CN105979924A - 用于皮肤递送的油包多元醇乳液 - Google Patents
用于皮肤递送的油包多元醇乳液 Download PDFInfo
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- CN105979924A CN105979924A CN201480064275.XA CN201480064275A CN105979924A CN 105979924 A CN105979924 A CN 105979924A CN 201480064275 A CN201480064275 A CN 201480064275A CN 105979924 A CN105979924 A CN 105979924A
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Abstract
本发明涉及一种光学透明的油包多元醇组合物,其中所述组合物包含:a)≥40重量%且≤90重量%的至少一种低分子量多元醇,b)≥1.0重量%且≤25重量%的至少一种化妆品或治疗活性物,c)≥1.0重量%且≤10重量%的至少一种不含聚醚的乳化剂,d)≥2.0重量%且≤25重量%的至少一种油组分,其中所述乳液包含尺寸在≥20nm且≤1000nm范围内的乳化剂包覆的液滴。
Description
发明领域
本发明涉及一种光学透明的油包多元醇组合物,其中所述组合物包含:a)≥40重量%且≤90重量%的至少一种低分子量多元醇,b)≥1.0重量%且≤25重量%的至少一种化妆品或治疗活性物,c)≥1.0重量%且≤10重量%的至少一种不含聚醚的乳化剂,d)≥2.0重量%且≤25重量%的至少一种油组分,其中所述乳液包含尺寸为≥20nm且≤1000nm的乳化剂包覆的液滴。
发明背景
在最近数十年中,药理学、皮肤病学和化妆品领域中开发了尖端草药配制剂,其能使高活性成分的递送性质适应设计应用的特殊要求。由于易于施用、功效、肤感和成本原因,大多使用含水的乳液型配制剂,其包括绝大部分在上述市场上可获得的产品。然而,由于水在该草药系统中的活性,在某些情况下可能难以确保配制剂具有足够的稳定性。当必须引入具有强烈的水解或任何其它类型的水引发降解倾向的活性组分时,尤其存在这种情况。
为了克服该类稳定性问题,已开发了若干种不同的方法以用于皮肤病学和化妆品应用,据称其能保护不稳定成分以防降解。因此,在储存期间,活性物浓度保持恒定,由此保持总体配制剂的功效。
一种保护不稳定成分的可能策略例如由JP2009215298A给出,其中描述了一种呈水包油型乳液形式的组合物,其包含:抗坏血酸化合物或水杨酸化合物;选自脂肪酸与聚乙二醇的酯、16-22C脂肪酸与失水山梨醇的酯,和16-22C脂肪酸与甘油的酯;和氧化乙烯和氧化丙烯的缩聚物。
另一种方法描述在EP2116223A1中,其公开了一种分散体组合物,所述组合物包含含类胡萝卜素的油组分,所述分散体组合物通过将含水分散体与含水组合物混合而获得,所述含水分散体包含乳液颗粒,所述乳液颗粒包含含类胡萝卜素的油组分和磷脂或其衍生物;所述含水组合物包含抗坏血酸或其衍生物和相对于全部分散体组合物为20质量%或更少的油组分;所述分散体组合物具有平均粒径为200nm或更小的乳液颗粒。还公开了通过将含水分散体与含水组合物混合而获得的分散体组合物,所述含水分散体包含乳液颗粒,所述乳液颗粒包含含类胡萝卜素的油组分和磷脂或其衍生物,所述含水组合物包含抗坏血酸或其衍生物和pH调节剂,所述分散体组合物具有5-7.5的pH值;和用于皮肤护理的化妆品制剂,其包含一种或其它分散体组合物。
此外,JP2006117534A描述了一种经乳化的化妆品,其在使用中具有优异的感觉且在漂白化妆品中具有随时间的稳定性,其包含抗坏血酸葡糖苷作为活性成分。所述经乳化的化妆品包含:(a)抗坏血酸葡糖苷,(b)聚丙烯酰胺,(c)山萮醇,和(d)具有>=10HLB的非离子表面活性剂,所述化妆品在25℃的粘度为2,000-20,000mPa·s。
