CN110934291B - 一种能够用于乳腺增生调理的组合物及其应用 - Google Patents
一种能够用于乳腺增生调理的组合物及其应用 Download PDFInfo
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Abstract
本发明公开了一种能够用于乳腺增生调理的组合物及其应用，所述组合物包含以下原料：麦芽提取粉、佛手粉、橘皮粉、昆布粉、玫瑰花提取物、玳玳花提取物、茶叶提取物和亚麻籽粉，且所述原料中麦芽提取粉、佛手粉、橘皮粉、昆布粉、玫瑰花提取物、玳玳花提取物、茶叶提取物和亚麻籽粉的重量比为(8～12):(1～4):(4～8):(1～3):(2～4):(1～3):(0.1～0.8):(1～5)。该组合物利用减肥成分与改善乳腺增生问题的药物复配，从而更好地改善乳腺增生症状。
Description
技术领域
本发明涉及食品技术领域，具体涉及一种能够用于乳腺增生调理的组合物及其应用。
背景技术
乳腺增生症为女性常见病，发病率约占全部乳腺疾病75％。常见于30-50岁育龄妇女，目前有年轻化趋势，主要表现为乳房疼痛、乳房肿块、乳头溢液，部分伴有月经不调、情志异常。乳房为性激素作用的靶器官，乳腺增生的发生与卵巢内分泌状态密切相关。在妇女乳腺疾病普查、调查分析中发现，育龄妇女当中，饮食偏荤者患病率高，原因在于荤食中含有较高的脂肪、蛋白质和热量，蛋白质是体内雌性激素合成的主要原料，而脂肪又可导致催乳素分泌增加，丘脑——垂体分泌雌激素分泌增加，使乳腺增生发病概率增加。与此同时，高热量的食物能加快内源性脂肪的合成，脂肪代谢负荷增加扰乱内分泌失调，最终增加乳腺增生发病率。
随着现代人们物质生活水平的提高，城市化发展，肥胖人群的比例逐年上升，而肥胖也是引发内分泌系统疾病的重要危险因素，肥胖女性体内脂肪组织较多，脂肪组织是重要的内分泌器官，其血浆中性激素与球蛋白结合能力下降，主要来源于脂肪组织的雌酮被利用转化成更具有生物性的雌二醇，引起内分泌系统的功能紊乱，增加乳腺增生的发生几率。肥胖是由于能量的摄入超过能量的消耗，剩余的热量以脂肪的形式储存在体内，导致人体脂肪的过多积累，引起体重的增加肥胖会增加雌激素的合成，降低血清性激素结合球蛋白(sex hormone-binding globulin，SHBG)水平，使具有生物学活性的雌激素水平升高，而雌激素水平失调是乳腺增生症发生的主要机制。因此，体型肥胖也是乳腺增生的危险因素。
基于此，针对肥胖合并乳腺增生的人群，减轻体重、改善肥胖症状可以调节体内激素水平，尤其是雌激素，进而能改善乳腺增生的情况。而目前，对肥胖的治疗，重点是要制造热量缺口，减肥药物主要是针对肥胖产生的机制进行治疗，常用的药物有食欲抑制剂、抑制肠道消化吸收药物、增加能量消耗药物。总的来说，要减轻体重，减少摄入的热量是其中一种途径，代餐冲剂是目前市面上常见的减肥产品。代餐冲剂的作用是取代部分或全部正餐的食物。通常，代餐食品具有高纤维、低热量、易有持续饱腹感等特性，肥胖人群能利用代餐更严格正确的控制食量和热量，从而达到减肥的目的。普通人每餐热量摄取约500～1000千卡，而利用代餐者，可以依说明书将热量正确地控制在150～500千卡左右，使热量摄取小于需要量，而又不会引起过度饥饿、乏力等不适，相比于直接节食进行减肥，更安全。
然而，目前市面上用于乳腺增生的口服产品，偏向于活血化瘀散结止痛，或者为复合维生素，通过调节内分泌起到改善乳腺增生的目的，配方方向单一，较少关注到乳腺增生人群的肥胖表现，忽视了肥胖在乳腺增生发病中的作用，使得治疗效果不佳或易复发。
发明内容
本发明旨在至少解决现有技术中存在的技术问题之一。为此，本发明提出一种组合物，该组合物利用减肥成分与改善乳腺增生问题的药物复配，从而更好地改善乳腺增生症状。
本发明还提出一种上述组合物的应用。
