CN101484564B - 对皮肤友好的广谱消毒组合物 - Google Patents
对皮肤友好的广谱消毒组合物 Download PDFInfo
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- CN101484564B CN101484564B CN2007800254858A CN200780025485A CN101484564B CN 101484564 B CN101484564 B CN 101484564B CN 2007800254858 A CN2007800254858 A CN 2007800254858A CN 200780025485 A CN200780025485 A CN 200780025485A CN 101484564 B CN101484564 B CN 101484564B
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- 125000006233 propoxy propyl group Chemical group [H]C([H])([H])C([H])([H])C([H])([H])OC([H])([H])C([H])([H])C([H])([H])* 0.000 description 1
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Classifications
-
- C—CHEMISTRY; METALLURGY
- C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
- C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
- C11D3/00—Other compounding ingredients of detergent compositions covered in group C11D1/00
- C11D3/39—Organic or inorganic per-compounds
- C11D3/3947—Liquid compositions
-
- A—HUMAN NECESSITIES
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Abstract
本发明公开了在泡沫分散器中使用的一种组合物,其包含:0.1-5%(w/w)的过氧化氢、21-55%(w/w)的C2-C6醇和0.01-2%(w/w)的泡沫促进剂。当从泡沫分散器中分散由36%(w/w)乙醇和0.2%(w/w)泡沫促进剂组成的组合物时,泡沫促进剂能够提供稳定的泡沫。作为泡沫提供的组合物适用于对皮肤和/或粘膜进行消毒。
Description
本发明涉及即用型对皮肤友好的、广谱消毒剂组合物,其包含醇和过氧化氢二者作为活性消毒组分。
感染控制是卫生保健工作者主要关注的问题。被污染的手上的病毒和细菌容易在卫生保健机构(如医院)中人群之间传播。当然,感染的风险也存在于除医院外的公共场所,如健身房、洗衣房、饭店和学校。
目前在医院设施和食品&酒店部门存在朝向更高水平感染控制的趋势。另外,对可以通过皮肤和呼吸系统传递的感染性疾病存在越来越多的认识。这些趋势决定了工业界要拿出在全天中可更频繁使用的杀生物溶液。这些溶液必须是低变应原的、无毒的并且不在皮肤上产生不希望的任何残留。
在某些环境如医院中,通过大部分通常可获得的产品不能达到需要的消毒水平。因此,已经开发了特定的手消毒剂,在需要的地方达到更高的消毒水平。这些类型的产品一般含有高浓度的抗微生物活性成分如醇、碘/碘载体、葡萄糖酸氯己定(CHG)、酚类化合物如对氯间二甲苯酚(PCMX)和Triclosan、季铵化合物或其组合。
这类产品的问题是它们常为了消毒活性的考虑而牺牲皮肤温和性,或反过来。例如,虽然提高活性成分的浓度可导致更高的消毒水平,但是其通常导致更高的皮肤刺激。
对氯间二甲苯酚(PCMX)和Triclosan是抗菌洗手溶液中使用的常见酚类化合物。尽管PCMX和Triclosan具有比其他酚更低的毒性并且对皮肤相当温和,但是它们的活性低并且取决于配制物成分。
碘和碘载体已在抗菌洗手配制物中长期使用。它们的杀菌活性低,并在存在有机物质时被降低。另外,这些成分是有毒的并可刺激和染色皮肤。
葡萄糖酸氯己定(CHG)被用作皮肤清洁剂、手术前清洗剂、杀菌手部冲洗剂和伤口清洁剂。与革兰氏阳性菌相比,其对革兰氏阴性菌不太有效,并显示相对低的杀菌活性。
