CN104511049B - A kind of biological medical degradable metal treating rheumatoid arthritis and application thereof - Google Patents
A kind of biological medical degradable metal treating rheumatoid arthritis and application thereof Download PDFInfo
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- CN104511049B CN104511049B CN201310454427.4A CN201310454427A CN104511049B CN 104511049 B CN104511049 B CN 104511049B CN 201310454427 A CN201310454427 A CN 201310454427A CN 104511049 B CN104511049 B CN 104511049B
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Abstract
The invention provides a kind of biological medical degradable metal treating rheumatoid arthritis, described biological medical degradable metal is magnesium alloy, containing magnesium and second component, described second component is one or more in zinc, manganese, selenium, strontium, calcium, content≤the 10wt% of the second component, surplus is magnesium.The magnesium alloy that the present invention provides has good biocompatibility and satisfied decay resistance, without obvious cytotoxicity, in biological fluid or blood, degradable absorbs, the medical field such as it is implanted at intravascular Interventional Treatment and bone and there is using value, particularly by vivo degradation releasing beneficial element, macrophage and other inflammatory cell can be suppressed to activate, promote osteoblast bone formation, suppression osteoclastic bone resorption function, has the effects such as potential treatment rheumatoid arthritis.
Description
Technical field
The present invention relates to a kind of alloy material, particularly relate to magnesium alloy and the application thereof of a kind of biodegradable absorption having good biocompatibility that can be used as medical embedded material.
Background technology
Biological degradable in vivo absorbing material has huge potential application foreground.At present biological degradable in vivo absorbing material mainly has two big classes, respectively polymeric material and ceramic material, but both exist that mechanical property is low or the shortcoming such as plasticity and toughness are poor.But metal material then possesses good combination property, therefore, Metal Substrate biology degradable in vivo absorbing material has important medical applications and is worth.
Magnesium ion is that human body cell includes flow control two macrocation, is the indispensable important nutrient of human body, participates in a series of metabolic processes of human body, including promoting osteoblastic formation and accelerating knitting ability etc..Evidence suggests in the recent period, magnesium ion shortage plays an important role in rheumatoid arthritis (RA) conditions of patients is in progress.RA is a kind of chronic inflammation disease, and synovium of joint and periarticular tissue often have macrophage or other inflammatory cell of a large amount of activation, cause cartilage, bone and immune system dysfunction, and late period can cause bone and cartilage defect, has a strong impact on patients ' life quality.External in a large number for the investigation discovery of activeness RA Nutritional Status of Patients, the most often there is various trace elements to lack performance, especially some metallic elements, such as Mg, Zn, Mn, Se, Cu etc..And these minor metallic elements are the important component parts of internal anti-oxidation metal enzyme, anti-oxidation metal enzyme can suppress activation and the release of the reactive oxygen free radical in tissue or immunocyte, the function that the shortage of above metallic element may result in anti-oxidation metal protease is suppressed, and the macrophage of activation or other inflammatory cell and then the release oxygen-derived free radicals isoreactivity factor increase the weight of RA pathogenesis.The minor metallic element of supplement therapy dosage can suppress macrophage activity, reduces oxyradical release, the most also can activate the enzymes such as superoxide dismutase, and then understands toxicity in vivo oxygen-derived free radicals group.The most a lot of clinical treatments all can obviously relieve RA patients symptomatic and disease process around supplement trace metallic element or its relevant enzymes, such as intraarticular injection superoxide dismutase；In an open research, intramuscular is placed copper complex and is made 60%RA conditions of patients obtain obvious alleviation；Separately having scholar to find, RA patient's Selenium Supplement element can the symptoms such as substantially alleviating pain and morning be stiff.
Magnesium and magnesium alloy have more than 70 year history as bone implant material, prove that magnesium and magnesium alloy have preferable biocompatibility although clinical, but too fast in human body internal corrosion degraded, and can produce hydrogen, become a big obstacle of its clinical practice.Meanwhile, often containing impurity, such as A1 element and rare earth element etc. in magnesium alloy, A1 element is not the trace element of needed by human, and has neurotoxicity, and the biocompatibility of rare earth element exists dispute, the existing toxic action of accumulation schedule.Therefore, it is necessary to develop existing good biocompatibility, there is again degradability, the magnesium alloy that toxicity is little simultaneously.
