CN106474380A - 具有护肝解酒功效的中药组合物、制剂及其制备方法 - Google Patents
具有护肝解酒功效的中药组合物、制剂及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种具有护肝解酒功效的中药组合物、制剂及其制备方法,所述具有护肝解酒功效的中药组合物由以下重量份的原料制备而成:葛花1‑20份、枳椇子3‑17份、车前子1‑20份、竹茹3‑17份、杭菊花2‑17份、茯苓6‑17份、枸杞子5‑18份、夏枯草2‑17份、山楂2‑13份、白扁豆3‑16份。本发明的具有护肝解酒功效的中药组合物配方合理,诸成分合力,共奏护肝解酒之功效;且制备方法简单,易于工业化生产;具有护肝解酒功效的制剂配方简单,便于携带、护肝解酒效果显著。
Description
技术领域
本发明属于保健食品技术领域,特别是涉及一种具有护肝解酒功效的中药组合物、制剂及其制备方法和应用。
背景技术
中国有着悠久的酒文化历史,无论是家庭中的喜事、丧事、还是工作、生活中的送往迎来,都少不了要喝酒,甚至一醉方休,但饮酒过量对人们的身体有着暨大的危害。全球疾病负担中有3.5%的残疾以及健康生存年损失由饮酒引起,估计全球每年有饮酒引起的死亡约为75万人,其中80%在发展中国家,全球饮酒疾病负担各区域不同,1.3%在低消耗的最贫穷国家。
喝酒过量伤身,首当其冲的受害者是肝脏,长期摄入过量乙醇,人体代谢发生障碍造成肝内的脂肪堆积,可导致肝硬化。近年研究发现,乙醇对肝细胞有直接毒害作用,认为是由于乙醇在肝细胞内氧化消化辅酶,抑制了粒腺体的三羧循环,使肝细胞内脂肪酸的氧化过程减弱,导致肝细胞脂肪变性。国外曾有人做过这样的观察,对不饮酒的学生自愿者给予高脂肪、高蛋白膳食,并用乙醇代替碳水化合物。结果,虽然每个志愿者血液的酒精浓度在法定中毒量以下,肝内都出现增加3-14倍的甘油三脂含量,并伴有组织的脂肪变性及粒腺体增大。所以有人把肝脏称之为酒精中毒中最明显的靶器官。长期过量饮酒在消化系统还会损害胃粘膜和小肠的超微结构及吸收功能,导致营养不良和贫血。
目前,解酒护肝药大体可以分为西药和中药制剂,西药在防治上的效果不理想,中药是多靶点、多环节用药,共同发挥作用。目前经国家食品药品监督管理局批准的合法上市销售的解酒护肝产品有一百余种,但是大部分的解酒护肝产品组方是相同的,也就是说不同厂家生产的护肝产品其实就是同一种产品,例如*城护肝片,主要作用疏肝理气,具有降低转氨酶作用,成分:柴胡、茵陈、板蓝根、五味子、猪胆粉、绿豆;**尔护肝片,主要作用疏肝理气,具有降低转氨酶作用,成分:柴胡、茵陈、板蓝根、五味子、猪胆粉、绿豆。因此,针对上述问题,有必要开发一款安全、高效、稳定的中药解酒护肝方。
发明内容
基于此,为了克服上述现有技术的缺陷,本发明提供了一种具有护肝解酒功效的中药组合物、固体饮料及其制备方法。
为实现上述目的,本发明采取以下技术方案:
一种具有护肝解酒功效的中药组合物,其由以下重量份的原料制备而成:葛花1-20份、枳椇子3-17份、车前子1-20份、竹茹3-17份、杭菊花2-17份、茯苓6-17份、枸杞子5-18份、夏枯草2-17份、山楂2-13份、白扁豆3-16份。
在其中一些实施例中,所述中药组合物由以下重量份的原料制备而成:葛花10-12份、枳椇子9-13份、车前子9-13份、竹茹8-15份、杭菊花7-12份、茯苓10-12份、枸杞子9-13份、夏枯草7-12份、山楂5-10份、白扁豆7-11份。
在其中一些实施例中,所述中药组合物由以下重量份的原料制备而成:葛花11份、枳椇子11份、车前子11份、竹茹11份、杭菊花9份、茯苓11份、枸杞子11份、夏枯草9份、山楂7份、白扁豆9份。
本发明所述的具有护肝解酒功效的中药组合物各组分的药理如下:
葛花:甘,凉。解酒醒脾,止血,用于伤酒烦热口渴,头痛头晕,脘腹胀满,呕逆吐酸等。
