CN109069384B - 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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- CN109069384B CN109069384B CN201780023090.8A CN201780023090A CN109069384B CN 109069384 B CN109069384 B CN 109069384B CN 201780023090 A CN201780023090 A CN 201780023090A CN 109069384 B CN109069384 B CN 109069384B
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- China
- Prior art keywords
- topical composition
- hydroxystearic acid
- salt
- emulsifier
- range
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- 239000000203 mixture Substances 0.000 title claims abstract description 122
- PAZZVPKITDJCPV-UHFFFAOYSA-N 10-hydroxyoctadecanoic acid Chemical compound CCCCCCCCC(O)CCCCCCCCC(O)=O PAZZVPKITDJCPV-UHFFFAOYSA-N 0.000 title claims abstract description 60
- 230000000699 topical effect Effects 0.000 claims abstract description 72
- ULQISTXYYBZJSJ-UHFFFAOYSA-N 12-hydroxyoctadecanoic acid Chemical compound CCCCCCC(O)CCCCCCCCCCC(O)=O ULQISTXYYBZJSJ-UHFFFAOYSA-N 0.000 claims abstract description 45
- 150000003839 salts Chemical class 0.000 claims abstract description 42
- 229940114072 12-hydroxystearic acid Drugs 0.000 claims abstract description 21
- 238000000034 method Methods 0.000 claims abstract description 8
- 238000001953 recrystallisation Methods 0.000 claims abstract description 6
- 230000002401 inhibitory effect Effects 0.000 claims abstract description 4
- 239000003995 emulsifying agent Substances 0.000 claims description 24
- 239000000839 emulsion Substances 0.000 claims description 15
- 239000012071 phase Substances 0.000 claims description 12
- 239000008346 aqueous phase Substances 0.000 claims description 10
- 239000007957 coemulsifier Substances 0.000 claims description 9
- RMGVATURDVPNOZ-UHFFFAOYSA-M potassium;hexadecyl hydrogen phosphate Chemical group [K+].CCCCCCCCCCCCCCCCOP(O)([O-])=O RMGVATURDVPNOZ-UHFFFAOYSA-M 0.000 claims description 7
- 125000004432 carbon atom Chemical group C* 0.000 claims description 6
- BXWNKGSJHAJOGX-UHFFFAOYSA-N hexadecan-1-ol Chemical compound CCCCCCCCCCCCCCCCO BXWNKGSJHAJOGX-UHFFFAOYSA-N 0.000 claims description 6
- VBICKXHEKHSIBG-UHFFFAOYSA-N 1-monostearoylglycerol Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCC(O)CO VBICKXHEKHSIBG-UHFFFAOYSA-N 0.000 claims description 5
- 239000003755 preservative agent Substances 0.000 claims description 5
- PAZZVPKITDJCPV-QGZVFWFLSA-N (R)-10-hydroxyoctadecanoic acid Chemical compound CCCCCCCC[C@@H](O)CCCCCCCCC(O)=O PAZZVPKITDJCPV-QGZVFWFLSA-N 0.000 claims description 4
- NOPFSRXAKWQILS-UHFFFAOYSA-N docosan-1-ol Chemical compound CCCCCCCCCCCCCCCCCCCCCCO NOPFSRXAKWQILS-UHFFFAOYSA-N 0.000 claims description 4
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- 229960000541 cetyl alcohol Drugs 0.000 claims description 3
- 229940075529 glyceryl stearate Drugs 0.000 claims description 3
