CN104955447A - 用于减轻口干燥症状和用于治疗口溃疡的局部口腔组合物 - Google Patents
用于减轻口干燥症状和用于治疗口溃疡的局部口腔组合物 Download PDFInfo
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Abstract
本发明涉及含牛磺酸、丙二醇和木糖醇的局部口腔组合物,及其用于减轻或消除口干燥的症状和/或预防或治疗口溃疡的用途。
Description
发明领域
本发明涉及含牛磺酸、丙二醇和木糖醇的局部口腔组合物,及其用于减轻或消除口干燥的症状和/或预防或治疗口溃疡的用途。
技术背景
口干燥(Dry mouth)或口干燥症(xerostomia)是由唾腺的活性下降引起的。唾液流量的下降通过引起口腔pH值下降和细菌生长的增加,能导致不适,影响讲话和吞咽,使得戴假牙困难,引起口臭,并损害口腔卫生。长期口干燥能导致严重的龋齿和口腔念珠菌病。在老年人中口干燥是常见的不适,影响约20%的老年人。
口干燥的原因各不相同,且涉及许多因素诸如应力、唾腺感染或药物诸如抗胆碱药、抗震颤麻痹药、抗肿瘤药的使用、头颈的辐射(用于癌症治疗)或其还可与某些疾病相关、诸如干燥综合征和HIV/AIDS、不受控的糖尿病和其他障碍。
目前使用口腔清洗剂治疗口干燥,通常是局部应用,还有唾液替代物或唾液刺激剂、诸如无糖糖果和口香糖。一些唾液刺激剂可商购获得。目前的治疗聚焦于缓解症状和预防牙龋洞。人工唾液产品经常是口干燥症患者的治疗选择。
口干燥能使口软组织、诸如口粘膜、龈组织和舌上的味蕾更易遭受物理、物理化学和生物学损伤。然而现有的治疗/产品没有解决软组织困扰的问题。本发明组合物通过保护和修复促进口软组织的效应来解决该问题。
口溃疡和口腔病损是发生在口腔黏膜上的具有类似于烧伤和损伤的红斑性病损的炎症形式,该疼痛的溃疡使得咀嚼和吞咽困难,损害患者的生活质量。它们令人疼痛是由于口腔黏膜层被除去露出了下面的神经末梢。
有多种原因,包括配合不良的支架和假牙、物理或化学创伤、口干燥、服用免疫抑制药物、烧伤、变态反应、微生物或病毒感染。一旦形成,溃疡可由于炎症和/或继发感染而持续存在。两种常见的口腔溃疡类型是口疮性溃疡(口疮)和感冒疮。感冒疮可以由单纯性疱疹病毒引起。
口溃疡使用局部冲洗剂、局部凝胶剂和液体、行为改进、镇痛药和预防措施来控制。
发明描述
根据本发明已经发现了局部应用于口腔粘膜的含牛磺酸、木糖醇和丙-1,3-二醇的组合物对口干燥产生有益的作用,并促进口腔粘膜再生。
本发明提供了包含牛磺酸或其盐、木糖醇和丙-1,3-二醇的局部口腔组合物。
牛磺酸(2-氨基乙磺酸)是广泛分布在动物组织中的有机酸。哺乳动物血浆和细胞中存在高浓度的牛磺酸,并在多种生物进程中起重要作用。已显示牛磺酸具有调节渗透、抗氧化、抗细胞凋亡(antiapoptopic)、抗炎和降脂活性。
木糖醇被归类为多元醇,且其被认为是“无糖”甜味剂。已知木糖醇降低龋齿风险。
丙-1,3-二醇以的商标销售,且已知其是润滑剂、湿润剂、手感改良剂或溶剂。
本发明的组合物能保护口软组织并促进它们的修复以减轻口软组织的炎症,预防味觉障碍(由于对味蕾的保护)和防止干燥损伤(由于润滑功能)。
牛磺酸在组合物中的浓度范围以重量计为0.01至5.0%,优选浓度以重量计为0.1至1.0%。
木糖醇在组合物中的浓度范围以重量计为0.1至10.0%,优选浓度以重量计为0.5至5.0%。
丙-1,3-二醇在组合物中的浓度范围以重量计为0.1至30.0%,优选浓度以重量计为2.0至20.0%。
组合物还可包含透明质酸钠。
透明质酸钠以重量计以0.01至1.0%的浓度存在,优选浓度以重量计为0.05至0.3%。透明质酸钠优选具有1.0-1.5x 106的分子量(MW)。
本发明的组合物还可包含组分诸如再矿化剂(remineralizing agent)、渗透保护剂、润滑剂、用于刺激唾液流的化合物。
再矿化剂优选选自氟阴离子、磷酸根阴离子、钠阳离子和钾阳离子,诸如氟化钾、氟化钠、单氟磷酸钠、氟化锡、胺氟化物(鲸蜡基胺氢氟酸盐、双-(羟乙基)氨基丙基-N-羟乙基-十八胺二氢氟酸盐、N-N',N'-三(聚氧乙烯)-N-鲸蜡基-丙二胺亚胺二氢氟酸盐或十八烯胺氢氟酸盐)、磷酸钾、焦磷酸钾、柠檬酸三钾、乳酸钙、泛酸钙和碳酸钙。
优选的再矿化剂为单氟磷酸钠,以重量计其优选以0.10至1.14%的浓度存在。
渗透保护剂优选为甜菜碱,以重量计其优选以0.5至5.0%的浓度存在。
优选的润滑剂是聚乙烯吡咯烷酮,以重量计其优选以0.01至5.0%的浓度存在。
用于刺激唾液流的化合物可以是柠檬酸盐或柠檬酸。优选的用于刺激唾液流的化合物是柠檬酸钠/柠檬酸,以重量计其优选以0.5至5.0%的浓度存在。本发明的组合物在各个情况下可以包括本领域技术人员已知的所有需要的成分以得到所需的感官和流变性质。
依据权利要求的局部口腔组合物可以为凝胶剂、喷雾、牙膏、漱口剂、口腔贴剂、口香糖和片剂形式。
实施例
实施例1
实施例2
实施例3
实施例4
Claims (17)
1.局部口腔组合物,其包含牛磺酸或其盐、木糖醇和丙-1,3-二醇。
2.权利要求1的局部口腔组合物,其中牛磺酸或其盐的浓度以重量计为0.01至5.0%。
3.权利要求1或2的局部口腔组合物,其中木糖醇的浓度以重量计为0.1至10.0%。
