CN112546167A - 一种具有健脾利湿功能的中药组合物及其制备方法和应用 - Google Patents
一种具有健脾利湿功能的中药组合物及其制备方法和应用 Download PDFInfo
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- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Abstract
本发明提供了一种具有健脾利湿功能的中药组合物及其制备方法和应用,该中药组合物由下述重量配比的原料组成:薏苡仁10~30份、白扁豆5~15份、茯苓5~15份、莲子5~15份、山药5~15份、山楂5~15份、麦芽5~15份、芡实5~15份。本发明该配方中,薏苡仁、白扁豆、茯苓健脾利湿,为方中君药;莲子、山药、芡实补脾止泻、益肾固精,为方中臣药;麦芽、山楂健脾行气、健胃消食,为方中佐药;本发明诸药合用,协同作用,能健脾祛湿,行气健胃,对于脾虚湿盛引起的单纯性肥胖有治疗作用。并且,本发明具有很高的安全性。
Description
技术领域
本发明涉及医药和食品技术领域,具体涉及一种具有健脾利湿功能的中药组合物及其制备方法和应用。
背景技术
随着现代社会竞争日益激烈,生活节奏不断加快,越来越多的人日常缺少运动,平时饮食无节制,尤其喜甜食或肥腻的食物。常吃肥腻或过甜的食物会导致人脾虚,因而生湿,人们容易出现四肢困乏、脘腹痞闷、大便稀软、神疲乏力等现象。这些现象虽然无法从西医的检查和诊断得出标准,但是从中医的角度入手,可以得出是脾虚湿阻证的临床表现。中医认为:脾主运化、主生血统血以及主升清的功能。根据最新的研究,脾虚湿阻与单纯性肥胖及其糖脂代谢紊乱等临床病症表现有关。
目前,市场上治疗因脾虚湿阻导致病变的药品较多,大多数为中成药和化学药品,其安全性存疑。因此,需要开发一种较高安全性的健脾利湿功能的中药组合物,可将其应用于保健食品领域中。
发明内容
有鉴于此,本申请提供一种具有健脾利湿功能的中药组合物及其制备方法和应用,本发明提供的中药组合物能健脾祛湿,行气健胃,并且具有较高的安全性。
为实现上述目的,本发明采用的技术方案如下:
本发明提供了一种具有健脾利湿功能的中药组合物,其由下述重量配比的原料组成:薏苡仁10~30份、白扁豆5~15份、茯苓5~15份、莲子5~15份、山药5~15份、山楂5~15份、麦芽5~15份、芡实5~15份。
在本申请的一些实施例中,所述具有健脾利湿功能的中药组合物由下述重量配比的原料组成:薏苡仁20~24份、白扁豆8~12份、茯苓7~12份、莲子5~14份、山药5~12份、山楂5~15份、麦芽10~12份、芡实5~12份。
优选地,所述具有健脾利湿功能的中药组合物由下述重量配比的原料组成:薏苡仁24份、白扁豆12份、茯苓12份、莲子12份、山药12份、山楂12份、麦芽12份、芡实10份。其制备方法包括以下步骤:按照配比(如以克计)称取薏苡仁、白扁豆、茯苓、莲子、山药、山楂、麦芽、芡实,加入1000份的水提取2次,每次1小时,合并滤液,过滤,浓缩成稠膏或干燥成粉末。
其中,薏仁又名薏苡仁、苡米、苡仁,土玉米等。薏苡仁为禾本科植物薏苡Coixlacryma-jobi L.var.mayuen(Roman.)Stapf的干燥成熟种仁。薏苡仁味甘、淡,性凉;归脾、胃、肺经。薏苡仁有利水渗透湿,健脾止泻,除痹,排脓,解毒散结的作用。现代医学研究表明,薏苡仁有抗炎、镇痛、提高机体免疫、抗菌等多方面的生理活性。以重量份计,本发明所述的中药组合物可以包括30份、24份、20份、15份、10份的薏苡仁。
白扁豆为豆科扁豆属植物扁豆Dolichos lablab L.的干燥成熟种子。味甘、性微温。归脾、胃经。有健脾化湿,和中消暑的作用。现代药理研究结果表明白扁豆水提液有抗菌、抗病毒的作用;临床用白扁豆治疗脾虚所致慢性泄泻、急性胃肠炎呕吐腹泻有较好的疗效。以重量份计,本发明所述的中药组合物可以包括15份、12份、10份、8份、5份的白扁豆。