- CHHHXKFHOYLYRE-UHFFFAOYSA-M 2,4-Hexadienoic acid, potassium salt (1:1), (2E,4E)- Chemical compound [K+].CC=CC=CC([O-])=O CHHHXKFHOYLYRE-UHFFFAOYSA-M 0.000 claims description 2
- QCDWFXQBSFUVSP-UHFFFAOYSA-N 2-phenoxyethanol Chemical compound OCCOC1=CC=CC=C1 QCDWFXQBSFUVSP-UHFFFAOYSA-N 0.000 claims description 2
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- WXMKPNITSTVMEF-UHFFFAOYSA-M sodium benzoate Chemical compound [Na+].[O-]C(=O)C1=CC=CC=C1 WXMKPNITSTVMEF-UHFFFAOYSA-M 0.000 claims description 2
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- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 description 6
- 125000005907 alkyl ester group Chemical group 0.000 description 6
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- 229910052708 sodium Inorganic materials 0.000 description 6
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- ALYNCZNDIQEVRV-UHFFFAOYSA-N 4-aminobenzoic acid Chemical group NC1=CC=C(C(O)=O)C=C1 ALYNCZNDIQEVRV-UHFFFAOYSA-N 0.000 description 4
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- FMRHJJZUHUTGKE-UHFFFAOYSA-N Ethylhexyl salicylate Chemical compound CCCCC(CC)COC(=O)C1=CC=CC=C1O FMRHJJZUHUTGKE-UHFFFAOYSA-N 0.000 description 4
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- WWZKQHOCKIZLMA-UHFFFAOYSA-N octanoic acid Chemical compound CCCCCCCC(O)=O WWZKQHOCKIZLMA-UHFFFAOYSA-N 0.000 description 4
- 229920001223 polyethylene glycol Polymers 0.000 description 4
- 239000002562 thickening agent Substances 0.000 description 4
- LADGBHLMCUINGV-UHFFFAOYSA-N tricaprin Chemical compound CCCCCCCCCC(=O)OCC(OC(=O)CCCCCCCCC)COC(=O)CCCCCCCCC LADGBHLMCUINGV-UHFFFAOYSA-N 0.000 description 4
- PUPZLCDOIYMWBV-UHFFFAOYSA-N (+/-)-1,3-Butanediol Chemical compound CC(O)CCO PUPZLCDOIYMWBV-UHFFFAOYSA-N 0.000 description 3
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- 239000002202 Polyethylene glycol Substances 0.000 description 3
- ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 description 3
- QAOWNCQODCNURD-UHFFFAOYSA-L Sulfate Chemical compound [O-]S([O-])(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-L 0.000 description 3
- 239000008168 almond oil Substances 0.000 description 3
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- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 description 3
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- OSCJHTSDLYVCQC-UHFFFAOYSA-N 2-ethylhexyl 4-[[4-[4-(tert-butylcarbamoyl)anilino]-6-[4-(2-ethylhexoxycarbonyl)anilino]-1,3,5-triazin-2-yl]amino]benzoate Chemical compound C1=CC(C(=O)OCC(CC)CCCC)=CC=C1NC1=NC(NC=2C=CC(=CC=2)C(=O)NC(C)(C)C)=NC(NC=2C=CC(=CC=2)C(=O)OCC(CC)CCCC)=N1 OSCJHTSDLYVCQC-UHFFFAOYSA-N 0.000 description 2
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- NKEQOUMMGPBKMM-UHFFFAOYSA-N 2-hydroxy-2-[2-(2-hydroxy-3-octadecanoyloxypropoxy)-2-oxoethyl]butanedioic acid Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCC(O)COC(=O)CC(O)(C(O)=O)CC(O)=O NKEQOUMMGPBKMM-UHFFFAOYSA-N 0.000 description 2
