CN116634996A - 用于治疗头发、头皮和皮肤的组合物 - Google Patents
用于治疗头发、头皮和皮肤的组合物 Download PDFInfo
- Publication number
- CN116634996A CN116634996A CN202180077957.4A CN202180077957A CN116634996A CN 116634996 A CN116634996 A CN 116634996A CN 202180077957 A CN202180077957 A CN 202180077957A CN 116634996 A CN116634996 A CN 116634996A
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- China
- Prior art keywords
- composition
- hair
- skin
- dimethylglycine
- alopecia
- Prior art date
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Abstract
本发明涉及一种组合物,该组合物除咖啡因外,还含有二甲基甘氨酸和/或二甲基甘氨酸的盐。本发明还涉及该组合物用于处理头发、头皮和/或皮肤的(化妆品和/或药用)用途。
Description
技术领域
本发明涉及一种组合物,该组合物除咖啡因外,还含有二甲基甘氨酸和/或二甲基甘氨酸的盐。此外,本发明涉及该组合物用于处理头发、头皮和/或皮肤的(化妆品和/或医药)用途。
背景技术
人的头发在很大程度上已经失去了作为身体保护功能的重要性。然而,健康的头发对世界各地的女性和男性都有着重要的文化意义,并且通常被视为财富和健康的象征。因此,脱发导致的头发稀疏例如往往会对生活质量产生负面影响。激素诸如雄激素引起的脱发被称为雄激素源性脱发(雄激素性脱发或AGA),并且是尤其是男性,也是女性最常见的脱发原因。可以对男性和女性的脱发模式进行区分。
头发生长和头发再生取决于血液为毛囊提供充足的营养。因此,头皮中的血流量(微循环)减少会促进甚至导致脱发。例如,秃头男性的流向头皮顶点区域的血流量比头皮头发正常的男性显著更少。因此,这种微循环的显著减少可以解释脱发和头发再生(从休止期到生长期的过渡)不足,例如雄激素性脱发。总的来说,脱发可以被视为外周血管血流量减少的最初临床症状之一。
咖啡因存在于原产于非洲、东亚和南美洲的各种植物的种子、坚果和叶子中,其中最著名的咖啡因来源是所谓的咖啡豆,即咖啡植物的种子。咖啡因已知具有多种药理作用。众所周知,它对中枢神经系统有刺激作用。它被认为是世界上最常用的精神活性物质,并且与其他精神活性物质不同,它是合法的,其使用在世界范围内几乎不受限制。例如,它可以经由咖啡和茶等饮品口服,甚至越来越多的证据表明,口服咖啡因摄入对某些功能障碍有积极影响。
此外,它相对容易穿透皮肤屏障,使咖啡因成为一种非常适合局部应用的化合物。因此,欧洲申请EP 1 396 261 A1描述了咖啡因作为皮肤护理组合物的活性成分的用途,特别是含咖啡因的皮肤护理组合物用于男性皮肤护理的用途,以及这种皮肤护理组合物制造方法。咖啡因的使用有助于表皮的再生,尤其是在男性皮肤中。咖啡因在治疗雄激素性脱发中的应用尤其在Daniels,G.,Akram,S.,Westgate,G.E.and Tamburic,S.(2019),Canplant-derived phytochemicals provide symptom relief for hair loss?(植物来源的植物化学物质能缓解脱发症状吗?)A critical review.Int J Cosmet Sci,41:332-345.doi:10.1111/ics.12554中进行了讨论。
到目前为止,很少有用于脱发诸如雄激素性脱发的经批准的药物治疗,现有的治疗要么不够有效,要么会带来令人不快的副作用。例如,当涉及到由炎症引起的圆形脱发(也称为斑秃或简称AA)的急性发作和其他原因引起的脱发的治疗选择时,这种情况同样令人不满意。
除了头发作为所谓的皮肤附属物之外,皮肤的功能对于健康的外表也非常重要。影响头发或发根的生理效应(诸如炎症)也以类似的方式影响皮肤。因此,皮肤的治疗非常重要,既有医学原因,诸如保护功能的改善和屏障性能的增强,也有纯粹的视觉和美学原因,诸如肤色更光滑、更美丽。
因此,仍然需要改进的治疗方法,特别是需要可以局部用于对抗脱发的组合物,其中这些组合物没有或只有可忽略的副作用。特别地,需要具有药物性质且不显示任何副作用或具有化妆品性质的组合物。
还需要改进的皮肤护理组合物,其改善皮肤的感觉和外观,同时增强皮肤的保护和屏障功能。
发明内容