Summary of the invention
It is an object of the invention to overcome above-mentioned deficiency, it is provided that a kind of biological medical degradable metal treating rheumatoid arthritis, described biological medical degradable metal is magnesium alloy, and this alloy has good biocompatibility and decay resistance, and bio-toxicity is low.
The first aspect of the invention is to provide a kind of biological medical degradable metal treating rheumatoid arthritis, described biological medical degradable metal is magnesium alloy, described magnesium alloy contains magnesium and second component, described second component is one or more in zinc, manganese, selenium, strontium, copper, and the content≤10wt%(of the second component is preferably 0.01-9.9wt%, more preferably 0.5-9wt%, more preferably 1-8.5wt%, more preferably 3-6wt%, more preferably 4-5.5wt%), surplus is magnesium.
Preferably, based on the total amount of magnesium alloy, second component contains:
Zinc 0-10wt%(is preferably 0.01-9.9wt%, more preferably 0.5-9wt%, more preferably 1-8.5wt%, more preferably 3-6wt%, more preferably 4-5.5wt%)；
Manganese 0-10wt%(is preferably 0.01-9.9wt%, more preferably 0.5-9wt%, more preferably 1-8.5wt%, more preferably 3-6wt%, more preferably 4-5.5wt%)；
Selenium 0-10wt%(is preferably 0.01-9.9wt%, more preferably 0.5-9wt%, more preferably 1-8.5wt%, more preferably 3-6wt%, more preferably 4-5.5wt%)；
Strontium 0-10wt%(is preferably 0.01-9.9wt%, more preferably 0.5-9wt%, more preferably 1-8.5wt%, more preferably 3-6wt%, more preferably 4-5.5wt%)；
Copper 0-10wt%(is preferably 0.01-9.9wt%, more preferably 0.5-9wt%, more preferably 1-8.5wt%, more preferably 3-6wt%, more preferably 4-5.5wt%)；
And the content of a kind of element is not 0 in zinc, manganese, selenium, strontium, copper.
Preferably, second component is four kinds in zinc, manganese, selenium, strontium, copper or five kinds, and the content i.e. having four kinds or five kinds elements in zinc, manganese, selenium, strontium, copper is not 0.
Second component can be zinc, manganese, selenium and strontium, or is zinc, manganese, selenium and copper, or zinc, manganese, strontium, copper, or is zinc, selenium, strontium, copper, or is manganese, selenium, strontium, copper, or is zinc, manganese, selenium, strontium, copper.
Wherein, described magnesium alloy, it is also possible to containing one or more in one or more in a small amount of impurity element, such as rare earth element, and/or ferrum, zirconium, stannum, nickel, copper and aluminum,
Preferably, every kind of content in described impurity element is less than 1wt%, more preferably less than 0.5wt%, more preferably less than 0.1wt%, more preferably less than 0.05wt%.
Preferably, described impurity element total amount is less than 1wt%, more preferably less than 0.6wt%, more preferably less than 0.4wt%, more preferably less than 0.1wt%.
The second aspect of the invention is to provide the magnesium alloy implant that a kind of medical degradable absorbs, and described magnesium alloy implant is made up of the biological medical degradable metal of any one the treated rheumatoid arthritis described in first aspect of the present invention.
Wherein, described magnesium alloy implant can be compact texture or loose structure.
Preferably, described magnesium alloy implant coats by degradable macromolecule coating and/or degradable ceramic coating, slow down magnesium alloy implant implanted internal after degradation speed.
Wherein, the constituent of described degradable macromolecule coating be preferably polyglycolic acid, polylactic acid, PLLA, polycaprolactone, poly-hydroxy acrylate, poly-to dioxane ketone, condensing model, poly phosphazene, polymer-amino-acid, poly-
Beta-hydroxy-butanoic acid ester and hydroxypentanoic acid
One or more combination in any in ester and copolymer etc. thereof.
Wherein, the constituent of described degradable ceramic coating is preferably one or more combination in any of hydroxyapatite, strontium containing hydroxyapatite, Silicon-Substituted Hydroxyapatite, bata-tricalcium phosphate and phosphoric acid oxygen four calcium etc..
