JP6608809B2 - 分解性止血剤組成物 - Google Patents
分解性止血剤組成物 Download PDFInfo
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- JP6608809B2 JP6608809B2 JP2016516239A JP2016516239A JP6608809B2 JP 6608809 B2 JP6608809 B2 JP 6608809B2 JP 2016516239 A JP2016516239 A JP 2016516239A JP 2016516239 A JP2016516239 A JP 2016516239A JP 6608809 B2 JP6608809 B2 JP 6608809B2
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- chitosan
- acid
- hemostatic
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Classifications
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Description
キトサンに対する酸の割合は、本発明の止血剤組成物の分解性の重要な要素になり得る。典型的には、例えばメドトレード・プロダクツ・リミテッド(MedTrade Products Ltd)のWO 2009/130485におけるように、止血剤組成物中の酸の量が、止血剤組成物の重量の約20%未満の場合、分解時間は30日より長くなる。30日を上回る分解期間は、本発明の製品が異なる薬剤規制と安全カテゴリー(medical regulatory and safety category)に分類されることを意味する。反対に、酸の割合が止血剤組成物の重量の約70%より大きくなると、典型的に止血剤組成物は血液と接触して急速に分解し、ゲル化特性を失い、過度に早く分解するので効果的な止血能力も失われる。
本発明の止血剤組成物は、それ自体は、リゾチーム溶液、血清及び模擬創傷液(simulated wound fluid)中で分解することが示されている。模擬創傷液は50%の牛胎児血清と50%のペプトン水(0.9%の塩化ナトリウム+0.1%の脱イオン化したH2O中のペプトン(Peptone))を含む。
典型的だが非限定的な例として、不織布の形態である本発明による止血剤組成物を製造する全体の過程で、キトサンはアルカリ溶液で洗浄され、キトサン塩又はキトサン誘導体の繊維は不織の形態にカーディングされる。次に不織布は生理学的に許容される酸が適用されてキトサン塩が形成され、続いて不織布は所望のサイズのピース(pieces)に最終的にカットされる前に、乾燥される。
方法
本発明の止血剤の総吸収量(total absorbency)は、模擬創傷液(simulated wound fluid)、血清及びリゾチーム溶液を使用して決定される。これは、それ以上吸収できなくなるまでゆっくりと液体を材料に加えることによって、材料の最大吸収量を決定することにより行われる。吸収された液体の量は、湿重量(wet weight)から乾重量(dry weight)を引くことにより計算される。
Claims (30)
- キトサン塩又はキトサン誘導体と生理学的に許容される酸からなる止血剤組成物であって、
前記生理学的に許容される酸は前記止血剤組成物の重量の25%と70%の間の量存在し、
前記止血剤組成物は、繊維状であり、且つ30日以内にヒト又は動物の体内で完全に分解することができ、
前記キトサン誘導体は、部分的に脱アセチル化されたキチン、カルボキシメチルキトサン、ヒドロキシルブチルキチン、N−アシルキトサン、O−アシルキトサン、N−アルキルキトサン、O−アルキルキトサン、N−アルキリデンキトサン、O−スルホニルキトサン、硫酸化キトサン、リン酸化キトサン、ニトロ化キトサン、アルカリキチン、アルカリキトサンまたはキトサンの金属キレートからなる止血剤組成物。 - 約24時間後には、まだ前記ヒト又は前記動物の体内に存在する請求項1の止血剤組成物。
- 完全な分解は、4日を超えた後30日未満に生ずる請求項2の止血剤組成物。
- 完全な分解は、7日を超えた後30日未満に生ずる請求項3の止血剤組成物。
- 前記生理学的に許容される酸は、前記止血剤組成物の重量の30%と60%の間の量存在する請求項1乃至4のいずれか1項の止血剤組成物。
- 前記生理学的に許容される酸は、前記止血剤組成物の重量の35%と55%の間の量存在する請求項5の止血剤組成物。
- 前記生理学的に許容される酸は、有機酸及び/又は無機酸からなる請求項1乃至6のいずれか1項の止血剤組成物。
- 前記有機酸はカルボン酸からなる請求項7の止血剤組成物。
- 前記カルボン酸は、ギ酸、酢酸、アスコルビン酸、ハロゲン酢酸、プロパン酸、プロペン酸、乳酸、コハク酸、アクリル酸、グリオキシル酸、ピルビン酸、またはヒドロキシプロピオン/ブタン酸、及びこれらのいずれかの2以上の組み合わせから選択される請求項8の止血剤組成物。
- 前記カルボン酸は、前記乳酸、前記酢酸及び前記コハク酸、及びこれらの2以上の組み合わせから選択される請求項9の止血剤組成物。
- 前記カルボン酸は前記乳酸である請求項10の止血剤組成物。
- 前記無機酸は塩酸及び/又は硫酸の1以上からなる請求項7の止血剤組成物。
