CN100469355C - 营养增补剂及其使用方法 - Google Patents
营养增补剂及其使用方法 Download PDFInfo
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- CN100469355C CN100469355C CNB028141482A CN02814148A CN100469355C CN 100469355 C CN100469355 C CN 100469355C CN B028141482 A CNB028141482 A CN B028141482A CN 02814148 A CN02814148 A CN 02814148A CN 100469355 C CN100469355 C CN 100469355C
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Abstract
一种用于提供和促进唾液腺健康和/或帮助正常或健康吞咽的营养增补剂,包括可从姜黄、生姜和山葵获得的成分。该营养增补剂还可能用来治疗诸如感冒、喉咙痛、充血,粘膜炎、喉炎、粘膜炎症与流涎、以及炎症和病毒感染的症状,或者用于抑制或根绝一种病毒。该营养增补剂可以给人口服。该营养增补剂还可以进一步包括诸如从滑榆树皮粉末与绿茶获得的任选成分,以及其他任选成分。该营养增补剂还可进一步包括药学上可接受的口服载体。本发明还公开了用于促进唾液腺健康和/或帮助正常或健康吞咽,以及用于治疗感冒、喉咙痛、充血、粘膜炎、喉炎、粘膜炎症与流涎症状而提供营养的方法.还公开了治疗炎症、以及病毒感染以及抑制或根绝病毒的方法。
Description
发明的背景技术
A.发明所属技术领域
本发明涉及一种营养增补剂及其使用方法。更特别地,本发明涉及一种用于促进各种健康效果的营养增补剂以及至少为了这些目的服用该营养增补剂的方法。
B.先有技术的描述
流涎的治疗
流涎,一种与肌萎缩性侧索硬化(抗淋巴细胞血清)、及其他例如失弛缓症、听神经瘤、Bell氏麻痹、大脑性麻痹、脑血管意外(中风)、舌、咽神经痛、传染性神经元炎、血钙过少、脓性颌下炎、智力迟钝、运动原-神经元疾病、肌肉萎缩、重症肌无力、肌强直性营养不良、瘫痪性的脊髓灰质炎、多肌炎、震颤性麻痹、极端的外科癌、Seventhnerve麻痹、香-德综合症、以及威尔逊症相关的症状,是由于诸如唾液腺生产过剩唾液的唾液腺机能障碍所导致的过度流口水。有时,流涎还可能由,诸如氯硝西泮、乙硫异烟胺、氟哌丁苯,以及尤其透过皮肤起作用的烟碱等药物引起的。流涎还可能由遭受例如抗淋巴细胞血清疾病(ALS)的病人不正常的或不健康的吞咽所引起的。
为治疗流涎已经做出了许多努力。Newall等报告利用β拮抗剂来控制口腔唾液腺的过度分泌成功率为75%(J.Neurol.Sci.,1996,139,43-4)。Mier等已经发现摄取的胃长宁能有效治疗幼儿流涎。然而,有20%的接受胃长宁治疗的儿童遭受相当大的副作用,这足以要求停止使用该疗法。Arch.Pediatr.Adolese.Med.,2000,154,1214-1218)。根据Rettori等最近的一项研究(Ann.N.Y.Acad.Sci.,2000;917;258-67),氧化氮合酶抑制剂(NOS)减少刺激唾液分泌,而NOS的施主却加强刺激唾液分泌。这表明氧化氮能在唾液分泌发挥一种刺激性角色。
炎症的治疗
现代的非草本的药物中,存在两种主要类型的抗炎的药物:甾体药物和非甾体药物。甾族抗炎药物是基于激素例如可的松的强效药物。甾族药物具有比非甾族药物更强的抗炎效果。甾体药物可以以药丸、血液注射、或直接注射到关节间隙中给药。有许多非甾族的抗炎药物。醋氨酚、乙酰水杨酸、布洛芬,和萘普生是最常用的非甾体抗炎药物。
非甾族抗炎药物具有三个主要作用,它们都与环加氧酶的抑制所导致的前列腺素类激素形成的减少相关。首先,可以通过减少产生血管扩张剂前列腺素(PGE2,PGI2)来实现其抗炎作用。其次,可以通过减少产生前列腺素(发炎介质血管舒缓激肽和5-羟色胺伤害性神经末梢的更少敏化)来达到止痛效果。第三,退热效果可以生产抗炎作用,这可能是由于在响应炎症热原质过程中产生的多数诸如白细胞间介素-1的PGE2介质的减少的缘故。
这两药物都存在副作用。它们可能包括,特别地,反胃、胃出血、或者溃疡,肾病和听觉问题以及踝肿胀。此外,甾体抗炎药物可能具有更严重的副作用,包括:骨质疏松、白内障、抗感染能力减弱、肿胀和肥胖、情绪不稳定、高血压、以及造血骨髓的疾病。
姜黄(Curcuma longa)
在北印度,姜黄或Haldi被广泛用作药物以及印度常见烹调成分。姜黄的根茎以细粉末形式用作药物和食物。
在Srimal和Dhawan等的论文“Pharmacology of diferuoylMethane,a Non-steroidal Anti-inflammatory Agent”(J.Pharm.Pharmac.,25:447-452(1973))中报导了可从姜黄分离得到的姜黄素具有抗炎效果。
Arora等观察发现姜黄与苯基保泰松以及氢化可的松相比具有显著的抗炎活性(Indian Journal of Medical Research,1971,59,1289-1291)。姜黄素,一种可从姜黄的酒精提出物分离得到的生物碱[二阿魏酰基甲烷(diferuoyl Methane)],已经被证明是一种有效的消炎剂。Thatte等还讲一步研究了其抗炎和抗风湿活性(Indian Journal of Pharmacology,1986,18(1),19-21)。已经发现姜黄在急性和慢性模型中都具有显著的抗炎活性。报导的姜黄单独使用达到最佳的活性的治疗剂量在每日5到10克干粉的范围之内(Patwardhan,美国专利号5,494,668)。然而,这样的剂量水平可能导致恶心的感觉。
姜黄不仅具有抗炎的性质,而且具有抗氧化、抗肿瘤及其他重要的性质。当以低浓度使用时,姜黄可以抑制氧化氮合酶(NOS),因此能抑制氧化氮的产生。例如,Brouet等(Biochem.Biophys.Res.Commun.,1995,Jan.17;206(2);533-40)已经报导在姜黄(10mM)下活化6-24小时的巨噬细胞的可溶性提取物中,NOS的活性比那些未经姜黄活化的巨噬细胞明显的低。RNA印迹和免疫印迹分析表明,相比那些没有使用姜黄活化的来说,用姜黄活化的巨噬细胞表达的诱导性NOS的130kDa蛋白和mRNA的水平显著地减低了。当姜黄与脂多糖(LPS)和γ-干扰素(γ-IFN)一起加入时,它对NOS诱导的抑制作用最大,并且当姜黄和γ-LPS/IFN的间隔增加到18小时时,显著地减小。
生姜(Zingiber officinale)