在此基础上,本发明的目的是提供一种用于治疗头发、头皮和皮肤,特别是用于预防和/或治疗脱发的耐受性良好的组合物。此外,该组合物应该能够局部应用并克服现有技术已知的组合物的缺点。
令人惊讶地,该目的通过根据权利要求1的组合物和根据权利要求7的该组合物的用途实现。在从属权利要求中指定优选的实施方案。
根据本发明,该目的通过提供包含(A)二甲基甘氨酸和/或二甲基甘氨酸的盐和(B)咖啡因的组合物来实现。
令人惊讶的是,已经表明,根据本发明的活性成分组合(咖啡因和二甲基甘氨酸和/或二甲基甘氨酸的盐)在治疗脱发,特别是遗传性脱发和与年龄相关的脱发方面比单独的咖啡因或二甲基甘氨酸和/或二甲基甘氨酸的盐具有增加的疗效。活性成分的组合出乎意料地增加皮肤和头皮的微循环,并显著改善对皮肤和发根的营养和氧气供应。此外,它在医学和美容方面对皮肤的耐受性都非常好。
发现二甲基甘氨酸(N,N-二甲基甘氨酸)存在于植物、动物和人类中,但它在人类中只形成极少量。它通过甜菜碱与甜菜碱同型半胱氨酸甲基化酶的转氨作用,形成为在从胆碱多步生物合成甘氨酸中的中间体。
N,N-二甲基甘氨酸,也称为(二甲基氨基)乙酸,由以下化学式1表示:
不仅是二甲基甘氨酸的用途,而且其盐、溶剂化物和水合物的用途都是创造性的。这些优选是二甲基甘氨酸的药学上或化妆品上可接受的盐。该盐特别优选为在20℃下在水中的溶解度至少为10g/l的水溶性盐。
在一个优选的实施方案中,二甲基甘氨酸的盐是二甲基甘氨酸的碱金属盐、碱土金属盐或铵盐。
实例为钠盐、钾盐、钙盐、镁盐和铵盐。在铵盐中,铵阳离子携带一至四个烷基,每个烷基独立地具有1至4个碳原子。优选的是二甲基甘氨酸的钠盐和钾盐,特别是二甲基甘氨酸钠盐,即N,N-二甲基甘氨酸钠。
在另一个优选实施方案中,二甲基甘氨酸的盐可以是无机酸和/或有机酸与二甲基甘氨酸的盐。
二甲基甘氨酸与无机酸的盐的实例是二甲基甘氨酸的盐酸盐、氢溴酸盐、氢碘酸盐、硫酸氢盐、硫酸盐、亚硫酸氢钠、亚硫酸盐、碳酸氢盐、碳酸盐、一磷酸盐、二磷酸盐和三磷酸盐,及其混合物。特别优选的是二甲基甘氨酸的盐酸盐。
二甲基甘氨酸与有机酸的盐的实例是二甲基甘氨酸的乙酸盐、乳酸盐、柠檬酸盐、琥珀酸盐、富马酸盐、马来酸盐和苯甲酸盐,及其混合物。
假设根据本发明的二甲基甘氨酸和/或二甲基甘氨酸的盐改善角质形成细胞中的氧气周转和细胞活性,从而也促进皮肤和毛囊中的细胞活性。此外,皮肤屏障得到加强,伤口愈合得到支持,皮肤变得光滑。根据本发明,它实现了显著的发根和皮肤强化效果,并以令人惊讶的清晰方式支持了根据本发明的咖啡因的效果,特别是在治疗日常或与年龄相关的压力或衰弱的皮肤和脱发,诸如遗传性脱发和与年龄有关的脱发中。
咖啡因的IUPAC名称为1,3,7-三甲基-3,7-二氢-1H-嘌呤-2,6-二酮。或者,咖啡因也被称为1,3,7-三甲基黄嘌呤。咖啡因由下面的化学式2表示。
咖啡因是一种属于甲基黄嘌呤类的甲基黄嘌呤生物碱。它是一种苦涩的结晶物质,可以被认为是嘌呤衍生物,与脱氧核糖核酸和核糖核酸的腺嘌呤和鸟嘌呤碱基化学相关。
基于组合物的总重量,根据本发明的组合物含有优选比例为0.001wt%至10.0wt%的二甲基甘氨酸和/或二甲基甘氨酸的盐。在一个优选的实施方案中,在每种情况下基于组合物的总重量,根据本发明的组合物含有比例为0.01wt%至8.0wt%,更优选0.1wt%至6.0wt%,更加优选0.3wt%至5.0wt%,特别是0.5wt%至3.0wt%的二甲基甘氨酸和/或二甲基甘氨酸的盐。在本发明的一个优选的实施方案中,在每种情况下基于组合物的总重量,根据本发明的组合物可以包含0.1wt%、0.2wt%、0.3wt%、0.4wt%、0.5wt%、0.6wt%、0.7wt%、0.8wt%、0.9wt%、1.0wt%、1.1wt%、1.2wt%、1.3wt%、1.4wt%、1.5wt%、2.0wt%或2.5wt%的二甲基甘氨酸和/或二甲基甘氨酸的盐。本发明的组合物优选含有作为纯化学物质的二甲基甘氨酸和/或二甲基甘氨酸的盐,包括各自的溶剂化物和水合物(例如二甲基甘氨酸钠的二水合物),因为这提高了组合物的纯度并减少了不期望的副作用的发生。
在一个优选的实施方案中,在每种情况下基于组合物的总重量,本发明的组合物含有0.001wt%至3.0wt%,更优选0.005wt%至2.50wt%,更加优选0.01wt%至2.0wt%,特别是0.1wt%至1.5wt%的咖啡因。在本发明的一个优选的实施方案中,在每种情况下基于组合物的总重量,根据本发明的组合物可以含有0.01wt%、0.05wt%、0.1wt%、0.2wt%、0.3wt%、0.4wt%、0.5wt%、0.6wt%、0.7wt%、0.8wt%、0.9wt%、1.0wt%、1.1wt%、1.2wt%、1.3wt%、1.4wt%或1.5wt%的咖啡因。
