JP5693470B2 - 銀イオンおよびメントールを含む消毒剤組成物並びにその使用 - Google Patents
銀イオンおよびメントールを含む消毒剤組成物並びにその使用 Download PDFInfo
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- JP5693470B2 JP5693470B2 JP2011548847A JP2011548847A JP5693470B2 JP 5693470 B2 JP5693470 B2 JP 5693470B2 JP 2011548847 A JP2011548847 A JP 2011548847A JP 2011548847 A JP2011548847 A JP 2011548847A JP 5693470 B2 JP5693470 B2 JP 5693470B2
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- menthol
- disinfectant composition
- concentration
- silver ions
- disinfectant
- Prior art date
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- BWMISRWJRUSYEX-SZKNIZGXSA-N terbinafine hydrochloride Chemical compound Cl.C1=CC=C2C(CN(C\C=C\C#CC(C)(C)C)C)=CC=CC2=C1 BWMISRWJRUSYEX-SZKNIZGXSA-N 0.000 description 1
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Classifications
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/24—Heavy metals; Compounds thereof
- A61K33/38—Silver; Compounds thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/02—Local antiseptics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/10—Antimycotics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
Description
材料:
LB培地を、10グラムのトリプトン(カタログ番号161200、Pronadisa、Conda)、5グラムの酵母抽出物(カタログ番号212750、DIFCO)、10グラムのNaCl(カタログ番号1.06404.1000、Merck)および2グラムのグルコース(カタログ番号1.08337.1000、Merck)を磁気撹拌および穏やかな加熱とともに高度精製水の1リットルの最終体積に溶解することによって調製した。LB寒天を、15グラムのBacto寒天(カタログ番号214010、BD)をLB培地に加えることによって調製した。
硝酸銀溶液およびメントール溶液を、10%グリセロール(高浸透圧剤)、メントール(0.5%TWEEN−20)および硝酸銀の最終濃度を50mMのTris緩衝剤溶液に加えることによって調製した。最終組成物は、氷酢酸を使用してpH7.45に滴定し、その後、0.22μmのPESメンブランフィルターでろ過した。このようにして得られた無菌溶液は透明で、沈殿物を有していなかった。
大腸菌成長プロトコル:
大腸菌 ATCC47076の凍結ストックを、培地のOD600nmが1.6〜1.8に達するまで一晩、振とう機インキュベーター(37℃で200rpm)で成長させた(1mlを9mlのLB培地において)。その後、培養培地の1mlのアリコートを50mlの新鮮な無菌LB培地に移し、培地のOD600nmが0.6〜0.8(2×108のコロニー形成単位/ml(CFU/ml))に達するまで2時間、振とう機インキュベーター(37℃で200rpm)に置いた。細菌懸濁物を無菌培地による希釈によって108CFU/mlに調節した。その後、細菌細胞を0.9%のNaNO3により3回洗浄した。NaNO3洗浄サイクルを、5mlの細菌懸濁物を15mlの試験管に移し、懸濁物を4℃での5分間の4000rpmにおける遠心分離に供し、その後、上清を除き、細菌細胞ペレットを5mlの0.9%NaNO3に再懸濁することによって行った。
様々な細菌細胞株を、Laboratory of Molecular Epidemiology and Antimicrobial Resistance(Tel Aviv Sourasky Medical Center)の臨床株コレクションから得た。したがって、試験された消毒剤組合せの殺細菌活性を、肺炎桿菌、黄色ブドウ球菌のメチシリン耐性臨床株(MRSA)、表皮ブドウ球菌の臨床株、広域スペクトルのβ−ラクタマーゼを産生する大腸菌の臨床株、多剤耐性アシネトバクター・バウマンニイの臨床株および多剤耐性緑膿菌の臨床株に対して試験した。