生姜生长于南亚,是一种2-4英尺高多年生植物并长有长达一英尺宽约一英寸的草状叶片。姜根,正如其在杂货店的叫法一样,事实上是由刮去树皮状外膜的该植物的地下茎组成。
从公元前四世纪开始,中国医学文献就指出生姜能有效治疗恶心、腹泻、胃疼、霍乱,牙疼、流血,以及风湿病。生姜后来被中医用于治疗各种呼吸疾病,包括咳嗽以及各种感冒的早起症状。
生姜的现代的使用可追溯到1880年代早期,当时一为名叫D.Mowrey的科学家注意到填充生姜的胶囊剂能够减轻他在流感期间的恶心症状。受此鼓舞,他进行了第一个关于生姜的双盲研究。德国的E委员会随后批准将生姜用于治疗消化不良以及运动疾病。生姜已经已被广泛用于治疗恶心。尽管其他人更谨慎,即使一些常规的医学文献也建议将生姜用于治疗恶心和妊娠呕吐。
生姜能减轻肌肉的不适以及疼痛。它抑制前列腺素以及白细胞三烯的生物合成以及组胺释放。因而它既可作为一种抗炎剂也可作为抗酸剂。它是一种脂加氧酶以及cycloxigenase系统的双重的抑制剂。生姜包含1-4%挥发油(松节油)。单独使用鲜姜要求使用相当高的剂量(每日50克),这不仅很麻烦并且还可能刺激胃粘膜。在任何具有明显效果的干态中,每日必须服用7到10克干的姜粉。如此大的生姜剂量对病人来说极不方便,并且影响病人的日常服用量(参见Potwardhan,美国专利号5,494,668)。
山葵(Armoracia rusticana)
山葵,一种十字花属(十字花属)多年生草本植物(山葵属Armoraciarusticana但是有时分在其他的属中)的,生长于中南欧洲,并长期被培养在花园中,并被种植在北美洲的许多地方。它主要是根的生长,并被入药,特别地用于抗坏血病。山葵还一种优秀的利尿剂,并且能有效治疗消化疾病。草药医生以山葵和蜂蜜联合用药治疗咳嗽和哮喘。此外,它有时被用于减轻由风湿引起的疼痛和僵硬。
Friedman的美国专利5,248,504和5,385,734中,已经使用山葵治疗鼻、窦官能障碍。还试图提供一种用于某些疾病的口服山葵药剂。Mays的美国专利98,875涉及一种缓解哮喘、咳嗽和感冒的药物。该化合物包括粉碎山葵。Diets,美国专利74,205公开了一种用于治疗消化疾病的包含山葵地药物。
滑榆(Ulmus rubra)
滑榆树生长于北美洲。滑榆已有超过100年的用于传统草药的历史。美洲土著以及早期的移民都使用滑榆树皮干燥的内部部分。滑榆是一种营养食品并被制成适用于那些食欲不佳的人的布丁。滑榆能柔顺发炎的组织并被制成膏药以促进创口的愈合。滑榆能滋补肾上腺、胃肠道、以及呼吸系统。它帮助躯体排出过量的粘液。使用滑榆的其他例子包括:脓肿、骨折、烧伤和烫伤、霍乱、结肠炎、幼儿便秘、虚弱、尿布疹、幼儿腹泻、憩室炎、痢疾、痔、食管裂孔疝、消化不良、阵痛、麻疯病以及咽喉痛。
绿茶(Camellia sinensis)
绿茶是灌木山茶Camellia sinensis的干的叶子和叶芽。主要产于中国和日本。干茶渣的主要已知植物化学组分是多酚(36%),主要是黄酮醇(包括儿茶素)、类黄酮和黄酮二醇。它的叶子中还有含植物碱(约4%),包括咖啡因、可碱和茶碱。多数对绿茶的研究集中在它潜在的抗癌活性。研究表明绿茶多酚具有一种防化学效果(E.Kaegi,CanadianMedical Association Journal,1998,158:1033-35)。
本发明的某些具体实施方案的一个目的是提供一种用于促进唾液腺健康和/或帮助正常或健康吞咽的营养增补剂。
本发明的某些具体实施方案的一个更进一步的目的是提供一种治疗流涎的组合物。
本发明的某些具体实施方案的另一更进一步的目的是提供一种用于治疗一些常见的炎症例如喉咙痛、充血、喉炎和粘膜炎症的组合物。
本发明的某些具体实施方案的另一更进一步的目的是提供一种通过服用天然草药组合物治疗如喉咙痛、充血、喉炎和粘膜炎症的方法。
本发明的某些具体实施方案的另一更进一步的目的在于提供一种通过服用天然草药组合物治疗流涎的方法。
本发明的某些具体实施方案的另一更进一步目的在于提供一种具有杀病毒的和/或阻止病毒生长的性质的营养增补剂。
本发明的上述及其它目的将可从本发明的概述及详细说明中明显得出。
发明概述
一方面,本发明涉及一种营养增补剂。本发明的营养增补剂可被用来提供营养,或任选地用于促进唾液腺健康和/或帮助正常或健康吞咽。该营养增补剂所包括的成分可以可从姜黄、生姜和山葵中获得。已经发现这些成分的组合能够提供一种有益营养的营养增补剂,并能有效促进唾液腺的健康和/或帮助正常或健康吞咽。
第二方面,本发明涉及一种通过服用有效量的本发明营养增补剂,以促进唾液腺健康和/或帮助正常或健康吞咽的方法。
第三方面,本发明涉及一种通过给病人口服有效量的含有可从姜黄、生姜和山葵得到的组合物,治疗一种或多种常见感冒和/或一种或多种如喉咙痛、充血、喉炎、粘膜炎、粘膜炎症和流涎的症状,并能很大程度缓解这些症状和病痛的方法。
第四方面,本发明涉及一种通过给病毒携带者服用一种含有可从姜黄、生姜和山葵得到的成分的组合物抑制病毒生长的方法。
第五方面,本发明涉及一种通过服用一种含有可从姜黄、生姜和山葵得到的成分的组合物治疗病毒感染的方法。
第六方面,本发明涉及一种通过服用一种含有可从姜黄、生姜和山葵得到的成分的组合物治疗炎症的方法。
优选技术方案的详细说明
一方面,本发明涉及一种营养增补剂。本发明的营养增补剂可以被用于提供营养。或者,本发明的营养增补剂还可能提供一些额外的好处,比如促进唾液腺的健康和/或帮助正常或健康的吞咽。本发明的营养增补剂包括可从姜黄、生姜和山葵的得到的成分。
此处所述的“营养的”或“营养增补剂”是指用于提供营养量的源于姜黄、生姜和山葵的一种或多种成分的本发明的营养增补剂。
此处所用术语“香料”包括水果和药材的香料。
此处的术语“甜味剂”包括糖,例如:葡萄糖、蔗糖和果糖。糖还包括高的果糖淀粉糖浆干粉、转化糖、包括山梨糖醇的糖醇,以及它们的混合物。人工甜味剂也包括在术语“甜味剂”的范围内。
此处术语“药学上可接受的”指的一种成分,即适合和人和/或动物的没有过度的不良副作用(比如毒性的、刺激及过敏反应),并具有合理的风险/受益比。此外,此处的术语“安全有效量”是指一种组合物的数量,足以产生所期望治疗效果且没有过度不良副作用(比如毒性、刺激或过敏反应)、并具有合理的风险/收益比。
姜黄、生姜,或山葵每一种都含有能促进唾液腺健康、帮助正常的或健康的吞咽,和/或治疗包括普通感冒症状、喉咙痛、充血、喉炎、粘膜炎和粘膜炎症的一种或多种症状中可提供一些有益效果的有效成分。此外姜黄和生姜还可以作为COX抑制剂用于治疗某些炎症例如关节炎。然而,在有效的剂量水平下的姜黄、生姜或山葵的味道对病人来说可能太过强烈了。已经发现本发明的营养增补剂中可从姜黄,生姜和山葵中获得的组合物具有相当好的效果,并且具有良好的口感,从而使其可口。
