CN115554468A - Bone cement containing bioactive glass and preparation method and application thereof - Google Patents
Bone cement containing bioactive glass and preparation method and application thereof Download PDFInfo
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- CN115554468A CN115554468A CN202211145681.1A CN202211145681A CN115554468A CN 115554468 A CN115554468 A CN 115554468A CN 202211145681 A CN202211145681 A CN 202211145681A CN 115554468 A CN115554468 A CN 115554468A
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- Prior art keywords
- bioactive glass
- phosphate
- bone cement
- solid powder
- calcium sulfate
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- 239000005313 bioactive glass Substances 0.000 title claims abstract description 112
- 239000002639 bone cement Substances 0.000 title claims abstract description 86
- 238000002360 preparation method Methods 0.000 title abstract description 14
- OSGAYBCDTDRGGQ-UHFFFAOYSA-L calcium sulfate Chemical compound [Ca+2].[O-]S([O-])(=O)=O OSGAYBCDTDRGGQ-UHFFFAOYSA-L 0.000 claims abstract description 84
- 239000000843 powder Substances 0.000 claims abstract description 63
- 239000007787 solid Substances 0.000 claims abstract description 63
- 210000000988 bone and bone Anatomy 0.000 claims abstract description 42
- 239000007788 liquid Substances 0.000 claims abstract description 38
- 229910019142 PO4 Inorganic materials 0.000 claims abstract description 37
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 claims abstract description 37
- 239000010452 phosphate Substances 0.000 claims abstract description 37
- 239000000463 material Substances 0.000 claims abstract description 28
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 22
- 239000000243 solution Substances 0.000 claims abstract description 13
- 239000000203 mixture Substances 0.000 claims abstract description 9
- 150000003839 salts Chemical class 0.000 claims abstract description 6
- NBIIXXVUZAFLBC-UHFFFAOYSA-M dihydrogenphosphate Chemical group OP(O)([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-M 0.000 claims abstract description 4
- 239000002245 particle Substances 0.000 claims description 23
- 230000007547 defect Effects 0.000 claims description 22
- 238000000034 method Methods 0.000 claims description 20
- ZOMBKNNSYQHRCA-UHFFFAOYSA-J calcium sulfate hemihydrate Chemical compound O.[Ca+2].[Ca+2].[O-]S([O-])(=O)=O.[O-]S([O-])(=O)=O ZOMBKNNSYQHRCA-UHFFFAOYSA-J 0.000 claims description 17
- YYRMJZQKEFZXMX-UHFFFAOYSA-L calcium bis(dihydrogenphosphate) Chemical compound [Ca+2].OP(O)([O-])=O.OP(O)([O-])=O YYRMJZQKEFZXMX-UHFFFAOYSA-L 0.000 claims description 16
- 235000019691 monocalcium phosphate Nutrition 0.000 claims description 16
- 239000001506 calcium phosphate Substances 0.000 claims description 15
- 229910000150 monocalcium phosphate Inorganic materials 0.000 claims description 12
- 238000002156 mixing Methods 0.000 claims description 7
- QAOWNCQODCNURD-UHFFFAOYSA-L Sulfate Chemical compound [O-]S([O-])(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-L 0.000 claims description 3
- LFVGISIMTYGQHF-UHFFFAOYSA-N ammonium dihydrogen phosphate Chemical compound [NH4+].OP(O)([O-])=O LFVGISIMTYGQHF-UHFFFAOYSA-N 0.000 claims description 3
- 229910000387 ammonium dihydrogen phosphate Inorganic materials 0.000 claims description 3
- 229910052925 anhydrite Inorganic materials 0.000 claims description 3
- ZBZJARSYCHAEND-UHFFFAOYSA-L calcium;dihydrogen phosphate;hydrate Chemical compound O.[Ca+2].OP(O)([O-])=O.OP(O)([O-])=O ZBZJARSYCHAEND-UHFFFAOYSA-L 0.000 claims description 3
- 229940079593 drug Drugs 0.000 claims description 3
- 239000003814 drug Substances 0.000 claims description 3
- 239000003102 growth factor Substances 0.000 claims description 3
- 150000004677 hydrates Chemical class 0.000 claims description 3
- QQFLQYOOQVLGTQ-UHFFFAOYSA-L magnesium;dihydrogen phosphate Chemical compound [Mg+2].OP(O)([O-])=O.OP(O)([O-])=O QQFLQYOOQVLGTQ-UHFFFAOYSA-L 0.000 claims description 3
- 235000019837 monoammonium phosphate Nutrition 0.000 claims description 3
- 235000019785 monomagnesium phosphate Nutrition 0.000 claims description 3
- 229910000401 monomagnesium phosphate Inorganic materials 0.000 claims description 3
- 235000019796 monopotassium phosphate Nutrition 0.000 claims description 3
- 229910000402 monopotassium phosphate Inorganic materials 0.000 claims description 3
- 235000019799 monosodium phosphate Nutrition 0.000 claims description 3
- 229910000403 monosodium phosphate Inorganic materials 0.000 claims description 3
- AJPJDKMHJJGVTQ-UHFFFAOYSA-M sodium dihydrogen phosphate Chemical compound [Na+].OP(O)([O-])=O AJPJDKMHJJGVTQ-UHFFFAOYSA-M 0.000 claims description 3
- VEXZGXHMUGYJMC-UHFFFAOYSA-M Chloride anion Chemical compound [Cl-] VEXZGXHMUGYJMC-UHFFFAOYSA-M 0.000 claims description 2
- 239000007864 aqueous solution Substances 0.000 claims description 2
- 102000007350 Bone Morphogenetic Proteins Human genes 0.000 claims 1
- 108010007726 Bone Morphogenetic Proteins Proteins 0.000 claims 1
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 1
- 229940112869 bone morphogenetic protein Drugs 0.000 claims 1
