CN105561006B - 一种具有治疗酒精性肝病功能药物组合物及其制备方法和用途 - Google Patents
一种具有治疗酒精性肝病功能药物组合物及其制备方法和用途 Download PDFInfo
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- A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
Abstract
本发明提供了一种具有解酒功能的食品、保健食品或药物组合物，它由包含下述重量配比的原料制备而成：葛根100－150份、枳椇60－150份、山楂90－120份、白茅根90－300份、青果50－100份、桑葚90－200份。本发明还提供了该组合物的制备方法和用途。本发明组合物以药食两用的天然植物为原料，按照特定配比组成。制备的口服液为纯植物饮品，不含任何添加剂，棕褐色，微甜，口感好，使用方便；制备成保健品或药品具有解酒功能，还具有保肝、护胃、利咽的功效，且效果明显优于单一原料，无明显毒副作用，适合长期使用，值得推广应用。
Description
技术领域
本发明涉及一种具有治疗酒精性肝病功能的药物组合物。
背景技术
酒精性肝病(alcoholic liver disease，ALD)是由于长期大量饮酒所致肝脏疾病。初期通常表现为酒精性脂肪肝，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；严重酗酒可诱发广泛肝细胞坏死甚或肝功能衰竭。目前，我国酒精性肝病的发病率呈上升趋势，现代医学治疗该病除了戒酒、对症治疗外，尚无特殊治疗方法，而中医通过选用具有解酒作用的中药防治该病具有一定的特色。
解酒dispel the effects of alcohol顾名思义，就是“醒酒”，使人从醉酒的状态中醒过来，恢复意识或回复自制力。通常不是自然清醒，而是采用某种方式快速解酒，起到节约时间的目的、减小乙醇对人体危害的目的。目前报道的解酒方法包括解酒中药，如传统护肝中药五味子，能促进肝脏的解毒过程、保护肝脏免受毒害，并能再生因滥用酒精、药物或肝炎而受损的肝脏组织。葛根能有效地抵抗酒精引起的肝和睾丸组织脂质过氧化损害，有望作为可靠的解酒药物来开发。还有紫葛花、黄松草、人参、冬虫夏草、灵芝、桑椹等，经典方有小柴胡颗粒。
此外，也有相关解酒中药专利报道，如专利申请号：CN200410063034，发明名称：一种具有解酒、醒酒，保肝、护胃保健作用的珍葛含片，公开了一种新的中药组合物珍葛含片及其制备。将葛根、枳椇子、青果、橘皮、白茅根、枸杞子、大枣、金银花、茯苓、甘草、山楂加水提取，过滤，将滤液浓缩，得到干膏粉，加入珍珠层粉、蔗糖、奶粉压片。或者将珍珠层粉和中药材一起回流提取，加入蔗糖，混匀，制粒。也可制成饮料。并可加入薄荷脑。该组合物具有清热解毒、和胃化湿、理气化瘀、解酒醒酒、保肝护胃的作用，用于增加人体对酒精的耐受力，减少酒精所致的头痛、恶心、呕吐、胃内不适，降低酒精对肝所形成的损伤。专利申请号：CN88105281，发明名称：一种醒酒品及其制备方法，一种中药组合物及其制备方法。将葛花、茵陈、菊花搓成碎片；葛根、茅根(白茅根)碾轧取末，粗物切丝；竹茹、竹叶、薄荷、藿香(广藿香)切丝；青果、白扁豆、绿豆、赤小豆、白梅、硼砂、丹参、党参、麦冬、升麻、芥穗(荆芥)、细辛、川芎、陈皮、山楂、莲子、甘草、云苓(茯苓)、五味子、枳椇子、半夏、白芷粉碎；生姜轧汁后混合，喷洒甘油调匀，用纸卷成圆柱或圆盘，用时点燃闻其烟雾，可用于醒酒。
