CN107496852A - 一种具有减肥功效的组合物及其制备方法、用途 - Google Patents
一种具有减肥功效的组合物及其制备方法、用途 Download PDFInfo
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Abstract
本发明涉及保健食品领域，公开了一种组合物及其制备方法、用途，尤其是一种具有减肥功效的组合物及其制备方法、用途。本发明选用绞股蓝、杜仲叶、泽泻、荷叶、姜黄五味药食同源的药材与绿茶、低聚木糖配合，以此为原料制成一种具有减肥功效的组合物，该组合物配方简单，各组分相互影响、协同作用，起到很好的降脂减肥作用。本发明所述组合物的制备方法将绞股蓝、杜仲叶、泽泻、荷叶、姜黄、绿茶、低聚木糖按一定比例混合制得，最大程度地保留了各原料的有效成分，制备得的组合物降脂减肥作用效果显著，同时操作简单，适合于工业化生产。
Description
技术领域
本发明涉及保健食品领域，具体涉及一种组合物及其制备方法、用途，尤其涉及一种具有减肥功效的组合物及其制备方法、用途。
背景技术
肥胖是指一定程度的明显超重与脂肪层过厚，是体内脂肪，尤其是甘油三酯积聚过多而导致的一种状态。由于食物摄入过多或机体代谢的改变而导致体内脂肪积聚过多造成体重过度增长并引起人体病理、生理改变或潜伏。临床上，通常将肥胖分为三大类：单纯性肥胖、病理性肥胖和特殊性肥胖。虽然肥胖本身并不致命，但已被世界卫生组织列为严重危害人类健康的5大疾病之一。肥胖与心血管疾病、Ⅱ型糖尿病、高血压、血脂异常、高尿酸血症、某些肿瘤以及睡眠呼吸紊乱等多种疾病的发生密切相关。
随着人们生活水平的提高以及对健康的重视，如何避免肥胖及肥胖并发症的发生，是人们十分关心的问题。而现有技术对肥胖的治疗效果并不理想。
发明内容
有鉴于此，本发明的目的在于提供一种减肥功效显著的组合物及其制备方法、用途。
为实现本发明的目的，本发明采用如下技术方案：
一种组合物，由如下原料制成：绞股蓝、杜仲叶、泽泻、荷叶、姜黄提取物、绿茶提取物和低聚木糖。
本发明选用绞股蓝、杜仲叶、泽泻、荷叶、姜黄五味药食同源的药材与绿茶、低聚木糖配合，以此为原料制成一种具有减肥功效的组合物，该组合物配方简单，各组分相互影响、协同作用，起到很好的降脂减肥作用。
其中，绞股蓝，又称：天堂草、福音草、超人参、公罗锅底、遍地生根、七叶胆、五叶参和七叶参等，为葫芦科、绞股蓝属绞股蓝的全草。绞股蓝味苦、微甘，性凉，归肺、脾、肾经，具有益气健脾、化痰止咳、清热解毒的功效，主要用于体虚乏力、虚劳失精、白细胞减少症、高脂血症、病毒性肝炎、慢性胃肠炎、慢性气管炎等病症。
杜仲(Eucommia ulmoides Oliver)，又名胶木，为杜仲科植物。具有补肝肾，治腰脊酸疼，足膝痿弱，小便余沥，阴下湿痒，高血压、安胎的功效。对免疫系统、内分泌系统、中枢神经系统、循环系统和泌尿系统都有不同程度的调节作用，杜仲能兴奋垂体-肾上腺皮质系统，增强肾上腺皮质功能。
泽泻，为多年生水生或沼生草本，味甘、性寒，归肾、膀胱经，具有利水、渗湿、泄热的功效，主治小便不利、水肿胀满、呕吐、泻痢、痰饮、脚气、淋病、尿血等病症。
荷叶，为睡莲科植物莲(Nelumbo nucifera Gaertn.)的干燥叶。荷叶味苦辛微涩、性凉，归心、肝、脾经，具有消暑利湿，健脾升阳，散瘀止血的功效主治暑热烦渴，头痛眩晕，水肿，食少腹胀，泻痢，白带，脱肛，吐血，衄血，咯血，便血，崩漏，产后恶露不净，损伤瘀血。
姜黄，姜黄(拉丁学名：Curcuma longa L.)又名：郁金、宝鼎香、毫命、黄姜等，为姜黄芭蕉目，姜科、姜黄属多年生草本植物。姜黄能行气破瘀，通经止痛。主治胸腹胀痛，肩臂痹痛，心痛难忍，产后血痛，疮癣初发，月经不调，闭经，跌打损伤。
