CN104511049A - Biomedical degradable metal capable of treating rheumatoid arthritis, and applications thereof - Google Patents
Biomedical degradable metal capable of treating rheumatoid arthritis, and applications thereof Download PDFInfo
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- CN104511049A CN104511049A CN201310454427.4A CN201310454427A CN104511049A CN 104511049 A CN104511049 A CN 104511049A CN 201310454427 A CN201310454427 A CN 201310454427A CN 104511049 A CN104511049 A CN 104511049A
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Abstract
The present invention provides a biomedical degradable metal capable of treating rheumatoid arthritis. The biomedical degradable metal is a magnesium alloy and contains magnesium and a second component, wherein the second component is one or a plurality of materials selected from zinc, manganese, selenium, strontium and calcium, the content of the second component is less than or equal to 10 wt%, and the balance is magnesium. According to the present invention, the magnesium alloy has characteristics of good biocompatibility, satisfactory corrosion resistance and no significant cytotoxicity, can be degraded and absorbed in biological body fluids or bloods, has application values in medical fields of endovascular interventional therapy, endosseous implant and the like, and especially releases beneficial elements through in vivo degradation so as to inhibit activation of macrophages and other inflammatory cells, promote osteoblast bone formation, and inhibit osteoclast bone resorption, such that the biomedical degradable metal has the potential effects of rheumatoid arthritis treating and the like.
Description
Technical field
The present invention relates to a kind of alloy material, particularly relate to a kind of magnesium alloy and the application thereof that have the biodegradable absorption of good biocompatibility that can be used as medical embedded material.
Background technology
Biological degradable in vivo absorbing material has huge potential application foreground.Current biological degradable in vivo absorbing material mainly contains two large classes, is respectively polymeric material and ceramic material, but both exist the shortcomings such as the low or plasticity and toughness of mechanical property are poor.But metal material then possesses good combination property, therefore, the biological degradable in vivo absorbing material of Metal Substrate has important medical applications value.
Magnesium ion is the second largest cation of human body cell intensive amount, is the indispensable important nutrient of human body, participates in a series of metabolic processes of human body, comprise and promote osteoblastic formation and accelerated bone healing ability etc.Evidence suggests in the recent period, magnesium ion shortage plays an important role in rheumatoid arthritis (RA) conditions of patients progress.RA is a kind of chronic inflammation disease, and synovium of joint and periarticular organize the macrophage or other inflammatory cell that often there are a large amount of activation, and cause cartilage, bone and immune system dysfunction, late period can cause bone and cartilage defect, has a strong impact on patients ' life quality.A large amount of for activeness RA Nutritional Status of Patients investigation discovery abroad, often there is various trace elements to lack performance, especially some metallic elements, such as Mg, Zn, Mn, Se, Cu etc. in patient body.And these minor metallic elements are important component parts of anti-oxidation metal enzyme in body, anti-oxidation metal enzyme can suppress activation and the release of the reactive oxygen free radical in tissue or immunocyte, the shortage of above metallic element can cause the function of anti-oxidation metal protease 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, also can activate the enzymes such as superoxide dismutase simultaneously, and then know toxicity in vivo oxygen-derived free radicals group.At present a lot of clinical treatment is all around supplement trace metallic element or its relevant enzymes, and such as intraarticular injection superoxide dismutase can obviously alleviate RA patients symptomatic and disease process; In an open research, intramuscular is placed copper complex and is made 60%RA conditions of patients obtain obvious alleviation; Separately have scholar to find, RA patient's Selenium Supplement element can the symptoms such as obviously alleviating pain and morning be stiff.
Mg-based hydrogen storage has more than 70 year history as bone implant material, although clinical proof Mg-based hydrogen storage has good biocompatibility, too fast in human body internal corrosion degraded, and can produce hydrogen, becomes a large obstacle of its clinical practice.Meanwhile, normal in magnesium alloy containing impurity, such as A1 element and rare earth element etc., 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, be necessary to develop existing good biocompatibility, again there is degradability, the magnesium alloy that toxicity is little simultaneously.
Summary of the invention
The object of the invention is to overcome above-mentioned deficiency, a kind of biological medical degradable metal for the treatment of rheumatoid arthritis is provided, described biological medical degradable metal is magnesium alloy, and this alloy has good biocompatibility and decay resistance, and bio-toxicity is low.
First aspect of the present invention is to provide a kind of biological medical degradable metal for the treatment of 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%, is more preferably 0.5-9wt%, be more preferably 1-8.5wt%, be more preferably 3-6wt%, be more preferably 4-5.5wt%), surplus is magnesium.
