WO2023174079A1 - Ciment osseux à base de céramique et de phosphate de calcium et son procédé de préparation - Google Patents

Ciment osseux à base de céramique et de phosphate de calcium et son procédé de préparation Download PDF

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Publication number
WO2023174079A1
WO2023174079A1 PCT/CN2023/079716 CN2023079716W WO2023174079A1 WO 2023174079 A1 WO2023174079 A1 WO 2023174079A1 CN 2023079716 W CN2023079716 W CN 2023079716W WO 2023174079 A1 WO2023174079 A1 WO 2023174079A1
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WIPO (PCT)
Prior art keywords
ceramic
bone cement
calcium phosphate
phosphate bone
tcp
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PCT/CN2023/079716
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English (en)
Chinese (zh)
Inventor
卢霄
卢建熙
刘欣
莫秀梅
范存义
姚宸维
高旭
韦荣华
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卢霄
卢建熙
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Publication of WO2023174079A1 publication Critical patent/WO2023174079A1/fr

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    • C—CHEMISTRY; METALLURGY
    • C04—CEMENTS; CONCRETE; ARTIFICIAL STONE; CERAMICS; REFRACTORIES
    • C04B—LIME, MAGNESIA; SLAG; CEMENTS; COMPOSITIONS THEREOF, e.g. MORTARS, CONCRETE OR LIKE BUILDING MATERIALS; ARTIFICIAL STONE; CERAMICS; REFRACTORIES; TREATMENT OF NATURAL STONE
    • C04B28/00—Compositions of mortars, concrete or artificial stone, containing inorganic binders or the reaction product of an inorganic and an organic binder, e.g. polycarboxylate cements
    • C04B28/34—Compositions of mortars, concrete or artificial stone, containing inorganic binders or the reaction product of an inorganic and an organic binder, e.g. polycarboxylate cements containing cold phosphate binders
    • C04B28/344—Compositions of mortars, concrete or artificial stone, containing inorganic binders or the reaction product of an inorganic and an organic binder, e.g. polycarboxylate cements containing cold phosphate binders the phosphate binder being present in the starting composition solely as one or more phosphates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/28—Bones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds

