CN104010662B - 使皮肤回春的组合物和方法 - Google Patents
使皮肤回春的组合物和方法 Download PDFInfo
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- CN104010662B CN104010662B CN201280050832.3A CN201280050832A CN104010662B CN 104010662 B CN104010662 B CN 104010662B CN 201280050832 A CN201280050832 A CN 201280050832A CN 104010662 B CN104010662 B CN 104010662B
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Abstract
本发明涉及例如治疗受损皮肤的系统，其包括药妆制剂，所述制剂包含a.约1‑10%的至少三个不同分子量的全氟化碳(PFC's)的混合物，和b.约0.001‑5%的分子量约100 kDa或更少的透明质酸(HA)，封装到气溶胶喷雾容器中。在本发明的实施方案中，所述药妆制剂是水性的，或其包含油和水的乳状液，其包含约80%纯化水和约10%油相组分。本发明还公开使用该系统治疗受损皮肤或预防皮肤因创伤或老化而受损的方法。
Description
本申请要求2011年8月16日提交的美国临时申请号61/524 021的申请日的权益，所述申请的全文通过引用并入本文。
发明领域
本发明涉及药妆用组合物(cosmeceutical compositions)和方法，例如包含低分子量的透明质酸和各种分子量的全氟化碳的制剂，被封装到一个手持式气雾剂/推进剂装置中；以及用它来治疗受损皮肤的方法。
背景资料
目前，用于治疗受损害的，诸如老化的皮肤的方法，需要访问某个机构，诸如诊所。例如高气压加压氧气机可用于输送氧气到皮肤上。然而，这种方法并不方便，且需要训练有素的人员和加压氧气瓶，必须对它进行灭菌和维护。其它的治疗方法包括令人痛苦的、侵入性的和昂贵的注射，这也必须由训练有素的人员施与。
对可在家庭环境中施与的治疗皮肤的简便、有效方法存在着需求。
附图说明
图1显示了用本发明的系统治疗前和后的图片。
图2显示了通过NOVAMETER测量的电导率。
图3显示了通过皮肤弹性测试仪(cutometer)测量皮肤弹性。
本发明的实施方案的描述
本发明人已经惊奇地发现，该包含不同分子量PFC's的全氟化碳(PFC)的混合物和低分子量的透明质酸的组合，当通过气溶胶/推进剂手持装置输送时，导致皮肤回春(rejuvenation)，包括对受损皮肤的显著作用，诸如水合好处、丰盈肌肤和线条和皱纹减少。通过在压力下将该制剂封装在密闭容器中，作为气雾剂递送，与例如含有这些成分的浆液、乳膏剂或其他制剂但是用例如手动泵存储和分配相比，挥发性组分，诸如PFC's的不稳定性(蒸发、分散)显著降低，导致大大增加的稳定性。在本权利要求的系统中，其中的制剂在压力下储存于密闭容器中，并分配成气雾剂，所述制剂以活性形式(例如PFC's保留其截留可以被传递到皮肤的氧的能力)保持至少一年，且通常2、3、4年或更多年。这种活性的稳定性是本发明的实施方案的一个重要的优点。
该制剂是药用化妆品，即适合于用化妆品上和/或药学上可接受的载体和组分局部给予受试者，并提供化妆品用和/或药用效果。本发明的一个方面是用于治疗受损皮肤的系统，所述系统包含药妆制剂，其包含：
a. 至少三个不同分子量的全氟化碳(PFC’s)的混合物(例如选自全氟丙烷、全氟丁烷、全氟戊烷、全氟己烷、全氟十氢化萘、全氟二甲基-环己烷、全氟全氢化菲、五氟-丙烷、全氟三丙胺、C6-C9全氟烷烃、全氟全氢荧蒽、全氟十氢化萘、全氟全氢-菲、双(全氟-己基)-1,2-乙烯、全氟-1,3-二甲基环己烷、全氟-甲基十氢化萘、全氟异丙基十氢化萘、全氟双二甲苯基甲烷和全氟双二甲苯基乙烷的混合物，和/或全氟全氢化菲和全氟正-丁基十氢化萘的混合物)，和
b. 分子量约100 kDa或更少(如，约50 kDa或更少，或约50 kDa)的透明质酸(HA)，
封装在气溶胶喷雾剂、手持式容器中(如在压力下存储，用推进剂并以气雾剂的形式给予)。
在本发明的一个实施方案中，药妆制剂是水性制剂。在另一个实施方案中，药妆制剂包含油和水乳状液(如包含约80％的纯化水和约10%的油相组分）。
“纯化水”是指不含有害成分的水，这些有害成分将有害于受试者，诸如人的皮肤，或会引起皮肤的不良反应。蒸馏水和/或去离子水都可以使用。
在本发明的实施方案中，全氟化碳的混合物的浓度可最高达约，或不超过1％、5％、6％、7％、8％、9％、10％、11％、12％、13％、14％、15％、16％、18％、20％、或25％。
在本发明的实施方案中，HA可在约0.0001-5％范围内，如最高达约或大于约0.0001%、0.0005%、0.001%、0.005%、0.01%、0.02%、0.04%、0.06%、0.08%、0.10%、0.12%、0.14%、0.16%、0.18%、0.2%、0.5%、1%、3%或5%。
