CN115607629A - 一种具有保肝解酒的中药组合物及其制备方法 - Google Patents
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Abstract
本发明属于食品、保健品和中药制剂领域,具体涉及一种同时具有保肝解酒的中药组合物。所述中药组合物的原料由以下组分组成：铁皮石斛、沙棘、葛根和甘草。所述的中药组合物的制备方法，包括先将沙棘榨汁，过滤，得滤液和滤渣，再将铁皮石斛、沙棘滤渣、葛根、甘草混合，然后加水依次提取两次，过滤，与鲜榨沙棘滤液合并，得提取液，加入添加剂后，滤液浓缩，离心灌装灭菌即得。本方配伍科学合理，经试验科学验证，充分利用其各药味功能，合理保留药味多糖类、黄酮成分，具有防醉醒酒、预防胃损伤和肝细胞损伤的确切疗效，尤其是制成中药口服液，具有明显的增强肝功能的免疫力。
Description
技术领域
本发明属于保健品和中药制剂领域,具体涉及一种具有保肝解酒的中药组合物及其制备方法。
背景技术
酒精过量对人体的损害作用是多方面的,如肝脏、神经、生殖毒性等，长期损害会造成胃溃疡、肝硬化等疾病。目前已有研究者关注到了解酒产品的研发领域。如中国发明专利申请CN112438333A公开了一种饮料，主要由以下原料配制：葛花、葛根、枳椇子、麦冬、玉竹、泽泻、知母、土茯苓、佩兰、白芍、茯苓、厚朴、丹参、半夏、陈皮、甘松、党参、甘草、桑椹、薄荷、石斛、沙棘、五味子、金银花。该发明以解酒、健身、养生为一体，具有清热降火、护肝养肝的良好效果，但是药味很多，其除了解酒等功效以外，其更多的成分对机体来讲是一种负担，不宜长期服用，对解酒的针对性也较弱。
又如中国发明专利申请CN101455354公开了以药用真菌发酵液作为添加剂，配以植物草药用溶剂提取的有效成分和超细微粉为辅剂，可制成泡腾片、***片、咀嚼片、内服片、糖果、巧克力、口香糖、口服液、颗粒剂、冲剂、胶囊、气雾剂、液体饮料、固体饮料等系列保健食品。制品具有解酒、养胃、保肝、协助缓解乙肝病毒及肝炎肝癌病情等作用,该发明声称不仅对药用真菌发酵工业中伴随着生产菌体制药而产生的大量活性发酵液的利用提供了很好的思路，同时，对北方地区广泛分布大量野生的酸枣和山楂等植物资源的利用提供了有效的增值途径。该发明以真菌与中药提取液进行发酵，工艺复杂，药味众多，且其解酒效果也并未得到验证，疗效并不确切。
因此，虽然目前的解酒的产品较多，但是中药组合物的药味很多，药效不确切，且解酒护胃保肝的针对性效果亟待提高。
而铁皮石斛含有多糖、生物碱、氨基酸、微量元素等有效成分，具有抗肿瘤、抗衰老、抑制血小板凝集、扩张血管、降血脂、降血糖及退热止痛等药理作用，目前的研究主要集中在石斛的现代药理学，而将现代药理学与传统中药药性理论结合的研究较少。铁皮石斛资源匮乏，急需开展更多的药理、提取和临床研究，进一步揭示铁皮石斛药效成分及作用机制，以期对铁皮石斛得到充分的开发利用。
目前提取纯化较为完善的是多种提取技术同时协同作用，如申请号为CN201310018056.5的发明专利，公开了采用的中草药霍山石斛鲜条为主要原料，对霍山石斛鲜条等进行微波萃取、生物酶解和膜分离等技术获取复合鲜汁，再将复合鲜汁与功能性低聚糖混匀后通过灌装封口、高温瞬间灭菌制成口服液。其制备工艺较为复杂，且生物酶解和膜分离成本较高，不适宜批量大规模的生产应用。
因此急需开发一种同时具有保肝解酒，且解酒效果好、药味简单、提取方法易操作，简单提取率高的护肝解酒产品。
发明内容
