CN103025387B - 用于治疗炎性疾病的罗望子种子多糖 - Google Patents
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- CN103025387B CN103025387B CN201180025375.8A CN201180025375A CN103025387B CN 103025387 B CN103025387 B CN 103025387B CN 201180025375 A CN201180025375 A CN 201180025375A CN 103025387 B CN103025387 B CN 103025387B
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Abstract
本发明涉及罗望子种子多糖(TSP)作为抗炎剂的用途以及含有其作为活性成分的抗炎组合物。含有TSP的抗炎组合物可特别用于在治疗皮肤和粘膜层的炎性疾病中的局部施用。
Description
发明技术领域
本发明涉及罗望子种子多糖作为抗炎剂的用途以及含有其作为活性成分的抗炎组合物。
发明背景
罗望子种子多糖(TSP)是从酸豆(Tamarindusindica)的种子获得的天然多糖聚合物，酸豆是一种可达到15米高并且产生豆荚形式的果实的常绿植物。它在印度、非洲以及整个远东地区非常常见，在这些地方，它主要作为食物种植。果实含有具有高比例多糖的大种子，多糖具有聚集和保存重要能量给予物质的功能。罗望子种子最初被认为是废品，后来发现在碾磨获得粉质产品(称为罗望子胶或罗望子坚果粉)后具有不同的应用。这些应用中最重要的是在纺织工业和造纸工业方面，其中罗望子胶被用作上浆剂和胶粘剂，以及在食品工业方面，其中它与其它多糖类似，在各种产品中用作增稠剂、胶凝剂、稳定剂和粘合剂。罗望子胶原料是含有65%至73%重量的多糖、15%至23%重量的蛋白质物质、3%至8%重量的脂肪和油和2%至4%重量的灰分以及较少量的生纤维(rawfibre)、鞣酸及其它杂质的可购买获得的产品。
近来，TSP也已经在药物领域用作泪液替代品中的活性成分(WO2009/044423)、局部施用的缓释眼用药物的载体(WO97/28787)和由于其粘膜粘附特性而更通常用作赋形剂(WO2006/131262)。
发明概述
本发明涉及罗望子种子多糖在治疗炎性疾病中的用途。
本发明还涉及包含与一种或多种可接受的赋形剂混合的作为活性成分的罗望子种子多糖的抗炎药物和/或皮肤美容化妆(dermocosmetic)组合物。
而且，本发明涉及治疗患有炎性疾病的患者的方法，该方法包括施用治疗有效量的罗望子种子多糖。
发明详述
我们现在已经发现，罗望子种子多糖(下文称为TSP)具有抗炎性质，特别是当局部施用时如此。
因此，本发明的目的是TSP作为抗炎剂的用途，特别是TSP作为用于局部施用的抗炎剂的用途。
本发明的另一目的是包含与一种或多种可接受的赋形剂混合的TSP的抗炎药物和/或皮肤美容化妆组合物，更特别是包含与一种或多种可接受的赋形剂混合的TSP的用于局部施用的抗炎药物和/或皮肤美容化妆组合物。
TSP可以单独地或与其它活性成分组合地用作本发明的抗炎剂。
因此，本发明的另一目的是TSP与一种或多种活性成分组合作为抗炎剂的用途，更特别是TSP与一种或多种活性成分组合作为用于局部施用的抗炎剂的用途。
包括与一种或多种可接受的赋形剂混合的TSP与一种或多种活性成分的组合的抗炎药物和/或皮肤美容化妆组合物和更特别是用于局部施用的抗炎药物和/或皮肤美容化妆组合物也构成了本发明的目的。
根据本发明，“TSP”指从可购买获得的罗望子胶(例如以商标获自DainipponSumitomoPharmaLtd.或以商标获自IndenaSpA)获得的富含多糖的级分。
可以与TSP组合使用的活性成分例如有抗微生物剂、抗炎剂、镇痛剂、创伤愈合剂。
优选的抗微生物剂有抗生素，如克林霉素、红霉素、苄青霉素、四环素、氯霉素、万古霉素和利奈唑胺。
抗炎剂包括甾体抗炎药物如可的松和非甾体抗炎药物如乙酰水杨酸和布洛芬(它们具有镇痛活性)。
创伤愈合剂可以是天然来源或合成来源的。
特别优选的是TSP与其它植物来源提取物、特别是具有抗微生物和/或抗炎和/或镇痛和/或创伤愈合性质的植物来源提取物的组合。
TSP与其它植物来源提取物组合使用可以对抗炎活性具有协同作用。
