CN113274551A - Absorbable bone cement regeneration repair material - Google Patents
Absorbable bone cement regeneration repair material Download PDFInfo
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- CN113274551A CN113274551A CN202110502348.0A CN202110502348A CN113274551A CN 113274551 A CN113274551 A CN 113274551A CN 202110502348 A CN202110502348 A CN 202110502348A CN 113274551 A CN113274551 A CN 113274551A
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- A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
- A61L27/3641—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the site of application in the body
- A61L27/3645—Connective tissue
- A61L27/365—Bones
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- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
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- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
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- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- 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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- 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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- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants
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Abstract
The invention discloses an absorbable bone cement regeneration and repair material. Comprises a variant bone, polycaprolactone and metal magnesium powder. The invention selects the allogeneic bone product as the powder of the bone cement, and the liquid phase of the bone cement selects and uses the polycaprolactone which has good biocompatibility, good organic polymer compatibility and good biodegradability, can be used as a cell growth supporting material, can be compatible with various conventional plastics and can be completely degraded in 6-12 months in natural environment. The research on the novel absorbable bone cement regeneration repair material is expected to achieve the mechanical strength of cancellous bone, has injectability, fluidity and plasticity, and can remarkably improve the osteogenic activity and bone repair effect of bone cement; the research yield is expected to have significant clinical significance and social and economic values.
Description
Technical Field
The invention belongs to the technical field of preparation of bone repair materials, and particularly relates to an absorbable bone cement regeneration repair material.
Background
Solving the activity problem and pursuing degradability-osteogenesis matching balance of the bone cement repair material are always the great problems troubling orthopedists. The patient needs to bear the major impact that the bone cement material can not be degraded in the pain, and most of the selected materials of the bone cement material can not be degraded and have no osteogenic activity, so that the requirement of defect repair is often difficult to meet; deformity and secondary pain of postoperative defects in the donor area also cause continued injury to the patient.
The absorbable bone cement regeneration and repair material is prepared by mixing a liquid phase and powder, wherein the liquid phase is polycaprolactone, the powder is prepared by treating bone tissues through different processes, the bone tissues are cleaned and degreased, the antigen is removed through deep low-temperature freezing, the antigen is removed through high-temperature calcination, the antigen is removed through a reagent, and the like, so that the acellular bone matrix, the calcined bone matrix and the decalcified bone matrix are obtained. The acellular bone matrix, the calcined bone matrix and the decalcified bone matrix are clinically used for filling and repairing bone defects, fusing joints and spines, bone reconstruction surgery and the like.
Disclosure of Invention
The invention aims to provide an absorbable bone cement regeneration and repair material.
An absorbable bone cement regeneration and repair material comprises bone powder, polycaprolactone and metal magnesium powder.
The content of the polycaprolactone is 40-90% of the mass of the bone meal.
The content of the metal magnesium powder is 1-8% of the mass of the bone powder.
The bone powder is one or a mixture of a plurality of acellular bone matrixes, calcined bone matrixes and decalcified bone matrixes.
A preparation method of an absorbable bone cement regeneration and repair material comprises the following steps:
(1) grinding bone powder, melting polycaprolactone at 60-85 deg.C, adding bone powder into the melted polycaprolactone, and stirring;
(2) adding metal magnesium powder, stirring uniformly, placing into a grinding tool for shaping, and taking out after cooling.
The grinding adopts agate grinding, and the powder is sieved by a 16-200 mesh sieve after being ground.
The invention has the beneficial effects that: the invention selects and uses bone powder as the powder of bone cement, the liquid phase of the bone cement selects and uses Polycaprolactone (PCL) which has good biocompatibility, good organic polymer compatibility and good biodegradability, can be used as a cell growth supporting material, can be compatible with various conventional plastics and can be completely degraded in 6-12 months under the natural environment. The research on the novel absorbable bone cement regeneration repair material is expected to achieve the mechanical strength of cancellous bone, has injectability, fluidity and plasticity, and can remarkably improve the osteogenic activity and bone repair effect of bone cement; the research yield is expected to have significant clinical significance and social and economic values. The traditional PMMA bone cement is chemically crosslinked, harmful substances can be generated, certain damage is caused to surrounding bone tissues, and the absorbable bone cement regeneration and repair material is mixed through the physical characteristics of the material and can be naturally solidified after being implanted, so that the damage to the surrounding tissues is reduced.