- PJNZPQUBCPKICU-UHFFFAOYSA-N phosphoric acid;potassium Chemical compound [K].OP(O)(O)=O PJNZPQUBCPKICU-UHFFFAOYSA-N 0.000 claims 1
- 238000011049 filling Methods 0.000 abstract description 9
- 238000002347 injection Methods 0.000 abstract description 9
- 239000007924 injection Substances 0.000 abstract description 9
- 239000000126 substance Substances 0.000 abstract description 6
- 239000005312 bioglass Substances 0.000 abstract description 3
- 230000000052 comparative effect Effects 0.000 description 23
- 239000004568 cement Substances 0.000 description 10
- 230000015556 catabolic process Effects 0.000 description 8
- 238000006731 degradation reaction Methods 0.000 description 8
- 230000002188 osteogenic effect Effects 0.000 description 8
- 229910000389 calcium phosphate Inorganic materials 0.000 description 7
- 229920003229 poly(methyl methacrylate) Polymers 0.000 description 6
- 239000004926 polymethyl methacrylate Substances 0.000 description 6
- 238000007711 solidification Methods 0.000 description 6
- 230000008023 solidification Effects 0.000 description 6
- 229940062672 calcium dihydrogen phosphate Drugs 0.000 description 4
- 230000000921 morphogenic effect Effects 0.000 description 4
- 102000004169 proteins and genes Human genes 0.000 description 4
- 108090000623 proteins and genes Proteins 0.000 description 4
- 229960001714 calcium phosphate Drugs 0.000 description 3
- 235000011010 calcium phosphates Nutrition 0.000 description 3
- 239000002131 composite material Substances 0.000 description 3
- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 description 3
- 208000018084 Bone neoplasm Diseases 0.000 description 2
- CEAZRRDELHUEMR-URQXQFDESA-N Gentamicin Chemical compound O1[C@H](C(C)NC)CC[C@@H](N)[C@H]1O[C@H]1[C@H](O)[C@@H](O[C@@H]2[C@@H]([C@@H](NC)[C@@](C)(O)CO2)O)[C@H](N)C[C@@H]1N CEAZRRDELHUEMR-URQXQFDESA-N 0.000 description 2
- 229930182566 Gentamicin Natural products 0.000 description 2
- QYSXJUFSXHHAJI-XFEUOLMDSA-N Vitamin D3 Natural products C1(/[C@@H]2CC[C@@H]([C@]2(CCC1)C)[C@H](C)CCCC(C)C)=C/C=C1\C[C@@H](O)CCC1=C QYSXJUFSXHHAJI-XFEUOLMDSA-N 0.000 description 2
- 239000003519 biomedical and dental material Substances 0.000 description 2
- 210000001124 body fluid Anatomy 0.000 description 2
- 239000010839 body fluid Substances 0.000 description 2
- FUFJGUQYACFECW-UHFFFAOYSA-L calcium hydrogenphosphate Chemical compound [Ca+2].OP([O-])([O-])=O FUFJGUQYACFECW-UHFFFAOYSA-L 0.000 description 2
- 238000000576 coating method Methods 0.000 description 2
- 230000003111 delayed effect Effects 0.000 description 2
- 235000019700 dicalcium phosphate Nutrition 0.000 description 2
- 238000002474 experimental method Methods 0.000 description 2
- 229960002518 gentamicin Drugs 0.000 description 2
- 239000007943 implant Substances 0.000 description 2
- 238000011065 in-situ storage Methods 0.000 description 2
- 239000006012 monoammonium phosphate Substances 0.000 description 2
- 230000000399 orthopedic effect Effects 0.000 description 2
- 150000003013 phosphoric acid derivatives Chemical class 0.000 description 2
- GNSKLFRGEWLPPA-UHFFFAOYSA-M potassium dihydrogen phosphate Chemical compound [K+].OP(O)([O-])=O GNSKLFRGEWLPPA-UHFFFAOYSA-M 0.000 description 2
- LWIHDJKSTIGBAC-UHFFFAOYSA-K potassium phosphate Substances [K+].[K+].[K+].[O-]P([O-])([O-])=O LWIHDJKSTIGBAC-UHFFFAOYSA-K 0.000 description 2
- 239000002002 slurry Substances 0.000 description 2
- 239000001488 sodium phosphate Substances 0.000 description 2
- 238000012360 testing method Methods 0.000 description 2
- QYSXJUFSXHHAJI-YRZJJWOYSA-N vitamin D3 Chemical compound C1(/[C@@H]2CC[C@@H]([C@]2(CCC1)C)[C@H](C)CCCC(C)C)=C\C=C1\C[C@@H](O)CCC1=C QYSXJUFSXHHAJI-YRZJJWOYSA-N 0.000 description 2
- 235000005282 vitamin D3 Nutrition 0.000 description 2
- 239000011647 vitamin D3 Substances 0.000 description 2
- 229940021056 vitamin d3 Drugs 0.000 description 2
- 229920002319 Poly(methyl acrylate) Polymers 0.000 description 1
- 239000012752 auxiliary agent Substances 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000000975 bioactive effect Effects 0.000 description 1
- 230000004071 biological effect Effects 0.000 description 1
- 230000010478 bone regeneration Effects 0.000 description 1
- 239000012267 brine Substances 0.000 description 1
- 150000003841 chloride salts Chemical class 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 238000012669 compression test Methods 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 238000001035 drying Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 239000013505 freshwater Substances 0.000 description 1
- 230000004927 fusion Effects 0.000 description 1
- 239000008187 granular material Substances 0.000 description 1
- 230000012010 growth Effects 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 238000002324 minimally invasive surgery Methods 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 239000000178 monomer Substances 0.000 description 1
- 230000011164 ossification Effects 0.000 description 1
- 238000011056 performance test Methods 0.000 description 1
- 238000003825 pressing Methods 0.000 description 1
- 230000001737 promoting effect Effects 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 230000008929 regeneration Effects 0.000 description 1