该制剂可含有，例如1％ PFC's的和0.01％ HA、20％ PFC's和3％ HA、1％ PFC's和3％ HA、20％ PFC's和0.01％ HA、5％ PFC's和0.05％ HA、10％ PFC's和0.1％ HA、10％PFC's和1％ HA，或5％ PFC's和1％ HA。
本发明的另一个方面是治疗受损皮肤的方法，该方法包括用气溶胶喷雾手持容器给予药妆制剂，所述制剂包含：
a. 至少三个不同分子量的全氟化碳(PFC’s)的混合物(如选自全氟丙烷、全氟丁烷、全氟戊烷、全氟己烷、全氟十氢化萘、全氟二甲基-环己烷、全氟全氢化菲、五氟-丙烷、全氟三丙胺、C6-C9全氟烷烃、全氟全氢荧蒽、全氟十氢化萘、全氟全氢-菲、双(全氟-己基)-1,2-乙烯、全氟-1,3-二甲基环己烷、全氟-甲基十氢化萘、全氟异丙基十氢化萘、全氟双二甲苯基甲烷和全氟双二甲苯基乙烷的混合物，和全氟全氢化菲和全氟正-丁基十氢化萘的混合物)，和
b. 分子量约100 kDa或更少(如，约50 kDa或更少，或约50 kDa)的透明质酸(HA)。
在该方法的一个实施方案中，药妆制剂是水性制剂。在另一个实施方案中，药妆制剂包含油和水乳状液(如包含约60％、70％、80％或90％的净化水和约5％、10％、20％或35％的油相组分，或其他值）。
除了上面提到的组分外，本发明的药妆制剂可包含一种或多种额外组分。这些组分包括，例如烟酸或其他的维生素、矿物质、酶、氨基酸、抗氧化剂、血液扩张成分和天然愉快的香料。例如，额外组分可包括以下的一个或多个：HSC (疏水性鞘脂复合)、Atoxelene(包括稳定的视黄醛，Retistar™)；清新淡雅的天然香料，诸如玫瑰花水、香草花水或仙人掌。
在本发明的一个实施方案中，对药妆制剂进行处理，以包含更多的氧气，这将是在正常条件下的结果。在该实施方案中，所述制剂可以是用氧部分饱和的，饱和或过饱和的。
本发明的方法对于多种类型的治疗可以是有效的，所述治疗包括，如辅助创伤愈合、治疗晒伤或痤疮损伤、治疗由化学去皮导致的损害、增加皮肤润湿和/或减少细纹和皱纹。
本发明的系统和方法的优点包括，它容易携带，并且可由个体施用而无需经培训人员的帮助或加压氧气罐，不需要进行杀菌或维持机器或其它设备。无必要外科手术或注射。没有副作用的风险，且可以达到即时抗衰老的效果。
如本文所用的，术语“约”指的是指示值的加或减10％。
如本文所使用的，单数形式“一”、“一个”和“该”包括其复数对象，除非上下文另有明确规定。
全氟化碳(PFC's)
对于适当细胞的新陈代谢而言氧是必要的。随着一个人年龄增加，向周围组织扩散氧的能力大大降低。因此，像胶原蛋白和弹性蛋白的生产和废物清除的过程受到损害。不希望受到任何特定机制的约束，建议本发明的PFC制剂增加了大量所需的氧到皮肤上，造成一个看上去更年轻、更加面色润泽的肤色。
全氟化碳(PFC's)是一种无害的、无色和无味的液体材料，具有高容量以输送气体，诸如氧、氮和二氧化碳。PFC's的物理结构是这样的，气体在其分子结构内被截留。这些气体通过扩散释放。当通过本发明的方法施用于皮肤时，PFC's增加皮肤中的水分含量，促进皮肤的呼吸和水合，和减少细纹和皱纹。
不希望受任何特定机制的束缚，但建议PFC's可起作用，以治疗受损皮肤(或防止对皮肤的损害)和通过任何各种可能的机制来逆转衰老的迹象。例如，二氧化碳比氧更易溶于PFC's；因此，当皮肤上存在二氧化碳时，它可以由PFC's吸取和从PFC's的氧会被释放。二氧化碳从皮肤细胞的清除，使得皮肤呼吸和更新，导致一个更年轻的，甚至是结实和健康的皮肤。此外，PFC's在性质上是绝缘的(di-electric)，且可能能够阻碍促进肌肉收缩的神经冲动。由于此绝缘特性，当局部施用于皮肤时，PFC's可能能够放松浅表肌肉，诸如眉间肌(glabellar muscle)，并因此产生如肉毒杆菌毒素(Botox)类似的效果。此外，PFC's可以起皮肤填充剂的作用，原因是其疏水性和疏油性的性质。PFC's可使其定位于皮肤的细胞内脂质和水分之间，导致了材料的结块，以最大限度地减少其与皮肤中水和脂质的接触。这可以通过在真皮创建三维六角形胶束结构，使真皮体积增大(volumize)，导致皱纹填充效应。此外，用本发明的PFC混合物的治疗，可能会对皮肤增加大量需要的营养物，导致看上去更年轻、更加面色润泽的肤色；充氧有助于杀死皮肤表面的细菌，这使未来的突破(futurebreakout)保持到最低限度。上述效果可被称为皮肤回春。
用于本发明的系统或方法中的PFC's的制剂，通常包含在不同时间渗透皮肤的不同分子量的三种或更多种PFC分子的混合物。组合的PFC's的不同半衰期和可变分子量最大限度地增加在真皮中的作用时间。低分子量PFC's渗透真皮容易且迅速，而较高的分子量PFC's渗透速度比较慢，保持初始结果，并进一步滋润真皮。PFC's可以是全氟丙烷、全氟丁烷、全氟戊烷、全氟己烷、全氟十氢化萘、全氟二甲基-环己烷和全氟全氢化菲中的两个或多个的混合物。PFC's可以是全氟十氢化萘、全氟己烷和全氟全氢化菲中两个或三个的组合。PFC's可以是五氟-丙烷、全氟三丙胺、C6-C9全氟烷烃、全氟全氢荧蒽、全氟十氢化萘、全氟全氢化菲、双(全氟-己基)-1,2-乙烯、全氟-1,3-二甲基环己烷、全氟-甲基十氢化萘、全氟异丙基十氢化萘中的两个或三个的混合物，和/或全氟全氢化菲和全氟正-丁基十氢化萘的混合物)。PFC's可为这些组中的不同组合。
