JP2021080303A - 病原性バイオフィルムと関連した状態を治療するための物質および方法 - Google Patents
病原性バイオフィルムと関連した状態を治療するための物質および方法 Download PDFInfo
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Abstract
Description
本出願は、参照によりその全体として本明細書に組み入れられる、2011年3月1日に提出された米国仮出願第61/447,735号の恩典を主張するものである。
適者のみが生存する世界において、細菌は、それらの環境に応じて適応しかつ進化する驚くべき能力を有する。いくつかの微生物は、その宿主との共生関係を通じて、重大な生存上の利点を進化させている。それらのヒト宿主中およびヒト宿主上の好都合な増殖「ニッチ」と引き換えに、これらの細菌は、これらの「友好的な」細菌が繁殖する表面上での病原菌のコロニー形成を直接阻害するなど、ある重要な生存上の利点を与える。通常の状況下において、ヒト免疫システムは、これらの同一の細菌を敵対的侵入物として撃退している。しかしながら、そのヒト宿主に対してある健康上の利益を与えることによって、これらの「プロバイオティクス」細菌は、微生物と人間との間の、有益に相助関係的な、進化的に利点のある、ゆえに進化的に保存された関係を作り出す。
[本発明1001]
バイオフィルムからの、バイオフィルムが増殖した培地からの、または患者から抽出し、次いでバイオフィルムとして増殖させた生物学的サンプルからの、単離された生物学的に活性な組成物。
[本発明1002]
バイオフィルムからの、バイオフィルムが増殖した培地からの、または患者から抽出し、次いでバイオフィルムとして増殖させた生物学的サンプルからの、単離された生物学的に活性な組成物であって、生物学的活性とは該組成物が投与される微生物叢を調節する能力である、組成物。
[本発明1003]
抽出によって単離される、本発明1001または1002の組成物。
[本発明1004]
抽出物が物理的または化学的処理によって獲得され得る、本発明1003の組成物。
[本発明1005]
抽出物が泡を用いた処理によって獲得され得る、本発明1004の組成物。
[本発明1006]
無細胞である、本発明1001または1002の組成物。
[本発明1007]
生物系界面活性剤を含む、本発明1001または1002の組成物。
[本発明1008]
生物学的活性とはバイオフィルムに影響を及ぼす活性である、本発明1001または1002の組成物。
[本発明1009]
前記活性が、付着阻害;増殖阻害;バイオフィルムマトリックス破壊;細胞外因子の分泌および/または放出を予防、阻害、および/または破壊すること;ならびに、クオラムセンシング機構を予防、阻害、および/または破壊することからなる群より選択される1つまたは複数の活性を含む、本発明1008の組成物。
[本発明1010]
前記活性が、付着促進;増殖促進;バイオフィルムマトリックスの安定化または凝集;細胞外因子の分泌および/または放出を促進、上方制御、または安定化すること;ならびに、クオラムセンシング機構を促進、上方制御、または安定化することからなる群より選択される1つまたは複数の活性を含む、本発明1008の組成物。
[本発明1011]
バイオフィルムがプロバイオティクス生物に由来する、本発明1001または1002の組成物。
[本発明1012]
動物に投与された場合に、免疫システムおよび/または炎症応答を調節する、本発明1001または1002の組成物。
[本発明1013]
本発明1001または1002の単離された生物学的に活性な組成物および任意の許容可能な担体を含む、動物への投与のために調製された化粧用または薬学的組成物。
[本発明1014]
プロバイオティクス、抗生物質、生物系界面活性剤、植物抽出物、ビタミン、プレバイオティクス、および蜜蜂製品からなる群より選択される1種類または複数種類の成分をさらに含む、本発明1013の組成物。
[本発明1015]
化粧用組成物であって、担体が化粧用途に適している、本発明1013の組成物。
[本発明1016]
薬学的組成物であって、担体が薬学的用途に適している、本発明1013の組成物。
[本発明1017]
局所投与のために調製された、本発明1013の組成物。
[本発明1018]
眼球、眼球周囲、副鼻腔、鼻、歯周、口腔咽頭、耳、角質化したおよび角質化していない皮膚表面、下気道、胃腸、ならびに泌尿生殖器からなる群より選択される位置への投与のために調製された、本発明1017の組成物。
