JP2020506164A - ポリビニルピロリドン及びユニチオールを含む消毒組成物並びにその組成物の使用 - Google Patents
ポリビニルピロリドン及びユニチオールを含む消毒組成物並びにその組成物の使用 Download PDFInfo
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Abstract
Description
本発明は、医学の分野、特に創傷ケア及び創傷面の治療の分野に関する。詳細には、本発明は、消毒効果、麻酔効果及び抗毒素効果を有する、創傷治療のため及び/又は外科的手術での使用のための消毒組成物に関する。加えて、本発明は、創傷を治療するため及び/又は外科的手術中の前記組成物の使用、並びにこれらの組成物を使用して創傷を治療するための方法に関する。
現在のところ、医療現場では、種々の組成物が創傷治療のために広く使用されており、前記組成物は、治癒過程を促進し、微生物による創傷の感染を防ぎ、環境から創傷面を物理的に保護するように設計されている。
コラーゲン加水分解物をベースとしている生分解性組成物は、創傷面でのその急速な生分解に起因して、病院前の段階では無効である場合がある;
公知の組成物は、損傷を受けた組織と病原性微生物代謝産物との両方から生じる、毒素を抑制するための抗毒素作用を示さない;
公知の組成物は、軟組織への及び血流への微生物の侵入を抑制する能力を持たない。
本発明者らは、上述の技術的問題を解決するために、ポリマーをベースとしている新しい消毒組成物を開発し、前記組成物は、創傷を治療すること及び/又は外科的手術中の使用を目的とするものであり、創傷面にフィルムを形成することができ、消毒効果、麻酔効果、抗炎症効果、創傷治癒効果、及び抗毒素薬効果、並びに創傷から血中への微生物の侵入を防ぐ能力を有する。
本発明において用語「創傷」とは、皮膚の完全性及び/又は粘膜の完全性の侵害を伴うヒト又は動物の身体の任意の部分の外傷として理解される。本発明において、「創傷」とは、物理的なインパクトによって引き起こされた損傷を表すためのものであることが好ましいが、その他の損傷要因によって引き起こされた損傷も本発明における「創傷」の意味に含まれる。
を有するポリマーを意味する。PVPは、錠剤調製物の補助結合剤として当技術分野において広く使用されている。創傷治療の分野では、ポリビニルピロリドンは、直接の消毒効果を有するヨウ素との錯体で主に使用される。こういった目的の場合、10〜60のフィケンチャー定数値(フィケンチャーK又はK値はポリマーの粘度を説明する係数である)を有するポリビニルピロリドンが、この値は約10,000〜約400,000Daの重量平均分子量の値におよそ相応し、先行技術において一般的に使用されている。本発明では、1,000,000〜3,000,000Daの分子量を有するPVPが使用される。
PVPは商業的供給源から得た。
ウサギの皮膚壊死モデルでの本発明による組成物の抗毒素活性を評価するために実験を行った。実験では、体重3.0〜3.5kgのチンチラ品種のウサギを使用した。
ウサギの皮膚壊死モデルでの、本発明による組成物が創傷から血中への日和見微生物の侵入を防ぐ能力を評価するために実験を行った。実験では、体重3.0〜3.5kgのチンチラ品種のウサギを使用した。
本発明による組成物が創傷内で感染を局部化し、創傷から血中への微生物の進入を防ぐ能力に及ぼすポリビニルピロリドンの分子量の効果を評価するために実験を行った。実験では、体重3.0〜3.5kgのチンチラ品種のウサギを使用した。黄色ブドウ球菌209P Oxfordの日毎の培養物を感染性因子として使用した。2種の類似の組成物を用いて研究を実施したが、この場合、500,000Daの分子量を有するポリビニルピロリドン(以下PVP−500)及び2,000,000Daの分子量を有するポリビニルピロリドン(以下PVP−2000と呼ぶ)を組成物ベースとして使用した。
