CN106975069B - 一种保肝护肝组合物及其制备方法 - Google Patents
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Abstract
本发明涉及保健品领域,具体而言,涉及一种保肝护肝组合物及其制备方法。按重量份数计,所述组合物包括如下组份:枳椇子1~5份、葛根0.5~4份、枸杞子0.5~4份、茯苓0.1~3份、玉米低聚肽粉0.1~3份、蚌肉多糖0.5~1份以及杭白菊0.05~0.4份。所述的组合物具有保护肝脏的功效,无明显的毒副作用,并兼具快速解酒醒酒功能。
Description
技术领域
本发明涉及保健品领域,具体而言,涉及一种保肝护肝组合物及其制备方法。
背景技术
肝脏是身体内以代谢为主的一个器官,并在身体里面扮演着去氧化、储存肝糖、分泌性蛋白质的合成等角色。同时,肝脏对来自体内和体外的许多非营养性物质如各种药物、毒物以及体内某些代谢产物,具有生物转化作用,通过新陈代谢将它们彻底分解或以原形排出体外,这种作用也被称作“解毒功能”。
现代人的生活环境和方式非常不利于肝脏的健康,熬夜是家常便饭,加班、吃药、饮食不当等等,都直接危害着肝脏的健康,近年来病毒性肝炎、肝纤维化、脂肪肝、酒精性肝病变、药物性肝损害及肝癌等肝病越来越成为威胁国人健康的主要疾病。各种肝病及肝病前期患者呈现持续增长及年轻化的特点,市场需求一种使用方便、无毒副作用且疗效好的保健护肝品。
有鉴于此,特提出本发明。
发明内容
本发明的第一目的在于针对上述技术问题提供一种保肝护肝组合物,所述的组合物具保肝护脏的功效,无明显的毒副反应,还兼具快速解酒醒酒功能,又能减轻醉酒后胃胀恶心、呕吐、头昏脑胀。
本发明的保肝护肝组合物,按重量份数计,包括如下组份:
枳椇子1~5份、葛根0.5~4份、枸杞子0.5~4份、茯苓0.1~3份、玉米低聚肽粉0.1~3份、蚌肉多糖0.5~1份以及杭白菊0.05~0.4份。
本发明的第二目的在于提供制备本发明组合物的方法。
在一种实施方式中,将各原料粉碎,混合在一起。
在一种实施方式中,本发明的方法包括以下步骤:
(a)将各原料用水煎煮,得到煎液,或用乙醇水溶液提取,得到提取液;
(b)用所述煎液或所述提取液制备所需剂型。
与现有技术相比,本发明的有益效果为:
(1)药效好,纯中药配方,无明显的毒副反应;
(2)以中药制剂形式用药,服用方便,效果好;
(3)不仅仅是解酒,还能达到长期护肝、保肝的目地。
附图说明
为了更清楚地说明本发明具体实施方式或现有技术中的技术方案,下面将对具体实施方式或现有技术描述中所需要使用的附图作简单地介绍,显而易见地,下面描述中的附图是本发明的一些实施方式,对于本领域普通技术人员来讲,在不付出创造性劳动的前提下,还可以根据这些附图获得其他的附图。
图1为本发明实验例1的实验结果;
图2为本发明实验例2的实验结果。
具体实施方式
本发明一方面涉及一种保肝护肝组合物,主要由以下原料制成:枳椇子、葛根、枸杞子、茯苓、玉米低聚肽粉、蚌肉多糖以及杭白菊。
按重量份数计,包括如下组份:
枳椇子1~5份、葛根0.5~4份、枸杞子0.5~4份、茯苓0.1~3份、玉米低聚肽粉0.1~3份、蚌肉多糖0.5~1份以及杭白菊0.05~0.4份。
优选的,如上所述的保肝护肝组合物,按重量份数计,包括如下组份:
枳椇子2~4份、葛根1~3.5份、枸杞子1~3.5份、茯苓0.5~2.5份、玉米低聚肽粉0.5~2.5份、蚌肉多糖0.6~0.9份以及杭白菊0.1~0.3份。
优选的,如上所述的保肝护肝组合物,按重量份数计,包括如下组份:
