JP6254243B2 - ヨウ素並びに糖及び/又は糖アルコールを含有する液体殺菌組成物 - Google Patents
ヨウ素並びに糖及び/又は糖アルコールを含有する液体殺菌組成物 Download PDFInfo
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- JP6254243B2 JP6254243B2 JP2016212021A JP2016212021A JP6254243B2 JP 6254243 B2 JP6254243 B2 JP 6254243B2 JP 2016212021 A JP2016212021 A JP 2016212021A JP 2016212021 A JP2016212021 A JP 2016212021A JP 6254243 B2 JP6254243 B2 JP 6254243B2
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- 229920002239 polyacrylonitrile Polymers 0.000 description 1
- 229920000768 polyamine Polymers 0.000 description 1
- 229920000447 polyanionic polymer Polymers 0.000 description 1
- 229920000573 polyethylene Polymers 0.000 description 1
- 238000000710 polymer precipitation Methods 0.000 description 1
- 229920002223 polystyrene Chemical group 0.000 description 1
- 239000013641 positive control Substances 0.000 description 1
- 239000002244 precipitate Substances 0.000 description 1
- 238000001556 precipitation Methods 0.000 description 1
- 238000004321 preservation Methods 0.000 description 1
- 230000002335 preservative effect Effects 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 235000010409 propane-1,2-diol alginate Nutrition 0.000 description 1
- 239000000770 propane-1,2-diol alginate Substances 0.000 description 1
- MCSINKKTEDDPNK-UHFFFAOYSA-N propyl propionate Chemical compound CCCOC(=O)CC MCSINKKTEDDPNK-UHFFFAOYSA-N 0.000 description 1
- 229960003415 propylparaben Drugs 0.000 description 1
- 239000008213 purified water Substances 0.000 description 1
- 150000003242 quaternary ammonium salts Chemical class 0.000 description 1
- 238000005956 quaternization reaction Methods 0.000 description 1
- 238000003044 randomized block design Methods 0.000 description 1
- 235000009566 rice Nutrition 0.000 description 1
- 238000010079 rubber tapping Methods 0.000 description 1
- 229960004889 salicylic acid Drugs 0.000 description 1
- FSYKKLYZXJSNPZ-UHFFFAOYSA-N sarcosine Chemical compound C[NH2+]CC([O-])=O FSYKKLYZXJSNPZ-UHFFFAOYSA-N 0.000 description 1
- 230000028327 secretion Effects 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- UQDJGEHQDNVPGU-UHFFFAOYSA-N serine phosphoethanolamine Chemical compound [NH3+]CCOP([O-])(=O)OCC([NH3+])C([O-])=O UQDJGEHQDNVPGU-UHFFFAOYSA-N 0.000 description 1