可以与TSP组合使用的植物来源提取物的优选实例有意大利蜡菊(Helichrysumitalicum)、阿魏(Ferulaspp.)、欧洲七叶树(Aesculushippocastanum)和花椒(Zanthoxylumbungeanum)的提取物。
意大利蜡菊、阿魏和欧洲七叶树的提取物已经分别已知具有抗炎作用。
意大利蜡菊提取物中的活性成分包含在植物的地上部分中，其含有非类黄酮的异戊烯化多酚。意大利蜡菊提取物是已知的，并且可以通过常规方法制得。
阿魏提取物的活性成分包含在全植物中，其含有ferutinin。阿魏提取物是已知的，并且可以通过常规方法制得。
欧洲七叶树提取物的活性成分包含在植物种子和树皮中，其含有原花色素A2(PA2)。
欧洲七叶树提取物是已知的，并且可以通过已知方法制得。
花椒提取物中的活性成分包含在果皮中，其含有链烷酰胺(alkamides)。花椒提取物是已知的，并且可以通过常规方法制得。
对于用作本发明的抗炎剂，TSP被配制在适宜的药物和/或皮肤美容化妆组合物中，优选配制在局部用药物和/或皮肤美容化妆组合物中。本发明的局部用药物和/或皮肤美容化妆组合物包含与一种或多种适宜的赋形剂混合的TSP，其可以例如是乳膏剂、软膏剂、凝胶剂、口胶剂、牙膏、嗽口剂或香波的形式。
TSP通常可以以0.1%至5%重量、优选0.1%至2%重量、甚至更优选0.2%至1%重量的量使用。
任选存在的与TSP组合的其它活性成分以适宜的有效量进行使用。对与TSP组合使用的其它植物来源提取物而言，它们的量通常可以为0.1%至5%重量、优选0.1%至2%重量、甚至更优选0.2%至1%重量。
可以用于本发明的组合物的适宜赋形剂的实例有溶剂、稀释剂、助流剂、防腐剂、树胶、甜味剂、包衣剂、粘合剂、崩解剂、润滑剂、助悬剂、分散剂、着色剂、矫味剂、无粘剂(non-stickagents)、表面活性剂、增塑剂、乳化剂、螯合剂和柔润剂。
优选使用的溶剂为水，但是也可以使用可能与水混合的醇或其它有机溶剂。
赋形剂的选择是本领域技术人员的常识的一部分，将主要取决于所选择的药物和/或皮肤美容化妆形式。
例如，乳膏剂可以通过将TSP掺入局部用载体中来制备，所述载体由利用润滑剂分散于水性介质中的液体石蜡组成。软膏剂可以通过将TSP与局部用载体如矿物油或蜡混合来制备。凝胶可以通过将TSP与含有胶凝剂的局部用载体混合来制备。
本发明的药物和/或皮肤美容化妆组合物也可以是涂布有或浸润了TSP与适宜载体或基质的混合物的纺织或无纺材料，TSP分散于所述载体或基质中以便与皮肤接触用于透皮施用。特定的实例有橡皮膏、纱布、小毛巾等。
药物和/或皮肤美容化妆形式的类型的选择将主要取决于待处理的区域，并且是本领域技术人员的常识的一部分。例如，口胶剂或嗽口剂可以更适于处置口腔，而乳膏剂、软膏剂、洗剂或小毛巾可以适于面部皮肤。
根据本发明用TSP进行治疗可有效地刺激抗炎反应，特别是当局部施用于皮肤和粘膜层时。
因此，本发明的组合物可用于治疗与炎性状态有关的任意皮肤或粘膜层病症。
根据本发明，术语“皮肤”以其常规含义使用，即，包括上皮组织在内的外部器官。术语“粘膜层”也以其常用含义使用，指身体的所有粘膜屏障，例如胃肠、肺、舌下、口腔、直肠、阴道、鼻、尿道和眼屏障。
本发明所涉及的组合物优选通过局部施用来直接应用于皮肤或粘膜层的发炎区域和/或应用于周围区域。
许多与炎性状态有关的皮肤和粘膜层病症是已知的。例如，可以通过应用本发明的组合物来有效治疗或预防的一种皮肤或粘膜层病症是皮炎。
皮炎是以形成水疱、红斑、水肿、渗出性病损、脱屑性病损、成痂性病损和剧烈瘙痒为特征的皮肤表面炎症。皮炎可以是接触性的、特应性的或脂溢性的类型。主要治疗包括除去触发物，通常是刺激性物质或变应原，但这不一定是可能的。
皮炎的一种特定形式是银屑病，它是影响约1-2%人群的慢性过度增殖性炎性皮肤疾病。每年报道了约150,000例银屑病新病例，并且约400例死亡是由该疾病引起的。银屑病对患者生活的影响不限于其对身体外观的影响，而且还影响他们的体质和寿命。银屑病最常见的类型是慢性斑块状银屑病，它通常是一种具有缓解和发作周期的慢性病症，特征为最经常位于头皮或者位于肘和膝的伸肌面上的红斑状脱屑性斑块。
皮炎的治疗通常基于皮质类固醇，其存在值得注意的副作用，例如免疫应答降低，其导致继发性细菌感染、尤其是真菌或念珠菌属(Candida)引起的那些。而且，该治疗需要频繁的中止期，并且在疾病的急性渗出期期间不能使用。