Preferably, described degradable macromolecule coating layer thickness is 0.01-5mm, more preferably 0.05-4.5mm, more preferably 0.1-4mm, more preferably 0.5-3.2mm, more preferably 0.5-2.6mm.
Preferably, the thickness of described degradable ceramic coating is 0.01-5mm, more preferably 0.05-4.5mm, more preferably 0.1-4mm, more preferably 0.5-3.2mm, more preferably 0.5-2.6mm.
Wherein, described magnesium alloy implant can be support, net, sticking patch, granule, microsphere, bone rod, nail, hone lamella etc..
The third aspect of the invention is to provide the application in the embedded material that preparation uses under human body or animal body environment of the biological medical degradable metal of any one the treated rheumatoid arthritis described in a kind of first aspect.
Any one magnesium alloy described in first aspect of the present invention can be applicable to prepare cardio-vascular interventional therapeutic material or bone inner implantation material.
Preferably, any one magnesium alloy described in first aspect of the present invention is applied to the product of preparation treatment rheumatoid arthritis.
The magnesium alloy that the present invention provides has good biocompatibility and satisfied decay resistance, without obvious cytotoxicity, in biological fluid or blood, degradable absorbs, the medical field such as it is implanted at intravascular Interventional Treatment and bone and there is using value, particularly by vivo degradation releasing beneficial element, macrophage and other inflammatory cell can be suppressed to activate, promote osteoblast bone formation, suppression osteoclastic bone resorption function, has the effects such as potential treatment rheumatoid arthritis.
Detailed description of the invention
Below in conjunction with specific embodiment, the present invention is further illustrated, to be more fully understood that the present invention.
Embodiment 1
Present embodiments provide a kind of Mg-Zn-Mn-Se-Cu alloy, Zn content be 3.5wt%, Mn content be 0.5wt%, Se content be 0.4wt%, Cu content be 0.2wt%, Mg surplus.Manufactured by the melting technique of highly purified raw material and high-cleanness, high.Thermally treated and deformation can be made into required profile and shape after processing, and makes various orthopaedics plant Application of device further in clinical treatment.
After testing, the Mg-Zn-Mn-Se-Cu strength of alloy that the present embodiment provides is 200Mpa, and elongation percentage is 12%.Biological assessment is carried out according to experimental technique described in GB/T16886.Test result indicate that, the Mg-Zn-Mn-Se-Cu alloy that the present embodiment provides does not has obvious cytotoxicity and hemagglutinin to supplementing stem cell between chondrocyte, osteoblast and bone marrow with money, does not has obvious sensitization, stimulation and genetoxic.
The Mg-Zn-Mn-Se-Cu alloy that the present embodiment provides is processed into diameter 1mm, the porous support materials of long 10mm, uses oxirane disinfection.Select the new zealand rabbit at 16 9 monthly ages, set up rheumatoid arthritis model.New zealand rabbit is randomly divided into A, B group, often group 8.Distal femur makes diameter 1mm, long 10mm Cranial defect, is implanted by Mg-Zn-Mn-Se-Cu porous support materials at A group new zealand rabbit defect, is implanted at B group new zealand rabbit defect by the pure titanium porous support materials of diameter 1mm, long 10mm.Postoperative routine observation arthroncus degree, serology, tissue slice are observed.When 8 weeks, compared to B group, at the new Bone Ingrowth timbering material of A group new zealand rabbit, surrounding bone increase in density, cartilage and subchondral bone destructiveness are substantially reduced, and rheumatoid factor RF, erythrocyte sedimentation rate ESR, C reactive protein CRP significantly reduce, and at synovial membrane, inflammatory reaction lightens, illustrate that the Mg-Zn-Mn-Se-Cu alloy that the present embodiment provides has good biocompatibility, there is the effect for the treatment of rheumatoid arthritis.When 8 weeks, material degradation 30%.