醇代表了提供快速消毒的一组公知的有效杀菌剂。它们还增强了表面上消毒溶液的干燥,或摩擦手时提供了无须冲洗的、留置自然干燥(1eave-to-dry)的应用。它们还为皮肤提供了焕然一新的感觉。然而,为了达到足够高的消毒率,消毒溶液必须含有至少60-70%的醇。这种水平的醇使皮肤极度脱脂和干燥,重复使用时引起干燥、皲裂或碎裂的皮肤。受损的皮肤可进一步提高细菌污染和存在细菌残留的机会,因为皮肤中的裂纹是难以到达并适当清洁的。另外,当在湿手上使用时,醇的抗微生物活性趋向于显著下跌,导致不足的微生物杀伤。
已知在组合物中包含额外的成分如柔润剂、致湿剂和表面活性剂,来克服醇的这些缺点中的一些。例如,美国专利6,617,294公开了一种无水消毒洗手液,其由60%到90%w/w的醇、基于硅酮的材料和致湿剂的混合物制成。然而,这些溶液提供了粘性的残留,并且由于不想要并令人不悦的硅酮材料积累而不能在一天中频繁使用。
US 5,916,568公开了用作洗手液的一种瞬干(flash-dry)消毒剂组合物,其包含55-80%的C2-C5醇、15-35%的过氧化氢溶液(提供约1.5-3.5%的有效过氧化氢浓度)和5-10%的抑菌皮肤柔润剂。高的醇浓度提供杀生物性质并允许快速干燥,但是也引起皮肤的严重脱脂,特别是在一天中重复使用后。还优选更高范围2.5-3.5%左右的过氧化氢浓度。然而,这种浓度漂白并刺激皮肤,特别是在一天中重复使用后。因此,该组合物尤其不适合频繁在皮肤上使用。另外,高水平醇是可燃的,因此在使用和储存中产生安全性风险。
US 4,900,721公开了用于皮肤和粘膜消毒的一种水性消毒剂,其包含8-25%的C2-C8醇和0.2-0.7%的过氧化氢。为了充分杀生物,该组合物要求存在额外的杀生物酚类化合物、季铵化合物和含氮双胍化合物如氯己定或Vantocil。后一化合物不适于用在皮肤上,特别是更频繁的使用,此时会发生积累。若干种酚类化合物也公知为皮肤变应原,特别是当组合物在全天中被重复使用时。避免使用季铵或酚类化合物同时仍然在足够短的接触时间中达到所需的消毒率是尤其有利的。
US 6,106,774公开了一种即用型水性硬表面清洁和消毒组合物,其包含0.1-20%的C1-6醇和0.1-10%过氧化氢。该组合物还应包含1.0-10%的二醇醚,或丁氧基丙醇或丙氧基丙醇,以提供想要的污渍和污物溶解效应。然而,与更高的醇百分比范围组合的更低的过氧化氢百分比范围(即适合皮肤应用的范围)不适于提供快速的消毒。
US 3,954,974公开了用于消毒皮肤的水包油乳剂。该乳剂包含过氧化氢,并任选地在水相中包含乙醇。存在于油相中的组分具有产生粘性残留的缺点。另外,这类乳剂不产生适当的泡沫。
WO 2005/030917公开了成泡的高醇含量组合物,其包含至少40%的C2-C4醇(在实施例中使用至少50%的醇)、抗微生物剂和含氟表面活性剂以产生成泡组合物。具有这类高醇含量的组合物需要含氟表面活性剂产生泡沫,而其他表面活性剂如烷基葡萄糖苷或甜菜碱不产生泡沫。即使它们能够产生瞬时泡沫,在皮肤上使用含氟表面活性剂也是不太好的。另外,含氟表面活性剂是对环境不友好的化合物。
因此,高度期望适用于皮肤和/或粘膜上的组合物,所述组合物能够在几分钟内消毒、在使用后不需要冲洗(因此适合于留置使用)、能够通过摩擦双手和/或双臂干燥、并对皮肤是友好的,因为其在重复使用后不产生粘稠度、不引起皮肤刺激和/或不是脱脂的。
本发明在第一方面提供了用于对皮肤和/或粘膜进行消毒的杀生物组合物,其包含C2-C6醇、过氧化氢和泡沫促进剂(foam booster)。以泡沫形式应用杀生物组合物似乎是高度有利的,从而提供精确的剂量、增加接触表面和接触时间,并因此提供足够的杀生物效力,且避免应用的剂量从手上流出或滴落(例如在应用喷雾配制品时会出现这种情况)。
本发明的可成泡组合物优选地是水性溶液的形式,并且不包括水包油乳剂。
因此,当利用泡沫分散器与空气混合时,本发明的组合物适合生产即时泡沫(instant foam)。可使用本领域已知的任何泡沫分散器,无论是加压的(带有气体推进剂)或非加压的体系(空气驱动的)。在非加压泡沫分散器的情况下,如下生产泡沫:将液体推过膜从而液体与空气在空气/液体混合腔中混合,使得能够从每次推进约0.2-3ml的液体产生即时泡沫。液体与空气混合至约6到20,优选地8到15,更优选地9到11的空气∶液体比例。以该方式生产了相对“干燥”的泡沫。
容纳组合物并且分散组合物的混合(成泡)腔可以是空气驱动的,即生产泡沫的气体主要由空气组成。由这样的装置生产的泡沫是充气泡沫。优选的泡沫分散装置包括可逆地可压缩和可减压的容器壳体,其在大气压下操作。合适的泡沫分散装置由Rexam Airspray和Keltec DispensingSystems生产,其递送奶油状的、高品质的泡沫而不使用非空气推进剂。
