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CN1646151B - 包含原花色素、用于治疗皮炎的局部用药物组合物 - Google Patents

包含原花色素、用于治疗皮炎的局部用药物组合物 Download PDF

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CN1646151B
CN1646151B CN038078589A CN03807858A CN1646151B CN 1646151 B CN1646151 B CN 1646151B CN 038078589 A CN038078589 A CN 038078589A CN 03807858 A CN03807858 A CN 03807858A CN 1646151 B CN1646151 B CN 1646151B
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CN1646151A (zh
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M·马斯特罗多纳托
R·恰蒂尼
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Abstract

本发明涉及用于局部施用的药物组合物，其包含作为活性成分的单独或与甘草次酸、替美斯丁、α-红没药醇或其它具有互补活性的成分组合的原花色素与适宜的载体的混合物，可用于治疗各种疾病如特应性皮炎、变应性接触性皮炎、脂溢性皮炎、放射性皮炎、银屑病、干燥病和异位性皮炎以及治疗粘膜炎性病症。

Description

包含原花色素、用于治疗皮炎的局部用药物组合物
本发明涉及用于局部施用的药物组合物，其包含作为活性成分的原花色素、甘草次酸和替美斯丁与适宜的载体的混合物。
本发明的局部药物组合物可用于治疗皮肤的炎性病症，如特应性皮炎、变应性接触性皮炎、脂溢性皮炎、放射性皮炎、银屑病、干燥病和异位性皮炎(atopia)以及粘膜和眼的炎性病症。
皮炎是表面的皮肤炎症，其特征是水疱、红斑、水肿、渗出、剥落性或结痂损伤以及强烈的瘙痒。存在各种类型的皮炎：接触性皮炎，其可由与皮肤接触的刺激物或者由个体对其过敏的非刺激性物质导致；特应性皮炎，其是一种慢性疾病，特征是强烈的瘙痒；脂溢性皮炎，其是主要影响面部和头皮的剥落性疾病。原则上，治疗在于除去侵入物，然而该侵入物在许多情况下不能被确定或除去。因此治疗基于皮质类固醇，然而其具有熟知的副作用：它们减少免疫防御，这可诱发主要由真菌或念珠菌引起的感染；治疗的中止应该逐渐进行；它们不能在急性渗出期间使用；在停止治疗时可能出现反弹效果。此外，皮质类固醇不应用于长期治疗，特别是在儿童中，因为它们可引发全身性影响。
对于脂溢性皮炎，基于氢化植物油或亲水性矿脂的备选治疗，或者加有药物的香波(基于吡硫锌、硫化硒、硫等)不是解除性的疗法。
对于粘膜炎性病症，尤其是口、齿龈、直肠、阴道和眼粘膜的炎性病症，可使用许多局部疗法，包括使用甾族或非甾族抗炎剂，同时存在这些药物的特征性问题和副作用。
在药物和化妆品领域已经述及原花色素的不同应用。EP 0694305公开了与香豆素(七叶苷等)组合的原花色素的局部用组合物，用于治疗外周性血管病，如褥疮、瘢疤、微血管扩张(couperose)、静脉曲张等。US 5,470,874描述了用于局部使用的原花色素和维生素C的组合，作为遮光剂，以刺激胶原合成并用于修复受损的胶原。最后，JP 6,336,421涉及用于化妆品用途和抗日晒的原花色素和抗炎剂组合的局部制剂，其中在抗炎剂中引述了甘草次酸及衍生物。然而，迄今为止，原花色素在治疗疾病如慢性皮炎、脂溢性皮炎和变应性皮炎中的用途尚未述及。
原花色素广泛分布于许多植物品种中。它们是含有生物类黄酮的植物提取物，具有明确的化学谱，由约15％二聚体、约20％三聚体和四聚体以及少量儿茶素和表儿茶素组成。原花色素发挥保护皮肤免受自由基攻击的作用和通过刺激胶原生成而对皮肤结构损害发挥修复作用。它们还含有与皮肤的亲水性皮脂屏障(hydrolipidic barrier)中的必需脂肪酸类似的必需脂肪酸，这些必需脂肪酸有助于保持所述屏障的完整性。最后，原花色素可降低酶如弹性蛋白酶、胶原酶、透明质酸酶和β-葡萄醛酸糖苷酶的浓度，这些酶是破坏弹性蛋白、胶原和透明质酸蛋白的原因。因此，由于其修复、再生、营养和重建作用而恢复皮肤的弹性和张性，原花色素被广泛用于制药和化妆品工业中。
