CN102105142B - 用于***的包括壳聚糖和二羧酸的组合物 - Google Patents
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Abstract
本发明涉及包含壳聚糖、壳聚糖衍生物或其生理上可接受的盐,和短-中链二羧酸酰胺或其生理上可接受的盐、在皮表使用后形成膜、用于保护面部皮肤和过敏、红斑狼疮和腿部毛细血管扩张的其他病变区域的组合物。
Description
技术领域
本发明涉及包括壳聚糖、壳聚糖衍生物或其生理上可接受的盐和短-中链二羧酸酰胺或其生理上可接受的盐、用于制备药剂、医学设备、卫生用品或化妆品、在面部或其他病变区域的皮表使用后形成膜、用于保护红斑狼疮的皮肤、慢性皮炎和由毛细血管扩张,如过敏和腿部毛细血管扩张表征的其他皮肤症状的组合物。
背景技术
红斑狼疮是一种估计会影响全世界超过1千3百万人的普遍但是常被误解的症状(Plewig & Jansen in:Fitzpatrick’s Dermatology inGeneral Medicine.Freedberg et al.Eds.,6th ed.,McGRAW-HILL pub.,NY2003,p.688)。它会影响凯尔特或北欧血统的白种人,且被命名为“凯尔特人的诅咒”。它在黑种人,如美洲和非洲黑人中较罕见。
红斑狼疮以在面部中心和横穿脸颊、鼻子或前额的红斑(脸红和发红,也被称作“过敏”)开始,但是虽罕见也能影响脖子和胸部。其他症状随着红斑狼疮的加重显露,如半永久红斑、毛细血管扩张(面部表面血管的扩张)、红色半球形丘疹(小肿块)和脓疱、红沙眼、灼烧和刺痛感和在一些严重情况,红色分叶状(lobulated)鼻子(肥大性酒糟鼻)。这种病症可与寻常粉刺和/或脂溢性皮炎混淆或共存。红斑狼疮会感染两性,但是在女性中更普遍,几乎为男性的三倍,在30多岁和40多岁普遍且在40到50岁之间达到顶峰。因为红斑狼疮主要是面部诊断,所以在头皮或耳朵出现皮疹作为鉴别诊断或同存的诊断。
红斑狼疮的病原未知,且各种因素都会疑似影响这种症状。在各种因素中,一直认为下述具有一定影响:引起小血管扩张,导致脸红、毛细血管扩张、红斑的血管周围/血管胶原质的退变;潜在炎症性物质在血管周围的渗漏;响应细胞因子和其他介质的异常组织;局部药物(皮质类固醇)的使用。暴露在极高温度下和激烈运动、太阳光热, 严重晒伤、冷风、冷热环境的变化导致面部变红。还有一些能引发脸红的食品和饮品,这些包括酒、咖啡因(热茶和咖啡)和辛辣食品。微生物也被认为对红斑狼疮的发展和复杂化具有影响,如毛囊蠕形螨(Demodex folliculorum)、幽门螺杆菌(Helicobacter pylori)或丙酸菌属粉刺(Propionibacterium acnes)。
红斑狼疮的治疗法是不确定的。***或局部的治疗包括抗菌、甲硝唑和抗真菌;类维生素A、一些β-受体阻滞药、螺内酯。不建议临时治疗,且通常长时间对症状治疗是必要的,因为几乎没有病例在症状方面得到永久缓解。药物本身的毒性限制红斑狼疮的长期治疗。
腿部毛细血管扩张表现为内径为0.1至1毫米较薄的曲张的毛细血管,分类如下:
1)由静脉机能不全导致的毛细血管扩张,伴随其他静脉机能不全的临床迹象。它们位于足底、外踝区域、腿和大腿内侧表面。
2)由荷尔蒙异常导致的毛细血管扩张,位于大腿内侧和前外侧表面。它们在初潮期、更年期、孕期或在避孕药疗法下自然发生。