来自Rexam Airspray的合适泡沫分散器的综述在下表中提供:
型号 | 空气∶液体比例 | 输出ml | 冲程mm |
L9 | 9 | 1.20 | 18.8 |
S10 | 10 | 0.40 | 11.0 |
L11 | 11 | 0.75 | 14.8 |
具体地,本发明的组合物包含0.1-5%的过氧化氢、21-55%的C2-C6醇和0.01-2%的泡沫促进剂。
除非另有说明,在本发明全文中,百分比被表达为基于组合物总重的重量百分比。
本发明的组合物包含C2-C6醇,优选地包含C2-C4醇如乙醇、丙醇、异丙醇、丁醇或1,3-丁二醇,或其混合物,更优选地包含乙醇;醇以21-55%、优选地26-50%、更优选地30-45%、最优选地30-40%的浓度(w/w)存在。
另外,组合物包含过氧化氢作为第二消毒剂。过氧化氢以0.1-5%、优选地0.2-3%、更优选地0.2-2%、进一步更优选地0.5-2%、最优选地0.5-1.5%(w/w)的量提供。达到医院强度的消毒水平典型地需要最少0.5%(w/w)的过氧化氢。在一天中重复使用时一般要避免比3%更高的浓度,因为已观察到这类水平可引起皮肤漂白。
本发明的组合物还包含泡沫促进剂,当从泡沫分散器分散组合物时该泡沫促进剂用于在存在醇时提供稳定的泡沫。
在本发明的上下文中,术语“泡沫促进剂”是指在存在本文所述浓度的醇时能够生产稳定泡沫的化合物。
优选地,当在约20℃下从泡沫分散器中将下述组合物分散在惰性和光滑的表面上时,本发明的组合物中使用的泡沫促进剂提供稳定的泡沫,所述组合物由36%(w/w)乙醇和0.2%(w/w)、优选地0.3%(w/w)的泡沫促进剂组成,所述泡沫分散器具有相对高的空气∶液体比例、优选地9-11的空气∶液体比例、更优选地11的空气∶液体比例。合适的泡沫泵为例如来自Rexam Airspray的L11泡沫泵,其具有11的空气∶液体比例,0.75ml的液体输出体积,14.8mm的冲程(stroke)。如本领域技术人员已知的,最理想的是通过对泡沫分散器应用稳定的速度和压强来生产泡沫。
根据本发明,稳定的泡沫是如上所述从泡沫分散器中分散后立即测量时,作为泡沫保持至少5-10秒、优选地至少10-15秒、更优选地至少15-20秒、进一步更优选地至少20-25秒、最优选地至少25-30秒的泡沫。
泡沫促进剂应当适合用于皮肤或粘膜,尤其是适合留置应用,即应用后不冲洗。泡沫促进剂优选地不引起皮肤刺激或变应性反应。
本发明因此提供了具有相对高的低级醇(C2-C6)含量的组合物,其能够作为泡沫被分散并能够消毒皮肤且在皮肤干燥后不引起任何不想要的残留。这种可成泡的组合物与空气混合时递送稳定的泡沫,所述泡沫能够被用于个人清洁和消毒的目的,并且在应用压强时(例如当使用者摩擦双手时或当泡沫应用后在表面上被摩擦时)破碎。根据醇浓度和泡沫促进剂的浓度和类型,生产的泡沫可广泛变化,从相对快破碎但是足够稳定而能够被适当地应用于皮肤上却不浪费的泡沫,直到长期存在的泡沫。
泡沫促进剂以0.01-2%、优选地0.02-1.5%、更优选地0.05-1%的浓度存在。泡沫促进剂的浓度会取决于组合物的水含量和醇含量及其他。一般地,为了得到稳定的泡沫,醇浓度的提高也要求泡沫促进剂浓度的提高。然而,泡沫促进剂浓度典型地应当尽可能地低,从而避免手上的残留积累,重复使用时所述残留积累引起粘性。泡沫促进剂还应在存在醇和过氧化氢时是稳定的。
泡沫促进剂可优选地选自以下物质的至少一种:i)烷氧基化的非离子表面活性剂,ii)含氮的两性表面活性剂或非离子表面活性剂,iii)线性的C12-C24 α-烯烃磺酸盐,和iv)C12-C20磺基琥珀酸盐。
在一个实施方案中,泡沫促进剂不选自如WO 2005/030917中公开的含氟表面活性剂的组。
尤其优选的泡沫促进剂选自:i)烷氧基化的非离子表面活性剂和/或ii)含氮的两性表面活性剂或非离子表面活性剂。
泡沫促进剂可优选地选自水包油乳化剂和增溶剂的组,如典型地存在于本文所述的烷氧基化的非离子表面活性剂的组中。
烷氧基化的非离子表面活性剂优选地为烷氧基化的C8-C30脂肪醇、脂肪酸和/或脂肪油(其均具有最小6的烷氧基化程度)和/或聚山梨酯。
烷氧基化的C8-C30脂肪醇包含脂肪醇组分,所述组分为伯醇和/或仲醇,优选地为线性伯醇和/或仲醇,更优选地为线性伯醇。上述C8-C30脂肪醇的优选的例子是C10-C20脂肪醇。烷氧基化的脂肪醇还具有至少6、优选地至少7的烷氧基化程度,更优选地具有7-14的烷氧基化程度。一个优选的烷氧基化的脂肪醇是具有7摩尔亚乙基氧化物的C12-C18脂肪醇乙氧基化物,如Cognis Dehydol LT 7。
