Preparation method of composite bone repair material

Abstract

The invention belongs to the technical field of preparation of composite bone repair materials, and particularly relates to a preparation method of a composite bone repair material, which comprises the following steps: step 1, raw material selection and proportioning: firstly, selecting raw materials with good biocompatibility, degradability and bone induction and bone conduction capabilities, and preparing a raw material mixture; wherein the raw materials comprise biological ceramics (hydroxyapatite and beta-tricalcium phosphate) and high-molecular polymers (polylactic acid, polyglycolic acid and copolymers thereof), and the preparation method of the composite bone repair material has the beneficial effects that the raw materials with good biocompatibility, degradability and bone induction and bone conduction capabilities are selected, so that the composite bone repair material is prepared; the material can stably exist in a human body, cannot cause serious inflammatory reaction or rejection reaction, is beneficial to long-term application of the material and regeneration of new bones, can be gradually degraded after being implanted into the human body, and is replaced by new bone tissues, so that the need of taking out by a secondary operation is avoided.

Description

Technical Field

[0001] The present invention belongs to the technical field of composite bone repair material preparation, and in particular relates to a method for preparing the composite bone repair material. Background Art

[0002] Spinal fusion plays an important role in reconstructing spinal stability, restoring normal spinal sequence, and relieving pain. In recent years, with the continuous improvement and development of spinal fixation devices and bone graft materials, the bone graft fusion rate has increased significantly, but spinal stability can ultimately only be achieved through bony fusion.

[0003] However, the existing composite bone repair materials still have problems such as poor protection against inflammatory or rejection reactions, poor degradation effects, and poor support stability. Summary of the Invention

[0004] In order to solve the problems raised in the above background technology, the present invention provides a method for preparing a composite bone repair material, which has the characteristics of good protection effect against inflammatory reaction or rejection reaction, good degradation effect and good support stability.

[0005] To achieve the above objectives, the present invention provides the following technical solution: a method for preparing a composite bone repair material, comprising the following steps: Step 1, raw material selection and proportioning: first, selecting raw materials with excellent biocompatibility, degradability, and osteoinduction and osteoconduction capabilities, wherein the raw materials include bioceramics (hydroxyapatite and β-tricalcium phosphate), polymers (polylactic acid and polyglycolic acid and their copolymers), and growth factors, wherein the ratio of bioceramics, polymers, and growth factors is 1-5:2-8:3-12. By selecting raw materials with excellent biocompatibility, degradability, and osteoinduction and osteoconduction capabilities, the material can be stably present in the human body without causing severe inflammatory reactions or rejection reactions, which is conducive to the long-term application of the material and the regeneration of new bone. After implantation into the human body, the material can gradually degrade and be replaced by new bone tissue, avoiding the need for secondary surgical removal. At the same time, by adjusting the degradation rate of the material, it can be matched with the growth rate of bone tissue, thereby promoting the repair of bone defects. The excellent mechanical properties enable the material to withstand a certain load, maintain the stability of the bone defect site, and facilitate the regeneration and repair of new bone. Step 2: Solution preparation and mixing: Dissolve the matrix material in an appropriate chloroform solvent, mix it thoroughly and evenly by means of magnetic stirring and ultrasonic vibration, and evenly mix the prepared solution according to a predetermined ratio. Use 3D printing technology to process the mixed raw materials into the required shape and size to form a preliminary product prototype; Step 3: Separation and freeze drying: freeze-dry the formed product at -75--82 degrees Celsius for 40-70 hours to remove the solvent in the material; Step 4: Leaching and disinfection: Use an organic solvent to leach the material for 4-6 hours to remove residual organic solvent, unreacted raw materials or other impurities, and then disinfect the material by ultraviolet irradiation; Step 5. Performance testing: The prepared composite bone repair material is subjected to comprehensive performance testing, including mechanical properties (compressive strength and elastic modulus), degradation properties and biocompatibility (cytotoxicity test and subcutaneous implantation test), as well as osteoinduction and osteoconduction ability tests; Step 6. Storage and application: Store the prepared composite bone repair material in a dry, cool, and ventilated place, away from direct sunlight and high temperature environment, and take it out for use when needed.

[0006] Preferably, the mixing process in step 2 requires the use of an ultrasonic cleaner, a drying oven, a grinder and a sieve tool.

[0007] Preferably, the molding operation in step 2 requires the use of a 3D printer.

[0008] Preferably, an ultraviolet lamp and a plasma processor are required in step four.

[0009] Preferably, the universal testing machine, biological experimental equipment and bone induction experimental device.

[0010] Compared with the prior art, the present invention has the following beneficial effects: 1. The present invention selects raw materials with excellent biocompatibility, degradability, and osteoinduction and osteoconduction capabilities. These materials can exist stably in the human body without causing severe inflammatory reactions or rejection reactions, which is conducive to the long-term application of the materials and the regeneration of new bone. After implantation into the human body, they can gradually degrade and be replaced by new bone tissue, avoiding the need for secondary surgery to remove them. At the same time, by adjusting the degradation rate of the material, it can be matched with the growth rate of bone tissue, promoting the repair of bone defects. The excellent mechanical properties enable the material to withstand a certain load, maintain the stability of the bone defect site, and promote the regeneration and repair of new bone. DETAILED DESCRIPTION

[0011] The following is a clear and complete description of the technical solutions in the embodiments of the present invention. Obviously, the embodiments described are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making any creative efforts are within the scope of protection of the present invention. Example

