CN101686912A - 稀土元素用于减肥的用途 - Google Patents
稀土元素用于减肥的用途 Download PDFInfo
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- CN101686912A CN101686912A CN200880015722A CN200880015722A CN101686912A CN 101686912 A CN101686912 A CN 101686912A CN 200880015722 A CN200880015722 A CN 200880015722A CN 200880015722 A CN200880015722 A CN 200880015722A CN 101686912 A CN101686912 A CN 101686912A
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Abstract
本发明公开了稀土元素用于促进脂类分解、抗脂肪堆积、增加皮肤紧致度、或用于减肥的用途,该稀土元素选自由镧(La)、铈(Ce)、镨(Pr)、钕(Nd)、钷(Pm)、钐(Sm)、铕(Eu)、钆(Gd)、铽(Tb)、镝(Dy)、钬(Ho)、铒(Er)、铥(Tm)、镱(Yb)、镥(Lu)、钪(Sc)、钇(Y),它们的混合物、盐或氧化物组成的组。
Description
技术领域
[01]本发明涉及稀土元素用于减肥的用途。更具体地,涉及稀土元素用于促进脂类分解、抗脂肪堆积、增加皮肤紧致度、或用于减肥的用途,该稀土元素选自由镧(La)、铈(Ce)、镨(Pr)、钕(Nd)、钷(Pm)、钐(Sm)、铕(Eu)、钆(Gd)、铽(Tb)、镝(Dy)、钬(Ho)、铒(Er)、铥(Tm)、镱(Yb)、镥(Lu)、钪(Sc)、钇(Y),它们的混合物、盐或氧化物组成的组。
背景技术
[02]人体具有大约200亿个脂肪细胞。脂肪细胞在哺乳动物体中起到积聚或释放能量的作用。脂肪细胞调节能量的积聚与释放的机理很复杂。如果能量的供应对于在那里的需求来说非常过量,那么在细胞中会贮存甘油三酸酯,其降解为甘油和自由脂肪酸来消耗能量,直到能量用尽。当上述过程的失调导致过量能量被积聚时就会导致肥胖。肥胖通常是指由于脂肪细胞尺寸和数量的增加导致表皮层下皮下脂肪组织的异常肥大。它通常是当从食物中获取的卡路里不必要地多于转化成能量的卡路里时,由过量卡路里以脂肪的形式在人体中积聚而导致的。由于积聚在表皮层下的脂肪的厚度,它使身体发胖并失去美感,进一步地,引起各种成人疾病。与肥胖紧密相关的疾病包括:高血压、动脉硬化、脑血管疾病、高血脂、缺血性心脏病、缺氧、肺动脉高压、关节炎、脂肪肝、妊娠毒血症、糖尿病、疲劳、呼吸急促等等。人体中脂肪组织的增加给心脏供血到那里增加了负担,其升高了血压。脂肪组织的增加也导致人体中对胰岛素需求的增加,因此在胰腺产生胰岛素方面增加了额外的负担,最后长期降低胰腺胰岛素的可生产性和私密性(secretability)。因此,万一由于肥胖引起了高血压和糖尿病,通过减肥可以使血压降低,也可以使血糖得到控制。另外,已有报道肥胖会增加关节炎、痛风、呼吸功能障碍、不孕、月经不调、癌症例如肠癌和女性乳腺癌等等的频率。像这样,肥胖作为减少人类寿命的主要因素之一,已经被报道会导致各种成人疾病以及乳腺癌、子宫癌、结肠癌等等,现在被认为不治之症的一种。(J.Biol.Chem.,273,32487~32490(1998)和Nature,404,652~660(2000))。肥胖在世界范围内广泛蔓延,进一步地,出现在每一个年龄组包括儿童期、少男或少女期、青春期和成人期。
[03]脂肪堆积描述了一种由于过量的脂肪和废料积聚导致的循环障碍,皮肤变得像桔皮一样不平坦的状态。它只发生在女性皮肤和皮下脂肪。除了皮下脂肪组织的异常过量积聚,当由于淋巴系统异常,淋巴液贮存在内组织空间时也会发生脂肪堆积肥胖,因此在那个区域会出现一种水肿使其看起来像一个肿块。如果淋巴液贮存在内组织空间,就不仅仅是像肥胖一样的美观问题,而是毒性物质在人体中积聚,对表皮细胞有不利影响并抑制用于细胞滋养的离子化,从而不仅导致皮肤的老化,而且导致细胞的坏死。因此,为了防止脂肪堆积肥胖,需要排出贮存的淋巴液。如上所述,脂肪堆积与一般肥胖的成因不同,但基本上由脂肪细胞尺寸和数目的增加导致。因此,脂肪细胞中脂肪的分解和排泄可以为保持健康并使身体苗条光滑给予极大的帮助。
