CN102085389B - Preparation method of injectable bone repair material - Google Patents
Preparation method of injectable bone repair material Download PDFInfo
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Abstract
The invention provides a preparation method of an injectable bone repair material. The injectable bone repair material comprises alpha-calcium sulfate hemihydrate, bone meal particles, biodegradable polymers, a nucleating agent and a curing solution. After the injectable bone repair material is cured, the compression strength can reach about 30Mpa, the porosity can reach 43.7%, and the pore diameter can be as high as 20-100 micrometers. The curing time of the injectable bone materials is between 7 min and 125 min. Therefore, the injectable bone repair material provided by the invention is suitable for clinical application for minimally invasive bone repair.
Description
Technical field
The present invention relates to a kind of preparation method of Injectable bone repair material.
Background technology
Bone is damaged to be one of modal disease of clinical orthopaedics, can be caused by infection, wound, tumor and congenital diseases etc., and major part can not spontaneous recovery and need carry out bone and transplant.Along with increasing of aged tendency of population and various wounds, to the also sustainable growth of demand of biomedical material especially bone grafting material.A lot of material and compositionss natural and that synthesize have been used to the damaged treatment of bone.
Be considered to for a long time the most effective bone renovating material from the body spongy bone, because it has osteoinductive and non-immunogenic simultaneously always.Yet because its source is not enough, intraoperative blood loss increases and postoperative complication etc. is asked unfavorable factor, limited application clinically.
Homogeneous allogenic bone and xenogenesis bone are present the most frequently used bone implant materials, and its clinical indication is very extensive, and the scope of application can comprise the indication of the bone implant material of nearly all classification.Studies show that in a large number the reparation degree of homogeneous allogenic bone transplantation is relevant with the bone graft size, the clinical success effect that particulate cancellous bone is transplanted and success rate all are higher than large block bone and transplant.This mainly is because particulate cancellous bone has better skeletonization effect than block bone.Particulate cancellous bone has been widely used in revision of total hip arthroplasty, cervical spinal fusion etc. at present.Yet simple particulate cancellous bone transplant structure is loose, and the shortcoming of easy-formation is not used separately and caused easily the complication such as granule migration, displacement, pressuring nerve, affects its bone repair ability and effect, has limited to a certain extent the clinical practice of particulate cancellous bone yet.
For a large amount of irregular bones that exist are damaged clinically, traditional bone renovating material needs external pre-formed, implants through behind the surgical incision, and patient need bear operation wound, and this mode wound is larger, and filling bone is damaged fully.In recent years, be accompanied by the development of minimally invasive surgery, the application of Injectable self-curable material has overcome this problem.Under accurate location of operation, injection material only needs small wound can arrive the bone defect, in certain hour, solidify and reach suitable mechanical strength, stimulate new osteogenesis or for osteoblast provides good support, self then gradually degraded in the defect repair process.
At present, calcium sulfate has obtained widely research and clinical practice as Injectable bone repairing material.Modern surgery level calcium sulfate provides higher initial strength and good injection operation character.Yet, adopt merely the aperture of calcium sulfate material and porosity and be unfavorable for osteoblastic moving into and angiogenesis.Therefore need a kind of Injectable bone repair material that combines the character such as suitable porosity, aperture, intensity.
Summary of the invention
Little in order to solve in the prior art calcium sulfate material aperture and porosity, be unfavorable for that osteoblast is grown into and the problem of angiogenic growth, the invention provides a kind of preparation method of Injectable bone repair material, described Injectable bone repair material comprises α-half-H 2 O calcium sulphate, the bone meal granule, biodegradable polymer and nucleator, described method comprises step: after each composition of described Injectable bone repair material is fully mixed, add consolidation liquid, make described consolidation liquid and described Injectable bone repair material evenly compound, the ratio of wherein said consolidation liquid and described Injectable bone repair material is 0.4～0.8ml consolidation liquid: the 1g Injectable bone repair material.Owing to contain the bone meal granule, not only improved the biocompatibility of this bone renovating material, go back so that porosity and the aperture of this Injectable bone repair material after solidifying is significantly improved.For example, its porosity can reach 23-38%, even 25.4-43.7%; Its aperture can reach the 2-18 micron, even the 20-100 micron; Its comprcssive strength can reach 4-30MPa.
