CN105433260A - 一种用于降低血脂的保健食品及其制备工艺 - Google Patents
一种用于降低血脂的保健食品及其制备工艺 Download PDFInfo
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- CN105433260A CN105433260A CN201510778057.9A CN201510778057A CN105433260A CN 105433260 A CN105433260 A CN 105433260A CN 201510778057 A CN201510778057 A CN 201510778057A CN 105433260 A CN105433260 A CN 105433260A
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Abstract
本发明提供了一种用于降低血脂的保健食品及其制备工艺。所述保健食品中包含:纳豆冻干粉、三七提取物、紫苏油和蜂蜡。本发明的制备工艺在进行产品制备时,分不同工艺对纳豆冻干粉、三七提取物、紫苏油和蜂蜡进行处理,并混合,最好地保留了各原料的有用成分。根据高脂血症的发病机理,本发明的申请人选用纳豆冻干粉、三七提取物、紫苏油和蜂蜡为主要原料组方开发了至御牌三七纳豆紫苏油软胶囊产品,各原料都具有很好的降低血胆固醇和甘油三酯及预防动脉粥样硬化的作用,相互配伍,相辅相承,最终达到辅助降血脂的目的,是一款辅助降血脂的理想保健食品。
Description
技术领域
本发明涉及医药领域,具体而言,涉及一种降低血脂的保健食品及制备工艺。
背景技术
人体是一个复杂的化工厂,脂质是人体内的重要物质之一,包括脂肪酸、甘油酸、磷脂、类固醇等,是细胞膜的主要成分,能够利用和储存能量,具有维持体温和神经传导等复杂的生理功能。一般将存在于血浆中的脂质称为血脂,包括胆固醇、胆固醇脂、甘油三酯、磷脂和未酯化的游离脂肪酸等,通常将血清胆固醇(TC)、甘油三脂(TG)、低密度脂蛋白胆固醇(LDL-C)、高密度脂蛋白胆固醇(HDL-C)水平升高,超过正常范围值时称为高脂血症。持续的血脂增高会导致动脉粥样硬化、引发心脑血管等疾病,与高血压、糖尿病关系密切。
高脂血症是由于脂肪代谢或运转异常使胆固醇、甘油三酯和(或)低密度脂蛋白过高和(或)高密度脂蛋白过低而引发的一种病症。
高脂血症属于代谢异常性疾病,与人们的日常饮食习惯和运动锻炼关系密切,该病发病属于隐匿性的,血脂增高初期,人体没有异常症状和感觉,当持续增高时血脂就会沉积于血管内壁,日久形成斑块,最后导致动脉粥样硬化,如果伴随有高血压、糖尿病等疾病时,导致中风、冠心病的危险性就会增加,据报道,血胆固醇每上升1%,冠心病的死亡率就会上升2%。如果能够在血脂增高初期,通过药物、调节饮食营养和适宜的运动使血脂水平保持在正常范围,就可以阻止病情发展,防止心脑血管等严重疾病的发生。高脂血症的直接损害是加强全身动脉粥样硬化,而全身的重要器官是依靠动脉供血、供氧的,一旦粥样斑块堵塞动脉,就会造成严重后果。可见,预防高脂血症的发生对人体健康具有十分重要的意义。
目前西药降脂药的降脂作用是通过阻断脂肪合成,或分解脂肪来达到的。在这过程中产生了大量的,比脂肪更有害,更难分解,更难排泄的人体毒素,真可谓是得不偿失。更主要的是,西药降血脂并没有真正解决人体生产脂肪过多,利用脂肪不足的真正病因,致使有些病人需终身服药,终身忍受巨大副作用毒害之苦;有些病人无论用何种降脂药,血脂都降不下来,有些病人用药后,血脂不降反而飚升。因此,采用西药来降低血脂会给人身体带来诸多危害和副作用。