[本発明1019]
内視鏡、舌下点滴器、針もしくはシリンジ技術、直接的もしくは間接的送達、洗浄、罹患部位への直接的もしくは間接的適用、カテーテル向けの適用、または血管内注入によって投与されるために調製された、本発明1013の組成物。
[本発明1020]
本発明1001または1002の単離された生物学的に活性な組成物および任意の許容可能な担体を含む、無生物表面への適用のために調製された組成物。
[本発明1021]
微生物叢、バイオフィルム、ならびに/または微生物叢および/もしくはバイオフィルムの周辺を、本発明1001または1002の組成物に曝露することを含む、微生物叢を操作するための方法。
[本発明1022]
ヒト微生物叢を操作するために用いられる、本発明1021の方法。
[本発明1023]
生物学的に活性な組成物が、操作されるのと同じ微生物叢から得られたバイオフィルムから単離される、本発明1021の方法。
[本発明1024]
動物における病的状態を治療するために用いられる、本発明1021の方法。
[本発明1025]
前記動物がヒトである、本発明1024の方法。
[本発明1026]
前記状態が急性または慢性の炎症である、本発明1024の方法。
[本発明1027]
前記状態が、ドライアイおよび他の慢性もしくは急性の眼球の状態;慢性もしくは急性の鼻副鼻腔炎;慢性もしくは急性の鼻炎;慢性もしくは急性の歯周炎;慢性もしくは急性の気管支炎、嚢胞性線維症、および呼吸器炎症の他の状態;急性および慢性の耳炎および外耳炎を含む炎症性の耳の状態;炎症性の皮膚の状態;胃炎および胃食道逆流を含む炎症性の腸の状態;炎症性の泌尿生殖器の状態;ならびに、炎症性の心血管系の状態からなる群より選択される、本発明1024の方法。
[本発明1028]
前記病的状態が、内視鏡、舌下点滴器、針もしくはシリンジ技術、直接的もしくは間接的送達、洗浄、罹患部位への直接的もしくは間接的適用、カテーテル向けの適用、または血管内注入を介した投与によって治療される、本発明1024の方法。
[本発明1029]
無生物表面上における、バイオフィルムの付着阻害;増殖阻害;バイオフィルムマトリックス破壊;細胞外因子の分泌および/または放出を予防、阻害、および/または破壊すること;ならびに、クオラムセンシング機構を予防、阻害、および/または破壊することに影響を及ぼすために用いられる、本発明1021の方法。
[本発明1030]
そのような調節を必要としている動物に、有効量の本発明1001または1002の組成物を投与することを含む、動物における免疫システムおよび/または炎症応答を調節するための方法。
[本発明1031]
前記動物がヒトである、本発明1030の方法。
[本発明1032]
バイオフィルムを増殖させる工程;
1つまたは複数の抽出物画分を作製するために、バイオフィルムまたはバイオフィルムが増殖している培地を物理的または化学的に処理する工程;
生物学的活性を同定するために、該画分を試験する工程;ならびに、
該画分が生物学的活性を有することが見出された場合にそれを選択する工程
を含む、生物学的に活性な組成物を同定するための方法。
[本発明1033]
バイオフィルムがプロバイオティクスバイオフィルムである、本発明1032の方法。
[本発明1034]
バイオフィルムまたは培地が患者から獲得される、本発明1032の方法。
[本発明1035]
バイオフィルムまたはそれが増殖している培地が、泡、溶解剤、および/またはpH調整剤を用いて処理される、本発明1032の方法。
[本発明1036]
本発明1032の方法によって選択される、画分。
[本発明1037]
選択された前記画分において1種類または複数種類の単離された化合物を同定することをさらに含み、該化合物が生物学的に活性である、本発明1032の方法。
[本発明1038]
本発明1037の方法によって同定される、化合物。
[本発明1039]
本発明1038の化合物、ならびに任意の化粧用および/または薬学的担体を含む、組成物。
[本発明1040]
本発明1001または1002の組成物を含む、吸入デバイス。
[本発明1041]
前記組成物が、生物系界面活性剤を含むように調製されている、本発明1040の吸引デバイス。
本発明は、容易に入手可能な非毒性の天然物質を用いて、先天性免疫を効果的に支援し、かつ/または病原性バイオフィルムを消散し、一方で正常な微生物の恒常性の回復を支援する物質および方法を提供する。
処方1:100B CFUの凍結乾燥した*S.サーモフィルス菌(S. thermophilus)+100μLの蜂蜜=1B CFU/ml 100%蜂蜜