枳椇子2.5~3.5份、葛根1.5~3份、枸杞子1.5~3份、茯苓1~2份、玉米低聚肽粉1~2份、蚌肉多糖0.7~0.8份以及杭白菊0.15~0.25份。
优选的,如上所述的保肝护肝组合物,按重量份数计,包括如下组份:
枳椇子3份、葛根2.7份、枸杞子2.7份、茯苓1.5份、玉米低聚肽粉1.5份、蚌肉多糖0.75份以及杭白菊0.2份。
优选的,如上所述的保肝护肝组合物,按重量份数计,所述组合物还包括干香菇1~5份;更优选为2~4份。
优选的,如上所述的保肝护肝组合物,按重量份数计,所述组合物还包括生姜0.05~0.4份;更优选为0.1~0.3份。
一、原料(组分)
枳椇子又名鸡距子,拐枣,为鼠李科植物枳椇(Hovenia duleis Thunb.)的干燥成熟的种子,性平,味甘酸,无毒,其主要功效为清热利尿,止渴除烦,解酒毒。用于热病烦渴,呃逆,呕吐,小便不利,酒精中毒等症状。祖国医学专著中称,枳椇子性平、味甘酸,入脾、肺二经,主治酒醉、烦热、口渴、呕吐、二便不利,有显著的利尿除酒毒作用,是一种解酒良药。现代医学研究表明,枳椇子含葡萄糖、果糖、硝酸钾、过氧化物酶等。枳椇子及其复方能显著降低乙醇在血液中的浓度,促进乙醇的清除,消除酒后体内产生的过量自由基,阻碍过氧化脂质的形成,从而减轻乙醇对肝组织的损伤,避免酒精中毒导致的各种代谢异常,诱发的各种疾病。此外,枳犋子还是消化人体过多脂肪的保健果品,常吃可以减肥健美。
葛根为豆科多年生落叶藤本植物葛(Pueraria lobata(ffilld)Ohw1.)的干燥根,属于***公布的既是食品又是药品的物品。《本草拾遗》谓其“解酒毒”。现代研究表明,葛根含有多种人体必需的矿物质、氨基酸、维生素及黄酮等,具有治疗心脑血管疾病、预防动脉硬化、抗氧化、解酒保肝等多种药理作用。
枸杞子为茄科植物宁夏枸杞(Lycuim barb arum L)的干燥成熟果实,作为传统的药食同源物质,是我国传统的名贵中药材,素有“红宝”美称,富含植物多糖、蛋白质、维生素等营养成分,具有“滋阴补血,益精明目”之功效,其具有滋补肝肾、益精明目、养血,增强免疫力等作用。
茯苓别名茯灵,平,甘、淡,归心、脾、肾经。利水渗湿、健脾安神。化学成分:含茯苓糖、茯苓酸、蛋白质、脂肪、卵磷脂、组胺酸、胆碱、麦角甾醇和钾盐等。属于药食同源品种,具有健脾安神之功效。
玉米低聚肽是从天然食品玉米中提取的玉米蛋白经过酶解技术而获得的小分子肽物质,含有高比例的亮氨酸、缬氨酸、丙氨酸等疏水性氨基酸以及支链氨基酸和中性氨基酸,很少含有赖氨酸等碱性氨基酸。这种特殊氨基酸组成,使得玉米低聚肽具有多种功能,如降血压、解酒、降低血清胆固醇等。
蚌肉多糖(Hyriopsis cumingii polysacchride)是从淡水双壳类软体动物三角帆蚌的蚌肉里提取、纯化而得到的一种白色粉末状天然多糖物质。对其的研究表明,蚌肉多糖对干细胞损伤有非常明显的保护作用。
杭白菊又称甘菊,是我国传统的栽培药用植物。经现代药理证明:其具有止痢、消炎、明目、降压、降脂、强身的作用。其对中枢神经有镇静作用,且有解热作用。
香菇营养丰富,味道鲜美,素有“菇中之王”、“蔬菜之冠”之美称。味甘,性平。归肝、胃经。富含支链氨基酸,促进肝损伤恢复。富含香菇多糖,可显著降低和抵抗有毒化学物质对肝脏的损害。富含B族维生素、多种微量元素等营养成分,护肝、保肝。
生姜味辛,性微温。归肺、脾经。用于暖胃、健脾。
二、形式和剂型
本发明提供的组合物既可以作为药物进行内服,也可以作为保健食品或饮料进行食用。
