CN108888723A - 一种润肠通便的组合物及其制备方法与应用 - Google Patents
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Abstract
本发明涉及一种润肠通便的组合物及其制备方法与应用。所述组合物包括如下重量份的组分:决明子提取物9~15份;罗汉果提取物9~15份;黑米提取物9~21份;普洱茶提取物1~15份。本发明提供的具有润肠通便功效的功能食品,安全、无依赖性、效果明显、适用人群广泛,可从早期预防及改善便秘情况,避免便秘带来严重后果,改善人们身体亚健康状态,提高生活质量。
Description
技术领域
本发明涉及一种用于预防和治疗便秘的润肠通便组合物及其应用,属于保健食品技术领域。
背景技术
便秘(constipation)是临床常见的复杂症状,而不是一种疾病,表现为排便次数减少、粪便干硬和(或)排便困难。排便次数减少指每周排便少于3次。排便困难包括排便费力、排出困难、排便不尽感、排便费时以及需手法辅助排便。慢性便秘病程至少为6个月。
随着人们饮食结构的改变及精神心理和社会因素的影响,便秘发病率有增高趋势。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。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;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;部分便秘和肛肠疾病,如痔、肛裂等有密切的关系。
常见的治疗便秘的药物有:1)容积型泻剂,该类泻剂可增加大便的体积,以增强粪便对肠道感受器的刺激,常用的有膳食纤维、果糖、山梨醇、甘露醇、聚乙二醇及盐类泻剂。应用后,可以使肠腔局部的渗透压升高,水分吸收减少,粪便体积增加。膳食纤维及果糖,虽副作用小但起效慢,不适于作为暂时性便秘的迅速通便治疗;而盐类泻剂如果导片,有很大的副作用,常服会产生抗药性,停用加重便秘,易造成肠道紊乱,产生依赖性。2)润滑性泻剂:在肠道不被吸收,但又可妨碍水分的吸收,因此常起到润滑肠壁、软化粪便的作用,常用的有液体石蜡、甘油及植物油类。长期应用此类泻剂影响维生素及钙的吸收,还会产生肛门刺激症状。3.刺激性泻剂:大黄及番泻叶片制剂。该类泻剂因对肠黏膜有刺激作用,并影响肠道中水分及电解质的吸收,故有较强的导泻作用。这类均较峻烈,有的还有毒副作用,故年老体弱、孕妇、产后、久病体虚、津伤阴亏、血虚者均应慎用。泻下剂易伤胃气,奏效即止,不可过服。
发明内容
为了解决上述技术问题,本发明提供一种具有润肠通便功效的功能食品。该功能食品安全、无依赖性、效果明显、适用人群广泛,可从早期预防及改善便秘情况,避免便秘带来严重后果,改善人们身体亚健康状态,提高生活质量。
本发明是采用如下技术方案实现的。
一种润肠通便的组合物,包括如下重量份的组分:
优选地,所述润肠通便的组合物,包括如下重量份的组分:
本发明中,所述决明子为豆科一年生草本植物决明或小决明的干燥成熟种子,始载于《神农本草经》,其味甘、苦、咸,微寒,归肝、大肠经,具有清热明目,润肠通便等功效。
进一步地,所述决明子提取物优选为醇提物
进一步地,所述决明子提取物中含有大黄酚、大黄素、大黄酸等化合物;其中,大黄酚的百分含量可以是0.01%,0.02%,0.03%,0.04%,0.05%,0.06%,0.07%,0.08%,0.09%,0.10%,0.12%,0.14%,0.17%,0.18%,0.19%,0.20%;优选含量为0.15%的大黄酚。