由于目前报道的解酒产品，单一使用效果不佳，复方配伍含有中药材，不能长期使用，且成本高，不利于开发成适合市场需求的产品。
发明内容
本发明的技术方案是提供了一种具有解酒功能的药物组合物。本发明的另一技术方案是提供了该组合物的制备方法和用途。
本发明提供了一种具有治疗酒精性肝病功能的药物组合物，进一步地，所述的组合物是由下述重量配比的原料制备而成：
葛根100－150份、枳椇60－150份、山楂90－120份、白茅根90－300份、青果50－100份、桑葚90－200份。
优选地，所述的组合物是由下述重量配比的原料制备而成：
葛根150份、枳椇150份、山楂100份、白茅根200份、青果50份、桑葚200份。
其中，所述的组合物是由葛根、枳椇、山楂、白茅根、青果、桑葚的原生药粉、水或有机溶剂提取物为活性成分，加入药学中可接受的辅料或辅助性成分制备而成的药品。
其中，所述的药品制剂是片剂、胶囊剂、颗粒剂、丸剂、口服液、液体剂或半固体制剂。
本发明提供了制备所述组合物的方法，它包括如下步骤：
a、称取各重量配比的原料；
b、加水浸泡，煎煮，收集煎煮液，浓缩，冷却，加入鸡蛋清，煮沸10分钟，冷却，过滤，加入药学中可接受的辅料或辅助性成分制备成药品。
本发明提供了所述的组合物在制备具有治疗酒精性肝病功能的药品中的用途。
本发明提供了所述的组合物在制备具有保肝功能的药品中的用途。
酒精性肝病在祖国医学中属“胁痛”、“积聚”、“黄疸”、“痰浊”等范畴，多为酒湿浊气郁结中焦、清浊相混，而导致气血瘀滞、脾虚愈甚，最终导致水不得泄，成为臌胀。本发明药物组合物以中医药理论为基础，通过长期的临床实践并结合酒城地方特点，研制出以六味药食同源的纯中药组成的具有显著解酒功能的药物组合物，用作对长期大量饮酒造成的醉酒及预防ALD的保健品。组方中，枳椇子“解酒毒、止渴除烦、润五脏、利大小便”(《本草拾遗》)为君药；葛根醒脾升清、解酒，山楂消食和胃、活血化瘀，现代药理研究生山楂有很好的降血脂作用，共为臣药；桑葚入肝肾经，滋阴补血，生津润燥。青果又名橄榄，最新研究表明，青果对酒精引起的肝细胞损伤有较好的保护作用；白茅根清肺胃之热、凉血止血、通利小便，古医籍《纲目》记载该药也能解酒毒。诸药合用，“清泻并举，功补兼施”，既排泄酒毒又保护脏器，全方具有“解酒降脂、滋肝补肾、健脾和胃、清热除湿”的功效。将上述六味药物按君臣佐使组合在一起，以期进一步加强其解酒降脂、健脾护肝之功效。
本发明组合物以药食两用的天然植物为原料，按照特定配比组成。制备的口服液为纯植物饮品，不含任何添加剂，棕褐色，微甜，口感好，使用方便；制备成保健品或药品具有解酒功能，还具有保肝、护胃、利咽的功效，且效果明显优于单一原料，无明显毒副作用，适合长期使用，值得推广应用。
以下通过具体实施方式对本发明作进一步的详细描述，但并不限制本发明，本领域技术人员根据本发明作出的各种改变和替换，只要不脱离本发明的精神，均应属于本发明所附权利要求的范围。
具体实施方式
实施例1本发明口服液的制备
组方如下：
葛根150g、枳椇150g、山楂100g、白茅根200g、青果50g、桑葚200g制备方法如下：
取各原料药加12倍量水浸泡1.5小时，煎煮2次，每次1小时，合并两次提取液，浓缩至850mL，放冷，加入鸡蛋清，煮沸10分钟，冷却，过滤，加纯化水至600mL，混匀，分装，灭菌，即得。
实施例2本发明口服液的制备
组方如下：
葛根100g、枳椇60g、山楂90g、白茅根90g、青果50g、桑葚90g制备方法如下：
取各原料药加10倍量水浸泡1小时，煎煮1次，每次1.5小时，合并两次提取液，浓缩至850mL，放冷，加入鸡蛋清，煮沸10分钟，冷却，过滤，加纯化水至600mL，混匀，分装，灭菌，即得。
