CN1612723A - 包含由抑制剂稳定化的酶的局部组合物 - Google Patents
包含由抑制剂稳定化的酶的局部组合物 Download PDFInfo
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- CN1612723A CN1612723A CNA028269810A CN02826981A CN1612723A CN 1612723 A CN1612723 A CN 1612723A CN A028269810 A CNA028269810 A CN A028269810A CN 02826981 A CN02826981 A CN 02826981A CN 1612723 A CN1612723 A CN 1612723A
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Abstract
免洗型个人护理组合物包括稳定化的酶、至少30%的水、低于5%的碱土金属盐和抑制常数(Ki)为10纳摩尔(nM)至25,000nM的酶抑制剂。也包括提供皮肤护理有益效果的方法,所述皮肤护理有益效果包括例如皮肤感觉和/或皮肤外观,优选皮肤增湿、皮肤柔软性和/或皮肤光滑性,所述方法包括将本发明所述的安全有效量的本发明的组合物局部地涂敷于需要这样的皮肤护理有益效果的皮肤上。进一步提供给消费者免洗型包含酶的个人护理产品的方法,其中酶在货架上是被抑制和无活性的,但其在皮肤上是有活性的并且不需要单独的再活化步骤,优选地其中所述免洗型包含酶的个人护理产品包括一种本文中所述的本发明组合物。
Description
发明背景
本发明涉及免洗型个人护理组合物,所述组合物包括稳定化的酶和酶抑制剂,所述酶抑制剂的抑制常数(Ki)具有的值在本发明所述范围内,并使用这种组合物用于个人护理以提供改善的皮肤感觉和外观,尤其是皮肤增湿、皮肤柔软性和皮肤光滑性。哺乳动物,优选人类,但包括马、犬、猫和其它低等动物的皮肤由覆盖和保护角蛋白的几层细胞和形成皮肤结构的骨架的胶原纤维蛋白组成,这些层的最外层通常称之为角质层。通常,包含在这一层中的死细胞脱落,但许多环境因素和用清洁剂的洗涤可以影响这一过程,导致死细胞的堆积,从而产生干燥的皮肤。例如,阴离子表面活性剂和有机溶剂典型地渗透角质层,并通过脱脂(即从角质层中去除类脂)破坏其完整性。这一皮肤表面结构的毁坏可导致粗糙的感觉并最终允许表面活性剂、溶剂或它们携带的试剂与角蛋白相互作用,从而造成刺激。未能保持穿过角质层的适当的水梯度可导致干燥、发痒或薄而易剥落的皮肤。保持这一梯度所需的大部分水分来自身体内部。如果湿度太低,如在寒冷和/或干燥气候下,不足的水分保持在角质层的最外面的部分以适当塑化组织,并且皮肤开始变干、剥落和/或变得发痒。
在个人护理组合物中使用酶来提供皮肤护理有益效果本身是已知的。据信,酶,尤其是蛋白酶,的功能主要是为涂敷这样组合物的皮肤提供剥落作用。据信,酶可去除皮肤表面上受损的(即干燥或薄而易剥落的)皮肤细胞,由此减少与此相关的粗糙感觉,并允许皮肤护理活性物质到达更多的活的皮肤细胞,从而提高它们的活性。由于酶减少了以前对皮肤的损害的影响,因此它们可以赋予皮肤更新鲜、更年轻的外观和感觉。因此,通过将酶,优选蛋白酶,任选地与安全(对消费者而言)和稳定(在货架上)形式的其它皮肤活性剂一起局部地涂敷来改善皮肤状况是令人期望的。通过将它们与酶,优选蛋白酶,组合而得到改善的皮肤活性剂的性能也是令人期望的。
然而,存在着与将酶包括在个人护理组合物中相关的问题。酶的总体稳定性包括它的热稳定性、pH稳定性、氧化稳定性和构象稳定性。在产品中稳定酶的一个问题是酶,尤其是蛋白酶,在水中是不稳定的,并迅速经历自动消化作用。对于这一问题已提出了几种解决方案。
一种途径是通过加入酶抑制剂(如阻碍酶的活性位点的直接抑制剂或产生驱动自动消化反应的总平衡返回左边(远离自动消化作用)的反应产物的间接抑制剂)来降低自动消化反应发生的速率而抑制酶的活性。典型地,速率降低的越多,酶在货架上保持稳定的时间就越久。但为了获得个人护理产品的商业上可行的储藏期限,速率必须被减缓至接近停止,致使酶无活性。其它途径是在包括在个人护理产品中之前胶囊包封酶(参见GB 1,255,284和JP 10-251,122);或将组合物缓冲,以使酶在使用之前保持无活性(参见WO 97/47,238);或配制无水组合物;或通过加入高含量的多元醇来显著地降低组合物中的水活性(参见JP 1,283,213和JP 3,294,211和EP 755,673和EP759,293);或配制各种乳液(参见EP 779,071);或分别包装包含稳定化的酶的第一隔室和包含活化剂的第二隔室,并在使用过程中混合(参见WO 97/27,841)。然而,使这些提出的解决方案复杂化的情况是一旦涂敷于消费者的皮肤,所述酶必须完全活化以提供皮肤护理有益效果。这需要单独的再活化步骤,如用水稀释包含酶的产品,其中所述酶在储藏过程中已被抑制剂失活,以在皮肤上再活化酶或破坏乳液或胶囊,或在皮肤上将两种前体产品混合成一种等等。也已提议使用依克多因(ectoin)或其衍生物来抑制酶的活性(参见DE 198 34 816和WO 01/54,446),然而,使用这样的渗透保护剂可能不提供在个人护理产品中的期望的充分改善的稳定性和活性有益效果。此外,稳定含酶产品的抑制剂的使用在此之前被限于洗去型产品制剂,因为需要随后的稀释步骤来再活化酶。
尽管已知在产品中使用某些抑制剂使酶去活,但以前还未知在含水免洗型个人护理产品中使用具有一定接合性质的抑制剂来稳定酶。申请者已惊人地发现,具有一定范围内抑制常数(Ki)的抑制剂可提供用于含酶免洗型组合物,其中酶在货架上是稳定的(非活性的),但其在皮肤上成为有活性的并且不需要单独的再活化步骤。不受理论的约束,据信Ki在一定范围内的抑制剂在货架上时可足够紧密地接合到酶上以稳定酶,但当免洗型组合物施用到皮肤上时却不够紧密使得需要单独的再活化步骤。使用过程中,足够的抑制剂从酶上“脱落”以使得酶被活化。因为免洗型产品被作为层施用到皮肤上,所以抑制剂浓度显著地超过可用的底物(即皮肤蛋白质),而酶抑制剂复合物形成的可能性显著减小。本发明的组合物将不需要进一步的再活化步骤,并且它们可以被储存的时期在商业上是可行的。这样的组合物可显著地改进酶的稳定性同时保持它们的功效。进一步讲,这样的组合物对改善皮肤状况和改善皮肤活性剂的性能可能是有用的。
发明概述
本发明涉及免洗型个人护理组合物,该组合物包括(a)稳定化的酶,(b)至少30%的水,(c)低于5%的碱土金属盐,和(d)抑制常数(Ki)为10纳摩尔(nM)至25,000nM的酶抑制剂。本发明也涉及提供皮肤护理有益效果,如皮肤感觉和/或皮肤外观,优选皮肤增湿、皮肤柔软性和/或皮肤光滑性的方法,所述方法包括将安全有效量的本发明所述的本发明组合物局部地涂敷于需要这样的皮肤护理有益效果的皮肤上。本发明还涉及提供给消费者免洗型包含酶的个人护理产品的方法,其中酶在货架上时是被抑制和无活性的,但其在皮肤上是有活性的并且不需要单独的再活化步骤,优选地其中所述免洗型包含酶的个人护理产品包括一种本发明所述的本发明组合物。
发明详述
当局部地涂敷于哺乳动物的皮肤时,所述组合物可改善皮肤感觉和外观,尤其是皮肤增湿、皮肤柔软性和皮肤光滑性。本发明的组合物可包括、由或基本上由本发明所述的本发明的基本要素和限定条件,以及任何附加的或任选的成分、组分或本发明所述的限定条件组成。本发明的组合物的组分,包括可任选地加入的那些,以及制备的方法,和其使用方法,和几个示例性实施方案在下文详细描述。除非另外指明,量代表成分的实际量的大约重量百分比,并且不包括溶剂、填充剂或在可商购获得的产品中可与成分组合的其它物质,并且所述量包括预期使用形式的组合物。
除非另外指明,所有包括份数、百分比和比例的量被理解为被词语“约”所修饰,并且量不打算指示重要数字。除非另外指明,冠词“一个”和“所述”是指““一个或多个”。本发明引用的所有出版物在此全文引入本文以供参考。
如本发明使用的术语“安全有效量”是指以在合理的医学判断范围内的合理的效险比,活性成分的量足够高以改变欲处理的状况或递送期望的皮肤护理有益效果,但又足够低以避免严重的副作用。活性成分的安全有效量将根据具体的活性物质、活性物质穿透皮肤或毛发的能力、年龄、健康状况和使用者的皮肤或毛发的状况和其它类似因素而改变。
本发明中使用的“可药用的”是指该术语描述的药物、药物治疗或惰性成分适用于人类和较低等动物并且没有不适当的毒性、不相容性、不稳定性、刺激性、过敏反应等。本发明中使用的“化妆用可接受的”是指该术语描述的成分适用于与人类和较低等动物的皮肤或毛发接触而没有不适当的毒性、不相容性、不稳定性、刺激性、过敏反应等。
本发明中使用的术语“酶”是指本身或通过聚合物部分的结合而化学改性的野生型或变体的酶。本发明中使用的术语“蛋白酶”是指任何底物是蛋白质的酶。本发明中使用的术语“野生型”是指未突变的宿主产生的酶。本发明中使用的术语“变体”是指由于产生该酶的宿主的基因突变而具有的氨基酸序列与野生型酶的氨基酸序列不同的酶。
本发明中使用的术语“免洗型”是指如此描述的组合物在使用时不需立即冲洗步骤,也就是说,将该组合物局部施用到皮肤上后,该组合物典型地停留在皮肤上的时间为至少2分钟,优选15分钟,更优选至少一小时,更优选几小时,并可能过夜。
用于本发明的氨基酸的缩写如下表所述。氨基酸的取代通过显示原始的氨基酸,随后是氨基酸位置,随后是被取代的氨基酸来表示,如“N76D”表示天冬酰胺在位置76被天冬氨酸取代。取代的组合使用在它们之间的破折号“-”表示,如“N76D-I122A-Y217L”表示在位置76、122和217所发生的取代。
A | Ala | 丙氨酸 | M | Met | 甲硫氨酸 |
B | Asx | 天冬酰胺或天冬氨酸 | N | Asn | 天冬酰胺 |
C | Cys | 半胱氨酸 | P | Pro | 脯氨酸 |
D | Asp | 天冬氨酸 | Q | Gln | 谷氨酰胺 |
E | Glu | 谷氨酸 | R | Arg | 精氨酸 |
F | Phe | 苯基丙氨酸 | S | Ser | 丝氨酸 |
G | Gly | 甘氨酸 | T | Thr | 苏氨酸 |
H | His | 组胺酸 | V | Val | 缬氨酸 |
I | Ile | 异亮氨酸 | W | Trp | 色氨酸 |
K | Lys | 赖氨酸 | Y | 酪氨酸 | 酪氨酸 |
L | Leu | 亮氨酸 | Z | Glx | 谷氨酰胺或谷氨酸 |
I.