烷氧基化的C8-C30脂肪油优选地包含氢化的脂肪油组分。更优选地,其为烷氧基化的氢化的C10-C30脂肪油,优选地具有至少20、更优选地20-60的烷氧基化程度。例子是烷氧基化的氢化蓖麻油、烷氧基化的氢化椰子油、烷氧基化的氢化棕榈油,和烷氧基化的氢化橄榄油。尤其优选的烷氧基化的氢化脂肪油非离子表面活性剂是Cognis的Eumulgin HRE 40或BASF的Cremophor CO。
烷氧基化的C8-C30脂肪酸优选地具有6-12的烷氧基化程度。例子是乙氧基化的癸酸酯、乙氧基化的辛酸酯、乙氧基化的椰油酸酯等等。
其他有利的烷氧基化的非离子表面活性剂是聚山梨酯。聚山梨酯是基于山梨醇的乳化剂。优选的聚山梨酯是聚山梨酯20、40、60或80,如Uniqema的Tween系列和Cognis的Eumulgin SML、SMO和SMS。
如上所述的烷氧基化的非离子表面活性剂优选地为乙氧基化的表面活性剂。
这些烷氧基化的、优选地乙氧基化的非离子表面活性剂可有利地也具有高湿润能力。表面活性剂的湿润能力是显著降低水表面张力的能力,从而增强水性组合物在皮肤上的扩展并通过减少干燥时间来促进皮肤的干燥。因为本发明的组合物还含有大量的水,所以也具有高湿润能力的泡沫促进剂的添加对于增强皮肤的干燥是有利的。
当目标是提高皮肤耐受和烷氧基化的非离子表面活性剂的湿润能力时,可选择具有更长烷基碳链(优选地至少C12,更优选地至少C14链)和更高烷氧基化程度的化合物。
含氮的两性表面活性剂或非离子表面活性剂优选地为氧化胺、甜菜碱、酰胺、羟基磺基甜菜碱(Hydroxysultaine)和/或咪唑啉衍生物。其包含至少一种氧化胺、甜菜碱、羟基磺基甜菜碱和/或酰胺基,和/或为咪唑啉衍生物,并还包含与氮连接的直链碳链,所述碳链含有至少8个碳原子,优选地至少10个碳原子,更优选地10-18个碳原子,最优选地12-18个碳原子。直链的含碳链可以是完全饱和的烷基或酰基链,或可以是含有双键的碳链和/或被氮和/或氧原子插入的碳链,例如(额外的)酰胺基。含碳链可任选地含有少量(例如1-3)甲基或乙基取代基。氧化胺和甜菜碱还含有一个或多个与氮连接的短链烷基,优选地为乙基和/或甲基。
这些含氮的两性表面活性剂或非离子表面活性剂有利地也可具有杀生物活性并与存在于组合物中的过氧化氢和/或醇协同作用。
优选的氧化胺为C8-C18、优选地C10-C18、更优选地C12-C18烷基二甲基氧化胺,如癸基二甲胺氧化物、月桂基二甲胺氧化物、十四烷基二甲胺氧化物,和/或C10-C18、优选地C12-C18烷基酰胺丙基二甲胺氧化物,如椰油酰氨基丙胺氧化物。优选的甜菜碱为C10-C18烷基二甲基甜菜碱,如月桂基甜菜碱,和/或C10-C18烷基酰氨基丙基二甲基甜菜碱,如辛/癸酰氨基丙基甜菜碱(capryl/capramidopropyl betaine)、椰油酰氨基丙基甜菜碱和/或油酰氨基丙基甜菜碱。优选的羟基磺基甜菜碱为C10-C18烷基羟基磺基甜菜碱,如月桂基羟基磺基甜菜碱或椰油酰氨丙基羟基磺基甜菜碱。优选的酰胺是C10-C18烷基单乙醇、二乙醇和/或三乙醇酰胺,如椰酰胺(cocamide)MEA、椰酰胺DEA和/或椰酰胺TEA,和/或乙氧基化的亚烷基酰胺,如PEG4菜籽酰胺(rapeseedamide)。优选的咪唑啉衍生物是C 10-C18咪唑啉衍生物两性表面活性剂,如椰油两性乙酸钠(sodiumcocoamphoacetate)、月桂两性乙酸钠(sodium lauroamphoacetate)、椰油两性二乙酸二钠(disodium cocoamphodiacetate)、椰油两性二丙酸二钠(disodiumcocoamphodipropionate)和/或月桂两性二乙酸二钠(disodiumlauroamphodiacetate)。
合适的线性C12-C24 α-烯烃磺酸盐存在于Hansa Group’s Hansanil OS(C14-C16烯烃磺酸钠)。
合适的磺基琥珀酸盐为长链(C12-C20)酰氨基类磺基琥珀酸盐,如椰酰氨基或MIPA磺基琥珀酸盐、油酰氨基或MIPA磺基琥珀酸盐,和C12-C20醇类磺基琥珀酸盐,如十六烷磺基琥珀酸盐和磺基琥珀酸脂肪醇聚氧乙烯醚二钠(disodium laureth sulfosuccinate)。
本领域技术人员应当明白,满足本文所述泡沫测试要求的任何泡沫促进剂都自然地具有作为泡沫促进剂的资格,并且一种或多种泡沫促进剂的选择不受本文所述组的限制。
优选地,该一种或多种泡沫促进剂还提供了皮肤护理作用,并且当在皮肤上摩擦时增强组合物的干燥时间。
单个泡沫促进剂以及不同泡沫促进剂的混合物可在根据本发明的组合物中使用。