3)由毛细血管***自身弱导致的较薄毛细血管扩张,主要在腿末梢部。这是由紫外辐射、和热冷温引起的。
4)席状(matting)毛细血管扩张
5)网状静脉曲张(reticular varicose veins):在多数情况下,它们代表毛细血管扩张相关区域的营养静脉。
关于腿部毛细血管扩张仍没有令人满意的治疗,仅有的可行疗法是美容整形。
因此,存在对用于保护非常容易受化学和物理损害的皮肤的安全有效的医疗工具的无法满足的需要。
在有关壳聚糖在不同制品中的应用的领域中已知,壳聚糖及其衍生物是衍生自由甲壳类动物的外壳提取的甲壳质的氨基多糖。KR20020084672公开了作为微球体成分的壳聚糖用作蛋白质或肽分离的载体;KR20020048534报道了包括作为有效组分的固体石腊的作为皮肤按摩的敷料(pack)组合物成分的壳聚糖;JP2005306746教导了壳聚糖作为肉毒杆菌毒素的似凝胶或海绵状制品的成分,以得到皱纹治疗剂的用途。WO2005055924报道了壳聚糖衍生物作为用作填充空 腔的伤口敷料的水凝胶成分。JP2004231604教导了具有高程度脱乙酰作用的壳聚糖组合物,作为有孔海绵质地的载体薄片成分。WO03042251公开了包括纳米尺寸纤维的网式壳聚糖的组合物。WO02057983公开了一种具有使药物长效发挥的规则薄片结构的多层、有气口的薄片壳聚糖;JP11060605教导了一种用作皮肤用药物的分散稳定剂或乳化剂的两亲壳聚糖衍生物。最后,EP1303249,公开了一种包括至少一种抗真菌剂和羟烷基或羧甲基壳聚糖的指甲油组合物,而WO2004/112814公开了一种基于一类来自木贼属的草本提取物,结合羟丙基壳聚糖的指甲修护组合物。
发明内容
令人惊奇地发现包含壳聚糖或其衍生物和至少一种短-中链(6至12个碳原子)脂肪族二羧酸酰胺的制品,在使用并干燥后,可在皮表形成弹性膜,适于保护皮肤免受化学或物理损害。膜的两种成分,糖类和脂类以协同方式作业且具有优于两种成分的单独保护作用的保护作用。
本发明的形成膜的组合物可易于喷洒到皮表,通过使其速干和弹性膜的易形成,避免皮肤油滑而惹人烦的感觉。本发明的形成膜的组合物可以通过温和地按摩用于皮肤上。干燥后形成的膜使皮肤免受热冷温度两者的损害,降低由紫外辐射导致的炎症并通过外包微生物和抑制其生命机能以阻碍其生长。
因此,本发明的目的在于一种药物的和/或美容的组合物,包括:
(A)至少壳聚糖、壳聚糖衍生物和/或其生理上可接受的盐,和;
(B)至少一种C6-C12二羧酸酰胺和/或其生理上可接受的盐。
在用于皮肤上且干燥后,所述组合物用于形成膜,保护面部和其他红斑狼疮病变区域和其他由毛细血管扩张表征的皮肤症状的皮肤。
在壳聚糖衍生物中,优选水溶性壳聚糖;羟烷基壳聚糖,如羟丙基壳聚糖,是最优选的水溶性壳聚糖衍生物。
在C6-C12二羧酸中,特别优选C8-C10二羧酸,最优选C9二羧酸;基于另外的优选具体实施方式,所述二羧酸是线性的和/或烷基酸。
用于本发明目的的C6-C12二羧酸酰胺优选由以下通式表示:
ROC-(CH2)n-COR
其中:
“n”为4至10,优选6至8,更优选7;
R是-N(R′)(R″)基团,其中:
R′是氢或C1-C4烷基基团,和
R″是氢、C1-C4烷基基团或C1-C4羧基基团。
根据优选的具体实施方式,所述C1-C4烷基基团是甲基或乙基而所述C1-C4羧基基团是羧甲基。
优选的C6-C12二羧酸是壬二酸。