- 前記止血剤組成物がキトサン塩を含む請求項1乃至12のいずれか1項の止血剤組成物。
- 前記キトサン塩は、酢酸キトサン、乳酸キトサン、コハク酸キトサン、リンゴ酸キトサン、アクリル酸キトサン、ギ酸キトサン、アスコルビン酸キトサン、フルオロ酢酸キトサン、クロロ酢酸キトサン、プロピオン酸キトサン、グリオキシル酸キトサン、ピルビン酸キトサン、硫酸キトサン及び塩酸キトサンから選択される1以上の塩を含む請求項1乃至13のいずれか1項の請求項の止血剤組成物。
- 前記キトサン塩は前記乳酸キトサンである請求項14の止血剤組成物。
- 前記止血剤組成物が20g/g未満の吸収量を有する請求項1乃至15のいずれか1項の止血剤組成物。
- 前記組成物が乾燥された後、いかなる熱処理も前記組成物が受けることことなく前記組成物が作られる請求項1乃至16のいずれか1項の止血剤組成物。
- 前記繊維は3mmの最小平均長さ及び500mmの最大長さを有する請求項1乃至17のいずれか1項の止血剤組成物。
- 前記繊維は10mmと76mmとの間の長さを有する請求項18の止血剤組成物。
- 前記繊維は100ミクロンを超えない直径を有する請求項1乃至19のいずれか1項の止血剤組成物。
- 前記止血剤組成物の調製に使用される前記キトサンの分子量は500,000未満である請求項1乃至20のいずれか1項の止血剤組成物。
- 前記止血剤組成物の調製に使用される前記キトサンの粘度が、20℃で測定されたときに40から200cpsまでである請求項1乃至21のいずれか1項の止血剤組成物。
- 止血剤組成物は繊維布又はパッドの形態である請求項1乃至22のいずれか1項の止血剤組成物。
- 前記止血剤組成物が滅菌されている請求項1乃至23のいずれか1項の止血剤組成物。
- 医薬品;湿潤剤;着色剤;加工助剤;増量剤;吸収性高分子;抗菌剤;増殖因子;サイトカイン;治癒を遅延させる物質を吸収する物質から選択された1以上の成分、及び/又はその他の止血剤成分をさらに含む請求項1乃至24のいずれか1項の止血剤組成物。
- 請求項1乃至25のいずれか1項の止血剤組成物の製造方法。
- 前記キトサン塩又はキトサン誘導体を生理学的に許容される酸で被覆することを含む請求項26の方法。
- 前記被覆する工程に先立って、前記キトサン塩の生成前にエンドトキシンの存在を低減するためにキトサンを洗浄する工程をさらに含み、前記洗浄は前記キトサンをアルカリ溶液と接触させて混合物を生成し、次に前記混合物を乾燥する前にある期間前記混合物を放置することを含む請求項26または27の方法。
- さらに前記繊維を織られた又は不織の繊維布に形成する請求項26乃至28のいずれか1項の方法。
- 前記生理学的に許容される酸は、前記繊維の織られた又は不織の繊維布への形成後にのみ適用される請求項27乃至29のいずれか1項の方法。
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US20170202994A1 (en) | 2017-07-20 |
KR20160034256A (ko) | 2016-03-29 |
BR112015029957B1 (pt) | 2020-07-14 |
US10434212B2 (en) | 2019-10-08 |
RU2015155734A3 (ja) | 2018-04-25 |
EP3003412B1 (en) | 2019-09-25 |
KR102342895B1 (ko) | 2021-12-22 |
CA2913665C (en) | 2024-01-09 |
US9867900B2 (en) | 2018-01-16 |
AU2018201124A1 (en) | 2018-03-08 |
RU2015155734A (ru) | 2017-07-06 |
PL3003412T3 (pl) | 2020-04-30 |
GB2514597A (en) | 2014-12-03 |
GB201309695D0 (en) | 2013-07-17 |
ES2763673T3 (es) | 2020-05-29 |
CA2913665A1 (en) | 2014-12-04 |
US20160121020A1 (en) | 2016-05-05 |
PT3003412T (pt) | 2020-01-08 |
BR112015029957A2 (pt) | 2017-07-25 |
SA515370211B1 (ar) | 2018-10-04 |
AU2014272869A1 (en) | 2016-01-21 |
EP3003412A1 (en) | 2016-04-13 |
CN112295012A (zh) | 2021-02-02 |
AU2014272869B2 (en) | 2018-03-01 |
MX2015016381A (es) | 2016-09-29 |
RU2682336C2 (ru) | 2019-03-19 |
US10300166B2 (en) | 2019-05-28 |
CN105431177A (zh) | 2016-03-23 |
DK3003412T3 (da) | 2020-01-13 |
JP2016521595A (ja) | 2016-07-25 |
US20170202997A1 (en) | 2017-07-20 |
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