CN107684574B - 具有降血脂功能的药食两用组合物及其制备方法 - Google Patents
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Abstract
本发明提供一种具有降血脂功能的药食两用组合物，包括如下重量份的各组分：绞股蓝提取物10‑40份、葛根提取物1‑30份、灵芝提取物1‑30份、雪莲培养物1‑30份及辅料25‑35份。该组合物及其保健食品具有辅助降血脂的功能。本发明以中医传统养生理论为指导，并结合现代医学和营养学在辅助降血脂功能方面的研究成果，针对血脂偏高的人群，采用温补脾肾，升发清阳，活血化痰，化浊降脂的保健方法，合理选择原料配伍，制成具有辅助降血脂功能的药食两用组合物，可满足保健食品市场的需求。
Description
技术领域
本发明涉及食品工程领域，具体地说，涉及一种具有降血脂功能的药食两用组合物及其制备方法。
背景技术
随着生活水平的提高，人们日常饮食中蛋白质摄入量显著提高，饮食结构不科学，导致高血脂人群显著增多。目前治疗高脂血症主要采用西药，如他汀类(减少胆固醇的生成)、贝特类(加速含甘油三酯的脂蛋白分解)等，会引起转氨酶升高导致肝功能损害，副作用多、复发率高，而且价格昂贵，不能满足临床上广大患者的需求。
雪莲为菊科凤毛菊属植物，是一种高原多年生珍稀草本植物，药用价值高。维吾尔医认为雪莲补肾活血，强筋骨，营养神经，调节异常体液。中医认为，雪莲温肾助阳，祛风胜湿，通经活血。现代药理研究证明，其有效成分主要为黄酮类化合物和多糖。雪莲培养物是甄选野生雪莲种子采用细胞培养技术获得的高科技产品，经检测含有多种天然雪莲的活性成分，对抗炎镇痛、调节血脂、抗疲劳、免疫调节和抗辐射有很好的疗效。
绞股蓝，别名七叶胆、小芍药云、罗锅底、遍地生根等。葫芦科绞股蓝属多年生草质藤本植物。中医学认为，绞股蓝味苦、性寒，具清热解毒、补气、止咳、祛痰之功能。现代药理学研究证明，绞股蓝具有降血脂、降血压、增加冠状动脉和脑血流量、抗衰老、强壮、增强免疫、护肝、镇静止痛、抗溃疡等作用，对防治动脉硬化、高血压、冠心病、中风、糖尿病、肥胖症、慢性肝炎、慢性萎缩性胃炎、慢性胆囊炎、溃疡病、支气管炎等多种疾病有较显著疗效。
葛根，为豆科植物野葛的干燥根。有解肌退热，透疹，生津止渴，升阳止泻之功。常用于表证发热，项背强痛，麻疹不透，热病口渴，阴虚消渴，热泻热痢，脾虚泄泻。
灵芝又称林中灵、琼珍(学名Ganoderma Lucidum Karst)。外形呈伞状，菌盖肾形、半圆形或近圆形，为多孔菌科真菌灵芝的子实体。具有扶正固本，增强免疫功能，提高机体抵抗力、补气安神、止咳平喘的功效，用于眩晕不眠、心悸气短、神经衰弱、虚劳咳喘，延年益寿。
目前，未见利用绞股蓝提取物、葛根提取物、灵芝提取物及雪莲培养物制备具有降血脂作用的保健食品方面的相关研究报道。
发明内容
本发明的目的是提供一种具有降血脂功能的药食两用组合物及其制备方法。
为了实现本发明目的，本发明的一种具有降血脂功能的药食两用组合物，包括如下重量份的各组分：绞股蓝提取物10-40份、葛根提取物1-30份、灵芝提取物1-30份、雪莲培养物1-30份及辅料25-35份。
优选地，所述组合物包括如下重量份的各组分：绞股蓝提取物20份、葛根提取物20份、灵芝提取物10份、雪莲培养物15份及辅料35份。
本发明所述辅料包括糊精和硬脂酸镁，二者按60-64：1的重量比混合；优选糊精和硬脂酸镁的重量比为60：1。
本发明所述绞股蓝提取物的制备方法为：向绞股蓝中加入70％乙醇，第一次加绞股蓝10倍重量的乙醇，常温提取2小时；第二次加绞股蓝8倍重量的乙醇，常温提取2小时；滤过，合并两次滤液减压浓缩至相对密度1.25-1.30，稠膏减压干燥，干膏粉碎，过80目筛，即得绞股蓝提取物，出膏率8％。