具体地,本发明提供一种上述决明子提取物的制备方法,包括:取决明子,粗碎(一般指粒径大于4mm或5目),用10倍重量75%乙醇提取两次,每次1h,分离上清液,浓缩,搅拌、离心分离黄色沉淀部分,取适量纯化水水洗,收集沉淀,真空干燥(40℃左右),即得决明子提取物。
本发明中,所述罗汉果为葫芦科罗汉果的干燥果实,性凉、味甘、无毒,归肺、大肠经,有润肺止咳、凉血滑肠之功效,用于治疗肺火燥咳、咽痛失音、肠燥便秘等。
进一步地,所述罗汉果提取物优选为水提物。
进一步地,所述罗汉果提取物中含有罗汉果苷、黄酮类等化合物;其中罗汉果苷的含量不低于25%。
具体地,本发明提供一种上述罗汉果提取物的制备方法,包括:取罗汉果,加入2-5倍重量的水,煎煮,过滤、浓缩、喷雾干燥,即得罗汉果提取物。
本发明中,所述黑米又称乌米,是禾本科植物黑稻谷的种仁,性湿,味甘,米质多为糯米型。明代李时珍在《本草纲目》中记载黑米具有“滋阴补肾、健脾暖肝、明目活血”等功效。
进一步地,所述黑米提取物优选为水提物。进一步地,所述黑米提取物中含有花青素(Anthocyandins)、花色甙(Anthocyanin)等化合物;其中花青素的含量不低于40%。
本发明中,所述普洱茶是以云南特有的大叶茶的晒青毛茶为原料,经特殊后发酵工艺生产而成的。研究表明普洱茶可清胃生津、消食化痰、解酒解毒、利尿散寒、降低血脂胆固醇。
进一步地,所述普洱茶提取物优选为水提物。
进一步地,所述普洱茶提取物中含有茶多酚、茶色素、黄酮类等功效物质;其中茶多酚的含量不低于20%。
具体地,本发明提供一种上述普洱茶提取物的制备方法包括:取普洱茶,加入2-5倍重量的水,煎煮,过滤、浓缩、喷雾干燥,即得普洱茶提取物。
本发明所选用的原料对人体安全,对环境友好,而且存在着不同的药理作用,其中部分原料已经发现对便秘有一定的治疗效果。本发明创造性地发现,将这几种成分进行配伍联合使用,可以起到协同增效、减轻毒副作用的效果,可以有效的预防治疗便秘。在此基础上,本发明进一步探索了配比比例,发现所获得的组合物效果得到了显著地提高。
本发明上述组合物中,决明子入肝、大肠经,清肝热,润肠燥,为君药;辅以清肺润肠的罗汉果,清热明目,润肠通便以祛其急,为臣药;以清胃生津、消食化痰、解酒解毒、利尿散寒的普洱茶为佐药,佐以黑米滋阴补肾,健脾暖肝,明目活血以安诸脏,调合诸药。
进一步地,上述组合物还包括菊花提取物、枸杞子提取物中的一种或两种。
其中,当所述组合物含包括菊花提取物时,按重量份计,所述组合物中还包括菊花提取物2~9份,优选为4~8份。
其中,当所述组合物含包括枸杞子提取物时,按重量份计,所述组合物中还包括枸杞子提取物1~15份,优选为2~10份。
进一步优选地,所述组合物包括如下重量份的组分:
在本发明进一步改进的组方中,菊花起清热解毒、养肝作用,枸杞子起滋补肝肾、润肺的作用,共为佐药,取其补水所以制火,益金所以平木,木平风息,火降热除以固其本的作用,共奏润肠通便、安心宁神、固本培元之效。
本发明还意外地发现,上述组合物中加入菊花提取物和枸杞子提取物后,不仅对润肠通便的功效有辅助作用,还能够进一步地理气润燥,改善睡眠质量;且有效提高了组合物的稳定性,使得本发明组合物体系稳定,保质期长。另外,使所制得的组合物更容易被人体吸收,显著提高了生物利用度,从而获得了更佳的润肠通便效果。
本发明中,所述菊花是菊科植物的干燥头状花序,富含绿原酸、氨基酸和多种微量元素。研究表明,菊花中主要含有挥发油、有机酸类、黄酮类等物质,菊花具有抗菌、降血脂、降血压、抗氧化和预防心血管疾病的作用。