本发明的营养增补剂的第一个成分可从姜黄中获得。姜黄根茎的黄色颜料由三个类姜黄素类化合物组成。三个类姜黄素是姜黄素(二阿魏酰基甲烷)、去甲氧姜黄素(羟基月桂酰基阿魏酰甲烷)以及双-去甲氧姜黄素(二羟基二月桂酰基甲烷)(参见Drug Analysis byChromatography and Microscopy,p.169,Ann Arbor Science Inc.,1973)。姜黄(curcuma longa)的精油主要由以下化合物组成的:d-樟脑(1%)、环异丙基月桂烯(85%)和对-甲苯基甲基甲醇(5%),(参见.E.Guner,The Essential Oil,pp.123-4,Van Nostrand Co.,1955)。
本发明的营养增补剂中可从姜黄得到的第一成分优选包括类姜黄素,例如姜黄素(二阿魏酰甲烷)、去甲氧姜黄素(羟基月桂酰基阿魏酰甲烷)和双-去甲氧姜黄素(二羟基二月桂酰基甲烷),以及两个或多个这些类姜黄素的混合物。
可从姜黄分离类姜黄素的方法是已知的(参见Janaki和Bose,AnImproved Method for the Isolation of curcumin From Turmeric,J.IndianChem.Soc.44:985(1967))。或者,可以通过合成制备本发明的类姜黄素。
可从姜黄中得到的第一个成分可以以各种不同的形式包含在本发明的营养增补剂中。这些不同形式优选包括姜黄提取物比如姜黄粉提取物、姜黄流体提取物浸膏或者一种或多种类姜黄素化合物和姜黄粉、部分或全部姜黄植物、它们的酊剂(tincture)以及它们的混合物。更优选,第一种成分是姜黄提取物。
本发明的营养增补剂的第二成分可以从生姜(通常也叫姜根)中获得。生姜抑制前列腺素类激素合成并产生5-脂肪氧合酶。在急性炎症试验中,生姜提取物的效能在相同研究中表现出与阿司匹林相同的效果。(Mascolo N.等Journal of Ethnopharmocology,1989,27,129-140)。
炎症的一个特征是二十碳四烯酸氧化的增加,它是通过两种酶途径代谢的:环加氧酶(CO)和5-脂肪氧合酶(5-LO),并分别导致产生前列腺素和白细胞三烯。还表明(Srivastava和Mustafa;Medical Hypotheses,1992,39342-348)生姜显示其改良效果的机制之一至少可能与其抑制前列腺素和白细胞三烯的生物合成有关。例如,它作为一种十二烷生物合成的双重抑制剂。
生姜含1-4%的精油(松节油)。已经对生姜的精油成分进行了许多化学研究。在生姜精油中已经确认有超过200不同的挥发性成分。生姜精油中含有各种萜烯和其它非萜类化合物的混合物。
可用于本发明的生姜活性化合物包括,但不限于:桉叶素、10-脱氢姜二酮、10-姜醇、6-姜二酮、6-姜醇、6-姜烯酚、8-β-17-环氧-λ-反-12-烯-15,16-二醇、8-姜醇、8-姜烯酚、9-氧橙花叔醇、乙醛、乙酸、丙氨酸、α-亚麻酸、α-亚麻酸、α-水芹烯、α-蒎烯、α-松油烯、α-萜品醇、α-姜烯、ar-姜黄烯、精氨酸、抗坏血酸、天门冬酰胺、β-没药醇、β-胡萝卜素、β-榄香烯、β-桉叶油醇、β-紫罗酮、β-香叶烯、β-水芹烯、β-蒎烯、β-芹子烯、β-倍半水芹烯、β-谷甾醇、β-侧柏酮、冰片基-醋酸盐、硼、咖啡酸、钙、莰烯、樟脑、癸酸、辛酸、辣椒素、石竹烯、萎叶酚、绿原酸、铬、柠檬醛、香茅醛、香茅醛、钴、铜、枯烯、姜黄、胱氨酸、飞燕草色素、δ-荜澄茄烯、榄香醇、乙酸乙酯、乙肉豆蔻酸盐、法呢醛、法呢烯、阿魏酸、糠醛、γ-氨基丁酸、石荠柠烯、香叶醛、香叶醇、香叶基-醋酸盐、姜酮、谷氨酸、甘氨酸、六氢姜黄素、组氨酸、已姜酮-B、异亮氨酸、堪非醇、卵磷脂、18-萜二烯、亚油酸、镁、锰、甲硫氨酸、mufa、月桂烯、杨梅黄酮、肉豆蔻酸、橙花醛、橙花醇、橙花叔醇、烟酸、镍、油酸、草酸、β-香豆酸、β-百里香素、β-羟基苯甲酸、棕榈酸、泛酸、非洲豆寇醇、广藿香醇、苯基丙氨酸、栎精、核黄素、硒、莽草酸、萜品烯-4-醇、硫胺素、色氨酸、香草酸、香草醛、锌以及姜油酮。同时还可使用两个或多个这些活性化合物的混合物。
可从生姜得到的本发明的营养增补剂第二成分可以以不同形式包含在本发明的营养增补剂中,例如生姜粉提取物,生姜流浸膏的提取物,包括生姜根粉末的姜粉,一种或多种生姜的活性化合物,以及生姜植物的部分或者全部,它们的酊剂,或者它们的混合物。此外,对任何合成路线是已知的特殊的生姜的活性化合物,也可合成制备这些活性化合物。优选本发明的营养增补剂的第二成分选自生姜提取物和姜根粉末。
本发明的营养增补剂的第三成分可从山葵,也常称为山葵根中获得。山葵的药理学活性主要取决于其活性化合物。可用于本发明的山葵活性化合物包括但是不限于:烯丙异硫氰酸盐、淀粉酶、精氨酸、抗坏血酸、天门冬酰胺、龙胆酸、堪非醇、18-萜二烯、烟酸、对-羟基苯甲酸、果胶、苯丙基-异硫氰酸盐、栎精、萝卜子素、核黄素、芦丁、硒、芥子酸、黑芥子硫苷酸钾、丹宁酸、硫胺素、香草酸和锌,以及两个或多种这些化合物的混合物。
可从山葵中得到的本发明的营养增补剂的第三成分可以以许多不同形式用于该营养增补剂中。这些不同形式包括山葵粉末、山葵提取物如山葵粉末提取物和山葵流体提取物;一种或多种山葵活性化合物,山葵植物的部分或全部,它们的酊剂,以及它们的混合物。对于那些合成路线已知的特定活性化合物,可以通过合成得到。优选本发明的营养增补剂的第三成分选自山葵粉和山葵提取物。
本发明的全部活性化合物可从其他适用资源获得。因此,短语“可从...处获得”或短语“可能从...处获得”是指包括那些可从姜黄、生姜、山葵、滑榆或绿茶得到的化合物,和合成得到的相同化合物,以及从其他来源中得到的化合物和/或组合物。
可从姜黄,生姜和山葵中获得的本发明的营养增补剂的成分,可以以姜黄粉、姜粉和山葵粉末形式使用,它们都可从姜黄根茎、姜根和山葵根中分别研磨而成。或者,也可从诸如Delavau公司等商业来源购买姜黄粉、姜粉、山葵粉末和/或包含一个或多个该活性化合物的混合物。或者,可以以姜黄提取物、生姜提取物和山葵提取物的形式用于本发明的成分中,它可用常见的提取方法可从姜黄根茎、姜根和山葵根从提取得到。适当的提取方法描述如下。
该提取方法通常包括以下步骤:
1)清洗用来提取药理和生物活性提取物的植物,去除其表面的任何异物;
2)研磨所得植物使其颗粒大小达到约0.001至约10mm3;以及
3)将该颗粒至于至少一种极性或者非极性溶剂中,以得到分别溶于不同溶剂中的单独馏分,然后混合所得馏分,如此可得到本发明的富集的植物提取物。
例如,姜黄的加工方法包括如下步骤:
1)清洗姜黄根以去除表面的用任何异物;
2)研磨所得的根,使其颗粒大小范围在0.001至约10mm3;
