CN102056614A - 用于治疗上呼吸道病症和流行性感冒综合征的组合物 - Google Patents
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Abstract
本发明涉及基于苯菲啶生物碱、沙棘提取物和狭叶紫锥菊提取物的组合物,其具有抗细菌、抗病毒以及抗炎症活性并且对于治疗上呼吸道的细菌和病毒感染,以及对于治疗流行性感冒是有用的。
Description
发明内容
本发明涉及基于苯菲啶生物碱、沙棘(Hippophae rhamnoides)提取物和狭叶紫锥菊(Echinacea angustifolia)提取物的组合物,其具有抗细菌、抗病毒以及抗炎症的活性并且对于治疗上呼吸道的细菌和病毒感染,以及对于治疗流行性感冒是有用的。
现有技术
流行性感冒的预防性以及治愈性治疗是重要的目标,因为这一疾病每年在全世界都侵袭数百万人,造成巨大的工作时间损失以及严重的并发症,它对于体弱患者、老年人以及儿童甚至可以是致命的。
流行性感冒由于其并发症而对于老年患者尤其危险,特别是如果他们已经罹患老年人惯发的呼吸病症。在婴儿中也有相同的问题,流行性感冒造成婴儿连续感冒和复发的后果。多年来,认为预防接种是针对病毒疾病的最有效方法。然而,在流行性感冒的情形下,由于新型的病毒抗性变种的出现所造成的异常抗原突变,这一措施的效力是有限的。
出于这一原因,病毒感染的化疗以及化学预防如今是金标准。存在多种治疗流行性感冒的产品,从十九世纪六十年代引入的过时的金刚烷到近年的神经氨酸酶抑制剂,然而,它们表现出低效力并且通常表现出毒性问题,造成病毒抗性的产生。这些物质对于菌株A和B具有不同的影响,因此当感染类型并非先验可知时,攻击两种菌株的物质是必要的。
喉咙的潮红、发炎以及细菌和/或病毒感染并伴有斑块形成是伴随常见流行性感冒、感冒以及类似病症的常见症状。普通感冒和流行性感冒平均每年影响儿童和成人达三次,它们主要与病毒感染相关,其中40%是由鼻病毒造成,10%由冠状病毒造成以及较小部分由腺病毒和副流感病毒造成。尽管对于这些病症没有特别的疗法,但是认为抗组胺药、解充血药以及抗炎药是有用的,因为它们降低水肿,减轻疼痛并使炎性病症时间缩短。
这些病症有时由于继发性细菌感染的发作而发生并发症,因为鼻窦的出口通常被粘膜充血所阻塞,致病病菌可以容易地在那里增殖,造成发烧和局部疼痛。在这种情形下,除了症状治疗外,还需要抗生素治疗。
如今使用的治疗辅助是基于消除可能的并发症,并且其以抗生素、抗炎药以及退热药为代表。然而,目前市售的制剂并非所有都可以被儿童和孕妇使用。抗生素,尤其对于婴儿,降低机体防御,造成复发。这意味着对于成人患者(包括孕妇)以及儿童都完全无害并且不造成抗性病毒产生的抗病毒制剂是必要的。因此医务工作者需要将良好耐受且作用于病症的所有方面的产品组合的可能性。
文献中已有报道苯菲啶生物碱具有抗微生物、抗真菌、抗病毒以及抗血管形成的活性。这些化合物的最主要代表是血根碱,它目前由于其抗病毒以及抗炎症作用而主要被用于牙科行业,它对于抑制菌斑以及保护牙龈是有用的。苯菲啶生物碱也表征为以纳摩尔浓度表现的与多种活性相关的抗炎症效应,如:
-对参与炎症以及参与感染的免疫反应的核因子NFkB的抑制;
-抗血管形成活性:血管生成过程涉及炎症并且取决于VEGF(血管内皮生长因子),它的作用已经在不同模型中通过体外对HUVECs迁移以及体内血管生成被证明。在体外,血根碱以剂量依赖的程度显著抑制细胞迁移的诱导,发展以及细胞存活;
-5-和12-脂加氧酶的抑制。
这些生物碱对炎症过程以及在细菌和真菌感染中表现出强有力的协同作用,而它们对于病毒感染的活性较不显著。沙棘提取物具有抗病毒以及温和的抗细菌特性。
发明详述
本发明涉及组合物,其基于:
a)苯菲啶生物碱;
b)沙棘提取物;
c)狭叶紫锥菊的亲脂性提取物,
具有抗细菌、抗病毒以及抗炎症的活性,对于治疗流行性感冒以及上呼吸道病症是有用的。
本发明的组合物对于最常见的流行性感冒病毒毒株发挥强大的抗病毒活性,以及发挥抗细菌作用,其阻止菌斑的形成以及经常由流行性感冒所导致的上呼吸道感染。一般地,根据本发明的组合物尤其适应于化脓性耳炎和口腔感染。此外,它们的抗炎症作用可用于治疗通常伴随感冒和流行性感冒的发烧和发炎。
而今出人意料地发现本发明的组合物具有极其有力的抗病毒、抗细菌和抗炎症的活性,这比单独施用的各种组分总和要大。所述效应可能是由于在本发明组合的各种组分之间发生的非先验可预见的协同作用机理。
根据本发明,该组合物将含有下述区间的多种组分(按每单位剂量的重量计):
a)苯菲啶生物碱:1至5;
b)沙棘提取物:10至100;
c)狭叶紫锥菊的亲脂性提取物:0.2至2。
根据尤其优选的方面,本发明的组合物将含有下述区间的多种组分(按每单位剂量的重量计):
a)苯菲啶生物碱:2至4;
b)沙棘提取物:15至45;
c)狭叶紫锥菊的亲脂性提取物:0.5至1。
根据本发明优选的方面,苯菲啶生物碱将选自血根碱、白屈菜赤碱和白屈菜碱,或者可以以含有它们(包括它们的异构体形式)的提取物的形式存在。所述提取物的实例是血根草(Sanguinaria canadensis)、博落回(Macleaya cordata)或小果博落回(Macleaya microcarpa),以及白屈菜(Chelidonium majus)的提取物。根据尤其优选的方面,苯菲啶生物碱将以生物碱滴定度为75和100%之间的博落回的纯化提取物的形式存在。
