CN112826872A - 一种胃肠排毒、减肥的组合物及其应用 - Google Patents
一种胃肠排毒、减肥的组合物及其应用 Download PDFInfo
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Abstract
本发明属于保健食品和生物医药技术领域,具体涉及一种胃肠排毒、减肥的组合物及其应用。本发明提供的组合物包含以下三类组分中的三类或任意两类组分:纤维素类,油脂类和吸附剂类。将所述的组合物中的各组分进行混合,添加赋形剂、附加剂可制成胶囊、丸剂、片剂、颗粒剂、混悬液、果冻、饮料等形式,可作为普通食品、保健食品和/或药品,能促进人体排出多种有害毒物,如胃肠道有害微生物、重金属、有害气体、有害有机物和无机物、致癌物等;有助于改善睡眠、低落情绪、痤疮、黄褐斑、妊娠斑、皮肤瘙痒、便秘、便少、腹泻、肛门湿臭痒、肠胀气排气多、排气臭、大便臭、降低血氨;也可以用于肥胖人群,具有减肥作用。
Description
技术领域
本发明涉及保健食品和生物医药技术领域,具体涉及一种胃肠排毒、减肥的组合物及其应用。
背景技术
随着人口的繁衍和科技的发展,环境受废气、废水、废渣的污染日趋严重,化肥、农药、其它化学品的使用规模和数量越来越大,也给大气、水体和土壤带来了污染,这种环境中生产的产品通过食物链最终进入人体,对健康可能造成各种各样的危害。目前已经从食物或人体检测到的有害物质主要有五类:第一类为重金属如镉、铬、铅、汞、砷等,有报道我国11个省市的农田涉及镉污染;第二类为有害气体,如氟化物、二氧化硫、氮氧化合物、煤烟粉尘、金属粉尘、NH3等;第三类为农药,包括杀虫剂、杀菌剂、除草剂、植物生长调节剂等,如有机氯、有机磷、氨基甲酸酯、拟除虫菊酯,这些农药具有致癌、致畸、致突变等危害,有报道某市的抽样检测发现韭菜、芹菜、芸豆的农药几乎全部超标,某城市52位哺乳妇女的母乳中滴滴涕(DDT)100%检出,16个省市生产的粮食中六六六的检出率100%;第四类为化肥,其中氮肥的污染和着色剂的使用导致人体强致癌物亚硝酸盐增高,化肥还有重金属和酚类有害物也可随食物链进入人体;第五类为致病微生物及其产物,如沙门菌、大肠杆菌、产气荚膜梭菌、黄曲霉素等,其中黄曲霉素为强致癌物,微生物毒素不仅会对人体产生直接感染、损伤,各种微生物抗原进入人体导致自身免疫性疾病,也可以引起皮肤色素沉着、皮肤疾病、瘙痒,研究发现梭形产气荚膜梭菌和肠道梭菌可导致人抑郁、睡眠障碍、诱发癌症等。随着环境污染越来越严重,人类已经不可避免地被笼罩和暴露于各种有害物质之中,因此采取各种措施促进人体将毒素及时排出去就显得格外重要和迫切。
胃肠道是环境中有毒物质通过食物链进入人体的主要门户,也是人体毒物的一个重要储存场所和最主要的排泄通道。因此,及时清除肠道毒素、减少毒素吸收、促进毒素排出对维持人体健康具有非常重要的作用。让各种毒素从肠道及时清除须同时满足三个条件:1)便量要足,正常成年人每日排便量应在100-300克以上;2)毒素汇集于便,也就是毒素要被吸附固定于便中,便中应含有不被胃肠道吸收的吸附性物质,能将各类毒素(重金属、有机物、无机物、致癌物、有害气体、致病菌等)固定于便中;3)及时排便顺畅,将含毒素的便排出体外,正常成年人每日应排便1-2次。三者之一不能满足,如进食纤维素过少导致便少,或进食能吸附毒素的物质数量和种类过少,或进食含毒物质较多的食物,或肠道致病菌过度增殖产生较多毒素,或存在肠蠕动减弱导致宿便等等,均可能导致肠道不能及时清除毒素。毒素滞留于人体严重危及健康,轻则出现便秘、腹泻、肛门湿臭痒、肠胀气、排气多、排气臭、口臭、睡眠障碍、抑郁、皮肤颜色灰暗色斑增多、皮肤瘙痒、肥胖等,重则发生各种自身免疫性疾病、微生物感染、重金属中毒、认知功能减退、各种癌症等。当出现上述情况时,除需及时调整饮食习惯和对症处理外,使用促进肠道排毒的产品也很有必要。
目前已经上市可以使用的促进肠道排毒的产品和已申请的专利主要为补充膳食纤维增便,或中药促进排便,前者多为含芦荟、车前子壳、大豆、荷叶、燕麦、荞麦等成分产品,后者多为含番泻叶、决明子等清热解毒和含油脂的药物。膳食纤维主要发挥增便作用,中药主要作用为刺激肠道排便,均对毒物的吸附力较弱,不能有效促进肠道排毒。此外,芦荟、番泻叶、决明子、何首乌、大黄、虎杖等均含蒽醌类物质,长期使用会导致结肠黑变病。中药作为药物,也具有毒副作用,不能长期使用。例如CN201510173027.5公开了一种便秘医学配方食品,是按下列原料及其用量进行配方,药食两用的提取物及新资源食品:石斛14g、番泻叶14g、生大黄14g、黄芪12g、车前子12g、蛹虫草12g、火麻仁12g、郁李仁12g、苏子12g、胖大海10g、蒲公英10g、甘草10g、决明子10g、莱菔子10g、百合10g、玉竹10g、芦荟8g、橘皮8g、山楂8g、桑椹8g、杏仁8g、乌梅8g、沙棘6g、罗汉果6g、桃仁6g、黄精6g、赤小豆6g、魔芋6g、麦芽6g、鱼腥草6g、金银花4g、螺旋藻4g、膳食纤维4g、酵母3g、裸藻3g、奇亚籽2g、圆苞车前子壳2g、杜仲雄花1g、乳矿物盐1g、多种益生菌300g、短肽200g、益生元100g、多种氨基酸100g、碳水化合物100g、有保健功能的油酯100g、维生素A0.01g、维生素D0.000015g、维生素E0.12g、维生素K0.0075g、维生素K10.00001g、维生素C10.625g、维生素B10.016g、维生素B20.016g、维生素B60.015g、维生素B0.0023g、维生素Be、维生素Bu、烟酸0.2g、叶酸0.003g、泛酸0.051g、胆碱2.5g、生物素0.000057g、钙6.2g、磷4.5g、钾10g、钠16.17g、镁1.7g、氯、铁0.15g、锌6.2g、硒0.00012g、铜0.007g、锰0.018g、碘0.00001g、氟0.00001g、铬0.00001g、钼0.00001g。虽然该食品能达到补充膳食纤维增便、促进排便的作用,但由于含有较多的含蒽醌类物质,长期使用会导致结肠黑变病,存在一定的安全隐患,因此不适合长期服用。
因此,急需研发出同时能满足“促进增加便量、汇集毒素、及时排便”三方面功能的且具有较高的安全性、可以长期使用的肠道排毒产品,以填补市场空白,有效保障人体健康。
发明内容
针对现有技术存在的不足,本发明要解决的技术问题是提供一种胃肠排毒、减肥的组合物,能促进人体胃肠排出多种有害毒物,具有减肥作用。
为解决上述技术问题,本发明提供以下技术方案:
一方面,本发明提供一种胃肠排毒、减肥的组合物,包含以下三类组分中的三类或任意两类组分:纤维素类,油脂类和吸附剂类;所述的纤维素类包括膳食纤维素,羧甲基纤维素,交联羧甲基纤维素,羟丙基甲基纤维素,甲基纤维素或纤维素盐中的任意一种或多种;所述的油脂类包括植物油,含植物油的果实、种子或胚芽,聚乙二醇,石蜡油或二甲硅油中的任意一种或多种;所述的吸附剂类包括含甘露糖苷和/或岩藻糖苷的多糖,蒙脱石,沸石,活性炭,壳聚糖或环状糊精中的任意一种或多种。
其中,所述的膳食纤维素是指天然食物中提取的纤维或半纤维素,也指膳食纤维较丰富的食物,包括但不限于车前子壳粉、欧车前亲水胶、桑叶粉、树胶、果胶、藻胶、豆胶等,还包括不同膳食纤维的混合物,但不包括芦荟胶、大黄、何首乌、虎杖、番泻叶等含有蒽醌类的植物来源纤维素。
所述的植物油是指从植物的果实/种子/胚芽中得到的油脂,包括但不限于花生油、豆油、亚麻油、蓖麻油、芝麻油、菜子油、山茶油、橄榄油、紫苏子油、火麻仁油等,也包括不同植物油的混合物。
所述的含植物油的果实、种子或胚芽,包括但不限于花生、大豆、芝麻、菜子、油茶籽、油橄榄果实、紫苏籽、火麻仁、郁李仁、松子仁、桃仁、冬瓜仁、杏仁、柏子仁、瓜蒌仁、莱菔子等,也包括多种果实、种子或胚芽的混合物,但不包括决明子等含有蒽醌类的果实、种子或胚芽。
所述的聚乙二醇,是指化学式为HO(CH CH O)nH的系列物质,包括分子量为200-20000的单体物质,也包括不同分子量聚乙二醇的混合物。
所述的石蜡油,为一种可以食用或药用的矿物油。
所述的二甲硅油,又名二甲基硅油、甲基硅油、聚二甲基硅氧烷液体,为二甲基硅氧烷的线性聚合物,分子式为CH3[Si(CH3)2]nSi(CH3)3,平均分子量5000-100000。
所述的含甘露糖苷和/或岩藻糖苷的多糖,包括但不限于魔芋胶、槐豆胶、褐藻胶(或海藻酸钠)、瓜尔豆胶、黄原胶,也包括所述多糖的混合物。
所述的蒙脱石,又称为胶岭石、高岭石、微晶高岭石,是指由颗粒极细的含水铝硅酸盐构成的层状矿物。
所述的沸石,是指含水的碱或碱土金属铝硅酸盐的沸石族矿物。
所述的活性炭,是指由果壳或植物经活化加工制备而成的,具有发达的孔隙结构、较大的比表面积和丰富的表面化学基团,特异性吸附能力较强的炭材料,也包括各种材料加工制备而成的活性碳纤维。
所述的壳聚糖,又称为脱乙酰甲壳质、可溶性甲壳素、聚氨基葡萄糖,是指由多糖甲壳素脱除部分乙酰基的产物,其脱乙酰度为50%-100%。
所述的环状糊精,又称为环糊精,是指含有6-12个D-吡喃葡萄糖单元以1,4-糖苷键结合成环的环状低聚糖,包括α-环状糊精、β-环状糊精、γ-环状糊精以及环状糊精的衍生物等。
优选地,所述的组合物包含以下重量份数的各组分:
当所述的组合物包含纤维素类,油脂类和吸附剂类三类组分时,各组分的重量份数为纤维素类10-90份,油脂类5-85份,吸附剂类5-85份;
当所述的组合物包含纤维素类和油脂类两类组分时,各组分的重量份数为纤维素类10-90份,油脂类10-90份;
当所述的组合物包含油脂类和吸附剂类两类组分时,各组分的重量份数为油脂类10-90份,吸附剂类10-90份;
当所述的组合物包含纤维素类和吸附剂类两类组分时,各组分的重量份数为纤维素类10-90份,吸附剂类10-90份。
更优选地,所述的组合物包含以下重量份数的各组分:
当所述的组合物包含纤维素类,油脂类和吸附剂类三类组分时,各组分的重量份数为纤维素类20-50份,油脂类10-60份,吸附剂类10-60份;
当所述的组合物包含纤维素类和油脂类两类组分时,各组分的重量份数为纤维素类20-80份,油脂类20-80份;
当所述的组合物包含油脂类和吸附剂类两类组分时,各组分的重量份数为油脂类10-60份,吸附剂类10-80份;
当所述的组合物包含纤维素类和吸附剂类两类组分时,各组分的重量份数为纤维素类20-79.5份,吸附剂类20.5-70份。
在一种具体的实施方案中,所述的组合物的配方成分:膳食纤维、交联羧甲基纤维素、羧甲基纤维素、羟丙甲基纤维素和/或甲基纤维素20-50份,山茶油、橄榄油、大豆油、聚乙二醇4000、聚乙二醇6000、石蜡油、二甲硅油、火麻仁(或油)、莱菔子(或油)和/或紫苏子(或油)10-60份,黄原胶、魔芋胶、瓜尔豆胶、褐藻胶(或海藻酸钠)和/或槐豆胶0.5-40份,蒙脱石、沸石、活性炭(或活性碳纤维)、壳聚糖和/或环状糊精10-60份。
在另一种具体的实施方案中,所述的组合物的配方成分:膳食纤维、交联羧甲基纤维素、羧甲基纤维素、羟丙甲基纤维素和/或甲基纤维素20-80份,山茶油、橄榄油、大豆油、聚乙二醇4000、聚乙二醇6000、石蜡油、二甲硅油、火麻仁(或油)、莱菔子(或油)和/或紫苏子(或油)20-80份。
在另一种具体的实施方案中,所述的组合物的配方成分:山茶油、橄榄油、大豆油、聚乙二醇4000、聚乙二醇6000、石蜡油、二甲硅油、火麻仁(或油)、莱菔子(或油)和/或紫苏子(或油)10-60份,蒙脱石、沸石、活性炭(或活性碳纤维)、壳聚糖和/或环状糊精10-80份,黄原胶、魔芋胶、瓜尔豆胶、褐藻胶(或海藻酸钠)和/或槐豆胶0.5-80份。
在另一种具体的实施方案中,所述的组合物的配方成分:膳食纤维、交联羧甲基纤维素、羧甲基纤维素、羟丙甲基纤维素和/或甲基纤维素20-79.5份,黄原胶、魔芋胶、瓜尔豆胶、褐藻胶(或海藻酸钠)和/或槐豆胶0.5-40份,蒙脱石、沸石、活性炭(或活性碳纤维)、壳聚糖和/或环状糊精20-70份。
另一方面,本发明提供了上述的组合物在制备胃肠排毒、减肥的普通食品、保健食品和/或药品中的应用。
又一方面,本发明提供了一种胃肠排毒、减肥的普通食品、保健食品和/或药品,包含上述的组合物、赋形剂和/或附加剂;所述的普通食品、保健食品和/或药品为胶囊、片剂、丸剂、颗粒剂、饮料、果冻、混悬液或洗漱液。
优选地,所述的赋形剂包括甘露醇、葡聚糖、麦芽糊精、葡萄糖、淀粉、乳糖、硬脂酸镁、糖精、滑石、明胶、白砂糖或碳酸镁中的任意一种或多种;所述的附加剂包括氨基酸、维生素和/或微量元素中的任意一种或多种。
上述的组合物制成的胶囊、片剂、丸剂、颗粒剂、饮料、果冻、混悬液、洗漱液可以通过口服、漱口、灌胃、灌肠、洗涤等形式给予,能促进人体排出多种有害毒物(包括胃肠道有害微生物、重金属、有害气体、有害有机物和无机物、致癌物等);有助于改善睡眠、低落情绪、痤疮、黄褐斑、妊娠斑、皮肤瘙痒、便秘、便少、腹泻、肛门湿臭痒、肠胀气排气多、排气臭、大便臭、降低血氨;还有助于肥胖人群减肥。
相对于现有技术,本发明具有以下有益效果:
(1)本发明组合物中所含的纤维素和毒素吸附剂可以有效增加每日排便量,以保障胃肠毒素的排出量;同时可以减少进食量、减少脂肪和糖类物质的吸收量,从而达到减肥的目的。本发明组合物中的纤维素类组分具有如下性能:
a)膳食纤维素:具有吸水膨胀增便功能;吸水膨胀产生饱腹感,结合脂肪酸减少脂肪的吸收率,达到减肥作用;还具有较弱的:调节血糖、降低胆固醇水平、吸附金属离子、吸附致癌毒素等功能;
b)交联羧甲基纤维素、羧甲基纤维素、羟丙甲基纤维素、甲基纤维素及盐:与膳食纤维素相比,其吸水保水能力和膨胀能力为膳食纤维的10倍左右,而且带有更多的阴离子,吸附阳离子和毒素的能力更强,因此可以减少纤维素的使用量的同时,提升增便排毒效果。
(2)由于环境污染因素,人体内可能同时存在多种毒素,包括重金属(如镉、铬、铅、汞、砷等)、有害气体(如氟化物、二氧化硫、氮氧化合物、NH3、NH4+等)、农药(如有机氯、有机磷、氨基甲酸酯、拟除虫菊酯等)、致癌物(如亚硝酸盐、黄曲霉素等)、致病微生物及其产物(如沙门菌、大肠杆菌、产气荚膜梭菌、艰难梭菌、各种抗原、内毒素等),而纤维素或通常情况下的大便成分对毒素的吸附力相对较弱,毒素清除能力有限。本发明组合物含有一种或多种吸附力强、专一性佳、互补性好的吸附剂,促使人体毒素集聚于大便中,极大提升排毒能力。本发明组合物中各吸附剂的毒素吸附性能如下:
a)含甘露糖苷和/或岩藻糖苷的多糖(包括但不限于魔芋胶、槐豆胶、褐藻胶(或海藻酸钠)、瓜尔豆胶、黄原胶,也包括所述多糖的混合物):大肠杆菌、沙门菌、幽门螺杆菌、产气荚膜梭菌、艰难梭菌等致病菌的荚膜和鞭毛可粘附于所述多糖的甘露糖和岩藻糖单元,减少致病菌粘附于胃肠粘膜,从而清除或减少胃肠道存在的致病菌;具有膨胀吸水增便、刺激肠道蠕动排便的功效;具有吸附重金属离子的作用;
b)蒙脱石(高岭石):可以吸附消毒剂(如三氯生)、脱氧雪腐镰刀菌烯醇、抗生素、黄曲霉素、重金属(As、Cd、Cr、Co、Cu、Fe、Pb、Mn、Ni、Zn)、致病菌、NH3、NH4 +等;也具有膨胀吸水增便、刺激肠道蠕动排便的功效;
c)沸石:可以吸附有机物、无机物、重金属、NH3、NH4 +等毒素;
d)活性炭(活性碳纤维):可吸附重金属(包括汞、镉、铀、Cu)、硫化氢、硫醇、噻吩、二噁英气、有害气体(如氨气)、抗生素、内毒素、甲醛、苯酚、二溴乙腈、腐殖酸、有机物等;
e)壳聚糖:壳聚糖可以螯合重金属离子(包括Hg、Ni、Pb2+、Cd、Mg、Zn、Cu、Fe);可以结合许多无机酸、有机酸和酸性化合物,甚至两性化合物;对大肠杆菌、荧光假单胞菌、金黄色葡萄球菌、枯草杆菌、真菌、放线菌等有良好的抑制作用。
F)环状糊精(α-、β-、γ-环糊精):环糊精分子(包括环状糊精的衍生物)具有略呈锥形的中空圆筒立体环状结构,可以吸附烯、醛、酮、醇、酯、胺、卤代烃等各种化合物,如有害气体(如NH3)和拟除虫菊酯等有害物质。
(3)为减少大便在肠道内的停留时间,减少毒素被吸收和与肠黏膜的接触机会,本发明组合物含有植物油、含植物油的果实/种子/胚芽、聚乙二醇、石蜡油和/或二甲硅油,以润肠、刺激肠道蠕动,以达到及时排便、排便通畅的目的。本发明组合物中润肠通便组分具有如下性能:
a)植物油以及含植物油的果实/种子/胚芽:除具有润肠通便的功能外,其含有的不饱和脂肪酸可降低脂肪和胆固醇,稳定血脂,软化血管,预防动脉粥样硬化;还富含维生素A、E、D、K;还富含钙、铁、钾等多种微量元素;还富含胆碱,改善记忆力,延缓脑功能减退;
b)聚乙二醇:具有优良的肠道润滑性;同时具有保湿性,维持大便中的水分;具有良好的分散性,促进组合物中的胶体物质吸水膨胀,防止结团;降低其他物质和毒素对胃肠道的刺激;促进胃肠道黏膜的屏障功能修复;可活络肠道抗生素、羟苯酯类物质;
c)石蜡油:对肠壁和粪便起润滑作用,且能阻止肠内水分吸收,软化大便作用;
d)二甲硅油:有消泡作用,促进肠排出有害气体;对肠道附着的粘液有消除作用,促进粘液中的毒素排出;
(4)与现有技术相比较,本发明所述含纤维素类和油脂类两类组分组成的组合物具有增加便量的同时,保持大便松软,排便更通畅的作用。
(5)与现有技术相比较,本发明所述含纤维素类和吸附剂类两类组分组成的组合物具有增加便量的同时,可极大提升大便的毒素排出量和排出的毒素种类的作用。
(6)与现有技术相比较,本发明所述含油脂类和吸附剂类两类组分组成的组合物兼具有增加便量、保持大便松软、提升大便的毒素排出量和排出的毒素种类的作用。
(7)与现有技术相比较,本发明所述含纤维素类、油脂类和吸附剂类三类组分组成的组合物能有效增加便量、保持大便松软、提升大便的毒素排出量和排出的毒素种类。
(8)与现有技术相比较,本发明所述组合物具有较高的安全性,可以长期使用,不会对人体产生不良影响,具体如下:
a)组分为食用材料或食品添加剂或不被肠道吸收,因此具有极高的安全性;
b)组合物中不含蒽醌类成分,长期使用不会产生黑肠病;不含有系统作用的药物活性成分,不用担心长期使用带来的药物副作用;
c)组合物中含有植物油和/或含植物油的果实/种子/胚芽,富含不饱和脂肪酸、多种脂溶性维生素、多种微量元素、胆碱等营养成分,可以抵消吸附剂对营养成分的过度吸附,防止出现营养素缺乏症状。
具体实施方式
下面结合具体实施例,对本发明作进一步详细的阐述,下述实施例不用于限制本发明,仅用于说明本发明。以下实施例中所使用的实验方法如无特殊说明,实施例中未注明具体条件的实验方法,通常按照常规条件,下述实施例中所使用的材料、试剂等,如无特殊说明,均可从商业途径得到。
实施例1
一种胃肠排毒、减肥的组合物,包含以下组分:
交联羧甲基纤维素90份,山茶油10份。
实施例2
一种胃肠排毒、减肥的组合物,包含以下组分:
车前子壳粉10份,紫苏籽粉90份。
实施例3
一种胃肠排毒、减肥的组合物,包含以下组分:
褐藻胶(或海藻酸钠)80份,聚乙二醇4000 20份。
实施例4
一种胃肠排毒、减肥的组合物,包含以下组分:
桑叶粉35份,羟丙基甲基纤维素25份,橄榄油5份,瓜蒌仁粉25份,液体石蜡油10份。
实施例5
一种胃肠排毒、减肥的组合物,包含以下组分:
欧车前亲水胶10份,甲基纤维素10份,火麻仁粉30份,冬瓜仁粉20份,莱菔子粉30份。
实施例6
一种胃肠排毒、减肥的组合物,包含以下组分:
大豆纤维(豆胶)20份,食用树胶30份,花生粉20份,桃仁粉10份,油橄榄果粉10份,莱菔子粉10份。
实施例7
一种胃肠排毒、减肥的组合物,包含以下组分:
交联羧甲基纤维素60份,聚乙二醇4000 38份,二甲硅油2份。
