CN109069381B - 10-羟基硬脂酸组合物 - Google Patents
10-羟基硬脂酸组合物 Download PDFInfo
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- CN109069381B CN109069381B CN201780023127.7A CN201780023127A CN109069381B CN 109069381 B CN109069381 B CN 109069381B CN 201780023127 A CN201780023127 A CN 201780023127A CN 109069381 B CN109069381 B CN 109069381B
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- 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
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Abstract
本发明涉及局部用组合物，所述组合物包含10‑羟基硬脂酸或其盐和至少一种非离子乳化剂。本发明还涉及延迟或抑制局部用组合物中10‑羟基硬脂酸或其盐的重结晶的方法，所述方法包括：在至少一种非离子乳化剂存在下配制10‑羟基硬脂酸或其盐。
Description
本发明涉及局部用组合物，所述组合物包含10-羟基硬脂酸或其盐和至少一种非离子乳化剂。本发明还涉及延迟或抑制局部用组合物中10-羟基硬脂酸或其盐的重结晶的方法，所述方法包括：在至少一种非离子乳化剂存在下配制10-羟基硬脂酸或其盐。
据报道，羟基脂肪酸如10-羟基硬脂酸(CAS：638-26-6)在以下方面具有有益的美容效果：治疗或预防由健康皮肤的生理稳态的负面发展引起的任何症状，以及促进毛发生长和防止脱发。然而，这些化合物都没有被开发成商业产品，原因在于难以建立这样的产品形式，其中活性物随时间保持可溶并且在储存后不会重结晶。
因此，持续需要克服现有技术的缺点并找到一种稳健且稳定的乳剂体系，该体系允许并入10-羟基硬脂酸并且在储存后不形成晶体。
出乎意料地发现，通过使用至少一种非离子乳化剂，可以显著延迟或甚至抑制10-羟基硬脂酸的重结晶。
因此，在第一个实施方式中，本发明涉及局部用组合物，所述组合物包含10-羟基硬脂酸或其盐和至少一种非离子乳化剂，前提条件是所述组合物不含对羟基苯甲酸异丁酯。
根据本发明的局部用组合物中10-羟基硬脂酸或其盐的量有利地选自0.001-5重量％的范围内，优选地0.01-3重量％的范围内，最优选地0.1-2重量％的范围内，例如特别地0.1-1.5重量％的范围内，所述量是基于所述组合物的总重量。
根据本发明的局部用组合物中非离子乳化剂的量有利地选自0.1-7重量％的范围内，优选地1-6重量％的范围内，最优选地1-5重量％的范围内，所述量是基于所述组合物的总重量。
10-羟基硬脂酸(CAS：638-26-6)可以例如如G.Schroepfer在BiologicalChemistry(1966),241(22),5441-7中所述制备，其具有下式：
根据本发明可以使用两种对映体，优选的对映体形式是(R)-10-羟基硬脂酸。
盐可以通过与有机碱或碱金属碱(alkali base)或碱土金属碱(earth alkalinebase)反应而形成，从而得到各自的盐。释放对皮肤无毒且/或不引起过敏反应的美容上可接受的阳离子的合适的碱是本领域技术人员公知的。有机盐的实例是各自的铵盐和烷基铵盐，例如特别是三乙醇铵盐。优选的碱金属盐或碱土金属盐是各自的锂盐、钠盐、钾盐、镁盐或钙盐。
美容品中使用的根据本发明待使用的非离子乳化剂是本领域技术人员公知的。
用于本发明目的的特别合适的非离子表面活性剂是脂肪醇的酯、聚亚烷基二醇烷基醚、聚亚烷基二醇脂肪酸酯、葡糖苷烷基醚、烷基葡萄糖酯、甘油烷基酯、脱水山梨糖醇脂肪酸酯以及聚乙二醇和聚丙二醇的嵌段聚合物。
术语“烷基”包括直链烷基和支链烷基。优选地，术语“烷基”是指直链C1-C28烷基和支链C3-C28烷基、更优选地直链C1-C28烷基、最优选地C1-C22烷基。
术语“脂肪醇”和“脂肪酸”分别指具有长脂族链的醇和酸，所述长脂族链是饱和或不饱和的并且还可以是支链的。优选地，并且如果没有另外限定，术语“脂肪醇”和“脂肪酸”分别指饱和或不饱和的直链或支链的C12-C28、优选C12至C22醇和羧酸。在一个特别优选的实施方式中，术语“脂肪醇”和“脂肪酸”分别指饱和或不饱和的直链C12-C28、优选C12至C22醇和羧酸。