本发明要解决的技术问题之一是预防和治疗酒后不良反应，降低肝炎、胃炎等疾病的发病，提供一种保肝、解酒的铁皮石斛中药组合物及其制备方法。
本发明的术语和声明：
1、如本文所用，冠词"一个"、"一种"和"所述"：除非以其它方式明确地限定到一个(种)对象，否则包括复数的对象。
2、如本文所用，数值范围：除非以其他方式明确指出，本文中公开的所有范围或比率将会被理解为包括其中包含的任何和所有的子范围或子比率。例如，声明的1至30的范围或比率应当被认为包含在最小值1和最大值30之间，并且包括断端点在内的任何子范围或子比率、整数、小数或由整数或小数构成的子范围或子比率。
3、如本文所用，术语“包含”、“包括”、“具有”、“具有”、“可以”、“含有”及其变化形式的意义是不排除另外组成或结构的可能性的开放式连接词语或术语。
本发明技术方案包括：
第一方面，本发明一种具有保肝解酒的中药组合物，所述中药组合物的原料由以下组分组成：铁皮石斛、沙棘、葛根和甘草。
对于一些实施方式，所述的中药组合物：按重量份数计，原料由以下组分组成：铁皮石斛6-12份、沙棘3-10份、葛根10-15份、甘草2-10份。
对于一些实施方式，所述的中药组合物：按重量份数计，原料由以下组分组成：铁皮石斛8-12份、沙棘6-10份、葛根12-15份、甘草4-10份。
对于一些实施方式，所述的中药组合物：原料还包括添加物，所述添加剂包括天门冬酰氨苯丙氨酸甲酯、柠檬酸钠和海藻酸钠。
对于一些实施方式，所述的中药组合物：其添加物包括天门冬酰氨苯丙氨酸甲酯0.10-0.50份、柠檬酸钠0.05-0.10份和海藻酸钠0.10-0.20份。
本发明铁皮石斛、沙棘、葛根、甘草，具有益胃生津，保肝明目，解酒毒的功效。
本发明中各药的药性、功效以及现代药理学研究的成果介绍如下：
铁皮石斛，甘，微寒。归胃、肾经，益胃生津，滋阴清热，用于热病津伤，口干烦渴，胃阴不足，食少干呕，病后虚热不退，阴虚火旺，骨蒸劳热，目暗不明，筋骨痿软。铁皮石斛含有的多糖，有抗细胞突变，清除体内衰老死伤细胞的作用，能稳定机体的生理状态，所以具有较强的抗肿瘤活性。铁皮石斛由于能增强人体的免疫力，所以临床常用于恶性肿瘤的放化疗辅助治疗，减轻放化疗的副作用，延长患者的生存时间。在本发明中为主要原料与其他组分相配伍，通过本发明所述制备工艺，形成以铁皮石斛营养成分为主体的解酒护肝制剂。
沙棘，酸、涩，温。归脾、胃、肺、心经。健脾消食，止咳祛痰，活血散瘀。用于脾虚食少，食积腹痛，咳嗽痰多，胸痹心痛，瘀血经闭，跌扑瘀肿。沙棘能治疗胃和十二指肠溃疡以及消化不良等，对慢性浅表性胃炎、萎缩性胃炎、结肠炎等病症疗效显著。
葛根，甘、辛，凉。归脾、胃、肺经。解肌退热，生津止渴，透疹，升阳止泻，通经活络，解酒毒。用于外感发热头痛，项背强痛，口渴，消渴，麻疹不透，热痢，泄泻，眩晕头痛，中风偏瘫，胸痹心痛，酒毒伤中。具有解热、降血糖、对内脏平滑肌具有双向作用，同时具有抗心肌缺血、抗血栓形成、抗心律失常和降低血压的作用。
甘草，甘，平。归心、肺、脾、胃经。补脾益气，清热解毒，祛痰止咳，缓急止痛，调和诸药。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、烈性。甘草具有解毒、抗病原微生物、抗消化性溃疡、解痉和保肝的作用。
第二方面，本发明提供了一种中药组合物制剂，所述制剂包含中药组合物；剂型选自液体制剂、糖浆剂、片剂、胶囊剂、散剂和颗粒剂。
对于一些实施方式，所述的中药组合物制剂的剂型为溶液剂或糖浆剂时，其辅料包括助溶剂、抗氧剂、矫味剂和防腐剂中的一种或多种；