本发明所述葛根提取物的制备方法为：向葛根中加入70％乙醇，浸泡2小时，然后用70％乙醇提取2次，每次提取2小时，第一次加葛根10倍重量的乙醇，常温提取2小时；第二次加葛根8重量的乙醇，常温提取2小时；滤过，合并两次滤液减压浓缩至相对密度1.25-1.30，稠膏减压干燥，干膏粉碎，过80目筛，即得葛根提取物，出膏率14％。
本发明所述灵芝提取物的制备方法为：向灵芝中加水，第一次加灵芝10倍重量的水，常温提取2小时；第二次加灵芝8倍重量的水，常温提取2小时；滤过，合并两次滤液减压浓缩至相对密度1.25-1.30，稠膏减压干燥，干膏粉碎，过80目筛，即得灵芝提取物，出膏率5％。
本发明所述雪莲培养物的制备方法参照ZL200510115902.0(新疆雪莲细胞组织培养物及其大规模继代培养的方法)中公开的一种新疆雪莲细胞组织培养物及其制备方法。具体如下：
I、植株诱导：
分别称取硝酸钾190重量份、硝酸铵165重量份、硫酸镁37重量份、磷酸二氢钾17重量份、氯化钙44重量份，分别加水1000体积份，并加热至完全溶解；将5种溶液混合，加水至5000体积份，混合均匀，得MS培养基母液A，4℃保存备用；
分别称取硫酸锰6.76重量份、硫酸锌3.44重量份、硼酸2.48重量份、碘化钾0.332重量份、钼酸钠0.1重量份、硫酸铜0.00005重量份、氯化钴0.00005重量份，分别加水200体积份，并加热到完全溶解；将7种溶液混合，加水至2000体积份，混合均匀，得MS培养基母液B，4℃保存备用；
分别称取EDTA-2Na7.45重量份、硫酸亚铁5.57重量份，分别加水1000体积份，并加热至完全溶解；将2种溶液混匀，加热，加水至2000体积份，得MS培养基母液C，4℃保存备用；
称取甘氨酸0.4重量份、盐酸硫胺素0.08重量份、盐酸吡哆素0.1重量份、烟酸0.1重量份、肌醇20重量份，加水1000体积份，并加热至完全溶解，加水至1000体积份，混合均匀，得MS培养基母液D，4℃保存备用；
取蔗糖120重量份，加水2000体积份溶解，加热至沸腾；加入MS培养基母液A100体积份、MS培养基母液B10体积份、MS培养基母液C20体积份、MS培养基母液D10体积份，得混合培养基母液；取琼脂24重量份，加水2000体积份搅拌后，加入上述混合培养基母液中，加热至沸腾，琼脂全部溶化；加水至4000体积份；滴加4％氢氧化钠，调pH至5.8，得植株诱导MS培养基；分装；灭菌；备用；
将保藏的新疆雪莲种子用70～75％酒精浸泡25～30分钟，再用0.1～0.15％的升汞摇晃灭菌10分种，最后用无菌水洗4～6次；将灭菌彻底的种子于无菌条件下接种在配好的植株诱导MS培养基上，每25ml培养基中接种8～15粒种子；在25℃，连续光照的条件下培养10天，出芽后，培养成雪莲植株；
II、诱导愈伤组织：
按I步骤中的方法配制MS培养基母液A5000体积份、MS培养基母液B2000体积份、MS培养基母液C2000体积份、MS培养基母液D1000体积份，4℃保存备用；取0.15～0.25重量份2，4-D，滴加4％氢氧化钠至完全溶解，加水至1000体积份，摇匀，得2，4-D母液，4℃保存备用；取0.05～0.15重量份6-BA，滴加4％氢氧化钠至完全溶解，加水至500体积份，摇匀，得6-BA母液，4℃保存备用；取蔗糖120重量份，加水2000体积份溶解，加热至沸腾；加入上述MS培养基母液A200体积份、MS培养基母液B20体积份、MS培养基母液C40体积份、MS培养基母液D20体积份、2，4-D母液20体积份、6-BA母液4体积份，得混合培养基母液；取琼脂24重量份，加水2000体积份，搅拌，加入上述混合培养基母液中，加热至沸腾，琼脂全部溶化；加水至4000体积份；滴加4％氢氧化钠，调pH至5.8，得诱导愈伤组织MS培养基；分装；灭菌；备用；
