CN105708725A - 止汗剂组合物 - Google Patents
止汗剂组合物 Download PDFInfo
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- CN105708725A CN105708725A CN201510970640.XA CN201510970640A CN105708725A CN 105708725 A CN105708725 A CN 105708725A CN 201510970640 A CN201510970640 A CN 201510970640A CN 105708725 A CN105708725 A CN 105708725A
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- A61K8/00—Cosmetics or similar toiletry preparations
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Abstract
本发明题为“止汗剂组合物”。本发明涉及局部止汗剂组合物，所述局部止汗剂组合物包含美容上可接受的局部用载体和以有效地抑制或防止出汗的量选自八胜肽和二胜肽的抗胆碱能剂，其中所述组合物基本上不含铝盐。
Description
技术领域
本发明涉及包含抗胆碱能剂作为活性止汗剂化合物的局部止汗剂组合物，该局部止汗剂组合物基本上不含铝盐。
背景技术
在世界各地，止汗剂和除臭剂组合物广泛用于控制局部出汗和气味。诸如腋下的那些的湿斑被视为不雅观的。另外，身体气味可妨碍正常人际关系并且引起社会排斥。这些问题在往往具有高湿度和较温暖气候的区域中更显著具体地呈现。除腋下区域之外，包括足部的其它身体区域可从止汗剂和除臭剂的使用中获得益处。
止汗剂通过阻止或降低汗腺的活性起作用。现在，止汗剂通常是在滚珠涂敷器中的固体或固体棒状物形式，并且包含铝基化合物、蜡、液体润肤剂和天然香味增强剂。当前市售的止汗剂通常采用收敛性金属盐，诸如铝盐或铝/锆盐。在典型的商业止汗剂中，在活性铝基化合物中封闭出汗活性完全保持的关键是配制约10％至25％的成分。来自铝盐诸如水合氯化铝和氯化铝的铝离子被吸入到沿人体的小汗腺导管排列的细胞中。小汗腺负责产生大部分的身体汗液并位于腋窝中。铝离子被带入到在表皮的开口、皮肤的顶层处沿小汗腺导管排列的细胞中。当铝离子被吸入到细胞中时，水随它们而进入。随着越来越多的水流入，细胞开始膨胀，挤压导管闭合。因此，通过皮肤排泄的汗液被直接封闭。一旦小汗腺管已被闭合，其它气味减少/屏蔽成分就向皮肤的顶层提供薄的涂层。腺管保持闭合直到在腺细胞外侧和内侧的水含量达到平衡为止，在此时细胞内容物开始通过渗透向回转出。
另一方面，除臭剂封闭汗液的气味。除臭剂通过以下方式起作用：限制细菌增殖、封闭汗液扩散、吸收恶臭并且进行酶抑制。除臭剂、止汗剂或两者可作为商业产品在市场上出售。
美国专利公布号2011/0020415涉及用于处理多汗的组合物。其包含止汗剂、至少一种肌肉放松剂、至少一种肽和至少一种植物剂。止汗剂优选地为四氯羟铝甘氨酸，并且肽可以是例如二胜肽、六胜肽、SYN-AKE、SNAP8等。
最近，由于担心铝可以被人体吸收并进入到血液中，所以在除臭剂和止汗剂中使用铝已成为有争议的。另外，包含铝的止汗剂气溶胶在制造和应用期间允许吸入。
本发明提供不需要铝盐的新型局部止汗剂产品。这些止汗剂组合物基本上不含，优选地100％不含铝盐。
发明内容
本发明提供局部止汗剂组合物，所述局部止汗剂组合物包含美容上可接受的局部用载体和以有效地抑制或防止出汗的量选自八胜肽和二胜肽的抗胆碱能剂，其中所述组合物基本上不含铝盐。
具体实施方式
本发明的化妆品止汗剂组合物适于局部施用于用户的皮肤，通常在腋下区域中。
该组合物基本上不含铝盐。具体地讲，该组合物基本上不含水合氯化铝和/或其衍生物。该制剂可偶尔包含铝残余。在用作组合物的成分的原材料中，这涉及痕量或极低量的铝元素作为残余物。这不是铝盐。
如本文所用，“基本上不含”成分意味着在最终制剂中包含小于约50ppm。
在一个实施例中，本发明的组合物完全不含铝盐。
抗胆碱能剂
在组合物中的抗胆碱能剂为八胜肽(例如可从LipotecSA商购获得的SNAP8)或二胜肽(例如可从PentapharmLtd.商购获得的SYN-AKE)。
不受理论的束缚，据信二胜肽通过封闭汗腺的乙酰胆碱受体起作用，而八胜肽通过防止来自乙酰胆碱从交感神经元释放起作用。
