CN106362020B - 一种具有改善通便作用的松花粉组合物及其制备方法 - Google Patents
一种具有改善通便作用的松花粉组合物及其制备方法 Download PDFInfo
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Abstract
一种具有改善通便作用的松花粉组合物及其制备方法,该组合物是由蒲公英提取物、槐花提取物、苦杏仁提取物、淡竹叶提取物、罗汉果提取物、松花粉、低聚木糖为有效组分以及在药品和食品中允许使用的辅助添加成分组成;其中,蒲公英提取物,60~200重量份;槐花提取物,50~160重量份;苦杏仁提取物,10~40重量份;淡竹叶提取物,10~40重量份;罗汉果提取物,4~20重量份;松花粉,130~350重量份;低聚木糖,130~400重量份。该组合物的成分全部为药食两用物质,在润肠通便的同时可以起到改善胃肠功能、调节血脂、稳定血糖的作用,不会造成腹泻,无毒副作用。
Description
技术领域
本发明涉及一种具有改善通便作用的松花粉组合物及其制备方法。
背景技术
便秘是临床常见的复杂症状,而不是一种疾病,主要是指排便次数减少、粪便量减少、粪便干结、排便费力等。便秘在人群中的患病率高达27%,但只有一小部分便秘者会就诊。便秘可以影响各年龄段的人。女性多于男性,老年多于青、壮年。因便秘发病率高、病因复杂,患者常有许多苦恼,便秘严重时会影响生活质量。
便秘常表现为:便意少,便次也少;排便艰难、费力;排便不畅;大便干结、硬便,排便不净感;便秘伴有腹痛或腹部不适。部分患者还伴有失眠、烦躁、多梦、抑郁、焦虑等精神心理障碍。便秘的“报警”征象包括便血、贫血、消瘦、发热、黑便、腹痛等和肿瘤家族史。如果出现报警征象应马上去医院就诊,作进一步检查。
由于便秘是一种较为普遍的症状,症状轻重不一,大部分人常常不去特殊理会,认为便秘不是病,不用治疗,但实际上便秘的危害很大。1.便秘在有些疾病如结肠癌、肝性脑病、乳腺疾病、早老性痴呆的发生中起重要作用,这方面有很多研究报告。2.便秘在急性心肌梗死、脑血管意外病人可导致生命意外,有很多惨痛事例让我们警觉。3.部分便秘和肛肠疾病,如痔、肛裂等有密切的关系。
因此,早期预防和合理治疗便秘将会大大减轻便秘带来的严重后果,改善生活质量,减轻社会和家庭负担。
目前针对于便秘的常用治疗手段有外用制剂和内服制剂之分。常用的外用制剂为开塞露,但其治标不治本,只能短期的缓解便秘症状,一旦停止使用,便秘症状继续存在。针对便秘的内服药品,大部分均有攻下导泻的副作用,便秘患者服用后,短时间内可以起到通便或腹泻的效果,表面上看虽然便秘症状缓解,但治标有余、治本不足,停药则便秘症状容易反复,甚至更加严重,只适合急性便秘的临时应急服用,起不到预防便秘的根本目的,不适合慢性便秘人群的长期调理。
综上,人们对疗效好、无毒副作用、无药物依赖性,在润肠通便的同时可以起到改善胃肠功能、调节血脂、稳定血糖的纯植物保健品/药品存在需求。
发明内容
本发明的目的是提供一种具有改善通便作用的组合物及其制备方法。该组合物具有清热化湿、解毒散结的功效,成分全部为药食两用物质,通便却不会造成腹泻,无毒副作用。
为实现上述目的,本发明包括如下技术方案:
一种具有改善通便作用的松花粉组合物,其是由松花粉、蒲公英提取物、槐花提取物、苦杏仁提取物、淡竹叶提取物、罗汉果提取物和低聚木糖为有效组分以及在药品和食品中允许使用的辅助添加成分组成;其中,松花粉,130~350重量份;蒲公英提取物,60~200重量份;槐花提取物,50~160重量份;苦杏仁提取物,10~40重量份;淡竹叶提取物,10~40重量份;罗汉果提取物,4~20重量份;低聚木糖,130~400重量份。