- 238000011069 regeneration method Methods 0.000 description 1
- 238000002791 soaking Methods 0.000 description 1
- HPALAKNZSZLMCH-UHFFFAOYSA-M sodium;chloride;hydrate Chemical compound O.[Na+].[Cl-] HPALAKNZSZLMCH-UHFFFAOYSA-M 0.000 description 1
- 206010041569 spinal fracture Diseases 0.000 description 1
- 238000003756 stirring Methods 0.000 description 1
- 239000011885 synergistic combination Substances 0.000 description 1
- 210000001519 tissue Anatomy 0.000 description 1
- 230000001988 toxicity Effects 0.000 description 1
- 231100000419 toxicity Toxicity 0.000 description 1
- 238000005303 weighing Methods 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/02—Inorganic materials
- A61L27/10—Ceramics or glasses
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/02—Inorganic materials
- A61L27/025—Other specific inorganic materials not covered by A61L27/04 - A61L27/12
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/02—Inorganic materials
- A61L27/12—Phosphorus-containing materials, e.g. apatite
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- 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
- A61L27/54—Biologically active materials, e.g. therapeutic substances
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- A—HUMAN NECESSITIES
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- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- 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
- A61L27/58—Materials at least partially resorbable by the body
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- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
- A61L2300/252—Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
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- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/412—Tissue-regenerating or healing or proliferative agents
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- A—HUMAN NECESSITIES
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- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/412—Tissue-regenerating or healing or proliferative agents
- A61L2300/414—Growth factors
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/428—Vitamins, e.g. tocopherol, riboflavin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/12—Materials or treatment for tissue regeneration for dental implants or prostheses
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/20—Materials or treatment for tissue regeneration for reconstruction of the heart, e.g. heart valves
Abstract
The invention relates to bone cement containing bioactive glass and a preparation method thereof, wherein the bone cement containing bioactive glass comprises solid powder or comprises solid powder and curing liquid; the solid powder consists of calcium sulfate, bioactive glass and phosphate; the solidifying liquid is pure water or a salt water solution; the phosphate is dihydrogen phosphate or a crystalline hydrate thereof. The bone cement material prepared by the invention has excellent injection property, setting property, mechanical property and degradability, is obviously superior to a calcium sulfate/bioglass composition, and obviously improves the physical and chemical properties of the prior BAG bone filling material.
Description
Technical Field
The invention relates to the field of biomedical materials, in particular to bone cement containing bioactive glass and a preparation method thereof.
Background
The bone cement is a self-setting biomedical material capable of being used in filling bone gap and bone defect, and is widely used in filling treatment of artificial joint, vertebral fracture, bone defect, etc. At present, polymethyl acrylate bone cement (PMMA), calcium phosphate bone cement (CPC), calcium sulfate bone cement (CSC) and the like are available on the market, but they all have respective disadvantages. For example, PMMA bone cement releases a large amount of heat in the curing process, and is not degradable and bioactive after being implanted into a human body; although CPC bone cement and CSC bone cement have certain biological activity, the degradation is too fast. The calcium sulfate bone cement has good self-curing property, convenient use and lower cost, can be used for various products on the market, is suitable for bone defect filling, minimally invasive surgery treatment and the like, and has wide application, but the bioactivity of the calcium sulfate bone cement is not outstanding, and the effect of promoting bone regeneration cannot be achieved.
The bioactive glass (BAG for short) is a biomedical material with good bioactivity, degradability, absorbability and biocompatibility, has been applied to clinical application of bone defect repair, but has the following defects: 1. the plasticity is poor, the BAG is a porous granular material, and the BAG is clinically filled in a granular or blocky form at present and cannot meet the personalized requirements. 2. The degradation rate is slow, and clinical cases show that the BAG particles still remain 14 years after the bone repair part operation of patients. 3. Mechanical properties are weak, and BAG materials have weak compressive strength.
