CN105878803A - 一种具有防治酒精性肝损伤的人参竹叶组合物 - Google Patents
一种具有防治酒精性肝损伤的人参竹叶组合物 Download PDFInfo
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Abstract
本发明涉及一种具有防治酒精性肝损伤的天然药物组合物，该组合物由人参总皂苷、显齿蛇葡萄总黄酮、竹叶总黄酮及狭基线纹香茶菜提取物组成。本发明还涉及所述组合物在制备防治急慢性酒精性肝损伤的保健食品以及在制备防治非酒精性脂肪肝的保健食品、饮料、茶中的应用。本发明组合物的各组份之间产生了良好的协同作用，疗效显著，且原料易得，成本相对较低，具有较强的实用性。
Description
技术领域
本发明属医药和食品领域，是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。
背景技术
酒精性肝损伤(ALD)是因长期过量饮酒引起的中毒性肝脏疾病，ALD是西方国家患者导致肝硬化的最主要原因。在我国酒精性肝病近年来有逐渐增加的趋势，目前已成为仅次于病毒性肝炎的第二大肝病病因。酒精性肝病是由于长期大量饮酒所致的肝脏疾病，初期通常表现为脂肪肝，进而可发展成酒精性肝炎、酒精性肝纤维化和酒精性肝硬化，严重酗酒时可诱发广泛肝细胞坏死甚或肝功能衰竭。至今临床上还没有有效防治肝脏疾病发生发展的理想药物。目前认为，酒精有直接损害肝细胞的毒性作用，是造成肝损害的基本原因，氧化应激和脂质过氧化是酒精引起肝脏损伤的重要因素之一。一般每日饮酒80～150g，连续5年即可造成肝损伤；大量饮酒在20年以上，40％～50％会发生肝硬化。目前ALD的发病机制并不十分清楚，自由基及其介导的脂质过氧化被认为是最主要的致病因素。乙醇在肝脏代谢时可产生大量自由基：O2 -、H2O2、OH-、C2H5O-和C2H5OH-，过量的自由基可引起肝细胞膜发生脂质过氧化反应，使细胞膜和细胞器结构破坏，膜流动性失常；大量肝细胞内酶(ALT、AST)释放入血，并可使清除自由基酶(SOD、GPx)耗竭，肝细胞损伤进一步加重，肝功能异常，脂肪代谢紊乱，最终导致肝细胞广泛坏死，细胞肿胀死亡。因此，清除自由基抑制脂质过氧化反应，保护肝细胞，恢复肝脏正常功能，是防治ALD发生和发展的关键。
降低体内血中乙醇及其代谢产物的浓度是解酒药物的作用关键，减轻其对各器官的损伤。当前的解酒药物主要以下两个方面发挥解酒作用。第一，解酒药物抑制酒精的胃肠吸收，加强乙醇在胃肠道首过效应，降低血中乙醇浓度；第二，解酒药物直接作用于肝代谢的酶系，加速乙醇及其代谢产物的消除速率，减轻其对细胞和组织的损害。长期以来，通过化学合成的方法研制解酒护肝药物并未取得大的突破。
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。
中医理论认为以解酒毒、清湿热，疏肝胆，行积滞，化痰结，通过增强肝脏解毒和酶解，以利尿作用加速体内乙醇的分解和排泄，阻止消化道对乙醇的吸收及中枢神经系统的作用，降低乙醇对肝脏的损害，促肝细胞再生，增加脑及冠状血管流量，缓解中毒症状为目的来组方。故选用人参总皂苷、显齿蛇葡萄总黄酮、竹叶总黄酮及、狭基线纹香茶菜提取物，通过中医药配伍的相须理论，可清热解毒，疏肝利胆，解酒祛湿，祛瘀行滞，共奏解酒护肝之功效。
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天然药物组合物。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。
