CN103483768A - Bioglass / polyether-ether-ketone composite materials, method for preparing same, application thereof, bone repair body and bone repair body preparation method - Google Patents

Bioglass / polyether-ether-ketone composite materials, method for preparing same, application thereof, bone repair body and bone repair body preparation method Download PDF

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CN103483768A
CN103483768A CN201310423215.XA CN201310423215A CN103483768A CN 103483768 A CN103483768 A CN 103483768A CN 201310423215 A CN201310423215 A CN 201310423215A CN 103483768 A CN103483768 A CN 103483768A
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ether
polyether
bone
powder
vitric
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CN103483768B (en
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魏杰
张珏
牛云飞
董谢平
刘昌胜
邓玉虎
吴钊英
蔡亮
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East China University of Science and Technology
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East China University of Science and Technology
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Abstract

The invention discloses bioglass / polyether-ether-ketone composite materials, a method for preparing the bioglass / polyether-ether-ketone composite materials, the application of the bioglass / polyether-ether-ketone composite materials, a bone repair body and a bone repair body preparation method. The composite material preparation method comprises the steps that 20-40wt% of 5-20-micron bioglass powder and 60-80wt% 10-20-micron polyether-ether-ketone powder are evenly mixed to obtain mixed powder; the mixed powder is processed and formed, and accordingly the composite materials are prepared. The composite materials have good biological activity and biocompatibility, the composite materials and bone tissues have good mechanical compatibility, and the composite materials can stimulate bone growth, accelerate bone cure, reduce cure time after bone repair materials are implanted, and have bacterium resistance performance. The preparation techniques of the composite materials can be adjusted according to clinic requirements to prepare bone repair bodies of different shapes, difference specifications and different mechanical properties. The bone repair body will not cause inflammatory responses after being implanted, the mechanical property of the bone repair body is matched with human bones, the negative effects that the bone repair materials loosen and bone resorption happens will not be caused, and the bone repair body can meet requirements of clinic for bone repair.

Description

Bio-vitric/polyether-ether-ketone composite material, bone prosthesis and its preparation method and application
Technical field
The present invention relates to the polyetheretherketone field of compound material, relate in particular to a kind of bio-vitric/Peek Composite Material and Preparation Method and application, especially also relate to a kind of bone prosthesis and preparation method thereof.
Background technology
Modern bone implant material is more and more emphasized the biological function of implant, and the bone integrated concept has been applied in the middle of the evaluation of bone implant widely., still there is the shortcoming that self is difficult to overcome in titanium base and the ceramic bone implant material of wide clinical application at present.Bioactivity glass (BG) has 40 years history so far from Hench invention in 1971, mainly, as the surrogate of bone, is applied to clinical nearly 30 years, has obtained good effect.BG biocompatibility and biological activity are good, by the whole world, are known as and are applicable to the Permanent implantation material.BG has bone conduction and promoting bone growing effect, and its outstanding feature: bone formation rate is fast; The BG repairing bone defect, can participate in metabolism and the regenerative process of osseous tissue directly, and form firmly chemical bonding with the surrounding bone tissue.In physiological environment, series of chemical can occur in the BG surface, the growth of the finally inorganic mineral (apatite layer) in its surface forms similar bone, and inducting osseous tissue, and this is that BG has bioactive reason.But BG also has the deficiency of self, as high as the Young's modulus of bio-vitric or devitrified glass, with the Young's modulus of osseous tissue, do not mate, easily cause stress shielding; Physical strength is low, and fragility is large, and these deficiencies easily cause implants failure, has seriously limited its use range.