3)蒸馏所得的颗粒,并且,如果有的话,从颗粒中得到挥发性馏分;
4)在极性溶剂,例如水中蒸煮蒸馏过的颗粒,以溶解蒸馏处理颗粒中的材料,由此获得第一溶液和第一残留物;
5)从第一溶液中过滤出第一残留物;
6)蒸发从第一溶液中得到的滤液以去除溶剂,从颗粒中得到溶质馏分A;
7)用第二种极性溶剂,例如75%到90%的乙醇处理第一残留物12到36小时,得到第二溶液和第二残留物;
8)从第二溶液中过滤出第二残留物,得到第二滤液;
9)蒸发第二滤液以去除溶剂,从颗粒中获得溶质馏分B;
10)用一种弱极性或非极性溶剂,例如石油醚,处理第二残留物12到36小时,得到第三溶液和第三残留物,从第三溶液中过滤出第三残留物,得到第三滤液;
11)蒸馏第三滤液去除溶剂,从颗粒中获得溶质馏分C;和
12)将挥发性馏分与颗粒中的馏分A,B和C均匀混合后得到富集的植物提取物;
该方法适合从上述任何植物中以一种方便的、可服用剂量的形式制备药学或生物活性植物提取物。
用于提取姜黄的溶剂包括水、乙醇、丙醇、石蜡、己烷、石油醚、甲苯、丙酮、丁酮以及常见的有机溶剂。优选使用水、乙醇和石油醚提取姜黄。用于提取生姜的溶剂包括水、乙醇、丙醇、石蜡、石油醚、己烷、甲苯、丙酮、丁酮及其他常见有机溶剂。优选使用乙醇、水和丙酮提取生姜。提取山葵的溶剂包括水、乙醇、丙醇、石蜡、石油醚、己烷、甲苯、丙酮、丁酮及其他常见有机溶剂。优选使用水和乙醇为溶剂提取山葵。
最优选本发明的营养增补剂包括姜黄提取物、姜根粉末和山葵根粉末,且各自提供一种或多种所述有益效果的安全有效量。
优选每克本发明的营养增补剂包含5-20毫克的姜黄粉提取物。最优选,每克本发明的营养增补剂包含7-15毫克的姜黄粉提取物。
优选每克本发明的营养增补剂优选包含30-150毫克的姜根粉末。最优选,每克该营养增补剂中包含50-110毫克的姜根粉末。
优选每克本发明的营养增补剂优选包含25-70毫克山葵根粉末。最优选,每克该营养增补剂包含40-60毫克的山葵根粉末。
优选本发明的营养增补剂还可能进一步包括第四成分,即一种可能缓和润滑病人口腔黏膜的适当的缓和剂。该缓和剂可以从滑榆中得到。或者,该润滑剂也可选自果胶、胶水和角叉菜胶。
可用于本发明的滑榆活性化合物包括但是不限于:抗坏血酸、β-胡萝卜素、β-谷甾醇、α-谷甾醇、镁、锰、胶水、烟酸、核黄素、硒、丹宁酸、硫胺素、锌和它们的混合物。
优选,从滑榆获得的本发明营养增补剂的第四成分可以以选自滑榆提取物如滑榆粉末提取物、滑榆流浸膏、一种或多种滑榆的活性化合物、滑榆树皮、浸剂或者它们的混合物的形式包含在本发明的营养增补剂中。可以通过研磨滑榆树皮得到滑榆树皮粉末。可以通过已知的提取方法从滑榆树皮生产滑榆提取物。对那些合成路线一直的特定的活性化合物,可以合成制备这些活性化合物。或者,从诸如Delavau公司等商业来源购买滑榆树皮粉末、滑榆提取物和/或滑榆的活性化合物。
优选本发明的营养增补剂的第四成分选自滑榆提取物和滑榆树皮粉末。更优选,该营养增补剂的第四成分是滑榆树皮粉末。优选每克本发明的营养增补剂优选包含50-150毫克滑榆树皮粉末。最优选每克该营养增补剂包含75-120毫克滑榆树皮粉末。
优选本发明的营养增补剂可能此外包括一种从绿茶获得的第五成分。从绿茶中获得的第五成分可能具有抗氧化作用。
绿茶的药学活性主要取决于其活性化合物。用于本发明的绿茶活性化合物包括但不限于:黄酮醇、儿茶素、类黄酮、黄酮二醇、植物碱、咖啡因、可碱、茶碱、酚酸、蛋白、碳水化合物和矿物。
从绿茶中获得的本发明营养增补剂的第五成分可以以绿茶粉末、绿茶提取物如绿茶粉末提取物、绿茶流浸膏,和一种或多种绿茶活性化合物、或绿茶植物的部分或者全部、绿茶叶、其酊剂或者它们的混合物的形式包含在本发明的营养增补剂中。可以通过研磨干的绿茶叶来获得绿茶粉末。也可常见的提取法从干的绿茶叶生产绿茶提取物。对那些合成路线已知的绿茶活性化合物,可以合成得到该活性化合物。或者,该绿茶粉末、该绿茶提取物和/或绿茶活性化合物可以从例如Delavau公司等商业来源购买得到.
优选本发明营养增补剂的第五成分选自绿茶茶叶、绿茶粉末和绿茶提取物。更优选本发明的营养增补剂的第五成分是绿茶提取物。优选每克本发明的营养增补剂优选包含5-20毫克绿茶提取物。最优选每克该营养增补剂包含7-15毫克的绿茶提取物。
需要提供营养时,可以通过简单摄取本发明的营养增补剂以提供营养。本发明的营养增补剂可能同时是被用于促进唾液腺的健康和/或帮助正常或健康的吞咽。通过促进唾液腺的健康和/或帮助正常或健康吞咽,本发明的营养增补剂可能用来提高那些遭受,诸如流涎或其他削弱唾液腺健康和/或正常或健康吞咽疾病的人的生活质量。
通过给遭受一种或多种下述疾病或症状的病人口服本发明的营养增补剂,它还可能用于治疗感冒和/或其一种或多种症状、喉咙痛、充血、喉炎、粘膜炎和/或粘膜炎症的。本发明的营养增补剂还可能用于治疗由于ALS(抗淋巴细胞血清)引起的流涎。本发明的营养增补剂还可能用来治疗由于诸如关节炎等炎症,这至少部分是因为从生姜、姜黄和绿茶所得到的成分具有对COX的抑制作用。本发明的营养增补剂可能进一步地用来治疗病毒感染。如本申请实施例所表明的那样,本发明的营养增补剂具有显著的杀病毒和阻止病毒生长的性质。
在一个优选的具体实施方案中,本发明的营养增补剂可能进一步包括其他一种或多种从黄连和伏牛花、零陵香、贝加尔湖黄芩、杖胡(日本蓼)、迷迭香、奥杜那干酪、小白菊和酒花中获得的天然COX-2抑制剂成分。
可能具有COX-2抑制性质的附加的成分包括但不限于:芹菜苏、黄岑黄素、黄连素、儿茶素、二十五烷酸、丁子香酚、吴茱萸烷、吴茱萸醇、律草酮、山奈醇、齐墩果醇酸、银胶菊醇、白藜芦醇、吴茱萸次碱、水杨酸、反-reveratrol和熊果酸中的一种或多种。这些附加的成分可以以粉末、整个或者部分植物、提取物粉末、流浸膏、酊剂以及它们的合适的混合物的形式包含在本发明的营养增补剂中。
本发明的营养增补剂可以以安全有效量的从姜黄、生姜和山葵得到的三种主要成分,以及一种或者多种可从滑榆或绿茶中得到上述任选成分,以及一个或多个如下所述该附加任选成分进行配制,以提供本发明所述的一种或多种有益效果。本发明的营养增补剂还可能与其药学上可接受的载体进行配制。
优选本发明的营养增补剂可以以任何口服剂型进行配制,这包括但不限于胶囊剂、片剂、锭剂、硬糖、粉末、喷雾剂、凝胶剂、酏剂、糖浆和悬浮液或溶液。
该药学上可接受的载体可能包括但不限于:(a)包括甜味剂在内的碳水化合物,更优选果糖、蔗糖、糖、葡萄糖、淀粉、乳糖、麦芽糖、麦芽糖糊精、淀粉糖浆干粉、蜂蜜固体,市售营养增补剂药片,包括Emdex.RTM.,Mor-Rex.RTM.,Royal-T.RTM.,Di-Pac.RTM.,Sugar-Tab.RTM.,Sweet-Rex.RTM.,和New-Tab.RTM.;(b)糖醇包括甘露醇、山梨糖醇和木糖醇;和(c)各种互不相溶的赋形剂,包括磷酸二钙、硫酸钙、碳酸钙、微晶纤维素及其他药物片剂成分。