实施例8
一种胃肠排毒、减肥的组合物,包含以下组分:
交联羧甲基纤维素10份,黄原胶90份。
实施例9
一种胃肠排毒、减肥的组合物,包含以下组分:
食用树胶90份,蒙脱石10份。
实施例10
一种胃肠排毒、减肥的组合物,包含以下组分:
羟丙基甲基纤维素钠60份,瓜尔豆胶35份,沸石5份。
实施例11
一种胃肠排毒、减肥的组合物,包含以下组分:
羧甲基纤维素钠70份,β-环状糊精30份。
实施例12
一种胃肠排毒、减肥的组合物,包含以下组分:
甲基纤维素10份,车前子壳粉10份,蒙脱石18份,沸石2份,活性炭10份,褐藻胶(或海藻酸钠)10份,羟丙基-β-环状糊精40份。
实施例13
一种胃肠排毒、减肥的组合物,包含以下组分:
桑叶粉29.5份,海藻酸钠20份,豆胶30份,魔芋胶0.5份,壳聚糖10份,γ-环糊精10份。
实施例14
一种胃肠排毒、减肥的组合物,包含以下组分:
甲基纤维素40份,黄原胶40份,活性炭20份。
实施例15
一种胃肠排毒、减肥的组合物,包含以下组分:
山茶油10份,黄原胶90份。
实施例16
一种胃肠排毒、减肥的组合物,包含以下组分:
火麻仁粉90份,魔芋胶10份。
实施例17
一种胃肠排毒、减肥的组合物,包含以下组分:
油茶籽粉25份,紫苏子粉35份,魔芋胶0.5份,β-环状糊精39.5份。
实施例18
一种胃肠排毒、减肥的组合物,包含以下组分:
聚乙二醇4000 10份,瓜尔豆胶80份,α-环状糊精10份。
实施例19
一种胃肠排毒、减肥的组合物,包含以下组分:
火麻仁油5份,莱菔子粉20份,聚乙二醇6000 15份,褐藻胶(或海藻酸钠)25份,蒙脱石10份,γ-环状糊精25份。
实施例20
一种胃肠排毒、减肥的组合物,包含以下组分:
橄榄油9份,桃仁粉5份,冬瓜仁粉5份,壳聚糖70份,活性炭5份,沸石5份,魔芋胶1份。
实施例21
一种胃肠排毒、减肥的组合物,包含以下组分:
大豆油5份,紫苏子油15份,瓜蒌仁粉15份,油橄榄果粉15份,魔芋胶5份,壳聚糖20份,β-环状糊精25份。
实施例22
一种胃肠排毒、减肥的组合物,包含以下组分:
聚乙二醇4000 60份,蒙脱石15份,活性碳纤维25份。
实施例23
一种胃肠排毒、减肥的组合物,包含以下组分:
食用藻胶10份,亚麻油5份,槐豆胶85份。
实施例24
一种胃肠排毒、减肥的组合物,包含以下组分:
车前子壳粉90份,山茶油5份,黄原胶5份。
实施例25
一种胃肠排毒、减肥的组合物,包含以下组分:
交联羧甲基纤维素钠30份,聚乙二醇4000 30份,药用炭40份。
实施例26
一种胃肠排毒、减肥的组合物,包含以下组分:
大豆纤维5份,食用果胶1份,甲基纤维素4份,橄榄油4份,紫苏籽粉80份,聚乙二醇2000 1份,魔芋胶1份,蒙脱石3份,β-环状糊精1份。
实施例27
一种胃肠排毒、减肥的组合物,包含以下组分:
食用藻胶15份,羧甲基纤维素5份,火麻仁油3份,蓖麻油2份,花生粉3份,油橄榄果粉2份,褐藻胶(或海藻酸钠)10份,α-环状糊精60份。
实施例28
一种胃肠排毒、减肥的组合物,包含以下组分:
桑叶粉25份,羟丙基甲基纤维素4.5份,菜子粉10份,油茶籽粉10份,火麻仁粉10份,瓜蒌仁粉20份,莱菔子粉10份,魔芋胶0.5份,活性碳纤维5份,壳聚糖5份。
实施例29
一种胃肠排毒、减肥的组合物,包含以下组分:
食用树胶20份,花生油5份,紫苏子油5份,芝麻籽粉15份,瓜尔豆胶40份,γ-环状糊精15份。
实施例30
一种胃肠排毒、减肥的组合物,包含以下组分:
食用藻胶15份,大豆纤维15份,豆油5份,芝麻油5份,杏仁粉10份,柏子仁粉5份,黄原胶15份,药用炭5份,壳聚糖15份,β-环状糊精10份。
实施例31
一种胃肠排毒、减肥的组合物,包含以下组分:
车前子壳粉15份,羟丙基甲基纤维素10份,菜子油5份,大豆粉10份,郁李仁粉15份,松子仁粉10份,蒙脱石10份,魔芋胶5份,α-环状糊精20份。
实施例32
一种胃肠排毒、减肥的组合物,包含以下组分:
车前子壳粉15份,交联羧甲基纤维素钠10份,火麻仁粉20份,莱菔子粉10份,蒙脱石10份,黄原胶15份,活性炭1份,β-环状糊精19份。
实施例33
一种胃肠排毒、减肥的组合物,包含以下组分:
桑叶粉15份,食用藻胶15份,桃仁粉10份,冬瓜仁粉10份,聚乙二醇6000 10份,瓜尔豆胶15份,活性碳纤维5份,γ-环状糊精20份。
实施例34
一种胃肠排毒、减肥的组合物,包含以下组分:
食用树胶5份,食用果胶15份,交联羧甲基纤维素钠5份,羟丙基甲基纤维素钠15份,聚乙二醇200 5份,聚乙二醇4000 15份,聚乙二醇12000 5份,α-环状糊精5份,β-环状糊精15份,γ-环状糊精15份。
实施例35
一种胃肠排毒、减肥的组合物,包含以下组分:
交联羧甲基纤维素25份,聚乙二醇4000 25份,黄原胶15份,蒙脱石15份,β-环状糊精20份。
实施例36
一种胃肠排毒、减肥的组合物,包含以下组分:
羧甲基纤维素钠25份,火麻仁粉31份,紫苏子粉14份,魔芋胶5份,活性炭10份,蒙脱石13份,沸石2份。
实施例37
一种胃肠排毒、减肥的组合物,包含以下组分:
羟丙基甲基纤维素25份,山茶油5份,莱菔子粉25份,聚乙二醇4000 15份,瓜尔豆胶25份,活性炭5份。
实施例38
一种胃肠排毒、减肥的组合物,包含以下组分:
车前子壳粉25份,桑叶粉15份,大豆纤维15份,橄榄油5份,紫苏子油5份,火麻仁油5份,魔芋胶5份,槐豆胶15份,褐藻胶(或海藻酸钠)10份。
实施例39
一种胃肠排毒、减肥的胶囊、片、丸、颗粒、饮料、果冻、混悬液的制备方法,包括如下具体步骤:
取实施例1-38种的任何一种组合物的组分;
将全部组分混合均匀,装入食用空胶囊中,制成胶囊剂;
或,将全部组分混匀,可以直接压片,也可以添加适量的其它附加剂(包括吸附剂、黏结剂、润滑剂、分散剂、润湿剂、崩解剂、香料、色料等)制成咀嚼片、分散片、泡腾片速释或缓释或控释片与肠溶片等片剂;
或,将全部组分混匀后取10份,加炼蜜3份、水9份;使粉粘合成为0.5-1mm大小的丸,并在基础上层层增大而成丸;将起模所制的小丸放入药粉中,摇动泛制成丸;
或,将全部组分混匀后取60份,加入90%乙醇40份搅拌,挤压通过14-22目筛网(板),制成均匀的颗粒剂;
或,将全部组分混匀后取10份,加果汁80份、蜂蜜10份,也可以添加适量的其它附加剂(包括防腐剂、分散剂、香料、色料等)制成饮料;
