CN105381263A - 一种具有解酒、对化学性肝损伤有辅助保护作用的保健食品组合物 - Google Patents
一种具有解酒、对化学性肝损伤有辅助保护作用的保健食品组合物 Download PDFInfo
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Abstract
本发明涉及一种中药组合物在制备具有解酒、对化学性肝损伤有辅助保护作用的保健食品中的应用，所述中药组合物由以下重量配比的中药原料药制备而成，百合30-80重量份、茯苓30-80重量份、玄参40-90重量份、川芎30-80重量份、鸡内金5-30重量份、泽泻20-60重量份、三七5-30重量份、白术10-50重量份、当归20-60重量份、地榆50-90重量份、蒲黄20-60重量份、白芍120-180重量份、石斛40-90重量份。
Description
发明领域
本发明涉及一种中药保健食品组合物的制备方法，特别涉及具有解酒、对化学性肝损伤有辅助保护作用的保健食品组合物的制备方法以及用该方法制备的药物制剂。
背景技术
由化学性肝毒性物质所造成的肝损伤。这些化学物质包括酒精、环境中的化学毒物及某些药物。作为人体的重要解毒器官的肝脏，具有肝动脉和肝静脉双重血液供应。化学物质可通过胃肠道门静脉或体循环进入肝脏进行转化，因此肝脏容易受到化学物中的毒性物质损害。大自然和人类工业生产过程中均存在一些对肝脏有毒性的物质，称为"亲肝毒物"，这些毒物在人群中普遍易感，潜伏期短，病变的过程与感染的剂量直接相关，可引起肝脏不同程度的肝细胞坏死、脂肪变形、肝硬化和肝癌。
肝损伤是临床常见的危害人类健康的疾病。肝损伤就是肝脏受到外界因素的入侵，从而引起的肝脏受顺。肝损伤分为病理性肝损伤和化学性肝损伤。中医药经过几千年的发展研究，对肝损伤有一定的促再生和修复作用，因此运用中医药综合治疗有独特优势，可服用单味中药或复方。
发明人在临床和生产实践中发现，现有技术配方量大，药材浪费严重，口服困难，而且没有报道过上述制剂具有解酒、对化学性肝损伤有辅助保护作用的保健食品的功效，本发明在现有技术的基础上对配方进行了改进，删除了部分价格昂贵的药材，在配方中采用药食两用的中药材、进行了保健食品方面的研究工作。本发明经过实验研究，意外的发现，本发明配方具有解酒、对化学性肝损伤有辅助保护作用的保健食品功效，从而完成了本发明。
发明内容：
本发明提供一种中药组合物在制备具有解酒、对化学性肝损伤有辅助保护作用的保健食品中的应用，
所述中药组合物由以下重量配比的中药原料药制备而成，
百合30-80重量份、茯苓30-80重量份、玄参40-90重量份、川芎30-80重量份、鸡内金5-30重量份、泽泻20-60重量份、三七5-30重量份、白术10-50重量份、当归20-60重量份、地榆50-90重量份、蒲黄20-60重量份、白芍120-180重量份、石斛40-90重量份。
优选的，所述中药组合物由以下重量配比的中药原料药制备而成，百合60重量份、茯苓60重量份、玄参75重量份、川芎45重量份、鸡内金15重量份、泽泻45重量份、三七15重量份、白术30重量份、当归45重量份、地榆75重量份、蒲黄45重量份、白芍150重量份、石斛75重量份。
中药原料中：白术用麸炒，鸡内金选用炒鸡内金。
以上组成中，重量是以生药计算的，以上组成是按重量作为配比的，在生产时可按照相应比例增大或减少，如大规模生产可以以公斤为单位，或以吨为单位，小规模生产也可以以克或毫克为单位，重量可以增大或者减小，但各组成之间的生药材重量配比的比例不变。本发明所述的组合物，优选的制备方法，步骤如下：
药材加水煎煮1-3次，每次1.5-3小时，合并煎液，滤过，滤液浓缩至适量，加入乙醇，使含醇量达60-80％，静置，滤过，回收乙醇，滤液浓缩，加水冷藏，滤过，得到活性物质，然后制备成保健品组合物。
最优选的，所述中药组合物制备方法步骤如下：
药材加水煎煮2次，每次2小时，合并煎液，滤过，滤液浓缩至适量，加入乙醇，使含醇量达7％，静置，滤过，回收乙醇，滤液浓缩，加水冷藏，滤过，得到活性物质，经过制剂方法，然后制备成保健品组合物。
上述制品的制备可以采用常规生产技术即可，如以本发明的活性物质作为活性成分，必要时加入辅料，如甜味剂，矫味剂，赋形剂等用制剂学常规技术制备成片剂，胶囊等，或以食品常规技术制备成食品。本发明的组合物可以是任何一种适合口服的制剂形式，如片剂，胶囊，颗粒剂，口服液，粉剂，丸剂等，也可以制备成适合的可食用的食品形式，如糖块，饼干，奶制品，冰棍，面包，果酱等。
方中，百合、玄参、石斛养阴益胃为君药，当归、白芍、川芎、蒲黄、三七养血通络为辅药，白术、茯苓、泽泻、地榆健脾利湿为佐药，气血旺、脾胃和、自然痛止病除。鸡内金理气止痛，祛瘀消积为使药。
实验证实本品种常规用量使用安全，方中组成相互配合具有协同增效作用。
本发明的方法和现有技术相比，差别在于，提供了一种新的用途以下通过实验数据说明本发明的有益效果：
对大鼠酒精性肝损伤的保护作用
一、药物及分组：
