CN109602005A - 一种调节脾胃湿热的组合物及其制备方法和应用 - Google Patents
一种调节脾胃湿热的组合物及其制备方法和应用 Download PDFInfo
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- CN109602005A CN109602005A CN201811612714.2A CN201811612714A CN109602005A CN 109602005 A CN109602005 A CN 109602005A CN 201811612714 A CN201811612714 A CN 201811612714A CN 109602005 A CN109602005 A CN 109602005A
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Abstract
本发明提供了一种调理脾胃湿热的组合物及其制剂,所述组合物包括按质量份计的以下成分:栀子提取物15~25份,茯苓提取物25~35份,陈皮提取物30~50份,莲子提取物25~35份,山药提取物30~50份,芦荟提取物15~25份,马铃薯提取物1~3份,发酵复合果蔬粉90~110份。本发明提供的组合物和制剂能够调理脾胃湿热,从而调节体质,增强机体能力,特别是对于脾胃湿热型的肥胖,配合其它常规减肥措施,能够有效减重,恢复身体健康。
Description
技术领域
本发明属于制剂产品领域,涉及脾胃湿热的调节。
背景技术
脾胃湿热,中医病证名,是指湿热蕴结脾胃,脾失健运胃失纳降而形成的证候,诊断表现为舌苔黄腻、脉濡数,症见脘腹胀满、肢体困倦、尿少色黄、大便溏泄不爽、纳少厌食、恶心呕吐等症,严重者引发慢性胃炎、慢性肠炎,甚至由胃肠消化不良导致胆道阻塞引起黄疸、胆结石等肝胆疾病。
现代社会生活节奏加快,处于高负荷工作压力下的人们常常饮食从简或不食、饮食不规律、暴饮暴食,而由于饮食不节造成肥胖的人群,常采取缩减饮食的不健康减重方式,更加重了消化系统负担,从而导致脾胃失衡,加之饮食结构中高糖、高脂比例不断增高,膏粱厚味难以消下,结湿于胃,湿热蕴脾,进而诱发一系列消化系统疾病。
现代医学针对脾胃湿热引起的胃肠道疾病,通常采用针对病症的单一治疗方式,如消化不良采用增强胃动力、促消化药物,胃部炎症用保护胃黏膜、养胃的三联疗法,肠炎泄泻则用调节肠道菌群、单纯止泻等药物,上述治法虽能够暂时缓解症状,但湿热未除,治标未能治本,使得疾病极易复发。
发明内容
本发明以中医理论为基础,研究出一种能够调节脾胃湿热的组合物,从而调整由此带来的不利结果,如消化不良、胃脘胀痛、腹泻等消化系统症状,以及继发引起的肢体倦怠之症。
在第一个方面,本发明提供一种组合物,包括按质量份计的以下成分:栀子提取物15~25份,茯苓提取物25~35份,陈皮提取物30~50份,莲子提取物25~35份,山药提取物30~50份,芦荟提取物15~25份,马铃薯提取物1~3份,发酵复合果蔬粉90~110份。
优选地,所述组合物包括按质量份计的以下成分:栀子提取物20份,茯苓提取物30份,陈皮提取物40份,莲子提取物30份,山药提取物40份,芦荟提取物20份,马铃薯提取物1份,发酵复合果蔬粉100份。
优选地,所述各提取物为水提粉。