Injectable bone repair material of the present invention needs to add consolidation liquid in use.This area consolidation liquid commonly used includes but not limited to: normal saline, water for injection, glucose injection etc.Those skilled in the art also can select other consolidation liquid as required.The ratio of wherein said consolidation liquid and described Injectable bone repair material is 0.4～0.8ml consolidation liquid: the 1g Injectable bone repair material.The described solid material of consolidation liquid and Injectable bone repair material is mixed into after the pastes with suitable viscosity, can uses the instruments such as syringe to use with injection system.By the ratio of adjusting component, material of the present invention can have more flexibly injectable time and hardening time.For example, the injectable time of Injectable bone repair material of the present invention generally in 5 minutes-94 minutes, hardening time generally at 7 minutes in 125 minutes.The scalable of wide region has increased the motility of use hardening time.
In one embodiment, the content of α-half-H 2 O calcium sulphate accounts for the 50-90% of the solid amount of described Injectable bone repair material by weight, preferred 60-85%.
In another embodiment, the content of bone meal granule can account for the 5-45% of the solid amount of described Injectable bone repair material by weight, preferred 10-35%.The particle diameter of bone meal granule can be in the scope of 0.05mm-1mm, between the preferred 0.3mm-0.5mm.Bone meal can be selected homogeneous allogenic bone or xenogenesis bone.Have suitable porosity and aperture after the material cured, and form three-dimensional net structure, be conducive to growing into of osteoblastic growth and new vessels, and the adding of bone meal has strengthened its biocompatibility and bone-inducting active.
In another embodiment, the content of biodegradable polymer be no more than described Injectable bone repair material solid amount 5%, preferably be no more than 2%.The biodegradable polymer includes but not limited to hyaluronic acid, chitosan, alginate, carboxymethyl cellulose, octadecanoid acid, polysaccharide etc.The biodegradable polymer can partly consist of the support of material of the present invention, so that suitable network structure to be provided.Because its degradability can be grown into along with osteoblastic, progressively degraded is for new bone formation is reserved enough spaces simultaneously.
In another embodiment, the content of nucleator be no more than described Injectable bone repair material solid amount 8%, preferably be no more than 2%.Nucleator can be selected from least a in calcium sulphate dihydrate, potassium sulfate and the sodium sulfate, but is not limited to this, the nucleator that those skilled in the art can be suitable according to this area knowledge-chosen.
In another embodiment, Injectable bone repair material of the present invention can further comprise plasticiser.Described plasticiser is selected from least a in hyaluronic acid and salt, calcium sulphate dihydrate, cellulose and derivant thereof, octadecanoid acid, the glycerol, preferably carboxymethyl cellulose.Can be used for plasticiser of the present invention and be not limited to this, the plasticiser that those skilled in the art can be suitable according to this area knowledge-chosen.Under the condition of not adding plasticiser, the porosity after described Injectable bone repair material solidifies is between 23-38%, and the aperture is between the 2-18 micron.After adding plasticiser, the porosity after the curing can reach between the 25.4-43.7%, and the aperture can reach between the 20-100 micron.
The specific embodiment
The invention provides a kind of multi-element composite material that mainly is comprised of calcium sulfate and granule bone meal, described particulate composition is applicable to mix with solution formation injectable, quick-setting bone renovating material.All components in the Injectable bone repair material of the present invention has all confirmed it is the good degradation material of biocompatibility.Compare with present use or the injectable bone repair materials reported, distinguishing feature of the present invention is: 1. have suitable pore diameter and porosity after the material cured, form three-dimensional net structure, be conducive to osteoblastic moving into and the growing into of new vessels, 2. material has more suitable degradation rate, 3. has suitable injectable time, hardening time and comprcssive strength.
