JP7118132B2 - 骨代替材料用のキャリアー組成物 - Google Patents
骨代替材料用のキャリアー組成物 Download PDFInfo
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- B28—WORKING CEMENT, CLAY, OR STONE
- B28B—SHAPING CLAY OR OTHER CERAMIC COMPOSITIONS; SHAPING SLAG; SHAPING MIXTURES CONTAINING CEMENTITIOUS MATERIAL, e.g. PLASTER
- B28B3/00—Producing shaped articles from the material by using presses; Presses specially adapted therefor
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Description
(a)エチレンオキシド(EO)-プロピレンオキシド(PO)ブロックコポリマーまたはエチレンオキシド(EO)-プロピレンオキシド(PO)ブロックコポリマーの混合物;および
(b)シリカナノ粒子
を含むヒドロゲルである。
式中、ブロックの長さは約a=101およびb=56である。本発明のキャリアー組成物を製造するための出発物質としてのポロキサマー407の使用が特に好ましいが、ポロキサマー188などの他のポロキサマーも使用することができる。
・EO-POブロックコポリマーの割合が約10%~約40%(w/w)、シリカナノ粒子の割合が約2%~約12%(w/w);
・EO-POブロックコポリマーの割合が約15%~約37%(w/w)、シリカナノ粒子の割合が約3%~約10%(w/w);
・EO-POブロックコポリマーの割合が約20%~約30%(w/w)、シリカナノ粒子の割合が約3%~約6%(w/w);
・EO-POブロックコポリマーの割合が約20%~約25%(w/w)、シリカナノ粒子の割合が約3%~約5%(w/w)。
(a)1種のエチレンオキシド(EO)プロピレンオキシド(PO)ブロックコポリマーまたは複数種のエチレンオキシド(EO)-プロピレンオキシド(PO)ブロックコポリマーの混合物の水溶液と、
(b)シリカナノ粒子と
をお互いに混合すること、およびそれらをヒドロゲルに調製することを含む、粒子状および顆粒状骨代替材料用のキャリアー組成物を製造するためのプロセスに関する。両方の成分とも混合時に水溶液として好ましく入手可能である。
(a)上記のキャリアー組成物;ならびに
(b)骨伝導性および/または骨誘導性粒子あるいは骨伝導性および/または骨誘導性顆粒。
(a)上記のキャリアー組成物を提供すること;
(b)必要に応じて、ガンマ線でキャリアー組成物を処理すること;ならびに
(c)キャリアー組成物を骨伝導性および/または骨誘導性粒子あるいは骨伝導性および/または骨誘導性顆粒と混合すること
を含む、骨代替材料を製造するための方法も提供する。
(a)1種のエチレンオキシド(EO)-プロピレンオキシド(PO)ブロックコポリマーまたは複数種のエチレンオキシド(EO)-プロピレンオキシド(PO)ブロックコポリマーの混合物;および
(b)シリカナノ粒子。 製造には、上記で定義した骨伝導性および/または骨誘導性粒子あるいは骨伝導性および/または骨誘導性顆粒との混合が含まれる。
(a)上記のキャリアー組成物;ならびに
(b)上記の骨伝導性および/または骨誘導性粒子あるいは骨伝導性および/または骨誘導性顆粒。 骨欠損は、骨折、海綿骨欠損、または空洞であり得る。
比較のために、Kolliphor P 407を基礎とするSiO2フリーおよびSiO2含有ヒドロゲルを製造した。SiO2フリーヒドロゲルの製造のために、BASFからの23.5gのKolliphor P 407を76.5gの水と混合した。SiO2を含有するヒドロゲルの場合、SiO2濃度がそれぞれ4%および6%のイオン交換によってゾルを調製した。Merkの濃縮ナトリウム水ガラス溶液(仕様:Na2O:7.5~8.5%;SiO2:25.5~28.5%)を使用し、超純水で希釈した。Lewatit MonoPlus SP 112Na+カラムをイオン交換体として使用した。ゾルのpH値は2.7であり、5℃まで冷却した。各76.5gのゾルにおいて、23.5gのKolliphor P 407を撹拌した。得られたヒドロゲルは、図1(分子量分布A)に示す分子量分布のポリマーを含有する。分子量分布は、クロマトグラフィーによって決定することができる。分析により、以下のピークが得られた:
ピーク1:位置:5,550g/mol、割合:17.8%
ピーク2:位置:11,000g/mol、割合:8.2%
ピーク3:位置:13,470g/mol、割合:73.1%
ピーク4:位置:25,500g/mol、割合:0.8%
ピーク1:位置:5,400g/mol、割合:8.1%
ピーク2:位置:11,000g/mol、割合:4.0%
ピーク3:位置:13,400g/mol、割合:37.0%
ピーク4:位置:17,000g/mol、割合:2.7%
ピーク5:位置:25,500g/mol、割合:4.2%
ピーク6:位置:35,000g/mol、割合:0.2%。
ピーク1:位置:5,350g/mol、割合:10.6%
ピーク2:位置:8,200g/mol、割合:13.7%
ピーク3:位置:13,470g/mol、割合:23.6%
ピーク4:位置:17,700g/mol、割合:1.9733%
ピーク5:位置:24,700g/mol、割合:1.5018%。
ピーク6:位置:35,000g/mol、割合:0.0%
モミの実の形態でハイドロキシアパタイト(HA)の骨誘導顆粒を使用した(Nanobone,Artoss GmbH,Rostock,Germany)。これらは平均で3mmの長さであり、直径は0.5~1.0mmを有した。HAは、生物学的HAの結晶学的形態に類似した結晶学的形態を示した。このHAをシリカキセロゲルの高度な多孔性のマトリックスに埋め込んだ。顆粒の多孔度は約50%であり、比表面積は約200m2/gであり、細孔径分布は4nmで最大を示した。
実験は雌ウサギ(ニュージーランドホワイト、3~4kg,Charles River,Sulzfeld,Germany)を使用して行った。実施例2に従って製造された骨代替材料を後肢の両側に移植した。真皮および皮下組織を通る切り傷の長さは約2.5cmである。怪我をできる限り小さく保つために、筋肉組織も小さな領域で切断し、次いで、配置される欠損部位の骨から骨膜を慎重に切り離した。次いで、円柱状の欠損(直径5mm、長さ10mm)を大腿骨の外側顆のそれぞれに挿入した。この目的には、標準ドリル(φ4.5mm)を使用した。欠陥の定着中、熱暴露による骨組織の壊死を防止するために、その領域を0.9%のNaCl溶液ですすいだ。
Claims (23)
- 粒子状および顆粒状骨代替材料用のキャリアー組成物であって、
(a)1種のエチレンオキシド(EO)-プロピレンオキシド(PO)ブロックコポリマーまたは複数種のエチレンオキシド(EO)-プロピレンオキシド(PO)ブロックコポリマーの混合物;および
(b)シリカナノ粒子
を含むヒドロゲルである、キャリアー組成物。 - 前記ヒドロゲル中の水の割合が、60%~90%(w/w)の範囲である、請求項1に記載のキャリアー組成物。
- 前記ヒドロゲル中のエチレンオキシド(EO)-プロピレンオキシド(PO)ブロックコポリマーの割合が、10%~40%(w/w)である、請求項1または2に記載のキャリアー組成物。
- 前記ヒドロゲル中のエチレンオキシド(EO)-プロピレンオキシド(PO)ブロックコポリマーの割合が、20%~37%(w/w)である、請求項3に記載のキャリアー組成物。
- シリカナノ粒子の割合が2%~12%(w/w)の範囲である、請求項1~4のいずれか一項に記載のキャリアー組成物。
- シリカナノ粒子の割合が3.5%~5%(w/w)の範囲である、請求項5に記載のキャリアー組成物。
- 前記シリカナノ粒子が、0.5nm~10nmのサイズを有する、請求項1~6のいずれか一項に記載のキャリアー組成物。
- 前記シリカナノ粒子が、0.5nm~1.5nmのサイズを有する、請求項7に記載のキャリアー組成物。
- 前記シリカナノ粒子が、200nm未満の平均サイズを有するフラクタル凝集クラスターを形成する、請求項1~8のいずれか一項に記載のキャリアー組成物。
- 前記キャリアー組成物中の前記エチレンオキシド(EO)-プロピレンオキシド(PO)ブロックコポリマーが、1,000g/mol~70,000g/molの分子量分布を有する、請求項1~9のいずれか一項に記載のキャリアー組成物。