本发明的锭剂、药片和片剂可能在形状、大小及生产技术上不相同。就药片而言,口服的药学上可接受的载体可能进一步包括乳糖和玉米淀粉。还可向药片中加入润滑剂,包括例如硬脂酸镁、十二烷基硫酸钠和滑石。药片还可能包含诸如柠檬酸钠、碳酸钙和磷酸钙的赋形剂。还可使用诸如淀粉、藻酸和复杂的硅酸盐配合物的崩解剂。药片还可能包括粘合剂诸如聚乙烯吡咯烷酮、白明胶、PEG-8000和阿拉伯树胶。
就口服锭剂而言,其常见的药学上可接受的载体可能进一步包括粘结剂例如PEG-8000。优选锭剂重量为0.1-15克,以在口服时提供适当的溶解速率。更优选锭剂重量1到6克。
为制造可压缩的锭剂,将活性成分被加入到PEG8000处理过的果糖;或将营养增补剂的活性成分加入到结晶果糖和市售糖果和诸如Mendell的sweet tablet.RTM.,Sweetrex.RTM.,或者Emdex.RTM.的直接压缩产品中,在需要时加入甜味剂例如糖精、香料、助流剂例如硅胶、以及润滑剂比如硬脂酸镁。混合物应当保持干燥并在混合后立即压片。可以使用常见的药物混合设备和压片设备将这些成分混合并压成锭剂。优选足以使该锭剂最大硬度、保存一个适当的溶解速率、并使该锭剂具有最大效果的压缩负荷力。口服时,锭剂应在一个持续的时间段内溶解,简而言之5到60分钟,并优选大约20到30分钟。优选将该营养增补剂保存在一个气密容器和在阴凉暗处。
可以使用上述方法制造药片和片剂并且可细微调整其中的任选成分。这些变化是普通熟练技术人员能够想到的。
或者,本发明的营养增补剂可以与一种溶剂或分散剂比如水或者其他的液体,以及任选的药学上可接受的载体制成液态比如糖浆、嗽口水或喷显剂,以在一个持续的时段内反复向口腔和口咽粘膜输送该营养增补剂。优选该治疗时间为约5到60分钟,更优选大约20到30分钟,以保证该营养增补剂与口腔和咽喉组织有长时间的接触。或者,该剂型可以被制成一种适合于用水或其他先前使用的材料稀释的浓缩形式。
该营养增补剂还可被制成可咀嚼的形式,比如软糖、橡皮糖、充液冰糖和口香糖,或牙齿产品形式,比如牙膏和嗽口水。使用中,优选将该可咀嚼组合物在该口腔里持续保持大约5到60分钟,更优选大约20到30分钟。可以以此类产品的常见使用方式使用牙齿产品。
本发明的营养增补剂可以被制成带有或不带有稀释剂的胶囊形式。对胶囊而言,有用的稀释的包括乳糖和干的玉米淀粉。当使用悬浮液时,可使该悬浮液乳化和/或在悬浮液中使用悬浮剂。此外,固体组合物包括一个或多个如上所述可以被用于软和硬胶囊的锭剂成分。
本发明的营养增补剂还可被制成鼻烟雾剂或吸入剂组合物。可以使用已知的方法来制备该组合物。对这些剂型而言,合适的载体可包括以下成分:含有一种或多种防腐剂的盐、提高生物利用率吸收促进剂、碳氟化合物、和/或普通溶解或分散剂。
可被任选包含在本发明的营养增补剂中的其他材料包括环己六醇、其他的维生素B复合物和抗炎剂。同时,本发明的营养增补剂还可包含诸如甜味剂、呈味素、着色剂、染料、防腐剂、乳化剂、悬浮剂、熔化剂、赋形剂等成分,以及诸如水、乙醇、丙二醇、甘油和它们的各种组合物。
可以被用于本发明的营养增补剂任选的甜味剂包括但不限于:糖精、天冬甜素、环磺酸盐、丁磺胺K、新橘皮苷二氢查耳酮、其他特等甜味剂,以及它们的混合物,它们可以以足够低的数量加入到该载体中,以免与该营养增补剂的主要成分发生化学作用。
可以被用于本发明的营养增补剂的任选的呈味素包括但不限于:胡椒薄荷、胡椒薄荷醇、桉树脑、鹿蹄草、甘草、丁香、肉桂、绿薄荷、樱桃、柠檬、橙、石灰、薄荷醇和它们的各种组合物。
优选上述源于姜黄、生姜和山葵地三种主要成分由大约占该营养增补剂总组合物0.5-90%重量比。更优选这这三种主要成分由占总组合物的10-70%重量比。最优选这这三种主要成分由占总组合物的20-40%重量比。
该营养增补剂中包可从姜黄、生姜、山葵、滑榆以及绿茶中获得的的非载体成分,并且基于该营养增补剂所用的载体数量按比例增减,并且不会对该营养增补剂的使用效果产生实质影响。
本发明还涉及一个通过服用营养量的本发明的营养增补剂产生营养的方法。本发明还涉及一种通过服用有效量的本发明的营养增补剂促进唾液腺的健康和/或帮助正常或健康的吞咽的方法。
该营养增补剂可以在需要时每日服用1-15次,更优选需要时每日2-12次,或最优选需要时每天6-10次。如上所讨论的,本发明的营养增补剂可以以任何可接受的口服剂型向病人给药,这包括但不限于:药片、胶囊剂、锭剂、片剂、硬糖、粉末、口腔喷雾剂、鼻喷雾剂、凝胶剂、酏剂、糖浆、咀嚼剂、牙齿产品、悬浮液和溶液。
优选在服用该营养增补剂时,它被人含在嘴中至少5到60分钟,以确保在其被完全溶解前,该营养增补剂的主要成分与口腔组织或咽喉接触。更优选该营养增补剂是被人含在口中至少15到30分钟。优选该营养增补剂的每次服用的有效量包含总共0.1克到1克的可从姜黄、生姜和山葵中获得的三种主要成分。更优选,每次服用的有效量的该营养增补剂分别包含总共0.2克到0.5克的这三种主要成分。
本发明还涉及一种给病人服用一定量的本发明营养增补剂的方法,该方法可有效的缓解一种或多种普通感冒的症状,以及喉咙痛、充血、喉炎、粘膜炎、粘膜炎症和流涎等症状的一种或多种。在该方法中,本发明的营养增补剂被用作一个治疗组合物。
基于治疗的病人的情况、给药方式、所用特殊活性成分的活性,年龄、体重、总体健康状况、性别和病人的饮食、用药时间、排泄率、所用成分的特别组合、该营养增补剂主要成分的总含量、病情或症状的严重程度的因素的不同,该营养增补剂的有效量也是不同的。考虑这些因素对本领域熟练技术人员来说是容易的。
本发明还包括给患有感冒、喉咙痛、充血、喉炎、粘膜炎、流涎和粘膜炎症中一种或者多种的病人服用本发明组合物的方法。该营养增补剂可以在需要时每日服用1-15次,更优选需要时每日2-12次,或最优选需要时每天6-10次。正如以上的讨论,本发明的营养增补剂可以以任何可接受的口服剂型给病人给药,这包括但不限于:药片、胶囊剂、锭剂、片剂、硬糖、粉末、口腔喷雾剂、鼻喷雾剂、凝胶剂、酏剂、糖浆、咀嚼剂产品、牙齿产品、悬浮液和溶液。
本发明的方法最初用于治疗急性症状,但是也可用于明显减轻普通感冒、喉咙痛、充血、喉炎、粘膜炎、流涎和粘膜炎症等一种或多种症状。本发明的方法还可被用于通过预防性服用有效量的该营养增补剂以防止普通感冒、喉咙痛、充血、喉炎和粘膜炎症。
优选在服用该营养增补剂时,该营养增补剂被病人含在口中至少5到60分钟,以确保营养增补剂的主要成分与口腔组织或咽喉接触。更优选,该营养增补剂被病人含在口中至少含15到30分钟。
