CN1853666B - 基于植物纤维的药用、营养医用、食品和营养组合物 - Google Patents
基于植物纤维的药用、营养医用、食品和营养组合物 Download PDFInfo
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- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
本发明涉及一种药用、营养医用、食品和营养组合物,该组合物含有:a)葡甘露聚糖,b)仙桃(Opuntia ficus indica),c)微晶纤维素。这些组合物在肠胃水平上表现出高膨胀指数,它产生瞬时饱食感,释放胆囊收缩素,并延缓胃排空从而延长饱食感。将三种植物纤维的复合物与冷冻干燥黏胶质混合物结合可增加其在肠胃区域的膨胀特性。
Description
技术领域
本发明涉及一种药用、营养医用(nutraceutical)、食品和营养组合物,该组合物含有:
a)葡甘露聚糖,
b)仙桃(Opuntia ficus indica),
c)微晶纤维素。
这些组合物在肠胃水平上表现出高膨胀指数,它产生瞬时饱食感,释放胆囊收缩素,并延缓胃排空从而延长饱食感。将三种植物纤维的复合物与冷冻干燥黏胶质混合物结合可增加其在肠胃区域的膨胀特性。
背景技术
膳食纤维
膳食纤维被定义为“来源于植物、不被人体消化器官分泌的酶水解且仅部分被肠内菌群水解的物质,分为如下几类:纤维素、改性纤维素、半纤维素、果胶、植物胶、黏胶质(mucilage)和木质素”。从其“难消化”的角度来看,由于人体消化器官产生的酶无法将组成纤维的多糖链分解为可被人体吸收的更简单的组分(单糖),因此纤维实际上没有营养或能量价值,但是在转运穿过消化道期间完成了一系列功能和代谢活动,这对正常肠道功能是必需的并且通常对整个机体的健康而言十分有利。
因而,膳食纤维作为一种饮食的必要组成而众所周知,大量流行病学研究证明,多吃富含植物纤维饮食的人群比饮食以低膳食纤维含量为特征的人群较少患有便秘、消化器官的多种其它常见紊乱(结肠炎、肠胃气胀、憩室炎等)以及代谢失调(肥胖症、血脂异常症和糖尿病)。经常摄入膳食纤维,加上富含蔬菜、谷类和水果的饮食,已经与减少消化器官肿瘤、尤其是结肠直肠癌的患病风险联系起来。
膳食纤维包括由多糖长链(通过α和β糖苷键聚合)构成的一组高度复杂的植物复合物,根据彼此连接的糖苷键类型、链长度、循环糖单元类型和分支程度来区分。
膳食纤维的各组分按水溶性分为:
*可溶性纤维:主要是以高度可溶性和或多或少可形成粘性胶状溶液的显著能力为特征的多糖;
*不溶性纤维:虽然它们与水接触时能通过增加质量来保留大部分水,但是不显著改变它们的结构;它们主要作为溶胀剂,产生公知的“压载效应(ballast effect)”。
当可溶性纤维置于水或含水溶液中时,倾向于在多糖链的不同片段之间建立“接触点”,形成类似于“天然凝胶”类的三维有机结构,它具有高粘性和吸收性,保留大量周围的液相和任何溶解于其中的溶质。可溶性纤维在体重控制上的作用基于它们在水合时形成浓的大体积的天然凝胶,结合并保留部分摄入的食物(尤其是糖和脂肪),接着后者随粪便(同纤维一起)在消化结束时排出,不以任何方式增加膳食的卡路里含量。
减少食物吸收的能力通过两种不同的补偿机制进行:第一种通过凝胶(它通过吸收将液体和溶于其中的营养物捕获于网格中)的“机械”作用,而第二种归因于纤维增加消化内容物的粘度并因此延缓肠绒毛对营养物的吸收率的能力,这阻碍了营养物的扩散过程并减少了营养物的吸收。由于纤维摄入的另一个后果是减少消化物转运穿过肠道的时间(由于纤维所形成的天然凝胶而“滑动”更快),因此吸收时间也被缩短。
除减少食物的吸收外,纤维引起饱食感延长,这不仅由于纤维在胃肠道内膨胀造成体积增加,而且最重要的是由于对肠内容物的粘度-控制作用,该作用延缓葡萄糖吸收过程,造成餐后葡萄糖峰值出现和消失要慢得多。