The Young's modulus of metal and ceramic bone implant material exceeds osseous tissue far away, and it implants and can produce stress shielding, causes bone resorption, atrophy, and even the complication such as implant is loosening.Polyether-ether-ketone (PK) not only has good biocompatibility and biologically stable, and fatigue resistance is good, erosion resistance is strong; Young's modulus and the osseous tissue of the artificial bone of manufacturing with PK are complementary, and high strength, hard wear resistant and through sterilizing repeatedly and physical strength is not degenerated.Oneself is designated as " best long-term bone grafting material " PK, and obtains the FDA authentication, and the U.S. has developed the osteoarthrosis, elbow joint etc. of long-term implantation with PK.Therefore, PK has more obvious advantage than metal and pottery, is applicable to long-term bone in body and implants.But PK lacks biological activity, can not with people's bone forming firmly key be combined.
Summary of the invention
Technical problem to be solved by this invention has been to overcome existing bone renovating material or not good with the mechanical compatibility of osseous tissue, the bone renovating material that easily causes stress shielding to cause becomes flexible and bone resorption, knitting speed is excessively slow, the shortage biological activity, can't with the defect of the firm bonding of bone forming, a kind of bio-vitric/Peek Composite Material and Preparation Method and application are provided, and a kind of bone prosthesis made by this bioactivity glass/polyether-ether-ketone composite material and preparation method thereof.This bio-vitric/polyether-ether-ketone composite material has good biological activity and biocompatibility, with osseous tissue, mechanical compatibility is preferably arranged, can stimulation of bone growth, and the accelerated bone healing, reduce the healing time after bone implant material, and have anti-microbial property.This bio-vitric/polyether-ether-ketone composite material simple for process, can prepare according to the preparation technology of corresponding this bio-vitric/polyether-ether-ketone composite material of adjustment of clinical demand the bone prosthesis of different shapes, specification and mechanical property.This bone prosthesis has good biocompatibility, biological activity, biomechanics of bone consistency and germ resistance, can shorten bone healing time, and its intensity is high, antifatigue, corrosion resistance are good, long service life.Reaction can not cause inflammation after this bone prosthesis implantation, and mechanical property and people's bone photo couplings such as its Young's modulus, toughness and breaking tenacity, the negative effects such as the loosening and bone resorption of the bone renovating material that can not cause stress shielding to cause, can meet the clinical needs of repairing for bone.
The present invention is achieved through the following technical solutions above-mentioned technique effect.
The invention provides a kind of preparation method of bio-vitric/polyether-ether-ketone composite material, it comprises the steps: raw material: bio-vitric powder and polyether-ether-ketone powder evenly mix, and obtain mixed powder; By described mixed powder machine-shaping, obtain; Wherein, the consumption of described bioactivity glass accounts for 20%~40% of raw material gross weight, and the consumption of described polyether-ether-ketone accounts for 60%~80% of raw material gross weight; The particle diameter of described bio-vitric powder is 5 μ m~20 μ m, and the particle diameter of described polyether-ether-ketone powder is 10 μ m~20 μ m.
Wherein, described bio-vitric can be the bio-vitric of this area routine, is preferably bio-vitric 45S5.
Wherein, the particle diameter of described bioactivity glass powder is preferably 10 μ m~12 μ m.
Wherein, the particle diameter of described polyether-ether-ketone powder is preferably 10 μ m~15 μ m.
Wherein, the method for described mixing and condition can be method and the condition of this area routine, to mix, are as the criterion.Described mixing is preferably carried out in mixing machine.
Wherein, the method for described machine-shaping and condition can be method and the condition of this area routine.Described machine-shaping is preferably injection moulding or molding sintering moulding.
The method of described injection moulding and condition can be method and the condition of this area routine.Described injection moulding is preferably carried out in injection moulding machine.The temperature of described injection moulding is preferably 360 ℃~380 ℃.The pressure of described injection moulding is preferably 30MPa~70MPa.
The method of described molding sintering moulding and condition can be method and the condition of this area routine.Described molding sintering moulding is preferably undertaken by following working method: by described mixed powder compression moulding, then heat up, sinter molding, get final product; The speed of described intensification is 2 ℃/min~4 ℃/min; The temperature of described sintering is 350 ℃~360 ℃; The soaking time of described sintering is 2 hours~3 hours, is preferably 2 hours.
