CN1812763A - 局部用的指甲重构组合物 - Google Patents
局部用的指甲重构组合物 Download PDFInfo
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- CN1812763A CN1812763A CNA2004800177364A CN200480017736A CN1812763A CN 1812763 A CN1812763 A CN 1812763A CN A2004800177364 A CNA2004800177364 A CN A2004800177364A CN 200480017736 A CN200480017736 A CN 200480017736A CN 1812763 A CN1812763 A CN 1812763A
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- chitosan
- water
- fingernail
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Abstract
本发明涉及含有来自木贼属的药草和成膜剂的组合物及其作为指甲局部制剂例如指甲油、霜、凝胶、洗液或泡沫的应用。本发明还涉及水溶性成膜剂作为指甲局部制剂中的添加剂的应用。这些组合物可用来处理指甲结构的特殊改变，例如强度减小、甲***和指甲脆弱。
Description
本发明涉及包含至少一种来自木贼属的药草和一种成膜剂的组合物及其作为指甲局部制剂的应用。本发明还涉及水溶性成膜剂作为指甲局部制剂中的添加剂的应用。这些组合物可用来处理指甲结构的特殊改变，例如强度减小、甲***和指甲脆弱。
指甲板的强度和物理性质取决于它的成分和构造。值得注意的构造的特征是横轴和纵轴的双弯曲，以及与背面相比腹板的柔性。前者提供刚性，而后者允许发生适度的弯曲变形和略小的延展性。基质的最邻近的组分提供背侧指甲表面的角膜细胞。这些通常提供光亮的表面。当基质因疾病而改变或者指甲表面受创伤时，该光泽就消失。
人们熟知，指甲伸张强度、弯曲强度和扯撕强度随年龄、性别和长出指甲的指而变。指甲对水的渗透性比皮肤大1000倍，所以，指甲结构对于长时间或反复接触水有反应。指甲浸在水中1小时后它的重量增大20％以上，此外，它使指甲柔性更大。2小时后，柔性仍在增大，而水含量不再增大。通过拉曼光谱对指甲的体内分析启示，在水中浸泡10分钟后，远侧指甲的α-螺旋形蛋白质构象变得更松弛，由于水占据空隙而使蛋白质之间的间距更大。反之，近端的指甲仍然显示浸渍前的高水合度。
甲***和指甲脆弱是主要影响家庭妇女、男女工人、裁缝、护士、还有雇员的普遍病况。
纵沟反映了长久的病况，它在生理上可作为浅而细的指沟出现，通常是平行的而且由浅而凸出的脊间隔。它们随年龄和在某些病理状况中变得更为显著。
纵脊(longitudinal ridges)是小的直线形凸起，它们从近端甲褶延伸直到指甲的游离缘，或者可能止于更近处。斜线(波浪形线)在儿童中比在成人中常见，而且人们对它们的重要性仍有争议。
呈沟状、受稍微升高的脊近端限制而且在相应的水平影响所有指甲的表面的横线被描述为一些病理状况的追溯指征。它们反映指甲床活性的暂时减小。
层状***(甲***)是一种见于27～35％的正常成年妇女的状况。处于该状况中的指甲的远端部分在水平方向***。指甲呈层状，类似于皮肤中鳞屑的形成：形成薄片然后断裂。外源的因素导致这种缺陷。干大量家务活的人们(他们的指甲反复泡在水中随后擦干)中常见该现象。
老人的手指甲改变很可能涉及组织修复作用的减小和远端指节间关节的炎性或退化性变化。这些影响因素与指甲纵向生长速度的减小、指甲板变薄和纵脊的增强相关。
老年人中出现脚趾甲厚度和一致性的改变，很可能是由于外周循环的改变引起的。
看上去健康的指甲应当是光滑的、弯曲的、没有任何斑点，而且不应当具有任何孔或脊。处于不良状况中的指甲可能对个体形象伤害很大，如果忽视的话就会引起慢性感染，关系到长久的困惑和疼痛。值得注意的是，可将它们看作社会问题和/或职业病。
手指甲反复的和长久的润湿和干燥是一个引起指甲***和脊的最常见的起因。指甲的***很少由体内疾病或维生素缺乏引起，指甲油去除剂引起甲***(层状***)，最后对手指的创伤促成甲***。