Definitions

  • the invention relates to the field of biomedical materials, and in particular to a ceramic calcium phosphate bone cement and a preparation method thereof.
  • Bone cement is a member of bone repair biomaterials. It forms self-curing through physical, chemical and chemical reactions between solid and liquid phases. Bone cement can be delivered to the target treatment area through small surgical incisions or even percutaneous injection, making the treatment simple and minimally invasive and promoting the patient's recovery.
  • CPC calcium phosphate bone cement
  • a solid phase and a liquid phase composed of one or several calcium phosphate salt compounds. It is uniformly formed into a slurry, solidified through chemical reactions under physiological conditions, and finally bioconverted into hydroxyapatite (HA) in the body because of its good fluidity, low heat release during the solidification process, bone conduction and biocompatibility. It is good, has the advantages of degradability and drug loading, and has important application value in bone repair.
  • the solid phase used in the current preparation of calcium phosphate bone cement is powder.
  • the calcium phosphate bone cement formed by chemical reactions between powders will degrade and produce a lot of particles after being implanted into the human body. These particles Particles can trigger an inflammatory response that can cause damage to human tissue.
  • the object of the present invention is to provide a ceramic calcium phosphate bone cement and a preparation method thereof, the core of which lies in the self-curing reaction of ⁇ -tricalcium phosphate ( ⁇ -TCP) ceramic particles with dicalcium phosphate powder through the medium of distilled water.
  • ⁇ -TCP ⁇ -tricalcium phosphate
  • the present invention provides a preparation method of ceramic calcium phosphate bone cement, which includes:
  • Distilled water was selected as the liquid phase of ceramic calcium phosphate bone cement
  • the ceramic calcium phosphate bone cement is obtained by self-curing reaction of the ⁇ -TCP ceramic particles and calcium dihydrogen phosphate powder in the liquid phase.
  • the steps of preparing the ⁇ -TCP ceramic particles include:
  • the ceramic body is sintered at 1000°C ⁇ 1200°C, mechanically pulverized, uniformly ground and washed and sieved to form the required ⁇ -TCP ceramic particles.
  • the particle size range of the ⁇ -TCP ceramic particles is 10 ⁇ m ⁇ 1000 ⁇ m.
  • the morphology of the ⁇ -TCP ceramic particles includes regular particles, irregular particles or a mixture of regular particles and irregular particles.
  • the structure of the ⁇ -TCP ceramic particles is dense, porous, or a mixture of dense and porous.
  • a mixing method is used to prepare the plastic ceramic calcium phosphate bone cement, and the steps include:
  • the injection-type ceramic calcium phosphate bone cement is prepared using a blending method, and the steps include:
  • the ⁇ -TCP ceramic particles and calcium dihydrogen phosphate powder are mixed with the liquid phase respectively to obtain a first semi-solid mixture and a second semi-solid mixture respectively;
  • the first semi-solid mixture and the second semi-solid mixture are blended to obtain the ceramic calcium phosphate bone cement through a self-curing reaction.
  • the proportion of the ⁇ -TCP ceramic particles in the total weight of the solid phase and the first semi-solid mixture is 5% to 95%.
  • calcium sulfate is added to both the solid phase and the second semi-solid mixture.
  • the present invention also provides a ceramic calcium phosphate bone cement, which is prepared by the preparation method of ceramic calcium phosphate bone cement.
  • the core of the ceramic calcium phosphate bone cement and its preparation method of the present invention lies in the self-curing reaction between ⁇ -TCP ceramic particles and calcium dihydrogen phosphate powder through the medium of distilled water, so that the chemical properties of the bone cement It has higher stability, better operability, stronger mechanical properties, and more controllable degradation; especially after being implanted in the body, it can avoid or reduce the inflammatory reaction and tissue and organ damage caused by the generation of degraded particles.
  • Figure 1 is a flow chart of a method for preparing ceramic calcium phosphate bone cement according to an embodiment of the present invention.
  • FIG. 1 is a flow chart of a method for preparing ceramic calcium phosphate bone cement according to one embodiment of the present invention.
  • the ceramic phosphate Calcium bone cement preparation methods include:
  • Step S1 prepare ⁇ -TCP ceramic particles
  • Step S2 use distilled water as the liquid phase of ceramic calcium phosphate bone cement
  • Step S3 using the ⁇ -TCP ceramic particles and calcium dihydrogen phosphate powder to undergo a self-curing reaction in the liquid phase to obtain the ceramic calcium phosphate bone cement.
  • the steps for preparing the ⁇ -TCP ceramic particles include: first, prepare a ceramic body from the ⁇ -TCP powder through molding techniques such as extrusion, extrusion or grouting; then, sintering the ceramic body, mechanically Crush, homogeneously grind, wash and sieve with water to obtain the required ⁇ -TCP ceramic particles. This process is to ceramize the ⁇ -TCP powder to obtain the ⁇ -TCP ceramic particles, making the structure of the ⁇ -TCP ceramic particles more solid and stable.
  • the ⁇ -TCP ceramic particles are not in the human body. It is easy to collapse, thereby improving the stability of the ceramic calcium phosphate bone cement.
  • the sintering temperature may be 1000°C ⁇ 1200°C.
  • the prepared ⁇ -TCP ceramic particles meet biocompatibility and corresponding mechanical strength requirements, and the morphology of the ⁇ -TCP ceramic particles can include regular particles or irregular particles or a mixture of regular particles and irregular particles.