根据本发明的第一方面实施例的组合物，所述组合物包含以下原料：麦芽提取粉、佛手粉、橘皮粉、昆布粉、玫瑰花提取物、玳玳花提取物、茶叶提取物和亚麻籽粉，且所述原料中麦芽提取粉、佛手粉、橘皮粉、昆布粉、玫瑰花提取物、玳玳花提取物、茶叶提取物和亚麻籽粉的重量比为(8～12):(1～4):(4～8):(1～3):(2～4):(1～3):(0.1～0.8):(1～5)。
根据本发明实施例的组合物，至少具有如下有益效果：本发明利用中药配方整体调理的优势，选用药食同源中药，组方的作用较温和，不仅关注乳腺增生的疼痛，还关注精神因素、体型肥胖对乳腺增生的影响，从情绪调节、饮食干预上进行配方设计，适合长期调理运用，更适应乳腺增生的病程特点。本配方考虑了乳腺增生合并肥胖的中医证型，选取中药进行配伍组方，并添加了能调节内分泌系统和胃肠功能的食物功能因子，关注乳腺增生人群的肥胖症状，利用减肥的成分直接或间接对乳腺增生进行调理。本发明方案的组合物基于中医药君臣佐使配伍理论进行搭配，其中，麦芽退乳消胀、行气通滞为君药；佛手、橘皮疏肝理气，行气止痛为臣药；昆布性味咸寒，软坚散结，消乳中结滞为佐；玫瑰花、玳玳花行气解郁，引诸药上行胸中，散胸中郁结。全方诸药相合，消胀缓痛、行气散结、宽胸解郁，以预防及改善乳腺增生症状，同时，本发明方案还在上述组方的基础上，创造性的加入了两个功能因子，即亚麻籽粉和茶叶提取物，这两个功能因子与组方中成分相互促进，不仅益于乳腺，同时，还具备一定的减肥功效。
根据本发明的一些实施例，所述原料中麦芽提取粉、佛手粉、橘皮粉、昆布粉、玫瑰花提取物、玳玳花提取物、茶叶提取物和亚麻籽粉的重量比为10:2:5:2:2:2:0.3:2。
根据本发明的一些实施例，所述组合物中还可以包含益生菌；优选地，所述益生菌可以为任意对乳腺有益处且具有减肥作用的可食用益生菌菌株，如嗜酸乳杆菌、乳双歧杆菌、罗伊氏乳杆菌、发酵乳杆菌等。在组合物中添加益生菌，调节雌、孕激素平衡，在缓解乳腺增生症的同时调节肠道菌群，将易引发乳腺增生的因子代谢出体外；同时，益生菌还能将中药成分中的成分分解成小分子物质，以利于肠道的吸收利用。
根据本发明的一些实施例，所述组合物中还可以包含燕麦麸皮、白芸豆粉或维生素中的至少一种。燕麦富含β-葡聚糖和不可溶性的膳食纤维，食用后易产生饱腹感，且可减少小肠对碳水化合物的吸收，能在一定程度上预防肥胖。白芸豆粉含有丰富活性酶和大量膳食纤维，能抑制身体对淀粉的分解，并能加快淀粉代谢，同时还能增加饱腹感，有一定的减肥作用。
根据本发明的一些实施例，所述维生素为叶酸、VB1、VB6和VB12的组合物。维生素B6是一种水溶性维生素，当妇女体内缺乏维生素B6时，会出现经前雌激素过剩的现象，导致痛经或月经不规律。乳腺增生患者服用维生素B6，能缓解经前紧张，调节内分泌，抑制乳腺组织的增生。维生素B1可促进乳腺分泌。通过饮食调整，提高血中叶酸和维生素B12的水平，可降低乳腺癌发生风险。
根据本发明的第二方面实施例的应用，一种能够用于乳腺增生调理的代餐产品，所述产品中含有上述组合物。
根据本发明的一些实施例，所述产品中还包含有辅料。
根据本发明的一些实施例，所述产品为粉剂、片剂、胶囊剂、颗粒剂或丸剂。
根据本发明的第二方面实施例的应用，上述组合物在制备能够用于治疗乳腺调理的代餐产品中的应用。
根据本发明的一些实施例，所述应用包括以下步骤：
S1、称取所述组合物及辅料，其中，所述组合物中的组分均为经超微粉碎处理后的组分，所述组合物与辅料的质量比为(20～45)：(4～20)；
S2、将上述物料过筛后，混合；
S3、将上述混合后的物料成型后，控制水分在3％以下，即得。
根据本发明实施例的应用，至少具有如下有益效果：本发明本着发挥中医药体质调理的优势，将针对乳腺增生的中药配方结合相关功能因子运用到乳腺增生的调理产品中，充分考虑了乳腺增生合并肥胖的中医证型，选择中药进行配伍组方，还添加了能调节内分泌系统和胃肠功能的食物功能因子，关注乳腺增生人群的肥胖症状，利用减肥的成分直接或间接对乳腺增生进行调理。
