CN106421929A - Injectable calcium phosphate/natural polymer composite material and preparation method and application thereof - Google Patents
Injectable calcium phosphate/natural polymer composite material and preparation method and application thereof Download PDFInfo
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- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
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- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
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- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
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- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
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Abstract
The invention discloses an injectable calcium phosphate/natural polymer composite material. The injectable calcium phosphate/natural polymer composite material is an injectable paste material formed by uniformly dispersing approximately spherical calcium phosphate ceramic particles with the particle size of 20-100 microns in a natural polymer (or its derivative) solution, wherein calcium phosphate is hydroxyapatite or diphasic calcium phosphate, 0-20% of bioactive glass can be added, the natural polymer or its derivative is one or more of sodium hyaluronate, collagen, chitosan, chondroitin sulfate and the like. The invention further discloses a preparation method of an injectable calcium phosphate/natural polymer composite material and a method for performing facial mini-plastic surgery by adopting the method. After the injectable calcium phosphate/natural polymer composite material is implanted in a body by adopting the method, a natural polymer in the material is degraded and absorbed, the calcium phosphate ceramic particles are fused with an autologous bone tissue together, a lasting shaping effect can be achieved, and clinical application prospect is good.
Description
Technical field
The present invention relates to a kind of injectable calcium phosphate/natural high molecular composite material and its preparation method and application, belong to
Biomedical materials field.
Background technology
According to statistics, the cranium jaw thin-skinned sclerous tissueses deformity that the whole world is caused because of congenital malformation, tumor resection, vehicle accident etc. every year
Or defect increases patient numbers newly and surpasses 1,000,000, and the number having facial plasty beauty treatment demand even more cannot count.
Since liquid paraffin in 1899 is used for clinic first as skin soft tissue filler, countries in the world scholar is to note
Penetrate packing material and its clinical practice has made intensive studies, and achieve multinomial progress, increasing injection fillers agent quilt
It is widely used in the fields such as Skin cosmesis and plastic surgery, in the hope of body configuration's defect and deformity are corrected by the method for injection.
Facial plasty beauty treatment material in the market based on filler, including autologous adipose tissue transplanting, natural
Or the biomaterial of synthetic.Autologous fat transplantation has preferable effect, but the survival rate of fat is still low and unstable,
Generally require second operation to correct.Natural or synthetic filler mainly includes degradable biomaterial (collagen, thoroughly
Bright matter acid sodium, polylactic acid, hydroxyapatite, polyvinyl alcohol etc.), non-degradable biomaterial (silica gel, polyacrylamide, poly- alkyl
Amide etc.) and their complex (polymethyl methacrylate+collagen, hydroxyethyl methylacrylate+hyaluronate sodium
Deng).Then there are some potential risks in non-degradable biomaterial, such as foreign body granuloma, dislodgment etc., when a problem occurs not
Easily take out, thus bringing great injury to patient；Degradable biomaterial has higher biological safety, but absorbs fast, dimension
Time of holding is short, recovers original state it is difficult to maintain plasticity effect for a long time typically in 0.5-1；Composite biomaterial can be fitted
Degree prolongation is held time, and is clinically good selection, but there is also some problems, such as produces granuloma etc..
, with the increasingly extensive shortcoming exposing them of application, some tissue reactions are relatively for these above-mentioned packing materials
Weight, some degradation speeds quickly, are far from reaching preferable effect.
Content of the invention
In order to solve the above problems, the invention provides a kind of new facial micro-shaping material, its for injectable calcium phosphate/
Natural high molecular composite material, can be, in fill to special syringe, to be implanted to this material direct injection by medical blunt needle
Face needs shaping or moulding position, the progressively degraded and absorbed of the natural polymer in material after certain time, and calcium phosphate ceramic
Grain is gradually combined together with autologous bone, and then reaches persistently moulding effect.
Injectable calcium phosphate/natural high molecular composite material of the present invention, it be containing calcium phosphate and natural polymer or its
The complex of derivant, wherein, natural polymer or derivatives thereof is hyaluronate sodium, collagen, shitosan, in chondroitin sulfate
One or more.