在一种实施方式中,本发明的组合物为简单混合物。制备过程为将各原料)简单混合即可。
在另一种实施方式中,本发明的组合物还可以做成中成药的形式。中成药的剂型包括但不限于丸剂、散剂、膏剂、片剂、颗粒剂(冲剂)、锭剂、胶囊剂、水剂、酊剂。
(1)丸剂
丸剂是药材细粉或药材提取物加适宜粘合剂或辅料,制成的球形或类球形的固体制剂,是中成药最古老的剂型之一。根据粘合剂的不同丸剂又分为蜜丸、水蜜丸、水丸、糊丸、浓缩丸、微丸等类型。
优选使用浓缩丸。浓缩丸是全部药材或部分药材的煎液或提取液,与适宜的辅料或药物细粉加适宜的粘合剂制成。根据粘合剂的不同,又分为浓缩蜜丸、浓缩水丸、浓缩水蜜丸。浓缩丸体积小,药物有效成分含量高,易于服用,在体内溶化吸收比较缓慢。
在一种优选的实施方式中,将全部药材或部分药材的煎液或提取液,与辅料或药物细粉加粘合剂制成浓缩丸。优选地,将全部药材煎液或提取液与粘合剂和可选的辅料制成浓缩丸。
(2)散剂
散剂是一种或多种药材混合制成的粉末状制剂,分内服散剂和外用散剂,是我国古代剂型之一。散剂治疗范围广,服用后分散快,奏效迅速,且具有制作方便、携带方便、节省药材等优点。
(3)膏剂
膏剂系药物剂型之一。膏剂是将药物用水或植物油煎熬浓缩而成的剂型。有内服和外用两种。内服膏通常又分流浸膏、浸膏、煎膏三种;外用膏有软膏、硬膏两种。其中内服煎膏和外用软膏是膏剂中常见的剂型。内服的煎膏又叫膏滋,是把药物加水煎熬,滤滓,加入冰糖、蜂蜜等,熬成稠厚的膏,可长期服用。常用于慢性疾病或身体虚弱者。外用的软膏称油膏,一般药膏,是把蜂蜡加入棉子油或花生油中,加热熔化,乘热加入应用的药物细粉,不断搅拌,待冷凝即成。冰片、樟脑等容易挥发的药,可在油膏冷后加入搅匀。外用药膏一般用于外涂皮肤疮疡疥癣等。
本发明优选使用煎膏剂,煎膏剂(膏滋)是药材用水煎煮、去渣浓缩后,加甜味剂制成的半固体制剂,又称膏滋。甜味剂可以为炼蜜或糖、木糖醇,优选木糖醇。煎膏剂具有吸收快,浓度高,体积小,便于保存,可备较长时间服用的特点。有滋补调理的作用,用于治疗慢性病和久病体虚者。
(4)片剂
片剂是药材细粉或提取物与适宜的辅料或药材细粉压制而成的片状制剂,分浸膏片、半浸膏片和全粉片等,是常用的现代剂型之一。片剂体积小,用量准确,易崩解生效快,且具有生产效率高、成本低、服用及储运方便的优点。片剂适用于各种疾病。本发明优选使用浸膏片。
(5)颗粒剂
颗粒剂(冲剂)是药材提取物与适宜的辅料或与药材细粉制成的颗粒状制剂,是在汤剂、散剂和糖浆剂的基础上发展起来的新剂型。有颗粒状和块状两种,分为可溶性、混悬性、泡腾性及含糖型、无糖型等不同类型。颗粒剂体积小,重量轻,服用简单,口感好,作用迅速,多用于补益、止咳、清热等作用的药物。
优选地,制备时采用水提取物(煎液)制备。
(6)锭剂
锭剂是药材细粉与适量粘合剂如蜂蜜、糯米粉或利用药材本身的粘性制成规定形状的固体制剂。可供内服或外用,内服作用与糊丸接近,外用多用水或醋磨汁后涂敷患处。锭剂型大多作噙化之用。
优选地,本发明的锭剂为内服锭剂。
(7)胶囊剂
胶囊剂包括硬胶囊剂和软胶囊剂。
硬胶囊剂是将适量的药材提取物、药材提取物加药粉或辅料制成均匀的粉末或颗粒,填充于硬胶囊中而制成的剂型。主要是口服。硬胶囊外观整洁美观,易于吞服,可掩盖药物的不良嗅味,崩解快,吸收好。适用于对光敏感、不稳定或遇湿、热不稳定的药物,或有特异气味的药物,或需要定时定位释放的药物。儿童用药、对胃粘膜刺激性强的药物不宜制成胶囊剂。
软胶囊剂是将油类或对明胶等囊材无溶解作用的液体药物或混悬液封闭于囊材内制成的剂型。特点与硬胶囊相似。硬胶囊和软胶囊经过适宜方法处理或用其他药用高分子材料加工,使囊壳不溶于胃液,但在肠液中崩解释放活性成分,为肠溶胶囊。
