CN110604773B - 调节脂代谢紊乱的组合物及其制备方法和用途 - Google Patents
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Abstract
本发明涉及调节脂代谢紊乱的组合物及其制备方法和用途，属于药品、保健品领域。本发明提供了调节脂代谢紊乱的组合物，由如下重量配比的原料制备而成：藏茶50‑60份、枸杞子20‑30份、甘草10‑20份、荷叶20‑30份、决明子20‑30份、桑叶20‑30份、山楂20‑30份。动物实验结果证明，本发明组合物对肥胖、非酒精性脂肪肝等代谢性疾病具有确切的治疗效果，同时，能够显著升高血清高密度脂蛋白水平，有助于动脉粥样硬化的防治。此外，服用该组合物还有助于调节肠道菌群紊乱，升高益生菌的丰度、降低致病菌丰度。
Description
技术领域
本发明涉及调节脂代谢紊乱的组合物及其制备方法和用途，属于药品、保健品领域。
背景技术
代谢性疾病即因代谢问题引起的疾病，包括代谢障碍和代谢旺盛等原因。非酒精性脂肪肝(non-alcoholic fatty liver disease，NAFLD)是一种常见的代谢性疾病，指在患者无过量饮酒史的条件下，肝脏内脂肪过度沉积并超过5～10％的肝重量为主要特征的临床病理综合征。NAFLD不仅能诱发肝脏组织的损伤，并与其他慢性脂肪相关的肝疾病并存，加剧肝脏脂肪性变、慢性丙型肝炎和血色病的进展与恶化。临床上的非酒精性脂肪肝代表着一系列进展性肝疾病，包括普通的肝性脂肪变性、进展性并伴随炎症、气球样变性的非酒精性脂肪肝炎(nonalcoholic steatohepatitis，NASH)。当疾病不断恶化，NASH将会诱发亚急性肝损伤的纤维化、肝硬化，而晚期的NASH可能导致肝功能衰竭和肝癌，唯一治疗方法则是肝脏移植手术。目前，临床上NAFLD与NASH的诊断主要是肝活组织检查。NAFLD的危险因素主要包括：高脂肪高热量膳食摄入、多坐少动的生活方式、胰岛素抵抗以及代谢综合征如肥胖、II型糖尿病、高血压等。
随着肥胖(BMI>30kg/m2)、糖尿病等代谢综合征全球化的流行趋势，NAFLD已成为西方发达国家和富裕地区第一大慢性肝疾病及肝功能紊乱的首要病因，患病率增长迅速，且呈低龄化趋势。NAFLD与NASH的发病率在西方发达国家总人口数中分别占到20～30％和2～3％，而肥胖人群患病率高达75％以上。病态肥胖患者中几乎都伴随着肝脏的脂肪变性，而这类病人中NASH发病率在25～70％之间。II型糖尿病患病人群中，NAFLD发病率在50～75％，并伴有谷丙转氨酶(alanine aminotransferase，ALT)水平升高，同时高血糖病人患NASH风险相对正常人群高2.6倍。当前NAFLD影响着全球2.6％的儿童，而22.5～52.8％的肥胖青少年患有NAFLD，疾病呈现低龄化趋势愈加严重。
在我国，NAFLD的流行态势同样不容乐观，成年人患病率平均在15％，7～18年龄段的青少年患病率在1.3％左右，城市患病率23.0％高于农村地区的12.9％。据最新调查结果显示，上海和香港地区分别达到38.2％和27.3％的患病率，富裕地区患病人数增长迅速。同时，NAFLD极大地增加了中老年人群患II型糖尿病、心血管疾病风险。NAFLD给患者带来了巨大的生活压力，也给家庭和社会带来了沉重的经济负担，已成为我国主要的公共健康问题。