In the present invention, the shape of the bio-vitric/polyether-ether-ketone composite material obtained after described machine-shaping is not limit.If the mould that in described machine-shaping, mould used is the bone prosthesis product, described bio-vitric/polyether-ether-ketone composite material can directly be used as bone prosthesis.If in described machine-shaping, mould used is not the mould of bone prosthesis product, can be by follow-up processing treatment operation, operations such as grinding, mechanical workout, to prepare the bone prosthesis of desired shape.
It is a kind of by the prepared bio-vitric/polyether-ether-ketone composite material of above-mentioned preparation method that the present invention also provides.
In the present invention, described bio-vitric/polyether-ether-ketone composite material is a kind of matrix material by the bio-vitric reinforced polyether ether ketone.
The present invention also provides the application of described bio-vitric/polyether-ether-ketone composite material in bone prosthesis.
Wherein, described bone prosthesis is spinal bone dummy or tooth implant.Described spinal bone dummy, also referred to as Invasive lumbar fusion device, comprises fusion device between strength Invasive lumbar fusion device and chest/lumbar vertebrae.
The present invention also provides a kind of preparation method of bone prosthesis, and it comprises the steps: raw material: bio-vitric powder and polyether-ether-ketone powder evenly mix, and obtain mixed powder; By the machine-shaping in the mould of bone prosthesis product of described mixed powder, obtain; Wherein, the consumption of described bioactivity glass accounts for 20%~40% of raw material gross weight, and the consumption of described polyether-ether-ketone accounts for 60%~80% of raw material gross weight; The particle diameter of described bio-vitric powder is 5 μ m~20 μ m, and the particle diameter of described polyether-ether-ketone powder is 10 μ m~20 μ m.
Wherein, described bio-vitric can be the bio-vitric of this area routine, is preferably bio-vitric 45S5.
Wherein, the particle diameter of described bioactivity glass powder is preferably 10 μ m~12 μ m.
Wherein, the particle diameter of described polyether-ether-ketone powder is preferably 10 μ m~15 μ m.
Wherein, the method for described mixing and condition can be method and the condition of this area routine, to mix, are as the criterion.Described mixing is preferably carried out in mixing machine.
Wherein, the mould of described bone prosthesis product is the conventional mould used while preparing the bone prosthesis product, is preferably the mould of spinal bone dummy or the mould of tooth implant.Described spinal bone dummy, also referred to as Invasive lumbar fusion device, comprises fusion device between strength Invasive lumbar fusion device and chest/lumbar vertebrae.
Wherein, the method for described machine-shaping and condition can be method and the condition of this area routine.Described machine-shaping is preferably injection moulding or molding sintering moulding.
The method of described injection moulding and condition can be method and the condition of this area routine.Described injection moulding is preferably carried out in injection moulding machine.The temperature of described injection moulding is preferably 360 ℃~380 ℃.The pressure of described injection moulding is preferably 30MPa~70MPa.
The method of described molding sintering moulding and condition can be method and the condition of this area routine.Described molding sintering moulding is preferably undertaken by following working method: by described mixed powder compression moulding, then heat up, sinter molding, get final product; The speed of described intensification is 2 ℃/min~4 ℃/min; The temperature of described sintering is 350 ℃~360 ℃; The soaking time of described sintering is 2 hours~3 hours, is preferably 2 hours.
In the present invention, in the preparation method of described bone prosthesis, after described machine-shaping, preferably also carry out the surface coarsening processing.Described surface coarsening is processed and preferably carried out in the steps below: use the surface coarsening machine, the block described machine-shaping obtained with bioglass particles carries out surface coarsening, the porous surface that is 100 μ m~600 μ m to described block surface formation aperture.The particle diameter of described bioglass particles is preferably 200 μ m~600 μ m.Described aperture is preferably 200 μ m~400 μ m.
The present invention also provides a kind of bone prosthesis made by above-mentioned preparation method.