500,000Daの分子量を有するポリビニルピロリドンをベースとしている組成物は、手術後の最初の3日は創傷から血中への微生物の侵入を完全に防ぐことはできなかったが、最初の3日後では、創傷から血中への微生物の侵入は全く観察されなかった。同時に、実験の結果によれば、組成物は手術後7日目に最高で104CFU/cm2の汚染レベルまでの抗菌効果を呈した。
2,000,000Daの分子量を有するポリビニルピロリドンをベースとしている本発明による組成物(実施例1からの試料3)の抗菌活性を評価し、この活性を「オフロメリド」軟膏の活性と比較するために実験を行った。寒天への拡散に関する標準法によって、オフロキサシン感受性微生物とオフロキサシン耐性微生物との両方に対して研究を実施した。試験病原菌の菌発育阻止ゾーン(mmで)によって結果を評価した。結果を表8に示す。
表3のデータから分かるように、「オフロメリド」軟膏は、オフロキサシン感受性レファレンス株に対して抗菌活性を持っていたが、標準的な感受性レベルを下回る微生物のオフロキサシン耐性の臨床分離株に対して有意に低下した活性を有していた(EUCAST−2015に準拠)。
Claims (20)
- 1つ又は複数の消毒剤、1,000,000〜3,000,000Daの範囲の分子量を有するポリビニルピロリドン(PVP)、ユニチオール、ジメチルスルホキシド、及び1つ又は複数の麻酔剤を含む消毒組成物。
- PVPの量が、前記組成物の総重量に対して、約5〜約10wt%、約6〜約9.5wt%、好ましくは約8〜約9wt%である、請求項1に記載の消毒組成物。
- 前記PVPの分子量が約2,000,000Daである、請求項1又は2に記載の消毒組成物。
- ユニチオールの量が、前記組成物の総重量に対して、約0.1〜約10wt%、約1〜約7wt%、好ましくは約3〜約5wt%である、請求項1〜3のいずれか一項に記載の消毒組成物。
- ジメチルスルホキシドの量が、前記組成物の総重量に対して、約0.05〜約5wt%、好ましくは約0.5〜約2wt%である、請求項1〜4のいずれか一項に記載の消毒組成物。
- 1つ又は複数の麻酔剤が1つ又は複数の局所麻酔剤である、請求項1〜5のいずれか一項に記載の消毒組成物。
- 前記麻酔剤のうちの1つ又は複数が、リドカイン、トリメカイン、テトラカイン、ノボカイン又はそれらの組合せ、好ましくはリドカインである、請求項6に記載の消毒組成物。
- 1つ又は複数の麻酔剤の量が、前記組成物の総重量に対して、約0.01〜約10wt%、好ましくは約0.5〜約5wt%、さらにより好ましくは約2〜約3%である、請求項1〜7のいずれか一項に記載の消毒組成物。
- 薬学的に許容される担体、好ましくは水性担体をさらに含む、請求項1〜8のいずれか一項に記載の消毒組成物。
- 前記1つ又は複数の消毒剤が、オキシキノリン誘導体、4級アンモニウム化合物、銀ベースの消毒剤、ビグアナイド、ビスフェノール、パラベン、アルコール、塩素化合物、ヨウ素化合物及びそれらの組合せから選択される、請求項1〜9のいずれか一項に記載の消毒組成物。
- 前記1つ又は複数の消毒剤が、ジオキシジン、塩化ベンザルコニウム、ミラミスチン、ポビアルゴール、クロルヘキシジン、トリクロサン、メチルパラベン、プロピルパラベン、グリセロール、次亜塩素酸ナトリウム、ポビドンヨード及びそれらの組合せから選択される、請求項10に記載の消毒組成物。
- 1つ又は複数の消毒剤の量が、前記組成物の総重量に対して、約0.01〜約20wt%、好ましくは約0.1〜約10wt%、さらにより好ましくは約0.5〜約5wt%である、請求項1〜11のいずれか一項に記載の消毒組成物。
- ジオキシジン、ポビアルゴール、塩化ベンザルコニウム、メチルパラベン及びプロピルパラベンの組合せが、1つ又は複数の消毒剤として使用されている、請求項1〜12のいずれか一項に記載の消毒組成物。
- ジオキシジンの量が、前記組成物の総重量に対して、約0.1〜約10wt%、好ましくは約0.5〜約5wt%、さらにより好ましくは約1.5〜約2wt%であり;