Preferably, by the total amount of magnesium alloy, second component contains:
Zinc 0-10wt%(is preferably 0.01-9.9wt%, is more preferably 0.5-9wt%, is more preferably 1-8.5wt%, is more preferably 3-6wt%, is more preferably 4-5.5wt%);
Manganese 0-10wt%(is preferably 0.01-9.9wt%, is more preferably 0.5-9wt%, is more preferably 1-8.5wt%, is more preferably 3-6wt%, is more preferably 4-5.5wt%);
Selenium 0-10wt%(is preferably 0.01-9.9wt%, is more preferably 0.5-9wt%, is more preferably 1-8.5wt%, is more preferably 3-6wt%, is more preferably 4-5.5wt%);
Strontium 0-10wt%(is preferably 0.01-9.9wt%, is more preferably 0.5-9wt%, is more preferably 1-8.5wt%, is more preferably 3-6wt%, is more preferably 4-5.5wt%);
Copper 0-10wt%(is preferably 0.01-9.9wt%, is more preferably 0.5-9wt%, is more preferably 1-8.5wt%, is more preferably 3-6wt%, is more preferably 4-5.5wt%);
And in zinc, manganese, selenium, strontium, copper, have at least a kind of content of element not to be 0.
Preferably, second component is four kinds or five kinds in zinc, manganese, selenium, strontium, copper, namely has the content of four kinds or five kinds elements not to be 0 in zinc, manganese, selenium, strontium, copper.
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, can also contain a small amount of impurity element, such as, in rare earth element one or more, and/or one or more in ferrum, zirconium, stannum, nickel, copper and aluminum,
Preferably, often kind of content in described impurity element is no more 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 no more than 1wt%, more preferably less than 0.6wt%, more preferably less than 0.4wt%, more preferably less than 0.1wt%.
Second aspect of the present 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 the present invention first aspect.
Wherein, described magnesium alloy implant can be compact texture or loose structure.
Preferably, described magnesium alloy implant applies by degradable macromolecule coating and/or degradable ceramic coating, slow down the degradation speed after in the implanted body of magnesium alloy implant.
Wherein, 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 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, B-trialcium phosphate and phosphoric acid oxygen four calcium etc.
Preferably, described degradable macromolecule coating layer thickness is 0.01-5mm, is more preferably 0.05-4.5mm, is more preferably 0.1-4mm, be more preferably 0.5-3.2mm, be more preferably 0.5-2.6mm.
Preferably, the thickness of described degradable ceramic coating is 0.01-5mm, is more preferably 0.05-4.5mm, is more preferably 0.1-4mm, be more preferably 0.5-3.2mm, be 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 biological medical degradable metal that 3rd aspect of the present invention is to provide any one the treated rheumatoid arthritis described in a kind of first aspect is being prepared in the application in the embedded material used under human body or animal body environment.
Any one magnesium alloy described in the present invention first aspect can be applicable to prepare cardio-vascular interventional therapeutic material or bone inner implantation material.
Preferably, any one magnesium alloy described in the present invention first aspect is applied to the product of preparation treatment rheumatoid arthritis.
Magnesium alloy provided by the invention has good biocompatibility and satisfied decay resistance, without obvious cytotoxicity, in biological fluid or blood, degradable absorbs, the medical field such as to be implanted at intravascular Interventional Treatment and bone and there is using value, particularly by vivo degradation releasing beneficial element, macrophage and the activation of other inflammatory cell can be suppressed, promote osteoblast bone formation, suppress osteoclastic bone resorption function, there is 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 understand the present invention better.
Embodiment 1
Present embodiments provide a kind of Mg-Zn-Mn-Se-Cu alloy, Zn content is 3.5wt%, Mn content be 0.5wt%, Se content be 0.4wt%, Cu content is 0.2wt%, Mg surplus.Manufactured by the melting technique of highly purified raw material and high-cleanness, high.After heat treatment and deformation processing, can be made into required profile and shape, make various orthopaedics Inner 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 percentage elongation is 12%.Biological assessment is carried out according to experimental technique described in GB/T16886.Experimental result shows, the Mg-Zn-Mn-Se-Cu alloy that the present embodiment provides to chondrocyte, supplement stem cell between osteoblast and bone marrow with money and there is no obvious cytotoxicity and hemagglutinin, there is no obvious sensitization, stimulation and genetoxic.