- RMAQACBXLXPBSY-UHFFFAOYSA-N silicic acid Chemical compound O[Si](O)(O)O RMAQACBXLXPBSY-UHFFFAOYSA-N 0.000 description 1
- 229910052710 silicon Inorganic materials 0.000 description 1
- 239000010703 silicon Substances 0.000 description 1
- 239000000344 soap Substances 0.000 description 1
- 235000010413 sodium alginate Nutrition 0.000 description 1
- 239000000661 sodium alginate Substances 0.000 description 1
- 229940005550 sodium alginate Drugs 0.000 description 1
- 235000009518 sodium iodide Nutrition 0.000 description 1
- 229940075560 sodium lauryl sulfoacetate Drugs 0.000 description 1
- 229910052938 sodium sulfate Inorganic materials 0.000 description 1
- 235000011152 sodium sulphate Nutrition 0.000 description 1
- KKDONKAYVYTWGY-UHFFFAOYSA-M sodium;2-(methylamino)ethanesulfonate Chemical compound [Na+].CNCCS([O-])(=O)=O KKDONKAYVYTWGY-UHFFFAOYSA-M 0.000 description 1
- HVFAVOFILADWEZ-UHFFFAOYSA-M sodium;2-[2-(dodecanoylamino)ethyl-(2-hydroxyethyl)amino]acetate Chemical compound [Na+].CCCCCCCCCCCC(=O)NCCN(CCO)CC([O-])=O HVFAVOFILADWEZ-UHFFFAOYSA-M 0.000 description 1
- UAJTZZNRJCKXJN-UHFFFAOYSA-M sodium;2-dodecoxy-2-oxoethanesulfonate Chemical compound [Na+].CCCCCCCCCCCCOC(=O)CS([O-])(=O)=O UAJTZZNRJCKXJN-UHFFFAOYSA-M 0.000 description 1
- XFTALRAZSCGSKN-UHFFFAOYSA-M sodium;4-ethenylbenzenesulfonate Chemical compound [Na+].[O-]S(=O)(=O)C1=CC=C(C=C)C=C1 XFTALRAZSCGSKN-UHFFFAOYSA-M 0.000 description 1
- 229950003429 sorbitan palmitate Drugs 0.000 description 1
- 230000007480 spreading Effects 0.000 description 1
- 238000003892 spreading Methods 0.000 description 1
- 239000003381 stabilizer Substances 0.000 description 1
- 229920003179 starch-based polymer Polymers 0.000 description 1
- 239000004628 starch-based polymer Substances 0.000 description 1
- 229940098760 steareth-2 Drugs 0.000 description 1
- 229940100459 steareth-20 Drugs 0.000 description 1
- 239000008223 sterile water Substances 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 125000000020 sulfo group Chemical group O=S(=O)([*])O[H] 0.000 description 1
- 229940117986 sulfobetaine Drugs 0.000 description 1