根据优选的方面,苯菲啶生物碱将以与淡黄青霉酸成盐的形式存在。所述盐是通过将所述生物碱的硫酸盐或盐酸盐与淡黄青霉酸的钠盐或钾盐反应,随后结晶而制备,该盐被证明对于本发明的目的尤其有效。
根据本发明优选的方面,沙棘提取物以从富含鞣花酸衍生物的地上部分提取所获得的沙棘提取物的形式存在。根据尤其优选的方面,沙棘提取物将具有90%的鞣花单宁滴定度。
沙棘提取物是这样制备的:用由水进行不同稀释的具有一至三个碳原子的醇,优选用50%v/v乙醇/水的混合物从地上部分提取,然后浓缩该水/乙醇提取物直到完全除去有机溶剂并向生成的浑浊混悬液中加入达生物量重量2%的聚乙烯吡咯烷酮。在聚苯乙烯树脂上吸附通过过滤而获得的澄清溶液,并冲洗树脂直到完全除去可溶物质。通过用90%乙醇冲洗树脂回收组成本发明所用提取物的活性成分,浓缩乙醇洗脱物至小量并在不超过50℃的温度下真空干燥残留物。
沙棘提取物对于流感A和B的多种毒株,以及对腺病毒、副粘病毒、单纯性疱疹(Herpes catarrhalis)病毒、巨细胞病毒和呼吸道合胞病毒表现出显著的抗病毒活性。该提取物也表现出抗细菌活性,并由下面的事实所加强:鞣酸单宁络合所述生物碱,将具有残留亲水部分的该络合物锚定在病毒或细菌蛋白质上,从而防止它们增殖并且同时降低该组合的总体毒性。
体外试验证明本发明的组合物诱导干扰素的产生,并且抑制细菌和真菌增殖以及炎性和疼痛反应。
根据优选的方面,本发明的组合物也将含有狭叶紫锥菊精油,或者它们中含有的异丁基酰胺类,异丁基酰胺类是大麻素CB1和CB2的配体,因而具有强大的抗炎症和止痛活性。
本发明的组合物将被方便地配制成在口腔中缓慢溶解的片剂或者缓慢释放活性组分的口香糖,在口腔中分散的漱口水、凝胶等形式。可以根据公知的常规方法,如″Remington′s Pharmaceutical Handbook″,Mack Publishing Co.,N.Y.,USA所述的那些,与适当的赋形剂一起制备所述制剂。
在下面的实施例中将详细说明本发明。
实施例-1000mg咀嚼片含有
沙棘提取物 20mg
狭叶紫锥菊的冻干提取物 0.5mg
博落回的醇提物 2mg
大豆卵磷脂 30mg
无水柠檬酸 5mg
L-半胱氨酸 5mg
乳糖 200mg
甘露醇 567.5mg
甲基纤维素 40mg
棕榈酰硬脂酰甘油酯 50mg
无核水果(Soft fruit)调味品 40mg
甘草酸钾 5mg
滑石 10mg
碳酸氢钠 25mg
Claims (10)
1.组合物,其基于:
a)苯菲啶生物碱;
b)沙棘提取物;
c)狭叶紫锥菊的亲脂性提取物。
2.如权利要求1所述的组合物,其基于:
a)选自血根碱、白屈菜赤碱和白屈菜碱的苯菲啶生物碱;
b)富含鞣花酸衍生物的沙棘提取物;
c)狭叶紫锥菊的亲脂性提取物。
3.如权利要求1和2所述的组合物,其中按每单位剂量的重量计,各种组分以下述区间存在:
a)苯菲啶生物碱:1至5;
b)沙棘提取物:10至100;
c)狭叶紫锥菊的亲脂性提取物:0.2至2。
4.如前述权利要求所述的组合物,其中苯菲啶生物碱血根碱、白屈菜赤碱和白屈菜碱以游离的形式或成盐的形式存在,本身以基本上纯的形式或以血根草、博落回或小果博落回或白屈菜的提取物的形式存在。
5.如权利要求4所述的组合物,其中所述苯菲啶生物碱以与淡黄青霉酸成盐的形式存在。
6.如权利要求1-5所述的组合物,其中所述沙棘提取物以从富含鞣花酸衍生物的地上部分提取所获得的沙棘提取物的形式存在。
7.如权利要求6所述的组合物,其中所述沙棘提取物具有90%鞣花单宁含量。
8.如权利要求1-7中任一项所述的组合物,其为在口腔中缓慢溶解的片剂或者缓慢释放活性成分的口香糖、在口腔中分散的漱口水、凝胶等形式。
9.a)苯菲啶生物碱;
b)沙棘提取物;
c)狭叶紫锥菊的亲脂性提取物,
在制备用于治疗上呼吸道的细菌和病毒病症的口服组合物中的用途。
10.如权利要求9所述的用途,其中所述上呼吸道的细菌和病毒病症是由于流行性感冒病毒所造成的感染的后遗症。
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
ITMI20081029 ITMI20081029A1 (it) | 2008-06-05 | 2008-06-05 | Composizioni per il trattamento delle affezioni delle prime vie respiratorie e delle sindromi influenzali |
ITMI2008A001029 | 2008-06-05 | ||
EP08425420A EP2133089A1 (en) | 2008-06-12 | 2008-06-12 | Compositions for the treatment of disorders of the upper respiratory tract and influenza syndromes |
EP08425420.0 | 2008-06-12 | ||