本发明的PFC's的应用增加了约10-15％的真皮体积，减少皱纹的出现。
本发明的PFC's是医疗级的，即是生物相容的，并适合于用作一种外用组合物，将其施用于受试者，诸如人的例如脸上。本发明的药妆制剂的所有组分均是医疗级的。在一些实施方案中(如其中不存在组分，诸如可含有变应原的薰衣草油)，该组合物为无过敏原的。
透明质酸(HA)
HA是皮肤保湿剂，其可以帮助失水的皮肤恢复水分。当依据本发明的方法应用时，HA分子可提供皮肤基本上即时的水合作用。
HA是非硫酸化的糖胺聚糖，在人体内天然发现的，是细胞外基质的主要成分。HA在皮肤中发现是高水平的，在那里其由两个成纤维细胞和角质形成细胞自然地产生，并作为中等分子量(600-1,000 kDa)的聚合物存在。HA的一项重要功能是在结缔组织的细胞间基质中保住水分。此项水结合能力对皮肤的弹性具显著贡献，起着水贮库的作用。随着老化和UV-B的伤害，皮肤中透明质酸的量和质量下降，从而导致弹性失去和皱纹的增加。
用于本发明的制剂中的HA可以是将对熟练工人而言是明显的任何各种形式。这些形式包括，例如盐(诸如钠盐，透明质酸钠)和衍生物，这对熟练工人而言将是显而易见的。
用于本发明的系统或方法中的HA的制剂，通常具有非常低的分子量，如为约100kDa或更小，约50kDa或更小，或约50kDa。这种低分子量，相对于高分子量的透明质酸而言，允许通过皮肤的渗透性增加。HA可通过改善其粘弹特性和显著减少深皱纹使皮肤回春。HA可商购自许多来源。
额外的组分
熟练的工人将认识到，可将其它任选的成分添加到本发明的制剂中。这些成分包括，如常规的促进剂、烟酸、维生素E、维生素C或其他的维生素、矿物质、酶、氨基酸、抗氧化剂、血液扩张成分和天然愉快的香料。例如，额外的组分可包括以下的一个或多个：HSC(疏水性鞘脂复合物)，其使角质层复原，使得对皮肤的水分的隔离；
Atoxelene，其减少细纹和皱纹；Retistar™ (稳定的视黄醇)，抗氧化剂混合物，其是对老化的皮肤的护理和保护皮肤免受光致老化的高效物质；清新淡雅的/天然香味，诸如舒缓和再生皮肤的玫瑰花卉水、使皮肤结实和新生的香草花水或将水分锁入皮肤的仙人掌。
在本发明的实施方案中，额外的任选成分可包括如在如上注明的适当的浓度范围内的以下的一或多种：
细胞内氧促进剂，诸如如Cerasome Oxygen (由ROVI cosmetics分销的含分子氧的神经酰胺基传递系统)，或旱金莲草花/叶/茎提取物(Tropaeolum Majus Flower/Leaf/Stem Extract) (0.005-30%)；
乳化剂，诸如非离子型、阳离子型、阴离子型或聚合的乳化剂，包括，如硬脂酸甘油酯、鲸蜡硬脂醇(cetearyl alcohol)、鲸蜡硬脂醇磷酸酯(cetearyl phosphate)、山嵛基三甲基氯化铵(behentrimonium chloride)、聚山梨醇酯-20、丙烯酸酯/C10-30烷基丙烯酸酯交联共聚物等
(0.1-20%)；
流变改性剂，包括，如聚丙烯酸聚合物、黄原胶、纤维素胶、硅酸盐、藻酸盐、水解胶体等(0.05-5%)；
润湿剂，诸如，如丙二醇、丙三醇和包括丁二醇的其他二醇(0.5-8%)；
表面活性剂，包括，例如阳离子和阴离子的，乙氧基化和非乙氧基化的，和氨基酸表面活性剂，包括聚山梨酯20、脱水山梨醇单油酸酯或月桂酰谷氨酸钠(0.1-5%)；
润肤剂，诸如，如角鲨烷、乙基己基棕榈酸酯、二聚二亚油酸二异丙酯(diisopropyl dimer dilinoleate)、C12-15烷基苯甲酸酯或互叶白千层(Melalencaalternifolia) (茶树叶) (0.1-20%)；
pH调节剂，诸如，如三乙醇胺、氢氧化钠、包括柠檬酸的酸化剂(0.005-2%)；
抗微生物剂，诸如，如水杨酸，或防腐剂，诸如，如苯氧基乙醇、苄醇或山梨酸钾(0.001-3%)；
芳香剂，以香料或精油的形式存在(0.005-5%)；
抗氧化剂，诸如，如抗坏血酸或其衍生物，包括抗坏血酸棕榈酸酯、抗坏血酸葡糖苷、抗坏血酸异硬脂酸酯(ascorbyl isostearate)、抗坏血酸磷酸钠(sodium ascorbylphosphate)、抗坏血酸磷酸镁、乙基抗坏血酸或氨基丙基抗坏血酸磷酸酯；或其生育酚的衍生物，包括生育酚乙酸酯、生育酚油酸酯或生育酚亚油酸酯。
护肤抗老化剂，诸如，如甘草提取物和衍生物、Retistar™ (稳定的视黄醇)(0.005-5%，如0.5-1%)；
适宜的缓冲剂。
另外，可将下列成分纳入制剂中，用于特定用途。
对于痤疮的治疗(成人)，可包含有效量(如0.001-3％)的水杨酸。
对于脂肪团的治疗，有效量的试剂以调节脂肪细胞的代谢，诸如，如可包含著名的脂肪生成抑制剂、脂质生成抑制剂或脂解剂
(0.005-20%)。这些试剂包括，如各种试剂，其中一些是可以不同的组合获得，为可商购的共混物，这对于熟练的工人而言将是显然的，包括，如丁二醇、昆诺阿藜籽(chenopodium quinoa seed)提取物、咖啡因、水杨酸钠、溶血卵磷脂、氢化卵磷脂、阿斯帕坦、野生大豆胚芽(glycine soja germ)提取物、二氧化硅、毛喉鞘蕊根(Coleusforskohlii root)提取物，小粒咖啡籽(Coffea arabica seed)提取物、丙三醇、龙眼籽
