JP6570593B2 - 抗微生物性組成物とその使用方法 - Google Patents
抗微生物性組成物とその使用方法 Download PDFInfo
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- JP6570593B2 JP6570593B2 JP2017194262A JP2017194262A JP6570593B2 JP 6570593 B2 JP6570593 B2 JP 6570593B2 JP 2017194262 A JP2017194262 A JP 2017194262A JP 2017194262 A JP2017194262 A JP 2017194262A JP 6570593 B2 JP6570593 B2 JP 6570593B2
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- bacteria
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- wound
- acid
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Description
この出願は出願日2011年10月8日の米国特許出願番号61/545,108、および出願日2012年6月15日の米国特許出願番号61/660,649の利益を請求する。その開示は本明細書中に参考として援用する。
背景
微生物が同伴されることのできるHAIs、および/またはバイオフィルムを防ぐか、または治すことができる方法および組成物;
移植可能なまたは移植された装置と物品でのバイオフィルムの成長を防ぐか、またはバイオフィルムを除去できる方法および組成物;
殺菌または他の方法で複数回使用される医療機器を処理することについて持たれている。
本発明はバクテリアを含むがこれに限定されない微生物の処理または排除に使用される組成物と物品に関し、それらがプランクトン、胞子、またはバイオフィルムの形態であるか否かにかかわらない。
「細菌」は、すべてのタイプの微生物を意味し、たとえばバクテリア、ウイルス、菌類、ウイルス様体、プリオン、および同様のものを包含するが、これらに限定されない。
「抗菌剤」は1以上の細菌の数を90%(1ログ(1 log))より多く低減する能力を有する物質を意味する。
「活性抗菌剤」は例えば細菌の細胞***のようなライフサイクルの活性の間のみ、またはその期間に主として有効な抗菌剤を意味する。
「バイオフィルム」は、細菌のコミュニティーを意味し、特にはバクテリアと菌類のコミュニティーを意味し、自己発生高分子マトリックス中にあるかまたはそれにより守られているコミュニティーメンバーにより表面に付着している。
「滞留時間」は、抗菌剤の細菌性バイオフィルムとの接触が許容されている時間を意味する。
「生物学的に適合している」は、哺乳類種の体表面または哺乳類種の体内における顕著な長期の有害な効果を示さないことを意味する。
「生物分解」は、酵素によるか、または化学的もしくは物理的な生体内のプロセスによる、より小さい化学種への変化を意味する。
「抗出血性物質」は、抑制性フィブリン溶解の防止、凝固の促進、血小板凝集の促進、または血管収縮を引き起こすことの1つまたはそれ以上により出血を抑制する化合物または物質を意味する。
「病院内感染」は、インキュベーションに関する証拠がないかまたは存在していない限局性または全身性感染を意味し、患者が入院が許可された時、大部分は入院の48時間以内に臨床的に明白になる。
「高分子電解質」は、水中で解離ができる電解質基を含む複数のモノマーからのポリマーを意味する。
「強高分子電解質」は電解質基が、3≦pH≦9で水中で完全に解離する高分子電解質をいう。
「弱高分子電解質」は、約2から約10までの解離定数を有する高分子電解質をいい、強高分子電解質の基が完全に解離される範囲内のpHで部分的に解離する。
「高分子両性電解質」は、いくらかのモノマーが陽イオン性電解質基を含み、他のモノマーが陰イオン性電解質基を含む高分子電解質である。
有用な塩基性(苛性の)液組成物は、少なくとも中程度に高い浸透圧モル濃度、すなわち多量の浸透圧的に活性の溶質と比較的高いか(7.5≦pH<9)、または非常に高いpH(9≦pH<11)を示す。多量の溶質が存在している界面活性剤と共に働いて、バクテリアの膜漏れを引き起こし、細胞分解に導く。
水、少なくとも1つの塩基の解離生成物、および少なくとも1つの界面活性剤。それのそれぞれが一般的に生物学的に適合していると考えられている。1種以上の塩類の解離生成物も含まれることができる。