処方2:250μL 100B CFU/mlの*S.サーモフィルス菌+500μLの蜂蜜=25B CFU/ml 75%蜂蜜
処方3:500μL 100B CFU/mlの*S.サーモフィルス菌+500μLの蜂蜜=50B CFU/ml 50%蜂蜜
処方4:750μL 100B CFU/mlの*S.サーモフィルス菌+250μLの蜂蜜=75B CFU/ml 33%蜂蜜
処方5:900μL 100B CFU/mlの*S.サーモフィルス菌+100μLの蜂蜜=90B CFU/ml 10%蜂蜜
*特異的株のS.サーモフィルス菌ATCC BAA-250;しかしながら、他の株を代用してもよい。
処方6:1mg/ml希釈のために、1000μL***PBS中に1000μgの**S.サーモフィルス菌生物系界面活性剤
処方7:0.5mg/ml希釈のために、1000μL***PBS中に500μgの**S.サーモフィルス菌生物系界面活性剤
処方8:2mg/ml希釈のために、250μL***PBS中に500μgの**S.サーモフィルス菌生物系界面活性剤
処方9:5mg/ml希釈のために、100μL***PBS中に500μgの**S.サーモフィルス菌生物系界面活性剤
処方10:10mg/ml希釈のために、1mL***PBS中に10mgの**S.サーモフィルス菌生物系界面活性剤
*生物系界面活性剤の単離方法の態様は下記に記載されている。
**特異的株のS.サーモフィルス菌ATCC BAA-250;しかしながら、他の株で代用してもよい。
***Medi-Honeyなどの蜂蜜または抗バイオフィルムを特徴とする蜂蜜を、滅菌したPBSの標準的溶液に代用してもよい。いずれのそのような溶液を、必要に応じてさらに希釈してよい。
本発明の成分を、粉末、懸濁液、および溶液を含むが、これらに限定されない種々の形態で調製することができる。加えて、プロバイオティクスなどの種々の成分を、凍結乾燥した粉末もしくは培養上清として、および/または適切な場合には濃縮した形態で調製することができる。
好都合なことには、本発明のある特定の組成物は、病原性バイオフィルムの形成を予防または阻害し得る。加えて、本発明のある特定の組成物は、既存の病原性バイオフィルムを低減、制御、または排除し得る。
a)候補成分もしくは候補成分の混合物を提供する工程であって、該候補成分が、微小生物、微小生物の抽出物、化学的置換物、細胞もしくは無細胞構成成分、微小生物の代謝産物、蜂蜜、蜜蜂製品、生物系界面活性剤、プレバイオティクス、植物抽出物、およびビタミンDからなる群より選択される、工程;
b)前記候補成分を関心対象の病原性微小生物と接触させる工程;ならびに
c)前記成分が関心対象の病原性微小生物によるバイオフィルムの形成を予防もしくは阻害した場合に、該候補成分を選択する工程
を含む。
一態様において、本発明は、バイオフィルムによって引き起こされる、またはそれと関連した疾患の予防および/または治療のための方法を提供する。一態様において、方法は、そのような治療を必要としている対象に、有効量の本発明の組成物を投与する工程を含む。
a)対象から生物学的サンプルを入手すること;および
b)自由に浮遊する(プランクトン様の)状態ではなく、バイオフィルム状態にある微小生物によって選択的に発現される1つまたは複数のバイオマーカー(例えば、タンパク質、mRNA)の存在を測定すること
によって検出することができる。
ある特定の態様において、本発明を用いて、皮膚炎、座瘡、慢性気管支炎、嚢胞性線維症、慢性歯肉炎、慢性炎症性腸疾患、慢性湿疹、慢性の治癒しない創傷、慢性膀胱炎、およびコンタクトレンズなどの医療用デバイスに関係する炎症を含むが、これらに限定されないバイオフィルム感染によって引き起こされる、またはそれらと関連した疾患を予防する、治療する、または改善することができる。本発明者らは、バイオフィルム感染が、例えば慢性眼瞼炎、ならびにドライアイ症候群、マイボーム腺炎、および酒さなどの眼球、眼球周囲、および皮膚上皮の他の慢性炎症状態などの疾患を引き起こす、またはそれらと関連していることも発見した。
本発明は、薬学的に許容可能な担体と組み合わせることができる形態の本発明の成分を含む、治療用または薬学的組成物も提供する。一態様において、本発明の組成物は、眼球、眼球周囲、鼻、歯、または肺への投与用に調製されている。