然而,上述策略要么包含呈稳定化形式的活性组分,要么从加工起始时开始起就在组合物中存在显著量的水。在后一情况下,这可导致在加工和/或储存过程中形成降解产物;在第一种情况下,由于使用保护基团,活性成分的功效可能降低。
考虑到许多有益的活性物仅微溶于常用的亲水性和疏水性乳液型环境中,且如上文所述,活性物的稳定性或功效受到水的存在或活性物的化学改性的不利影响,仍需要提供进一步被皮肤病学所接受的、可易于施用的草药配制剂,其能在储存期间保护敏感成分免受降解。
因此,本发明的目的是提供不具有现有技术的一种或多种缺点的该类组合物,即能溶解显著量的亲水性或疏水性活性物、在施用至身体表面上时具有舒适感觉、显示出优异的稳定性和渗透行为且可容易地加工的组合物。
发明简述
已令人惊讶地发现,一种光学透明的油包多元醇组合物可合适地用于以高浓度均匀溶解宽范围的不同化学品或皮肤病学活性物,且与现有技术的含水乳液相比为提高的活性物稳定性提供安全的环境,其特征在于所述组合物包含:a)≥40重量%且≤90重量%的至少一种低分子量多元醇,b)≥1.0重量%且≤25重量%的至少一种化妆品或治疗活性物,c)≥1.0重量%且≤10重量%的至少一种不含聚醚的乳化剂,d)≥2.0重量%且≤25重量%的至少一种油组分,其中所述乳液包含尺寸在≥20nm且≤1000nm范围内的乳化剂包覆的液滴。此外,本发明的组合物还能均匀引入微溶性成分,由此形成光学透明的乳液。由于不存在水,因此水解敏感性成分的稳定性得以提高,且即使在较高的储存温度下也保持化妆品或治疗活性物的活性。本发明的组合物是非常皮肤友好的,且获得了亲水性和疏水性活性物的良好渗透特性。不受限于理论,由于通过渗入皮肤的疏水性脂质外套膜中,亲水性组合物中的疏水性活性物的热力学活性降低,因此可提高疏水性成分的渗透。由于本发明的乳化剂包覆的液滴尺寸足够小以至于获得乳化剂包覆的液滴与皮肤的良好接触,因此可实现亲水性活性物的良好渗透。此外,由于存在不含聚醚的乳化剂,在储存期间避免不希望的过氧化物降解产物(其可通过含聚醚的乳化剂如PEG或PPG的自氧化产生)。这样的降解产物可能对皮肤结构具有高侵蚀性,或者可导致配制剂的令人不快的气味。此外,整个组合物可易于加工,且对引入另外的功能性化合物如香料、pH调节剂、粘度调节剂、颜料等具有非常高的容忍度。此外有利的是,当超过临界相-体积比时,所述油包多元醇组合物形成具有反立方结构的溶致液晶相。不受限于理论,这样的相可有助于热力学稳定所述组合物并且有效保护活性物。
根据本发明的油包多元醇组合物是光学透明的,即所述组合物是光学澄清的或者仅稍微不透明的。这与现有技术的油包多元醇组合物相反,现有技术的油包多元醇组合物由于存在未溶解的活性物或较大的乳化剂包覆的液滴而通常是不透明的乳液。
就本发明而言,低分子量多元醇具有小于500g/mol,优选小于400g/mol,且更优选小于300g/mol的分子量和多于一个羟基结构部分。这种类型的多元醇具有在施用时间内渗入皮肤或毛发中的正确尺寸,因此有助于化妆功效,此外还能稳定化妆品活性物。这些多元醇包含多于一个醇结构部分并且为环状、直链和支化的多元醇,如丙二醇、甘油、聚甘油、山梨醇、甘露糖醇、苏糖醇、阿糖醇、木糖醇、核糖醇、丁二醇、戊二醇、己二醇和二甲基异山梨醇。本发明的油包多元醇组合物还可通过使用多元醇混合物获得。特别优选的是包含多于一个醇结构部分的非乙氧基化多元醇。这样的多元醇较不易于自氧化,因此能够提高组合物的化学稳定性。特别优选的多元醇可以例如为丙二醇、甘油、山梨醇、甘露糖醇、苏糖醇、阿糖醇、木糖醇、核糖醇、丁二醇、戊二醇、己二醇和二甲基异山梨醇。