每剂该营养增补剂包含有效量的该营养增补剂的至少这三种主要成分。每次服用的药物有效量包含总共0.1克到1克的可从姜黄、生姜和山葵中获得的三种主要成分。更优选,该营养增补剂每次服用的药物有效量包含总共0.2克到0.5克的这三种主要成分。
优选每克本发明的营养增补剂包含5-20毫克的姜黄粉提取物。最优选每克本发明的营养增补剂包含7-15毫克的姜黄粉提取物。优选每克本发明的营养增补剂优选包含30-150毫克的姜根粉末。最优选,每克该营养增补剂中包含50-110毫克的姜根粉末。优选每克本发明的营养增补剂优选包含25毫克-70毫克山葵根粉末。最优选每克该营养增补剂包含40-60毫克的山葵根粉末。
用于治疗流涎时,很少剂量的该营养增补剂就足以产生提供有效的缓解作用。用于流涎时优选每日1-6剂。用于治疗流涎时,更优选每日1-2剂。
另一方面,本发明涉及一种通过给携带病毒的载体服用本发明的包含可从姜黄、生姜和山葵中获得的成分的营养增补剂,抑制病毒生长和/或清除病毒的方法。在该方法中,该载体可以是人、体外细胞或者动物。优选,该载体是人。在该方法中,本发明的营养增补剂被用作抗病毒剂,并且同时具有阻止病毒生长效果和杀病毒效果或者具有其中的一种。
在该方法中,可以被本发明的营养增补剂抑制的病毒包括鼻病毒、疱疹病毒、流感病毒、艾滋病病毒和西尼罗河病毒中的一些病毒。在一个优选的具体实施方案中,可以被该营养增补剂抑制的病毒至少包括人鼻病毒16、疱疹I病毒(HSV-1)、流行性感冒病毒A/Moscow/10/99和B/Guangdong/120/00。“抑制”病毒是指减少或防止该病毒的进一步生长和/或从受治疗的人或动物身上部分或者全部消除该病毒。在实施例中讨论了决定病毒抑制的合适方法。
该营养增补剂可以在需要时每日服用1-15次,更优选需要时每日2-12次,或最优选需要时每天6-10次。本发明的营养增补剂可以以任何可接受的口服剂型给病人给药,这包括但不限于药片、胶囊剂、锭剂、片剂、硬糖、粉末、口腔的喷雾剂、鼻喷雾剂、凝胶剂、酏剂、糖浆、咀嚼剂、牙齿产品、悬浮液或溶液。
每剂该营养增补剂包含有效量的该营养增补剂的至少这三种主要成分。每次服用的有效量包含总共0.1克到1克的可从姜黄、生姜和山葵中获得的三种主要成分。更优选,该营养增补剂每次服用的有效量包含总共0.2克到0.5克这三种主要成分。
优选每克本发明的营养增补剂包含5-20毫克的姜黄粉提取物。最优选,每克本发明的营养增补剂包含7-15毫克的姜黄粉提取物。优选每克本发明的营养增补剂优选包含30-150毫克的姜根粉末。最优选,每克该营养增补剂中包含50-110毫克的姜根粉末。优选每克本发明的营养增补剂优选包含25-70毫克山葵根粉末。最优选每克该营养增补剂包含40-60毫克的山葵根粉末。
优选每次服用该营养增补剂时,该组合物被含在口中至少5到60分钟,以保证在其完全溶解前该营养增补剂的主要成分与口腔组织或咽喉接触。更优选该营养增补剂被含在口中至少15到30分钟。
本发明还涉及一种通过服用本发明的包括可从姜黄、生姜和山葵中获得的成分营养增补剂,以治疗病毒感染或一种或多种由病毒感染引起的症状。
可通过本发明的方法治疗的由病毒感染引起的症状可以包括头痛、关节疼痛、发烧、咳嗽、打喷嚏、肌肉疼痛、鼻水、口干燥、眩晕以及与病毒感染有关的其它症状的一种或多种。鼻病毒引起的病毒感染可以包括人鼻病毒、疱疹病毒诸如疱疹I病毒(HSV-1)、流感病毒诸如流行性感冒病毒A/Moscow/10/99和B/Guangdong/120/00,HIV-病毒以及西尼罗河病毒。
该营养增补剂可以在需要时每日服用1-15次,更优选需要时每日2-12次,或最优选需要时每天6-10次。本发明的营养增补剂可以以任何可接受的口服剂型给病人给药,这包括但不限于药片、胶囊剂、锭剂、片剂、硬糖、粉末、口腔的喷雾剂、鼻喷雾剂、凝胶剂、酏剂、糖浆、咀嚼剂、牙齿产品、悬浮液或溶液。
优选在每次服用该营养增补剂时,该营养增补剂被含在口中至少5到60分钟,以确保该营养增补剂的主要成分与口腔组织或咽喉接触。更优选该营养增补剂被含在口中至少15到30分钟。
每剂该营养增补剂包含有效量的该营养增补剂的至少这三种主要成分。每次服用的有效量包含总共0.1克到1克的可从姜黄、生姜和山葵中获得的三种主要成分。更优选,该营养增补剂每次服用的药物有效量包含总共0.2克到0.5克的这三种主要成分。
优选每克本发明的营养增补剂包含5-20毫克的姜黄粉提取物。最优选,每克本发明的营养增补剂包含7-15毫克的姜黄粉提取物。优选每克本发明的营养增补剂优选包含30-150毫克的姜根粉末。最优选,每克该营养增补剂中包含50-110毫克的姜根粉末。优选每克本发明的营养增补剂优选包含25-70毫克山葵根粉末。最优选,每克该营养增补剂包含40-60毫克的山葵根粉末。
另一方面,本发明涉及一种通过服用本发明包含作为治疗组合物的可从姜黄、生姜和山葵中获得的成分营养增补剂,治疗一种或多种由例如关节炎所引起炎症的症状的方法。该症状的炎症可以包括关节疼痛、关节活动不灵以及关节僵硬中的一种或多种。
已经发现本发明的营养增补剂由于能抑制COX-2,因而具有止痛和抗炎作用。本发明的营养增补剂可用于减轻由于关节炎或导致炎症的类似病症引起的疼痛和其它症状。为了减轻关节炎的症状,需要时每天服用1-15次该营养增补剂,需要时更优选每日2-12次,或者需要时最优选每日6-10次。正如以上的讨论、本发明的营养增补剂可以任何可接受的口服剂型给药,这包括但不限于药片、胶囊剂、锭剂、片剂、硬糖、粉末、口腔喷雾剂、鼻喷雾剂、凝胶剂、酏剂、糖浆、咀嚼剂、牙齿产品、悬浮液或溶液。
优选该营养增补剂每次服药时被含在口中至少5-60分钟以确保该主要成分与口腔组织或咽喉接触。更优选该营养增补剂被含在口中至少15到30分钟。
每剂该营养增补剂包含有效量的该营养增补剂的至少这三种主要成分。每次服用的有效量包含总共0.1克到1克的可从姜黄、生姜和山葵中获得的三种主要成分。更优选,该营养增补剂每次服用的药物有效量包含总共0.2克到0.5克的这三种主要成分。
优选每克本发明的营养增补剂包含5-20毫克的姜黄粉提取物。最优选,每克本发明的营养增补剂包含7-15毫克的姜黄粉提取物。优选每克本发明的营养增补剂优选包含30-150毫克的姜根粉末。最优选,每克该营养增补剂中包含50-110毫克的姜根粉末。优选每克本发明的营养增补剂优选包含25-70毫克山葵根粉末。最优选,每克该营养增补剂包含40-60毫克的山葵根粉末。
本发明的各种方法都可以被用于人或动物。
通过下面的实施例进一步说明本发明,但并不试图限制本发明的内容。本发明的范围将由后面所附的权利要求所决定。
实施例
实施例1 本发明的营养增补剂
本发明的营养增补剂的锭剂制剂使用上述方法制备。锭剂的成分如下:
糖 1克
滑榆树皮 118毫克
姜黄提取物(5%姜黄) 18毫克
姜根 140毫克