抗胆碱能剂以有效地抑制或显著减少出汗的量存在于组合物中，例如在局部施用于人类用户的腋下区域后的该区域中。组合物将大体包含约0.01重量/重量％至约30.0重量/重量％的抗胆碱能剂。
在一个实施例中，组合物包含约0.1重量/重量％至约20.0重量/重量％、或约0.5重量/重量％至约15.0重量/重量％的八胜肽。
在另一个实施例中，组合物包含约0.05重量/重量％至约6.0重量/重量％、或约0.1重量/重量％至约4.0重量/重量％的二胜肽。
组合物还可任选地包含一种或多种其它抗胆碱能剂，所述其它抗胆碱能剂包含例如双性缩胺酸，诸如五肽、六肽或八肽，肉毒杆菌毒素(肉毒素)、乙酰基六肽-8、苯海索(安坦)、甲磺酸苄托品(苄托品)、比哌立登、丙环定、2,5-抗组胺剂(奥芬那君)、阿托品、黄酮哌酯(泌尿灵)、奥昔布宁(尿多灵、奥昔布宁)、东莨菪碱、莨菪碱(天仙子胺)、托特罗定(托特罗)、颠茄生物碱、非索罗定(富马酸非索罗定)、索非那新(卫喜康)、达非那新(替尼达普)、丙胺太林(普鲁本辛)。
吸水剂
该组合物可任选地包含吸水剂。此类吸水剂在化妆品应用中为已知的并且通常为多孔成分，该多孔成分由微通道构成，从而获得高吸收能力和吸收各种不同材料的能力。此类化合物对亲水性或亲脂性分子可具有亲和力。在一些情况下，优选的是组合多种吸水剂以使得吸收能力最大化。
合适的吸水剂包括二氧化硅、棉粉、竹丝和沸石。
在一个实施例中，该组合物包含印度簕竹根茎粉(例如，购自PolytechnoIndústriasQuímicasLtda/IonQuímica的竹丝PW)、二氧化硅(例如，购自Kobo的MSS500/3H和/或购自Presperse的SPHERONL-1500)。
本发明的化妆品止汗剂组合物在最终组合物中将大体包含约0.01重量/重量％至约20.0重量/重量％的吸水剂。在优选的实施例中，组合物将包含约0.1重量/重量％至约10.0重量/重量％的吸水剂，并且在更优选的实施例中，化妆品止汗剂组合物将包含约0.5重量/重量％至约6.0重量/重量％的吸水剂。
该组合物可包含止汗剂、除臭剂或化妆品领域中已知的其它成分。在大多数实施例中，止汗剂将包含向用户的身体提供有益效果的其它功能成分。通常，此类材料对于相关的个人护理组合物领域的普通技术人员而言为熟知的，并且可包括保湿剂、抗菌剂、除臭剂和香料。
其它成分可包括成膜剂。例如，聚合物的水不溶性膜在腋窝皮肤上产生闭合作用，从而减小腋下湿度。此类膜为汗液通道的阻隔物。所用的聚合物应为闭合的、不溶于水的，并且粘度高，诸如丙烯酸酯/辛基丙烯酰胺共聚物。
该组合物还可包含已知具有抗菌和除臭特性的成分。这些物质可包括，例如，1,6-二-(4-氯苯基双胍)己烷(氯己定)、3,4,4'-三氯碳酰苯胺、季铵化合物、丁香油、薄荷油、百里香油、三乙基柠檬酸盐、金合欢醇(3,7,11-三甲基-2,6,10-十二碳三烯-1-醇)、乙基己基甘油醚或聚甘油-3辛酸酯。具体地讲，具有亲酯性的聚甘油3辛酸酯(CosmoP813，购自Degussa/Evonik)、植物源酯可以用于以极低的浓度来减少在皮肤上引起气味的细菌。
该组合物还可包含由CTFA分类的作为“乳化稳定”剂的直链醇、胺、醚醇、鲸蜡醇、硬脂醇和鲸蜡硬脂醇。
在止汗剂组合物中可包含香料和芳香剂。香料产生呈香味形式的嗅觉响应，并且此外可有助于遮蔽体臭。
需要防腐剂以防止产品受到由细菌、酵母菌或霉菌引起的损坏，并且保护产品免于消费者在使用期间不经意地污染。可用的防腐剂包括：苯甲酸钠、乙基己基甘油和1,2-辛二醇、苄醇、对羟基苯甲酸甲酯、对羟基苯甲酸丙酯、DMDM乙内酰脲、甲基氯异噻唑啉酮、甲基异噻唑啉酮、咪唑烷基脲苯氧基乙醇、苯甲酸钠和苯甲酸。EDTA及其盐通常用于进一步增强防腐性。
应当添加抗氧化剂以保护制剂避免氧化过程。可用的抗氧化剂包括抗坏血酸、生育酚乙酸酯和多元酚。在本发明中，诸如生育酚乙酸酯(稳定的维生素E)的抗氧化剂可用作抗氧化剂。
在该组合物中可包含湿润剂和保湿剂。合适的成分包含疏水剂、亲水剂以及它们的组合。保湿剂的例子为尿囊素、甘油、聚异丁烯酸甘油酯、泛醇、多元醇、神经酰胺、琉璃苣油(亚油酸)、透明质酸、吡咯烷酮酸钠(PCA钠)、小麦蛋白(例如，月桂基二甲基羟丙基胺水解小麦蛋白)、毛发角蛋白氨基酸、泛醇；月见草油；GLA3以及其它鱼油，其可包括例如ω-3和ω-6油和/亚油酸；和亚麻籽油，以及它们的混合物。还可使用其它保湿剂。
另外，可以添加皮肤调理剂以防止或舒缓皮肤刺激。例如，可以添加植物提取物。棉奶(可从Symrise商购获得)可向皮肤提供滋润、镇静和软化特性。在一个实施例中，本发明的组合物包含约34重量％至约40重量％乳蛋白质。
本发明的止汗剂组合物中可包含颜料和着色剂。
