CN107823430B - 一种滋阴明目,通便润肠的组合物及其制备方法和用途 - Google Patents
一种滋阴明目,通便润肠的组合物及其制备方法和用途 Download PDFInfo
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Abstract
本发明提供一种滋阴明目,润肠通便的食品、保健品或药物组合物,它是含有下述重量配比的原料制备而成:黑茶0.3~1.3份、桑椹0.5~1.5份、低聚半乳糖0.1~0.3份、低聚麦芽糖0.1~0.3份、玉竹0.5~1.5份、决明子1.0~2.0份、杏仁0.9~1.5份、枳椇子0.9~1.5份。试验表明,本发明食品、保健品或药物组合物能够改善和治疗便秘,同时能够增殖人体肠道有益菌,并具有滋阴明目的效果。本发明组合物为药食两用,安全无毒,适合长期使用,为临床用药提供了一种新的选择。
Description
技术领域
本发明涉及一种滋阴明目,通便润肠的食品、保健品或药物组合物及其制备方法和用途。
背景技术
便秘是指由于大肠传导功能失常导致的以大便排出困难,排便时间或排便间隔时间延长为临床特征的一种大肠病症,虽不是大病,但对人体的危害很大,甚至可以致命。便秘对消化系统的影响是最为常见的,其可导致腹痛、腹胀、食欲不振、直肠溃疡等等;便秘还可引发自身中毒,造成精神和内分泌紊乱,引发痤疮、心烦、失眠、脾气暴躁等。此外,严重便秘还可造成急性肠壁坏死、破裂、穿孔,严重时也会危及生命。
肠道菌群对人体有着重要的生理和病理意义,便秘人群常伴随肠道菌群的失衡,而失衡的肠道菌群会对人体产生诸多的不利影响如产生多种肠内毒素,诱发结肠癌,加速人的衰老,以及促发多种肠道疾病。
目前,市场上常用的通便润肠产品主要有以下几类:盐类泻剂、刺激性泻剂、容积性泻剂、润滑性泻剂、中药泻剂和渗透性泻剂。以上通便润肠产品能够一定程度上治疗便秘,但是并不能改善肠道菌群,功能单一,具有一定的局限性。
因此,现在急需一种能够滋阴明目,又能改善或治疗便秘,并能改善肠道菌群的多功能产品。
发明内容
为了解决上述问题,本发明提供了一种滋阴明目,通便润肠的食品、保健品或药物组合物,其特征在于:它是含有下述重量配比的原料制备而成:
黑茶0.3~1.3份、桑椹0.5~1.5份、低聚半乳糖0.1~0.3份、低聚麦芽糖0.1~0.3份、玉竹0.5~1.5份、决明子1.0~2.0份、杏仁0.9~1.5份、枳椇子0.9~1.5份。
进一步地,它是由下述重量配比的原料制备而成:
黑茶0.3~1.3份、桑椹0.5~1.5份、低聚半乳糖0.1~0.3份、低聚麦芽糖0.1~0.3份、玉竹0.5~1.5份、决明子1.0~2.0份、杏仁0.9~1.5份、枳椇子0.9~1.5份。
进一步地,它是由下述重量配比的原料制备而成:
黑茶0.8份、桑椹1.0份、低聚半乳糖0.2份、低聚麦芽糖0.2份、玉竹1.0份、决明子1.5份、杏仁1.2份、枳椇子1.2份。
进一步地,所述杏仁为甜杏仁;所述低聚半乳糖的聚合度为3~4;所述低聚麦芽糖的聚合度为4~5。
进一步地,所述枳椇子为鼠李科枳椇属植物北枳椇Hovenia dulcis Thunnb,枳椇Hovenia acerba Lindl,和毛果枳椇Hovenia trichocarpa Chun et Tsiang的成熟种子或带花序轴的果实。
进一步地,它是由原料药的药粉、原料药的水或有机溶剂提取物为活性成分,加上药学中可接受的辅料或者辅助性成分制备而成的制剂。
进一步地,所述制剂为口服制剂;优选的,所述口服制剂为口服液、颗粒剂、胶囊剂、膏剂、丸剂、片剂或散剂。
本发明还提供了上述食品、保健品或药物组合物的制备方法,其特征在于:它包括如下步骤:
a)按重量配比称取各原料;
b)打粉,或用水或有机溶剂提取;
c)加入辅料,即得。
本发明还提供了上述食品、保健品或药物组合物在制备滋阴明目,通便润肠的药物中的用途。
本发明还提供了上述食品、保健品或药物组合物在制备调节肠道菌群的药物中的用途。