在指甲的化妆品损伤中，可能包括下列形式：破裂、***、断裂、脆性、白斑或脊、指甲生长不良、出现颜色或形状的改变。
矿物油对柔性没影响，尽管它可能的作用是保持吸入水而引起的一定的柔性。该原理适用于甲***的处理，此时指甲板重复的水合和干燥导致游离缘处的***。可通过在指甲被水浸泡后施用润肤剂部分地克服***。指甲油-通常是水不溶性聚乙烯基树脂膜的应用，也可减少水损失：该方法的不利之处在于，由有机溶剂除去指甲油可进一步因增大脆性和***而损伤指甲结构。
因此，本发明的目的是提供克服上述缺点的指甲局部制剂，它可容易地配制、制备和贮存并且提供良好的指甲重构、硬化和增强效果。
发明描述
本发明的目的是提供新型指甲局部制剂，它包含
a)至少一种来自木贼属的药草提取物，
b)至少一种成膜剂。
此外，本发明还涉及所述组合物作为指甲局部制剂例如指甲油、霜、凝胶、乳或泡沫的应用。
本发明的组合物包含作为组分a)的至少一种来自木贼属的药草提取物。所述药草提取物可选自属于木贼属的任何已知的种，此外，它可能是干提取物，或是醇提取物，或是水醇提取物，或是乙二醇提取物。实例包括：
-呈植物或植物的部分、汁、干提取物、水醇提取物或乙二醇提取物形式的问荆(Equisetum arvense)
-呈植物或植物的部分、汁、干提取物、水醇提取物或乙二醇提取物形式的木贼(Equisetum hiemale)
所述药草提取物优选选自问荆。
所述药草提取物可单独用或者可以是不同提取物的混合物。组合物中组分a)的优选的量在总组合物的重量的0.1～15wt％、更优选0.3～15wt％、最优选0.5～10wt％的范围内。
本发明的组合物还包含作为组分b)的至少一种成膜剂，优选是水溶性成膜剂。该水溶性成膜剂可选自本领域已知的任意水溶性成膜剂。成膜剂的定义为(例如见DIN 55945(12/1988))对形成膜(即，薄层或覆盖层)来说必不可少的粘合剂的组分。
术语“水溶的”在本文表示所述成膜剂完全与水相容，所以，在20℃下一份成膜剂溶于100份或更少、优选50份或更少、更优选30份或更少、最优选10份或更少的水中。
由于水溶性成膜剂的存在，可应用多种作用剂，于是保证药物容易施用和简化制剂的贮存。由于成膜剂可与多种溶剂一起应用，所以，可这样选择制剂，以至本发明的指甲局部制剂组合物不烧伤指甲，也不引起刺激而且不用有机溶剂就容易除去。此外，用于本发明的组合物中的水溶性成膜剂提供无光泽的、不粘的和塑性很大的膜，它具有女人和男人都喜爱的无光泽的自然外观。
作为用于本发明的成膜剂，通常可应用合成的或天然源的大分子化合物，它们是水溶性的或者已经被官能团衍生以赋予水溶性。优选地，应用天然聚合物的水溶性衍生物或天然聚合物的衍生物。特别优选的是应用脱乙酰壳多糖的水溶性衍生物，脱乙酰壳多糖是甲壳质的脱乙酰产物而且自身是水不溶的。甲壳质是构成例如甲壳动物和很多昆虫的甲壳的天然物质。
特别合适的是羟烷基脱乙酰壳多糖和羧基烷基脱乙酰壳多糖。羟烷基脱乙酰壳多糖包括通过具有1～3个羟基的C1-6烷基衍生的脱乙酰壳多糖。例如，可提及羟丙基脱乙酰壳多糖。羧基烷基脱乙酰壳多糖包括通过具有1～3个羟基的C1-6烷基衍生的脱乙酰壳多糖。例如，可提及羧甲基脱乙酰壳多糖。水溶性成膜剂(组分b))可呈只要能形成所述组合物的膜的量应用。通常，所述组分b)的量在总组合物的重量的0.1～10wt％、更优选0.3～8wt％、最优选0.5～5wt％的范围内。
本发明的组合物通常还包含作为组分c)的至少一种生理上可接受的载体，优选是溶剂。
所述溶剂通常是水基溶剂以免指甲和邻接的皮肤频繁和反复暴露于侵蚀性的有机溶剂。这样，生理上可接受的溶剂包括水和水与助溶剂的混合物。
可与水组合用于本发明的组合物中的助溶剂不是特别关键的，而是选自通常生理上安全的本领域已知的有机溶剂。通常，助溶剂是亲水性溶剂，而且优选选自醇类。
合适的醇是具有1～3个羟基和2～6个碳原子的支化或线形的醇，于是可将羟基部分地转化为醚。特别合适的醇是乙醇、1-丙醇、2-丙醇(异丙醇)。特别合适的是乙醇或异丙醇。优选地，与本发明的组合物中存在的水组合使用的助溶剂的总量具有足够的挥发性以提供所述指甲局部制剂的可接受的干燥时间。通常的干燥时间，即，通过接触干燥的时间，小于约5分钟，优选小于约2分钟。