对于在美学上更令人愉悦的产品而言，可包含润肤剂，诸如，肉豆蔻酸异丙酯、矿物油和植物油，该润肤剂通常产生呈增大的皮肤润滑性形式的触觉响应。该组合物可包含任何期望量的润肤剂，从而实现期望的润肤效应。
在本发明中，非挥发性润肤剂为优选的。非挥发性润肤剂的种类包括非硅氧烷润肤剂和硅氧烷润肤剂。非挥发性、非硅氧烷润肤剂包括C12-15烷基苯甲酸盐。非挥发性硅氧烷材料可为聚醚硅氧烷、聚烷芳基硅氧烷或聚醚硅氧烷共聚物。本发明中的例示性非挥发性硅氧烷材料为聚苯基三甲基硅氧烷。润肤剂的非限制性例子可见于美国专利号6,007,799。例子包括但不限于PPG-14丁基醚、PPG-15硬脂基醚、PPG-3肉豆蔻醚、硬脂醇、硬脂酸、单蓖麻油酸甘油酯、棕榈酸异丁酯、单硬脂酸甘油酯、异鲸蜡硬脂酸酯、硫酸化牛脂、油醇、丙二醇、月桂酸异丙酯、貂油、硬脂酸脱水山梨糖醇酯、鲸蜡醇、氢化蓖麻油、硬脂醇硬脂酸酯、氢化大豆甘油酯、异硬脂酸异丙酯、月桂酸己酯、十三碳二酸二甲酯、油酸癸酯、己二酸二异丙酯、正二丁基癸二酸酯、癸二酸二异丙酯、2-乙基己基棕榈酸酯、异壬酸异壬酯、异壬酸异癸酯、异十三酸异壬酯、2-乙基己基棕榈酸酯、2-乙基己基硬脂酸酯、二-(2-乙基己基)己二酸酯、二-(2-乙基己基)琥珀酸酯、肉豆蔻酸异丙酯、棕榈酸异丙酯、硬脂酸异丙酯、二十八醇、硬脂酸丁酯、单硬脂酸甘油酯、聚乙二醇、油酸、三甘醇、羊毛脂、蓖麻油、乙酰化羊毛脂醇、乙酰化羊毛脂、凡士林、羊毛脂的异丙酯、脂肪酸、矿物油、肉豆蔻酸丁酯、异硬脂酸、棕榈酸、PEG-23油醚、油醇油酸酯、亚油酸异丙酯、乳酸鲸蜡酯、乳酸月桂酯、乳酸肉荳蔻酯、季铵化的羟基烷基、氨基葡萄糖酸酯、植物油、油酸异癸酯、异硬脂醇新戊酸酯、肉豆蔻酸肉豆蔻酯、油基乙氧基肉豆蔻酸酯、二甘醇硬脂酸酯、乙二醇单硬脂酸酯、硬脂酸肉荳蔻酯、羊毛脂酸异丙酯、石蜡、甘草酸、硬脂酸羟乙基酰胺。
在一个实施例中，润肤剂选自线性硅氧烷、环状硅氧烷、烃类、具有多于3个碳原子的多羟基醇、包含聚丙二醇(PPG)部分并且以烷基醚封端的液体或固体聚亚烷基二醇醚，以及它们的组合。在另一个实施例中，润肤剂为挥发性硅氧烷，诸如环状聚甲基硅氧烷或三硅氧烷，该挥发性硅氧烷的闪点为100℃或更低。在另一个实施例中，润肤剂为非挥发性硅氧烷，诸如聚二甲基硅氧烷醇或更长链的聚二甲基硅氧烷。
表面活性剂和乳化剂可用于本发明的止汗剂组合物。典型的表面活性剂公开于美国2003/0007939A1中。可用于该组合物的乳化剂包含非离子、阴离子、阳离子、两性或两性离子物质及它们的共混物。合适的乳化剂公开于美国专利号3,755,560和美国专利号4,421,769中。例子为聚乙二醇20、单月桂酸脱水山梨糖醇酯(聚山梨酸酯20)、聚乙二醇20硬脂醚(苄泽78，硬脂基聚氧乙烯醚20)、月桂醇的聚乙二醇醚(月桂基聚氧乙烯醚23)、聚山梨酸酯80(吐温80)，和卵磷脂。
纤维素树胶也可以在本发明的组合物中用作添加剂。优选的纤维素树胶包括水溶性羟烷基纤维素聚合物，诸如羟甲基纤维素、羟乙基纤维素和羟丙基纤维素。可以使用的其它增稠剂包括阿拉伯胶、琼脂、藻酸酯、角叉菜胶、黄蓍胶、黄原胶、胶原、羧聚乙烯、单硬脂酸甘油酯、聚乙烯吡咯烷酮和聚丙烯酰胺。
如本领域已知的，该组合物可以为固体或凝胶棒、霜膏、洗剂、喷雾剂、挤压产品等的形式。
因此，抗胆碱能剂和其它活性剂可包含在如本领域中已知的载体中。止汗剂载体的主要类型在最多情况下落在以下类别中：(a)溶液；(b)乳液，水包油和油包水两者；并且包括洗剂和霜膏；(c)悬浮液；(d)凝胶；和(e)包括棒状产品的固体和半固体。在包括液体、凝胶、悬浮液和乳液的一些载体中，可通过如本领域已知的滚涂式涂敷器提供止汗剂产品用于涂敷。
在很多情况下用于个人护理组合物的溶剂的例子(除水之外)为聚丙二醇、聚乙二醇、乙醇、甘油、乙二醇、1,2,4-丁三醇、1,2,6-己三醇、乙醇、异丙醇、丁三醇、山梨醇酯、丁二醇、丁烯乙二醇、己二醇、甲基丙二醇、吡咯烷酮、N-甲基吡咯烷酮、二甲基亚砜、二甲基砜和类似的溶剂以及它们的混合物。
本发明的组合物可为包括水-醇挤压产品的挤压产品。
止汗剂组合物可为凝胶形式。根据本发明的“凝胶”为胶体，其中分散相已与连续相结合以产生粘稠的胶状产品。根据本发明的凝胶可为水性的或非水性的。凝胶将通常包含载体，该载体包含诸如以上所述的胶凝剂。凝胶的载体通常还将包含溶剂。还可包含为实现稳定性所需要的硅氧烷表面活性剂。