如上所述的组合物,优选地,所述松花粉,180~260重量份;蒲公英提取物,80~140重量份;槐花提取物,80~120重量份;苦杏仁提取物,15~30重量份;淡竹叶提取物,15~30重量份;罗汉果提取物,6~10重量份;低聚木糖,220~300重量份。
如上所述的组合物,优选地,所述松花粉,210重量份;蒲公英提取物,110重量份;槐花提取物,90重量份;苦杏仁提取物,20重量份;淡竹叶提取物,20重量份;罗汉果提取物,8重量份;低聚木糖,270重量份。
如上所述的组合物,优选地,所述松花粉为破壁松花粉。
如上所述的组合物,优选地,所述各提取物的提取方法如下:
蒲公英、槐花、苦杏仁、淡竹叶和罗汉果均使用水煎煮法获得提取物。
如上所述的组合物,优选地,该保健食品中还含有辅料,辅料选自木糖醇、山梨糖醇、异麦芽酮糖醇、异麦芽酮糖、甘露醇、淀粉、糊精、微晶纤维素、乳糖、羟丙甲基纤维素、魔芋粉、硬脂酸镁中的的一种或几种。
另一方面,本发明提供如上所述的组合物的制备方法,该方法包括以下步骤:
取所述有效组分与0.5-4倍有效组分重量的辅料均匀混合;加入75-95%的乙醇溶液做润湿剂制软材,过筛制粒;湿颗粒在35-75℃下通风干燥;过筛整粒,即得。
如上所述的制备方法,优选地,该方法包括以下步骤:取所述有效组分与2倍有效组分重量的辅料,过80目筛,均匀混合;加入90%的乙醇溶液做润湿剂制软材,过14目筛制粒;湿颗粒在55℃下通风干燥1小时;过14目筛整粒,即得。
又一方面,本发明提供如上所述的组合物在制备具有改善通便作用的保健食品和药品中的应用。
如上所述的应用,优选地,所述的组合物以有效组分的总量计,口服剂量为5-25g/天。
本发明的有益效果在于:该组合物的成分全部为药食两用物质,在润肠通便的同时可以起到改善胃肠功能、调节血脂、稳定血糖的作用,不会造成腹泻,无毒副作用。应用本发明的组合物对便秘动物模型进行的实验结果表明,本发明组合物能够显著提高肠蠕动抑制小鼠的墨汁推进率,可以显著地促进小肠运动,并可以显著减少排便时间。
具体实施方式
以下实施例用于说明本发明,但不用来限制本发明的范围。
本发明的主要原料为蒲公英、槐花、苦杏仁、淡竹叶、罗汉果、松花粉和低聚木糖。
蒲公英:苦、甘、寒。归肝、胃经。具有清热解毒,消肿散结的功效,用于热毒疮疡、黄疸、热淋、目赤肿痛。
槐花:苦、微寒。归肝、大肠经。具有清气凉血、清肝明目的功效。用于血热出血证、肝火上炎之目赤肿痛、头胀头痛。
苦杏仁:苦、微温。归肺、大肠经。具有利气机化湿、止咳平喘、润肠通便的功效,用于多种咳喘症、肠燥便秘。
淡竹叶:甘、淡,寒。归心、胃、小肠经。具有利湿导热下行、利尿的功效。用于解热、利尿、口舌生疮。
罗汉果:性凉味甘,归肺、大肠经,有润肺止咳、生津止渴的功效。用于肺热或肺燥咳嗽、百日咳及暑热伤津口渴等,此外还有润肠通便的功效。
松花粉:性温味甘,归肝、脾经。具有收敛止血,燥湿敛疮。松花粉是松树花蕊的精细胞,富含多种营养成分和生物活性物质,其中的维生素B1可以促进肠道蠕动,增强消化功能,其中的膳食纤维特别是木质素含量很高,对治疗便秘、预防肠结石方面有显著功效。研究发现在大鼠饲料中添加5%的松花粉,可以纠正慢性应激导致的大鼠肠道微生态紊乱,增加大鼠肠道双歧杆菌数量。实验表明,在家猪饲料中添加3.5%的松花粉,发现松花粉饲料显著增加了家猪粪便中甘油三酯、胆固醇、脂肪酸及胆酸的排泄量。松花粉含有近百种酶,可调节胃肠功能紊乱;此外能吸收水分软化粪便,使排便顺畅,直接进入大肠。
低聚木糖:低聚木糖很难为人体消化酶所分解,双歧杆菌可利用低聚木糖,产生大量的短链脂肪酸;能刺激肠道蠕动,增加粪便湿润度,并保持一定的渗透压,从而防止便秘发生。