本发明的附加方面和优点将在下面的描述中部分给出，部分将从下面的描述中变得明显，或通过本发明的实践了解到。
具体实施方式
为详细说明本发明的技术内容、所实现目的及效果，以下结合实施方式予以说明。
本发明的实施例一为：一种具有乳腺增生调理功能的组合物及其应用，该组合物由如下重量份的原料制成：中药复方提取物(麦芽粉10份、橘皮粉2份、昆布粉5份、佛手粉2份、玳玳花提取粉0.2份、玫瑰花提取粉0.2份)、燕麦麸皮3份、白芸豆粉1份、茶叶提取物0.3份、亚麻籽粉2份、维生素组合(叶酸、VB1、VB6、VB12其重量占比为：80:3600:3600:1)0.00142份。
将上述组合物应用于代餐颗粒冲剂的制备中，具体包括以下步骤：
(1)配料：根据配方要求，按照用量称取上述组合物及辅料(抗性糊精3份、聚葡萄糖8份、淀粉3.5份(可以为3～4份))；
(2)粉碎：取上述物料，其中，中药材经超微粉碎；
(3)混合：将过筛后的物料加入混合罐中混合15min；
(4)干燥：制粒，热风干燥，控制水分3％；
(5)包装：将混合后的粉末5g/袋密封包装，即得。
本发明实施例二为：上述组合物在片剂类代餐产品的制备中的应用，包括以下步骤：
(1)取实施例1的组合物20重量份，乳糖15重量份，微晶纤维素2重量份，微粉硅胶0.5重量份，高速(搅拌浆速度为450rpm，切碎刀的速度为1500rpm，可视混合物料量和混合机大小调整合适的速度，搅拌桨的速度在30～500rpm之间，切碎刀速度范围在300～3000rpm)混合10min，控制水分3％；
(2)压片；
(3)检验，包装，出库。
本发明实施例三为：上述组合物在胶囊类代餐产品的制备中的应用，包括以下步骤：
(1)取实施例1的组合物40重量份，微晶纤维素3重量份，微粉硅胶1重量份，高速混合10min，控制水分3％；
(2)制粒；
(3)装胶囊；
(4)检验，包装，出库。
本发明的对照例一为：一种具有乳腺增生调理功能的组合物及其应用，该组合物为中药复方提取物(麦芽粉10份、橘皮粉2份、昆布粉5份、佛手粉2份、玳玳花提取粉0.2份、玫瑰花提取粉0.2份)，按照实施例1的工艺方法制备成颗粒剂。
本发明的对照例二为：一种具有乳腺增生调理功能的组合物及其应用，该组合物包括中药复方提取物(麦芽粉10份、橘皮粉2份、昆布粉5份、佛手粉2份、玳玳花提取粉0.2份、玫瑰花提取粉0.2份)、茶叶提取物0.3份和亚麻籽粉2份，按照实施例1的工艺方法制备成颗粒剂。
取实施例1、对照例1和2制得的产品进行效果测试，具体如下：
1、乳腺增生改善测试：
根据乳腺增生诊断标准(2002年中华中医外科学会乳腺专业委员会第八次会议通过的乳腺增生病的诊断标准)，选取90名测试者(均分为三组)，分别取对比例1、对比例2及实施例1制得的产品口服1个疗程(3个月)，每日2次，早晚各一次。根据视觉模拟评分法VAS(0分为无痛，10分为难以忍爱的疼痛，小于3分为良好，3～5分为基本满意，大于5分为差))，对疗程前、后实验组、对照组在乳房疼痛相关症状、体征(乳房疼痛程度、乳腺触痛程度)及血清中E2(雌二醇)及黄体生成素进行比较。
记录疼痛相关症状及体征所得数值并计算平均值，结果如下表1所示：
表1乳腺疼痛相关症状、体征
*P<0.05，差异有统计学意义；***P<0.001，相比于疗程前存在十分显著的差异。
由表1可知，对比例2和实施例1制备的口服样品，在服用3个月后，进行前后乳腺疼痛相关症状体征比较，差异均有统计学意义(P＜0.05或P＜0.001)，认为对比例2和实施例1的方案均能缓解乳腺疼痛相关症状体征且燕麦麸皮、白芸豆粉和维生素具有协同作用。因此，本发明含特定组合物的口服物具有缓解乳腺增生性疼痛症状的效果，且茶叶提取物、亚麻籽粉对中药方有促进作用，效果更明显。