模型组，
空白对照组，生理盐水，
本发明实施例1的药物活性物质，分成大中小三个剂量组分别为100mg/kg，50mg/kg，10mg/kg
二、实验方法
通过白酒灌胃建立大鼠酒精性肝损伤模型,治疗组分别给予药物,对照组给生理盐水,连续8周,测定血清谷草转氨酶(AST)、谷丙转氨酶(ALT)及三酰甘油(TG)的含量,并观察肝脏的病理组织学改变。
三：实验结果：
见下表：
表1、对大鼠酒精性肝损伤的保护作用
具体实施方式：
以下通过实施例进一步说明本发明，但不作为对本发明的限制。
实施例1
实施例1
百合60重量份、茯苓60重量份、玄参75重量份、川芎45重量份、鸡内金15重量份、泽泻45重量份、三七15重量份、白术30重量份、当归45重量份、地榆75重量份、蒲黄45重量份、白芍150重量份、石斛75重量份。
其制备方法如下：
药材加水煎煮2次，每次2小时，合并煎液，滤过，滤液浓缩至适量，加入乙醇，使含醇量达70％，静置，滤过，回收乙醇，滤液浓缩，加水冷藏，滤过，得到活性物质，进一步根据制剂学常规技术制备成丸剂。
实施例2
百合30重量份、茯苓30重量份、玄参40重量份、川芎30重量份、鸡内金5重量份、泽泻20重量份、三七5重量份、白术10重量份、当归20重量份、地榆50重量份、蒲黄20重量份、白芍120重量份、石斛40重量份。
其制备方法如下：
药材加水煎煮1次，每次1.5小时，合并煎液，滤过，滤液浓缩至适量，加入乙醇，使含醇量达60％，静置，滤过，回收乙醇，滤液浓缩，加水冷藏，滤过，得到活性物质，进一步根据制剂学常规技术制备成片剂。
实施例3
百合80重量份、茯苓80重量份、玄参90重量份、川芎80重量份、鸡内金30重量份、泽泻60重量份、三七30重量份、白术50重量份、当归60重量份、地榆90重量份、蒲黄60重量份、白芍180重量份、石斛90重量份。
其制备方法如下：
药材加水煎煮3次，每次3小时，合并煎液，滤过，滤液浓缩至适量，加入乙醇，使含醇量达80％，静置，滤过，回收乙醇，滤液浓缩，加水冷藏，滤过，得到活性物质，进一步根据制剂学常规技术制备成颗粒剂。
实施例4
胶囊剂的制备
取实施例1得到的药物活性物质，经过常规的制剂制备方法，制备成胶囊剂
实施例5
片剂的制备
取实施例1得到的药物活性物质，经过常规的制剂制备方法，制备成片剂
实施例6
丸剂的制备
取实施例1得到的药物活性物质，经过常规的制剂制备方法，制备成丸剂
实施例7
颗粒剂的制备
取实施例1得到的药物活性物质，经过常规的制剂制备方法，制备成颗粒剂
实施例8
口服液的制备
取实施例1得到的药物活性物质，经过常规的制剂制备方法，制备成口服液剂。
Claims (6)
1.一种中药组合物在制备具有解酒、对化学性肝损伤有辅助保护作用的保健食品中的应用，所述中药组合物由以下重量配比的中药原料药制备而成，
百合30-80重量份、茯苓30-80重量份、玄参40-90重量份、川芎30-80重量份、鸡内金5-30重量份、泽泻20-60重量份、三七5-30重量份、白术10-50重量份、当归20-60重量份、地榆50-90重量份、蒲黄20-60重量份、白芍120-180重量份、石斛40-90重量份。
2.根据权利要求1所述的应用，其特征在于，所述中药组合物由以下重量配比的中药原料药制备而成，
百合60重量份、茯苓60重量份、玄参75重量份、川芎45重量份、鸡内金15重量份、泽泻45重量份、三七15重量份、白术30重量份、当归45重量份、地榆75重量份、蒲黄45重量份、白芍150重量份、石斛75重量份。
3.权利要求1所述的应用，其特征在于，其中所述中药组合物制备方法步骤如下：
药材加水煎煮1-3次，每次1.5-3小时，合并煎液，滤过，滤液浓缩至适量，加入乙醇，使含醇量达60-80％，静置，滤过，回收乙醇，滤液浓缩，加水冷藏，滤过，得到活性物质，然后制备成保健品组合物。
4.根据权利要求3所述的应用，其特征在于，其中所述中药组合物制备方法步骤如下：
药材加水煎煮2次，每次2小时，合并煎液，滤过，滤液浓缩至适量，加入乙醇，使含醇量达7％，静置，滤过，回收乙醇，滤液浓缩，加水冷藏，滤过，得到活性物质，经过制剂方法，然后制备成保健品组合物。
5.根据权利要求1所述的应用，其特征在于，所述中药组合物为任何一种可服用的药物剂型。
6.根据权利要求1所述的应用，其特征在于，所述中药组合物为胶囊剂，片剂，丸剂，颗粒剂，口服液，滴丸剂，膏剂。
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| 李钧: "《保健食品注册技术精讲》", 31 August 2006, 中国医药科技出版社 * |
| 苏振武 等: "《医院常用药物手册》", 30 June 2011, 军事医学科学出版社 * |
| 郭爱玲: "曲美布汀与摩罗丹联用治疗功能性消化不良疗效观察", 《世界最新医学信息文摘》 * |
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