CN103096908B - 喷鼻剂 - Google Patents
喷鼻剂 Download PDFInfo
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- CN103096908B CN103096908B CN201180043089.4A CN201180043089A CN103096908B CN 103096908 B CN103096908 B CN 103096908B CN 201180043089 A CN201180043089 A CN 201180043089A CN 103096908 B CN103096908 B CN 103096908B
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Abstract
本发明涉及一种药品，其没有拟交感神经药，在普通感冒、花粉热、鼻干和拟交感神经药依赖的情形中对鼻粘膜具有有利作用，并且以喷鼻剂、洗鼻剂或滴鼻剂的形式提供。
Description
技术领域
本发明涉及无拟交感神经药的药品，其以喷鼻剂、洗鼻剂或滴鼻剂的形式在普通感冒、花粉热或其它鼻炎（rhinitides）、鼻干和/或拟交感神经药依赖（dependence）中对鼻粘膜具有有利作用。
背景技术
在普通感冒（卡他性鼻炎）、花粉热、其它鼻炎（rhinitides）或鼻干中，鼻粘膜经受肿胀。迄今为止，通常以滴鼻剂或喷鼻剂的形式局部使用拟交感神经药来进行治疗，以实现粘膜肿胀的减轻。然而，拟交感神经药因吸收而具有许多不期望的副作用并且可能导致心悸和呼吸障碍。此外，它们使鼻粘膜变干，并且当长期施用时，可能出现对鼻粘膜上皮的永久性损伤。这种拟交感神经药依赖被称为药物性鼻炎（Apotheker-Journal12,30-34(1985),Otto Hoffmanns Verlag,Munich）。
EP 0 216 917 B1涉及用于对鼻施用的药物制剂，其除其它之外含有增稠剂。例如，甲基纤维素被提及作为所述增稠剂。US5,843,881A涉及喷雾组合物。具体地，该组合物含有醇、聚合物和掩醇香料添加剂。组合物被施用于皮肤、毛发或粘膜。
近年来，已逐渐确立了基于海盐和/或普通盐的无拟交感神经药的喷鼻剂。他们对鼻粘膜不具有急性药理作用（药品），但通过使粘膜湿润清洁（尤其是在数次施用之后）能够缓解粘膜并由此缓解症状。
由于溶液的停留时间较短，须非常频繁地施用溶液，并且当疾病严重时缓解程度经常不足。
发明内容
因此，本发明的目的是提供与已知产品相比对鼻粘膜具有更强缓解作用的药品。但其不会导致使用含有拟交感神经药的产品时会出现的依赖性。
惊人地是，发现薄荷醇、薄荷油和/或樟脑连同湿润剂一起对鼻粘膜具有比含有普通盐和/或海盐的常用喷剂更强的清洁作用。具体实施方式还含有泛醇尤其是右泛醇。
因此，本发明的第一实施方式包括用于缓解鼻粘膜的无拟交感神经药的药品，其特征在于包括薄荷醇、薄荷油和泛醇尤其是右泛醇、以及至少一种湿润剂，该湿润剂包括在含水体系中形成凝胶或粘性溶液的水溶性或水分散性的天然或合成的聚合物、多元醇、单-、二-和/或多糖。优选使用聚合物。合适的聚合物包括，例如胶原衍生物（源自动物和植物）、聚亚烷基二醇尤其是聚乙二醇、聚丙三醇、藻酸盐、角叉菜胶、果胶、黄蓍胶、树胶尤其是阿拉伯胶、纤维素衍生物尤其是纤维素醚和/或纤维素酯、聚乙烯醇、聚乙烯吡咯烷酮及其衍生物、和/或葡聚糖。
本发明含义内特别优选的纤维素衍生物包括羟乙基纤维素和/或甲基羟丙基纤维素。
根据本发明的药品还可以含有樟脑。
湿润剂和泛醇的组合连同薄荷醇和薄荷油和任选樟脑引起鼻粘膜的湿化。此外，鼻粘膜达到缓解。薄荷醇和薄荷油和任选的樟脑对鼻粘膜具有降温作用。结合湿润剂，鼻粘膜达到缓解。惊人地是，发现在根据本发明的喷鼻剂中这两种身体效应很好地互补，并且与含有海盐和/或普通盐的喷鼻剂相比具有改善的效果。
本发明含义内的“缓解鼻粘膜”是指使鼻粘膜保持湿润。使用根据本发明的喷鼻剂，并不出现在使用含有拟交感神经药的喷鼻剂时出现的干燥感。此外，“缓解”还包括较轻程度的肿胀或者甚至减轻受刺激的鼻粘膜肿胀。
当基于常规基础使用时，根据本发明的制剂是含有拟交感神经药的喷鼻剂的替代品。这对依赖于含有拟交感神经药的喷鼻剂的人来说也可以是有益的。
在感染普通感冒时通常依赖于使用含有拟交感神经药的喷雾剂的数名受试者在一周的时间内接受喷雾剂形式的本发明产品。两名受试者在一周的感染期间内能够完全免除含有拟交感神经药的喷雾剂。四名受试者在采用根据本发明的产品时将含有拟交感神经药的喷雾剂的使用量减少到一半。