记录疼痛相关症状及体征所得数值并计算平均值，结果如下表1所示：
表2疗程前后血清中E2及黄体生成素水平比较
*P<0.05，相比于疗程前存在显著性差异。
由表2可知，对比例2和实施例1制备的口服样品在服用3个月后，比较疗程前后血清E2及黄体生成素水平，较前有改善，且P＜0.05，差异有统计学意义，认为对比例2和实施例1能有效改善血清中E2及黄体生成素水平。因此，本发明含特定组合物的口服物具有调节乳腺增生患者激素水平的效果，且茶叶提取物、亚麻籽粉对中药方有促进作用，效果更明显。
2、减肥效果
选取90名单纯性肥胖女性(分成三组)，取上述各实施例样品口服1个疗程(3个月)，每日2次，早晚各一次。比较疗程前后的体重、腰围和BMI值，结果如下表3所示：
表3体重、BMI值、腰围
由表3可知，经t检验，受试者疗程前后体重、腰围均有明显下降，说明本发明含特定组合物的口服物具有减轻体重、减少腰围的减肥效果。
本发明实施例方案的组合物中，各组分的功效如下：
(1)麦芽：中药麦芽性味甘，平。归脾、胃经。主治行气消食，健脾开胃，退乳消胀。用于食积不消，脘腹胀痛，脾虚食少，乳汁郁积，乳房胀痛，妇女断乳。麦芽含α和β淀粉酶，有助消化作用。淀粉在α和β淀粉酶的作用下可分解成麦芽糖与糊精。麦芽煎剂对胃酸与胃蛋白酶的分泌似有轻度促进作用。另外有研究显示，麦芽能调节性腺轴功能的紊乱，其含有的麦角类化合物有拟多巴胺激动剂样的作用。多巴胺可通过作用于下丘脑，并与其受体结合，使泌乳素释放因子(prolactin inhibiting factor，PIF)释放增多，而PIF可明显抑制PRL(prolactin releasing factor)的分泌，一定程度上抑制了乳腺增生的发生。
(2)佛手：性味辛、苦、酸，温。归肝、脾、肺经。功能舒肝理气，和胃止痛。用于肝胃气滞，胸胁胀痛，胃脘痞满，食少呕吐。中医认为，乳房属胃，肝为刚脏，主硫泄，恶抑郁，一有佛郁则肝失调达，影响脾胃，积湿生痰，日久气滞庚凝，结聚乳房，发为乳房肿块，其肿块常随喜怒而消长。佛手能化痰理气、行气消胀，消乳中积滞。
(3)橘皮：性味辛、苦、温。入脾、肺经。功能理气，调中，燥湿，化痰。主治胸腹胀满，不思饮食，呕吐哕逆，咳嗽痰多。亦解鱼、蟹毒。橘皮能益气，去滞气，推陈致新。含有橙皮苷，在药理实验中能显著降低小鼠血液中甘油三酯、胆固醇、低密度脂蛋白的含量。
(4)昆布：中药昆布性味咸，寒。归肝、胃、肾经。主治软坚散结，消痰，利水。用于瘿瘤，瘰疬，睾丸肿痛，痰饮水肿。昆布主要含有海带多糖、无机盐、蛋白质、维生素、氨基酸等活性成分，有清热凉血解毒的功效；对急性期的血管通透性渗出和水肿均有拮抗、润燥软坚的作用，且可借渗透作用来消肿；局部应用可抗炎止血不同浓度昆布多糖刺激乳腺癌细胞与刺激浓度呈正相关，使碘转运体基因和蛋白的表达均增加，还可调节乳腺癌细胞NIS基因、蛋白的表达来改善细胞摄碘能力。
(5)玫瑰花：中药玫瑰花性味甘、微苦，温。归肝、脾经。功能理气解郁；和血调经。主治肝气郁结所致胸膈满闷，脘胁胀痛，乳房作胀，月经不调，痢疾，泄泻，带下，跌打损伤痈肿。鲜花含挥发油(玫瑰油)约0.03％，主要成分为香茅醇、牻牛儿醇、橙花醇、丁香油酚、苯乙醇等。其中，香茅醇能显著抑制人乳腺癌MCF-7细胞的增殖，同时引起其G1期阻滞，更高浓度时引起G2/M期阻滞，但其并非进一步通过破坏甲羟戊酸的合成来发挥抗乳腺癌作用。玫瑰花提取液中含有黄酮、黄酮醇和二氢黄酮等黄酮类酮化合物，通过干预TGF-β1的表达和其调控的miR-21和miR-29a/b水平，而抑制乳腺增生EMT发生的程度，能够有效抑制模型动物的乳腺炎和乳腺增生。
(6)玳玳花：中药玳玳花味辛、甘、微苦，性平。功能理气宽胸、和胃止呕，主治胸中痞闷、脘腹胀痛、不思饮食、恶心呕吐。玳玳花所含之挥发油与柑橘属类植物所含之黄酮类相似，对胃肠有温和的刺激作用，能促进消化腺分泌，排除肠内积气。