[04]目前,治疗肥胖的试剂主要分为作用于中枢神经系统以控制食欲和作用于肠胃道以抑制吸收。由于表现出副作用例如原发性肺动脉高压和心脏瓣膜损伤,以前使用的药物中许多已经被禁用。它们也表现出血压降低和乳酸性酸中毒,因此不能用来治疗心力衰竭和肾脏病的病人。最近,在用于减肥和抗脂肪堆积有效清除过量的皮下脂肪和增加皮肤紧致度的美容剂方面已经有持续增长的需求。已知的用于抑制和治疗肥胖的美容剂包括:咖啡因、胆茶碱、L-肉碱、它们表现出可以认可但不能令人满意的效果。PCT公开号WO04/093865第一次公开了茶氨酸,绿茶的味觉元素,可以促进脂类分解,类似于在美容剂领域已知的作为脂类分解正控制剂的咖啡因,但通过不同的机理。PCT公开号WO04/084885也公开了染料木黄酮和肉碱通过不同于茶氨酸或咖啡因的机理,可以有效地防止和抑制肥胖。
[05]稀土元素是微量金属元素,其在地壳中的含量约为0.016%,是指包括17种元素的矿物,15种元素的原子数从57到71(La,Ce,Pr,Nd,Pm,Sm,Eu,Gd,Tb,Dy,Ho,Er,Tm,Yb,Lu)和2种元素在元素周期表中的3A族元素(Sc,Y)。它们以元素混合物的形式存在,物理和化学性质非常相似,分离成单独的元素复杂,但利用互相之间的微小差别可能分离。稀土元素可以以盐的形式存在,其中它与其反荷离子形成离子键,例如以硫酸盐、硝酸盐、碳酸盐、醋酸盐、磷酸盐、盐酸盐的形式等等,或者以氧化物包括氢氧化物的形式存在。稀土元素非常有用,即使它们只在两百年前被发现,且仍然不为公众熟知。因为稀土元素由于它们单一的电子结构而具有单一的物理和化学作用,所以它们已经被用于机械、石油化学、光化学等等,作为永磁体、超导体或荧光基团,并且最近已经被试着应用到农业、林业、畜牧业、工业等各个领域。此外,作为生物效应,稀土元素在高等植物中促进光合作用和叶绿素的生产;促进茎干形成;增强根的生命力;激活呼吸作用;促进植物体中营养素传输;控制湿度;促进细胞分裂、激素转移、以及营养素的吸收和传输;激活新陈代谢;增加在叶子中蛋白质和RNA的合成等等。另外,它们延缓叶子的衰老,增加绿藻中蛋白质含量,通过促进光合作用和氧气释放活性来促进蛋白质和叶绿素的合成。已知La3+用于增强人类红细胞细胞膜上(Na+,K+)-三磷酸腺苷酶和Mg2+-三磷酸腺苷酶的活性,因此,增强了人体中Ca2+的功能(The journalof Biological Chemistry,1986;261(20);9552-9557)。某些稀土元素已知具有抗菌活性(Chem.Pharm.Bull,2003;51(5);494-498)和通过组织反应性氧气类的产生的抗氧化活性(Biochemical and BiophysicalResearch Communication,2006;2;86-91)。它们也被知晓在饲养肥猪中用于增加重量和饲料转化率(FCR)(J.Anim.Physiol.a.Anim.Nutr.,2001;85;263-270)。此外,发现稀土元素是低毒性的,通过消化器官可以被非常少量地吸收,几乎不积聚在体内,并且不产生畸形、诱变或致癌(Environmental Health Perspectives,1996;104;85-95)。但是,既没有教导也没有建议稀土元素、其盐或氧化物、或其混合物可以通过促进脂类分解、消除脂肪堆积或增加皮肤紧致度来表现出减肥效果。
发明内容
技术问题
[06]考虑到肥胖的成因,本发明人注意到为了解决肥胖问题来减少体内脂肪是极难的,而不是仅仅地体重减少,因此必须找出一个方法来分解积聚在人体中的不必要的脂肪和激活它的氧化作用。然后,他们做了广泛的研究以找出对人体安全并能促进脂肪细胞中脂类分解和有效地增强脂肪氧化作用的成分。结果,他们发现一种或多种稀土元素可以有效地促进脂肪细胞中中性脂肪的分解,而且,包含一种或多种稀土元素的组合物可以通过优异的脂类分解促进活性、抗脂肪堆积和皮肤紧致度增强活性来降低皮下脂肪和脂肪堆积的厚度,从而极大帮助使得和保持皮肤和身体的苗条和紧致,这样,完成了本发明。
