JP2023520289A - 呼吸器病原体を処置するためのヨウ素化合物 - Google Patents
呼吸器病原体を処置するためのヨウ素化合物 Download PDFInfo
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Abstract
Description
ヨウ素溶液は、皮膚用、水溶液用、および空気滅菌用の防腐剤として知られている。
KI(aq)+I2(s)→KI3(aq)
I3は溶解性が高いため、溶液中にある間、I2は少量しか利用できない。それにより、吸気から毒性が軽減される。I2が病原体と反応すると、平衡状態により、KI3からより多くのI2の作製が引き出される。ヨウ素放出性化合物は非常に溶解性が高いため、これらの溶液中に遊離ヨウ素はほとんど存在せず、一部の研究によると1~10%の場合がある。
5HIO→HIO3+2I2+2H2O。
緊急時には高い百万分率の短パルスでウイルスを死滅させることができ、公表されている毒性標準は長時間の曝露を想定して作られているため、安全とされる量より多くの量を使用するという代替手段もある。仮に従来のヨウ素に着目した方法を使用し、投与量を溶液中のヨウ素分子の数またはヨウ素の重量に従い決めた場合、本明細書中で提唱する処置は、実際よりも毒性が強いと考えられるであろう。その理由として、元素状ヨウ素はほとんど存在せず、溶液中では部分的にしか保持されていないため、感染面に着地するまでの気道通過時において毒性はほとんど認められないからである。
溶液中のウイルスに対するヨウ素の有効性に関する文献は、ほとんど全て冷ヨウ素溶液に関するものであり、いずれも空気や水の除菌を目的とした人体外のものである。
本発明者はコロナウイルス感染症を患い、次の日記に詳述されているようにヨウ素蒸気を吸入して治癒した。
さらに別の実施形態では、ヨウ素の効果を向上させるためにpHが調整される。HsuおよびNomura(Hsu and Nomura,Sterilization Action Of Chlorine And Iodine On Bacteria And Viruses In Water Systems (US Army Technical Report))は、実験10で、pHが高いほど殺菌率が高くなることを発見した。ある実施形態では、ヨウ素/蒸気の組み合わせが肺に苛性にならずにそのpHを高くすることができる物質が、処置の有効性を高める方法および製剤を構成する。Gomez et al.は、炭酸水素塩溶液のエアロゾルの吸入を提案し、多くの場合pHが7から8まで上昇し、嚢胞性線維症における痰の粘性が低下した。(Gomez et al.,Safety,Tolerability,and Effects of Sodium Bicarbonate Inhalation in Cystic Fibrosis.Clinical Drug Investigation,Nov.13,2019)。別の製剤はカーボネートまたは水酸化物を含み得る。
呼吸器系は、口、鼻、副鼻腔、咽頭(上気道系)、ならびに気管、および肺(下気道系)で構成されている。ほとんどの呼吸器病原体は両方に影響を及ぼすが、通常、肺の感染はより深刻である。気管および/または肺における感染症は、本明細書に下気道感染症と呼ばれ、そのような感染症は、記載される方法、組成物、使用、および製造品によって処置される疾患の一実施形態を示す。
用語「ヨウ素」は、本明細書では元素自体を指すために使用され、例えば、その一般的な分子形態「I下付き2」である。ヨウ素放出性化合物は、次亜ヨウ素酸などのヨウ素放出性塩、およびヨウ素を含有するおよび放出するイオン分子を包含する。ヨウ素およびヨウ素放出性化合物を含有する溶液は、記載される方法、組成物、使用および製造品において包含される。ある実施形態では、記載される化合物は、蒸発の目的で生体利用可能なヨウ素(I下付き2)を生成することができる。ある実施形態では、ヨウ素は、記載される蒸気の中に治療上有効な量、すなわち、抗微生物活性がある量で存在する。他の実施形態では、ヨウ素は、本明細書に言及された量または範囲のいずれかで存在する。