Wherein, described bone prosthesis is spinal bone dummy or tooth implant.Described spinal bone dummy, also referred to as Invasive lumbar fusion device, comprises fusion device between strength Invasive lumbar fusion device and chest/lumbar vertebrae.
In the present invention, the shape of described bone prosthesis and specification can be according to actual needs by selecting different moulds to be changed.
In the present invention, the mechanical performance index that described bone is repaired is roughly as follows:
Young's modulus is 4GPa~6GPa, and ultimate compression strength is 117MPa~160GPa, and tensile strength is 76MPa~105MPa, and bending strength is 86MPa~115MPa.
On the basis that meets this area general knowledge, above-mentioned each optimum condition, but arbitrary combination obtains the preferred embodiments of the invention.
Agents useful for same of the present invention and raw material be commercially available obtaining all.
Positive progressive effect of the present invention is:
(1) this bio-vitric/polyether-ether-ketone composite material of the present invention is simple for process, can prepare according to the preparation technology of corresponding this bio-vitric/polyether-ether-ketone composite material of adjustment of clinical demand the bone prosthesis of different shapes, specification and mechanical property.
(2) adopt the surface coarsening technology to be processed the composite material molded body surface, form vesicular structure at composite material surface, osteocyte/osseous tissue is easily grown in the porous hole, use osseous tissue to form firmly and be combined with implant, the glass particle that surface exposes makes implant surfaces have germ resistance.
(3) bio-vitric/polyether-ether-ketone composite material of the present invention has good biological activity and biocompatibility, with osseous tissue, mechanical compatibility is preferably arranged, can stimulation of bone growth, the accelerated bone healing, healing time after the minimizing bone implant material, it has anti-microbial property (bio-vitric dissolves aobvious alkalescence, has germicidal action).
(4) bone prosthesis of the present invention has good biocompatibility, biological activity, biomechanics of bone consistency and germ resistance, can shorten bone healing time.Reaction can not cause inflammation after using this bone prosthesis to implant, and mechanical property and people's bone photo couplings such as its Young's modulus, toughness and breaking tenacity, the negative effects such as the loosening and bone resorption of the bone renovating material that can not cause stress shielding to cause, can meet the clinical needs of repairing for bone.
The accompanying drawing explanation
The shape picture of the bio-vitric used in the cytotoxicity test experiments that Fig. 1 is effect embodiment 2/polyether-ether-ketone composite material sample (Ф 10 * 2mm).
Fig. 2 is the bio-vitric that carries out cytotoxicity experiment in effect embodiment 2/polyether-ether-ketone composite material optical density(OD) figure.
The sample photo that Fig. 3 is bone prosthesis in effect embodiment 3 (embodiment 7 samples).
The surface topography SEM photo that Fig. 4 is bone prosthesis in effect embodiment 3 (embodiment 7 samples).
Fig. 5 be in effect embodiment 3 at dog femoral implantable bone dummy the macro morphology photo after 3 months.
Fig. 6 is that the bone prosthesis in effect embodiment 3 is implanted the tissue slice of the damaged place of dog femoral after 3 months.
Fig. 7 is at the gross examination of skeletal muscle photo of dog alveolus place implantable bone dummy (embodiment 3 samples) after March in effect embodiment 3.
Fig. 8 is that the bone prosthesis (embodiment 3 samples) in effect embodiment 3 is implanted the tissue slice of dog Alveolar Bone Defect place after 3 months.
The sample photo that Fig. 9 is the bone prosthesis (fusion device sample between vertebra) in embodiment 8.
The sample photo that Figure 10 is the bone prosthesis (tooth implant sample) in embodiment 3.
Embodiment
Mode below by embodiment further illustrates the present invention, but does not therefore limit the present invention among described scope of embodiments.The experimental technique of unreceipted actual conditions in the following example, according to ordinary method and condition, or select according to catalogue.
In following embodiment, bio-vitric powder and bioglass particles used are the 45S5 bio-vitric, purchased from Shanghai Inst. of Silicate, Chinese Academy of Sciences; .