当将水与一种或多种助溶剂组合应用时，重要的是，各溶剂彼此相容并且形成清亮的溶液，它稳定而不随时间发生相分离。此外，按本发明使用的溶剂体系应当不但提供均匀的蒸发速率和良好的稳定性，而且能赋予良好的流动粘度特性以便容易施用所述指甲局部制剂。
通常呈合适的量应用所述至少一种生理上可接受的溶剂(组分c))以便赋予上述性质。优选的是，组分c)在本发明的组合物中存在的量是总组合物的重量的40～99.8wt％、更优选60～99wt％、最优选80～95wt％。组分c)中的水含量通常是组分c)的重量的15～70wt％、优选30～65wt％，以便赋予所需的性质。
本发明的组合物除了含木贼属药草提取物之外，还可含其它活性剂，例如硫供体、抗真菌剂、抗生剂、抗炎剂、防腐剂和/或局部麻醉剂。
硫供体可与指甲角蛋白的形成和/或重构过程相互作用。
可含于本发明的组合物中的硫供体的实例包括硫酸化氨基酸和衍生物，1-蛋氨酸、1-半胱氨酸、1-胱氨酸、牛磺酸、4-噻唑烷羧酸、甲磺酰甲烷。
这些作用剂可以本领域常规的各自的量应用。它们通常以0.1～20wt％、优选0.2～10wt％的量应用。
可含于本发明的组合物中的抗真菌剂的实例是咪唑衍生物及其盐，***衍生物及其盐，吡啶酮衍生物例如环吡酮、羟甲辛吡酮及其盐，多烯衍生物及其盐，烯丙基胺衍生物例如特比萘酚及其盐，吗啉衍生物例如阿莫罗芬及其盐，溴柳苯胺衍生物及其盐，制霉菌素和相关的化合物，灰黄霉素和相关的化合物，氯苯甘醚和相关的化合物，氯登妥因和相关的化合物，十一烯酸及其盐和WO 02/07863A1中公开的抗真菌剂。
这些作用剂可以本领域常规的各自的量应用。它们通常以0.1～15wt％的量应用。
可列于本发明的组合物中的抗生剂的实例包括氨基糖苷类及其盐，抗分枝杆菌剂及其盐，头孢菌素和相关的β-内酰胺及其盐，氯霉素和相关的化合物，糖肽及其盐，fusidane衍生物及其盐，林可酰胺类及其盐，大环内酯及其盐，莫匹罗星和相关的化合物，硝基呋喃衍生物及其盐，噁唑烷酮衍生物及其盐，青霉素及其盐，膦酸衍生物及其盐，多粘菌素(polimixins)及其盐，多肽抗细菌剂和相关的化合物，喹诺酮及其盐，磺胺类和二氨基嘧啶类及其盐，四环素类及其盐。
这些抗生剂可以本领域常规的各自的量应用。抗生剂通常以0.1～10wt％的量应用。
可用于本发明的组合物中的抗炎剂包括类固醇和非类固醇抗炎剂。
类固醇抗炎剂的实例包括21-醋酸基孕烯诺龙、阿氯米松或其二丙酸盐、阿尔孕酮、安西奈德、倍氯米松或其二丙酸盐，倍他米松及其盐，包括例如苯甲酸倍他米松、二丙酸倍他米松、倍他米松磷酸酯钠、倍他米松磷酸和醋酸酯钠、以及戊酸倍他米松，氯倍他索或其丙酸盐、氯可托龙新戊酸盐、氢化可的松及其盐，包括例如醋酸氢化可的松、氢化可的松丁酸盐、氢化可的松环戊丙酸盐、磷酸氢化可的松、氢可松磷酯钠、氢化可的松琥珀酸酯钠、叔丁醋酸氢化可的松和戊酸氢化可的松，醋酸可的松、布***、***、去羟米松、***及其盐，例如醋酸盐和磷酸钠，双醋二氟拉松、醋酸氟氢可的松、氟尼缩松、氟轻松、醋酸氟轻松、氟米龙、氟氢缩松、哈西奈德、甲羟松、甲泼尼龙及其盐，例如醋酸盐、琥珀酸钠，糠酸莫米松、醋酸帕拉米松、***龙及其盐，例如醋酸盐、二乙氨基醋酸盐、磷酸钠、琥珀酸钠、叔丁醋酸盐、三甲基醋酸盐，***、曲安西龙及其衍生物，例如曲安奈德、苯曲安奈德、去炎松、己曲安松。
非类固醇抗炎剂的实例包括乙酰水杨酸、丁基(buthyl)吡唑烷及其盐、醋酸衍生物及其盐、oxicam衍生物及其盐、丙酸衍生物及其盐、phenamates及其盐、coxibs及其盐、尼美舒利和相关的化合物。
这些抗炎剂可以本领域常规的各自的量应用。抗炎剂通常以0.1～5wt％的量应用。
可用于本发明的组合物中的防腐剂的实例包括苯扎氯铵、苄索氯铵、西曲溴铵、氯己定、地喹氯铵、三氯卡班、三氯生、水杨酸、苯甲酸、山梨酸及其盐、对羟基苯甲酸及其酯。
这些防腐剂可以本领域常规的各自的量应用。防腐剂通常以0.01～5wt％的量应用。
可用于本发明的组合物中的局部麻醉剂的实例包括苯佐卡因、氨苯丁酯及其苦味酸盐、盐酸哌罗卡因、盐酸奥布卡因、盐酸丁卡因、盐酸利多卡因、盐酸辛***、奥昔卡因、propiocaine盐酸盐、盐酸布比卡因、盐酸甲哌卡因、盐酸达克罗宁、盐酸福莫卡因、盐酸奎尼卡因、polydocanol和苄醇。