用于本发明目的的特别合适的脂肪醇的酯包括脂肪醇的脂肪酸酯，例如特别是C12-C22-醇的C12-C22-烷基酯。用于本发明目的的特别合适的脂肪醇的酯是鲸蜡硬脂醇和衍生自(氢化)橄榄油的脂肪酸的酯或C16-C18和C18-不饱和醇的C16-C18-烷基酯。
用于本发明目的的特别合适的聚亚烷基二醇烷基醚是聚乙二醇烷基醚(PEG-醚)，其例如可通过用脂肪醇醚化各聚乙二醇而获得。聚乙烯链中环氧乙烷单体的数目通常选自2至150，更优选2至50，最优选2至30。因此，本发明的所有实施方式中待使用的特别有利的PEG-醚涵盖环氧乙烷数目为2至30的聚乙二醇C12-C22-烷基醚，例如硬脂醇聚醚-2、硬脂醇聚醚-21、月桂醇聚醚-4、月桂醇聚醚-7、椰油醇聚醚-7和鲸蜡硬脂醇聚醚-12。在本发明的所有实施方式中，最优选的PEG-醚是环氧乙烷数目为2至30的聚乙二醇C18-烷基醚，例如硬脂醇聚醚-2和硬脂醇聚醚-21。
用于本发明目的的特别合适的聚亚烷基二醇脂肪酸酯是聚乙二醇脂肪酸酯(PEG-酯)，其例如可通过用脂肪酸酯化各聚乙二醇而获得。聚乙烯链中环氧乙烷单体的数目通常选自2至150，更优选10至110，最优选20至100。因此，本发明的所有实施方式中待使用的特别有利的PEG-酯涵盖环氧乙烷数目为2至150的聚乙二醇C12-C22-脂肪酸酯，例如特别是PEG-20硬脂酸酯、PEG-40硬脂酸酯、PEG-100硬脂酸酯、PEG-40氢化蓖麻油、PEG-40蓖麻油、PEG-30二聚羟基硬脂酸酯、PEG-30甘油基硬脂酸酯和PEG-7甘油基椰油酸酯。在本发明的所有实施方式中，最优选的PEG-酯是环氧乙烷数目为10至110的聚乙二醇硬脂酸酯，例如特别是PEG 40硬脂酸酯和PEG-100硬脂酸酯。
用于本发明目的的特别合适的葡糖苷烷基醚是癸基葡糖苷、月桂基葡糖苷、辛基葡糖苷和鲸蜡硬脂基葡糖苷。
用于本发明目的的特别合适的烷基葡萄糖酯是(聚甘油基)烷基葡萄糖烷基酯，例如烷基葡萄糖烷基酯甲基葡萄糖倍半硬脂酸酯或聚甘油基烷基葡萄糖烷基酯聚甘油基-3甲基葡萄糖二硬脂酸酯。
用于本发明目的的特别合适的甘油烷基酯是甘油(单-或二-)C12-C22脂肪酸酯，其可通过甘油和相应的C12-C22脂肪酸的酯化获得(例如特别是甘油月桂酸酯或甘油硬脂酸酯)以及聚甘油和C12-C22脂肪酸的酯化产物(例如聚甘油-6二硬脂酸酯)。
用于本发明目的的特别合适的脱水山梨糖醇脂肪酸酯是脱水山梨糖醇(单-、二-或三-)脂肪酸酯，其可通过用脂肪酸酯化脱水山梨糖醇来制备。特别合适的脱水山梨糖醇脂肪酸酯是脱水山梨糖醇的脂肪酸单酯(例如可以以商品名SPAN商购获得)，例如脱水山梨糖醇倍半油酸酯、脱水山梨糖醇异硬脂酸酯和脱水山梨糖醇三油酸酯；或脱水山梨糖醇和(氢化)橄榄油脂肪酸的酯(化学名称：D-山梨醇，与橄榄油脂肪酸的1,4-酐-,6-单酯，例如可以以商品名脱水山梨糖醇橄榄油酸酯商购获得)或脱水山梨糖醇硬脂酸酯(例如可以以Arlatone 2121商购获得)以及聚乙氧基化脱水山梨糖醇酯(例如可以以商品名Tween商购获得)。
用于本发明目的的特别合适的聚乙二醇和聚丙二醇的嵌段聚合物是烷基PEG/PPG，其是烷基醇与一当量或更多当量的环氧乙烷和环氧丙烷中的每种的反应产物(分别形成(PEG)和聚丙二醇(PPG)聚乙二醇的重复)。优选的烷基醇是脂肪醇，例如特别是C12-C22-烷基醇。聚乙二醇和聚丙二醇的嵌段聚合物的示例性醚包括PPG-1-PEG-9月桂基乙二醇醚和PPG-1-PEG-9月桂基乙二醇醚。用于本发明目的的另一种合适的聚乙二醇和聚丙二醇的嵌段聚合物是由聚二甲基硅氧烷和聚氧乙烯和聚氧丙烯制成的聚合物，例如PEG/PPG-18/18聚二甲基硅氧烷和鲸蜡基PEG/PPG-10/1聚二甲基硅氧烷。
在一个优选的实施方式中，所述至少一种非离子乳化剂选自C12-C22-醇的C12-C22-烷基酯，聚乙二醇烷基醚，例如更优选地环氧乙烷数目为2至30的聚乙二醇C12-C22-烷基醚，聚乙二醇脂肪酸酯，例如更优选地环氧乙烷数目为2至150的聚乙二醇C12-C22脂肪酸酯，(聚甘油基)烷基葡萄糖烷基酯，甘油C12-C22脂肪酸酯和脱水山梨糖醇单脂肪酸酯。
在一个最优选的实施方式中，根据本发明的至少一种非离子乳化剂选自聚甘油-3甲基葡萄糖二硬脂酸酯(CAS 187339-62-4，例如可商购的