所述化妆品或治疗活性物可选自本领域技术人员已知的适于经皮施用的化妆品或药物活性剂,即包括具有用于不同适应症和应用领域的广谱的足够治疗潜力,特别是抗痤疮剂、抗微生物剂、止汗剂、收敛剂、除臭剂、脱毛剂、皮肤调理剂、皮肤滑爽剂、用于提高皮肤水合的试剂,例如脲,防晒剂、角质层分离剂、用于自由基的自由基受体、防腐活性成分、用于处理皮肤老化指征的活性成分和/或调节皮肤分化和/或增殖和/或染色的药剂、维生素如维生素C,具有刺激性副作用的活性成分,例如α-羟基酸、β-羟基酸、α-酮酸、β-酮酸、维甲类(视黄醇、视黄醛、视黄酸)、蒽啉类(二羟基蒽酚)、anthranoid类、过氧化物(特别是过氧化苯甲酰)、米诺地尔、锂盐、抗代谢药、维生素D及其衍生物;儿茶酚类、类黄酮类、神经酰胺类、月见草油、植物卵磷脂(例如大豆卵磷脂)、分离自植物的鞘脂类/神经酰胺类、多不饱和脂肪酸、必需脂肪酸(例如γ-亚麻酸)、酶、辅酶、酶抑制剂、水合试剂、皮肤舒缓剂、清洁剂或起泡剂,和无机或有机合成去光填料、摩擦剂。本发明的油包多元醇组合物还通过使用不同活性物的混合物获得。
根据本发明,使用不含聚醚的乳化剂来形成本发明的油包多元醇组合物。可用于化妆品目的的合适不含聚醚的乳化剂可例如见于Michael Ash和Irene Ash的Handbook of Green Chemicals,第2版,2004年6月,ISBN-13:978-1890595791。通常,可使用甘油酯、失水山梨醇酯、山梨醇酯、脂肪醇、丙二醇酯、烷基葡糖苷(glycosit)酯、糖酯、卵磷脂、硬脂酸、肉豆蔻酸、月桂酸、琥珀酸酯、脂肪酸的乙醇酰胺或酰胺和硅乳化剂。还可使用不同类型的乳化剂的混合物。再次,出于稳定性原因,可特别地使用非乙氧基化的硅乳化剂。
优选地,所述乳化剂选自氨基官能的乳化剂。该乳化剂可有效地形成油包多元醇乳液且已知为非常皮肤友好的乳化剂。
油组分可选自所有种类的化妆品或药理学可接受的油。适用于化妆品目的的油的实例例如在CTFA transactions,Cosmetic IngredientHandbook,第1版,1988年,The Cosmetic,Toiletry and FragranceAssociation,Inc.,Washington中提及。可用于本发明的油包多元醇组合物中的合适实例可例如为矿物油如链烷烃油或凡士林油、硅油,植物油如椰子油、甜杏仁油、杏仁油、玉米油、霍霍巴油、橄榄油、鳄梨油、芝麻油、棕榈油、桉树油、迷迭香油、薰衣草油、松油、百里香油、薄荷油、小豆蔻油、橙花油、大豆油、麸油、米糠油、菜籽油和蓖麻油,脂肪酸酯、脂肪醇的酯如甘油三酯。
此外,也可将硅油用于本发明中,其呈挥发性和/或非挥发性硅油形式。优选的硅油为非挥发性硅油,其INCI名称已知为聚二甲基硅氧烷和聚二甲基硅氧烷醇(dimethiconol)。挥发性硅油如环状聚甲基硅氧烷可与非挥发性有机硅和/或其它蜡和/或上文所述的油组合使用。它们可由各公司商购获得,例如Dow Corning的已知DC系列、WackerChemie和Toray silicones。所有市售的非挥发性有机硅均适用于本发明的组合物中。此外,本发明的组合物中可有利地包含在其分子中包括至少一个芳基的芳基化有机硅,如苯基聚甲基硅氧烷、苯基聚三甲基硅氧烷、二苯基聚二甲基硅氧烷、二苯基甲硅氧烷基苯基聚三甲基硅氧烷、四甲基四苯基三硅氧烷、三苯基聚三甲基硅氧烷、四甲基四苯基三硅氧烷和三甲基五苯基三硅氧烷。
特别地,使用非极性油如硅油、环状聚甲基硅氧烷、链烷烃油、异链烷烃油、凡士林或角鲨烷会导致形成非常稳定的乳化剂包覆的液滴,因此该组非极性油可以优选用于构建本发明的油包多元醇组合物。
本发明的组合物包含尺寸为≥20nm且≤1000nm的乳化剂包覆的液滴。优选地,乳化剂包覆的液滴的尺寸范围可以在≥50nm且≤600nm,另外优选≥100nm且≤500nm的范围内。这样的尺寸范围能稳定地形成乳液,而不形成任何乳化剂包覆的液滴的聚结体,且是所述油包多元醇组合物为光学澄清的先决条件。乳化剂包覆的液滴的尺寸可通过散射技术如激光散射测定。在此,特别可以将MALLS(多角度激光散射)用于测定乳化剂包覆的液滴的尺寸分布。