本发明的组合物中,蒲公英清热解毒,消肿散结;槐花可清气凉血;苦杏仁通过利气机化湿,使湿气通过肌肤宣发;淡竹叶可利湿导热下行;罗汉果具有清热润肺,滑肠通的作用;松花粉含有近百种酶,可调节胃肠功能紊乱,并具有促进新陈代谢、促进肠胃蠕动、平稳血糖的作用;低聚木糖能刺激肠道蠕动,增加粪便湿润度,并保持一定的渗透压,从而防止便秘发生。全方共奏清热化湿、解毒散结之功,已达到润肠通便的功效。
以下例举本发明提供的具有改善通便作用的组合物几种具体实施例:
以下实施例中所使用的破壁松花粉通过市购获得,各提取物的制备方法如下:
(1)蒲公英提取物的制备方法如下:
取蒲公英饮片,每次第一次加8倍重量的水煎煮二次,第一次1小时,第二次加8倍重量的水煎煮1小时,合并二次煎液,滤过,滤液浓缩至相对密度为1.08~1.10(80℃)的清膏,搅匀,喷雾干燥,混匀,即得。每制备1g提取物使用约11g蒲公英中药饮片。
(2)槐花提取物的制备方法如下:
取槐花饮片,第一次加8倍重量的水煎煮1小时,第二次加8倍重量的水煎煮1小时,合并二次煎液,滤过,滤液浓缩至相对密度1.06~1.08(80℃)的清膏,搅匀,喷雾干燥,混匀,即得。每制备1g提取物使用约7g槐花中药饮片。
(3)苦杏仁提取物的制备方法如下:
取苦杏仁饮片,第一次加10倍重量的水煎煮2小时,第二次加8倍重量的水煎煮1.5小时,合并二次煎液,滤过,滤液浓缩至相对密度为1.07(80℃)的清膏,搅匀,喷雾干燥,混匀,即得。每制备1g提取物使用约14g苦杏仁中药饮片。
(4)淡竹叶提取物的制备方法如下:
取淡竹叶饮片,第一次加8倍重量的水煎煮1小时,第二次加6倍重量的水煎煮0.5小时,合并二次煎液,滤过,滤液浓缩至相对密度为1.04~1.06(80℃)的清膏,按照淡竹叶饮片与麦芽糊精重量比为100∶3向清膏中加入麦芽糊精,搅匀,喷雾干燥,混匀,即得。每制备1g提取物使用约14g淡竹叶中药饮片。
(5)罗汉果提取物的制备方法如下:
罗汉果饮片,加3倍量的水,煎煮提取2次,合并煎液,滤过,滤液浓缩至相对密度为1.07(80℃)的清膏,搅匀,喷雾干燥,混匀,即得。
实施例1:具有改善通便作用的组合物(一)
(1)原料组成:松花粉,210重量份;蒲公英提取物,110重量份;槐花提取物,90重量份;苦杏仁提取物,20重量份;淡竹叶提取物,20重量份;罗汉果提取物,8重量份;低聚木糖,270重量份。
辅料:乳糖,10重量份;麦芽糊精,480重量份。
(2)制备步骤:
分别称取上述原料,然后将物料按重量比接近的组分由小到大等体积混合,充分搅拌均匀,使用75%乙醇作为粘合剂,制软材,将上述软材经14目筛网的摇摆制粒机中制成颗粒,将颗粒置入多功能沸腾干燥机中,50℃沸腾干燥约40分钟,控制颗粒水分在5%,然后整粒,装袋,制成5g/袋。
实施例2:具有改善通便作用的组合物(二)
(1)原料组成:松花粉,185重量份;蒲公英提取物,130重量份;槐花提取物,110重量份;苦杏仁提取物,25重量份;淡竹叶提取物,25重量份;罗汉果提取物,10重量份;低聚木糖,230重量份。
辅料:硬脂酸镁,22重量份;异麦芽酮糖,317重量份;魔芋粉,142重量份。
(2)制备步骤:
分别称取上述原料,然后将物料按重量比接近的组分由小到大等体积混合,充分搅拌均匀,使用70%乙醇作为粘合剂,制软材,将上述软材经14目筛网的摇摆制粒机中制成颗粒,将颗粒置入多功能沸腾干燥机中,45℃沸腾干燥约40分钟,控制颗粒水分在5%,然后整粒,装袋,制成5g/袋。
实施例3:具有改善通便作用的组合物(三)