因此,在C6-C12二羧酸酰胺中,优选壬二酸酰胺,如壬二酰甘氨酰甘氨酸,且可以以盐的形式,优选钠盐或钾盐,如壬二酰二甘氨酸钾。
本发明的组合物可通过温和地按摩用于皮肤上,或可通过干燥后使其形成弹性膜而喷洒。本发明的组合物可以持续长时间的紧密接触且在应用后对皮肤连续保护多个小时。
本发明的组合物是液体、半流体或者半固体制品的形式,包括溶液、悬浮物、洗液、乳液、胶体、霜剂、凝胶,组分(A)的含量为0.1至10重量%(重量百分比基于整个制品),优选0.2至5重量%,更优选0.25至2.0重量%,和组分(B)的含量为0.1至30重量%(重量百分比基于整个制品),优选0.25至25%,更优选0.5至20重量%。
本发明的组合物优于传统配方,在于本发明的组合物留有均匀且不可见的膜。并且,本发明的组合物不会变脏,不会如凝胶和洗液那样干燥,并当使用时不存在像其他的硬膜制品带来的惹人烦的感觉。
使用可相容的赋形剂、佐剂和/或药品或美容可接受的载体,根据常用技术制备药物组合物,并且药物组合物可包含、结合具有互补的或在任何情况下,有用的活性的其他有效成分。
根据本发明制备的这些组合物的实例包括:用于病变皮肤的溶液、乳剂、悬浮体、胶体、霜剂、凝胶。
本发明的组合物可包括选自溶剂、遮光剂、皮肤护理剂、软化剂、保湿剂、乳化剂、增稠剂、A类紫外辐射滤片、植物提取物、抗氧化剂的一种或多种添加剂。
将通过如下实施例更全面地描述药物组合物和本发明的用途。但应注意的是这些实施例仅用于举例说明本发明而非限制本发明。
具体实施方式
实施例1
制备具有以下w/w%组成的水包油型霜剂:
1、棕榈酰水解小麦蛋白钾 1.00%
2、甘油硬脂酸酯 2.00%
3、棕榈醇 2.00%
4、自行乳化的甘油硬脂酸酯 1.00%
5、二辛醚 4.00%
6、甲氧基肉桂酸乙基己酯 4.00%
7、丁基甲氧基二苯甲酰甲烷 1.00%
8、卵磷脂 0.02%
9、生育酚 0.001%
10、抗坏血酸棕榈酸酯 0.001%
11、柠檬酸 0.001%
12、醋酸生育酚 0.50%
13、纯净水 81.00%
14、羟丙基壳聚糖 0.50%
15、黄原胶 0.50%
16、变性乙醇 1.00%
17、苯乙醇 0.50%
18、辛乙二醇 0.50%
19、壬二酰二甘氨酸钾 0.50%
制备
相A:将羟丙基壳聚糖分散于占水总重的大约50重量%的水中,直至得到澄清溶液。在65℃±2℃下加热溶液且加入黄原胶并搅拌直至得到均相溶液。
相B:将棕榈酰钾、甘油硬脂酸酯、棕榈醇、自行乳化的甘油硬 脂酸酯、二辛醚、甲氧基肉桂酸乙基己酯、丁基甲氧基二苯甲酰甲烷、卵磷脂、生育酚、抗坏血酸棕榈酸酯、柠檬酸和醋酸生育酚一起混合并在65℃±2℃下加热。
在搅拌(涡轮增压机)下将相B加入到相A中,以进行乳化。将所得的乳化剂在连续混合下冷却到35℃±2℃。
在制备的最后将溶解到苯乙醇中的辛乙二醇,溶解在剩余的纯净水(50重量%)中的壬二酰二甘氨酸钾和乙醇混入乳化剂中。对产物持续缓慢搅拌直至得到均相的水包油型霜剂。
实施例2
制备具有以下w/w%组成的水包油型霜剂:
1、棕榈酰水解小麦蛋白钾 3.00%
2、甘油硬脂酸酯 5.00%
3、棕榈醇 5.00%
4、自行乳化的甘油硬脂酸酯 3.00%
5、二辛醚 6.00%
6、甲氧基肉桂酸乙基己酯 6.00%
7、丁基甲氧基二苯甲酰甲烷 3.00%
8、卵磷脂 0.04%
9、生育酚 0.01%
10、抗坏血酸棕榈酸酯 0.01%
11、柠檬酸 0.01%
12、醋酸生育酚 1.00%