在本发明的另外方面中,乳化剂包覆的液滴的尺寸分布为高斯类型。Lorentz或Cauchy类型尺寸分布不是优选的,因为这种尺寸分布可能在油包多元醇组合物的储存期间导致稳定性问题。
在本发明的优选方面中,所述组合物的水含量可小于≤1重量%,优选≤0.5重量%,甚至更优选≤0.1重量%。如果要求组合物显示出自防腐性质,则低水含量是尤其合适的。在此,并不必须添加另外的防腐剂。包含低水含量的组合物还可视为浓缩物,其可在紧接施用前通过添加水而被调节至合适的粘度或活性范围,由此形成水包油包多元醇(polyol-in-oil-in-water,POW)组合物。
实际上,当本发明的组合物包含水时,上文所述的乳化剂包覆的液滴的尺寸针对内部液滴,即乳化剂包覆的多元醇液滴。
在本发明的另一实施方案中,所述组合物可以以基本上不含防腐剂的方式配制。配制剂的高的多元醇含量可导致所述组合物中的水活性显著降低,这又产生了自防腐体系。
优选实施方案详述
在本发明组合物的另一目的中,所述乳化剂为氨基官能的硅衍生物。特别地,已证明氨基官能的硅衍生物非常适合于所述油包多元醇组合物的容易加工。此外,这样的乳化剂是非常皮肤友好的,且即使在低浓度下也非常有效。不受限于理论,由于硅主链和氨基官能结构部分的组合,情况尤其如此。合适的氨基官能的乳化剂可选自WackerADM范围或ClariantSilicone WSI范围。在本发明的优选实施方案中,特别可以使用酰胺基聚甲基硅氧烷。
在本发明组合物的另一优选方面中,所述乳化剂为氨基封端的聚二甲基硅氧烷甘油氨基甲酸酯(glycerocarbamate)。已令人惊讶地发现,氨基封端的聚二甲基硅氧烷甘油氨基甲酸酯尤其能有效地形成显示异常高的稳定性的稳定的油包多元醇组合物。此外,该乳化剂能有助于活性物的分散过程。不受限于理论,这可能是由该不含氧化乙烯的有机硅乳化剂的高分子量所导致的。该乳化剂在环境温度下为液体,并且可在宽pH范围内使用,仅显示出中等粘度。这些特征使得加工和处理变得容易。此外,优选乳化剂氨基封端的聚二甲基硅氧烷甘油氨基甲酸酯是所述体系中仅有的乳化剂,从而获得显示出良好的储存稳定性且易于处理的不含聚醚的组合物。
根据本发明的一个另外的实施方案包括一种组合物,其中另外存在其量为≥0.5重量%且≤15重量%的低分子量醇。已令人惊讶地发现,本发明的油包多元醇组合物的肤感可通过添加一元醇而显著改变。因此,可调节施用后的不同的皮肤感受如凉爽感或肤感。可适合用于本发明中的低分子量醇为具有1-4个碳原子和1个OH结构部分的一元脂族醇。具体实例可以包括乙醇、丙醇、异丙醇、异丁醇和叔丁醇。优选地,可使用乙醇。此外,低分子量醇能够有效地改变某些活性物的渗透行为。在将难以渗透通过皮肤的脂质层的活性物递送至更深的皮肤层的情况下,低分子量醇的该含量可有利地用于提高活性物的皮肤渗透性。在≥1.5重量%且≤10重量%,优选≥3.0重量%且≤7.5重量%的醇浓度下,可另外获得合适的肤感效果。
本发明的优选特征公开了一种组合物,其中另外存在其量为≥0.5重量%且≤15重量%的聚乙烯基吡咯烷酮和/或聚乙烯基己内酰胺。聚乙烯基吡咯烷酮和/或聚乙烯基己内酰胺的引入可导致乳液和活性物进一步稳定化。此外,不同分子量的聚乙烯基吡咯烷酮和/或聚乙烯基己内酰胺可有效地提高活性物的渗透性。因此,可以将分子量为≥500Da且≤2×106Da,优选≥1000Da且≤500,000Da的聚乙烯基吡咯烷酮和/或聚乙烯基己内酰胺用于提高活性物的释放和渗透特性。在某些情况下,也可在所述油包多元醇组合物中引入浓度为≥1.0重量%且≤12重量%和≥5.0重量%且≤10重量%的聚乙烯基吡咯烷酮和/或聚乙烯基己内酰胺。也可使用聚乙烯基吡咯烷酮和/或聚乙烯基己内酰胺的混合物。
