CN102281889A - 用于预防和治疗胃-食道返流和化学治疗诱导的呕吐的包含姜和狭叶紫锥菊的亲脂提取物的组合物 - Google Patents
用于预防和治疗胃-食道返流和化学治疗诱导的呕吐的包含姜和狭叶紫锥菊的亲脂提取物的组合物 Download PDFInfo
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Abstract
本发明涉及包含通过在超临界条件下用二氧化碳提取获得的姜和狭叶紫锥菊的亲脂提取物组合的组合物，其用于预防和治疗食道返流和化学治疗诱导的呕吐。
Description
发明概述
本发明涉及包含姜(Zingiber officinale)和狭叶紫锥菊(Echinaceaangustifolia)的亲脂提取物联合的组合物，其用于预防和治疗食道返流和化学治疗诱导的呕吐。
现有技术
胃肠道癌是第二个最常见类型的癌症并且是该领域第二高致死原因。食道癌和胃在发达国家并不是很常见，但非常致命。
已经鉴定出这两种肿瘤的多种辅因，例如酗酒、经常伴有吸烟、富含硝酸盐的饮食和/或破坏胃和食道的粘液屏障的产品或习惯。接着检查了不同大陆人群的饮食习惯和某些痕量元素的缺乏(普-文综合征和佩-凯综合征)，试图通过改变饮食习惯和生活方式以及应用药物或膳食产品来预防所述辅因引起的胃癌和食道癌。尽管已经消除了很多所述的辅因，但是全球的发病率还在增加，这是由于遭受胃-食道返流并且时常伴有饮食和/或食道裂孔疝的人的数量在增加，这是食道肿瘤的主要原因之一。腺癌主要通过食道的末端部分的混合型柱状上皮显示的，几乎时常出现慢性返流和胃上皮化生(巴雷特食道)，其在肥胖个体中常见，并且超过50％病例会恶化。
因此，降低该障碍的发病率是非常重要的。
因此，研究主要集中在能够降低返流的药物，特别是通过修饰胃排空。特别的是，研究者试图开发很好耐受的天然促运动药，因为对于预防基础，潜在的药物需要长期服用很多年，或者，取决于消化需要间断服用。
然而，近来用于修饰胃排泄的很多药物出现影响CNS的严重副作用或具有致癌作用，因此已经或正要退出市场。目前胃-食道返流是用混合药物治疗，例如质子泵抑制剂(雷尼替丁、-拉唑或简单的抗酸药)、酶、多种消化药物和促运动药，例如多潘立酮。然而，长期应用质子泵抑制剂通常导致很多消化问题。
因此，现在研究集中在新的治疗方法。
发明描述
现在已经发现包含姜和狭叶紫锥菊的亲脂提取物(都是通过在超临界条件下用二氧化碳提取制备的)的组合具有令人惊讶的促运动和止吐活性，使消化功能不改变并且消除胃的沉重感和呕吐，这些是食道返流的辅因；因此其用于预防和治疗食道返流和化学治疗诱导的呕吐。
因此，本发明涉及组合物，该组合物包含：
a)姜的亲脂提取物，和
b)狭叶紫锥菊的亲脂提取物，
其用于预防和治疗食道返流和化学治疗诱导的呕吐。
更特别的是，根据本发明，狭叶紫锥菊的亲脂提取物是通过在超临界条件下用二氧化碳提取制备的，如申请人提交的专利EP 464298中所公开的。姜的亲脂提取物也可以在相同条件下用粉碎的根开始提取。
应用以多种方式处理的姜的根和根茎，特别是在亚洲和中东，作为香料并且在传统医学中用于治疗消化障碍、肠胃胀气、腹泻、咳嗽，并且在较小的程度上保护粘膜，消炎，治疗尿失禁等。
姜的亲脂提取物中存在的活性组分主要包括姜醇(通常存在的浓度范围为10至15％)，其具有抗消化不良、抗恶心和抗呕吐活性，并且可用于治疗晕动病、嗳气、消化障碍、绞痛、呕吐、消化不良以及胃和结肠疼痛。然而，考虑到姜醇的众所周知的化学不稳定性，最近临床试验表明传统方法制备的姜的亲脂提取物存在低活性；因此，由于缺乏有力的证据，美国药典推荐完整的评审植物的性质。传统方法制备的姜的亲脂提取物中含有的姜醇快速分解，产生一系列化合物，例如姜烯酚和其它氧化产物，这些物质没有功效。这些不一致的数据部分是由于通常使用的提取物中的活性组分的不稳定性。然而，本发明中应用的提取物是在明确的超临界条件下用二氧化碳稳定和制备的亲脂提取物。
狭叶紫锥菊的根和地上部分的亲脂提取物的特征在于存在具有镇痛和抗炎性质、抗恶心和抗呕吐活性的多不饱和酸的异丁基酰胺，这与它们和大麻素受体的相互作用相关。本发明的组合具有令人惊讶的显著促运动和抗消化不良作用，使消化功能不改变并且消除胃的沉重感和呕吐，这些是食道返流的辅因。因此，该组合可以用于预防和治疗食道返流和化学治疗诱导的呕吐。
本发明的组合物增加胃排空，非常有效并且完全意外的效果，因为所述的活性不是所治疗的任何患者中的单个组分能证明的。实际上，如上所述，观察到施用狭叶紫锥菊的烷基酰胺减缓了胃和肠的排泄，而不是促进它。
根据优选的方面，本发明的组合物包含以下重量范围的两种组分：
a)姜的亲脂提取物：1至25mg；和
b)狭叶紫锥菊的亲脂提取物：1至10mg。
根据特别优选的方面，组合物包含以下重量的两种组分：
a)姜的亲脂提取物：12.5mg；和
b)狭叶紫锥菊的亲脂提取物：5mg。
根据优选的方面，本发明的组合物包含根据EP 464298所描述的方法制备的狭叶紫锥菊的亲脂提取物，其特征在于异丁基酰胺含量为25-50％，特别是十二碳-2E，4E，8Z，10Z-四烯酸异丁基酰胺。
根据优选的方面，姜的亲脂提取物和狭叶紫锥菊的亲脂提取物配制在富含ω3/ω6多不饱和脂肪酸(例如月见草油)的植物油中。
根据进一步的方面，本发明的组合物可以与具有有效或互补活性的其它物质一起施用。
