CN105878559A - 一种具有润肠通便功效的药物组合物或保健食品 - Google Patents
一种具有润肠通便功效的药物组合物或保健食品 Download PDFInfo
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Abstract
本发明公开了一种具有润肠通便功效的药物组合物或保健食品，由以下重量份的原料制成：白术200～500份，当归200～300份，玄参200～300份，莱菔子200～300份，郁李仁200～300份，番泻叶40～120份。制备方法为：取各原料，混合，加5～15倍量水煎煮提取1～3次；合并滤液，将滤液浓缩至稠膏，稠膏干燥，粉碎，即得。使用时口服，服用量为2～4片/日或2～4粒/日或20～40克/日，对于便秘者，通常15～30日见效。本发明的具有润肠通便功效的药物组合物或保健食品，具有很好的润肠通便作用，且对肠道刺激性小，不易形成依赖性，可用于多种原因引起的便秘，治疗效果优于同类药物(比如麻仁润肠丸)。
Description
技术领域
本发明涉及一种具有润肠通便功效的药物组合物或保健食品，属于药品、保健食品技术领域。
背景技术
便秘主要是指排便次数减少、粪便量减少、粪便干结、排便费力等症状。便秘可引发体内毒素的蓄积，从而影响机体正常生理功能。
近年来，随着我国经济的高速发展，人们(特别是城镇居民)生活水平的不断提高，许多“现代病”的发病率呈不断上升的趋势，据有关调查结果显示，北京、天津和西安地区60岁以上的人群中，慢性便秘患病率高达15％～20％。北京地区成年人中，慢性便秘患病率大约为6％左右，其中女性的患病率大约是男性的4倍以上。便秘是危害人们身体健康的重要因素，随着人们饮食结构的改变，患病人群越来越多，它成为诱发心肌梗塞、脑溢血、结肠癌的重要因素。因此，通便产品具有较大的市场需求。
目前，用于便秘的药品、保健食品主要有两大类，一类为膨胀性充肠剂，如小麦麸皮、玉米麸皮、魔芋淀粉、琼脂、甲基纤维素、车前子制剂等；这种制剂含纤维素，吸水后形成柔软的凝胶，对肠道狭窄者可致堵塞，通便功能差。另一类为泻下药，由大黄、芒硝、芦荟等中药组成，该类泻下药会使肠道的敏感性减弱，停药后会出现严重便秘，具有病情出现反复及难治的缺点，且这类泻下药多含多糖或多羟基结构，易与明胶发生氧化、交联反应，从而导致崩解时限长，影响通便效果。
发明内容
针对上述现有技术，本发明提供了一种具有润肠通便功效的药物组合物或保健食品，其润肠通便效果显著，对肠道刺激性小，不易形成依赖性。
本发明是通过以下技术方案实现的：
一种具有润肠通便功效的药物组合物或保健食品，由以下重量份的原料制成：白术200～500份，当归200～300份，玄参200～300份，莱菔子200～300份，郁李仁200～300份，番泻叶40～120份。
优选的，是由以下重量份的原料制成的：白术333份，当归250份，玄参250份，莱菔子250份，郁李仁250份，番泻叶83份。
所述具有润肠通便功效的药物组合物或保健食品的制备方法，如下：取各原料，混合，加5～15倍量水(重量倍数)煎煮提取1～3次；合并滤液，将滤液浓缩至稠膏，稠膏干燥，粉碎，即得，或进一步地，加入适量药学或食品学可接受的辅料，制粒，干燥，制成相应制剂(如片剂、颗粒剂、胶囊剂、丸剂等)。
优选的，每次提取时间为1～2小时。
优选的，步骤如下：
(1)称取白术、当归、玄参、莱菔子、郁李仁和番泻叶，加10倍量水提取2次，第一次提取2小时，第二次提取1.5小时，200目筛过滤，合并滤液，备用；