依赖于含有拟交感神经药的喷鼻剂的五名其他受试者可选地使用本发明的喷雾剂。为了能够在夜间深度呼吸，受试者之前在睡觉前使用含有拟交感神经药的喷雾剂，其全部或部分被本发明的喷雾剂代替。两周之后，五名受试者中有一名可以完全摈弃使用含有拟交感神经药的喷鼻剂。其他人可以将含有拟交感神经药的喷鼻剂的使用量减少到约一半。
根据本发明，药品可以以0.1～5重量%的量尤其是以0.5～2重量%的量含有至少一种湿润剂。
如果该至少一种湿润剂的量太低，则可持续膜（sustainable film）的形成被抑制，而如果该至少一种湿润剂的量太高，则药品的粘度不期望地增加。
在另一实施方式中，根据本发明的药品含有高达其饱和限度的薄荷油和薄荷醇以及任选樟脑。使用更高的浓度，在根据本发明的药品中不能保证均相。因此，薄荷油和薄荷醇和任选樟脑的浓度针对各个用途会广泛地变化。此外，在非仅使用薄荷油、薄荷醇和/或樟脑时，鼻粘膜在施用过程中会达到不均匀地润湿。任选泛醇和湿润剂的均匀施用也不能得到保证。
根据本发明的药品优选含有多于0.002g尤其是多于0.003g的薄荷油和薄荷醇。如果在药品中存在樟脑，则药品优选含有多于0.002g尤其是多于0.003g的樟脑。使用更低的含量时，对于鼻粘膜不能保证充足的缓解作用。
本发明的另一优选实施方式的特征在于，药品另外还含有普通盐和/或海盐。将其取代或者与之结合，其它促紧张添加剂（tonicizing additives）例如生理盐、缓冲剂、或者离子或非离子的生理可接受物质可以用作基础。在现有技术中普遍使用普通盐或海盐。相应的试剂可以含有具有痕量元素和矿物质的天然海水。
通过pH控制剂，可以将本发明药品的pH值调节至生理上可耐受的pH，如果可以的话不低于6.5。本发明含义内的特别优选的pH控制剂包括氢氧化钠、磷酸钠、柠檬酸钠和其它生理上可耐受的缓冲体系例如磷酸盐或柠檬酸盐缓冲剂。上述限度与通常用于喷鼻剂的pH值对应，其由粘膜相容性确定。
通常将本发明药品的渗透压（tonicity）朝向轻微的高渗透压（更优选为400mosmol）调节。特别优选的促紧张剂（tonicizing agent）具体包括葡萄糖、山梨醇、甘露醇和/或木糖醇。使用低渗溶液（小于290mosmol），存在损伤鼻粘膜细胞的风险。强烈高渗溶液被发现是不宜人的。
根据通常用于含水滴鼻剂制剂的盖仑方法和规则（H.Sucker,P.Fuchs andP.Speiser:Pharmazeutische Technologie,Thieme Verlag,Stuttgart（1978）），可以实施根据本发明的药品的盖仑制剂。更优选地，根据本发明，以水溶液的形式制备药品。
在另一实施方式中，药品还包括精油。根据本发明，优选百里香油、桉树油和/或鼠尾草油。他们对药品提供宜人的气味。
根据本发明的无拟交感神经药的药品优选没有防腐剂。防腐剂会降低对鼻粘膜的减充血作用。此外，它们还频繁地引起鼻粘膜刺激并损伤鼻纤毛。
根据本发明，具体地，在另一实施方式中，药品是水溶液的形式。可以向这种水溶液中添加精油直到其最大溶解度。
另一实施方式涉及本发明药品的用途。特别优选的是将其用于由感冒或由花粉热引起的鼻粘膜刺激。除其它之外，还可能因加热系统的干燥空气所导致的鼻干而引起鼻粘膜刺激。此外，通过根据本发明的药品，可以减轻因拟交感神经药依赖引起的鼻粘膜刺激。优选地，以滴剂、喷雾剂和/或冲洗剂的形式使用根据本发明的药品。
具体实施方式
实施例
实施例1：
实施例2：
比较例1：
Claims (11)
1.一种喷鼻剂、冲洗剂或滴鼻剂形式的用于制备治疗由感冒、由花粉热、鼻干和/或拟交感神经药依赖引起的鼻粘膜刺激的药物的无拟交感神经药的药品，特征在于包括薄荷醇、薄荷油和樟脑以及泛醇以及至少一种湿润剂，所述湿润剂包括在含水体系中形成凝胶或粘性溶液的水溶性或水分散性的天然或合成的聚合物，所述药品以0.1～5重量％的量含有所述湿润剂。
2.根据权利要求1所述的无拟交感神经药的药品，其中所述药品以0.5～2重量％的量含有所述湿润剂。
3.根据权利要求1或2所述的无拟交感神经药的药品，特征在于所述聚合物选自聚亚烷基二醇、藻酸盐、角叉菜胶、果胶、树胶、纤维素醚、纤维素酯、聚乙烯醇、聚乙烯吡咯烷酮和/或葡聚糖。
4.根据权利要求3所述的无拟交感神经药的药品，特征在于所述聚合物是聚乙二醇或聚丙三醇。
5.根据权利要求3所述的无拟交感神经药的药品，特征在于所述聚合物是黄蓍胶或阿拉伯胶。
6.根据权利要求1或2所述的无拟交感神经药的药品，特征在于另外还含有普通盐和/或海盐。
7.根据权利要求1或2所述的无拟交感神经药的药品，特征在于另外还含有选自百里香油、桉树油和/或鼠尾草油的精油。