Embodiment 2
Present embodiments provide a kind of Mg-Zn-Mn-Sr-Cu alloy, Zn content be 2.5wt%, Mn content be 0.5wt%, Sr content be 2wt%, Cu content be 0.9wt%, Mg surplus.Manufactured by the melting technique of highly purified raw material and high-cleanness, high.Thermally treated and deformation can be made into required profile and shape after processing, and makes various orthopaedics plant Application of device further in clinical treatment.
After testing, the Mg-Zn-Mn-Sr-Cu strength of alloy that the present embodiment provides is 220Mpa, and elongation percentage is 11%.Biological assessment is carried out according to experimental technique described in GB/T16886.Test result indicate that, the Mg-Zn-Mn-Sr-Cu alloy that the present embodiment provides does not has obvious cytotoxicity and hemagglutinin to supplementing stem cell between chondrocyte, osteoblast and bone marrow with money, does not has obvious sensitization, stimulation and genetoxic.
The Mg-Zn-Mn-Sr-Cu alloy that the present embodiment provides is processed into diameter 1mm, the porous support materials of long 10mm, uses oxirane disinfection.Select the new zealand rabbit at 16 9 monthly ages, set up rheumatoid arthritis model.New zealand rabbit is randomly divided into A, B group, often group 8.Distal femur makes diameter 1mm, long 10mm Cranial defect, is implanted by Mg-Zn-Mn-Sr-Cu porous support materials at A group new zealand rabbit defect, is implanted at B group new zealand rabbit defect by the pure titanium porous support materials of diameter 1mm, long 10mm.Postoperative routine observation arthroncus degree, serology, tissue slice are observed.When 8 weeks, compared to B group, at the new Bone Ingrowth timbering material of A group new zealand rabbit, surrounding bone increase in density, cartilage and subchondral bone destructiveness are substantially reduced, and rheumatoid factor RF, erythrocyte sedimentation rate ESR, C reactive protein CRP significantly reduce, and at synovial membrane, inflammatory reaction lightens, illustrate that the Mg-Zn-Mn-Sr-Cu alloy that the present embodiment provides has good biocompatibility, there is the effect for the treatment of rheumatoid arthritis.When 8 weeks, material degradation 25%.
Embodiment 3
Present embodiments provide a kind of Mg-Mn-Se-Sr-Cu alloy, Mn content be 0.6wt%, Se content be 1.4wt%, Sr content be 1.8wt%, Cu content be 0.5wt%, Mg surplus.Manufactured by the melting technique of highly purified raw material and high-cleanness, high.Thermally treated and deformation can be made into required profile and shape after processing, and makes various orthopaedics plant Application of device further in clinical treatment.
After testing, the Mg-Mn-Se-Sr-Cu strength of alloy that embodiment provides is 210Mpa, and elongation percentage is 11%.Biological assessment is carried out according to experimental technique described in GB/T16886.Test result indicate that, the Mg-Mn-Se-Sr-Cu alloy that the present embodiment provides does not has obvious cytotoxicity and hemagglutinin to supplementing stem cell between chondrocyte, osteoblast and bone marrow with money, does not has obvious sensitization, stimulation and genetoxic.
The Mg-Mn-Se-Sr-Cu alloy that the present embodiment provides is processed into diameter 1mm, the porous support materials of long 10mm, uses oxirane disinfection.Select the new zealand rabbit at 16 9 monthly ages, set up rheumatoid arthritis model.New zealand rabbit is randomly divided into A, B group, often group 8.Distal femur makes diameter 1mm, long 10mm Cranial defect, is implanted by Mg-Mn-Se-Sr-Cu porous support materials at A group new zealand rabbit defect, is implanted at B group new zealand rabbit defect by the pure titanium porous support materials of diameter 1mm, long 10mm.Postoperative routine observation arthroncus degree, serology, tissue slice are observed.When 8 weeks, compared to B group, at the new Bone Ingrowth timbering material of A group new zealand rabbit, surrounding bone increase in density, cartilage and subchondral bone destructiveness are substantially reduced, and rheumatoid factor RF, erythrocyte sedimentation rate ESR, C reactive protein CRP significantly reduce, and at synovial membrane, inflammatory reaction lightens, illustrate that the Mg-Mn-Se-Sr-Cu alloy that the present embodiment provides has good biocompatibility, there is the effect for the treatment of rheumatoid arthritis.