(Nephelium longana seed)提取物。
对于作为化妆用的粉底而言，适当的着色剂，诸如，可包括如FD＆C颜色(由美国认证并允许用于食品、医药品、化妆品及个人护理行业的颜色)、氧化铁、二氧化钛，包括硅处理过的颜料，(0.001-30%)，以粉末颗粒或预分散体的形式存在于各种分散剂，诸如蓖麻油、硅烷三醇、硅树脂、羟基硬脂酸、矿物油或C12-C15烷基苯甲酸酯中。
在本发明的药妆制剂可缺如的组分中，有例如全氟二甲基环己烷；醇类；硅树脂表面活性剂、氟代表面活性剂或它们的混合物；挥发性硅树脂、全氟烷基改性硅树脂；全氟烷基改性甲基苯基聚硅氧烷；胶体金属；肉碱衍生物；防晒剂；具有3-20个碳原子的2-羟基链烷酸；精胺或其它多胺，或非支链的脂肪族多胺(polyazamine)。
下表1显示了本发明的PFC/HA配方的示例性制剂。组合这些组分的方法在现有技术中为常规和公知的。
制备工序：
通过常规的方法合并前述组分。加至适宜的容器中，作为用在如期望的比率(如约5-20%)下的液化推进剂加压的气溶胶。推进剂可以是，如1-10个碳原子的液化烃，诸如正-丙烷、正丁烷、异丁烷、异戊烷、正-戊烷和混合物，和/或醚类(如二甲醚)、氮、压缩空气或其它惰性气体。
另一个例证性制剂示于表2中：
表2
成分INCI / CTFA名称 大约% W/W
制备工序：
合并水相和油相，使均质化和混合直到均匀，然后加入全氟化碳。加至合适的容器中作为用液化推进剂加压的气溶胶(如约5-20%)。该推进剂可为，如1-10个碳原子的液态烃；正-丁烷、异丁烷、异戊烷、正-戊烷和混合物和/或醚(如二甲醚)、压缩空气或其它惰性气体。
另一个例证性制剂示于表3中：
表3
成分INCI / CTFA名称 大约% W/W
制备工序：
合并水相和油相，并加热至60-80°C，将油加入水中，使其均质化并混合直至均匀，冷却至室温并加入全氟化碳和香料。加至合适的容器中作为用期望的比例(如约5-20%)的液化推进剂加压的气溶胶。该推进剂可为，如1-10个碳原子的液态烃；正-丙烷、正-丁烷、异丁烯、异戊烷、正-戊烷和混合物和/或醚(如二甲醚)、氮、压缩空气或其它惰性气体。
在本发明的一个实施方案中，本发明的药妆制剂在压力下封装在密闭容器中作为气溶胶递送之前，被氧部分饱和、饱和的或过饱和。在该实施方案中，对或者PFCs的混合物或者最终制剂进行处理以使其含更多的氧，这将是在正常条件下的结果。
在一个实施方案中，本发明的PFC组分或最终的药妆制剂被氧饱和。在该实施方案中，在1个大气压下，每一ml的PFC组分或最终制剂中，氧的浓度至少为约0.3ml的氧(STP)。在此实施方案中，该制剂的氧分压或pO2通常在760 mm Hg以上。
在另一个实施方案中，PFC组分或最终的药妆制剂是氧过饱和的。在本实施方案中，氧的浓度为每1 ml的PFC组分或制剂至少约1 ml 的氧(STP)。在另一个实施方案中，氧气的浓度为每ml的PFC组分或制剂至少约2 ml 的氧(STP)。在所述乳液中的氧分压或pO2通常在10,000 mm Hg以上，并可高达11,000 mm Hg或更高。
将所添加的氧引入本发明的PFC组分或药妆制剂的方法是常规的。例如，在使乳状液充分气化至预定程度的条件下，可使制剂中的PFC组分或完整的制剂暴露于氧气。可在大气压下或高于大气压的压力下将其暴露于氧。例如，可在180 psi下将其暴露于氧气足够的时间，以达到溶液中的pO2为至少约10,000 mm Hg。
不论是否将额外的氧添加到本发明的药妆制剂中，优选在压力下将药妆制剂储存在容器(如一个分发瓶)，以防止氧的溶解和从制剂中逸出。此外，压力容器可在制剂中溶解的氧与加压的氧之间保持相平衡。在一个实施方案中，保持该制剂的加压容器应最低限度地维持其内部压力，维持等于或大于等量的溶解的氧的分压。此外，在一个实施方案中，加压容器中允许气体输送剂的完全配发，如PFC混合物(大于总的分发的充填重量的95％)。
应用的设备
适合于包装和递送本发明的制剂的设备，包括在0.5-10盎司范围的气雾剂瓶。在本发明的一个实施方案中，该装置是一种推进剂驱动的手持式系统，诸如有定向喷嘴的铝罐。可用常规方法对用于本发明的涂药器(applicator)的材料进行优化，以确保它们与PFC/HA制剂适配。可以使用常规浓度的推进剂，如5-25％的推进剂，例诸如A-17推进剂或如上所述其它推进剂。在本发明的其它实施方案中，该装置是利用泵喷雾的塑料瓶，或是利用泵喷雾的玻璃瓶。使用这样的装置，可使本发明的制剂直接喷洒到待治疗的区域，诸如鱼尾纹、笑纹、前额皱纹和如将从即时丰盈和水合获益的其他区域。
施用本发明药妆制剂的方法
在本发明的实施方案中，例如在脸上，一天两次施用作为气溶胶制剂的本发明的药妆制剂。在一个实施方案中，首先振摇容器(诸如瓶子)。在使用前，远离面部启动(primed)涂药器喷涂约3次。然后，使用者按压致动器按钮，并在右侧面部(颧骨、嘴到耳朵、颚线(jaw line))递送约3个条带，并立即按摩。在左侧重复该过程。然后在整个额头分发约一个条带并按摩。