一態様において、本発明の組成物を、局部投与によって、目、歯、歯茎、耳、および皮膚を含むが、これらに限定されない生物学的表面;ならびにカテーテル、整形外科用デバイス、インプラント、人工心臓弁、人工関節、整形外科用インプラント、シャント、ペースメーカーと除細動器、気管内チューブ、血液透析/腹膜透析デバイス、歯科用インプラント、および血管内カテーテルを含むが、これらに限定されない医療用デバイスなどの非生物学的表面に送達する。
プロバイオティクスは、あるやり方でヒトの身体に利益を提供する微小生物である。2001年の世界保健機関によるプロバイオティクス微小生物に関するシンポジウムは、これらの生物を「適切な量で消費された場合、その宿主の健康にプラス効果を有する生きた微小生物」として定義した(世界保健機関、生きた乳酸菌を有する粉末ミルクを含む食品におけるプロバイオティクスの健康および栄養特性の評価に関するFAO/WHO合同専門家会議、2001年10月)。しかしながら、注目すべきことには、本発明における使用に採用され得るプロバイオティクス生物は生きていなくてもよく、その上、それらは、事実、ヒト宿主に片利共生的であるまたは病原性でさえあると通常見なされる微小生物またはその画分を含んでよい。
すでに論じられているように、本発明は、細菌性および非細菌性の微小生物およびバイオフィルムの増殖および回収に関する種々の物質および方法を用いる。例えば、酵母サッカロミセス属由来の濾過液を、Krasowska Aらによって記載されるもの「The antagonistic effect of Saccharomyces boulardii on Candida albicans fi lamentation, adhesion and biofilm formation」, FEMS Yeast Res (2009) 1312-1321などのプロトコールを用いて獲得してよい。次いで、以前に参照された技術のいずれかを用いて、プランクトン様およびバイオフィルムの細菌性および非細菌性培養物の、核、核内、細胞質、溶解物、上清、使用済み培地、細胞膜、生物系界面活性剤、細胞外DNA、細胞外RNAなどの種々の亜区画への分画が生じてよい。
感染症を含む種々の病気の治療において何世紀にもわたって用いられ、蜂蜜は、抗微生物効果ならびに抗炎症効果を有することが示されている(Viuda-Martos, M,「Functional Properties of honey, propolis and royal jelly」, J Food Sci 2008 Nov; 73(9):R117-24)。これらの効果の理由には、メチルグリオキサール、MGOと称されるポリサッカライド(Adams, C,「The origin of methylglyoxal in New Zealand manuka (Leptospermum scoparium) honey」, Carbohydrate Research, 2009年5月26日; 344(8): 1050-1053)、過酸化水素活性、低pH、高浸透圧、および抗微生物ペプチド活性(Kwakman, P,「How honey kills bacteria」, FASEB J, 2010, 7月;24(7):2576-82)が含まれる。ある特定の蜂蜜は、いくつかの病原菌に対する抗バイオフィルム効果を有することが示されているが、疾患に関係したバイオフィルムの治療、除去、または予防を示された市販の蜂蜜ベースの製品は存在しない。
滅菌した蜜蜂製品の種々の抽出物の調製
本発明の調製中、蜂蜜、プロポリス、ロイヤルゼリー、蜂パン、または蜂の花粉などの蜜蜂製品から構成される種々のサンプルを、種々の方法を用いて加工してよく、かつ/または加工しないままであってもよい。加工には、化学的手段によるタンパク質、糖類、花粉、ポリフェノール、もしくは他の構成要素の分画、高速液体クロマトグラフィー、物理的(フィルター)限外濾過、ゲル電気泳動、熱処理、酵素処理、微粉化、超音波処理、結晶化、脱水、または凍結乾燥が含まれてよい。
生物系界面活性剤とは、微小生物によって放出される化合物であり、一般に非毒性かつ生分解性である。一態様において、本発明による有用な生物系界面活性剤は、乳酸を産生しない細菌および乳酸を産生する細菌(LAB)を含むプロバイオティクスによって放出される。一態様において、本発明による有用な生物系界面活性剤は、バクテロイデス菌、ビフィズス菌、および乳酸菌を含むが、これらに限定されないプロバイオティクスによって放出される。