水包油型和油包水型的乳液，诸如洗剂和霜膏是化妆品领域所熟知的并且可用于本发明。也可使用三相乳液，诸如，水包油包水型。可用于乳液类型又可用于溶剂型载体中的溶剂的油通常包括烃油和蜡(例如，矿脂、矿物油、微结晶蜡、聚烯烃、石蜡、野樱素、地蜡、聚乙烯、鲨烷、聚α烯烃、氢化聚异丁烯以及它们的组合)。优选的是脂肪酸衍生物、胆固醇、胆固醇衍生物、甘油二酯和甘油三酯(例如，蓖麻油、大豆油、衍生的大豆油诸如马来酸大豆油、红花油、棉籽油、玉米油、核桃油、花生油、橄榄油、鱼肝油、杏仁油、鳄梨油、棕榈油、芝麻油、植物油和植物油衍生物、葵花籽油、椰子油和衍生的椰子油、棉籽油和衍生的棉籽油、霍霍巴油、可可脂以及它们的组合，以及已部分或完全氢化的上述油中的任一种)、乙酰甘油酯(例如，乙酰化单甘油酯)、烷基酯、烯基酯(例如，肉豆蔻酸油酯、硬脂酸油酯、油酸油酯以及它们的组合)、羊毛脂及其衍生物(例如，羊毛脂、羊毛脂油、羊毛脂蜡、羊毛脂醇、羊毛脂脂肪酸、羊毛脂酸异丙酯、乙酰化羊毛脂、乙酰化羊毛脂醇、羊毛脂醇亚油酸酯、羊毛脂醇蓖麻油酸酯、羟基化羊毛脂、氢化羊毛脂以及它们的组合)、蜡酯(例如，蜂蜡和蜂蜡衍生物、鲸蜡、肉豆蔻酸肉豆蔻酯、硬脂醇硬脂酸酯以及它们的组合)、甾醇和磷脂以及它们的组合。烷基酯的例子包括脂肪酸的异丙酯和长链脂肪酸的长链酯，例如，SEFA(脂肪酸的蔗糖酯)、季戊四醇酯、芳族单酯、芳族二酯或芳族三酯、蓖麻油酸鲸蜡酯、棕榈酸异丙酯、肉豆蔻酸异丙酯、蓖麻油酸鲸蜡酯和蓖麻油酸硬脂基酯。其它例子包括月桂酸己酯、月桂酸异己酯、棕榈酸异己酯、油酸癸酯、油酸异癸酯、硬脂酸十六烷酯、硬脂酸癸酯、异硬脂酸异丙酯、己二酸二异丙酯、己二酸二异己酯、己二酸二己基癸酯、癸二酸二异丙酯、乳酸酰基异壬酸月桂酯、乳酸肉豆蔻酯、乳酸鲸蜡酯，以及它们的组合。另外，其它合适的油包括乳三甘油酯(例如，羟基化乳甘油酯)和多元醇脂肪酸聚酯。还为可用的是，植物蜡，诸如，巴西棕榈蜡和小烛树蜡；甾醇，诸如，胆固醇、胆固醇脂肪酸酯；和磷脂，诸如，卵磷脂和衍生物、鞘脂、神经酰胺、糖鞘脂，以及它们的组合。
基于水的滚涂式通常为水包油乳液而非油包水体系，因为后者的功效较弱。水包油乳液的活性成分存在于外相中的可易于触及的溶液形式中。由于该活性成分在溶解状态下失去活性，因此配制人员可使用液体或固体止汗剂活性物质。
本发明的组合物还可为透明的滚涂式油包水。这些组合物在市场上为相对新型的。它们展示出优异的美观并且在施用之后不会在皮肤上留下残余或沉积物。仅按照指定的添加次序在室温下就可实现澄清度。
另选地，该组合物可为气溶胶。喷剂或气溶胶具有在施用时不用与手直接接触的优点。推进剂气体可为例如烃(丙烷、异丁烯)、氯氟烃、二氧化碳或一氧化二氮。
本发明的组合物可为悬浮液。
在一个实施例中，该组合物为洗剂或霜膏。
在另一个实施例中，该组合物为固体或半固体或棒，并且包含有效量的抗胆碱能剂和固化剂，其中该组合物在室温下(例如，25℃及以下)为固体或半固体的形式。因此，该组合物可包含例如蜡和油以及水性溶液的混合物，例如由硬酯酸钠固化的丙二醇和/或乙醇混合物。优选地，固化剂选自蜡和硬脂酸钠。
本发明的固体组合物还可细分并且以粉末形式使用。
几乎所有止汗剂固体使用硬脂醇作为胶凝剂。通常添加润肤剂以赋予较柔和的感觉并且添加润滑能力。大多数固体还包含滑石和/或二氧化硅。二氧化硅为有效的悬浮剂，该悬浮剂有助于保持活性成分均匀地悬浮在整个棒中。杂项成分通常包括着色剂、二氧化钛(遮光剂)和尿囊素(抚慰剂)。
棒和固体为复合化学体系，该复合化学体系需要成分的平衡，该成分被设计来产生大多数若干性能因素，该性能因素包括支出、滑动或润滑、化学稳定性、软化温度和功效。
本发明的组合物还可为泡沫。因此，上述液体载体可包含气体在液相中的分散体。气体小球可具有从胶态到宏观的任何尺寸，与在肥皂泡中一样。典型的液体泡沫为用于剃刮膏等的那些。
实例
实例1
以下组合物为本发明的水-醇挤压喷雾制剂。
表1
| 成分 | 功能 | 重量/重量％ |
| A：SD醇40 | 溶剂 | 38.00 |
| B：丙二醇 | 湿润剂 | 3.50 |
| C：去离子水 | 溶剂 | 48.00 |
| D：吸收剂 | 吸收剂 | 6.00 |
| E：芳香剂 | 香料 | 0.50 |
| F：八胜肽或二胜肽 | 止汗剂 | 4.00 |
步骤
1.使用顶置式搅拌器混合A和C
2.添加B混合10min
3.添加D、E和F，当均匀时，倒入合适容器中。
实例2
以下产品为根据本发明的油包水乳液，其中连续相和分散相的折射率相同地进行匹配。硅氧烷表面活性剂用于实现稳定的乳液。
表2
步骤
1.组合A、B、C、D和H并且混合至均匀
2.在独立容器中组合E、F和G并且混合至均匀
3.将相1和相2的折射率进行匹配
4.缓慢地将来自步骤2的水相添加到来自步骤1的油相并在低速下匀化。粘度将缓慢地增大。
5.添加I并混合至均匀。
6.剧烈地匀化(5000rpm)至获得坚固的凝胶(通常1min至5min)