山葵根 70毫克
绿茶叶提取物(30%儿茶素和多酚) 14毫克
实施例2 喉咙痛的治疗
选取七个患咽喉炎的病人,每人每两小时摄取一粒实施例1的锭剂,并将其含在口中大约15-30分钟直到该锭剂完全溶解。每个病人每天摄取得锭剂不超过10颗。
在摄取从2到20锭剂之后,接受治疗的病人的喉咙痛症状得到完全缓解。还发现每个锭剂可以减轻喉咙痛最长达6小时。
实施例3 流涎的治疗
两名患因抗淋巴细胞血清引起的流涎的病人在3周时间内每天摄取1-2粒实施例1的锭剂。通过这两个病人还发现,摄取锭剂能有效控制唾液的过度分泌。这两个病人过度流口水的症状明显减轻。
实施例4 该营养增补剂杀病毒活性的体外试验
本实施例使用的用于杀病毒的活性的体外试验方案以人鼻病毒16(以下简称“HRV-16”)作为靶病毒,并且与如Jacobs等在Characteristics of Human diploid MRC-5,Nature(London),227,p 168-170(1970)所述的人体组织相关的MRC-5细胞株作为HRV-16病毒的宿主细胞。通过使用显微观察计算由病毒复制诱导的细胞病变效应(CPE),在生长鼻病毒的MRC-5细胞系上滴定测量伴随具有该病毒的试验物质的孵化的残余病毒的传染性。更具体地说,CPE是通过观察在MRC-5中培养的膨胀/圆形细胞来划分的。
为了测定其杀病毒的活性,实施例1的营养增补剂组合物(以下称为“物质I”)最开始被稀释到1/20,然后进一步使用盐水连续稀释。该稀释组合物使用HRV-16在一个设定时间内孵化,然后使用传染细胞媒介调整到中性pH以终止反应。将所得溶液在进行细胞感染的检验片上稀释到1/10,然后在MRC-5细胞上滴定。每个片上具有一个仅包含HRV-16感染的MRC-5细胞的对照病毒,以及一个仅包含未感染MRC细胞的对照细胞。
该片在感染后被进一步地孵化4天。通过上述试验测量残余病毒的传染性。从表1-4所示的结果来看,该片上的所有对照物都是适用的。
从该试验可以推断,1/20稀释的物质1,在1分钟的孵化期内,能有效的产生1.50(-log 10 TCID 50)的HRV16病毒的对数衰减。1/40稀释的物质1也能在1分钟的孵化期内产生1.00(-log10 TCID 50)的对数衰减。在2分钟和5分钟孵化期后,达到HRV-16滴度的1/2对数衰减。所以,该结果表明在物质1和HRV-16之间1分钟的接触时间能产生最有效的病毒的滴度衰减。
表1给出了不同稀释度的物质1于一个终止时间点上,在MRC-5细胞上感染鼻病毒16的残余病毒滴度和对数衰减
表1
表2-4给出了不同稀释度的物质1于三个不同的终止时间点上,在MRC-5细胞上的传染性的HRV-16的残余病毒滴度以及对数衰减的第二次试验结果。
表2
表3
表4
使用其它病毒,包括以Vero细胞为宿主细胞的疱疹病毒(HSV-1)、以MDCK细胞为宿主细胞的流行性感冒A/Moscow/10/99和B/Guangdong/120/00进行了物质1类似的杀病毒试验。这些杀病毒试验的结果如下表5-13所示。
表5-7给出了不同稀释度的物质1于三个不同的终止时间点上,在Vero细胞上的传染性的HRV-16的残余病毒滴度以及对数衰减的结果。
表5
表6
表7
表8-10给出了不同稀释度的物质1在三个不同时间点上流感病毒A/Moscow/10/99的残余病毒滴度和对数衰减。
表8
表9
表10
表11-13给出了不同稀释度的物质1在三个不同时间点上流感病毒B/Guangdong/120/00的残余病毒滴度和对数衰减。
表11
表12
表13
在表1-13中,TCID 50=-log 10 TCID 50。
从上述结果可以看出,物质1能抑制或根绝流感病毒和人鼻病毒。因此,物质I能有效的治疗流行性感冒和普通感冒。
实施例5 该营养增补剂的阻止病毒生长活性体外试验
该实施例采用的杀病毒的活性体外试验方案使用人鼻病毒16(HRV-16)作为靶病毒,以及如Conant等Basis for an umbering system.IHela cells for propagation and serologic procedure,J.Immunol.,100,p107-113(1968)中所述的涉及人体组织的对鼻病毒敏感的海拉细胞株作为HRV-16的宿主细胞。
实施例1的营养增补剂,即物质1,按照如下比例稀释溶于感染媒介中:1/20,1/40,1/80,1/160以及1/320。这些稀释液在37℃下在MRC-5细胞板上孵化30分钟(5%CO2)。在潜伏期后,在已知的滴度2.30(-log 10 TCID 50)下将板孔中带有MRC-5物质1的稀释液置于HRV-16下。各个板上都放有对照病毒(不含物质1且被海拉细胞感染上的HRV-16)、对照细胞(仅有海拉细胞)以及不同稀释度的测试化合物(仅含有测试物质的海拉细胞)。板上所有其他样品包含有被HRV-16病毒感染的海拉细胞和不同浓度的物质1。该板在感染后被进一步孵化4小时。
通过使用下述方法测量由病毒诱导的细胞病变效应(CPE),测定在生长鼻病毒的海拉细胞株上滴定用物质1孵化后残余病毒的传染性。
以结晶紫溶液给用物质1孵化后的剩余存活海拉细胞着色。然后洗去过量的结晶紫并使用甲醇和乙酸的混合物溶解结晶紫着色的细胞。然后以酶联免疫吸附片在540纳米下测量溶液的吸光率。病毒诱导CPE的水平与吸光率成反比。
结晶紫试验所得的结果表明,物质1的中毒浓度与有效浓度可以由下面的等式决定,y=mx+c,其中x表示物质1稀释度,y表示物质1对该细胞的毒性百分比。由该等式,TC50(表现出50%细胞毒性的物质1的浓度)是物质1的1/571倍的稀释液。
由结晶紫试验测量得到的结果与不同浓度的物质1时的细胞存活百分比有很好的相关性,如下表14所示。
不含病毒的物质1的稀释度 | %存活细胞 |
1/320 | 89.7 |
1/160 | 94.6 |
1/80 | 97.6 |
1/40 | 109.3 |
1/20 | 168.2 |
表14
使用相同等式,其中x仍然表示物质1的释液度,而y表示物质1对该病毒的效力百分比,在1/91倍稀释的物质1下测量其EC50(对病毒表现出50%效力的该物质的浓度)。如表15所示,由结晶紫试验测量得到的结果与在物质1的各种稀释度下的存活细胞的百分比有很好的相关性。
含病毒的物质1的稀释度 | %存活细胞 |
1/320+HRV-16 | 79.3 |
1/160+HRV-16 | 62.3 |
1/80+HRV-16 | 39.0 |
1/40+HRV-16 | 15.9 |
1/20+HRV-16 | -220.0 |
表15
在表14和15中,%存活细胞=(纯化合物/纯细胞)x100;以及%存活细胞=(纯细胞-化合物+病毒)/(纯细胞-纯病毒)x100.
