JP6033082B2 - 次亜塩素酸を含有する溶液及びその使用方法 - Google Patents
次亜塩素酸を含有する溶液及びその使用方法 Download PDFInfo
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- JP6033082B2 JP6033082B2 JP2012516208A JP2012516208A JP6033082B2 JP 6033082 B2 JP6033082 B2 JP 6033082B2 JP 2012516208 A JP2012516208 A JP 2012516208A JP 2012516208 A JP2012516208 A JP 2012516208A JP 6033082 B2 JP6033082 B2 JP 6033082B2
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- antimicrobial
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Classifications
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/20—Elemental chlorine; Inorganic compounds releasing chlorine
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- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N25/00—Biocides, pest repellants or attractants, or plant growth regulators, characterised by their forms, or by their non-active ingredients or by their methods of application, e.g. seed treatment or sequential application; Substances for reducing the noxious effect of the active ingredients to organisms other than pests
- A01N25/02—Biocides, pest repellants or attractants, or plant growth regulators, characterised by their forms, or by their non-active ingredients or by their methods of application, e.g. seed treatment or sequential application; Substances for reducing the noxious effect of the active ingredients to organisms other than pests containing liquids as carriers, diluents or solvents
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- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N59/00—Biocides, pest repellants or attractants, or plant growth regulators containing elements or inorganic compounds
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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
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
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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
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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
- 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
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
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- A61P31/14—Antivirals for RNA viruses
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- A61K2121/00—Preparations for use in therapy
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/10—Dispersions; Emulsions
- A61K9/12—Aerosols; Foams
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- 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
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Description
本発明は、低pH抗菌溶液及びそのような溶液の使用方法に関する。
遊離塩素(FAC)水溶液(超酸化水溶液としても知られる)は、広範な細菌、ウイルス、及び胞子に対するその迅速で高い抗菌活性に起因して、殺菌剤及び創傷処置治療として幅広い用途を示している。FAC水溶液は、典型的には環境上安全であり、従って、コストのかかる廃棄手順の必要がない。また、FAC水溶液は、微生物の抵抗性又は耐性(従来の抗生物質治療では発現され得る)を促進しない。これらの溶液は、典型的には5から7の間のpHを有し、高濃度の多数の反応性の高い塩素種(例、次亜塩素酸、次亜塩素酸ナトリウム等)及び抗菌特性を与える他の酸化性化学種(oxidative species)を含有する。
本発明は、次亜塩素酸及び水を含む低pH抗菌溶液に関する。本発明の低pH抗菌溶液は約4〜約6のpHを有し、緩衝液を更に含み得る。このような溶液は、障害された(impaired)か又は損傷された組織を治療するため、及び生体及び/又は無生物の表面を殺菌するために使用され得る。
本発明は、次亜塩素酸及び水を含む低pH抗菌溶液に関する。本発明の低pH抗菌溶液は、約1〜約7の任意の酸性pHであり得る。この関連で、抗菌溶液は、それらが表面を損傷させたり、溶液と接触するヒトの皮膚などの対象を害したりすることなく、表面に適切な量で安全に適用され得るような、任意の低いpHであり得る。典型的には、抗菌溶液のpHは約4〜約6である。更なる実施形態において、本発明の抗菌溶液は約4.9〜約5.6のpHを有する。抗菌溶液は、別の実施形態において約4.5から約5.6のpHを有する。