Embodiment 1
The preparation method of bio-vitric/polyether-ether-ketone composite material, it comprises the steps:
By raw material: 2kg(20wt%) bio-vitric powder (particle diameter is 20 μ m) and 8kg(80wt%) polyether-ether-ketone powder (particle diameter is 10 μ m) in mixing machine, evenly mix, obtain mixed powder; Then with injection moulding machine by mixed powder injection moulding (using the mould of non-bone prosthesis product), obtain; Wherein, the temperature of injection moulding is 360 ℃; The pressure of injection moulding is 30MPa.The mechanical property of this bio-vitric/polyether-ether-ketone composite material is in Table 1.
Embodiment 2
The preparation method of bio-vitric/polyether-ether-ketone composite material, it comprises the steps:
By raw material: 3kg(30wt%) bio-vitric powder (particle diameter is 20 μ m) and 7kg(70wt%) polyether-ether-ketone powder (particle diameter is 10 μ m) carry out raw material evenly mix in mixing machine, obtain mixed powder; Then with injection moulding machine by mixed powder injection moulding (using the mould of non-bone prosthesis product), obtain; Wherein, the temperature of injection moulding is 380 ℃; The pressure of injection moulding is 70MPa.The mechanical property of this bio-vitric/polyether-ether-ketone composite material is in Table 1.
Embodiment 3
The preparation method of bone prosthesis, it comprises the steps:
By raw material: 4kg(40wt%) bio-vitric powder (particle diameter is 20 μ m) and 5kg(50wt%) polyether-ether-ketone powder (particle diameter is 10 μ m) carry out raw material evenly mix in mixing machine, obtain mixed powder; Then with injection moulding machine by mixed powder injection moulding in the mould of dog alveolar repair body, obtain; Wherein, the temperature of injection moulding is 370 ℃; The pressure of injection moulding is 50MPa.The mechanical property of this bone prosthesis is in Table 1.
Embodiment 4
The preparation method of bio-vitric/polyether-ether-ketone composite material, it comprises the steps:
By raw material: 2kg(20wt%) bio-vitric powder (particle diameter is 20 μ m) and 8kg(80wt%) polyether-ether-ketone powder (particle diameter is 10 μ m) carry out raw material evenly mix in mixing machine, obtain mixed powder; Then with mould by mixed powder compression moulding (using the mould of non-bone prosthesis product), then heat up in sintering oven, sinter molding, obtain; Wherein, sintering temperature is 350 ℃; The heat-up rate of sintering oven is 2 ℃/min; Soaking time is 2 hours.The mechanical property of this bio-vitric/polyether-ether-ketone composite material is in Table 1.
Embodiment 5
The preparation method of bio-vitric/polyether-ether-ketone composite material, it comprises the steps:
By raw material: 3kg(30wt%) bio-vitric powder (particle diameter is 20 μ m) and 7kg(70wt%) polyether-ether-ketone powder (particle diameter is 10 μ m) carry out raw material evenly mix in mixing machine, obtain mixed powder; Then with mould by mixed powder compression moulding (using the mould of non-bone prosthesis product), then heat up in sintering oven, sinter molding, obtain; Wherein, sintering temperature is 360 ℃; The heat-up rate of sintering oven is 4 ℃/min; Soaking time is 3 hours.The mechanical property of this bio-vitric/polyether-ether-ketone composite material is in Table 1.
Embodiment 6
The preparation method of bio-vitric/polyether-ether-ketone composite material, it comprises the steps:
By raw material: 4kg(40wt%) bio-vitric powder (particle diameter is 20 μ m) and 5kg(50wt%) polyether-ether-ketone powder (particle diameter is 10 μ m) carry out raw material evenly mix in mixing machine, obtain mixed powder; Then with mould by mixed powder compression moulding (using the mould of non-bone prosthesis product), then heat up in sintering oven, sinter molding, obtain; Wherein, sintering temperature is 355 ℃; The heat-up rate of sintering oven is 2 ℃/min; Soaking time is 2 hours.The mechanical property of this bio-vitric/polyether-ether-ketone composite material is in Table 1.