这些局部麻醉剂可以本领域常规的各自的量应用。局部麻醉剂通常以0.3～10wt％的量应用。
此外，本发明的组合物还可含化妆用或医用指甲油中通常存在的其它常规添加剂，特别是渗透增强剂。渗透增强剂包括本领域已知的可增强药理活性化合物透过皮肤或透过指甲的任何化合物。换句话说，渗透增强剂改善药物的深度扩散。合适的渗透增强剂包括水杨酸(salycilic acid)、脲、一硫代甘油、N-乙酰半胱氨酸、醋酸乙酯、二甲亚砜(DMSO)、二甲基乙酰胺和WO 99/39680中公开的渗透增强剂。渗透增强剂可以总组合物重量的0～10wt％、优选0.1～8wt％、最优选1～5wt％的量应用。
化妆用或医用指甲制剂中通常存在的其它常规添加剂可包括沉积阻滞剂、螯合剂、抗氧化剂、硅酸盐、芳香物质、润湿剂、羊毛脂衍生物、光稳定剂和抗细菌物质。
本发明的组合物可根据下列制剂领域常用的典型方法来制备：液体制剂，例如溶液、指甲油、洗液或泡沫，或者半固态制剂，例如霜或凝胶。就液体制剂来说，可通过常规混合方法将所述至少一种来自木贼属的药草提取物和所述至少一种水溶性成膜剂与一种溶剂或几种溶剂的混合物和其它液体组分同时地或分别地接触。各组分的添加不需特定的次序。优选的是提供搅拌以保证所述组分完全溶解。如果所述组分的任一种呈固体形式，特别优选的是往液体组分中逐渐添加这种组分以防结块。
就半固态制剂来说，可通过常规混合方法将所述至少一种来自木贼属的药草提取物和所述至少一种水溶性成膜剂与合适的赋形剂，例如溶剂、乳化剂、表面活性剂和/或硬化剂同时地或分别地混合。优选的是在加热下提供搅拌和装入过量的溶剂以免蒸发的损失。
作为膜或作为薄层将本发明的组合物施用于指甲表面以预防和/或处理指甲结构的特殊改变，例如强度减小、甲***和指甲脆弱。通常，将根据指甲状况而定，在几周或数月期间重复应用所述组合物。通常，施用的组合物将含足量要扩散入指甲的活性组分，所以，每天只应重复施用一次或两次以保证它的效果。
当与木贼属药草提取物一起应用时，本发明优选的成膜剂显示意外的增效作用。对于羟烷基脱乙酰壳多糖和羧基烷基脱乙酰壳多糖来说，该效果特别显著。
虽然在合适的体系中测试时所述成膜剂本身不显示任何的指甲硬化或重建效果，但是当在本发明中与成膜剂组合应用时，木贼属自身的效果得以增强。
阐述了本发明的组合物及其作为指甲重构和硬化制剂的应用，但不限于如下实施例。以％表示的所有的量都是wt％。
实施例1
制备了具有下列重量组成的指甲油制剂：
1.净化水 52.5％
2.乙醇 40.0％
3.木贼属乙二醇提取物 5.0％
4.羟丙基脱乙酰壳多糖(HPCH) 1.0％
5.L-蛋氨酸 1.0％
6.二乙二醇单甲醚 0.5％
应用具有搅拌器的合适的密闭容器制备了该制剂。往该容器内添加乙醇、去离子水和二乙二醇单甲醚而形成混合物。随后，在它们溶解后，添加问荆乙二醇提取物和L-蛋氨酸。最后，添加羟丙基脱乙酰壳多糖并将形成的混合物搅拌24小时或直到溶解。
获得的指甲油组合物即使长时间贮存后还具有清亮而均匀的外观和淡黄色。此外，该指甲油能形成可牢固地粘附在指甲上的无光泽的、不粘的塑性膜。当施用时，该透湿、透气的油不烧伤或引起邻近的皮肤或甲周床刺激。
实施例2
制备了具有下列重量组成的指甲油制剂：
1.净化水 50.5％
2.乙醇 40.0％
3.木贼属乙二醇提取物 4.0％
4.樱桃香精(aroma cherry) 3.0％
5.羟丙基脱乙酰壳多糖(HPCH) 1.0％
6.4-噻唑烷羧酸 1.0％
7.十六醇十八醇混合物 0.5％
如实施例1中所示那样制备了制剂，所得指甲油表现与实施例1中所述相同的性质。
实施例3
制备了具有下列重量组成的指甲油制剂：
1.净化水 51.0％
2.乙醇 40.0％
3.木贼属乙二醇提取物 5.0％
4.热带香精(aroma Tropical) 3.0％
5.羟丙基脱乙酰壳多糖(HPCH) 0.5％
6.醋酸乙酯 0.5％
如实施例1中所示那样制备了制剂，所得指甲油表现与实施例1中所述相同的性质。
实施例4
制备了具有下列重量组成的指甲油制剂：
1.净化水 52.5％
2.乙醇 40.0％
3.木贼属乙二醇提取物 5.0％
4.羟丙基脱乙酰壳多糖(HPCH) 1.0％
5.甲磺酰甲烷 1.0％
6.二乙二醇单甲醚 0.5％
如实施例1中所示那样制备了制剂，所得指甲油表现与实施例1中所述相同的性质。
