CN102784248A - 一种防治酒精性肝损伤的中药组合物 - Google Patents
一种防治酒精性肝损伤的中药组合物 Download PDFInfo
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- CN102784248A CN102784248A CN2012103197690A CN201210319769A CN102784248A CN 102784248 A CN102784248 A CN 102784248A CN 2012103197690 A CN2012103197690 A CN 2012103197690A CN 201210319769 A CN201210319769 A CN 201210319769A CN 102784248 A CN102784248 A CN 102784248A
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Abstract
本发明提供了一种以清热化浊,活血通络为主要功效的防治酒精性肝损伤的中药组合物,该组合物由活性成份和医学上可接受的辅料组成,其中所述的活性成份由以下原料药制成:积雪草、虎杖、丹参、五味子、葡萄籽。经药效学实验证明,本发明组合物对酒精所致急、慢性肝炎都有很好的防治作用,并能提高机体免疫能力。可制成具有解酒、保肝作用的药物或保健食品。
Description
技术领域
本发明涉及一种具有防治酒精性肝损伤等相关疾病的天然产物的组合物,属医药和食品领域。
背景技术
肝脏是人体最大的腺体,它在人的代谢、胆汁生成、解毒、凝血、免疫、热量产生及水与电解质的调节中均起着非常重要的作用。一般来说,造成肝损伤主要有两大类致病因素,一类是由病原微生物如病 毒感染而引起的肝脏炎症,如甲肝、乙肝等。另一类则是化学性肝损伤,它由各种毒性物质,如食物中的酒精、环境中的化学毒物及某些药物等对肝脏造成的损伤。酒精性肝损伤是指由于过量摄入酒精而导致的肝脏损害等一系列病变。酒精性肝损伤可以分为急性酒精性肝损伤以及慢性酒精性肝损伤。急性酒精性肝损伤是由于一次摄入过量酒精而造成肝功能损害,表现为食欲不振、恶心、肝部不适黄疸等类急性肝炎症状。慢性酒精性肝损伤是由于长期摄入酒精而导致肝细胞纤维化变性、坏死,肝脏免疫功能遭到破坏,常表现为酒精性脂肪肝,酒精性肝炎以及酒精性肝硬化。治疗酒精性肝损伤的药物主要有:抗内毒素药物、抗氧化剂、糖皮质激素、对抗和改善乙醇代谢的药物。这些药物对急性酒精性肝损伤和慢性酒精性肝损伤初期有一定的疗效,但到了酒精性肝损伤的后期,人体免疫机能严重下降,肝功能受损严重,只有进行肝移植才能能显著改善症状和增加生存率。总而言 之,现代医学对于治疗急慢性酒精性肝损伤并无一特效良药。
由于长期饮酒能阻碍脂肪酸的分解,引起中性脂肪蓄积,由于过 剩的H+能阻碍肝细胞线粒体内作为能源的脂肪酸分解,引起脂肪肝。肝细胞的脂肪化严重影响了肝的正常功能,抑制了体内三羧酸循环的进行,导致酒的代谢途径受阻,加重酒精对正常组织的损害,形成恶性循环。因此研究一种可以降低酒精毒性,并可对酒精所致肝损伤有恢复作用的药物有着较大的社会效益及应用前景。
本发明就是将从天然植物中发现和提取的一种具有防治酒精性肝损伤的中药组合物。该组合物是由有效成分创新组合成天然产物组合物,从几种不同作用机制上入手治疗酒精性肝损伤,多组分多靶点协同作用,达到长短结合,标本兼治的效果,以期从疗效和安全性上有显著的突破和提高。