Embodiment 4
Present embodiments provide a kind of Mg-Mn-Zn-Se-Sr alloy, Mn content be 0.1wt%, Se content be 4.2wt%, Sr content be 1.8wt%, Zn content be 3.6wt%, Mg surplus.Manufactured by the melting technique of highly purified raw material and high-cleanness, high.Thermally treated and deformation can be made into required profile and shape after processing, and makes various orthopaedics plant Application of device further in clinical treatment.
After testing, the Mg-Mn-Zn-Se-Sr strength of alloy that embodiment provides is 210Mpa, and elongation percentage is 11%.Biological assessment is carried out according to experimental technique described in GB/T16886.Test result indicate that, the Mg-Mn-Zn-Se-Sr alloy that the present embodiment provides does not has obvious cytotoxicity and hemagglutinin to supplementing stem cell between chondrocyte, osteoblast and bone marrow with money, does not has obvious sensitization, stimulation and genetoxic.
The Mg-Mn-Zn-Se-Sr alloy that the present embodiment provides is processed into diameter 1mm, the porous support materials of long 10mm, uses oxirane disinfection.Select the new zealand rabbit at 16 9 monthly ages, set up rheumatoid arthritis model.New zealand rabbit is randomly divided into A, B group, often group 8.Distal femur makes diameter 1mm, long 10mm Cranial defect, is implanted by Mg-Mn-Zn-Se-Sr porous support materials at A group new zealand rabbit defect, is implanted at B group new zealand rabbit defect by the pure titanium porous support materials of diameter 1mm, long 10mm.Postoperative routine observation arthroncus degree, serology, tissue slice are observed.When 8 weeks, compared to B group, at the new Bone Ingrowth timbering material of A group new zealand rabbit, surrounding bone increase in density, cartilage and subchondral bone destructiveness are substantially reduced, and rheumatoid factor RF, erythrocyte sedimentation rate ESR, C reactive protein CRP significantly reduce, and at synovial membrane, inflammatory reaction lightens, illustrate that the Mg-Mn-Zn-Se-Sr alloy that the present embodiment provides has good biocompatibility, there is the effect for the treatment of rheumatoid arthritis.
Embodiment 5-24
The component of the magnesium alloy that embodiment 5-24 provides is as shown in table 1.
The magnesium alloy that table 1 embodiment 5-24 provides
After testing, the tensile strength of the Mg alloy that embodiment 5-24 provides is 170-230Mpa, and elongation percentage is 9-13.5%.
Biological assessment is carried out according to experimental technique described in GB/T16886.Test result indicate that, the Mg alloy that embodiment 5-24 provides does not has obvious cytotoxicity and hemagglutinin to supplementing stem cell between chondrocyte, osteoblast and bone marrow with money, does not has obvious sensitization, stimulation and genetoxic.
The Mg alloy that embodiment 5-24 provides is made porous support and carries out zoopery and vivo degradation experiment according to the method similar with embodiment 1-4, result shows, at the new Bone Ingrowth timbering material of experimental group new zealand rabbit, surrounding bone increase in density, cartilage and subchondral bone destructiveness are substantially reduced, rheumatoid factor RF, erythrocyte sedimentation rate ESR, C reactive protein CRP significantly reduces, and at synovial membrane, inflammatory reaction lightens.When 8 weeks, material degradation 20-30%.
In sum, the magnesium alloy that the present invention provides has good biocompatibility and satisfied decay resistance, and without obvious cytotoxicity, in biological fluid or blood, degradable absorbs, and has the effect of potential treatment rheumatoid arthritis.
Being described in detail the specific embodiment of the present invention above, but it is intended only as example, the present invention is not restricted to particular embodiments described above.To those skilled in the art, any equivalent modifications carrying out the present invention and replacement are the most all among scope of the invention.Therefore, the impartial conversion made without departing from the spirit and scope of the invention and amendment, all should contain within the scope of the invention.
Claims (9)
1. the biological medical degradable metal that can treat rheumatoid arthritis, it is characterized in that, described biological medical degradable metal is magnesium alloy, containing magnesium and second component, described second component is four kinds in zinc, manganese, selenium, strontium, copper or five kinds, content≤the 10wt% of the second component, surplus is magnesium.