实施例5
制备了具有下列重量组成的指甲油制剂：
1.净化水 49.0％
2.乙醇 40.0％
3.木贼属乙二醇提取物 5.0％
4.樱桃香精 3.0％
5.羧基甲基脱乙酰壳多糖(HPCH) 1.0％
6.甲磺酰甲烷 1.0％
7.十六醇十八醇混合物 0.5％
8.醋酸乙酯 0.5％
如实施例1中所示那样制备了制剂，所得指甲油表现与实施例1中所述相同的性质。
实施例6
制备了具有下列重量组成的指甲油制剂：
1.净化水 49.0％
2.乙醇 40.0％
3.木贼属乙二醇提取物 5.0％
4.樱桃香精 3.0％
5.羟丙基脱乙酰壳多糖(HPCH) 1.0％
6.L-蛋氨酸 1.0％
7.二乙二醇单甲醚 0.5％
如实施例1中所示那样制备了制剂，所得指甲油表现与实施例1中所述相同的性质。
实施例7
制备了具有下列组成的霜制剂：
1.净化水 61.5％
2.十六醇 5.5％
3.十八醇 5.5％
4.2-辛基十二醇 5.5％
5.木贼属乙二醇提取物 5.0％
6.椰子油脂肪酸二乙醇酰胺 4.0％
7.白凡士林(vaseline album) 3.5％
8.聚山梨酯 603.5％
9.轻质液体石蜡 2.5％
10.脱水山梨糖醇单硬脂酸酯 1.5％
11.羟丙基脱乙酰壳多糖(HPCH) 1.0％
12.苄醇 1.0％
应用配备了恒温(thermosetting)***和搅拌器的合适的不锈钢槽制备该制剂。在该槽中添加十六醇、十八醇、2-辛基十二醇、椰子油脂肪酸二乙醇酰胺、白凡士林、聚山梨酯60、轻质液体石蜡、脱水山梨糖醇单硬脂酸酯和苄醇。将混合物加热并在搅拌条件下保持在70～75℃。随后，在搅拌下添加问荆乙二醇提取物和羟丙基脱乙酰壳多糖。最后，在75～80℃下添加水并搅拌5分钟。填充的水过量10％以免蒸发损失。然后将混合物在28～30℃冷却并从不锈钢槽卸料。
获得的霜组合物即使长时间贮存后还具有清亮而均匀的外观和淡黄色。当应用于指甲时，该霜能形成可牢固地粘附在指甲上的塑性层，不烧伤或引起邻近的皮肤或甲周床刺激。
实施例8
制备了具有下列重量组成的泡沫制剂：
1.丙二醇 60.3％
2.纯化水 30.0％
3.木贼属乙二醇提取物 5.0％
4.椰子油脂肪酸二乙醇酰胺 3.5％
5.羟丙基脱乙酰壳多糖(HPCH) 1.0％
6.三甲基十六烷基对甲苯磺酸铵 0.2％
应用配备了搅拌器的合适的不锈钢槽制备该制剂。将木贼属提取物溶于丙二醇，然后添加含羟丙基脱乙酰壳多糖的水溶液、三甲基乙酰基对甲苯磺酸铵和椰子油脂肪酸二乙醇酰胺。在搅拌条件下将混合物保持在25～30℃。
上述液体，一旦放入配备合适的装置的容器内，就提供柔软而持久的泡沫，可将它敷在指甲上形成牢固地粘附在指甲表面的无光泽的膜。通过应用上述组合物与气体推进剂在常压下或者与液体推进剂在高压下(例如处于常规的加压瓶中的异丁烷)实现了相同的结果。
实施例9
制备了具有下列重量组成的洗液制剂：
1.聚乙二醇400 93.89％
2.木贼属乙二醇提取物 5.00％
3.羟丙基脱乙酰壳多糖(HPCH) 1.00％
4.乳酸 0.10％
5.丁基(buthyl)羟基苯甲醚 0.01％
应用配备了搅拌器和加热-冷却夹套的合适的不锈钢溶解槽制备该制剂。通过迫使蒸汽通过溶解槽的加热夹套将聚乙二醇加热到32～35℃。然后，在搅拌下添加各组分并溶解。在溶解时，将混合物搅拌3小时以均化。
上述洗液一旦施在指甲上就提供牢固地粘在指甲表面的无光泽的膜。
实施例10
对36名妇女进行了临床研究，这些妇女由于以前患有指甲病(例如甲癣、牛皮癣、细菌感染)或外源性因素(化学品、创伤、水分)而具有指甲改变，例如营养不良、甲剥离、甲***和指甲脆弱，她们志愿施用通过与实施例1中所示相同的方法获得的组合物达28天。研究是随机的、对比的，与试验者中的未处理作比较。单边每天(优选在晚上)一次施用所述产品，施用在一只手的所有指甲上，施用在整个指甲表面，连续施用28天。受处理的手是随机确定的，另一只手作为未处理的对比物。