或者，银屑病可以通过局部施用地蒽酚、维生素D3类似物或他扎罗汀进行治疗。这些活性成分存在各种副作用，例如刺激性、毒性和致癌性。用UVA或UVB放射进行的光疗也可以用于治疗银屑病，特别是当患者对局部治疗没有响应时。然而，光疗不是没有副作用，例如在UVB放射的情况下有皮肤红斑、发疱和过早老化的风险或者在UVA放射的情况下出现恶心、红斑、头痛、皮肤疼痛、光化性角化病、皮肤过早老化、不规律的色素沉着和鳞状细胞癌。
本发明的组合物允许有效地治疗所有类型的皮炎。
甚至是粘膜层、尤其是口腔、直肠和阴道粘膜层的炎症也可以用本发明的组合物进行治疗。
特别地，TSP可用于局部治疗口腔粘膜炎症如粘膜炎和口炎。
术语粘膜炎和口炎通常可互换使用，尽管这两种病症可存在一些差异。
粘膜炎是影响胃肠道的毒性炎性反应，可以由于暴露于化疗剂或电离辐射而引起。粘膜炎通常表现为类似于灼伤的红斑状病损或者表现为从局部扩散的随机的溃疡性病损。
口炎是一种影响口腔粘膜的、有或无溃疡形成的炎性反应，其可以由药理学治疗、特别是化疗或放疗引起或加剧。
口炎的程度可以是轻度至重度，患有严重口炎的患者可能不能通过口来进食或饮水或服用医学产品。
许多女性在月经周期的某些阶段患有口腔溃疡，同时在生殖道、特别是外阴和阴道存在同类型的溃疡。它们有时非常严重，可引起尿潴留，需要强的镇痛剂和镇静剂。
最严重的形式已知为Behcet’s综合征。
根据本发明，粘膜炎的更概括的术语将也用于指口炎。
红斑状粘膜炎可以早在暴露于化疗或放疗后三天出现，但是更通常在5-7天后出现。发展为溃疡性粘膜炎在开始化疗的7天内发生，有时可以变得如此严重以至于需要停止药理学治疗。粘膜炎可涉及口和口咽道以及从口至肛门的胃肠道。在本文中，除非另有说明，否则指涉及更容易达到的区域如口、咽、食道和直肠的粘膜炎。
由于接受化疗的患者出现不同严重程度的粘膜炎的百分比高(30-40%)，因此特别需要有效的和方便的治疗。目前没有获得有效的治疗，解决该问题的尝试包括使用镇痛剂、抗菌剂和症状的口腔卫生措施或减弱。
而且，该问题不限于癌症患者，因为粘膜炎也经常出现在HIV患者(特别是当伴有卡波西肉瘤时)、患有非霍奇金淋巴瘤的患者、虚弱的老年患者和接受BRM(生体应答调节剂)如白细胞介素-2、干扰素、淋巴因子活化的淋巴细胞等的患者中。
提供了下述实施例来进一步阐述本发明。
实施例
实施例1—局部用乳膏剂
实施例2—口服糊剂
实施例3—阴道用乳膏剂
实施例4—皮肤PMN中的髓过氧化物酶表达
通过测定多形核中性粒细胞(PMN)中髓过氧化物酶(MPO)活性的抑制，测试了罗望子种子多糖(单独或与标准化植物提取物组合)降低炎症细胞反应的能力。炎症、特别是急性期期间的炎症通过趋化性引起PMN向炎症部位迁移。还已知MPO活性的程度与组织中存在的PMN数目和与炎性应答成正比。因此，PMN数目减少对应于髓过氧化物酶活性降低，然后可以得出结论：炎症的细胞应答相应地减少。
在直径100mm的细菌学培养皿中培养人皮肤PMN。细胞培养基是补充有青霉素(100U/ml)、链霉素(100mcg/ml)、L–谷氨酰胺(2mM)和10%热灭活和过滤的FCS(胎牛血清)的RPMI-1640。然后，通过向培养基中加入LPS(脂多糖)来刺激PMN。
将不同的标准化植物提取物(在培养基中0.2%浓度)单独或与罗望子种子多糖(在培养基中0.2%浓度)组合地加入到培养皿中。使用0.1%的地塞米松(已知为炎性反应和MPO活性的强抑制剂)作为阳性参照化合物。详细内容报道在表1中。
培养6小时后，采用酶免疫测定试剂盒(ELISA)在PMN细胞上清液中对髓过氧化物酶(MPO)活性的总体抑制进行定量。结果记录在表2中。
*p<0.01vs.对照
**p<0.01vs.阳性参照(地塞米松)
Claims (10)
1.抗炎的药物或皮肤美容化妆组合物，包含与一种或多种可接受的赋形剂混合的作为活性成分的罗望子种子多糖以及赫蒙阿魏(Ferulahermonis)提取物。
2.根据权利要求1的组合物，用于局部施用。
3.根据权利要求1或2的组合物，其为软膏剂、洗剂、口胶剂、牙膏、嗽口剂或香波的形式。
4.根据权利要求1或2的组合物，其为乳膏剂的形式。
5.根据权利要求1或2的组合物，其为凝胶剂的形式。
6.根据权利要求1或2的组合物，至少包含选自抗炎剂、镇痛剂和创伤愈合剂的其它活性成分。
7.根据权利要求1或2的组合物，至少包含选自抗微生物剂的其它活性成分。
8.根据权利要求1或2的组合物，还包含欧洲七叶树(Aesculushippocastanum)的提取物。