二甲基甘氨酸和/或二甲基甘氨酸的盐与咖啡因之间的重量比的范围优选为10:1至1:10,优选为6:1至1:6,更优选为4:1至1:4,特别优选为2:1至1:2。在本发明的一个优选的实施方案中,二甲基甘氨酸和/或二甲基甘氨酸的盐与咖啡因之间的重量比为0.5、0.6、0.7、0.8、0.9、1.0、1.1、1.2、1.3、1.4、1.5、1.6、1.7、1.8、1.9或2.0。
在一个优选的实施方案中,根据本发明的组合物可以含有至少一种其他活性成分,其中所述至少一种其它活性成分选自薄荷醇、生物素、锌PCA、烟酰胺、泛醇、依克多因、泛醌-10、牛磺酸、泛酰内酯、紫锥菊、肉毒碱、醋酸生育酚,及其组合。
薄荷醇是一种单环单萜烯醇,可以作为刺激血液流动的活性成分添加到根据本发明的组合物中。此外,薄荷醇可以对头皮产生使人精神振作的感官刺激。
生物素,也被称为维生素B7或维生素H,是一种来自B复合体的水溶性维生素。根据本发明,生物素可以进一步减少脱发并强化皮肤。
锌PCA是L-吡咯烷酮羧酸盐的锌盐,并且可以作为具有抗微生物作用的物质添加到根据本发明的组合物中。
烟酰胺(也称烟碱)是烟酸的酰胺,也被称为维生素B3。除了诸如减少氧化应激的其他特性外,根据本发明的烟酰胺还具有毛发生长刺激作用。
泛醇是一种在体内转化为泛酸(维生素B5)的维生素原。后者是辅酶A的一部分,因此对皮肤代谢很重要。根据本发明,泛醇的作用进一步改善了皮肤的弹性和水分。此外,瘙痒和炎症得到缓解,伤口愈合得到促进。
依克多因是环状氨基酸,并作为共振稳定的两性离子存在于水溶液中。依克多因具有保湿效果,并且根据本发明,进一步稳定头发的自然结构。还表明,依克多因防止UV辐射,并有助于治疗炎症性疾病。
泛醌-10(Q10或辅酶Q10)是一种醌衍生物。属于泛醌库的Q10被认为是一种抗氧化剂,并且根据本发明,它对头发,特别是发根具有稳定作用。
根据本发明,牛磺酸或2-氨基乙磺酸作为抗氧化剂,对皮肤和头发,特别是发根也具有进一步的稳定作用。
泛酰内酯来自被取代的内酯组,并且根据本发明,泛酰内酯进一步刺激发根的生长因子。
根据本发明,紫锥菊对皮肤和头皮有镇静作用,并且缓解产生的瘙痒和紧张。此外,紫锥菊可以刺激头皮的血液循环,从而为毛囊提供富含氧气和营养的血液,这对头发,特别是对发根有进一步的稳定作用。
根据本发明,肉毒碱可能会抑制头发生长减少因子的形成,并且以这种方式,它也对脱发起作用。
醋酸生育酚具有抗氧化特性,并且根据本发明,对皮肤和头发,特别是对发根具有进一步的稳定作用。
在本发明的一个优选的实施方案中,根据本发明的组合物含有选自薄荷醇、生物素、锌PCA、烟酰胺、泛醇、依克多因、泛醌、牛磺酸、泛酰内酯、紫锥菊、肉毒碱、醋酸生育酚及其组合的至少一种其他活性成分,基于该组合物的总重量,每种成分的比例为0.001wt%至10.0wt%,更优选0.005wt%至7.50wt%,甚至更优选0.01wt%至5.0wt%,特别是0.1wt%至3.0wt%。
此外,根据本发明的组合物优选是基于水的。这意味着它优选含有45.0wt%至85.0wt%的水。
该组合物的粘度优选为800至6000mPa·s,特别优选为1000至5700mPa·s,非常特别优选为2500至5500mPa·s,特别是用于皮肤/皮肤的治疗,在每种情况下均根据DIN53019-1:2008-09使用流变仪Haake RheoStress1(ThermoFisher Scientific)在20℃和板-板几何结构(旋转体PP60Ti)中10/s的剪切速率下进行测量。
在一个实施方案中,该组合物包括表面活性剂。表面活性剂可以是阴离子、非离子、阳离子或两性离子表面活性剂。表面活性剂优选为阴离子或非离子表面活性剂,特别是尽可能温和(即特别是对皮肤无害)的阴离子或非阳离子表面活性剂。根据本发明,使用非离子表面活性剂特别是因为它们具有非常好的乳化特性和优异的皮肤护理特性。阴离子表面活性剂是优选的,因为它们具有特别高的清洁性能。因此,它们在清洁组合物诸如洗发水中特别有用。阳离子表面活性剂具有优异的头发护理特性,并且根据本发明特别用于头发护理组合物,诸如用于护发素、洗发水和治疗中。
根据本发明的组合物含有的表面活性剂的量优选为2wt%至40wt%,特别是5wt%至30wt%,优选7wt%至20wt%,尤其优选10wt%至17wt%,在每种情况下基于组合物的总重量。表面活性剂的合适量为:8wt%、9wt%、10wt%、11wt%、12wt%、13wt%、14wt%、15wt%、16wt%、17wt%、18wt%、19wt%、20wt%、21wt%、22wt%、23wt%、24wt%、25wt%,在每种情况下基于组合物的总重量。本发明的局部组合物特别优选含有一种或多种阴离子表面活性剂,其量为0.1wt%至20wt%,优选1wt%至17wt%,特别优选5wt%至15wt%,在每种情况下基于组合物的总重量。阴离子表面活性剂的合适量为:1wt%、2wt%、3wt%、4wt%、5wt%、6wt%、7wt%、8wt%、9wt%、10wt%、11wt%、12wt%、13wt%、14wt%、15wt%、16wt%、17wt%、18wt%、19wt%、20wt%,在每种情况下基于组合物的总重量。在这些量下,表面活性剂具有特别高的清洁性能,并且对皮肤、头皮和头发具有非常好的耐受性。