在基线以及14天和28天后记录了根据该方案的效能参数。它包括临床评估处理过和未处理的指甲以及通过硅树脂制作的两只手的拇指指甲的铸模。按照批准过的方法通过计算机化的光学prophylometry分析了铸模。作为指甲铸模上的平均粗糙度记分测定了纵脊(Ra)。在用实施例1的组合物处理过的指甲上，Ra记分在基线时是10.96±SD 2.58，14天后是9.46±2.08，28天后是8.99±1.72。平均说来，在中间评估时刻减小14％，而在施用结束时减小18％。反之，未处理的指甲粗糙度没有改变，它的Ra记分在基线时是9.78±3.37，14天后是9.82±3.31和观察期结束时是10.32±3.4。在处理过的指甲和未处理的指甲之间，结束时与基线相比Ra记分的差别是高度显著的(p＜0.001)。图1中归纳了数据。
在临床参数中，以4个点的半定量标度测定了营养不良、甲剥离、甲***和指甲脆弱。虽然任一组都没有营养不良或甲剥离的改变，但对处理过的指甲记录了甲***和指甲脆弱两者的明确的改善，这两个参数显著优于(p＜0.001)在未处理的指甲中记录的结果。
将数据归纳于表1中：
表1-关于处理过的指甲和未处理的对比物，与基线相比第21天的临床参数评估
| 临床参数 | 处理过的指甲 | 未处理的对比指甲 |
| 甲*** | 15％(没有改变)70％(1级改善)15％(2级改善) | 91％(没有改变)9％(恶化了) |
| 指甲脆弱 | 30％(没有改变)67％(1级改善)3％(2级改善) | 94％(没有改变)3％(1级改善)3％(恶化了) |
| 营养不良 | 100％(没有改变) | 100％(没有改变) |
| 甲剥离 | 100％(没有改变) | 100％(没有改变) |
实施例11
对60名具有甲***和指甲脆弱的妇女进行了临床研究，她们志愿施用通过与实施例1中所示相同的方法获得的组合物达4周。该研究是随机的、对比的、双盲的、平行组比较：
-如实施例1中所示的组合物，不含木贼属药草提取物
-如实施例1中所示的组合物，不含羟丙基脱乙酰壳多糖
每一名试验者接受一项随机分配的处理。每天一次(优选在晚上)将产品施用于两只手的整个指甲表面，连续进行4周。
在基线时和每周记录了根据该方案的效能参数。它们包括临床评估指甲，通过从0＝无到4＝很严重的5个点的半定量标度测定了甲***和指甲脆弱。结束时，还通过下列标度记录了试验者的总体印象：恶化的；没有改变；改善；恢复。图2中归纳了结果。在用通过与实施例1中所示相同的方法获得的组合物处理过的第1组的指甲中记录了甲***和指甲脆弱两者的明确的改善。在施用了如实施例1中所示、只是不存在羟丙基脱乙酰壳多糖的组合物的第2组以及施用了如实施例1中所示、只是不存在木贼属药草提取物的组合物的第3组这两组中记录的参数改善都显著更好。
在该研究结束时记录的试验者的总体印象给出表2中报导的结果：
表2 用实施例1的组合物处理(第1组)、用不含羟丙基脱乙酰壳多糖的如实施例1中所示的组合物(第2组)以及用不含木贼属药草提取物的如实施例1中所示的组合物(第3组)处理4周后试验者的总体印象：第1组和第2组之间p＜0.001；第1组和第3组之间p＜0.001。
| 组 | 恶化的试验者数 | 没有改变试验者数 | 改善试验者数 | 恢复试验者数 |
| 1 | 0 | 0 | 12 | 8 |
| 2 | 1 | 8 | 11 | 0 |
| 3 | 0 | 14 | 6 | 0 |
Claims (24)
1.一种组合物，它包含：
a)至少一种来自木贼属的药草提取物，
b)至少一种成膜剂。
2.权利要求1的组合物，它还包含c)至少一种生理上可接受的载体。
3.前述权利要求任一项的组合物，它还包含d)至少一种硫供体。
4.前述权利要求任一项的组合物，其中，所述组分a)选自：呈植物或植物的部分、汁、干提取物、醇提取物、水醇提取物或乙二醇提取物形式的问荆，或者呈植物或植物的部分、汁、干提取物、醇提取物、水醇提取物或乙二醇提取物形式的木贼。
5.前述权利要求任一项的组合物，其中，所述组分a)是问荆的乙二醇提取物。
6.前述权利要求任一项的组合物，其中，所述组分b)是水溶性成膜剂。
7.权利要求6的组合物，其中，所述水溶性成膜剂是脱乙酰壳多糖的衍生物。
8.权利要求7的组合物，其中，所述脱乙酰壳多糖衍生物选自羟烷基脱乙酰壳多糖和/或羧基烷基脱乙酰壳多糖。
9.权利要求8的组合物，其中，所述羟烷基脱乙酰壳多糖选自通过具有1～3个羟基的C1-6烷基衍生的脱乙酰壳多糖，优选是羟丙基脱乙酰壳多糖。
10.权利要求8的组合物，其中，所述羧基烷基脱乙酰壳多糖选自通过具有1～3个羟基的C1-6烷基衍生的脱乙酰壳多糖，优选是羧甲基脱乙酰壳多糖。