(2)药滤液减压浓缩(-0.06～-0.08MPa，60～80℃)至相对密度1.25～1.35(60℃测)的稠膏，备用；
(3)稠膏减压干燥(-0.06～-0.08MPa，60～80℃)，粉碎，过80目筛，得干膏粉，加入适量的二氧化硅、淀粉，置混合机中混合30分钟，用90％乙醇溶液(体积浓度)为粘合剂，16目制粒，50℃干燥，取干颗粒和硬脂酸镁置混合机中混合15分钟，压片即得。
本发明的具有润肠通便功效的药物组合物或保健食品，使用时，口服，服用量为2～4片/日(实施例1)或2～4粒/日(实施例2)或20～40克/日(实施例3)，对于便秘者，通常15～30日见效。
本发明所选用的原料多为药食同源的常见药材，简介如下：
白术为菊科植物白术Atractylodes macrocephala Koidz.的根茎。主产于浙江、湖北、湖南等地。白术药性甘、苦、温。归脾、胃经。具有益气健脾，燥湿利水的功效。现代药理研究表明：白术水煎液对小鼠有明显促进胃排空及小肠推进功能作用。
当归为伞形科植物当归Angelica sinensis(Oliv.)Diels的干燥根。甘、辛，温。归肝、心、脾经。补血活血，调经止痛，润肠通便。用于血虚萎黄，眩晕心悸，月经不调，经闭痛经，虚寒腹痛，肠燥便秘，风湿痹痛，跌扑损伤，痈疽疮疡。
玄参Scrophularia ningpoensis Hemsl.)为玄参科草本植物，清热凉血，泻火解毒，滋阴。主治：温邪入营，内陷心包，温毒发斑，热病伤阴、舌绛烦渴、津伤便秘、骨蒸劳嗽、目赤、咽痛、瘰疬、白喉、痈肿疮毒。
莱菔子为十字花科植物萝卜Raphanus sativus.的干燥成熟种子，味辛、甘，性平，有下气、祛痰、消食化积的功能，用于饮食停滞、脘腹胀痛、大便秘结、积滞泻痢。莱菔子水煎剂1，2，4×10-2mol/L浓度时，均能使离体兔肠的收缩幅度增高。
郁李仁为蔷薇科欧李Prunus humilis Bge.、郁李Prunus japonica Thunb.或长柄扁桃Prunus pedunculata Maxim.的干燥成熟种子，味辛、苦、甘，具有缓泻、利尿的功能。用于津枯肠燥、食积气滞、腹胀便秘、水肿、小便不利。
番泻叶为豆科植物狭叶番泻Cassia angustifolia Vahl或尖叶番泻Cassia acutifolia Delile的干燥小叶。具有“泻热行滞，通便，利水”之功效，用于热结积滞，便秘腹痛，水肿胀满。研究表明，番泻苷抑制非前冲性收缩，刺激蠕动收缩，通过这种方式，结肠的正常生理能动性和结肠功能得到恢复，转运速率和水分吸收在正常范围内，粪便的硬度也在正常范围内。
本发明中各原料的用量也是发明人经大量摸索总结得出的，各原料用量在上述重量份配比范围内均具有很好的润肠通便作用，且对肠道刺激性小，不易形成依赖性，可用于多种原因引起的便秘，治疗效果优于现有技术中的同类药物(比如麻仁润肠丸等)。整个组方合理、严谨，可制备成多种剂型的药物、保健食品及配制酒、茶、袋泡茶、凉茶、饮料，原料易得，制备工艺相对简单，成本能够得以控制。同时，本发明还对本发明组合物用量保护范围之外的量进行了试验研究，结果表明仅本发明所述用量范围内的组合物才可较好的有益技术效果。
具体实施方式
下面结合实施例和实验对本发明作进一步的说明。
实施例1 制备具有润肠通便功效的药物组合物
步骤如下：
(1)称取白术333g、当归250g、玄参250g、莱菔子250g、郁李仁250g和番泻叶83g，加10倍量水提取(煎煮)2次，第一次提取2小时，第二次提取1.5小时，200目筛过滤，合并滤液，备用；