Wherein, described calcium phosphate is subsphaeroidal hydroxyapatite or the two-phase phosphoric acid being added with 0-20% bioactivity glass
Calcium (complex of hydroxyapatite and the biphase composition of tricalcium phosphate) ceramic particle, its particle diameter is 20-100 μm.
Wherein, described calcium phosphate is the biphasic calcium phosphate ceramic particles being added with 5-10% bioactivity glass, its particle diameter
For 20-40 μm.
Wherein, described modified natural polymer is hyaluronate sodium, collagen, shitosan, chondroitin sulfate through appropriatenessization
Learn modified acquisition, there is good biocompatibility and the viscosity flow characteristic of appropriateness.
Wherein, described injectable calcium phosphate/natural high molecular composite material is paste, the wherein solid content of calcium phosphate
For 60-90 (w/w) %, the solid content of natural polymer or derivatives thereof is 0.05-1.0 (w/w) %, and remaining is water.
Wherein, the solid content of described calcium phosphate ceramic granule is 65-75 (w/w) %, natural polymer or derivatives thereof
Solid content be 0.1-0.6 (w/w) %, remaining be water.
Present invention also offers the preparation method of aforementioned injectable calcium phosphate/natural high molecular composite material, specifically include
Following steps：
1) natural polymer or derivatives thereof is configured to be suitable for the aqueous solution of viscosity；
2) the calcium phosphate ceramic granule containing bioactivity glass for the preparation：By hydroxyapatite (or biphasic calcium phosphate) micropowder and
Bioactivity glass micropowder is distributed in the polyvinyl alcohol water solution of concentration 0.5-1.5%, proceeds in ball mill and carries out ball milling, obtains
To slurry, then this slurry is delivered in spray dryer by peristaltic pump carries out spray drying treatment, collect spray drying powder
And sinter at 600-1100 DEG C, then after standard sub-sieve is to sintering, powder body sieves, and obtaining particle diameter is 20-100 μ
The calcium phosphate ceramic granule containing bioactivity glass of m；
3) weigh step 2) the calcium phosphate ceramic granule that obtains, it is added to step 1) natural polymer that obtains or it is derivative
In the aqueous solution of thing, it is sufficiently stirred for making solid particle dispersed in the solution, obtain required paste complex；
4) by step 3) calcium phosphate/natural polymer paste complex of obtaining irrigated to syringe by filling apparatus
In, sterilization treatment, obtain required injectable calcium phosphate/natural high molecular composite material product.
Present invention also offers aforementioned injectable calcium phosphate/natural high molecular composite material answering in facial micro-shaping
With.
Present invention also offers a kind of method of face micro-shaping, step is as follows：Take aforementioned injectable calcium phosphate/natural height
Molecular composite material, implantation face needs between soft tissue and the periosteum at shaping position, you can.
Wherein, the method for implantation is injection.
Injectable calcium phosphate/natural high molecular composite material of the present invention, is implanted certain time using the inventive method
Afterwards, natural polymer therein is degraded and absorbed, and calcium phosphate ceramic granule and autologous osseous tissue gradually combine together, permissible
Reach persistently moulding effect, and granule no substantially migration and displacement, moulding respond well, potential applicability in clinical practice is good.
Below by specific embodiment, the present invention is described in further details, but is not the limit to the present invention
System, according to the above of the present invention, according to ordinary technical knowledge and the customary means of this area, above-mentioned without departing from the present invention
Modification, replacement or the change of other various ways under the premise of basic fundamental thought, can also be made.
Brief description
Fig. 1 injectable calcium phosphate/natural high molecular composite material sample；
Fig. 2 injectable calcium phosphate/tissue section strain after 3 months for the natural high molecular composite material animal et al. Ke divides
Analysis.