PCT/EP2009/003673 WO2009146807A1 (en) | 2008-06-05 | 2009-05-25 | Compositions for the treatment of disorders of the upper respiratory tract and influenza syndroms |
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CN102056614A true CN102056614A (zh) | 2011-05-11 |
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US (1) | US9101604B2 (zh) |
EP (1) | EP2285393B1 (zh) |
JP (2) | JP5992171B2 (zh) |
KR (1) | KR20110027671A (zh) |
CN (1) | CN102056614A (zh) |
AU (1) | AU2009254262B2 (zh) |
CA (1) | CA2726872C (zh) |
DK (1) | DK2285393T3 (zh) |
ES (1) | ES2393239T3 (zh) |
HR (1) | HRP20120874T1 (zh) |
IL (1) | IL209714A (zh) |
PL (1) | PL2285393T3 (zh) |
PT (1) | PT2285393E (zh) |
RU (1) | RU2518738C2 (zh) |
SI (1) | SI2285393T1 (zh) |
WO (1) | WO2009146807A1 (zh) |
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CN114984009A (zh) * | 2019-08-31 | 2022-09-02 | 广州自远生物科技有限公司 | 异喹啉类化合物制备抗冠状病毒产品中的用途 |
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WO2011082835A1 (en) * | 2010-01-11 | 2011-07-14 | Vitro-Bio Sarl | New synergistic compositions for the treatment of topical viral infections |
IT1402018B1 (it) * | 2010-10-11 | 2013-08-28 | Indena Spa | Formulazioni per il trattamento delle affezioni delle prime vie respiratorie. |
AU2013244472B9 (en) * | 2012-04-03 | 2015-02-19 | The Shizuoka Chamber Of Commerce And Industry | Composition for improving resistance to environmental stress of plant and method for improving resistance to environmental stress of plant |
JP6320842B2 (ja) * | 2014-05-15 | 2018-05-09 | 株式会社シオンテック | 抗菌性繊維の製造方法及び抗菌性繊維 |
JP7104926B1 (ja) * | 2021-08-03 | 2022-07-22 | 宇航人ジャパン株式会社 | ヘルパーt細胞増加剤およびヘルパーt細胞増加用の食品組成物 |
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US4818533A (en) * | 1985-07-09 | 1989-04-04 | Vipont Pharmaceutical, Inc. | Production of high purity alkaloids |
RU2098111C1 (ru) | 1994-03-30 | 1997-12-10 | Научно-производственное объединение "Всероссийский научно-исследовательский институт лекарственных и ароматических растений" | Способ получения противовирусного препарата "гипорамин" |
US20020132021A1 (en) * | 1997-04-30 | 2002-09-19 | Ilya Raskin | Elicited plant products |
JP2000109428A (ja) * | 1998-10-05 | 2000-04-18 | Taisho Pharmaceut Co Ltd | 咽頭粘膜用組成物 |