11.前述权利要求任一项的组合物，其中，所述组分c)是水或者水和至少一种助溶剂的混合物。
12.权利要求11的组合物，其中，所述助溶剂是醇。
13.权利要求12的组合物，其中，所述醇是具有1～3个羟基和2～6个碳原子的支化或线形醇，优选是乙醇、1-丙醇和/或异丙醇。
14.前述权利要求任一项的组合物，其中，所述组分d)选自硫酸化氨基酸及其衍生物、1-蛋氨酸、1-半胱氨酸、1-胱氨酸、牛磺酸、4-噻唑烷羧酸和/或甲磺酰甲烷。
15.前述权利要求任一项的组合物，它还包含渗透增强剂、沉积阻滞剂、螯合剂、抗氧化剂、硅酸盐、芳香物质、润湿剂、羊毛脂衍生物、光稳定剂和/或抗细菌物质。
16.前述权利要求任一项的组合物，它还包含另外的选自下列的活性剂：抗真菌剂、抗生剂、抗炎剂、防腐剂和/或局部麻醉剂。
17.前述权利要求任一项的组合物，其中，所述组分a)存在的量是总组合物的重量的0.1～15wt％、优选0.3～15wt％、更优选0.5～10wt％。
18.前述权利要求任一项的组合物，其中，所述组分b)存在的量是总组合物的重量的0.1～10wt％、优选0.3～8wt％、更优选0.5～5wt％。
19.前述权利要求任一项的组合物，其中，所述组分c)存在的量是总组合物的重量的40～99.8wt％、优选60～99wt％、更优选80～95wt％。
20.权利要求19的组合物，其中，组分c)中的水含量是组分c)的重量的15～70wt％、优选30～65wt％。
21.前述权利要求任一项的组合物，其中，所述组分d)存在的量是总组合物的重量的0.1～20wt％、优选0.2～10wt％。
22.前述权利要求任一项的组合物，它基本上由下列物质组成：
c)至少一种来自木贼属的药草提取物，
d)至少一种成膜剂，
e)至少一种生理上可接受的载体，
f)至少一种硫供体。
23.前述权利要求任一项的组合物作为指甲局部制剂的应用。
24.至少一种来自木贼属的药草提取物和至少一种成膜剂在制备用于处理甲***的局部组合物中的应用。
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| CN101641103A (zh) * | 2007-02-14 | 2010-02-03 | 波利化学公司 | 脱乙酰壳多糖用于治疗指/趾甲炎症性疾病的用途 |
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| US20060127342A1 (en) * | 2004-12-09 | 2006-06-15 | Georgia Levis | Taurine-based compositions, therapeutic methods, and assays |
| US10201490B2 (en) | 2007-02-14 | 2019-02-12 | Polichem Sa | Use of chitosans for the treatment of nail inflammatory diseases |
| EP1958638A1 (en) * | 2007-02-14 | 2008-08-20 | Polichem S.A. | Use of chitosans to increase nail growth rate |
| EP1958613A1 (en) * | 2007-02-15 | 2008-08-20 | Polichem S.A. | Dermal film-forming liquid formulations for drug release to skin |
| IT1390844B1 (it) * | 2008-07-29 | 2011-10-19 | Trasdeco Int S R L | Composizione cosmetica per unghie e relativo metodo di applicazione |
| EP2153836A1 (en) * | 2008-08-04 | 2010-02-17 | Polichem S.A. | Film-forming liquid formulations for drug release to hair and scalp |