实施例3本发明口服液的制备
组方如下：
葛根150g、枳椇150g、山楂120g、白茅根300g、青果100g、桑葚200g制备方法如下：
取各原料药加12倍量水浸泡2小时，煎煮2次，每次2小时，合并两次提取液，浓缩至850mL，放冷，加入鸡蛋清，煮沸10分钟，冷却，过滤，加纯化水至600mL，混匀，分装，灭菌，即得。
以下通过具体实验证明本发明的有益效果。
实验例1本发明口服液配方筛选试验
品评人数：18人
试验样品：
按下表选择不同配比，按实施例1的方法制备成口服液
| 样品1 | 样品2 | 样品3 | 样品4 | 样品5 | 样品6 | |
| 葛根 | 150g | 200g | 150g | 150g | 150g | 150g |
| 枳椇 | 150g | 200g | 150g | 150g | 150g | 150g |
| 山楂 | 100g | 100g | 100g | 100g | 100g | 100g |
| 白茅根 | 200g | 200g | 200g | 200g | 200g | 200g |
| 青果 | 50g | 0g | 0g | 100g | 50g | 100g |
| 桑葚 | 200g | 150g | 150g | 150g | 150g | 200g |
| 鱼腥草 | 0g | 200g | 0g | 0g | 0g | 0g |
| 西青果 | 0g | 0g | 30g | 0g | 0g | 0g |
| 口感评价 | 最佳 | 味淡 | 非常苦涩 | 酸、苦涩 | 稍显苦涩 | 稍显苦涩 |
经过多次试验显示：样品1较之其他配方口感最佳，其他配方中青果用量过大，会出现不同程度的涩味，影响口感；用量过小，则起不到解酒、护肝、利咽的作用。因此本发明口服液的最佳配方为：葛根150份、枳椇150份、山楂100份、白茅根200份、青果50份、桑葚200份。
实验例2本发明口服液预防酒精性肝病120例临床疗效观察
本发明通过临床试验观察本发明口服液对长期饮酒人群的肝脏保护作用。收治120例确诊的酒精性肝病患者对采用本发明口服液干预后的临床疗效进行总结分析。
1资料与方法
1.1一般资料选择本院2015年1月～2016年1月肝胆内科门诊和体检中心发现的酒精性肝病共计120例，在排除病毒性肝炎、自身免疫性肝病、药物性肝病和非酒精性脂肪肝等外，全部为男性患者，饮酒史均>5年，每天饮酒量均>40g。四组患者在年龄、嗜酒程度、病程长短、病情轻重、肝功能指标等方面无统计学差异，具有可比性(P>0.05)。
1.2西医诊断标准参照中华医学会肝脏病学分会脂肪肝和酒精性肝病学组制定的酒精性肝病诊断标准拟定：(1)患者有长期的饮酒史，一般超过5年，折合酒精量：男性>40g/d，女性>20g/d，或2周内有大量饮酒史，折合酒精量>80g/d；(2)戒酒后血清天门冬氨酸氨基转移酶、丙氨酸氨基转移酶、γ-谷氨酰转肽酶明显下降，且肿大的肝脏1周内明显缩小，4周内基本恢复正常；(3)有不同程度的乏力、食欲下降、肝区胀闷或隐痛，或肝脏明显肿大；(4)B超示脂肪肝，且肝内血管显示不清晰或纤细，肝后缘回声减弱；(5)cT检查示：肝密度普遍降低；(6)除外非酒精性脂肪肝以及合并HBV或HCV感染、药物或代谢异常引起的肝损害等。
1.3治疗方法
给予受试者本发明口服液，1支/次，一日三次，餐前口服，疗程3个月。
1.4疗效判定标准