进一步地，所述助溶剂包括聚氧乙烯脱水山梨醇脂肪醇醚类；聚氧乙烯脂肪酸脂类，即卖泽类；聚氧乙烯脂肪醇醚类，国产的如平平加－O，平平加－A；氧乙烯氧丙烯聚合物等；
进一步地，所述抗氧剂选自亚硫酸钠、焦亚硫酸钠、亚硫酸氢钠和硫代硫酸钠；
进一步地，所述矫味剂包括甜味剂和芳香剂，其中矫味剂选自蔗糖、阿斯巴甜和甘露醇；所述芳香剂选自香精，具体为苹果香精、香蕉香精和芒果香精。
对于一些实施方式，所述的中药组合物制剂的剂型为片剂、胶囊剂、散剂和颗粒剂时，其辅料包括崩解剂、粘合剂、润滑剂和助流剂中的一种或几种。
进一步地，所述崩解剂选自羧甲基淀粉钠、干淀粉和泡腾崩解剂；
进一步地，所述润滑剂选自硬脂酸镁、滑石粉和微粉硅胶；
进一步地，所述助粘合剂选自水、淀粉浆、糖浆。
第三方面，本发明中药组合物的制备方法，包括如下步骤：
(1)将沙棘榨汁，过滤，得滤液与滤渣；
(2)再将铁皮石斛、沙棘滤渣、葛根、甘草混合，然后加水依次提取两次，过滤，与鲜榨沙棘滤液合并，得提取液；
(3)加入相应添加剂后，滤液浓缩至相对密度约为1.05g/mL，离心灌装灭菌即得。
对于一些实施方式，步骤(2)所述提取方式为加热回流提取，提取的温度为100℃，回流提取的时间均为30min；
进一步地，所述水用量均为8倍量。
对于一些实施方式，步骤(3)中所述离心前，需先在水溶液中加入添加剂混合，在40-50℃下保温30-60min；
进一步地，所述离心前，然后加入添加物，然后在40-50℃下保温30-60min。
进一步地，所述离心参数为10000r/min离心10min，灭菌方法为湿热灭菌法。
第四方面，本发明还提供上述中药组合物或中药组合物制剂或上述制备方法制备得到的中药组合物在制备预防或治疗解酒护肝产品中的应用。
本发明的有益效果包括：
(1)本发明方中以铁皮石斛为君药，益胃生津，滋阴清热；以沙棘、葛根为臣药，沙棘活血化瘀，健胃消食，葛根解肌退热，生津，透疹，助力君药生津养阴，清热解毒之功效，甘草为使药，补脾益气，清热解毒，缓急止痛，以调和诸药。四药共奏健胃保肝、清热解毒，生津解酒之功效。
(2)本发明配伍科学合理，处方精简，制备工艺简单，临床适用性强，保肝、护胃、解酒的药效确切，尤其是制成中药口服液后，可增强肝脏功能的免疫力，具有保护肝功能的作用。
(3)本发明进一步对原料的制备方法进行了研究，得到了最佳的制备工艺为将沙棘榨汁，过滤，得滤液与滤渣；包括先将沙棘榨汁，过滤，得滤液和滤渣，再将铁皮石斛、沙棘滤渣、葛根、甘草混合，然后加水依次提取两次，过滤，与鲜榨沙棘滤液合并，得提取液。加入相应添加剂后，滤液浓缩至相对密度约为1.05g/mL，离心灌装灭菌，即得。该方法得到的多糖类、黄酮类成分的保留率更高，药物适用性更好，成分组合群药效更优，解酒效果显著。
附图说明
图1为肝轻松口服液对急性醉酒小鼠醉酒时间和醒酒时间的比较；其中，醉酒时间和解酒时间中从左至右柱状图依次为空白对照组、模型对照组、阳性药物组、实施例1、2、3组、对比例1、2、3组；
图2为肝轻松口服液对急性醉酒小鼠肝脏ADH水平的影响；其中从左至右柱状图依次为空白对照组、模型对照组、阳性药物组、实施例1、2、3组和对比例1、2、3组；
图3为肝轻松口服液对急性醉酒小鼠肝脏MDA水平的影响；其中其中从左至右柱状图依次为空白对照组、模型对照组、阳性药物组、实施例1、2、3组和对比例1、2、3组；
图4为肝轻松口服液对大鼠胃损伤模型的预防保护作用。
具体实施方式