Specific embodiment
The preparation of embodiment 1 injectable calcium phosphate/hyaluronate sodium composite of the present invention
1st, preparation method
1) hyaluronate sodium (molecule of 1,4- butanediol glycidyl ether (BDDE) modified (modification degree 6-10%) of learning from else's experience
Amount 1000kDa, Shandong Bloomage Freda Biopharm Co., Ltd.) derivant is configured to the aqueous solution of 10ml 2.5%；
2) take the hydroxylapatite ceramic granule of 70-100 μm of 15g particle diameter, be added in above-mentioned sodium hyaluronate solution and stir
Mix uniformly, (solid content 60 (w/w) % of calcium phosphate ceramic granule, the solid content of hyaluronate sodium is 1.0 to form paste complex
(w/w) %)；
The preparation of the hydroxylapatite ceramic granule of 70-100 μm of particle diameter：Hydroxyapatite micropowder is distributed to 1.5% gather
In vinyl alcohol aqueous solution, it is transferred to ball milling 24 hours in ball mill, form the good slurry of particle dispersion, defeated by peristaltic pump
Deliver to and in spray dryer, carry out spray drying treatment, collect spray drying powder and sinter at 1100 DEG C, then use standard scores sample
Sieve carries out screening process to powder body after sintering, obtains the subsphaeroidal hydroxylapatite ceramic granule of mean diameter 70-100 μm.
3) by above-mentioned paste complex fill to syringe, sterilization treatment, obtain injectable calcium phosphate/hyaluronate sodium
Composite product (accompanying drawing 1).
The preparation of embodiment 2 injectable calcium phosphate/collagen composite materials of the present invention
1st, preparation method
1) medical collagen is taken to be configured to the aqueous solution of 10ml 1.0%；
2) biphasic calcium phosphate ceramic particles (hydroxyapatite/tricalcium phosphate=70/30) that 30g particle diameter is 40-70 μm are taken,
It is added in above-mentioned collagen solution and stirs, (solid content of calcium phosphate ceramic granule is 75 (w/ to form paste complex
W) %, the solid content of collagen is 0.25 (w/w) %)；
The preparation of the biphasic calcium phosphate ceramic particles of 40-70 μm of particle diameter：Biphasic calcium phosphate micropowder is distributed to 1.0% poly- second
In enol aqueous solution, it is transferred to ball milling 24 hours in ball mill, form the good slurry of particle dispersion, conveyed by peristaltic pump
Carry out spray drying treatment to spray dryer, collect spray drying powder and sinter at 800 DEG C, then use standard sub-sieve pair
After sintering, powder body carries out screening process, obtains the subsphaeroidal biphasic calcium phosphate ceramic particles that particle diameter is 40-70 μm.
3) by above-mentioned paste complex fill to syringe, sterilization treatment, obtain injectable calcium phosphate/collagen composite wood
Material products.
The preparation of embodiment 3 injectable calcium phosphate/hyaluronate sodium-chondroitin sulfate composite of the present invention
1st, preparation method
1) hyaluronate sodium (molecular weight 500kDa, Shandong Bloomage Freda Biopharm Co., Ltd.) and chondroitin sulfate are taken
It is water-soluble that plain (Shanghai Aladdin Reagent Company) is configured to the mixing containing 1.5% hyaluronate sodium and 0.5% chondroitin sulfate for the 10ml
Liquid；
2) 30g particle diameter is taken to be 20-40 μm containing 5% bioactivity glass (45S5 bio-vitric, Kunshan overseas Chinese science and technology green wood
Material company limited) hydroxylapatite ceramic granule, be added in above-mentioned hyaluronate sodium-chondroitin sulfate mixed solution stirring
Uniformly, (solid content of calcium phosphate ceramic granule is 75 (w/w) %, hyaluronate sodium and chondroitin sulfate to form paste complex
Solid content be 0.5 (w/w) %)；
The preparation of the hydroxylapatite ceramic granule containing 5% bioactivity glass：Hydroxyapatite micropowder and biology are lived
Property glass micro mist according to 95/5 ratio mixing after be distributed in 0.5% polyvinyl alcohol water solution, be transferred to ball milling in ball mill
24 hours, form the good slurry of particle dispersion, be delivered in spray dryer by peristaltic pump and carry out spray drying treatment,
Collect spray drying powder to sinter at 1000 DEG C, then with standard sub-sieve, screening process are carried out to powder body after sintering, obtain grain
The subsphaeroidal hydroxylapatite ceramic granule containing 5% bioactivity glass in about 20-40 μm of footpath.