[07]因此,本发明的第一个目的是提供一种用于促进脂类分解、抗脂肪堆积、增强皮肤紧致度或用于减肥的组合物,包含一种或多种稀土元素作为活性成分。
[08]本发明的第二个目的是提供一种或多种稀土元素用于促进脂类分解、抗脂肪堆积、增强皮肤紧致度或用于减肥的用途。
[09]本发明的第三个目的是提供一种促进脂类分解、抗脂肪堆积、增强皮肤紧致度或减肥的方法,包括使用一种或多种稀土元素。
[10]本发明的第四个目的是提供通过使用一种或多种稀土元素来制备用于促进脂类分解、抗脂肪堆积、增强皮肤紧致度或用于减肥的试剂的方法。技术方案
[11]本发明的第一个方面涉及一种组合物,包括:选自由镧(La)、铈(Ce)、镨(Pr)、钕(Nd)、钷(Pm)、钐(Sm)、铕(Eu)、钆(Gd)、铽(Tb)、镝(Dy)、钬(Ho)、铒(Er)、铥(Tm)、镱(Yb)、镥(Lu)、钪(Sc)、钇(Y),它们的混合物、盐或氧化物组成的组的作为活性成分的稀土元素,用于促进脂类分解、抗脂肪堆积、增强皮肤紧致度或用于减肥。
[12]本发明的第二个方面涉及选自由镧(La)、铈(Ce)、镨(Pr)、钕(Nd)、钷(Pm)、钐(Sm)、铕(Eu)、钆(Gd)、铽(Tb)、镝(Dy)、钬(Ho)、铒(Er)、铥(Tm)、镱(Yb)、镥(Lu)、钪(Sc)、钇(Y),它们的混合物、盐或氧化物组成的组的稀土元素用于促进脂类分解、抗脂肪堆积、增强皮肤紧致度或用于减肥的用途。
[13]本发明的第三个方面涉及一种促进脂类分解、抗脂肪堆积、增强皮肤紧致度或为需要的目的减肥的方法,包括应用物质稀土元素的步骤,该稀土元素选自由镧(La)、铈(Ce)、镨(Pr)、钕(Nd)、钷(Pm)、钐(Sm)、铕(Eu)、钆(Gd)、铽(Tb)、镝(Dy)、钬(Ho)、铒(Er)、铥(Tm)、镱(Yb)、镥(Lu)、钪(Sc)、钇(Y),它们的混合物、盐或氧化物组成的组。
[14]本发明的第四个方面涉及一种制备用于促进脂类分解、抗脂肪堆积、增强皮肤紧致度或用于减肥的试剂的方法,包括使用选自由镧(La)、铈(Ce)、镨(Pr)、钕(Nd)、钷(Pm)、钐(Sm)、铕(Eu)、钆(Gd)、铽(Tb)、镝(Dy)、钬(Ho)、铒(Er)、铥(Tm)、镱(Yb)、镥(Lu)、钪(Sc)、钇(Y),它们的混合物、盐或氧化物组成的组的稀土元素。
附图说明
[15]图1是在老鼠脂肪细胞中混合的稀土元素脂类分解效果图。
[16]图2是在3T3 L1细胞线中混合的稀土元素脂类分解效果图。
[17]图3是本发明组合物在皮肤紧致方面的效果图;
[18]图4是混合的稀土元素口服后的重量变化图;
[19]图5是混合的稀土元素口服后的脂类分解效果图;
[20]图6是诱发肥胖动物保持高脂肪饮食组口服混合的稀土元素后的重量变化图。
[21]图7是诱发肥胖动物正常药片转变组口服混合的稀土元素后的重量变化图。
具体实施方式
[22]此后,将详细描述本发明。
[23]本发明所用的术语“减肥”不但是指从健康角度抑制肥胖症而且是指通过减少脂肪堆积使皮肤紧致光滑。
[24]稀土元素具有相似的物化性能,且用于本发明的稀土元素的种类没有特别的限制,并且任意一种稀土元素能够单独或者与其它稀土元素混合使用。只要药学或美容学可接受的稀土元素的盐是无毒的,它也可以使用。其中的实例包括但不仅限于硫酸盐、硝酸盐、碳酸盐、醋酸盐、磷酸盐、盐酸盐等。进一步地,只要药学或美容可接受的稀土元素的氧化物(例如,Ce2O3,La2O3等)是无毒的,它也可以无限制的使用。本发明中,稀土元素的氧化物包括稀土元素的氢氧化物(例如,Ce(OH)3、La(OH)3等)。
[25]为了本发明的使用,稀土元素可以被磨成细粉末,并且可以含有0.0001-20重量%的稀土元素,特别是0.001-1重量%。
[26]根据本发明的组合物促进细胞中中性脂肪的分解并且有选择地消除皮下脂肪,紧接着蔓延到皮肤,因此,有助于使身体变得苗条。进一步地,该组合物不但减少皮下脂肪或者腹内脂肪而且减少由女人脂肪堆积区域中的肥胖脂肪细胞引起的凹痕或肿块,对恢复皮肤的紧致和光滑显示了优异的抗脂肪堆积效果。具体地,本发明的组合物对人体没有伤害和有细微的皮肤刺激,因此可以安全的使用。也就是,当以前用于改善肥胖症的试剂是被动的试剂,只针对促进脂肪细胞分化或者脂类分解时,本发明的组合物是主动的试剂,分解脂肪细胞中形成的脂肪以及完全地消除分解产物阻止中性脂肪的重复累积,因此能够消退和抑制肥胖症。