由于上述所有原因,膳食纤维被广泛用做低卡路里食物的助剂和纤维补充剂。目前市场上以膳食纤维为基础的产品有CM3,一种以高度交联纤维素为基础的医疗装置;Normaline Herbs,以葡甘露聚糖和纤维素为基础;Forlip,以仙人掌属植物、壳聚糖和纤维素为基础;以及Dicoplus100,以葡甘露聚糖为基础。一种称为SyndRx的产品,含有葡甘露聚糖和仙人掌属植物并指明用于血糖控制,在美国也有销售。纤维的理化性质
多糖的生理特性可部分根据其理化性质如发酵、水保留能力、粘性和与胆汁酸的结合来推测。
WBC(保水能力):在遭受物理应激如离心时系统不释放的水量。该参数受pH、离子强度和凝胶微观结构的影响。
WHC(持水能力):定义为未遭受物理应激时系统在网格中捕获的水量,与系统的湿度直接相关。
吸收和吸收有机物质的能力:某些可溶性纤维在它们的网格中捕获胶状有机分子的能力,所述胶状有机分子例如是胆汁酸、甾醇、毒性化合物以及其它从人体排出的废弃物质。
离子交换能力:纤维作为弱离子交换树脂起作用,这归因于糖残基中存在的大量游离羧基以及多糖的糖醛酸含量。
凝胶形成:置于水中的可溶性纤维呈现粘性的胶状结构,该结构的特征在于能保留液相的三维固体大分子网格。
溶解性和粘性:大多数多糖在溶液中以无序线圈或“缠结”的方式存在,在达到临界浓度时分散于液体并与邻近分子相互作用,产生牢固的流阻。粘性与胃排空的延迟和通过小肠的转运增加有关。胃排空的减慢可能归因于多种因素,如高粘性多糖在胃环境下体积增加造成胃壁膨胀。这种膨胀引起胆囊收缩素(CCK)释放增加,反过来又减慢胃排空。此外,CCK释放的增加可能与摄取高粘度多糖时脂肪的吸收和消化减少有关。
WHC和WBC指纤维置入水性介质中时膨胀以及在静态或动态情况下在骨架中保留水的能力。高粘度多糖通常具有高的WHC/WBC值;在小肠中,多糖增加肠内容物的总体积,尤其是含水相的体积,从而稀释从含水相中吸收的营养物的浓度,并减缓吸收速率。小肠中含水相的膨胀还有助于降低脂质的吸收速率,脂质在含水相中不溶,但是形成可从该相转移至细胞表面的胶束。
高WHC/WBC值允许水溶性或亲水性物质渗透进入纤维骨架,减少其在细胞表面的扩散,从而有助于减少可吸收营养物的利用率。在大肠内,该现象允许微生物渗透进入纤维骨架并从而提供更多通过微生物消化多糖的途径(生物前效应)。
尽管WHC可代表比系统俘获的水量更真实的数值,但是在确定该值时有一些物理限制。事实上,样品必须达到平衡条件,这种平衡条件必须针对每种单独的原料来定义并标准化,并且对同一原料而言随空间(dimensional)分布的不同而变化。出于这些原因,使用WBC作为纤维特征参数。WBC与时间无关,因为通过在系统中加入过量溶剂使系统超过饱和限制时,达到平衡条件。多种因素影响纤维的WBC值:与溶质的相互作用、毛细管吸力和表面相互作用力。
存在有不同的计算WBC的方法:Baumann仪器、吸收等温线以及离心法。每种方法通过各自的吸水机制进行。Baumann测定法基于通过毛细管力和纤维膨胀的作用吸水。吸水等温线基于蒸汽吸收。离心测定反映了纤维首次吸水(使膨胀)和随后施加离心力于纤维-水系统的综合作用。离心法被认为是计算高水分活度(Aw>0.98)系统中所包括的原料的WBC的最佳选择,所述的系统如片剂在胃环境中崩解所形成的分散液。事实上,认为原料被水“饱和”,并且离心测试类似于达到“饱和”状态的加速方式。
发明内容
已经发现如下定义的药用、营养医用、食品和营养组合物表现出高膨胀指数,它产生瞬时饱食感,释放胆囊收缩素,并延缓胃排空从而延长饱食感,该组合物含有:
a)葡甘露聚糖,
b)仙桃,
c)微晶纤维素。
已经发现,将经冷冻干燥的胶浆混合物加入本发明的组合物中可增加其胃肠膨胀特性。
仙人掌属植物(仙桃)或仙人掌类植物(Nopal)为来源于美洲热带的仙人掌。其活性成分存在于叶状茎中,由黏性物质、纤维、蛋白质和矿物盐构成。在墨西哥传统医学中,基于仙人掌属植物的叶片的制剂用于治疗糖尿病。近来,大量研究论证了其降血糖活性、对其它代谢紊乱如肥胖症和高脂血的有益作用、食饱效应以及抗炎、消化和止痛性质。活性成分由从至少4年生植物采摘的脱水叶状茎的肉质构成;去刺后,将叶状茎切为薄片,干燥至全干,最后切碎为所需的微粉。干燥的产品为细的淡绿色粉末。这是一种全天然原料,它由于膳食纤维含量高而对饮食综合平衡非常有意义。