様々な実施形態では、空気(酸素を含む)、蒸気、または薬剤を対象の呼吸器系に提供するすべてのシステムは、ヨウ素およびヨウ素放出性化合物を送達する手段として包含される。それは、例えば、人工呼吸器、加湿器、蒸発器、および温められた蒸気または蒸気を発生させ得る特殊な加熱容器と特殊でない加熱容器の両方(例えば、キッチンポットなど)を含む。用語「人工呼吸器」は、対象が吸入する空気の組成物を物理的に含み、それに影響を与えるあらゆる種類の装置を包含することを意図している。ある実施形態では、記載される人工呼吸器は密閉され、または他の実施形態では、少なくとも部分的に密閉される。他の実施形態では、人工呼吸器は呼吸チューブを含む。密閉型人工呼吸器システム(例えば、PAPR)(電動ファン付き呼吸用保護具)が含まれている。アンブ蘇生器(バッグ・バルブ・マスク)は人工呼吸器の別の実施形態と考えられる。「フェイスマスク」は、薬剤の有無にかかわらず、吸入された空気の呼吸を可能にするマスクを指し、別の実施形態では、人工呼吸器の構成要素ともみなされる(保護フェイスマスクは包含されない)空気吸入用の鼻プロング(通常は補助酸素)も、別の実施形態では、人工呼吸器の構成要素とされる。ある実施形態では、記載される人工呼吸器は、機械式人工呼吸器であり、呼吸が停止した、失敗している、または不十分な患者の肺への空気および/または酸素の送達または移動を可能にする機械化された装置として定義される。さらなる実施形態では、機械化された人工呼吸器は、以下の属性(単独でまたは組み合わせで)のいずれかを有する:a.ガス送達をモニタリングおよびカスタマイズする、b.(例えば、肺胞の崩壊を防ぐために)肺内圧を最小限に維持する、およびc.口または鼻から気管に挿入された管を介して、肺に空気および/または酸素を送達する。
言及される方法、組成物、使用、または製造品のいずれかによって処置される病原体は、いくつかの実施形態では、ウイルスである。より具体的な実施形態では、ウイルスはCOVID-19である。
ある実施形態では、理論によって限定されることを望むことなく、記載された方法及び組成物は、表面タンパク質および/または脂肪酸の修飾によって効果を発揮する。McDonnellおよびRussellは、「塩素に似ている、ヨウ素の抗菌力は低濃度でさえ、迅速であるが、正確な作用様式は未知である。McDonnellとRussellは、「塩素と同様に、ヨウ素の抗菌作用は低濃度でも速やかに起こるが、正確な作用機序は不明である。ヨウ素は、微生物に急速に浸透し、タンパク質(特に遊離硫黄アミノ酸のシステインおよびメチオニン)、ヌクレオチド、脂肪酸の主要な群を攻撃し、細胞死に至る。ヨウ素の抗ウイルス作用についてはあまり知られていないが、非脂質ウイルスおよびパルボウイルスは、脂質エンベロープウイルスよりも感受性が低い。細菌と同様に、ヨウ素はエンベロープウイルスの表面タンパク質を攻撃すると考えられるが、不飽和炭素結合と反応して膜脂肪酸を不安定にする可能性もある。」と書いている。
別の実施形態では、ヘパリンまたは他の抗凝固剤が併用投与される。特に血液凝固時間の遅い患者にヨウ素剤を使用することの価値の一つは、このコロナの合併症において抗凝固剤の使用を最小限に抑えることである。
さらに他の実施形態では、記載される方法、組成物、使用、または製造品は、細胞内pHまたはリソソームpHを増加させる追加の活性剤をさらに含むか、または利用する。いくつかの実施形態では、薬物はクロロキンまたはヒドロキシクロロキンである。細胞内pHまたはリソソームpHを増加させる活性剤の他の非限定的な例は、アミノキノリン、例えば、アモジアキン、ヒドロキシクロロキン(HCQ)、クロロキンなどの4-アミノキノリン;プリマキンおよびパマキンなどの8-アミノキノリン;ならびにメフロキンなどである。ある実施形態では、さらなる活性薬剤は、ヨウ素またはヨウ素放出性化合物と同じ組成物で投与される。
ある実施形態では、記載される組成物、方法、使用、および製造品によって処置される対象は、ヒトである。他の実施形態では、対象は動物であり、それらの非限定的な例はイヌ、ネコ、ウマ、およびウシである。
Claims (20)
- 呼吸器病原体に感染した対象の気道に投与するための蒸気を含む組成物であって、ここで、
(a)前記蒸気は、pHが7.0~10.0の水溶液を、摂氏30~80度(°C)の温度まで加温することによって生成され、前記水溶液は、ヨウ素放出性イオン化合物と元素状ヨウ素を総ヨウ素量0.5~10ppmで含み、
(b)前記投与は、一日当たり2時間以下であり、
(c)前記患者の気道に送達される総ヨウ素が、一日当たり8mg/kg体重を超えない、組成物。 - 呼吸器病原体に感染した対象を処置するためのシステムであって、