The bone renovating material of injectable of the present invention and self-curing forming, mainly the powder by α-half-H 2 O calcium sulphate, bone meal granule is formed, and contains simultaneously a small amount of biodegradable polymer and nucleator.α in the Injectable bone repair material-half-H 2 O calcium sulphate quality accounts for 50%～90% of gross mass, more preferably ratio is 60%～85% of Injectable bone repair material gross mass, the bone meal granule accounts for 5%～45% of gross mass, and more preferably ratio is 10%～35% of Injectable bone repair material gross mass.All the other are biodegradable polymer and nucleator, and wherein the biodegradable polymer quality ratio that accounts for the Injectable bone repair material gross mass is no more than 5%, and ideal ratio is no more than 2%; The ratio that the nucleator quality accounts for the Injectable bone repair material gross mass is no more than 8%, and ideal ratio is no more than 5%.
Said bone meal granule in the above-mentioned Injectable bone repair material can be selected from spongy bone granule, cortical bone granule or the spongy bone and the cortical bone hybrid particles that comprise allogeneic, pig or Niu Laiyuan.The diameter general control of bone meal granule is between 0.05mm～1mm, and ideal particle diameter is controlled between 0.3mm～0.5mm.
The use of the Injectable bone repair material of Injectable self-curable of the present invention, that described pulverous Injectable bone repair material and the curing solution ratio with 0.4～0.8ml/g (liquid-solid ratio) fully is in harmonious proportion, become reach meet the pasty state Injectable bone repair material body with suitable viscosity that injection requires after, namely the instrument such as available corresponding syringe uses with injection system.Said consolidation liquid wherein, can be selected from clinical in any in widely used sodium chloride injection, water for injection or the glucose injection.
The result of experiment shows that the presetting period of Injectable bone repair material of the present invention (injectable time), final setting time (hardening time) was generally between 7min～125min generally between 5min～94min.One of most important physical property that above-mentioned two time index are syringeability bone material too short or oversizely all is unfavorable for the carrying out of performing the operation.The injectable time of Injectable bone repair material and hardening time can be by changing α-half-H 2 O calcium sulphate and ratio, increase or the minimizing plasticiser of bone meal granule in the Injectable bone repair material consumption, interpolation or do not add the mode such as nucleator component and adjust accordingly.For example, increase the content of the calcium sulfate in the Injectable bone repair material, can reduce injectable and hardening time, the increase plasticiser then makes and prolongs injectable and hardening time 5～10 times in Injectable bone repair material, in order to adjust this two time index, make it to satisfy the needs of clinical practice, can adjust by the mode that increases nucleator.Experimental result is presented at adds nucleator when increasing plasticiser, can make all General Requirements of compound clinical practice of two time index.
The result that experiment detects shows that the comprcssive strength after described Injectable bone repair material solidifies can reach 4～30MPa, surpasses or be equal to the comprcssive strength of human body spongy bone.The comprcssive strength of the granularity of bone meal after for material cured has obvious impact, and the diameter of general bone meal granule is between 0.3～0.5mm the time, and the comprcssive strength after the material cured is best, can reach about 30MPa.Add plasticiser and can reduce comprcssive strength after the material cured to 16MPa.
The result that experiment detects shows that under the condition of not adding plasticiser, the porosity after described Injectable bone repair material solidifies is between 23～38%, and pore diameter is between 2～18 microns.Under the condition of adding plasticiser, the porosity after described Injectable bone repair material solidifies is between 25.4～43.7%, and pore diameter is between 20～100 microns.
Hereinafter specify in conjunction with the embodiments preferred implementation of the present invention.
Embodiment 1
1) grinding of homogeneous allogenic bone powder particles with sieve
With the bone meal cryogrinding, cross successively 75 orders and 150 eye mesh screens, screening obtains average diameter at the bone meal granule of 0.1～0.2mm, and the vacuum seal transparent complex pocket of packing into is for subsequent use with the gamma-radiation sterilization of 25kGy again.