优选地,本发明的胶囊为将煎液或提取液获得的药材提取物加辅料制成均匀的粉末或颗粒,填充于硬胶囊中而制成的剂型。
(8)水剂
水剂是中药组合物的水溶液,药剂以离子或分子状态均匀分散在水中,药剂的浓度取决于原药的水溶解度,一般情况是其最大溶解度,使用时再兑水稀释。为了使得药物中的有效成分释放完全,可以采用热水煎制等方法制备水剂,煎制的次数可以为1次、2次或更多次。
(9)酊剂
酊剂是药物用规定浓度的乙醇浸出或溶解制成的澄清液体制剂,也可以用流浸膏稀释制成。分内服和外用两种。酊剂制备无需加热,成分较纯净,有效成分含量高,剂量准确,吸收迅速,适宜于制备含有挥发性成分或不耐热成分的制剂。优选地,本发明的酊剂为内服酊剂。
三、用途
本发明一方面涉及本发明的组合物在制备用于保肝护肝药物中的用途。
本发明另一方面还请求保护含有如上所述的组合物的食品或饮料。
所述食品包括小吃、点心、原料(stock)、汤、炖品(stew)、酱或肉汁等。
四、制备方法
本发明另一方面涉及保肝护肝组合物的制备方法。
1、简单混合物的制备
可以将上述原料简单混合在一起,从而制备本发明的简单混合物。
在一种实施方式中,制备该组合物的方法包括以下步骤:将各组分粉碎,混合在一起。
2、中成药的制备
在一种实施方式中,制备本发明组合物的方法包括以下步骤:
(a)将上述原料用水煎煮,得到煎液,或用乙醇水溶液提取,得到提取液;
(b)用煎液制备所需剂型。
剂型可以是上述剂型,例如丸剂、散剂、膏剂、片剂、颗粒剂(冲剂)、锭剂、胶囊剂、水剂或酊剂。
当然,也可以服用中成药剂型。在上述煎液剂量的基础上,中成药剂型服用量通过本领域内的临床实验可以确定。
下面将结合实施例对本发明的实施方案进行详细描述,但是本领域技术人员将会理解,下列实施例仅用于说明本发明,而不应视为限制本发明的范围。实施例中未注明具体条件者,按照常规条件或制造商建议的条件进行。所用试剂或仪器未注明生产厂商者,均为可以通过市售购买获得的常规产品。
实施例1
枳椇子5g、葛根4g、枸杞子0.5g、茯苓3g、蚌肉多糖1g以及杭白菊0.05g。
加入1.5升饮用水煲沸60分钟,然后浓缩至膏状,与玉米低聚肽粉3g混合,制作成丸。
实施例2
枳椇子2g、葛根3.5g、枸杞子1g、茯苓2.5g、玉米低聚肽粉0.5g、蚌肉多糖0.9g以及杭白菊0.1g。
加入1.5升饮用水煲沸60分钟,然后浓缩,加入木糖醇,制得煎膏剂。
实施例3
枳椇子4g、葛根3.5g、枸杞子3.5g、茯苓0.5g、玉米低聚肽粉2.5g、蚌肉多糖0.6g以及杭白菊0.3g。
加入1.5升饮用水煲沸60分钟,然后浓缩,加入糊精混合,压制,干燥,制得片剂。
实施例4
枳椇子3.5g、葛根1.5g、枸杞子1.5g、茯苓2g、玉米低聚肽粉1g、蚌肉多糖0.8g以及杭白菊0.15g。
加入1.5升饮用水煲沸40分钟,浓缩至100mL,即得水剂。
实施例5
枳椇子2.5g、葛根3g、枸杞子3g、茯苓1g、玉米低聚肽粉2g、蚌肉多糖0.7g、杭白菊0.25g以及干香菇5g。
加入1.5升饮用水煲沸40分钟,浓缩至100mL,即得水剂。
实施例6
枳椇子3g、葛根2.7g、枸杞子2.7g、茯苓1.5g、玉米低聚肽粉1.5g、蚌肉多糖0.75g、杭白菊0.2g、干香菇3g以及生姜0.2g。
分两次煎药,第一次加水165ml,煲沸90min;第二次加水125ml,煲沸60min,将2次煎液合并,浓缩至30ml,即得水剂。
实验例1