本実施例は、緩衝液への塩素の添加を含む化学プロセスにより1リットルの低pH抗菌溶液を製造する本発明の一実施形態を示す。
本実施例は、電気化学プロセスを用いて低pH抗菌溶液を製造する本発明の別の実施形態を示す。
第一リン酸ナトリウム(以下のうちの1つ):
1. 1430g NaH2PO4、
2. 1645g NaH2PO4・H2O、又は
3. 1859g NaH2PO4・2H2O
第二リン酸ナトリウム(以下のうちの1つ):
1. 64g Na2HPO4
2. 121g Na2HPO4・7H2O
3. 161g Na2HPO4・12H2O
本実施例は、本発明の低pH抗菌溶液の安定性を示す。上記実施例2において(即ち、電気化学プロセスにより)製造した1ロットの低pH抗菌溶液を、1サンプル/ロット;1サンプル/時点で、40℃における安定性試験に供した。フィンガーポンプスプレーヘッド(製造の時点でボトルに固定した)を有する120mL PET容器に溶液を入れた。加速試験のために40℃±2℃に設定した環境試験チャンバーにサンプルを置いた。ロットリリースデータは、T=0を表した。各データ点を未開封のボトルで表した。
試験 仕様
遊離塩素(FAC) 70−150ppm
pH 4.5−6.0 pH単位
本実施例は、より高いpHの既知の塩素含有溶液と比較して、本発明の低pH抗菌溶液の安定性の向上を示す。より具体的には、3つの溶液をガラスバイアル中に密封し、80℃に加熱し、分解を比較した。第一のものは7.3のpHを有し、第二のものは緩衝液を含まず5.6のpHを有し、そして第三のものは5.6のpHを有しリン酸緩衝液を含有した。3つの溶液はいずれも、およそ130mg/Lの遊離塩素含量を有した。87時間後の反応速度(1/3が分解した)を下記表2に記載する。
本実施例は、より高い塩化物含量を有する既知の塩素含有溶液と比較して、本発明の低pH抗菌溶液の安定性の向上を示す。pH4−6における分解の速度への塩化物イオンの効果を試験した(表3)。引き上げ式のふたを有する8oz HDPEボトルに3つの溶液を入れ、40℃で保管した。
本実施例は、本発明の低pH抗菌溶液と従来技術の高塩化物/pH溶液との間の反応機構の違いを示す。特に、Pseudomonas aeruginosaを、2つの溶液(即ち、pH5及びpH7.5)で処理した。処理後、電子顕微鏡を使用して、細胞サンプルを評価した。全ての細菌が両方の溶液により殺された。しかしながら、pH5溶液で処理した細菌(図2)についての細胞の形態は、pH7.5で処理した細菌(図3)とは異なっていた。本発明のpH5溶液を使用した処理は、細胞の形態の変化がない(即ち、膜損傷がない)死んだ細菌細胞を示す電子顕微鏡写真を与えた。一方、従来技術の溶液(即ち、7.5のpHを有する溶液)を使用した処理は、破裂した細胞由来の大量の残骸及び膜損傷の証拠を示す電子顕微鏡写真をもたらした。このデータは、本発明のHOCl溶液(pH5)が、従来技術のHOCl/NaOCl/Cl2O溶液(pH7.5)とは異なる抗菌機構により反応していることを支持する。
本実施例は、より高いpHを有する溶液と比較して、本発明の低pH抗菌溶液についての有機物負荷の処理の改善を示す。特に、2つの溶液(pH4.9及び7.0)を、アルブミン(傷の有機物負荷を刺激し、抗菌剤を不活性化することが知られている妨害物質)の存在下で、種々の細菌に対して試験した。血清アルブミンは、ヒト血漿中の最も多いタンパク質の1つであるため、有機物負荷を表すための論理的な選択である。結果を下記表4に示す。
Claims (10)
- 次亜塩素酸及び水を含有する低pH抗菌溶液であって、該溶液は、4〜6のpHを有し、10mg/L〜250mg/Lの遊離塩素含量を有し、4mg/L〜120mg/Lの塩化物イオン含量を有し、第一リン酸ナトリウムと第二リン酸ナトリウムとの組合せである緩衝剤を更に含み、且つ少なくとも2ヶ月間安定である、前記溶液。
- pHが4.5〜6.0である、請求項1に記載の溶液。
- 該溶液が5mg/L〜200mg/Lの量で次亜塩素酸を含む、請求項1に記載の溶液。
- 次亜塩素酸及び水を含有する低pH抗菌溶液を含む、患者における障害されたか又は損傷された組織の治療用医薬であって、該溶液が、4〜6のpHを有し、10mg/L〜250mg/Lの遊離塩素含量を有し、4mg/L〜120mg/Lの塩化物イオン含量を有し、第一リン酸ナトリウムと第二リン酸ナトリウムとの組合せである緩衝剤を更に含み、且つ少なくとも2ヶ月間安定である、前記医薬。
- 該溶液が5mg/L〜200mg/Lの量で次亜塩素酸を含む、請求項4に記載の医薬。
- 組織が、外科的切開、口腔手術、グラフト手術、インプラント手術、トランスプラント手術、焼灼、切断、放射線、化学療法、又はそれらの組合せにより障害されているか又は損傷されている、請求項4に記載の医薬。
- 組織が、熱傷、切り傷、擦過傷、掻き傷、発疹、潰瘍、穿刺、又はそれらの組合せにより障害されているか又は損傷されている、請求項4に記載の医薬。
- 障害されたか又は損傷された組織が感染されている、請求項4に記載の医薬。
- 次亜塩素酸及び水を含有する低pH抗菌溶液の製造方法であって、該溶液が、4〜6のpHを有し、10mg/L〜250mg/Lの遊離塩素含量を有し、4mg/L〜120mg/Lの塩化物イオン含量を有し、且つ少なくとも2ヶ月間安定であり、
当該方法は、緩衝剤及び水を含む緩衝液に塩素ガスを添加する工程を含み、該緩衝剤が、第一リン酸ナトリウムと第二リン酸ナトリウムとの組合せである、前記方法。 - 該方法が5mg/L〜200mg/Lの量で次亜塩素酸を含む溶液を製造する、請求項9に記載の方法。
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WO2022045535A1 (ko) * | 2020-08-25 | 2022-03-03 | 백현아 | 차아염소산수 기반의 천연물 살균소독제 및 그 제조 방법 |
KR20220026203A (ko) * | 2020-08-25 | 2022-03-04 | 백현아 | 차아염소산수 기반의 천연물 살균소독제 및 그 제조 방법 |
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KR20120030524A (ko) | 2012-03-28 |
BRPI1011886B1 (pt) | 2022-05-03 |
BRPI1011886A2 (pt) | 2019-09-24 |
CN102480972A (zh) | 2012-05-30 |
US20120269904A1 (en) | 2012-10-25 |
CA2765696A1 (en) | 2010-12-23 |
JP2012530142A (ja) | 2012-11-29 |
MX348304B (es) | 2017-06-02 |
US10342825B2 (en) | 2019-07-09 |
KR101781229B1 (ko) | 2017-09-22 |
MX2011013682A (es) | 2012-04-19 |
WO2010148004A1 (en) | 2010-12-23 |
CA2765696C (en) | 2018-03-06 |
CN102480972B (zh) | 2014-12-10 |
BRPI1011886A8 (pt) | 2022-03-29 |
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