  • the regular particles can be spherical or regular polyhedron.
  • the structure of the ⁇ -TCP ceramic particles can be dense, porous, or a mixture of dense and porous.
  • the particle size range of the ⁇ -TCP ceramic particles is required for the preparation of ceramic calcium phosphate bone cement.
  • the screened ⁇ -TCP ceramic particles can be dried at a temperature of 60°C to 120°C, and the baking time can be 20h to 50h.
  • the particle size range of the selected ⁇ -TCP ceramic particles is 10 ⁇ m ⁇ 1000 ⁇ m.
  • step S2 distilled water is selected as the liquid phase of the ceramic calcium phosphate bone cement.
  • the ⁇ -TCP ceramic particles and calcium dihydrogen phosphate powder form a chemical reaction to achieve the goal of self-curing.
  • Step S3 using the ⁇ -TCP ceramic particles and calcium dihydrogen phosphate powder to undergo a self-curing reaction in the liquid phase to obtain the ceramic calcium phosphate bone cement.
  • a mixing method can be used to obtain the plastic ceramic calcium phosphate bone cement, and the steps can include:
  • Step S31 mix the ⁇ -TCP ceramic particles and calcium dihydrogen phosphate powder in corresponding proportions to obtain the solid phase of ceramic calcium phosphate bone cement; the solid phase is commercialized by long-term storage and transportation after dehydration. lay the foundation;
  • Step S32 the solid phase and the liquid phase are mixed and stirred in a certain proportion to form a pasty first intermediate of the ceramic calcium phosphate bone cement.
  • the first intermediate has good fluidity and can be used. Operability, providing corresponding operating time for clinical application; and, the first intermediate forms a paste-like second intermediate through a partial self-curing reaction, and the second intermediate has good plasticity and is convenient for clinical application; then , the second intermediate forms the solid ceramic calcium phosphate bone cement with strength through a complete self-curing reaction to achieve the ultimate clinical treatment goal.
  • calcium sulfate powder can also be added to the solid phase as a retarder, with an addition ratio of 0.1% to 30%, to slow down the self-curing reaction of the first intermediate and prevent the reaction from being too fast.
  • the resulting operating time is too short, making it possible to regulate the operating and curing time of the ceramic calcium phosphate bone cement.
  • the ⁇ -TCP ceramic particles, the calcium dihydrogen phosphate powder and the calcium sulfate powder can be mixed according to a certain proportion, and after drying at a temperature of 60°C to 80°C for 20h to 50h, the mixture can be Add to the mixing container and stir evenly to obtain a dry and evenly mixed solid phase.
  • the surface of the mixing container is smooth, so that no powder adheres to the surface of the mixing container during the mixing process, ensuring that the particle size distribution of each raw material in the solid phase is accurate and uniform.
  • the mixing container can be metal or glass.
  • the ⁇ -TCP ceramic particles may account for 5% to 95% of the total weight of the solid phase, and the calcium dihydrogen phosphate powder may account for 5% to 95% of the total weight of the solid phase. Moreover, the purity of the ⁇ -TCP ceramic particles, the calcium dihydrogen phosphate powder and the calcium sulfate powder are all greater than 95%.
  • disodium dihydrogen pyrophosphate and sodium hydroxide can also be added to the distilled water, that is, the liquid phase is a mixed solution of disodium dihydrogen pyrophosphate, sodium hydroxide and distilled water in a certain proportion.
  • disodium dihydrogen pyrophosphate is also used as a retarder to slow down the chemical reaction after the solid phase and the liquid phase are mixed, preventing the reaction from being too fast and causing the operating time to be too short, so that the ceramicization can be controlled.
  • the operation and curing time of calcium phosphate bone cement; sodium hydroxide is used to adjust the pH value so that the acidity of the prepared ceramic calcium phosphate bone cement will not be too strong and trigger a tissue reaction in the body.
  • the proportion of disodium dihydrogen pyrophosphate to the total weight of the liquid phase can be 0.1% to 30%, the proportion of sodium hydroxide to the total weight of the liquid phase is 0.1% to 30%, and the pyrophosphate
  • the purity of disodium dihydrogen and sodium hydroxide is both greater than 95%.
  • the blending method can be used in the step S3 to obtain the injection type of the ceramicized calcium phosphate bone cement, and the steps can include:
  • Step S31 mix the ⁇ -TCP ceramic particles and calcium dihydrogen phosphate powder with the liquid phase in corresponding proportions to obtain the first semi-solid mixture and the second semi-solid with good injectability respectively.
  • Mixture since the first semi-solid mixture and the second semi-solid mixture are in a physical mixing state, no chemical reaction occurs, which facilitates long-term storage and transportation, laying the foundation for commercialization;
  • Step S32 Mix the first semi-solid mixture and the second semi-solid mixture by stirring and mixing to form a pasty first intermediate of the ceramic calcium phosphate bone cement.
  • the first intermediate The body has good fluidity and injectability, providing corresponding operating time and convenience for clinical application; and, the first intermediate forms a paste-like second intermediate through a partial self-curing reaction, and the second intermediate has Very good plasticity, convenient for clinical application; Then, the second intermediate forms the solid ceramic calcium phosphate bone cement with strength through a complete self-curing reaction to achieve the final clinical treatment goal.
  • disodium dihydrogen pyrophosphate and sodium hydroxide can also be added to the distilled water, that is, the liquid phase is disodium dihydrogen pyrophosphate, sodium hydroxide and distilled water.