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Abstract
本发明涉及局部用组合物，所述组合物包含10‑羟基硬脂酸或其盐与12‑羟基硬脂酸或其盐的组合。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12‑羟基硬脂酸或其盐存在下配制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-羟基硬脂酸或其盐与 12-羟基硬脂酸或其盐的组合。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12-羟基硬脂酸或其盐存在下配制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，通过将10-羟基硬脂酸与12-羟基硬脂酸或其盐混合配制，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12-羟基硬脂酸或其盐。
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，所述量始终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12-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，所述量始终是基于所述组合物的总重量。
优选地，10-羟基硬脂酸或其盐与12-羟基硬脂酸或其盐的(摩尔)比选自20:1至1:10的范围内、优选15:1至1:10的范围内、最优选10:1至 1:1的范围内。
10-羟基硬脂酸(同义词：10-羟基十八烷酸，CAS：638-26-6)可以例如如G.Schroepfer在Biological Chemistry(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。
12-羟基硬脂酸(同义词：12-羟基十八烷酸，CAS：106-14-9)例如可以分别在Sigma-Aldrich和Alberdink Boley商购获得，其具有下式：
优选地，根据本发明使用的12-羟基硬脂酸是从蓖麻油通过氢化和水解获得的，具有至少80％、例如80-85％的纯度。
各自的盐可以通过与有机碱或碱金属碱(alkali base)或碱土金属碱 (earthalkaline base)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，例如特别是钾盐和钠盐。
根据本发明的局部用组合物优选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12-羟基硬脂酸或其盐存在下配制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，其中水相优选占组合物的至少 50重量％，油相优选占组合物的至少10重量％。更优选地，水相占至少 60重量％，油相占少于40重量％。特别地，水相占总组合物的至少70重量％，油相占总组合物的少于30重量％。在本发明的所有实施方式中，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。
优选地，根据本发明的局部用组合物是O/W乳剂。
在一个优选的实施方式中，这些O/W乳剂含有至少一种选自以下的 O/W-乳化剂或Si/W-乳化剂：鲸蜡硬脂醇硫酸钠，甘油基硬脂酸酯柠檬酸酯，甘油基硬脂酸酯，硬脂酸，硬脂酸盐，聚甘油基-3甲基葡萄糖二硬脂酸酯，甲基葡萄糖倍半硬脂酸酯，鲸蜡硬脂醇硫酸钠，油酸甘油酯磷酸钠，氢化植物甘油酯，脱水山梨糖醇油酸酯，脱水山梨糖醇倍半油酸酯，脱水山梨糖醇异硬脂酸酯，脱水山梨糖醇三油酸酯，鲸蜡硬脂醇葡糖苷，鲸蜡硬脂醇橄榄油酸酯，月桂基葡糖苷，癸基葡糖苷，硬脂酰谷氨酸钠，蔗糖多硬脂酸酯，水合聚异丁烯，磷酸酯乳化剂例如特别是C8-10烷基乙基磷酸酯，C9-15烷基磷酸酯，鲸蜡硬脂醇聚醚-2磷酸酯，鲸蜡硬脂醇聚醚-5磷酸酯，鲸蜡醇聚醚-8磷酸酯，鲸蜡醇聚醚-10磷酸酯，鲸蜡基磷酸酯，C6-10链烷醇醚-4磷酸酯，C12-15链烷醇醚-2磷酸酯，C12-15链烷醇醚-3磷酸酯， DEA-鲸蜡硬脂醇聚醚-2磷酸酯，DEA-鲸蜡基磷酸酯，DEA-油醇聚醚-3磷酸酯，鲸蜡基磷酸钾，癸醇聚醚-4磷酸酯，癸醇聚醚-6磷酸酯和三月桂醇聚醚-4磷酸酯，聚乙二醇烷基醚(PEG-醚)，例如特别是硬脂醇聚醚-2和硬脂醇聚醚-21，聚乙二醇脂肪酸酯(PEG-酯)例如特别是PEG-40硬脂酸酯和PEG-100硬脂酸酯，聚乙二醇和聚丙二醇的嵌段聚合物例如特别是 PPG-1-PEG-9月桂基乙二醇醚，PPG-1-PEG-9月桂基乙二醇醚，PEG/PPG- 18/18聚二甲基硅氧烷和十六烷基PEG/PPG-10/1聚二甲基硅氧烷以及具有乳化性质的合成聚合物例如PVP二十碳烯共聚物，丙烯酸酯/丙烯酸C10-30烷基酯交联聚合物，以及这些乳化剂的混合物。
基于组合物的总重量，至少一种O/W乳化剂或Si/W乳化剂的使用量 (总量)优选为0.5-10重量％，特别地在0.5-6重量％的范围内，例如更特别地在0.5-5重量％的范围内，例如最特别地在0.5-4重量％的范围内。
根据本发明的局部用组合物中待使用的特别合适的O/W乳化剂包括鲸蜡硬脂醇硫酸钠(Lanette E)、甘油基硬脂酸酯柠檬酸酯(Imwitor)和十六烷基磷酸钾(
K)。在本发明的所有实施方式中，最优选的是十六烷基磷酸钾(
K)，例如可在DSM Nutritional Products Ltd Kaiseraugst商购获得。
在一个有利的实施方式中，本发明涉及具有本文给出的所有限定和优选方案的局部用组合物，其为O/W乳剂的形式，包含在O/W乳化剂存在下分散在水相中的油相，其中所述O/W乳化剂是鲸蜡基磷酸钾。
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选自山嵛醇(例如可从BASF以Lanette 22商购获得)、鲸蜡醇(例如可从BASF以Lanette16 商购获得)、甘油基硬脂酸酯(例如可从Croda以Cithrol GMS 40商购获得或可从BASF以Cutina GMS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)及其混合物。
基于根据本发明的局部用组合物的总重量，所述组合物中助乳化剂的 (总)量优选选自0.1-20重量％的范围内、更优选0.5-10重量％的范围内、最优选1-5重量％的范围内。