人参总皂苷为五加科植物人参Panax ginseng C.A.Mey.的根经提取、纯化、加工制成的总皂苷。其主要功能为提高人体免疫力、促进物质代谢、抗肿瘤、抗疲劳、抗衰老等作用。药理学研究表明，人参的滋补作用和其对肝功能的影响有一定的关系，人参对肝脏的解毒、排泄、代谢及各种实验性肝损伤均有影响。有报道称人参对化合物引起的肝毒性有明显的保护作用，这说明人参对毒素导致的过氧化有保护作用。人参皂苷对肝脏具有解毒的作用，可以修复急性肝损伤，抑制脂肪肝的变性。大鼠同时服用乙醇(312g/kg)和人参水提物后，血中乙醇浓度明显低于对照组，但腹腔注射则无此效果。可见服用人参提取物主要是通过抑制乙醇吸收或加强胃肠首过效应发挥解酒作用。目前已证实产生此种作用的主要成分为皂苷类。大鼠合用人参皂苷与乙醇6d后，给药组乙醇脱氢酶的活性明显高于对照组，而且由于长期饮酒引起的血中脂肪酸和甘油三酯升高也得到了有效控制。在大鼠急性酒精中毒模型中，人参皂苷可以降低乙醇所致血清谷氨酸转氨酶的升高，提高血清及肝中谷胱甘肽过氧化物酶的活性，抑制过氧化产物丙二醛的生成。提示人参皂苷可以清除乙醇在肝组织产生的自由基。
显齿蛇葡萄是国家规定的新资源食品。显齿蛇葡萄总黄酮是从葡萄科蛇葡萄属植物显齿蛇葡萄(藤茶)Ampelopsis Grossedenta(Hand-Mazz.)W.T.Wa中提取纯化而得。显齿蛇葡萄嫩茎叶中总黄酮的含量高达43.4％-45.52％。显齿蛇葡萄中的黄酮化合物种类多样，有二氢杨梅素、槲皮素、花旗松素、山奈酚、显齿蛇葡萄素、杨梅苷、橙皮素、洋芹素等。其中二氢杨梅素是显齿蛇葡萄中的主要活性成分。显齿蛇葡萄为民间传统用药，早在《名医别录》中就有记载，广泛用于消炎解毒，治疗骨髓炎，急性淋巴结炎，急性乳腺炎，脓疱疮，湿疹，丹毒疖肿，嗜盐菌食物中毒等。并可治疗恶心，呕吐腹泻兼能通利小便；预防肝内部分纤维变化为肝硬化。研究表明，显齿蛇葡萄总黄酮毒性小，小鼠灌胃给药，最大耐受量为22.5g/kg(钟正贤,广西藤茶总黄酮保肝作用的实验研究，广西科学，2002，第1期，57)，并且具有广泛的生理活性，其抗氧化作用可清除氧自由基，可抑制机体内的氧化损伤，免疫功能的调节作用可调节人体免疫机能；降低血糖血脂作用可用于防治糖尿病、动脉粥样硬化、高血脂等症。显齿蛇葡萄含有二氢杨梅素，具有明显的保肝护肝作用，抑制脂肪肝的形成。研究发现蛇葡萄中的杨梅树皮素能明显降低四氯化碳、D-半乳糖胺和异硫氰酸萘酯致小鼠急性肝损伤模型血清中ALT、AST活性和T-BIL含量，减轻肝组织的变性和坏死，从而达到保肝降酶退黄的作用。陈晓军研究表明显齿蛇葡萄总黄酮可明显降低蛋黄型高脂血症小鼠血清TC、TG及AI值，对实验性高脂血症鹌鹑可明显降低血清TC、TG，升高血清HDL-C，降低AI值；明显减少主动脉及肝脏TC含量，抑制动脉粥样硬化及肝脏脂肪化病变，具有降血脂、抗动脉粥样硬化和抑制脂肪肝形成的作用(广西中医药，2001，第5期，53)。
竹叶总黄酮为禾本科刚竹属植物毛环竹(Phyllostachys meyeri)经提取、浓缩、纯化得到的总黄酮。主要成分为荭草苷、异荭草苷、牡荆苷和异牡荆苷等。除具有抗自由基、抗氧化、抗炎、增强免疫、延缓衰老的功效外，还具有显著的耐缺氧、抗疲劳、抗应激及保肝作用。竹叶总黄酮可显著提高四氯化碳受损细胞存活率及胞内抗氧化酶SOD、CAT活性，降低因细胞损伤引起的AST、ALT及MDA含量的升高，对改善NCTC-1469损伤有明显的效果，且浓度越高其改善肝细胞损伤的效果越显著，证明竹叶总黄酮对CCl4诱导的肝细胞损伤有良好保护效果。
狭基线纹香茶菜提取物为唇形科香茶菜属狭基线纹香茶菜(Isodon lophanthoides(Buchanan-Hamilton ex D.Don)H.Hara var.gerardianus(Bentham)H.Hara)经过提取浓缩得到。主要含有黄酮及三萜酸类成分。具有清热利湿，凉血散瘀的功效。候少贞研究表明，狭基线纹香茶菜提取物能显著降低急性酒精中毒小鼠血清ALT、AST含量和慢性酒精性脂肪肝大鼠的死亡率，减轻肝脏组织的病理损伤程度；能促进正常大鼠的胆汁分泌，但对胆汁瘀积型肝损伤的作用不明显(中药新药与临床药理，2010年11月第21卷第6期)。长尾由纪子研究表明，狭基线纹香茶菜可显著降低急性肝损伤大鼠血清ALT，AST，ALP水平和T-Bil含量，对肝重量增大和胸腺萎缩有抑制作用，病理检查结果也显示有明显的保肝作用(中国中药杂志，2006年第31卷第7期)。林朝展研究表明狭基线纹香茶菜可显著降低免疫性肝损伤小鼠血清ALT、AST，对肝重量增大和胸腺萎缩有抑制作用，病理检查结果也显示有明显的保肝作用(中药新药与临床药理，2006年9月第17卷第5期)。