组分
本发明组合物包括酶、水和具有本发明所述Ki范围的某些抑制剂,以及少量的碱土金属盐(如果存在的话)。包括本发明组合物的成分以及其它任选组分在下文详细描述。如本领域已知的那样,许多化妆品成分在制剂中有多种功能并因此可被包括在几种功能组中。相应地,应该理解尽管可用于本发明的活性成分被通过它们的治疗有益效果或它们的假定的作用模式而分类,一些这样的成分可在一些情况下提供多于一种化妆品的和/或治疗有益效果或通过多于一种的作用模式而起作用。因此,本发明的分类是为了方便的目的而不旨在将活性成分限制于具体的应用或所列的应用。此外,除非另外指明,这些活性成分的可美容和可药用的盐可用于本发明。
A.
酶
本发明的组合物包括作为基本组分的酶,所述酶的量足以有效地使表皮片状脱落,如促进干燥皮肤薄片的去除和/或强化皮肤活性剂的活性。典型地,安全有效的量为0.0001%至1%,优选0.0005%至0.5%,更优选0.001%至0.1%。适用于本发明的酶包括但不限于蛋白酶和脂肪酶(如描述于美国专利6,284,246B1(宝洁公司)中的那些脂肪酶)。
根据国际生物化学和分子生物学联合会(IUBMB)的推荐(1992)以酶分类号E.C.3.4(羧酸酯水解酶)对蛋白酶进行分类。适用于本发明的蛋白酶也描述于PCT出版物WO 95/30010、WO 95/30011和WO95/29979,所有的三个公布于1995年11月9日(宝洁公司),和在美国专利6,284,246B1((宝洁公司),尤其是在所述文献中的那些命名为蛋白酶“A”至“F”的)。优选的用于本发明的蛋白酶包括,但不限于枯草杆菌蛋白酶、胰凝乳蛋白酶和弹性蛋白酶及其变体,更优选枯草杆菌蛋白酶、与枯草杆菌蛋白酶有同族关系的那些蛋白酶(“类枯草杆菌蛋白酶”)及任何一种的变体。枯草杆菌蛋白酶是由嗜碱杆菌、解淀粉芽胞杆菌、淀粉糖化杆菌、地衣型芽胞杆菌、迟缓芽孢杆菌和枯草芽孢杆菌微生物天然产生的。已知几种枯草杆菌蛋白酶的氨基酸序列,并参见例如在1989年7月13日公布的WO 89/06279(Novo Nordisk)。适用于本发明的枯草杆菌蛋白酶包括,但不限枯草杆菌蛋白酶BPN、枯草菌溶素(subtilisin Carlsberg)、枯草杆菌蛋白酶DY、枯草杆菌蛋白酶147、枯草杆菌蛋白酶168、枯草杆菌蛋白酶309和淀粉糖酵母枯草杆菌蛋白酶(subtilisin amylosaccaritus),优选枯草杆菌蛋白酶BPN’。木瓜蛋白酶、菠萝蛋白酶、thermitase和aqualysin也是适合的。
适用于本发明的蛋白酶也包括变体,优选枯草杆菌蛋白酶和它们的同系物的变体,具有通过在一个或多个如下位置加成、取代或消除而改性的氨基酸序列:5、19、22、32、33、36、41、50、64、68、71、75、76、77、78、79、80、81、87、89、104、109、115、116、117、119、120、122、131、136、151、153、155、156、166、169、170、171、172、173、174、176、181、189、193、195、196、206、208、209、211、214、217、218、219、222、235、251和271。
优选的取代包括,但不限于P5S、R19G、Q19G、T22C、M50F、V68M、V68C、T71E、T71D、N76D、N77D、S78D、I79A、I79E、S87C、E89S、N109A、N109S、I115A、A116V、N117A、M119A、H120D、I122A、G131D、S153A、G169A、K170D、R170Y、Y171Q、P172D、P172E、S173D、N181D、V193M、G195Q、G195D、Q206D、Q206V、Q206C、Y209L、L211D、Y217K、Y217L、N218D、N218S、G219C、M222C、M222A、K235L、K251E和Q271E。
优选的取代的组合包括,但不限于:(a)N76D-I122A-Y217L,(b)I79A-I122A-Y217L,(c)N76D-I79A-I122A-Y217L,和(d)a至c的任意组合进一步与一种或多种选自P40Q、D41A、Q206L、N218S和H238Y的取代的组合。
优选的消除包括,但不限于在位置75至83的氨基酸的消除。进一步与这一消除组合的优选的取代包括在9、31、126、156、166、169、188、212、217、222和254中的一个或多个位置的取代,更优选S9A、I31L、E156S、G166S、G169A、S188P、N212G、K217L、L126I、M222Q和T254A。另一优选的消除包括在位置75至83的氨基酸的消除和在位置1至22的一个或多个氨基酸的消除,优选所有1至17的位置。进一步与这些消除组合的优选的取代包括在2、3、5、9、31、43、50、73、126、156、166、169、188、206、212、217、218、221、222、254和271中的一个或多个位置的取代,更优选Q2K、S3C、P5A、S9A、I31L、K43N、M50F、A73L、L126I、E156S、G166S、G169A、S188P、Q206C、N212G、K217L、N218S、S221C、M222Q、T254A和Y271K。
合适的脂肪酶的具体的非限制性实施例是LIPOLASE(RTM)、LIPOLASE ULTRA(RTM)、LIPOZYME(RTM)、PALATASE(RTM)、NOVOZYM 435(RTM)、LECITASE(RTM),所有这些均可得自NovoNordisk(丹麦),和LUMAFAST(RTM)、LIPOMAX(RTM),均得自Genencor(旧金山)。合适的蛋白酶的具体的非限制性实施例是ALCALASE(RTM)、ESPERASE(RTM)、SAVINASE(RTM),所有这些均得自Novo Nordisk(丹麦),和MAXATASE(RTM)、MAXACAL(RTM)、MAXAPEM 15(RTM),所有这些均得自Gist-Brocades(荷兰),和枯草杆菌蛋白酶BPN’,其可以商购获得。
B.
水
本发明的组合物包括作为基本组分的水,所述水的量足以有效强化酶的活性和溶解新发明的组合物中其它基本成分。典型地,安全有效量将是至少30%,优选至少40%,更优选至少50%。
包含水的介质的“水活性aw”是在相同的温度下产品的水蒸汽压“PH2O产品”与纯水蒸汽压“PH2O纯”的比率。它也可被表示为水分子数目“NH2O”与总分子数目“NH2O+N溶解的物质”的比率,其考虑了溶解的物质的分子“N溶解的物质”。它通过如下式给出:
可以使用各种方法来测定水的活性。最常用的是压力计测量法,通过该方法直接测量蒸汽压。典型地,本发明的组合物将具有大于0.65,优选大于0.75,更优选大于0.85的水活性。典型地,本发明的组合物将具有低渗透压(如低于10个大气压)。
C.
碱土金属盐
本发明的组合物包括,如果存在的话,足以有效强化酶的稳定性的最小量的碱土金属盐。典型地,安全有效量将低于5%,优选低于0.1%,更优选低于0.05%,还更优选低于0.02%,还仍优选低于0.015%。不受理论的约束,据信碱土金属盐可以插入酶的钙结合位置,因此构象上对其稳定化,然而超过5%后,碱土金属盐通过增加归因于渗透效应的自动消化而使酶脱稳定化。这样的碱土金属盐包括镁、钙和锶。
D.
酶抑制剂
本发明的组合物包括作为基本组分酶抑制剂稳定剂,所述稳定剂的量足以降低酶的自动消化速率从而强化酶的稳定性。典型地,安全有效的量为0.00005%至5%,优选0.005%至2%,更优选0.025%至1%。本发明报导的Ki值是近似值并可测量,例如,使用陈述于““Kinetcs of Subtilisin and Thiolsubtilisin”,Philipp M.和BenderM.L.,Molecular & Cellular Biochemistry,第51卷,第5-32页(1983)中的方法。另一个合适的方法陈述于“Protease Stabilization byCarboxylic Acid Salts:Relative Efficencies and Mechanisms,”Crossin,Michael C.,J.A.O.C.S.第66卷,第7期,第1010-1014页(1989年7月)。适用于本发明的抑制剂应具有抑制常数,这样使得产品中抑制剂显示具有接合酶的能力,但另一方面当涂敷于皮肤上时应具有足够的“脱落速度”使得酶在皮肤上应是有活性的,不需要单独的再活化步骤。具有太低Ki的抑制剂倾向于与酶结合得太紧密,而不能使酶在皮肤上具有活性,而具有太高Ki的抑制剂倾向于接合得不够紧密不足以稳定货架上的酶。本发明所使用的“脱落速度”是酶抑制剂复合物分解释放未抑制的酶的速度。抑制常数(Ki)定义为抑制酶活性50%所需的抑制剂浓度,并可表示为Ki=[E]*[I]/[EI],其中E是酶,I是抑制剂,而EI是酶抑制剂复合物。适用于本发明的抑制剂典型地应具有的Ki为10nM至25,000nM,优选50nM至5,000nM,更优选100nM至1,000nM。优选地,酶与抑制剂的摩尔比为2∶1至1∶20,更优选1∶1至1∶15。
合适的抑制剂包括但不限于符合下式的芳基硼酸衍生物:
Ki=8,900nM,和
Ki=360nM。
适用于本发明的抑制剂也包括具有下式的酶抑制剂缀合物:
[Poly]-(L)z-[R-CHO]
其中[Poly]是水溶性、非肽聚合物组分,L是可任选地存在的连接基,y具有至少1的值;z具有0或1的值,和-RCHO是具有下式的基质(能与一种或多种酶作用以可逆地抑制酶):
其中,R4和R5各自独立地选自取代的或未取代的:苯基、苄基、萘基、直链的或支链的C1-C7烷基、以及它们的混合物;和W单元是调整R4、R5和-CHO单元之间距离的间隔单元。优选地,
-RCHO具有下式:
其中每个R6独立地选自氢、甲基、羟甲基、1-羟乙基、1-甲基乙基、1-甲基丙基、2-甲基丙基、苯基、4-羟基苯基、2-吡咯烷基、巯甲基、(甲硫基)甲基、羧甲基、羧乙基、3-吲哚基甲基、4-氨基丁基、3-胍基丙基、1H-3-咪唑基-、以及它们的混合物。
优选的酶抑制剂缀合物具有下式:
其中R4和R5独立地选自取代的或未取代的:苯基、苄基、萘基、直链的或支链的C1-C7烷基、以及它们的混合物;和n为3至200。
优选的酶抑制剂缀合物具有如下结构:
Ki=200nM
适用于本发明的抑制剂也包括链霉菌枯草杆菌蛋白酶抑制剂(SSI)的变体和与SSI具有至少70%氨基酸序列同源性的那些抑制剂(“类SSI”抑制剂),其中所述变体包括下列取代的一个或多个:A62K、L63I、M73P、D83C、S98D、S98E。聚乙二醇改性的形式的SSI和类SSI抑制剂及它们的变体也是合适的。
因为它们的接合性质不适于本发明的抑制剂包括但不限于链霉菌枯草杆菌蛋白酶抑制剂(SSI)(Ki<1nM)和缺少上述取代的与SSI具有至少70%氨基酸序列同源性的那些抑制剂(“类SSI”抑制剂),以及那些符合以下结构的抑制剂:
Ki=2.5nM。
II.