本发明的表面活性剂特别描述于Milton Rosen和Joy Kunjappu的书《表面活性剂和界面现象》("Surfactants and interfacial phenomena")中,出版商John Wiley&Sons,Inc.,2012年第4版。
在一个优选的实施方案中,表面活性剂是选自烷基磺酸盐、烷基硫酸盐、烷基醚硫酸盐、烷基磷酸盐、烷基肌氨酸盐、烷基牛磺酸盐、氨基酸表面活性剂及其混合物的阴离子表面活性剂。更优选地,表面活性剂选自烷基硫酸盐、烷基肌氨酸盐、烷基牛磺酸盐、烷基谷氨酸盐诸如椰油酰基谷氨酸钠/椰油酰基谷氨酸二钠、烷基甘氨酸盐、烷基丙氨酸盐诸如椰油酰基丙氨酸钠,及其混合物。由于其清洁性能,还优选脂肪醇聚甘油醚硫酸盐、单甘油酯硫酸盐、单烷基和/或二烷基磺基琥珀酸盐、脂肪酸羟乙基磺酸盐和α-烯烃磺酸盐。
烷基硫酸盐具有通式ROSO3M,烷基肌氨酸盐具有通式RC(O)N(CH3)CH2CO2M,并且烷基牛磺酸盐具有通式RC(O)N(CH3)CH2CH2SO3M,其中每个R为C4-C26烷基或C4-C26烯基,并且M为水溶性阳离子,诸如铵、钠或钾。优选地,M为钠阳离子。优选地,R为C12-C16烷基或C12-C18烷基。
在一个实施方案中,表面活性剂是非离子表面活性剂。非离子表面活性剂的非限制性实例包括甘油脂肪酸酯、一种或多种脂肪醇的聚氧乙烯醚、烷氧基化脂肪酸烷基酯、脂肪醇的聚甘油醚、脂肪酸的聚甘油酯、聚乙二醇和/或聚丙二醇醚、脂肪酸酰胺、烷基酚聚乙二醇醚、胺氧化物和烷基聚葡糖苷。
在一个实施方案中,表面活性剂选自甘油脂肪酸酯、一种或多种脂肪醇的聚氧乙烯醚、脂肪醇的聚甘油醚、脂肪酸的聚甘油酯及其混合物。
在本发明中,术语“甘油脂肪酸酯”是指甘油单脂肪酸酯或甘油二脂肪酸酯。甘油二脂肪酸酯具有式R3-COO-(CH2CH(OH)CH2)-OOR4或R3-COO-(CH2CH(OOR4)CH2)-OH。甘油单脂肪酸酯具有式R3-COO-(CH2CH(OH)CH2)-OH或HO-(CH2CH(OOR3)CH2)-OH。这里,R3和R4独立地选自C6-C28烷基和C6-C28烯基。甘油单脂肪酸酯含有经由酯键连接到单个脂肪酸的甘油基团。实例为单硬脂酸甘油酯、单山嵛酸甘油酯、单辛酸甘油酯、单癸酸甘油酯和单月桂酸甘油酯。
聚氧乙烯醚是式R5(OC2H3)nOH的化合物,其中R5选自C6-C28烷基、C6-C28烯基、取代的和未取代的苯氧基基团;并且n为大于1的整数。一种或多种脂肪醇的聚氧乙烯醚优选地选自硬脂醇聚醚-2、硬脂醇聚醚-21、聚乙二醇十六十八烷基醚-12、鲸蜡硬脂醇聚醚-25、聚乙二醇十六十八烷基醚-20和上述化合物的混合物。更优选地,聚氧乙烯醚是选自鲸蜡硬脂醇聚醚-25、聚乙二醇十六十八烷基醚-20和上述的混合物的化合物。
术语“脂肪醇的聚甘油醚”是指式R6O-(C3H6O2)n-H的化合物,其中R6为支链或直链C6-C28烷基或C6-C28烯基,n为大于1的整数,优选2至10的整数。优选的是该组合物含有0.01至15.0wt%、0.1至10.0wt%或1至5.0wt%的聚甘油醚。
术语“脂肪酸的聚甘油酯”是指含有聚甘油部分和至少一个C6-C26烷基或C6-C26烯基羧酸部分的化合物。这些化合物可以具有式R7-R8-(C3H6O2)n-H,其中R7为C6-C26烷酸酯或C6-C26烯酸酯基团,R8为合适的连接分子或直接键。因此,聚甘油部分和C6-C26烷基或C6-C26烯基羧酸部分可以通过酯键直接连接,或者可以包含将这两个部分连接在一起的连接部分。该组的非限制性实例为聚甘油3-甲基葡萄糖二硬脂酸酯、聚甘油聚三氯醇酯、聚甘油二异硬脂酸、聚甘油2-月桂酸酯、聚甘油2-倍半异硬脂酸、聚甘油3-二硬脂酸酯(CremophorGS 32)、聚甘油3-油酸酯、聚甘油3-甲基葡萄糖二硬脂酯、聚甘油4-癸酸酯(聚甘油4-癸酸酯T2010190)、聚甘油4-二异硬脂酸酯/聚羟基硬脂酸酯/癸二酸酯(Isolan GPS)和聚甘油4-异硬脂酸酯。
在一个实施方案中,表面活性剂包括阳离子表面活性剂,诸如季铵表面活性剂。季铵表面活性剂含有至少一个与4个烷基或芳基基团共价连接的N原子。无论pH值如何,其都会产生正电荷。烷基甜菜碱、烷基酰胺丙基甜菜碱和烷基酰胺丙基羟基磺胺是有利的。根据本发明使用的阳离子表面活性剂还可以优选地选自季铵化合物,特别是苄基三烷基氯化铵或苄基三烷基溴化铵,诸如苄基二甲基硬脂基氯化铵,也可以选自烷基三烷基铵盐,例如十六烷基三甲基氯化铵或十六烷基三甲基溴化铵,烷基二甲基羟乙基氯化铵或烷基二甲基羟乙基溴化铵,二烷基二甲基氯化铵或二烷基二甲基溴化铵,烷基酰胺乙基三甲基铵醚硫酸盐,烷基吡啶鎓盐,例如十二烷基或十六烷基吡啶鎓氯化物,咪唑啉衍生物和具有阳离子性质的化合物,诸如胺氧化物,例如烷基二甲胺氧化物或烷基氨基乙基二甲胺氧化物。使用十六烷基三甲基铵盐是特别有利的。