泡沫促进剂还应当是对皮肤适合的,即不刺激皮肤、眼睛或粘膜组织,并在存在醇时稳定。
出人意料地,本领域中已知为良好成泡表面活性剂的若干种表面活性剂在本发明的组合物中不是特别有效的泡沫促进剂。在存在醇时不能提供根据本发明的稳定泡沫的泡沫促进剂是高度成泡的表面活性剂,如十二烷基苯磺酸、若干种高成泡烷基多葡萄糖苷和月桂基醚硫酸钠(sodium laurylether sulphate)。
本发明的组合物可有利地在对E.coli、S.aureus、E.hirae和P.aeruginosa的EN 1276悬浮液测试中于60秒内、优选地于30秒内产生至少log 5的微生物计数减少。
为了确保在更低醇水平下足够的消毒能力,组合物中可存在若干种额外的化合物。
酸优选的存在于本发明的组合物中。酸可以是无机或有机酸。酸的混合物也被认为是有用的。酸以有效量存在,为根据本发明的组合物建立目标pH范围。尽管可使用任何数量的酸,但是酸优选的为单个酸。一种尤其优选的酸是羧酸,如柠檬酸、羟乙酸、乳酸、琥珀酸、水杨酸、酒石酸、氨基磺酸、戊二酸、2-呋喃羧酸或苯甲酸。
本发明的组合物具有3-8的pH,优选地3-7的pH,更优选地4-6,最优选地4-5。可以通过例如包含一种或多种本文所述的酸或合适的pH缓冲液维持这类pH。
为了改进组合物的皮肤调节特性,组合物还可包含一种或多种皮肤调节剂。
例如,组合物可含有柔润剂或湿润剂,如甘油、聚合甘油、甘油酯、肉碱、山梨醇、蓖麻油、芦荟、尿囊素、羊毛脂及其衍生物、乙酰胺MEA、琼脂糖、乳酸铵、精氨酸PCA、透明质酸苄基酯、羧甲基壳聚糖琥珀酸酰胺、壳聚糖PCA、鲸蜡醇、玉米甘油酯、双甘油、二甲基咪唑啉酮、赤藓糖醇、果糖、葡萄糖胺、葡萄糖、葡萄糖谷氨酸盐(glucoseglutamate)、葡糖醛酸、谷氨酸、glycereth-7、glycereth-12、glycereth-20、glycereth-26、glycereth-31、氢化蜂蜜、氢化淀粉水解产物、氢化玉米淀粉、氢化小麦淀粉、羟乙基棕榈基氧羟丙基棕榈酰胺(hydroxyethyl palmityloxyhydroxypropyl palmitamide)、羟乙基山梨醇、菊糖、乳酰胺、乳酰胺DEA、乳酰胺MEA、乳酸、乳糖醇、乳糖、乳果糖、赖氨酸PCA、镁PCA、麦芽糖醇、麦芽糖、镁PEA、甘露醇、甲氧基丙基葡糖酰胺(methoxypropylgluconamide)、甲基gluceth-10、甲基gluceth-20、PCA、PEG-10丙二醇、聚氨基糖缩合物、聚甘油酸(polyglucorinic acid)、聚合甘油-3、聚合甘油-4、聚合甘油-6、聚合甘油-10、乳酸钾、钾PCA、丙二醇、丙二醇柠檬酸酯、糖水解产物、糖异构物(isomerate)、天冬氨酸钠、葡醛酸钠、透明质酸钠交叉聚合物、乳酸钠、苹果酸钠、钠PCA、多聚天冬氨酸钠、山梨醇硅烷二醇(sorbityl silanedio1)、tea-乳酸盐、tea-PCA、尿素、木糖醇、木糖和两种或更多这些柔润剂的组合。
组合物可还包含皮肤调节剂,如山嵛基三甲基氯化铵(behentrimoniumchloride)、西曲氯铵(cetrimonium chloride)、司拉氯铵(stearalkoniumchloride)、山嵛酰氧基PG-三甲基氯化铵(behenoyl PG-trimoniumchloride)。
优选地,皮肤调节剂以0.01-2%、更优选地0.02-1%的浓度使用。
选择泡沫促进剂时,考虑泡沫促进剂也具有皮肤调节特性可以是有利的。
具有“皮肤调节特性”的泡沫促进剂能够改善皮肤湿润并提供良好的皮肤使用后感受,即对皮肤具有柔润或柔化的作用并防止重复使用造成的皮肤干燥。这类泡沫促进剂的例子是具有湿润能力的非离子表面活性剂,其存在于上文定义的烷氧基化的脂肪酸醇和烷氧基化的脂肪油中。
为了避免本发明的组合物在皮肤上的积累和粘性,优选将表面活性剂的多种特征组合在尽可能少量的表面活性剂中,更优选地以最低可行浓度应用。因此,在本发明的一个实施方案中,泡沫促进、湿润和皮肤调节功能包括在一种化合物中。
重要的是为了执行适用的消毒标准,本发明的组合物可被重复地应用而不使用任何其他冲洗,并且不留下大量的不想要的残留。
因此,重要的是本发明的组合物尽可能地有皮肤调节作用和对皮肤是友好的,即该组合物不仅具有皮肤调节作用,而且不产生任何形式的皮肤刺激、变应性反应,最重要的是不在皮肤上产生任何粘性残留。
粘性残留的生产可伴随着许多表面活性剂发生,这些表面活性剂一般可被本领域技术人员考虑用在皮肤上。重要的是选择显示上述特征的表面活性剂或表面活性剂组合。本发明中陈述的例子示出了多种组合物,其有利地具有良好的皮肤调节特性以及良好的皮肤相容性二者。