任选组分
在一些实施方案中,本发明的组合物还包括已知的或另外有效地用于局部涂敷的个人护理产品的附加任选组分,其实施例描述如下。任何任选组分应该与组合物的基本组分物理地和化学地相容,并且不应该不适当地损害产品的稳定性、美观性或性能。
A.
多元醇
本发明的组合物附加地包括多元醇,所述醇的量足以有效强化酶的稳定性和/或独立地水化皮肤。典型地,安全有效量应为0.5%至40%,更优选1%至30%,更优选2%至20%,更优选1%至15%。多元醇和水的量可被选定以使多元醇与水的比率(重量/重量百分比)典型地为1∶2至1∶100,优选1∶3至1∶50,更优选1∶5至1∶25,还更优选1∶6至1∶10。这可使皮肤上酶的活性最大化。如本发明使用的“多元醇”是指包括两个或更多醇官能度的有机化合物或其烷氧基化的衍生物。典型地,适用于本发明的多元醇将具有低于50,000,优选低于35,000,更优选低于2,000的数均分子量。当本发明的组合物被配制为水包油乳液时,优选地,多元醇存在于连续相。
适用于本发明的多元醇包括,但不限于聚乙烯醇(如得自Clariant(德国)的MOWIOL 4-88(RTM))、聚亚烷基二醇,优选亚烷基二醇和它们的衍生物,包括丙二醇、双丙甘醇、聚丙二醇、聚乙二醇及其衍生物、山梨醇、羟丙基山梨醇、赤藓醇、苏来醇、季戊四醇、木糖醇、葡萄糖醇、甘露糖醇、己二醇、丁二醇(如1,2-丁二醇和1,3-丁二醇)、己三醇(如1,2,6-己三醇)、2,4,4-三甲基戊二醇、新戊二醇、甘油、乙氧基化甘油、1,3-丙二醇、丙氧基化甘油、肌醇、帕拉金糖醇(异麦芽)、1,4-丁二醇、丁氧基三醇、以及它们的混合物。任何上述多元醇的烷氧基化衍生物也适用于本发明。本发明的优选的多元醇是甘油、聚乙二醇(更优选具有平均分子量200至400的那些)、己三醇、1,4-丁二醇、丁氧基三醇、赤藓醇、木糖醇以及它们的混合物,更优选甘油、聚乙二醇(更优选具有平均分子量200至400的那些)、以及它们的混合物。
合适的还有:(a)单糖,如核糖、核酮糖、阿拉伯糖、木糖、木酮糖、来苏糖、阿洛糖、阿卓糖、葡萄糖、甘露糖、古洛糖、伊杜糖、半乳糖、塔罗糖、阿洛酮糖、果糖、山梨糖、塔格糖、以及它们的混合物;(b)二糖,如乳糖、麦芽糖、异麦芽糖、纤维二糖、海藻糖、蔗糖、以及它们的混合物;(c)低聚糖,如麦芽低聚糖、纤维低聚糖、以及它们的混合物;和(d)它们的混合物。
B.
渗透保护剂
本发明的组合物可附加地包括用量足以有效稳定酶的渗透保护剂,其可使所用抑制剂的用量减少。典型地,安全有效量按组合物的重量计应在1%至50%,优选3%至25%,更优选5%至15%,还更优选7%至12%,仍更优选7%至10%的范围内。本发明所述的渗透保护剂的质子化的和脱质子化的形式都适用于本发明的组合物,质子化的形式是优选的。典型地,成分的溶解度和疏水性是相反的关系。适用于本发明的渗透保护剂在pH7,在水中,在25℃下典型地具有大于1%的溶解度。还适用于本发明的是渗透保护剂依克多因(ectoin)和羟基依克多因(hydroxyectoin)。
适用于本发明的渗透保护剂包括,但不限于:
(i)符合下式的渗透保护剂(I):
其中R1、R2和R3独立地选自-H、-CH3、-CH2CH3和
[-CH2CH(OH)R4,其中R4选自-H和C1至C4烷烃];且其中n=1至3的整数,优选1;
优选地其中(R1、R2和R3都是-CH3,并且n是1)或(R1、R2和R3均为
-CH3,并且n是3)或(R1和R2是-CH3,R3是-H,并且n是1)或(R1是-CH3,R2和R3是-H,并且n是1);或(R1和R2是-CH2(OH)R4,R4是-H,R3是-H,并且n是1);
(ii)符合式(I)的渗透保护剂,其中R1、R2和R3中任意两个独立地选自-H和-CH3,并且R1、R2和R3中的第三个结构部分选自-H和-(CH2)mCH3其中m是4或5;和其中n=1至3的整数,优选1;优选其中(R1和R2是-CH3,R3是-(CH2)mCH3其中m是5,并且n是1);
(iii)符合式(II)的渗透保护剂:
其中R1、R2、R3、R4和n如上述部分(i)所定义,且其中R5选自PO3和SO3;
优选其中(R1、R2和R3是-CH3;n是1;和R5是PO3);
(iv)渗透保护剂选自丙氨酸、甘氨酸、丝氨酸、脯氨酸、肉毒碱、牛磺酸、三甲基胺氧化物、依克多因(ectoin)和羟基依克多因(hydroxyection);
优选选自丝氨酸、脯氨酸、肉毒碱;
(v)选自麦黄酮、二甲基脯氨酸、γ-丁基甜菜碱、β-丙氨酸甜菜碱、缬氨酸甜菜碱、赖氨酸甜菜碱、鸟氨酸甜菜碱、丙氨酸甜菜碱、谷氨酸甜菜碱和苯丙氨酸甜菜碱的渗透保护剂;
优选选自麦黄酮和γ-丁内铵盐;和
(vi)它们的混合物。
用于本发明的优选的渗透保护剂的非限制性实施例紧接着如上被确认。优选的渗透保护剂的具体实施例包括,以商品名TEGOCAREAP(RTM)得自T.H.Goldschmidt(德国)的三甲基甘氨酸水合物,以商品名脯氨酸得自Huls-Degaussa(德国)的脯氨酸和以商品名N-二(羟乙基)甘氨酸得自Sigma Chemical(美国)的N-二(羟乙基)甘氨酸。
C.
易溶的稳定剂
本发明的组合物还可以足以有效强化酶的稳定性的量包括易溶的稳定剂。典型地,安全有效量应为0.1%至5%,优选0.5%至3%,更优选0.2%至2%。适用于本发明的易溶的稳定剂典型地可以它们的盐形式被掺入,其中阳离子是任何一价离子,优选地选自碱金属、铵、三[羟甲基]氨基甲烷(TRIS)、乙酰胺单乙醇胺(AMEA)和三乙醇胺(TEA),更优选选自钠、钾、锂和乙酰胺单乙醇胺(AMEA)。
适用于本发明的易溶的稳定剂包括,但不限于甲酸盐、乙酸盐、丙酸盐、甘醇酸盐、甘油酸盐、丙二酸盐、琥珀酸盐、己二酸盐、苹果酸盐、酒石酸盐、磺基琥珀酸盐、硫酸盐、磷酸盐、柠檬酸盐、羟乙基磺酸盐、甘油磷酸盐、苯甲酸盐、戊二酸盐、庚二酸盐、辛二酸盐、肌醇六磷酸以及它们的混合物;优选甲酸盐、甘醇酸盐、己二酸盐、丙二酸盐、硫酸盐、磷酸盐、琥珀酸盐、以及它们的混合物。
还有合适的是:(a)氧化的单糖,如核糖酸、核酮糖酸、阿拉伯糖酸、木糖酸、木酮糖酸、来苏糖酸、阿洛糖酸、阿卓糖酸、葡萄糖酸、甘露酸、古洛糖酸、伊杜糖酸、半乳糖酸、塔龙酸、葡庚糖酸、阿洛酮糖酸、果糖酸、山梨酸、塔格糖酸、葡糖醛酸、以及它们的混合物;(b)氧化的二糖,如乳糖酸、麦芽糖酸、异麦芽糖酸、纤维二糖酸、以及它们的混合物;(c)氧化的低聚糖,如氧化的麦芽低聚糖、氧化的纤维低聚糖、以及它们的混合物;(d)氧化的多糖,如氧化的纤维素、甲克质、阿拉伯胶、刺梧桐树胶、黄原胶、氧化的瓜耳胶、氧化的刺槐豆胶、氧化的琼脂、氧化的褐藻胶、氧化的结冷胶、以及它们的混合物;和(e)以及它们的混合物。
D.
附加酶抑制剂
除了上述那些本发明的基本组分以外本发明组合物还包括酶抑制剂,其用量足以降低酶的自动消化速率从而强化酶的稳定性。典型地,安全有效量应为0.1%至5%,优选0.5%至0.01%,更优选1.5%至2%。
合适的附加抑制剂包括但不限于Ki>1,000,000nM的硼酸、Ki=7,200,000nM的丁基硼酸、Ki=160,000nM的苯基硼酸、和符合下式的芳基硼酸衍生物:
Ki=780,000nM;和
Ki=300,000nM。
适用于本发明的附加抑制剂也包括符合下式的抑制剂:
也适用于本发明的其它天然衍生的抑制剂有如亮氨酸肽(leupeptide)Ki=230,000nM。
E.
pH改性剂和缓冲剂
本发明的组合物还可以足以有效调节组合物的pH在5.5至9范围内,优选6至8.5,更优选6.5至8的量包括pH改性剂。本领域的技术人员将会理解,欲加入的pH改性剂的量将取决于选定以制造本发明所述组合物的其它成分的量和类型。
适用于本发明的pH改性剂包括,但不限于: 氢氧化物,优选的是这些的钠盐。此外,本发明的组合物还可以足以有效最小化pH漂移的量包括缓冲剂。适用于本发明的缓冲剂包括,但不限于组胺酸、1,4-哌嗪二乙磺酸(PIPES)、三[羟甲基]氨基甲烷(TRIS)、[双-(2-羟乙基)亚氨基]-三-[(羟甲基)甲烷](BIS-TRIS)、1-[4-(2-羟乙基)-1-哌嗪基]乙烷-2-磺酸(HEPES)、N-(2-乙酰胺基)-2-亚氨基二乙酸(ADA)、2-[(2-氨基-2-氧代乙基)氨基]乙磺酸(ACES)、N,N-双(2-羟乙基)-牛磺酸(BES)、吗啉基丙磺酸(MOPS)、N-[2-羟基-1,1-双(羟甲基)乙基]-牛磺酸(TES)、3-[双(2-羟乙基)氨基]-2-羟基丙烷磺酸(DIPSO)和(磷酸盐、焦磷酸盐、柠檬酸盐和苯六甲酸酯),以及它们的混合物,优选磷酸盐。
F.