Embodiment 7
The preparation method of bone prosthesis, it comprises the steps:
Composition of raw materials and preparation method according to embodiment 1 are operated, in the mould of dog femoral dummy after injection moulding, carry out the operation of surface coarsening processing, specific as follows: as to use the surface coarsening machine, block with bioglass particles after to moulding carries out the surface coarsening processing, porous surface to described block surface formation aperture is 100 μ m~200 μ m, obtain bone prosthesis; Wherein, the particle diameter of bioglass particles is 200 μ m~300 μ m.After carrying out the surface coarsening processing, Fig. 4 is shown in by the scanning electron microscope of this bone prosthesis (SEM) photo.
Embodiment 8
The preparation method of bone prosthesis, it comprises the steps:
Composition of raw materials and preparation method according to embodiment 4 are operated, carry out the molding sintering moulding in the mould of fusion device product between vertebra after, carry out the operation of surface coarsening processing, specific as follows: as to use the surface coarsening machine, block with bioglass particles after to moulding carries out the surface coarsening processing, porous surface to described block surface formation aperture is 100 μ m~200 μ m, obtain bone prosthesis; Wherein, the particle diameter of bioglass particles is 200 μ m~300 μ m.Fig. 9 is shown in by the photo of this bone prosthesis.
Embodiment 9
The preparation method of bio-vitric/polyether-ether-ketone composite material, it comprises the steps:
By raw material: 2kg(20wt%) bio-vitric powder (particle diameter is 5 μ m) and 8kg(80wt%) polyether-ether-ketone powder (particle diameter is 20 μ m) in mixing machine, evenly mix, obtain mixed powder; Then with injection moulding machine by mixed powder injection moulding (using the mould of non-bone prosthesis product), obtain; Wherein, the temperature of injection moulding is 360 ℃; The pressure of injection moulding is 70MPa.The mechanical property of this bio-vitric/polyether-ether-ketone composite material is in Table 1.
Embodiment 10
The preparation method of bio-vitric/polyether-ether-ketone composite material, it comprises the steps:
By raw material: 2kg(20wt%) bio-vitric powder (particle diameter is 10 μ m) and 8kg(80wt%) polyether-ether-ketone powder (particle diameter is 15 μ m) carry out raw material evenly mix in mixing machine, obtain mixed powder; Then with mould by mixed powder compression moulding (using the mould of non-bone prosthesis product), then heat up in sintering oven, sinter molding, obtain; Wherein, sintering temperature is 355 ℃; The heat-up rate of sintering oven is 2 ℃/min; Soaking time is 2 hours.The mechanical property of this bio-vitric/polyether-ether-ketone composite material is in Table 1.
The comparative example 1
Raw material: 1kg bio-vitric powder (particle diameter is 20 μ m) and 9kg polyether-ether-ketone powder (particle diameter is 10 μ m), carry out the preparation of matrix material according to the preparation method of embodiment 1.The mechanical property of this matrix material is in Table 1.
The comparative example 2
Raw material: 2kg bio-vitric powder (particle diameter is 50 μ m) and 8kg polyether-ether-ketone powder (particle diameter is 10 μ m), carry out the preparation of matrix material according to the preparation method of embodiment 1.The mechanical property of this matrix material is in Table 1.
The comparative example 3
Raw material: 5kg bio-vitric powder (particle diameter is 20 μ m) and 5kg polyether-ether-ketone powder (particle diameter is 10 μ m), carry out the preparation of matrix material according to the preparation method of embodiment 1.The mechanical property of this matrix material is in Table 1.
Effect embodiment 1
Mechanical property test:
Bone prosthesis to embodiment 1~5 and comparative example 1~3 has carried out Mechanics Performance Testing, and test result is in Table 1.