本发明所述组合物中，采用姜黄提取物，所述姜黄提取物可通过购买得到，也可通过一些常规方法提取得到，提取方法为：(请补充具体的提取方法)。
绿茶是以适宜茶树新梢为原料，经杀青、揉捻、干燥等典型工艺过程制成的茶叶。其干茶色泽和冲泡后的茶汤、叶底以绿色为主调，故名绿茶。绿茶是未经发酵制成的茶，保留了鲜叶的天然物质，含有的茶多酚、儿茶素、叶绿素、咖啡碱、氨基酸、维生素等营养成分也较多。绿茶中的这些天然营养成份对防衰老、防癌、抗癌、杀菌、消炎、醒脑提神、利尿解乏、缓解疲劳等具有特殊效果，常饮绿茶能防癌，降血脂和减肥。吸烟者可减轻尼古丁伤害。
本发明所述组合物中，采用绿茶提取物，制备方法为：取绿茶，经水浸、浓缩、灭菌、干燥即得。
低聚木糖，(xylo-oligosaccharides)是由2～7个D-木糖(xylose)以β-1，4-糖苷键连接而成的直链或支链低度聚合糖，部分还含有阿拉伯糖醛酸、葡萄糖醛酸侧链，其中以木二糖(xylobiose，X2)和木三糖(xylotriose，X3)为主，是一种功能性寡聚糖类益生元。
作为优选，各原料重量份为：绞股蓝35～200份、杜仲叶20～180份、泽泻30～150份、荷叶30～150份、姜黄1～30份、绿茶提取物1～30份和低聚木糖1～30份。
更优选，各原料重量份为：绞股蓝60份、杜仲叶50份、泽泻42份、荷叶36份、姜黄提取物4份、绿茶提取物2份和低聚木糖6份。
在一些具体实施例中，本发明所述组合物由如下重量份原料制成：
绞股蓝120份、杜仲叶20份、泽泻70份、荷叶60份、姜黄提取物2份、绿茶提取物10份和低聚木糖20份。
在一些具体实施例中，本发明所述组合物由如下重量份原料制成：
绞股蓝36份、杜仲叶120份、泽泻30份、荷叶80份、姜黄提取物1份、绿茶提取物8份和低聚木糖10份
本发明还提供了所述的组合物的制备方法，其特征在于，包括如下步骤：
将绞股蓝、杜仲叶、泽泻、荷叶用乙醇进行提取，将提取液浓缩后与绿茶提取物、姜黄提取物、低聚木糖混合，制得所述组合物。
作为优选，所述乙醇的体积分数为75％。
本发明还提供了所述组合物在制备具有减肥功效的药物中的应用。
在一个具体实施例中，本发明采用肥胖模型法考察本发明所述组合物对肥胖模型大鼠体重、摄食量、摄入总热量、大鼠体内脂肪重量、脂/体比的影响。结果显示，本发明所述组合物对大鼠总摄食量、摄入总热量没有明显影响，但对大鼠体重增加、体内脂肪重量以及脂/体比影响显著。给予本发明所述组合物6周后大鼠酶百克饲料体重增重量明显减少，具有统计学意义(P<0.05)；体内脂肪重量和脂/体比都显著减少，并且具有统计学意义(P<0.05)。
本发明还提供了一种药物，包括所述的组合物和药学上可接受的辅料。
作为优选，所述剂型为片剂、口服液剂、胶囊剂、粉剂、丸剂或颗粒剂。
本领域技术人员可以根据不同使用者的需求将本发明所述组合物加入制备不同剂型时所需的各种药学上可接受的辅料，如崩解剂、润滑剂、乳化剂、粘合剂等，以常规制剂方法，经常规加工直接或间接的加入药学上的可接受的辅料制成常用制剂，如片剂、口服液剂、胶囊剂、粉剂、丸剂、颗粒剂等。
本发明选用绞股蓝、杜仲叶、泽泻、荷叶、姜黄五味药食同源的药材与绿茶、低聚木糖配合，以此为原料制成一种具有减肥功效的组合物，该组合物配方简单，各组分相互影响、协同作用。动物实验显示，本发明所述组合物对大鼠体重增加、体内脂肪重量以及脂/体比影响显著。给予本发明所述组合物6周大鼠每百克饲料体重增重量明显降低，具有统计学意义(P<0.05)；体内脂肪重量和脂/体比也显著减少，并且具有统计学意义(P<0.05)。结果表明，本发明所述组合物减肥作用效果显著。
具体实施方式