pHが7.0~10.0の水溶液が入れられた容器であって、前記水溶液は、ヨウ素放出性イオン化合物と元素状ヨウ素を総ヨウ素量0.5~10ppmで含む、容器と、
前記容器の中の前記水溶液を摂氏30~80度(°C)の温度まで加温し、これによって蒸気を生成するように構成された加熱要素と、
前記蒸気が呼吸器病原体に感染した対象の気道に到達するように前記蒸気を供給するために構成された人工呼吸器と、を含み、
ここで、前記人工呼吸器は、1日当たり2時間以下前記蒸気を投与するために構成され、前記気道に送達される総ヨウ素が、1日当たり8mg/kg体重を超えない、システム。 - 元素状ヨウ素とヨウ素放出性イオン化合物を含む一定量の投与量パックであって、(a)前記投与量パックをpHが7.0~10.0、かつ総ヨウ素量0.5~10ppmの水溶液に導入すること、(b)前記水溶液を摂氏30~80度(°C)の温度まで加温し、それによって、蒸気を生成すること、(c)前記蒸気を呼吸器病原体に感染した対象の気道に投与することであって、ここで、前記投与が1日当たり2時間以下の投与であり、前記気道に送達される総ヨウ素が、1日当たり8mg/kg体重を超えない、投与することを行うための指示書に伴う、一定量の投与量パック。
- 製造品であって、請求項2に記載のシステムと、呼吸器病原体に感染した対象の気道に蒸気を投与することにおいて前記システムを使用するための指示書と、を含む、製造品。
- 前記ヨウ素は前記対象の下気道に供給される、請求項1~4のいずれか1つに記載の組成物、システム、一定量の投与量パック、または製造品。
- 前記呼吸器病原体は、ウイルス、細菌、真菌類およびミコバクテリアからなる群から選択される、請求項1~5のいずれか1つに記載の組成物、システム、一定量の投与量パック、または製造品。
- 前記呼吸器病原体はウイルスである、請求項6に記載の組成物、システム、一定量の投与量パック、または製造品。
- 前記呼吸器病原体はCOVID-19である、請求項7に記載の組成物、システム、一定量の投与量パック、または製造品。
- 前記ヨウ素放出性イオン化合物は、ヨウ化カリウムまたはポビドンヨウ素である、請求項1~8のいずれか1つに記載の組成物、システム、一定量の投与量パック、または製造品。
- 前記蒸気は、ACE阻害剤、ビタミンD、ヒドロキシクロロキン、亜鉛、コルチコステロイドと抗凝固剤から選択される薬剤、マウスウォッシュ、イベルメクチン、あるいは前記対象の細胞において細胞内pHまたはリソソームpHを増大させる薬物と同時に投与される、請求項1~9のいずれか1つに記載の組成物、システム、一定量の投与量パック、または製造品。
- 前記蒸気および前記対象は、密閉空間内に配置される、請求項1~10のいずれか1つに記載の組成物、システム、一定量の投与量パック、または製造品。
- 前記蒸気は、呼吸チューブ内に配置される、請求項1~11のいずれか1つに記載の組成物、システム、一定量の投与量パック、または製造品。
- 前記蒸気は、呼吸器系フェイスマスク内に配置される、請求項1~11のいずれか1つに記載の組成物、システム、一定量の投与量パック、または製造品。
- 前記蒸気は、鼻プロング内に配置される、請求項1~11のいずれか1つに記載の組成物、システム、一定量の投与量パック、または製造品。
- 前記蒸気は、人工呼吸器内に配置される、請求項1または3~14のいずれか1つに記載の組成物、システム、一定量の投与量パック、または製造品。
- 前記人工呼吸器は、前記水溶液を含む溶液容器と、前記水溶液の蒸発を促進する加熱要素と動作可能に連結されている、請求項2または15のいずれか1つに記載の組成物、システム、一定量の投与量パック、または製造品。
- 前記人工呼吸器の圧力および頻度は、前記対象の深呼吸を可能にするように構成される、請求項2または15~16のいずれか1つに記載の組成物、システム、一定量の投与量パック、または製造品。
- 前記人工呼吸器はヨウ素の自動補充システムを含む、請求項2または15~17のいずれか1つに記載の組成物、システム、一定量の投与量パック、または製造品。
- 前記人工呼吸器はアルカリの自動補充システムをさらに含む、請求項18に記載の組成物、システム、一定量の投与量パック、または製造品。
- 前記人工呼吸器はアルカリの自動補充システムを含む、請求項2または15~17のいずれか1つに記載の組成物、システム、一定量の投与量パック、または製造品。
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