积雪草是伞形科植物积雪草Centella asiatica Linn.的全草,别名有崩大碗、缺碗草、马蹄草、雷公根等。始载于《神农本草经》,列为中品,苦、辛、寒,归肝、脾、肾经,具有清热利湿,解毒消肿的功效。用于湿热黄疸,中暑腹泻,砂淋血淋,痈肿疮毒,跌打损伤。我国民间常用于治疗感冒、扁桃腺炎、传染性肝炎、痢疾、跌打损伤、疔疮肿毒、流行性脑脊髓膜炎等。《岭南草药志》记载,崩大碗每次约八两至一斤,煎水服,用于治肝脏肿大。《江西民间草药》记载积雪草一两,冰糖一两,水煎服,用于治湿热黄疸。《广东中药》Ⅱ记载,积雪草具有清暑热,去湿热,治肝肿大等作用。积雪草的有效成分为积雪草总皂苷、积雪草酸、羟基积雪草酸等。近年研究报道积雪 草有促进伤口愈合,软化疤痕,抗牛皮癣,抗抑郁,抗乳腺增生,抗肝纤维化,抗癌,治疗水肿,保肝,降血糖及并发症的治疗等作用。王胜浩等发明专利(公开号:CN100441201C)报道了积雪草总苷具有治疗外伤、手术创伤、烧伤,疤痕疙瘩及硬皮病及抗抑郁和治疗肝肾纤维化作用。国内专利公开了积雪草酸及衍生物有治疗皮肤创伤、抗抑郁、抗阿尔茨海默病以及保肝、保护心脑血管和诱导肿瘤细胞调亡等多种作用(CN1238692、CN1248918、CN1543964及CN1582946)。积雪草酸还有治疗肝纤维化、肺纤维化作用(专利申请号:200610122561.4、200610118041.6)。李洪钟研究表明羟基积雪草苷对小鼠急性肝损伤具有明显的保护作用。张丽娜研究表明积雪草苷对小鼠脓毒症致急性肝损伤具有明显的保护作用。
虎杖为蓼科植物虎杖Polygonum cuspidatum Sieb.et Zucc.的干燥根茎及根。虎杖主要含二苯乙烯类和蒽醌类化合物,性微寒、味苦酸,归肝、胆、肺经。具有清热解毒,利胆退黄,祛风利湿,散瘀定痛,止咳化痰的功效。用于关节痹痛,湿热黄疸,经闭,癓瘕,咳嗽痰多,水火烫伤,跌扑损伤,痈肿疮毒。在临床上的应用已越来越广泛。虎杖煎剂能明显对抗四氯化碳引起的大鼠肝损伤,显著降低血清AST、ALT含量,肝组织病理学变化也发现肝细胞变性坏死的严重程度随虎杖煎剂的剂量增大而减轻,其保肝护肝除通过抗氧化发挥保护作用外,还可通过抑制 TNF-α的分泌,下调 Bax和上调Bcl-2的表达,提高Bcl-2/Bax比值而抑制细胞凋亡以及保护内皮细胞功能产生,而且药物本身对肝脏无明显损伤作用。江庆澜等应用RT-qPC方法检测 分析虎杖水提物对NAFLD动物模型药物干预效果,4周之后NAFLD大鼠脂肪组织的 TNF-mRNA 相对水平和肝组织总胆固醇含量显著低于对照组,甘油三酯和葡萄糖的指标也低于对照组,而且肝细胞的脂变大泡现象基本消失,说明虎杖水提物具有降低肝脂和肝糖的功效,并可使TNF-基因的表达水平显著下调,有利于增加脂酶活性和缓解胰岛素抵抗,可调节肝脏脂肪和糖的代谢以及改善肝细胞内脂类积聚和脂肪变性的状况这对于应用虎杖干预NAFLD,尤其是伴有肥胖胰岛素抵抗和肝炎症状的病例具有治疗作用。同时虎杖中含有的白藜芦醇及虎杖苷能够降低小鼠血清中的GOT和GPT的水平,降低LPO和减少血清FFA、血清中的TC、TG、HDL-ch水平不变;阻止过氧化物在鼠肝内微粒体ADP和N-ADPH所诱导。服用白藜芦醇对TC、TG在肝中积聚有一定抑制作用;虎杖苷对血清TG和LDL-ch的提高有一定抑制作用;减少了致动脉粥样硬化指数。白藜芦醇和虎杖苷减少了在小白鼠肝中的14C-软脂酸的脂肪生成。虎杖煎剂能明显降低血清肝红素量和降低血清谷丙转氨酶活力的作用。