(2)滤液减压浓缩(-0.06～-0.08MPa，60～80℃)至相对密度1.25～1.35(60℃测)的稠膏，备用；
(3)稠膏减压干燥(-0.06～-0.08MPa，60～80℃)，粉碎，过80目筛，得干膏粉，加入适量的二氧化硅、淀粉置混合机中混合30分钟，用90％乙醇溶液为粘合剂，16目制粒，50℃干燥，取干颗粒和硬脂酸镁置混合机中混合15分钟，压片即得。
实施例2 制备具有润肠通便功效的药物组合物
步骤如下：
(1)称取白术667g、当归100g、玄参300g、莱菔子100g、郁李仁300g、番泻叶50g，加5倍量水提取(煎煮)3次；第一次提取2小时，第二次提取1.5小时，第三次提取1小时，200目筛过滤，合并滤液，备用；
(2)滤液减压浓缩(-0.06～-0.08MPa，60～80℃)至相对密度1.25～1.35(60℃测)的稠膏，备用；
(3)稠膏减压干燥(-0.06～-0.08MPa，60～80℃)，粉碎，过80目筛，得干膏粉，加入适量的二氧化硅、淀粉置混合机中混合30分钟，用90％乙醇溶液为粘合剂，16目制粒，50℃干燥，装填胶囊即得。
实施例3 制备具有润肠通便功效的药物组合物
步骤如下：
(1)称取白术200g、当归300g、玄参100g、莱菔子300g、郁李仁100g、番泻叶166g，加15倍量水提取(煎煮)1.5小时，200目筛过滤，合并滤液，备用；
(2)药液减压浓缩(-0.06～-0.08MPa，60～80℃)至相对密度1.25～1.35(60℃测)的稠膏，备用；
(3)稠膏减压干燥(-0.06～-0.08MPa，60～80℃)，粉碎，过80目筛，得干膏粉，加入适量的二氧化硅、淀粉置混合机中混合30分钟，用90％乙醇溶液为粘合剂，16目制粒，50℃干燥即得。
实验例1 药理学实验
受试药物：
通便制剂：取实施例1、2、3步骤(3)所得干膏粉，用蒸馏水配成所需浓度混悬液(约为0.75g/ml)备用。
阳性对照：取麻仁润肠丸(购自南京同仁堂药业有限公司，批号2014120725)内容物，用蒸馏水配成所需浓度混悬液(约为0.75g/ml)备用。
受试动物：昆明种小白鼠和Wistar大白鼠，一级合格实验动物，由山东大学实验动物中心提供，合格证号：SCXK(鲁)2015-09。
试验环境：实验室温度20～25℃，相对湿度50～65％。
仪器与试剂：印度墨水；复方地芬诺酯片，江苏平光制药有限责任公司，国药准字H32021238，批号：15021261；戊巴比妥钠，SERVA进口分装，沙陀利斯精密电子天平。
试验方法及结果：
1、通便制剂对正常小鼠的排便影响
取体重22～25g健康小鼠，雌雄各半，随机分成5组，空白对照组、实施例1、2、3组和麻仁润肠组。空白对照组灌胃给予用蒸馏水配制的2％的墨汁混悬液，给药组则灌胃给予用药液配制成的2％的墨汁混悬液，给药量为0.5ml/10g，给药后，将小鼠置小鼠盒中，每盒1只，盒底垫白色干净滤纸，观察记录每只小鼠首次排出黑粪便的时间(min)和4小时内小鼠排出黑粪便的总量(g)。t检验各组间差异的显著性。结果见表1。
表1通便制剂对正常小鼠排便的影响
| 组别 | 动物数(只) | 首次排黑便时间(min) | 4小时排黑便总量(g) |
| 空白对照组 | 10 | 150.3±35.6 | 2.1±1.98 |
| 实施例1组 | 10 | 91.2±41.3** | 10.5±2.01** |
| 实施例2组 | 10 | 101.4±37.1** | 9.2±2.92** |
| 实施例3组 | 10 | 95.2±31.7** | 12.5±4.34** |