“纯化合物”表示在预定稀释度下从仅含海拉细胞和物质1的孔中的测量结果。
“纯细胞”表示仅含未感染海拉细胞的孔中的测量结果。
“化合物+病毒”表示在预定稀释度下从包含HRV-16感染的海拉细胞和物质1的孔中的测量结果。
“纯病毒”表示从仅含被HRV-16病毒感染的海拉细胞的孔中的测量结果。
可以在不背离本发明的精神和范围内,对上述化合物和本发明的方法进行变化。上述全部内容仅作为对本发明的说明解释但不试图限制本发明的内容。本发明的范围由后面所附的权利要求所决定。
Claims (21)
1.一种杀病毒和/或阻止病毒生长的组合物,其中含有:
选自姜黄粉提取物、姜黄流浸膏、姜黄提取物、类姜黄素化合物、姜黄粉、至少是整个姜黄植物的一部分、姜黄酊剂以及它们的混合物的第一成分;
获自生姜的第二成分;
获自山葵的第三成分;以及
选自绿茶粉末、绿茶粉末提取物、绿茶流浸膏、至少是整个绿茶植株的一部分、绿茶酊剂、和它们的混合物的第四成分;
其中第一,第二,第三和第四成分在组合物中的量能有效地共同提供杀病毒和/或阻止病毒生长的效果。
2.如权利要求1所述的杀病毒和/或阻止病毒生长的组合物,其中
第二成分选自:生姜粉提取物、生姜流浸膏、生姜粉、至少是整个生姜植物的一部分、生姜酊剂、生姜所含一种或多种化合物以及它们的混合物,和
第三成分选自:山葵粉、山葵粉提取物、山葵流浸膏、至少是整个山葵植物的一部分、山葵所含一种或多种化合物、山葵酊剂以及它们的混合物。
3.如权利要求1或2所述的杀病毒和/或阻止病毒生长的组合物,其中所述第一成分包括姜黄提取物。
4.如权利要求3所述的杀病毒和/或阻止病毒生长的组合物,其中每克该杀病毒和/或阻止病毒生长的组合物含有5-20毫克姜黄提取物。
5.如权利要求1所述的杀病毒和/或阻止病毒生长的组合物,其中所述第二成分包括生姜根粉。
6.如权利要求5所述的杀病毒和/或阻止病毒生长的组合物,其中每克该杀病毒和/或阻止病毒生长的组合物含有30-150毫克生姜根粉。
7.如权利要求1所述的杀病毒和/或阻止病毒生长的组合物,其中所述第三成分包括山葵根粉。
8.如权利要求7所述的杀病毒和/或阻止病毒生长的组合物,其中每克该杀病毒和/或阻止病毒生长的组合物含有25-75毫克山葵根粉。
9.如权利要求1所述的杀病毒和/或阻止病毒生长的组合物,其中进一步包括从滑榆获得的成分。
10.如权利要求9所述的杀病毒和/或阻止病毒生长的组合物,其中所述从滑榆获得的成分包括滑榆树皮粉,且每克该杀病毒和/或阻止病毒生长的组合物含有50-150毫克该成分。
11.如权利要求1所述的杀病毒和/或阻止病毒生长的组合物,其中每克该杀病毒和/或阻止病毒生长的组合物含有5-20毫克第四成分。
12.如权利要求1所述的杀病毒和/或阻止病毒生长的组合物,其中进一步含有药学上可接受的载体。
13.如权利要求1所述的杀病毒和/或阻止病毒生长的组合物,其中所述杀病毒和/或阻止病毒生长的组合物被制成选自锭剂和片剂形式的制剂。
14.如权利要求1所述的杀病毒和/或阻止病毒生长的组合物,其中含有:
姜黄提取物;
生姜根粉;
山葵根粉;
选自绿茶粉末、绿茶粉末提取物、绿茶流浸膏、至少是整个绿茶植株的一部分、绿茶酊剂、和它们的混合物的第四成分;和
药学上可接受的载体,并且该杀病毒和/或阻止病毒生长的组合物中所含姜黄提取物、生姜根粉与山葵根粉和第四成分的量能有效地提供杀病毒和/或阻止病毒生长的效果。
15.权利要求1-14的杀病毒和/或阻止病毒生长的组合物在制备用于治疗一种或多种以下症状的药物中的应用,所述症状选自:普通感冒、流涎、喉咙痛、由病毒感染引起的充血、喉炎和粘膜炎症。
16.如权利要求15所述的应用,其中按每克该杀病毒和/或阻止病毒生长的组合物计,组合物含有5-20毫克姜黄提取物。
17.如权利要求15所述的应用,其中按每克该杀病毒和/或阻止病毒生长的组合物计,组合物含有30-150毫克生姜根粉。
18.如权利要求15所述的应用,其中每克该杀病毒和/或阻止病毒生长的组合物计含有25-75毫克山葵根粉。
19.如权利要求15所述的应用,其中每克该组合物含有5-20毫克第四成分。
20.如权利要求15所述的应用,其中所述组合物进一步含有从滑榆树皮获得的成分。
21.如权利要求20所述的应用,其中所述从滑榆获得的成分包括滑榆树皮粉,且每克该组合物中含有50-150毫克该成分。
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- 2002-08-06 CN CNB028141482A patent/CN100469355C/zh not_active Expired - Fee Related
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- 2002-08-06 EP EP02794664A patent/EP1414415A2/en not_active Withdrawn
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US6596313B2 (en) | 2003-07-22 |
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NZ530187A (en) | 2007-02-23 |
CA2455391A1 (en) | 2003-02-20 |
KR20040035720A (ko) | 2004-04-29 |
WO2003013428A3 (en) | 2003-11-06 |
AU2002332464B2 (en) | 2006-11-09 |
IL159357A0 (en) | 2004-06-01 |
CN1527702A (zh) | 2004-09-08 |
US20030099730A1 (en) | 2003-05-29 |
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