优选地,所述栀子提取物的提取比例为5:1~20:1,优选10:1;所述茯苓提取物中多糖的质量含量为10%~50%,优选20%;所述陈皮提取物中总黄酮的质量含量为10%~50%,优选30%;所述莲子提取物的提取比例为5:1~20:1,优选10:1;所述山药提取物的提取比例为5:1~20:1,优选10:1;所述芦荟提取物的提取比例为100:1~200:1,优选100:1,进一步优选地,所述芦荟提取物为库拉索芦荟凝胶粉;所述马铃薯提取物中蛋白酶抑制剂PI2含量为2%~10%,优选为5%。
上述提取物以及提取方法都是本领域公知常识,本领域技术人员根据需要可以毫无困难地获得这些提取物。
在第二个方面,本发明提供一种制剂,包括有效成分和辅料,其中有效成分为本发明所述的组合物,在制剂中的质量含量为30%~40%,所述辅料为制剂学上可接受的辅料,包括甜味剂、果粉、香精中的一种或多种。
优选地,所述甜味剂包括菊粉、低聚果糖、低聚异麦芽糖、低聚木糖、三氯蔗糖、甜菊糖苷、赤藓糖醇、木糖醇、异麦芽酮糖醇、麦芽糖醇、山梨糖醇中的一种或多种。
所述果粉为任意果粉,可以利用果汁浓缩喷雾干燥制成,如橙子汁粉。
所述香精为任意风味的香精,如橙粉末香精。
辅料的添加量可以根据需要而定。本领域技术人员依据具体要求能够适当地添加辅料并生产所述制剂。
优选地,所述制剂为药品、食品或保健品。优选地,所述制剂的剂型为粉剂、颗粒剂、丸剂、片剂、胶囊剂、膏剂、口服液,优选为颗粒剂。
在第三个方面,提供本发明的制剂的制备方法,包括称取配方量的有效成分和辅料,混合均匀,即得。
在第四个方面,提供本发明的组合物在制备调理脾胃湿热的制剂中的应用。
进一步地,提供本发明的组合物在制备用于减肥的制剂中的应用。
本发明提供的组合物和制剂能够调理脾胃湿热,从而调节体质,增强机体能力,特别是对于脾胃湿热型的肥胖,配合其它常规减肥措施,能够有效减重,恢复身体健康。
具体实施方式
下面将结合具体实施方式说明本发明,但本发明的内容不限于此。以下实施例中所使用的药材、试剂、仪器都可以通过商购的方式获得;所使用的方法等也是本领域常规方法,本领域技术人员根据说明书所述内容,可以毫无疑义地实施所述过程并获得相应结果。
本发明是基于中医药保健学,所选用组合物原料均来自于药食同源,或根据国家法规能用于保健食品的原料目录。根据常规的中医辨证论治原则,因脾胃湿热造成的胃肠道消化系统症状,通常以清热燥湿、消食养胃、理气和中为治疗方法。本申请发明人认为,脾胃湿热所致消化不良诸症,其症候显于胃肠,其本质归于脾阴不足造成的脾失运化,进而结湿于胃、湿热蕴脾。《素问·太阴阳明论》指出“四肢皆禀气于胃,而不得至经,必因于脾,乃得禀也。今脾病不能为胃行其津液,四肢不得禀水谷气,气日以衰,脉道不利,筋骨肌肉,皆无气以生,故不用焉……脾脏者常著胃土之精也,土者生万物而法天地”,因此本发明以病因入手,治脾以养胃,清热以燥湿,理气以和中,从而达到由本治标的目的。经过多次实验,将多种成分进行合理的配伍,得到本发明的组合物和制剂,其中,
山药甘,平。归脾、肺、肾经,《神农本草经》载其“补中,益气力,长肌肉”,可补脾益气,滋养脾阴。
陈皮味苦、辛,性温;归肺、脾经,《神农本草经》云“主胸中痰热逆气,利水谷。下气,止呕咳……主脾不能消谷,气冲胸中,吐逆霍乱”;《本草纲目》称“其治百病,总取其理气燥湿之功,同补药则补,同泻药则泻,同升药则升,同降药则降”,可用于脘腹胀满、食少吐泻等症。
莲子味甘、涩,性平;归脾、肾、心经;《玉楸药解》称“莲子甘平,甚益脾胃,而固涩之性”,补脾止泻,益肾涩精,养心安神。
