CN1953670A - 组合物、组合物的用途以及治疗肥胖症的方法 - Google Patents
组合物、组合物的用途以及治疗肥胖症的方法 Download PDFInfo
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- CN1953670A CN1953670A CNA2005800153970A CN200580015397A CN1953670A CN 1953670 A CN1953670 A CN 1953670A CN A2005800153970 A CNA2005800153970 A CN A2005800153970A CN 200580015397 A CN200580015397 A CN 200580015397A CN 1953670 A CN1953670 A CN 1953670A
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Abstract
本发明涉及食物许可的乳化剂在制备旨在阻止脂肪吸收的制品中的用途、含有用于阻止脂肪吸收的乳化剂的营养组合物和其特征在于含有有效量的食物许可的乳化剂的功能性食物。
Description
发明背景
肥胖症正在成为世界上最严重的健康问题。WHO世界健康组织估计患有肥胖症的人数已超过3亿。
在美国，官方估计成年人群体中的肥胖人(体重指数＞30)比例是27％。超重人(体重指数25到30)比例约占成年人群体的33％(NCCDPHP2003)。这在芬兰也是重大的健康问题：五分之一的成年人超重。工业化国家的肥胖人数在大约20年中增加了一倍，并且该趋势没有转变的迹象(WHO 2003)。肥胖的根本原因在于减少的体育活动和营养物中增加的或不变的能量。
在营养物中脂肪含有最多的能量，而且随着进化，人们不仅将其作为能量来源，而且还由于其美味而愈加地看重脂肪。在几乎所有的工业化国家中，营养物中的脂肪含量超过推荐量。脂肪的持续过度的摄取不仅伴随着肥胖损害美观，而且还产生严重的健康问题和涉及疾病如心血管疾病、呼吸疾病和糖尿病的并发症。还有伴随着上述全国性疾病的大量费用。
防止过多脂肪的不利影响的最优选方法是增加锻炼和调整获取自食物的能量。可以通过例如执行严格的饮食、使用低脂肪制品或者阻止对食物能量的全额度利用以减少能量摄取。
减少食品中的脂肪含量的目标对食品工业提出新的挑战。WHO和食物加工工业已经启动关于开发更健康的未来食品的公开讨论。其它专家机构也增加了对工业的压力(如IASO 2003)。结果一些食品公司已经制定了关于在产品中提高脂肪质量和减少其含量的目标。
能量降低的脂肪混合物在例如国际专利公布WO 00/15043中描述，且首批该类的脂肪组合物正在进入市场。然而，在欧洲，包括花费数年的批准程序的严格立法使该过程减慢。
对于过度脂肪问题的更有效的解决方案是阻止脂肪吸收。对于胆固醇，基于此想法的解决方案包括例如基于植物甾醇和植物甾烷醇的方法，例如在国际专利公布WO 03/026672中所述的方法。
例如，美国专利公布US 5,453,282公开了用于阻止脂肪中主要组分三酰基甘油(TAG)吸收的含有脱乙酰壳多糖的营养物，但是，暂时，最有效的阻止仅通过药物疗法获得成功。公开于欧洲专利EP 129748的处方药奥利司他(orlistat)(四氢利普司他汀)可以用于减少30％的三酰基甘油的吸收(Zhi等人，1994)。
然而，使用奥利司他的问题在于它的相对的无效性和涉及药物疗法需要拜访医师的事实。
通过功能性食物实现阻止脂肪吸收将成为对这一严重的国际公认问题的极为令人关注的解决方案。
发明简述
目前已意外地观察到食物许可的乳化剂几乎完全阻止从消化道吸收脂肪。因此，本发明涉及乳化剂在制备旨在阻止脂肪吸收的产品中的用途。在该类产品制备中使用食物许可的乳化剂满足由官方制定的安全性要求，因而使功能性食物的制备满足规章。这样的制品是已证实几乎完全地阻止人类脂肪吸收的首批功能性食物。
本发明还涉及用于阻止脂肪吸收的食物组合物，其中乳化剂选自脱水山梨糖醇衍生物、聚氧乙烯山梨糖醇衍生物、脂肪酸蔗糖酯和其它脂肪酸衍生物。