根据本发明，尤其优选从葡萄籽和葡萄(Vitis vinifera)皮提取的原花色素。最优选的是根据US 4,963,527所公开的方法制备的来自葡萄的原花色素和磷脂的复合物。
已知自光果甘草(Glycyrrhiza glabra)的根提取的18-β-甘草次酸具有对皮肤、尤其是对灼伤和充血(redness)的皮肤的抗炎性质。
替美斯丁(N-乙氧甲酰基-4-噻唑烷甲酸)发挥对抗造成皮肤损伤的氧化剂的抗游离基和保护作用，以及抑制弹性蛋白酶和胶原酶的作用。
本发明的局部用药物组合物可含有与适宜载体、优选富含多不饱和脂肪酸的载体混合的活性成分。根据本发明，适宜的载体包括角鲨烯、脂肪酸、脂肪酸酯、植物油、天然或合成的甘油三酯。更优选地，适宜的载体包括角鲨烯、烛果油、棕榈酸辛酯和月见草油。
具体地，烛果油(也称为牛油脂)是一种由饱和和不饱和脂肪的混合物组成的脂肪，其从北部非洲的一种树即牛油果(Butirospermum parkii)的种子提取，其被用于化妆品是由于其保护和软化作用，该作用使其尤其可用于敏感皮肤以及容易充血的皮肤。
月见草油(也称为夜来香油)自植物月见草(Oenothera biennis)提取，其富含皮肤和所有细胞组织再生所不可缺少的必需多不饱和脂肪酸，尤其是γ-亚麻酸。
根据优选的实施方案，本发明的药物组合物还可含有具有抗氧化活性的化合物，如生育酚和抗坏血酸或其酯，优选生育酚醋酸酯和棕榈酸抗坏血酸酯或四棕榈酸抗坏血酸酯，以进一步增强对细胞膜的保护效果和减缓多不饱和脂肪酸的氧化。
本发明的组合物可以还含有其他对治疗皮肤病具有互补或至少有用作用的活性成分。
所述活性成分的实例为：
-水杨酸，其发挥溶角蛋白作用，可用于治疗脂溢性皮炎；
-透明质酸，其由于其水合和修复作用而可用于治疗放射性皮炎；
-α-红没药醇，存在于春黄菊精油(母菊花)中的活性成分之一，其具有润泽和抗充血作用；
-吡咯烷酮羧酸锌(zinc pidolate)，其发挥轻微的收敛、润滑和润泽作用，由于其对铁离子的竞争作用而阻碍和防止自由基形成，并且在皮肤代谢的酶促过程中具有活性；
-尿囊素，其具有收敛、轻微的溶角蛋白和修复作用；
-保湿剂或润湿剂；
-羟吡酮(羟甲辛吡酮，即Octopirox)，已知具有抗皮脂溢出活性的活性剂。
因此，进一步优选的实施方案涉及用于治疗脂溢性皮炎、还含有水杨酸的本发明的药物组合物。
进一步优选的实施方案涉及用于治疗放射性皮炎、还含有透明质酸的本发明的药物组合物。
进一步优选的实施方案涉及还含有α-红没药醇和尿囊素的本发明的药物组合物。
进一步优选的实施方案涉及还含有吡咯烷酮羧酸锌的本发明的药物组合物。
本发明的局部用药物组合物可以呈霜剂、凝胶剂、洗剂、混悬剂、喷雾剂、软膏剂、泡沫剂的形式。
本发明的局部用药物组合物可含有以下浓度(w/w)的活性成分：
a)磷脂复合物形式的原花色素：0.01％至1％；
b)甘草次酸：0.1至5％，优选1至2％；
c)替美斯丁：0.01％至1％；和
-载体(角鲨烯、烛果油、棕榈酸辛酯和月见草油)：10-50％；
-抗氧化剂(生育酚醋酸酯0.5-5％；棕榈酸抗坏血酸酯0.01-0.1％)；
-水杨酸0.1-5％；
-透明质酸0.1-10％；
-α-红没药醇0.1-3％；
-吡咯烷酮羧酸锌0.01-1％；
-尿囊素0.1-2％。
日剂量将由医生确定；例如，其将由一或多次的每日应用、甚至更多次数的应用组成。
以下显示了根据本发明的制剂的一些实施例。
实施例1
霜剂
  来自葡萄的原花色素和磷脂的复合物   0.100
  甘草次酸   0.800
  替美斯丁   0.100
  棕榈酸辛酯   7.000
  戊二醇   5.000
  烛果油   4.000
  二十烷醇、二十二醇、C12-20烷基葡糖苷   4.000
  甘油硬脂酸酯和甘油(100)OE硬脂酸酯   3.000
  月见草油   2.000
  辛酰基甘氨酸(capryloyl glycine)   1.500
  红没药醇   1.200
  维生素E醋酸酯   1.000
  卡波姆   0.700
  辛基甘油(octyl glycerin)   0.600