随着肥胖、糖尿病及非酒精性脂肪肝病人群增多，导致带有功能的健康食品需求越来越旺盛，因此传统医学中的“药食同源”具有潜在的优势。回顾国内外健康食品的发展历程，无论是风靡全球的欧美健康食品，还是挤入中国保健品行业的日本功能食品，还有正在兴起的即将走出国门迈向世界的中国药食同源食品,其理论基础都是药食同源。到目前为止，药食同源还没有统一的定义，通常是指许多中药材既是药品又是食品。我国现存最早的重要医书《黄帝内经》，提出了药食同源观点，该观点距今已有2000多年的历史。如《黄帝内经》记载：“大毒治病，十去其六；常毒治病，十去其七；小毒治病，十去其八；无毒治病，十去其九；谷肉果菜，食养尽之，无使过之，伤其正也。《黄帝内经-太素》也提到：“空腹食之为食物，患者食之为药物。”这些描述表现出药食同功及药食同理的朴素思想，可称为最早的食疗原则。我国现存最早的药学专著《神农本草经》记载：大枣、枸杞子、五味子、地黄、薏苡仁、茯苓、沙参、生姜、葱白、当归、贝母、杏仁、乌梅、核桃、莲子、蜂蜜、桂圆、百合等,都是有药性的食物,常作为配制药膳的原料。充分体现了药品和食品没有严格区分标准的思想,是药食同源思想的萌芽状态。
发明内容
本发明的目的在于提供调节脂代谢紊乱的组合物及其制备方法和用途。
本发明提供了调节脂代谢紊乱的组合物，由如下重量配比的原料制备而成：藏茶50-60份、枸杞子20-30份、甘草10-20份、荷叶20-30份、决明子20-30份、桑叶20-30份、山楂20-30份。
进一步地，所述的组合物由如下重量配比的原料制备而成：藏茶60份、枸杞子25份、甘草15份、荷叶25份、决明子25份、桑叶25份、山楂25份。
进一步地，所述的藏茶为雅安藏茶。
进一步地，所述的组合物是以所述重量配比的原料或其提取物作为活性成分，加入可接受的辅料或者辅助性成分制备而成的制剂。
进一步地，所述的制剂为口服制剂。
本发明提供了所述组合物的制备方法，包括如下步骤：取各重量配比的原料，打粉或用溶剂提取，加入可接受的辅料或者辅助性成分，即得。
优选地，所述的溶剂为水。
进一步地，所述的提取方法为：加入原料总重量10～15倍的水，煎煮2～3次，每次2～3小时，合并滤液，浓缩，即可。
本发明提供了所述组合物在制备防治肥胖和/或非酒精性脂肪肝的药品或保健品中的用途。
本发明提供了所述组合物在制备降低血脂的药品或保健品中的用途。
本发明提供了所述组合物在制备升高血清高密度脂蛋白水平的药品或保健品中的用途。
本发明提供了所述组合物在制备防治动脉粥样硬化的药品或保健品中的用途。
本发明提供了所述组合物在制备调节肠道菌群紊乱的药品或保健品中的用途。
本发明组合物中：藏茶是少数民族中近六百万藏族同胞的主要生活饮品，又称为藏族同胞的民生之茶，从古到今，按历史时期和各地风俗不同又称为大茶、马茶、乌茶、黑茶、粗茶、南路边茶、砖茶、条茶、紧压茶、团茶、边茶等。中国藏茶自唐朝有记录以来，已是千年古茶。是采摘于海拔在1000米以上高山，当年生成熟茶叶和红苔，经过特殊工艺精制而成的后发酵茶。藏茶属于最典型的黑茶，它的颜色呈深褐色，又是后发酵茶。现代医学研究表明：通过特殊工艺持久发酵制作而成的藏茶包含近500种对人体有益的有机化合物，约700种香气化合物，无机物也相当丰富，包括磷、钾、镁、硒等不少于15种矿物质。
枸杞子，其功能主治为滋肾，润肺，补肝，明目。治肝肾阴亏，腰膝酸软，头晕，目眩，目昏多泪，虚劳咳嗽，消渴，遗精。《药性论》记载其能补益精诸不足，易颜色，变白，明目，安神。《食疗本草》记载其坚筋耐老，除风，补益筋骨，能益人，去虚劳。《纲目》中记载其滋肾，润肺，明目。《本草述》中记载其疗肝风血虚，眼赤痛痒昏翳。治中风眩晕，虚劳，诸见血证，咳嗽血，痿、厥、挛，消瘅，伤燥，遗精，赤白浊，脚气，鹤膝风。化学成分研究表明枸杞子主要含有含多糖、脂肪酸、甜菜碱、胡萝卜素、核黄素、烟酸、氨基酸、维生素C及多种微量元素等。另含阿托品、胡萝卜苷、隐黄质、玉蜀黍黄质、东莨菪素等成分。