| 麻仁润肠组 | 10 | 115.2±50.9* | 6.7±1.87* |
与空白对照组比较*p＜0.05**P＜0.01；a计量单位为g/kg。
由表1可见，与空白对照组比较，实施例1、2、3组排便时间和排便数量差异均具统计学意义，显示通便制剂对正常小鼠有较显著的泻下作用。
2、通便制剂对小鼠肠容积的影响
取体重20～25g健康小鼠，雌雄各半，随机分成5组，空白对照组、实施例1、2、3组和麻仁润肠组。禁食不禁水12小时后，各组按剂量灌胃给药，空白对照组给等量蒸馏水，给药容积0.5ml/10g体重，给药2.5小时后将动物断颈椎处死，剪开腹腔，暴露肠管，在幽门下端和回盲部结扎，自幽门处剪下肠管，小心用剪刀沿肠管向下剪下肠系膜，在回盲部剪断肠管，于电子天平上准确称量肠管重量。t检验各组间的显著性。结果见表2。
表2通便制剂对正常小鼠肠容积的影响
| 组别 | 动物数(只) | 肠管重量(g) |
| 空白对照组 | 10 | 1.32±0.14 |
| 实施例1组 | 10 | 1.63±0.19* |
| 实施例2组 | 10 | 1.56±0.15* |
| 实施例3组 | 10 | 1.59±0.23* |
| 麻仁润肠组 | 10 | 1.52±0.26* |
与空白对照组比*P＜0.05；a剂量单位为g/kg。
由表2可见，与空白对照组比，实施例1、2、3组小鼠肠管重量增大，其差异有统计学意义，证明通便制剂有增加小鼠肠管容积的作用。
3、通便制剂对燥结失水便秘模型小鼠的排便试验
取体重23～26g健康小鼠，雌雄各半，随机分成六组，空白对照组、模型对照组、实施例1、2、3组和麻仁润肠组。除空白对照组外，其他各组小鼠禁水不禁食72小时，造成燥结失水便秘模型。空白对照组灌胃给予用蒸馏水配制成的2％的墨汁混悬液，给药组则灌胃给予用药液配制的2％的墨汁混悬液，给药容积0.5ml/10g，给药后将小鼠放入小鼠盒中，每盒1只，下垫白色干净滤纸，观察记录每只小鼠首次排热出黑粪的时间(min)和4小时内小鼠排出黑粪总量。t检验各组间的显著性。结果见表3。
表3通便制剂对燥结失水模型小鼠排便的影响试验
| 组别 | 动物数(只) | 首次排黑便时间(min) | 4小时排黑便总量(g) |
| 空白对照组 | 10 | 150.9±38.8 | 2.3±1.6 |
| 模型对照组 | 10 | 305.0±25.4△△ | 0.2±0.1△△ |
| 实施例1组 | 10 | 191.2±64.2** | 2.0±1.7** |
| 实施例2组 | 10 | 206.0±62.1* | 2.3±1.2** |
| 实施例3组 | 10 | 203.3±56.6* | 2.3±1.4** |
| 麻仁润肠组 | 10 | 265.0±59.5 | 1.5±0.3 |
与空白对照组比△△P＜0.01与模型对照组比*P＜0.05**P＜0.01，a剂量单位为g/kg。
由表3.可见，模型对照组明显比空白对照组小鼠首次排出黑粪时间延长，且4小时内排除黑粪总数减少，其差异有统计学意义，说明小鼠燥结失水便秘模型造型成功。与模型对照组相比，实施例1、2、3组小鼠首次排出黑粪的时间缩短，小鼠在4小时内排除黑粪总数增多，其差异有统计学意义，显示通便制剂对燥结失水便秘模型小鼠有较显著的缩短小鼠排便时间，增加小鼠排便次数的泻下作用。
4、通便制剂对复方地芬诺酯(DC)模型小鼠的排便试验
