CN109601996A - 一种具有辅助降血脂作用的组合物及其应用 - Google Patents
一种具有辅助降血脂作用的组合物及其应用 Download PDFInfo
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Abstract
本发明制备了一种具有辅助降血脂作用的组合物，按重量份计该组合物含有藜麦粉2‑50份、大豆蛋白粉1‑30份、螺旋藻粉0.1‑2份、纳豆提取物0.1‑2份和苦瓜提取物0.1‑2份。在一些优选的方案中，所述组合物中还可以添加叶酸类化合物0.0001‑0.001份、绿茶粉0.1‑3份、玉米花丝粉0.1‑3份。本发明所述的组合物可以用于制备多种具有辅助降血脂作用的制剂。该组合物不仅具有明显的辅助降低血清中总胆固醇(TC)和甘油三酯(TG)的含量、提高高密度脂蛋白胆固醇(HDL‑C)含量的功效，还具有保存时间长，副作用小的优点，适合各个年龄阶段的多种人群使用。
Description
技术领域
本发明属于保健食品领域，具体涉及一种具有辅助降血脂作用的组合物及其应用。
背景技术
脂质是生物体内重要的有机化合物，但过多摄入脂质会使血液中脂质代谢发生异常，引起高脂血症。高脂血症可直接引起一些严重危害人体健康的疾病，如动脉粥样硬化、冠心病、胰腺炎等。降血脂药物具有降低血液中胆固醇(TC)、甘油三酯(TG)、极低密度脂蛋白(VLDL)、低密度脂蛋白(LDL)含量和提高高密度脂蛋白(HDL)含量的作用，可以用来治疗高脂血症。目前常用的治疗高脂血症的药物，主要有以下几类。
一是以降低血总胆固醇和低密度脂蛋白为主的药物：(1)他汀类，如辛伐他汀、普伐他汀和氟伐他汀；但是该类药物易导致肠胃不适、眩晕、头痛、皮疹，严重可见肌痛、肌炎、平滑肌溶解、肾功能衰竭、急性胰腺炎；(2)胆汁酸结合树脂，如考来烯胺、考来替泊；该类药物易引起恶心、腹胀、便秘、脂溶性维生素缺乏、高氯性酸血症；(3)多烯脂肪酸类，如亚油酸；该类药物易导致尿频、口干、恶心。
二是以降低甘油三酯为主的药物：(1)氯贝丁酯类，如氯贝丁酯；该类药物易导致胸痛、气短、心绞痛、腹泻与恶心；(2)苯氧酸类，如非诺贝特；该类药物易导致恶心、腹胀、腹痛、皮疹、脱发、血象及肝功能异常；(3)烟酸类，如阿昔莫司；该类药物易导致恶心、呕吐、腹泻、皮肤瘙痒、肝功能异常。
可见目前的降血脂药物的缺点：副作用大，需长期服用且费用高。基于此，中国专利公告CN103566150B公开了一种具有降血脂作用的药食同源的组合物及其应用，该组合物以植物甾醇、葛根粉、山楂果粉、沙棘粉、昆布粉、洋葱粉、葡萄皮粉、马齿苋粉、绿茶粉为原料，具有显著的降血脂功效。但是，该发明组合物在降血脂的同时并不能促进体重的降低，而且在使用的过程中，没有考虑该组合物对人体是否存在不良影响。
藜麦中淀粉含量低，含有丰富的蛋白质，是一种高钾低钠的食物，能够满足人们每日对矿物质的需要，并且还是膳食纤维的良好来源。藜麦属于易熟易消化食品，口感独特，有淡淡的坚果清香或者人参香，具有均衡补充营养、增强机体功能、修复体质、调节免疫和内分泌、提高机体应激能力、预防疾病、抗癌、减肥、辅助治疗等功效，尤其适于高血糖、高血压、高血脂、心脏病等慢性病。中国专利公布CN107136405A公开了一种全营养藜麦组合物及其制备加工工艺，包括以下原料组成：藜麦粉30-50份、藜麦多糖10-30份、亚麻籽油微囊粉20-40份、胡萝卜粉5-10份、植脂末1-5份。该申请以营养丰富的藜麦粉为基础原料，从而保证全营养组成的基础，且通过藜麦多糖和亚麻籽油微囊粉的协同作用，有效降低血脂，但是该申请并没有充分挖掘藜麦粉本身的降血脂功效。