3) by above-mentioned paste complex fill to syringe, sterilization treatment, obtain injectable calcium phosphate/hyaluronic acid
Sodium-chondroitin sulfate composite product.
The preparation of embodiment 4 injectable calcium phosphate/hyaluronate sodium composite of the present invention
1st, preparation method
1) hyaluronate sodium (molecular weight 500kDa, Shandong Bloomage Freda Biopharm Co., Ltd.) is taken to be configured to 10ml
0.5% aqueous solution of sodium hyaluronate；
2) take 90g particle diameter be 20-40 μm containing 10% bioactivity glass, (45S5 bio-vitric, Kunshan overseas Chinese science and technology is new
Materials Co., Ltd) hydroxylapatite ceramic granule, be added in above-mentioned hyaluronate sodium mixed solution and stir, formed
(solid content of calcium phosphate ceramic granule is 90 (w/w) % to paste complex, and the solid content of hyaluronate sodium is 0.05 (w/
W) %)；
The preparation of the hydroxylapatite ceramic granule containing 5% bioactivity glass：Hydroxyapatite micropowder and biology are lived
Property glass micro mist according to 95/5 ratio mixing after be distributed in 0.5% polyvinyl alcohol water solution, be transferred to ball milling in ball mill
24 hours, form the good slurry of particle dispersion, be delivered in spray dryer by peristaltic pump and carry out spray drying treatment,
Collect spray drying powder to sinter at 1000 DEG C, then with standard sub-sieve, screening process are carried out to powder body after sintering, put down
The subsphaeroidal hydroxylapatite ceramic granule containing 5% bioactivity glass of equal about 20-40 μm of particle diameter.
3) by above-mentioned paste complex fill to syringe, sterilization treatment, obtain injectable calcium phosphate/hyaluronate sodium
Composite product.
Prove beneficial effects of the present invention with the mode of experimental example below：
The repairing effect experiment of experimental example 1 composite of the present invention
1st, experimental technique
Injectable calcium phosphate/natural high molecular composite material the product of Example 3 preparation, by medical blunt needle after sterilizing
This ointment material is injected between leg muscle and the femur periosteum of implantation new zealand white rabbit, form local eminence, whole
Observation period is implanted into the no obvious inflammatory reaction in position, and rabbit mobility is good.March after implantation, measurement local ridge height
With volume no significant change.Put to death animal further to draw materials, after fixing embedding, carry out tissue slice analysis.
2nd, experimental result
Experimental result, as shown in Fig. 2 there being obvious tissue to grow between solid particle, has preferable fusion with host bone, and
Granule no substantially migration and displacement, shows good moulding effect.
Experimental result illustrates, injectable calcium phosphate/natural high molecular composite material of the present invention, using the inventive method implantation
After internal, natural polymer therein is degraded and absorbed, and calcium phosphate ceramic granule and autologous bone tissue fusion are integrated, permissible
Reach persistently moulding effect, potential applicability in clinical practice is good.
Claims (10)
1. a kind of injectable calcium phosphate/natural high molecular composite material it is characterised in that：It is containing calcium phosphate and natural polymer
The complex of son or derivatives thereof, wherein, natural polymer or derivatives thereof is hyaluronate sodium, collagen, shitosan, sulphuric acid are soft
One or more of ossein.
2. composite according to claim 1 it is characterised in that：Described calcium phosphate is to be added with 0-20% biological activity
The subsphaeroidal hydroxyapatite of glass or biphasic calcium phosphate ceramic particles, its particle diameter is 20-100 μm.
3. composite according to claim 2 it is characterised in that：Described calcium phosphate is to be added with 5-10% biological activity
The biphasic calcium phosphate ceramic particles of glass, its particle diameter is 20-40 μm.