- 230000000153 supplemental effect Effects 0.000 description 1
- 238000013268 sustained release Methods 0.000 description 1
- 239000012730 sustained-release form Substances 0.000 description 1
- 229960001367 tartaric acid Drugs 0.000 description 1
- 239000012085 test solution Substances 0.000 description 1
- UWHCKJMYHZGTIT-UHFFFAOYSA-N tetraethylene glycol Chemical compound OCCOCCOCCOCCO UWHCKJMYHZGTIT-UHFFFAOYSA-N 0.000 description 1
- 239000010409 thin film Substances 0.000 description 1
- 231100000419 toxicity Toxicity 0.000 description 1
- 230000001988 toxicity Effects 0.000 description 1
- 235000010487 tragacanth Nutrition 0.000 description 1
- 239000000196 tragacanth Substances 0.000 description 1
- 229940116362 tragacanth Drugs 0.000 description 1
- 229960003500 triclosan Drugs 0.000 description 1
- 229940072029 trilaureth-4 phosphate Drugs 0.000 description 1
- RRHXZLALVWBDKH-UHFFFAOYSA-M trimethyl-[2-(2-methylprop-2-enoyloxy)ethyl]azanium;chloride Chemical compound [Cl-].CC(=C)C(=O)OCC[N+](C)(C)C RRHXZLALVWBDKH-UHFFFAOYSA-M 0.000 description 1
- 239000006150 trypticase soy agar Substances 0.000 description 1
- 238000009827 uniform distribution Methods 0.000 description 1
- 238000012800 visualization Methods 0.000 description 1
- 239000011782 vitamin Substances 0.000 description 1
- 235000013343 vitamin Nutrition 0.000 description 1
- 229940088594 vitamin Drugs 0.000 description 1
- 229930003231 vitamin Natural products 0.000 description 1
- 229920003169 water-soluble polymer Polymers 0.000 description 1
- UHVMMEOXYDMDKI-JKYCWFKZSA-L zinc;1-(5-cyanopyridin-2-yl)-3-[(1s,2s)-2-(6-fluoro-2-hydroxy-3-propanoylphenyl)cyclopropyl]urea;diacetate Chemical compound [Zn+2].CC([O-])=O.CC([O-])=O.CCC(=O)C1=CC=C(F)C([C@H]2[C@H](C2)NC(=O)NC=2N=CC(=CC=2)C#N)=C1O UHVMMEOXYDMDKI-JKYCWFKZSA-L 0.000 description 1
- 239000004711 α-olefin Substances 0.000 description 1
Classifications
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- 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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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61K31/047—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates having two or more hydroxy groups, e.g. sorbitol