进一步地,所述菊花提取物优选为水提物。
进一步地,所述菊花提取物中含有黄酮类、有机酸类等化合物;其中总黄酮的含量不低于10%。
具体地,本发明提供一种上述菊花提取物的制备方法包括:取菊花,加入2-5倍重量的水,煎煮,过滤、浓缩、喷雾干燥,即得菊花提取物。
本发明中,所述枸杞子为茄科植物宁夏枸杞的干燥成熟果实。始载于《神农本草经》:“味苦寒。主五内邪气、热中、消渴、周痹。久服,坚筋骨,轻身不老”,具有抗肿瘤、防衰老、降血脂、抗氧化、增加造血等方面的功效。
进一步地,所述枸杞子提取物优选为水提物。
进一步地,所述枸杞子提取物中含有枸杞多糖、黄铜类等化合物;其中枸杞多糖的含量不低于40%。
具体地,本发明提供一种上述枸杞子提取物的制备方法包括:取枸杞子,加入2-5倍重量的水,煎煮,过滤、浓缩、喷雾干燥,即得枸杞子提取物。
在不影响功效的情况下,上述组合物还可含有本领域可用的其他原料,例如具有润肠通便功能的原料:番泻叶、大黄、芦荟、紫苏子、荷叶或者具有其他功能的原料或者普通食品原料或辅料。
本发明上述组合物可按本领域常规方法制成。
本发明还包括上述组合物在制备润肠通便功能食品上的应用。
本发明还提供一种润肠通便的功能食品,由上述组合物单独制成;或由上述组合物与食品领域可用的原辅料或载体制成。
上述功能食品可按本领域常规方法制成食品上各种剂型,例如饮料(包括固体饮料、液体饮料)、口服液、片剂、胶囊剂、颗粒剂、冲剂、糖果(包括压片糖果)等。
具体地,上述功能食品为片剂(主要功能是润肠通便),包括活性组分和辅料,其中,所述活性组分包括如下重量份的组分:
所述辅料包括如下重量份的组分:
优选地,所述功能食品为片剂,包括活性组分和辅料,其中,所述活性组分包括如下重量份的组分:
所述辅料包括如下重量份的组分:
所述粘合剂选自淀粉浆、明胶溶液、羟甲基纤维素钠、羟丙基纤维素中的一种或几种;
所述崩解剂选自干淀粉、羟甲基淀粉钠、低取代羟丙基纤维素钠、交联羟甲基纤维素钠中的一种或几种;
所述润滑剂选自硬脂酸镁、滑石粉、微粉硅胶、氢化植物油、中的一种或几种;
所述矫味剂选自糖精钠、三氯蔗糖、甜蜜素、甜菊苷、阿斯巴甜或甜菊糖中的一种或几种;
所述填充剂选自淀粉、糊精、甘露醇、赤藓糖醇、微晶纤维素中的一种或几种。
更优选地,所述片剂包括活性组分和辅料,其中,所述活性组分包括如下重量份的组分:
所述辅料包括如下重量份的组分:
本发明还提供一种上述功能食品(例如片剂)的制备方法,包括:按配比取各组分,按本领域常规方法制成。
具体地,上述片剂的制备方法包括:按配比取活性组分,混匀;加入填充剂、崩解剂、矫味剂,混匀;再加入粘合剂,混匀;制粒;湿粒干燥后,整粒;加入润滑剂,混匀;压片;制成片剂。
整个过程在操作规程规定下完成,并符合质量标准的规定。
本发明所用原料均可市售购得,或按本领域常规方法制备。
在符合本领域常识的基础上,上述各优选条件,可以相互组合,即得本发明各较佳实例。
此外,应理解,本文中,“包括”、“包含”、“含有”等术语的含义中也包括了“由……组成”、“由……构成”、“由……制成”等。
本发明具有如下有益效果:
本发明利用各成分不同的药用机理,充分发挥各成分间的协同增效作用,使得所得的组合物可以有效治疗和预防便秘,对长期受到便秘困扰的患者提供了极大的帮助。
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。实施例中未注明具体技术或条件者,按照本领域内的文献所描述的技术或条件,或者按照产品说明书进行。所用试剂或仪器未注明生产厂商者,均为可通过正规渠道商购买得到的常规产品。