枳椇子:甘,平。解酒毒,止咳除烦,止呕,利大小便。用于醉酒,烦渴,呕吐,二便不利等。
车前子:甘,凉。清心,豁痰,开窍,凉肝,息风,解毒。用于热病神昏,中风痰迷等。
竹茹:甘,微寒。清热化痰,除烦,止呕。用于清热化痰,除烦,止呕。用于痰热咳嗽,胆火挟痰,惊悸不宁等。
杭菊花:辛、甘、苦,微寒。疏散风热,平肝明目。清热解毒。用于风热感冒。发热头痛,目赤昏花、眩晕惊风等。
茯苓:甘,淡、平。利水渗湿,健脾,宁心。用于水肿尿少,痰饮眩悸、脾虚食少、心神不安等。
枸杞子:甘,平。滋补肝肾,益精明目。用于虚劳精亏、,腰膝酸软,眩晕耳鸣,阳痿遗精,目昏不明等。
夏枯草:辛、苦,寒。清肝泻火,明目,散结消肿。用于目赤肿痛,目珠夜痛,头痛眩晕等。
山楂:酸、甘,微温。消食健脾,行气散瘀,化浊降脂。用于肉食积滞,胃脘胀满,心腹刺痛,胸痹心痛等。
白扁豆:甘,微温。健脾化湿,和中消暑。用于脾胃虚弱,食欲不振,大便溏泻等。
本发明还提供了上述具有护肝解酒功效的中药组合物的制备方法,包括如下步骤:
(1)按照上述分量称取葛花、枳椇子、车前子、竹茹、杭菊花、茯苓、枸杞子、夏枯草、山楂、白扁豆;
(2)将葛花、枳椇子、车前子、竹茹、杭菊花、茯苓、枸杞子、夏枯草、山楂、白扁豆混合,得混合物;
(3)将混合物用水和/或乙醇溶液进行提取,过滤,得滤液;
(4)将滤液浓缩至稠膏,即得具有护肝解酒功效的中药组合物;或将稠膏干燥后,得膏粉,即得具有护肝解酒功效的中药组合物。
本发明还提供了上述具有护肝解酒功效的中药组合物在制备具有护肝解酒功效的药品或食品中的应用。
在其中一些实施例中,所述具有护肝解酒功效的药品为片剂、颗粒剂或茶剂。
与现有技术相比,本发明具有以下有益效果:
1、本发明的具有护肝解酒功效的中药组合物配方合理,诸成分合力,共奏护肝解酒之功效;且制备方法简单,易于工业化生产;
2、本发明的具有护肝解酒功效的药品配方简单,便于携带、护肝解酒效果显著。
具体实施方式
下面结合具体实施例进一步叙述本发明,本发明未述及之处适用于现有技术。下面给出本发明的具体实施例,但实施例仅是为了进一步详细叙述本说明,并不限制本发明的权利要求。
以下实施例中所使用的原料,均来源于市售。
实施例1 具有护肝解酒功效的中药组合物
本实施例的具有护肝解酒功效的中药组合物,由下述重量份的原料提取制备而成:葛花12份、枳椇子9份、车前子20份、竹茹3份、杭菊花7份、茯苓17份、枸杞子9份、夏枯草12份、山楂13份、白扁豆7份。
本实施例的中药组合物的制备方法,包括如下步骤:
(1)按照上述分量称取葛花、枳椇子、车前子、竹茹、杭菊花、茯苓、枸杞子、夏枯草、山楂和白扁豆;
(2)将葛花、枳椇子、车前子、竹茹、杭菊花、茯苓、枸杞子、夏枯草、山楂和白扁豆混合,得混合物,混合物置于提取罐中;
(3)加原料重量6倍量的水煎煮提取3次,每次1.5小时,合并3次提取液,过滤,得滤液;
(4)将滤液浓缩至稠膏,将稠膏置于真空干燥箱内进行干燥,得膏粉,即为具有护肝解酒功效的中药组合物。
实施例2 具有护肝解酒功效的中药组合物
本实施例的具有护肝解酒功效的中药组合物,由下述重量份的原料提取制备而成:葛花10份、枳椇子13份、车前子13份、竹茹8份、杭菊花12份、茯苓10份、枸杞子13份、夏枯草7份、山楂5份、白扁豆11份。
本实施例的中药组合物的制备方法,包括如下步骤:
(1)按照上述分量称取葛花、枳椇子、车前子、竹茹、杭菊花、茯苓、枸杞子、夏枯草、山楂和白扁豆;
(2)将葛花、枳椇子、车前子、竹茹、杭菊花、茯苓、枸杞子、夏枯草、山楂和白扁豆混合,得混合物,粉碎,得粗粉,将粗粉置提取罐中;
(3)加原料重量6倍量的质量分数为30%的乙醇溶液回流提取2次,每次1.5小时,滤过,滤液回收乙醇;
(4)将滤液浓缩至稠膏,将稠膏置于真空干燥箱内进行干燥,得干膏粉,即为具有护肝解酒功效的中药组合物。
实施例3 具有护肝解酒功效的中药组合物
