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JP5678361B2 - Artificial bone material - Google Patents
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JP5678361B2 - Artificial bone material - Google Patents

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JP5678361B2
JP5678361B2 JP2010115215A JP2010115215A JP5678361B2 JP 5678361 B2 JP5678361 B2 JP 5678361B2 JP 2010115215 A JP2010115215 A JP 2010115215A JP 2010115215 A JP2010115215 A JP 2010115215A JP 5678361 B2 JP5678361 B2 JP 5678361B2
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artificial bone
bone material
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sodium
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怜 本島
怜 本島
井上 晃
晃 井上
公彰 高見
公彰 高見
希 小松
希 小松
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Osferionbiomaterials Corp
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Olympus Terumo Biomaterials Corp
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Description

本発明は、人工骨材料に関するものである。   The present invention relates to an artificial bone material.

従来、リン酸ナトリウムカルシウムとクエン酸塩硬化剤とを含むセメントが知られている(例えば、特許文献1参照。)。
このセメントによれば高い生体適合性を有し、硬化前に整形可能なペーストが形成され取り扱い容易である。
Conventionally, a cement containing sodium calcium phosphate and a citrate hardener is known (for example, see Patent Document 1).
This cement has high biocompatibility and is easy to handle because a paste that can be shaped before curing is formed.

特表平9−509583号公報Japanese National Patent Publication No. 9-509583

しかしながら、特許文献1のセメントは、体液等の液中にて硬化させる用途においては十分な強度が得られないという不都合がある。
本発明は、上述した事情に鑑みてなされたものであって、液中で硬化させる用途においても高い強度を得ることができる人工骨材料を提供することを目的としている。
However, the cement of Patent Document 1 has a disadvantage that sufficient strength cannot be obtained in applications in which it is cured in a liquid such as a body fluid.
This invention is made | formed in view of the situation mentioned above, Comprising: It aims at providing the artificial bone material which can obtain high intensity | strength also in the use hardened in a liquid.

上記目的を達成するために、本発明は以下の手段を提供する。
本発明は、カルシウム/ナトリウム比率が1/1以上3/1以下の範囲内のリン酸ナトリウムカルシウム粉末と、αリン酸三カルシウムと、βリン酸三カルシウムとを含み、前記リン酸ナトリウムカルシウム粉末の平均粒径が、300μm以下であり、前記αリン酸三カルシウムが、平均粒径5以上15μm未満の粉末である人工骨材料を提供する。
In order to achieve the above object, the present invention provides the following means.
The present invention includes a sodium calcium phosphate powder having a calcium / sodium ratio in the range of 1/1 to 3/1, α-tricalcium phosphate, and β-tricalcium phosphate, and the sodium calcium phosphate powder the average particle diameter of, 300 [mu] m Ri der hereinafter the α-tricalcium phosphate provides the average particle size of 5 or more 15μm less powder der Ru artificial bone material.

本発明によれば、適量の蒸留水とともに混練して整形可能なペーストを形成し、整形直後に生理食塩水等の液中に浸漬して養生した後においても、骨として必要とされる最低限の強度である5MPaより大きな強度を得ることができる。すなわち、液中で硬化させる用途に適用しても骨として十分に機能させ得る高い強度を得ることができる。
特に、上記発明においては、リン酸ナトリウムカルシウム粉末の平均粒径を300μmとすることにより、上記カルシウム/ナトリウム比率が1/1以上3/1以下の範囲内において15MPaの圧縮強度を達成でき、液中においても皮質骨として十分に機能させ得る高い強度を得ることができる。
According to the present invention, a paste that can be shaped by kneading with an appropriate amount of distilled water to form a paste that can be shaped and immersed in a solution of physiological saline or the like immediately after shaping and then cured as a minimum A strength greater than 5 MPa, which is the strength of the above, can be obtained. That is, even if it is applied to an application for curing in a liquid, a high strength that can sufficiently function as bone can be obtained.
In particular, in the above invention, by setting the average particle size of the sodium calcium phosphate powder to 300 μm, a compressive strength of 15 MPa can be achieved within the range of the calcium / sodium ratio of 1/1 to 3/1, Even inside, high strength that can sufficiently function as cortical bone can be obtained.