以下实施例及对比例中:
决明子提取物的制备方法包括:取决明子粗碎,用10倍重量75%乙醇提取两次,每次1h,分离上清液,浓缩,搅拌、离心分离黄色沉淀部分,取适量纯化水水洗,收集沉淀,真空干燥(40℃左右),即得。
大黄提取物的制备方法包括:取大黄粗碎,用10倍重量75%乙醇提取两次,每次1h,分离上清液,浓缩,搅拌、离心分离黄色沉淀部分,取适量纯化水水洗,收集沉淀,真空干燥(40℃左右),即得。
罗汉果提取物、普洱茶提取物、黑米提取物、菊花提取物、枸杞子提取物分别是指其提取物,其制备方法包括:分别取各药材,加入2倍重量的水,煎煮,过滤、浓缩、喷雾干燥,即得。
对比例1~4及实施例1~4润肠通便的组合物
对比例1~4及实施例1~4的配方见表1。
表1
按表1配方取各原料,混匀,即可制得各组合物。
进一步地,分别取上述制得的组合物,选用适当辅料,按常规方法制成饮料(包括固体饮料、液体饮料)、口服液、片剂、胶囊剂、颗粒剂、冲剂、糖果(包括压片糖果)等。
对比例5~8及实施例5~10润肠通便的组合物
对比例5~8及实施例5~10的配方见表2。
表2
按表2配方取各原料,混匀,即可制得各组合物。
进一步地,分别取上述制得的组合物,选用适当辅料,按常规方法制成饮料(包括固体饮料、液体饮料)、口服液、片剂、胶囊剂、颗粒剂、冲剂、糖果(包括压片糖果)等。
对比例9~12及实施例11-14润肠通便的片剂
为了阐述本发明的优点,本发明按表3配方,制备成片剂,并进行人体食用试验,证明本发明的有益效果。
(1)对比例9~12及实施例11~14的配方见表3。
表3
(2)润肠通便片剂按本领域常规方法制备。
(3)人体试验(对便秘的治疗效果)
选取确诊为便秘的患者每组30人。供试者符合如下标准:①便秘病程大于6个月,最近3个月有症状发作;②年龄大于16岁,小于80岁者;③患者签署知情同意书,自愿参加本研究。
便秘临床评分:①自主排便:有(0分),借助药物、手助或灌肠排便(3分);②便意感:有(0分),无(1分);③自行排便频率:1~2日排便一次(0分),3~4日排便一次(1分),5~6日排便一次(2分),6日以上排便一次(3分),不能自行排便(4分);④排便费力程度:自然排便,无排便费力(0分),须用力排便(1分),努挣方能排便(2分);⑤每次排便时间:1~10min(0分),11~20min(1分),21~30min(2分),30min以上(3分);⑥便质:硬块散在(3分),硬块成条(2分),呈条有裂纹(1分),成条光软(0分);⑦腹胀、腹痛、排便不尽感、肛门坠胀感、肛门梗阻感、排气不畅感6个症状均以无(0分),轻微(1分),明显(2分),难忍(3分)4级来评分。
疗效评定标准《中药新药临床研究指导原则》,并结合临床,自拟以下主症疗效评价标准:①临床痊愈:主症消失,排便正常,便秘临床症状积分为0;②显效:临床症状明显改善,临床症状积分较治疗前降低≥2/3;③有效:临床症状好转,但临床症状积分降低1/2~2/3;④好转:临床症状出现好转,但临床症状积分较治疗前降低≤1/2;⑤无效:临床症状无改善或加重,临床症状积分无降低或反而升高。
结果见表4:
表4
注:总有效率=(临床痊愈+显效+有效+好转)/每组总例数×100%
对比例13~16及实施例15~20润肠通便的片剂
(1)对比例13~16及实施例15~20润肠通便片剂配方见表5。
表5
(2)润肠通便片剂按本领域常规方法制备。
(3)人体试验(对便秘的治疗效果)
选取确诊为便秘的患者每组40人。供试者纳入标准同前。