プレバイオティクスとは、多くの植物に見出される、大腸によって代謝されてブチラートなどの短鎖脂肪酸を形成する、消化されない繊維状のフラクトオリゴ糖またはガラクトオリゴ糖(FOSまたはGOS)である。これらの脂肪酸は、腸内のプロバイオティクスコロニーを代謝的に支援し、ならびに有効な局部先天性免疫応答を引き起こすのを手助けする。その結果として、プレバイオティクス添加は、プロバイオティクス添加の効率を上昇させ得る。この組み合わせは、シンバイオティクス療法として知られている。
植物抽出物は、抗炎症および抗微生物特性を有することが知られている。本発明のいくつかの態様において用いられる植物抽出物には、オオグルマ(イヌラ・ヘレニウム L.、キク科(Asteraceae)、エレキャンペーン)、バラ(ロサ・ダマスケナ L.(Rosa damascena L.)、バラ科(Rosaceae))、ラベンダー(ラヴァンデュラ・アングスティフォリア L.(Lavandula angustifolia L.)、シソ科(Labiatae))、カモミール(マトリカリア・レクティカ L.(Matricaria recutica L.)、キク科)、オレンジ(ミカン科(Rutaceae))、ユーカリ(ユーカリプタス・グロブラス L.(Eucalyptus globulus L.)、フトモモ科(Myrtaceae))、ゼラニウム(ヒメフロウ(Geranium robertianum L.)、フロウソウ科(Geraniaceae))、ジュニパー(セイヨウネズ(Juniperus communis L.)、ヒノキ科(Cupressaceae))、柑橘類(オレンジ(Citrus sinensis L.)、ミカン科)、ティーツリー(メラロイカ・アルテルニフォリア(Melaceuca alternifolia))、マヌカ低木(ギョリュウバイ)、ニーム・ツリー(インドセンダン(Azadirachta indica, A. Juss))、茶樹(チャノキ(Camellia sinensis))、およびローズマリー油(ロスマリヌス・オフィキナリス L.(Rosmarinus officinalis L.)、シソ科(Lamiaceae))が含まれる。上記の植物のエッセンシャルオイルまたは水蒸留物を用いてよい。例えば、マヌカオイルを1〜10%容量/容量(植物抽出物/本発明)の間の濃度で用いてよい。薬学的グレード品質の植物材料、蒸留物、および植物油を供給業者から直接購入してよく、または1〜10%容量/容量(植物抽出物/本発明)の間の濃度で用いられてもよい、下記に記載される方法を通じて、水蒸気蒸留エッセンスを産出してもよい。
Clevengerタイプの装置または類似の技術を用いた植物抽出物の調製方法
本発明の調製中、植物抽出物を、特にそれらのエッセンシャルオイルの精製に関して種々の方法で調製してよい。参照によりその全体として本明細書に組み入れられる、Clevenger, JF,「Apparatus for the determination of volatile oil」, 1928; J Am Pharm Assoc, 17; 346を参照されたい。Vian, M et al,「Microwave hydrodiffusion and gravity, a new technique for extraction of essential oils」, Journal of Chromatography A, 1190 (2008), 14-17またはFarhat, A et al,「Eco-friendly and cleaner process for isolation of essential oil using microwave energy - experimental and theoretical study」, Journal of Chromatography A, 1216 (2009), 5077-5085に記載されるものなどの他の技術を用いてもよい。
本発明は、茶(チャノキ)誘導体も活用する。より具体的には、L-テアニンおよび/または没食子酸エピガロカテキン(EGCG)などの緑茶ポリフェノールを、それぞれ10mcg/ml〜10mg/mlの量で用いてよい。
ビタミンDは、骨代謝に対するその周知の効果に加えて、先天性免疫システムに対する近年発見された効果を有する。ビタミンD3は、皮膚および目などの身体表面上でのカテリシジン(LL37)などの抗微生物ペプチド(AMP)の産生を誘導する。