Care 450)，鲸蜡硬脂基葡糖苷(CAS 246159-33-1，例如可商购的
Care CG 90)，甲基葡萄糖倍半硬脂酸酯(CAS 68936-95-8，例如可商购的TEGO Care PS)，鲸蜡硬脂醇橄榄油酸酯(CAS 348616-34-2)，脱水山梨糖醇橄榄油酸酯(CAS 223706-40-9)，鲸蜡硬脂醇橄榄油酸酯和脱水山梨糖醇橄榄油酸酯的混合物(例如可商购的
1000)，PEG-40硬脂酸酯(CAS 9004-99-3，例如可商购的MyrjTMS40)，PEG-100硬脂酸酯(CAS 9004-99-3)，甘油硬脂酸酯(CAS 123-94-4)，PEG-100硬脂酸酯和甘油硬脂酸酯的混合物(例如可商购的ArlacelTM 165或Simulsol165)，硬脂醇聚醚-2(CAS 9005-00-9(Generic)/16057-43-5，例如可商购的BrijTM S2)和硬脂醇聚醚-21(CAS 9005-00-9(Generic)，例如可商购的BrijTM S721)，以及它们的混合物。
在另一个有利的实施方式中，本发明涉及局部用组合物，其中至少一种非离子乳化剂选自PEG-醚或PEG-酯，所有限定和优选方案如上所述，可选地与阴离子乳化剂(例如硬脂酸)组合，因为这些PEG-乳化剂的使用导致特别好的结果。
根据本发明的局部用组合物不含对羟基苯甲酸异丁酯，然而，更优选地，该组合物不含任何对羟基苯甲酸酯，例如特别地不含对羟基苯甲酸甲酯、对羟基苯甲酸乙酯、对羟基苯甲酸丙酯和对羟基苯甲酸丁酯。
在另一个优选的实施方式中，根据本发明的局部用组合物还不含冷却剂和/或放热剂。
术语“冷却剂”是本领域技术人员公知的，其是指在皮肤上产生清凉感的美容成分，例如1-薄荷醇和薄荷醇衍生物(例如薄荷基Ruguri甘油醚、乳酸薄荷酯、1-薄荷基3-羟基丁酸酯、水杨酸薄荷酯、薄荷酮)，dl-樟脑，丁子香酚，薄荷和桉树。
术语“放热剂”是指与水混合时产生热的组分，例如氯化钙、氯化镁、氯化铝、三氯化铁、氯化锌、硫酸钙、硫酸镁、硫酸锌、硫酸铝、硫酸亚铁、碳酸钙和碳酸钠。
根据本发明的局部用组合物优选另外含有助乳化剂。根据本发明特别优选的共乳化剂是具有12-22个碳原子的非离子固体脂肪醇及其混合物，例如优选月桂醇、肉豆蔻醇、十五烷醇、鲸蜡醇、十七烷醇、硬脂醇、异硬脂醇、棕榈油醇及其混合物。特别优选的助乳化剂是山嵛醇(例如可从BASF以Lanette 22商购获得)、鲸蜡醇(例如可从BASF以Lanette 16商购获得)和鲸蜡硬脂醇(即鲸蜡醇和硬脂醇的混合物，例如可从BASF以
O商购获得)。
根据本发明的局部用组合物中助乳化剂的量优选地选自0.1-20重量％的范围内，更优选地0.5-10重量％的范围内，最优选地1-5重量％的范围内，所述量是基于所述组合物的总重量。
在本发明的一个特别有利的实施方式中，至少一种非离子乳化剂选自聚甘油-3甲基葡萄糖二硬脂酸酯、鲸蜡硬脂基葡糖苷、鲸蜡硬脂醇橄榄油酸酯、脱水山梨糖醇橄榄油酸酯、甲基葡萄糖倍半硬脂酸酯、PEG-100硬脂酸酯、甘油基硬脂酸酯、硬脂醇聚醚-2和硬脂醇聚醚-21及其混合物，助乳化剂选自鲸蜡醇、山嵛醇和鲸蜡硬脂醇及其混合物。
在另一个实施方式中，本发明涉及延迟或抑制局部用组合物中10-羟基硬脂酸或其盐的重结晶的方法，所述方法包括：在非离子乳化剂存在下配制10-羟基硬脂酸或其盐，其中所有优选方案和限定如上所述。
在本文中使用时，术语“局部用组合物”特别指可以局部施用到哺乳动物角质组织(例如，人体皮肤或毛发，特别是人体皮肤)的美容组合物。
在本申请中使用时，术语“美容组合物”是指在
Lexikon Chemie,第10版,1997,Georg Thieme Verlag Stuttgart,New York中的标题“Kosmetika”下限定的美容组合物，以及如A.Domsch,"Cosmetic Preparations",Verlag für chemische Industrie(H.Ziolkowsky编),第4版,1992中公开的美容制品。
优选地，根据本发明的局部用制品为乳剂或微乳剂(特别是O/W型)、PIT-乳剂、多重乳剂(例如O/W/O型和W/O/W)或者皮克林乳剂(pickering emulsion)的形式。
在本发明的所有实施方式中，根据本发明的局部用组合物优选为包含水相和油相的乳剂，最优选地所述局部用组合物为O/W乳剂。优选地，水相占组合物的至少50重量％，油相占组合物的至少10重量％。特别地，水相占至少60重量％，油相占少于40重量％。特别地，水相占组合物的至少70重量％，油相占组合物的少于30重量％。最优选地，基于组合物的总重量，水相的量选自70-90重量％的范围，油相的量选自10-30重量％的范围。