茯苓,又称玉灵、茯灵、万灵桂等;茯苓系多孔菌科真菌茯苓Poria cocos(Schw.)Wolf的干燥菌核。茯苓味甘、淡,性平;归心、肺、脾、肾经。茯苓具有利水渗湿,健脾,宁心等功效。现代药理研究结果表明,茯苓具有抗氧化、免疫调节、抗炎等作用。本发明所述的中药组合物可以包括15份、12份、9份、7份、5份的茯苓,优选为12重量份。
芡实为睡莲科植物芡Euryale ferox Salisb.的干燥成熟种仁。味甘、涩,性平。归脾、肾经。有益肾固精,补脾止泻,除湿止带的功效。现代药理研究结果表明芡实具有保护胰脏和肝脏、抗氧化、抑菌、抗神经细胞毒性的作用,临床多用于治疗肾炎蛋白尿、慢性肾炎、原发肾病综合征、慢性肾功能不全等肾脏疾病以及乳糜血尿、慢性肠炎、遗精、中风后遗症、早期糖尿病肾病等症。
山药为薯蓣科植物薯蓣Dioscorea opposita Thunb.的干燥根茎。味甘、性平。入肺、脾、肾经。有健脾,补肺,固肾,益精的功效。现代药理研究结果表明,山药具有抗氧化、免疫调节、调节脾胃功能;临床多用于治疗脾虚久泻、慢性肠胃炎等症。
莲子为睡莲科植物莲Nelumbo nucifera Gaertn.的干燥成熟种子。味甘、涩,性平。归脾、肾、心经。有补脾止泻,止带,益肾涩精,养心安神的功效。现代药理研究结果表明,莲子有抗氧化、抗菌消炎等作用。
麦芽为禾本科植物大麦Hordeum vulgare L.的成熟果实经发芽干燥的中药炮制加工品。味甘、性平。归脾、胃经。有行气消食,健脾开胃,回乳消胀的功效。现代临床多用于治疗慢性肝炎、消化不良、小儿腹泻、围绝经期综合症等疾病。
山楂为蔷薇科植物山里红Crataegus pinnatifida Bge.var.major N.E.Br.或山楂Crataegus pinnatifida Bge.的干燥成熟果实。味酸、甘,性微温。归脾、胃、肝经。有消食健胃,行气散瘀,化浊降脂的功效。现代药理研究结果表明,山楂对胃肠道有双向调节作用,并有保护肝脏、抗菌等作用。
与现有技术相比,根据中医理论,本发明提供一种健脾利湿的中药组合物,该配方中,薏苡仁、白扁豆、茯苓健脾利湿,为方中君药;莲子、山药、芡实补脾止泻、益肾固精,为方中臣药;麦芽、山楂健脾行气、健胃消食,为方中佐药;本发明诸药合用,协同作用,能健脾祛湿,行气健胃,对于脾虚湿盛引起的单纯性肥胖有治疗作用。
并且,本发明组合物中的原料均在原卫生部公布的《既是食品又是药品的物品名单》中,属于药食同源的中药原料,用于药品、保健食品具有安全性;本发明采取传统的水提工艺,进一步提升安全性。
本申请实施例提供了如前文所述的中药组合物的制备方法,包括以下步骤:按照重量配比称取薏苡仁、白扁豆、茯苓、莲子、山药、山楂、麦芽和芡实,用水提取2~3次,每次0.5~2小时,过滤,合并滤液,浓缩或干燥即得。其中,所述提取、过滤等为本领域人员熟知的技术操作;本发明优选用400目滤布过滤。
在本申请的优选实施例中,称取各原料混合后,加入1000份的水提取2~3次,每次1~1.5小时;进一步优选加入1000份的水提取2次,每次1小时。过滤,合并滤液后,本发明一些实施例将合并的滤液浓缩成一定量稠膏,另一些实施例也可干燥成粉末。
本发明提供了如前文所述的中药组合物在制备用于治疗单纯性肥胖的药品或保健食品中的应用;其中,可用于保健食品领域日常食用。
在本申请的一些实施例中,所述中药组合物对脾虚湿盛引起的单纯性肥胖有减肥和/或调节糖代谢、脂代谢的功效。
在本申请的具体实施例中,所述用于治疗单纯性肥胖的药品或保健食品的形态可为液态、固态或膏状,例如粉末状、颗粒状、丸状、稠膏状、胶囊状、片状等。此外,本发明可在该中药组合物中进一步添加本领域可接受的辅料,按照常规方式制成不同形态的健脾利湿的药品、食品。
具体实施方式
下面对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。