[27]为了把本发明的组合物制成化妆品,可以用传统技术中的任意制剂制造。其中实例包括但不仅限于溶液、悬浮液、乳液、糊剂、凝胶、乳剂、洗液、粉末、肥皂、含表面活性剂的清洁剂、油、粉状粉底、乳液状粉底、蜡状粉底、喷雾等。更具体地,它可以制成吸水色粉(hydrating toner)、营养色粉(nutrition toner)、营养洗液(nutrition lotion)、按摩霜(message cream)、营养霜(nutrition cream)、浆液(serum)、眼霜(eyecream)、清洁霜(cleansing cream)、清洁泡沫(cleansing foam)、清洁水(cleaning water)、包(pack)、凝胶(gel)、喷雾(spray)或者粉末(powder)。本发明的化妆品组合物可以除含有活性成分外还含有传统化妆品成分。其中的实例包括传统的助剂或者载体例如防老剂、稳定剂、增溶剂、维生素、色素和香料。如果本发明的制剂是糊剂、霜或凝胶,动物油、植物油、蜡、石蜡、浆糊、西黄蓍胶、纤维素衍生物、聚乙二醇、有机硅、膨润土、硅胶、滑石粉或者氧化锌可以用作载体。如果本发明的制剂是粉末或者喷雾,乳糖、滑石粉、硅胶、氢氧化铝、硅酸钙或者聚酰胺粉末可以用作载体、具体地,对于喷雾,可以另外包含推进剂例如氯氟碳水化合物(chlorofluorohydrocarbon)、丙烷/丁烷、二甲醚。当本发明的制剂是溶液或者乳液,溶剂、增溶剂或者乳化剂例如水、乙醇、异丙醇、碳酸乙酯、醋酸乙酯、苯甲醇、苯甲酸苄酯、丙二醇、1,3-乙二醇丁油、甘油脂肪酯、聚乙二醇或者脱水山梨糖醇的脂肪酸酯可以用作载体。如果本发明的制剂是悬浮液,液体稀释剂例如水、乙醇或者丙二醇;悬浮剂例如乙氧基异硬脂醇(ethoxylated isostearyl alcohol),聚氧乙烯山梨糖醇酯和聚氧乙烯脱水山梨糖醇酯;微晶纤维素、偏氢氧化锂(aluminummetahydroxide)、膨润土、琼脂、西黄蓍胶等可以用作载体。如果本发明的制剂是含表面活性剂的清洁剂,可用的载体包括脂肪醇硫酸酯(aliphatic alcohol sulfate)、脂肪醇醚硫酸酯(aliphatic alcoholether sulfate)、磺基琥珀酸单酯、羟乙基磺酸盐、咪唑盐衍生物、甲基牛磺酸盐(methyltaurate)、肌氨酸盐、脂肪酸酰胺醚硫酸酯、烷基酰胺基甜菜碱(alkylamidobetaine)、脂肪醇、脂肪酸甘油酯、脂肪酸二乙醇酰胺、植物油、羊毛脂衍生物、乙氧基甘油脂肪酸酯等。
[28]如果本发明的组合物制成药用制剂,活性成分可以与一种或多种药学可接受的载体结合或者根据给药的目的制成口服制剂例如药片(tablets)、硬或软胶囊(hard or soft capsules)、颗粒(granules)、咀嚼片(chewable tablets)、药丸(pills)、粉末(powder)、酏剂(elixir)、悬浮液(suspension)、乳液(emulsion)、溶液(solution)和糖浆(syrup)或者注射给药制剂例如气雾剂(aerosol)、囊剂(sachet)、无菌注射溶液或无菌粉末(sterilized injectable solution or powder)。当本发明的活性成分制成用于口服的药片、胶囊、颗粒、咀嚼片、药丸、粉末、酏剂、悬浮液、乳液、溶液、糖浆等时,制剂可能含有粘合剂例如阿拉伯胶、玉米淀粉、微晶纤维素或明胶;赋形剂例如磷酸氢钙或乳糖;崩解剂例如海藻酸、玉米淀粉或土豆淀粉;润滑剂例如硬脂酸镁;甜味剂例如蔗糖或糖精;香精例如薄荷、水杨酸甲酯或水果香精。如果单位剂量形式是胶囊,除了含有上述载体,还可能含有液体载体例如聚乙二醇或脂肪油。以溶液或悬浮液形式用于注射(parenteral)给药的注射液可以注射给药,例如,皮下给药、静脉内给药、肌内给药或者腹膜内给药。通常,通过均匀混合有效量活性成分和具有一种或多种药学可接受的液体载体例如水、盐水、水性葡萄糖和相关糖溶液、不挥发油、乙醇、丙三醇、乙二醇例如聚乙二醇以及丙二醇制备可注射溶液或悬浮液。另外,如果有需要,可以包含一种或多种助剂例如抗生素、螯合剂、缓冲剂、防腐剂等。只要它们是药学惰性且基本无毒以及在活性成分的活性中没有有害作用,上述药学可接受的载体包括任意一种。