13、纯净水 59.93%
14、羟丙基壳聚糖 1.00%
15、黄原胶 1.00%
16、变性乙醇 3.00%
17、苯乙醇 1.00%
18、辛乙二醇 1.00%
19、壬二酰二甘氨酸钾 1.00%
制备
采用与实施例1中所述相同的方法制备所述制剂。
实施例3
制备具有以下w/w%组成的水包油型霜剂:
1、棕榈酰水解小麦蛋白钾 2.00%
2、棕榈醇 5.00%
3、自行乳化的甘油硬脂酸酯 3.00%
4、二辛醚 5.00%
5、甲氧基肉桂酸乙基己酯 4.00%
6、卵磷脂 0.04%
7、抗坏血酸棕榈酸酯 0.01%
8、柠檬酸 0.01%
9、醋酸生育酚 1.00%
10、纯净水 72.94%
11、羟丙基壳聚糖 1.00%
12、黄原胶 1.00%
13、变性乙醇 3.00%
14、苯乙醇 1.00%
15、壬二酰二甘氨酸钾 1.00%
制备
相A:将羟丙基壳聚糖分散于占水总重的大约50重量%的水中,直至得到澄清溶液。在65℃±2℃下加热溶液且加入黄原胶并搅拌直至得到均相溶液。
相B:将棕榈酰钾、棕榈醇、自行乳化的甘油硬脂酸酯、二辛醚、甲氧基肉桂酸乙基己酯、卵磷脂、抗坏血酸棕榈酸酯、柠檬酸和醋酸生育酚一起混合并在65℃±2℃下加热。
在搅拌(涡轮增压机)下将相B加入到相A中,以进行乳化。将所得的乳化剂在连续混合下冷却到35℃±2℃。
在制备的最后将苯乙醇,溶解在剩余的纯净水(重量50%)中的 壬二酰二甘氨酸钾和乙醇混到乳化剂中。对产物持续缓慢搅拌直至得到均相的水包油型霜剂。
实施例4
制备具有以下w/w%组成的水包油型霜剂:
1、棕榈酰水解小麦蛋白钾 2.00%
2、甘油硬脂酸酯 4.00%
3、棕榈醇 4.00%
4、自行乳化的甘油硬脂酸酯 2.00%
5、二辛醚 5.00%
6、甲氧基肉桂酸乙基己酯 8.00%
7、丁基甲氧基二苯甲酰甲烷 2.00%
8、双乙基己基氧化酚甲氧苯基三嗪 3.00%
9、卵磷脂 0.040%
10、生育酚 0.002%
11、抗坏血酸棕榈酸酯 0.002%
12、柠檬酸 0.002%
13、醋酸生育酚 0.20%
14、羟丙基壳聚糖 1.00%
15、黄原胶 0.30%
16、变性乙醇 2.00%
17、苯乙醇 0.50%
18、辛乙二醇 0.50%
19、壬二酰二甘氨酸钾 0.50%
20、纯净水适量到 100.00%
制备
如实施例1进行制备。得到均相的水包油型霜剂。
实施例5
相较于两种不同的制品,分别称为LPOL2899A(与实施例4的制 品相同,但不含有壬二酰二甘氨酸钾),LPOL2899B(与实施例4的制品相同,但不含有羟丙基壳聚糖)和LPOL2899C(与实施例4的制品相同,但不含有壬二酰二甘氨酸钾和羟丙基壳聚糖),通过实施例4的制品测试对VEGF(血管内皮生长因子)在人体3D人造皮肤上释放的抑制的比较评估。
通过对由发炎刺激引起的血管内皮生长因子(VEGF)在3D人类表皮上的产生的抑制来测试四种制品的效果。VEGF是明显影响血管渗透性且其本质由角化细胞,如皮肤细胞表达的强血管原的蛋白。在压力条件下,如暴露在如IL-1α的可溶炎症介质中,表皮的角化细胞增加VEGF的合成和释放。
在细胞培养液中用IL-1α处理表皮单元以引发VEGF合成的增加,且同时在表皮角质层上用未稀释的研究样品处理。经过24小时处理后,在收集表皮单元下的细胞培养液且通过酶联免疫吸附试验(ELISA)分析VEGF含量。