本实施例的具有护肝解酒功效的中药组合物,由下述重量份的原料提取制备而成:葛花5份、枳椇子17份、车前子1份、竹茹17份、杭菊花17份、茯苓6份、枸杞子18份、夏枯草17份、山楂2份、白扁豆16份。
本实施例的中药组合物的制备方法,包括如下步骤:
(1)按照上述分量称取葛花、枳椇子、车前子、竹茹、杭菊花、茯苓、枸杞子、夏枯草、山楂和白扁豆;
(2)将葛花、枳椇子、车前子、竹茹、杭菊花、茯苓、枸杞子、夏枯草、山楂和白扁豆混合,得混合物,粉碎,得粗粉,将粗粉置提取罐中;
(3)加入所述原料重量6倍的体积分数为55%的乙醇溶液超声提取2次,收集提取液,过滤,干燥得干膏粉,即为所述具有护肝解酒功效的中药组合物。
实施例4 具有护肝解酒功效的中药组合物
本实施例的具有护肝解酒功效的中药组合物,由下述重量份的原料提取制备而成:葛花15份、枳椇子4份、车前子9份、竹茹15份、杭菊花2份、茯苓12份、枸杞子5份、夏枯草2份、山楂10份、白扁豆3份。
本实施例的中药组合物的制备方法,包括如下步骤:
(1)按照上述分量称取葛花、枳椇子、车前子、竹茹、杭菊花、茯苓、枸杞子、夏枯草、山楂和白扁豆;
(2)将葛花、枳椇子、车前子、竹茹、杭菊花、茯苓、枸杞子、夏枯草、山楂和白扁豆混合,得混合物,粉碎,得粗粉,将粗粉置提取罐中;
(3)加原料重量6倍量的质量分数为65%的乙醇溶液回流提取2次,收集提取液,过滤,干燥得干膏粉,即为所述具有护肝解酒功效的中药组合物。
实施例5 具有护肝解酒功效的中药组合物
本实施例的具有护肝解酒功效的中药组合物,由下述重量份的原料提取制备而成:葛花11份、枳椇子11份、车前子11份、竹茹11份、杭菊花9份、茯苓11份、枸杞子11份、夏枯草9份、山楂7份、白扁豆9份。
本实施例的中药组合物的制备方法,包括如下步骤:
(1)按照上述分量称取葛花、枳椇子、车前子、竹茹、杭菊花、茯苓、枸杞子、夏枯草、山楂和白扁豆;
(2)将葛花、枳椇子、车前子、竹茹、杭菊花、茯苓、枸杞子、夏枯草、山楂和白扁豆混合,得混合物,粉碎,得粗粉,将粗粉置提取罐中;
(3)将粗粉置于超声提取器中,加入所述原料重量6倍量45%乙醇超声2次,每次为1小时;
(4)收集提取液,过滤,将所得滤液干燥得干膏,即为所述具有解酒保健功效的中药组合物。
实施例6 具有护肝解酒功效的制剂
将实施例5所述具有护肝解酒保健功效的中药组合物加入乳糖、淀粉和倍他环糊精,制成颗粒剂。
试验例1 实施例1-5所述中药组合物的翻正反射实验
实验方案
分组:将60只ICR雄性小鼠随机平均分为空白对照组、A组(实施例1中药组合物)、B组(实施例2中药组合物)、C(实施例3中药组合物)、D(实施例4中药组合物)、E(实施例5中药组合物)。
处理:试验前,所有小鼠禁食一夜(12h),不禁水。然后,空白对照组不做处理,A-E组灌胃药物(根据小鼠体重,按3709.24mg/kg、将实施例1-5所述中药组合物溶解于纯水分别配成药液,进行灌胃),30min后,A-E组小鼠灌胃56度红星二锅头0.3mL/20g,以小鼠翻正反射消失为观察指标,即将小鼠背向下轻轻放在动物笼里,若仰位姿势保持30s以上,则认为翻正反射消失。
实验期间,A组小鼠活动正常,A-E组小鼠从灌酒到翻正反射消失的潜伏时间(T1)和翻正反射恢复时间(T2)如表1所示。
表1
表1结果表明:与空白对照组比较,实施例5组的小鼠潜伏时间(T1)和翻正反射恢复时间(T2)分别被显著推迟与缩短,由此说明实施例5组中药组合物显著推迟了小鼠醉倒时间,缩短了小鼠昏睡时间。
试验例2 本发明的具有护肝解酒功效的制剂的翻正反射试验
实验方案:
分组:清洁级昆明小鼠,雌雄各半,体重18-22g。
试剂与药材:红星二锅头,按0.15ml/10g体重灌胃,动物可明显致醉且无大量死亡,实验方剂包括了实施例6的具有护肝解酒功效的制剂与*家赶黄草。