很容易理解，水相和油相一起形成乳剂，然而，其中也可存在少量(至多5重量％)其余成分，例如防腐剂、活性剂、芳香剂等，其可以添加到其中一种相中，或者例如在制备结束时单独添加，这是本领域技术人员公知的。
用于形成根据本发明的局部用组合物的油相的特别合适的油组分和溶剂包括：乙醇；甘油三酸酯；二醇类，例如丙二醇、丙二醇二苯甲酸酯、丁二醇、戊二醇和PPG-15乙氧基二甘醇硬脂基醚；二烷基醚类，例如二辛基醚、PPG-3肉豆蔻醚等；链长为3-30个碳原子的饱和和/或不饱和的支链和/或无支链的烷烃羧酸与链长为3-30个碳原子的饱和和/或不饱和的支链和/或无支链的醇的酯，或芳族羧酸与链长为3-30个碳原子的饱和和/或不饱和的支链和/或无支链的醇的酯，例如肉豆蔻酸异丙酯、棕榈酸异丙酯、油酸异丙酯、硬脂酸正丁酯、月桂酸正己酯、油酸正癸酯、异壬酸异壬酯、棕榈酸2-乙基己基酯、苯甲酸乙基己基酯、苯甲酸C12-15烷基酯、硬脂酸2-己基癸酯、油酸油醇酯、油酸芥醇酯(erucyl oleate)、芥酸芥醇酯、丙二醇二辛酸酯/二癸酸酯、己二酸二异丙酯、月桂酸异戊酯、新戊酸辛基十二烷基酯、酒石酸二-C12-C13烷基酯以及这些酯的合成、半合成和天然混合物，例如荷荷巴油；碳酸酯如碳酸二辛酯；甘油三酯，如辛酸/癸酸甘油三酯，PEG-8辛酸/癸酸甘油三酯；硅油类；具有8-20个碳原子的直链或支链烃，例如癸烷、十二烷、十三烷、十四烷和C8-20异链烷烃；源自于动物、植物或矿质来源的天然油和脂肪(包括脂(butter))，例如，杏仁油、野杏仁油、阿干树油、鳄梨脂、鳄梨油、可可脂(可可油)、山茶油、低芥酸菜子油(canola oil)、胡萝卜籽油、蓖麻油、柑桔核油、椰子油、玉米油、棉籽油、黄瓜油、蛋黄油、葡萄籽油、大麻籽油、霍霍巴油、羊毛脂油、亚麻油、澳洲坚果油、白池花籽油、矿物油、貂油、橄榄油、棕榈仁油、桃仁油、花生油、菜籽油、玫瑰果油、红花油、芝麻油、鲨鱼肝油、牛油果树脂、大豆油、向日葵籽油、甜杏仁油、动物脂(tallow)(牛)油、动物脂(羊)油、鳖油(turtle oil)、植物油和小麦胚芽油以及这些油组分和溶剂的混合物。
用于形成根据本发明的局部用组合物的油相的特别合适的油和溶剂组分是棕榈酸异丙酯、辛酸/癸酸甘油三酯、PPG-15硬脂基醚、丁二醇、二辛基碳酸酯、二辛基醚、酒石酸二-C12-C13烷基酯、己二酸二异丙酯、甘油三酸酯、丙二醇二辛酸酯/二癸酸酯、月桂酸异戊酯、新戊酸辛基十二烷酯、苯甲酸乙基己基酯、戊二醇、PEG-8辛酸/癸酸甘油三酯、丙二醇二苯甲酸酯、PPG-3肉豆蔻醚、乙氧基二甘醇、苯甲酸C12-15烷基酯和乙醇以及它们的混合物。
水相有利地基本上由水、保湿剂和增稠剂组成。合适的增稠剂包括例如黄原胶(例如可作为Keltrol CG-RD获得的)、瓜儿胶(Guar-Gum)、藻酸酯/盐、聚丙烯酸酯、聚季铵盐、硅酮基聚合物、卡波姆、丙烯酸酯/丙烯酸C10-30烷基酯共聚物、羟乙基纤维素、丙烯酰基二甲基牛磺酸铵/VP共聚物以及其它丙烯酰基二甲基牛磺酸盐共聚物。优选的增稠剂是黄原胶或丙烯酸酯/丙烯酸C10-30烷基酯共聚物或聚丙烯酸(INCI：卡波姆)。
根据本发明，黄原胶优选以低浓度使用，例如基于局部用组合物的总重量，以选自0.05-1重量％范围内、优选地0.05-0.3重量％范围内的浓度使用。
根据本发明，丙烯酸酯/丙烯酸C10-30烷基酯优选以低浓度使用，例如，基于局部用组合物的总重量，以选自0.05-1重量％范围内、优选地0.05-0.3重量％范围内的浓度使用。
根据本发明，聚丙烯酸优选以低浓度使用，例如，基于局部用组合物的总重量，以选自0.05-1重量％范围内、优选地0.05-0.3重量％范围内的浓度使用。
特别合适的保湿剂是甘油，但不限于此。可以使用的其他保湿剂有：例如，糖类同分异构体(saccharide isomerate)(例如可作为
获得的)，戊二醇(例如可作为
获得的)丙二醇，丁二醇，尿素等。
根据本发明，甘油优选以低浓度使用，例如，基于局部用组合物的总重量，以选自0.5-10重量％范围内、更优选地1-6重量％范围内的浓度使用。
用于根据本发明的局部用组合物中的特别合适的防腐剂是苯氧基乙醇、乙基己基甘油、山梨酸钾和苯甲酸钠及其混合物。
