CN103189066A - 用于治疗各种起因的外周溃疡的组合物 - Google Patents

用于治疗各种起因的外周溃疡的组合物 Download PDF

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CN103189066A
CN103189066A CN2011800517648A CN201180051764A CN103189066A CN 103189066 A CN103189066 A CN 103189066A CN 2011800517648 A CN2011800517648 A CN 2011800517648A CN 201180051764 A CN201180051764 A CN 201180051764A CN 103189066 A CN103189066 A CN 103189066A
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E·邦巴尔代利
P·莫拉佐尼
M·龙基
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Abstract

本发明涉及含有具有血管动力学性质的细胞增殖刺激剂与具有抗炎/镇痛性质的抗微生物剂、抗真菌剂和抗病毒剂的组合的组合物，其可用于治疗多种起因的外周溃疡，例如糖尿病性溃疡、由四肢静脉淤滞所导致的溃疡、褥疮和相关皮肤感染。所述组合可以是用于局部使用或全身使用的制剂的形式。

Description

用于治疗各种起因的外周溃疡的组合物
发明概述
本发明涉及含有具有血管动力学(vasokinetic)性质的细胞增殖刺激剂与具有抗炎/镇痛性质的抗微生物剂、抗真菌剂和抗病毒剂的组合的组合物，其可用于治疗各种起因的外周溃疡(peripheral ulcer)，例如糖尿病性溃疡、由四肢静脉淤滞所导致的溃疡、褥疮和相关皮肤感染。更特定地，本发明涉及含有儿茶素多酚、花色苷或含有它们的欧洲七叶树(Aesculus hippocastanum)、葡萄(Vitis vinifera)或杜鹃花科(Ericaceae)提取物以及紫松果菊属物种(Echinacea sp.)提取物的组合物。
所述组合物适合用于局部使用或全身使用。
技术背景
尽管其呈现出共同的症状，但是诸如外周溃疡(无论它们是糖尿病性溃疡、由四肢静脉淤滞所导致的溃疡，还是褥疮和相关皮肤感染)等障碍具有不同的病因学。一些障碍涉及外周循环和微循环，而许多障碍与动脉硬化相关，所述动脉硬化导致小动脉和中动脉阻塞及随之发生的水肿，并且由于偶然原因或由瘙痒所导致的搔抓，会导致损伤，所述损伤由于随后的细菌和/或真菌感染而难以愈合。
与慢性静脉功能不全相关的溃疡需要用具有不同的、协同的作用的物质的组合进行漫长的治疗。糖尿病性溃疡与前者具有类似的起因，并且伴有外周疼痛和紫癜。
血管动力学和血管保护性物质通常改善伤口愈合，尤其是在褥疮的情况下。因此具有伤口愈合和血管动力学作用的物质与快速消除感染和疼痛的物质一起的可利用性将是符合需要的。利用淋巴引流保持动脉微循环活跃和从溃疡的区域移除蛋白质渗出进一步加速了组织上皮再形成(re-epithelialisation)。
发明详述
已经发现儿茶素多酚或花色苷与紫松果菊属物种提取物的组合诱导令人惊奇地快速的伤口愈合，伴有周围水肿减少和上皮再形成，这是由于纤维蛋白产生和蛋白质渗出的立即减少造成的，其使得伤口清洁和肉芽组织快速增殖。
因此，本发明涉及用于治疗各种起因的外周溃疡例如淤滞溃疡(stasis ulcer)、糖尿病性溃疡、褥疮和相关皮肤感染的组合物，其含有作为活性成分的：
a)儿茶素多酚或花色苷或含有它们的提取物，和
b)紫松果菊属物种提取物。
已知儿茶素多酚对成纤维细胞增殖具有体外活性、对结缔组织的基质具有抗蛋白酶活性、在静脉和淋巴水平具有血管动力学活性。根据本发明，所述多酚可以以单分子形式或以含有它们的提取物的形式存在。当它们以提取物的形式存在时，优选使用欧洲七叶树或葡萄提取物。所述提取物优选是通过提取所述植物的地上部分获得的。
根据一个优选的方面，儿茶素多酚以由欧洲七叶树的树皮、树枝和果皮获得的提取物的形式存在。所述提取物主要含有两类物质：原花青素A2(procyanidin A2)，其不仅是强效的蛋白酶抑制剂，而且在静脉和淋巴水平具有作为微血管动力学(microvasculokinetic)物质的活性；和大量的七叶苷糖，其在动脉水平是强效的血管动力学物质。
根据一个优选的方面，儿茶素多酚选自欧洲七叶树的酒精提取物、原花色素A2(proanthocyanidin A2)和由葡萄籽提取的原花色素低聚物(oligomeric proanthocyanidin)。
根据一个优选的方面，术语“花色苷”既包括被恰当地如此称呼的花色苷，也包括它们的苷元(花色素)。
花色苷优选地来源于杜鹃花科提取物，特别是越桔属(Vaccinium)的各物种的提取物。