The Mg-Zn-Mn-Se-Cu alloy provided by the present embodiment is processed into the porous support materials of diameter 1mm, long 10mm, uses oxirane disinfection.Select the new zealand rabbit at 16 9 monthly ages, set up rheumatoid arthritis model.New zealand rabbit is divided into A, B group at random, often organizes 8.Distal femur makes diameter 1mm, long 10mm Cranial defect, and Mg-Zn-Mn-Se-Cu porous support materials is implanted A group new zealand rabbit defect place, and the pure titanium porous support materials of diameter 1mm, long 10mm is implanted B group new zealand rabbit defect place.Postoperative routine observation arthroncus degree, serology, tissue slice are observed.When 8 weeks, compared to B group, the new Bone Ingrowth timbering material place of A group new zealand rabbit, surrounding bone increase in density, cartilage and subchondral bone destructiveness significantly reduce, and rheumatoid factor RF, erythrocyte sedimentation rate ESR, C reactive protein CRP significantly reduce, and the inflammatory reaction of synovial membrane place 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 is 2.5wt%, Mn content be 0.5wt%, Sr content be 2wt%, Cu content is 0.9wt%, Mg surplus.Manufactured by the melting technique of highly purified raw material and high-cleanness, high.After heat treatment and deformation processing, can be made into required profile and shape, make various orthopaedics Inner 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 percentage elongation is 11%.Biological assessment is carried out according to experimental technique described in GB/T16886.Experimental result shows, the Mg-Zn-Mn-Sr-Cu alloy that the present embodiment provides to chondrocyte, supplement stem cell between osteoblast and bone marrow with money and there is no obvious cytotoxicity and hemagglutinin, there is no obvious sensitization, stimulation and genetoxic.
The Mg-Zn-Mn-Sr-Cu alloy provided by the present embodiment is processed into the porous support materials of diameter 1mm, long 10mm, uses oxirane disinfection.Select the new zealand rabbit at 16 9 monthly ages, set up rheumatoid arthritis model.New zealand rabbit is divided into A, B group at random, often organizes 8.Distal femur makes diameter 1mm, long 10mm Cranial defect, and Mg-Zn-Mn-Sr-Cu porous support materials is implanted A group new zealand rabbit defect place, and the pure titanium porous support materials of diameter 1mm, long 10mm is implanted B group new zealand rabbit defect place.Postoperative routine observation arthroncus degree, serology, tissue slice are observed.When 8 weeks, compared to B group, the new Bone Ingrowth timbering material place of A group new zealand rabbit, surrounding bone increase in density, cartilage and subchondral bone destructiveness significantly reduce, and rheumatoid factor RF, erythrocyte sedimentation rate ESR, C reactive protein CRP significantly reduce, and the inflammatory reaction of synovial membrane place 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 is 0.6wt%, Se content be 1.4wt%, Sr content be 1.8wt%, Cu content is 0.5wt%, Mg surplus.Manufactured by the melting technique of highly purified raw material and high-cleanness, high.After heat treatment and deformation processing, can be made into required profile and shape, make various orthopaedics Inner 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 percentage elongation is 11%.Biological assessment is carried out according to experimental technique described in GB/T16886.Experimental result shows, the Mg-Mn-Se-Sr-Cu alloy that the present embodiment provides to chondrocyte, supplement stem cell between osteoblast and bone marrow with money and there is no obvious cytotoxicity and hemagglutinin, there is no obvious sensitization, stimulation and genetoxic.
The Mg-Mn-Se-Sr-Cu alloy provided by the present embodiment is processed into the porous support materials of diameter 1mm, long 10mm, uses oxirane disinfection.Select the new zealand rabbit at 16 9 monthly ages, set up rheumatoid arthritis model.New zealand rabbit is divided into A, B group at random, often organizes 8.Distal femur makes diameter 1mm, long 10mm Cranial defect, and Mg-Mn-Se-Sr-Cu porous support materials is implanted A group new zealand rabbit defect place, and the pure titanium porous support materials of diameter 1mm, long 10mm is implanted B group new zealand rabbit defect place.Postoperative routine observation arthroncus degree, serology, tissue slice are observed.When 8 weeks, compared to B group, the new Bone Ingrowth timbering material place of A group new zealand rabbit, surrounding bone increase in density, cartilage and subchondral bone destructiveness significantly reduce, and rheumatoid factor RF, erythrocyte sedimentation rate ESR, C reactive protein CRP significantly reduce, and the inflammatory reaction of synovial membrane place 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 is 0.1wt%, Se content be 4.2wt%, Sr content be 1.8wt%, Zn content is 3.6wt%, Mg surplus.Manufactured by the melting technique of highly purified raw material and high-cleanness, high.After heat treatment and deformation processing, can be made into required profile and shape, make various orthopaedics Inner 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 percentage elongation is 11%.Biological assessment is carried out according to experimental technique described in GB/T16886.Experimental result shows, the Mg-Mn-Zn-Se-Sr alloy that the present embodiment provides to chondrocyte, supplement stem cell between osteoblast and bone marrow with money and there is no obvious cytotoxicity and hemagglutinin, there is no obvious sensitization, stimulation and genetoxic.