因此,市场上需要一种无毒副作用,能够有效降低人体血脂的保健食品。
发明内容
针对上述问题,本申请人研发了一种新的降低血脂的产品“至御牌三七纳豆紫苏油软胶囊”。
本发明根据高脂血症的发病机理,选用纳豆冻干粉、三七提取物和紫苏油为原料组方开发了至御牌三七纳豆紫苏油软胶囊。
纳豆冻干粉
纳豆是一种豆类发酵食品,在日本已有上千年的历史,以大豆为原料,经煮熟之后加入纳豆菌发酵而成,含有钙、磷、钠、钾及维生素B2、维生素PP、维生素E等,营养价值极高。近几年研究发现,纳豆中含有许多重要的活性成分如纳豆激酶、超氧化物歧化酶、异黄酮、生育酚及谷氨酸等,对骨质疏松、心脑血管疾病及肿瘤有一定的预防和治疗作用。
纳豆冻干粉中主要活性成分纳豆激酶能有效降低LDL-C的含量,提高抗氧化酶SOD活性,增强机体的抗氧化作用,减轻机体抗氧化损伤,防止泡沫细胞形成,可预防动脉粥样硬化发生。
三七
三七具有活血化瘀的功效,可有效降低血液的黏稠度,预防高脂血症的发生。同时,三七所含活性成分三七皂苷可有效降低血浆胆固醇和甘油三酯含量,清除体内氧自由基,抗脂质过氧化,预防动脉粥样硬化形成。
三七提物物为三七经加工的提取物。三七味甘、微苦、性温。归肝、胃经。主要成分有三七皂苷、黄酮苷等成分。具有止血、补血、活血化瘀的功效。三七素有“止血之神药”之说,为伤科要药,三七水溶性成分三七素,能够缩短小鼠的凝血时间,并使血小板的数量显著增加,通过机体代谢、诱导血小板释放凝血物质而产生止血作用。三七中所含的皂苷类成分可以增强血浆蛋白C的活性,具有抗凝和促纤溶活性,能明显的抗凝、抑制血小板聚集、促进纤维蛋白溶解,提高SOD活性,抗脂质过氧化。近年来三七越来越多的被用于治疗冠心病、心绞痛、心脑血管病,脑出血后遗症、肿瘤、肝脏及新陈代谢等方面。
紫苏油
紫苏油是由紫苏的种子为原料提取而成。我国食用、药用历史悠久,在《神农本草经》中早有记载,具有很高的营养和药用价值,具有镇咳、平喘、抗过敏、治疗心脑血管等作用。紫苏籽含油率一般为30~45%,主要是多不饱和脂肪酸系列,脂肪酸组成以α-亚麻酸最高,α-亚麻酸是人体的必需脂肪酸,自身不能合成,需要从食物中供给,在人体内,α-亚麻酸在酶的作用下,能够生成对人体有重要作用的二十碳五烯酸(EPA)和二十二碳六烯酸(DHA),EPA在体内能够调节血脂、降低血液粘度、软化血管。DHA是人脑神经系统的基本成分之一,对人体视觉功能及提高记忆力具有重要作用。α-亚麻酸能够降低血清中甘油三脂的含量,抑制内源性胆固醇的合成,对机体的血脂具有很好的调节作用。同时紫苏油能够抑制血小板的聚集能和血清素的游离能,抑制体内的血栓生成,对预防和治疗心脑血管疾病具有重要作用。
紫苏油中所含脂肪酸α-亚麻酸,在酶的作用下,能够形成对人体有重要作用的EPA和DHA,EPA在体内可以调节血脂,降低血液黏度,软化血管。综上所述,本品各原料都具有很好的降低血胆固醇和甘油三酯及预防动脉粥样硬化的作用,相互配伍,相辅相承,最终达到辅助降血脂的目的,是一款辅助降血脂的理想保健食品。
具体而言,本发明提供一种用于降低血脂的保健食品,其特征在于,所述保健食品中包含:纳豆冻干粉、三七提取物、紫苏油和蜂蜡。
优选地,在所述保健食品中,按质量计各原料的用量为:纳豆冻干粉100-200份、三七提取物20-60份、紫苏油200-400份和蜂蜡15-30份。