或,将全部组分混匀后取5份,加白糖15份、果冻粉0.8份,水79.2份,也可以添加适量的其它附加剂(包括酸味调节剂、防腐剂、甜味剂、食用香精、色素等),搅拌,加热至100℃,溶化形成胶冻液,模具中冷却制备成果冻;
或,将全部组分混匀后取20份,加生理盐水80份,也可以添加适量的其它附加剂(包括防腐剂、分散剂、香料、色料等)制成混悬液,可用于口服、灌胃、灌肠、洗涤等;
作为本发明的产品剂型制备配方组成,可包含传统的载体及添加剂如辅料。本发明所述的载体,只要是药理学上得到公认的载体,包括:pH缓冲水溶液、磷酸或柠檬酸等,水溶性聚合物-聚乙烯吡咯烷酮,甘氨酸、谷氨酸盐、天冬酰胺、精氨酸或赖氨酸等氨基酸,以及葡萄糖、甘露糖、葡聚糖等碳水化合物也能作为载体。EDTA等螯合剂、甘露醇、山梨醇以及非极性表面活性剂吐温也可以作为载体使用。作为药理学上得到公认的载体和稀释剂,包括所有种类的溶液、分散剂、崩解剂及渗透剂,以及吸收延迟剂,这些药理学上活性物质相关制剂的利用方法是公知的,如同已有的文献所记载的,包括除非与药物活性物质不符的制剂之外的所有制剂。该组合物中还可以加入其他的补充成分,如还可以含有锰、锌、尼克酸、维生素B6、维生素B12、羟基柠檬酸、及共轭亚油酸等。
本发明所述组合物制作成溶液、悬浮液、丸剂、粉末等形态时,也可以添加药理学上得到认可的无毒害作用的赋形剂,作为可以使用的赋形剂包括:甘露醇、葡聚糖、麦芽糊精、葡萄糖、淀粉、乳糖、硬脂酸镁、糖精、滑石、葡萄糖、明胶、白砂糖、碳酸镁等。
此外,对于制作成所述制剂形态时,还可以含有如下辅料。如刺梧桐树胶洋槐、玉米淀粉、明胶等粘合剂,磷酸钙等赋形剂,玉米淀粉、土豆淀粉及海藻酸等分解剂,硬脂酸镁等润滑剂,白砂糖、乳糖等甜味剂,从薄荷、鹿蹄草、樱桃等中提取的芳香剂,还可添加液态载体。如果采用糖浆剂或酊剂形式,则与有效成分一起,可含有白砂糖等甜味剂和作为防腐剂的木精和尼泊金丙酯。作为着色剂和芳香剂也可以添加樱桃和橙子芳香剂。配制单位容量时所使用的所有辅料应当为精制的、无毒的,比如可以添加乳糖、白砂糖、磷酸钙等稀释剂,硬脂酸镁等润滑剂,淀粉、聚乙烯吡咯烷酮、洋槐树胶、明胶、纤维素等粘合剂。
在本发明所述的组合物中,添加溶菌酶、乳铁蛋白、黄连素等抗菌抑菌物质或配伍时,可以提升肠道致病菌及毒素的清除功能;添加乳果糖、乳酸盐等改变肠道pH值的物质或配伍时,也可以提升肠道致病菌及毒素的清除功能;添加清热解毒的药物成分或配伍时,可以提升润肠通便的功能;添加调血脂、调血糖、抗氧化等物质成分或配伍时,可以提升调血脂、血糖调节能力;添加消化酶抑制剂、脂肪吸收抑制剂、糖吸收抑制剂等物质成分或配伍时,可以提升减肥的效果。
实施例40
便秘小鼠润肠通便作用研究:选用成年Balb/c雄性小鼠,体重18-22g,SPF级,每组6只。试验组分别给予实施例1、2、8、9、15、16、23、24组合物,阳性对照组给予为已上市美国NOW FOODS产膳食纤维车前子胶囊(psyllium husk/seed,以下简称车前子组),给予量均为0.5g/kg/D,每日分1-3次灌胃。连续灌胃7天后,各组小鼠禁食不禁水16小时,经口灌胃给予造模药物复方地芬诺酯(10mg/kg)建立小鼠便秘模型,灌胃复方地芬诺酯30min后,阴性对照组和模型对照组小鼠用墨汁灌胃,试验组和阳性对照组给予混有适量墨汁的受试物0.2g/kg,动物均单笼饲养,正常饮水进食。测定小鼠的首粒排黑便排便时间、6h内排便粒数和排便重量、便干重量情况。
结果显示,对小鼠体重影响,试验组和车前子组与阴性对照组和模型组相比无统计学差异;墨汁推进率,车前子组小鼠(31.35±4.27%)显著高于模型组(61.25±6.41%,P<0.05),试验组小鼠均显著高于车前子组(P<0.01),高出57.96%-153.2%;与阴性对照组小鼠首粒黑便时间(120.19±6.53min)、排便粒数(51.58±3.17)及排便重量(0.98±0.09g)相比,模型组小鼠首粒黑便时间(260.41±7.84min)显著推迟(P<0.05),排便粒数(24.03±2.39)及排便重量(0.42±0.05g)均显著降低(P<0.05),表明便秘模型建立成功。与模型组相比较,车前子组小鼠的首粒黑便时间(255.56±5.97min)无显著性差异,但排便粒数(34.13±1.81)和排便重量(0.62±0.07g)均明显增加(P<0.05);与车前子组相比,试验组小鼠的首粒黑便时间、排便粒数和排便重量均显著性增加(P<0.02),首粒黑便时间提前了24.57%-51.89%,排便粒数增加了27.64%-37.31%,便重量增加了21.35%-34.15%;6h粪便由硬到软分别为:模型组>车前子组>阴性对照组>1#、2#、8#、9#>15#、16#、23#、24#,均无腹泻。
本研究显示,本发明产品具有增加便量和润肠功能,且缓解大便干燥的功能强于已上市的膳食纤维素胶囊。
实施例41
调节肠道菌群研究:选取KM小鼠,8周龄,18-22g,雄性,每组6只,试验组分别给予实施例3、4、10、11、17、18、25、26;对照组给予美国NOW FOODS车前子胶囊,给予量均为0.5g/kg/D,给予时间30天。在给予受试样品之前,采取小鼠肛门内粪便0.1g,10倍系列稀释,选择合适的稀释度分别接种在各培养基上。培养后,以菌落形态、革兰氏染色镜检、生化反应等鉴定计数菌落,计算出每克湿便中的菌数,取对数后进行统计处理。最后一次给予受试样品之后24h,与实验前同样方式取直肠粪便,检测肠道菌群,观察指标为体重、双歧杆菌、乳杆菌、肠球菌、肠杆菌、产气荚膜梭菌。
结果显示,灌胃第0天,小鼠新鲜粪便中菌群数量组间差异无显著性(P>0.05);灌胃受试物30d后,与阴性对照组小鼠新鲜粪便中各菌群数量相比较,车前子组和3#、4#可促进双歧杆菌和乳杆菌的增殖(P<0.05),但不能降低产气荚膜梭菌、肠杆菌、肠球菌的数量(P>0.05);同车前子组相比,10#、11#、17#、18#、25#、26#可显著降低粪便中细菌总量(P<0.01),尤其是显著降低产气荚膜梭菌、肠杆菌、肠球菌的数量和占比(P<0.01),显著增加菌群双歧杆菌和乳杆菌的占比(P<0.05),改善程度上,26#、25#>17#、18#、10#、11#>车前子。
本研究显示,本发明产品能调节胃肠道菌群,尤其是含吸附剂的组方混合物与已上市纤维素胶囊相比较,具有显著减少肠道致病菌的作用。
实施例42