取体重23-25g健康小鼠。雌雄各半，随机分成6组，空白对照组、模型对照组、实施例1、2、3组和麻仁润肠组。各组小鼠禁水不禁食12小时，除空白对照组给等量蒸馏水外，其余各组灌胃给予复方地芬诺酯(DC)混悬液50mg/kg，30分钟后，各组动物灌胃给予药物，给药体积0.5ml/10g体重，空白对照组及模型对照组给等量蒸馏水。观察记录每组小鼠排出干粪总数、稀粪总数及不排便的动物数，连续观察12小时，比较各组指标。t检验各组间差异的显著性。结果见表4。
表4通便制剂对DC便秘模型小鼠排便的影响试验
| 组别 | 动物数(只) | 干粪数(g) | 稀粪数(g) | 不排便动物数 |
| 空白对照组 | 10 | 7.8±3.12 | 2.3±1.6 | 0 |
| 模型对照组 | 10 | 2.3±2.45△△ | 0.2±0.1△△ | 2 |
| 实施例1组 | 10 | 6.3±3.12* | 0.8±0.27* | 0 |
| 实施例2组 | 10 | 4.8±2.65* | 0.5±0.37 | 0 |
| 实施例3组 | 10 | 5.7±2.74 | 0.7±0.48 | 0 |
| 麻仁润肠组 | 10 | 3.8±2.27 | 0.3±0.22 | 0 |
与空白对照组比△△P＜0.01与模型对照组比*P＜0.05**P＜0.01，#剂量单位为g/kg。
由表4可见，模型对照小鼠12小时内排除的干粪总数减少，不排便的动物数增多，与空白对照组比，其差异有统计学意义，说明小鼠DC便秘模型造型成功。与模型对照组比，实施例1、2、3组小鼠12小时内排出的干粪总数增多，稀粪总数增多，不排便动物数减少，与模型对照组比，其差异有统计学意义，显示通便制剂对DC便秘模型小鼠有较显著的泻下作用。
Claims (5)
1.一种具有润肠通便功效的药物组合物或保健食品，其特征在于：由以下重量份的原料制成：白术200～500份，当归200～300份，玄参200～300份，莱菔子200～300份，郁李仁200～300份，番泻叶40～120份。
2.根据权利要求1所述的具有润肠通便功效的药物组合物或保健食品，其特征在于：是由以下重量份的原料制成的：白术333份，当归250份，玄参250份，莱菔子250份，郁李仁250份，番泻叶83份。
3.权利要求1或2所述的具有润肠通便功效的药物组合物或保健食品的制备方法，其特征在于：取各原料，混合，加5～15倍量水(重量倍数)煎煮提取1～3次；合并滤液，将滤液浓缩至稠膏，稠膏干燥，粉碎，即得，或进一步地，加入适量药学或食品学可接受的辅料，制粒，干燥，制成制剂。
4.根据权利要求3所述的制备方法，其特征在于：所述提取时，每次的提取时间为1～2小时。
5.根据权利要求3或4所述的制备方法，其特征在于：步骤如下：
(1)称取白术、当归、玄参、莱菔子、郁李仁和番泻叶，加10倍量水提取2次，第一次提取2小时，第二次提取1.5小时，200目筛过滤，合并滤液，备用；
(2)药滤液减压浓缩至相对密度1.25～1.35(60℃测)的稠膏，备用；
(3)稠膏减压干燥，粉碎，过80目筛，得干膏粉，加入适量的二氧化硅、淀粉，置混合机中混合30分钟，用90％乙醇溶液为粘合剂，16目制粒，50℃干燥，取干颗粒和硬脂酸镁置混合机中混合15分钟，压片即得。
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| CN116870062A (zh) * | 2023-08-11 | 2023-10-13 | 江苏师范大学 | 一种具有润肠通便的组合物及其应用 |
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