本发明完成前，还未发现由人参总皂苷、显齿蛇葡萄总黄酮、竹叶总黄酮及狭基线纹香茶菜提取物组成的组合物具有防治酒精性肝损伤的作用，也未发现本发明组合物在防治酒精性肝损伤的药品和保健品中的应用。
发明内容
本发明人依据科学理论、经过反复试验，选用了人参总皂苷、显齿蛇葡萄总黄酮、竹叶总黄酮及狭基线纹香茶菜提取物组方，具有解酒毒、清湿热，疏肝胆，行积滞，化痰结，通过增强肝脏解毒和酶解，以利尿作用加速体内乙醇的分解和排泄，阻止消化道对乙醇的吸收及中枢神经系统的作用，降低乙醇对肝脏的损害，促肝细胞再生，增加脑及冠状血管流量，缓解中毒症状等作用。本制剂具有原料天然可长期服用、易吸收、效果显著等特点。
本组合物与欧美、日本畅销的以添加兴奋剂、止痛剂、维生素和矿物质等类型解酒剂具有明显的不同，这些解酒剂只能暂时缓解醉酒引起的症状，但对于酒精引起的肝损伤并无确切疗效；同时与目前已有的护肝解酒类保健食品相比，具有作用更确切，药效物质组成更清楚的优势，具有明显的特色，这是本发明的突出贡献。
本发明的突出贡献在于：本发明组合物体现了复方药效成分相互协同、多靶点、多途径作用，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。具有明显的创新性和技术进步。
本发明另一突出贡献在于：本发明组合物配方设计科学合理，制剂工艺简单可行，质量可控，安全性高，比相同剂量下的单一的人参总皂苷、显齿蛇葡萄总黄酮、竹叶总黄酮及狭基线纹香茶菜提取物具有更优的改善酒精性肝损伤症状的作用，适宜于广大酒精性肝损伤人群的使用。
本发明所要解决的技术问题在于从天然植物人参、显齿蛇葡萄、竹叶及狭基线纹香茶菜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天然药物组合物，该组合物包括人参总皂苷50-200份，显齿蛇葡萄总黄酮100-400份，竹叶总黄酮50-200份，狭基线纹香茶菜提取物25-100份。优选人参总皂苷100份，显齿蛇葡萄总黄酮200份，竹叶总黄酮100份，狭基线纹香茶菜提取物50份。按照上述比例混合组成活性成份与药用辅料制成的。
本发明的另一目的是提供了本组合物的制备方法：
(1)人参用6-12倍量水煎煮提取1-3次，每次2-3小时，过滤，滤液浓缩，浓缩液通过预先处理好的D-101大孔吸附树脂柱，先用去离子水洗脱，弃去洗脱液，继用50-90％乙醇洗脱，收集洗脱液，回收乙醇，干燥，得人参总皂苷；
(2)显齿蛇葡萄叶用50-85％乙醇回流提取2-3次，每次2-3小时，过滤，滤液回收乙醇，得乙醇提取液，乙醇提取液通过预先处理好的AB-8大孔树脂柱，先用去离子水洗脱，弃去洗脱液，再用10-25％乙醇洗脱，弃去洗脱液，继用60-90％乙醇洗脱，收集洗脱液，回收乙醇，干燥，得显齿蛇葡萄总黄酮；
(3)毛环竹叶用50-95％乙醇回流提取2-3次，每次1-2小时，过滤，滤液回收乙醇，得乙醇提取物，乙醇提取物通过预先处理好的AB-8大孔树脂柱，先用去离子水洗脱，弃去洗脱液，再用10-25％乙醇洗脱，弃去洗脱液，继用60-90％乙醇洗脱，收集洗脱液，回收乙醇，干燥，得竹叶总黄酮；
(4)狭基线纹香茶菜用8-14倍量水煎煮提取1-3次，每次2-3小时，过滤，滤液浓缩，干燥，得狭基线纹香茶菜提取物；
(5)将人参总皂苷、显齿蛇葡萄总黄酮、竹叶总黄酮及狭基线纹香茶菜提取物，按照比例混合均匀后，加入辅料均匀，即得。
由于本发明首次公开了由人参总皂苷、显齿蛇葡萄总黄酮、竹叶总黄酮及狭基线纹香茶菜提取物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。
由人参总皂苷、显齿蛇葡萄总黄酮、竹叶总黄酮及狭基线纹香茶菜提取物组成的组合物(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。