The Mg-Mn-Zn-Se-Sr alloy provided by the present embodiment is processed into the porous support materials of diameter 1mm, long 10mm, uses oxirane disinfection.Select the new zealand rabbit at 16 9 monthly ages, set up rheumatoid arthritis model.New zealand rabbit is divided into A, B group at random, often organizes 8.Distal femur makes diameter 1mm, long 10mm Cranial defect, and Mg-Mn-Zn-Se-Sr porous support materials is implanted A group new zealand rabbit defect place, and the pure titanium porous support materials of diameter 1mm, long 10mm is implanted B group new zealand rabbit defect place.Postoperative routine observation arthroncus degree, serology, tissue slice are observed.When 8 weeks, compared to B group, the new Bone Ingrowth timbering material place of A group new zealand rabbit, surrounding bone increase in density, cartilage and subchondral bone destructiveness significantly reduce, and rheumatoid factor RF, erythrocyte sedimentation rate ESR, C reactive protein CRP significantly reduce, and the inflammatory reaction of synovial membrane place 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 percentage elongation is 9-13.5%.
Biological assessment is carried out according to experimental technique described in GB/T16886.Experimental result shows, the Mg alloy that embodiment 5-24 provides to chondrocyte, supplement stem cell between osteoblast and bone marrow with money and there is no obvious cytotoxicity and hemagglutinin, there is no obvious sensitization, stimulation and genetoxic.
The Mg alloy provided by embodiment 5-24 is made porous support and is carried out zoopery according to the method similar with embodiment 1-4 and vivo degradation is tested, result shows, the new Bone Ingrowth timbering material place of experimental group new zealand rabbit, surrounding bone increase in density, cartilage and subchondral bone destructiveness significantly reduce, rheumatoid factor RF, erythrocyte sedimentation rate ESR, C reactive protein CRP significantly reduces, and the inflammatory reaction of synovial membrane place lightens.When 8 weeks, material degradation 20-30%.
In sum, magnesium alloy provided by the invention 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.
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. can treat the biological medical degradable metal of rheumatoid arthritis for one kind, it is characterized in that, 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, copper, content≤the 10wt% of the second component, surplus is magnesium.
2. biological medical degradable metal according to claim 1, is characterized in that, described second component is four kinds or five kinds in zinc, manganese, selenium, strontium, copper.
3. biological medical degradable metal according to claim 1, it is characterized in that, also containing 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, often kind of content in impurity element is no more than 1wt%.
4. biological medical degradable metal according to claim 3, is characterized in that, often kind of content in described impurity element is no more than 0.1%, and total amount is no more than 0.4%.
5. a magnesium alloy implant for medical degradable absorption, it is characterized in that, described magnesium alloy implant is made up of the biological medical degradable metal of the treated rheumatoid arthritis described in claim 1-4.
6. magnesium alloy implant according to claim 5, is characterized in that, described magnesium alloy implant is compact texture or loose structure.
7. magnesium alloy implant according to claim 5, is characterized in that, described magnesium alloy implant applies by degradable macromolecule coating and/or degradable ceramic coating.
8. magnesium alloy implant according to claim 7, 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; 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.
9. according to the magnesium alloy implant in claim 7 or 8 described in any one, it is characterized in that, degradable macromolecule coating layer thickness is 0.01-5mm, and the thickness of degradable ceramic coating is 0.01-5mm.
10. the application of biological medical degradable metal in the product of preparation treatment rheumatoid arthritis of rheumatoid arthritis described in a claim 1, can be treated.
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| CN107198796A (en) * | 2017-05-22 | 2017-09-26 | 北京科技大学 | A kind of bio-medical Zn Mn Cu systems kirsite and preparation method thereof |
| CN111467572A (en) * | 2020-04-09 | 2020-07-31 | 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 |
| CN111787928A (en) * | 2017-07-31 | 2020-10-16 | 慧创骨科药品有限公司 | Multi-mineral supplement for increasing bone density |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN111467572A (en) * | 2020-04-09 | 2020-07-31 | 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 |
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| 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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