Drawings
FIG. 1 shows the preparation process of commercially available bone meal.
FIG. 2 is an electron microscope image of 3 bone cement;
in the figure, A is PCL composite acellular matrix; b is PCL composite decalcified bone matrix; c is PCL composite calcined bone matrix.
Figure 3 is an X-ray diffraction pattern of a PCL composite acellular matrix bone cement (sample is the product prepared in example 1).
FIG. 4 shows the results of bone cement plasticity tests; the first on the left is the bone cement prepared in example 1, and the third is the bone cement of the control group.
Detailed Description
In order that the invention may be more fully understood, reference will now be made to the following description. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete.
The bone meal used in the following examples was obtained from bone meal stored in the fourth medical center of general hospital of the people's liberation army of China, which includes acellular matrix bone meal, calcined matrix bone meal, and decalcified matrix bone meal, and was prepared by the process shown in fig. 1.
EXAMPLE 1 PCL composite acellular matrix bone cement
An absorbable bone cement regeneration and repair material comprises the following raw material components in parts by weight: 100 parts of acellular bone matrix, 35 parts of polycaprolactone and 5 parts of metal magnesium powder.
The preparation method of the absorbable bone cement regeneration and repair material comprises the following steps:
(1) grinding the acellular bone matrix (adopting agate grinding, and sieving with a 80-mesh sieve after grinding), then melting polycaprolactone at 70 ℃, adding the acellular bone matrix into the melted polycaprolactone, and uniformly stirring;
(2) adding metal magnesium powder, stirring uniformly, placing into a grinding tool for shaping, and taking out after cooling.
EXAMPLE 2 PCL composite calcined bone matrix bone cement
An absorbable bone cement regeneration and repair material comprises the following raw material components in parts by weight: 100 parts of calcined bone matrix, 35 parts of polycaprolactone and 5 parts of metal magnesium powder.
The preparation method of the absorbable bone cement regeneration and repair material comprises the following steps:
(1) grinding the calcined bone matrix (agate grinding is adopted, and the ground bone matrix is sieved by a 80-mesh sieve), then melting polycaprolactone at 70 ℃, adding the calcined bone matrix into the melted polycaprolactone, and uniformly stirring;
(2) adding metal magnesium powder, stirring uniformly, placing into a grinding tool for shaping, and taking out after cooling.
Example 3 PCL composite decalcified bone matrix cement
An absorbable bone cement regeneration and repair material comprises the following raw material components in parts by weight: 100 parts of decalcified bone matrix, 35 parts of polycaprolactone and 5 parts of metal magnesium powder.
The preparation method of the absorbable bone cement regeneration and repair material comprises the following steps:
(1) grinding the decalcified bone matrix (agate grinding, sieving with 80 mesh sieve), melting polycaprolactone at 70 deg.C, adding the decalcified bone matrix into the melted polycaprolactone, and stirring;
(2) adding metal magnesium powder, stirring uniformly, placing into a grinding tool for shaping, and taking out after cooling.
Comparative example 1
An absorbable bone cement regeneration and repair material comprises the following raw material components in parts by weight: 100 parts of acellular bone matrix and 35 parts of polycaprolactone.
The preparation method of the absorbable bone cement regeneration and repair material comprises the following steps:
(1) grinding the acellular bone matrix (adopting agate grinding, and sieving with a 80-mesh sieve after grinding), then melting polycaprolactone at 70 ℃, adding the acellular bone matrix into the melted polycaprolactone, uniformly stirring, placing into a grinding tool for shaping, and taking out after cooling.
Comparative example 2
An absorbable bone cement regeneration and repair material comprises the following raw material components in parts by weight: 100 parts of calcined bone matrix and 35 parts of polycaprolactone.
The preparation method of the absorbable bone cement regeneration and repair material comprises the following steps:
(1) grinding the calcined bone matrix (agate grinding, sieving with a 80-mesh sieve after grinding), then melting polycaprolactone at 70 ℃, adding the calcined bone matrix into the melted polycaprolactone, uniformly stirring, placing into a grinding tool for shaping, and taking out after cooling.