(1)原料组成:松花粉,260重量份;蒲公英提取物,90重量份;槐花提取物,90重量份;苦杏仁提取物,15重量份;淡竹叶提取物,15重量份;罗汉果提取物,6重量份;低聚木糖,290重量份。
辅料:糊精,360重量份;乳糖,144重量份;硬脂酸镁,9重量份。
(2)制备步骤:
将上述原辅料(除硬脂酸镁)按等量递加法混合均匀,使用水作为粘合剂,制软材,将上述软材经14目筛网的摇摆制粒机中制成颗粒,将颗粒置入多功能沸腾干燥机中,在50℃沸腾干燥约40分钟,控制颗粒水分在5%,整粒,然后在颗粒中加入硬脂酸镁,总混,压片,分装即得。
比较例1
(1)原料组成:蒲公英提取物,110重量份;槐花提取物,90重量份;苦杏仁提取物,20重量份;淡竹叶提取物,20重量份;罗汉果提取物,8重量份。
辅料:木糖醇,34重量份;麦芽糊精,130重量份。
(2)制备步骤:
分别称取上述原料,然后将物料按重量比接近的组分由小到大等体积混合,充分搅拌均匀,使用75%乙醇作为粘合剂,制软材,将上述软材经14目筛网的摇摆制粒机中制成颗粒,将颗粒置入多功能沸腾干燥机中,50℃沸腾干燥约40分钟,控制颗粒水分在5%,然后整粒,装袋,制成5g/袋。
比较例2
(1)原料组成:松花粉,210重量份;低聚木糖,270重量份。
辅料:山梨糖醇,14重量份;麦芽糊精,315重量份。
(2)制备步骤:
分别称取上述原料,然后将物料按重量比接近的组分由小到大等体积混合,充分搅拌均匀,使用70%乙醇作为粘合剂,制软材,将上述软材经14目筛网的摇摆制粒机中制成颗粒,将颗粒置入多功能沸腾干燥机中,50℃沸腾干燥约40分钟,控制颗粒水分在5%,然后整粒,装袋,制成5g/袋。
比较例3
(1)原料组成:松花粉,480重量份。
辅料:山梨糖醇12重量份;麦芽糊精,308重量份。
(2)制备步骤:
分别称取上述原料,然后将物料按重量比接近的组分由小到大等体积混合,充分搅拌均匀,使用70%乙醇作为粘合剂,制软材,将上述软材经14目筛网的摇摆制粒机中制成颗粒,将颗粒置入多功能沸腾干燥机中,50℃沸腾干燥约40分钟,控制颗粒水分在5%,然后整粒,装袋,制成5g/袋。
实验例1组合物辅助改善通便功能的实验研究
一.试验原理:
采取直接灌胃给予胃肠蠕动抑制剂,如复方地芬诺酯,建立小鼠小肠蠕动抑制模型,通过计算一定时间内小肠的墨汁蠕动推进率,来评价药物对胃肠蠕动功能的影响。
二.试验材料:
供试品:实施例1-3制备的组合物,比较例1-3制备的组合物。
人服用每日标准剂量(低剂量):18.5g/天。
阳性药物:通便灵胶囊,产品批号:1401206;
试剂:活性碳粉、阿拉伯树胶。
实验动物:ICR小鼠购自北京维通利华有限公司,合格证号:SCXK(京)2014-0001,雄性。饲养于中国医学科学院药用植物研究所SPF级动物房,动物房温度20~26℃,相对湿度40~70%。
仪器:台式高速低温离心机(Sigma,3K30型),微孔板扫描酶标仪(美国基因公司)等。
三.试验方法:
1、小肠运动试验
雄性ICR小鼠随机分成十五组:正常、模型、阳性对照通便灵胶囊(0.25g/kg)、实施例1-3(3.0、6.0g/kg)、比较例1-3(3.0、6.0g/kg)各低中两个剂量,每周称量体重,灌胃给药一周后,灌胃给药一周后,给予复方地芬诺酯(5mg/kg)0.5小时后,灌胃墨汁,25分钟后处死动物,计算墨汁推进率。
2、排便时间、粪便粒数和粪便重量的测定:
雄性ICR小鼠随机分成九组:正常,模型,阳性对照,实施例、比较例受试物各两个剂量共十五组,每周称量体重,灌胃给药一周后,灌胃给药一周后,给予复方地芬诺酯(5mg/kg)0.5小时后,灌胃墨汁,记录每只动物首粒黑便排出时间、5小时内排黑便粒数及重量。
四.统计方法