本发明还涉及特征为包含了有效量食物许可的乳化剂的功能性食物。
本发明还涉及包含有效量的乳化剂的药物组合物，所述乳化剂选自脱水山梨糖醇衍生物、聚氧乙烯山梨糖醇衍生物、脂肪酸蔗糖酯和其它脂肪酸衍生物。
本发明还涉及乳化剂在制备旨在阻止脂肪吸收的药物产品中的用途。
本发明还涉及用于预防、治疗或减轻肥胖症的方法和减少与肥胖症相关的患病风险的方法，所述方法的特征在于向患有肥胖症的人或动物施用这样的制品，所述制品含有用于阻止脂肪吸收的有效量的药物可接受的乳化剂和任选的其它药物可接受的添加剂和载体。
本发明优选的实施方案描述在从属权利要求中。
附图简述
下面将参考附图对本发明优选的实施方案进行详细描述，其中
图1显示在摄入测试产品A后0到6小时期间从受试者血浆测量的TAG浓度；
图2显示在摄入测试产品B后0到6小时期间从受试者血浆测量的TAG浓度；
图3图示受试者吸收的脂肪量，表达为iAUC值；且
图4图示所吸收的脂肪量，表达为每种测试产品的百分数。
发明详述
本发明基于令人惊奇的观察结果，即食物许可的乳化剂几乎完全地阻止从消化道的脂肪吸收。上述观察结果从这样的临床试验获得，所述临床实验的目的是找出不同的疗法和制剂如何影响有价值脂肪的吸收。
因此本发明涉及将食物许可的乳化剂作为食物产品中的添加剂或成分的用途，作为营养添加剂或药物制品的用途，以实现增进健康的效果(即部分或全部的阻止脂肪的吸收)。
在本文中，食物许可的乳化剂指可作为食物添加剂的化合物、去垢剂、乳化剂或稳定剂。在根据本发明的用途中，优选的食物许可的乳化剂包括式I的脱水山梨糖醇衍生物。
其中
w+x+y+z＝约20，或w、x、y和z＝0，
且R是H、OOC-(CH2)10-CH3、OOC-(CH2)14-CH3、OOC-(CH2)7-(CH)2-(CH2)7-CH3或3XOOC-(CH2)16-CH3。
特别优选脱水山梨糖醇衍生物，例如脱水山梨糖醇一硬脂酸酯(E491)、脱水山梨糖醇三硬脂酸酯(E 492)、脱水山梨糖醇一月桂酸酯(E493)、脱水山梨糖醇一油酸酯(E 494)和脱水山梨糖醇一棕榈酸酯(E 495)，或不同的聚氧乙烯脱水山梨糖醇衍生物，例如聚氧乙烯脱水山梨糖醇一月桂酸酯(E 432)、聚氧乙烯脱水山梨糖醇一油酸酯(E 433)、聚氧乙烯脱水山梨糖醇一棕榈酸酯(E 434)、聚氧乙烯脱水山梨糖醇一硬脂酸酯(E435)和聚氧乙烯脱水山梨糖醇三硬脂酸酯(E 436)。根据本发明特别优选的乳化剂是脱水山梨糖醇一油酸酯(E 494)。
其它优选的食物许可的乳化剂包括脂肪酸的蔗糖酯(E 473)和其它脂肪酸衍生物，例如(脂肪酸衍生的)钠盐、钾盐和钙盐(E 470a)、镁盐(E 471)、单酸甘油酯和二脂酰甘油酯(E 471)、单酸甘油酯和二脂酰甘油酯的乙酸酯(E 472a)、单酸甘油酯和二脂酰甘油酯的乳酸酯(E 472b)、单酸甘油酯和二脂酰甘油酯的柠檬酸酯(E 472c)、单酸甘油酯和二脂酰甘油酯的酒石酸酯(E 472d)、单酸甘油酯和二脂酰甘油酯的单乙酰和二乙酰酒石酸酯(E 472e)以及单酸甘油酯和二脂酰甘油酯的乙酸和酒石酸酯的混合物(E 472f)。根据本发明特别优选的脂肪酸衍生物乳化剂包括脂肪酸蔗糖酯。
本发明的营养组合物是已证实几乎完全地阻止人或动物的脂肪吸收的首批功能性食物。
本文中的“功能性食物”指已证明不仅具有常规的营养特征、还以增进健康或降低疾病风险的方式对有机体的一种或多种功能具有积极影响的营养物/食物产品。
根据本发明的功能性食物可以是向其加入了本发明的乳化剂的任意食物产品，但是优选的食物产品包括饮料和其它液体食物产品，例如果汁、乳品饮料、麦片粥、汤和调味料。含脂肪的食物产品或食物产品成分的实例(可向其中加入食物许可的本发明的乳化剂)包括用于烘焙或其它用途的脂肪乳剂、仿乳油制品、冰淇淋、乳化调味料(例如汉堡调味料、沙拉调味料和沾料)、热加工的肉制品(如加热的汉堡)和不同的巧克力。本发明的功能性食物还包括含脂肪的食物产品，如馅饼、饼干、薯片、汉堡和巧克力，在这些制品中使用上述含脂肪的乳剂。对于本领域技术人员而言其它的优选的使用形式是显而易见的，且以上实例并非意在限制本发明范围之外的其它应用。