9.根据权利要求1或2的组合物，其中所述罗望子种子多糖的量为0.1％至5％重量。
10.权利要求1-9任一项的组合物在制备用于治疗炎性疾病的药物中的用途。
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| DE102013213596A1 (de) | 2013-07-11 | 2015-01-15 | Henkel Ag & Co. Kgaa | Mund- und Zahnpflege- und -reinigungsmittel zur Zahnfleischvitalisierung |
| EP3348273B8 (en) | 2014-04-15 | 2019-09-18 | Devintec, Sagl | Compositions based on xyloglucan and proteins for the treatment of intestinal disorders |
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| EP3103438B1 (en) | 2015-06-11 | 2018-11-14 | Novintethical Pharma SA | Topical nasal compositions containing xyloglucans for use as decongestans |
| IT201900021483A1 (it) * | 2019-11-18 | 2021-05-18 | S I I T S R L Servizio Int Imballaggi Termosaldanti | Composizioni comprendenti xiloglucano e D-mannosio e loro uso per il trattamento di disturbi del tratto genito-urinario |
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| IT1283911B1 (it) * | 1996-02-05 | 1998-05-07 | Farmigea Spa | Soluzioni oftalmiche viscosizzate con polisaccaridi della gomma di tamarindo |
| IT1284971B1 (it) * | 1996-10-17 | 1998-05-28 | Indena Spa | Formulazioni farmaceutiche e cosmetiche ad attivita' antiacne |
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| FR2851469B1 (fr) * | 2003-01-14 | 2007-09-21 | Jean Noel Thorel | Composition et procede de soin contenant un inhibiteur de glucosidase |
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| WO2005063186A1 (en) * | 2003-12-30 | 2005-07-14 | Council Of Scientific & Industrial Research | Herbal oro-dental care composition and process for preparing the same |
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| WO2009044423A1 (en) * | 2007-10-02 | 2009-04-09 | Rmfa Trading S.A. | Ophthalmic compositions based on tamarind seed polysaccharide and hyaluronic acid |
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