在人中证明有效的剂量是每剂量1至25mg的姜的亲脂提取物和1至10mg的狭叶紫锥菊的亲脂提取物；更特别的是，每剂量12.5mg的姜的亲脂提取物和5mg的狭叶紫锥菊的亲脂提取物，与每顿主食一起服用，或适合所治疗的障碍。
根据常规方法配制本发明的组合物，例如“Remington’sPharmaceutical Handbook(雷明顿药物手册)”Mack Publishing Co.，N.Y.，USA中描述的那些方法。特别的是，本发明的组合物是根据用于口服施用的亲脂成分的常规配制技术来配制，主要是设计在胃里快速分散的油舌下片剂或者软明胶或纤维素胶囊剂。亲脂形式应用富含ω-3脂肪酸的油，其促进活性成分的快速吸收，从而分散活性组分。口服制剂的实例是片剂、锭剂、软和硬明胶胶囊剂以及纤维素胶囊剂。
以下实施例进一步说明本发明。
实施例1-软明胶胶囊剂
单位组合物：
实施例2-硬明胶胶囊剂
单位组合物：
Claims (7)
1.组合物，该组合物包含通过在超临界条件下用二氧化碳提取获得的：
a)姜的亲脂提取物，和
b)狭叶紫锥菊的亲脂提取物。
2.权利要求1的组合物，其包含以下重量范围的两种组分：
a)姜的亲脂提取物：1至25mg；和
b)狭叶紫锥菊的亲脂提取物：1至10mg。
3.权利要求1和2的组合物，其包含以下重量的两种组分：
a)姜的亲脂提取物：12.5mg；和
b)狭叶紫锥菊的亲脂提取物：5mg。
4.上述权利要求的组合物，其包含狭叶紫锥菊的亲脂提取物，其中异丁基酰胺的含量为25至50％。
5.上述权利要求的组合物，其用于口服施用。
6.权利要求5的组合物，其是软明胶胶囊剂或硬明胶胶囊剂的形式。
7.通过在超临界条件下用二氧化碳提取获得的
a)姜的亲脂提取物，和
b)狭叶紫锥菊的亲脂提取物
在制备用于增加胃排空、预防和治疗食道返流和化学治疗诱导的呕吐的组合物中的用途。
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IT000049A ITMI20090049A1 (it) | 2009-01-20 | 2009-01-20 | Composizioni a base di estratti lipofili di zingiber officinale e di echinacea angustifolia per la prevenzione e il trattamento del riflusso gastro-esofageo e dell'emesi indotta da chemioterapici |
| ITMI2009000049 | 2009-01-20 | ||
| PCT/EP2010/000204 WO2010083967A1 (en) | 2009-01-20 | 2010-01-15 | Compositions comprising lipophilic extracts of zingiber officinale and echinacea angustifolia for the prevention and treatment of gastro-oesophageal reflux and chemotherapy-induced emesis |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN102281889A true CN102281889A (zh) | 2011-12-14 |
Family
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2010800048072A Pending CN102281889A (zh) | 2009-01-20 | 2010-01-15 | 用于预防和治疗胃-食道返流和化学治疗诱导的呕吐的包含姜和狭叶紫锥菊的亲脂提取物的组合物 |
Country Status (21)
| Country | Link |
|---|---|
| US (2) | US8361521B2 (zh) |
| EP (1) | EP2379095B1 (zh) |
| JP (1) | JP2012515715A (zh) |
| KR (1) | KR101740491B1 (zh) |
| CN (1) | CN102281889A (zh) |
| AU (1) | AU2010206326B2 (zh) |
| BR (1) | BRPI1006849B8 (zh) |
| CA (1) | CA2750025C (zh) |
| CL (1) | CL2011001751A1 (zh) |
| DK (1) | DK2379095T3 (zh) |
| ES (1) | ES2429018T3 (zh) |
| HR (1) | HRP20130977T1 (zh) |
| IL (1) | IL214161A (zh) |
| IT (1) | ITMI20090049A1 (zh) |
| MX (1) | MX2011007685A (zh) |
| PL (1) | PL2379095T3 (zh) |
| PT (1) | PT2379095E (zh) |
| RU (1) | RU2524625C2 (zh) |
| SG (1) | SG173054A1 (zh) |
| SI (1) | SI2379095T1 (zh) |