  • calcium sulfate powder as a retarder can also be added to the second semi-solid mixture to improve the operation and curing time of the ceramic calcium phosphate bone cement.
  • the first semi-solid mixture is a paste or paste-like semi-solid mixture containing the ⁇ -TCP ceramic particles
  • the second semi-solid mixture is a paste or paste containing the calcium dihydrogen phosphate powder.
  • the proportion of the ⁇ -TCP ceramic particles to the total weight of the first semi-solid mixture can be 5% to 95%
  • the proportion of the calcium dihydrogen phosphate powder to the total weight of the second semi-solid mixture can be is 5% to 95%
  • the proportion of the calcium sulfate powder to the total weight of the second semi-solid mixture can be 5% to 50%
  • the proportion of the disodium dihydrogen pyrophosphate to the total weight of the first semi-solid mixture and the second semi-solid mixture can be 0.1% to 30% respectively
  • the sodium hydroxide accounts for the first half of the total weight.
  • the proportion of the total weight of the solid mixture and the second semi-solid mixture can be 0.1% ⁇ 30% respectively.
  • the purity of the ⁇ -TCP ceramic particles, the calcium dihydrogen phosphate powder, the calcium sulfate powder, the disodium dihydrogen pyrophosphate and sodium hydroxide are all greater than 95%.
  • step S3 by adjusting the particle size, morphology and proportion of the ⁇ -TCP ceramic particles to the total weight of the solid phase and the first semi-solid mixture, the ceramic calcium phosphate can be regulated
  • the operating time of the bone cement i.e., in the early stage of the chemical reaction, the ceramic calcium phosphate bone cement has good fluidity and injectability, and the doctor has enough operating time
  • curing time mechanical properties and degradation properties after curing.
  • the solid phase and the described solid phase can be mixed according to the quality requirements of the ceramic calcium phosphate bone cement (i.e., operating time, curing time, mechanical properties and degradation properties after curing, etc.)
  • the liquid phase is mixed in a certain proportion and the first semi-solid mixture and the second semi-solid mixture are mixed in a certain proportion, and then the first intermediate of the ceramic calcium phosphate bone cement is obtained; then, in the After the first intermediate partially self-cures to form the second intermediate, the second intermediate is injected into the treatment target site to perform an in-situ solidification reaction until it is completely solidified into the ceramic calcium phosphate bone cement.
  • the surface of the ⁇ -TCP ceramic particles is mixed with the diphosphate
  • a chemical reaction occurs between hydrogen calcium powders to form calcium phosphate (DCPD).
  • DCPD calcium phosphate
  • the chemical reaction formula for the formation of calcium phosphate is as follows:
  • the particle size of the ⁇ -TCP ceramic particles is much larger than the particle size of the powder material, and the structure of the ⁇ -TCP ceramic particles is more stable than the powder material.
  • the ceramic calcium phosphate bone cement is stronger, has higher chemical stability, and has better controllability of degradation properties, thus making the ceramic Calcium phosphate bone cement will not be dispersed into small-sized (for example, 1.5 ⁇ m in diameter) particles during the degradation process of the treatment site, but will slowly dissolve and degrade, thereby reducing the inflammatory response.
  • the ceramic calcium phosphate bone cement will undergo a biological reaction, that is, the calcium phosphate bone cement will gradually transform into hydroxyapatite (HA), and the unreacted ⁇ -TCP wrapped by the calcium phosphate bone cement will gradually transform into hydroxyapatite (HA).
  • the ceramic particles gradually transform into biological hydroxyapatite.
  • the ceramic calcium phosphate bone cement releases calcium ions and phosphorus ions, which can promote and/or induce bone regeneration and provide a scaffold for blood vessel ingrowth and new bone formation, thereby achieving guidance. and/or induce new bone formation, while at the same time, the material can be completely degraded and absorbed.
  • the preparation method of ceramic calcium phosphate bone cement of the present invention provides a plastic or injectable self-curing bone repair material; and, due to the use of ⁇ -TCP ceramic particles and calcium dihydrogen phosphate powder in the ceramic
  • the ceramic calcium phosphate bone cement is obtained from the self-curing reaction in the liquid phase of the ceramic calcium phosphate bone cement, which makes the ceramic calcium phosphate bone cement have higher chemical stability, better operability, and stronger mechanical properties.
  • the degradation performance is more controllable; especially after implantation in the body, it can avoid or reduce the inflammatory response and tissue and organ damage caused by the generation of degradation particles.
  • One embodiment of the present invention provides a ceramic calcium phosphate bone cement, which is prepared by the preparation method of the ceramic calcium phosphate bone cement provided by the present invention, so that the chemical stability of the ceramic calcium phosphate bone cement is higher. It has better operability, stronger mechanical properties, and more controllable degradation performance; especially after being implanted in the body, it can avoid or reduce the inflammatory reaction and damage to tissues and organs caused by the generation of degraded particles.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Ceramic Engineering (AREA)
  • Inorganic Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Materials Engineering (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Structural Engineering (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Materials For Medical Uses (AREA)