7.填充到气密容器中
实例3
以下组合物为根据本发明的乳液滚涂式制剂，其表现出优异的物理稳定性和施用特性。
表3
步骤
1.组合A、B、C和D并加热至700℃
2.在700℃下单独加热E
3.在搅拌下将A、B、C和D添加到E
4.匀化混合物1min-3min
5.在连续搅拌下冷却至35℃
6.在搅拌下将F缓慢添加到乳液中
7.在搅拌下添加H和G
8.再次匀化混合物1min-3min
9.填充到合适的容器中
实例4
根据本发明的该组合物提供优异的美观并且在施用之后不会在用户的皮肤上留下残余或沉积物。其是在室温下(20-22℃)使用下面的添加顺序用以下成分制成的澄清止汗剂产品。
表4
步骤
1.用顶置式混合(介质搅拌)组合A和B
2.缓慢添加C，混合均匀
3.缓慢添加D，混合均匀
4.缓慢添加E和F，混合均匀
5.预混H和I，缓慢添加到主批料
6.缓慢添加G，混合均匀
7.缓慢添加K和J，混合均匀至澄清
8.倒入适当的容器中
实例5
本发明的呈气溶胶形式的组合物是通过以下步骤制备的：
表5
| 成分 | 功能 | 重量/重量％ |
| A：膨润土凝胶VS-5PC | 悬浮剂 | 18.50 |
| B：环状聚甲基硅氧烷 | 溶剂 | 21.20 |
| C：聚二甲基硅氧烷，50厘沲 | 皮肤调理剂 | 8.50 |
| D：肉豆蔻酸异丙酯 | 皮肤调理剂 | 1.50 |
| E：吸收剂 | 吸收剂 | 6.00 |
| F：芳香剂 | 香料 | 0.30 |
| G：八胜肽或二胜肽 | 止汗剂 | 4.00 |
| H：异丁烷 | 推进剂 | 40.00 |
步骤
1.组合A、B、C和D。充分混合约10min或至均匀。
2.添加E，混合至均匀
3.添加G，混合至均匀
4.添加F并混合5min
5.将混合物置于合适的容器中并按照说明装入H。
实例6
根据本发明的以下组合物为固体制剂。
表6
| 成分 | 功能 | 重量/重量％ |
| A：挥发性硅氧烷 | 溶剂 | 56.70 |
| B：硬脂醇 | 表面活性剂 | 20.00 |
| C：PPG-3肉豆蔻醚 | 皮肤调理剂 | 5.00 |
| D：PEG-8二硬脂酸酯 | 表面活性剂 | 2.00 |
| E：滑石 | 吸收剂 | 1.00 |
| F：二氧化硅 | 吸收剂 | 1.50 |
| G：聚乙烯 | 成膜剂 | 3.00 |
| H：吸收剂 | 吸收剂 | 6.00 |
| I：芳香剂 | 香料 | 0.80 |
| J：八胜肽或二胜肽 | 止汗剂 | 4.00 |
步骤
1.加热A至65℃
2.在搅拌下添加C和D
3.缓慢添加B。保持65℃
4.添加E、F、G和H。
5.冷却至60℃。添加I和J。
6.在54℃下倒入棒状壳体中。
实例7
使用表7中的成分和下面的过程，制备包含乙酰基六肽-8的对比物滚涂式组合物。
表7
| 成分 | 功能 | 重量/重量％ |
| A：水 | 溶剂 | 79.51 |
| B：硬脂基聚氧乙烯醚-2 | 表面活性剂 | 3.00 |
| C：硬脂基聚氧乙烯醚-21 | 表面活性剂 | 1.00 |
| D：PPG-15硬脂醚 | 润肤剂 | 4.00 |
| E：乙基己基甘油；1,2-辛二醇 | 皮肤调理剂 | 1.00 |
| F：聚甘油-3辛酸酯 | 乳化剂 | 0.30 |
| G：柠檬酸 | pH调节剂 | 0.68 |
| H：氢氧化钠 | pH调节剂 | 0.01 |
| I：苯甲酸钠 | 防腐剂 | 0.50 |
| J：乙酰基六肽-8 | 止汗剂 | 10.00 |
过程：
1.油相：在辅助箱中组合B、C、D、E和F。开始加热至75℃-80℃。
2.水相：在主箱中组合A和I。开始加热至75℃-80℃。
3.乳化步骤：在水相上添加油相(均为75℃-80℃)。混合5min。匀化4min。
4.冷却步骤：将乳液冷却至25℃。添加G、H和J。混合10min。
实例8
使用表8中的成分和下面的过程，制备根据本发明的包含八胜肽的滚涂式组合物。
表8
| 成分 | 功能 | 重量/重量％ |
| A：水 | 溶剂 | 79.51 |
| B：硬脂基聚氧乙烯醚-2 | 表面活性剂 | 3.00 |
| C：硬脂基聚氧乙烯醚-21 | 表面活性剂 | 1.00 |
| D：PPG-15硬脂醚 | 润肤剂 | 4.00 |
| E：乙基己基甘油；1,2-辛二醇 | 皮肤调理剂 | 1.00 |
| F：聚甘油-3辛酸酯 | 乳化剂 | 0.30 |
| G：柠檬酸 | pH调节剂 | 0.68 |
| H：氢氧化钠 | pH调节剂 | 0.01 |
| I：苯甲酸钠 | 防腐剂 | 0.50 |