| WO (1) | WO2010083967A1 (zh) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104540514A (zh) * | 2012-07-27 | 2015-04-22 | 因德纳有限公司 | 治疗癌症相关性疲劳的组合物 |
Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| IT1401141B1 (it) | 2010-07-26 | 2013-07-12 | Indena Spa | Formulazioni contenenti estratti di echinacea angustifolia e di zingiber officinale utili nella riduzione dell'infiammazione e del dolore periferico |
| JP6198427B2 (ja) * | 2013-03-29 | 2017-09-20 | 小林製薬株式会社 | ゼラチン類を含有する経口組成物 |
| ITMI20130807A1 (it) | 2013-05-16 | 2014-11-17 | Indena Spa | Combinazioni di estratti di serenoa repens e di estratti lipofili di zingiber officinalis e di echinacea angustifolia, loro uso e formulazioni che li contengono |
| KR101549746B1 (ko) * | 2013-08-22 | 2015-09-04 | 충북대학교 산학협력단 | 생강의 용매분획을 유효성분으로 포함하는 기능성 위장장애 및 위장관 운동장애의 예방 및 치료용 약학적 조성물 |
| KR101868225B1 (ko) | 2016-09-22 | 2018-06-15 | 주식회사 담터 | 생강으로부터 쇼가올을 추출하는 방법 |
| EP3335716A1 (en) * | 2016-12-15 | 2018-06-20 | Indena S.p.A. | Process for the preparation of powder compositions |
| IT202000003092A1 (it) * | 2020-02-17 | 2021-08-17 | Neilos S R L | Composizione per la protezione della mucosa gastro-intestinale e per la prevenzione e il trattamento di patologie ad essa associate |
Family Cites Families (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ATE123947T1 (de) * | 1990-07-05 | 1995-07-15 | Indena Spa | Echinacea-extrakte, verfahren zur herstellung und zubereitungen, die sie enthalten. |
| US5744187A (en) * | 1996-12-16 | 1998-04-28 | Gaynor; Mitchel L. | Nutritional powder composition |
| WO1999021007A1 (en) * | 1997-10-23 | 1999-04-29 | Pharmaprint, Inc. | Pharmaceutical grade echinacea |
| DE19859499C2 (de) * | 1998-12-22 | 2002-10-24 | Schwabe Willmar Gmbh & Co | Stabile Ingwerextraktzubereitung |
| US6261607B1 (en) * | 1999-10-19 | 2001-07-17 | Thomas Newmark | Composition for promoting prostate health containing selenium and herbal extracts |
| TWI290469B (en) * | 2000-07-12 | 2007-12-01 | Medical & Pharm Ind Tech & Dev | Method for manufacturing product with component capable of efficiently preventing inflammation and platelets agglutination form ginger and medical composition with the efficient component |
| US6274177B1 (en) * | 2000-08-26 | 2001-08-14 | National Science Council | Method of preparing an extract potent in anti-inflammation and anti-platelet aggregation from Zingiber officinale and pharmaceutical compositions containing said extract |