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
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- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/18—Iodine; Compounds thereof
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- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/24—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
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- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
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- A61P31/02—Local antiseptics
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Description
好ましい活性抗菌剤は、元素ヨウ素(I2)であり、これはヨードフォールの形態で提供され得る。殆どのヨウ素含有患者プレップ中と同様、ヨウ素に加えて他のヨウ素含有種が存在し得る。それらの種は、例えば、次亜ヨウ素酸(HOI)、ヨージド(I−)、トリヨージド(I3 −)、ヨーデート(IO3 −)及び同様物を含む。元素ヨウ素は、最も活性な抗菌種であると広く認識されている。例えば、Disinfection,Sterilization,and Preservation by Seymour S.Block,4.sup.th edition,Chapter 8「Iodine and Iodine Compounds,」Lea & Febiger,Philadelphia,PA.,1991を参照されたい。少量のBr−及び又はCl−も存在し得る。
本明細書で使用される単糖は、化学式(CH2O)n+mを有し、化学構造はH(CHOH)nC=O(CHOH)mHである。n又はmがゼロの場合、これはアルデヒドであり、アルドースと称され、さもなくばケトンであり、ケトースと称される。単糖は、ケトン又はアルデヒド官能基のいずれかを含み、非カルボニル炭素原子の殆ど又は全部にヒドロキシル基を含む。単糖は最も有用であると見出され、5個及び6個の炭素原子(n+m=5又は6)からなる化合物である。それらはD体若しくはL体又はそれらの組み合わせで見出され得る。最も好ましい単糖は、キシロース、キシルロース、リキソース、マンノース、麦芽糖、ソルボース、エリトロース、ブドウ糖(右旋糖)、果糖、ガラクトース及びリボースである。
本発明の組成物は、好ましくは保管中のpHドリフトを防止するよう緩衝される。例えば、ヨウ素含有システムにおいては、pHは一般に2〜6、好ましくは3〜5に維持することが望ましいことが周知である。pHが6を越えて上昇するにつれ、ヨウ素はヨージドに急速に変換され、それ故、抗菌効果は、それが所望される場合、不活性化され得る。pH2をかなり下回ると、組成物は刺激性となり得る。本発明の組成物では、pHは、3.0〜4.5、より好ましくは3.5〜4.2に調整されることが好ましい。
本発明の組成物は、皮膚及び粘膜組織上での有効な殺傷のために、好ましくは1種以上の界面活性剤を含有する。必要なこととして、界面活性剤は、抗菌剤、単糖及び/又は糖アルコール、並びに例えば増粘剤又はフィルム形成ポリマー等の、場合による任意の他の成分と適合性を有する必要がある。フィルム形成ポリマーと共に調製する際、1種以上の界面活性剤を含んで組成物中のポリマーの溶解度及び安定性を向上させることが特に望ましいと思われる。加えて、界面活性剤は、組成物が皮膚を湿潤させることを助け、滑らかな均一のコーティングを確実にする。誤りのない容易な適用を確実にするよう、完全な範囲を有するコーティング(好ましくは、持続性の)を提供することが望ましい。例えば殆どの粘膜表面等の視認が困難な組織上では、界面活性剤を使用して、湿潤を助け、抗菌剤が組織を横切り拡散し及び/又は毛細管現象により分配されることを確実にすることが望ましい。皮膚上では、急速に乾燥するであろう薄い比較的均一なコーティングが適用されることが好ましい。加えて、所定の界面活性剤は、抗菌活性を増大させ得る。