根据一个优选的方面，花色苷来源于酸果蔓的果实和叶的提取物(大果越桔(Vaccinium macrocarpon)、小果蔓越桔(V.oxycoccus)、南方蔓越桔(V.erythrocarpum)、小果红莓苔子(V.microcarpum)、小果越桔(V.oxycoccos))。
根据一个另外的优选的方面，花色苷来源于欧洲越桔(Vacciniummyrtillus)提取物。覆盆子(欧洲越桔)提取物是一种具有显著抗炎活性、尤其是在局部水平具有显著抗炎活性的产品，这是由于其对毛细管脆性和通透性的作用造成的。含有花色苷的覆盆子提取物的制备是已知的。此外，覆盆子花色苷例如原花青素具有防止细菌和真菌粘附的抑菌作用。
紫松果菊属(Echinacea)提取物发挥镇痛、抗病毒、抗炎和抗微生物活性，这导致伤口愈合的总体改善；它还对所有形式的瘙痒(一种经常伴随着由静脉淤滞所导致的疮形成的病症)具有显著的作用，并且在疮的愈合以及尤其是预防中有用。
根据本发明的一个优选的方面，紫松果菊属物种提取物是狭叶松果菊(Echinacea angustifolia)或紫松果菊(Echinacea purpurea)的酒精提取物。
对于儿茶素多酚、花色苷或含有它们的提取物而言，活性成分的百分比可以在0.05%至2%范围内，而对于紫松果菊属物种提取物而言，浓度可以在0.01%至1%范围内。
因此，根据一个优选的方面，本发明的组合物含有下列百分比范围内的活性成分：
a)儿茶素多酚、花色苷或含有它们的提取物：0.05%至2%；
b)紫松果菊属物种提取物：0.01%至1%。
根据一个特别优选的方面，所述组合物含有下列百分比范围内的活性成分：
a)儿茶素多酚、花色苷或含有它们的提取物：0.1%至1%；
b)紫松果菊属物种提取物：0.05%至0.5%。
本发明的组合物可以局部施用或全身施用，例如以水/油乳剂、无菌撒布粉或闭塞性制剂(occlusive formulation)的形式局部施用或全身施用。
根据一个优选的方面，闭塞性制剂是被设计为在应用时被水化的固体形式，其含有海藻酸作为胶凝多糖。
用在制剂中的优选的赋形剂是多糖，例如透明质酸和硫酸软骨素或海藻酸，其帮助形成刺激伤口愈合的保护膜。
在人药理学治疗中，将制剂应用于伤口，并放置使其被吸收。特定地，感染的伤口应当被粘性膏药(sticking plaster)覆盖以形成封闭敷裹。所述伤口治疗一天重复一次至三次，同时注意保护伤口或疮避免发生机械创伤。
本发明的组合物与合适的赋形剂一起根据众所周知的常规方法、例如在“Remington’s Pharmaceutical Handbook”,Mack Publishing Co.,N.Y.,USA中所描述的那些方法被制备。
下面的实施例详细地举例说明了本发明。
制备实施例
实施例1—欧洲七叶树树皮提取物的制备
用95%的乙醇从5Kg来自精细研磨的欧洲七叶树树枝的树皮中反复提取原花青素A2和七叶苷糖，直到提净。将提取溶剂浓缩至与起始生物质相等的重量，将浓缩物过滤以除去不需要的物质。将滤液于不超过40°C的温度下真空浓缩至干。获得570g具有35%的七叶苷糖含量和11.2%的原花青素A2的米黄色提取物。该提取物可以“照原样”用在本发明的制剂中。
实施例2—狭叶松果菊根提取物的制备
于50°C用95%的乙醇从2Kg精细研磨的狭叶松果菊根中提取松果菊苷、咖啡酰奎尼酸和异丁酰胺，直到提净。用松果菊苷作为标志物，利用薄层色谱法检测是否提净。将提取溶剂于25°C真空浓缩，同时注意在蒸汽流中不要蒸馏含有异丁酰胺的碱性油。通过浓缩溶剂至干，获得150g具有4%的松果菊苷含量和0.5%的异丁酰胺含量的提取物。该提取物可以“照原样”用在本发明的制剂中。
药理学实施例
实施例3—对由下肢静脉淤滞所导致的溃疡的作用
本研究包括50名患有下肢静脉淤滞溃疡、未并发其它血管障碍的患者(每组10名)。
用实施例7中所述的制剂治疗患者，将其一天两次应用于损伤。然后将被治疗的损伤用绷带覆盖以确保乳膏剂不被除去，并且保护它们避免接触外部物质和/或发生机械创伤。对损伤监测21天，通过测量两个直径评价了上皮再形成。结果用所测量的两个直径的均值表示。
结果如下表所示。
Figure BDA00003107715300051
*P<0.05;**P<0.001Student“t”检验
一些制剂实施例如下文所示。
制剂实施例
实施例4—用于制备即配型含水凝胶(extempore aqueous gel)的小药囊 的颗粒
Figure BDA00003107715300052
实施例5—含水凝胶
Figure BDA00003107715300053
Figure BDA00003107715300061
实施例6—撒布粉
Figure BDA00003107715300062
实施例7—含水凝胶
Figure BDA00003107715300063
实施例8—乳膏剂(O/W乳剂)
Figure BDA00003107715300064
Figure BDA00003107715300071