根据本发明，防腐剂(总量)优选以低浓度使用，例如，基于局部用组合物的总重量，以选自0.1-3重量％范围内、更优选地0.5-2重量％范围内、最优选地0l5-1重量％范围内的浓度使用。
根据本发明的局部用组合物可以是液体、洗剂、增稠洗剂、凝胶、霜剂、乳、软膏或糊剂的形式，并且任选地可被包装为气雾剂，以及可以以摩丝(比如气雾剂摩丝)、泡沫或喷雾泡沫、喷雾、棒的形式提供。
根据本发明的局部用组合物可任选地与其它美容活性成分组合，例如用于皮肤亮白；防止晒黑；处理色素沉着过度和/或橘皮组织；预防或减少痤疮、皱纹、纹理、萎缩和/或发炎；瘦身(例如植烷酸)、紧致、润湿和赋活(energizing)、自我美黑、舒缓的成分，以及改善弹性和皮肤屏障的试剂。本领域技术人员公知，本文中可用的美容活性成分在一些情况下能够提供多于一种益处或通过多于一种作用模式发挥作用。
如果存在另外的美容活性成分，则基于局部用制品的总重量，其含量通常为至少0.001重量％。通常，基于局部用组合物的总重量，使用量为约0.001重量％至约30重量％、优选约0.001重量％至约10重量％的另外的美容活性剂。
本发明的局部用美容组合物还可含有常用的美容佐剂和添加剂，如防腐剂/抗氧化剂、脂肪物质/油、水、有机溶剂、硅酮、增稠剂、软化剂、乳化剂、防晒剂、消泡剂、美学组分如芳香剂、表面活性剂、填料、掩蔽剂、络合剂、阴离子、阳离子、非离子或两性聚合物或其混合物、推进剂、酸化剂或碱化剂、染料、着色剂/染色剂、磨料、吸附剂、精油、皮肤感觉剂、收敛剂、颜料或纳米颜料，例如适于通过物理阻断紫外线辐射而提供光保护效果的那些，或通常配制到美容组合物中的任何其他常用的美容佐剂或添加剂。
适用于本发明的组合物中的通常用于皮肤护理行业中的活性成分以及美容佐剂和添加剂例如描述于CTFA Cosmetic Ingredient Handbook,第2版(1992)中，但不限于此。
活性成分以及美容佐剂和添加剂的必需量可由本领域技术人员基于期望的产品容易地选择，并将在实施例中进行阐明，但不仅限于此。
当然，本领域技术人员应小心地选择上述任选的一种或多种附加化合物和/或其量，使得与根据本发明的组合本质上相关的有利性质不受或基本上不受所设想的一种或多种添加的不利影响。
待掺入根据本发明的局部用组合物中的合适的UV滤光物质是已知被添加到局部用组合物例如美容品或皮肤病日晒护理产品中的常规UVA和/或UVB和/或广谱UV滤光物质。此类UV滤光物质包含吸收在波长400nm到320nm(UVA)和320nm到280nm(UVB)或甚至更短波长(UVC)范围内的光并且被用作或者能被用作美容上可接受的UV滤光物质的所有类型。此类UV滤光物质例如列在Nadim A.Shaath的“The Encyclopedia of Ultraviolet Filters”(ISBN:978-1-932633-25-2)或CTFA Cosmetic ingredient Handbook中。
合适的UV滤光物质可以是有机化合物或无机化合物。示例性有机UV滤光物质包括例如丙烯酸酯，例如2-乙基己基2-氰基-3,3-二苯基丙烯酸酯(奥克立林(octocrylene)，
340)，乙基2-氰基-3,3-二苯基丙烯酸酯；樟脑衍生物，例如4-甲基亚苄基樟脑(
5000)、3-亚苄基樟脑、甲基硫酸樟脑苯甲烷铵(camphor benzalkoniummethosulfate)、聚丙烯酰氨基甲基亚苄基樟脑、磺基亚苄基樟脑、磺基甲基亚苄基樟脑、对苯二亚甲基二樟脑磺酸(
SX)；肉桂酸酯衍生物，例如甲氧基肉桂酸乙基己基酯(
MCX)、甲氧基肉桂酸乙氧基乙基酯、甲氧基肉桂酸异戊酯，以及键合到硅氧烷上的肉桂酸衍生物；对氨基苯甲酸衍生物，例如对氨基苯甲酸、2-乙基己基对二甲基氨基苯甲酸酯、N-氧亚丙基化的对氨基苯甲酸乙酯、甘油对氨基苯甲酸酯；二苯甲酮，例如二苯甲酮-3、二苯甲酮-4、2,2',4,4'-四羟基-二苯甲酮、2,2'-二羟基-4,4'-二甲氧基二苯甲酮；亚苄基丙二酸的酯，例如二-(2-乙基己基)4-甲氧基亚苄基丙二酸酯；含有生色团的有机硅氧烷化合物，例如聚硅酮-15(
SLX)、甲酚曲唑三硅氧烷(drometrizoletrisiloxane)(
XL)；咪唑衍生物，例如，2-苯基苯并咪唑磺酸(
HS)及其盐，例如钠盐或钾盐、铵盐、吗啉盐、伯胺盐、仲胺盐和叔胺盐，如单乙醇胺盐、二乙醇胺盐；水杨酸酯衍生物，例如水杨酸异丙基苄酯、水杨酸苄酯、水杨酸丁酯、水杨酸乙基己基酯(
EHS，Neo
OS)、水杨酸异辛酯或水杨酸高孟基酯(胡莫柳酯,