本发明需要的组合物(由实例5制备得到，人参总皂苷：显齿蛇葡萄总黄酮：竹叶总黄酮：狭基线纹香茶菜提取物＝2：4：2：1)、人参总皂苷、显齿蛇葡萄总黄酮、竹叶总黄酮及狭基线纹香茶菜提取物均由吉林省中医药科学院植物化学研究所提供。阳性对照药联苯双酯滴丸由北京协和药厂生产(20150801)、东宝肝泰由吉林通化东宝药业股份有限公司生产(20151202)。
1、本发明组合物对酒精性肝损伤的保护作用
小鼠100只，随机分为10组，即本发明组合物分别按100、200及400mg/kg三个剂量组，人参皂苷剂量组、显齿蛇葡萄总黄酮剂量组、竹叶总黄酮剂量组、狭基线纹香茶菜剂量组各400mg/kg灌胃小鼠，酒精模型组，空白对照组和阳性对照组(联苯双酯滴丸)50mg/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9组动物(本发明组合物低、中、高三个剂量组，人参皂苷剂量组、显齿蛇葡萄总黄酮剂量组、竹叶总黄酮剂量组、狭基线纹香茶菜剂量组，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。
表1本发明组合物对酒精损伤小鼠血清ALT、AST及肝脏系数的影响
与空白对照组比较：*P<0.05，**P<0.01，***P<0.001；
与酒精组比较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。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。相同剂量下组合物较各单一组分活性更强。
表2本发明组合物对酒精损伤小鼠肝脏MDA、GSH-PX、SOD的影响
与空白对照组比较：*P<0.05，**P<0.01，***P<0.001；
与酒精组比较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。相同剂量下本发明组合物较各单一组分活性更强。
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100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500mg/kg，给药剂量组：本发明组合物设100mg/kg、200mg/kg和400mg/kg三个剂量组，人参皂苷剂量组、显齿蛇葡萄总黄酮剂量组、竹叶总黄酮剂量组、狭基线纹香茶菜剂量组各400mg/kg。共10组，每组10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
与正常对照组比较：*P<0.05，**P<0.01，***P<0.001；
与模型组比较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，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。相同剂量下本发明组合物较各单一组分活性更强。
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
与正常对照组比较：*P<0.05，**P<0.01，***P<0.001；
与模型组比较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。相同剂量下本发明组合物较各单一组分活性更强。
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、人参总皂苷的制备
人参5kg，用10倍量水煎煮提取3次，每次2小时，过滤，滤液浓缩，浓缩液通过预先处理好的D-101大孔吸附树脂柱，先用去离子水洗脱4倍柱体积，弃去洗脱液，继用70％乙醇洗脱4倍柱体积，收集洗脱液，回收乙醇，干燥，得人参总皂苷。以人参皂苷Re为对照品，采用紫外分光光度法测定，人参总皂苷的含量为86.5％。
实施例2、显齿蛇葡萄总黄酮的制备
