CN-121987846-A - Porous bone cement and preparation method thereof

Abstract

The invention discloses porous bone cement and a preparation method thereof, and belongs to the technical field of biomedical materials. The porous bone cement consists of bone cement powder, liquid A and liquid B. According to the invention, the magnesium powder and the water of the liquid B synchronously produce gas to cause holes, so that an internally communicated porous structure (with the aperture of 50-1000 mu m) is formed, the elastic modulus (1398-1656 MPa) is reduced to avoid stress shielding, the mechanical requirement of the compressive strength of not less than 70MPa is ensured, the liquid B can integrate the functions of antibiosis, osseointegration promotion and the like, the developer is used for monitoring after the adaptation operation, the biocompatibility is good, and the liquid B is suitable for bone surgery such as bone defect repair and the like.

Inventors

• LI MENGXIA
• CUI YONGSHUN
• LIU CHUNFANG
• WANG TAIPING
• SUN RONGRONG
• REN YIBIN

Assignees

• 山东明德生物医学工程有限公司

Dates

Publication Date

20260508

Application Date

20260211

Claims (10)

1. 1.A porous bone cement, characterized in that: The porous bone cement consists of three parts of bone cement powder, bone cement liquid A and bone cement liquid B, The bone cement powder comprises polymethyl methacrylate, magnesium powder and degradable developer, The bone cement liquid A consists of N, N-dimethyl-p-toluidine, hydroquinone and methyl methacrylate, The bone cement liquid B is a medium which can react with magnesium powder in the bone cement powder to generate gas so as to form a porous structure, and the medium does not obstruct polymerization and curing reaction of the bone cement powder and the liquid A, and can optionally contain functional active ingredients; The ratio of the bone cement powder to the bone cement liquid A to the bone cement liquid B is 2 g-3 g:1 mL:0.029-0.5 mL; the bone cement powder comprises 75-91% of polymethyl methacrylate, 0-20% of degradable developer and 1-10% of magnesium powder; The bone cement liquid A comprises, by mass, 0.5% -5% of N, N-dimethyl-p-toluidine, 0.05% -2% of hydroquinone, and 93% -99.45% of methyl methacrylate.
2. 2. A porous bone cement according to claim 1, characterized in that: the degradable developer is any one of sodium diatrizoate, iohexol and iopromide.
3. 3. A porous bone cement according to claim 2, characterized in that: the degradable developer is sodium diatrizoate.
4. 4. A porous bone cement according to claim 1, characterized in that: The mass percent of magnesium in the magnesium powder is more than or equal to 95 percent.
5. 5. A porous bone cement according to claim 1, characterized in that: The magnesium powder can be replaced by one or more of magnesium hydride, lithium metal powder, calcium metal powder, sodium metal powder, lithium hydride, sodium hydrogen, magnesium carbide, magnesium nitride and magnesium silicide.
6. 6. A porous bone cement according to claim 1, characterized in that: the particle size distribution of the magnesium powder is 1-100 μm.
7. 7. The porous bone cement according to claim 6, wherein: The particle size distribution of the magnesium powder is 10-50 μm.
8. 8. A porous bone cement according to claim 1, characterized in that: The bone cement liquid B is one of water, zinc chloride solution, silver nitrate solution and gentamycin sulfate solution.
9. 9. The porous bone cement of claim 8, wherein: The bone cement liquid B is one of gentamicin sulfate solution with the mass percentage concentration of 0.3-12%, silver nitrate solution with the mass percentage concentration of 5-8% and zinc chloride solution with the mass percentage concentration of 3-8%.
10. 10. A preparation method of porous bone cement is characterized in that: uniformly mixing a certain amount of polymethyl methacrylate with magnesium powder and a degradable developer to obtain bone cement powder; Uniformly mixing a certain amount of N, N-dimethyl-p-toluidine, hydroquinone and methyl methacrylate to obtain bone cement liquid A; thirdly, the solid-liquid ratio of the bone cement powder to the bone cement liquid A and the bone cement liquid B is 2g-3g:1mL:0.029-0.5mL, the corresponding bone cement liquid B is measured according to the solid-liquid ratio, the bone cement liquid A and the bone cement liquid B are added into the bone cement powder at the same time, and the bone cement powder is filled and solidified after being uniformly mixed.