本发明的优选特征公开了一种组合物,其中另外存在其量为≥0.5重量%且≤15重量%的聚乙烯基己内酰胺。聚乙烯基己内酰胺的引入可导致乳液和活性物进一步稳定化。此外,不同分子量的聚乙烯基己内酰胺能够有效地提高活性物的渗透性。因此,可以将分子量为≥500Da且≤2×106Da,优选≥1000Da且≤500,000Da的聚乙烯基己内酰胺用于提高活性物的释放和渗透特性。在某些情况下,也可在所述油包多元醇组合物中适当地引入浓度为≥1.0重量%且≤12重量%和≥5.0重量%且≤10重量%的聚乙烯基己内酰胺。此外,也可将聚乙烯基己内酰胺和聚乙烯基吡咯烷酮的混合物合适地用于本发明的组合物中。
此外,本发明的组合物可包含选自如下组的化妆品或治疗活性物:抗坏血酸、生育酚、视黄醇、β-胡萝卜素、多酚、6-羟基-2,5,7,8-四甲基色满-2-羧酸(trolox)、槲皮素、芸香苷、杨梅树皮素、山奈酚、儿茶酸、表没食子儿茶精、表儿茶素、白藜芦醇、红葡萄酒提取物、白葡萄酒提取物、葡萄提取物、红茶提取物、绿茶提取物、白茶提取物。上述组的活性物可适当地引入本发明的油包多元醇组合物中且获得澄清的油包多元醇组合物。所述组的所有成员均显示出≤2μM的LDL-氧化抑制值IC50。因此,所述成分是强效抗氧化剂,并通常在含水标准乳液中显示出严重的降解。在本发明的优选实施方案中,所述化妆品或治疗活性物显示出≥0.001μM且≤5μM,优选≥0.01μM且≤2μM的LDL-氧化抑制值IC50。这些物质在本发明的油包多元醇组合物中被有效地保护,且即使在低浓度下也在皮肤上显示出显著的防护效果。LDL-氧化抑制值IC50可根据McDowell IF等,“A rapid method formeasurement of the susceptibility to oxidation of low-densitylipoprotein”,Ann.Clin.Biochem.1995年3月;32(Pt 2):167-74测定。
此外,其中所述化妆品或治疗活性物为抗坏血酸的组合物落入本发明的范围之内。抗坏血酸可使用本发明的油包多元醇组合物有效地溶解且显示出优异的稳定特性。即使在升高的储存温度下也不能检测到所述油包多元醇组合物的褪色。不受限于理论,这可由于所述油包多元醇组合物中的低水活性和在乳化剂包覆的液滴中有效引入抗坏血酸(这额外保护了抗坏血酸)而实现。在本发明的优选实施方案中,还可引入抗坏血酸和维生素E的组合。此外,已证明维生素C(抗坏血酸)和植物来源的多酚的组合可获得光学澄清的组合物。此外,已显示这样的混合物在本发明的组合物中非常稳定。在所述组合物中的这样的稳定性也可基于与本发明的油包多元醇递送体系组合的组合多酚/抗坏血酸的pH特性。
此外,其中另外存在其量为≥1.0重量%且≤10重量%的水的组合物落入本发明的范围之内,所述组合物包含水包油包多元醇(POW)结构。已令人惊讶地发现,即使在水存在下,所述油包多元醇组合物也能有效地保护敏感成分。不受限于理论,这是可能的,因为活性物在很大程度上被引入乳化剂包覆的液滴(其无论如何也构成了所述组合物的较大体积量)。因此,活性物被有效保护以免与水接触,从而导致更高的活性物总体稳定性。
在本发明组合物的另一目的中,所述组合物的浊度为≥0.01NTU且≤50NTU,根据DIN EN ISO 7027。有利地,可通过使用本发明的组合物获得光学澄清或仅稍微不透明的油包多元醇组合物。不受限于理论,由于本发明的组合物导致形成具有足够小以至于防止光散射的尺寸的乳化剂包覆的液滴,可实现该效果。此外,可容易地将活性物溶解在所选的油/乳化剂混合物中。这与其中活性物仅粗分散的其它组合物相反。较高的NTU值未落入本发明的范围之内,因为在这种情况下,整个组合物会变得过于半透明。该行为可影响消费者的接受度。组合物的NTU值可根据本领域已知的方法,例如根据DIN EN ISO7027测定。
制备本发明组合物的方法也落入本发明的范围之内,其中在如下步骤中:
1)将低分子量多元醇加热至≥50℃且≤100℃的温度,
2)通过搅拌将化妆品或治疗活性物溶解在步骤1)的加热的低分子量多元醇中,直至获得澄清溶液,
3)通过在层状拉伸流动条件下搅拌而将步骤2)的组合物添加至至少一种不含聚醚的乳化剂与至少一种油组分的混合物中。
