JP2018130322A - 塞栓材及びその製造方法 - Google Patents
塞栓材及びその製造方法 Download PDFInfo
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Abstract
【解決手段】塞栓材は、少なくとも1種のポリマーと、脂溶性造影剤と、を含む。塞栓材は、例えば、前記脂溶性造影剤に溶解した薬剤をさらに含む。塞栓材の製造方法では、ポリマーと、脂溶性造影剤と、を含み、溶融状態にある原料を溶媒中に押し出し、前記原料を冷却して固化させる。前記溶媒中に押し出された前記原料は、例えば、球形である。前記原料は、例えば、前記脂溶性造影剤に溶解した薬剤をさらに含む。
【選択図】 図1
Description
本開示の別の態様は、少なくとも1種のポリマーと、脂溶性造影剤と、を含み、溶融状態にある原料を溶媒中に押し出し、前記原料を冷却して固化させる塞栓材の製造方法である。本開示の塞栓材の製造方法により製造した塞栓材は、脂溶性造影剤を含むため、X線透視下における視認性が高い。また、本開示の塞栓材の製造方法により製造した塞栓材は、粒子径の均一性が高い。
1.塞栓材
塞栓材は少なくとも1種のポリマーを含む。ポリマーは体内分解性を有することが好ましい。ポリマーが体内分解性を有する場合、塞栓材に起因する正常組織での合併症を抑制することができる。また、ポリマーが体内分解性を有する場合、同一の被験者において、塞栓材を繰り返し使用することが容易になる。
本開示の塞栓材の製造方法では、少なくとも1種のポリマーと、脂溶性造影剤と、を含み、溶融状態にある原料を溶媒中に押し出し、原料を冷却して固化させる。
(1)原料の調製
フラスコ内に、ポリカプロラクトン10gと、リピオドール10gとを投入した。また、マグネティックスターラーの攪拌子をフラスコ内に投入した。フラスコ内は窒素雰囲気とした。フラスコ内を窒素雰囲気とすることにより、リピオドールが酸化することを抑制できる。
塞栓材の製造に用いる製造装置1の構成を図1に基づき説明する。製造装置1は、温水槽3と、配管5と、冷水槽7と、ローラポンプ9と、シリンジ11と、シリンジポンプ13と、加熱器15と、ミキサー16と、を備える。
前記(1)で調製した原料と、製造装置1とを用いて、以下のようにして塞栓材を製造した。温水槽3に80℃の温水4を貯留した。後述する工程においても、温水4の温度は80℃に維持した。温水4は溶媒に対応する。また、冷水槽7に0℃の冷水8を貯留した。後述する工程においても、冷水8の温度は0℃に維持した。また、ミキサー16により、冷水槽7内の冷水8を継続的に攪拌した。
前記(3)で製造した塞栓材の粒子径分布を算出した。その方法は以下のとおりである。まず、光学顕微鏡を用いて、塞栓材の集合の写真を取得した。その写真において、ソフトウェアを用いて、個々の塞栓材の直径を測定した。その測定結果に基づき、粒子径分布を算出した。算出した粒子径分布を図2に示す。塞栓材の平均粒子径は527μmであった。図2に示すように、塞栓材の粒子径における分布は狭かった。すなわち、塞栓材における粒子径の均一性は高かった。
前記(3)で製造した塞栓材のX線造影性を評価した。その方法は以下のとおりである。サンプル瓶に、前記(3)で製造した塞栓材と水とを入れた。このサンプル瓶を、X線透過装置を用いて撮影した。図3は、撮影により得られたX線透過図である。図3における「PCL/Lipビーズ」が、前記(3)で製造した塞栓材を入れたサンプル瓶である。「PCL/Lipビーズ」では、塞栓材が黒く表示されていた。
(6−1)評価用塞栓材の調製
リピオドール4.3gに、ミリプラ70mgを溶解させた。次に、そのリピオドールと、ポリ乳酸4.3gとを、フラスコ内に投入した。また、マグネティックスターラーの攪拌子をフラスコ内に投入した。フラスコ内は窒素雰囲気とした。フラスコを80℃のウォーターバスを用いて加熱した。加熱のとき、攪拌子を50rpmで回転させた。その結果、ポリ乳酸と、リピオドールと、ミリプラとを含み、溶融状態にある原料を得た。この原料を用い、前記(3)と同様の方法で塞栓材を製造した。製造した塞栓材は、ポリ乳酸と、リピオドールと、ミリプラとを含む。以下では、製造した塞栓材を評価用塞栓材とする。
評価用塞栓材について、薬剤徐放性を評価した。その方法は以下のとおりである。まず、評価用塞栓材の質量を計測した。次に、その質量に基づき、評価用塞栓材に含まれるPtの質量を算出した。なお、Ptはミリプラの成分である。
以上、本開示の実施形態について説明したが、本開示は上述の実施形態に限定されることなく、種々変形して実施することができる。
Claims (9)
- 少なくとも1種のポリマーと、脂溶性造影剤と、を含む塞栓材。
- 請求項1に記載の塞栓材であって、
前記脂溶性造影剤は薬剤を含むことができる塞栓材。 - 請求項1又は2に記載の塞栓材であって、
前記ポリマーが、体内分解性を有する塞栓材。 - 請求項1〜3のいずれか1項に記載の塞栓材であって、
前記ポリマーが、ポリカプロラクトン、ポリ乳酸、ポリカプロラクトンとポリ乳酸との共重合体、ポリカプロラクトンとポリ乳酸との混合物、及び、ポリカプロラクトンとポリ乳酸との複合物からなる群から選択される1以上である塞栓材。 - 少なくとも1種のポリマーと、脂溶性造影剤と、を含み、溶融状態にある原料を溶媒中に押し出し、
前記原料を冷却して固化させる塞栓材の製造方法。 - 請求項5に記載の塞栓材の製造方法であって、
前記溶媒中に押し出された前記原料は球形である塞栓材の製造方法。 - 請求項5又は6に記載の塞栓材の製造方法であって、
前記脂溶性造影剤は薬剤を含むことができる塞栓材の製造方法。 - 請求項5〜7のいずれか1項に記載の塞栓材の製造方法であって、
前記ポリマーが、体内分解性を有する塞栓材の製造方法。 - 請求項5〜8のいずれか1項に記載の塞栓材の製造方法であって、
前記ポリマーが、ポリカプロラクトン、ポリ乳酸、ポリカプロラクトンとポリ乳酸との共重合体、ポリカプロラクトンとポリ乳酸との混合物、及び、ポリカプロラクトンとポリ乳酸との複合物からなる群から選択される1以上である塞栓材の製造方法。
Priority Applications (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2017026126A JP6925014B2 (ja) | 2017-02-15 | 2017-02-15 | 塞栓材の製造方法 |
US16/485,955 US11253627B2 (en) | 2017-02-15 | 2018-02-15 | Embolic material and method for producing same |
KR1020197026948A KR20190112816A (ko) | 2017-02-15 | 2018-02-15 | 색전재 및 그 제조방법 |
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US11253627B2 (en) | 2022-02-22 |
EP3583961A1 (en) | 2019-12-25 |
KR20190112816A (ko) | 2019-10-07 |
EP3583961A4 (en) | 2020-12-30 |
EP3583961B1 (en) | 2022-06-15 |
JP6925014B2 (ja) | 2021-08-25 |
US20200054783A1 (en) | 2020-02-20 |
WO2018151214A1 (ja) | 2018-08-23 |
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