  来自葡萄的原花色素和磷脂的复合物   0.100
  水杨酸   0.500
  羟甲辛吡酮   0.500
  氢氧化钠   0.387
  尿囊素   0.350
  吡咯烷酮羧酸锌   0.100
  EDTA二钠盐   0.08
  棕榈酸抗坏血酸酯   0.05
  没食子酸丙酯   0.02
  水   65.013
  总计   100.000
实施例2
霜剂
  来自葡萄的原花色素和磷脂的复合物   0.100
  甘草次酸   0.800
  替美斯丁   0.100
  棕榈酸辛酯   7.000
  戊二醇   5.000
  烛果油   4.000
  二十烷醇、二十二醇、C12-20烷基葡糖苷   4.000
  甘油硬脂酸酯和甘油(100)OE硬脂酸酯   3.000
  来自葡萄的原花色素和磷脂的复合物   0.100
  角鲨烯   2.000
  月见草油   2.000
  辛酰基甘氨酸   1.500
  红没药醇   1.200
  维生素E醋酸酯   1.000
  卡波姆   0.700
  辛基甘油   0.600
  氢氧化钠   0.387
  吡咯烷酮羧酸锌   0.100
  EDTA二钠盐   0.08
  棕榈酸抗坏血酸酯   0.05
  没食子酸丙酯   0.02
  水   66.013
  总计   100.000
实施例3
霜剂
  来自葡萄的原花色素和磷脂的复合物   0.100
  甘草次酸   0.800
  替美斯丁   0.010
  Dub po   7.000
  来自葡萄的原花色素和磷脂的复合物   0.100
  Hydrolite-5   5.000
  烛果油   4.000
  Montanov 202   4.000
  Arlacel 165   3.000
  Squalene ex   2.000
  月见草油   2.000
  Lipacide C8G   1.500
  红没药醇   1.200
  维生素E醋酸酯   1.000
  Carbopol ultrez 10   0.700
  Sensiva SC 50   0.600
  羟甲辛吡酮   0.500
  氢氧化钠滴剂P.P.A   0.387
  尿囊素   0.350
  1，3-羟甲基-5，5-二甲基乙内酰脲(Nipaguard DMDMH)   0.300
  吡咯烷酮羧酸锌(Zincidone)   0.100
  EDTA二钠盐   0.080
  棕榈酸抗坏血酸酯   0.050
  没食子酸丙酯   0.020
  水   65.303
  来自葡萄的原花色素和磷脂的复合物   0.100
  总计   100.000
实施例4
霜剂
来自葡萄的原花色素和磷脂的复合物   0.100
甘草次酸   0.800
替美斯丁   0.010
Dub po   7.000
Hydrolite-5   5.000
烛果油   4.000
Montanov 202   4.000
Arlacel 165   3.000
Squalene ex   2.000
月见草油   2.000
Lipacide C8G   1.500
红没药醇   1.200
维生素E醋酸酯   1.000
Carbopol ultrez 10   0.700
Sensiva SC 50   0.600
水杨酸   0.500
羟甲辛吡酮   0.500
来自葡萄的原花色素和磷脂的复合物   0.100
氢氧化钠滴剂P.P.A   0.465
尿囊素   0.350
1，3-羟甲基-5，5-二甲基乙内酰脲(Nipaguard DMDMH)   0.300
吡咯烷酮羧酸锌(Zincidone)   0.100
EDTA二钠盐   0.080
棕榈酸抗坏血酸酯   0.050
没食子酸丙酯   0.020
水   64.725
总计   100.000
实施例5
霜剂
来自葡萄的原花色素和磷脂的复合物   0.100
甘草次酸   0.800
替美斯丁   0.010
Dub po   7.000
Hydrolite-5   5.000
烛果油   4.000
Montanov 202   4.000
Arlacel 165   3.000
角鲨烯   2.000
来自葡萄的原花色素和磷脂的复合物   0.100