Description

Porous bone cement and preparation method thereof Technical Field The invention relates to a biomedical material, in particular to porous bone cement and a preparation method thereof. Background PMMA bone cement is mainly polymerized by methyl methacrylate Polymer (PMMA) and Monomer Methyl Acrylate (MMA), belongs to the traditional bone substitute material, and is widely applied to bone surgery (such as joint replacement and vertebral body shaping). PMMA bone cement has many advantages of good injectability, good viscosity, good adhesion with bones and implantation devices, excellent mechanical strength, quick curing time and the like as a fillable material in the orthopedic operation. However, it has the following significant key drawbacks: 1. The pore-forming technology has the essential defect that the pore-forming modes of the existing porous bone cement mainly comprise three types. (1) The degradable biological material is subjected to pore-forming (such as Chinese patent CN 113577369A), the porous biological material is slowly degraded in the body to form pores, but PMMA is solidified to form a compact polymer network to prevent water molecules from penetrating, so that the internal pore-forming agent cannot be completely degraded, the residual products influence the mechanical property and the biocompatibility, the pores are mostly closed pores, and the bone growth effect is limited; (2) The surface of the metal magnesium powder is subjected to pore-forming (for example, the academic paper "FabricationandCharacterizationsofMetallicMgContainingPMMA-BasedPartiallyDegradableCompositeBoneCements"）, only can form a porous structure on the surface of bone cement, the inside is still in a compact state, a through channel can not be provided for bone tissue ingrowth, and the bone-cement interface binding force is low; (3) The salting-out method or chemical foaming agent is used for pore generation, the former has uneven pore distribution, the latter has easy bubble breakage, and the latter has the problems of poor pore connectivity and incompatibility with PMMA polymerization reaction. 2. The function is single, and the requirements of multiple scenes cannot be met, namely the existing bone cement can not only pursue a porous structure (no antibacterial and developing functions), but also can only add an antibacterial agent (no porous structure and too fast drug release rate), and is difficult to adapt to complex orthopaedics scenes (such as the requirement of 'porous+powerful antibacterial+developing' on polluted bone defects, and the requirement of 'porous+osseointegration promotion' on osteoporosis fracture). 3. The mechanical property is not matched with that of human bones, the elastic modulus (1700-2000 MPa) of the traditional PMMA bone cement is far higher than that of human cancellous bones (100-1000 MPa), so that the stress shielding effect is caused, and the traditional porous bone cement can not meet the mechanical support requirement of the human body by sacrificing the compression strength to replace the low modulus (for example, the compression strength of part of the scheme is less than 60MPa and is lower than 70MPa of ISO5833 mandatory standard). Disclosure of Invention Aiming at overcoming the defects of the prior art, the application provides a novel porous bone cement and a preparation method, which are realized by the following technical scheme: The porous bone cement comprises three parts, namely bone cement powder, bone cement liquid A and bone cement liquid B, wherein the bone cement powder comprises polymethyl methacrylate, magnesium powder and a degradable developer, the bone cement liquid A comprises N, N-dimethyl-p-toluidine, hydroquinone and methyl methacrylate, the bone cement liquid B is a medium which can react with magnesium powder in the bone cement powder to generate gas so as to form a porous structure, the medium does not inhibit polymerization and solidification reaction of the bone cement powder and the liquid A, and can optionally contain functional active ingredients, and the ratio of the bone cement powder to the bone cement liquid A to the bone cement liquid B is 2 g-3 g 1 mL:0.029-0.5 mL. The bone cement powder comprises 75-91% of polymethyl methacrylate, 0-20% of degradable developer and 1-10% of magnesium powder; The bone cement liquid A comprises, by mass, 0.5% -5% of N, N-dimethyl-p-toluidine, 0.05% -2% of hydroquinone, and 93% -99.45% of methyl methacrylate. Further, the degradable developer is any one of sodium diatrizoate, iohexol and iopromide. Further, the degradable developer is sodium diatrizoate. Further, the mass percent of magnesium in the magnesium powder is more than or equal to 95 percent. Further, the magnesium powder may be replaced with one or more of magnesium hydride, lithium metal powder, calcium metal powder, sodium metal powder, lithium hydride, sodium hydrogen, magnesium carbide, magnesium nitride, and magnesium silicide. Further, the parti