Comparative example 3
An absorbable bone cement regeneration and repair material comprises the following raw material components in parts by weight: 100 parts of decalcified bone matrix and 35 parts of polycaprolactone.
The preparation method of the absorbable bone cement regeneration and repair material comprises the following steps:
(1) grinding the decalcified bone matrix (agate grinding, sieving with 80 mesh sieve), melting polycaprolactone at 70 deg.C, adding the decalcified bone matrix into the melted polycaprolactone, stirring, shaping in a grinding tool, cooling, and taking out.
Experimental example:
1. and (3) detecting mechanical strength:
the test items are a bending test (3-point bending), a tensile test, the bone cement regeneration repair materials of test examples 1 to 3 and comparative examples 1 to 3, and the sizes of the test pieces: 10x5x5mm, control was a commercially available PMMA bone cement. The test results are shown in table 1:
TABLE 1
Note: represents P <0.05 compared to the example 1 group.
SEM Electron microscopy
As shown in FIG. 2, the microstructure of the absorbable high-strength novel bone cement regeneration and repair material can be obviously seen through electron microscope observation.
3. Plasticity of
Bone cement was prepared according to the formulation and method of example 1, and the prepared material and control (commercially available PMMA bone cement) were placed in a circular mold with a diameter of 1CM, and the time and setting were recorded (fig. 4). It can be seen from fig. 4 that the bone cement prepared by the present invention is comparable in plasticity to the commercially available PMMA bone cement.
4. Cell experiments
4.1 cytotoxicity
The test method comprises the following steps:
leaching a sample: taking a sample, cutting into small pieces of about 1cm × 1cm, adding 1640 culture medium containing 10% serum according to the proportion of 0.2g/mL, and leaching at 37 ℃ for 72h for later use; blank control solution: the same batch of 1640 culture medium containing 10% serum is prepared by the same method.
The MTT test method specified in GB/T14233.2-2005 was followed. The cell suspension 1X 104/mL was seeded in 96-well plates at 100. mu.L per well in 5% CO2Culturing at 37 deg.C for 24 hr, and discarding the stock culture solution. Adding sample leaching solution, blank control solution, negative control solution and positive control solution, 100 μ L per well, placing in CO2Culturing at 37 deg.C for 72h, adding 5g/L MTT solution 20 μ L into each well, culturing for 4h, discarding the solution in the well, adding DMSO 150 μ L, shaking for 10min, and measuring absorbance (OD value) at 570nm and 630nm wavelength of microplate reader.
The relative cell proliferation rate (RGR) was calculated according to equation (1):
RGR ═ A/A0X 100% formula (1)
And (4) judging a result: judged according to RGR according to the ranking criteria of Table 1. The reaction of the negative control group is not more than grade 1, and the judgment result is reliable when the reaction of the positive control group is at least grade 3.
As a result: has no toxicity
4.2 cell adhesion
Well-growing cells were digested with 0.25% trypsin and seeded at 4 × 104 cells per well. The cells were incubated at 37 ℃ in a 5% CO2 incubator. Cell adhesion number determination: after the cells inoculated on the surface of the material were cultured for 5, 7, and 9 days, the culture wells were washed with PBS 2 times per well, non-adherent cells were removed, and the adherent cells were quantitatively analyzed using CCK-8.
5. In vitro degradation test
The materials are prepared according to proper proportion, and the materials of each group and a control group are prepared according to the same quality. Weighing, and sterilizing by irradiation. Filtering and sterilizing Simulated Body Fluid (SBF) in a super clean bench, filling the simulated body fluid into a sterile centrifuge tube, and mixing the Simulated Body Fluid (SBF) with the solution 20: 1, placing the mixed material (the mixed material is sterilized by irradiation) in a sealed way and placing the mixed material in a shaking table. After 3 months, the material was removed, dried naturally and weighed. The degradability was examined.
The test results are shown in table 2:
TABLE 2
Note: represents P <0.05 compared to the example 1 group.
X-ray diffraction
And (3) carrying out element crystal system analysis on the microstructure of the absorbable high-strength novel bone cement regeneration repair material obtained by using a microcomputer tomography with the X-ray energy of 70keV and a sample of metal magnesium powder cement of the PCL composite bone powder.