用いられ得る他の生存能力のあるまたは生存能力のない微小生物には、ヒト片利共生生物、環境中に見出される海洋生物などのある特定の生物、または地熱口もしくは温泉に見出される生物などの極限環境生物、および/あるいはそれらの抽出物または代謝産物を含む、ヒトに安全に投与することができるものが含まれる。ヒト片利共生生物は、通常ヒト身体にコロニー形成するが疾患を引き起こさない非病原性生物である。これらには、子嚢菌門(phylum Ascomycota)を含む、モネラ(Monera)界および菌(Fungi)界の特定のメンバーが含まれる。
スピルリナ・プラテンシス(Spirulina platensis)からのポリサッカライド抽出物の調製
本発明の調製中、特定の抽出物を、藍藻類のスピルリナ・プラテンシスを含む他の非細菌性生物から調製してよい。とりわけ、Yang, L et al,「Inhibitory effects of polysaccharhide extract from Spirulina platensis on corneal neovascularization」, Molecular Vision 2009; 15: 1951-1961またはPugh, N et al,「Isolation of three high molecular weight polysaccharide preparations with potent immuno stimulatory activity from Spirulina platensis, Aphanizomenon flos-aqae and Chlorella pyrenoidosa」, Planta Med 67 (2001) 737-742に記載される方法を用いてよい。
本発明の組成物の具体的な投与の部位には、眼球、鼻、口、および皮膚が含まれるが、これらに限定されない。本発明による有用な担体には、スプレー、クリーム、軟膏、ローション、ゲル、点滴剤、石鹸、または投与の部位に適した他の任意の形態が含まれるが、これらに限定されない。当業者に公知の標準的方法を用いて、これらの組成物を調製することができる。
2mlのS.サーモフィルス菌1000億 CFU/1ml 滅菌PBS
5mlの希釈していないマヌカ蜂蜜
3mlの滅菌した通常生理食塩溶液
10mlの20B CFU/ml 50%蜂蜜溶液
500B CFUのフリーズドライしたS.サーモフィルス菌
5mlの希釈していない蜂蜜
45mlの冷却クリーム基剤
冷却クリーム基剤中に50mlの10B CFU/ml 10%蜂蜜
10mlの滅菌していないまたは滅菌したマヌカ蜂蜜(Medi-Honey, Comvita Inc., New Zealand)
39mlの最終濃度20% v/vまでの滅菌した通常生理食塩溶液
1mlの50B CFU/ml PBSのフリーズドライした不活性化S.サーモフィルス菌(ATCC BAA-250)
通常の生理食塩基剤中に50mlの1B CFU/ml 20%蜂蜜
500mgの脱水したマヌカ蜂蜜(手順については上記を参照されたい)
250mlの水に再構成した場合に1000億CFU/ml(必要な場合には、適切な賦形剤を用いて)のフリーズドライした不活性化S.サーモフィルス菌(ATCC BAA-250)
2.5mlのマヌカ蜂蜜(Medi-Honey, Comvita Inc., New Zealand)
2.0mlの中性pHの滅菌した通常生理食塩溶液
0.5mlの滅菌PBS中100B CFU/mlのフリーズドライした不活性化S.サーモフィルス菌(ATCC BAA-250)
5mlの2B CFU/ml 1%蜂蜜溶液(消費者による最終的な再構成)
製剤6−慢性的に刺激を受けた乾燥した皮膚および/または通常の皮膚の洗浄のためのゲル
50mlのマヌカ蜂蜜、滅菌したまたは滅菌していない
5%メチルセルロース 1500cP、10% v/vを含有している40mlの中性pHの通常生理食塩溶液
10mlの滅菌PBS中100B CFU/mlのフリーズドライした不活性化S.サーモフィルス菌(ATCC BAA-250)
100mlの10B CFU/ml 50%蜂蜜溶液
50mlのグリセリン液体石鹸基剤
50mlの本発明の濃縮した液体形態(すなわち、上記の製剤5)
100mlの1B CFU/ml 0.5%蜂蜜溶液
10gのクエン酸ナトリウム
20gの重炭酸ナトリウム
10gの結晶化したまたは脱水したマヌカ蜂蜜(上記を参照されたい)
100B CFUのフリーズドライした不活性化S.サーモフィルス菌(ATCC BAA-250)
5mlのラベンダーのエッセンシャルオイル
5mlのマヌカのエッセンシャルオイル
50gmの2B CFU/gm 20%蜂蜜混合物
製剤9−病原性バイオフィルムによるコロニー形成に曝露され得る無生物表面の洗浄のための環境用抗バイオフィルムスプレー