In order to improve the plasticity of the BAG bone repair material, the BAG and other materials are compounded to form injectable bone cement, for example, calcium sulfate hemihydrate (CSH for short) is compounded with the BAG to form CSH/BAG composite bone cement, so that the problem of poor plasticity of the BAG bone repair material can be solved to a certain extent, the defect of low bioactivity of calcium sulfate-based bone cement can be improved, the bone inductivity of the bone cement is improved, and the regeneration capability of bone tissues is promoted. However, the CSH/BAG composite bone cement has the problem of poor curing performance, which is shown in that the formed bone cement is long in curing time and even not cured, and meanwhile, the formed artificial bone is weak in pressure resistance, so that the clinical use of the formed artificial bone cement is limited.
In addition, the PMMA bone cement is compounded with the BAG to improve the biological performance of PMMA, but the problems of nondegradable PMMA, exothermic curing and residual monomer toxicity still exist, so that the clinical use of PMMA is still limited.
To date, no BAG-containing bone cement material having excellent injection properties, setting properties, mechanical properties and absorbability has been reported.
Disclosure of Invention
Based on this, it was an object of the present invention to provide a bone cement material containing bioactive glass (BAG) having excellent setting properties, mechanical properties and absorbability.
In order to achieve the above object, the present invention includes the following technical solutions.
In a first aspect of the invention, a bone cement containing bioactive glass is provided, which comprises solid powder, or comprises solid powder and solidifying liquid; the solid powder consists of calcium sulfate, bioactive glass and phosphate; the curing liquid is pure water or a salt water solution; the phosphate is dihydrogen phosphate or a crystalline hydrate thereof.
When the bone cement containing bioactive glass of the present invention does not contain a curing liquid, the solid powder is directly filled into a bone defect site, and after absorbing body fluid, the solid powder material forms bone cement in situ at the bone defect site and is cured.
If the bone cement containing the bioactive glass comprises the curing liquid, when the bone cement containing the bioactive glass is used, the solid powder and the curing liquid are mixed to form bone cement paste or paste, then the bone cement paste or paste is injected into a bone defect part through an injector, and then the material is solidified to form a hard artificial bone.
In some embodiments, the content of calcium sulfate in the solid powder is not less than 5% by mass of the solid powder, the content of bioactive glass is not less than 5% by mass of the solid powder, and the content of phosphate is not more than the content of bioactive glass.
In some of these embodiments, the solid powder is composed of the following components in weight percent: 50-90% of calcium sulfate, 7-40% of bioactive glass and 3-20% of phosphate.
In some of these embodiments, the solid powder is composed of the following components in weight percent: 70-85% of calcium sulfate, 10-30% of bioactive glass and 4-10% of phosphate.
In some of these embodiments, the solid powder is composed of the following components in weight percent: 78-82% of calcium sulfate, 14-16% of bioactive glass and 4-6% of phosphate.
In some of these embodiments, the solid powder is composed of the following components in weight percent: 80% of calcium sulfate, 15% of bioactive glass and 5% of phosphate.
In some of these embodiments, the phosphate salt is selected from at least one of monocalcium phosphate, monoammonium phosphate, monosodium phosphate, monopotassium phosphate, magnesium dihydrogen phosphate, and crystalline hydrates thereof.
In some of these embodiments, the phosphate salt is selected from monocalcium phosphate and/or monocalcium phosphate monohydrate.
In some of these embodiments, the bioactive glass has a composition of (SiO) 2 ) n -(CaO) m -(P 2 O 5 ) x Wherein, m is 25 to 45, x is 5 to 20, and the content of the compound is 40 to 70.
In some of these embodiments, n is 50-60, m is 30-40, and x is 8-15.
In some of these embodiments, n is from 52 to 56, m is from 34 to 36, and x is from 10 to 11.
In some of these embodiments, the bioactive glass has a composition of (SiO) 2 ) 54.2 -(CaO) 35 -(P 2 O 5 ) 10.8 。
In some of these embodiments, the bioactive glass has an average particle size of no greater than 10 mesh.
In some of these embodiments, the bioactive glass has an average particle size of no greater than 40 mesh.
In some of these embodiments, the bioactive glass has an average particle size of 100 mesh to 2000 mesh.
In some of these embodiments, the calcium sulfate is selected from at least one of calcium sulfate hemihydrate, calcium sulfate anhydrite, and calcium sulfate dihydrate.
In some of these embodiments, the calcium sulfate has an average particle size of no greater than 40 mesh.
In some of these embodiments, the calcium sulfate has an average particle size of no greater than 500 mesh.
In some embodiments, the mass ratio of the solidifying liquid to the solid powder is 0.20-1.2:1.
in some embodiments, the mass ratio of the solidifying liquid to the solid powder is 0.25-0.5:1.
in some of these embodiments, the brine solution is an aqueous solution containing phosphate, sulfate, and/or chloride salts.