虽然现有技术公开的产品均具有一定的降血脂功效，但是有的产品只考虑到降血脂功效，并不具有其他功效；有的产品配方主要为食材加工品，产品保质期相对较短，且为了延长保质期不得不添加对人体健康有影响的防腐剂。
目前急需一种能够高效降低服用者的血脂、副作用小、保质期长的辅助降血脂组合物。
发明内容
本发明提供了一种具有辅助降血脂作用的组合物，该组合物多以天然物质作为有效成分，具有降低血脂水平、减轻体重、增强体质的作用，并且在服用过程中，不会对人体产生不良影响。
本发明提供了一种具有辅助降血脂作用的组合物，包括按重量份计的：藜麦粉2-50份、大豆蛋白粉1-30份、螺旋藻粉0.1-2份、纳豆提取物0.1-2份和苦瓜提取物0.1-2份。
苦瓜提取物：功效成分为苦瓜甙，含量10％-30％。
纳豆提取物：主要成分为纳豆激酶，含量70％-90％。
优选地，所述的组合物包括按重量份计的：藜麦粉5-50份、大豆蛋白粉1-20份、螺旋藻粉0.1-1份、纳豆提取物0.1-1份和苦瓜提取物0.1-1份。
在一些优选的实施方案中，所述组合物还包括按重量份计的：叶酸类化合物0.0001-0.001份、绿茶粉0.1-3份、玉米花丝粉0.1-3份。
所述的叶酸类化合物为叶酸、甲酰四氢叶酸、(6S)-5-甲基四氢叶酸、L-甲基叶酸、叶酸可药用盐、叶酸或叶酸可药用盐的活性代谢产物和可在体内代谢和/或生成叶酸的物质中的一种或几种。
在一些优选的实施方案中，所述组合物还包括按重量份计的：叶酸类化合物0.0001-0.0005份、绿茶粉0.1-1份、玉米花丝粉0.1-1份。
在一些更优选的实施方案中，所述组合物含有按重量份计的：藜麦粉5份、大豆蛋白粉5份、螺旋藻粉0.5份、纳豆提取物0.25份、苦瓜提取物0.25份、叶酸0.0003份、绿茶粉0.3份、玉米花丝粉0.3份。
所述具有辅助降血脂作用的组合物的制备方法，其特征在于，称取配方量的各组分混合均匀即得。
所述具有辅助降血脂作用的组合物在制备辅助降血脂产品中的应用。
所述的辅助降血脂产品为辅助降血脂固体制剂。
所述辅助降血脂固体制剂中含有重量百分比为92％-98％的权利要求1所述的组合物、1％-5％的助流剂和余量的调味剂。
所述助流剂为二氧化硅、硅酸钙、磷酸三钙中的一种或几种。
所述调味剂为甜味剂、咸味剂、鲜味剂或酸味剂中的一种或多种。
藜麦属于易熟易消化食品，口感独特，有淡淡的坚果清香或者人参香，具有均衡补充营养、增强机体功能、修复体质、调节免疫和内分泌、提高机体应激能力、预防疾病、抗癌、减肥、辅助治疗等功效，适于所有群体食用，尤其适于高血糖、高血压、高血脂、心脏病等慢性病患者。
在众多的植物性蛋白质中，营养价值最高的是豆类蛋白质(又称大豆蛋白)，而且豆类食物不含胆固醇，可以降低高胆固醇患者的血脂，避免胆固醇对心脏的不利影响。
螺旋藻对三高有一定预防和抑制作用(高血压、高血脂、高血糖)，对慢性胃肠病、胃及十二指肠溃疡症有一定的疗效，还能通便、美容、减肥。
纳豆中的纳豆激酶是在纳豆发酵过程中由纳豆枯草杆菌产生的一种丝氨酸蛋白酶，具有溶解血栓，降低血粘度，改善血液循环，软化和增加血管弹性等作用。
苦瓜中的苦瓜甙能改善胰岛素功能、修复β细胞、减轻和控制Ⅱ型高血糖并发症，还具有调节高血压、高血脂、高胆固醇，保护心脑血管的功效。
与现有技术相比，本发明的有益效果为：
(1)本发明提供了一种具有辅助降血脂作用的组合物，该组合物多以天然物质作为有效成分，各种组分之间发挥正向的相互作用，使该组合物能够有效降低食用者的血脂水平。
(2)本发明的组合物在辅助降低人体血脂水平的同时，基本没有副作用的产生，适合高脂血症患者长期服用。