在另一个实施方案中,根据本发明的组合物包含至少一种添加剂。通常用于治疗皮肤、头皮和头发的洗发水、护发素和乳液中的添加剂是优选的。所述至少一种添加剂可以以0.01wt%至12.0wt%,更优选0.25wt%至10.0wt%,特别是1.0wt%至7.0wt%的比例存在。
所述至少一种添加剂还可以选自头发调节剂、脂质补充物、防腐剂、稳定剂、芳香剂、抗氧化剂、流变改性剂、增稠剂、护发素、染料、珠光剂、增白剂、溶剂、pH调节剂(包括缓冲体系)及其组合。
头发调节剂可以通过中和头发表面的电荷来减少头发中的静电。头发调节剂的实例是季铵化合物。
脂质补充物,也称为脂质补充剂或富脂剂,是可以防止对表皮屏障功能的破坏作用的亲脂性物质。脂质补充物的实例为羊毛蜡、角鲨烯、液体石蜡、植物油、硅酮和十六烷基棕榈酸酯。
防腐剂是用于通过杀死和/或抑制降解组合物的微生物的生长来保存组合物的物质。优选地,防腐剂可以选自苯甲酸、苯甲酸衍生物、山梨酸、山梨酸衍生物、水杨酸、水杨酸衍生物、苯氧乙醇、对羟基苯甲酸酯及其组合。在一个优选的实施方案中,苯甲酸钠和/或山梨酸钾被用作根据本发明的组合物中的防腐剂。苯甲酸钠在微酸性环境中释放苯甲酸和山梨酸钾释放山梨酸。这两种酸都具有抗菌作用。
稳定剂可以保护光敏组分免受辐射,并且优选是UV吸收剂,诸如二苯甲酮衍生物。
芳香剂的添加可以为组合物提供令人愉快的气味。实例是本领域技术人员已知的芳香剂。
氧化剂或抗氧化剂是延缓或完全消除本发明组合物中其他组分氧化的化合物。可能的抗氧化剂的实例有柠檬酸、抗坏血酸和丁基羟基茴香醚。
流变改性剂和增稠剂可以帮助改善本发明组合物的应用性能。添加食盐(氯化钠)可以被认为是一种流变改性剂和增稠剂。根据本发明的组合物的流动性可以在一定限度内受到影响,并通过添加氯化钠调节到所需的水平。纤维素衍生物或聚丙烯酸酯也可以用作增稠剂。
在应用的背景下,护理产品应理解为护理头发和/或(头皮)皮肤的物质。水解小麦蛋白和尿囊素滋养头皮和头发。水解小麦蛋白主要具有保湿特性。
任选地使用染料使本发明的组合物具有特征性的颜色,从而可以容易地将其与其他产品区分开来。然而,在本发明的范围内,染料也可以用于给人的头发上色。
可以使用本领域技术人员惯用的溶剂或溶剂混合物作为溶剂。优选的溶剂是乙醇或丁二醇,特别是1,4-丁二醇、丙二醇和异丙醇。乙醇是优选的。这些溶剂可以优选以0.1wt%至70wt%的量包含在根据本发明的组合物中。溶剂可以优选地包含在使用组合物时保留在头部上的组合物中(免洗制剂)。它们的使用可以带来新鲜感,而且由于快速干燥,对发型的影响很小。此外,溶剂有助于活性成分的渗透,从而提高其功效。
合适的pH调节剂可以是稳定或影响组合物的pH的酸、碱和/或缓冲体系。根据本发明的典型pH调节剂是己二酸、柠檬酸、苹果酸、琥珀酸、酒石酸、抗坏血酸、磷酸、乳酸和富马酸及其相应的盐,以及藻酸钠、聚丙烯酸、碳酸钠和碳酸氢钠。在pH调节剂的情况下,除非另有规定,术语盐是指碱金属盐或碱土金属盐。
组合物的pH优选为3.0至5.9,优选为3.5至5.4,特别优选为4.0至5.0(使用pH计Mettler Toledo SevenCompact S220在21℃下测量)。在这个范围内,根据本发明使用的组合物不仅在化学、物理和微生物方面特别稳定,而且在医学和化妆品方面对头皮和头发也具有非常好的耐受性。本发明所用组合物的特别合适的pH值为:3.5、3.6、3.7、3.8、3.9、4.0、4.1、4.2、4.3、4.4、4.5、4.6、4.7、4.8、4.9、5.0、5.1、5.2、5.3和5.4。
根据本发明,组合物是局部应用的。局部应用是指外部应用,特别是局部外部应用。根据本发明的组合物优选为皮肤、头皮和头发护理产品(即,处理剂,诸如洗发水、护发素、护理剂、乳液、洗液、沐浴露、日霜、面霜、面部液体和/或补品),而不是(纯)造型产品。换言之,本发明的局部组合物只是不具有头发造型的主要目的,其中效果施加在角质化的头发本身上,而不是施加在头皮上(即,在代谢活性的发根中)。相反,重点是皮肤、头皮和头发的医疗/药物或美容处理。
在一个优选的实施方案中,组分,特别是活性成分二甲基甘氨酸或二甲基甘氨酸的盐和咖啡因,均匀分散在根据本发明的组合物的水相中。术语“水相”包括可能存在的与水混溶的有机溶剂(例如醇)。这特别意味着根据本发明的组合物优选不具有载体物质。本发明的组合物优选不含层状结构(特别是不含囊泡和/或层状双膜结构和/或脂质体)。它优选也不包含形成层状结构(特别是囊泡和/或层状双膜结构)的物质。
在一个优选的实施方案中,根据本发明的组合物可以是免洗制剂或冲洗制剂的形式。
