CN106237228B - 一种解酒护肝抗氧化的中药组合物及其应用 - Google Patents
一种解酒护肝抗氧化的中药组合物及其应用 Download PDFInfo
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Abstract
本发明属于中药药物研发技术领域，具体的是一种解酒护肝抗氧化的中药组合物。一种解酒护肝抗氧化的中药组合物，按重量份数计由以下原料组成：石斛10‑30份、芒果汁30‑50份、罗汉果20‑60份、葛花50‑100份、山楂20‑40份、藿香30‑50份、砂仁30‑50份和薏苡仁50‑100份。本发明的中药组合物的各中药原料之间具有协同增效作用，具有解酒护肝抗氧化的功效；本发明的中药组合物均采用中草药制成，无任何毒副作用，安全性好，且不易产生耐药性，可以长期服用，有利于保持机体的正常功能；本发明通过现代制剂技术将中药组合物制成溶液剂、颗粒剂、膏方、片剂、胶囊剂，便于携带，同时更适合解酒人群的及时服用。
Description
技术领域
本发明属于中药药物研发技术领域，具体的是一种解酒护肝抗氧化的中药组合物及其应用。
背景技术
中国是以酒文化而著称的国家，饮酒往往是日常生活的一部分，尤其在节假日、喜庆、聚会等场合多见。大量研究表明酒精诱导氧化应激与乙醇代谢有关，乙醇代谢在体内的经典途径是：在乙醇脱氢酶作用下，乙醇被催化为乙醛。如果长期大量饮酒，可导致内源性抗氧化酶活力下降，不能有效地清除自由基；体内自由基的增加，进而消耗机体的谷胱甘肽等非酶抗氧化物质，从而造成氧化应激损伤，最终伤及肝细胞，形成系列疾病(如：酒精性脂肪肝、肝炎、肝纤维化、肝硬化等)。
降低机体血液中乙醇及其代谢产物的浓度是解酒的关键，同时也可以减轻氧化应激的损伤。目前的解酒药普遍采用加速酒精分解而起到解酒的作用，但解酒疗效缓慢，只能缓解因体内酒精浓度过高而导致的机体不适等症状，对乙醇引起的氧化应激损伤没有有效的保健效果。
公开于该背景技术部分的信息仅仅旨在增加对本发明的总体背景的理解，而不应当被视为承认或以任何形式暗示该信息构成已为本领域一般技术人员所公知的现有技术。
发明内容
本发明目的在于提供一种解酒护肝抗氧化的中药组合物及其应用。该中药组合物来源于纯天然植物，不添加任何化学添加剂，解酒效果好、见效快，能有效缓解酒后的头晕、口渴、乏力、胃部不适等症状；同时能有效减小因乙醇造成的氧化应激损伤，保护了肝脏。
本发明所提供的技术方案是：
一种解酒护肝抗氧化的中药组合物，按重量份数计由以下原料组成：石斛10-30份、芒果汁30-50份、罗汉果20-60份、葛花50-100份、山楂20-40份、藿香30-50份、砂仁30-50份和薏苡仁50-100份。
作为优选，所述的中药组合物，按重量份数计由以下原料组成：石斛10份、芒果汁40份、罗汉果30份、葛花80份、山楂30份、藿香40份、砂仁40份和薏苡仁80份。
本发明还提供一种中药制剂，包括所述的中药组合物和药学可接受的辅料。
作为优选，所述的药学可接受的辅料为防腐剂、矫味剂、着色剂、赋形剂、粘合剂、润滑剂和崩解剂。
作为优选，所述的防腐剂为尼泊金酯类、苯甲酸钠或山梨酸钾；所述的矫味剂为蔗糖、阿司帕坦、甘露醇或山梨醇；所述的着色剂为焦糖；所述的赋形剂为淀粉或糊精；所述的粘合剂为淀粉浆、明胶浆或西黄蓍胶浆；所述的润滑剂为硬脂酸镁或滑石粉；所述的崩解剂为干淀粉。
作为优选，所述中药制剂的剂型为溶液剂、颗粒剂、膏方、片剂或胶囊剂。
本发明还提供了所述的中药组合物或中药制剂在制备解酒护肝药物或食品中的应用。
本发明还提供了所述的中药组合物或中药制剂在制备抗氧化药物或食品中的应用。
与现有技术相比，本发明具有如下有益效果：
(1)本发明的中药组合物的各中药原料之间具有协同增效作用，具有解酒护肝抗氧化的功效。
(2)本发明的中药组合物均采用中草药制成，无任何毒副作用，安全性好，且不易产生耐药性，可以长期服用，有利于保持机体的正常功能。