便秘临床评分同前。
疗效评定标准同前。
结果如表6。
表6
上述结果可知,进一步添加菊花提取物、枸杞子提取物中的一种或几种,可以使所得的本润肠通便产品获得更加的效果,即决明子提取物、罗汉果提取物、黑米提取物、普洱茶提取物中的一种或几种与由菊花提取物、枸杞子提取物组成的组合物间具有协同增效作用。
对比例17-22润肠通便的片剂
为了进一步阐述本发明的优点,本发明将实施例17~20中的决明子提取物更换成同样有润肠通便效果的大黄提取物,其他成分不变,组合物及适当的辅料,制备成润肠通便片剂。另外,按表7配方制备对比例21-22片剂。将以上样品进行人体食用试验,更深入地证明本发明的有益效果。(大黄是多种蓼科大黄属的多年生植物的合称,也是中药材的名称。大黄具有泻热通便功效,用于胃肠实热积滞、大便秘结、腹部胀满、疼痛拒按,甚至高热不退、神昏谵语,如大承气汤;或脾阳不足之冷积便秘,如温脾汤。)
(1)对比例17~22片剂配方见表7。
表7
(2)润肠通便片剂按本领域常规方法制备。
(3)人体试验
选取确诊为便秘的患者每组40人。供试者纳入标准同前。
便秘临床评分同前
疗效评定标准同前。
结果如表8:
表8
上述结果可知,如配方中缺少决明子提取物,虽然加入同样具有润肠通便作用的大黄,其最后的有效率远远低于决明子提取物组,且伴有腹痛症状,决明子提取物组未见腹痛症状。配方中缺少主要功效原料的对比例21和22,基本无润肠通便作用。
虽然,上文中已经用一般性说明及具体实施方案对本发明作了详尽的描述,但在本发明基础上,可以对之作一些修改或改进,这对本领域技术人员而言是显而易见的。因此,在不偏离本发明精神的基础上所做的这些修改或改进,均属于本发明要求保护的范围。
Claims (10)
1.一种润肠通便的组合物,其特征在于,包括如下重量份的组分:
2.根据权利要求1所述的组合物,其特征在于,还包括菊花提取物2~9份;和/或,还包括枸杞子提取物1~15份;
优选地,还包括菊花提取物4~8份;和/或,还包括枸杞子提取物2~10份。
3.根据权利要求2所述的组合物,其特征在于,所述菊花提取物中总黄酮的含量不低于10%;和/或,所述枸杞子提取物中枸杞多糖的含量不低于40%。
4.根据权利要求1-3任一项所述的组合物,其特征在于,所述决明子提取物为醇提物,含有大黄酚、大黄素、大黄酸;和/或,
所述罗汉果提取物中罗汉果苷的含量不低于25%;和/或,
所述黑米提取物中花青素的含量不低于40%;和/或,
所述普洱茶提取物中茶多酚的含量不低于20%。
5.权利要求1-4任一项所述组合物在制备润肠通便功能食品上的应用。
6.一种润肠通便功能食品,其特征在于,由权利要求1-4任一项所述组合物单独制成;或由权利要求1-4任一项所述组合物与食品领域可用的原辅料或载体制成。
7.根据权利要求6所述的功能食品,其特征在于,所述功能食品的剂型包括饮料、口服液、片剂、胶囊剂、颗粒剂、冲剂、糖果。
8.根据权利要求6所述的功能食品,其特征在于,其为片剂,包括活性组分和辅料,其中,所述活性组分包括如下重量份的组分:
所述辅料包括如下重量份的组分:
9.根据权利要求6所述的功能食品,其特征在于,其为片剂,包括活性组分和辅料,其中,所述活性组分包括如下重量份的组分:
所述辅料包括如下重量份的组分:
10.根据权利要求6所述的功能食品,其特征在于,其为片剂,包括活性组分和辅料,其中,所述活性组分包括如下重量份的组分:
所述辅料包括如下重量份的组分:
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