通过使用该方法,可获得具有极高活性物含量和极窄液滴尺寸分布的油包多元醇乳液,从而获得光学澄清的产品。此外,所述乳液是稳定的且不发生聚结,从而获得储存稳定的光学澄清的乳液。此外,特别地保护敏感的活性物,从而导致活性物的优异储存稳定性。需要的话,例如为了调节乳液粘度,可在低分子量多元醇相中添加NaCl。全部工艺步骤1)-3)的温度可以在≥50℃且≤100℃,优选≥60℃且≤85℃范围内。这样的温度范围可使得活性物的溶解变得容易,且可另外有利于形成均一液滴。
如果当肉眼观察时在所述组合物中看不到颗粒,则在步骤2)中获得了光学澄清的溶液。此外,可通过应用仅使用层状拉伸流动条件的混合程序而获得均一的液滴尺寸分布。这与其中仅可获得较不均一的液滴尺寸分布的湍流混合程序相反。不受限于理论,层状拉伸流动条件可在第一步骤中形成自发破碎成均一液滴的蠕虫状液滴。因此,通过使用本发明的方法,可获得均一的液滴尺寸分布。
本发明的另一特征可进一步包括一种方法,其中在步骤2)中另外添加聚乙烯基吡咯烷酮或聚乙烯基己内酰胺。已令人惊讶地发现,将聚乙烯基吡咯烷酮或聚乙烯基己内酰胺添加至所述组合物中可进一步增加一些益处。一方面,组合物的特征如粘度可受到该类物质的添加的影响,这又可影响所述组合物的储存稳定性。另一方面,这样的物质也能够影响活性物的皮肤递送(或吸收)。因此,也可通过使用该渗透改进剂而调节活性物的渗透特性。聚乙烯基吡咯烷酮或聚乙烯基己内酰胺的浓度可为≥0.5重量%且≤15重量%,优选≥2.5重量%且≤12重量%,进一步优选≥5重量%且≤10重量%。这样的浓度可有助于获得良好的活性物渗透性。
在本发明方法的另一方面中,步骤2)和3)中的剪切速率为≥10l/s且≤100000l/s。该剪切速率范围可有助于将搅拌限制为层状拉伸流动,这又可导致形成非常均一的液滴尺寸分布。
本发明方法的优选特征可包括任选的步骤4),其中在低剪切混合下将步骤3)的混合物与水相组合,从而形成水包油包多元醇乳液。任选的步骤4)可在紧接工艺步骤1)-3)之后在同一或分开的容器中或不同的腔中进行。这也可包括在紧接施用前形成水包油包多元醇(POW)乳液,例如在家用处理中。后一方法能提供POW乳液,包括将限定含量的水施用至皮肤上,但还使时间最少,其中使所述油包多元醇组合物(包括活性物)与水接触。该短接触时间可减少引入防腐剂的必要性,这又有助于所述配制剂的皮肤病学接受性。在本发明的优选实施方案中,水与油包多元醇组合物的重量比可为≥1:100且≤1:1,优选为≥1:10且≤1:1。更高的水浓度不落入本发明的范围之内,因为这可导致加速的活性物降解且妨碍活性物的渗透。更低的浓度不能获得均一的POW。
此外,落入本发明范围之内的是公开了本发明组合物在皮肤病学、药理学或化妆品皮肤护理处理中的用途。所公开的油包多元醇组合物能安全地引入高活性成分且确保足够的储存稳定性。由于这些乳液可在零或极低水含量下配制这一事实,所述配制剂可非常干净,从而避免可能的过敏原如防腐剂或香料。此外,由于所述多元醇、乳化剂和油的组合,可实现活性物在皮肤中的有效递送。因此,配制了非常皮肤友好且有效的组合物,其非常适于上述应用领域。
此外,本发明的组合物可用于皮肤护理处理中,其中所述皮肤护理处理为增白或防晒处理。尤其是在增白和防晒应用领域中,必须使用高效成分。在第一种应用领域中,这是必须的,因为黑色素极其稳定且位于真皮的较深层中。因此,除高活性成分之外,还必须使用允许活性物渗入较深的皮肤层中的有效载体。对防晒应用而言,必须确保成分的稳定性(在此例如对自由基清除剂而言),从而可靠地保护皮肤免于晒伤。