以下结合实施例对本发明做进一步的阐述。
实施例1
组成配比：铁皮石斛12份、沙棘8份、葛根10份、甘草8份。
制备方法：
(1)按上述单方药味的重量称取原料药，沙棘洗净榨汁，过滤，得沙棘滤液和滤渣，其余各个组分的原料分别进行压扁处理，洗净后烘干，分别粉碎过50目筛备用，混合；
(2)将步骤(1)中所述的混合粉末及滤渣放置容器中，加8倍量水先后100℃加热回流提取两次，每次30min，过滤，合并水提液和沙棘滤液，得提取液；
(3)提取液在45℃条件下保温40min，将提取液投入真空浓缩器中，减压浓缩至20℃时相对密度约为1.05g/mL的溶液；
(4)然后在10000r/min条件下离心10min后，取上清液，灌装湿热灭菌。
实施例2
组成配比：铁皮石斛11份、沙棘10份、葛根13份、甘草4份。
制备方法：
(1)按上述单方药味的重量称取原料药，沙棘洗净榨汁，过滤，得沙棘滤液和滤渣，其余各个组分的原料分别进行压扁处理，洗净后烘干，分别粉碎过50目筛备用，混合；
(2)将步骤(1)中所述的混合粉末及滤渣放置容器中，加8倍量水先后100℃加热回流提取两次，每次30min，过滤，合并水提液和沙棘滤液，得提取液；
(3)提取液在45℃条件下保温40min，将提取液投入真空浓缩器中，减压浓缩至20℃时相对密度约为1.05g/mL的溶液；
(4)然后在10000r/min条件下离心10min后，取上清液，灌装湿热灭菌。
实施例3
组成配比：铁皮石斛12份、沙棘8份、葛根10份、甘草8份。
添加物：天门冬酰氨苯丙氨酸甲酯0.22份、柠檬酸钠0.06份和海藻酸钠0.17份。
制备方法：
(1)按上述单方药味的重量称取原料药，沙棘洗净榨汁，过滤，得沙棘滤液和滤渣，其余各个组分的原料分别进行压扁处理，洗净后烘干，分别粉碎过50目筛备用，混合；
(2)将步骤(1)中所述的混合粉末及滤渣放置容器中，加8倍量水先后100℃加热回流提取两次，每次30min，过滤，合并水提液和沙棘滤液，得提取液；
(3)加入添加剂混合，在45℃条件下保温40min，将提取液投入真空浓缩器中，减压浓缩至20℃时相对密度约为1.05g/mL的溶液；
(4)然后在10000r/min条件下离心10min后，取上清液，灌装湿热灭菌。
对比例1
名称：葛枳解酒口服液(葛枳解酒口服液的制备工艺及其质量标准)
组成及配比：葛根200g；枳椇子100g；单糖浆40mL，照文献中方法，称取处方量饮片，加水煎煮两次，滤过，合并两次滤液，浓缩，醇沉至含醇量75％，静置48h，滤过，滤液除去乙醇，加辅料40mL,加蒸馏水至40mL,加热至40℃灌装于10mL口服液瓶中密封即得。
对比例2
名称：一种护胃解酒的口服液(CN201710490937.5)
组成及配比：瓦楞子35克(打碎)、川厚朴10克、地榆12克、佛手10克、姜半夏8克、葛花10克、枳棋子15克、大黄粉5克、田七粉5克(混合分3次吞服)、甘草10克、延胡索13克、竹茹8克，采用专利申请CN201710490937.5中具体实施方式的制备方法进行制备。
对比例3
名称：一种解酒护肝口服液(CN202210230024.0)
65份的葛根、55份的的枳椇子、40份葛花、30份的茯苓、25份的甘草、20份的菊花、2份的豆蔻片、5份的维生素B、2份的牛磺酸和3份的蜂蜜，采用专利申请CN202210230024.0实施例1的制备方法制备得均质的混合液，再将混合液杀菌、冷却后灌装。
实验一、本发明中药组合物对小鼠急性醉酒模型的预防解酒护肝作用