一般地，要避免与眼睛和嘴唇接触。在某些情况下，该产品会导致皮肤短时间地略为刺痛和脸红。如果出现不适，使用者应注意避免直接喷在脸上。相反，使用者应该将产品分发到指尖，并使用他或她的手指轻轻按摩于脸部和额头上。在一些使用者中，可出现轻度的皮肤刺激性。若出现刺激作用，推荐使用者减少施用的频率至每天一次，或隔日一次；并且如果刺激变得不能继续使用，应咨询医生。
本领域技术人员很明显知道，可使用其他方法，有时与如上的喷雾装置结合使用，以应用本发明的组合透明质酸/ PFD制剂。例如，可用或不用气溶胶应用，与提供发泡作用的Bliss®三重焕氧瞬效活肤面膜(triple oxygen instant energizing mask)组合，应用所述制剂。给药的其它适宜的方法，包括渗透性加压的装置，其为包含可被喷洒到受试者的面部的成分的压力罐；或渗透性雾化器，其具有或者小把手(hand pieces)，将溶液雾化或喷洒到皮肤上，或者具有完全的面罩，即覆盖在脸上和将溶液雾化在皮肤上。这种装置有一个小的碗(如塑料碗)，溶液或安瓿被倒入其中，然后被喷在皮肤上。另一种合适的递送装置采用电喷雾电离。
在本发明的另一个实施方案中，给予本发明的药妆制剂，所述制剂不是作为气溶胶而是作为浆液(serum)、发泡剂、雾或乳膏。
在前述的和下面的实施例中，所有的温度设定为未经校正的摄氏度；并且除非另有说明，所有的份数和百分数均以重量计。
实施例
实施例I
进行临床研究，其中将本发明的药妆组合物作为气雾剂施加到受试者，在应用后立即、2周或4周分析结果。一些结果示于图1。
在一个受试者刚使用后，临床仪器测量到皮肤中的水分最多增加到130％。两周后，受测试的女性有83％报告说，她们的纹线似乎大大地更光滑和柔软。90％的女性报告说她们皮肤的整体外观有改善。
实施例II-概述于实施例I中的实验的清单。
对照的用途研究以评估抗衰老产品的耐受性和功效
测试来自Kate Somerville Skin Care的配方#176-64C-6。使用皮肤复制品(SkinREPLICA)图像分析系统仪器进行皱纹评估。测定皮肤的弹性以及粘弹性特性，作为采用Cutometer的柔韧性和紧致度(firmness)的函数。使用Nova Dermal Phase Meter (Nova真皮相仪表)测定皮肤保水量。此外，产品的有效性是采用经由问卷答复的专门小组成员自我评估进行主观评价。
试验材料：
入选标准：35至55岁之间的女性受试者，一般健康状况良好，无任何会干扰结果的健康问题，包括神经系统、皮肤或全身性疾病。选择经历面部皱纹、紧致度损失和干燥的个体。受试者在研究启动(commencement)前为期72小时放弃使用任何抗衰老或保湿产品，并在试验期间只使用指定的测试材料。
排除标准：该项研究排除在医生照护下的个体、服用可能会掩盖或干扰测试结果的药物的个体、诊断为慢性皮肤过敏的个体，在进行肉毒杆菌毒素治疗程序的个体、为孕妇、哺乳期的个体、在研究启动之前为期六个月内已经怀孕或分娩的个体、任何形式的皮肤癌、黑色素瘤、红斑狼疮、银屑病、结缔组织病、糖尿病病史或任何将增加与参与研究相关的风险的疾病的患者、对任何化妆品具有刺激感或敏感的个体、具有已知敏感症或皮肤和/或眼睛的病症的个体。
人口统计特征：
入选的受试者人数：…………………………30
完成研究的受试者人数：……………………30
年龄范围……………………………………37-55
性别………………女性……………………30
种族…………………白人…………………30
程序：
在研究启动之前，所有专业小组成员被指示使用温和的清洁剂(Cetaphil)用温水清洗他们的脸，确定冲洗干净。然后，在应用测试产品前，受试者到周围环境(70°F±2°和40%±2%相对湿度)下适应为期三十分钟的时间。使用标准模板在面部表面标记涉及到的区域，以确保仪器在每次访问时再次定位于相同的地方。
受试者按下列指示奉命应用测试产品：
AM/PM。每天使用两次。瓶充分摇匀。在使用之前，远离面部喷洒三次以启动涂药器，在各次喷洒之间再次摇瓶。把持涂药器离右侧面部的1/2"。按致动器按钮，以递送制剂，只有3个横条纹穿过右侧面部：一个跨越颧骨，一个从嘴到耳朵，而一个穿过颚线。立即将产品充分按摩进入面部和颈部。再次充分摇瓶，对左侧面部重复上面的步骤。将产品充分按摩进入面部和颈部。再次充分摇瓶，并将一个横条纹施用于额头。充分按摩。
在基线、首次应用后立即(10分钟)和使用后2周和4周(Cetaphil)再次收集生物物理测量值(经由Novameter的皮肤保湿[电导率]，经由Cutometer的皮肤弹性)以及皮肤修复印象(Replica Impressions)。测试材料的首次应用在试验场所发生。所有研究参与者被要求在首次应用后立即、使用2周和4周后再次填写自我评估问卷。
以下独特的非侵入性的方法被用来建立评估参数：
经由Novameter的电导率—皮肤保湿：
采用Nova Dermal Phase Meter (Nova皮肤相仪表), 型号DPM 9003 (Nova,Technology Corp., Gloucester, Mass.)，以获取皮肤表面阻抗测量值，以确定治疗部位电导率。该仪表提供了作为皮肤的介电值的函数的皮肤保水量的相对测量值。当达到平衡时自动记录皮肤阻抗。
经由Cutometer的皮肤弹性：