落入本发明范围之内的还有各部分的成套包装,其包括双室分散器,所述双室分散器至少包括:a)一个包含本发明的油包多元醇组合物的室,和b)一个包含含水组合物的室,所述含水组合物包含含量为大于或等于70重量%且小于或等于100重量%的水。由于本发明的油包多元醇组合物的配方,可在紧接施用前通过使用双室分散器产生POW。这是有利的,因为在大多数时间内,活性物被保护在所述油包多元醇组合物中,而不与水直接接触。仅在紧接施用前,才添加水并产生POW。另外的水含量对整个组合物的肤感可能是有益的,且还可对皮肤脂质层造成轻微干扰,由此提高活性物的渗透性。通过另外的水含量,还可获得另外的感觉益处如稍凉的效果。第二室中的含水组合物的水含量可为大于或等于80重量%且小于或等于100重量%,优选大于或等于90重量%且小于或等于100重量%。
就前文所述的各部分的成套包装的另外优点和特征而言,明确参考本发明方法、本发明用途和本发明组合物的公开内容。此外,还应认为本发明各部分的成套包装的方面和特征可适用且公开于本发明的方法、本发明的用途和本发明的组合物中。此外,权利要求书和/或说明书中所公开的至少两个特征的所有组合均落入本发明的范围之内,除非另外明确说明。在实施所请求的发明时,本领域技术人员可通过研究公开内容和所附的权利要求书而理解和实施所公开实施方案的其它变型。在权利要求书中,措辞“包含/包括”不排除其它要素或步骤,不定冠词“一个”或“一种”不排除多个/多种。仅仅彼此不同的从属权利要求中描述了特定衡量指标这一事实不表明不能使用这些衡量指标的组合。
实施例
制备下述包含维生素C(抗坏血酸)作为活性成分的配制剂。
可根据如下方法对本发明的光学透明的油包多元醇组合物进行加工:
加工:
步骤1)将相A加热至70℃并搅拌,直至NaCl溶解;
步骤2)将粉末相B添加至相A中并搅拌,直至获得澄清溶液;
步骤3)将组合的相A+B添加至相C中,同时在层状拉伸流动条件下混合。
获得了光学透明的油包多元醇组合物,组合物粒度的测定(例如借助MALLS,多角度激光散射)揭示了非常均一的单峰液滴尺寸分布,其包含在200-400nm范围内的小液滴尺寸,即
实施例 | 1 | 2 | 3 | 4 |
粒度[μm] | 0.230 | 0.250 | 0.236 | 0.322 |
标准偏差[μm] | 0.0671 | 0.0688 | 0.0728 | 0.0755 |
所有组合物均显示出该组合物本身,特别是活性组分的非常好的储存稳定性。组合物保持光学澄清,且在室温下在420天的储存时间内,不能检测到维生素C的降解。
皮肤病学测试
使用本发明的光学透明的油包多元醇组合物实施数种皮肤病学测试。
A).皮肤病学贴剂测试
使用配制剂1实施皮肤病学贴剂测试。在贴剂测试(n=20)中检测到无不利效果。
B).老人斑处理
将包含10%维生素C的2mg/cm2测试产品施用至特定区域,每天一次,持续四周。在30天后,可检测到颜色变淡20%。颜色变淡的测定是通过色谱法进行的。
C).减少脂质-过氧化物的形成
在UVA照射(10J/cm2)下测试由于皮肤脂质如角鲨烯的氧化所诱发的皮肤上的自由基的形成。与未经处理的样品相比,包含10%维生素C的光学透明的油包多元醇组合物能将脂质氧化物质的形成减少约30%。
Claims (15)
1.光学透明的油包多元醇组合物,其特征在于所述组合物包含:
a)≥40重量%且≤90重量%的至少一种低分子量多元醇,
b)≥1.0重量%且≤25重量%的至少一种化妆品或治疗活性物,
c)≥1.0重量%且≤10重量%的至少一种不含聚醚的乳化剂,
d)≥2.0重量%且≤25重量%的至少一种油组分,
其中所述乳液包含尺寸在≥20nm且≤1000nm范围内的乳化剂包覆的液滴。
2.根据前述权利要求中任一项的组合物,其中所述乳化剂为不含聚醚的氨基官能的硅衍生物。
3.根据前述权利要求中任一项的组合物,其中所述乳化剂为氨基封端的聚二甲基硅氧烷甘油氨基甲酸酯。
4.根据前述权利要求中任一项的组合物,其中另外存在其量为≥0.5重量%且≤15重量%的低分子量醇。
5.根据前述权利要求中任一项的组合物,其中另外存在其量为≥0.5重量%且≤15重量%的聚乙烯基吡咯烷酮和/或聚乙烯基己内酰胺。