丹参是唇形科植物丹参Salvia miltiorrhiza Bge的干燥根及根茎,具有活血祛淤、安神宁心、止痛等功效。丹参素、丹参酮是其主要药理成份。现代药理研究表明,丹参是天然的抗氧化剂,丹参具有清除毒性自由基、抑制正常及损伤肝细胞脂质过氧化的作用。丹参素、丹参酮对四氯化碳和D-氨基半乳糖诱导的小鼠急性肝损伤和四氯化碳诱导的大鼠肝纤维化有保护作用。南京医科大学的李菁等的试验证明,丹参素对能使正常肝细胞增殖,能消除活性氧自由基,增强肝细 胞SOD活力,抑制膜的脂质过氧化反应,减轻肝细胞变性坏死。白求恩医科大学的叶红军等人的研究显示,丹参减轻肝细胞坏死、脂肪变性、促进肝细胞再生,改善肝脾血液循环及减轻其淤血及缺血状态作用均优于辅酶Q10。辽宁中医学院附属医院的吴百灵的研究表明,丹参可抑制ALT、AST酶活性增高,其作用是因为丹参具有显著的抗脂质过氧化作用。山西医科大学郑晓宾等人的研究证明了丹参防治实验性肝损伤的途径之一可能是减少了TNF-α的释放,降低了TNF-α的毒性而发挥作用。南京铁道医学院附属医院的刘怡晟等人研究表明,丹参对CCl4所致肝损伤有明显的保护作用。丹参能明显降低血 清ALT、血清和肝匀浆MDA以及肝细胞的钙含量,也能减少血清及肝组织SOD活力的下降,光镜和电镜下肝组织病理病变明显减轻,同时发现丹参能明显降低血清TNF-α,表明丹参的作用机制是通过减轻肝细胞膜脂质过氧化,保持自由基清除能力,减轻钙超载,同时抑制TNF-α的释放,加速其灭活。
五味子为木兰科植五味子Schisandra chinensis (Turcz.)Baill的果实。性温,味酸、甘。入心、肾经,具有收敛固,益气生津,补肾宁心的功效。《日华子》中记载能解酒毒。木脂素为降酶护肝成分,代表化合物为五味子乙素。能明显诱导肝微粒体的细胞色素P-450活性,增强肝脏的解毒功能。还具有抗肝细胞损害,减轻乙醇中毒所致肝脂质过氧化损伤的药理作用(中国医学科学院药物研究所,中草药现代研究,北京:北京医科大学,中国协和医科大学联合出版社,第一版.1995,第一卷,372- 375)。六十年代末和七十年代初,我国临床首 先发现五味子粉剂或蜜丸对病毒性肝炎病人有降血清谷丙转氨酶(SGPT)及改善某些症状的效果。国内外学者已从各种五味子植物中分离出90余种木脂素类及有机酸和一些挥发性成份。目前我国在五味子的临床疗效、有效成份、药理作用及植物资源方面作了大量研究,已发现五味子对肝脏的作用具有明显的保护作用。包天桐、刘耕陶等用四氯化碳、硫代乙酰胺和乙炔雌二醇环戊醚引起小鼠肝损伤为模型,发现五味子的醇提物和从五味子中分离出的上述五味子甲素、乙素、丙素、醇甲、醇乙、酯甲和酯乙均有不同程度的降低因化学物质引起的血清转氨酶升高作用,能明显减轻肝小叶的坏死,所以,五味子对四氯化碳损伤大鼠肝脏的保护作用可能是通过肝细胞内蛋白质合成代谢实现的。用五味子醇提物,预先24h给药能显著降低大剂量扑热息痛(400mg/kg)肝中毒所致的小鼠死亡率,并防止肝内谷胱甘肽的耗竭,增强肝微粒体代谢扑热息痛的速度,血中扑热息痛含量下降。睢大员、高普军等发现,北五味子多糖可显著减低四氯化碳中毒小鼠肝中丙二醛的含量,抑制小鼠肝脏脂质过氧化反应,促进正常小鼠的胆汁分泌和部分肝切除后肝的再生。