优选地,所述保健食品为中药软胶囊,所述软胶囊包括明胶、甘油、二氧化钛、纯化水以及焦糖色。
另一方面,本发明提供一种述保健食品的应用,其特征在于,所述保健食品用于辅助治疗心脑血管疾病。
另一方面,本发明提供一种降低血脂的保健食品的制备工艺,其特征在于,其包括如下步骤:
1)、分别按预定比率准备纳豆冻干粉、三七提取物、紫苏油份和蜂蜡;
2)、将步骤1)中所准备的纳豆冻干粉和三七提取物混合均匀;
3)、将步骤1)中所准备的紫苏油和蜂蜡混合;
4)、将所述步骤2)和3)中所获得的混合物进一步混合,获得内容物物料。
优选地,所述制备工艺还包括:
5)准备纯化水、甘油、焦糖色、二氧化钛,以及明胶;
6)将所述纯化水、甘油、焦糖色、二氧化钛混合,获得相应混合物,将混合物加热至70-80℃;
7)将明胶加入到加热后的混合物中,使明胶溶解,并搅拌均匀,获得胶液;
8)将所述内容物物料与所述胶液,压制成软胶囊。
优选地,所述制备工艺还包括:对所述软胶囊使用乙醇溶液进行清洗,并进行干燥处理。
优选地,每粒胶囊加入0.4-0.5g所述内容物物料。
优选地,各原料的比率为:纳豆冻干粉100-200份、三七提取物20-60份、紫苏油200-400份和蜂蜡15-30份。
本发明中所用的原料均为常规市售中药材
在另一种优选实现方式中,本发明产品中还添加了罗布麻叶60份、银杏叶80份、葛根25份、红曲85-170份以及木耳、桂圆和枸杞的水提取物粉末。所述保健品应用于治疗心血管疾病。
需要说明的是,虽然本发明是以保健食品为主题对该专利申请的内容进行描述的,但是本领域技术人员应该理解,本文中所提到的保健食品既可以指通常意义中所讲的用于保健养生的产品,而且也可以指中药。
另外,本发明的配方及在此基础上的改进配方,将于后续以“至御牌三七纳豆紫苏油软胶囊”的名义投放市场,任何对该配方的使用均需要得到健道康元(北京)生物科技有限公司的允许。
另外,需要说明的是,虽然权利要求书中限定了各原料的质量,但是,本领域技术人员应该理解,各原料的成分是可以等比例增加或减少的。
本发明的保健品的优点和效果:
根据高脂血症的发病机理,我公司选用纳豆冻干粉、三七提取物和紫苏油为原料组方开发了至御牌三七纳豆紫苏油软胶囊产品,其中纳豆冻干粉中主要活性成分纳豆激酶能有效降低LDL-C的含量,提高抗氧化酶SOD活性,增强机体的抗氧化作用,减轻机体抗氧化损伤,防止泡沫细胞形成,可预防动脉粥样硬化发生。中药三七具有活血化瘀的功效,可有效降低血液的黏稠度,预防高脂血症的发生。同时,三七所含活性成分三七皂苷可有效降低血浆胆固醇和甘油三酯含量,清除体内氧自由基,抗脂质过氧化,预防动脉粥样硬化形成。紫苏油中所含必需脂肪酸α-亚麻酸,在酶的作用下,能够形成对人体有重要作用的EPA和DHA,EPA在体内可以调节血脂,降低血液黏度,软化血管。综上所述,本品各原料都具有很好的降低血胆固醇和甘油三酯及预防动脉粥样硬化的作用,相互配伍,相辅相承,最终达到辅助降血脂的目的,是一款辅助降血脂的理想保健食品。
本发明本着安全有效,适合中老年人长期服用的思路,各原料经药理试验证明均具有很好的降血脂功效,相互配伍,可以促进降血脂的功能。
至御牌三七纳豆紫苏油软胶囊产品,主要针对高脂血症的病因组方,选用纳豆冻干粉、三七提取物和紫苏油为原料,纳豆冻干粉和紫苏油均为普通食品,三七提取物为中草药提取物,原料天然无毒,价格低廉,功效明确,适合中老年人长期服用。相信投放市场后必将成为人们喜闻乐见的保健佳品。