In some embodiments, the bone cement further comprises one or more of drugs, bone morphogenic proteins, and growth factors, such as gentamicin, active vitamin D3, bone Morphogenic Proteins (BMPs), and the like.
In a second aspect of the present invention, there is provided a method for preparing the bone cement containing bioactive glass, comprising the following steps: and uniformly mixing the calcium sulfate, the bioactive glass and the phosphate to obtain solid powder, and mixing the obtained solid powder with the curing liquid to obtain the bone cement containing the bioactive glass.
In a third aspect of the present invention, there is provided a use of the bone cement containing bioactive glass in a bone defect repairing material. The restoration includes filling and/or reconstruction, for example, as applied to orthopedic and dental restorations, as well as implant coatings, and the like.
In some of these embodiments, the bone defect repair material is a bone defect repair material for non-weight bearing bone defect repair of a limb and/or spine.
In some embodiments, the bone defect repairing material is used for repairing delayed union or nonunion of fractured bones fused with joints or replacement and revision of filled joints after bone tumor operation.
Compared with the prior art, the invention has the following beneficial effects:
the inventor of the invention unexpectedly discovers that the setting performance and mechanical property of the bone cement can be obviously improved by adding specific types and dosage of phosphate (dihydric phosphate) into a CSH/BAG composite bone cement system without adding other complex auxiliary agents, so that the bone cement material prepared by the invention has excellent injection performance, setting performance, mechanical property and degradability, is obviously superior to a calcium sulfate/bioglass composition, and obviously improves the physical and chemical properties of the conventional BAG bone filling material.
Further, the setting performance and the mechanical property of the obtained bone cement can be further improved by further optimizing the proportion of the calcium sulfate, the bioactive glass and the phosphate and the type of the phosphate, and the compressive strength of the obtained bone cement can exceed 50MPa.
In addition, the bone cement provided by the invention has good bioactivity, biocompatibility and degradation performance, and can form firm chemical bonding with bone tissues after being implanted, so that osteogenesis can be induced, and the growth of tissues around the bone can be promoted.
Detailed Description
Experimental procedures for the invention not specifically indicated in the following examples are generally carried out under conventional conditions, or as recommended by the manufacturer. The various chemicals used in the examples are commercially available.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.
The terms "comprises" and "comprising," as well as any variations thereof, are intended to cover non-exclusive inclusions. For example, a process, method, apparatus, article, or device that comprises a list of steps is not limited to only those steps or modules listed, but may alternatively include other steps not listed or inherent to such process, method, article, or device.
The "plurality" referred to in the present invention means two or more. "and/or" describes the association relationship of the associated objects, meaning that there may be three relationships, e.g., a and/or B, which may mean: a exists alone, A and B exist simultaneously, and B exists alone. The character "/" generally indicates that the former and latter associated objects are in an "or" relationship.
In one aspect, the invention provides a bone cement containing bioactive glass, which comprises solid powder or comprises solid powder and a curing liquid; the solid powder consists of calcium sulfate, bioactive glass and phosphate; the solidifying liquid is pure water or a salt water solution; the phosphate is dihydrogen phosphate or a crystalline hydrate thereof.
When the bone cement containing bioactive glass of the present invention does not contain a curing liquid, the solid powder is directly filled into a bone defect site, and after absorbing body fluid, the solid powder material forms bone cement in situ at the bone defect site and is cured.
If the bone cement containing the bioactive glass comprises the curing liquid, when the bone cement containing the bioactive glass is used, the solid powder and the curing liquid are mixed to form bone cement paste or paste, then the bone cement paste or paste is injected into a bone defect part through an injector, and then the material is solidified to form a hard artificial bone. Wherein, the mass ratio range of the curing liquid to the solid powder can be adjusted according to the use requirement, and is preferably 0.20-1.2:1, more preferably 0.25 to 0.5:1, more preferably 0.25 to 0.35:1.
the bone cement material has excellent injection performance, setting performance, mechanical property and degradability, is superior to a calcium sulfate/bioglass composition and a bioactive glass/dihydric phosphate combination, and obviously improves the physical and chemical properties of the conventional BAG bone filling material.
In the solid powder, the content of calcium sulfate is preferably not less than 5% of the mass of the solid powder, the content of bioactive glass is preferably not less than 5% of the mass of the solid powder, and the content of phosphate is preferably not more than the mass of bioactive glass contained in the solid powder; further preferred weight percentages are as follows: 50-90% of calcium sulfate, 7-40% of bioactive glass and 3-20% of phosphate; more preferred weight percentages are as follows: 70-85% of calcium sulfate, 10-30% of bioactive glass and 4-10% of phosphate; more preferred weight percentages are as follows: 78-82% of calcium sulfate, 14-16% of bioactive glass and 4-6% of phosphate; the most preferred weight percentages are as follows: 80% of calcium sulfate, 15% of bioactive glass and 5% of phosphate.
The phosphate of the present invention includes, but is not limited to, at least one of monocalcium phosphate, monoammonium phosphate, monosodium phosphate, monopotassium phosphate, magnesium dihydrogen phosphate, and crystalline hydrates thereof, and more preferably monocalcium phosphate or monocalcium phosphate monohydrate.