本发明组合物中低聚半乳糖与低聚麦芽糖配合使用,全面增殖人体肠道主要益生菌,显著增殖双歧杆菌;桑椹、决明子、甜杏仁、枳椇子均有利水通便、治疗便秘的作用,其中决明子更有明目之功效;玉竹不寒不燥,滋养气血,平补而润,玉竹中含多种多糖物质,可调节整个药物组方口感,久服不伤脾胃。
本发明食品、保健品或药物组合物能够改善和治疗便秘,同时能够增殖人体肠道有益菌,并具有滋阴明目的效果。本发明组合物为药食两用,安全无毒,适合长期使用,为临床用药提供了一种新的选择。
显然,根据本发明的上述内容,按照本领域的普通技术知识和惯用手段,在不脱离本发明上述基本技术思想前提下,还可以做出其它多种形式的修改、替换或变更。
以下通过实施例形式的具体实施方式,对本发明的上述内容再作进一步的详细说明。但不应将此理解为本发明上述主题的范围仅限于以下的实例。凡基于本发明上述内容所实现的技术均属于本发明的范围。
具体实施方式
原料:黑茶,购自四川青衣美人茶业有限公司;桑葚、玉竹、决明子、甜杏仁、枳椇子,均购自四川新荷花中药饮片股份有限公司;低聚半乳糖(聚合度3~4)、低聚麦芽糖(聚合度4~5),均购自宝齡保生物股份有限公司。
实施例1、本发明食品、保健品或药物组合物的制备
1、处方:黑茶0.3份、桑椹0.5份、低聚半乳糖0.1份、低聚麦芽糖0.1份、玉竹0.5份、决明子1.0份、甜杏仁0.9份、枳椇子0.9份。
2、制备方法:将上述各原料分别进行性拣选,去除杂质、虫蛀、霉变等;取处方量的各原料用自来水淋洗2-5min,沥干;将各原料处理成适宜的形态(片、节、段或粉等);加入10倍热水量(约82.8kg),加热煮沸1.5h,200目过滤,收集滤液,滤渣待用;滤渣继续加8倍热水量(66.24kg),继续加热煮沸1h,200目过滤,收集滤液,滤渣丢弃;将滤液通过高速管式离心机,进行离心(转鼓转速:20000r/min),收集离心液;加热蒸发浓缩离心液,浓缩到适宜相对密度约1.05~1.10;将离心液均匀铺放到真空微波干燥箱托盘内,厚度不超过3cm,调节微波功率500W,干燥温度60℃,打开真空泵开关(真空度-0.08MPa)开始进行干燥,时间约为3h或干燥后提取粉的水分控制不超过5%;即得提取干燥粉。
使用方法:温开水冲服,每日1袋,1袋5g。
实施例2、本发明食品、保健品或药物组合物的制备
1、处方:黑茶1.3份、桑椹1.5份、低聚半乳糖0.3份、低聚麦芽糖0.3份、玉竹1.5份、决明子2.0份、甜杏仁1.5份、枳椇子1.5份。
2、制备方法:同实施例1。
使用方法:同实施例1。
实施例3、本发明食品、保健品或药物组合物的制备
1、处方:黑茶0.8份、桑椹1.0份、低聚半乳糖0.2份、低聚麦芽糖0.2份、玉竹1.0份、决明子1.5份、甜杏仁1.2份、枳椇子1.2份。
2、制备方法:同实施例1。
使用方法:同实施例1。
以下通过具体试验例证明本发明的有益效果。
试验例1
(一)实验对象
随机选取患者200名,年龄30~60岁,男性100例,女性100例,平均分成4组。
(二)治疗方法
1.给药方法:明确诊断后,一号治疗组50例患者采用实施例1制备的药物;二号治疗组50例患者采用实施例2制备的药物;三号治疗组50例患者采用实施例3制备的药物;四号组50例患者不服用任何药物。
每日一袋,一袋5g,连续服用30天。
便秘的诊断标准如下:
①.患者平均有轻度便秘,症状表现为每2-4天排便一次,且每次排便时间在5分钟以上。
②.无明显用药禁忌、无其他并发症者。
(三)治疗结果
表1
上述实验结果表明:本发明的药物组合物具有很好的治疗便秘的效果,其中三号组的药物治疗效果最佳。
试验例2
(一)实验对象
随机选取患者200名,年龄30-60岁,男性100例,女性100例,平均分成4组。
(二)治疗方法
1.给药方法:明确诊断后,
一号治疗组50例患者采用实施例3制备的药物;
二号治疗组50例患者采用如下药物:黑茶0.8份、桑椹1.0份、低聚半乳糖0.2份、玉竹1.0份、决明子1.5份、甜杏仁1.2份、枳椇子1.2份,制备方法同实施例1;