聚合增稠剂
本发明的组合物还可以包括聚合增稠剂,所述聚合增稠剂的量足以为消费者有效提供令人愉悦的应用体验。典型地,安全有效量将在0.1%至10%,优选0.5%至8%,更优选1%至5%的范围内。用于本发明的优选的增稠剂将具有足以为包含电解质的组合物提供最小的粘度损失的增加的电解质。典型地,本发明所述组合物将具有大于4,000mPa.s的粘度(通过如Brookfield粘度计DVII+Spindle Cheliopath 5rpm在25℃下测得)。适用于本发明的聚合增稠剂将具有大于50,000,优选大于100,000的数均分子量。
用于本发明的优选的聚合增稠剂包括但不限于非离子增稠剂和阴离子增稠剂,以及它们的混合物。合适的非离子增稠剂包括聚丙烯酰胺聚合物、交联的聚(N-乙烯基吡咯烷酮)、多糖、天然或合成的树胶、聚乙烯吡咯烷酮和聚乙烯醇(如得自Clariant(德国)的MOWIOL40-88(RTM))。适用的阴离子增稠剂包括丙烯酸/丙烯酸乙酯共聚物,羧乙烯基聚合物和交联的烷基乙烯基醚和马来酸酐共聚物。用于本发明的优选的增稠剂是聚丙烯酰胺/AMPS聚合物,如聚丙烯酰胺和异链烷烃和月桂基聚氧乙烯醚-7,以商品名SEPIGEL 305(RTM)得自Seppic Corporation,和丙烯酸/丙烯酸乙酯共聚物和羧基乙烯基聚合物,包括其疏水改性的衍生物,以商品名CARBOPOL(RTM)树脂得自Noveon(俄亥俄州克立夫兰)。其它还合适的树脂描述于WO98/22085。也优选的是丙烯酸/丙稀酰胺聚合物,优选具有4∶1至1000∶1的丙烯酸与丙稀酰胺的比率的那些,和通过乳液聚合方法生产,其中一种这样的聚合物是丙烯酸铵/丙稀酰胺交联聚合物,以商品名EX-617(RTM)得自Noveon(Cleveland,Ohio),和丙烯酸羟乙酯/AMPS聚合物,以商品名SEPIGEL NS(RTM)得自SeppicCorporation。适用于本发明的还有树胶,如黄原胶、刺梧桐树胶、结冷胶、wellan、阿拉伯胶、角叉菜胶、生物糖胶-1(如FUCOGEL 1000(RTM),得自Solabia(法国)),和刺槐豆胶。藻酸盐和琼脂糖也是合适的。
G.
皮肤活性剂
本发明的组合物可包括安全有效量的皮肤活性剂。当存在时,这些活性剂被包括的用量典型地为0.1%至20%,优选1%至10%,更优选2%至8%。
用于本发明的一些优选的皮肤活性剂包括,但不限于维生素B化合物、泛醇、维生素E、生育酚乙酸酯、视黄醇、视黄基丙酸酯、视黄基十六烷酸酯、视黄酸、维生素C、维生素D、咖啡因、可可碱、尿囊素、α-羟基羧酸(如乙醇酸、乳酸、2-羟基辛酸)、β-羟基羧酸(如水杨酸)、(α-和β-羟基羧酸与甘草酸、α-没药醇(bisabol)和三氯生的盐组合)、金合欢醇、植烷三醇、葡糖胺、抗坏血酸磷酸镁、抗坏血酸基葡糖苷、吡哆素、十六烷基五肽-3(以商品名MATRIXYL(RTM)得自Sederma公司)、比太拉(pitera)(酵母提取物)、植物甾醇(如豆甾醇、谷甾醇、菜子甾醇、菜油甾醇)、类黄酮(如查耳酮、色酮、黄酮、异黄酮)、HMG-coA-还原酶抑制剂(如美伐他汀、洛伐他汀),以及它们的混合物,包括任何在递送时在纳米胶囊内的描述的那些。皮肤活性剂的优选的组合是包括烟酰胺、泛醇和视黄醇化合物的复合物。其它合适的皮肤活性剂如本发明所述。
本发明的组合物可包括安全有效量的维生素B3化合物。维生素B3化合物对于调节皮肤状况尤其有用,如公布于1997年10月30日的WO 97/39733A1中所描述。当加入维生素B3化合物时,典型的量将是0.1%至10%,更优选0.5%至8%,更优选1%至5%,还更优选2%至5%。适用于本发明的维生B3化合物包括但不限于具有下式的化合物:
其中R为-CONH2(即烟酰胺)、-COOH(即烟酸)或-CH2OH(即烟醇);及其衍生物;和任意前述化合物的盐。上述维生素B3化合物的示例的非限制性衍生物包括烟酸酯,包括烟酸的非血管舒张性酯(如生育酚烟酸酯)、烟基氨基酸、烟基醇羧酸酯、烟酸N-氧化物和烟酰胺N-氧化物。
本发明的组合物还可以包含类视色素。本文中使用的“类视色素”包括对于皮肤具有维生素A生物活性的所有天然和/或合成的维生素A类似物或类似视黄醇化合物,以及这些化合物的几何异构体和立体异构体。所述类视色素优选视黄醇、视黄酯(如视黄醇的C2-C22烷基酯,包括视黄基十六烷酸酯、视黄基乙酸酯、视黄基丙酸酯)、视黄醛和/或视黄酸(包括全反式视黄酸和/或13-顺式-视黄酸),更优选视黄酸以外的类视色素。这样的化合物是已知的,并且可商购自如SigmaChemical Company(St.Louis,MO),和Boerhinger Mannheim(Indianapolis,IN)。其它可用于本发明中的类视色素描述在如下美国专利中:公布于1987年6月30日的Parish等人的4,677,120;公布于1989年12月5日的Parish等人的4,885,311;公布于1991年9月17日的Purcell等人的5,049,584;公布于1992年6月23日的Purcell等人的5,124,356;和公布于1992年9月22日的Purcell等人的重新公布34,075;其它合适的类视色素有生育酚视黄酸酯[视黄酸(反式-或顺式-)的生育酚酯,阿达帕林{6-[3-(1-金刚烷基)-4-甲氧基苯基]-2-萘甲酸}和他佐罗汀(6-[2-(4,4-二甲基二氢苯并噻喃-6-基)-乙炔基]烟酸乙酯)。优选的类视色素有视黄醇、视黄基十六烷酸酯、视黄基乙酸酯、视黄基丙酸酯、视黄醛和它们的组合。当存在时,类视色素的量将典型地为0.005%至2%,优选0.01%至2%。视黄醇优选以0.01%至0.15%的量使用;视黄酯优选以0.01%至2%的量使用;视黄酸优选以0.01%至0.25%的量使用;生育酚视黄酸酯、阿达帕林、和他佐罗汀优选以0.01%至2%的量使用。
H.
油相
本发明的组合物可以被配制为乳液,其包括一个或多个油相在一个或多个水相中,每个油相包括单一油组分或以可混合的或均一化形式的油组分混合物。油相组分的总含量将典型地为0.1%至60%,优选1%至30%,更优选1%至10%,还更优选2%至10%。当存在时,油相可包括优选地包括润肤剂、硅氧烷油或其混合物;它们也可包括附加的油组分,如选自矿物、植物和动物油(如羊毛脂)、脂肪和蜡、脂肪酸脂、脂肪醇、脂肪酸、以及它们的混合物的天然或合成的油。优选的用于本发明的是,例如饱和脂肪醇,如二十二醇、鲸蜡醇和硬脂醇,和烃,如矿物油和凡士林。适用于本发明的进一步的实施例公开于WO 98/22085。优选的实施方案可包括0.1%至5%的如描述于WO 98/22085的不饱和脂肪酸或酯。
I.
润肤剂
本发明的组合物可包括润肤剂,当存在时,其量典型地为0.1%至10%,优选0.1%至8%,更优选0.5%至5%。
合适的润肤剂物质包括具有约100至约15,000,优选约100至1000的重均分子量的支链烃;化合物符合下式:
其中R1选自-H或-CH3,R2、R3和R4独立地选自C1至C20直链的或支链的烷基,并且x是1至20的整数。符合该式的合适的酯润肤剂物质包括但不限于:异硬脂酸甲酯、异硬脂酸异丙酯、新戊酸异硬脂基酯、异壬酸异壬基酯、辛酸异癸基酯、异壬酸异癸基酯、异壬酸十三烷基酯、辛酸十四烷基酯、壬酸辛基酯、异壬酸辛基酯、肉豆蔻酸十四烷基酯、新戊酸十四烷基酯、辛酸十四烷基酯、丙酸十四烷基酯、肉豆蔻酸异丙酯、以及它们的混合物。
适用于本发明的润肤剂也包括符合下式的化合物:
其中R5选自可任选地羟基或C1至C4烷基取代的苄基,和R6选自C1至C20支链的或直链的烷基;以及它们的混合物。符合该式的合适的酯润肤剂物质包括但不限于苯甲酸的C12-15烷基酯。
适用于本发明的润肤剂也包括植物油和氢化植物油,如红花油、椰子油、棉籽油、鲱油、棕榈仁油、棕榈油、花生油、大豆油、油菜籽油、亚麻籽油、米糠油、松油、芝麻油、向日葵籽油、池花子油、牛油树脂、来自前述来源的部分或完全氢化的油、以及它们的混合物。
适用于本发明的支链的烃润肤剂包括但不限于异十二烷、异十六烷、异二十烷、isooctahexacontane、isohexapentacontahectane、isopentacontaoctactane、以及它们的混合物,如那些以商品名PERMETHYL(RTM)出售的、得自Presperse(新泽西)的那些支链的脂族烃。
用于本发明的其它合适的润肤剂是全羟基化角鲨烯、全氟聚醚、甲基葡糖倍半硬脂酸酯、三丁基柠檬酸酯、甘油硬脂基柠檬酸酯、丁二醇二辛酸二癸酸酯、癸酸辛酸甘油三酯、以及它们的混合物。
用于本发明的优选的润肤剂是异十六烷、isooctacontane、异壬酸异壬基酯、辛酸异癸基酯、异壬酸异癸基酯、异壬酸十三烷基酯、辛酸十四烷基酯、异壬酸辛基酯、肉豆蔻酸十四烷基酯、异硬脂酸甲酯、异硬脂酸异丙基酯、苯甲酸的C12-15烷基酯以及它们的混合物,更优选异十六烷、异壬酸异壬基酯、异硬脂酸甲酯、异硬脂酸异丙基酯、以及它们的混合物。
本发明的组合物还可包括作为附加的润肤剂的多元醇羧酸酯,典型的量为0.01%至20%,优选0.1%至15%,更优选0.1%至10%。按组合物中油的重量计,多元醇酯的含量典型地为1%至30%,优选为5%至20%。多元醇羧酸酯与前述润肤剂物质的重量比率将典型地为5∶1至1∶5,优选2∶1至1∶2。用于本发明的优选的多元醇聚酯是糖或相关物质的C1至C30一或多酯,如棉籽油或大豆油脂肪酸的蔗糖酯,和描述于WO 96/16636中的那些物质;更优选INCI名称为蔗糖聚棉籽酯的物质。
J.