葡萄籽是葡萄酒厂的下脚料,经晒干后分离葡萄皮、葡萄梗后所得产物。葡萄籽含有丰富的氨基酸、维生素、矿物质及大量的原花青素。葡萄籽提取物(Grape Proanthocyanidins,GPC)是从葡萄籽中提取的多酚类化合物,主要含原花青素(OPC)。葡萄籽提取物在市面上的工厂有公开生产。中医认为,葡萄性平、味甘酸,能补气血,强筋骨,益肝阴,利小便,舒筋活血,暖胃健脾,除烦解渴。葡萄中所含的多 酚类物质是天然的自由基清除剂,具有很强的抗氧化活性,可以有效地调整肝脏细胞的功能,抵御或减少自由基对它们的伤害。原花青素拥有强有力的抗氧化能力,在体内其抗氧化、清除自由基能力是维生素E的50倍、维生素C的20倍。葡萄籽提取物对乙醇肝损伤有预防和治疗作用,对四氯化碳肝损伤也有一定治疗作用。能抑制红细胞膜和低密度脂蛋白的脂质过氧化。还能促进内皮细胞松弛因子NO的形成,对细胞和组织的损伤起保护作用(高军涛等. 葡萄籽中多酚类物质对氧自由基清除作用的ESR研究,波谱学杂志,1999,16(5):409- 414)。程彦杰经研究发现服用原花青素可明显降低动物的醉倒率,提高动物对酒精的耐受能力,改善长期服用酒精的动物的肝功能,降低过氧化脂质在肝中的沉积,增加动物对疼痛的耐受力,同时可明显改善长期饮酒后头痛人群的头痛症状,有效率为72.7%。
综上所述,积雪草、虎杖、丹参、五味子、葡萄籽五味药合用以不同的药效物质从不同的作用靶点和途径有非常明确的防治酒精想性肝损伤的作用,可有效的预防和治疗酒精性肝损伤。因此该组合物可用于制备具有防治酒精性肝损伤的药品和保健品。
发明内容
本发明提供一种具有清热化浊,活血通络之功效的中药组合物,可用于制备具有防治酒精性肝损伤的药品和保健品。
本发明人依据中医理论、经过反复试验,选用了积雪草、虎杖、丹参、五味子、葡萄籽等五种卫生部规定的既是食品又是药品和可用于保健食品的原料,所以该处方组成非常安全,用以制备具有防治酒 精性肝损伤的保健食品,无任何毒副作用。在选取本发明保健食品的各原料进行组合搭配时,充分发挥了它们各自的功效,并经合理搭配所能产生的协调效果。本组合物与欧美、日本畅销的解酒剂(添加兴奋剂、止痛剂、维生素和矿物质等类型的产品,只能暂时缓解宿醉引起的症状,但对于酒精引起的肝损伤并无确切疗效)具有明显的不同;同时与目前已有的护肝解酒类保健食品相比,具有活性更确切,化学组成具有明显的特色,这是本发明的突出贡献。
本发明目的是,基于现代病理学,药理学和药物化学机制和传统中医理论相结合的原则,经过大量的研究发现本发明的组合物对于酒精性肝损伤的治疗具有显著的疗效,可以用来制备成防治酒精性肝损伤的药物或保健品。这种现代天然产物组合物,其中蕴涵了大量抗肝纤维化,修复损坏组织,增加胆汁分泌,降低转氨酶,降低血清胆红素含量、ALT和AST活性,降低碱性磷酸酶、γ-谷氨酰转移酶及组织中胆固醇、TG和游离脂肪酸的含量,减少肝脏胶原沉积,减少肝细胞坏死、脂肪变性,促进肝细胞再生,消除氧自由基等化学成分成分。这些化学成分相互协同、多靶点、多途径作用,五味药组合从根本上全面调节肝损伤人的机体,改善身体健康状况。本发明适用于饮酒较多造成酒精性肝损伤者,通过降低乙醇在血中的浓度,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,从而减轻了乙醇对肝组织的损伤,起到对肝损伤的辅助保护功能,并有美容护肤的功效。具有明显的创新性和技术进步。
本发明选用民间常用中药的积雪草为君药,积雪草早于古书《岭 南草药志》、《江西民间草药》、《广东中药》Ⅱ中有记载,用于治疗湿热黄疸、肝肿大。现代研究表明,积雪草皂苷及积雪草酸具有抗肝纤维化、修复损坏组织、抗炎等药理活性。本发明是根据古方中积雪草的用途与现代成分化学相结合,经过试验证明,具有明显的抗肝损伤的活性,同时兼顾中医理论,与虎杖、丹参、五味子、葡萄籽组方,与目前市场上用于治疗酒精性肝损伤的药物具有实质的区别和明显的技术进步,也是本发明的又一创新点。