试验样品是根据实施例4的制品和所述两种比较制品LPOL2899A和LPOL2899B。用IL-1α处理的皮肤单元仅用作阳性对照。重复进行实验三次。
使用的体外试验***包括人体表皮的三维人造***(Mattek,美国),即包括常人表皮角化细胞的重组的人造人体皮肤模型,以完整的三维细胞培养模型成长,优选地,在体外模仿人体皮肤。模型显示出正常的屏障作用(以分化的角质层存在)。
将约20毫克的每份未稀释样品用于表皮单元上,重复三次,除了对照物,在细胞培养液中将暴露30分钟后使用产物的表皮单元用500pg/ml的IL-1α(Prospec)处理2小时,以改善VEGF的合成。
2小时后,去除并改变细胞培养液。在37℃、5%的二氧化碳中进行样品的孵化24小时。
同样地,使用仅由IL-1α处理的阳性对照表皮单元。在暴露阶段的最后,去除产物,用磷酸盐缓冲液(PBS)温和地冲洗组织以进行进一步MTT和存活率检测,并收集培养液以进行VEGF检测。
在下表中记录了经IL-1α,500pg/ml处理后的且由样品处理和未处理的VEGF释放检测。
制品包含媒介物,但不包含壬二酰二甘氨酸钾和羟丙基壳聚糖两种成分的制品抑制IL-1α引发的血管内皮生长因子的释放,但仅为18%。包含羟丙基壳聚糖的制品的效果为25.7%的抑制率和包含壬二酰二甘氨酸钾的制品为33.9%的抑制率。实施例4的制品具有最强的抑制效果(46.4%的抑制率),由此确定两种成分在保护皮肤免受IL-1α损害的协同活性。
Claims (18)
1.一种组合物,包括
(A)至少羟丙基壳聚糖和/或其生理上可接受的盐,和;
(B)至少壬二酰二甘氨酸钾。
2.如权利要求1所述的组合物,其特征在于所述羟丙基壳聚糖溶于水。
3.如权利要求1所述的组合物,其特征在于所述羟丙基壳聚糖的生理上可接受的盐是钠盐和/或钾盐。
4.如权利要求1所述的组合物,其特征在于组分(A),以整个组合物的重量计,为0.1至10%。
5.如权利要求4所述的组合物,其特征在于组分(A),以整个组合物的重量计,为0.2至5%。
6.如权利要求5所述的组合物,其特征在于组分(A),以整个组合物的重量计,为0.25至2.0%。
7.如权利要求1所述的组合物,其特征在于组分(B),以整个组合物的重量计,为0.1至30%。
8.如权利要求7所述的组合物,其特征在于组分(B),以整个组合物的重量计,为0.25至25%。
9.如权利要求8所述的组合物,其特征在于组分(B),以整个组合物的重量计,为0.5至20重量%。
10.如权利要求1所述的组合物,其特征在于该组合物是液体、半流体或半固体形式。
11.如权利要求10所述的组合物,其特征在于所述液体、半流体或半固体形式是溶液、悬浮体、胶体、霜剂或凝胶。
12.如权利要求11所述的组合物,其特征在于所述溶液是洗液,所述霜剂是乳液。
13.如权利要求1所述的组合物,其特征在于该组合物包含药物和/或美容的可接受的活性成分和/或载体。
14.如权利要求13所述的组合物,其特征在于所述载体是赋形剂和/或佐剂。
15.如权利要求1-14任一项所述的组合物,用于治疗和/或预防红斑狼疮。
16.如权利要求1-14任一项所述的组合物,用于治疗和/或预防毛细血管扩张。
17.如权利要求16所述的组合物,用于治疗和/或预防腿部毛细血管扩张。
18.如权利要求1-14任一项所述的组合物,用于治疗和/或预防过敏。
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