クエン酸、2−メチルプロパン−1,2,3−トリカルボン酸、ベンゼントリカルボン酸、ニトリロトリ酢酸、および同様のもののようなトリプロトン酸;プレニト酸、ピロメリット酸、および同様のもののようなテトラプロトン酸;より多官能の酸類(例えば、ペンタ、ヘキサ、ヘプタプロトン酸など)も使用できる。ここで、トリ−、テトラ−、およびより多官能の酸が使用される場合、カルボキシルプロトンの1以上がカチオン性の原子または基(例えば、アルカリ金属イオン)で置き換えることができ、これらは同じであるか、または異なったものであってよい。
効力とは微生物に対する致死性、および/またはある特定の細菌コロニーがあるEPS/ECPSを崩壊するかまたは取り除く事ができる能力をいい、低い効力はバクテリア(特に強固なバイオフィルム中のバクテリア)の低減が<2ログ、またはさらには<1ログのものをいい、高い効力は>2ログ、>3ログ、>4ログ、>5ログ、および>6ログの低下を示す。効力は、pHが中性から遠ざかるにつれて、界面活性剤の量が増えるにつれて、毒性が大きくなるにつれて大きくなる。界面活性剤の構造(例えば、より高い電荷の可能性、荷電された部位の近くのより小さい基、より小さい親水性の部位など)、またはタイプ(すなわち、カチオン性>両性イオン性>アニオン性>非イオン性)により最適化される。
多くの病原バクテリアが創傷と創傷の周りにしばしば存在している。グラム陽性菌はエンテロコッカス−フェカーリス(Enterococcus faecalis)、表皮ブドウ球菌(Staphylococcus epidermidis)、および黄色ブドウ球菌(Staphylococcus aureus)を包含する。
グラム陰性菌はクレブシェラ肺炎杆菌(Klebsiella pneumonia)、アシネトバクター バウワニー(Acinetobacter baumanii)、ヘモフィールスインフルエンザ(Haemophilus influenza)、バルクホルデリアセノセパシア(Burkholderia cenocepacia)、および緑膿菌(Pseudomonas aeruginosa)を包含する。また、種々の菌類は火傷にも存在している。
次に、組織トロンボプラスチンは凝固経路を活性化し、フィブリン形成に導き、血小板と赤血球が捕らえられるプラグを形成し、その結果凝塊を形成する。
代わりに、別々に変数の多くについて議論するだろう。そして、当業者は特定の形態を提供するためにこれらの個々の説明を結合できる。これらは創傷または治癒過程の特定のステージの特定のタイプの創傷に使用できる。
慢性と急性の創傷の両者は、表皮と真皮だけに影響するか、または筋膜組織に影響する。
基本的な創傷部のケアプロトコールは、洗浄(すなわち、破片の取り出しと壊死組織の軟化)、可能なデブリードマン、余分な滲出液の吸収、肉芽と上皮形成の促進、および感染治療を含む。この段階で使用される清浄化薬剤は、汚れとバクテリアの物理的除去を目的とする界面活性剤に基づき、バクテリアの殺害能力はあっても非常に小さい。
例えば、一般用医薬品(OTC薬)と処方箋薬品(Rx)またはプログレード薬品は、以下の表1に示されたような組成と特性を持っている:
表1:
例示の創傷ケア組成物
中間的な性質を持っているグレードも企図される。
軍事および緊急医療機関で使用される一般的な抗出血性薬剤の例としては、フィブリン、コラーゲン酸化でんぷん、カルボキシメチルセルロース、トロンビンおよびキトサンがあげられる。消毒組成物または材料の様々な実施態様が、抗出血性薬剤または物品に加えられることができ、たとえば止血性包帯(HemCon Medical Technologies;ポートランド、オレゴン)、Tisseel(登録商標)フィブリンシーラント(バクスター・インターナショナル社;ディアフィールド、イリノイ州)、Thrombi−Gel(登録商標)ゼラチン発泡止血薬(ファイザー社;ニューヨーク、ニューヨーク)、GelFoam(登録商標)−ゼラチンスポンジ(ファイザー)、GelFoam(登録商標)プラス止血キット(バクスター)などがあげられる。別法として、抗出血性物質の液体消毒組成物、固体の消毒物質または物品への添加も有用である。例として、少なくとも約5%、しばしば少なくとも約10%、一般には少なくとも約20%の消毒性組成物または物質が、固体または半固形の抗出血性物質(例えば、ゲル−フォームとキトサン包帯)中に存在する。逆に、消毒組成物または物質中に、約1から約80%、一般には約3から約70%(重量基準)、典型的には約5から約60%の抗出血性物質が加えられることができる。量は例えば、トロンビン、キトサン、酸化セルロース、またはカルボキシメチルセルロースである抗出血性物質の種類と効力に基づいて異なる。