本发明提供了可改善与治疗酒后头晕、头痛、恶心、呕吐、胃内不适症状及酒精性肝损伤、脂肪肝的药物组合物。该组合物具有清热化浊、活血通络,行敛相兼,从多环节共同发挥解酒护肝之保健功效。符合成分化学的研究,同时也符合中医理论,《内经》云:“肝苦急,急食甘以缓之。肝欲散,急食辛以散之,用甘补之,酸泻之”。其从中医理论的角度指出了辛、甘、酸三味与肝病的重要关系。积雪草,苦、辛、寒,归肝、脾、肾经,具有清热利湿、解毒消肿的功效,用于湿热黄疸,肝肿大,故为君药。虎杖,性微寒、味苦酸,归肝、胆、肺经,具有清热解毒,利胆退黄,祛风利湿,散瘀定痛的功效。丹参,活血化瘀、清热安神,与虎杖共为臣药。五味子,味酸、甘,入、心、肾经,具有收敛固涩,益气生津,补肾宁心,解酒毒的功效,为佐药。葡萄籽,酸、甘、平,利尿解毒,为使药。诸药合用,共奏解酒醒酒、养肝扶肝,具有清热化浊,活血通络之功效。通过人体试食实验证明,本发明确实能够解酒醒酒,对酒精性肝损伤有治疗作用。
本发明所要解决的技术问题在于从天然植物积雪草、虎杖、丹参、 五味子、葡萄籽中提取具有防治酒精性肝损伤作用的活性组分、制备天然产物组合物。
本发明提供了一种具有防治酒精性肝损伤的中药制成的组合物,该组合物包括积雪草100-500份、虎杖100-400份、丹参100-400份、五味子50-250份、葡萄籽50-250份。优选积雪草250份、虎杖150份、丹参150份、五味子100份、葡萄籽100份。也可由以上五味药提取物组成,积雪草提取物25-150份、虎杖提取物25-100份、丹参提取物20-100份、五味子提取物10-50份、葡萄籽提取物10-50份。优选积雪草提取物50份、虎杖提取物30份、丹参提取物30份、五味子提取物20份、葡萄籽提取物20份。按照上述比例混合组成活性成份与药用辅料制成的。
本发明中葡萄籽提取物可以由市售原花青素代替,其用量为葡萄籽提取物的五分子一至八分子一。
本发明的另一目的是提供了本组合物的制备方法:
(1)五味子用去离子水浸泡,去酸,干燥,粉碎成粗粉;
(2)将葡萄籽粉碎成粗粉;
(3)五味子粗粉、虎杖、丹参、葡萄籽粗粉四味中药用8-15倍40%-95%的乙醇溶液,提取2-3次,每次1-3 小时,过滤,滤液回收乙醇,浓缩,干燥,粉碎,即得乙醇提取物;
(4)积雪草用8-20倍去离子水,提取2-4次,每次1-3 小时,过滤,滤液浓缩,干燥,粉碎,即得水提取物;
(5)将乙醇提取物、水提取物混合后,再与药用辅料一起混合,按常规方法制成口服制剂。
由于本发明首次公开了由积雪草、虎杖、丹参、五味子、葡萄籽组成的组合物具有防治酒精性肝损伤的作用,因此,将本组合物单独或与其它活性组份或辅料配合制成药剂,只要是该药剂用于预防和治疗酒精性肝损伤,均属于本发明的保护范围。本发明的组合物在制成任何一种剂型时,均具有预防和治疗酒精性肝损伤的作用。
由积雪草、虎杖、丹参、五味子、葡萄籽组成的组合物(简称组合物)具有防治酒精性肝损伤作用,通过以下药效学实验得到证实。
1、本发明组合物对酒精性肝损伤的保护作用
小鼠60只,随机分为6组,即本发明组合物低、中、高三个剂量组,酒精模型组,空白对照组和阳性对照组。本发明组合物组分别按200、400及800mg/kg灌胃小鼠,阳性对照组(联苯双酯滴丸)60mg/kg, 1次/d,共14d,酒精模型组和空白组对照组分别灌胃等体积蒸馏水,1次/d,共14d。末次给药后禁食12小时,除空白对照组仍然灌胃等量蒸馏水外,其他5组动物(本发明组合物低、中、高三个剂量组,阳性药对照组,酒精模型组)分别灌胃50%乙醇15mL/kg,6h后眼静脉取血,测定血清中丙氨酸氨基转移酶(ALT)和天门冬氨酸氨基转移酶(AST)含量,取小鼠肝脏称重,测定肝器指数,取右叶测定超氧化物歧化酶的(SOD),谷胱甘肽过氧化酶(GSH-PX)活性,丙二醛(MDA)含量。