式中、a=0又は1であり、R3は、(C7〜C21)アルキル基(飽和又は不飽和直鎖、分岐鎖又は環状基)、(C6〜C22)アリール基又は(C6〜C22)アラルキル基若しくはアルカリル基(飽和直鎖、分岐鎖又は環状基)であって、R3は、所望により、1個以上のN、O若しくはS原子又は1個以上のヒドロキシル、カルボキシル、アミド若しくはアミン基によって置換されていてよく、R4は、H又は(C1〜C8)アルキル基(飽和若しくは不飽和直鎖、分岐鎖又は環状基)であって、R4は、所望により、1個以上のN、O若しくはS原子又は1個以上のヒドロキシル基、カルボキシル基、アミン基、(C6〜C9)アリール基又は(C6〜C9)アラルキル基若しくはアルカリル基によって置換されていてよく、R5及びR6は、それぞれ独立して、同一であっても異なってもよい(C1〜C10)アルキレン基であって、所望により、1個以上のN、O若しくはS原子又は1個以上のヒドロキシル基若しくはアミン基によって置換されていてよい。
式中、R3−R6及び「a」は、カルボン酸アンモニウム双極性イオンに関して上記に定義した通りである。例としては、コカミドプロピルヒドロキシスルタインヤシ及びラウラミドプロピルヒドロキシスルタイン(マッカム(MACKAM)50−SBとしてマッキンタイア・グループ(McIntyre Group Ltd.)から商業的に入手可能)が挙げられる。
式中、R4は、カルボン酸アンモニウム双極性イオンに関して上記に定義され、R7はR3(カルボン酸アンモニウム双極性イオンに関して上記に定義した通りである)であるが、但し、R7は、R7が、例えば、ホスファチジルコリン等のグリセロールエステル誘導体の場合、複数のR3も含み得る。例としては、レシチン、ホスファチジルコリン及びホスファチジルエタノールアミンが挙げられる。商標名アルラシルク(Arlasilk)リン脂質CDM(ヤシ油(coco)PG−ジモニウムクロリドホスフェート)、アルラシルク(Arlasilk)リン脂質EFA(リノールアミドプロピルPG−ジモニウムクロリドホスフェート)でユニケマ/クローダ(Uniqema/Croda)から販売されているもの等、鎖内の第四級アンモニウム基と、末端リン酸基とを所有する通称「逆リン脂質」も可能である。
及び、
R3−CH[SO3−M+]−R7
式中、a及びb=0又は1であり、n、p、m=0〜100(好ましくは0〜40、より好ましくは0〜20)であり、R3は、双極性イオンに関して上記に定義した通りであり、R7は、場合によりN、O、若しくはS原子又はヒドロキシル、カルボキシル、アミド若しくはアミン基で置換されてもよい(C1〜C12)アルキル基(飽和の直鎖、分岐鎖又は環式基)であり、Ph=フェニルであり、Mは、例えばNa、K、Li、アンモニウム、トリエタノールアミン又は第四級アンモニウム基等のプロトン化第三級アミン等の、カチオン性対イオンである。
式中、Ph、R3、a、n、p、及びMは、上記に定義され、rは0〜2であり、q=1〜3であり、但し、q=1の場合、r=2であり、またq=2の場合、r=1であり、またq=3の場合、r=0である。上記と同様、エチレンオキシド基(即ち、「n」基)及びプロピレンオキシド基(即ち、「p」基)は、逆の順番並びに無作為、順次又はブロック配列で生じる場合がある。
式中、R3は、上記に定義され、各R3は、同一又は異なっていてもよい。
本発明の殺菌組成物のための好適なビヒクル(好ましくは、所定の実施形態における23℃で液体のビヒクル)は、単糖及び/又は糖アルコールが可溶であり、室温で光路長1センチメートル(cm)を有するキュベット内で85%を越える550ナノメートル(nm)でのパーセント透過率を有する、透明かつ澄んだ溶液を形成するビヒクルを含む。試験溶液は、より少量の抗菌剤、及び任意の増粘剤又はフィルム形成ポリマー、並びに界面活性剤及び例えば充填剤又は他の微粒子等の任意の他の不溶性種を含む組成物である。好ましい組成物は、23℃で2週間放置した後も安定かつ透明である。それ故、単糖及び/又は糖アルコールの可溶性を確実にするために、ビヒクルは一般に、水、アセトン、アルコール(特に(C1〜C4)アルコール(即ち、低級アルコール)例えばエタノール、2−プロパノール、及びn−プロパノール等)、又はそれらの混合物を含む。
1種以上の増粘剤、特にポリマー性増粘剤(フィルム形成ポリマーであってもよい)及び/又はフィルム形成ポリマーを殺菌組成物に加えて、持続性(例えば、血液及び体液暴露による洗い落としに対する耐性)を向上させ、PSA被覆製品の粘着を向上させ、粘度を増大させて液だれ等を防止し、及び/又は組成物の粘着性を低減することが特に望ましい。本発明の殺菌組成物の好ましいポリマー性増粘剤及び/又はフィルム形成ポリマーは持続性であり、例えば水、生理食塩水及び体液等の流体に対する長時間の暴露による除去に耐性であるが、尚、有機溶媒を必要とせずに容易かつ穏やかに除去することができる。
b.疎水変性高分子増粘剤
c.ポリマー/界面活性剤の組み合わせ
d.乳化剤(鑞を含む)
e.無機コロイド状増粘剤
局所皮膚殺菌剤のための高分子増粘剤(例えば、手術前及びIVプレップ)。