三号治疗组50例患者采用如下药物:黑茶0.8份、桑椹1.0份、低聚麦芽糖0.2份、玉竹1.0份、决明子1.5份、甜杏仁1.2份、枳椇子1.2份,制备方法同实施例1;
四号组50例患者不服用任何药物。
每日一袋,一袋5g,连续服用30天。
便秘的诊断标准同试验例1。
(三)治疗结果
表2
排便频次 | 排便时间及难易度 | 有益益生菌数量 | |
一号组 | 1天1次 | 2-5分钟,排便顺畅 | 比服用前增加12% |
二号组 | 1-2天1次 | 3-6分钟,排便一般 | 比服用前增加6% |
三号组 | 1-2天1次 | 3-6分钟,排便一般 | 比服用前增加4% |
四号组 | 2-3天1次 | 5-10分钟偶尔饮食较困难 | 无变化 |
上述实验结果表明:单独配以低聚半乳糖或低聚麦芽糖对人体肠道有益菌的增殖均没有两者配合后高,说明本发明的药物组合物对人体肠道有益菌群有加倍增殖作用。
试验例3
(一)实验方法:小鼠30只随机分为3组,每组10只,选用的小鼠视网膜层次出现不规则结构,有灶性浓缩,部分出现不规则碎核。
1号组采用实施例1所制备的药物,1次/天,5g/次;2号组采用实施例3所制备的药物,1次/天,5g/次;3号组采用生理盐水。
小鼠灌胃给药,连续灌胃给药1周后观察。
(二)判定方法:光镜观察法,取小鼠视网膜标本,用4%多聚甲醛固定,石蜡包埋,间断连续切片,切片厚4微米,HE染色,光镜下观察视网膜超微结构变化。
(三)判定标准:
“-”级:视网膜形态正常,视杆细胞排列整齐,结构层次清楚
“+”级:视网膜结构层次清楚,视杆细胞排列基本整齐,外核层出现灶性脱落
“++”级:视网膜结构基本清楚,有灶性核浓缩,部分出现不规则碎核。
(四)治疗结果
表3
分组 | 数量N | “-”级 | “+”级 | “++”级 |
一号组 | 10 | 1 | 3 | 6 |
二号组 | 10 | 7 | 3 | 0 |
三号组 | 10 | 0 | 0 | 10 |
上述实验结果表明:本发明的药物组合物对视网膜超微结构的损伤均有修复作用,其中,二号组的药物组合配方的滋阴明目效果最佳。
综上所述,本发明食品、保健品或药物组合物能够改善和治疗便秘,同时能够增殖人体肠道有益菌,并具有滋阴明目的效果。本发明组合物为药食两用,安全无毒,适合长期使用,为临床用药提供了一种新的选择。
Claims (7)
1.一种具有明目功效的食品、保健品或药物组合物,其特征在于:
它是由下述重量配比的原料制备而成:
黑茶0.8份、桑椹1.0份、低聚半乳糖0.2份、低聚麦芽糖0.2份、玉竹1.0份、决明子1.5份、杏仁1.2份、枳椇子1.2份;
所述杏仁为甜杏仁;所述低聚半乳糖的聚合度为3~4;所述低聚麦芽糖的聚合度为4~5。
2.根据权利要求1所述的食品、保健品或药物组合物,其特征在于:所述枳椇子为鼠李科枳椇属植物北枳椇Hovenia dulcis Thunnb,枳椇Hovenia acerba Lindl,和毛果枳椇Hovenia trichocarpa Chun et Tsiang的成熟种子或带花序轴的果实。
3.根据权利要求1所述的食品、保健品或药物组合物,其特征在于:它是由原料药的药粉、原料药的水或有机溶剂提取物为活性成分,加上药学中可接受的辅料或者辅助性成分制备而成的制剂。
4.根据权利要求3所述的食品、保健品或药物组合物,其特征在于:所述制剂为口服制剂。
5.根据权利要求4所述的食品、保健品或药物组合物,其特征在于:所述口服制剂为口服液、颗粒剂、胶囊剂、膏剂、丸剂、片剂或散剂。
6.一种制备权利要求1~5任一项所述食品、保健品或药物组合物的方法,其特征在于:它包括如下步骤:
a)按重量配比称取各原料;
b)对各原料进行加工,所述加工的方法为打粉、用水提取或用有机溶剂提取中的一种;
c)向步骤b)加工后得到的产物中加入辅料,即得。
7.权利要求1~5任一项所述食品、保健品或药物组合物在制备具有明目功效的药物中的用途。
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