与空白对照组比较:* P < 0.05,* * P < 0.01,* * * P < 0.001;酒精组比较Δp<0.05,ΔΔp<0.01。
从表1可知,灌胃酒精使小鼠肝指数显著增加,灌胃本发明组合物可使酒精损伤小鼠肝脏指数显著降低。灌胃酒精使小鼠血清ALT、AST显著增加,灌胃本发明组合物可使酒精损伤小鼠血清ALT、AST显著降低,尤其是高、中剂量组显著性更明显。阳性对照药可使小鼠血清ALT、AST显著降低,也可显著降低小鼠肝脏指数。
表2 本发明组合物对酒精损伤小鼠肝脏MDA、GSH-PX、SOD的影响( ±s)
与空白对照组比较:* P < 0.05,* * P < 0.01,* * * P < 0.001;酒精组比较Δp<0.05,ΔΔp<0.01。
从表2结果表明,酒精能引起小鼠肝脏MDA含量显著升高、引起GSH-PX酶、SOD活性显著降低,而本发明组合物能显著降低MDA含量,能显著升高GSH-PX酶、SOD活性。阳性对照药也能显著降低MDA含量、显著升高GSH-PX酶、SOD活性,本发明组合物高、中剂量组显著特别明显。
2、本发明组合物对酒精引起的脂肪肝的改善功能
试验大鼠120只,随机分为正常对照组;脂肪肝模型组;阳性对照药东宝肝泰600mg/kg给药剂量组:本发明组合物设200mg/kg、40mg/kg和800mg/kg三个给药剂量组。共6组,每组20只。除正 常对照组外,其余各组大鼠每日上午8:30灌胃给予(56%乙醇+0.5mL鱼油)1次,乙醇剂量开始为7g/kg,随后每周递增0.2g/kg,连续4周。正常对照组大鼠灌胃给予等热量的56%葡萄糖+0.5mL鱼油。受试药物用蒸馏水配制成混悬液,每日下午1:00灌胃给予1次,正常对照组与模型对照组大鼠灌胃给予等量的蒸馏水,灌胃体积为10ml/kg/d。试验过程中大鼠自由摄食饮水,每周称量体重1次,以调整给药剂量。于给药第四周末处死动物。标本采集及观测指标,试验结果以均数加减标准差( ±s)表示,统计学处理方法采用组间t检验。实验结果见表3和表4。
表3本发明组合物对酒精性脂肪肝大鼠血清ALT、AST和LDH活性的影响( ±s)
与正常对照组比较:* P < 0.05,* * P < 0.01,* ** P < 0.001;模型组比较Δp<0.05,ΔΔp<0.01,ΔΔΔp<0.001。
本发明组合物高、中剂量组动物血清ALT和AST活性非常明显的低于模型组,低剂量组也有明显降低ALT和AST的活性。本试验结果表明,本发明组合物可明显降低酒精性脂肪肝大鼠血清中异常升高的ALT、AST的活性,说明本发明组合物对肝细胞具有良好的保护作用。本发明组合物高、中剂量组对酒精性脂肪肝动物血清LDH水平的异常升高具有明显的降低作用,此项试验结果表明,本发明组合物对酒精所致脂肪肝有很好的保护作用。
表4本发明组合物对酒精性脂肪肝大鼠血清TC、TG和MDA含量及肝组织TG含量的影响( ±s)
与正常对照组比较:* P < 0.05,* * P < 0.01,* ** P < 0.001;模型组比较Δp<0.05,ΔΔp<0.01。
本发明组合物可降低脂肪肝模型动物血清MDA含量,抑制脂肪肝时肝细胞的脂质过氧化反应,从而发挥保护肝细胞免受损伤的作用。本发明组合物高、中两个剂量组动物血清中TC、TG含量及肝组织TG含量显著低于模型对照组。表明本发明组合物可以降低酒精所致脂肪肝大鼠血脂含量及肝脏脂类含量的升高,具有抑制肝脏脂肪堆积的作用。