1.实验材料：
动物：健康ICR小鼠，雌雄各半，SPF级，体重20±2g，南京中医药大学动物中心提供。
实验原理：通过行为学观察判断本发明中药组合物对急性醉酒的解酒作用，通过对肝脏中ADH(乙醇脱氢酶)、MDA(丙二醛)含量的检测研究本发明对肝脏的保护作用。
药物：本发明实施例1-实施例3组，对比例1-对比例3组，阳性组解酒固体饮料(CN201510878028.X)，包括陈皮、山楂、金银花、枳椇子、葛根、枸杞子、桑椹、菊花和甘草等组分，生产商为广东橘香斋陈皮有限公司，制备方法为开水冲服6g解酒固体饮料。
2方法：
2.1动物分组及给药
小鼠适应性饲养后1周，随机分组为空白对照组、模型对照组、阳性药物组、实施例1-3组和对比例1-3组，每组10只，雌雄各半。空白对照组小鼠不做处理；模型对照组小鼠灌胃同体积蒸馏水30min后，按照0.12ml/10g的剂量给予53°红星二锅头；阳性药物组小鼠给药开水冲服6g的解酒固体饮料30min后，按照0.12ml/10g的剂量给予53°红星二锅头(给药剂量按生药量0.77g/kg，给药体积为0.10mL/10g)；实施例1-3和对比例1-3组小鼠最后一次给予相应组制备的药物30min后，按照0.12ml/10g的剂量给予53°红星二锅头。其中，实施例1-3给药量均按照生药量4.9g/kg配制，对比例1组给药量按生药量38.7g/kg；对比例2组给药量按生药量18.2g/kg；对比例3组给药量按生药量27.2g/kg；以0.10mL/10g的灌胃体积配成相应的给药溶液。
2.2实验方法
2.2.1各组小鼠灌胃白酒后，立刻开始计时并进行翻正反射实验判断小鼠是否醉酒(观察小鼠是否可以保持背部向下30s，能则判定为醉酒，反之则没醉)，并记录醉酒时间(末次灌胃时间-翻正反射消失时间)、醒酒时间(翻正反射消失时间-翻正反射恢复时间)。
2.2.2取4h后处死的小鼠肝脏，以1∶9比例混入生理盐水进行液氮研磨，在4℃，4500r/min的条件下离心10min后取上清液。取上述10％肝匀浆，使用试剂盒检测4.0h的ADH和MDA水平。结果如图1-3所示。
3.实验结果
表1肝轻松口服液对急性醉酒小鼠醉酒时间和醒酒时间的影响
| 组别 | 醉酒时间/min | 醒酒时间/min |
| 空白对照组 | 0.00±0.00 | 0.00±0.00 |
| 模型对照组 | 25.31±3.25## | 205.33±42.38## |
| 阳性药物组 | 46.28±4.27* | 162.38±56.29 |
| 实施例1 | 50.33±3.86** | 122.38±47.27** |
| 实施例2 | 60.32±4.57** | 103.27±38.29** |
| 实施例3 | 50.89±4.27** | 121.97±48.29** |
| 对比例1 | 47.28±2.23* | 164.38±65.29* |
| 对比例2 | 38.21±4.67 | 184.25±57.83 |
| 对比例3 | 37.21±3.85 | 172.36±47.38 |
注：“*”表示模型组比较差异显著(P＜0.05)，“**”表示模型组比较差异极显著(P＜0.01)，“#”表示与空白组比较差异显著(P＜0.05)，“##”表示空白组比较差异极显著(P＜0.01)，下同。
表2肝轻松口服液对急性醉酒小鼠肝脏ADH、MDA水平的影响
结果表明，本发明在解酒护肝方面的除杂效果较好，与同类产品比较，具有显著的解酒保肝作用。