雪莲植株继续培养至5～8cm，选取生长良好的雪莲植株作为外植体；将外植体接种于诱导愈伤组织MS培养基上，每25ml培养基中接种6～10块直径为0.5cm的外植体，暗培养5～10天；诱导产生愈伤组织，愈伤组织在光照条件下培养，光照条件为8-12小时/天，白光，温度为22℃～28℃；
III、培养物继代培养：
按I步骤中的方法配制MS母液A5000体积份、MS母液B2000体积份、MS母液C2000体积份、MS母液D1000体积份，4℃保存备用；取1.5～2.5重量份NAA，滴加4％氢氧化钠至完全溶解，移入加水至10000体积份，摇匀，备用，得NAA母液，4℃保存备用；取0.5～1.5重量份6-BA，滴加4％氢氧化钠至完全溶解，加水至5000体积份，摇匀，备用，得6-BA母液，4℃保存备用；称取蔗糖1200重量份，加水20000体积份溶解，加热至沸腾；加入培养基母液A2000体积份、培养基母液B200体积份、培养基母液C400体积份、培养基母液D200体积份、NAA母液600体积份、6-BA母液40体积份，得混合培养基母液；取琼脂240重量份，加水20000体积份搅拌，加入上述混合培养基母液中，加热至沸腾，琼脂全部溶化；加水至40000体积份；滴加4％氢氧化钠，调pH至5.8，得继代培养MS培养基；分装；灭菌；备用；
筛选高产细胞系，选取生长旺盛、颜色鲜艳、紫红色特征的愈伤组织进行周期性的继代培养，愈伤组织的培养条件为：15重量份的愈伤组织种子需要在1000体积份的继代培养MS培养基培养，培养周期为15～20天，培养温度为20～30℃；至培养期，选取生长旺盛、颜色鲜艳、紫红色特征的愈伤组织作为种子，种子量为生产量的15％，其他收集并低温真空干燥即得雪莲细胞组织培养物。
所收集的雪莲细胞组织培养物应符合如下质量标准：水分不得过12.0％，总灰分不得过12.0％，酸不溶性灰分不得过3.0％，浸出物不得少于15％；总黄酮不得少于10.0％，绿原酸不得少于0.15％。
所述II步骤中外植体为雪莲植株的茎尖；培养基MS培养基添加2，4-D为0.2重量份，6-BA为0.1重量份。
所述III步骤中培养基MS培养基添加NAA为2重量份，6-BA为1重量份；愈伤组织的培养温度为25℃，培养周期为20天。
所述III步骤中低温真空干燥条件为真空回旋干燥，干燥温度为40℃。
本发明提供的具有降血脂功能的药食两用组合物可以制成片剂、胶囊剂、丸剂、颗粒剂或粉剂等剂型。其活性成分为总黄酮、总皂苷及葛根素。
本发明还提供所述组合物的制备方法，将绞股蓝提取物、葛根提取物、灵芝提取物、雪莲培养物及辅料，分别过筛后混合均匀，向混合粉中加入混合粉重量15％-25％的80％乙醇水溶液制软材，过18-25目筛后进行制粒、干燥、整粒，即得。
本发明进一步提供所述组合物在制备具有降血脂作用的保健食品中的应用。
本发明以中医传统养生理论为指导，并结合现代医学和营养学在辅助降血脂功能方面的研究成果，针对血脂偏高的人群，采用温补脾肾，升发清阳，活血化痰，化浊降脂的保健方法，合理选择原料配伍，制成具有辅助降血脂功能的药食两用组合物，可满足保健食品市场的需求。本品具备以下特点和优势：
(一)配方设计中吸取了传统中医学理论的经验，充分利用绞股蓝提取物、葛根提取物、灵芝提取物和雪莲培养物的多方面功效，在降低血脂的基础上注重人体脏腑机能的综合调理，使用者在降低血脂的同时不会产生任何的不适，获得较高的生活质量；
(二)借鉴了现代药理学研究成果，并采用了先进的制剂技术，降脂效果显著；