2) preparation of α-half-H 2 O calcium sulphate/compound injectable materials of homogeneous allogenic bone powder particles binary
α-half-H 2 O calcium sulphate is mixed according to mass ratio with the homogeneous allogenic bone powder particles at 4: 1, and with magnetic stirring apparatus stirring at room 30 minutes.After stirring, according to the 0.5ml/g liquid-solid ratio, fully be in harmonious proportion 1 minute with distilled water and pressed powder.Can obtain the injectable bone renovating material of Wicresoft, its injectable time is 17 minutes, and be 25 minutes hardening time.Comprcssive strength reaches 30MPa.But its porosity only is 36%, and pore size is at 2～20 microns.
Embodiment 2
1) grinding of homogeneous allogenic bone powder particles with sieve
With the bone meal cryogrinding, cross successively 75 orders and 150 eye mesh screens, screening obtains average diameter at the bone meal granule of 0.1～0.2mm, and the vacuum seal transparent complex pocket of packing into is for subsequent use with the gamma-radiation sterilization of 25kGy again.
2) preparation of consolidation liquid
Dispose 2.5% hyaluronic acid solution with distilled water, stir homogeneous and be placed on 37 ℃ of water-baths 2 hours, in addition the abundant swelling of hyaluronic acid solution.
3) preparation of α-half-H 2 O calcium sulphate/homogeneous allogenic bone powder particles/hyaluronic acid tri compound injectable materials
α-half-H 2 O calcium sulphate is mixed according to mass ratio with the homogeneous allogenic bone powder particles at 4: 1, and with magnetic stirring apparatus stirring at room 30 minutes.After stirring, according to the 0.4ml/g liquid-solid ratio, fully be in harmonious proportion 1 minute with hyaluronic acid solution and pressed powder.Can obtain the injectable bone renovating material of Wicresoft, its porosity is 47%, pore size is between 70～150 microns.But the injectable time is 87 minutes, and be 110 minutes hardening time.Comprcssive strength reaches 14MPa.
Embodiment 3
1) grinding of homogeneous allogenic bone powder particles with sieve
With the bone meal cryogrinding, cross successively 75 orders and 150 eye mesh screens, screening obtains average diameter at the bone meal granule of 0.1～0.2mm, and the vacuum seal transparent complex pocket of packing into is for subsequent use with the gamma-radiation sterilization of 25kGy again.
2) preparation of consolidation liquid
Dispose 2.5% hyaluronic acid solution with normal saline, stir homogeneous and be placed on 37 ℃ of water-baths 2 hours, in addition the abundant swelling of hyaluronic acid solution.
3) preparation of α-half-H 2 O calcium sulphate/homogeneous allogenic bone powder particles/hyaluronic acid tri compound injectable materials
α-half-H 2 O calcium sulphate is mixed according to mass ratio with the homogeneous allogenic bone powder particles at 4: 1, add again 2% calcium sulphate dihydrate, and with magnetic stirring apparatus stirring at room 30 minutes.After stirring, according to the 0.4ml/g liquid-solid ratio, fully be in harmonious proportion 1 minute with hyaluronic acid solution and pressed powder.Can obtain the injectable bone renovating material of Wicresoft, its porosity is 45%, pore size is between 70～150 microns.But the injectable time is 19.2 minutes, and be 27.4 minutes hardening time.Comprcssive strength reaches 18MPa.
Comparative Examples 1
Prepare bone renovating material with the method identical with embodiment 1, just wherein do not add bone meal.
Porosity with the material of the method preparation is 17%, and the aperture is 1～15 micron, and the injectable time is 3 minutes, and be 15 minutes hardening time.Comprcssive strength is 35MPa.
Comparative Examples 2
Prepare bone renovating material with the method identical with embodiment 2, just do not add hyaluronic acid in the consolidation liquid.Porosity with the material of the method preparation is 31%, and the aperture is 2～20 microns, and the injectable time is 19 minutes, and be 24 minutes hardening time.Comprcssive strength is 30MPa.