| US7037524B2 (en) * | 2001-10-03 | 2006-05-02 | Herbalscience, Llc | Oral delivery of a botanical |
| US20080160116A1 (en) | 2006-12-07 | 2008-07-03 | Herbalscience Singapore Pte. Ltd | Compositions and Methods Comprising Zingiber Species |
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- 2010-01-15 JP JP2011545686A patent/JP2012515715A/ja active Pending
- 2010-01-15 DK DK10700810.4T patent/DK2379095T3/da active
- 2010-01-15 SG SG2011052255A patent/SG173054A1/en unknown
- 2010-01-15 RU RU2011129984/15A patent/RU2524625C2/ru active
- 2010-01-15 KR KR1020117016829A patent/KR101740491B1/ko active IP Right Grant
- 2010-01-15 CN CN2010800048072A patent/CN102281889A/zh active Pending
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2012
- 2012-12-20 US US13/721,298 patent/US8859019B2/en active Active
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104540514A (zh) * | 2012-07-27 | 2015-04-22 | 因德纳有限公司 | 治疗癌症相关性疲劳的组合物 |
| CN104540514B (zh) * | 2012-07-27 | 2020-03-27 | 因德纳有限公司 | 治疗癌症相关性疲劳的组合物 |
Also Published As
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| CA2750025C (en) | 2017-07-11 |
| US8859019B2 (en) | 2014-10-14 |
| IL214161A0 (en) | 2011-08-31 |
| PT2379095E (pt) | 2013-10-02 |
| ITMI20090049A1 (it) | 2010-07-21 |
| DK2379095T3 (da) | 2013-09-08 |
| IL214161A (en) | 2015-08-31 |
| KR20110107339A (ko) | 2011-09-30 |
| SG173054A1 (en) | 2011-08-29 |
| US20130108720A1 (en) | 2013-05-02 |
| US8361521B2 (en) | 2013-01-29 |
| BRPI1006849B1 (pt) | 2021-04-06 |
| ES2429018T3 (es) | 2013-11-12 |
| RU2524625C2 (ru) | 2014-07-27 |
| EP2379095B1 (en) | 2013-07-31 |
| AU2010206326A1 (en) | 2011-08-11 |
| US20120040031A1 (en) | 2012-02-16 |
| BRPI1006849A2 (pt) | 2016-03-15 |
| MX2011007685A (es) | 2011-08-12 |
| RU2011129984A (ru) | 2013-02-27 |
| KR101740491B1 (ko) | 2017-05-26 |
| AU2010206326B2 (en) | 2014-04-24 |
| CL2011001751A1 (es) | 2011-11-11 |
| CA2750025A1 (en) | 2010-07-29 |
| BRPI1006849B8 (pt) | 2021-05-25 |
| HRP20130977T1 (hr) | 2013-11-22 |
| EP2379095A1 (en) | 2011-10-26 |
| WO2010083967A1 (en) | 2010-07-29 |
| SI2379095T1 (sl) | 2013-10-30 |
| JP2012515715A (ja) | 2012-07-12 |
| PL2379095T3 (pl) | 2013-12-31 |
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