葡甘露聚糖是一种可溶性膳食纤维,由亲水胶体多糖构成,所述多糖基于通过β1-4键彼此连接的D-葡萄糖和D-甘露糖残基。葡甘露聚糖通过碾碎魔芋(Amorphophallus konjac)的块茎而获得,魔芋仅生长于特定区域如中国和日本,是这些国家的传统食品。
纤维素是不溶性纤维的来源,由纤维素浆在酸性条件下水解获得。它由葡萄糖分子通过β1-4键结合形成的线形聚合物构成,不被肠内的酰胺水解酶所攻击。它高度不溶,代表谷糠的主要组分。
黏胶质属于水溶性纤维,此处来自于亚麻科(亚麻(Linumusitatissimum))种属的可食用种子以及锦葵科(药蜀葵)和椴树科(椴树(lime))的根、叶和花。通过活性成分的水性提取和之后的冷冻干燥得到的冷冻干燥提取物特别富含水溶性纤维,尤其是黏胶质。
更具体而言,本发明涉及的药用、营养医用、食品和营养组合物含有以下浓度范围的各种成分:
a)来自魔芋的葡甘露聚糖,30至70%;
b)仙桃,10至50%;
c)微晶纤维素,20至50%。
根据优选的方面,仙桃以脱水的茎浆形式存在。
根据优选的方面,本发明的组合物还含有浓度在1-10%之间的黏胶质。
根据优选的方面,黏胶质混合物由来自亚麻种子(Linum usitatissimum)、药蜀葵根(Althea officinalis)和椴树花(阔叶椴(Tilia platyphyllos))的冷冻干燥黏胶质构成。
本发明组合物的各组分具有如下特性:
-葡甘露聚糖能水合和膨胀,形成在酸性条件下稳定的高粘度凝胶状水溶液。粘度增加影响胃排空时间,导致饱食感延长。
-纤维素产生“压载效应”,粪便重量增加,肠内转运速率增加,管腔内结肠压力增加,并且脂肪球和胆汁盐(它们被捕获保留在纤维网格中)吸收减少。
-仙桃含有在酸性条件下可提高其粘度的水溶性纤维(尤其是果胶),以及不溶性纤维(尤其是纤维素和半纤维素)。
-亚麻、椴树和药蜀葵黏胶质还能水合并形成类似凝胶的系统。
在酸性环境下,仙人掌属植物形成比在中性pH下倾向于形成的纤维素材料的网格更大的网格。该网格的膨胀在结构上还涉及葡甘露聚糖、黏胶质和纤维素纤维,这提高了每种组分的表面并从而增加了保水位点,导致WBC协同作用。纤维复合物所占体积和所保留的水分增加。
因此,就膨胀指数和WBC而言,本发明的组合物由于组合物组分之间的协同作用而表现出比各组合组分单独实施后所获得的效果总和更大的效果。
当各组分采取以下比例时,产生了特别令人感兴趣的协同作用,即,与单独组分贡献的综合相比,膨胀指数高150%,WBC高140%:
a)来自魔芋的葡甘露聚糖 40±5%
b)仙桃的脱水茎浆 27±5%
c)微晶纤维素 30±5%
d)黏胶质混合物 3±2%
这样,根据一个特别优选的方面,本发明的组合物含有上述比例的各组分。
本发明的组合物提供了比由单独组分的加和所获得的那些更大的WBC和膨胀指数值,产生更大体积的粘性凝胶系统,该系统使纤维对胃肠系统产生有益作用。由于胃延伸,膨胀作用产生饱食感瞬间增加(由于迷走神经的直接刺激)和胆囊收缩素释放(胃和小肠上部分泌的局部激素),这两者延缓胃排空并延长饱食感。纤维的保水能力(WBC)还增加肠内容物体积,降低营养物的吸收速率。因此,主餐前数分钟摄入本发明的组合物有助于减少/减弱胃的饥饿感并导致肠内食物的吸收率低。
本发明的组合物可配制成适于口服施用的形式,可根据制药工艺学公知的常规方法、采用适于最终用途的赋形剂、稀释液、填充剂和抗结块剂来制备,所述方法例如“Remington’s Pharmaceutical Handbook”(Mack出版公司,N.Y.,USA)中所述。这些制剂的实例包括片剂、可咀嚼片剂、食物棒和混悬液等。
本发明的组合物还可含有具有补偿或其它有用活性的额外成分。这些成分的实例是来源于植物如菊苣的粉末和/或提取物以及精油如大茴香子和小茴香。