(三)原料绞股蓝提取物、葛根提取物和灵芝提取物均来自天然植物，雪莲培养物来源于菊科植物天山雪莲的愈伤组织。其中绞股蓝属于可用于保健食品的植物，葛根是药食两用的植物，灵芝为可用于保健食品的真菌菌种，雪莲培养物为我国卫生部批准使用的新食品原料。针对血脂偏高的人群，能协同增效，增强功能；本品所用原料均为安全的保健食品原料，生产工艺符合食品卫生相关要求，产品无任何毒副作用，适于长期食用；
(四)可将本发明组合物制成片剂，定量准确，吸收快；表面光滑，口感好，易吞服；携带方便、食用安全，具有良好的市场前景。
具体实施方式
以下实施例用于说明本发明，但不用来限制本发明的范围。若未特别指明，实施例中所用的技术手段为本领域技术人员所熟知的常规手段，所用原料均为市售商品。
实施例1-6 具有降血脂功能的药食两用组合物及其制备方法
实施例1-6提供的具有降血脂功能的药食两用组合物配方见表1。
表1
制备方法如下：将绞股蓝提取物、葛根提取物、灵芝提取物、雪莲培养物及辅料，分别过筛后搅拌30分钟至混合均匀，向混合粉中加入混合粉重量20％的80％乙醇水溶液制软材，过18目筛后进行制粒、干燥、整粒，得到的颗粒再混合20分钟后压片即得具有降血脂作用的雪莲片。
实施例7 雪莲片的降血脂功效(实验动物)
维持饲料喂养大鼠适应，7天后，按体重分为两组，分别为模型饲料组40只，空白对照组10只，空白对照组大鼠正常饲养，模型对照组大鼠用模型饲料，喂养14天后不禁食眼底静脉采血测定TC、TG、LDL-C、HDL-C，根据TC水平随机分为4组，三个剂量组、一个高脂模型对照组。三个剂量组给予模型饲料和不同剂量的实施例1的雪莲片(高、中、低剂量组分别按0.94g/kg·bw/0.47g/kg·bw和0.24g/kg·bw剂量施用)，高脂模型对照组给予模型饲料和蒸馏水，空白对照给予维持饲料和蒸馏水。
其中，所用维持饲料购自北京科澳协力饲料有限公司。所用模型饲料是向维持饲料中添加20％蔗糖、15％猪油、1.2％胆固醇及0.2％胆酸钠，另外加入适量酪蛋白、磷酸氢钙、石粉等。
试验结束时称重，给予不同剂量雪莲片的三个剂量组的动物体重无明显影响。
试验结果见表2-表4，高、中两个剂量组大鼠血清中TC值明显低于高脂模型对照组，且差异有显著性(P<0.01、P<0.05)；高剂量组大鼠血清中TG值明显低于高脂模型对照组，且差异有显著性(P<0.05)；高剂量组大鼠血清中LDL-C值明显低于高脂模型对照组，且差异有显著性(P<0.05)。且高脂模型对照组TC、TG、LDL-C均值明显高于空白对照组且差异有显著性(P<0.01)，说明高脂模型造模成功。由此说明，本发明提供的雪莲片具有辅助降血脂的功能。
表2 雪莲片对大鼠血清TC的影响
注：各剂量组与高脂模型对照组比较，**表示P＜0.01，*表示P＜0.05。
表3 雪莲片对大鼠血清TG的影响
注：各剂量组与高脂模型对照组比较，**表示P＜0.01，*表示P＜0.05。
表4 雪莲片对大鼠血清LDL-C的影响
注：各剂量组与高脂模型对照组比较，**表示P＜0.01，*表示P＜0.05。
实施例8 雪莲片的降血脂功效(人体试食试验)
采用自身与组间两种对照设计。110例符合要求的有效高血脂受试者，试食组52例、对照纽约例。试食组按要求服用实施例1中制备的雪莲片，每日2次，每次2片，口服，对照组为空白对照。受试期间保持平日的生活和饮食习惯，服用60天后未见不良反应，主要临床症状有所改善。试食前两组间血清总胆固醇、甘油三醋、高密度脂蛋白胆固醇无显著差异，具有可比性；试食组试食前后自身比较，血清总胆固醇平均下降(0.62土0.50)mmol/L(P＜0.001)，平均下降百分率为10.72％，有效率59.6％；血清甘油三醋平均下降(0.48土0.31)mmol/L(P＜0.001)，平均下降百分率为24.22％，有效率71.2％；血清低密度脂蛋白胆固醇下降(P＜0.001)，血清高密度脂蛋白胆固醇含量差异无显著性(P＞0.05)。