显齿蛇葡萄叶5kg，用8倍量60％乙醇回流提取2次，每次3小时，过滤，滤液回收乙醇，浓缩至7500ml，通过预先处理好的AB-8大孔树脂柱，先用去离子水洗脱5倍柱体积，弃去洗脱液，再用10％乙醇洗脱3倍柱体积，弃去洗脱液，继用65％乙醇洗脱4倍柱体积，收集洗脱液，回收乙醇，干燥，得显齿蛇葡萄总黄酮。以芦丁为对照品，采用紫外分光光度法测定，总黄酮的含量为92.1％。
实施例3、竹叶总黄酮的制备
毛环竹叶5kg，用8倍量65％乙醇回流提取2次，每次2小时，过滤，滤液回收乙醇，浓缩至5000ml，通过预先处理好的AB-8大孔树脂柱，先用去离子水洗脱5倍柱体积，弃去洗脱液，再用25％乙醇洗脱3倍柱体积，弃去洗脱液，继用75％乙醇洗脱4倍柱体积，收集洗脱液，回收乙醇，干燥，得竹叶总黄酮。以芦丁为对照品，采用紫外分光光度法测定，总黄酮的含量为88.6％。
实施例4、狭基线纹香茶菜提取物的制备
狭基线纹香茶菜5kg，用12倍量水煎煮提取2次，每次2小时，过滤，合并滤液，滤液浓缩，干燥，得狭基线纹香茶菜提取物。
实施例5、组合物的制备
取人参总皂苷20g，显齿蛇葡萄总黄酮40g，竹叶总黄酮20g，狭基线纹香茶菜提取物10g，混合均匀，即得本发明组合物。
实施例6、胶囊剂的制备
取人参总皂苷50g，显齿蛇葡萄总黄酮100g，竹叶总黄酮50g，狭基线纹香茶菜提取物25g，混合均匀，加入适量淀粉，用80％乙醇制粒，干燥，装胶囊，制成1000粒。
实施例7、片剂的制备
取人参总皂苷50g，显齿蛇葡萄总黄酮100g，竹叶总黄酮50g，狭基线纹香茶菜提取物25g，混合均匀，加入适量淀粉，用80％乙醇制粒，干燥，压片，制成1000片。
实施例8、饮料的制备
取人参总皂苷50g，显齿蛇葡萄总黄酮100g，竹叶总黄酮50g，狭基线纹香茶菜提取物25g，蔗糖2.5kg，柠檬酸5g，苹果酸5g，加入50kg水加热溶解，灌装，制成100瓶。
Claims (5)
1.一种具有防治酒精性肝损伤的天然药物组合物，其特征在于，它是由下述重量份的原料制成：人参总皂苷50-200份，显齿蛇葡萄总黄酮100-400份，竹叶总黄酮50-200份，狭基线纹香茶菜提取物25-100份。
2.根据权利要求1所述一种具有防治酒精性肝损伤的天然药物组合物，其特征在于，它是由下述重量份的原料制成：人参总皂苷100份，显齿蛇葡萄总黄酮200份，竹叶总黄酮100份，狭基线纹香茶菜提取物50份。
3.根据权利要求1、2所述的天然药物组合物，其制备方法如下：
(1)人参用6-12倍量水煎煮提取1-3次，每次2-3小时，过滤，滤液浓缩，浓缩液通过预先处理好的D-101大孔吸附树脂柱，先用去离子水洗脱，弃去洗脱液，继用50-90％乙醇洗脱，收集洗脱液，回收乙醇，干燥，得人参总皂苷；
(2)显齿蛇葡萄叶用50-85％乙醇回流提取2-3次，每次2-3小时，过滤，滤液回收乙醇，得乙醇提取液，乙醇提取液通过预先处理好的AB-8大孔树脂柱，先用去离子水洗脱，弃去洗脱液，再用10-25％乙醇洗脱，弃去洗脱液，继用60-90％乙醇洗脱，收集洗脱液，回收乙醇，干燥，得显齿蛇葡萄总黄酮；
(3)毛环竹叶用50-95％乙醇回流提取2-3次，每次1-2小时，过滤，滤液回收乙醇，得乙醇提取物，乙醇提取物通过预先处理好的AB-8大孔树脂柱，先用去离子水洗脱，弃去洗脱液，再用10-25％乙醇洗脱，弃去洗脱液，继用60-90％乙醇洗脱，收集洗脱液，回收乙醇，干燥，得竹叶总黄酮；
(4)狭基线纹香茶菜用8-14倍量水煎煮提取1-3次，每次2-3小时，过滤，滤液浓缩，干燥，得狭基线纹香茶菜提取物；
(5)将人参总皂苷、显齿蛇葡萄总黄酮、竹叶总黄酮及狭基线纹香茶菜提取物，按照比例混合均匀后，加入辅料均匀，即得。
4.一种具有防治酒精性肝损伤的天然药物组合物口服制剂，其特征在于将权利要求1-3所述的天然药物组合物，与药用辅料混合，制成口服制剂，它可以是硬胶囊、软胶囊、片剂、颗粒剂、散剂、丸剂、袋泡茶、软糖、口服液、饮料中的任意一种。
5.根据权利要求1-4所述的天然药物组合物在制备对酒精性肝损伤辅助保护作用的保健品及药品中的应用。
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