本发明公开了一种组合物及其制备方法、用途，本领域技术人员可以借鉴本文内容，适当改进工艺参数实现。特别需要指出的是，所有类似的替换和改动对本领域技术人员来说是显而易见的，它们都被视为包括在本发明。本发明的方法及应用已经通过较佳实施例进行了描述，相关人员明显能在不脱离本发明内容、精神和范围内对本文所述的方法和应用进行改动或适当变更与组合，来实现和应用本发明技术。
对所公开的实施例的说明，使本领域专业技术人员能够实现或使用本发明。对这些实施例的多种修改对本领域的专业技术人员来说将是显而易见的，本文中所定义的一般原理可以在不脱离本发明的精神或范围的情况下，在其它实施例中实现。因此，本发明将不会被限制于本文所示的这些实施例，而是要符合与本文所公开的原理和新颖特点相一致的最宽的范围。
下面结合实施例，进一步阐述本发明：
实施例1本发明所述组合物
各原料重量份为：绞股蓝60份、杜仲叶50份、泽泻42份、荷叶36份、姜黄提取物4份、绿茶提取物2份和低聚木糖6份。
实施例2本发明所述组合物
各原料重量份为：绞股蓝120份、杜仲叶20份、泽泻70份、荷叶60份、姜黄提取物2份、绿茶提取物10份和低聚木糖20份。
实施例3本发明所述组合物
各原料重量份为：绞股蓝36份、杜仲叶120份、泽泻30份、荷叶80份、姜黄提取物1份、绿茶提取物8份和低聚木糖10份。
实施例4本发明具有减肥功效的片剂
处方如表1所示。
表1片剂处方
| 种类 | 质量百分数(％) |
| 实施例1的组合物 | 70％ |
| 微晶纤维素 | 15％ |
| 异麦芽酮糖醇 | 10％ |
| 二氧化硅 | 2％ |
| 硬脂酸镁 | 1％ |
| 羧甲基纤维素钠 | 1％ |
制备工艺：
(1)制粒：取实施例1所述组合物干燥后与微晶纤维素、异麦芽酮糖醇混合，用羧甲基纤维素钠液作为粘合剂，进行制粒、整粒；
(2)混合：干颗粒与二氧化硅、硬脂酸镁混合后，备用；
(3)压片：总混粉进行压片。
实施例5本发明具有减肥功效的硬胶囊
处方如表2所示。
表2硬胶囊处方
| 种类 | 质量百分数(％) |
| 实施例1的组合物 | 76％ |
| 预胶化淀粉 | 23％ |
| 二氧化硅 | 1％ |
制备工艺：
取实施例1所述组合物干燥，与预胶化淀粉和二氧化硅进行混合30min后填装0#胶囊。
实施例6本发明具有减肥功效的口服液
处方如表3所示。
表3口服液处方
| 种类 | 质量百分数(％) |
| 实施例1的组合物 | 89％ |
| 柠檬酸 | 7％ |
| 香精 | 2％ |
| 安赛蜜 | 2％ |
制备工艺：
(1)配液：取实施例1的组合物，加入柠檬酸、柳橙味香精、安赛蜜搅拌均匀，定容，备用。
(2)过滤，均质：上述液体过20-100μm过滤，再经过均质机。
(3)灭菌：溶液通过UHT设备进行灭菌。
(4)罐装：趁热罐装。注意检查罐装密封性。
(5)灭菌：灌装产品通过巴氏灭菌设备，进行灭菌。
(6)包装：检验合格后，包装。按企业标准抽取样品检验，合格后入库。
实施例7本发明具有减肥功效的粉剂
处方如表4所示。
表4粉剂处方
| 种类 | 质量百分数(％) |
| 实施例1的组合物 | 75％ |
| 异麦芽酮糖醇 | 15％ |
| 柠檬酸 | 7％ |
| 香精 | 2％ |
| 安赛蜜 | 1％ |
制备工艺
(1)混合：取实施例1所述组合物干燥，加入异麦芽酮糖醇、柠檬酸、柳橙味香精、安赛蜜混合均匀；
(2)袋包：采用颗粒机，用铝箔膜进行袋包。注意关注袋包装量稳定性、袋包密封性。
实施例8
1材料和方法
1.1、实验动物：雄性SD大鼠，SPF级，105只。试验开始体重：161.2～218.5g。由广东省医学实验动物中心提供；实验动物生产许可证：SCXK(粤)2013-0002。动物饲养在广东省医学实验动物中心SPF级动物房，实验动物使用许可证号：SYXK(粤)2013-0002/