(3)本发明的组合物，不仅能够辅助降低人体血脂水平，而且还具有调理体质、强身健体的功效。
(4)苦瓜提取物具有良好的降血糖功效，号称植物胰岛素，本申请出乎意料的发现，苦瓜提取物能够进一步增强辅助降血脂成分的降脂功效。
(5)本发明通过调整添加组分的种类和各组分的添加量，能够在获得辅助降血脂效果的同时，延长产品的保存期限。
具体实施方式
实施例1一种具有辅助降血脂作用的组合物
其按重量份计包括：藜麦粉50份、大豆蛋白粉1份、螺旋藻粉2份、纳豆提取物0.1份和苦瓜提取物2份。
实施例2一种具有辅助降血脂作用的组合物
其按重量份计包括：藜麦粉2份、大豆蛋白粉30份、螺旋藻粉0.1份、纳豆提取物2份和苦瓜提取物0.1份。
实施例3一种具有辅助降血脂作用的组合物
其按重量份计包括：藜麦粉20份、大豆蛋白粉15份、螺旋藻粉1份、纳豆提取物1.5份和苦瓜提取物1.3份，其中，苦瓜提取物中功效成分苦瓜甙的含量为10％，纳豆提取物中纳豆激酶的含量70％。
实施例4一种具有辅助降血脂作用的组合物
其按重量份计包括：藜麦粉50份、大豆蛋白粉5份、螺旋藻粉1.2份、纳豆提取物1份和苦瓜提取物1份，其中，苦瓜提取物中功效成分苦瓜甙的含量为30％，纳豆提取物中纳豆激酶的含量90％。
实施例5
其按重量份计包括：藜麦粉5份、大豆蛋白粉5份、螺旋藻粉0.5份、纳豆提取物0.25份、苦瓜提取物0.25份。
实施例6
其按重量份计包括：藜麦粉50份、大豆蛋白粉5份、螺旋藻粉1.2份、纳豆提取物1份、苦瓜提取物1份、叶酸0.001份、绿茶粉0.1份、玉米花丝粉3份，其中，苦瓜提取物中功效成分苦瓜甙的含量为30％，纳豆提取物中纳豆激酶的含量90％。
实施例7一种具有辅助降血脂作用的组合物
其按重量份计包括：藜麦粉30份、大豆蛋白粉5份、螺旋藻粉1.2份、纳豆提取物1份、苦瓜提取物1份、叶酸0.0001份、绿茶粉3份、玉米花丝粉0.1份，其中，苦瓜提取物中功效成分苦瓜甙的含量为25％，纳豆提取物中纳豆激酶的含量75％。
实施例8一种具有辅助降血脂作用的组合物
其按重量份计包括：藜麦粉30份、大豆蛋白粉5份、螺旋藻粉1.2份、纳豆提取物1份、苦瓜提取物1份、甲酰四氢叶酸0.0001份、绿茶粉3份、玉米花丝粉0.1份，其中，苦瓜提取物中功效成分苦瓜甙的含量为25％，纳豆提取物中纳豆激酶的含量75％。
实施例9一种具有辅助降血脂作用的组合物
其按重量份计包括：藜麦粉30份、大豆蛋白粉5份、螺旋藻粉1.2份、纳豆提取物1份、苦瓜提取物1份、(6S)-5-甲基四氢叶酸0.0001份、绿茶粉3份、玉米花丝粉0.1份，其中，苦瓜提取物中功效成分苦瓜甙的含量为25％，纳豆提取物中纳豆激酶的含量75％。
实施例10一种具有辅助降血脂作用的组合物
其按重量份计包括：藜麦粉5份、大豆蛋白粉5份、螺旋藻粉0.5份、纳豆提取物0.25份、苦瓜提取物0.25份、叶酸0.0003份、绿茶粉0.3份、玉米花丝粉0.3份。
对比例1一种具有辅助降血脂作用的组合物
在实施例3的基础上省略了苦瓜提取物的添加。
对比例2一种具有辅助降血脂作用的组合物
在实施例4的基础上，将大豆蛋白粉的添加量由5份，调整为0.5份。
对比例3一种具有降血脂作用的药食同源食品的组合物
中国专利公告CN103566150B中实施例1制备的一种具有降血脂作用的药食同源食品的组合物。
实验例1降血脂功效评价
(1)检测依据：卫生部《保健食品检验与评价技术规范》(2003年版)。采用实施例1-10和对比例1-3制备得到的组合物作为受试样品。
(2)高脂饲料配方：按重量计78.8％基础饲料、1％胆固醇、10％蛋黄粉、10％猪油、0.2％胆盐。