高脂饮食诱导的肥胖小鼠的减肥作用研究:SPF级C57BL/6J小鼠,6周龄,雄性,18-22g,小鼠经过1周的适应性饲养,每组5只,随机分为阴性对照组、高脂肥胖组、车前子组、试验组(实施例5#、19#、12#、27#等)。车前子组和试验组灌胃给予剂量为0.5g/kg/D,每日分为2-3次灌胃,阴性对照组和高脂肥胖组灌胃等体积无菌水。实验以第一天灌胃为第0周,共持续8周,每周3次记录小鼠的体重和摄食量,第8周末所有小鼠禁食过夜,处死小鼠,立即收集血液样本,并在4℃下3500×g离心10min,取上层血清用于生化测定。迅速解剖小鼠,分离肝脏组织用于病理学检测。
结果显示,与阴性对照组比较,高脂肥胖组小鼠的日均摄食量在实验周期内基本稳定,而车前子组、试验组小鼠的摄食量均有一定程度减少(P>0.05),减少程度在15.34%-32.83%之间。对8周实验过程中各组小鼠的平均体重进行比较。第0周时,各组小鼠具有相似的初始体重,经过8周的高脂饮食诱导,高脂肥胖组小鼠体重量(32.16±2.83g)与阴性对照组(21.16±2.07g)相比具有显著性差异(P<0.05);第4周起,阳性车前子组(25.27±1.51g)、19#(23.13±2.36g)和5#(24.73±2.82g)组的体重较为接近,均显著低于高脂肥胖组(P<0.05),而12#(22.69±2.05g)和27#(22.38±2.44g)组的体重最接近阴性对照组。
与阴性对照组相比,高脂肥胖组小鼠的总胆固醇、甘油三酯和LDL-C浓度显著升高,HDL-C浓度显著下降(P<0.05)出现高血脂症状,证明高脂肥胖小鼠模型建立成功;经过受试物干预后,与高脂肥胖组相比较,同样喂食高脂饲料的阳性车前子组和试验组的总胆固醇、甘油三酯和LDL-C浓度显著降低,HDL-C浓度显著升高(P<0.05),其中,12#和27#组的LDL-C浓度基本恢复至阴性对照组水平。
阴性对照组小鼠肝脏组织油红O染色面积较小,脂滴也很小,肝细胞形态正常;而高脂肥胖组肝脏组织中出现肝细胞脂肪变性,脂滴数目明显增多且呈堆积状,融合为大块的红色脂滴;相比之下,阳性车前子组和试验组的肝脏切片红色脂滴体积明显减小,较为稀疏,呈小颗粒状不均匀分布,肝细胞脂肪轻度变性,尤其是12#和27#组的肝细胞脂肪接近阴性对照组水平。
研究说明,本发明产品具有降血脂、减肥功效,且功能显著优于已经上市的美国NOWFOODS的车前子纤维素胶囊。
实施例43
体外毒素吸附作用研究:配制人工胃液(取1mol/mL的稀盐酸,加水,调节pH为1.5,每100mL液体中加入1g胃蛋白酶,混匀,用0.2μm的无菌滤头过滤)和人工肠液(用KH2PO46.8g加水500mL溶解,用0.4%(w/w)的NaOH回调pH为6.8,每100mL液体中加入1g胰蛋白酶,混匀,用0.2μm的无菌滤头过滤);测定美国NOW FOODS生产的车前子、实施例6#、12#、21#、28#、30#对铅(Pb(Ac)2 .3H20,Pb浓度为1200mg/L,原子吸收分光光度法测定Pb含量)、农药α-六六六(配制浓度1200μg/L,按照GB/T5009.19-1996方法进行测定),致癌物黄曲霉素B1(用油溶解配制浓度为0.1mg/L,用HPLC法测定,C18柱为固定相,以水:异丙醇:乙腈=80:12:8为流动相,用荧光检测器进行检测,其激发波长为365nm,发射波长为450nm,样品用甲醇和水混合液进行萃取)、内毒素(配制40EU/mL的内毒素浓度,鲎试剂法进行检测)等毒素的吸附作用。将毒素配制液与同体积的人工胃液、人工肠液混匀,取待测物2g加纯水50mL搅拌成糊状,完全转移至上述盛有毒素的量瓶中,室温25℃,震荡15min,放置1.5h后过滤,测定过滤液中的毒素,测定吸附百分率,重复试验三次,结果见下表1。
由结果可见,纤维素(NOW FODDS生产的车前子纤维素对毒素的吸附作用有限,本发明专利产品对多种毒素均有较强的吸附作用。
表1受试物对毒素的体外吸附研究结果
实施例44
对内毒素血症小鼠肠道屏障功能的保护作用研究:健康雄性C57BL/6小鼠,体重18-22g,每组6只,设阴性对照组、模型组(内毒素血症)、试验组(NOW FOODS生产车前子纤维、实施例7#、13#、20#、29#、31#);腹腔注射10mg/kg内毒素建立模型;试验组灌胃给予受试物0.3g/kg 30min后腹腔注射10mg/kg内毒素,阴性对照组在相应时间点给予等容量生理盐水灌胃。各组小鼠内毒素处理3h后处死,进行病理学检测和肠通透性测定。病理学检测:无菌留取各组回肠组织(距盲肠10cm处取材),制备蜡块切片,HE染色后,光镜下观察。肠黏膜损伤程度判断:0级为正常;1级为绒毛端上皮下有间隙增宽;2级为绒毛顶端上皮下间隙进一步扩大,绒毛尖端上皮抬高与固有膜剥离;3级为绒毛上皮成片脱落;4级为上皮完全脱落,仅有固有膜;5级为固有层崩解,出现出血与溃疡。肠道通透性测定:各组取出5cm末端回肠和右侧结肠,轻轻洗涤肠腔,并结扎肠的一侧。将200μL的40mg/mL 4-Kda FITC-葡聚糖注入肠腔,然后将其另一侧结扎。将肠袋在37℃下轻轻浸入10mL生理盐水中60min。通过测量肠袋外FITC-葡聚糖的泄漏量来离体评估肠壁通透性变化。
结果显示,各组小鼠回肠组织HE染色后光镜下观察,阴性对照组回肠组织结构正常、肠绒毛完整、排列整齐;内毒素血症组回肠组织可见中性粒细胞浸润,肠绒毛分离,绒毛顶端缺损,基底层断裂,毛细血管暴露、出血;车前子组和7#回肠组织损伤略微减轻,而13#、20#、29#、31#组的回肠组织损伤显著减轻。
内毒素诱导后3h,通过测量肠袋中FITC-葡聚糖的泄漏来评估离体肠道黏膜通透性。阴性对照组的FITC-葡聚糖水平分为2.51±0.72μg/mL,模型组为62.49±6.17μg/mL,车前子组和7#组分别为49.07±5.82μg/mL和40.17±5.31μg/mL,13#(28.51±2.47μg/mL)、20#(26.82±2.29μg/mL)、29#(14.69±1.37μg/mL)、31#(12.31±1.76μg/mL)组均在28.51μg/mL以下。
本研究结果显示,本发明所含吸附剂组合物均能有效清除体内的内毒素,保护肠道黏膜屏障。
实施例45
小鼠有机磷急性中毒的解毒作用研究:NIH小鼠18-22g,雌雄均有,每组5只。取4g受试物(NOW FOODS生产车前子纤维胶囊、实施例3#、12#、22#、32#、33#组合物),加入60mL水搅匀待用。实验前禁食12h,先以终浓度为0.62%敌敌畏0.02mL/g灌胃,随后立即用0.02mL/g的受试物灌胃,对照组生理盐水灌胃,观察小鼠中毒反应和2周的存活率。