上記に簡潔に記載したように、例えば殆どの粘膜及び創傷組織等の湿潤組織での使用のための組成物は、好ましくはより高い粘度を有するよう調製される。これらの組成物は、適用により乾燥し切れ得ないため、より高い粘度の組成物を使用することにより、組織上の組成物はより長期間維持され得る。例えば、鼻道内で使用された場合、鼻纖毛は組成物を鼻道から咽喉へと下方に洗い去るよう試みるであろう。同様に、口腔又は食道腔内で使用された場合、口腔分泌物は組成物を咽喉へと下方に洗い流す傾向があるであろう。それ故、これらの組成物の増粘して、組織上で殺菌剤を長期間保持し、十分な殺菌を確実にすることが有利である。これらの組成物は、当技術分野にて公知の手段により、特に以下の1つ以上を使用して増粘することができる:高分子増粘剤、無機コロイド状増粘剤、疎水変性高分子増粘剤、ポリマー/界面活性剤の組み合わせ、乳化剤、及びそれらの組み合わせ。
1種以上の他の(二次的な)抗菌剤を、保存剤及び/又は活性成分としてヨウ素と組み合わて含有することが望ましいと思われる。他の活性物質としては、例えばポリヘキサメチレンビグアニド(PHMB、アーチ・バイオサイド(Arch Biocides)からのコスモシル(COSMOCIL)CQ)、例えばグルコン酸クロルヘキシジン、酢酸クロルヘキシジン及び同様物等のクロルヘキシジン塩等のカチオン性物質、並びに米国特許出願公開第2006/0051384号に開示されている他のカチオン性殺菌剤を含む。例えば米国特許出願公開第2006/0051384号に開示されているもの等の天然油殺菌剤を加えてもよい。加えて、例えば米国特許出願公開第2005/0089539号に記載されているもの等の抗菌脂質を加えることが望ましいと思われるが、所定の実施形態において、本発明の組成物は抗菌脂質を含まない。例えばトリクロサン、パラクロロメタキシレノール及び米国特許出願公開第2006/0052452号に開示されている他のもの等のフェノールタイプの抗菌剤も有用であり得る。
本発明の組織殺菌組成物は、組織(特に皮膚又は粘膜組織、例えば口腔組織及び食道組織等)の消毒のための多様な方法に使用することができる。例えば、組成物は、対象の鼻道の脱コロニー化(decolonize)に使用することができ、これは内部の細菌の量を低減することを意味する。これは細菌の殺傷を含み得るが、手術部位の感染の機会を減少させ、及び/又は患者及び医療スタッフ間の例えばメチシリン耐性黄色ブドウ球菌(Staphylococcus aureus)(MRSA)等の細菌の感染の危険を低減することを助けるレベルに低下される限り、常に必要というわけではない。典型的には、そのような方法は、単に組成物を対象の組織に適用することにより生じる。そのような組織の消毒方法は、好ましくは対象に侵襲的手順(例えば、手術手順)が実施される前に行われ、又は患者間でMRSA等の細菌の感染を防止する。例えば、本発明の組成物は、組織に直接適用されてもよく、又は例えば綿球、発泡体、拭き取り用品等の基材中に含浸された後、場合により幾分かの洗浄除去又は拭い作用と共に鼻に適用されてもよい。基材は、直ぐに除去されるか、又は場合により、除去前に定位置に一定時間保持されてもよい(例えば、15〜60分間)。
本発明は、番号を付与した以下の実施形態を提供する。
組成物が健康な志願者の背部(「乾燥」部位を考慮して)に適用され、ASTM方法のセクション7.1に提示されるベースライン細菌叢数が、同様に高くないことを除いて、多数の組成物の抗菌活性を、手術前皮膚製剤の評価のためのASTM試験方法E−1173〜93標準試験と類似した方法にて調べた。プレップは、製造業者の指示に従って、ベタジン・サージカル・スクラブ(BETADINE Surgical Scrub)(7.5%ポビドン−ヨウ素、パーデュー・フレデリック(Purdue Frederick)、コネチカット州ノーウォーク)及びベタジン・サージカル・ソリューション(BETADINE Surgical Solution)(10%ポビドン−ヨウ素「顔料」、パーデュー・フレデリック(Purdue Frederick)、コネチカット州ノーウォーク)の2ステップ適用、又は3Mワンステップ(One-Step)プレップ(3M社(3M Company)、ミネソタ州セントポール)と常に比較された。全ての研究は、無作為化ブロック設計であった。研究の日、ベースライン微生物数に関する2つのサンプルを、脊柱の反対側上の上背部から1つ、及び下背部から1つ取り出された。試験製剤及び対照を背部上に、通常、上背部を横切り4つ、及び下背部を横切り4つに無作為化した。適用から2分後、全部位から、残留した細菌のサンプルを採取した。全ての試験サンプルは、試験組成物で飽和された(完全に湿潤及び滴下した)無菌ガーゼを使用して適用され、以下のように適用された。1つの方法では、約5.1cm×5.1cm(2×2インチ)範囲を、適度の圧力を用いて60秒間「洗浄除去」した。ベタジン・サージカル・スクラブ(BETADINE Surgical Scrub)及びベタジン・サージカル・ソリューション(BETADINE Surgical Solution)を、製造業者の指示に従って適用した。簡潔には、ベタジン・サージカル・スクラブ(BETADINE Surgical Scrub)は飽和ガーゼを用いて適用され、5分間洗浄除去され、拭き取られ、ベタジン・サージカル・ソリューションは中心から外方向螺旋にて適用された。