1.2主要实验仪器与试剂
BS-3000A电子天平，精度0.1g，上海友声衡器有限公司；ACS电子天平，精度0.1g，中山衡新电子有限公司；BS223S电子分析天平，精度0.001g，德国Sartorius公司；BS224S电子分析天平，精度0.0001g，德国Sartorius
1.3剂量设计与分组
适应期结束后动物按体重随机分成2组，10只大鼠给予维持饲料作为空白对照组，95只给予高热量饲料作为模型组；喂养2周后，模型组大鼠按体重增重排序，淘汰体重增重较低的肥胖抵抗大鼠15只，余下80只大鼠按体重随机分为8组，即模型对照组和七个试验组，第一试验组～第七试验组，10只/组。按标准人60kg计算，以人体剂量的20倍作为给药量。
1.4饲料配方
普通饲料配方：基础饲料3.55kcal/g
高热量饲料配方：猪油15％，蔗糖15％，酪蛋白8％，磷酸氢钙1％，石粉0.5％，盐0.2％，基础饲料60.3％，热量为4.4kcal/g
1.5实验方法：除空白对照组给予普通饲料外，其余各组均给予高热量模型饲料。取表5所示配方的组合物，加入一定体积的去离子水，配制成浓度为200mg/mL的药液。各试验组每天给予所述药液(1mL/100g体重)。空白对照组、模型对照组给予等量去离子水，1次/天，连续42天。试验结束不禁食，称量体重，1％戊巴比妥钠(0.5mL/100g)麻醉，解剖取肾周围脂肪、睾丸周围脂肪，并称重，计算脂/体比。
表5药物组成
1.6观察指标
1.6.1观察：从实验开始至实验结束，每天观察动物皮毛色泽、行为活动等情况。
1.6.2体重、给食量、撒食量、剩食量：试验开始及试验结束各测量体重1次；试验期间，每周测量体重、给食量、撒食量、剩食量各1次。
1.6.3体重增重：为试验期间体重值与试验前体重值的差值。
1.6.4每百克饲料体重增重＝(同期内体重的增量/同期内的摄食量)×100
1.6.5摄食量、摄入总热量、食物利用率
日摄食量＝给食量-摄食量-撒食量；
试验期间摄食量＝每周摄食量之和；
摄入总热量＝试验期间摄食量×每公斤饲料热量；
食物利用率＝(同期内体重的增量/同期内的摄食量)×100％。
1.6.6体内脂肪重量、脂肪/体重：体内脂肪重量＝肾周围脂肪+睾丸周围脂肪；脂/体比＝体内脂肪重量/体重×100％。
1.7数据处理和分析：
采用SPSS21.0软件进行统计分析，所有实验结果的数据以均数±标准差表示，采用方差分析，方差齐，计算F值，F值<F0.05，结论：各组均数间差异无显著性；F值≥F0.05，P≤0.05，用多个实验组和一个对照组间均数的两两比较方法进行统计；对非正态或方差不齐的数据进行适当的变量转换，待满足正态或方差齐要求后，用转换后的数据进行统计；若变量转换后仍未达到正态或方差齐的目的，改用秩和检验进行统计。采用方差分析加Q检验进行统计。
2试验结果
2.1各试验组药物对肥胖模型大鼠体重的影响，结果见表6。
表6各实验组对肥胖模型大鼠体重的影响(x±s，g，♂)sx
注：与空白对照组相比，“▲”P<0.05，“▲▲”P<0.01；与模型对照组相比，“★”P<0.05。
由表6结果可知，与空白对照组大鼠比较，模型对照组大鼠在给药42d的体重、每百克饲料体重增重均增加，具有统计学差异(P<0.05)，体重增重值增加，但未见统计学差异(P>0.05)；与模型对照组比较，各治疗组在给药42d的体重、体重总增重值均未见统计学差异(P>0.05)；与模型组对照组比较，第三试验组～第六试验试验组的体重总增重和每百克饲料的体重总增重均无明显变化，结果比较接近。第一、二试验组的体重总增重和每百克饲料的体重增重明显降低，且每百克饲料的体重增重具有统计学意义(P<0.05)，其余各试验组大鼠的每百克饲料体重增重均未见统计学差异(P>0.05)。