免洗制剂的特征在于其在施用后保持与待处理的(头皮)皮肤和/或待处理的头发接触。这创造了一种活性成分库,可以在更长的时间期限内发挥其功效。免洗制剂可以配制成,例如,水凝胶或乳液,或者水溶液或水-酒精溶液(补品)。免洗制剂优选为微粘性制剂的形式,使得它们保持集中在头皮和/或头发上,并且较少能够扩散到发干中。然而,对于这些免洗制剂,重要的是要确保头发不会受到赋予其平滑度的物质的压力,因为它们会留下一些蓬乱的印象。
冲洗制剂的特征在于,根据本发明的组合物的应用组分在使用后被再次冲洗掉。通过这种方式,可以避免对头皮和/或头发施加过大的压力。冲洗制剂可以优选以洗发水、护发素或皮肤、头皮和/或头发护理剂的形式存在。在一个优选的实施方案中,对于作为冲洗制剂应用的本发明的组合物,应提供约2至5分钟的暴露时间。通过这种方式,可以使活性成分必要地渗透到头皮和/或发根中。
本发明进一步涉及本发明的组合物用于治疗头发、头皮和皮肤的用途。
在一个优选的实施方案中,头发和头皮的治疗涉及脱发的治疗和/或预防。术语“脱发”包括女性和男性的斑秃(圆形脱发)、雄激素性脱发(遗传性脱发)、弥漫性秃头(弥漫性脱发)、与年龄相关的脱发(衰老性脱发)和化学疗法引起的脱发。
待治疗的脱发特别优选为遗传性脱发(雄激素性脱发)。
待治疗的脱发也特别优选为与年龄相关的脱发(衰老性脱发)。
在一个优选的实施方案中,皮肤的治疗涉及纯粹的光学美学改善,诸如创造更光滑和更美丽的肤色。然而,根据本发明还实现了超越这一点的美容/医疗效果,诸如改善的保护功能和增强的阻隔特性。此外,伤口愈合得到改善。
换言之,根据本发明的用途导致表皮屏障功能和表皮屏障完整性的显著改善,皮肤外观的改善,以及皮肤水分含量的增加。这与角质层的内聚力和皮肤屏障的稳态的增加相关,并最终导致对感染(微生物疾病)的保护得到改善。
在医疗用途的情况下,本发明包括皮肤病的治疗和预防处理。疾病优选为微生物皮肤感染、皮肤炎症、皮肤粗糙、皮肤干燥、皮肤刺激、发痒、瘙痒、过敏、牛皮癣、银屑病关节炎、湿疹、硬皮病、特应性皮炎、接触性皮炎、系统性红斑狼疮、痤疮和对接触性过敏的易感性。
非治疗性用途(即纯化妆品用途)特别包括治疗皮肤的化妆品适应症,特别是选自皮肤粗糙、皮肤干燥、皮肤刺激、发痒和瘙痒,以及预防皮肤感染和降低对接触性过敏的易感性。
具体实施方式
本发明将在以下组合物的基础上进行说明,但不希望将其局限于具体的实施例。
实验部分
以下组合物通过本领域技术人员已知的均化程序制备。在每种情况下选择组分的量使其在最终组合物中的重量比例对应于所示的重量比例。
实施例1
洗发水形式的组合物(pH 4.8),其含有以下成分:
实施例2
护发素形式的组合物(pH 4.4),其含有以下成分:
实施例3
润发油形式的组合物,其含有以下成分:
实施例4
乳液形式的组合物,其含有以下成分:
实施例5
水包油乳液形式的组合物,其含有以下成分:
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实施例6
水包油乳液形式的组合物,其含有以下成分:
参考实施例1a
洗发水形式的组合物(无二甲基甘氨酸钠,无咖啡因),其含有以下成分:
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参考实施例1b
洗发水形式的组合物(无二甲基甘氨酸钠,无咖啡因),其含有以下成分:
参考实施例1c
洗发水形式的组合物(无二甲基甘氨酸钠,无咖啡因),其含有以下成分:
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研究设计和结果
1.作为体外研究的一部分,检测了咖啡因或二甲基甘氨酸钠及其组合在具有人角形成角质形成细胞的细胞培养模型中的作用。为此,将HaCaT细胞在DMEM培养基(包括胎牛血清和抗生素-抗真菌混合物)中培养1、3、5和7天,并且除其他外,使用合适的测量方法测定细胞的活力、增殖和迁移,并测量与细胞生长相关的生长因子的表达。
活力证明:
对于该测量,使用所谓的MTT测定法来确定作为细胞活力和细胞毒性的指标的细胞代谢活性。该比色测定基于代谢活性细胞将黄色的四唑盐(3-(4,5-二甲基噻唑-2-基)-2,5-二苯基四唑溴化物或MTT)还原为紫色的甲赞晶体。
将人表皮角质形成细胞(HaCaT)以5000个细胞/孔的细胞密度接种在96孔板中,并在培养基(含有10% FBS、1%青霉素-链霉素、0.5%两性霉素B(fungizone)的DMEM)中培养。第二天以及在37℃和5体积%的CO2下培养24小时、48小时和72小时后,用不含(对照)或含有活性成分浓度的二甲基甘氨酸钠(DMG)和咖啡因(coff)或其组合处理细胞培养基。该测量与之前在B.I.Tóth,N.Dobrosi,A.Dajnoki,G.Czifra,A.Oláh,A.G.I.Juhász,K.Sugawara,R.Paus,T.Bíró,J Invest Dermatol 2011,131,1095-1104中发表的研究类似。