The mechanical property of the bone prosthesis of table 1 embodiment 1~5
Figure BDA0000382896640000101
From table 1, compared to the prepared matrix material of comparative example, the Young's modulus of bio-vitric/polyether-ether-ketone composite material of the present invention and people's bone is more approaching, and the parameters index in mechanical property is more excellent, is very suitable for the equivalent material (bone and tooth) as human body hard tissue.
Effect embodiment 2
The cytotoxicity experiment of bio-vitric/polyether-ether-ketone composite material:
Bio-vitric/polyether-ether-ketone composite material that embodiment 1 and 4 is made carries out cytotoxicity experiment, and wherein sample diameter is 10mm, and thickness is 2mm, specifically sees Fig. 1.The concrete grammar of cytotoxicity experiment is as follows:
Biological safety according to ISO:10993-5 cytotoxicity standard testing matrix material.Under 37 ℃, two kinds of samples (200mg/mL) in serum-free cell culture medium soak 24 hours, filter to obtain vat liquor.With 3 * 10 2the concentration in/hole is inoculated into 96 hole tissue culturing plates by inoblast, after continuing to hatch 1 day, discards substratum, and PBS cleans 3 times; Add the vat liquor containing 10%FBS, continue to cultivate 1 day; Do not add containing the material vat liquor of 10%FBS as experiment blank group.While putting in the test duration, every hole adds 30 microlitre MTT solution, continues to hatch and cultivates after 4 hours, discards nutrient solution, PBS cleans 3 times, and every hole adds 100 microlitre DMSO, and room temperature is after standing 10 minutes, at 490nm wavelength place, survey the absorbance of solution by microplate reader, see Fig. 2.As seen from Figure 2, with blank (TCP of tissue culturing plate), compare, the absorbance of experimental group (embodiment 1 and 4 sample) does not have significant difference, shows that these two kinds of matrix materials do not have negative impact to fibroblastic growth.Known as calculated, the ratio of the cell survival rate of the cell in the material vat liquor and blank group, all more than 95%, proves that these two samples all do not have toxicity to inoblast.
Effect embodiment 3
Animal is implanted experiment:
(1) bone prosthesis of embodiment 7 prepared dog femorals (concrete shape is shown in Fig. 3) is implanted to the damaged place of dog femoral.Fig. 5 carries out for implanting the damaged place of dog femoral the photo that roughly observation post obtains after 3 months, the bone prosthesis of arrow points place for implanting.Fig. 6 is that this bone prosthesis is implanted the tissue slice of the damaged place of dog femoral after 3 months.In Fig. 6, long arrow represents the bonding interface of bone and embedded material, and M represents bone prosthesis, the new osseous tissue formed of B representative.As seen from Figure 6, this bone prosthesis and osseous tissue closely, in conjunction with growing together (bone integration), illustrate that this bone prosthesis has good biological activity and biocompatibility thus, can, as body implanting material, repair and the replacement bone tissue.Result shows, this bone prosthesis can promote the formation of osseous tissue and be grown in around bone prosthesis, and bone prosthesis forms firmly and is combined with osseous tissue.
(2) bone prosthesis in embodiment 3 (concrete shape is shown in Figure 10) is implanted to dog Alveolar Bone Defect place, Fig. 7 is the photomacrograph behind implantation Alveolar Bone Defect place, the bone prosthesis of arrow points place for implanting, combine to the soft or hard tissue tight of visible bone prosthesis and dog, repaired tooth damaged.
Fig. 8 is that the bone prosthesis of embodiment 3 is implanted the tissue slice of dog Alveolar Bone Defect place after 3 months.In Fig. 8, long arrow represents the bonding interface of bone and embedded material, and M represents bone prosthesis, the new osseous tissue formed of B representative.As seen from Figure 8, bone prosthesis and osseous tissue closely, in conjunction with growing together (bone integration), illustrate that this bone prosthesis has good biological activity and biocompatibility thus.Result shows, this bone prosthesis can promote the formation of osseous tissue and be grown in around bone prosthesis, and bone prosthesis forms firmly and is combined with osseous tissue.