下文给出了本发明组合物的一些实施例。
实施例1-组合物A
成分 | % |
葡甘露聚糖 | 41.7 |
微晶纤维素 | 30.8 |
仙桃 | 27.5 |
实施例2-组合物B
成分 | % |
葡甘露聚糖 | 40.8 |
微晶纤维素 | 30.2 |
仙桃 | 26.8 |
冷冻干燥黏胶质的混合物 | 2.2 |
实施例3-680mg片剂的组合物
成分 | |
来自魔芋块茎的葡甘露聚糖 | 258.4mg |
微晶纤维素 | 191mg |
仙人掌属植物的茎浆粉末 | 170mg |
亚麻种子,冷冻干燥黏胶质 | 4.8mg |
椴树花,冷冻干燥黏胶质 | 4.8mg |
药蜀葵花,冷冻干燥黏胶质 | 4.8mg |
菊苣根菊粉 | 27.2mg |
调味剂 | 17mg |
小茴香精油 | 1mg |
大茴香子精油 | 1mg |
实施例4-4g袋装组合物
成分 | |
来自魔芋块茎的葡甘露聚糖 | 1.02g |
微晶纤维素 | 755mg |
仙人掌属植物茎浆粉末 | 670mg |
亚麻种子,冷冻干燥黏胶质 | 18.3mg |
椴树花,冷冻干燥黏胶质 | 18.3mg |
药蜀葵花,冷冻干燥黏胶质 | 18.3mg |
麦芽糖糊精合剂 | 1g |
调味剂 | 0.5g |
本发明的组合物接受保水能力(WBC)和膨胀指数测试。
1.保水能力测试
WBC的测定使得评价单种原料或原料混合物在酸性环境(类似于胃环境)下结合的水量成为可能。
方法:将20g pH=2(用HCl酸化)的溶液加入0.5g干物质中。搅拌至获得均一混悬液,然后静置30分钟,使水被物质吸收并因此膨胀。混悬液于4000RPM离心30分钟,从上清液中分离出片状沉淀物。保水能力等于片状沉淀物重量减去空白所保留的水量。所得的值除以无水样品的总重量。结果如表1所示。
表1
样品 | 代表符号 | WBC(g/g)实测值 | WBC(g/g)理论值 | 协同 |
葡甘露聚糖 | A | 18.85 | ||
微晶纤维素 | B | 2.3 | ||
仙桃 | C | 3.2 | ||
亚麻种子,冷冻干燥黏胶质 | D | 6.5 | ||
药蜀葵花,冷冻干燥黏胶质 | E | 1 | ||
椴树花,冷冻干燥黏胶质 | F | 2.7 | ||
组合物A | G | 21 | 9.5 | +121% |
组合物B | H | 23 | 9.4 | +144% |
2.膨胀指数
根据官方药典第11版的方法在中性pH的去离子水中进行测定。原料的细分程度将在后期产品中呈现。膨胀指数为1g活性成分、包括所粘附的黏胶质在水液体中放置4小时溶胀后所占的体积毫升数。结果如表2所示。
表2
样品 | 代号 | 活性成分的量 | 溶剂量 | 实测膨胀指数 | 理论膨胀指数 | 协同 |
葡甘露聚糖 | A | 1g | 100ml | 75 | ||
仙人掌属植物 | B | 1g | 100ml | 20 | ||
纤维素 | C | 1g | 100ml | 0 | ||
冷冻干燥黏胶质混合物 | D | 1g | 100ml | 0 | ||
组合物A | E | 1g | 100ml | 89 | 37 | +140% |
组合物B | F | 1g | 100ml | 96 | 37 | +160% |
Claims (8)
1.用于调节体重的药用、营养医用、食品和营养组合物,该组合物含有下列浓度范围的作为仅有的膳食成分的:
a)葡甘露聚糖,30至70%;
b)仙桃(Opuntia ficus indica),10至50%;
c)微晶纤维素,20至50%。
2.如权利要求1所要求的组合物,其中所述葡甘露聚糖来自魔芋(Amorphophallus konjac)。
3.如权利要求1所要求的组合物,其中各组分具有下列浓度范围:
a)来自魔芋的葡甘露聚糖,40±5%;
b)仙桃,27±5%;
c)微晶纤维素,30±5%。
4.如权利要求1-3任一项所要求的组合物,其中仙桃以脱水茎浆的形式存在。