上記発明においては、前記αリン酸三カルシウムが、平均粒径5以上15μm未満の粉末である。
このようにすることで、上記カルシウム/ナトリウム比率が1/1以上3/1以下の範囲内において15MPaの圧縮強度を達成でき、液中においても皮質骨として十分に機能させ得る高い強度を得ることができる。
In the above invention, the α tricalcium phosphate, Ru powder der less than 15μm mean particle size of 5 or more.
By doing in this way, the compressive strength of 15 MPa can be achieved within the above-mentioned calcium / sodium ratio range of 1/1 or more and 3/1 or less, and high strength that can sufficiently function as cortical bone even in liquid is obtained. Can do.

また、上記発明においては、前記βリン酸三カルシウムが、平均粒径300以上500μm未満の粉末であることが好ましい。
このようにすることで、上記カルシウム/ナトリウム比率が1/1以上3/1以下の範囲内において15MPaの圧縮強度を達成でき、液中においても皮質骨として十分に機能させ得る高い強度を得ることができる。
Moreover, in the said invention, it is preferable that the said beta tricalcium phosphate is a powder with an average particle diameter of 300-500 micrometers.
By doing in this way, the compressive strength of 15 MPa can be achieved within the above-mentioned calcium / sodium ratio range of 1/1 or more and 3/1 or less, and high strength that can sufficiently function as cortical bone even in liquid is obtained. Can do.

本発明によれば、液中で硬化させる用途においても高い強度を得ることができるという効果を奏する。   According to the present invention, there is an effect that a high strength can be obtained even in an application for curing in a liquid.

本発明の第1の実施形態に係る人工骨材料を構成するリン酸ナトリウムカルシウム粉末の平均粒径(目開き)をパラメータとした、カルシウム/ナトリウム比率と圧縮強度との関係のグラフを示す図である。It is a figure which shows the graph of the relationship between calcium / sodium ratio and compressive strength which made the average particle diameter (opening) of the sodium calcium phosphate powder which comprises the artificial bone material which concerns on the 1st Embodiment of this invention a parameter. is there. 本発明の第2の実施形態に係る人工骨材料を構成するαリン酸三カルシウム粉末の平均粒径(目開き)をパラメータとした、カルシウム/ナトリウム比率と圧縮強度との関係のグラフを示す図である。The figure which shows the graph of the relationship between a calcium / sodium ratio and compressive strength by making into a parameter the average particle diameter (opening) of (alpha) tricalcium phosphate powder which comprises the artificial bone material which concerns on the 2nd Embodiment of this invention. It is. 本発明の第3の実施形態に係る人工骨材料を構成するβリン酸三カルシウム粉末の平均粒径(目開き)をパラメータとした、カルシウム/ナトリウム比率と圧縮強度との関係のグラフを示す図である。The figure which shows the graph of the relationship between calcium / sodium ratio and compressive strength which made the average particle diameter (opening) of (beta) tricalcium phosphate powder which comprises the artificial bone material which concerns on the 3rd Embodiment of this invention as a parameter. It is.

本発明の第1の実施形態に係る人工骨材料について、図1を参照して以下に説明する。
本実施形態に係る人工骨材料は、カルシウム/ナトリウム比率が1/1以上3/1以下の範囲内のリン酸ナトリウムカルシウム粉末を含み、αリン酸三カルシウム(以下、α−TCP)および、βリン酸三カルシウム(以下、β−TCP)を含んでいる。また、本実施形態に係る人工骨材料は、リン酸ナトリウムカルシウム粉末の平均粒径が300μmである。
The artificial bone material according to the first embodiment of the present invention will be described below with reference to FIG.
The artificial bone material according to the present embodiment includes sodium calcium phosphate powder having a calcium / sodium ratio in the range of 1/1 to 3/1, α-tricalcium phosphate (hereinafter α-TCP), and β It contains tricalcium phosphate (hereinafter β-TCP). In the artificial bone material according to the present embodiment, the average particle diameter of the sodium calcium phosphate powder is 300 μm.

図1は、メカノケミカル法を用いて合成されたリン酸カルシウムナトリウム(CSP)におけるカルシウム/ナトリウム比率(Ca/Na)を変化させたときの圧縮強度を、含有するリン酸ナトリウムカルシウム粉末の平均粒径をパラメータとして棒グラフで表示した図である。   FIG. 1 shows the compressive strength when the calcium / sodium ratio (Ca / Na) in calcium sodium phosphate (CSP) synthesized using the mechanochemical method is changed, and the average particle diameter of the sodium calcium phosphate powder contained therein. It is the figure displayed by the bar graph as a parameter.