The bioactive glass of the present invention preferably consists of (SiO) 2 ) n -(CaO) m -(P 2 O 5 ) x The bioactive glass of (1), wherein, m is from 40 to 70, m is from 25 to 45, x is from 5 to 20; more preferably, n is 50-60, m is 30-40, x is 8-15; more preferably, n is 52-56, m is 34-36, x is 10-11; for example, the bioactive glass of the present invention can be (SiO) 2 ) 54.2 -(CaO) 35 -(P 2 O 5 ) 10.8 。
The average particle size of the bioactive glass is preferably not more than 10 meshes, and the particle size range is more preferably not more than 40 meshes; more preferably 100 mesh to 2000 mesh.
The calcium sulfate of the present invention may be at least one of calcium sulfate hemihydrate, calcium sulfate anhydrite and calcium sulfate dihydrate, and is preferably calcium sulfate hemihydrate. The average particle size of the calcium sulfate is preferably not more than 40 meshes, more preferably not more than 500 meshes, and more preferably 500 meshes to 2000 meshes.
The solidifying liquid is pure water or a salt water solution, wherein the salt water solution preferably contains phosphate, sulfate and/or chloride.
The bone cement of the present invention may further comprise one or more of drugs, bone morphogenic proteins and growth factors, such as gentamicin, active vitamin D3, bone Morphogenic Proteins (BMPs), etc.
In another aspect, the present invention provides a method for preparing the bone cement containing bioactive glass, comprising the following steps: and uniformly mixing the calcium sulfate, the bioactive glass and the phosphate to obtain solid powder, and mixing the obtained solid powder with the curing liquid to obtain the bone cement containing the bioactive glass.
In a third aspect, the invention provides an application of the bone cement containing the bioactive glass in a bone defect repairing material. The restoration includes filling and/or reconstruction, for example, as applied to orthopedic and dental restorations, as well as implant coatings, and the like. The bone defect repairing material is used for repairing non-bearing bone defects of limbs and/or spines; for example, the bone defect repairing material is used for repairing delayed union or bone nonunion of joint fusion comminuted fractured bones or for replacing and reconstructing joint after bone tumor operation.
The present invention will be described in further detail with reference to specific examples.
The materials used in the following examples are illustrated below:
calcium sulfate hemihydrate: the average particle diameter of the product from medical instruments Ltd of the family Zhongzhongke Si Gu (Dongguan) is 500-2000 mesh.
Bioactive glass: source Hua Kui science tezhou ltd, consisting of (SiO) 2 ) 54.2 -(CaO) 35 -(P 2 O 5 ) 10.8 。
Calcium dihydrogen phosphate: purchased from Sigma-Aldrich, recrystallized and ground to 500-2000 mesh.
Example 1
The preparation method of the bone cement containing the bioactive glass provided by the embodiment is as follows:
1.6g of calcium sulfate hemihydrate (average particle size 500 mesh to 2000 mesh), 0.3g of bioactive glass (100 mesh to 200 mesh) and 0.1g of monocalcium phosphate (500 mesh to 2000 mesh) were mixed uniformly to obtain a solid powder, and the solidified liquid was 0.6mL of water.
And (3) injectable time detection: and mixing the solid powder and the curing liquid, stirring to obtain the bone cement slurry, transferring the bone cement slurry into a 10mL disposable injector within one minute, performing injection, and recording the time for smooth injection, namely the injectable time. The results are shown in Table 1.
And (3) detecting the solidification time: the method is carried out according to the YY 0642-2018 method. The cement paste was filled into a cylindrical mold (specification of the inner cavity of the mold: diameter 6mm, height 12 mm), the setting time was recorded and the sample was taken out. The results are shown in Table 1.
And (3) detecting the compressive strength: the samples were tested for compressive strength after standing at room temperature for 24 hours. Referring to the YY0549-2003 method, a uniaxial compression test was carried out with a universal material tester under a load of 5KN and a pressing rate of 5mm/min until the sample was completely destroyed. Sample size: cylinder, diameter high =6mm high 12mm and the results are shown in table 1.
Accelerated degradation experiments: preparing a cylindrical sample with the specification of 12mm in height and the diameter of 6mm, soaking the cylindrical sample in 500mL of water at 37 +/-2 ℃, replacing fresh water once a day, taking out the sample every 6 days, weighing the residual mass after drying for 24 hours at 60 ℃, and calculating the residual ratio. The results are shown in Table 2.
Example 2
The preparation method of the bone cement containing bioactive glass provided by the embodiment is as follows:
1.2g of calcium sulfate hemihydrate (average particle size 500 mesh to 2000 mesh), 0.6g of bioactive glass (100 mesh to 200 mesh) and 0.2g of monocalcium phosphate (500 mesh to 2000 mesh) were mixed uniformly to obtain a solid powder, and the solidified liquid was 0.6mL of water.
The solid powder and the curing liquid were mixed and stirred to prepare an osteogenic cement paste, and the injectable time, the setting time and the compressive strength were measured by the method of example 1. The results are shown in Table 1.