(3)本发明通过现代制剂技术将中药组合物制成溶液剂、颗粒剂、膏方、片剂、胶囊剂，便于携带，同时更适合解酒人群的及时服用。
具体实施方式
下面结合具体例对本发明作进一步详细的说明。实施例中所提到的中草药按药典规定药用部位
实施例1：中药制剂溶液剂的制备
(1)按质量份称取石斛10份、罗汉果20份、葛花50份、山楂20份、藿香30份、砂仁30份和薏苡仁50份；放入多功能提取罐内，加水8倍量进行提取，得到提取液①；
(2)将第一次提取后的药渣重新加水6倍量进行提取，得到提取液②；
(3)打开油水分离器阀门，收集挥发油，加β-环糊精制成挥发油包合物水溶液③；
(4)将新鲜的芒果去核，用打浆机打浆，用酶解法酶解后，灭酶、压榨、离心，得到芒果汁④；
(5)将提取液①、②合并，减压浓缩至相对密度1.20(80℃)的清膏，冷却后加入乙醇，使含乙醇量达60％，静置24h，滤过，回收乙醇，浓缩至相对密度1.30(80℃)的稠膏⑤；
(6)将③、④和⑤混合，加水成1000重量份，灌封、灭菌，包装，即得溶液剂。
实施例2：中药制剂颗粒剂的制备
(1)按质量份称取石斛30份、罗汉果60份、葛花100份、山楂40份、藿香50份、砂仁50份和薏苡仁100份；放入多功能提取罐内，加水8倍量进行提取，得到提取液①；
(2)将第一次提取后的药渣重新加水6倍量进行提取，得到提取液②；
(3)打开油水分离器阀门，收集挥发油，加β-环糊精制成挥发油包合物水溶液③；
(4)将新鲜的芒果去核，用打浆机打浆，用酶解法酶解后，灭酶、压榨、离心，得到芒果汁④；
(5)将提取液①、②合并，减压浓缩至相对密度1.20(80℃)的清膏，冷却后加入乙醇，使含乙醇量达60％，静置24h，滤过，回收乙醇，浓缩至相对密度1.30(80℃)的稠膏⑤；
(6)将③、④和⑤混合，进行喷雾干燥。干燥进风温度200±20℃，出风口温度100±10℃，雾化器转速15000±1000rpm，蠕动泵转速15±5mL/min。喷雾结束后，收集干粉；
(7)将收集的干粉用适量无水乙醇制粒，过10-20目筛，在50±5℃下干燥3-4h，然后用10-20目筛网整粒，包装，即得颗粒剂。
实施例3：中药制剂片剂的制备
(1)按质量份称取石斛20份、罗汉果40份、葛花80份、山楂30份、藿香40份、砂仁40份和薏苡仁80份；放入多功能提取罐内，加水8倍量进行提取，得到提取液①；
(2)将第一次提取后的药渣重新加水6倍量进行提取，得到提取液②；
(3)打开油水分离器阀门，收集挥发油，加β-环糊精制成挥发油包合物水溶液③；
(4)将新鲜的芒果去核，用打浆机打浆，用酶解法酶解后，灭酶、压榨、离心，得到芒果汁④；
(5)将提取液①、②合并，减压浓缩至相对密度1.20(80℃)的清膏，冷却后加入乙醇，使含醇量达60％，静置24h，滤过，回收乙醇，浓缩至相对密度1.30(80℃)的稠膏⑤；
(6)将③、④和⑤混合，进行喷雾干燥。干燥进风温度200±20℃，出风口温度100±10℃，雾化器转速15000±1000rpm，蠕动泵转速15±5mL/min。喷雾结束后，收集干粉；
(7)将步骤(6)所得干粉，按干粉重量的5％加入羧甲基淀粉钠、1％加入硬脂酸镁，混合均匀，压片，压力为10±2KN，制成片剂。
实施例4：中药制剂的效果试验
3-5岁食蟹猴20只，雄性，体重2.5-3.5kg，共分为4组：空白组(蒸馏水，5mL/只·天)、实施例1(溶液剂，5mL/只·天)、实施例2(颗粒剂，2g/只·天，将颗粒溶于5mL蒸馏水)、实施例3(片剂，2片/只·天，将药片混悬于5mL蒸馏水)。
在实验室适应性饲养1周后根据对应剂量灌胃，连续灌胃14天，于末次灌胃后给酒1.5g乙醇/kg，在规定的时间从前臂静脉采血。
4.1解酒实验：用Ethanol Assay Kit乙醇(酒精)检测分析试剂盒测定血液中酒精浓度，结果见表1。