| J：八胜肽 | 止汗剂 | 10.00 |
过程：
1.油相：在辅助箱中组合B、C、D、E和F。开始加热至75℃-80℃。
2.水相：在主箱中组合A和I。开始加热至75℃-80℃。
3.乳化步骤：在水相上添加油相(均为75℃-80℃)。混合5min。匀化4min。
4.冷却步骤：将乳液冷却至25℃。添加G、H和J。将其混合10min。
实例9
使用表9中的成分和下面的过程，制备根据本发明的包含二胜肽的滚涂式组合物。
表9
过程：
1.油相：在辅助箱中组合B、C、D、E和F。开始加热至75℃-80℃。
2.水相：在主箱中组合A和I。开始加热至75℃-80℃。
3.乳化步骤：在水相上添加油相(均为75℃-80℃)。混合5min。匀化4min。
4.冷却步骤：将乳液冷却至25℃。添加G、H和J。将其混合10min。
实例10
使用对于2003年版非处方止汗药产品的效果测试的美国食品药品监督管理局指南，如下执行实例7、实例8和实例9的组合物的八小时的止汗功效的体内研究。实例7为对比物，如上面所指出的。
十五个受检者用于测试每种组合物。受检者首先经受以14天的清洗期开始的21天的调整期。在14天的清洗期期间，受检者使用由进行研究的机构供应的标准条皂和抑菌除臭剂。受检者不除去腋毛。在此之后，在15天至21天指导受检者仅使用标准皂并停止抑菌除臭剂。
在调整期期间，由受过训练的技术人员指导并监督受检者根据下面的过程来洗涤他们的腋下：a)用标准皂2.0％的水性溶液洗涤腋下中的一个10秒；b)用自来水彻底冲洗至皂完全除去；c)用纸巾擦干腋下；以及d)对于另一个腋下重复该过程。
在完成清洗期后，在腋下使用棉签检查每个受检者在调整期期间未授权使用止汗剂产品。
接着，开始30天施用期。在每个受检者的腋下上标记150cm2的随机分布的区域。然后在30天施用期期间每天将测试样品施用于每个受检者的一个腋下，同时另一个腋下未经处理作为对照物。每个星期五晚上受检者被涂蜡或剃光他们的腋下。
在30天施用期的第30天，每个受检者被提供有预先用水和没有芳香剂的中性皂洗涤并且再仅用水洗涤的100％纯棉T恤。指导受检者穿该T恤八小时。
在八小时之后，受检者被安排在37.8℃±1℃下以及30％和40％之间的相对湿度的房间中80分钟。在高温室中40分钟之后，将预先称重并储存在密封的聚乙烯袋中的垫从袋子中取出，并立即放置到受检者的腋下上，并且然后每20分钟更换一次。当进入高温室和另外40分钟后时受检者摄取200mL水，以保持水合的内部水平，从而允许汗液自由流动和证明仅是所测试的产品的制剂的效应。初始的40分钟时期被认为是环境适应期。
每20分钟收集所用的垫并称重。根据使用具有威尔科克森符号秩检验(FDA协议)的统计分析和与用于出汗评估的改善的单边假设配对的学生t检验的FDA指南，比较使用前和使用后垫的重量。在对比分析中考虑的置信水平为95％。软件：XLSTAT2013和MINITAB14。
结果示于表10中。
表10
| 抗胆碱能剂 | 具有相对于对照物的减少的受检者％ | 汗液减少(mg)的平均％ |
| 乙酰基六肽-8 | 66.7 | 8.0％ |
| 八胜肽 | 81.8 | 20.7 |
| 二胜肽 | 92.3 | 25.6 |
根据本发明的包含八胜肽和二胜肽的组合物相对于至少50％的受检者(81.8％和92.3％)的对照物分别使汗液减少了20.7％和25.6％的平均值。这确认了止汗剂活性。FDA指南要求在至少50％志愿者中最少20％的汗液减少。相比之下，包含乙酰基六肽-8的比较组合物示出相对于对照物汗液减少了仅8.0％的平均值，这不满足成功标准。
Claims (5)
1.一种局部止汗剂组合物，所述局部止汗剂组合物包含美容上可接受的局部用载体和以有效地抑制或防止出汗的量选自八胜肽和二胜肽的抗胆碱能剂，其中所述组合物基本上不含铝盐。
2.根据权利要求1所述的组合物，所述组合物包含约0.01重量/重量％至约30.0重量/重量％的所述抗胆碱能剂。
3.根据权利要求1所述的组合物，所述组合物包含约0.1重量/重量％至约20.0重量/重量％的八胜肽。
4.根据权利要求1所述的组合物，所述组合物包含约0.05重量/重量％至约6.0重量/重量％的二胜肽。
5.根据权利要求1所述的组合物，所述组合物还包含吸水剂。
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US14/577,136 US20160175224A1 (en) | 2014-12-19 | 2014-12-19 | Antiperspirant composition |
| US14/577,136 | 2014-12-19 |