[0012] The present invention provides the following technical solution: a method for preparing a composite bone repair material, comprising the following steps: Step 1, selecting and proportioning raw materials: first, selecting raw materials with good biocompatibility, degradability, and osteoinduction and osteoconduction capabilities, wherein the raw materials include bioceramics (hydroxyapatite and β-tricalcium phosphate), polymers (polylactic acid and polyglycolic acid and copolymers thereof), and growth factors, wherein the ratio of bioceramics, polymers, and growth factors is 1-5:2-8:3-12; Step 2: Solution preparation and mixing: Dissolve the matrix material in an appropriate chloroform solvent, mix it thoroughly and evenly by means of magnetic stirring and ultrasonic vibration, and evenly mix the prepared solution according to a predetermined ratio. Use 3D printing technology to process the mixed raw materials into the required shape and size to form a preliminary product prototype; Step 3: Separation and freeze drying: freeze-dry the formed product at -75--82 degrees Celsius for 40-70 hours to remove the solvent in the material; Step 4: Leaching and disinfection: Use an organic solvent to leach the material for 4-6 hours to remove residual organic solvent, unreacted raw materials or other impurities, and then disinfect the material by ultraviolet irradiation; Step 5. Performance testing: The prepared composite bone repair material is subjected to comprehensive performance testing, including mechanical properties (compressive strength and elastic modulus), degradation properties and biocompatibility (cytotoxicity test and subcutaneous implantation test), as well as osteoinduction and osteoconduction ability tests; Step 6. Storage and application: Store the prepared composite bone repair material in a dry, cool, and ventilated place, away from direct sunlight and high temperature environment, and take it out for use when needed.

[0013] Specifically, the mixing process in step 2 requires an ultrasonic cleaner, a drying oven, a grinder and a sieve tool.

[0014] Specifically, the molding operation in step 2 requires the use of a 3D printer.

[0015] Specifically, step 4 requires the use of an ultraviolet lamp and a plasma processor.

[0016] Specifically, the universal testing machine, biological experimental equipment and bone induction experimental device.

[0017] The working principle and use process of the present invention: Step 1: Raw material selection and ratio: First, select raw materials with good biocompatibility, degradability, osteoinduction and osteoconduction capabilities. The raw materials include bioceramics (hydroxyapatite and β-tricalcium phosphate), polymers (polylactic acid and polyglycolic acid and their copolymers), and growth factors. The ratio of bioceramics, polymers, and growth factors is 1-5:2-8:3-12; Step 2: Solution preparation and mixing: Dissolve the matrix material in an appropriate chloroform solvent, mix it thoroughly and evenly by means of magnetic stirring and ultrasonic vibration, and evenly mix the prepared solution according to a predetermined ratio. Use 3D printing technology to process the mixed raw materials into the required shape and size to form a preliminary product prototype; Step 3: Separation and freeze drying: freeze-dry the formed product at -75--82 degrees Celsius for 40-70 hours to remove the solvent in the material; Step 4: Leaching and disinfection: Use an organic solvent to leach the material for 4-6 hours to remove residual organic solvent, unreacted raw materials or other impurities, and then disinfect the material by ultraviolet irradiation; Step 5. Performance testing: The prepared composite bone repair material is subjected to comprehensive performance testing, including mechanical properties (compressive strength and elastic modulus), degradation properties and biocompatibility (cytotoxicity test and subcutaneous implantation test), as well as osteoinduction and osteoconduction ability tests; Step 6. Storage and application: Store the prepared composite bone repair material in a dry, cool, and ventilated place, away from direct sunlight and high temperature environment, and take it out for use when needed.

[0018] Finally, it should be noted that the above descriptions are merely preferred embodiments of the present invention and are not intended to limit the present invention. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art will be able to modify the technical solutions described in the aforementioned embodiments or substitute equivalents for some of the technical features. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention shall be included within the scope of protection of the present invention.

Claims

1. A method for preparing a composite bone repair material, comprising the following steps, characterized in that: Step 1: Raw material selection and ratio: First, select raw materials with good biocompatibility, degradability, osteoinduction and osteoconduction capabilities. The raw materials include bioceramics (hydroxyapatite and β-tricalcium phosphate), polymers (polylactic acid and polyglycolic acid and their copolymers), and growth factors. The ratio of bioceramics, polymers, and growth factors is 1-5:2-8:3-12; Step 2: Solution preparation and mixing: Dissolve the matrix material in an appropriate chloroform solvent, mix it thoroughly and evenly by means of magnetic stirring and ultrasonic vibration, and evenly mix the prepared solution according to a predetermined ratio. Use 3D printing technology to process the mixed raw materials into the required shape and size to form a preliminary product prototype; Step 3: Separation and freeze drying: freeze-dry the formed product at -75--82 degrees Celsius for 40-70 hours to remove the solvent in the material; Step 4: Leaching and disinfection: Use an organic solvent to leach the material for 4-6 hours to remove residual organic solvent, unreacted raw materials or other impurities, and then disinfect the material by ultraviolet irradiation; Step 5. Performance testing: The prepared composite bone repair material is subjected to comprehensive performance testing, including mechanical properties (compressive strength and elastic modulus), degradation properties and biocompatibility (cytotoxicity test and subcutaneous implantation test), as well as osteoinduction and osteoconduction ability tests; Step 6. Storage and application: Store the prepared composite bone repair material in a dry, cool, and ventilated place, away from direct sunlight and high temperature environment, and take it out for use when needed.

2. The method for preparing a composite bone repair material according to claim 1, characterized in that: The mixing process in step 2 requires an ultrasonic cleaner, a drying oven, a grinder and a sieve tool.

3. The method for preparing a composite bone repair material according to claim 1, characterized in that: The molding operation in step 2 requires a 3D printer.

4. The method for preparing a composite bone repair material according to claim 1, wherein: In step 4, an ultraviolet lamp and a plasma processor are required.

5. The method for preparing a composite bone repair material according to claim 1, characterized in that: The universal testing machine, biological experimental equipment and bone induction experimental device.