3.2实验结论
中医认为酒为湿热之品，易出现腹满无食欲，湿邪中阻，中焦不适等，本发明采用铁皮石斛滋阴清热利尿；配伍沙棘活血化瘀，健胃消食，葛根清热生津，促进机体清热解酒，理气消滞，甘草补脾益气，调和诸药，共助机体解酒排毒。由药效学实验结果可知，肝轻松口服液对于小鼠急性酒精中毒的具有较好的预防结果，与阳性药解酒固体饮料相比较具有显著的优势，而本发明一方面减少了组分的药对，另一方面对于小鼠的醉酒行为学具有更为显著的积极作用；与对比例1-3相比，本发明的配比以及制备方法，能具备更加有效的解酒功效。
实验二、对大鼠胃损伤模型的预防保护作用
1.实验材料：
动物：健康SD大鼠60只，雄性，SPF级，体重220～250g，南京中医药大学动物中心提供。
材料：本发明实施例2中药组合物，对比例2中药组合物，60％食用乙醇溶液。2方法：
2.1动物分组及给药
将试验大鼠分为6组，分别为正常组、阳性药物组(对比例2中药组合物)、模型对照组、低剂量组、中剂量组、高剂量组，每组10只。
正常组正常饲养大鼠，不进行任何试验处理；模型对照组大鼠先正常饲养，然后诱导胃损伤；3个试验组将实施例2中药组合物(肝轻松口服液)分别按1mL/100g对试验组SD大鼠每天实施灌胃1次，灌胃3天，不同剂量组给药量按照生药量3.4、6.8、13.7g/kg，以0.10mL/10g的灌胃体积配成相应的给药溶液。
2.2胃损伤大鼠造模方法
2周后对除正常组外的各组大鼠用1mL乙醇溶液(60％食用乙醇溶液)进行灌胃胃损伤诱导，1h后处死各组大鼠，取大鼠血浆进行测定。
3方法
取2mL动脉血，4℃下3000r/min离心10min，取上层血清。IL-6和TNF-α定量酶联检测试剂盒按ELISA方法操作后，用Bio-Rad 550酶标仪(美国)检测血清中上述2种细胞因子的水平。
4实验结果：
通过酶联免疫法测定大鼠血清中IL-6的细胞因子水平，结果见图4。正常组、对照组及用2.2、4.4、8.8g/kg浓度实施例2口服液灌胃各组的因子水平分别为50.4、240.3、162.4、142.6、108.7、65.9pg/ml。TNF-α的细胞因子水平与IL-6相似，各组大鼠的TNF-α细胞因子水平平均为108.2、775.3、403.2、378.2、206.6、100.1pg/mL。由结果可知，随着口服液灌胃浓度的提高，IL-6和TNF-α细胞因子的水平随之下降，试验各组大鼠的细胞因子水平均明显低于对照组。IL-6和TNF-α细胞因子水平的降低表示炎症程度降低，表明口服液能降低胃损伤程度。
5实验结论：
本研究以本发明肝轻松口服液为基准进行动物体内抗胃损伤的比较试验，从血清细胞因子水平证实本品具有一定的胃损伤预防效果，且优于同类产品。
实验三、对乙醇诱导的肝细胞损伤的保护作用
1.实验材料
L-02肝细胞；食用级乙醇；药物为实施例2中药组合物；全波段酶标仪；总超氧化物歧化酶(total superoxide dismutase，T-SOD)；四甲基噻唑蓝[3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromid,MTT]。
2.方法
L-02肝细胞按照处理方式不同分为：空白对照组、药物组(10μg/mL)、乙醇模型组(CH3CH2OH，100mmol/L)及药物+乙醇组，分别取L-02肝细胞对照组给予无血清培养基，药物组给予肝轻松口服液预处理8h，乙醇模型组暴露于含DM EM的100mmol/L的乙醇溶液12h，药物+乙醇组先给予实施例1口服液8h后，再暴露于含DMEM的100mmol/L的乙醇溶液12h。采用MTT检测OD值，细胞存活率＝(OD实验组/OD对照组)×100％；总超氧化物歧化酶(totalsuperoxide dismutase，T-SOD)结合酶标仪测定其含量水平。