结果显示,对照组中毒症状明显,存活率0;车前子组存活率为20%;3#存活率60%,12#、22#的存活率为80%,而32#、33#的存活率为100%。
研究结果显示,本发明产品与已上市纤维素产品相比,具有显著的有机磷吸附解毒作用。
实施例46
黄曲霉素B1攻毒小鼠的解毒作用研究:5周龄健康昆明雄鼠,体重18-22g,饲喂标准日粮,自由饮水,待3天后小鼠对环境已基本适应,每组5只。试验组(NOWFOODS车前子纤维素胶囊、实施例5#、19#、14#、34#、35#组合物)灌胃0.2g/kg/次,早晚各灌胃1次,黄曲霉素B1攻毒组和阴性对照组用生理盐水灌胃,连续灌胃10d。首次灌胃为第1d,在第4d开始试验组和攻毒组每日中午灌胃给予黄曲霉素B1二甲亚砜溶液(250μg/kg,溶解于0.5mL二甲亚砜中),阴性对照组用同体积生理盐水灌胃,连续给药攻毒7d。在试验结束时,试验小鼠禁食过夜自由饮水,次日眼球采血,保存在收集管中。离心后,收集血清保存在-20℃。检测血清AST、ALT、ALP、总蛋白和白蛋白含量,摘取小鼠肝脏进行病理学检查。
研究结果显示,攻毒组小鼠较阴性对照组小鼠的血清总蛋白、白蛋白、球蛋白量均减少(p>0.05),攻毒组小鼠AST、ALT、ALP的酶活性单位分别升高了72.13%(p<0.01)、38.45%(p<0.05)、19.29%(p>0.05)。试验组血清总蛋白、白蛋白、球蛋白量均有升高趋势(p>0.05),升高幅度由大到小依次为34#、35#>19#、14#>5#>车前子组;车前子、5#、14#、19#、34#、35#试验组AST的升高幅度分别为67.37%、51.23%、35.09%、11.23%、10.03%、10.94%;车前子、5#、14#、19#、34#、35#试验组ALT的升高幅度分别为30.76%、21.83%、15.27%、3.05%、4.19%、3.37%;车前子、5#、14#、19#、34#、35#试验组ALP的升高幅度分别为12.40%、11.05%、7.86%、1.42%、0.31%、0.95%。
肝脏病理检查结果,攻毒组小鼠肝小叶中央静脉充血,肝索排列紊乱,肝细胞弥漫性重度肿胀,颗粒变性和水泡变性,肝窦受挤压贫血被膜下肝细胞肿胀程度更加严重,少数肝细胞由重度水泡变性发展至溶解性坏死。车前子和5#组多数肝窦中含血量较对照组略多,肝细胞变性的严重程度与攻毒组比较有明显缓解,被膜下肝细胞轻度肿胀,其余部位肝细胞轻度肿胀和脂变,肝组织中部分区域再生现象明显,见有较多细胞体积和胞核体积较大,且胞核染成深蓝色的新生肝细胞,及双核肝细胞。14#、19#、34#、35#试验组的肝细胞排列呈清晰的索状结构,被膜下肝细胞形态恢复近正常,仅3只小鼠局部肝细胞可见有轻微脂肪变性,被膜附近和组织中局部区域再生修复明显,见有较多新生肝细胞。
研究结果显示,本发明产品具有较强的清除黄曲霉素,保护肝脏的功能,且显著优于已上市产品。
实施例47
清除小鼠肠源性内毒素和降低血氨作用的研究:自身免疫性肝炎是一种病因不明的肝脏慢性炎症疾病,目前认为细胞免疫反应和体液免疫反应均参与了其发病机制,细胞毒性T细胞是主要的致病因素。刀豆蛋白A是一种植物蛋白成分提取物,T淋巴细胞表面有其受体,肝脏是刀豆蛋白A作用的靶器官之一。由于肝内存在Kupffer细胞、T细胞等大量免疫细胞,因此尾静脉注射后刀豆蛋白A能够经血液循环特异性地与肝窦内T细胞表面的受体结合并引起T细胞活化,从而导致肝脏炎症及损伤。由于解剖学上的联系,肝脏长期暴露于较低浓度的肠道细菌及细菌产物的刺激下,并且肝脏是最主要的肠道菌群及肠道抗原、毒素(内毒素、氨等)的过滤器官。肝脏内有大量的免疫细胞如巨噬细胞、树突状细胞、T淋巴细胞以及B淋巴细胞,因此正常肝脏能够迅速有效地清除肠道来源的细菌及细菌产物(抗原、毒素)。当肝脏的功能受损时,肠源性细菌产物可通过门静脉或其侧支循环进入血液形成内毒素血症、升高血氨。肠源性内毒素是强有力的致炎因子,能够引起肝内大量免疫细胞的活化,从而引起肝内大量炎症因子的分泌,这些炎症因子加重了肝脏已有炎症的发生、发展。血氨升高可以引起多器官功能衰竭。
雄性C57BL/6小鼠,6-8周,体重16-20g,每组5只,阳性对照组(联合使用氨苄西林1g/L、甲硝唑1g/L、万古霉素0.5g/L、硫酸新霉素1g/L)溶于小鼠饮用水中,连续喂4周,清除小鼠体内肠道来源性内毒素;试验组(NOW FODDS车前子、实施例36#、37#、38#组合物)0.2g/kg/次,每日早晚灌胃1次,连续1周;阴性对照组和模型组给予同体积生理盐水。阳性对照组、模型组、试验组尾静脉注射刀豆蛋白A(15mg/kg)造模急性自身免疫性肝炎,阴性对照组注射同体积生理盐水,分别在0、6h、12h、20h小时眼眶取血后测定血清中内毒素(鲎试剂检测试剂盒法进行检测)和血氨水平,然后处死小鼠,摘取肝脏进行病理学检测。
研究结果显示,模型组小鼠尾静脉注射刀豆蛋白6h后血清中内毒素水平明显增高,肝脏内出现大量的充血、炎症反应以及组织坏死,20h后血清中内毒素和血氨水平增高更显著,肝组织炎症坏死更加明显。阳性对照组使用抗生素清除肠源性毒素后小鼠6h和20h血清中内毒素和血氨水平接近阴性对照组,肝脏损伤明显减轻,主要表现为镜下肝脏充血减轻、坏死明显减少;36#、37#、38#试验组小鼠的内毒素水平p>0.05)和肝保护作用与阳性对照组(抗生素组)相当;车前子试验组小鼠6h和20h血清中内毒素水平(p>0.05)、血氨水平(p>0.05)和肝损伤均略好于模型组。
研究结果显示,本发明产品可有效清除肠内内毒素,降低血氨水平,对肠源性内毒素所致的自身免疫性疾病有较好的改善作用。
实施例48
人试食润肠通便功能评价:纳入标准:排便次数减少和粪便硬度增加者,大便一周少于3次者,无器质性便秘者;习惯性便秘者。排出标准:不能经口进食者或不能按规定服用受试样品者;主诉不清者;体质虚弱无法进行试验者;30天内进行过外科手术引起便秘症状发生者;因严重器质病变引起的近期排便困难者(结肠癌,严重的肠炎、肠梗阻,炎症性肠病等);便秘困难并拌有疼痛者;30天内发生过急性胃肠道疾病者;孕期及经期妇女;合并有心血管、肝、肾和造血系统等严重全身疾病患者;有其它伴随疾病正在治疗者;短期内服用与受试功能有关的物品,影响到对结果的判断者。入选人员随机分成两组,一组口服美国NOWFODDS产车前子胶囊(0.4g/粒),一组口服本实施例5#胶囊(0.4g/粒),两组口服剂量均为每次3粒,每日早晚1次,连续服用15D,观察至停药后15D。试验期间不改变原来的饮食习惯,正常饮食。共有10人参加,每组5人,试验期间无脱落。