硅氧烷油
本发明的组合物可包括至少一种硅氧烷油相,典型地,所述油占组合物的0.1%至20%,优选0.5%至10%,更优选0.5%至5%。硅氧烷组分可以是流体,包括直链的、支链的和环状的硅氧烷。可适用于本发明的硅氧烷流体包括硅氧烷,所述硅氧烷包括聚烷基硅氧烷流体、聚芳基硅氧烷流体、环状和线性聚烷基硅氧烷、聚烷氧基化的硅氧烷、氨基和季铵改性的硅氧烷、聚烷基芳香基硅氧烷,或聚醚硅氧烷共聚物,以及它们的混合物。硅氧烷流体可以是挥发性的或非挥发性的。硅氧烷流体通常具有小于200,000的重均分子量。合适的硅氧烷流体具有100,000或更小的分子量,优选50,000或更小,更优选10,000或更小。优选地,所述硅氧烷流体选自具有重均分子量在100至50,000,和优选在200至40,000范围内的硅氧烷流体。
典型地,硅氧烷液体的粘度在25℃下为约0.65至约600,000mm2.s-1,优选为约0.65至约10,000mm2.s-1。粘度可通过玻璃毛细管粘度计用1970年7月29日的Dow Corning Corporate Test MethodCTM0004中所述的方法测得。可适用于本发明的聚二甲基硅氧烷包括例如以商品名SF和VISCASIL(RTM)系列得自通用电气公司的那些和以商品名DOW CORNING 200(RTM)系列得自道康宁的那些。适用的还有基本上是非挥发性的聚烷基芳基硅氧烷,例如在25℃下具有的粘度为约0.65至30,000mm2.s-1的聚甲基苯基硅氧烷。这些硅氧烷,例如,可以商品名SF 1075(RTM)甲基苯基流体得自通用电气或以商品名556 COSMETIC GRADE FLUID(RTM)得自道康宁。适用于本发明的环状的聚二甲基硅氧烷是具有导入约3至约7个(CH3)2SiO部分的环状结构的那些。优选地,所述聚硅氧烷流体选自聚二甲基硅氧烷、十甲基环五硅氧烷、八甲基环四硅氧烷、苯基甲基硅氧烷、以及它们的混合物。
聚硅氧烷树胶也可被用于本发明。本发明的术语“聚硅氧烷树胶”是指具有重均分子量超过200,000和优选200,000至4,000,000的高分子量聚硅氧烷。被包括的是非挥发性聚烷基和聚芳基硅氧烷树胶。在优选的实施方案中,硅氧烷油相包括硅氧烷树胶或包含硅氧烷树胶的硅氧烷混合物。典型地,聚硅氧烷树胶在25℃具有超过1,000,000mm2s-1的粘度。所述聚硅氧烷树胶包括如描述于Noll、Walter,“Chemistry and Technology of Silicones”,New York:Academic Press1968中的聚二甲基硅氧烷。也描述了聚硅氧烷树胶的是GeneralElectric Silicone Rubber Product Data Sheets SE 30、SE 33、SE 54和SE 76。聚硅氧烷树胶的具体的实施例包括聚二甲基硅氧烷、(聚二甲基硅氧烷)(甲基乙烯基硅氧烷)共聚物、聚(二甲基硅氧烷)(二苯基)(甲基乙烯基硅氧烷)共聚物、以及它们的混合物。用于本发明的优选的硅氧烷树胶具有200,000至4,000,000的分子量,选自聚二甲基硅氧烷醇和聚二甲基硅氧烷以及它们的混合物。
本发明中的硅氧烷相优选包括硅氧烷树胶,它是作为硅氧烷树胶-流体共混物中的一部分掺入到该组合物中的。当聚硅氧烷树胶作为聚硅氧烷树胶-流体共混物的一部分被掺入时,聚硅氧烷树胶按聚硅氧烷树胶-流体共混物重量计典型地包括5%至40%,优选10%至20%。本发明的合适的聚硅氧烷树胶-流体共混物是混合物,其包括:
(i)具有200,000至4,000,000的分子量的硅氧烷,选自聚二甲基硅氧烷醇、氟代硅氧烷和聚二甲基硅氧烷以及它们的混合物;和
(ii)载体,其为聚硅氧烷流体,所述载体具有0.65mm2.s-1至100mm2.s-1的粘度,
其中,i)与ii)的比率为10∶90至20∶80,和其中所述基于聚硅氧烷树胶的组分具有100mm2.s-1至100,000mm2.s-1,优选500mm2.s-1至10,000mm2.s-1的最终粘度。
用于本发明的组合物的优选的基于聚硅氧烷树胶-流体共混物的组分是具有200,000至4,000,000的分子量的聚二甲基硅氧烷醇树胶以及粘度约0.65至100mm2.s-1的硅氧烷流体载体。这些硅氧烷组分的实施例是得自道康宁的DOW CORNING Q2-1403(RTM)(85%5mm2.s-1的聚二甲基硅氧烷流体/15%聚二甲基硅氧烷醇)和DOWCORNING Q2-1402(RTM)。
进一步适用于本发明的硅氧烷油中的硅氧烷成分是交联的聚有机硅氧烷聚合物,它任选地分散在一种液体载体中。通常,当存在时,所述交联的聚有机硅氧烷聚合物,以及其载体(如果存在的话),包括0.1%至20%,优选0.5%至10%,更优选0.5%至5%。这样的聚合物包括通过交联剂交联的聚有机硅氧烷聚合物。合适的交联剂公开于WO 98/22085中。适用于本发明的聚有机硅氧烷聚合物的实施例包括甲基乙烯基聚二甲基硅氧烷、甲基乙烯基二苯基聚二甲基硅氧烷、和甲基乙烯基苯基甲基二苯基聚二甲基硅氧烷。
用于本发明的具体的可商购获得的交联的聚有机硅氧烷聚合物是硅氧烷乙烯基交联聚合物混合物,可以商品名KSG(RTM)获得,由Shinetsu Chemical Co.,Ltd提供,例如KSG-15、KSG-16、KSG-17、KSG-18和得自道康宁的DC9040(RTM)。这些物质包含交联的聚有机硅氧烷聚合物和聚硅氧烷流体的组合物。优选的与有机两亲的乳化剂物质组合用于本发明的是KSG-18(RTM)。KSG-15、KSG-16、KSG-17和KSG-18的分配的INCI命名分别为环甲基聚硅氧烷聚二甲硅氧烷/乙烯基聚二甲基硅氧烷交联聚合物、聚二甲硅氧烷聚二甲硅氧烷/乙烯基聚二甲基硅氧烷交联聚合物、环甲基聚硅氧烷聚二甲硅氧烷/乙烯基聚二甲基硅氧烷交联聚合物、和苯基三甲聚硅氧烷聚二甲基硅氧烷/苯基乙烯基聚二甲基硅氧烷交联聚合物。
适用于本发明的硅氧烷油相中的另一类硅氧烷成分包括聚二有机硅氧烷-聚氧化亚烷基共聚物,它包含至少一个聚二有机硅氧烷片段和至少一个聚氧化亚烷基片段。合适的聚二有机硅氧烷片断和其共聚物公开于WO 98/22085。合适的聚二有机硅氧烷-聚亚烷基共聚物可以商品名BELSIL(RTM)商购自Wacker-Chemie(德国)和ABIL(RTM)得自Goldschmidt(英格兰),如BELSIL 6031(RTM)和ABIL B88183(RTM)。用于本发明的优选的共聚物流体共混物包括道康宁的DC5225C(RTM),其CTFA命名为聚二甲基硅氧烷/聚二甲基硅氧烷共聚醇。癸基甲基硅氧烷、辛基甲基硅氧烷、C16至C18甲基硅氧烷也是有用的,并以商品名SF1632(RTM)得自通用电气公司(美国)。
K.
乳化剂/表面活性剂
本发明组合物还包括乳化剂和/或表面活性剂,通常用于帮助将分散相分散和悬浮于连续的水相中(当配制成乳液时)。本发明所使用的乳化剂将和表面活性剂一起讨论。
用于本发明的许多合适的表面活性剂描述于WO 00/24372中。优选的这种类型的表面活性剂是癸基葡糖苷(得自癸基醇与葡萄糖聚合物缩合的产物)。癸基葡糖苷可任选地被掺入本文所述的本发明组合物中。不受理论的约束,据信癸基葡糖苷可通过允许更有效的润湿的发生而增加酶与底物(皮肤)的接触。在免洗型制剂中,癸基葡糖苷可以被有利地用于执行这一功能,而其它表面活性剂,典型地为阴离子表面活性剂,可造成对皮肤的不可接受的刺激。当被用于免洗型制剂时,人们发现癸基葡糖苷不会增加对皮肤的刺激。
合适的非离子表面活性剂包括(聚环氧乙烷/聚环氧丙烷)共聚物和(聚环氧乙烷/聚环氧丁烷)共聚物,如以商品名PLURONIC,尤其是PLURONIC L92得自BASF(德国)的共聚物。
合适的表面活性剂是非离子的,例如长链醇,如C8-30醇,与糖或淀粉聚合物,如葡糖苷的缩合产物。其它适用的非离子表面活性剂包括氧化亚烷与脂肪酸的缩合产物(即脂肪酸的氧化亚烷酯)。这些物质具有通式RCO(X)nOH,其中R是C10-30烷基,X是-OCH2CH2-(即得自乙二醇或环氧乙烷)或-OCH2CHCH3-(即得自丙二醇或环氧丙烷),并且n是6至200的整数。其它非离子表面活性剂是氧化亚烷与2摩尔脂肪酸的缩合产物(即氧化亚烷的脂肪酸二酯)。这些物质具有通式RCO(X)nOOCR,其中R是C10-30烷基,X是-OCH2CH2-(即得自乙二醇或环氧乙烷)或-OCH2CHCH3-(即得自丙二醇或环氧丙烷),并且n是6至100的整数。用于本发明的优选的乳化剂是基于脱水山梨糖醇脂肪酸酯和蔗糖脂肪酸酯的混合物脂肪酸酯共混物,即脱水山梨糖醇硬脂酸酯和蔗糖椰油酸酯的共混物。这可以商品名ARLATONE 2121(RTM)商购自ICI。甚至进一步的合适的实施例包括鲸蜡醇、鲸蜡基葡糖苷的混合物,如以商品名MONTANOV 68(RTM)得自Seppic和以EMULGADE PL68/50(RTM)得自Henkel的那些。
可用于本发明的亲水的表面活性剂可以另外或附加地包括本领域内已知的各种阳离子、阴离子、两性离子和两性的表面活性剂(参见McCutcheon′s,“Detergents and Emulsifiers”,北美版(1986),AlluredPublishing Corporation)。可用于本发明的也有烷基酰基(alkoyl)羟乙基磺酸盐(如C12-C30)烷基和烷基醚硫酸盐及其盐,烷基和烷基醚磷酸盐及其盐,烷基甲基牛磺酸盐(如C12-C30)和脂肪酸的皂(如碱金属盐,如钠或钾盐),以及糖和氨基糖(如N-丁酰基D-葡糖胺和6-O-辛酰基-D-麦芽糖)。
当配制为乳液时,本发明的组合物可包括包含硅氧烷的表面活性剂,如有机改性的有机聚硅氧烷,也称为硅氧烷表面活性剂。适用的硅氧烷乳化剂包括聚二甲基硅氧烷共聚醇。这些物质是已被改性而包括聚醚侧链,如聚环氧乙烷链、聚环氧丙烷链、这些链的混合物和包含得自环氧乙烷和环氧丙烷的部分的聚醚链的聚二甲基硅氧烷。其它实施例包括烷基改性的聚二甲基硅氧烷共聚多元醇,如包含C2至C30下垂侧链的化合物。其它可使用的聚二甲基硅氧烷共聚醇还包括具有各种不同的阳离子、阴离子、两性和两性离子下垂部分的物质。
L.
暴浮剂
本发明的组合物也优选地包括一种或多种悬浮剂。适用于本发明的悬浮剂包括任意的几种长链酰基衍生物物质或这样的物质的混合物。被包括的是含有16至22个碳原子的脂肪酸的乙二醇酯。优选的是乙二醇硬脂酸酯,包括一和二硬脂酸酯,但尤其是包含低于约7%的一硬脂酸酯的二硬脂酸酯。其它被发现有用的悬浮剂是脂肪酸的链烷醇酰胺,含有16至22个碳原子,优选16至18个碳原子。优选的链烷醇酰胺是硬脂酸一乙醇酰胺、硬脂酸二乙醇酰胺、硬脂酸一异丙醇酰胺和硬脂酸一乙醇酰胺硬脂酸酯。
悬浮剂优选以0.1%至5%的量,优选0.1%至3%的量存在。悬浮剂的作用是辅助悬浮水不溶性油并且可为产品提供珠光。悬浮剂的混合物也适用于本发明。
M.
