alloy, the content of silver is 1wt%, and surplus is magnesium.
Biological safety
Biological assessment is carried out according to experimental technique described in GB/T16886.Experimental result shows, the postoperative anti-adhesion membrane 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 postoperative anti-adhesion membrane that the present embodiment provides is 97%, 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 postoperative anti-adhesion membrane 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 postoperative anti-adhesion membrane 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 postoperative anti-adhesion membrane 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 postoperative anti-adhesion membrane 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. the post-operation adhesion preventing material that the degradable with infection function absorbs, it is characterized in that, by weight percentage, the component of described post-operation adhesion preventing material comprises: anti material of main part 40-95wt%, magnesium-base metal surplus; Wherein, described anti material of main part is one or more the mixture in hyaluronic acid, hyaluronate, polylactic acid.
2. post-operation adhesion preventing material according to claim 1, is characterized in that, the component of described post-operation adhesion preventing material comprises: anti material of main part 48-90wt%, magnesium-base metal surplus.
3. post-operation adhesion preventing material according to claim 2, is characterized in that, the component of described post-operation adhesion preventing material comprises: anti material of main part 55-85wt%, magnesium-base metal surplus.
4. according to the post-operation adhesion preventing material in claim 1-3 described in any one, it is characterized in that, described magnesium-base metal is pure magnesium or magnesium base alloy.
5. post-operation adhesion preventing material according to claim 4, is characterized in that, in described magnesium base alloy, the content of magnesium is >=90wt%.
6. post-operation adhesion preventing material according to claim 5, it is characterized in that, in described magnesium base alloy except magnesium elements, also containing other elements, other elements described are one or more in copper, zinc, manganese, selenium, strontium, calcium, ferrum, zirconium, stannum, nickel, aluminum, silver etc., and/or one or more in rare earth metal, often kind of content≤5wt% in other elements in described magnesium base alloy.
7. post-operation adhesion preventing material according to claim 6, is characterized in that, containing silver in described magnesium base alloy, and in described magnesium base alloy, silver content is≤5wt%, and surplus is magnesium.
8. post-operation adhesion preventing material according to claim 6, is characterized in that, containing copper in described magnesium base alloy, and in described magnesium base alloy, copper content is≤5wt%, and surplus is magnesium.
9. post-operation adhesion preventing material according to claim 1, is characterized in that, described post-operation adhesion preventing material is diaphragm, and thickness is 0.01-5mm.
10. post-operation adhesion preventing material according to claim 1, is characterized in that, the thickness of described diaphragm is 0.03-3mm.
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| WO2017124613A1 (en) * | 2016-01-19 | 2017-07-27 | 周倩 | Fully degradable magnesium alloy and preparation method thereof |
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