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。其他合适的保湿剂包括糖类同分异构体(saccharide isomerate)(例如可作为
获得的)，戊二醇(例如可作为
获得的)丙二醇，丁二醇和尿素及其混合物。
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选自苯氧基乙醇、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0.5-1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400 nm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 UltravioletFilters”(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EP 1471995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。
待掺入根据本发明的局部用组合物中的优选的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。
待掺入根据本发明的局部用组合物中的优选的广谱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。
待掺入根据本发明的局部用组合物中的优选的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。
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为3-10，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所示，制备了不使用脂肪酸(参照1)或使用不同脂肪酸作为添加剂(硬脂酸(参照2)、油酸(参照3)和12-羟基硬脂酸(本发明)) 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1 中。
表1
Claims (22)
1.一种以O/W乳剂形式的局部用组合物，所述组合物包含10-羟基硬脂酸或其盐和12-羟基硬脂酸或其盐和O/W乳化剂，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，并且所述12-羟基硬脂酸或其盐的量选自0.1-2重量％的范围内，并且所述O/W乳化剂是鲸蜡基磷酸钾。
2.根据权利要求1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。
3.根据权利要求1-2中任一项所述的局部用组合物，其特征在于：基于根据本发明所述的局部用组合物的总重量，所述组合物中12-羟基硬脂酸或其盐的量选自0.1-1.5重量％的范围内。
4.根据权利要求1-2中任一项所述的局部用组合物，其特征在于：10-羟基硬脂酸或其盐与12-羟基硬脂酸或其盐的摩尔比选自20:1至1:10的范围内。
5.根据权利要求1-2中任一项所述的局部用组合物，其特征在于：10-羟基硬脂酸或其盐与12-羟基硬脂酸或其盐的摩尔比选自15:1至1:10的范围内。
6.根据权利要求1-2中任一项所述的局部用组合物，其特征在于：10-羟基硬脂酸或其盐与12-羟基硬脂酸或其盐的摩尔比选自10:1至1:1的范围内。
7.根据权利要求1-2中任一项所述的局部用组合物，其特征在于：使用10-羟基硬脂酸。
8.根据权利要求1-2中任一项所述的局部用组合物，其特征在于：使用(R)-10-羟基硬脂酸。
9.根据权利要求1-2中任一项所述的局部用组合物，其特征在于：使用12-羟基硬脂酸。
10.根据权利要求1-2中任一项所述的局部用组合物，其特征在于：所述局部用组合物包含水相和油相以及至少一种O/W乳化剂或Si/W乳化剂。
11.根据权利要求10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，所述水相占至少50重量％，所述油相占至少10重量％。
12.根据权利要求10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，所述至少一种O/W乳化剂或Si/W乳化剂的使用总量为0.5-10重量％。
13.根据权利要求10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，所述至少一种O/W乳化剂或Si/W乳化剂的使用总量在0.5-6重量％的范围内。
14.根据权利要求10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，所述至少一种O/W乳化剂或Si/W乳化剂的使用总量在0.5-5重量％的范围内。
15.根据权利要求10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，所述至少一种O/W乳化剂或Si/W乳化剂的使用总量在1-4重量％的范围内。
16.根据权利要求1-2中任一项所述的局部用组合物，其特征在于：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。
17.根据权利要求1-2中任一项所述的局部用组合物，其特征在于：所述局部用组合物包含助乳化剂，所述助乳化剂选自鲸蜡醇、山嵛醇、甘油硬脂酸酯和鲸蜡硬脂醇及其混合物。
18.根据权利要求16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。
19.根据权利要求16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。
20.根据权利要求16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。
21.根据权利要求1-2中任一项所述的局部用组合物，其特征在于：所述组合物包含至少一种防腐剂，所述防腐剂选自苯氧基乙醇、乙基己基甘油、山梨酸钾和苯甲酸钠及其混合物。
22.一种延迟或抑制以O/W乳剂形式的局部用组合物中10-羟基硬脂酸或其盐的重结晶的方法，所述方法包括：在12-羟基硬脂酸或其盐和O/W乳化剂存在下配制10-羟基硬脂酸或其盐，并且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，并且所述12-羟基硬脂酸或其盐的量选自0.1-2重量％的范围内，并且所述O/W乳化剂是鲸蜡基磷酸钾。
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