抗微生物和杀真菌活性物质
适用于本发明的任选的抗微生物和杀真菌活性物质包括但不限于:β-内酰胺药物、喹诺酮药物、环丙杀星、诺氟杀星、四环素、红霉素、氨基羟丁基卡那霉素A、2,4,4′-三氯-2′-羟基二苯醚、3,4,4′-三氯banilide、苯氧基乙醇、苯氧基丙醇、苯氧基异丙醇、强力霉素、卷曲霉素、洗必太、氯四环素、土霉素、克林霉素、乙胺丁醇、去氧苯比妥羟乙基磺酸盐、甲硝唑、戊脒、庆大霉素、卡那霉素、lineomycin、甲烯土霉素、六亚甲基四胺、米诺环素、新霉素、奈替米星、巴龙霉素、链霉素、托普霉素、咪康唑、四环素盐酸盐、红霉素、红霉素锌、无味红霉素、红霉素硬脂酸盐、氨基羟丁基卡那霉素A硫酸盐、强力霉素盐酸盐、卷曲霉素硫酸盐、洗必太葡萄糖酸盐、洗必太盐酸盐、氯四环素盐酸盐、土霉素盐酸盐、克林霉素盐酸盐、乙胺丁醇盐酸盐、甲硝唑盐酸盐、戊脒盐酸盐、庆大霉素硫酸盐、卡那霉素硫酸盐、lineomycin盐酸盐、甲烯土霉素盐酸盐、六亚甲基四胺马尿酸酯、六亚甲基四胺扁桃酸盐、米诺环素盐酸盐、新霉素硫酸盐、奈替米星硫酸盐、巴龙霉素硫酸盐、链霉素硫酸盐、托普霉素硫酸盐、咪康唑盐酸盐、amanfadine盐酸盐、amanfadine硫酸盐、羟甲辛吡酮、对氯间二甲苯酚、制霉菌素、托萘酯、克霉唑、氯化十六烷基吡啶(CPC)、羟甲辛吡酮乙醇胺、硫化硒、酮康唑、三氯卡班、三氯生、三氯二苯脲,也称为三氯碳酰苯胺、六氯酚(3,4,5-三溴N-水杨酰苯胺)、吡啶硫酮锌、伊曲康唑、积雪草酸、扁柏酚、mipirocin和描述于EP 680,745中的那些、clinacycin盐酸盐、过氧化苯甲酰、苄基过氧化物、米诺环素、苯氧基异丙醇以及它们的混合物。
N.
防西剂
本发明的组合物可包括具有UVA吸收性质、UVB吸收性质或其混合物的有机防晒剂。优选的防晒剂包括但不限于二苯甲酰甲烷及其衍生物,如4-(1,1-二甲基乙基)-4’-甲氧基二苯甲酰甲烷、4-异丙基二苯甲酰甲烷、对氨基苯甲酸、羟甲氧二苯酮、高薄荷基水杨酸酯、水杨酸辛酯、肉桂酸及其衍生物,如2-乙基己基对甲氧基肉桂酸和辛基对甲氧基肉桂酸、TEA水杨酸酯、辛基二甲基PABA、樟脑衍生物及其衍生物、以及它们的混合物。除了所述有机防晒剂之外,本发明的组合物可包括无机物理的防晒霜,优选锌氧化物和二氧化钛、以及它们的混合物,其可以是未覆盖的或以各种物质覆盖的,包括但不限于氨基酸、铝化合物,如氧化铝、硬脂酸铝和月桂酸铝;羧酸及其盐,如硬脂酸;磷脂,如卵磷脂;有机硅化合物;无机硅化合物,如二氧化硅和硅酸盐;以及它们的混合物。优选的二氧化钛是可商购自Tayca(日本),并且由Tri-K Industries(新泽西)以商品名MT销售的微离子化系列(如MT 100SAS(RTM))。
O.
颗粒物质
本发明的组合物可包括颜料,在水不溶性的情况下,有助于油相成分并被包括在油相成分的总含量中。适用于本发明的颜料可以是有机的和/或无机的。术语“颜料”也包括具有低色度或光亮度的物质,如表面打毛剂和光散射剂。优选地,本发明的组合物包括具有1.3至1.7的折射指数的颗粒物质、分散于组合物中的颗粒物质并具有2微米至30微米的中值粒径。优选地,用于本发明的颗粒具有相对窄的分布,也就是说多于50%的颗粒落在各自的中值任一边的3微米内。另外优选的是50%以上,优选60%以上,更优选70%以上的颗粒落在各自中值的指定的尺寸范围内。适宜的颗粒物质是有机或有机硅氧烷并且优选为有机硅氧烷聚合物。
优选的颗粒是自由流动的实心材料。“实心”是指所述颗粒不是中空的。在空心颗粒的中心存在空隙会对折射率产生不良影响,也因此会影响颗粒对皮肤或组合物的视觉效果。合适的有机颗粒物质包括由聚甲基倍半硅氧烷、聚酰胺、聚乙烯、聚丙烯腈、聚丙烯酸、聚甲基丙烯酸、聚苯乙烯、聚四氟乙烯(PTFE)、尼龙(如得自ElfAtochem的ORGASOL 2002 NAT COS D(RTM)和得自Optima(英格兰)的NYLON POLYWL10)和聚(1,1-二氯乙烯)制成的那些。得自前述物质的单体的共聚物也可以被使用。无机材料包括二氧化硅和氮化硼。本发明的有用的颗粒物质的有代表性的可商购获得的实施例是TOSPEARL145和TOSPEARL 2000(RTMs),得自GE Silicones(纽约),其具有4.5微米的中值粒径,和EA-209(RTM),得自KoboProducts(美国),其为具有10微米的中值粒径的乙烯/丙烯酸共聚物。合适的颜料的进一步的实施例是二氧化钛、预分散的二氧化钛,如GWL75CAP(RTM),得自Kobo Products(美国),氧化铁、酰基谷氨酸铁氧化物(acyglutamate iron oxides)、群青颜料蓝、D&C染料、胭脂红、以及它们的混合物,和淀粉辛烯基琥珀酸铝(aluminium starchoctenylsuccinate)(以商品名DRY FLO(RTM)得自National Starch &Chemical Ltd)。颜料也可用如氨基酸、硅氧烷、卵磷脂和酯油的化合物处理。
P.
其它任选组分
其它合适的任选成分包括但不限于:抗静电剂;泡沫促进剂(如脂肪族酯(如C8-C22)一和二-(C1-C5,尤其是C1-C3)链烷醇酰胺,优选椰子一乙醇酰胺、椰子二乙醇酰胺及其混合物);粘度改性剂和增稠剂(如氯化钠、硫酸钠和硫酸镁);珠光助剂;香料;防腐剂,如DMDM乙内酰脲、烷基苄基二甲基铵氯化铵、对羟基苯甲酸甲酯、对羟基苯甲酸丙酯和苄基醇;去头皮屑活性剂,如吡啶硫酮盐、硫化硒、颗粒硫及其混合物;生物添加剂;增量剂;螯合剂(如1,2-乙二胺四乙酸(EDTA),和糠偶酰二肟);悬浮剂,如烷基(C16-C22)二甲基胺氧化物,如硬脂酰二甲基胺氧化物和以THIXIN(RTM)购自Rheox(USA)的三羟基硬脂酸甘油酯;其它添加剂,着色剂、化妆品收敛剂、化妆品杀虫剂、变性剂、药物收敛剂、亮肤剂、外用止痛剂、成膜剂、遮光剂、还原剂、皮肤漂白剂、抗炎剂、抗氧化剂/基清除剂;和已知用于个人护理组合物的其它成分,如存在于Wenninger和McEwen编的CTFAInternational Cosmetic Ingredient Dictionary and Handbook,第八版,第2卷,(The Cosmetic,Toiletry,and Fragrance Association,Inc.,Washington,DC,1999年)中的那些。
配制方法
本发明的组合物可使用任何常规方法合成。通常,水相,和当存在时,油相将分别制备,相同相分隔的物质以任何顺序被加入。如果最终的产品是乳液,则在剧烈搅拌下将两相混合。如果可行,可以在制备将近结束时的乳化之后,在温和搅拌下加入制剂中任何高度挥发性或者易于被高温水解的成分。适用于本发明的典型方法描述于WO00/71093和WO 00/48569中,(前述为与身体露剂制剂尤其相关)和WO 01/02477(与凝胶贴剂制剂相关)(所有的都授予宝洁公司)。
这样的组合物可以是递送安全有效量的酶和/或任何其它皮肤活性剂的任何形式;合适的形式包括但不限于、霜膏、凝胶、水凝胶、凝胶或水凝胶贴剂、膜(包括面膜)、露剂、免洗型染发剂、滋补剂、喷剂、油膏剂、泥敷剂、泡沫、摩丝、润发油和糊剂,特别地,所述形式应配制成“免洗型”产品,不过,施用后几分钟内不需要洗去的“洗去型”产品也是合适的。新发明的组合物也可用或通过基质被递送和/或包装,如涂敷器刷、垫、擦拭物、布、小毛巾、海绵、粉扑、洗涤器等。
尽管典型地,和甚至是优选地,本发明所述组合物将在单一容器中配制,它们也可被包装在包括多个容器的套盒中,如在涂敷时或在涂敷前不久被分开使用的分离的容器,或者是一体的分开的容器,如双重包装,以同时递送它们各自的组合物。例如,一个隔室可包含酶、水和确定Ki的抑制剂,而另一隔室可包含某种皮肤活性剂,所述皮肤活性剂如由于稳定性和pH的原因与第一个容器的内容物是不相容的。在另一实施例中将提供一件套盒,所述套盒包括酶、水和确定Ki的抑制剂和一种或多种单独包装的组分,所述组分包含其它个人护理组合物,如防晒剂或附加的湿润剂、卸装油膏等,在包括最初提到的容器的方法的预处理或后处理步骤中是有用的,所述方法对于满足消费者的具体的需要是有用的。
使用方法
本发明的方法包括本发明所述组合物用于改善皮肤感觉和外观的用法。这样的组合物将局部地给药于皮肤和/或毛发,如为了到达长出毛发的头皮皮肤。组合物的量和涂敷至皮肤的频度可根据期望的效果和/或个人护理需要而不同。本发明的组合物可被用于对附加的皮肤护理方法的预处理或后处理步骤,所述附加的皮肤护理方法的发生是为了进一步强化皮肤感觉和外观。在合适的情况下,消费者可以被指导在经过合适的时间后,在局部涂敷之后擦去,而不是洗去本发明的组合物。
实施例
如下是本发明的实施方案的非限制性实施例。实施例的给出仅是为了举例说明之目的,不应被解释为是对本发明的限制,因为在不背离本发明的精神和范围的情况下,其许多明显的和/或等价的改变是可能的,这将被本领域的普通技术人员所认识到。在所述实施例中,除非另外指明,所有浓度均被列为重量百分比。对本领域的技术人员来说显而易见的是,成分的选定将根据选定的具体成分的物理和化学特性而不同,以制造本发明所述的发明。实施例的组合物可使用如上所示的常规方法被制造。
在所有的所述实施例中,蛋白酶1是在N76D-I122A-Y217L具有氨基酸取代组合的枯草杆菌蛋白酶BPN的变体;蛋白酶2是枯草杆菌蛋白酶BPN’,和蛋白酶3是枯草菌溶素。抑制剂1是酶抑制剂缀合物,其具有结构:
抑制剂2是包括氨基酸取代A62K-L63I-M73P-D83C-S98E的SSI变体。抑制剂3是硼酸衍生物,其具有下式结构:
实施例I至XI可配制成身体露剂,或面部/身体/脚润肤霜:
I | II | III | IV | V | VI | VII | VIII | VIIII | X | XI | |
抑制剂1 | 0.2 | 0.5 | 0.2 | 0.75 | 0.1 | ||||||
抑制剂2 | 0.5 | 0.15 | 0.7 | ||||||||
抑制剂 3 | 0.5 | 0.2 | 0.5 | ||||||||
三甲基甘氨酸 | 10 | 5 | 8 | 5 | |||||||
甲酸钠 | 1.0 | 1.5 | 0.5 | 1.0 | |||||||
甲酰基苯基硼酸 | 1.0 | 0.5 | |||||||||