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| Publication Number | Publication Date |
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| CN105708725A true CN105708725A (zh) | 2016-06-29 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN201510970640.XA Pending CN105708725A (zh) | 2014-12-19 | 2015-12-21 | 止汗剂组合物 |
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| Country | Link |
|---|---|
| US (1) | US20160175224A1 (zh) |
| EP (1) | EP3034131A1 (zh) |
| KR (1) | KR20160075356A (zh) |
| CN (1) | CN105708725A (zh) |
| AU (1) | AU2015261596A1 (zh) |
| BR (1) | BR102015031692A2 (zh) |
| CA (1) | CA2915656A1 (zh) |
| CO (1) | CO7560107A1 (zh) |
| MX (1) | MX2015017662A (zh) |
| RU (1) | RU2015153704A (zh) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107469065A (zh) * | 2017-07-19 | 2017-12-15 | 广州医科大学 | 类蛇毒三胜肽在制备用于治疗皮肤溃疡的药物中的应用 |
| CN111885916A (zh) * | 2018-01-11 | 2020-11-03 | 加法尔企业R&D公司 | 浸渍有挥发性有机物质和特定酯的固体聚合物材料及其用途 |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2023511956A (ja) * | 2020-01-24 | 2023-03-23 | レゲネロン ファーマシューティカルス，インコーポレーテッド | タンパク質－抗ウイルス化合物コンジュゲート |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3755560A (en) | 1971-06-30 | 1973-08-28 | Dow Chemical Co | Nongreasy cosmetic lotions |
| US4421769A (en) | 1981-09-29 | 1983-12-20 | The Procter & Gamble Company | Skin conditioning composition |
| ZA966814B (en) | 1995-08-18 | 1998-02-12 | Colgate Palmolive Co | Clear cosmetic gel composition. |
| US20030007939A1 (en) | 1998-07-31 | 2003-01-09 | Howard Murad | Pharmaceutical compositions and methods for managing dermatological conditions |
| US8147815B2 (en) * | 2005-12-16 | 2012-04-03 | Celmatrix Corporation | Topical administration carrier composition and therapeutic formulations comprising same |
| EP2262469A4 (en) * | 2008-04-15 | 2013-12-04 | Immanence Integrale Dermo Correction Inc | SKIN CARE COMPOSITIONS AND METHODS OF USE |
| EP2143418A1 (en) * | 2008-07-08 | 2010-01-13 | Unilever PLC | Antiperspirant compositions |