[29]除了上述药学试剂,通过混合本发明的组合物和碳酸饮料、矿泉水、酒精饮料、口香糖、焦糖、糖果、冰激凌、点心等或者通过在营养食品或含维生素或矿物质的健康添加物或者食品添加剂中含有本发明组合物,本发明的组合物还可以制成食物或食物添加物。
[30]本发明的组合物可以照惯例以0.1~10mg/kg的日剂量给药,但是该剂量可以根据病人的年龄、性别、饮食和健康状况、疾病的严重度、给药方法、给药时间以及药物的混合等适当的调整。
最佳实施方式
[31]此后,将结合实施例来具体描述本发明,但它们不能被认为是以任何方式来限定本发明的保护范围。
[32]实施例1:制备减肥和抗脂肪堆积组合物
[33]使用表1中所示的组分和含量,混合稀土元素粉末与其他组分均匀混合,然后,过滤混合物以制备洗剂形式的减肥和抗脂肪堆积组合物。制得的减肥和抗脂肪堆积组合物是肉色、透明的,pH为5.0-8.5。
[34]【表1】
[35]减肥或抗脂肪堆积洗剂的组分和含量
组分 | 含量(重量%) | |
1 | 纯净水 | 加至100 |
2 | 混合的稀土元素 | 0.1 |
3 | 植物氢化油 | 1.5 |
4 | 硬脂酸 | 0.6 |
5 | 聚甘油-10五硬脂酸酯&山嵛醇&硬脂酰乳酸钠 | 1.0 |
6 | 花生基山嵛醇&花生醇苷 | 1.0 |
7 | 鲸蜡基芳基醇&鲸蜡基芳基醇苷 | 2.0 |
8 | PEG-100硬脂酸盐&甘油油酸&丙烯乙二醇 | 1.5 |
9 | 羊脂酸/发酸甘油三酸酯 | 4.0 |
10 | 绣线菊籽油 | 3.0 |
11 | 辛酸十六烷酯 | 3.0 |
12 | 环甲基硅油 | 6.0 |
13 | 对羟基苯甲酸甲酯 | 0.2 |
14 | 对羟基苯甲酸丙酯 | 0.1 |
15 | EDTA二钠 | 0.02 |
16 | 三甲醇铵 | 0.13 |
17 | 甘油 | 8.0 |
[36]实施例2-11:制备减肥和抗脂肪堆积组合物
[37]通过与上述实施例1基本相同的步骤制备减肥和抗脂肪堆积洗剂,除了单独使用La(实施例2)、Ce(实施例3)、Pr(实施例4)、Nd(实施例5)、Pm(实施例6)、Sm(实施例7)、Eu(实施例8)、Gd(实施例9)、Tb(实施例10)和Dy(实施例11)代替混合的稀土元素。
[38]比较例1:
[39]从表1中排除组分2后制备洗剂。
[40]实验实施例1:老鼠脂肪细胞中稀土元素脂类分解效果的测定
[41]将Wistar雄鼠的皮下脂肪组织分离并用剪刀剪碎。在0.05%的胶原蛋白酶溶液中,37℃下培养1小时,过滤得到各个单独脂肪细胞。为了评价每种物质对于促进脂肪细胞中中性蛋白分解的作用,使用上述方法分离的脂肪细胞进行如下实验。
[42]将添加10%胎牛血清(FBS)的不含脂肪酸的DMEM(改性DulbeccoEagle培养基)以每孔1×106的量加入到所述脂肪细胞中。2小时后,加入10μg各自的稀土元素或混合的稀土元素,测定从脂肪细胞释放到培养基中的甘油的浓度,以评价脂类分解程度。所述甘油用从Sigma-Aldrich(St.Louis,MO,USA)购买的GPO-Trinder试剂盒进行颜色反应定量。用ELISA读数器测定540nm处的吸收。结果表示为对照组的%。既不加稀土元素也不加混合的稀土元素只有培养基加入到所述对照组。
[43]结果示于图1中。如图1所示,发现与对照组相比,用混合的稀土元素处理组释放到培养基中甘油浓度显著增加。另外,在单独稀土元素处理组中,可以得到与混合的稀土元素处理组基本上相同的结果。
[44]实验实施例2:测定3T3L1细胞线中稀土元素的脂类分解效果
[45]将大鼠前体脂肪细胞(3T3-L1细胞,ATCC CCL-92.1)在添加有10%胎牛血清和抗生素的DMEM中,在CO2培养箱中37℃培养2天至5×104细胞/ml。然后,加入2μmol胰岛素、250μmol异丁基甲基黄嘌呤和10μmol地塞米松以诱导分化成脂肪细胞。每隔两天加入所述培养基和所述分化诱导剂,培养细胞以检测分化程度。在5天或更长时间后它们被分化成脂肪细胞,然后,所述培养基被置换成添加有10%胎牛血清和抗生素的新的培养基,加入每种10μg的单独的稀土元素或混合的稀土元素。根据实验实施例1相同的方法定量所述甘油。