显效：症状和体征消失或明显改善，肝功能指标恢复正常，但GGT仍有轻度升高，其数值<80U；好转：症状和体征有所改善，肝功能指标ALT(谷丙转氨酶)、AST(谷草转氨酶)、GGT(谷氨酰转肽酶)较治疗前数值均下降50％以上；无效：症状和体征无改善，肝功能各项指标未达好转标准。
1.5所有数据输入计算机采用SPSSl7.0软件进行分析，计量资料用均数±标准差(x±s)表示，并采用t检验率比较，P<0.05为差异有统计学意义。
2结果
2.1本发明口服液治疗疗效结果，见表1。
表1本发明口服液疗效结果[n(％)]
结果显示：本发明口服液可明显改善肝功能损伤，促进肝功能指标恢复正常，治疗酒精性肝病的总有效率达90％以上，表明本发明口服液具有显著的解酒、护肝作用。
2.2本发明口服液治疗前后患者肝功能、血脂比较，见表2。
表2本发明口服液治疗前后患者肝功能比较(x±s)
注：同组治疗前后比较：p<0.05
结果显示：本发明口服液可明显改善肝功能指标，使患者的ALT、AST、GGT指标较治疗前数值均下降50％以上，表明本发明口服液具有显著的解酒、护肝作用。
2.3四组患者不良反应及依从性比较
患者均按时完成了临床观察，在此期间除部分患者治疗中出现了依从性较差，在一定程度影响治疗，未发现该治疗方法有明显的毒副作用。
综上，本发明组合物以药食两用的天然植物为原料，按照特定配比组成。制备的口服液为纯植物饮品，不含任何添加剂，棕褐色，微甜，口感好，使用方便；制备成保健品或药品具有解酒功能，还具有保肝、护胃、利咽的功效，且效果明显优于单一原料，无明显毒副作用，适合长期使用，值得推广应用。
Claims (8)
1.一种具有治疗酒精性肝病功能的药物组合物，其特征在于：它由下述重量配比的原料制备而成：
葛根100－150份、枳椇60－150份、山楂90－120份、白茅根90－300份、青果50－100份、桑葚90－200份。
2.根据权利要求1所述的组合物，其特征在于：它是由下述重量配比的原料制备而成：
葛根150份、枳椇150份、山楂100份、白茅根200份、青果50份、桑葚200份。
3.根据权利要求1或2所述的组合物，其特征在于：它是由葛根、枳椇、山楂、白茅根、青果、桑葚的原生药粉或水提取物为活性成分，加入药学中可接受的辅料或辅助性成分制备而成的药品。
4.根据权利要求3所述的组合物，其特征在于：所述的药品的制剂是片剂、胶囊剂、颗粒剂、丸剂、液体剂或半固体制剂。
5.根据权利要求3所述的组合物，其特征在于：所述的药品的制剂为口服液。
6.一种制备权利要求1-5任意一项所述的组合物的方法，它包括如下步骤：
a、称取各重量配比的原料；
b、加水浸泡，煎煮，收集煎煮液，浓缩，冷却，加入鸡蛋清，煮沸10分钟，冷却，过滤，加入药学中可接受的辅料或辅助性成分制备成药品。
7.权利要求1-5任意一项所述的组合物在制备具有治疗酒精性肝病的药品中的用途。
8.权利要求1-5任意一项所述的组合物在制备具有保肝功能的药品中的用途。
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| CN103656286A (zh) * | 2013-12-09 | 2014-03-26 | 云南白药天颐茶品有限公司 | 缓解酒后不适及降低酒精性肝损伤的组合物及应用 |
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| CN103656286A (zh) * | 2013-12-09 | 2014-03-26 | 云南白药天颐茶品有限公司 | 缓解酒后不适及降低酒精性肝损伤的组合物及应用 |
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