任选地,组合物可包含0.01-0.5%的络合剂,以稳定组合物中的过氧化氢并络合或掩蔽干扰的金属离子。这样的过氧化氢稳定剂优选的是阳离子掩蔽剂,并可选自乙二胺四乙酸(EDTA)、二乙烯三胺五乙酸(DTPA)、N-(羟乙基)-乙二胺四乙酸(HEDTA)、次氮基三乙酸(NTA)、2-羟乙基亚氨二乙酸(HEIDA)、及其盐,或更优选地选自乙酰苯胺、乙二胺二琥珀酸三钠、具有1到5个膦酸基团的膦酸衍生物,例如Dequest phosphonate(Solutia)、1-羟基亚乙基-1,1-二膦酸(HEDP)、氨基三(亚甲基膦酸)、二亚乙基三胺-五(亚甲基膦酸)、2-羟基乙亚氨基双(亚甲基膦酸)和乙二胺四(亚甲基膦酸)。
另外,组合物可包含香料、着色剂和/或增溶剂。在包含香料的组合物中,常期望包含香料稳定剂,所述香料稳定剂有助于香料组份在水性基质中的分散、溶解或混合。这些增溶剂包括已知的化合物,如2到30摩尔环氧乙烷与脱水山梨糖醇单-和三-C10-C20链烷酸酯的缩合物,其也已知为非离子表面活性剂。
另外,可任选地添加特定的清洁剂或洗涤剂。特别是在抹布(毛巾)中应用组合物时清洁剂的添加是优选的,从而使得组合物同时清洁和消毒。当使用组合物对手进行清洁和消毒时这尤其有用。
组合物的平衡由去离子水组成,所述去离子水优选地具有少于5微西门子(microSiemens)的电导率。应当明白去离子水的电导率越低,产品的保质期越长。
在一个优选的实施方案中,本发明的组合物基本上不含季铵化合物、酚类化合物、双胍化合物和/或抗微生物精油。基本上不含表示组合物包含少于0.05%(w/w)、优选地少于0.01%(w/w)的所述化合物。
第二方面,本发明提供了第一方面的组合物用于消毒和/或卫生处理皮肤和/或粘膜、优选地用于消毒和/或卫生处理手和臂的用途。本发明提供了组合物在泡沫分散器中产生即时泡沫的用途,所述即时泡沫可容易地应用在皮肤或粘膜上。
除了能够用在皮肤上以外,组合物也可以被用于其他消毒和/或卫生处理目的,如用于坚硬表面上。
组合物的使用导致革兰氏阳性或革兰氏阴性生物、真菌、酵母和包膜与未包膜病毒的根除或数量减少。
通常保健装置中的处方要在皮肤上使用某特定量的消毒液,并维持表面湿润以允许期望的接触时间。作为泡沫使用的本发明的组合物有利地允许非常精确的体积被产生和应用在皮肤上、组合物在皮肤上的良好扩展和适当接触时间的精确维持,这对于满足消毒需要是重要的。另外,因为醇水平相对低,本发明的组合物在到达要求的接触时间之前不蒸发并且是较不可燃的,以提高其实用性和避免使用与储存的预防措施。
为了满足适当的消毒需要,产品还应当允许在一天中重复使用,至少在每个患者或可能引起手部感染的特定活动之后重复使用。本发明的组合物有利地被重复使用而不在皮肤上显著积累组合物的组份。执业医生因此被激励使用本发明的组合物,这也有助于消毒。
实施例
使用受控的杀菌悬浮液测试来测试示例组合物的杀生物活性,所述测试为针对化学消毒剂和抗菌剂的欧洲标准EN 1276(EN 1276:食物、工业、化妆品和公共领域使用的评价化学消毒剂和抗菌剂的杀菌活性的定量悬浮液测试:测试方法和要求)。向要测试的8ml组合物中添加每ml含有约108cfu测试微生物的1ml测试悬浮液,并添加1ml milli-Q水。通过添加牛血清白蛋白(分别为0.3%和3.0%)来增强洁净和肮脏的条件。30秒或1分钟的接触时间后,测定有活力的细菌的量。EN 1276标准规定了5分钟接触时间后活菌计数的log 5减少。
化合物的解释
变性的乙醇 可商业获得的,用适合皮肤并低臭的化合物变性
过氧化氢 可商业获得(Akzo Nobel,Solvay)
Dehydol LT 7 C12-C187摩尔EO脂肪醇(Cognis)
Tego甜菜碱F 椰油酰氨基丙基甜菜碱(Degussa)
Tego甜菜碱F 50 椰油酰氨基丙基甜菜碱(Degussa)
Rewoteric AMC 椰油两性乙酸钠(Sodium cocoamphoacetate)(Degussa)
Natrulon H6 C6聚合甘油(Lonza Inc.)
Natrulon H10 C10聚合甘油(Lonza Inc.)
Rewopol SB FA 30 磺基琥珀酸脂肪醇聚氧乙烯醚二钠
(Disodium Laureth Sulfosuccinate)(Degussa)
Natrulon RC 50DG L-肉碱和Decaglycerol混合物(Lonza Inc.)
Eumulgin HRE 40 PEG-40氢化蓖麻油(Cognis)
柠檬酸 可广泛地商业获得(多个供应商)
苯甲酸 可广泛地商业获得(多个供应商)
Barlox 10s N,N-二甲基癸基胺N-氧化物(Lonza Inc.)