二水合氯化钙 | 0.01 | 0.01 | 0.01 | 0.01 | 0.01 | 0.01 | 0.01 | 0.01 | |||
甘油 | 10 | 5 | 1.5 | 5 | 10 | 4 | 10 | 3 | |||
聚乙二醇200 | 5 | 4 | 7 | 2 | |||||||
赤藓醇 | 2 | 4 | 2 | ||||||||
聚丙烯酰胺/异链烷烃/月桂基聚氧乙烯醚-7 | 2.5 | 2.0 | 5.0 | 3.0 | 2.5 | 2.0 | 3.0 | 3.5 | |||
聚丙烯酸铵/丙稀酰胺 | 1.5 | 2.0 | 1.5 | ||||||||
聚环氧乙烷/聚环氧丙烷共聚物 | 0.8 | ||||||||||
烟酰胺 | 3.5 | 5.0 | 2.0 | 1.0 | |||||||
泛醇 | 0.5 | 1.0 | 1.0 | 1.0 | |||||||
生育酚烟酸酯 | 2.0 | 2.0 | 5.0 | ||||||||
视黄基丙酸酯 | 0.1 | 0.1 | 0.1 | 0.1 | |||||||
生育酚乙酸酯 | 0.25 | 0.25 | 1.0 | ||||||||
甲氧基肉桂酸辛酯 | 2.0 | ||||||||||
聚二甲基倍半硅氧烷 | 2.0 | 1.0 | 1.0 | 0.25 | 2.0 | ||||||
尼龙12 | 2.0 | 1.0 | 1.0 | 2.0 | |||||||
二氧化钛 | 0.1 | 0.4 | 0.55 | ||||||||
鲸蜡基葡糖苷 | 0.1 | 0.1 | 0.2 | 0.5 | 0.1 | 0.1 | 0.4 | 0.1 | 0.1 |
硬脂醇 | 0.5 | 0.5 | 1.0 | 0.5 | 0.5 | 0.2 | 0.4 | 0.5 | 0.7 | 0.5 | |
硬脂酸 | 0.1 | 0.1 | 0.1 | 0.2 | 0.5 | 0.1 | 0.8 | 0.1 | 0.1 | ||
鲸蜡醇 | 0.7 | 0.5 | 0.8 | 1.0 | 0.7 | 1.0 | 0.5 | 0.7 | 0.7 | 1.0 | |
二十二醇 | 0.5 | 0.5 | |||||||||
PEG100硬脂酸酯 | 0.1 | 0.1 | 0.3 | 0.4 | 0.5 | 0.1 | 0.1 | 0.1 | 0.1 | 0.1 | |
癸基葡糖苷 | 0.2 | ||||||||||
磷酸钾 | 0.1 | 0.1 | 0.2 | 0.05 | |||||||
Tris | 0.5 | 0.3 | |||||||||
ADA | 0.3 | 0.2 | 0.1 | ||||||||
蛋白酶1 | 0.1 | 0.1 | 0.01 | 0.001 | 0.025 | 0.05 | |||||
蛋白酶2 | 0.05 | 0.01 | 0.01 | 0.01 | |||||||
蛋白酶3 | 0.1 | 0.02 | |||||||||
异十六烷 | 2.0 | 2.5 | 1.0 | 2.5 | 3.0 | 2.0 | 2.0 | 2.2 | 1.0 | ||
异硬脂酸异丙酯 | 0.7 | 0.5 | 0.7 | 1.0 | 0.7 | 1.0 | 1.5 | 0.5 | 0.1 | ||
蔗糖聚棉子酸酯 | 0.3 | 0.3 | 0.3 | 0.1 | 0.2 | 1.0 | 0.5 | 0.5 | 0.5 | ||
聚二甲基硅氧烷/聚二甲基硅氧烷醇 | 1.0 | 2.0 | 1.0 | 2.5 | 1.0 | 1.5 | 2.0 | 1.5 | 1.0 | 1.0 | |
癸酸/辛酸甘油三脂 | 2.0 | 1.0 | |||||||||
凡士林 | 2.0 | 2.0 | 2.0 | ||||||||
环甲基聚硅氧烷/聚二甲基硅氧烷Colpolyol | 3.0 | 2.0 | |||||||||
EDTA | 0.15 | 0.15 | 0.2 | 0.2 | 0.14 | 0.15 | |||||
PH值 | 7.0 | 6.5 | 6.8 | 7.3 | 7.0 | 8.0 | 8.5 | 7.9 | 6.5 | 7.3 | 7.0 |
水 | ---适量---至100---- |
实施例XII至XV可被配制为凝胶/水凝胶贴剂和/或面部遮盖剂:
XII | XIII | XIV | XV | |
抑制剂1 | 0.5 | |||
抑制剂2 | 0.2 | 0.5 | ||
抑制剂3 | 0.1 | 0.1 | ||
N-(二羟乙基)甘氨酸 | 8 | 5 | ||
甘醇酸钾 | 1.5 | |||
二水合氯化钙 | 0.01 | 0.01 | 0.01 | |
甲酰基苯基硼酸 | 0.1 | |||
甘油 | 5 | 12 | ||
聚乙二醇200 | 2 | |||
己二醇 | 5 | 2 | ||
聚乙烯醇(31,000mwt) | 5 | 3 | 10 | |
聚乙烯醇(205,000mwt) | 5 | 8 | 6 | |
琼脂糖 | 2.0 | 1.0 | 0.5 | |
黄原胶/刺槐豆胶 | 0.5 | 1.0 | 0.75 | |
烟酰胺 | 8 | 5 | ||
泛醇 | 1.0 | 1.0 | 2.0 | |
生育酚烟酸酯 | 5.0 | |||
癸基葡糖苷 | 0.4 | |||
磷酸钾 | 0.1 | |||
Tris | 0.1 | |||
ADA | 0.1 | |||
蛋白酶1 | 0.1 | 0.1 | 0.01 | |
蛋白酶2 | 0.05 | |||
蛋白酶3 | 0.1 | 0.25 | ||
EDTA | 0.1 | 0.1 | 0.1 | |
PH值 | 6.0 | 7.5 | 6.0 | 8.0 |
水 | --适量至100-- |
实施例XXIII至XXVI可以被配制为油包水乳液:
XVI | XVII | XVIII | XIX | |
抑制剂1 | 0.5 | |||
抑制剂2 | 0.2 | 0.1 | ||
抑制剂3 | 1 | 0.5 | ||
三甲基甘氨酸 | 10 | |||
甲酸钠 | 1 | |||
甲酰基苯基硼酸 | 1 | 0.5 | ||
二水合氯化钙 | 0.01 | 0.01 | 0.01 | |
甘油 | 10 | 5 | 5 | |
聚乙二醇200 | 5 | 15 | ||
12%聚二甲基硅氧烷/乙烯基聚二甲基硅氧烷交联共聚物 | 10 | 8 | 20 | |
25%聚二甲基硅氧烷/共聚醇在聚二甲基硅氧烷中的交联共聚物 | 2.5 | 2.5 | 2.5 | |
环甲基聚硅氧烷/聚二甲基硅氧烷共聚醇 | 10 | |||
环甲基聚硅氧烷 | 5 | 2 | 20 | 5 |
癸基葡糖苷 | 0.1 | |||
烟酰胺 | 2 | 2 | 5 | |
泛醇 | 1 | 1 | ||
生育酚烟酸酯 | 1 | 0.1 | ||
视黄基丙酸酯 | 0.25 | |||
生育酚乙酸酯 | 0.5 | 0.5 | ||
聚二甲基倍半硅氧烷 | 1 | 1 | 1 | |
二氧化钛 | 0.5 | 0.5 | ||
聚山梨酸酯40 | 2 | |||
聚甘油基-3二异硬脂酸酯 | 0.5 | |||
PPG-15硬脂基醚 | 1 | 1 | ||
C12-15苯甲酸烷基酯 | 1 | |||
磷酸钾 | 0.2 | 0.1 | ||
ADA | 0.1 | 0.1 | ||
蛋白酶1 | 0.1 | 0.01 | ||
蛋白酶2 | 0.1 | |||
蛋白酶3 | 0.001 | |||
棕榈酸异丙酯 | 1.0 | |||
凡士林 | 2.0 | |||
EDTA | 0.15 | 0.15 | ||
PH值 | 7.0 | 7.5 | 6.5 | 6.5 |
水 | -- -- -- 适量 |
Claims (50)
1.局部应用于个人护理的免洗型组合物,所述组合物包括(a)稳定化的酶,(b)按所述组合物的重量计,至少30%的水,其特征在于它包括:(c)按所述组合物的重量计,低于5%的碱土金属盐,和(d)抑制常数(Ki)为10nM至25,000nM的酶抑制剂。
2.如权利要求1所述的组合物,所述组合物包括:
(a)按所述组合物的重量计,0.0001%至1%,优选0.0005%至0.5%,更优选0.001%至0.1%的所述酶;
(b)按所述组合物的重量计,至少40%,优选至少50%的水;
(c)按所述组合物的重量计,低于0.1%,更优选低于0.05%,更优选低于0.02%,更优选低于0.015%的所述碱土金属盐;和
(d)按所述组合物的重量计,0.00005%至5%,优选0.005%至2%,更优选0.025%至1%的所述抑制剂。
3.如前述任一项权利要求所述的组合物,其中酶与抑制剂的摩尔比率为2∶1至1∶20,优选为1∶1至1∶15。
4.如前述任一项权利要求所述的组合物,其中所述酶为蛋白酶,优选地选自枯草杆菌蛋白酶、与枯草杆菌蛋白酶具有至少70%氨基酸序列同源性的酶,以及这两者的变体;更优选枯草杆菌蛋白酶或其变体,其选自枯草杆菌蛋白酶BPN’、枯草菌溶素、枯草杆菌蛋白酶DY、枯草杆菌蛋白酶147、枯草杆菌蛋白酶168、枯草杆菌蛋白酶309、和淀粉糖酵母枯草杆菌蛋白酶;更优选枯草杆菌蛋白酶BPN’及其变体。
5.如权利要求4所述的组合物,其中所述酶为在一个或多个下列位置具有氨基酸取代的变体:9、31、76、77、79、122、156、169、188、206、212、217、218、222、254和271。
6.如权利要求4或5所述的组合物,其中所述酶为具有一个或多个下列氨基酸取代的枯草杆菌蛋白酶变体:S9A、I31L、N76D、N77D、I79A、I79E、I122A、E156S、G169A、S188P、Q206D、Q206L、Q206V、Q206C、N212G、Y217K、Y217L、N218S、M222A、M222Q、T254A和Y271K;优选具有取代的组合:
8.如权利要求7所述的组合物,其中所述蛋白酶为在一个或多个如下位置具有氨基酸取代的变体:9、31、76、77、79、122、156、169、188、206、212、217、218、222、254和271。