3.实验结果
与对照组相比，100mmol/L乙醇可导致细胞活力降至0.50±0.03(P＜0.05)，药物组预处理可显著改善乙醇诱导的细胞活力降低，活力水平为0.85±0.05，较乙醇组显著升高(P＜0.05)；药物预处理组，T-SOD水平为(13.95±0.75)U/mL，显著高于乙醇组(P＜0.05)。
4.实验结论
肝轻松口服液对于乙醇诱导的肝细胞损伤具有显著的保护作用，能有有效缓解细胞活力的下降，升高总超氧化物歧化酶。
实验四、对小鼠肝功能保护作用影响研究
1.实验材料
动物：SPF级昆明小鼠50只，雌雄兼用，体重20±2g，南京中医药大学动物中心提供。
药物：护肝片(生产商为黑龙江葵花药业股份有限公司)
仪器：酶标仪(美国Bio-Rad)；
2.方法：
分组：昆明小鼠50只，随机分为正常对照组、模型组、护肝片(0.14g/kg)阳性对照组和药物低剂量组(实施例1肝轻松口服液3.2g/kg)、药物高剂量组(实施例1肝轻松口服液6.4g/kg)，每组10只。
造模：除正常对照组外，其余各组分别皮下注射2％ CCl4花生油溶液，2mL/kg，2次/w，连续8w。
给药：造模后，次日除正常对照组和模型组灌胃蒸馏水外，其余各组按相应药物剂量给药，1次/d。给药3天，于最后一次给药12h后，采集标本测定肝功能生化指标。
3.实验结果：
| 组别 | IL-6 | TNF-α |
| 空白对照组 | 24.67±5.28 | 114.21±22.56 |
| 模型对照组 | 82.23±4.53<sup>##</sup> | 303.54±43.23<sup>##</sup> |
| 阳性对照组 | 55.39±6.74<sup>*</sup> | 238.53±26.53<sup>*</sup> |
| 药物低剂量组 | 58.54±6.78<sup>**</sup> | 244.24±32.13<sup>*</sup> |
| 药物高剂量组 | 43.16±7.34<sup>**</sup> | 194.78±19.67<sup>**</sup> |
4.实验结论：
表明肝轻松口服液对小鼠受损的肝功能和肝脏组织具有改善与修复作用，且效果显著。
实验五、肝轻松口服液解酒护胃功效临床研究
1.实验材料
实施例2制备的肝轻松口服液；对比例1制备的口服液；
2.实验对象：选取年龄为30-55岁，体重65kg(±6％)，因长期饮酒肝或胃脏器有一定损伤，其他方面均没有异常的100名男性自愿者。试验对象排除标准为：(1)有过敏、胃肠道、肾、肝、心脏病史者；(2)开始试验前2周内服用药物者；(3)其他不适合者。
3.实验方法
随机志愿者分为3组，分别是空白对照组，药物组(实施例2)，阳性对照组(对比例1)，每组60人；在治疗前，对选取的的志愿着进行身体情况检测，确定治疗前肝脏以及肠胃存在的问题，是否存在言语增多、目赤红肿和焦虑失眠的问题；然后对照组不给药，每组志愿者开始服用相应组制备的口服液，实施例组和对比例组每次服用2支(10ml/支)，实施例和对比例组每组口服液分别每支生药量为0.95g/mL、7.5g/mL，餐后口服，每天两次，连续1月，再次进行身体情况检测，检查治疗前存在的症状等是否解决或有所减轻，并询问个人对于口服液的口感。