6.根据前述权利要求中任一项的组合物,其中所述化妆品或治疗活性物选自:抗坏血酸、生育酚、视黄醇、β-胡萝卜素、多酚、6-羟基-2,5,7,8-四甲基色满-2-羧酸、槲皮素、芸香苷、杨梅树皮素、山奈酚、儿茶酸、表没食子儿茶精、表儿茶素、白藜芦醇、红葡萄酒提取物、白葡萄酒提取物、葡萄提取物、红茶提取物、绿茶提取物、白茶提取物。
7.根据前述权利要求中任一项的组合物,其中化妆品或治疗活性物为抗坏血酸。
8.根据前述权利要求中任一项的组合物,其中另外存在其量为≥1.0重量%且≤10重量%的水,且所述组合物包含水包油包多元醇(POW)结构。
9.根据前述权利要求中任一项的组合物,其中所述组合物的浊度为≥0.01NTU且≤50NTU,根据DIN EN ISO 7027。
10.制备根据前述权利要求中任一项的组合物的方法,其中在如下步骤中:
1)将低分子量多元醇加热至≥50℃且≤100℃的温度,
2)通过搅拌将化妆品或治疗活性物溶解在步骤1)的加热的低分子量多元醇中,直至获得澄清溶液,
3)通过在层状拉伸流动条件下搅拌而将步骤2)的组合物添加至至少一种不含聚醚的乳化剂与至少一种油组分的混合物中。
11.根据权利要求10的方法,其中在步骤2)中,另外添加聚乙烯基吡咯烷酮或聚乙烯基己内酰胺。
12.根据权利要求10-11的方法,其中在任选的步骤4)中,将步骤3)的混合物在低剪切混合下与水相混合,从而形成水包油包多元醇乳液。
13.根据权利要求1-10中任一项的组合物用于皮肤病学、药理学或皮肤护理处理中的用途。
14.根据权利要求13的用途,其中皮肤护理处理为增白或防晒处理。
15.各部分的成套包装,其包括双室分散器,所述分散器至少包括:
a)一个包含根据权利要求1-9中任一项的油包多元醇组合物的室,和
b)一个包含含水组合物的室,所述含水组合物包含含量为大于或等于70重量%且小于或等于100重量%的水。
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CN107468549A (zh) * | 2017-10-13 | 2017-12-15 | 武汉百思凯瑞纳米科技有限公司 | 一种苦油楝树油纳米组合物及其制备方法和应用 |
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CN110063901A (zh) * | 2019-03-18 | 2019-07-30 | 曼秀雷敦(中国)药业有限公司 | 一种适用于敏感肌的防晒乳霜及其制备方法 |
CN110101611A (zh) * | 2019-06-21 | 2019-08-09 | 广州市澳源科技集团有限公司 | 一种维生素a无水乳液及其制备方法 |
CN110101611B (zh) * | 2019-06-21 | 2022-03-11 | 广州市澳源科技集团有限公司 | 一种维生素a无水乳液及其制备方法 |
CN113546016A (zh) * | 2021-07-28 | 2021-10-26 | 上海应用技术大学 | 一种油包水型疤痕修复微乳液及其制备方法 |
CN113546009A (zh) * | 2021-07-30 | 2021-10-26 | 上海应用技术大学 | 一种油包水型芸香苷微乳液及其制备方法 |
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WO2015078738A1 (en) | 2015-06-04 |
JP2016537395A (ja) | 2016-12-01 |
KR20160089514A (ko) | 2016-07-27 |
US20160296431A1 (en) | 2016-10-13 |
EP2875803A1 (en) | 2015-05-27 |
EP3073987A1 (en) | 2016-10-05 |
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