Comparative Examples 3
Prepare bone renovating material with the method identical with embodiment 3, just wherein do not add calcium sulphate dihydrate.
Porosity with the material of the method preparation is 49%, and the aperture is 70～160 microns, and the injectable time is 85 minutes, and be 107 minutes hardening time.Comprcssive strength is 16MPa.
By the above results as seen, the adding of bone meal has significantly increased porosity, hyaluronic adding significant prolongation injectable time and hardening time, injectable time and hardening time have then been shortened in the adding of calcium sulphate dihydrate, have accelerated solidification process.The present invention has utilized hyaluronic acid and calcium sulphate dihydrate simultaneously, and by regulating the consumption of hyaluronic acid and calcium sulphate dihydrate, so that Injectable bone repair material of the present invention not only has more suitable porosity, aperture and comprcssive strength, also have scope is wider, can regulate as required injectable time and hardening time.
Although the present invention has been described in conjunction with specific embodiments; but it will be recognized by one of ordinary skill in the art that; the above only is preferred embodiment of the present invention; not in order to limit the present invention; within the spirit and principles in the present invention all; any modification of making, be equal to replacement, improvement etc., all should be included within the scope of protection of the invention.
Claims (1)
1. the preparation method of an Injectable bone repair material, described Injectable bone repair material comprises α-half-H 2 O calcium sulphate, bone meal granule, biodegradable polymer and nucleator, described method comprises step:
1) grinding of homogeneous allogenic bone powder particles with sieve
With the bone meal cryogrinding, cross successively 75 orders and 150 eye mesh screens, screening obtains average diameter at the bone meal granule of 0.1～0.2mm, and the vacuum seal transparent complex pocket of packing into is for subsequent use with the gamma-radiation sterilization of 25kGy again;
2) preparation of consolidation liquid
Dispose 2.5% hyaluronic acid solution with normal saline, stir homogeneous and be placed on 37 ℃ of water-baths 2 hours, make the abundant swelling of hyaluronic acid solution;
3) preparation of α-half-H 2 O calcium sulphate/homogeneous allogenic bone powder particles/hyaluronic acid tri compound injectable materials
α-half-H 2 O calcium sulphate is mixed according to mass ratio 4:1 with the homogeneous allogenic bone powder particles, add again 2% calcium sulphate dihydrate, and with magnetic stirring apparatus stirring at room 30 minutes; After stirring, according to the 0.4ml/g liquid-solid ratio, fully be in harmonious proportion 1 minute with hyaluronic acid solution and pressed powder; Can obtain the injectable bone renovating material of Wicresoft.
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| CN102989043A (en) * | 2012-12-21 | 2013-03-27 | 上海纳米技术及应用国家工程研究中心有限公司 | Preparation method of bone cement porous scaffold by taking carbonate or hydrocarbonate as solid foaming agent |
| CN102989042A (en) * | 2012-12-21 | 2013-03-27 | 上海纳米技术及应用国家工程研究中心有限公司 | Injectable porous bone cement and preparation method thereof |
| CN104208747B (en) * | 2014-09-25 | 2016-04-13 | 佛山市乙太医疗用品有限公司 | A kind of bone renovating material and preparation and application thereof |
| CN106581774A (en) * | 2016-12-09 | 2017-04-26 | 苏州纳贝通环境科技有限公司 | Injectable bone repairing material and preparation method thereof |
| CN106474542A (en) * | 2016-12-29 | 2017-03-08 | 黄志峰 | A kind of injectable bone substitution material and its preparation method and application |
| CN107050514A (en) * | 2017-01-09 | 2017-08-18 | 中关村竞成细胞及组织工程研究院 | Injectable bone graft materials |
| CN110314251B (en) * | 2018-03-30 | 2022-04-05 | 北京纳通医学科技研究院有限公司 | Composite bone repair material and preparation method thereof |
| CN116036362B (en) * | 2023-02-23 | 2024-05-24 | 山东大学 | Sea squirt nanocellulose/calcium sulfate bone supporting material and preparation method thereof |
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