1、翻正实验:实验小鼠按雌雄各半随机分组,每组十只,实验前禁食用,12小时,根据小鼠体重,将实施例6所述颗粒剂溶解于纯水分别配成药液,按高剂量4945.65mg/kg、中剂量3709.24mg/kg、低剂量2472.83mg/kg体重,进行灌胃),另设对照组代以等体积蒸馏水。给药30min后,各组均用红星二锅头按0.15ml/10g体重灌服,随机记录各小鼠翻正反应小时时间和消失持续时间。
2、醉酒睡眠实验:动物分组与处置方法同上,灌服白酒后随机观察小鼠活动情况。以小白鼠爬行不稳、后腹拖地、闭眼懒动为睡眠(醉酒)指标,记录小鼠入睡时间和苏醒时间,算出睡眠耐受时间(从灌酒至入睡的时间)及持续时间(从入睡到苏醒的时间)。
3、攀附实验:动物分组与处置方法同上,灌服白酒后随即将小鼠放在垂直的金属网上,记录各小鼠在网上的攀附时间。
4、全血乙醇含量测定:动物分组与处置方法同上,分别于灌服白酒30/60/90/120/150/180min后,随即抽取各组小鼠8只,经眼球取血0.1ml抗凝,内标法检测全血乙醇含量。检测方法参照《中华人民共和国药典》乙醇量测定方法。
有关实验结果对比如下。
表2 实验小鼠翻正反应/醉酒睡眠时间/攀附时间观察结果(x+s)
结论:1,翻正实验结果、醉酒睡眠实验结果与攀附实验结果均显示(见表2),与对照组比较,实施例6制剂实验小鼠的翻正反应消失时间和消失持续时间、睡眠潜伏时间和睡眠持续时间均得到改善;小鼠攀附时间明显延长。效果优于*家赶黄草。
表3 实验小鼠乙醇含量检测结果(μL/mL)(x±s))
血乙醇含量检测结果显示,与对照组比较,本发明所述具有护肝解酒功效的制剂的高剂量和中剂量能够显著降低酒后血液乙醇浓度。
以上所述实施例的各技术特征可以进行任意的组合,为使描述简洁,未对上述实施例中的各个技术特征所有可能的组合都进行描述,然而,只要这些技术特征的组合不存在矛盾,都应当认为是本说明书记载的范围。
以上所述实施例仅表达了本发明的几种实施方式,其描述较为具体和详细,但并不能因此而理解为对发明专利范围的限制。应当指出的是,对于本领域的普通技术人员来说,在不脱离本发明构思的前提下,还可以做出若干变形和改进,这些都属于本发明的保护范围。因此,本发明专利的保护范围应以所附权利要求为准。
Claims (7)
1.一种具有护肝解酒功效的中药组合物,其特征在于,其由以下重量份的原料制备而成:葛花1-20份、枳椇子3-17份、车前子1-20份、竹茹3-17份、杭菊花2-17份、茯苓6-17份、枸杞子5-18份、夏枯草2-17份、山楂2-13份、白扁豆3-16份。
2.根据权利要求1所述的具有护肝解酒功效的中药组合物,其特征在于,其由以下重量份的原料制备而成:葛花10-12份、枳椇子9-13份、车前子9-13份、竹茹8-15份、杭菊花7-12份、茯苓10-12份、枸杞子9-13份、夏枯草7-12份、山楂5-10份、白扁豆7-11份。
3.根据权利要求2所述的具有护肝解酒功效的中药组合物,其特征在于,其由以下重量份的原料制备而成:葛花11份、枳椇子11份、车前子11份、竹茹11份、杭菊花9份、茯苓11份、枸杞子11份、夏枯草9份、山楂7份、白扁豆9份。
4.权利要求1~3任一项所述的具有护肝解酒功效的中药组合物的制备方法,其特征在于,包括如下步骤:
(1)将各原料混合后,用水和/或乙醇溶液进行提取,过滤,得滤液;
(2)将滤液浓缩至稠膏,即得;或将稠膏干燥后,得膏粉,即得。
5.一种具有护肝解酒功效的制剂,其特征在于,其以权利要求1~3任一项所述的中药组合物为活性成分。
6.根据权利要求5所述的具有护肝解酒功效的制剂,其特征在于,所述制剂为片剂或颗粒剂。
7.权利要求5或6所述的具有护肝解酒功效的制剂的制备方法,其特征在于,包括以下步骤:将权利要求1~3任一项所述的中药组合物与所需辅料混合,按常规方法制成片剂或颗粒剂。
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