ホストの食物における、炭水化物の増加する濃度により、口腔環境は初期的に変化する。これらの炭水化物の発酵により、プラークバイオフィルム中の嫌気性細菌は酸を生成し、その結果バイオフィルムのpHを減少させる。組成物におけるこのシフトの原因となるいくつかの、より一般的なバクテリアは、ミュータンス菌(S.mutans)、ミュータンス群レンサ菌(S.sorbrinus)、およびカゼイ菌(Lactobacillus casei)である。そのすべてがpHレベル最小3.0で生き残る。pHが低下するのに従って、ミクロフローラは酸性耐性バクテリアに向かってシフトする。不耐性のバクテリアが形成された酸性条件下で生き残ることができないからである。
消毒または殺菌の前に、すべての再利用できる医療用品を徹底的に清浄化しなければならない。この工程はすべての表面、内部および外部に要求され、いわゆるバイオバーデン、すなわち、組織および流体の残渣、バクテリア、菌類、ウイルス、蛋白質類、および炭水化物を完全に除かなければならない。人手によるかまたは機械による表面処理の後に、すべてのバイオバーデン残渣と洗浄薬を取り除くために装置を徹底的にすすがなければならない。現状技術では、装置が清潔でないなら、消毒を達成できない。
清浄化の後に2,3の生菌が残っていても、時間がたつにつれてバイオフィルムの中に蓄積する。一般的に使用される酵素の洗浄剤は生存可能な細菌数を減少させることも、細菌性のEPSを取り除くこともできないことが見い出された。高酵素活性を有するクリーナーは、ある種のバイオフィルムを取り除くが、2ログを(すなわち、99%)以上にバクテリア数を減らすことはできず、いくつかの酵素の溶液は実際にバイオフィルムの形成に貢献する。従って、適切な消毒が下方制御された微生物を殺し、バイオフィルムの形成を防ぐのに必要である。
感染症の基本的なルートは接触(直接的および間接的)、液滴、空気、一般的なビヒクル(食物、水、薬物、器具および装置などの汚染物質)、および保菌生物(カ、ハエ、齧歯動物など)を通した伝播を伴う。最も頻繁なモードは直接接触である。
最終的には殺菌されるが、インプランテーションの間の、およびその前の医療用品インプラントは、環境または医療労働者からのバクテリアにより、またはより一般的には患者自身の皮膚に存在しているバクテリアからコロニー形成されることがある。挿入の後に、インプラント表面が宿主免疫によって保護されないので、インプラントは全身性バクテリアからコロニー形成されるようになり、表面にバイオフィルムを形成する。
Claims (5)
- 創傷部を治療するための組成物であって、該組成物は2から4のpHと、1.8から2.8 Osm/Lの総溶質濃度を有し、本質的に以下からなる組成物:
(1) 水、
(2) 1以上の有機酸と少なくとも1つの1以上の有機酸の塩を含む緩衝系、および
(3) 0.9から1.7g/Lの少なくとも1つのカチオン性界面活性剤。 - 該1以上の有機酸が、少なくとも1つのポリ酸を含む、請求項1記載の組成物。
- 該少なくとも1つの1以上の有機酸の塩が、ポリ酸の塩を含む、請求項1記載の組成物。
- 該少なくとも1つのカチオン性界面活性剤が、ベンザルコニウムクロリドを含む、請求項1記載の組成物。
- 該少なくとも1つのカチオン性界面活性剤が、ベンザルコニウムクロリドである、請求項1記載の組成物。
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Cited By (2)
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US11219208B2 (en) | 2013-05-02 | 2022-01-11 | Next Science IP Holdings Pty Ltd | High osmolarity antimicrobial composition containing one or more organic solvents |
US11234435B2 (en) | 2013-05-02 | 2022-02-01 | Next Science IP Holdings Pty Ltd | High osmolarity antimicrobial composition containing one or more organic solvents |
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