上述三者合用,行益气养脾、理气健脾、养阴补脾之功,用为君。
茯苓甘、淡,平,归心、脾、肾经,《世补斋医书》云“茯苓一味,为治痰主药,痰之本,水也,茯苓可以行水;痰之动,湿也,茯苓又可行湿”,有利水渗湿,健脾助运之功。
栀子苦,寒,归心、肺、三焦经,《神农本草经》言其“主五内邪气,胃中热气”,既能清泻三焦火邪,又能清利湿热。
芦荟味苦,性寒,归肝、胃、大肠经,可清肝泻火,泻下通便。
这三者同用,辅利水渗湿、清热泻火之效,用为臣。
马铃薯为茄科植物马铃薯的块茎,味甘,性平,归胃、大肠经,首载于《植物名实图考》,中医认为其具有和胃健中;解毒消肿之功效(和胃止痛)。
发酵复合果蔬粉是由多种水果、蔬菜以超滤浓缩及冷冻干燥等独特的高科技技术精制而成的酵素粉剂,亦称为“果蔬酵素粉”,现代医学研究表明其具有清理肠道毒素、改善胃肠功能的作用。
上述二者相辅,可和胃止痛、利肠通便,是为佐使。
诸品同用,君药健脾益气、温补脾阴而行运化之功,臣药清热利水而化湿热之症,再佐以和胃润肠之剂,腑(胃肠)疾而脏(脾)治,清热化湿,脾健食消;《素问·太阴阳明论》有云“四肢皆禀气于胃,而不得至经,必因于脾,乃得禀也”,即中医所认为的“脾主四肢”,因此,本组合物亦能用于改善由脾胃湿热导致的肢体倦怠等症。
实施例1:
按照表1所示的各实验例和对比例的配方购买或制备符合相应质量标准要求的各成分,放置于洁净区,备用。其中,各提取物通过水提方法获得,生产方法如下:取原材料,加10倍原材料总质量水浸泡1小时,煎煮1.5小时,过滤,得到第一遍提取液;再加8倍原材料总质量的水,再次煎煮1.5小时,过滤,得到第二遍提取液,合并两次提取液。提取液经减压浓缩干燥,得相应原材料提取物(水提粉),备用。
表1中的发酵复合果蔬粉的生产厂家为大汉酵素生物科技股份有限公司。
各实验例和对比例中各成分的量均为重量份,含量为质量含量。
表1:制剂配方
2)将上述各成分混合30分钟,均匀混合,即得。
测试例1:人体感受评价
募集经诊断为脾胃湿热型受试者120人,年龄在35-45岁之间。随机分成4组,每组30人,分别服用上述实施例1和2、对比例1和2的制剂。每天一次,每次8g,冲服。服用两个月,配合低脂低盐低糖饮食,每日三餐,每餐七分饱。进行以下测试。
测试一:体倦身重、精力不济感变化
根据自身体会,比较服用制剂前后的体倦身重、精力不济感是否有变化,按照以下标准打分:5分-明显减轻,身体轻盈,精力充沛;4分-减轻,偶尔感觉体倦、精力不济;3分-一般程度减轻,体倦和精力有一定好转;2分-减轻不明显,时常体倦、精力不济;1分-与服用前基本没变化,甚至更重。
统计不同服用不同制剂后体倦身重、精力不济感的分数及对应的人数,见表2:
表2:体倦身重、精力不济感减轻度结果
由上表可见,服用本发明的制剂两个月后,体倦身重、精力不济感明显降低,90%以上的受试者反应身体状态变好,体质增强。这一结果远远好于对比制剂。
测试二:舌苔黄腻症状
同样比较服用制剂前后的口苦、舌苔黄腻情况,按照以下标准打分:5分-明显减轻,舌苔基本正常;4分-减轻,舌苔略有黄腻,偶尔口苦;3分-一般程度减轻,舌苔尚有黄腻,口苦频率减少;2分-减轻不明显,舌苔常见黄腻,口苦时有发生;1分-与服用前基本没变化,甚至更重。
统计不同服用不同制剂后急躁易怒现象发生情况,见表3:
表3:舌苔黄腻症状统计
实验例1 | 实验例2 | 对比例1 | 对比例2 | |