HMS，Neo
HMS)；三嗪衍生物，例如乙基己基三嗪酮(
T-150)、二乙基己基丁酰胺基三嗪酮(
HEB)、双-乙基己氧基苯酚甲氧基苯基三嗪(
S)、2,4,6-三([1,1'-联苯]-4-基)-1,3,5-三嗪(三联苯基三嗪，TinosorbA2B)；苯并三唑衍生物例如2,2'-亚甲基-双-(6-(2H-苯并三唑-2-基)-4-(1,1,3,3,-四甲基丁基)-苯酚(
M)；被包封的UV滤光剂，例如被包封的甲氧基肉桂酸乙基己基酯(
UV-pearls)或装有例如EP1471995中公开的UV滤光剂的微胶囊；二苯甲酰甲烷衍生物，例如4-叔丁基-4'-甲氧基二苯甲酰甲烷(
1789)、二甲氧基二苯甲酰甲烷、异丙基二苯甲酰甲烷；亚苯基-1,4-双-苯并咪唑磺酸或盐，例如，2,2-(1,4-亚苯基)双-(1H-苯并咪唑-4,6-二磺酸)(Neoheliopan AP)；经氨基取代的羟基二苯甲酮，例如2-(4-二乙氨基-2-羟基-苯甲酰基)-苯甲酸己酯(氨基二苯甲酮，
A Plus)；苯并噁唑衍生物例如2,4-双-[5-1(二甲基丙基)苯并噁唑-2-基-(4-苯基)-亚氨基]-6-(2-乙基己基)-亚氨基-1,3,5-三嗪(
K2A)。无机UV滤光物质包括颜料，例如微粒化的氧化锌或二氧化钛(例如以
TX商购获得)。术语“微粒化的”是指粒度为约5nm至约200nm，特别是约15nm至约100nm。也可以用其它金属氧化物(例如氧化铝或氧化锆)或有机涂料(例如多元醇、聚甲基硅氧烷、硬脂酸铝、烷基硅烷)涂布颗粒。这种涂层是本领域公知的。
为了增强日晒防护产品的光稳定性，可期望添加光稳定剂。本领域技术人员已知的示例性光稳定剂包括例如3,3-二苯基丙烯酸酯衍生物，例如奥克立林(
340)或聚酯-8
亚苄基樟脑衍生物例如4-甲基亚苄基樟脑(
5000)；亚苄基丙二酸酯衍生物，例如，聚硅氧烷-15(
SLX)或亚丁香基丙二酸二乙基己基酯(Oxynex ST液)；萘二酸二烷基酯，如萘二酸二乙基己基酯(Corapan TQ)，但不仅限于此。其他稳定剂的综述例如在‘SPF Boosters&Photostability of UltravioletFilters’，HAPPI，2007年10月，第77-83页中给出，所述文献通过引用并入本文。相对于局部用组合物的总重量，光稳定剂的用量通常为0.05-10重量％。
通常，基于根据本发明的局部用组合物的总重量，局部用组合物中每种UV滤光物质的量选自约0.1-10重量％的范围内，优选地约0.2-10重量％的范围内，最优选地约0.5-10重量％的范围内。
基于根据本发明的局部用组合物的总重量，局部用组合物中UVA滤光物质(特别是丁基甲氧基二苯甲酰甲烷)的总量优选地选自约0.5-8重量％的范围内，特别地约1-6重量％的范围内，最特别地约1-5重量％的范围内。
基于根据本发明的局部用组合物的总重量，局部用组合物中UV滤光物质的总量优选地在约1-40重量％的范围内，优选地约5-30重量％的范围内，特别地8-30重量％的范围内。
根据本发明优选的UVB滤光物质包括聚硅氧烷-15、苯基苯并咪唑磺酸、奥克立林、甲氧基肉桂酸乙基己基酯、水杨酸乙基己基酯和/或胡莫柳酯。
根据本发明优选的广谱UV滤光物质包括不对称的s-三嗪衍生物，例如2,4-双-{[4-(2-乙基-己氧基)-2-羟基]-苯基}-6-(4-甲氧基苯基)-1,3,5-三嗪或2,4,6-三([1,1'-联苯]-4-基)-1,3,5-三嗪(三联苯基三嗪，Tinosorb A2B)，某些二苯甲酮例如2-羟基-4-甲氧基-二苯甲酮，2,2'-亚甲基-双-(6-(2H-苯并三唑-2-基)-4-(1,1,3,3-四甲基-丁基)-苯酚)和/或二氧化钛。
根据本发明优选的UVA滤光物质是丁基甲氧基二苯甲酰甲烷。优选地，丁基甲氧基二苯甲酰甲烷是根据本发明的局部用组合物中唯一的UVA滤光物质。
在一个特别优选的实施方式中，所述组合物包含至少一种UV滤光物质，所述UV滤光物质选自丁基甲氧基二苯甲酰甲烷、奥克立林、胡莫柳酯和水杨酸乙基己基酯及其混合物。在一个特别有利的实施方式中，根据本发明的组合物中存在丁基甲氧基二苯甲酰甲烷、奥克立林、胡莫柳酯和水杨酸乙基己基酯。