5.如权利要求1-3任一项所要求的组合物,还含有由来自亚麻(Linumusitatissimum)种子、药蜀葵(Althea officinalis)根和阔叶椴(Tilia platyphyllos)花的冷冻干燥黏胶质构成的冷冻干燥黏胶质混合物。
6.如权科要求5所要求的组合物,其中冷冻干燥黏胶质混合物的浓度为1至10%,并且各组分含量之和为100%。
7.如权利要求6所要求的组合物,其中冷冻干燥黏胶质混合物的浓度为3±2%。
8.下列浓度范围的下述成分作为仅有的膳食成分在制备用于调节体重的药用、营养医用、食品和营养组合物中的用途:
a)葡甘露聚糖,30至70%;
b)仙桃,10至50%;和
c)微晶纤维素,20至50%;以及任选的
d)由来自亚麻种子、药蜀葵根和阔叶椴花的冷冻干燥黏胶质构成的冷冻干燥黏胶质混合物。
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IT000010A ITMI20050010A1 (it) | 2005-01-05 | 2005-01-05 | Composizioni farmaceutiche nutraceutiche dietetiche nutrizionali a base di fibre vegetali |
ITMI2005A000010 | 2005-01-05 |
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US (1) | US7410660B2 (zh) |
EP (1) | EP1679009B8 (zh) |
CN (1) | CN1853666B (zh) |
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HK (1) | HK1093904A1 (zh) |
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CA2564632C (en) | 2004-05-10 | 2019-06-18 | Den Kgl. Veterinaer - Og Landbohojskole | Flaxseeds for body weight management |
EP2190303A1 (en) | 2007-09-12 | 2010-06-02 | Københavns Universitet | Compositions and methods for increasing the suppression of hunger and reducing the digestibility of non-fat energy satiety |
EP2057994A1 (de) * | 2007-11-06 | 2009-05-13 | Finzelberg GmbH & Co. KG | Feigenkakteen-Extraktzubereitung |
ES2667033T3 (es) | 2011-03-01 | 2018-05-09 | Nestec S.A. | Viscosidad extensional para favorecer una deglución segura de los bolos de alimentos |
DE102011084162A1 (de) * | 2011-10-07 | 2013-04-11 | BIO-Garten GmbH & Co. KG | Pflanzliche Zubereitung |
WO2013087916A1 (en) * | 2011-12-15 | 2013-06-20 | Nestec S.A. | Extensional viscosity to promote safe swallowing of food boluses |