2.2各试验组药物对肥胖模型大鼠摄食量、摄入总热量、食物利用率、体内脂肪重量、脂/体比的影响，结果见表7。
表7各组大鼠摄食量、摄入总热量、食物利用率、体内脂肪重量、脂/体比的比较(x±s，g，♂)sx
注：除体内脂肪重量、脂肪/体重数据采用非参数K-W检验分析外，其余数据采用方差分析方法。与空
白对照组相比，“▲▲”P<0.01；与模型对照组相比，“★”P<0.05。
由表7结果可知，与空白对照组大鼠比较，模型对照组大鼠给药期间摄食量减少(P<0.01)，摄入总热量未见统计学差异(P>0.05)，食物利用率升高(P<0.05)；与模型对照组大鼠比较，各给药组大鼠的摄食量、摄入总热量均未见统计学差异(P>0.05)，第一、二试验组大鼠的食物利用率下降(P<0.05)，其余各治疗组大鼠的食物利用率均未见统计学差异(P>0.05)。
与空白对照组比较，模型对照组大鼠体内脂肪重量、脂/体比均增加(P<0.01)；与模型对照组大鼠比较，第一、二试验组大鼠体内脂肪重量、脂/体比均减少(P<0.05)，第三试验组大鼠体内脂/体比均减少(P<0.05)，其余各治疗组大鼠体内脂肪重量、脂/体比均无统计学差异(P>0.05)。
以上结果显示，给予肥胖模型大鼠第一试验组或第二试验组所示组合物，大鼠每百克饲料体重增重、体内脂肪重量，脂/体比均显著降低，具有统计学差异(P<0.05)，摄食量未见统计学差异，表明第一、二试验组所示组合物对营养性肥胖大鼠具有显著的减肥效果。给予第三试验组所示组合，该组大鼠脂/体比减少，但未见体重、体重增重、每百克饲料体重增重、食物利用率显著下降，表明第三试验组组合物对营养性肥胖大鼠的减肥效果不明显。给予第四试验组～第六试验组所示组合物，大鼠的体重、体重增重、每百克饲料体重增重、大鼠脂/体比减少和食物利用率均未发生明显变化，表明第四试验组～第六试验组所示组合物对营养性肥胖大鼠的减肥效果极不明显。
取实施例3所述组合物进行上述试验，结果与实施例1～2的效果相同或相近，无显著差异(P＞0.05)。
以上所述仅是本发明的优选实施方式，应当指出，对于本技术领域的普通技术人员来说，在不脱离本发明原理的前提下，还可以做出若干改进和润饰，这些改进和润饰也应视为本发明的保护范围。
Claims (10)
1.一种组合物，其特征在于，由如下原料制成：绞股蓝、杜仲叶、泽泻、荷叶、姜黄提取物、绿茶提取物和低聚木糖。
2.根据权利要求1所述的组合物，其特征在于，各原料重量份为：绞股蓝35～200份、杜仲叶20～180份、泽泻30～150份、荷叶30～150份、姜黄1～30份、绿茶提取物1～30份和低聚木糖1～30份。
3.根据权利要求1所述的组合物，其特征在于，各原料重量份为：绞股蓝60份、杜仲叶50份、泽泻42份、荷叶36份、姜黄提取物4份、绿茶提取物2份和低聚木糖6份。
4.权利要求1～3任一项所述的组合物的制备方法，其特征在于，包括如下步骤：
将绞股蓝、杜仲叶、泽泻、荷叶用乙醇进行提取，将提取液浓缩后与绿茶提取物、姜黄提取物、低聚木糖混合，制得如权利要求1～3任一项所述的组合物。
5.权利要求4所述的制备方法，其特征在于，所述乙醇的体积分数为75％。
6.权利要求1～3所述组合物在制备具有减肥功效的药物中的应用。
7.一种药物，其特征在于，包括权利要求1～3所述的组合物和药学上可接受的辅料。
8.根据权利要求7所述的药物，其特征在于，其剂型为片剂、口服液剂、胶囊剂、粉剂、丸剂或颗粒剂。
9.一种保健食品，其特征在于，包括权利要求1～3所述的组合物和药学上可接受的辅料。
10.根据权利要求9所述的保健食品，其特征在于，其剂型为片剂、口服液剂、胶囊剂、粉剂、丸剂或颗粒剂。
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