图1示出了培养24小时、48小时和72小时后的细胞活力,并且可以看出由于DMG和咖啡因的联合添加而产生的72小时后的增加。使用MTT比色法测定细胞活力。一式四份测量吸收,并在24小时时标准化为对照。显示的是具有标准偏差的平均值。
增殖的证据:
进行所谓的CyQUANT测定法来测量增殖。在这种基于荧光的测定中,所使用的荧光染料与DNA(脱氧核糖核酸)结合,其中细胞DNA的含量是样品中细胞数量的直接测量。
将人表皮角质形成细胞(HaCaT)以5000个细胞/孔的细胞密度接种在96孔板中,并在培养基(含有10% FBS、1%青霉素-链霉素、0.5%两性霉素B的DMEM)中培养。第二天以及在37℃和5体积%的CO2下培养24小时、48小时和72小时后,改变不含(对照)或含有已经存在二甲基甘氨酸钠(DMG)和咖啡因(coff)或其组合的活性成分浓度的细胞培养基。该测量与之前在A.Oláh,B.I.Tóth,I.Borbíró,K.Sugawara,A.G.G.Czifra,B.Pál,L.Ambrus,J.Kloepper,E.Camera,The Journal of clinical investigation2014,124,3713-3724中发表的研究类似。
图2示出了培养24小时、48小时和72小时后的细胞增殖,并且可以看出由于DMG和咖啡因的联合添加而产生的72小时后明显不成比例的增加。使用CyQUANT测定法来测定细胞增殖。一式三份测量荧光,并在24小时时标准化对照。给出了带有标准偏差的平均值。
迁移的证据:
根据之前发表在T.Kawabata,T.Otsuka,K.Fujita,G.Sakai,R.Matsushima-Nishiwaki,O.Kozawa,H.Tokuda,International journal of molecular medicine(《国际分子医学杂志》)2018,42,3149-3156中的研究,进行了所谓的伤口愈合试验来测量迁移。该原理基于测量细胞向尚未定植的培养表面随时间推移的迁移。为此,将每份20000个细胞接种到由硅树脂插入物(具有标准化的宽度)隔开的两个相邻的孔或腔中,并在培养基(含有5% FBS、1%青霉素-链霉素、0.5%两性霉素B的DMEM)中,在37℃和5体积%的CO2下培养48小时。然后移除塑料插入物(“伤口的形成”),并通过使用图像确定随时间推移的未被细胞定植的培养表面来记录细胞的迁移。同时,在移除塑料插入物后(0小时)和再过24小时后,立即改变不含(对照)或含有在每种情况下已经存在的DMG和咖啡因的活性物质浓度以及组合的细胞培养基。使用软件(ImageJ)进行图像的评估和未被细胞定植的培养表面的测定。
图3示出了随着时间推移和使用不同浓度的DMG和咖啡因的迁移。与对照和单独使用DMG或咖啡因相比,使用DMG和咖啡因组合的迁移或伤口闭合不成比例地发生得更快。在时间0小时产生伤口,并在培养16小时、20小时和24小时后拍摄图像。基于图像,使用ImageJ软件确定尚未被细胞定植的培养表面。将测量值标准化为0小时的时间点(伤口的最大尺寸),并以%表示。
检测VEGF的基因表达:
VEGF(血管内皮生长因子)促进新的血管和淋巴管的生长和形成。使用称为定量实时PCR(qRT-PCR)的标准方法测量基因表达。
将人表皮角质形成细胞(HaCaT)以140000个细胞/孔的细胞密度接种在6孔板中,并在37℃和5体积%的CO2下在培养基(含有10% FBS、1%青霉素-链霉素、0.5%两性霉素B的DMEM)中培养。第二天,改变不含(对照)或含有在每种情况下已经存在的活性物质浓度的细胞培养基,并在24小时后收获细胞。基于已经发表在B.V.Diaz,M.-C.Lenoir,A.Ladoux,C.Frelin,M.Demarchez,S.Michel,Journal of Biological Chemistry 2000,275,642-650中的研究,使用qRT-PCR测量基因表达。
图4示出了培养24小时后VEGF的基因表达,并且可以看到通过添加DMG组合咖啡因,基因表达显著增加。显示了通过VEGF的qRT-PCR(三重测定,标准化为组成表达基因的相应基因表达;GAPDH-甘油醛-3-磷酸脱氢酶)测定的相对基因表达。给出了具有标准偏差的平均值。
总之,令人惊讶地发现,特别是咖啡因与DMG的组合对与生长相关的HaCaT细胞参数具有积极效果,并且与单独用咖啡因或DMG处理HaCaT细胞相比,生长因子VEGF的表达显著增加。
2.作为随机、安慰剂对照研究设计的双盲研究的一部分,遗传性脱发的男性和女性也使用来自实施例1的根据本发明的洗发水和来自参考实施例1a、1b和1c的洗发水6个月。在开始时和6个月后,对脱发率进行皮肤科监督测量,并要求受试者在应用结束时主观评估其脱发的减少情况,使用调查问卷记录这些结果。
已经发现,使用来自实施例1的根据本发明的洗发水的受试者能够确定脱发的最显著减少。这与结果相匹配,该结果中与使用过三种参考洗发水之一的受试者相比,同一组受试者中测得的脱发率显著增加。