计量资料数据用平均值±标准误(mean±standard error)表示,各组间差异比较采用t检验,由EXCEL统计软件完成。p<0.05为有显著差异,p<0.01为有极显著差异。
五.试验结果:
1、组合物对墨汁推进率的影响:
结果详见表1。小鼠造模后,墨汁推进率显著降低。与模型对照组比较,实施例1-3的组合物和比较例1-3的组合物两个剂量组均能提高墨汁推进率,而且呈现良好的量效关系。其中实施例1两个剂量组可以明显提高墨汁推进率32.6%、55.2%(p<0.01),表明该组合物能有效促进小肠运动。
表1组合产品对墨汁推进率的影响
与正常对照组比较,##p<0.01,有极显著性差异
与模型对照组比较,*p<0.05,有显著性差异;**p<0.01,有极显著性差异
2、组合物对排便时间和粪便重量的影响
小鼠造模后,小鼠首粒黑便排便时间显著延长,黑便重量显著减少。与模型对照组比较,实施例1-3的组合物和比较例1-3的组合物均可以缩短黑便排便时间,其中,实施例1中剂量组可以缩短黑便排便时间24.0%(p<0.05)。各组合物对粪便重量均未见明显的增加作用。
表2组合产品对排便时间和排便量的影响
与正常对照组比较,#p<0.05,有显著性差异;##p<0.01,有极显著性差异
与模型对照组比较,*p<0.05,有显著性差异;**p<0.01,有极显著性差异
六、结论
实施例1-3的组合物均能够及显著提高肠蠕动抑制小鼠的墨汁推进率,即可以显著地促进小肠运动,并可以显著减少排便时间。以上结果表明本发明组合物通过促进小肠的运动及大肠的蠕动而达到显著改善通便的作用。
Claims (8)
1.一种具有改善通便作用的松花粉组合物,其特征在于,其是由松花粉、蒲公英提取物、槐花提取物、苦杏仁提取物、淡竹叶提取物、罗汉果提取物和低聚木糖为有效组分以及在药品和食品中允许使用的辅助添加成分组成;其中,松花粉,180~260重量份;蒲公英提取物,80~140重量份;槐花提取物,80~120重量份;苦杏仁提取物,15~30重量份;淡竹叶提取物,15~30重量份;罗汉果提取物,6~10重量份;低聚木糖,220~300重量份;各提取物的提取方法如下:蒲公英、槐花、苦杏仁、淡竹叶和罗汉果均使用水煎煮法获得提取物。
2.如权利要求1所述的组合物,其特征在于,所述松花粉,210重量份;蒲公英提取物,110重量份;槐花提取物,90重量份;苦杏仁提取物,20重量份;淡竹叶提取物,20重量份;罗汉果提取物,8重量份;低聚木糖,270重量份。
3.如权利要求1所述的组合物,其特征在于,所述松花粉为破壁松花粉。
4.根据权利要求1-3中任一项所述的组合物,其特征在于,所述组合物中还含有辅料,辅料选自木糖醇、山梨糖醇、异麦芽酮糖醇、异麦芽酮糖、甘露醇、淀粉、糊精、微晶纤维素、乳糖、羟丙甲基纤维素、魔芋粉、硬脂酸镁中的一种或几种。
5.一种权利要求1-4中任一项所述的组合物的制备方法,其特征在于,该方法包括以下步骤:
取所述有效组分与0.5-4倍有效组分重量的辅料均匀混合;加入75-95%的乙醇溶液做润湿剂制软材,过筛制粒;湿颗粒在35-75℃下通风干燥;过筛整粒,即得。
6.根据权利要求5所述的制备方法,其特征在于,该方法包括以下步骤:取所述有效组分与2倍有效组分重量的辅料,过80目筛,均匀混合;加入90%的乙醇溶液做润湿剂制软材,过14目筛制粒;湿颗粒在55℃下通风干燥1小时;过14目筛整粒,即得。
7.权利要求1-4中任一项所述的组合物在制备具有改善通便作用的保健食品和药品中的应用。
8.如权利要求7所述的应用,其特征在于,所述的组合物以有效组分的总量计,口服剂量为5-25g/天。
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