(3)实验动物：SD健康成年雄性大鼠140只，体重180±5g。在实验条件下喂饲基础饲料观察7天，测定TC、TG及HDL-C水平。随后换用高脂饲料喂饲7天，取尾血，测定血清TC、TG及HDL-C水平，与喂饲高脂饲料前相比，血清TC、TG及HDL-C水平升高，差异有显著性(P＜0.05)，判定高脂血症模型造模成功。将造模成功后的大鼠按照TC水平随机分为1个高脂对照组、10个实施例组及3个对比例组，每组10只。
(4)实验方法：本组合物人体推荐量为每人每日10g(0.17g/kg)，大鼠实验用剂量设置为每日0.85g/kg(相当于人体推荐量的5倍)。将样品用蒸馏水配制，每日一次经口灌胃给予，灌胃体积为0.5mL/100g鼠重。高脂对照组用蒸馏水代替本发明中的样品，每日灌胃体积与以上各组相同，连续饲喂30天，在第30天喂食结束后禁食16小时，随后测定血清TC、TG及HDL-C水平，结果如表1所示。
(5)数据处理：对各组大鼠血清TC、TG和HDL-C水平做方差分析，P＜0.05表示有显著差异。
表1
将表1中实施例1-10的实验数据和对照组进行比较，可以发现，本发明制备的组合物不仅具有良好的降低血清中TC和TG含量的功效，而且还具有提高血清中HDL-C含量的功效，有明显的辅助降血脂效果。
将对比例1和实施例3进行比较，可以发现，苦瓜提取物的添加，能够增强组合物的降血脂功效。
进一步比较实施例4和实施例6的实验数据，可以发现，在藜麦粉、大豆蛋白粉、螺旋藻粉、纳豆提取物和苦瓜蛋白粉添加量相同的基础上，通过添加0.001份的叶酸、0.1份的绿茶粉、3份的玉米花丝粉，能够进一步提升本发明组合物的降血脂效果。
实施例7-9组合物的区别在于叶酸类化合物的种类不同，表1中的实验数据显示，在其他条件相同的情况下，添加叶酸比添加甲酰四氢叶酸、(6S)-5-甲基四氢叶酸具有更好的降血脂功效。
本发明同时检测了大鼠血清中AST(谷草转氨酶)、ALT(谷丙转氨酶)、BUN(血尿素氮)、CR(血清肌酐)、UA(尿酸)含量的变化，实验结果显示，服用本发明组合物的大鼠血清中的AST、ALT、BUN、CR、UA含量和对照组中的相应数值相比，没有明显区别，说明本发明制备的组合物，基本没有副作用。但是实验数据显示，服用对比例3组合物的大鼠的血清中AST(谷草转氨酶)含量发生了变化，产生了一定的副作用。
实验例2保存时间
实验前验证组合物的降血脂功效，之后将组合物暴露于温度37±2℃，湿度为75±5％的环境中存放，0个月末、1个月末、2个月末再次验证组合物的降血脂功效。
所述降血脂功效采用如下方法进行检测：
(1)采用实施例1-10和对比例1-2制备得到的组合物作为样品；
(2)实验动物：SD健康大鼠，平均分组，每组10只；
(3)剂量为0.85g/Kg·BW。将样品用生理盐水配制，每日一次经口给予，连续灌胃30天后测各项指标，大鼠灌胃体积为0.5mL/100g鼠重，对照组用生理盐水代替本发明中的样品，每日灌胃体积与以上各组相同；
(4)高脂饲料配方：按重量计78.8％基础饲料、1％胆固醇、10％蛋黄粉、10％猪油、0.2％胆盐；
(5)实验方法：在实验环境下大鼠喂饲基础饲料观察10天，大鼠禁食16小时，取血测定血清总胆固醇(TC)、甘油三脂(TG)和高密度脂蛋白胆固醇(HDL-C)的平均浓度，然后在给予高脂饲料的同时分别灌胃提供的样品，对照组给予体积相等的生理水，给予样品30天后禁食16小时，测定喂食后的TC的平均浓度；
(6)计算：TC的变化率＝(喂食后平均浓度-喂食前平均浓度)/喂食前平均浓度×100％，结果如表2所示：
表2