メントールおよび銀イオンが相乗的に作用するかどうかを評価するために、メントールおよび銀イオンが一緒に投与されたときに観測される殺細菌活性を、これらの化合物のそれぞれが単独で投与されるときに観測される殺細菌活性と比較した(これらを、Lehmann、2000、「Synergism in Disinfectant Formulation in、Disinfection,Sterilization,and Preservation」(第5版)(S.S.Block(編者)、Lippincott Williams and Wilkins、459頁〜472頁)にならって求めた)。
メントールおよび銀イオンの殺細菌活性が、それぞれの化合物が単独で特定の濃度で試験されたときに観測される殺細菌活性の相加値よりも大きかったとき;または
メントールおよび銀イオンの殺細菌活性の特定のレベルが検出されるまでの時間が、それぞれの薬剤が単独で特定の濃度で試験されたときに測定される時間よりも短かったとき。
大腸菌 ATCC47076に対する、10%(v/v)グリセロールの高浸透圧溶液におけるメントールおよび銀イオンの殺細菌活性の相乗作用
メントールおよび銀イオンの間での殺細菌活性における相乗作用を評価するために、銀イオンおよびメントールの様々な濃度組合せを表1に詳述されるように使用した。
様々なタイプの細菌に対する、10%(v/v)グリセロールを含有する高浸透圧溶液における0.01%(w/v)銀イオンおよび0.05%(w/v)メントールの組合せの殺細菌活性
様々なタイプの細菌の成長および生存性に対する、0.01%の銀イオンおよび0.05%のメントール(0.5%(v/v)のTWEEN20によって可溶化される)の組合せの影響を評価した。
0.01%(w/v)銀イオンおよび0.05%(w/v)メントールの組合せの最小阻害濃度(MIC)および最小殺細菌濃度(MBC)の決定
総論:
試験を、チューブ希釈法を使用して、試験細菌に対する試験された銀イオン−メントール組合せの効果的な使用希釈度を求めるために行った。連続希釈物を細菌成長培地で被試験試料から作製した。試験細菌を生成物の希釈物に加え、成長させるために温置した。試験細菌の視認される成長を全く明らかにしなかった被試験試料の希釈物を、生成物の致死性を確認するために平板に置床した。この手順は、抗微生物剤のための標準的な感受性アッセイであり、アメリカ微生物学会(ASM)の方法論の趣旨を取り込んでいる。中和が70%以上で確認された。
使用された被試験試料を、1mlの緩衝化溶液あたり0.1mgの硝酸銀を含有する250mlのストック溶液から採取した。それぞれの被試験試料が下記の成分を含有した:
グリセロール:10%(v/v)
メントール:0.05%(w/v)
TWEEN20:0.5%(v/v)
AgNO3:0.01%(w/v)
Tris:50mM
下記の微生物株を本試験では使用した:
大腸菌 ATCC番号8739;表皮ブドウ球菌ATCC番号12228;肺炎桿菌ATCC番号4352;および黄色ブドウ球菌ATCC番号6538
採用基準:すべての陽性対照群は標的生物の成長を明らかにしなければならない。すべての培地および陰性対照群は標的生物の成長を明らかにしてはならない。
試験細菌の成長を阻害した、試験された被試験試料の最低希釈物(MIC)を、2x培地における試験細菌の中和回復について試験した。試験された試料希釈物の0.1mlのアリコートをNUAGに三連で置床した。3つのさらなる平板を力価対照群としてそれぞれの細菌のために調製した。平板には100CFU以下の試験細菌が添加された。平板を37±2℃で2日間〜4日間温置した。力価対照群から得られるカウント数を試験試料のカウント数と比較した。
MICおよびMBCについての結果が表3に示される。
表4は中和結果を示す。
試験は、上記で言及された採用基準を満たしていた。
USP微生物限界の決定
試験を、非無菌試料において好ましくないかもしれないか、または、病原性であると見なされるかもしれない黄色ブドウ球菌、大腸菌、緑膿菌、サルモネラsp.および他の関連細菌の存在を求めるために行った。これらの細菌の存在は、類似する病原性細菌の成長を許す環境を示している。
採用基準:未処理の平板計数結果は平板あたり30コロニー形成単位〜300コロニー形成単位(CFU)の範囲内でなければらないか、または、推定値として報告されなければならない。アスペルギルス・ニゲル(Aspergillus niger)および他の類似する細菌は、平板あたりわずかに8CFU〜80CFUにより正確に読み取られ得るだけである。コロニーが見つからないならば、結果が、試料希釈未満として報告される。平板計数は、陰性モニターが、現在の手順で確立されるパラメーターの範囲内であるときに有効である。認定のための陽性対照群は特徴的な成長を明らかにしなければならない。選択的スリーニングのための陰性試験モニターは指標細菌の成長を明らかにしてはならない。
サルモネラ:亜セレン酸塩−シスチンブロスおよびテトラチオン酸塩ブロス−30℃〜35℃で12時間〜24時間;ブリリアントグリーン寒天、亜硫酸ビスマス寒天およびXLD寒天−30℃〜35℃で24時間〜48時間;
P.aeruginosa:セトリミド寒天−30℃〜35℃で24時間〜48時間;
S.aureus:マンニトール塩寒天−30℃〜35℃で24時間〜48時間;
大腸菌:MacConkey寒天−30℃〜35℃で24時間〜48時間;
疑わしいコロニーはどれも、生化学試験を使用して確認した。
認定試験を下記のようにこの試料タイプの最初の試験で行った:
4つの試験細菌の24時間ブロス培養物を30℃〜35℃で成長させ、1:1000で希釈した。接種のために使用された細菌アリコートは試料調製物の1%以下であった。接種物をブロスにおける試料の希釈の1時間以内に加えた。スクリーニング手順を続けた。4つすべての試験細菌が回復しなければならない。これにより、試料の中和が明らかにされる。
被試験溶液は1:10の希釈で認定に合格した。好気性微生物総数と、カビおよび酵母の合計数との両方について観測された値が、「非検出」を示す10未満であった。
したがって、常法的分析を1:10の試料希釈で行った。
病原性スクリーニングにおいて、結果は、すべての被試験細菌が好気性総数および真菌総数に存在しなかったことを示した。平板計数結果は細菌回復または真菌回復のためには認定されない。
試験は採用基準を満たしていた。
抗微生物剤感受性試験
試験を、銀イオンおよびメントールを含有する試験試料を抗微生物活性についてスクリーニングするために行った。チャレンジ細菌が黄色ブドウ球菌ATCC番号6538および大腸菌ATCC番号8739であった。試験手順は、抗生物質感受性試験のためのディスク拡散(Kirby−Bauer)法の改変法であった。
培養調製:Mueller−Hintonブロスにストック培養物からのS.aureusおよび大腸菌を接種し、30℃〜35℃で18時間〜24時間温置した。試験細菌を、0.5のMcFatland標準に等しい細胞密度を達成するために生理学的食塩水を使用して標準化した。接種物を標準化後15分以内に使用した。
使用された被試験試料を、1mlの緩衝化溶液あたり0.1mgの硝酸銀を含有する250mlのストック溶液から採取した。それぞれの被試験試料が下記の成分を含有した:
グリセロール:10%(v/v)
メントール:0.05%(w/v)
TWEEN20:0.5%(v/v)
AgNO3:0.01%(w/v)
Tris:50mM
結果が表5に示され、被試験試料に対する細菌の感受性を明らかにする。
銀イオンおよびメントールを含有する溶液の殺真菌/静真菌活性と、市販のB.Braun社のPRONTOSANの殺真菌/静真菌活性との比較試験
本明細書中に記載される組成物(本明細書中上記の実施例5に記載される被試験試料)の抗真菌活性を試験し、市販されている製造物のPRONTOSAN(登録商標)(B.Braunによる製造物)、MICROCYN(登録商標)(Occulusによる製造物)およびANASEPT(登録商標)(Anacapaによる製造物)の抗真菌活性と比較した。
ELISAプレートウエルにおけるSDB寒天(100μl)に被試験株を接種し、30℃での24時間の温置による最初の成長に供した。
Claims (15)
- メントールと、銀イオンとを有効成分として含み、かつ、医薬的に許容される担体を含む消毒剤組成物であって、前記組成物中の前記銀イオンの濃度が0.29〜0.6mMの範囲であり、前記メントールの濃度が0.64〜6.4mMの範囲である消毒剤組成物。
- 前記銀イオンの濃度が0.6mMであり、かつ、前記メントールの濃度が3.2mMである、請求項1に記載の消毒剤組成物。
- グリセロール、ポリエチレングリコール、塩化ナトリウム、多糖、マンニトール、塩化アンモニウム、硫酸マグネシウム、およびこれらの組み合わせからなる群から選択される高浸透圧剤をさらに含む、請求項1または2に記載の消毒剤組成物。
- シクロデキストリン、ポリビニルピロリドン、ポリオキシエチレンソルビタン脂肪酸エステル、ポリオキシエチレンn−アルキルエーテル、n−アルキルアミンn−オキシド、ポロキサマー、有機溶媒、リン脂質、およびこれらの組み合わせからなる群から選択される可溶化剤をさらに含む、請求項1〜3のいずれか一項に記載の消毒剤組成物。
- 前記医薬的に許容される担体は水溶液である、請求項1〜4のいずれか一項に記載の消毒剤組成物。
- 局所用投薬形態物として配合される、請求項1〜5のいずれか一項に記載の消毒剤組成物。
- 包装材と、前記包装材に包装されている請求項1〜6のいずれか一項に記載の消毒剤組成物とを含む消毒キット。
- 表面を殺菌することにおける使用のために前記包装材の中または表面において印刷により特定される、請求項7に記載の消毒キット。
- 創傷の処置における使用のために前記包装材の中または表面において印刷により特定される、請求項7に記載の消毒キット。
- 表面を殺菌することにおいて使用するための請求項1〜6のいずれか一項に記載の消毒剤組成物であって、前記殺菌することが前記消毒剤組成物を前記表面に局所適用することによって行われる、消毒剤組成物。
- 前記表面は身体表面であり、前記消毒剤組成物は、その必要性のある被験者の前記身体表面を殺菌するためのものである、請求項10に記載の消毒剤組成物。
- 前記身体表面における感染症を処置するためのものである、請求項11に記載の消毒剤組成物。
- 創傷をその必要性のある被験者において処置することにおいて使用するためのものである、請求項1〜6のいずれか一項に記載の消毒剤組成物。
- 請求項1〜6のいずれか一項に記載の消毒剤組成物を調製する方法であって、前記銀イオンの供給源、前記メントールおよび前記医薬的に許容される担体を混合し、それにより、消毒剤組成物を得ることを含む方法。
- 銀イオンを含む消毒剤組成物における銀イオンの消毒剤濃度を0.29〜0.6mMの範囲の濃度に低下させる方法であって、0.64〜6.4mMの範囲の相乗作用有効量のメントールを消毒剤組成物と混合することを含む方法。
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