9.如权利要求8所述的组合物,其中所述变体为具有一个或多个下列氨基酸取代的枯草杆菌蛋白酶变体:S9A、I31L、N76D、N77D、I79A、I79E、I122A、E156S、G169A、S188P、Q206D、Q206L、Q206V、Q206C、N212G、Y217K、Y217L、N218S、M222A、M222Q、T254A和Y271K。
10.如权利要求9所述的组合物,其中所述枯草杆菌蛋白酶变体包括选自下列取代组合:(a)N76D-I122A-Y217L,(b)I79A-I122A-Y217L,和(c)N76D-I79A-I122A-Y217L。
11.如权利要求10所述的组合物,其中所述枯草杆菌蛋白酶变体包括氨基酸取代组合N76D-I122A-Y217L。
12.如权利要求1所述的组合物,其中所述抑制剂具有的Ki在约50nM至约5,000nM的范围内。
13.如权利要求12所述的组合物,其中所述抑制剂具有的Ki为约100nM至约1,000nM。
15.如权利要求1所述的组合物,其中所述抑制剂为具有下式的酶抑制剂缀合物:
其中R4和R5各自独立地选自取代的或未取代的:苯基、苄基、萘基、直链的或支链的C1-C7烷基、以及它们的混合物;并且n为3至200。
16.如权利要求15所述的组合物,其中所述酶抑制剂缀合物具有如下结构:
17.如权利要求1所述的组合物,其中所述抑制剂选自链霉菌枯草杆菌蛋白酶抑制剂、与SSI具有至少约70%氨基酸序列同源性的那些抑制剂、和这两者的变体。
18.如权利要求17所述的组合物,其中所述抑制剂选自链霉菌枯草杆菌蛋白酶抑制剂和与SSI具有至少约70%氨基酸序列同源性的那些抑制剂的变体,其中所述变体包括一个或多个下列取代:A62K、L63I、M73P、D83C、S98D、S98E。
19.如权利要求1所述的组合物,所述组合物还包括按所述组合物的重量计约0.1%至约50%的多元醇。
20.如权利要求19所述的组合物,所述组合物包括约1%至约15%的所述多元醇。
21.如权利要求19所述的组合物,其中所述多元醇选自甘油、聚乙二醇、己三醇、1,4-丁二醇、丁氧基三醇、赤藓醇、木糖醇、以及它们的混合物。
22.如权利要求22所述的组合物,其中所述多元醇选自木糖醇、甘油和平均分子量为约200至约400的聚乙二醇。
23.如权利要求19所述的组合物,所述组合物包括按所述组合物的重量计约2%至约20%的甘油。
24.如权利要求19所述的组合物,其中多元醇与水的比率为约1∶3至约1∶50。
25.如权利要求24所述的组合物,其中多元醇与水的比率为约1∶5至约1∶25。
26.如权利要求19所述的组合物,其中所述多元醇具有小于约35,000的数均分子量。
27.如权利要求26所述的组合物,其中所述多元醇具有小于约2,000的数均分子量。
28.如权利要求1所述的组合物,所述组合物还包括按所述组合物的重量计约1%至约50%的渗透保护剂,所述渗透保护剂选自:
(i)符合式(I)的渗透保护剂:
其中R1、R2和R3独立地选自-H、-CH3、-CH2CH3和
[-CH2CH(OH)R4,其中R4选自-H,和C1至C4烷烃];并且其中n=1至3的整数;
(ii)符合式(I)的渗透保护剂,其中R1、R2和R3中的任意两个独立地选自-H和-CH3,R1、R2和R3中的第三个结构部分选自-H和-(CH2)mCH3,其中m为4或5;且其中n=1至3的整数;
(iii)符合式(II)的渗透保护剂:
其中R1、R2、R3,R4和n如上述部分(i)所定义,并且其中R5选自PO3和SO3;
(iv)渗透保护剂,其选自丙氨酸、甘氨酸、丝氨酸、脯氨酸、肉毒碱、牛磺酸、三甲基胺氧化物、依克多因和羟基依克多因;
(v)渗透保护剂,其选自麦黄酮、二甲基脯氨酸、γ-丁内铵盐、β-丙氨酸甜菜碱、缬氨酸甜菜碱、赖氨酸甜菜碱、鸟氨酸甜菜碱、丙氨酸甜菜碱、谷氨酸甜菜碱和苯丙氨酸甜菜碱;和
(vi)它们的混合物。
29.如权利要求28所述的组合物,其中:
(i)(i)中所述渗透保护剂选自符合式(I)的那些渗透保护剂,其中(R1、R2和R3均为-CH3,并且n为1),其中(R1、R2和R3均为-CH3,并且n为3),其中(R1和R2为-CH3,R3为-H,且n为1),其中(R1为-CH3,R2和R3为-H,并且n为1),或其中(R1和R2为-CH2(OH)R4,R4为-H,R3为-H,并且n为1);
(ii)(ii)中所述渗透保护剂符合式(I),其中(R1和R2为-CH3,R3为-(CH2)mCH3,其中m为5,并且n为1);
(iii)(iii)中所述渗透保护剂符合式(II),其中(R1、R2和R3为-CH3;n为1;并且R5为PO3);
(iv)(iv)中所述渗透保护剂选自丝氨酸、脯氨酸和肉毒碱;和
(v)(v)中所述渗透保护剂选自麦黄酮和γ-丁内铵盐。
30.如权利要求1所述的组合物,所述组合物还包括按所述组合物的重量计约0.1%至约5%的易溶的稳定剂。
31.如权利要求30所述的组合物,其中所述易溶的稳定剂选自甲酸盐、甘醇酸盐、己二酸盐、丙二酸盐、硫酸盐、磷酸盐、琥珀酸盐、以及它们的混合物。
32.如权利要求31所述的组合物,其中构成所述盐的阳离子选自碱金属、铵、三[羟甲基]氨基甲烷、乙酰胺单乙醇胺,和三乙醇胺。
33.如权利要求32所述的组合物,其中构成所述盐的阳离子选自钠、钾、锂和乙酰胺单乙醇胺。
35.如权利要求1所述的组合物,所述组合物还包括附加酶抑制剂,其选自硼酸、丁基硼酸、苯基硼酸、亮氨酸肽、以及它们的混合物。
36.如权利要求1所述的组合物,所述组合物还包括增稠剂,所述增稠剂选自具有丙烯酸与丙烯酰胺比率为4∶1至1000∶1的丙烯酸铵/丙烯酰胺交联共聚物;聚丙烯酰胺/AMPS共聚物;和黄原胶。
37.如权利要求1所述的组合物,所述组合物还包括按所述组合物的重量计约3%至约25%的表面活性剂。
38.如权利要求37所述的组合物,其中所述表面活性剂选自烷基聚葡萄糖、烷基醚硫酸盐、烷基硫酸盐、皂、一烷基磷酸盐、酰基肌氨酸盐、酰基两性乙酸盐、烷基酰氨基丙基甜菜碱、烷基甜菜碱、α-烯烃磺酸酯、烷基乙氧基化物、烷基聚甘氨酸盐、烷基甘油磺酸盐、烷基单乙醇酰胺、烷基醚羧酸盐、酰基羟乙基磺酸盐、烷基改性的聚二甲基硅氧烷共聚多元醇、酰基谷氨酸盐、聚环氧乙烷/聚环氧丙烷共聚物、以及它们的混合物。
39.如权利要求38所述的组合物,其中所述表面活性剂选自癸基葡糖苷、月桂基葡糖苷、月桂基磷酸钾、月桂基硫酸钠、月桂基醚硫酸钠、月桂基硫酸铵、月桂基醚硫酸铵、月桂基两性乙酸钠、以及它们的混合物。
40.如权利要求39所述的组合物,所述组合物包括约0.01%至约2%的癸基葡糖苷。
41.如权利要求1所述的组合物,所述组合物还包括皮肤活性剂,所述皮肤活性剂选自烟酰胺、泛醇、金合欢醇、葡糖胺、视黄基丙酸酯、维生素E、生育酚乙酸酯、生育酚烟酸酯、视黄醇、视黄基棕榈酸酯、视黄酸、维生素C、维生素D、咖啡因、可可碱、尿囊素、α-没药醇、植烷三醇、抗坏血酸磷酸镁、抗坏血酸基葡糖苷、吡哆素、棕榈基五肽-3、比太拉、美伐他汀、洛伐他汀以及它们的混合物。
42.如权利要求41所述的组合物,其中所述皮肤活性剂选自烟酰胺、泛醇、金合欢醇、视黄基丙酸酯、维生素E、生育酚乙酸酯、生育酚烟酸酯、视黄醇、视黄基棕榈酸酯、视黄酸、咖啡因、可可碱、尿囊素、α-没药醇、吡哆素、棕榈基五肽-3、比太拉、以及它们的混合物。
43.如权利要求42所述的组合物,其中所述皮肤活性剂被形成为包括烟酰胺、泛醇和生育酚乙酸酯化合物的复合物。
44.如权利要求1所述的组合物,其中所述组合物具有大于约0.65的水活性。
45.如权利要求44所述的组合物,其中所述组合物具有大于约0.85的水活性。
46.如权利要求1所述的组合物,所述组合物具有小于10个大气压的渗透压。
47.局部应用于个人护理的免洗型组合物,所述组合物包括(a)按所述组合物的重量计,约0.001%至约0.1%的枯草杆菌蛋白酶蛋白酶变体,(b)按所述组合物的重量计,至少约30%的水,(c)按所述组合物的重量计,低于约0.05%的碱土金属盐,和(d)按所述组合物的重量计,约0.005%至约2%的酶抑制剂,所述酶抑制剂选自(i)具有以下结构的酶抑制剂缀合物:
(ii)SSI和与SSI具有至少约70%氨基酸序列同源性的类SSI抑制剂的变体,其中所述变体包括一个或多个下列取代:A62K、L63I、M73P、D83C、S98D、S98E,和(iii)SSI和具有至少约70%氨基酸序列同源性的类SSI抑制剂的聚乙二醇改性形式。
48.如权利要求1所述的组合物,其中所述组合物被配制为霜膏、凝胶、水凝胶、凝胶贴剂、水凝胶贴剂、面膜、露剂、免洗型染发剂、滋补剂、喷剂、油膏剂、泥敷剂、泡沫、摩丝、润发油或糊剂。
49.套盒,所述套盒包括(a)如权利要求48所述的组合物和(b)一套使用说明书,指导使用者在一段时间后擦去所述组合物而不是洗去所述组合物。
50.提供皮肤护理有益效果的方法,所述皮肤护理有益效果选自皮肤增湿、皮肤柔软性、皮肤光滑性、以及它们的组合,所述方法包括将安全有效量的如权利要求1所述的组合物局部涂敷于需要这种皮肤护理有益效果的皮肤上。
51.为消费者提供免洗型含酶个人护理产品的方法,其中所述酶在货架上是被抑制和无活性的,但其在皮肤上是有活性的并且不需要单独的再活化步骤,所述免洗型含酶个人护理产品包括如权利要求1所述的组合物。
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EP (1) | EP1446096A1 (zh) |
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- 2002-11-07 WO PCT/US2002/035765 patent/WO2003041680A1/en not_active Application Discontinuation
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CN114028245B (zh) * | 2021-11-29 | 2024-03-26 | 浙江宜格企业管理集团有限公司 | 一种温和去角质组合物及其制备方法 |
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