4. composite according to claim 1 it is characterised in that：Described modified natural polymer is hyaluronic acid
Sodium, collagen, shitosan, the modified product of chondroitin sulfate.
5. composite according to claim 1 it is characterised in that：Described injectable calcium phosphate/natural polymer is multiple
Condensation material is paste, and wherein the solid content of calcium phosphate is 60-90 (w/w) %, the solid content of natural polymer or derivatives thereof
For 0.05-1.0 (w/w) %, remaining is water.
6. composite according to claim 5 it is characterised in that：The solid content of described calcium phosphate ceramic granule is
65-75 (w/w) %, the solid content of natural polymer or derivatives thereof is 0.1-0.6 (w/w) %, and remaining is water.
7. a kind of side of the injectable calcium phosphate/natural high molecular composite material prepared described in claim 1～6 any one
Method is it is characterised in that specifically include following steps：
1) natural polymer or derivatives thereof is configured to aqueous solution；
2) the calcium phosphate ceramic granule containing bioactivity glass for the preparation：By hydroxyapatite (or biphasic calcium phosphate) micropowder and biology
Activity glass micropowder is distributed in the polyvinyl alcohol water solution of concentration 0.5-1.5%, proceeds in ball mill and carries out ball milling, is starched
Material, then this slurry is delivered in spray dryer by peristaltic pump carries out spray drying treatment, collection spray drying powder and
Sinter at 600-1100 DEG C, then after standard sub-sieve is to sintering, powder body sieves, obtaining particle diameter is 20-100 μm
Calcium phosphate ceramic granule containing bioactivity glass；
3) weigh step 2) the calcium phosphate ceramic granule that obtains, it is added to step 1) natural polymer that obtains or derivatives thereof
In aqueous solution, it is sufficiently stirred for making solid particle dispersed in the solution, obtain required paste complex；
4) by step 3) calcium phosphate/natural polymer paste complex of obtaining irrigated to syringe by filling apparatus, goes out
Bacterium is processed, and obtains required injectable calcium phosphate/natural high molecular composite material product.
8. the injectable calcium phosphate/natural high molecular composite material described in claim 1～6 any one is in facial micro-shaping
Application.
9. a kind of method of face micro-shaping is it is characterised in that step is as follows：Take described in claim 1～6 any one can
Injection calcium phosphate/natural high molecular composite material, is implanted between facial soft tissue and periosteum, you can.
10. according to claim 9 face micro-shaping method it is characterised in that：The method of implantation is injection.
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Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN107952109A (en) * | 2017-11-27 | 2018-04-24 | 山东明德生物医学工程有限公司 | A kind of injected bone packing material and preparation method |
| CN108187139A (en) * | 2018-02-09 | 2018-06-22 | 重庆医科大学附属永川医院 | It is a kind of for drug-loaded artificial bone material of repairing bone defect and preparation method thereof |
| CN108744054A (en) * | 2018-06-15 | 2018-11-06 | 北京水元生生物科技有限公司 | A kind of injection-type beauty and shaping facial bulking agent compositions gel and preparation method thereof |
| CN108744060A (en) * | 2018-05-29 | 2018-11-06 | 四川大学 | A kind of bone renovating material and preparation method thereof of injectable multi-modal pore system structure |
| CN109602951A (en) * | 2018-11-30 | 2019-04-12 | 重庆医科大学附属永川医院 | A kind of load medicine spine repair materials of injectable and preparation method thereof and application method |
| CN110575565A (en) * | 2019-10-11 | 2019-12-17 | 许和平 | bone substitute material and preparation method and application thereof |
| CN111346262A (en) * | 2020-03-17 | 2020-06-30 | 四川大学 | Injectable calcium-phosphorus ceramic for promoting healing of tendon and bone and preparation method and application thereof |
| US20210060321A1 (en) * | 2018-01-07 | 2021-03-04 | Avraham Amir | High-load microneedles and compositions for skin augmentation |
| CN113413484A (en) * | 2021-06-21 | 2021-09-21 | 浙江苏嘉医疗器械股份有限公司 | Implant material for human soft tissue filling |
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