结果显示,服用车前子组受试者精神、睡眠、饮食试食前后无明显变化,大便量增加,大便次数无变化,大便成形似香蕉,前段较硬排出困难,后段较顺滑,停用后第2天恢复至试食前状态;服用5#胶囊受试者试食后饮食无明显变化,精神、睡眠有改善,大便量增加,大便每日增加1-2次,大便松软似泥块,排便顺滑,停用后第3天恢复至试食前状态。
试食结果显示,与已上市产品相比较,本发明产品具有较好的润肠通便、改善便秘的功能。
实施例49
人试食评价肠道排毒功能:
纳入标准:有皮肤色斑(老年斑、黄褐斑、妊娠斑、痤疮);口臭;肠胀气,肠鸣音亢进;肠道排气多、排气臭,大便臭;肛门湿痒臭;自觉情绪低落;夜间皮肤瘙痒;自觉睡眠者;自身体重不满意(25>BMI者)。
排除标准:不能经口进食者或不能按规定服用受试样品者;主诉不清者;体质虚弱无法进行试验者;30天内进行过外科手术引起便秘症状发生者;因严重器质病变引起的近期排便困难者(结肠癌,严重的肠炎、肠梗阻,炎症性肠病等);便秘困难并拌有疼痛者;30天内发生过急性胃肠道疾病者;孕期及经期妇女;合并有心血管、肝、肾和造血系统等严重全身疾病患者;有其它伴随疾病正在治疗者;短期内服用与受试功能有关的物品,影响到对结果的判断者。
入选人员随机分成两组,一组口服美国NOWFODDS产车前子胶囊(0.4g/粒),一组口服本实施例35#胶囊(0.4g/粒),以减肥为目的的受试者每顿餐前口服3粒,用200mL温水口服,其他受试者每日6-9粒,分1-3次口服。连续服用30天,观察至停药后15D。试验期间不改变原来的饮食习惯,正常饮食。共有10人参加,年龄25-89岁,每组均有5人,试验期间无脱落。
结果显示,服用车前子组受试者精神、睡眠、饮食试食前后无明显变化,大便量增加,大便次数无变化,大便成形似香蕉,前段较硬排出困难,后段较顺滑,停用后第2天恢复至试食前状态,且对皮肤色斑(老年斑、黄褐斑、妊娠斑、痤疮)、口臭、肠胀气、肠鸣音亢进、大便臭、肠道排气臭多、肛门湿痒臭、情绪低落、夜间皮肤瘙痒等无改善,1例肥胖者体重下降1.9kg。服用35#胶囊受试者试食后饮食无明显变化,大便量增加,大便每日增加1-2次,大便松软似泥块,排便顺滑,皮肤色斑(老年斑、黄褐斑、妊娠斑、痤疮)3例明显减淡,2例完全消失,口臭和肠胀气、肠鸣音亢进、肠道排气臭多、肛门湿痒臭等症状完全消失,大便臭味明显减轻或消失,情绪改善,夜间皮肤瘙痒完全消失,停用后第7天逐渐恢复至试食前状态,2例肥胖者体重分别下降了2.1kg和2.9kg。
试食结果显示,与已上市产品相比较,本发明产品具有较好的排毒养颜、改善睡眠和情绪,改善皮肤瘙痒、改善肠道胀气和肛门湿痒等症状,也具有明显的减肥功能。
最后应当说明的是,以上内容仅用以说明本发明的技术方案,而非对本发明保护范围的限制,本领域的普通技术人员对本发明的技术方案进行的简单修改或者等同替换,均不脱离本发明技术方案的实质和范围。
Claims (10)
1.一种胃肠排毒、减肥的组合物,其特征在于,所述的组合物包含以下三类组分中的三类或任意两类组分:纤维素类,油脂类和吸附剂类;所述的纤维素类包括膳食纤维素,羧甲基纤维素,交联羧甲基纤维素,羟丙基甲基纤维素,甲基纤维素或纤维素盐中的任意一种或多种;所述的油脂类包括植物油,含植物油的果实、种子或胚芽,聚乙二醇,石蜡油或二甲硅油中的任意一种或多种;所述的吸附剂类包括含甘露糖苷和/或岩藻糖苷的多糖,蒙脱石,沸石,活性炭,壳聚糖或环状糊精中的任意一种或多种。
2.根据权利要求1所述的组合物,其特征在于,所述的膳食纤维素包括车前子壳粉、欧车前亲水胶、桑叶粉、树胶、果胶、藻胶或豆胶中的任意一种或多种。
3.根据权利要求1所述的组合物,其特征在于,所述的植物油为花生油、豆油、亚麻油、蓖麻油、芝麻油、菜子油、山茶油、橄榄油、紫苏子油或火麻仁油中的任意一种或多种。
4.根据权利要求1所述的组合物,其特征在于,所述的含植物油的果实、种子或胚芽包括花生、大豆、芝麻、菜子、油茶籽、油橄榄果实、紫苏籽、火麻仁、郁李仁、松子仁、桃仁、冬瓜仁、杏仁、柏子仁、瓜蒌仁或莱菔子中的任意一种或多种。
5.根据权利要求1所述的组合物,其特征在于,所述的含甘露糖苷和/或岩藻糖苷的多糖包括魔芋胶、槐豆胶、褐藻胶、瓜尔豆胶或黄原胶中的任意一种或多种。
6.根据权利要求1所述的组合物,其特征在于,所述的组合物包含以下重量份数的各组分:
当所述的组合物包含纤维素类,油脂类和吸附剂类三类组分时,各组分的重量份数为纤维素类10-90份,油脂类5-85份,吸附剂类5-85份;
当所述的组合物包含纤维素类和油脂类两类组分时,各组分的重量份数为纤维素类10-90份,油脂类10-90份;
当所述的组合物包含油脂类和吸附剂类两类组分时,各组分的重量份数为油脂类10-90份,吸附剂类10-90份;
当所述的组合物包含纤维素类和吸附剂类两类组分时,各组分的重量份数为纤维素类10-90份,吸附剂类10-90份。
7.根据权利要求6所述的组合物,其特征在于,所述的组合物包含以下重量份数的各组分:
当所述的组合物包含纤维素类,油脂类和吸附剂类三类组分时,各组分的重量份数为纤维素类20-50份,油脂类10-60份,吸附剂类10-60份;
当所述的组合物包含纤维素类和油脂类两类组分时,各组分的重量份数为纤维素类20-80份,油脂类20-80份;
当所述的组合物包含油脂类和吸附剂类两类组分时,各组分的重量份数为油脂类10-60份,吸附剂类10-80份;
当所述的组合物包含纤维素类和吸附剂类两类组分时,各组分的重量份数为纤维素类20-79.5份,吸附剂类20.5-70份。
8.权利要求1-7任一项所述的组合物在制备胃肠排毒、减肥的普通食品、保健食品和/或药品中的应用。
9.一种胃肠排毒、减肥的普通食品、保健食品和/或药品,其特征在于,所述的普通食品、保健食品和/或药品包含权利要求1-7任一项所述的组合物、赋形剂和/或附加剂;所述的普通食品、保健食品和/或药品为胶囊、片剂、丸剂、颗粒剂、饮料、果冻、混悬液或洗漱液。
10.根据权利要求9所述的普通食品、保健食品和/或药品,其特征在于,所述的赋形剂包括甘露醇、葡聚糖、麦芽糊精、葡萄糖、淀粉、乳糖、硬脂酸镁、糖精、滑石、明胶、白砂糖或碳酸镁中的任意一种或多种;所述的附加剂包括氨基酸、维生素和/或微量元素中的任意一种或多种。
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