试食组52例中，总有效14例，总有效率26.9％，显著高于对照组(P＜0.01)。试食后试食组与对照组组间比较，血清总胆固醇平均下降0.41mmol/L(P＜0.01)、甘油三酯平均下降0.51mmol/L(P＜0.001)、血清低密度脂蛋白胆固醇显著低于对照组(P<0.05)，血清高密度脂蛋白胆固醇含量显著高于对照组(P<0.05)。试食者试食前后血常规、尿常规、便常规及血生化〈除血脂外)指标均在正常范围，说明本品对试食者身体健康无不良影日向:在试食过程中未观察到过敏及其它不良反应。根据国家食品药品监督管理局(国食药监保化[2012]107号〉附件6中辅助降血脂功能人体试食试验的判定标准，结果显示实施例1中制备的雪莲片具有辅助降血脂功能。
实施例9 雪莲片的降血脂功效
实验组：服用雪莲茶。雪莲茶，系在茶的基础上添加雪莲培养物制成的袋泡茶，每袋含雪莲培养物100mg。
对照组：服用安慰剂。安慰剂采用与实验组相同的袋泡茶，但其中不含雪莲培养物。
实验方法：选择年龄介于18和65周岁之间且血清总胆固醇大于5.2mmol/L、甘油三酯大于1.7mmol/L的自愿受试者20人，任选8人为对照组，其余12人列为实验组。对照组人员服用安慰剂，实验组服用雪莲茶，每日1袋。连续服用2个月。
分别采集实验组及对照组受试者的静脉血，获取血脂数据，结果如表5所示。结果显示，与对照组相比，实验组在服用后血液总胆固醇和甘油三酯含量明显降低，说明雪莲培养物能够显著降低高血脂人群的血清总胆固醇和甘油三酯含量，具有显著的降血脂作用。
表5 雪莲培养物对血脂水平的影响(mmol/L)
*与对照组比较，P<0.05，有显著差异。
虽然，上文中已经用一般性说明及具体实施方案对本发明作了详尽的描述，但在本发明基础上，可以对之作一些修改或改进，这对本领域技术人员而言是显而易见的。因此，在不偏离本发明精神的基础上所做的这些修改或改进，均属于本发明要求保护的范围。
Claims (4)
1.一种具有降血脂功能的药食两用组合物，其特征在于，由如下重量份的各组分制成：绞股蓝提取物20份、葛根提取物20份、灵芝提取物10份、雪莲培养物15份及辅料35份；
所述辅料为糊精和硬脂酸镁，二者按60：1的重量比混合；
所述绞股蓝提取物的制备方法为：向绞股蓝中加入70％乙醇，第一次加绞股蓝10倍重量的乙醇，常温提取2小时；第二次加绞股蓝8倍重量的乙醇，常温提取2小时；滤过，合并两次滤液减压浓缩至相对密度1.25-1.30，稠膏减压干燥，干膏粉碎，过80目筛，即得绞股蓝提取物，出膏率8％；
所述葛根提取物的制备方法为：向葛根中加入70％乙醇，浸泡2小时，然后用70％乙醇提取2次，每次提取2小时，第一次加葛根10倍重量的乙醇，常温提取2小时；第二次加葛根8重量的乙醇，常温提取2小时；滤过，合并两次滤液减压浓缩至相对密度1.25-1.30，稠膏减压干燥，干膏粉碎，过80目筛，即得葛根提取物，出膏率14％；
所述灵芝提取物的制备方法为：向灵芝中加水，第一次加灵芝10倍重量的水，常温提取2小时；第二次加灵芝8倍重量的水，常温提取2小时；滤过，合并两次滤液减压浓缩至相对密度1.25-1.30，稠膏减压干燥，干膏粉碎，过80目筛，即得灵芝提取物，出膏率5％。
2.根据权利要求1所述的组合物，其特征在于，所述组合物为片剂、胶囊剂、丸剂、颗粒剂或粉剂。
3.权利要求1或2所述的组合物的制备方法，其特征在于，将绞股蓝提取物、葛根提取物、灵芝提取物、雪莲培养物及辅料，分别过筛后混合均匀，向混合粉中加入混合粉重量15％-25％的80％乙醇水溶液制软材，过18-25目筛后进行制粒、干燥、整粒，即得。
4.权利要求1或2所述组合物在制备具有降血脂作用的保健食品中的应用。
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