向本发明的营养物组合物加入可获得期望效果的量的食物许可的乳化剂。有效量可取决于所述食物产品的组成和每次摄入的上述食物产品的剂量大小而明显变化。乳化剂的有效量还可以根据所用的乳化剂、食物产品和摄取的食物产品的量而变化。乳化剂的有效量是0.1到100g/kg食物产品，优选1到25g/kg，且最优选5到10g/kg。
根据本发明优选的使用形式是在正常营养物之外单独消化摄入的功能性食品，例如作为快餐或“能量饮料”。
还可以通过将本发明的乳化剂作为单独的增补剂摄入而实现有效阻止脂肪吸收。本发明的增补剂可以是例如含有有效量本发明的乳化剂的胶囊。胶囊可以是软胶囊或硬胶囊，且胶囊化材料选自明胶、琼脂、淀粉、修饰淀粉、修饰的淀粉末、鹿角菜、糖，特别是蔗糖、乳糖或果糖。
如果将本发明的营养组合物作为正常营养物之外的增补剂消化，每次摄入剂量中乳化剂的优选量大于1mg、优选1到10000mg、更优选100到5000mg、更加优选500到5000mg、且最优选2000mg。这些优选量相当于0到65mg/kg人重，最优选约25到60mg/kg。在上述参考值和实施例中所述实验的基础上，食物产品领域熟悉营养物的技术人员可以容易地确定获得期望效果所需乳化剂的有效量。
本发明还涉及药物组合物，该药物组合物取决于所用的乳化剂可以是片剂、胶囊、溶液或乳剂。可以使用常规方法制备本发明的药物组合物。本发明的药物剂型可以是例如含有有效量的本发明乳化剂的胶囊。胶囊可以是软胶囊或硬胶囊，胶囊化材料选自明胶、琼脂、淀粉、修饰淀粉、修饰的淀粉末、鹿角菜、糖，特别是蔗糖、乳糖或果糖。
可以使用常规方法制备本发明含乳化剂的药物制品(见例如Remington’s Pharmaceutical Sciences，16卷，1990)。每单位乳化剂的治疗有效量根据所期望的效果可以是1到10000mg、优选100到5000mg、更优选500到5000mg、且最优选2000mg。除乳化剂之外，本发明的药物制品还可以包括在本领域常用的其它添加剂和载体，例如药物可接受的植物油，如石蜡油、粕酒油、芝麻油、橄榄油、酱油和杏仁核油。
本发明还涉及在所需动物或人中阻止脂肪从消化道部分或全部吸收的方法，其方法是施用有效量的含有食物许可的乳化剂的本发明的营养组合物或药物组合物。本发明的方法实现美容的或治疗的体重控制，并由此预防对与过度使用脂肪相关的健康危险或疾病，或降低患病风险。可以通过摄入本发明的功能性食物代替部分的正常营养物(通过摄入除正常含脂肪营养品之外的功能性食物，例如一剂饮料)，或者通过摄入单独的增补剂(例如以胶囊形式)作为对正常营养物的补充来实施根据本发明的治疗。
与每餐有关的即每日三次的有效单剂量是500mg/剂，该剂量可实现对脂肪吸收所期望的阻止。
实施例
实施例1
含乳化脂肪的测试产品的制备
饮料(产品A)
成分 ％
1.水 72.81
2.浓缩果汁混合物 9.13
3.柠檬酸 0.01
4.蔗糖 7.03
5.黑醋栗香料 0.07
6.黑醋栗籽油 9.98
7.E494 0.98
8.维生素A 2800IU/100g
9.维生素E 20IU/100g
制备：
根据标准的工业制备方法将成分1到5混合。在剧烈搅拌下将成分6、7、8和9加入到产品中。
燕麦片饮料(产品B)
成分 g ％
1.水 70.00 67.6
2.燕麦片 10.00 9.7
3.酸化剂 0.10 0.1
4.油菜籽油 0.45 0.4
5.浆果制品* 12.00 11.6
6.黑醋粟籽油 9.97 9.6
7.E494 0.98 0.9
8.维生素A 2800IU/100g
9.维生素E 20IU/100g
*)包含6％的果糖、浆果浆、果胶、香料
制备：
根据标准的工业制备方法将成分1到3混合并酸化。将成分4和5混合加入到酸化的产品中。在剧烈搅拌下将成分6、7、8和9加入到产品中。
根据以上说明制备对照产品，但不含有成分7。
实施例2
乳化的植物油在人体中的吸收
临床试验目的是研究来自不同营养制品的一些植物油的吸收。在实验中向健康人受试者给予含油的测试产品。从受试者收集血液样品并进行脂肪分析，基于该分析定量地评估油的吸收。