| EP2116237A1 (en) | 2008-08-05 | 2009-11-11 | Polichem SA | Compositions for treating rosacea comprising chitosan and a dicarboxylic acid |
| TR201103770A1 (tr) * | 2011-04-19 | 2012-11-21 | Sanovel İlaç Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ | Nimesulid ve metilsülfonilmetanin topikalfarmasötik bileşimleri. |
| US8697753B1 (en) | 2013-02-07 | 2014-04-15 | Polichem Sa | Method of treating onychomycosis |
| EP2845597A1 (en) * | 2013-09-10 | 2015-03-11 | Polichem S.A. | Hydroxypropyl chitosan for the treatment of onychomycosis |
| EP2952208A1 (en) * | 2014-06-04 | 2015-12-09 | Universidade de Santiago de Compostela | Hydroalcoholic system for nail treatment |
| JP6570316B2 (ja) * | 2015-05-25 | 2019-09-04 | ロート製薬株式会社 | 爪用組成物 |
| KR102485403B1 (ko) | 2020-08-31 | 2023-01-17 | 주식회사 비앤에이치웍스 | 손발톱 강화용 조성물 |
| KR102597564B1 (ko) * | 2023-03-03 | 2023-11-03 | 장병모 | 조갑 및 피부 백선의 예방 또는 치료용 약학적 조성물 |
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| FR2681782B1 (fr) * | 1991-09-26 | 1993-12-17 | Oreal | Composition pour le traitement des ongles contenant un aminoacide soufre. |
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2003
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2004
- 2004-06-15 PT PT04740007T patent/PT1635852E/pt unknown
- 2004-06-15 DE DE602004008272T patent/DE602004008272T2/de not_active Expired - Lifetime
- 2004-06-15 CN CNB2004800177364A patent/CN100430044C/zh not_active Expired - Lifetime
- 2004-06-15 JP JP2006515978A patent/JP5037121B2/ja not_active Expired - Lifetime
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101641103A (zh) * | 2007-02-14 | 2010-02-03 | 波利化学公司 | 脱乙酰壳多糖用于治疗指/趾甲炎症性疾病的用途 |
| CN101641103B (zh) * | 2007-02-14 | 2013-05-15 | 波利化学公司 | 脱乙酰壳多糖在制备用于治疗指/趾甲炎症性疾病的药物中的用途 |
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