ポビアルゴールの量が、前記組成物の総重量に対して、約0.1〜約10wt%、好ましくは約0.5〜約5wt%、さらにより好ましくは約1.5〜約2wt%であり;
塩化ベンザルコニウムの量が、前記組成物の総重量に対して、約0.01〜約2wt%、好ましくは約0.05〜約0.5wt%、さらにより好ましくは約0.1〜約0.3wt%であり;
メチルパラベンの量が、前記組成物の総重量に対して、約0.001〜約2wt%、好ましくは約0.01〜約1wt%、さらにより好ましくは約0.05〜約0.2wt%であり;
プロピルパラベンの量が、前記組成物の総重量に対して、約0.001〜約2wt%、好ましくは約0.01〜約1wt%、さらにより好ましくは約0.05〜約0.1wt%である、
請求項13に記載の消毒組成物。 - 医薬品、湿潤剤、界面活性剤、粘度調整剤、安定剤、組織再生及び成長を促進する物質、サイトカイン、ビタミンK、フィブリノーゲン、トロンビン、第VII因子、第VIII因子、着色剤並びに香味剤を含む群から選択される補助成分をさらに含む、請求項1〜14のいずれか一項に記載の消毒組成物。
- 前記補助成分が、20wt%以下、好ましくは10wt%以下、又は2wt%以下の量で前記組成物に存在する、請求項15に記載の消毒組成物。
- 創傷治療での使用のための、請求項1〜16のいずれか一項に記載の消毒組成物。
- 創傷治療のための薬剤としての、請求項1〜17のいずれか一項に記載の消毒組成物の使用。
- 請求項1〜17のいずれか一項に記載の消毒組成物を使用して創傷を治療するための方法であって、前記組成物を創傷面に適用するステップを含む方法。
- 滅菌ガーゼドレッシング材を使用して、前記組成物を前記創傷面にさらに固定する、請求項19に記載の方法。
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BR112019016560A2 (pt) | 2020-03-31 |
KR102096257B1 (ko) | 2020-04-06 |
ZA201905343B (en) | 2021-08-25 |
CN110198721B (zh) | 2022-06-07 |
GEP20207136B (en) | 2020-07-27 |
JP6690816B2 (ja) | 2020-04-28 |
EA037319B1 (ru) | 2021-03-11 |
WO2018156051A1 (en) | 2018-08-30 |
KR20190099338A (ko) | 2019-08-26 |
MA46159A1 (fr) | 2021-04-30 |
US20190381176A1 (en) | 2019-12-19 |
MX2019009761A (es) | 2019-10-07 |
EP3585399A1 (en) | 2020-01-01 |
AU2017400650A1 (en) | 2019-07-18 |
CN110198721A (zh) | 2019-09-03 |
US11045551B2 (en) | 2021-06-29 |
CL2019002259A1 (es) | 2020-01-03 |
CA3054002C (en) | 2021-07-20 |
EA201991275A1 (ru) | 2019-11-29 |
MA46159B1 (fr) | 2022-04-29 |
SG11201903097UA (en) | 2019-09-27 |
PL3585399T3 (pl) | 2022-05-30 |
CA3054002A1 (en) | 2018-08-30 |
AU2017400650B2 (en) | 2019-09-26 |
RU2649785C1 (ru) | 2018-04-04 |
UA121949C2 (uk) | 2020-08-10 |
EP3585399B1 (en) | 2022-02-09 |
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