Claims (10)
1.一种组合物,其包含
(A)二甲基甘氨酸和/或二甲基甘氨酸的盐,和
(B)咖啡因。
2.根据权利要求1所述的组合物,其中所述组合物含有0.001wt%至10.0wt%的二甲基甘氨酸和/或二甲基甘氨酸的盐。
3.根据权利要求1和/或权利要求2所述的组合物,其中所述组合物含有0.001wt%至3.0wt%的咖啡因。
4.根据前述权利要求中任一项所述的组合物,其中所述组合物包含选自薄荷醇、生物素、锌PCA、烟酰胺、泛醇、依克多因、泛醌-10;牛磺酸、泛酰内酯、紫锥菊、肉毒碱、醋酸生育酚及其组合的至少一种其它活性成分。
5.根据前述权利要求中任一项所述的组合物,其中所述组合物包含选自头发调节剂、脂质补充剂、防腐剂、稳定剂、芳香剂、抗氧化剂、流变改性剂、增稠剂、护发素、染料、珠光剂、增白剂、溶剂、pH调节剂及其组合的至少一种添加剂。
6.根据前述权利要求中任一项所述的组合物,其中所述组合物被局部应用和/或其中所述化合物是优选用于促进皮肤和头发的新陈代谢的护理组合物。
7.根据前述权利要求中任一项所述的组合物用于治疗头发、头皮和/或皮肤的用途。
8.根据权利要求7所述的用途,其中所述头发和头皮的治疗是用于治疗和/或预防脱发,并且所述皮肤的治疗是用于改善表皮屏障功能和表皮屏障完整性,从而改善皮肤外观并增加皮肤的含水量,以及改善伤口愈合。
9.根据权利要求7和/或权利要求8所述的用途,其中所述脱发选自斑秃(圆形脱发)、女性和男性的雄激素性脱发(遗传性脱发)、弥漫性秃头(弥漫性脱发),与年龄相关的脱发(衰老性脱发)和由化学疗法引起的脱发。
10.根据权利要求7至9中任一项所述的用途,其中所述用途是化妆品或医药用途。
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DK1259218T3 (da) * | 2000-02-25 | 2010-09-20 | Kuhs Gmbh | Kosmetisk sammensætning til behandling af aldrende og/eller stresset hud |
DE10241395A1 (de) | 2002-09-06 | 2004-03-18 | Alcina Cosmetic Dr. Kurt Wolff Gmbh & Co. Kg | Coffein enthaltende Zusammensetzung als Hautpflegemittel |
DE10243233A1 (de) * | 2002-09-17 | 2004-04-15 | Phenion Gmbh & Co. Kg | Verwendung von Substanzen zum Schutz der Haut |
EP2001460A4 (en) | 2006-03-28 | 2011-01-12 | Novus Int Inc | COMPOSITIONS FOR PROMOTING HAIR GROWTH |
DE102007030099A1 (de) * | 2007-06-28 | 2009-01-02 | Henkel Ag & Co. Kgaa | Kosmetische Zusammensetzung enthaltend einen Champagner-Extrakt |
US20140271890A1 (en) * | 2013-03-14 | 2014-09-18 | Thaer Ahmad | Controlled-release pharmaceutical composition |
DE102015203818A1 (de) | 2015-03-04 | 2016-09-08 | Henkel Ag & Co. Kgaa | "Kosmetische Mittel mit Bio-Aktivstoff und einem Dipeptid" |
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EP4221675A1 (de) | 2023-08-09 |
BR112023006085A2 (pt) | 2023-05-09 |
US20240197605A1 (en) | 2024-06-20 |
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WO2022069738A1 (de) | 2022-04-07 |
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CA3194574A1 (en) | 2022-04-07 |
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