Example 3
The preparation method of the bone cement containing bioactive glass provided by the embodiment is as follows:
1.4g of calcium sulfate hemihydrate (average particle size 500 mesh-2000 mesh), 0.4g of bioactive glass (500 mesh-2000 mesh) and 0.2g of monocalcium phosphate (500 mesh-2000 mesh) were mixed uniformly to obtain a solid powder, and the solidified liquid was 0.6mL of water.
The solid powder and the curing liquid were mixed and stirred to prepare an osteogenic cement paste, and the injectable time, the setting time and the compressive strength were measured by the method of example 1. The results are shown in Table 1.
Comparative example 1
The preparation method of the bone cement containing the bioactive glass provided by the comparative example is as follows:
1.7g of calcium sulfate hemihydrate (average particle size 500-2000 mesh) and 0.3g of bioactive glass (100-200 mesh) were mixed uniformly to obtain a solid powder, and the solidification solution was 0.6mL of water.
The solid powder and the curing liquid were mixed and stirred to prepare an osteogenic cement paste, and the injectable time, the setting time, the compressive strength and the accelerated degradation test were conducted by the method of example 1. The results of the measurements are shown in tables 1 and 2.
Comparative example 2
The preparation method of the bone cement containing the bioactive glass provided by the comparative example is as follows:
1.4g of calcium sulfate hemihydrate (average particle size 500-2000 mesh) and 0.6g of bioactive glass (100-200 mesh) were mixed uniformly to obtain a solid powder, and the solidification solution was 0.6mL of water.
The solid powder and the curing liquid were mixed and stirred to prepare an osteogenic cement paste, and the injectable time, the setting time and the compressive strength were measured by the method of example 1. The results are shown in Table 1.
Comparative example 3
The preparation method of the bone cement containing the bioactive glass provided by the comparative example comprises the following steps:
1.6g of calcium sulfate hemihydrate (average particle size 500-2000 mesh) and 0.4g of bioactive glass (500-2000 mesh) were mixed uniformly to obtain solid powder, and the solidifying solution was 0.6mL of water.
The solid powder and the curing liquid were mixed and stirred to prepare an osteogenic cement paste, and the injectable time, the setting time and the compressive strength were measured by the method of example 1. The results are shown in Table 1.
Comparative example 4
The preparation method of the bone cement containing the bioactive glass provided by the comparative example comprises the following steps:
1.5g of bioactive glass (100-200 mesh) was mixed with 0.5g of monocalcium phosphate (500-2000 mesh) to obtain a solid powder, and the solidified solution was 0.6mL of water.
The solid powder and the curing liquid were mixed and stirred to form cement paste, and the injectable time, setting time and compressive strength were measured by the method of example 1. The results are shown in Table 1.
Comparative example 5
The preparation method of the bone cement containing the bioactive glass provided by the comparative example is as follows:
1.6g of calcium sulfate hemihydrate (average particle size 500-2000 mesh), 0.3g of bioactive glass (100-200 mesh) and 0.1g of calcium hydrogen phosphate (500-2000 mesh) are mixed uniformly to obtain solid powder, and the solidifying liquid is 0.6mL of water.
The solid powder and the curing liquid were mixed and stirred to prepare an osteogenic cement paste, and the injectable time, the setting time and the compressive strength were measured by the method of example 1. The results are shown in Table 1.
Comparative example 6
The preparation method of the bone cement containing the bioactive glass provided by the comparative example is as follows:
1.6g of calcium sulfate hemihydrate (average particle size 500-2000 mesh), 0.3g of bioactive glass (100-200 mesh) and 0.1g of calcium phosphate (500-2000 mesh) were mixed uniformly to obtain a solid powder, and the solidification solution was 0.6mL of water.
The solid powder and the curing liquid were mixed and stirred to prepare an osteogenic cement paste, and the injectable time, the setting time and the compressive strength were measured by the method of example 1. The results are shown in Table 1.
Comparative example 7
The preparation method of the bone cement containing the bioactive glass provided by the comparative example is as follows:
1.3g of calcium sulfate hemihydrate (average particle size 500 mesh to 2000 mesh), 0.3g of bioactive glass (100 mesh to 200 mesh) and 0.4g of monocalcium phosphate (500 mesh to 2000 mesh) were mixed uniformly to obtain a solid powder, and the solidified liquid was 0.6mL of water.
The solid powder and the curing liquid were mixed and stirred to prepare an osteogenic cement paste, and the injectable time, the setting time and the compressive strength were measured by the method of example 1. The results are shown in Table 1.
TABLE 1 bone cement raw material compositions and Performance test results of examples 1-3 and comparative examples 1-7
TABLE 2 accelerated degradation test results
Note: in the table, "pure PSC" means a composition of (SiO) 2 ) 54.2 -(CaO) 35 -(P 2 O 5 ) 10.8 The bioactive glass of (1).
As can be seen from the results of table 1 and table 2: the bone cement prepared by the invention can be injected for a long time, can better meet the clinical injection requirements, has short solidification time, can be quickly solidified within 10 minutes, has high compressive strength, excellent injection performance, solidification performance, mechanical property and degradability, and obviously improves the physical and chemical properties of the current BAG bone filling material.