使用Cutometer SEM 575 (型号575 Courage + Khazaka)测量皮肤的粘弹性特性。测量原理是基于抽吸方法。在装置中产生负压，可将负压调节在20和500mbar之间。通过负压将皮肤吸入到所述探针的校准孔，在那里皮肤穿透深度由非接触式光学测量系统确定。光学测量系统由光发射器和光接收器，以及彼此面对的两个玻璃棱镜组成，所述棱镜将光从发射器投射到接收器。光的强度由于皮肤的穿透深度而变化。
活皮肤轮廓测量技术(Profilometry)—皮肤复制品图像分析(Skin ReplicaImage Analysis)
REPLICA™品牌定位器是专为制备皮肤表面的硅橡胶铸型而设计的，目的是评估的纹理和皱纹。大面积定位器(Large Area Locator)是专为获得皮肤轮廓的复制品而设计的，以评估脂肪团。重量较重的纸张及泡沫粘接系统对固化的复制品(cured replica)提供坚实的支持，同时与测试部位的一般轮廓保持一致性水平。定位器有一个用于样品标识的大的书写标签(write-on tab)区域，和用于准确定位的模切缺口(die cut notches)。
REPLICA™抽样技术：从载体层的剥离定位器后，将粘接剂侧安置贴在皮肤上，将预混树脂(SILFLO或REPLIFLO)放置在内部并用木制刮刀(wooden spatula)滑出，以使树脂溢出纸板表面之上2-3mm。在树脂固化且复制品从皮肤表面上剥离后，从纸板框架分离泡沫粘合剂间隔层并弃去。可用复制品易于实施图像分析。
利用使有关皮肤的视觉信息转换成数字数据的计算机图像分析技术分析REPLICA™样品。
分析方法的参考文献：
1. Leveque, J.L., de Rigal, J.: 研究皮肤湿润的阻抗方法(ImpedanceMethods for Studying Skin Moisturization), J. Soc. Cosmet. Chem., 34: 419-428, 1983.
2. Agache, P.G., Monneur, C, Leveque, J.L., 和de Rigal, J. 活体皮肤的机械性能和杨氏模量(Mechanical properties and Young's modulus of human skinin- vivo), Arch. Dermatol. Res., 269, 221, 1980.
3. De Rigal, J. 和Leveque, J. J., 角质层弹性的体内测量(In vivomeasurement of the stratum corneum elasticity), Bioeng. Skin, 1, 13, 1985.
4. 皮肤轮廓测量技术－一种证明化妆效果的有用工具(Profilometry of skin-A useful tool for the substantiation of cosmetic efficacy), Cook, J SocCosmet Chem 1980; 31: 339-359.
5. 光学皮肤轮廓测量技术：一种定量面部皱纹的客观方法(Opticalprofilometry: An objective method for quantification of facial wrinkles),Grove, Grove, and Leyden. J AM ACAD DERMATOL 1989;21: 631-7.
6. 用局部用维甲酸治疗光致损伤的面部皮肤(Treatment of
photodamaged facial skin with topical tretinoin), Leyden et al. J AMACAD DERMATOL 1989;21: 638-44.
7. 粗糙度(用光学皮肤轮廓测量技术测量：机械、光学和激光) Roughness(measured by profilometry: mechanical, optical, and laser), Muller, in "生物工程学与皮肤：方法和仪器(Bioengineering and the Skin: Methods andInstrumentation)" Berardesca et al, Eds. CRC Press, Boca Raton, 1995.
8. 来自"非侵入性方法和皮肤手册"的综述(Review articles from "Handbookof Non-Invasive Methods and the Skin"), Serup and Jemec, Eds. CRC Press, BocaRaton, 1995. 皮肤表面轮廓测量描记方法(Stylus method for skin surface contourmeasurement),. Gassmuller et al p83. 皱纹和起皱的皮肤复制品图像分析(Skinsurface replica image analysis of furrows and wrinkles), Corcuff and Leveque,p89. Laser Profilometry, Elfsen et al, p97 皮肤表面的三维评价：微观和宏观面貌(Three dimensional evaluation of skin surface: micro and macro-relief),Mignot, 107.