从以上的药效学实验可知,本发明组合物具有预防和治疗酒精性肝损伤、酒精性脂肪肝的作用,并且长期服用没有副作用。
本发明是通过下面的实施例进行详细的说明,但不意味着本发明仅限于此,具体实施方案如下:
实施例1、(片剂)
(1)五味子250g,用去离子水浸泡,去酸,干燥,粉碎成粗粉;
(2)取葡萄籽250g,粉碎成粗粉;
(3)五味子粗粉、虎杖375g、丹参375g、葡萄籽粗粉四味中药用10倍70%的乙醇溶液,提取2次,每次2小时,过滤,滤液回收 乙醇,浓缩,干燥,粉碎,即得乙醇提取物;
(4)积雪草625g,用12倍去离子水,提取3次,每次2 小时,过滤,滤液浓缩,干燥,粉碎,即得水提取物;
(5)将乙醇提取物、水提取物混合后,加入适量淀粉,混匀,制粒,干燥,整粒,压片,制成1000片,即得。每次2片、每日3次。
实施例2、(胶囊剂)
(1)五味子250g,用去离子水浸泡,去酸,干燥,粉碎成粗粉;
(2)取葡萄籽250g,粉碎成粗粉;
(3)五味子粗粉、虎杖375g、丹参375g、葡萄籽粗粉四味中药用10倍70%的乙醇溶液,提取2次,每次2小时,过滤,滤液回收乙醇,浓缩,干燥,粉碎,即得乙醇提取物;
(4)积雪草625g,用12倍去离子水,提取3次,每次2 小时,过滤,滤液浓缩,干燥,粉碎,即得水提取物;
(5)将乙醇提取物、水提取物混合后,加入适量淀粉,混匀,制粒,干燥,整粒,装胶囊,制成1000粒,即得。每次2粒、每日3次。
Claims (9)
1.一种具有清热化浊,活血通络的中药组合物,其特征在于:由积雪草、虎杖、丹参、五味子、葡萄籽组方而成。
2.根据权利要求1所述的中药组合物,其特征在于,它是由下述重量份的原料制成:
积雪草100-500份 虎杖100-400份
丹参100-400份 五味子50-250份
葡萄籽50-250份。
3.根据权利要求1所述的中药组合物,其特征在于,它是由下述重量份的原料制成:
积雪草250份 虎杖150份
丹参150份 五味子100份
葡萄籽100份。
4.根据权利要求1所述的中药组合物,其特征在于每种原料均可被其提取物代替,提取物的组成重量比为:
积雪草提取物25-150份 虎杖提取物25-100份
丹参提取物20-100份 五味子提取物10-50份
葡萄籽提取物10-50份。
5.根据权利要求1所述的药物组合物,其特征在于每种原料均可被其提取物代替,提取物的组成重量比为:
积雪草提取物50份 虎杖提取物30份
丹参提取物30份 五味子提取物20份
葡萄籽提取物20份。
6.根据权利要求1所述的中药组合物,其特征在于:所述中药组合物的制备方法包括以下步骤:
(1)五味子用去离子水浸泡,去酸,干燥,粉碎成粗粉;
(2)将葡萄籽粉碎成粗粉;
(3)五味子粗粉、虎杖、丹参、葡萄籽粗粉四味中药用8-15倍40%-95%的乙醇溶液,提取2-3次,每次1-3 小时,过滤,滤液回收乙醇,浓缩,干燥,粉碎,即得乙醇提取物;
(4)积雪草用8-20倍去离子水,提取2-4次,每次1-3 小时,过滤,滤液浓缩,干燥,粉碎,即得水提取物;
(5)将乙醇提取物、水提取物混合后,再与药用辅料一起混合,按常规方法制成口服制剂。
7.根据权利要求1所述中药组合物,其特征在于:它是硬胶囊、软胶囊、片剂、颗粒剂、散剂、丸剂、袋泡茶、药酒中的一种或多种。
8.权利要求4所述的药物组合物,其特征在于葡萄籽提取物用市售原花青素类化合物代替。
9.根据权利要求1所述的中药组合物可用于制备防治酒精性肝损伤的药品或保健品中的应用。
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