[46]结果示于图2中。如图2所示,发现与对照组相比,用混合的稀土元素处理组释放到培养基中甘油浓度显著增加。另外,在单独稀土元素处理组中,可以得到与混合的稀土元素处理组基本上相同的结果。
[47]实验实施例3:稀土元素的皮肤刺激性评估
[48]用新西兰小白鼠对稀土元素的皮肤刺激性做了如下评估。
[49]将载体或10%混合的稀土元素涂在老鼠皮肤上,一天两次,4天共8次。然后,红斑及成痂的分数和形成水肿的分数累积得到累积的皮肤刺激指数。根据下图2中所示的标准来评估所述皮肤刺激指数。结果示于表3中。所述皮肤刺激指数是根据原发刺激指数(P.I.I)(见Draize,J.H.,Appraisal of the safety of chemical in foods,drugs and cosmetics)的传统方法得到的。
[50】【表2】
[51]【表3】
成分 | 原发刺激指数(0~4) |
载体 | 0.6 |
混合的稀土元素 | 0.8 |
[52]图表3所示,发现混合的稀土元素几乎没有皮肤刺激性。
[53]实验实施例4:本发明组合物减肥效果的评估
[54]为了评估本发明组合物对于20位(每组10位)年龄为20~50岁、体重指数(BMI)为22~30并且无其他代谢异常的成年女性的减肥效果,每天早晚推拿上述实施例和对比例得到的洗液,每天两次共8周。8周中的变化在时间点推拿洗液之前、4周后和8周后被检测。
[55]测量身高和体重。身高用Martin式生物计以cm为单位记录,体重用电子秤以kg为单位记录。为了得到被试者体内脂肪的%,使用了生物电子阻抗(体内脂肪分析仪TBF-105,tanita,Japan)。结果示于表4中。
[56]【表4】
[57]如表4所示,与对比例的组合物相比,本发明的组合物在减轻体重、降低BMI、体内脂肪重量和体内脂肪%的方面表现出明显更高的效果。
[58]实验实施例5:本发明组合物抗脂肪堆积效果的评估
[59]进行本实验是为了找出本发明组合物在脂肪堆积方面的效果,除了肥胖指数。为了测量被试者身体每一部分的皮下脂肪厚度,所述被试者被命令用他们的左手拇指和食指从上往下抓着他们的皮肤和皮下脂肪,离手抓区域1cm的区域用皮下脂肪测定计(Dongwha Science DT-8皮下脂肪测定计)正确地夹住,读到0.1mm单位。重复测量三次后,在得到恒定值的时候的数值作为测定值。测定部位是三头肌、腹部和大腿。
[60]-三头肌皮褶厚度:在右三头肌肩后部和肘部的中间部分
[61]-腹部皮褶厚度:肚脐右侧2cm处
[62]-大腿皮褶厚度:右大腿前部和膝关节的中间部分
[63]比较处理前后得到的数据并进行统计学分析。结果示于表5中。
[64]【表5】
[65]如表5所示,本发明的组合物比对比例的组合物表现出更高的消除脂肪堆积的效果。
[66]实验实施例6:本发明组合物在皮肤紧致度方面效果的评价
[67]为了检验本发明组合物在皮肤紧致度方面的效果,由测试人进行了目测。作为目测的指数,对皮肤紧致度打分从最高9分到最低1分。所得分值通过处理前后比较来进行分析。
[68]结果示于图3中。如图3所示,涂了本发明的组合物后皮肤紧致度增强。
[69]实验实施例7:本发明组合物在人体中皮肤刺激性和副作用的评估
[70]在测试过程中,皮肤安全性由皮肤病学家检查对人体皮肤刺激性和副作用后作出评估。所述评估是根据与实验实施例4相同的方法进行的,使用了表2中所示的评估标准。结果示于表6中。
[71]【表6】
试剂 | 原发刺激指数(0~4) |
载体 | 0.6 |
本发明的组合物 | 0.8 |
[72]如表6所示,本发明的组合物被证明几乎没有皮肤刺激性。
[73]实验实施例8:测定口服的稀土元素减重效果和毒性
[74]将稀土元素口腔注射到实验动物体中检测重量变化和成活率。所述实验动物体为8周大的雄性ICR鼠(30±1g)。在进行实验前,无限制地用药片(Samyang Co.)和水饲养。为了适应环境,初步在聚丙烯箱(453×293×247(H)mm,191)中饲养一周(20~24℃,60~80%湿度)。作为口服,将1mg混合的稀土元素溶解在1ml三重蒸馏水中,所述溶液通过口腔探针(Oral Zonde)(0.9×50mm,不锈钢)以每天早晨和下午各100mg/kg的量给药8周。