ここで、CSP1〜7のカルシウム/ナトリウム比率は以下の通りである。
CSP1 Ca/Na=4/1
CSP2 Ca/Na=3/1
CSP3 Ca/Na=5/2
CSP4 Ca/Na=2/1
CSP5 Ca/Na=702/465
CSP6 Ca/Na=23/20
CSP7 Ca/Na=1/1
Here, the calcium / sodium ratio of CSP1-7 is as follows.
CSP1 Ca / Na = 4/1
CSP2 Ca / Na = 3/1
CSP3 Ca / Na = 5/2
CSP4 Ca / Na = 2/1
CSP5 Ca / Na = 702/465
CSP6 Ca / Na = 23/20
CSP7 Ca / Na = 1/1

各CSPは、1100℃で10時間焼成し、得られたCSP粉末を粉砕し、目開き(平均粒径)が106μm、300μm、500μmの3種類に篩い分けた。
各平均粒径のCSPをそれぞれ0.7g、α−TCPを0.3g、β−TCPを0.1g量り取り、さらに無水クエン酸を0.2g加えて混合した。そして、0.2mLの練和液(例えば、蒸留水)を添加して混練することによりセメントを作成し、作成後、5分以内にセメントを直径7mm、高さ10mmの円柱状に整形し、整形後、直ちに生理食塩水中に浸漬して100時間養生させた。
圧縮強度の測定は、生理食塩水中での養生後に行った。
Each CSP was baked at 1100 ° C. for 10 hours, the obtained CSP powder was pulverized, and sieved into three types having an opening (average particle size) of 106 μm, 300 μm, and 500 μm.
0.7 g of CSP of each average particle size, 0.3 g of α-TCP and 0.1 g of β-TCP were weighed out, and 0.2 g of citric anhydride was further added and mixed. Then, a cement is prepared by adding and kneading 0.2 mL of a kneading liquid (for example, distilled water). Immediately after shaping, it was immersed in physiological saline and allowed to cure for 100 hours.
The compressive strength was measured after curing in physiological saline.

図1によれば、カルシウム/ナトリウム比率が1/1以上3/1以下の範囲内であれば、平均粒径が300μm以下の場合、すなわち、目開き106μmおよび300μmの場合に、5MPa以上の圧縮強度を得ることができ、目開き300μmの場合に、15MPa以上の圧縮強度を得ることができた。すなわち、これらの条件を満たす本実施形態に係る人工骨材料CSP2〜CSP7によれば、骨として機能させるための5MPa以上の圧縮強度および皮質骨として機能させるための15MPa以上の圧縮強度を達成できるという利点がある。   According to FIG. 1, when the calcium / sodium ratio is in the range of 1/1 to 3/1, the compression is 5 MPa or more when the average particle size is 300 μm or less, that is, when the openings are 106 μm and 300 μm. The strength could be obtained, and a compressive strength of 15 MPa or more could be obtained when the mesh opening was 300 μm. That is, according to the artificial bone materials CSP2 to CSP7 according to the present embodiment satisfying these conditions, a compressive strength of 5 MPa or more for functioning as bone and a compressive strength of 15 MPa or more for functioning as cortical bone can be achieved. There are advantages.

そして、このように構成された本実施形態に係る人工骨材料によれば、液中において硬化させる用途、例えば、体液で満たされている骨欠損部等に補填する場合においても、骨として機能し得る十分な圧縮強度を発揮することができるという利点がある。   And, according to the artificial bone material according to the present embodiment configured as described above, it functions as a bone even in an application for hardening in a liquid, for example, in a case where a bone defect part filled with a body fluid is compensated. There is an advantage that sufficient compressive strength can be exhibited.

次に、本発明の第2の実施形態に係る人工骨材料について、図2を参照して以下に説明する。
本実施形態に係る人工骨材料は、α−TCP粉末の平均粒径が5μm以上15μm未満である点で、第1の実施形態に係る人工骨材料と相違している。
Next, an artificial bone material according to a second embodiment of the present invention will be described below with reference to FIG.
The artificial bone material according to the present embodiment is different from the artificial bone material according to the first embodiment in that the average particle diameter of the α-TCP powder is 5 μm or more and less than 15 μm.