在实验开始前，实验的研究计划得到西南芬兰区医院伦理委员会的同意。对于产品及其摄入次序随机选择受试者。在实验当天早上，受试者摄入实施例1的测试产品(产品A)。摄取量与受试者的体重成比例，从而乳化剂的量约为65mg/千克体重。因此，测试产品平均的单剂量为490ml。对照组的受试者摄入相应的不含乳化剂的含油产品(产品A0)。接下来的6小时中受试者在实验室于监视下度过，并从每个受试者采集共7份血液样品。分别于测试样品摄入前和摄入后的30、60、180、270和360分钟收集血液样品。在实验第二天联系受试者，以查明是否有任何急性副反应。第二次实验(Experimental day 2)在2到4周之后进行，除了摄入的测试产品外实验安排相同。
收集的样品立即用于分析，或者被分级并冷冻等待用于稍后进行的分析。特别地研究了乳糜微粒的组分，因为其中含有的脂质直接反映从膳食吸收的脂肪和脂溶性化合物。通过超速离心从血浆分离乳糜微粒，并通过微型硅胶柱将乳糜微粒进一步分级为脂肪酸和磷脂级分。使用气相色谱分析级分中的脂肪酸。用SPSS软件对结果进行统计观察。
酶促检测血浆中的三酰基甘油含量表明没有乳化油的吸收。该结果非常出人意料，因为看起来似乎吸收是被完全地阻止了。
对乳糜微粒进行的TAG分析给出了相同的结果。因此，含有乳化油的测试产品A根本未被吸收。
维生素E和维生素A作为棕榈酸视黄酯(其溶解方式与脂肪相同)被加入到测试产品中。它能够使脂肪得以吸收，并且在一定程度上能够使血液循环中的乳糜微粒数(即从血液循环中排出的脂肪)得以监测。在给予含乳化剂产品的受试者样品中不能检测到维生素E和A。该结果进一步支持乳化油产品根本未被吸收这一令人惊奇的观察结果。
测试产品不含胆固醇。然而，在产品A和A0之间观察到胆固醇值的明显差异。因为脂肪吸收影响有机体自身的胆固醇代谢，该结果进一步支持乳化油不可吸收的观察结果。
实施例3
乳化剂剂量对脂肪吸收的影响
在本实验中，受试者摄入不同量的含乳化剂产品。测试产品是实施例1所制备的产品A和B，其中E494的量为0.1％(A1和B1)、0.4％(A2和B2)、0.98％(A3和B3)或0％(A0和B0)。实验和取样安排如实施例2所述。
测试产品的摄入量与受试者体重成比例，从而乳化剂剂量按表1所示。因而平均的单剂量是490ml。
表1
| 测试产品 | g/m2皮肤 | g/kg体重 |
| A0A1A2A3 | 00.251.02.5 | 06.52565 |
| B0B1B2B3 | 00.251.02.5 | 06.52565 |
图1显示了摄入测试产品A的受试者在0到6小时期间的血液脂肪值，而图2是摄入测试产品B的受试者的血液脂肪值情况。图3是显示在图1和2的曲线下保留面积(iAUC)的柱形图，iAUC是个体吸收脂肪量的指标，并在该领域被普遍使用。如图所示，本实施例所用的剂量水平对于产品A而言具有线性效果。关于产品B，所述效果在全部剂量水平上可见，但是在B1和B2水平的效果是等同的。这说明在剂量应答曲线存在可能的平台。已经在更低的剂量水平清楚地证明了测试产品阻止脂肪吸收的效果。
图4显示所实现的阻止脂肪吸收的程度与乳化剂的剂量成比例(100％＝B0和A0，B0和A0根本不含任何乳化剂)。
关于产品B，较低的总水平可能是由于产品更为复杂(例如含有蛋白质和复合碳水化合物)，由此对脂肪吸收的效果不象产品A那样强。另一方面，产品B所显示出的效果表明本发明的功能性食物实现了期望的效果。
对于本领域技术人员显而易见的是，随着技术提高，本发明的基本概念能够以多种方法实现。因此，本发明及其实施方案并不限制于上述实施例，而是可以在权利要求的范围内改变。
参考文献
Zhi J；Melia A T；Guerciolini R；Chung J；Kinberg J；Hauptman H B；Patel I H.Retrospective population-based analysis of the dose-response(fecal fat excretion)relationship of orlistat in normal and obese volunteers.Clinical Pharmacology And Therapeutics 1994，56(1)，82-5.