附图说明
图1为根据本发明一个实施例的保健品的制备流程示意图。
具体实施方式
实施例一
在本实施例中,制备所采用原料如下:
下面结合附图1对药物制备的过程进行详细描述。
1、配料、前处理
首先按照配方要求配齐质量合格的原辅料,检查、去掉合格的外包装后转入洁净区内,将纳豆冻干粉过80目筛,三七提取物过80目筛,按配方量称量备用。
2、胶液的配制
将配方量的纯化水、甘油、焦糖色、二氧化钛置化胶罐中,加热至70~80℃后,加入明胶,搅拌至完全融化,在-0.06至-0.08MPa下抽取真空脱气泡,过100目筛,得胶液,60~65℃保存、备用
3、内容物物料的配制
取配方量紫苏油加热至60℃投入蜂蜡,搅拌至蜂蜡完全溶解后,降至室温,得混合油料;取配方量纳豆冻干粉、三七提取物加至混合油料中,充分混合搅拌均匀,搅拌时间25分钟,再过胶体磨研磨2~3次后,0.08Mpa抽真空脱泡,过100目筛,得内容物物料,备用。
4、压丸、定型、洗丸、干燥、拣丸
将内容物物料与胶液分别投入到软胶囊机中压丸(压丸操作间控制温度18~24℃、相对湿度30~45%),控制装量0.5g/粒。生产出的胶丸定型干燥约4小时。定型干燥后的胶丸用95%的食用乙醇洗丸,再转送温度为25~35℃,相对湿度为15~35%的环境下,继续干燥12~18小时,干燥后拣丸,剔除异形丸、有气泡或漏油丸等不合格品,得合格胶丸。
5、内包装
将合格的胶丸分装于口服固体药用高密度聚乙烯瓶(符合国家药品包装材料标准YBB00122002)中,每瓶装量60粒。
6、外包装,检验、入库
内包装后,将产品外包装、装箱,入库,并随机抽取样品按本品企业标准检验。
生产环境及管理应符合保健食品GMP要求,生产过程中的胶液、内容物物料的制备,压丸,定型,洗丸,干燥,拣丸,内包装等工序均在符合要求的十万级生产洁净区进行,其他工序在一般生产区。
效果检验
为了验证本实施例中所制备的中药制品的效果,申请人利用大鼠进行动物实验。
具体而言,首先,准备100只雄性大鼠,分别用高脂饲料进行喂养,饲养环境选在温度20-25度,湿度40-70%RH。在喂养半个月之后,从这100只大鼠中,选出体重100-170g、血清总胆固醇含量在2.2mmol/L以上,血清甘油三酯含量在1.8mmol/L以上的雄性大鼠50只。将这50只大鼠的分成两组,每组25只,保证两组大鼠的平均胆固醇含量以及平均甘油三脂含量基本相等。
两组大鼠分别作为受试组和对照组,然后分别对两组大鼠喂食1/3的高脂饲料和2/3的正常饲料。只是对于受试组中的大鼠,每天额外给予0.05-0.1g的本发明的药粉,坚持喂养半个月之后,抽血再次检查两组大鼠的血清甘油三酯和胆固醇含量。
表2
通过上面的动物实验可以发现,本发明的产品能够明显降低动物体内甘油三酯和胆固醇的含量。
此外,在进行了动物实验之后,本发明的申请人在推出其产品之前,还对大量心血管病患者进行了临床实验。本发明的产品具有降低血脂的功效。
实施例二
在本实施例中,采用与实施例一中类似的制备方法,只是调整了原料的配比。在本实施例中,所采用的原料配比如下:
表3
采用与实施例一中基本相同的方法,申请人基于表3中的原料配比制备相应的内容物物料。
类似地,对于该配方所生产的产品,申请人也进行了实验,实验方法基本相同。经实验证明,该剂量比的产品,比实施例一的剂量比能够更有效地降低胆固醇。对于胆固醇高,而甘油三酯相对低的患者可以采用该配方。