甘草，具有补脾益气，清热解毒，祛痰止咳，缓急止痛，调和诸药之功效。常用于脾胃虚弱，倦怠乏力，心悸气短，咳嗽痰多，脘腹、四肢挛急疼痛，痈肿疮毒，缓解药物毒性和烈性等。《本经》中记载其主五脏六府寒热邪气，坚筋骨，长肌肉，倍力，金疮肿，解毒。《纲目》记载其解小儿胎毒、惊痼，降火止痛。《中国药植图鉴》记载其"治消化性溃疡和黄疸。甘草主要含甘草苷、甘草酸、甘草甜素、子丁香烯氧化物、甘草萜醇、异甘草次酸、甘草香豆精、刺芒柄花素、新甘草查耳酮D、光果甘草苷元、异甘草黄酮醇、三萜皂苷、香豆素等成分。
荷叶，其主治清暑化湿，升发清阳，凉血止血，属清热药下分类的清热凉血药。化学成分主要含斑点亚洲罂粟碱、荷叶碱、原荷叶碱、消旋亚美罂粟碱、番荔枝碱、柠檬酸、苹果酸等成分。
决明子，其主治清热明目、润肠通便，属清热药下分类的清虚热药。《本草纲目》记载其除肝胆风热，淫肤白膜，青盲。《中华本草》述其应用较为广泛，载曰：清肝益肾，明目，利水通便。主治目赤肿痛，羞明泪多、青盲、雀目、头痛头晕、视物昏暗、肝硬化腹水、小便不利，习惯性便秘。外治肿毒、癣疾。化学成分主要含游离羟基蒽醌衍生物，为橙黄决明素、大黄酚、大黄素、大黄素甲醚、大黄素蒽酮、大黄素-6-葡糖苷、决明素、黄决明素、钝叶素、钝新素、决明蒽酮、决明子苷等多种成分。
桑叶，其主治疏散风热、清肺润燥、清肝明目，属解表药下属分类的辛凉解表药。化学成分研究表明桑叶主含黄酮类化合物、甾体及三萜类化合物、牛膝甾酮、蜕皮甾酮、芸香苷、槲皮素、绿原酸、香豆素、生物碱、绿原酸及微量挥发油等成分。
山楂，其功能主消食健胃，行气散瘀。用于肉食积滞，胃脘胀满，泻痢腹痛，瘀血经闭，产后瘀阻，心腹刺痛，疝气疼痛；高脂血症。焦山楂消食导滞作用增强。用于肉食积滞，泻痢不爽。化学成分主要含有机酸(柠檬酸及其甲酯、苹果酸等)及黄酮类化合物(金丝桃苷、槲皮素、牡荆素等)。
本发明针对代谢性疾病提供了一种药食同源茶组合物，以藏茶为主要原料，添加枸杞子、甘草、荷叶、决明子、桑叶和山楂6种“药食同源”植物，根据道中医药理论和道医药理论，勤求古训，博采众方，精心研制而制成，在调节脂代谢紊乱方面具有巨大优势。动物实验结果证明，本发明组合物对肥胖、非酒精性脂肪肝等代谢性疾病具有确切的治疗效果，同时，能够显著升高血清高密度脂蛋白水平，有助于动脉粥样硬化的防治。此外，服用该组合物还有助于调节肠道菌群紊乱，升高益生菌的丰度、降低致病菌丰度。
附图说明
图1为试验例1中小鼠体重、附睾脂肪和肝重及摄食量变化图；
图2为试验例1中小鼠血甘油三酯、总胆固醇变化图；
图3为试验例1中小鼠血清谷丙转氨酶和谷草转氨酶变化图；
图4为试验例1中小鼠血清高密度脂蛋白含量变化图；
图5为试验例1中小鼠肝脏甘油三酯和总胆固醇含量变化图；
图6为试验例1中小鼠肝脏HE病理染色图；
图7为试验例1中小鼠肠道菌群丰度变化图。
具体实施方式
下面将结合实施例对本发明的方案进行解释。本领域技术人员将会理解，下面的实施例仅用于说明本发明，而不应视为限定本发明的范围。实施例中未注明具体技术或条件的，按照本领域内的文献所描述的技术或条件或者按照产品说明书进行。所用试剂或仪器未注明生产厂商者，均为可以通过市购获得的常规产品。
实施例1本发明组合物干膏粉的制备