取实施例6制得的组合物水剂用作细胞毒性试验:
细胞采用:Chang Cell,剂量相当于0~8瓶/日。当细胞存活率≥90%的条件下即判断为无毒性。结果如表1和图1所示。
表1
结果:服用当量为≤8瓶/日的条件下,没有表现出细胞毒性。
结论:在正常服用量1~2瓶/日的条件下,对人体无毒副作用。
实验例2
取实施例6制得的组合物水剂做CCl4引起小鼠急性肝损伤的实验观察:
将60只小鼠随机分为6组,正常对照组10只,CCl4模型组10只,样品组高中低各10只,阳性对照(葵花护肝片)10只。用橄榄油配制CCl4浓度为1%,按照10ml/kg体重腹腔注射。灌胃给药1周后,CCl4模型组和样品组小鼠腹腔内注射0.1%CCl4油溶液造模。18h后每只小鼠用眼眶取血法取血,分离血清,常规方法检测肝功能指标(ALT、AST),结果见表2及图2。
表2
组别 | 动物数 | ALT(U/L) | AST(U/L) |
空白组 | 10 | 33.90±10.90** | 28.90±3.57** |
对比组 | 10 | 347.15±41.33** | 126.07±14.71** |
模型组 | 10 | 484.51±93.39 | 143.43±24.78 |
小剂量组 | 10 | 297.31±50.23** | 100.07±15.33** |
中剂量组 | 10 | 249.35±48.56** | 90.93±15.45** |
大剂量组 | 10 | 198.13±45.01** | 82.90±10.75** |
阳性组 | 10 | 234.55±52.01** | 98.73±12.93** |
注:与模型组比较,*P<0.05,**P<0.01。
其中,空白组为没有经过急性肝损伤处理的小鼠;
对比组采用公开号CN102960809A,公开日2013年3月13日,优先权日2012年12月5日的实施例5中采用的解酒抗疲劳饮料;
模型组为经过急性肝损伤处理但没有任何保肝处理的小鼠;
小剂量组所服用的药物浓度为810mg/kg;
中剂量组所服用的药物浓度为1620mg/kg;
大剂量组所服用的药物浓度为3240mg/kg;
阳性组为服用葵花护肝片的小鼠,服用量为560mg/kg。
本样品三个剂量均能降低ALT活力,与模型组比较,有极显著差异(P<0.01);
本样品三个剂量均能降低AST活力,三个剂量组与模型组比较,有极显著差异(P<0.01)。实验结果说明,本样品对肝损伤具有显著的保护作用,具有明显的保肝作用。
最后应说明的是:以上各实施例仅用以说明本发明的技术方案,而非对其限制;尽管参照前述各实施例对本发明进行了详细的说明,但本领域的普通技术人员应当理解:其依然可以对前述各实施例所记载的技术方案进行修改,或者对其中部分或者全部技术特征进行等同替换;而这些修改或者替换,并不使相应技术方案的本质脱离本发明各实施例技术方案的范围。
Claims (2)
1.一种保肝护肝组合物,其特征在于,按重量份数计,由如下组份制备得到:
枳椇子3份、葛根2.7份、枸杞子2.7份、茯苓1.5份、玉米低聚肽粉1.5份、蚌肉多糖0.75份、杭白菊0.2份、干香菇3份以及生姜0.2份;
所述组合物的剂型为丸剂、散剂、膏剂、片剂、颗粒剂、锭剂、胶囊剂、水剂或酊剂;
所述的组合物的制备方法,包括以下步骤:
(a)将各原料用水煎煮,得到煎液;
(b)用所述煎液制备所需剂型。
2.含有权利要求1所述的组合物的食品或饮料。
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