Comparative examples 1 to 3 compared with examples 1 to 3, comparative examples 1 to 3, in which calcium dihydrogen phosphate was not added, resulted in a significant increase in the setting time, a significant decrease in the compressive strength, and a certain decrease in the degradation rate of the resulting bone cement, indicating that the present invention can significantly improve the setting properties and mechanical properties of the resulting bone cement and can improve the degradability to a certain extent by adding a certain amount of calcium dihydrogen phosphate.
Comparative example 4 in comparison to example 1, comparative example 4 did not add calcium sulfate hemihydrate, resulting in a bone cement that set quickly in less than 1 minute and could not be injected.
Comparative examples 5 to 6 in comparison with example 1, comparative examples 5 and 6, in which calcium dihydrogen phosphate in example 1 was replaced with calcium hydrogen phosphate and calcium phosphate, respectively, resulted in a significant decrease in the setting speed and compressive strength of the resulting bone cement.
Comparative example 7 in comparison with example 1, comparative example 7 added monocalcium phosphate in an amount of 20% higher than the bioactive glass content, resulting in rapid setting of the resulting bone cement in less than 1 minute, and failure to inject.
The above results show that the bone cement of the invention can ensure excellent injection performance and obviously improve the setting performance, mechanical property and degradation performance by the synergistic combination of calcium sulfate hemihydrate, bioactive glass and dihydric phosphate according to a certain proportion.
All possible combinations of the technical features of the above embodiments may not be described for the sake of brevity, but should be considered as within the scope of the present disclosure as long as there is no contradiction between the combinations of the technical features.
The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.
Claims (10)
1. The bone cement containing the bioactive glass is characterized by comprising solid powder or comprising the solid powder and a curing liquid; the solid powder consists of calcium sulfate, bioactive glass and phosphate; the curing liquid is pure water or a salt water solution; the phosphate is dihydrogen phosphate or a crystalline hydrate thereof.
2. The bone cement containing bioactive glass according to claim 1, characterized in that the solid powder consists of the following components in percentage by weight: 50-90% of calcium sulfate, 7-40% of bioactive glass and 3-20% of phosphate; and the content of the phosphate does not exceed the content of the bioactive glass.
3. The bone cement containing bioactive glass according to claim 2, characterized in that the solid powder consists of the following components in percentage by weight: 70-85% of calcium sulfate, 10-30% of bioactive glass and 4-10% of phosphate.
4. The bone cement containing bioactive glass according to claim 3, characterized in that the solid powder consists of the following components in percentage by weight: 78-82% of calcium sulfate, 14-16% of bioactive glass and 4-6% of phosphate.
5. The bioactive glass-containing bone cement according to any of claims 1 to 4, wherein the phosphate is selected from at least one of monocalcium phosphate, ammonium dihydrogen phosphate, sodium dihydrogen phosphate, potassium dihydrogen phosphate, magnesium dihydrogen phosphate, and crystalline hydrates thereof;
preferably, the phosphate is selected from monocalcium phosphate and/or monocalcium phosphate monohydrate.
6. Bone cement comprising a bioactive glass according to any of claims 1 to 4, characterised in that the composition of the bioactive glass is (SiO) 2 ) n -(CaO) m -(P 2 O 5 ) x Wherein n is 40-70, m is 25-45, x is 5-20;
preferably, n is 50 to 60, m is 30 to 40, x is 8 to 15;
preferably, n is 52-56, m is 34-36, x is 10-11;
preferably, the composition of the bioactive glass is (SiO) 2 ) 54.2 -(CaO) 35 -(P 2 O 5 ) 10.8 。
7. Bone cement comprising a bioactive glass as claimed in any of claims 1 to 4, characterized in that the bioactive glass has an average particle size of not more than 10 mesh; and/or the presence of a gas in the gas,
the calcium sulfate is selected from at least one of calcium sulfate hemihydrate, calcium sulfate anhydrite and calcium sulfate dihydrate; and/or the presence of a gas in the gas,
the average particle size of the calcium sulfate is not more than 40 meshes; and/or the presence of a gas in the gas,
the mass ratio of the curing liquid to the solid powder is 0.20-1.2:1; and/or the presence of a gas in the gas,
the saline solution is an aqueous solution containing phosphate, sulfate and/or chloride; and/or the presence of a gas in the atmosphere,
the bone cement also comprises one or more of drugs, bone morphogenetic proteins and growth factors.
8. Bone cement comprising a bioactive glass according to claim 7, characterised in that the bioactive glass has an average particle size of 100 mesh to 2000 mesh, and/or,
the calcium sulfate has an average particle size of no greater than 500 mesh, and/or,
the mass ratio of the solidified liquid to the solid powder is 0.25-0.5:1.
9. a method for preparing a bone cement comprising a bioactive glass as claimed in any of claims 1 to 8, comprising the steps of: and uniformly mixing the calcium sulfate, the bioactive glass and the phosphate to obtain solid powder, and mixing the obtained solid powder with the curing liquid to obtain the bone cement containing the bioactive glass.
10. Use of a bone cement comprising a bioactive glass as claimed in any of claims 1 to 8 in a bone defect repair material.
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