本发明的局部用美容组合物还可含有常用的美容佐剂和添加剂，如防腐剂/抗氧化剂、脂肪物质/油、水、有机溶剂、硅酮、增稠剂、软化剂、乳化剂、防晒剂、消泡剂、保湿剂、美学组分如芳香剂、表面活性剂、填料、掩蔽剂、阴离子、阳离子、非离子或两性聚合物或其混合物、推进剂、酸化剂或碱化剂、染料、着色剂/染色剂、磨料、吸附剂、精油、皮肤感觉剂、收敛剂、消泡剂、颜料或纳米颜料，例如适于通过物理阻断紫外线辐射而提供光保护效果的那些，或通常配制到美容组合物中的任何其他成分。适用于本发明的组合物中的通常用于皮肤护理行业中的此类美容成分例如描述于CTFA Cosmetic Ingredient Handbook,第2版(1992)中，但不限于此。
美容品以及皮肤病学佐剂和添加剂的必需量可由本领域技术人员基于期望的产品容易地选择，并将在实施例中进行阐明，但不仅限于此。
当然，本领域技术人员应小心地选择上述任选的附加化合物及其量，使得与根据本发明的组合本质上相关的有利性质不受或基本上不受所设想的一种或多种添加的不利影响。
根据本发明的局部用组合物的粘度优选为至少1000mPs(通过TA Instruments AR550测定，剪切速率为1s-1，25℃，板为SST ST 40mm)，优选在2000-15000mPas的范围内，例如在5000-13000mPas的范围内。
根据本发明的局部用组合物的pH优选为3-10，更优选pH为4-8，最优选pH为4-7。
提供以下实施例以进一步阐明本发明的组合物和效果。这些实施例仅是说明性的，并不意图以任何方式限制本发明的范围。
实施例1：
如表1和2所示，制备了使用不同乳化剂(阴离子(Ref)和非离子(Inv))的各种制剂。最初，通过显微镜分析在任何制剂中均未观察到晶体。然后将制剂在室温下储存，并多次通过显微镜分析10-羟基硬脂酸的重结晶，直至3个月。其结果列于表2中。
表1
制备程序
第1：将A部分加热至90℃，将B部分加热至80℃。
第2：合并A部分和B部分，并以10.000rpm均化1分钟。
第3：在搅拌条件下冷却。
第4：在搅拌条件下，在35℃下加入C部分。
第5：最后，在搅拌条件下冷却至室温。
表2
从表2可以得出：使用非离子乳化剂能够显著延迟或甚至抑制局部用组合物中10-羟基硬脂酸的重结晶。
实施例2
制备了包含表3中列出的非离子PEG基乳化剂(PEG-40硬脂酸酯)和阴离子乳化剂(硬脂酸)的制剂。
即使在3个月后，该制剂也不导致任何晶体形成。
表3
| INCI | 重量％ |
| BHT | 0.1 |
| 10-羟基硬脂酸 | 1.0 |
| 硬脂酸 | 17.0 |
| 肉豆蔻酸异丙酯 | 10.0 |
| PEG-40硬脂酸酯 | 5.0 |
| 硬脂醇 | 3.0 |
| 山梨酸 | 0.2 |
| 黄原胶 | 0.3 |
| 水 | 加至100 |
| ……后显微镜方面结晶 | 3个月后无晶体 |
Claims (21)
1.一种局部用组合物，所述组合物包含：
10-羟基硬脂酸或其盐，
至少一种非离子乳化剂，和
助乳化剂，所述助乳化剂选自具有12-22个碳原子的非离子固体脂肪醇及其混合物，
其中所述局部用组合物是包含水相和油相的O/W乳剂，并且基于所述组合物的总重量，所述水相占至少50重量％，所述油相占至少10重量％，
并且其中基于所述组合物的总重量，所述10-羟基硬脂酸或其盐的量选自0.001-5重量％的范围内，所述非离子乳化剂的量选自0.1-7重量％的范围内，
前提条件是所述组合物不含任何对羟基苯甲酸酯。
2.根据权利要求1所述的局部用组合物，其还不含冷却剂和/或放热剂。
3.根据权利要求1或2所述的局部用组合物，其特征在于：基于所述组合物的总重量，所述10-羟基硬脂酸或其盐的量选自0.01-3重量％的范围内。
4.根据权利要求1或2所述的局部用组合物，其特征在于：基于所述组合物的总重量，所述10-羟基硬脂酸或其盐的量选自0.1-2重量％的范围内。
5.根据权利要求1或2所述的局部用组合物，其特征在于：基于所述组合物的总重量，所述10-羟基硬脂酸或其盐的量选自0.1-1.5重量％的范围内。
6.根据权利要求1或2所述的局部用组合物，其特征在于：基于所述组合物的总重量，所述非离子乳化剂的量选自1-6重量％的范围内。
7.根据权利要求1或2所述的局部用组合物，其特征在于：基于所述组合物的总重量，所述非离子乳化剂的量选自1-5重量％的范围内。
8.根据权利要求1或2所述的局部用组合物，其特征在于：使用10-羟基硬脂酸。
9.根据权利要求1或2所述的局部用组合物，其特征在于：使用(R)-10-羟基硬脂酸。
10.根据权利要求1或2所述的局部用组合物，其特征在于：所述至少一种非离子乳化剂选自脂肪醇的酯、聚亚烷基二醇烷基醚、聚亚烷基二醇脂肪酸酯、葡糖苷烷基醚、烷基葡萄糖酯、甘油烷基酯、脱水山梨糖醇脂肪酸酯以及聚乙二醇和聚丙二醇的嵌段聚合物。