希釈アルコールまたは酢の基剤中の80mlの洗浄用スプレー媒体
10mlの滅菌していないマヌカ蜂蜜
10mlの100B CFU/ml PBSのフリーズドライした不活性化S.サーモフィルス菌ATCC BAA-250
100mlの100億 CFU/ml 10%蜂蜜溶液
製剤10−慢性的に刺激を受けた、炎症を起こした耳の症状軽減のための点耳薬
3mlのγ線照射した滅菌マヌカ蜂蜜(Medi-Honey, Comvita Inc., New Zealand)
6mlの滅菌したグリセリン
1mlのS.サーモフィルス菌1000億 CFU/1ml 滅菌PBS
10mlの100億 CFU/ml 3%蜂蜜溶液
製剤11−吸入用溶液
50mgのクエン酸、無水
2mlのγ線照射した滅菌マヌカ蜂蜜(Medi-Honey, Comvita Inc., New Zealand)
1mlの500億 CFU/mlのS.サーモフィルス菌CFU/ml 滅菌PBS
97mlの滅菌した通常生理食塩水
100mlの5億CFU/mlのS.サーモフィルス菌CFU/ml 2%蜂蜜溶液
製剤12−歯磨き粉
15mlのキシリトール
3mgのNaCl
38grのグリセリン
2mlのチモール蒸留物(すなわち、モナルダ(Monarda)属)
20grのマヌカ蜂蜜
1mlのS.サーモフィルス菌1000億 CFU/1ml 滅菌PBS
80mlのS.サーモフィルス菌1.25B CFU/1ml
製剤13−歯周炎の治療のための掻爬剤
凍結乾燥したS.サーモフィルス菌、10B CFU/g媒体の最終濃度
マヌカ蜂蜜、120Fで脱水され、粉末に破砕された;50gr/媒体の最終濃度
ポリラクチド(PLA)、ポリグリコリド(PGA)、ポリカプロラクトン(PCL)、または他の生分解性共重合体上のポリ(エステル)を、歯周ポケット内への歯肉縁下投与を意図した本製剤のための送達媒体として用いてよい。
Claims (29)
- 微生物バイオフィルムから、またはバイオフィルムが増殖した培地から単離された、単離された抗炎症または抗微生物組成物であって、該組成物が、プランクトン様の非バイオフィルム状態で増殖した前記微生物から単離された組成物により示されない抗炎症または抗微生物特性を有する、組成物。
- 無細胞である、請求項1記載の組成物。
- 生物系界面活性剤を含む、請求項1記載の組成物。
- 組成物が、抗バイオフィルム効果を有する、請求項1記載の組成物。
- 組成物が、付着阻害;増殖阻害;バイオフィルムマトリックス破壊;細胞外因子の分泌および/または放出を予防、阻害、および/または破壊すること;ならびに、クオラムセンシング機構を予防、阻害、および/または破壊することからなる群より選択される1つまたは複数の活性を有する、請求項4記載の組成物。
- バイオフィルムがプロバイオティクス生物に由来する、請求項1記載の組成物。
- 請求項1記載の単離された生物学的に活性な組成物および任意の許容可能な担体を含む、動物への投与のために調製された化粧用または薬学的組成物。
- プロバイオティクス、抗生物質、生物系界面活性剤、植物抽出物、ビタミン、プレバイオティクス、および蜜蜂製品からなる群より選択される1種類または複数種類の成分をさらに含む、請求項7記載の組成物。
- 化粧用組成物であって、担体が化粧用途に適している、請求項7記載の組成物。
- 薬学的組成物であって、担体が薬学的用途に適している、請求項7記載の組成物。
- 局所投与のために調製された、請求項7記載の組成物。
- 眼球、眼球周囲、副鼻腔、鼻、歯周、口腔咽頭、耳、角質化したおよび角質化していない皮膚表面、下気道、胃腸、ならびに泌尿生殖器からなる群より選択される1つまたは複数の位置への投与のために調製された、請求項11記載の組成物。
- 内視鏡、舌下点滴器、針もしくはシリンジ技術、直接的もしくは間接的送達、洗浄、罹患部位への直接的もしくは間接的適用、カテーテル向けの適用、または血管内注入によって投与されるために調製された、請求項7記載の組成物。
- 請求項1記載の単離された生物学的に活性な組成物および任意の許容可能な担体を含む、無生物表面への適用のために調製された組成物。
- (1)微生物バイオフィルムを増殖させる工程;
(2)工程(1)のバイオフィルムから抽出物および/または画分を回収する工程;
(3)生物学的活性を同定するために、該抽出物および/または画分を試験する工程;ならびに、
(4)該抽出物および/または画分が生物学的活性を有することが見出された場合にそれを選択する工程であって、該生物学的活性が抗微生物又は抗炎症活性である工程