表1本发明的中药制剂对食蟹猴血液酒精浓度的影响(n＝5，单位：mg/100mL)
注：*表示与空白组比较，p<0.05；**表示与空白组比较，p<0.01。
由表1可知，实施例1-3的实验结果与空白组差异较大，各实施例均能显著缩短血液中酒精的达峰时间，且还能明显减低达峰浓度。尤其在达峰后的各个时间点，血中酒精浓度均明显低于空白组。说明食蟹猴喂食本发明，能加速机体对酒精的代谢和排泄，达到解酒的功能。
4.2护肝实验：将饮酒前和饮酒后12小时的血液样本用全自动生化分析仪测定其中的谷丙转氨酶(ALT)、门冬氨酸转氨酶(AST)、谷丙酰转肽酶(GGT)，结果见表2。
表2本发明的中药制剂对喂食酒精前后肝功能的影响(n＝5，U/L)
注：Δ表示与平均值比较，p<0.05；*表示与空白组比较，p<0.05。
由表2可知，实施例1-3的实验结果与空白组存在有差异，尤其是ALT、GGT的差异具有显著性。说明食蟹猴喂食本发明，能减轻酒精对肝脏的损伤，起到护肝的功能。
4.3抗氧化实验：将饮酒前和饮酒后12小时的血液样本用试剂盒测定其中的超氧化物歧化酶(SOD)、谷胱甘肽过氧化物酶(GSH)、一氧化氮合酶(iNOS)、丙二醛(MDA)和过氧化氢(H2O2)，结果见表3。
表3本发明的中药制剂对喂食酒精前后氧化应激的影响(n＝5)
注：Δ表示与平均值比较，p<0.05；*表示与空白组比较，p<0.05。
由表3可知，空白组与饮酒前的平均比较有显著差异，说明食蟹猴给予酒精后，体内体内氧化与抗氧化作用失衡；而实施例1-3的各项指标向正常值好转，且与空白组存在显著性差异。说明食蟹猴喂食本发明，能改善氧化应激相关的指标，减少超氧化物破坏机体细胞的正常结构。
综上所述，本发明的中药组合物的各中药原料之间具有协同增效作用，具有解酒护肝抗氧化的功效；本发明的中药组合物均采用中草药制成，无任何毒副作用，安全性好，且不易产生耐药性，可以长期服用，有利于保持机体的正常功能。
前述对本发明的具体示例性实施方案的描述是为了说明和例证的目的。这些描述并非想将本发明限定为所公开的精确形式，并且很显然，根据上述教导，可以进行很多改变和变化。对示例性实施例进行选择和描述的目的在于解释本发明的特定原理及其实际应用，从而使得本领域的技术人员能够实现并利用本发明的各种不同的示例性实施方案以及各种不同的选择和改变。本发明的范围意在由权利要求书及其等同形式所限定。
Claims (7)
1.一种解酒护肝抗氧化的中药组合物，其特征在于，按重量份数计由以下原料组成：石斛10-30份、芒果汁30-50份、罗汉果20-60份、葛花50-100份、山楂20-40份、藿香30-50份、砂仁30-50份和薏苡仁50-100份。
2.根据权利要求1所述的中药组合物，其特征在于，按重量份数计由以下原料组成：石斛10份、芒果汁40份、罗汉果30份、葛花80份、山楂30份、藿香40份、砂仁40份和薏苡仁80份。
3.一种中药制剂，其特征在于，由权利要求1-2任一所述的中药组合物和药学可接受的辅料制成。
4.根据权利要求3所述的中药制剂，其特征在于，所述的药学可接受的辅料为防腐剂、矫味剂、着色剂、赋形剂、粘合剂、润滑剂和崩解剂；
所述的防腐剂为尼泊金酯类、苯甲酸钠或山梨酸钾；所述的矫味剂为蔗糖、阿司帕坦、甘露醇或山梨醇；所述的着色剂为焦糖；所述的赋形剂为淀粉或糊精；所述的粘合剂为淀粉浆、明胶浆或西黄蓍胶浆；所述的润滑剂为硬脂酸镁或滑石粉；所述的崩解剂为干淀粉。
5.根据权利要求3所述的中药制剂，其特征在于，所述中药制剂的剂型为溶液剂、颗粒剂、片剂或胶囊剂。
6.根据权利要求1-2任一所述的中药组合物或权利要求3-5任一所述的中药制剂在制备解酒护肝药物中的应用。
7.根据权利要求1-2任一所述的中药组合物或权利要求3-5任一所述的中药制剂在制备抗氧化药物或食品中的应用。
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