GB2501242A (en) * | 2012-03-23 | 2013-10-23 | Ajit Ramanial Patel | A composition for the treatment of obesity |
US9897565B1 (en) | 2012-09-11 | 2018-02-20 | Aseko, Inc. | System and method for optimizing insulin dosages for diabetic subjects |
US9171343B1 (en) | 2012-09-11 | 2015-10-27 | Aseko, Inc. | Means and method for improved glycemic control for diabetic patients |
CN103416598B (zh) * | 2013-07-04 | 2014-07-02 | 新疆农业大学 | 一种微囊包被卵黄源胆囊收缩素抗体的制备方法 |
US9486580B2 (en) | 2014-01-31 | 2016-11-08 | Aseko, Inc. | Insulin management |
US9233204B2 (en) | 2014-01-31 | 2016-01-12 | Aseko, Inc. | Insulin management |
US11081226B2 (en) | 2014-10-27 | 2021-08-03 | Aseko, Inc. | Method and controller for administering recommended insulin dosages to a patient |
WO2016069475A1 (en) | 2014-10-27 | 2016-05-06 | Aseko, Inc. | Subcutaneous outpatient management |
RS64061B1 (sr) | 2014-11-26 | 2023-04-28 | Omega Pharma Innovation And Dev Nv | Kompozicija dijetalnih vlakana |
US9886556B2 (en) | 2015-08-20 | 2018-02-06 | Aseko, Inc. | Diabetes management therapy advisor |
CN116075240A (zh) * | 2020-08-26 | 2023-05-05 | 阿波卡-阿格里科拉共同股份公司 | 用于治疗代谢综合征的具有新兴特性的新系统 |
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TW200637566A (en) | 2006-11-01 |
DE602005009123D1 (de) | 2008-10-02 |
TWI429445B (zh) | 2014-03-11 |
CN1853666A (zh) | 2006-11-01 |
EP1679009B1 (en) | 2008-08-20 |
ES2313197T3 (es) | 2009-03-01 |
PT1679009E (pt) | 2008-11-18 |
EP1679009B8 (en) | 2008-10-08 |
US7410660B2 (en) | 2008-08-12 |
ATE405177T1 (de) | 2008-09-15 |
ITMI20050010A1 (it) | 2006-07-06 |
US20060147560A1 (en) | 2006-07-06 |
PL1679009T3 (pl) | 2009-04-30 |
EP1679009A1 (en) | 2006-07-12 |
HK1093904A1 (en) | 2007-03-16 |
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