[75]结果示于图4中。如图4所示,发现与无处理组和载体处理组相比,在混合的稀土元素处理组中,体重降低了12.5%。因此,可以得出结论口服混合的稀土元素可以有效地减轻体重。另外,在单独稀土元素处理组中,可以得到和混合的稀土元素处理组基本上相同的结果。
[76]在8周的实验中,没有观察到死亡和副作用,因此,可以证明口服稀土元素没有毒性和副作用。
[77]实验实施例9:口服稀土元素脂类分解效果的评价
[78]稀土元素被口腔注射到实验动物体中以评价它们的脂类分解效果。收集实验实施例8中每个实验动物体的血液,只分离血清定量其中的甘油。所述甘油用从Sigma-Aldrich(St.Louis,MO,USA)购买的GPO-Trinder试剂盒进行颜色反应定量。用ELISA读数器测定540nm处的吸收。结果表示为对照组的%。
[79]结果示于图5中。如图5所示,发现与无处理组相比,在混合的稀土元素处理组中,释放到血清中的甘油浓度明显增加。另外,在单独稀土元素处理组中,可以得到和混合的稀土元素处理组基本上相同的结果。
[80]实验实施例10:在诱导肥胖的实验动物体中,口服稀土元素在脂类分解和肥胖症上的效果的评价
[81]诱导肥胖的实验动物体口服稀土元素能够消除它们在脂类分解和肥胖症上的作用。给60个三周大的公Sprague-Dawley大鼠(200g±10g)无限制地提供药片(Samyang Co.)和水一周。为了适应环境,初步在20~24℃湿度为60~80%下饲养它们,然后用高脂肪食物诱导肥胖四周。食物诱导的肥胖在AIN-93G(美国营养研究所-93G)的基础上对于脂肪含量(脂肪20%w/w)具有各5%的大豆油(Q-one)、牛油(Lotte Samkang)、猪油(LotteSamkang)以及玉米油。1%胆固醇(Junsei Chemical)和酪蛋白(DaejungChemical & Metals Co.)用于蛋白质供应。为了供应碳水化合物(碳水化合物49%w/w),混合玉米淀粉(Doosan Corn Products Korea)和蔗糖(白糖)诱导高胆固醇型肥胖。然后,根据它们的体重应用随机化完全模块设计把它们分成十组:三个保持高脂肪饮食的组(无处理组、载体处理组和混合稀土元素处理组)和三个转变正常药片组(无处理组、载体处理组和混合稀土元素处理组)。作为口服,1mg混合稀土元素溶于1ml三重蒸馏水中且每天早上和中午各100mg/kg的剂量用口腔探针(Oral Zonde)(φ0.9×50mm,不锈钢)给药8周。用实验食物喂养动物四周后,测量它们的体重,收集它们的血液。该血液允许在4℃下停留30分钟且以3,000rpm离心30分钟。然后,血浆从上清液中分离出来并在-70℃下保存用于实验。
[82]为了评估血清中的脂类浓度,分别在555、500和505nm用OlympusAU400(Tokyo,Japan)测量总的胆固醇(TC,Olympus kit)、HDL-胆固醇(HDL-C,Hbi kit)和甘油三酸酯(TG,Olympus kit)的吸收。用以下弗里德瓦尔德(Friedewald)公式计算LDL-胆固醇(LDL-C):
LDL-C=TC-(HDL-C+TG/5)。
[83]保持高脂肪饮食组的相对体重增长示于图6中。如图6所示,口服混合的稀土元素可以抑制体重增长。
[84]保持高脂肪饮食组的TG、TC、HDL-C、和LDL-C结果示于表7中。
[85]【表7】
TC(mg/dl) | TG(mg/dl) | HDL-C(mg/dl) | LDL-C(mg/dl) | |
无处理组 | 81.87±3.85 | 84.07±4.55 | 24.53±5.00 | 40.52±0.93 |
载体处理组 | 82.50±3.11 | 83.25±2.22 | 25.03±4.32 | 40.82±1.50 |
混合的稀土元素处理组 | 67.50±3.11 | 61.50±3.70 | 34.50±2.89 | 20.70±3.62 |