实施例三
在本实施例中,对实施例二进行了进一步地改进,在本实施例中,原料配比如下:
表4
在本实施例中,依然按照图1中所示的步骤进行产品制备,只是在药物混合之前,加入木耳、罗布麻叶、银杏叶、葛根、红曲、枸杞的水提物。水提采用80-100摄氏度的水温,分两次提取,然后将提取后的产物干燥、粉碎,混入药粉中,均匀混合。此外,加入绞股蓝、金银花、肉苁蓉的醇提物。
本实施例在配方中加入了食品成分的提取物,成本更加低廉,健康环保,并且,木耳中含有木耳多糖,具有降低血脂的功效。采用水提可以更好地获得其有效成分。木耳、桂圆、银耳、枸杞与之前加入的五味药配合起来更加温和,对血管的修复效果更好,对于脾胃虚寒患者也可以服用。
此外,加入了绞股蓝、金银花,能够有效降低甘油三酯。本发明中所采用的各成分的配比是经过中医专家经过潜心研究之后而发现的最佳配比,而且经临床验证效果良好。
类似地,对于该配方所生产的产品,申请人也进行了实验,实验方法基本相同。经实验证明,该剂量比的产品,比实施例一的剂量比能够更有效地降低甘油三酯。对于甘油三酯高,而胆固醇相对低的患者可以采用该配方。
需要说明的是,虽然上面结合具体实施例和附图对本发明进行了详细地描述,但是,上面的描述仅仅是示意性地说明,以便于本领域技术人员对本发明的理解,图中所示部件的具体细节并非对发明保护范围的限定。本领域技术人员也应该理解,上述实施例也仅仅是对本发明的示意性实现方式的解释,并非对本发明范围的限定。
Claims (9)
1.一种用于降低血脂的保健食品,其特征在于,所述保健食品中包含:纳豆冻干粉、三七提取物、紫苏油和蜂蜡。
2.根据权利要求1所述的保健食品,其特征在于,所述保健食品中,按质量计各原料的用量为:纳豆冻干粉100-200份、三七提取物20-60份、紫苏油200-400份和蜂蜡15-30份。
3.根据权利要求2所述的保健食品,其特征在于,所述保健食品为中药软胶囊,所述软胶囊包括明胶、甘油、二氧化钛、纯化水以及焦糖色。
4.一种根据权利要求1-3任意一项所述的保健食品的应用,其特征在于,所述保健食品用于辅助治疗心脑血管疾病。
5.一种降低血脂的保健食品的制备工艺,其特征在于,其包括如下步骤:
1)、分别按预定比率准备纳豆冻干粉、三七提取物、紫苏油和蜂蜡;
2)、将步骤1)中所准备的纳豆冻干粉和三七提取物混合均匀;
3)、将步骤1)中所准备的紫苏油和蜂蜡混合;
4)、将所述步骤2)和3)中所获得的混合物进一步混合,获得内容物物料。
6.根据权利要求5所述的保健食品的制备工艺,其特征在于,所述制备工艺还包括:
5)准备纯化水、甘油、焦糖色、二氧化钛,以及明胶;
6)将所述纯化水、甘油、焦糖色、二氧化钛混合,获得相应混合物,将混合物加热至70-80℃;
7)将明胶加入到加热后的混合物中,使明胶溶解,并搅拌均匀,获得胶液;
8)将所述内容物物料与所述胶液,压制成软胶囊。
7.根据权利要求6所述的保健食品的制备工艺,其特征在于,所述制备工艺还包括:对所述胶丸使用乙醇溶液进行清洗,并进行干燥处理。
8.根据权利要求6所述的保健食品的制备工艺,其特征在于,每粒胶囊加入0.4-0.5g所述内容物物料。
9.根据权利要求5所述的保健食品的制备工艺,其特征在于,各原料的比率为:纳豆冻干粉100-200份、三七提取物20-60份、紫苏油200-400份和蜂蜡15-30份。
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