月见草油   2.000
Lipacide C8G   1.500
红没药醇   1.200
维生素E醋酸酯   1.000
Carbopol ultrez 10   0.700
Sensiva SC 50   0.600
羟甲辛吡酮   0.500
氢氧化钠滴剂P.P.A   0.387
尿囊素   0.350
1，3-羟甲基-5，5-二甲基乙内酰脲(Nipaguard DMDMH) 0.300
吡咯烷酮羧酸锌(Zincidone)   0.100
EDTA二钠盐   0.080
棕榈酸抗坏血酸酯   0.050
透明质酸钠盐   0.030
没食子酸丙酯   0.020
水   65.273
总计   100.000
实施例6
霜剂
 来自葡萄的原花色素和磷脂的复合物   0.100
 甘草次酸   2.000
 替美斯丁   0.010
 棕榈酸乙基己酯   9.000
 牛油果   6.000
 戊二醇   5.000
 丁二醇   3.000
 PEG-100硬脂酸酯   1.500
 甘油硬脂酸酯   1.500
 辛酰基甘氨酸   1.500
 二十烷基葡糖苷   1.360
 二十烷醇   1.320
 二十二醇   1.320
 红没药醇   1.200
 生育酚醋酸酯   1.000
 卡波姆   0.700
 乙基己基甘油   0.600
 羟吡酮   0.500
 氢氧化钠   0.387
 尿囊素   0.350
 DMDM乙内酰脲   0.300
 来自葡萄的原花色素和磷脂的复合物   0.100
 透明质酸钠   0.200
 EDTA二钠   0.080
 四己基癸基抗坏血酸(tetrahexyldecyl ascorbate)   0.050
 没食子酸丙酯   0.020
 水   61.003
 总计   100.000
实施例7
霜剂
  来自葡萄的原花色素和磷脂的复合物   0.100
  甘草次酸   2.000
  替美斯丁   0.010
  棕榈酸乙基己酯   9.000
  牛油果   6.000
  戊二醇   5.000
  丁二醇   3.000
  PEG-100硬脂酸酯   1.500
  甘油硬脂酸酯   1.500
  辛酰基甘氨酸   1.500
  二十烷基葡糖苷   1.360
  二十烷醇   1.320
  二十二醇   1.320
  来自葡萄的原花色素和磷脂的复合物   0.100
  红没药醇   1.200
  水杨酸   1.000
  生育酚醋酸酯   1.000
  氢氧化钠   0.785
  卡波姆   0.700
  乙基己基甘油   0.600
  羟吡酮   0.500
  尿囊素   0.350
  DMDM乙内酰脲   0.300
  EDTA二钠   0.080
  四己基癸基抗坏血酸   0.050
  没食子酸丙酯   0.020
  水   59.805
  总计   100.000
实施例8
霜剂
  来自葡萄的原花色素和磷脂的复合物   0.100
  甘草次酸   2.000
  替美斯丁   0.010
  棕榈酸乙基己酯   9.000
  牛油果   6.000
  戊二醇   5.000
  来自葡萄的原花色素和磷脂的复合物   0.100
  丁二醇   3.000
  PEG-100硬脂酸酯   1.500
  甘油硬脂酸酯   1.500
  辛酰基甘氨酸   1.500
  二十烷基葡糖苷   1.360
  二十烷醇   1.320
  二十二醇   1.320
  红没药醇   1.200
  生育酚醋酸酯   1.000
  卡波姆   0.700
  乙基己基甘油   0.600
  羟吡酮   0.500
  氢氧化钠   0.387
  尿囊素   0.350
  DMDM乙内酰脲   0.300
  透明质酸钠   0.100
  EDTA二钠   0.080
  四己基癸基抗坏血酸   0.050
  没食子酸丙酯   0.020
  水   61.103
  总计   100.000
本发明的组合物显示出非常好的耐受性.它们不含有变应原性物质、动物来源的衍生物(如羊毛脂、蜂蜡、动物脂肪)、防腐剂(如对羟基苯甲酸酯类、异噻唑啉酮(isothiazolone)、酚衍生物等)，这些物质通常是造成变应性接触性皮炎的原因.