8.根据权利要求1或2所述的无拟交感神经药的药品，特征在于还含有pH控制剂和/或促紧张剂。
9.根据权利要求8所述的无拟交感神经药的药品，特征在于所述促紧张剂是葡萄糖、山梨醇、甘露醇或木糖醇。
10.根据权利要求1或2所述的无拟交感神经药的药品，其为水溶液形式。
11.根据权利要求1至10中任一项所述的无拟交感神经药的药品在制备用于治疗由感冒、由花粉热、鼻干和/或拟交感神经药依赖引起的鼻粘膜刺激的药物中的用途。
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| MX2017001812A (es) * | 2014-08-08 | 2017-07-17 | Shenzhen Hightide Biopharmaceutical Ltd | Composiciones de formulacion liquida, aparatos de administracion de medicamentos, y metodos de preparacion y uso de los mismos. |
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| CN109011058A (zh) * | 2018-08-08 | 2018-12-18 | 马必芳 | 岩盐精油吸入器及其制备方法与应用 |
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| AT16516U1 (de) * | 2019-03-18 | 2019-11-15 | Ulrich Sekotill Mba | Nasenspray |
| US11052041B1 (en) | 2020-10-01 | 2021-07-06 | King Abdulaziz University | Nanotechnology-based nostril drops for relief of respiratory ailments |
| AU2021376310A1 (en) * | 2020-11-09 | 2023-06-08 | Rucker Capital Advisors | Oral rinse, nasal spray and methods for prevention of covid-19 by lowering viral load of covid-19 |
| US20230015630A1 (en) * | 2021-07-19 | 2023-01-19 | Chuckie C Weber | Cold Medicine Composition, Preparation Method and Use Thereof |
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| HRP20151381T1 (hr) | 2016-01-15 |
| DE202010012255U1 (de) | 2010-11-18 |
| PL2613793T3 (pl) | 2016-05-31 |
| PT2613793E (pt) | 2016-01-26 |
| EA025945B1 (ru) | 2017-02-28 |
| ES2559516T3 (es) | 2016-02-12 |
| EA201390351A1 (ru) | 2013-08-30 |
| CA2842454C (en) | 2019-09-24 |
| CN103096908A (zh) | 2013-05-08 |
| HUE027474T2 (en) | 2016-09-28 |
| US20130156868A1 (en) | 2013-06-20 |
| RS54507B1 (en) | 2016-06-30 |
| EP2613793A1 (de) | 2013-07-17 |
| JP2013536874A (ja) | 2013-09-26 |
| CA2842454A1 (en) | 2012-03-15 |
| DK2613793T3 (en) | 2016-02-29 |
| JP5841151B2 (ja) | 2016-01-13 |
| EP2613793B1 (de) | 2015-11-18 |
| WO2012031979A1 (de) | 2012-03-15 |
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