分别称取雅安藏茶600g，枸杞子250g，甘草150g，荷叶250g，决明子250g，桑叶250g和山楂250g，冲淋沥干。加总重量的10倍的水，煎煮3次，每次3小时。合并滤液，在-0.085MPa、65℃条件下减压干燥，粉碎，过80目筛后，得本发明组合物干膏粉250g，产率约12.5％。
以下通过试验例来证明本发明的有益效果。
试验例1本发明组合物调控代谢的功效实验
实验动物：8-9周龄的雄性ApoE基因敲除小鼠30只和同窝野生型小鼠10只。实验前至少1周恒温环境下标准化实验日粮饲养，饮水不限。
动物分组与给药方式：30只ApoE基因敲除小鼠分为3组：①40％高脂饲料组10只；②40％高脂饲料加低剂量组合物干膏粉(100mg/kg)10只；③40％高脂饲料加高剂量组合物干膏粉(400mg/kg)10只；同窝野生型小鼠10只给予低脂对照饲料。取根据实施例1制备得到的本发明组合物干膏粉，配水混匀后口服灌胃，治疗周期为12周。实验结束后，麻醉眼球取血并留取肝脏、肾脏、脂肪组织等标本用于检测。
实验结果：
1、体重、附睾脂肪和肝重及摄食量变化
从图1可以看出，相对于正常对照组，40％高脂饲料明显加速ApoE基因缺陷小鼠的体重、附睾脂肪和肝脏重量的增长，这是肥胖和非酒精性脂肪肝的典型表现。经过高剂量组合物(400mg/kg)12周的口服灌胃，ApoE基因缺陷小鼠的体重增长、附睾脂肪和肝脏重量，较40％高脂饲料模型组明显降低。同时，高剂量组合物达到的效果整体上优于低剂量组合物(100mg/kg)。除此之外，实验表明各组间小鼠的摄食量并无统计学差异，说明本发明组合物不影响小鼠食欲。
2、血甘油三酯、总胆固醇及谷丙转氨酶和谷草转氨酶变化
从图2可以看出，12周40％高脂饲料诱导ApoE基因缺陷小鼠血清的甘油三酯和总胆固醇含量，明显高于正常对照组，这是高血脂症和非酒精性脂肪肝的典型表现。经过高剂量组合物(400mg/kg)12周的口服灌胃，ApoE基因缺陷小鼠血清的甘油三酯和总胆固醇含量，较40％高脂饲料模型组明显降低。同时，高剂量组合物达到的效果整体上优于低剂量组合物(100mg/kg)。除此之外，从图3可以看出，各组间小鼠的谷丙转氨酶和谷草转氨酶无统计学差异，说明本发明组合物对肝脏功能无明细影响。
3、血清高密度脂蛋白含量变化
高密度脂蛋白具有抗动脉粥样硬化的作用。高密度脂蛋白能增强血脂代谢能力，保持血管畅通，使血管更清洁，且对血管没有任何损伤，安全、稳定，是国际医学唯一公认的、真正的血管内脂质“清道夫”。从图4可以看出，12周40％高脂饲料诱导ApoE基因缺陷小鼠血清高密度脂蛋白含量与正常对照组无统计学意义的差别。经过高剂量组合物(400mg/kg)12周的口服灌胃，ApoE基因缺陷小鼠血清高密度脂蛋白含量，较40％高脂饲料模型组明显升高。同时，高剂量组合物达到的效果整体上优于低剂量组合物(100mg/kg)。
4、肝脏甘油三酯和总胆固醇含量变化
ApoE基因缺陷小鼠经过12周40％高脂饲料喂养后，取肝脏组织加入适量生理盐水捣碎，3000转离心10分钟后，取上清液分别使用小鼠肝脏甘油三酯和总胆固醇检测试剂盒检测。从图5可以看出，12周40％高脂饲料诱导，ApoE基因缺陷小鼠肝脏内甘油三酯和总胆固醇含量明显高于正常对照组。经过高剂量组合物(400mg/kg)12周的口服灌胃，ApoE基因缺陷小鼠肝脏甘油三酯和总胆固醇含量，较40％高脂饲料模型组明显降低。同时，高剂量组合物达到的效果整体上优于低剂量组合物(100mg/kg)。
5、小鼠肝脏病理HE染色