4.实验结果
实验结果最终对照组由于未给药，长期饮酒带来的问题仍然存在；
药物组以及阳性药物组有不同程度的治疗效果：
药物组有48人症状基本消失，其余皆有不同程度的症状缓解；
阳性药物组有35人症状基本消失，2人仍有眼睛红肿的症状，其余皆有不同程度的症状缓解。
5.实验结论
试验表明肝轻松口服液具有改善长期饮酒造成的慢性酒精中毒症状的作用，可用于治疗长期饮酒带来的身体的免疫能力降低的问题。
临床实验案例
1：王先生，男，58岁，于2020年11月感全身乏力、四肢怠惰、腰腿酸软、精神不振等不适，曾多次去医院检查身体，了解到王先生长期饮酒，造成机体免疫力下降，常感疲乏无力，肝功能有所损害。经长期服用本发明口服液2个月后，自觉疲乏无力、腰腿酸软等不适明显改善，感觉精力充沛。至今未见上述不适症状。
2：葛女士，女，40岁，于2021年3月，感觉全身疲乏无力、嗜睡，面色苍白、精神萎靡、***等不适症状。医院诊断为葛女士是外企高管，长期进行伏案作业，压力巨大，造成的机体免疫力下降。经服用本发明两个半月后，其面色转红润，精神转佳，月经不***况明显改善，其他不适症状均消失。
最后应当说明的是，以上内容仅用以说明本发明的技术方案，而非对本发明保护范围的限制，本领域的普通技术人员对本发明的技术方案进行的简单修改或者等同替换，均不脱离本发明技术方案的实质和范围。
Claims (8)
1.一种具有保肝解酒的中药组合物，其特征在于：所述中药组合物的原料由以下组分组成：铁皮石斛、沙棘、葛根和甘草。
2.根据权利要求1所述的中药组合物，其特征在于：按重量份数计，所述中药组合物的原料由以下组分组成：铁皮石斛6-12份、沙棘3-10份、葛根10-15份、甘草2-10份。
3.根据权利要求1或2所述的中药组合物，其特征在于：按重量份数计，所述中药组合物的原料由以下组分组成：铁皮石斛8-12份、沙棘6-10份、葛根12-15份、甘草4-10份。
4.根据权利要求1所述的中药组合物，其特征在于：按重量份数计，所述中药组合物的原料由以下组分组成：铁皮石斛12份、沙棘8份、葛根10份、甘草8份；或：铁皮石斛11份、沙棘10份、葛根13份、甘草4份。
5.一种中药组合物制剂，其特征在于：所述制剂包含权利要求1-4任意一项所述的中药组合物；所述制剂的剂型选自液体制剂、糖浆剂、片剂、胶囊剂、散剂和颗粒剂中的一种。
6.根据权利要求1-4任意一项所述的中药组合物的制备方法，其特征在于：包括如下步骤：
(1)将沙棘榨汁，过滤，得滤液与滤渣；
(2)再将铁皮石斛、滤渣、葛根、甘草混合，然后加水依次提取两次，过滤，与鲜榨沙棘滤液合并，得提取液；
(3)加入添加剂后，浓缩至相对密度约为1.05g/mL，离心灌装灭菌即得。
7.根据权利要求6所述的制备方法，其特征在于：步骤(2)中所述提取为回流提取，加水的用量均为8倍；所述回流提取的温度为100℃，回流提取的时间为30min；步骤(3)中加入添加剂混合，在40-50℃下保温30-60min；所述添加剂包括天门冬酰氨苯丙氨酸甲酯、柠檬酸钠和海藻酸钠；所述离心参数为10000r/min离心10min；所述灭菌方法为湿热灭菌法。
8.一种权利要求1-4任意一项所述的中药组合物或6-7任意一项所述的中药组合物制剂及制备方法制备得到的中药组合物在制备预防或治疗解酒护肝产品中的应用。
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