| WO2010003861A1 (en) * | 2008-07-08 | 2010-01-14 | Unilever Plc | Antiperspirant products |
| WO2010003828A2 (en) * | 2008-07-08 | 2010-01-14 | Unilever Plc | Antiperspirant products |
| US20100215726A1 (en) * | 2009-02-25 | 2010-08-26 | Peter Thomas Roth | Compositions for Diminishing the Appearance of Wrinkles |
| US8337821B2 (en) | 2009-07-27 | 2012-12-25 | Dermadoctor, Inc. | Composition for treatment of hyperhidrosis |
-
2014
- 2014-12-19 US US14/577,136 patent/US20160175224A1/en not_active Abandoned
-
2015
- 2015-11-25 AU AU2015261596A patent/AU2015261596A1/en not_active Abandoned
- 2015-12-10 CO CO15293695A patent/CO7560107A1/es unknown
- 2015-12-14 RU RU2015153704A patent/RU2015153704A/ru not_active Application Discontinuation
- 2015-12-17 BR BR102015031692A patent/BR102015031692A2/pt not_active Application Discontinuation
- 2015-12-17 KR KR1020150180864A patent/KR20160075356A/ko unknown
- 2015-12-17 MX MX2015017662A patent/MX2015017662A/es unknown
- 2015-12-18 CA CA2915656A patent/CA2915656A1/en not_active Abandoned
- 2015-12-18 EP EP15201283.7A patent/EP3034131A1/en not_active Withdrawn
- 2015-12-21 CN CN201510970640.XA patent/CN105708725A/zh active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107469065A (zh) * | 2017-07-19 | 2017-12-15 | 广州医科大学 | 类蛇毒三胜肽在制备用于治疗皮肤溃疡的药物中的应用 |
| CN107469065B (zh) * | 2017-07-19 | 2021-05-18 | 广州医科大学 | 类蛇毒三胜肽在制备用于治疗皮肤溃疡的药物中的应用 |
| CN111885916A (zh) * | 2018-01-11 | 2020-11-03 | 加法尔企业R&D公司 | 浸渍有挥发性有机物质和特定酯的固体聚合物材料及其用途 |
Also Published As
| Publication number | Publication date |
|---|---|
| EP3034131A1 (en) | 2016-06-22 |
| KR20160075356A (ko) | 2016-06-29 |
| US20160175224A1 (en) | 2016-06-23 |
| CO7560107A1 (es) | 2016-03-31 |
| AU2015261596A1 (en) | 2016-07-07 |
| BR102015031692A2 (pt) | 2016-06-21 |
| RU2015153704A (ru) | 2017-06-19 |
| CA2915656A1 (en) | 2016-06-19 |
| MX2015017662A (es) | 2017-02-20 |
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