11.根据权利要求1或2所述的局部用组合物，其特征在于：所述至少一种非离子乳化剂选自C12-C22-醇的C12-C22-烷基酯，聚乙二醇烷基醚，聚乙二醇脂肪酸酯，(聚甘油基)烷基葡萄糖烷基酯，甘油C12-C22脂肪酸酯和脱水山梨糖醇单脂肪酸酯。
12.根据权利要求1或2所述的局部用组合物，其特征在于：所述至少一种非离子乳化剂选自环氧乙烷数目为2至30的聚乙二醇C12-C22-烷基醚和环氧乙烷数目为2至150的聚乙二醇C12-C22脂肪酸酯。
13.根据权利要求1或2所述的局部用组合物，其特征在于：所述至少一种非离子乳化剂选自聚甘油-3甲基葡萄糖二硬脂酸酯、鲸蜡硬脂基葡糖苷、甲基葡萄糖倍半硬脂酸酯、鲸蜡硬脂醇橄榄油酸酯、脱水山梨糖醇橄榄油酸酯、PEG-40硬脂酸酯、PEG-100硬脂酸酯、甘油基硬脂酸酯、硬脂醇聚醚-2和硬脂醇聚醚-21。
14.根据权利要求1或2所述的局部用组合物，其特征在于：所述助乳化剂选自鲸蜡醇、山嵛醇和鲸蜡硬脂醇及其混合物。
15.根据权利要求1或2所述的局部用组合物，其特征在于：基于所述组合物的总重量，所述助乳化剂的量选自0.1-20重量％的范围内。
16.根据权利要求1或2所述的局部用组合物，其特征在于：基于所述组合物的总重量，所述助乳化剂的量选自0.5-10重量％的范围内。
17.根据权利要求1或2所述的局部用组合物，其特征在于：基于所述组合物的总重量，所述助乳化剂的量选自1-5重量％的范围内。
18.根据权利要求1或2所述的局部用组合物，其特征在于：所述组合物包含防腐剂，所述防腐剂选自苯氧基乙醇和乙基己基甘油及其混合物。
19.一种延迟或抑制局部用组合物中10-羟基硬脂酸或其盐的重结晶的方法，所述方法包括：在至少一种非离子乳化剂存在下配制10-羟基硬脂酸或其盐，其中基于所述组合物的总重量，所述10-羟基硬脂酸或其盐的量选自0.001-5重量％的范围内，所述非离子乳化剂的量选自0.1-7重量％的范围内，所述局部用组合物包含助乳化剂，所述助乳化剂选自具有12-22个碳原子的非离子固体脂肪醇及其混合物。
20.根据权利要求19所述的方法，其特征在于：所述至少一种非离子乳化剂选自聚甘油-3甲基葡萄糖二硬脂酸酯、鲸蜡硬脂基葡糖苷、鲸蜡硬脂醇橄榄油酸酯、脱水山梨糖醇橄榄油酸酯、甲基葡萄糖倍半硬脂酸酯、PEG-40硬脂酸酯、PEG-100硬脂酸酯、甘油基硬脂酸酯、硬脂醇聚醚-2和硬脂醇聚醚-21及其混合物。
21.根据权利要求20所述的方法，其特征在于：所述至少一种非离子乳化剂选自PEG-40硬脂酸酯、PEG-100硬脂酸酯、硬脂醇聚醚-2和硬脂醇聚醚-21及其混合物。
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| EP3181121B1 (en) * | 2010-12-03 | 2020-10-28 | EPI Health, LLC | Pharmaceutical cream compositions comprising oxymetazoline to treat rosacea |
| US8613939B2 (en) | 2010-12-15 | 2013-12-24 | Conopco, Inc. | Leave-on nonsolid skin conditioning compositions containing 12-hydroxystearic acid and ethoxylated hydrogenated castor oil |
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| WO2007039057A1 (en) * | 2005-09-23 | 2007-04-12 | Dsm Ip Assets B.V. | Cosmetic compositions comprising hydroxyfatty acids |
| JP2009286739A (ja) * | 2008-05-30 | 2009-12-10 | Mandom Corp | 非水系温感皮膚洗浄用組成物 |
| CN105407861A (zh) * | 2013-08-01 | 2016-03-16 | 莱雅公司 | 包含聚甘油酯、多元醇和表面活性剂的无水组合物 |
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