[86]如表7所示,混合的稀土元素处理组比无处理组和载体处理组具有更低的TC、TG、和LDL-C,而具有更高的HDL-C。从这些结果可以发现,用混合的稀土元素处理可以消除和阻止肥胖。另外,在单独稀土元素处理组中,可以得到和混合的稀土元素处理组基本上相同的结果。
[87]正常药片转变组的相对体重增长示于图7中。如图7所示,在转变成正常药片后口服混合的稀土元素可以抑制体重增长。
[88]正常药片转变组的TG、TC、HDL-C、和LDL-C结果示于表8中。
[89]【表8】
TC(mg/dl) | TG(mg/dl) | HDL-C(mg/dl) | LDL-C(mg/dl) | |
无处理组 | 77.00±5.10 | 76.75±4.65 | 24.25±4.99 | 37.40±9.08 |
载体处理组 | 75.00±3.56 | 75.25±4.65 | 25.75±3.69 | 34.20±6.90 |
混合的稀土元素处理组 | 58.00±4.83 | 58.00±4.97 | 35.25±3.59 | 11.15±7.94 |
[90]如表8所示,混合的稀土元素处理组比无处理组和载体处理组具有更低的TC、TG、和LDL-C,而具有更高的HDL-C。从这些结果可以发现,用混合的稀土元素处理可以消除肥胖。另外,在单独稀土元素处理组中,可以得到和混合的稀土元素处理组基本上相同的结果。
[91]工业实用性
[92]稀土元素促进积聚在脂肪细胞中的中性脂肪分解为甘油和自由脂肪酸并促进其排泄,减少人体脂肪以抑制肥胖,减少皮下脂肪以使得身体苗条,并消除导致不平坦皮肤的脂肪堆积以使得皮肤紧致和光滑,而且,对人体无害也不具有皮肤刺激性。
[93]尽管已示出和描述了本发明的优选实施例,可以设想,本领域的技术人员可在所附权利要求的精神和范围内设计对本发明的各种修改。
Claims (11)
1.一种用于促进脂类分解、抗脂肪堆积、增强皮肤紧致度或用于减肥的组合物,其包括选自由镧(La)、铈(Ce)、镨(Pr)、钕(Nd)、钷(Pm)、钐(Sm)、铕(Eu)、钆(Gd)、铽(Tb)、镝(Dy)、钬(Ho)、铒(Er)、铥(Tm)、镱(Yb)、镥(Lu)、钪(Sc)、钇(Y)、它们的混合物、盐或氧化物所组成的组中的作为活性成分的稀土元素。
2.权利要求1的组合物,包括相对于组合物的总量0.0001~20重量%的活性成分。
3.权利要求1或2的组合物,进一步包括一种或多种无毒的惰性载体。
4.权利要求3的组合物,其被制成吸水色粉、营养色粉、营养洗液、按摩霜、营养霜、浆液、眼霜、清洁霜、清洁泡沫、清洁水、包、凝胶、喷雾或粉末。
5.权利要求3的组合物,其被制成药片、硬或软胶囊、颗粒、咀嚼片、药丸、粉末、酏剂、悬浮液、乳液、溶液、糖浆、气雾剂、囊剂、无菌注射溶液或粉末、洗液、软膏、凝胶、乳膏、药膏或喷雾。
6.权利要求3的组合物,其被用作皮肤外用制剂或营养食品。
7.选自由镧(La)、铈(Ce)、镨(Pr)、钕(Nd)、钷(Pm)、钐(Sm)、铕(Eu)、钆(Gd)、铽(Tb)、镝(Dy)、钬(Ho)、铒(Er)、铥(Tm)、镱(Yb)、镥(Lu)、钪(Sc)、钇(Y)、它们的混合物、盐或氧化物所组成的组中的稀土元素用于促进脂类分解、抗脂肪堆积、增强皮肤紧致度或用于减肥的用途。
8.权利要求7的用途,其中所述稀土元素采用经皮注射或口服。
9.一种促进脂类分解、抗脂肪堆积、增强皮肤紧致度或为需要的目的减肥的方法,其包括应用物质稀土元素的步骤,该稀土元素选自由镧(La)、铈(Ce)、镨(Pr)、钕(Nd)、钷(Pm)、钐(Sm)、铕(Eu)、钆(Gd)、铽(Tb)、镝(Dy)、钬(Ho)、铒(Er)、铥(Tm)、镱(Yb)、镥(Lu)、钪(Sc)、钇(Y)、它们的混合物、盐或氧化物所组成的组。
10.权利要求9的方法,其中所述稀土元素采用经皮注射或口服。
11.一种制备用于促进脂类分解、抗脂肪堆积、增强皮肤紧致度或用于减肥的试剂的方法,其包括使用选自由镧(La)、铈(Ce)、镨(Pr)、钕(Nd)、钷(Pm)、钐(Sm)、铕(Eu)、钆(Gd)、铽(Tb)、镝(Dy)、钬(Ho)、铒(Er)、铥(Tm)、镱(Yb)、镥(Lu)、钪(Sc)、钇(Y)、它们的混合物、盐或氧化物所组成的组中的稀土元素。
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