Barlox 12 椰油烷基二甲基胺,N-氧化物(Lonza Inc.)
Tween 80 聚山梨酯80(Uniqema)
EDTA 乙二胺四乙酸
Dequest SPE 9505 二亚乙基三胺五(亚甲基磷酸)(Solutia)
组合物I
38% 乙醇
1.5% 过氧化氢
0.6% Dehydol LT 7
0.3% Natrulon H-6
0.2% 苯甲酸
0.1% Barlox 12(椰油胺氧化物)
0.1% EDTA
pH约4.5
根据EN 1276在1分钟的接触时间下log 10减少
洁净 肮脏
E.coli ATCC 25922 >6.2 >6.2
Pseudomonas aeruginosa ATCC 15442 >6.2 >6.2
Enterococcus hirae ATCC 10541 >5.6 >5.6
Staphylcoccus aureus ATCC 6538 >5.6 >5.6
组合物II
35% 乙醇
1% 过氧化氢
0.7% Dehydol LT 7
0.15% Barlox 12
0.2% 苯甲酸
pH约5
根据EN 1276在1分钟的接触时间下log 10减少
洁净 肮脏
E.coli ATCC 25922 >6.2 >6.2
Pseudomonas aeruginosa ATCC 15442 >6.2 >6.2
Enterococcus hirae ATCC 10541 >5.6 >5.6
Staphylcoccus aureus ATCC 6538 >5.6 >5.6
组合物III
40% 乙醇
0.7% 过氧化氢
0.6% Dehydol LT 7
0.1% Barlox 10s(癸基胺氧化物)
0.2% 苯甲酸
0.1% Dequest
pH约4.6
根据EN 1276在30秒的接触时间下log 10减少
洁净 肮脏
E.coli ATCC 25922 5 5
Pseudomonas aeruginosa ATCC 15442 5 5
Enterococcus hirae ATCC 10541 5 5
Staphylcoccus aureus ATCC 6538 5 5
组合物还提供了广谱抗微生物活性,通过欧洲杀真菌悬浮液测试(EN1275化学消毒剂和抗菌剂-用于评价化学消毒剂和抗菌剂的基础杀真菌或基础杀酵母活性的定量悬浮液测试-测试方法和要求(第1段)和EN 1650化学消毒剂和抗菌剂-食物、工业、家用和公共领域使用的评价化学消毒剂和抗菌剂的杀真菌活性的定量悬浮液测试-测试方法和要求(第2段,第1步))证明。
组合物IV
33% 乙醇
1.5% 过氧化氢
0.3% Eumulgin HRE 40(PEG-40氢化蓖麻油)
0.5% Protelan LS 9011(十二烷基肌氨酸钠)
0.2% 水杨酸
pH约4.2
在欧洲标准悬浮液测试中log 10减少:
EN 1257 5分钟
Candida Albicans ATCC 12031 >log4
EN 1275和EN 1650(洁净&肮脏) 15分钟
Candida Albicans ATCC 12031 >5
Aspergillus Niger ATCC 16404 >5
组合物V
20% 乙醇
10% 异丙醇
1% 过氧化氢
0.2% Tween 80
0.2% Tego甜菜碱L7(椰油酰氨基甜菜碱)
0.2% 乳酸
0.1% Dequest
pH约5
根据EN 1276在30秒的接触时间下log 10减少
洁净 肮脏
E.coli ATCC 25922 5 5
Pseudomonas aeruginosa ATCC 15442 5 5
Enterococcus hirae ATCC 10541 5 5
Staphylcoccus aureus ATCC 6538 5 5
除了具有良好的杀生物活性外,当从S10或L11分散器(RexamAirspray)分散时,上文公开的组合物I到V提供了稳定的泡沫。
表1显示具有良好的泡沫品质和轻微差异的皮肤后期感受(after-feel)的多种组合物。重量百分比是以组合物总重为基础的成分的净重百分比。
E.coli和Staphylococcus aureus的减少在EN 1276悬浮液测试中测试,并显示组合物分别对革兰氏阴性和革兰氏阳性细菌的抗微生物效力。
表1
1 2 3 4 5 6
乙醇 35% 36% 38% 40% 42% 36%
H2O2 0.5% 0.7% 0.3% 0.3% 0.6% 1%
Dehydol LT 7 0.2% 0.3% 0.5% 0.6% 0.7% 0.3%
Barlox 10s 0.1%
Barlox 12 0.1% 0.1%
Tego甜菜碱F 0.1%
Tego甜菜碱F 50
Rewopol SB FA 30
Rewoteric AMC
Natrulon RC 50DG 0.3% 0.3%
Natrulon H6 0.2%
Natrulon H10 0.2%
甘油 0.5%
柠檬酸 0.1% 0.1% 0.1%
苯甲酸 0.3% 0.4% 0.3%
EDTA 0.2% 0.1% 0.2%
Dequest SPE 9505 0.1% 0.1%
E.coli >5 >5 >5 >5 >5 >5
Staph.Aureus >5 >5 >5 >5 >5 >5
泡沫品质 ++ ++ ++ ++ ++ ++
皮肤感受 ++ ++ ++ + +/- ++
7 8 9 10 11 12