Claims (10)

1. the preparation method of a bio-vitric/polyether-ether-ketone composite material, it comprises the steps: raw material: bio-vitric powder and polyether-ether-ketone powder evenly mix, and obtain mixed powder; By described mixed powder machine-shaping, obtain; Wherein, the consumption of described bioactivity glass accounts for 20%~40% of raw material gross weight, and the consumption of described polyether-ether-ketone accounts for 60%~80% of raw material gross weight; The particle diameter of described bio-vitric powder is 5 μ m~20 μ m, and the particle diameter of described polyether-ether-ketone powder is 10 μ m~20 μ m.
2. preparation method as claimed in claim 1, is characterized in that, described bio-vitric is bio-vitric 45S5; And/or the particle diameter of described bioactivity glass powder is 10 μ m~12 μ m; And/or the particle diameter of described polyether-ether-ketone powder is 10 μ m~15 μ m; And/or described being blended in mixing machine carried out; And/or described machine-shaping is injection moulding or molding sintering moulding.
3. preparation method as claimed in claim 2, is characterized in that, described injection moulding is carried out in injection moulding machine; The temperature of described injection moulding is 360 ℃~380 ℃; The pressure of described injection moulding is 30MPa~70MPa;
And/or described molding sintering moulding is undertaken by following working method: by described mixed powder compression moulding, then heat up, sinter molding, get final product; The speed of described intensification is 2 ℃/min~4 ℃/min; The temperature of described sintering is 350 ℃~360 ℃; The soaking time of described sintering is 2 hours~3 hours.
4. one kind by the prepared bio-vitric/polyether-ether-ketone composite material of the described preparation method of claim 1~3 any one.
5. the application of bio-vitric/polyether-ether-ketone composite material in bone prosthesis as claimed in claim 4.
6. the preparation method of a bone prosthesis, it comprises the steps: raw material: bio-vitric powder and polyether-ether-ketone powder evenly mix, and obtain mixed powder; By the machine-shaping in the mould of bone prosthesis product of described mixed powder, obtain; Wherein, the consumption of described bioactivity glass accounts for 20%~40% of raw material gross weight, and the consumption of described polyether-ether-ketone accounts for 60%~80% of raw material gross weight; The particle diameter of described bio-vitric powder is 5 μ m~20 μ m, and the particle diameter of described polyether-ether-ketone powder is 10 μ m~20 μ m.
7. preparation method as claimed in claim 6, is characterized in that, described bio-vitric is bio-vitric 45S5; And/or the particle diameter of described bioactivity glass powder is 10 μ m~12 μ m; And/or the particle diameter of described polyether-ether-ketone powder is 10 μ m~15 μ m; And/or described being blended in mixing machine carried out; And/or described machine-shaping is injection moulding or molding sintering moulding; And/or, the mould that the mould of described bone prosthesis product is the spinal bone dummy or the mould of tooth implant.
8. preparation method as claimed in claim 7, is characterized in that, described injection moulding is carried out in injection moulding machine; The temperature of described injection moulding is 360 ℃~380 ℃; The pressure of described injection moulding is 30MPa~70MPa;
And/or described molding sintering moulding is undertaken by following working method: by described mixed powder compression moulding, then heat up, sinter molding, get final product; The speed of described intensification is 2 ℃/min~4 ℃/min; The temperature of described sintering is 350 ℃~360 ℃; The soaking time of described sintering is 2 hours~3 hours.
9. preparation method as described as claim 6~9 any one, is characterized in that, after described machine-shaping, also carries out the surface coarsening processing; Described surface coarsening is processed and carried out in the steps below: use the surface coarsening machine, the block described machine-shaping obtained with bioglass particles carries out surface coarsening, the porous surface that is 100 μ m~600 μ m to described block surface formation aperture.
10. the bone prosthesis made as claim 6~9 any one preparation method.
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