Claims (12)

1.组合物，其包含：
a)儿茶素多酚或花色苷或含有它们的提取物，和
b)紫松果菊属物种的提取物。
2.权利要求1所要求保护的组合物，其中所述的含有儿茶素多酚的提取物是欧洲七叶树或葡萄的提取物。
3.权利要求1所要求保护的组合物，其中所述的含有花色苷的提取物是杜鹃花科的提取物。
4.权利要求2所要求保护的组合物，其中所述的欧洲七叶树的提取物是树皮、树枝和果皮的酒精提取物。
5.权利要求2所要求保护的组合物，其中所述的葡萄的提取物是籽的提取物。
6.权利要求3所要求保护的组合物，其中所述的杜鹃花科的提取物是欧洲越桔、大果越桔、小果蔓越桔、南方蔓越桔或小果红莓苔子的提取物。
7.权利要求1所要求保护的组合物，其中所述的紫松果菊属物种的提取物是狭叶松果菊或紫松果菊的酒精提取物。
8.权利要求1所要求保护的组合物，其含有下列百分比范围内的活性成分：
a)儿茶素多酚或花色苷或含有它们的提取物：0.05%至2%；
b)紫松果菊属物种的提取物：0.01%至1%。
9.权利要求8所要求保护的组合物，其含有下列百分比范围内的活性成分：
a)儿茶素多酚或花色苷或含有它们的提取物：0.1%至1%；
b)紫松果菊属物种的提取物：0.05%至0.5%。
10.根据以上权利要求所述的组合物，其用于局部施用或全身施用。
11.用于治疗各种起因的外周溃疡和相关皮肤感染的组合物，其包含：
a)儿茶素多酚或花色苷或含有它们的提取物，和
b)紫松果菊属物种的提取物。
12.权利要求11所要求保护的组合物，其中所述的溃疡是糖尿病性溃疡、四肢的静脉淤滞溃疡或褥疮。
CN2011800517648A 2010-10-28 2011-10-21 用于治疗各种起因的外周溃疡的组合物 Pending CN103189066A (zh)

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ITUA20161822A1 (it) * 2016-03-18 2017-09-18 Indena Spa Composizioni utili nella prevenzione e/o nel trattamento di patologie del cavo orale, delle prime vie aeree e dell’esofago
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