- 前記キャリアー組成物中の前記エチレンオキシド(EO)-プロピレンオキシド(PO)ブロックコポリマーの少なくとも30%(w/w)が、9,800~14,600g/molの範囲の平均分子量を有するポロキサマーからなる、請求項1~10のいずれか一項に記載のキャリアー組成物。
- 前記キャリアー組成物中の前記エチレンオキシド(EO)-プロピレンオキシド(PO)ブロックコポリマーの少なくとも40%(w/w)が、9,800~14,600g/molの範囲の平均分子量を有するポロキサマーからなる、請求項11に記載のキャリアー組成物。
- 前記ポロキサマーがポロキサマー407である、請求項11または12に記載のキャリアー組成物。
- (a)請求項1~13のいずれかに記載のキャリアー組成物;
(b)骨伝導性および/または骨誘導性粒子あるいは骨伝導性および/または骨誘導性顆粒
を含む、骨代替材料。 - 前記骨伝導性および/または骨誘導性粒子が、5μm~100μmのサイズを有する、請求項14に記載の骨代替材料。
- 前記骨伝導性および/または骨誘導性粒子が、20μm~40μmのサイズを有する、請求項15に記載の骨代替材料。
- 前記骨伝導性および/または骨誘導性粒子が、開口部を有する中空球体である、請求項14~16のいずれかに記載の骨代替材料。
- 前記中空球体が、100μm~3,000μmのサイズのクラスターを形成する、請求項17に記載の骨代替材料。
- 前記骨伝導性および/または骨誘導性粒子あるいは骨伝導性および/または骨誘導性顆粒が、骨の生物学的ヒドロキシアパタイトの形態を有し、シリカキセロゲルのマトリックスでコーティングされたヒドロキシアパタイト微結晶からなる、請求項14~16のいずれかに記載の骨代替材料。
- 前記骨伝導性および/または骨誘導性粒子あるいは前記骨伝導性および/または骨誘導性顆粒が、シリカゲルでコーティングされている、請求項14~18のいずれかに記載の骨代替材料。
- 前記シリカゲル中のシリカ濃度が3%~10%である、請求項20のいずれかに記載の骨代替材料。
- 骨代替材料を調製するための方法であって、
(a)請求項1~13に記載のキャリアー組成物を提供する工程;
(b)必要に応じて、ガンマ線で前記キャリアー組成物を処理する工程;
(c)前記キャリアー組成物を骨伝導性および/または骨誘導性粒子と、あるいは骨伝導性および/または骨誘導性顆粒と混合する工程;
を含む、方法。 - 前記骨伝導性および/または骨誘導性粒子あるいは前記骨伝導性および/または骨誘導性顆粒が、シリカヒドロゲルでコーティングされている、請求項22に記載の方法。
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KR102523981B1 (ko) | 2023-04-20 |
AU2018246310B2 (en) | 2023-07-20 |
EP3600464B1 (de) | 2022-05-04 |
RU2768695C2 (ru) | 2022-03-24 |
US20210093752A1 (en) | 2021-04-01 |
CA3058253A1 (en) | 2018-10-04 |
EP3600464A1 (de) | 2020-02-05 |
ES2917406T3 (es) | 2022-07-08 |
JP2020512175A (ja) | 2020-04-23 |
RU2019132821A3 (ja) | 2021-06-21 |
KR20200021447A (ko) | 2020-02-28 |
AU2018246310A1 (en) | 2019-10-24 |
RU2019132821A (ru) | 2021-04-29 |
CN110650754B (zh) | 2022-07-22 |
CN110650754A (zh) | 2020-01-03 |
EP3381479A1 (de) | 2018-10-03 |
US11324859B2 (en) | 2022-05-10 |
WO2018178266A1 (de) | 2018-10-04 |
MX2019011659A (es) | 2022-04-04 |
BR112019020029A2 (pt) | 2020-04-28 |
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