源数据为：
-在初次应用测试产品15分钟后，以及于每天两次再使用测试产品14天和28天后，收集主观评估。在初次应用测试产品前、初次应用测试产品后10分钟，以及于每天两次再使用测试产品14天和28天后，收集Novameter读数。
-在初次应用测试产品前和初次应用测试产品10分钟后，以及于每天两次再使用测试产品14天和28天后，收集Cutometer读数。
-在初次应用测试产品前和初次应用测试产品10分钟后，以及于每天两次再使用测试产品14天和28天后，收集皮肤复制品(Skin Replicas)。
结果于表和图中给出。在任何的受试者上未观察到任何种类的不良反应或意外的反应。
结论：通过多数测试专业小组成员报告该测试材料，其是一种改善皮肤的整体状况的有效的抗衰老产品，。主观问卷调查结果显示，在研究结束时，产品使得他们的皮肤看起来和感觉更保湿、更紧致、更容光焕发、更均匀、更柔软，更平滑。对试验产品进行的额外的仪器分析表明，用该产品在处理部位增加皮肤的含水量。所证明的平均保湿值增加被认为在每个评估时间点均具有统计学上的显著意义。
表4 -保湿研究(Moisturization Study) –经由Novameter的电导率
* 统计学显著意义
Cutometer读数表明，试验材料增加作为紧致度的函数的皮肤弹性。增加值被认为在统计学具有显著意义。
表5 –经由Cutometer的皮肤弹性
*统计学显著意义
皮肤复制品图像分析结果表明，依据三个关键参数，63％的面板展示(panelexhibiting)皱纹的抚平，试验材料在统计学具有显著意义地改善在10分钟时间点的皱纹状况。在第2周和第4周的时间点，面板的56％和59％的多数展示出用于三个关键参数的皱纹的抚平。
仪器分析(Novameter, Cutometer和皮肤复制品图像分析(Skin Replica ImageAnalysis))证实从主观问卷调查获得的信息。
经由Novameter的电导率
使用Nova皮肤相仪表(Nova Dermal Phase Meter)，型号DPM 9003 (Nova,Technology Corp., Gloucester, Mass.)，获取皮肤表面阻抗测量值，以确定测试部位的电导率。该表提供了作为皮肤介电值的函数的皮肤保水量的相对度量。当达到平衡时，自动记录皮肤阻抗。数据示于表6，并且在图2中以图形方式呈现。
经由Cutometer测定的皮肤弹性
使用Cutometer SEM 575 (型号575 Courage + Khazaka)测量皮肤的粘弹性特性。测量原理是基于抽吸方法。在装置中产生负压，可将负压调节在20和500mbar之间。通过负压将皮肤吸入到所述探针的校准孔，在那里皮肤穿透深度由非接触式光学测量系统确定。光学测量系统由光发射器和光接收器，以及彼此相面对的两个玻璃棱镜组成，所述棱镜将光从发射器投射到接收器。光的强度由于皮肤的穿透深度而变化。数据示于表7，并且在图3中以图形方式呈现。
表6 -经由Novameter的电导率
*统计学显著意义
表7 –经由Cutometer测定的皮肤弹性，制剂#176-64C-6
*统计学上显著意义
表8
图８（续）
表9 –皮肤复制品分析(Skin Replica Analysis) –统计学-自基线的变化；和面板展示的皱纹抚平的性能概述
RZ -对于每个10条穿过样品的线的五个相等的长度段的亮度值的平均值的最大差值。
IDL-10条扫描线的亮度痕迹的集成产生的长度(integrated developedlength)。这是作为直线距离的比例的亮度线的总长度。即，平淡无奇的(flatfeatureless)样品具有1.000的IDL。
Num Wr-在10个频带或用于计算间距和宽度的子区域，检测到的特征的总数。
从前面的描述中，本领域的技术人员可以容易地确定本发明的本质特征，在不脱离其精神和范围的情况下，可对本发明进行变化和修改，以使其适应各种用途和条件，并最大限度地利用本发明。前述优选的具体实施方案应被理解为仅是说明性的，而不是以任何方式对本发明的范围的限制。以上列举的所有申请、专利和出版物的全部公开内容，包括2011年8月16日提交的美国临时申请61/524,021，在此全文通过引用结合于本文。
Claims (19)
1.一种治疗受损皮肤的系统，该系统包括化妆品用和/或药用制剂，其包含
1-10%重量的至少三种不同分子量的全氟化碳(PFC’s)的混合物和
0.001-5%重量的分子量为100 kDa或更小的透明质酸(HA)。
2.权利要求1的系统，其中的制剂是水性的或包含油和水乳状液。
3.权利要求1-2的任一项的系统，其中PFC’s的混合物包含全氟丙烷、全氟丁烷、全氟戊烷、全氟十氢化萘、全氟二甲基-环己烷、全氟全氢化菲、五氟丙烷、全氟三丙胺、C6-C9全氟烷烃、全氟全氢荧蒽、双(全氟-己基)-1,2-乙烯、全氟-1,3-二甲基环己烷、全氟-甲基十氢化萘、全氟异丙基十氢化萘、全氟双二甲苯基甲烷和全氟双二甲苯基乙烷的混合物，和/或全氟全氢化菲和全氟正-丁基十氢化萘的混合物。
4.权利要求1或2中任一项的系统，其中所述制剂包含10%重量的全氟化碳。
5.权利要求1或2中任一项的系统，其中的制剂还包含烟酸或其他维生素、矿物质、酶、氨基酸、抗氧化剂、血液扩张成分或天然的令人愉快的香料中的一种或多种。
6.权利要求1或2中任一项的系统，其中的制剂还包含HSC (疏水性鞘脂复合物)、Atoxelene；和清新淡雅的天然香料。
7.权利要求1或2中任一项的系统，其中的制剂还包含以下物质的一种或多种：细胞内氧促进剂；乳化剂；流变改性剂；润湿剂；表面活性剂；润肤剂；pH值调节剂；抗微生物剂；着色剂；芳香剂；或抗氧化剂。
8.权利要求7的系统，其中的细胞内氧促进剂是旱金莲草花/叶/茎提取物；乳化剂是非离子型、阳离子型、阴离子型或聚合的乳化剂；流变改性剂是聚丙烯酸聚合物、黄原胶、纤维素胶、硅酸盐、藻酸盐或水解胶体；润湿剂是丙二醇、丙三醇或其他二醇；表面活性剂是阳离子型、阴离子型、乙氧基化的或非-乙氧基化的；抗微生物剂是防腐剂；着色剂是FD&C颜料、氧化铁或二氧化钛；芳香剂是以香料或精油的形式存在的；而抗氧化剂是抗坏血酸。
9.权利要求1或2中任一项的系统，其中的制剂用于：
(a) 治疗成人痤疮，且该制剂还包含水杨酸；
(b) 治疗脂肪团，且该制剂还包含脂肪生成抑制剂、脂质生成抑制剂和/或脂解剂；或
(c) 作为化妆的粉底使用，且该制剂还包含一种或多种适宜的着色剂。
10.权利要求1或2中任一项的系统，其中
(a) HA的分子量小于或为50 kDa；
(b) HA的量为0.1%重量；或
(c) HA的分子量小于或为50 kDa且HA的量为0.1%重量。
11.权利要求1或2中任一项的系统，其中的制剂是用氧部分饱和、饱和或过饱和的。
12.一种治疗受损皮肤的系统，该系统包括化妆品用和/或药用制剂，其包含：0.005-30%重量至少三种不同分子量的全氟化碳的混合物、0.005-30%重量细胞内氧扩散促进剂、0.005-5%重量千道尔顿范围的透明质酸、0.1-20%重量非离子型、阳离子型、阴离子型和聚合的乳化剂、0.05-5%重量流变改性剂、0.5-5%重量润湿剂、0.1-5%重量表面活性剂、0.1-20%重量润肤剂、0.005-5%重量抗氧化剂、0.005-2%重量pH值调节剂、0.001-3%重量抗微生物剂、0.001-30%重量着色剂、0.005-5%重量芳香剂、0.005-20%重量脂肪细胞代谢调节剂以及5-50%重量推进剂。
13.权利要求1、2或12中任一项的系统，其中所述制剂被封装在气溶胶喷雾手持容器中。
14.权利要求1、2或12中任一项中所述的化妆品用和/或药用制剂在制备药物中的用途，所述药物用于治疗受损皮肤。
15.权利要求14的用途，其中所述药物在辅助创伤愈合、治疗晒伤或痤疮损伤、治疗由化学去皮导致的损害、增加皮肤润湿，和/或减少细纹和皱纹中是有效的。