从图6可以看出，野生型对照组小鼠具有完整的肝脏病生理结构，无脂肪沉积。经40％高脂饲料诱导ApoE基因敲除小鼠12周后，肝脏组织脂肪空泡化程度显著高于野生型对照组。经过高低剂量组合物12周灌胃治疗后，显著减轻了小鼠肝脏组织脂肪积累和空泡化的程度，且高剂量组合物(400mg/kg/天)达到的效果明显优于低剂量组合物(100mg/kg/天)。
6、肠道菌群的变化
采用16S RNA基因高通量测序技术对各组小鼠回肠内容物肠道菌群谱的组成和结构进行分析。从图7可以看出，与野生型对照组小鼠相比，经40％高脂饲料诱导ApoE基因敲除小鼠12周后，肠道内的益生菌群放线菌(Actinobacteria)、拟杆菌(Bacteroidetes)、疣微菌(Verrucomicrobia)和互养菌(Synergistetes)丰度明显下降，致病菌群厚壁菌(Firmicutes)和螺旋体菌(Saccharibacteria)丰度明显上升。经过本发明组合物12周灌胃治疗后，肠道内菌群Actinobacteria丰度较高脂饲料模型组有所回升，且高剂量组合物(400mg/kg/天)达到的效果明显优于低剂量组(100mg/kg/天)。菌群Bacteroidetes和Verrucomicrobia丰度经过治疗后较高脂饲料模型组也有所升高，但低剂量组合物(100mg/kg/天)达到的效果明显优于高剂量组合物(400mg/kg/天)。结果显示只有高剂量组合物(400mg/kg/天)能够明显调节菌群Synergistetes丰度升高。对于菌群Firmicutes和Saccharibacteria，高、低剂量的本发明组合物均能有效减少其丰度。
以上实验结果表明，本发明组合物具有调节肠道菌群紊乱的作用，能够促进益生菌丰度升高，致病菌丰度降低。
上述动物实验证明，本发明组合物干膏粉在给药剂量为100～400mg/kg/d时对小鼠非酒精性脂肪肝能够发挥显著的治疗作用。按成人体重70kg计算，换算出成人每天给药剂量范围为2g～6g。
Claims (13)
1.调节脂代谢紊乱的组合物，其特征是：由如下重量配比的原料制备而成：藏茶50-60份、枸杞子20-30份、甘草10-20份、荷叶20-30份、决明子20-30份、桑叶20-30份、山楂20-30份。
2.如权利要求1所述的组合物，其特征是：由如下重量配比的原料制备而成：藏茶60份、枸杞子25份、甘草15份、荷叶25份、决明子25份、桑叶25份、山楂25份。
3.如权利要求1所述的组合物，其特征是：所述的藏茶为雅安藏茶。
4.如权利要求1~3任意一项所述的组合物，其特征是：它是以所述重量配比的原料或其提取物作为活性成分，加入可接受的辅料制备而成的制剂。
5.如权利要求4所述的组合物，其特征是：所述的制剂为口服制剂。
6.权利要求1~5任意一项所述组合物的制备方法，其特征是：包括如下步骤：取各重量配比的原料，打粉或用溶剂提取，加入可接受的辅料，即得。
7.如权利要求6所述的制备方法，其特征是：所述的溶剂为水。
8.如权利要求6所述的制备方法，其特征是：所述的提取方法为：加入原料总重量10~15倍的水，煎煮2~3次，每次2~3小时，合并滤液，浓缩，即可。
9.权利要求1~5任意一项所述组合物在制备防治肥胖和/或非酒精性脂肪肝的药品的用途。
10.权利要求1~5任意一项所述组合物在制备降低血脂的药品中的用途。
11.权利要求1~5任意一项所述组合物在制备升高血清高密度脂蛋白水平的药品中的用途。
12.权利要求1~5任意一项所述组合物在制备防治动脉粥样硬化的药品中的用途。
13.权利要求1~5任意一项所述组合物在制备调节肠道菌群紊乱的药品中的用途。
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