したがって、本発明の組成物は、ベタジン(BETADINE)洗浄除去及び塗布手順が有した時間と比較して、遙かに短い殺傷のための時間を有した。ASTM試験方法E1173のセクション8.2〜8.3に従って、最小限の8人の対象を用いた。全ての対象は、抗菌製品の使用を最低2週間控えた。試験組成物を、厚さ5×5cm(2×2インチ)2.5cmのウィルソーブ(Wilsorb)ポリウレタンオープンセルスポンジ(ウィルソーブ(Wilsorb)可撓性オープンセルポリウレタンスポンジ、イルブルック社(Illbruck Inc.)ポリウレタンポリエステル、ポリウレタンスポンジ発泡体;密度=1.8 lb/ft3(ASTM 3574);圧縮力=25%圧縮にて3.8kPa(0.56psi)又は65%圧縮にて5.5kPa(0.81psi))の小片を使用して適用した。各組成物に関して、ベースラインからの平均log低下を測定した。複数の部位を試験した場合、各部位に関するlog低下を測定した。結果は、平均log低下(log低下値の数値の平均)にて報告する。ASTM試験方法E1173〜93セクション6.7に従って、試験した各製剤に関して適切な中和剤を最初に決定したことに留意されたい。殆どのポリマーシステムに以下の中和試料採取溶液を使用した:リン酸二水素カリウム0.4g、リン酸水素ナトリウム10.1g、テキサス州ヒューストンのユニオン・カーバイド社(Union Carbide Corp.)から入手可能なトリトン(TRITON)X100界面活性剤1.0g、レシチン(CAS#8002〜43〜5、ニュージャージー州フェアローンのフィッシャー・サイエンティフィック(Fisher Scientific)からCatNo.03376〜250として入手可能)4.5g、ツイーン(TWEEN)80(ICI)45.0g、チオ硫酸ナトリウム1.0g、及び総容積を1リットルにするための脱イオン水。全成分を一緒に加え、溶解する迄撹拌しながら約60℃に加熱することにより試料採取溶液を調製した。これを次に、容器内に配置し、蒸気滅菌した。
接種製剤:リン酸緩衝水中の約108テトラサイクリン耐性黄色ブドウ球菌(S.aureus)(ATCC#27217)の接種材料を、0.5マクファーランド濁度標準液と比較して調製した。
粘度は、エンジニアリング・ラボ社(Engineering Labs Inc.)(マサチューセッツ州ミドルボロ)から商業的に入手可能な、小さいサンプルアダプタ(ULAアダプタ)LVDVI+を有するブルークフィールドRVT ROTOVISCO粘度計を使用して測定した。測定値は、低粘度サンプルに関しては23℃〜25℃でスピンドルサイズ00を使用して、1分間当たり30回転(rpm)の速度にて獲得した。1000を越える粘度を有するサンプルに関しては、粘度は23℃にて周囲圧力で、モデルDブルークフィールドヘリオパス(heliopath)及びTスピンドルB−Fを搭載したブルークフィールドLVDV−I+粘度計を使用して測定した。スピンドル及び速度は、特定の各サンプルに関して選択し、それにより粘度計はその範囲の中間にて作動された。全サンプルは測定前に23℃で24時間平衡化された。好ましくは、粘度は、粘度計範囲の20〜80%以内に、より好ましくは範囲の30〜70%間に留まる一方、可能な限り低速で獲得された。全ての場合において、サンプル寸法及び容器外形は、壁効果が全く存在しないことを確実にするよう選択された。「壁効果」により、粘度値が容器による影響を受けず、無限大の容器内で得た粘度と本質的に等価であることが意味される。そのため、より低い粘度のサンプルは、より大きいスピンドルに適応するためにより、大きいサンプル寸法を必要とした。以下の表1に、様々なサンプル粘度にとって好ましいスピンドルを概略したが、最大のスピンドルをサンプル寸法に使用する必要がある。
表2に示す組成物を、以下に記載する一般的手順を使用して調製した。
表3に示す組成物を調製し、拡がりに関して試験した。
表4に示す組成物を、以下に記載する一般的手順を使用して調製した。
ポリマー濃度を調製し、即ちセルカット(Celquat)SC230Mの濃度を調製した以外は、実施例2を繰り返した。バランスを水で置き換えた。
ポリマー濃度を調製し、即ちセルカット(Celquat)SC230Mの濃度を調製した以外は、実施例7を繰り返した。バランスを水で置き換えた。
1%ポリマーのみを含む(ポリマーを水で置き換えた)実施例5、実施例10、実施例13及び比較例Cを、本明細書に記載した手順に従って、ヒト皮膚抗菌活性に関して試験した。サンプルを3Mワンステップ(One-Step)プレップと比較した。この結果を表7に示す。
鼻腔内での使用:サンプル5、7及び10をヒト志願者の鼻孔に適用した。各組成物0.25mLのサンプルを両方の前鼻孔内に適用し、鼻を15秒間マッサージすることにより擦り込んだ。組成物を除去せずに鼻孔/小鼻内に滞在させた。4時間後、次のサンプルを評価した。全サンプルは非刺激性であると見出された。ヨウ素の匂いは検出可能であったが、その匂いは不快なものではなかった。