It can be seen from fig. 3 that the position 23 is the element crystal structure of PCL, and the positions on the left and right of 38 are the element crystal structure of hydroxyapatite.
In the investigation, the product in the existing market has no biodegradability, and the bone cement of the same product in the market is not easy to operate and use. The bone cement product is made of materials which meet the strength of the homogeneous bone and have certain strength. The materials used are selected and verified to be degradable through experiments. Experimental data of similar materials show that the biocompatibility is good.
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 (6)
1. An absorbable bone cement regeneration and repair material is characterized by comprising bone meal, polycaprolactone and metal magnesium powder.
2. The absorbable bone cement regeneration and repair material of claim 1, wherein the polycaprolactone is 40-90% of the bone powder.
3. The absorbable bone cement regeneration and repair material of claim 1, wherein the content of the magnesium metal powder is 1-8% of the mass of the bone powder.
4. The absorbable bone cement regeneration and repair material as claimed in claim 1, wherein the bone powder is one or more of acellular bone matrix, calcined bone matrix and decalcified bone matrix.
5. The preparation method of the absorbable bone cement regeneration and repair material is characterized by comprising the following steps:
(1) grinding bone powder, melting polycaprolactone at 60-85 deg.C, adding bone powder into the melted polycaprolactone, and stirring;
(2) adding metal magnesium powder, stirring uniformly, placing into a grinding tool for shaping, and taking out after cooling.
6. The preparation method of the absorbable bone cement regeneration repair material according to claim 5, wherein the grinding is performed by agate grinding, and the ground material is sieved by a 16-200 mesh sieve.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113577393A (en) * | 2021-08-27 | 2021-11-02 | 北京科健生物技术有限公司 | Bone repair material and preparation method and application thereof |
| CN115317670A (en) * | 2022-08-05 | 2022-11-11 | 武汉启思达科技发展有限公司 | Plastic calcined bone repair material and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2013036525A2 (en) * | 2011-09-09 | 2013-03-14 | Orthocon, Inc. | Absorbable multi-putty bone cements and hemostatic compositions and methods of use |
| CN109999223A (en) * | 2019-03-25 | 2019-07-12 | 山东百多安医疗器械有限公司 | Adjustable and controllable artificial bone repair system for repairing alveolar bone |
| TW202116363A (en) * | 2019-10-09 | 2021-05-01 | 百聯盛生醫股份有限公司 | Biodegrable and injectable bone composite and uses thereof |
| CN113616852A (en) * | 2021-08-23 | 2021-11-09 | 西北工业大学 | Magnesium powder/calcium phosphate composite bone cement material and preparation method thereof |
-
2021
- 2021-05-08 CN CN202110502348.0A patent/CN113274551A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2013036525A2 (en) * | 2011-09-09 | 2013-03-14 | Orthocon, Inc. | Absorbable multi-putty bone cements and hemostatic compositions and methods of use |
| CN109999223A (en) * | 2019-03-25 | 2019-07-12 | 山东百多安医疗器械有限公司 | Adjustable and controllable artificial bone repair system for repairing alveolar bone |
| TW202116363A (en) * | 2019-10-09 | 2021-05-01 | 百聯盛生醫股份有限公司 | Biodegrable and injectable bone composite and uses thereof |
| CN113616852A (en) * | 2021-08-23 | 2021-11-09 | 西北工业大学 | Magnesium powder/calcium phosphate composite bone cement material and preparation method thereof |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113577393A (en) * | 2021-08-27 | 2021-11-02 | 北京科健生物技术有限公司 | Bone repair material and preparation method and application thereof |
| CN113577393B (en) * | 2021-08-27 | 2023-02-10 | 北京科健生物技术有限公司 | Bone repair material and preparation method and application thereof |
| CN115317670A (en) * | 2022-08-05 | 2022-11-11 | 武汉启思达科技发展有限公司 | Plastic calcined bone repair material and preparation method thereof |
| CN115317670B (en) * | 2022-08-05 | 2023-11-07 | 武汉启思达科技发展有限公司 | Plastic calcined bone repair material and preparation method thereof |
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Application publication date: 20210820 |