Biological medical degradable metal the most according to claim 1, it is characterized in that, possibly together with a small amount of impurity element, described impurity element is one or more in rare earth element, and/or one or more in ferrum, zirconium, stannum, nickel, copper and aluminum, every kind of content in impurity element is less than 1wt%.
Biological medical degradable metal the most according to claim 2, it is characterised in that every kind of content in described impurity element is less than 0.1%, total amount is less than 0.4%.
4. the magnesium alloy implant that a medical degradable absorbs, it is characterised in that described magnesium alloy implant is made up of the biological medical degradable metal of the treated rheumatoid arthritis described in any one of claim 1-3.
Magnesium alloy implant the most according to claim 4, it is characterised in that described magnesium alloy implant is compact texture or loose structure.
Magnesium alloy implant the most according to claim 4, it is characterised in that coat by degradable macromolecule coating and/or degradable ceramic coating on described magnesium alloy implant.
Magnesium alloy implant the most according to claim 6, it is characterized in that, the constituent of described degradable macromolecule coating is polyglycolic acid, polylactic acid, polycaprolactone, poly-hydroxy acrylate, gathers one or more combination in any in dioxane ketone, condensing model, poly phosphazene, polymer-amino-acid, poly-β-hybroxybutyric acid and hydroxyl valerate and copolymer thereof；The constituent of described degradable ceramic coating is hydroxyapatite, strontium containing hydroxyapatite, Silicon-Substituted Hydroxyapatite, bata-tricalcium phosphate and one or more combination in any of phosphoric acid oxygen four calcium.
8., according to the magnesium alloy implant described in claim 6 or 7, it is characterised in that degradable macromolecule coating layer thickness is 0.01-5mm, the thickness of degradable ceramic coating is 0.01-5mm.
9. the application in the product of preparation treatment rheumatoid arthritis of the biological medical degradable metal of rheumatoid arthritis described in a claim 1, can be treated.
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| CN104928517B (en) * | 2015-06-24 | 2016-10-26 | 南华大学 | Porous magnesium based hydroxylapatite composite material and preparation method thereof and resulting materials thereof |
| CN106214232A (en) * | 2016-07-19 | 2016-12-14 | 上海交通大学医学院附属第九人民医院 | A kind of magnesium-base metal infection chain pearl device |
| CN107198796B (en) * | 2017-05-22 | 2020-08-25 | 北京科技大学 | Biomedical Zn-Mn-Cu zinc alloy and preparation method thereof |
| WO2019027428A1 (en) * | 2017-07-31 | 2019-02-07 | Avalon Bone Supplement (Hk) Limited | Multi-mineral supplement for improved bone density |
| CN111467572B (en) * | 2020-04-09 | 2022-07-29 | 上海交通大学医学院附属第九人民医院 | Implant material and preparation method and application thereof |
| CN112773931B (en) * | 2021-01-04 | 2022-06-21 | 北京华钽生物科技开发有限公司 | Absorbable reinforced bone implant material and preparation method thereof |
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| CN102170921A (en) * | 2008-08-11 | 2011-08-31 | App生物材料有限公司 | Implant made of magnesium and magnesium alloy for an implant, and method for the production thereof |
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| US20090081313A1 (en) * | 2006-04-28 | 2009-03-26 | Biomagnesium Systems Ltd. | Biodegradable Magnesium Alloys and Uses Thereof |
| AU2007297991B2 (en) * | 2006-09-22 | 2011-02-17 | U & I Corporation | Implants comprising biodegradable metals and method for manufacturing the same |
| WO2011117298A1 (en) * | 2010-03-25 | 2011-09-29 | Biotronik Ag | Implant made of a biodegradable magnesium alloy |
| CN102433477B (en) * | 2011-12-22 | 2015-04-15 | 江阴宝易德医疗科技有限公司 | Biomedical Mg-Sn-Zn-Mn magnesium alloy and preparation method thereof |
| CN102580143A (en) * | 2012-02-17 | 2012-07-18 | 浙江海圣医疗器械有限公司 | Medical degradable and absorbable Mg-Sr system magnesium alloy implant and preparation method thereof |
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