α−TCP粉末として、平均粒径5μm未満、5μm以上15μm未満および15μm以上の3種類を用意し、上記と同様にして混練、整形したセメントの圧縮強度測定を行った。
その結果、図2に示されるように、α−TCP粉末の平均粒径が5μm以上15μm未満である本実施形態に係る人工骨材料によれば、カルシウム/ナトリウム比率が1/1以上3/1以下の範囲内であれば、15MPa以上の圧縮強度を得ることができた。
Three types of α-TCP powder having an average particle size of less than 5 μm, 5 μm or more and less than 15 μm and 15 μm or more were prepared, and the compressive strength of the cement kneaded and shaped in the same manner as described above was measured.
As a result, as shown in FIG. 2, according to the artificial bone material according to this embodiment in which the average particle diameter of the α-TCP powder is 5 μm or more and less than 15 μm, the calcium / sodium ratio is 1/1 or more and 3/1. Within the following range, a compressive strength of 15 MPa or more could be obtained.

このように構成された本実施形態に係る人工骨材料によれば、液中において硬化させる用途、例えば、体液で満たされている骨欠損部等に補填する場合においても、皮質骨として機能し得る十分な圧縮強度を発揮することができるという利点がある。   According to the artificial bone material according to the present embodiment configured as described above, it can function as a cortical bone even when it is used for hardening in a liquid, for example, in a case where a bone defect filled with a body fluid is compensated. There is an advantage that sufficient compressive strength can be exhibited.

次に、本発明の第3の実施形態に係る人工骨材料について、図3を参照して以下に説明する。
本実施形態に係る人工骨材料は、β−TCP粉末の平均粒径が300μm以上500μm未満である点で、第1の実施形態に係る人工骨材料と相違している。
Next, an artificial bone material according to a third embodiment of the present invention will be described below with reference to FIG.
The artificial bone material according to the present embodiment is different from the artificial bone material according to the first embodiment in that the average particle size of β-TCP powder is 300 μm or more and less than 500 μm.

β−TCP粉末として、平均粒径300μm未満、300μm以上500μm未満および500μm以上の3種類を用意し、上記と同様にして混練、整形したセメントの圧縮強度測定を行った。
その結果、図3に示されるように、β−TCP粉末の平均粒径が300μm以上500μm未満である本実施形態に係る人工骨材料によれば、カルシウム/ナトリウム比率が1/1以上3/1以下の範囲内であれば、15MPa以上の圧縮強度を得ることができた。
Three types of β-TCP powder having an average particle size of less than 300 μm, 300 μm or more and less than 500 μm and 500 μm or more were prepared, and the compressive strength of the cement kneaded and shaped as described above was measured.
As a result, as shown in FIG. 3, according to the artificial bone material according to this embodiment in which the average particle size of the β-TCP powder is 300 μm or more and less than 500 μm, the calcium / sodium ratio is 1/1 or more and 3/1. Within the following range, a compressive strength of 15 MPa or more could be obtained.

このように構成された本実施形態に係る人工骨材料によれば、液中において硬化させる用途、例えば、体液で満たされている骨欠損部等に補填する場合においても、皮質骨として機能し得る十分な圧縮強度を発揮することができるという利点がある。   According to the artificial bone material according to the present embodiment configured as described above, it can function as a cortical bone even when it is used for hardening in a liquid, for example, in a case where a bone defect filled with a body fluid is compensated. There is an advantage that sufficient compressive strength can be exhibited.

Claims (3)

カルシウム/ナトリウム比率が1/1以上3/1以下の範囲内のリン酸ナトリウムカルシウム粉末と、αリン酸三カルシウムと、βリン酸三カルシウムとを含み、
前記リン酸ナトリウムカルシウム粉末の平均粒径が、300μm以下であり、
前記αリン酸三カルシウムが、平均粒径5以上15μm未満の粉末である人工骨材料。
Sodium calcium phosphate powder having a calcium / sodium ratio in the range of 1/1 to 3/1, α-tricalcium phosphate, and β-tricalcium phosphate,
The average particle diameter of the sodium calcium phosphate powder state, and are less 300 [mu] m,
The α-tricalcium phosphate, Ru powder der less than 15μm mean particle size of 5 or more artificial bone material.
前記リン酸ナトリウムカルシウム粉末の平均粒径が、300μmである請求項1に記載の人工骨材料。   The artificial bone material according to claim 1, wherein the sodium calcium phosphate powder has an average particle size of 300 μm. 前記βリン酸三カルシウムが、平均粒径300以上500μm未満の粉末である請求項1または請求項2に記載の人工骨材料。   The artificial bone material according to claim 1 or 2, wherein the β-tricalcium phosphate is a powder having an average particle size of 300 or more and less than 500 µm.
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