を含む、請求項1記載の組成物を調製するための方法。 - バイオフィルムがプロバイオティクスバイオフィルムである、請求項15記載の方法。
- バイオフィルムがヒト患者から得られた生物学的サンプルから増殖される、請求項15記載の方法。
- バイオフィルムまたはそれが増殖している培地が、泡、溶解剤、および/またはpH調整剤を用いて処理される、請求項15記載の方法。
- 請求項1記載の組成物を含む、吸入デバイス。
- 前記組成物が、生物系界面活性剤を含むように調製されている、請求項19記載の吸引デバイス。
- バイオフィルムからの前記組成物が、プランクトン様状態で増殖した微生物からの抽出物よりも毒性が少ない、請求項1記載の組成物。
- 免疫応答活性の向上が抗炎症活性である、請求項1記載の組成物。
- メチシリン耐性黄色ブドウ球菌(methicillin resistant Staphylococcus aureus)((MRSA)、黄色ブドウ球菌(Staphylococcus aureus)、表皮ブドウ球菌(S. epidermidis)、緑膿菌(Pseudomonas aeruginosa)、シュードモナス菌(Pseudomonas)、インフルエンザ菌(Haemophilus influenza)、コリネバクテリウム属(Corynebacterium)、カンジダ菌(Candida)、およびアスペルギルス菌(Aspergillus)からなる群より選択される微生物に対する抗微生物活性を有する、請求項1記載の組成物。
- バイオフィルムを形成する微生物が、アエロコッカス属(Aerococcus)、大腸菌(E.coli)、バシラス属(Bacillus)、エンテロコッカス属(Enterococcus)、フソバクテリウム属(Fusobacterium)、ラクトコッカス属(Lactococcus)、リューコノストック属(Leuconostoc)、メリソコッカス属(Melissacoccus)、ミクロコッカス属(Micrococcus)、オエノコッカス属(Oenococcus)、スポロラクトバチルス属(Sporolactobacillus)、レンサ球菌(Streptococcus)、ブドウ球菌(Staphylococcus)、サッカロミセス属(Saccharomyces)、ペディオコッカス属(Pediococcus)、ペプトストレプトコッカス属(Peptostreptococcus)、プロピオニバクテリウム属(Proprionebacterium)、およびワイセラ属(Weissella)からなる群より選択される、請求項1記載の組成物。
- 生物学的活性が抗微生物活性である、請求項15記載の方法。
- 生物学的活性が抗炎症活性である、請求項15記載の方法。
- バイオフィルムが非多孔性媒体上で増殖する、請求項15記載の方法。
- 非多孔性媒体が球体を含む、請求項27記載の方法。
- 抽出物または画分が、付着阻害;増殖阻害;マトリックス破壊;細胞外因子の分泌および/または放出を予防、阻害、および/または破壊すること;ならびに、クオラムセンシング機構を予防、阻害、および/または破壊することからなる群より選択されるバイオフィルムに対する1つまたは複数の抗微生物特性について試験される、請求項15記載の方法。
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US20170216377A1 (en) | 2017-08-03 |
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US20170281699A1 (en) | 2017-10-05 |
US9504739B2 (en) | 2016-11-29 |
US10925908B2 (en) | 2021-02-23 |
CN111518866A (zh) | 2020-08-11 |
US10004771B2 (en) | 2018-06-26 |
JP6594269B2 (ja) | 2019-10-23 |
US20240099308A1 (en) | 2024-03-28 |
EP2680866A1 (en) | 2014-01-08 |
US10086025B2 (en) | 2018-10-02 |
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US11825848B2 (en) | 2023-11-28 |
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