4.根据权利要求1-3中任意一项的局部口腔组合物,其中丙-1,3-二醇的浓度以重量计为0.1至30.0%。
5.根据权利要求1-4中任意一项的局部口腔组合物,其还包含透明质酸钠。
6.根据权利要求1-5中任意一项的局部口腔组合物,其还包含再矿化剂。
7.权利要求6的局部口腔组合物,其中再矿化剂选自氟阴离子、磷酸根阴离子、钠阳离子和钾阳离子,诸如氟化钾、氟化钠、单氟磷酸钠、氟化锡、胺氟化物(鲸蜡基胺氢氟酸盐、双-(羟乙基)氨基丙基-N-羟乙基-十八胺二氢氟酸盐、N-N',N'-三(聚氧乙烯)-N-鲸蜡基-丙二胺亚胺二氢氟酸盐或十八烯胺氢氟酸盐)、磷酸钾、焦磷酸钾、柠檬酸三钾、乳酸钙、泛酸钙和碳酸钙。
8.权利要求7的局部口腔组合物,其中再矿化剂为单氟磷酸钠或氟化钠。
9.根据权利要求1-8中任意一项的局部口腔组合物,其还包含渗透保护剂。
10.权利要求9的局部口腔组合物,其中渗透保护剂为甜菜碱。
11.根据权利要求1-10中任意一项的局部口腔组合物,其还包含润滑剂。
12.根据权利要求11的局部口腔组合物,其中润滑剂为聚乙烯吡咯烷酮。
13.权利要求1-12的局部口腔组合物,其还包含用于刺激唾液流的化合物。
14.权利要求13的局部口腔组合物,其中用于刺激唾液流的化合物是柠檬酸盐或柠檬酸。
15.凝胶剂、喷雾、牙膏、漱口剂、口腔贴剂、口香糖和片剂形式的根据权利要求1-14中任意一项的局部口腔组合物。
16.用于减轻或消除口干燥的症状的根据权利要求1-15中任意一项的局部口腔组合物。
17.用于预防或治疗口腔溃疡的根据权利要求1-15中任意一项的局部口腔组合物。
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EP12197696.3A EP2745836B1 (en) | 2012-12-18 | 2012-12-18 | Topical oral composition for alleviating dry mouth symptoms and for treating mouth ulcers |
PCT/EP2013/076080 WO2014095489A1 (en) | 2012-12-18 | 2013-12-10 | Topical oral composition for alleviating dry mouth symptoms and for treating mouth ulcers |
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US (1) | US9895326B2 (zh) |
EP (1) | EP2745836B1 (zh) |
JP (1) | JP6461002B2 (zh) |
CN (1) | CN104955447B (zh) |
CA (1) | CA2895249C (zh) |
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WO2016106071A1 (en) * | 2014-12-23 | 2016-06-30 | Colgate-Palmolive Company | Oral care composition |
JPWO2016153015A1 (ja) * | 2015-03-25 | 2018-05-10 | 株式会社ファルマクリエ神戸 | 高分子薬効成分を含有した口腔内施用物および口腔内への高分子薬効成分の投与方法 |
JP7455317B2 (ja) * | 2017-06-30 | 2024-03-26 | 小林製薬株式会社 | 口腔用組成物 |
US10245236B1 (en) * | 2018-01-12 | 2019-04-02 | Lisa Carroll | Method and product for treating mouth-related disorders |
EP4200025A1 (en) * | 2021-01-25 | 2023-06-28 | Colgate-Palmolive Company | Solid oral care compositions comprising pvp and hec as binder system |
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US9895326B2 (en) | 2018-02-20 |
ES2593618T3 (es) | 2016-12-12 |
EP2745836A1 (en) | 2014-06-25 |
EP2745836B1 (en) | 2016-08-31 |
US20150320701A1 (en) | 2015-11-12 |
CN104955447B (zh) | 2019-02-22 |
CA2895249A1 (en) | 2014-06-26 |
JP6461002B2 (ja) | 2019-01-30 |
WO2014095489A1 (en) | 2014-06-26 |
CA2895249C (en) | 2021-06-22 |
JP2016510308A (ja) | 2016-04-07 |
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