5分 | 8 | 7 | 1 | 0 |
4分 | 15 | 14 | 4 | 3 |
3分 | 5 | 8 | 8 | 6 |
2分 | 2 | 1 | 12 | 11 |
1分 | 0 | 0 | 5 | 10 |
由表3可见,相比于对比制剂,服用本发明的制剂后,舌苔黄腻、口苦等症状明显减轻,身热口渴等相关症状同样减轻,饮水正常。
测试三:体重、体脂率的变化
脾胃湿热导致体重过重、体脂率高,也是本发明希望解决的问题。通过服用本发明的制剂并配合减重餐饮,检测体重和体脂率的减轻和降低情况。
体重测量:每日固定作息、固定时间测量,最终以服用前和服用两个月后的结果进行比较。
表4:体重变化结果
注:考虑到测量误差,减轻≤1kg视为无变化。
由表4可见,服用实验例1和实验例2制剂的受试者,体重减轻非常明显,几乎所有人都有减重效果,且减重量适当,大部分受试者两个月减重2~4kg,对身体基本没有不良影响。
体脂率以服用前和服用两个月后的测量结果进行计算,测量和计算方式按照常规方式进行。体脂降低率采用如下公式计算:
(服用前体脂率-服用后体脂率)/服用前体脂率×100%。
表5:体脂率降低量结果
体脂率降低量 | 实验例1 | 实验例2 | 对比例1 | 对比例2 |
>10% | 2 | 1 | 0 | 0 |
7%~10%(含) | 7 | 5 | 0 | 0 |
4%~7% | 16 | 14 | 6 | 6 |
1%(不含)~4% | 5 | 9 | 11 | 8 |
≤1% | 0 | 1 | 13 | 16 |
注:考虑到测量误差,减轻≤1%视为无变化。
由于脾胃湿热型患者代谢紊乱,普通减重餐饮并不能有效减轻体重并降低体脂率,需要从根源处解决脾胃湿热情况。服用本发明的实验例1和实验例2的制剂两个月后,体脂率明显降低,有部分受试者的体脂率已经回归到正常状态。
实施例2:动物实验
近年研究发现,前列腺素E2在胃黏膜损伤的保护和修复方面发挥重要作用。本实施例通过构建大鼠慢性胃炎脾胃湿热证模型,探究本发明制剂对大鼠胃黏膜前列腺素E2含量的影响,从而验证本发明制剂的效果。
清洁级大鼠60只,雄性,质量在180~200g(购自北京维通利华实验动物技术有限公司),实验前后均自由饮食,12h光亮/黑暗条件,22~25℃环境温度,50%~60%相对湿度条件下饲养。
大鼠随机分成4组,每组15只,分为正常对照组、模型对照组、实验组、对比组。所有组动物均在造模前禁食12小时,自由饮水,测定体重,造模时间15天。
正常对照组:如上所述环境下饲养,普通饲料正常喂养,连续22天后处死。
模型对照组:在普通饲料基础上,加用200g/L蜂蜜水自由饮用,每日灌服2%水杨酸钠2mL/200g,连续15天,且第1~10天隔日按大鼠体重灌服油脂2g/200g,并与油脂隔日灌服2mL/200g白酒,共10天。第11~15天,每日8:00~22:00置于人工气候箱中(箱中环境设置为:温度,31~35℃;相对湿度,95%),共5天,造模结束后,移至自然环境,7天后处死大鼠。
实验组:造模方法同模型对照组。造模结束后移至自然环境12h后,每天灌服实验例1的制剂2ml/200g(提前配制成1g/mL混悬液),每天1次,7天后处死大鼠。
对比组:造模方法同模型对照组。造模结束后移至自然环境12h后,每天灌服对比例1的制剂2ml/200g(提前配制成1g/mL混悬液),每天1次,7天后处死大鼠。
前列腺素E2的检测:
大鼠在处死后,立即剖腹,取胃,沿胃大弯剪开,用冰盐水冲去胃内容物,在胃窦部(避开溃疡和糜烂)取胃黏膜组织数块,立即置于液氮冷冻,称取3mg放入匀浆器中,加无水乙醇0.4g,研磨,再加生理盐水1.6mL,研磨制成匀浆,离心,将上清液吸出,加重蒸馏乙酸乙酯5mL,置混匀器上2min,离心(3500r/min,15min)。上清液吸至20mL液闪瓶中,再加5mL乙酸乙酯提取一次。两次提取液合并,吹干,-20℃保存待测。所有样品按照前列腺素E2放射免疫分析测定盒(上海钰博生物科技有限公司)说明书的要求检测前列腺素E2含量。所有数据采用SPSS 17.0处理。P<0.05为显著差异。结果见表6。
表6:前列腺素E2检测结果
注:#,与正常对照组比较,P<0.05;*,与模型对照组比较,P<0.05
根据结果可知,模型对照组相对于正常对照组,前列腺素E2含量明显下降,说明造模成功。实验组相对于模型对照组显著上升,说明本发明制剂对于前列腺素E2的恢复有明显作用,也说明本发明制剂能够有效地改善脾胃湿热型慢性胃炎的胃动力。
Claims (10)
1.一种组合物,包括按质量份计的以下成分:栀子提取物15~25份,茯苓提取物25~35份,陈皮提取物30~50份,莲子提取物25~35份,山药提取物30~50份,芦荟提取物15~25份,马铃薯提取物1~3份,发酵复合果蔬粉90~110份;优选地,所述各提取物为水提粉。
2.根据权利要求1所述的方,其中,所述组合物包括按质量份计的以下成分:栀子提取物20份,茯苓提取物30份,陈皮提取物40份,莲子提取物30份,山药提取物40份,芦荟提取物20份,马铃薯提取物1份,发酵复合果蔬粉100份。
3.根据权利要求1或2所述的组合物,其中,所述栀子提取物的提取比例为5:1~20:1,优选10:1;所述茯苓提取物中多糖的质量含量为10%~50%,优选20%;所述陈皮提取物中总黄酮的质量含量为10%~50%,优选30%;所述莲子提取物的提取比例为5:1~20:1,优选10:1;所述山药提取物的提取比例为5:1~20:1,优选10:1;所述芦荟提取物的提取比例为100:1~200:1,优选100:1,进一步优选地,所述芦荟提取物为库拉索芦荟凝胶粉;所述马铃薯提取物中蛋白酶抑制剂PI2含量为2%~10%,优选为5%。
4.一种制剂,包括有效成分和辅料,其中有效成分为权利要求1~3任一项所述的组合物,在制剂中的质量含量为30%~40%,所述辅料为制剂学上可接受的辅料,包括甜味剂、果粉、香精中的一种或多种。
5.根据权利要求4所述的制剂,其中,所述甜味剂包括菊粉、低聚果糖、低聚异麦芽糖、低聚木糖、三氯蔗糖、甜菊糖苷、赤藓糖醇、木糖醇、异麦芽酮糖醇、麦芽糖醇、山梨糖醇中的一种或多种;所述果粉为任意果粉,优选橙子汁粉;所述香精为任意风味的香精,优选橙粉末香精。
6.根据权利要求4或5所述的制剂,其中,所述制剂为药品、食品或保健品。
7.根据权利要求6所述的制剂,其中,所述制剂的剂型为粉剂、颗粒剂、丸剂、片剂、胶囊剂、膏剂或口服液。
8.权利要求4~7任一项所述制剂的制备方法,包括称取配方量的有效成分和辅料,混合均匀,即得。
9.权利要求1~3任一项所述组合物在制备调理脾胃湿热的制剂中的应用。
10.权利要求1~3任一项所述组合物在制备用于减肥的制剂中的应用。
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