乙醇 36% 36% 36% 36% 36% 36%
H2O2 1% 1% 1% 1% 1% 1%
Dehydol LT 7
Barlox 10s 0.2%
Barlox 12 0.2%
Tego甜菜碱F 0.2%
Tego甜菜碱F 50 0.2%
Rewopol SB FA 30 0.2%
Rewoteric AMC 0.2%
Natrulon RC 50DG
Natrulon H6
Natrulon H10
甘油
柠檬酸
苯甲酸 0.3% 0.3% 0.3% 0.3% 0.3% 0.3%
EDTA
Dequest SPE 9505
E.coli >5 >5 >5 >5 >5 >5
Staph.Aureus >5 >5 >5 >5 >5 >5
泡沫品质 + ++ ++ ++ + +
皮肤感受 + ++ + + +/- +/-
Claims (20)
1.用于提供泡沫的水性组合物,所述组合物包含:
0.1-5%(w/w)的过氧化氢,
26-50%(w/w)的C2-C6醇,和
0.01-2%(w/w)的泡沫促进剂,其中所述泡沫促进剂选自以下物质中的至少一种:i)烷氧基化的非离子表面活性剂,ii)含氮的两性表面活性剂或非离子表面活性剂,iii)线性的C12-C24α-烯烃磺酸盐,和iv)C12-C20磺基琥珀酸盐。
2.权利要求1的组合物,其中所述泡沫促进剂选自以下物质中的至少一种:i)烷氧基化的非离子表面活性剂,和ii)含氮的两性表面活性剂或非离子表面活性剂。
3.权利要求1或2的组合物,其中当所述组合物与空气混合时,所述组合物和空气的混合物形成泡沫。
4.权利要求1的组合物,其中酚类化合物、季铵化合物、双胍化合物和/或抗微生物精油中任一种的含量少于0.05%(w/w)。
5.权利要求1的组合物,其中所述组合物在对大肠杆菌(E.coli)、金黄色葡萄球菌(S.aureus)、海氏肠球菌(E.hirae)和绿脓杆菌(P.aeruginosa)的EN 1276悬浮液测试中于60秒内产生至少log 5的微生物计数减少。
6.权利要求1的组合物,其中所述烷氧基化的非离子表面活性剂i)选自烷氧基化的C8-C30脂肪醇、烷氧基化的C8-C30脂肪酸和烷氧基化的C8-C30脂肪油和聚山梨酯中至少一种,所述脂肪醇、脂肪酸和脂肪油均具有最小6的烷氧基化程度。
7.权利要求6的组合物,其中所述烷氧基化的脂肪醇含有下述脂肪醇组分,所述脂肪醇组分为C10-C20伯醇和/或仲醇。
8.权利要求6的组合物,其中所述烷氧基化的脂肪油是氢化的C10-C20脂肪油。
9.权利要求6的组合物,其中所述烷氧基化的非离子表面活性剂为乙氧基化的表面活性剂。
10.权利要求1的组合物,其中所述含氮的两性表面活性剂或非离子表面活性剂ii)选自氧化胺、甜菜碱、酰胺、羟基磺基甜菜碱,和/或咪唑啉衍生物中至少一种。
11.权利要求1的组合物,其还包含0.01-2%(w/w)的皮肤调节剂。
12.权利要求11的组合物,其中所述皮肤调节剂为甘油、聚合甘油、甘油酯、肉碱、山梨醇、蓖麻油、芦荟、尿囊素、羊毛脂及其衍生物、和鲸蜡醇中至少一种。
13.权利要求1的组合物,其中所述泡沫促进剂除了促进泡沫以外,还具有湿润和/或皮肤调节的功能。
14.权利要求1的组合物,其还包含无机和/或有机酸。
15.权利要求14的组合物,其中所述有机酸为羧酸。
16.权利要求1的组合物,其具有3-8范围内的pH。
17.权利要求1-16中任一项的组合物用于对皮肤或粘膜和/或坚硬表面进行消毒和/或卫生处理的用途。
18.权利要求1-16中任一项的组合物在泡沫分散器中用于生产泡沫的用途。
19.对皮肤或粘膜进行消毒和/或卫生处理的方法,包括将权利要求1-16中任一项的组合物作为泡沫应用在皮肤或粘膜上。
20.产生泡沫的方法,包括从泡沫分散器中分散权利要求1-16中任一项的组合物。
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US6086856A (en) * | 1994-03-28 | 2000-07-11 | Oralcare Systems, Inc. | System for delivering foamed oral hygiene compositions |
CN1208435A (zh) * | 1996-02-23 | 1999-02-17 | 普罗格特-甘布尔公司 | 消毒组合物和消毒表面的方法 |
CN1237203A (zh) * | 1996-11-12 | 1999-12-01 | 雷克特和科尔曼公司 | 含水消毒洗涤组合物 |
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WO2008003779A1 (en) | 2008-01-10 |
PL2041254T3 (pl) | 2013-04-30 |
CA2656491C (en) | 2014-11-18 |
EP2041254B1 (en) | 2012-11-07 |
CA2656491A1 (en) | 2008-01-10 |
US20090324508A1 (en) | 2009-12-31 |
EP2041254A1 (en) | 2009-04-01 |
CN101484564A (zh) | 2009-07-15 |
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