NCCDPHP(National Center for Chronic Disease Prevention and HealthPromotion)，29.8.2003 11:00 GMT.
http://www.cdc.gov/nccdphp/dnpa/obesity/defining.htm
WHO，Technical Report Series 916.Diet，Nutrition and the Prevention ofChronic Diseases.Geneva 2003.
IASO 2003，
http://www.iotf.org/media/iotfian29.htm
Claims (15)
1.用于阻止脂肪吸收的组合物，其特征在于含有有效量的食物许可的乳化剂。
2.如权利要求1所述的组合物，其特征在于食物许可的乳化剂选自脱水山梨糖醇衍生物、聚氧乙烯脱水山梨糖醇衍生物、脂肪酸蔗糖酯和其它脂肪酸衍生物。
3.如权利要求2所述的组合物，其特征在于食物许可的乳化剂选自脱水山梨糖醇一硬脂酸酯(E 491)、脱水山梨糖醇三硬脂酸酯(E 492)、脱水山梨糖醇一月桂酸酯(E 493)、脱水山梨糖醇一油酸酯(E 494)和脱水山梨糖醇一棕榈酸酯(E 495)。
4.如权利要求2所述的组合物，其特征在于食物许可的乳化剂选自聚氧乙烯脱水山梨糖醇一月桂酸酯(E 432)、聚氧乙烯脱水山梨糖醇一油酸酯(E 433)、聚氧乙烯脱水山梨糖醇一棕榈酸酯(E 434)、聚氧乙烯脱水山梨糖醇一硬脂酸酯(E 435)和聚氧乙烯脱水山梨糖醇三硬脂酸酯(E436)。
5.如权利要求2所述的组合物，其特征在于食物许可的乳化剂选自脂肪酸蔗糖酯(E 473)、钠盐、钾盐和钙盐(E 470a)、镁盐(E 471)、单酸甘油酯和二脂酰甘油酯(E 471)、单酸甘油酯和二脂酰甘油酯的乙酸酯(E 472a)、单酸甘油酯和二脂酰甘油酯的乳酸酯(E 472b)、单酸甘油酯和二脂酰甘油酯的柠檬酸酯(E 472c)、单酸甘油酯和二脂酰甘油酯的酒石酸酯(E 472d)、单酸甘油酯和二脂酰甘油酯的单乙酰和二乙酰酒石酸酯(E 472e)、以及单酸甘油酯和二脂酰甘油酯的乙酸和酒石酸酯的混合物(E 472f)。
6.如权利要求1到5中任一项所述的组合物，其特征在于所述组合物是食物产品。
7.包含如权利要求1到6中所述组合物的功能性食物。
8.如权利要求7所述的食物，其特征在于其中含有的乳化剂每摄入的单剂量是1到10000mg、优选100到5000mg、更优选500到5000mg、且最优选2000mg。
9.包含有效量的食物许可的乳化剂的药物组合物。
10.食物许可的乳化剂在制备旨在阻止脂肪吸收的产品中的用途。
11.如权利要求10所述的用途，其特征在于所述产品是药物。
12.如权利要求10所述的用途，其特征在于所述产品是食物增补剂。
13.如权利要求10所述的用途，其特征在于所述产品是功能性食物。
14.治疗肥胖症的方法，其特征在于向需要治疗的动物或人施用有效量的食物许可的乳化剂，所述乳化剂阻止消化道的脂肪吸收。
15.阻止脂肪从消化道吸收的方法，其特征在于向动物或人施用有效量的食物许可的乳化剂。
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