Claims (2)
- ヨウ素(I2)、ヨードフォール、及びそれらの組み合わせからなる群より選択され、
利用可能なヨウ素濃度0.1重量%〜2重量%を提供するのに十分な濃度で存在する、抗菌剤と、
単糖;キシリトール、マンニトール若しくはそれらの組み合わせから選択される糖アルコール;又は単糖及び上記糖アルコールの組み合わせと、
2.5重量%を超える量でヒドロキシカルボン酸緩衝液と、
23℃で液体であるビヒクルと、を含み、
23℃で液体である、組織殺菌組成物。 - ヨウ素(I2)、ヨードフォール、及びそれらの組み合わせからなる群より選択され、
利用可能なヨウ素濃度0.1重量%〜2重量%を提供するのに十分な濃度で存在する、抗菌剤と、
単糖;キシリトール、マンニトール若しくはそれらの組み合わせから選択される糖アルコール;又は単糖及び上記糖アルコールの組み合わせと、
ヒドロキシカルボン酸緩衝液と、を含み、
1000cpsを越える粘度を有し、
23℃で液体であり、
pHが3〜4.5である、組織殺菌組成物。
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US20050058673A1 (en) | 2003-09-09 | 2005-03-17 | 3M Innovative Properties Company | Antimicrobial compositions and methods |
CN102845422A (zh) * | 2003-09-09 | 2013-01-02 | 3M创新有限公司 | 抗菌组合物和方法 |
DE10360847A1 (de) | 2003-12-20 | 2005-07-28 | Cord Contract Research And Development Gmbh | Medizinisches Gleitgel |
US20050191270A1 (en) | 2004-02-27 | 2005-09-01 | Hydromer, Inc. | Anti-infectious hydrogel compositions |
US8198326B2 (en) | 2004-09-07 | 2012-06-12 | 3M Innovative Properties Company | Phenolic antiseptic compositions and methods of use |
US20060051384A1 (en) | 2004-09-07 | 2006-03-09 | 3M Innovative Properties Company | Antiseptic compositions and methods of use |
US20070048345A1 (en) * | 2005-08-31 | 2007-03-01 | Kimberly-Clark Worldwide, Inc. | Antimicrobial composition |
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2008
- 2008-12-29 AU AU2008346755A patent/AU2008346755B2/en not_active Ceased
- 2008-12-29 EP EP08870511.6A patent/EP2249805B1/en active Active
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CA2711663A1 (en) | 2009-07-16 |
US20090169647A1 (en) | 2009-07-02 |
CN101951887A (zh) | 2011-01-19 |
CA2711663C (en) | 2017-01-10 |
JP2015057429A (ja) | 2015-03-26 |
JP6117460B2 (ja) | 2017-04-19 |
EP2249805B1 (en) | 2014-11-05 |
JP2017039770A (ja) | 2017-02-23 |
AU2008346755A1 (en) | 2009-07-16 |
BRPI0819566A2 (pt) | 2015-05-05 |
US10052384B2 (en) | 2018-08-21 |
EP2249805A1 (en) | 2010-11-17 |
WO2009088826A1 (en) | 2009-07-16 |
AU2008346755B2 (en) | 2012-09-27 |
CN101951887B (zh) | 2013-03-13 |
JP2011507976A (ja) | 2011-03-10 |
JP6268082B2 (ja) | 2018-01-24 |
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