16.权利要求1的系统，其中所述制剂在压力下封装在密闭容器中作为气溶胶递送。
17.权利要求3的系统，其中所述C6-C9全氟烷烃是全氟己烷。
18.权利要求1或2中任一项的系统，其中的制剂还包含以下物质的一种或多种：0.005-30%重量的细胞内氧促进剂；0.1-20%重量的乳化剂；0.05-5%重量的流变改性剂；0.5-8%重量的润湿剂；0.1-5%重量的表面活性剂；0.1-20%重量的润肤剂；0.005-2%重量的pH值调节剂；0.001-3%重量的抗微生物剂；0.001-30%重量的着色剂；0.005-5%重量的芳香剂；或0.005-5%重量的抗氧化剂。
19.权利要求8的系统，其中所述抗微生物剂是水杨酸。
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| US10610294B2 (en) | 2012-04-22 | 2020-04-07 | Newuro, B.V. | Devices and methods for transurethral bladder partitioning |
| US9132295B2 (en) * | 2013-08-23 | 2015-09-15 | Indermica, Inc. | Composition having stabilized perfluorocarbons |
| US10307446B2 (en) | 2014-03-21 | 2019-06-04 | St&T International, Inc. | Cannabis extraction method and compositions |
| US20160303043A1 (en) * | 2015-04-16 | 2016-10-20 | Kate Somerville Skincare, LLC | Self-foaming compositions and methods |
| KR102031586B1 (ko) * | 2015-05-15 | 2019-10-14 | 뷰티건 에스.엘. | 미용 제품을 투여하기 위한 장치, 대응하는 프로세스, 사용법 및 용기 |
| ITUB20152498A1 (it) * | 2015-07-24 | 2017-01-24 | Nati Srl | Composizione cosmetica anti-invecchiamento e metodo per la sua preparazione |
| US9925137B2 (en) * | 2015-08-19 | 2018-03-27 | Maple Mountain Group, Inc. | Skin rejuvenation and defense system |
| US10660419B2 (en) | 2016-12-15 | 2020-05-26 | Elc Management Llc | Packaged skin treatment composition and method |
| US10076484B1 (en) | 2017-05-01 | 2018-09-18 | Robert Baron | Formulation and method of conditioning skin and preserving cosmetics applied thereto |
| WO2019032756A1 (en) * | 2017-08-08 | 2019-02-14 | Theracell, Inc. | COSMETIC PRODUCT IN WHICH THERAPEUTIC GAS IS PERFUSED, AND METHODS OF INFUSION |
| WO2020033450A1 (en) * | 2018-08-06 | 2020-02-13 | Kate Somerville Skincare, LLC | Wrinkle reducing compositions and methods |
| US12083212B2 (en) * | 2018-12-06 | 2024-09-10 | Colgate-Palmolive Company | Personal care compositions |
| US20210000910A1 (en) | 2019-07-03 | 2021-01-07 | Jysk Skin Solutions Pte Ltd | Topical compositions |
| CN112972757A (zh) * | 2021-03-05 | 2021-06-18 | 江苏菌均君隽生物科技有限公司 | 一种全氟萘烷水凝胶促愈合敷料及其制备方法和用途 |
| CN112999410B (zh) * | 2021-03-05 | 2022-11-15 | 江苏君隽生物科技有限公司 | 含全氟萘烷的纳米氧合水凝胶促愈合敷料及其制法和用途 |
| US12083204B2 (en) | 2022-06-02 | 2024-09-10 | L'oreal | Topical composition for homeostatic delivery of nitric oxide and uses thereof |
| EP4392011A1 (en) * | 2022-06-03 | 2024-07-03 | Colgate-Palmolive Company | Skin care compositions and methods of use |
| EP4431160A1 (en) * | 2023-03-17 | 2024-09-18 | Vida S.R.L. | Biphasic composition for topical use |
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| FR2280360A1 (fr) * | 1974-08-02 | 1976-02-27 | Sogeras | Composition cosmetologique oxygenante |
| JPS6293211A (ja) | 1985-10-17 | 1987-04-28 | Shiseido Co Ltd | エアゾ−ル組成物 |
| GB8821129D0 (en) | 1988-09-09 | 1988-10-12 | Unilever Plc | Cosmetic composition |
| US5542935A (en) * | 1989-12-22 | 1996-08-06 | Imarx Pharmaceutical Corp. | Therapeutic delivery systems related applications |
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| DE60222238D1 (de) | 2001-02-01 | 2007-10-18 | Hydron Technologies Inc | Zusammensetzung und verfahren zur perkutanen superoxygenierung |
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| DE10245727A1 (de) * | 2002-10-01 | 2004-04-15 | Beiersdorf Ag | Als Aerosol versprühbare W/O-Emulsionen |
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