IL152827A0 (en) * | 2000-05-18 | 2003-06-24 | Herbal composition useful for treatment of oral cavity and a method for the local delivery thereof | |
ITMI20021691A1 (it) * | 2002-07-30 | 2004-01-30 | Indena Spa | Estratti di echinacea angustifolia |
RU2311192C2 (ru) * | 2003-03-31 | 2007-11-27 | Каунсил Оф Сайентифик Энд Индастриал Рисерч | Способ получения антибактериальной и антиоксидантной фракции из семян облепихи (hippophae rhamnoides l.) |
US20050031718A1 (en) * | 2003-04-10 | 2005-02-10 | Pharmanex, Llc | Sea Buckthorn compositions and associated methods |
ITMI20042414A1 (it) * | 2004-12-17 | 2005-03-17 | Indena Spa | Formulazione per il trattamento di affezioni delle prime vie respiratorie |
US7491414B2 (en) | 2005-10-12 | 2009-02-17 | Gaia Herbs, Inc. | Anti-inflammatory substances extracted from Echinacea |
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2009
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- 2009-05-25 CN CN2009801209083A patent/CN102056614A/zh active Pending
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- 2009-05-25 ES ES09757190T patent/ES2393239T3/es active Active
- 2009-05-25 DK DK09757190.5T patent/DK2285393T3/da active
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
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CN114984009A (zh) * | 2019-08-31 | 2022-09-02 | 广州自远生物科技有限公司 | 异喹啉类化合物制备抗冠状病毒产品中的用途 |
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HRP20120874T1 (hr) | 2012-11-30 |
CA2726872C (en) | 2017-05-02 |
RU2518738C2 (ru) | 2014-06-10 |
AU2009254262A1 (en) | 2009-12-10 |
JP2011521982A (ja) | 2011-07-28 |
KR20110027671A (ko) | 2011-03-16 |
US20110135769A1 (en) | 2011-06-09 |
EP2285393B1 (en) | 2012-08-15 |
AU2009254262B2 (en) | 2014-02-13 |
PT2285393E (pt) | 2012-11-29 |
WO2009146807A8 (en) | 2010-02-04 |
PL2285393T3 (pl) | 2013-01-31 |
IL209714A0 (en) | 2011-02-28 |
DK2285393T3 (da) | 2012-10-22 |
IL209714A (en) | 2014-02-27 |
JP2016147914A (ja) | 2016-08-18 |
JP5992171B2 (ja) | 2016-09-14 |
WO2009146807A1 (en) | 2009-12-10 |
ES2393239T3 (es) | 2012-12-19 |
US9101604B2 (en) | 2015-08-11 |
EP2285393A1 (en) | 2011-02-23 |
SI2285393T1 (sl) | 2012-12-31 |
RU2010153660A (ru) | 2012-07-20 |
CA2726872A1 (en) | 2009-12-10 |
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