将表2中对比例2和实施例4的实验数据进行比较，可以发现，大豆蛋白粉的添加量，会对组合物的保存时间产生影响，在其他条件相同的情况下，当大豆蛋白粉的添加量，不在本申请限定的范围时，会降低本发明组合物降血脂效果稳定性。
实施例11一种具有辅助降血脂作用的固体制剂
98重量份的实施例4制备的组合物，1重量份的助流剂二氧化硅和1重量份的甜味剂木糖醇。
实施例12一种具有辅助降血脂作用的固体制剂
92重量份的实施例6制备的组合物，5重量份的助流剂硅酸钙和3重量份的酸味剂乳酸。
实验例3人体试食实验
按照2012年国家食品药品监督管理局修订发布的辅助降血脂保健食品功能评价方法中人体试食实验对受试者的要求，选择合适志愿者150名，随机分成3组，每组50人，测试并记录此时三组志愿者的TC、TG及HDL-C水平。一组服用本发明实施例11制备的制剂，一组服用本发明实施例12制备的制剂，一组作为空白对照组，服用量为10g/日，每日一次，连续服用45天，测试此时三组志愿者的TC、TG及HDL-C水平。
达到以下标准者认为有效：TC降低率>10％；TG降低率>15％；HDL-C上升>0.104mmo1/L。未达到该标准者认为无效。
TC降低率＝(TC试食前-TC试食后)/TC试食前×100％
TG降低率＝(TG试食前-TG试食后)/TG试食前×100％
试食前两组患者年龄、性别、病程、TC、TG和HDL-C均无明显差异(P＞0.05)，具有可比性。试食前后统计的TC、TG和HDL-C数据如表3所示。
表3
将试食后实施例的实验数据与空白对照组的相应数据进行比较，均有显著性差异(P<0.05)。
从上述实验结果可以看出，含有本发明制备的组合物的制剂，对人体具有同样降血脂的功效，在添加了一定量的叶酸、绿茶粉和玉米花丝粉后，效果更好。并且其他实施例中的组合物，对人体具有和实施例11、12相同或相近的实验效果。
Claims (10)
1.一种具有辅助降血脂作用的组合物，其特征在于，包括以下重量份的各组分：藜麦粉2-50份、大豆蛋白粉1-30份、螺旋藻粉0.1-2份、纳豆提取物0.1-2份和苦瓜提取物0.1-2份。
2.根据权利要求1所述的组合物，其特征在于：所述苦瓜提取物中功效成分苦瓜甙的含量为10％-30％，纳豆提取物中纳豆激酶的含量为70％-90％。
3.根据权利要求1所述的组合物，其特征在于还含有以下重量份的各组分：叶酸类化合物0.0001-0.001份、绿茶粉0.1-3份、玉米花丝粉0.1-3份。
4.根据权利要求3所述的组合物，其特征在于：所述的叶酸类化合物为叶酸、甲酰四氢叶酸、(6S)-5-甲基四氢叶酸、L-甲基叶酸、叶酸可药用盐、叶酸或叶酸可药用盐的活性代谢产物和可在体内代谢和/或生成叶酸的物质中的一种或几种。
5.根据权利要求3所述的组合物，其特征在于含有以下重量份的各组分：藜麦粉5份、大豆蛋白粉5份、螺旋藻粉0.5份、纳豆提取物0.25份、苦瓜提取物0.25份、叶酸类化合物0.0003份、绿茶粉0.3份、玉米花丝粉0.3份。
6.根据权利要求1-5任一项所述的组合物在制备辅助降血脂产品中的应用。
7.根据权利要求6所述的应用，其特征在于：所述的辅助降血脂产品为辅助降血脂固体制剂。
8.根据权利要求7所述的应用，其特征在于：所述固体制剂中含有重量百分比为92％-98％的权利要求1所述的组合物、1％-5％的助流剂和余量的调味剂。
9.根据权利要求8所述的应用，其特征在于：所述助流剂为二氧化硅、硅酸钙、磷酸三钙中的一种或几种。
10.根据权利要求8所述的组合物，其特征在于：所述调味剂为甜味剂、咸味剂、鲜味剂或酸味剂中的一种或几种。
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