Abstract

La présente invention concerne un ciment osseux à base de céramique et de phosphate de calcium, ainsi que son procédé de préparation. Le procédé de préparation du ciment osseux à base de céramique et de phosphate de calcium consiste : à préparer une particule de céramique β-TCP ; à sélectionner une eau distillée comme phase liquide du ciment osseux à base de céramique et de phosphate de calcium ; et à utiliser la particule de céramique β-TCP et une poudre de dihydrogénophosphate de calcium pour déclencher une réaction d'auto-durcissement dans la phase liquide pour obtenir le ciment osseux à base de céramique et de phosphate de calcium. Par utilisation de processus de préparation tels qu'un procédé de mélange et un procédé d'homogénéisation, le ciment osseux à base de céramique et de phosphate de calcium moulable et à injection sont respectivement formés. La solution technique de la présente invention accroît la stabilité chimique du ciment osseux à base de céramique et de phosphate de calcium, améliore l'efficacité fonctionnelle, renforce la propriété mécanique, permet une meilleure régulation de la dégradabilité et peut éviter ou réduire une réponse inflammatoire et l'endommagement tissulaire d'organes provoqués par une particule dégradée, en particulier après l'implantation in vivo du ciment osseux à base de céramique et de phosphate de calcium.
PCT/CN2023/079716 2022-03-14 2023-03-06 Ciment osseux à base de céramique et de phosphate de calcium et son procédé de préparation WO2023174079A1 (fr)

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CN114591066B (zh) * 2022-03-14 2023-03-17 卢霄 陶瓷化磷酸钙骨水泥及其制备方法
CN114956026A (zh) * 2022-06-09 2022-08-30 卢霄 精准原子配对悬浮合成磷酸钙粉体方法
CN117122733B (zh) * 2023-04-28 2024-05-17 鹏拓生物科技(杭州)有限公司 一种高强度-速固化磷酸盐骨水泥及其制备方法

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