在以上的中药组方中，麦芽退乳消胀、行气通滞为君药，佛手、橘皮疏肝理气，行气止痛为臣药；昆布性味咸寒，软坚散结，消乳中结滞为佐；玫瑰花、玳玳花行气解郁、引诸药上行胸中，散胸中郁结。全方诸药相合，消胀缓痛、行气散结、宽胸解郁，以预防及改善乳腺增生症状。
(7)亚麻籽粉：亚麻籽为亚麻的成熟种子。主要成分为脂肪、蛋白质、膳食纤维，其含有的木脂素可调节体内荷尔蒙的含量。由于亚麻籽含有温和的植物雌激素，可以对抗体内过多的雌激素，因此，通常认为它具有抗癌效果。而α-亚麻脂酸可降低胆固醇、增加肠蠕动、改善便秘。
(8)茶叶提取物：儿茶素能显著抑制脂肪细胞的增殖、分化，抑制细胞内的脂质积累。对脂类代谢过程具有调节作用，它通过刺激机体热生成、降低机体对食物营养成分的吸收等作用而减机体的能量摄入和存储。具有减肥作用。将茶多酚0.15g/kg用于大鼠有效下调乳腺组织雌激素受体(estrogen receptor，ER)和孕酮受体(progesterone receptor，PR)表达、抗氧化，结果发现其具有良好的效果。
以上所述仅为本发明的实施例，并非因此限制本发明的专利范围，凡是利用本发明说明书内容所作的等同变换，或直接或间接运用在相关的技术领域，均同理包括在本发明的专利保护范围内。
Claims (8)
1.一种能够用于乳腺增生调理的组合物，其特征在于：所述组合物由以下原料制成：麦芽提取粉、佛手粉、橘皮粉、昆布粉、玫瑰花提取物、玳玳花提取物、茶叶提取物和亚麻籽粉，以及包含燕麦麸皮、白芸豆粉或维生素中的至少一种，且所述原料中麦芽提取粉、佛手粉、橘皮粉、昆布粉、玫瑰花提取物、玳玳花提取物、茶叶提取物和亚麻籽粉的重量比为（8~12）:（1~4）:（4~8）: （1~3）: （2~4）: （1~3）: （0.1~0.8）: （1~5）。
2.根据权利要求1所述的能够用于乳腺增生调理的组合物，其特征在于：所述原料中麦芽提取粉、佛手粉、橘皮粉、昆布粉、玫瑰花提取物、玳玳花提取物、茶叶提取物和亚麻籽粉的重量比为10: 2 :5 : 2 : 2 : 2 : 0.3 : 2。
3.根据权利要求1所述的能够用于乳腺增生调理的组合物，其特征在于：所述组合物中还包含益生菌。
4.根据权利要求1所述的能够用于乳腺增生调理的组合物，其特征在于：所述维生素为叶酸、VB1、VB6和VB12的组合物。
5.一种能够用于乳腺增生调理的代餐产品，其特征在于：所述产品中含有如权利要求1至4任一项所述的组合物。
6.根据权利要求5所述的能够用于乳腺增生调理的代餐产品，其特征在于：所述产品为粉剂、片剂、胶囊剂、颗粒剂或丸剂。
7.如权利要求1至4任一项所述的组合物在制备能够用于调理乳腺增生的代餐产品中的应用。
8.根据权利要求7所述的应用，其特征在于：包括以下步骤：
S1、称取所述组合物及辅料，其中，所述组合物中的组分均为经超微粉碎处理后的组分，所述组合物与辅料的质量比为（20~45）：（4~20）；
S2、将上述物料过筛后，混合；
S3、将上述混合后的物料成型后，控制水分在3%以下，即得。
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| CN110433259A (zh) * | 2019-08-27 | 2019-11-12 | 中山市中智药业集团有限公司 | 一种干预气郁体质的中药组合物、破壁组合物及其制备方法 |
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| CN109420089A (zh) * | 2017-08-25 | 2019-03-05 | 王停 | 一种用于乳腺增生调理和预防的中药方剂 |
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