因此，由于以上提及的特征，本发明的组合物可用于治疗已经存在的皮肤变应性反应，用于防止复发形式，并且作为治疗慢性疾病如特应性皮炎、变应性接触性皮炎、脂溢性皮炎、放射性皮炎、干燥病和异位性皮炎的佐剂。
更具体地，本发明的组合物可用于治疗如刺激性和湿疹性皮炎等病症，作为敏感、脆弱皮肤的保湿剂和润泽剂；用于由药物、洗涤剂、溶剂导致的变应性刺激；用于过度暴露于日光照射导致的红斑；用于昆虫叮咬、各种原因的充血、削刮后的刺激、轻微灼伤、皮肤超反应性；作为美容治疗如用羟基乙酸或激光治疗脱皮后的平衡剂。
本发明组合物的优异的耐受性使得它们也适用于儿科。
本发明还涉及原花色素在制备局部用药物中的用途，所述药物用于治疗皮肤炎症，尤其是特应性皮炎、变应性接触性皮炎、脂溢性皮炎、放射性皮炎、干燥病、银屑病和异位性皮炎，以及治疗粘膜炎性病症，尤其是阴道、直肠、眼、齿龈和口腔粘膜的炎性病症。

Claims (18)

1.用于局部施用的药物组合物，其包含作为活性成分的原花色素、甘草次酸和替美斯丁与适宜的载体的混合物。
2.权利要求1所述的药物组合物，其中原花色素以磷脂复合物的形式使用。
3.权利要求1或2所述的药物组合物，其中原花色素还与α-红没药醇组合使用。
4.前述权利要求任一项所述的药物组合物，其中原花色素还与羟吡酮组合使用。
5.前述权利要求任一项所述的药物组合物，其中原花色素还与湿润剂和保湿剂组合使用。
6.前述权利要求任一项所述的药物组合物，其呈霜剂、凝胶剂、洗剂、混悬剂、喷雾剂、软膏剂、泡沫剂的形式。
7.前述权利要求任一项所述的药物组合物，其中的载体包括角鲨烯、脂肪酸、脂肪酸酯、植物油、天然或合成的甘油三酯。
8.前述权利要求任一项所述的药物组合物，其中的载体包括角鲨烯、烛果油、棕榈酸辛酯和月见草油。
9.前述权利要求任一项所述的药物组合物，其还包含生育酚、抗坏血酸或其酯。
10.前述权利要求任一项所述的药物组合物，其包含生育酚醋酸酯和棕榈酸抗坏血酸酯或四棕榈酸抗坏血酸酯。
11.前述权利要求任一项所述的药物组合物，其包含水杨酸。
12.前述权利要求任一项所述的药物组合物，其包含透明质酸。
13.前述权利要求任一项所述的药物组合物，其还包含至少一种选自α-红没药醇、吡咯烷酮羧酸锌、尿囊素、羟吡酮的化合物。
14.前述权利要求任一项所述的药物组合物，其中活性成分的浓度如下：
a)磷脂复合物形式的原花色素：0.01％至1％；
b)甘草次酸：0.1％至5％；
c)替美斯丁：0.01％至1％。
15.权利要求14所述的组合物，其中甘草次酸的浓度为1％至2％。
16.前述权利要求任一项的药物组合物在制备用于治疗的药物中的用途。
17.权利要求1-15任一项所述的药物组合物在制备用于治疗皮肤和粘膜的炎性病症的药物中的用途。
18.权利要求17的用途，其中炎性病症选自特应性皮炎、变应性接触性皮炎、脂溢性皮炎、放射性皮炎、银屑病、干燥病和异位性皮炎，以及阴道、直肠、口和眼粘膜的炎性病症。
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