为了进一步理解本申请,下面结合实施例对本申请提供的具有健脾利湿功能的中药组合物及其制备方法和应用进行具体地描述。其中,本发明对各原料的来源没有特殊限制。
实施例1:
按照配方称取薏苡仁24g、白扁豆12g、茯苓12g、莲子12g、山药12g、山楂12g、麦芽12g、芡实10g。加入1000份的水提取2次,每次1小时,400目滤布过滤,合并滤液,浓缩成100g稠膏。
实施例2:
按照配方称取薏苡仁30g、白扁豆5g、茯苓9g、莲子15g、山药8g、山楂7g、麦芽12g、芡实15g。加入1000份的水提取2次,每次1.5小时,400目滤布过滤,合并滤液,浓缩成100g稠膏。
实施例3:
按照配方称取薏苡仁20g、白扁豆15g、茯苓7g、莲子14g、山药15g、山楂9g、麦芽12g、芡实12g。加入1000份的水提取3次,每次2小时,400目滤布过滤,合并滤液,浓缩成100g稠膏。
实施例4:
按照配方称取薏苡仁10g、白扁豆8g、茯苓15g、莲子5g、山药10g、山楂5g、麦芽12g、芡实8g。加入1000份的水提取2次,每次0.5小时,400目滤布过滤,合并滤液,浓缩成100g稠膏。
实施例5:
按照配方称取薏苡仁15g、白扁豆10g、茯苓5g、莲子9g、山药5g、山楂15g、麦芽12g、芡实5g。加入1000份的水提取2次,每次1小时,400目滤布过滤,合并滤液,浓缩成100g稠膏。
对比例1:
按照配方称取薏苡仁5g、白扁豆20g、茯苓3g、莲子2g、山药25g、山楂20g、麦芽12g、芡实3g。加入1000份的水提取2次,每次1小时,400目滤布过滤,合并滤液,浓缩成100g稠膏。
对比例2:
按照配方称取薏苡仁50g、白扁豆3g、茯苓20g、莲子18g、山药2g、山楂2g、麦芽12g、芡实25g。加入1000份的水提取2次,每次1小时,400目滤布过滤,合并滤液,浓缩成100g稠膏。
对比例3:
与实施例1相比,不含有白扁豆和茯苓,其余相同。
对比例4:
与实施例1相比,不含有白扁豆和山楂,其余相同。
对比例5:
与实施例1相比,不含有山药和芡实,其余相同。
对比例6:
与实施例1相比,不含有白扁豆、山药和山楂,其余相同。
实施例6
本发明提供了上述实施例及对比例制品的动物试验研究:
实验动物分组与造模:SPF级健康昆明种小鼠,体重18~22g,4周龄,雌雄各半,采用随机数字法随机分为两组:正常对照组10只,模型制作组120只。正常对照组每日喂饲基础饲料,模型制作组每日喂饲高脂低蛋白饲料。造模70d,建立单纯性肥胖小鼠模型。
继续将模型制作组采用随机数字法随机分为12组,每组10只,分别为模型空白组1组、实施例组5组、对比例组6组。
给药方法:正常对照组,模型空白组每日灌胃4.0g/kg BW纯净水,实施例组按编号每日灌胃给予对应的实施例样品4.0g/kg BW,对比例组按编号每日灌胃给予对应的对比例样品4.0g/kg BW。各组均连续给药42d,给药期间,正常对照组喂饲基础饲料,其余各组喂饲高脂低蛋白饲料。
实验方法及结果:
1、样品对小鼠体重的影响
给药前和给药结束后,分别对各组小鼠测量体重,结果见表1。
注:a与正常对照组相比,P<0.01;c与模型空白组相比,P<0.01;d与模型空白组相比,P<0.05;双上标表明样品组分别与正常组及模型组比较。
由表1可见,给药6周后,给药前、给药后样品实施例组的小鼠体重及试验期间小鼠体重增长值与模型空白组比较,有显著性差异(P<0.05),表明该样品对单纯性肥胖的小鼠的体重降低作用。其中,实施例1组体重下降效果较为明显。
2、样品对小鼠血糖、胰岛素水平的影响
给药结束后,对各组小鼠进行葡萄糖耐量实验(GTT)和胰岛素抵抗实验(ITT),结果见表2。
注:a与正常对照组相比,P<0.01;b与正常对照组相比,P<0.05;c与模型空白组相比,P<0.01;d与模型空白组相比,P<0.05。
由表2可见,模型空白组小鼠的血糖和胰岛素水平明显高于正常组,实施例组经对应的实施例样品治疗后,实施例组血糖和胰岛素水平均有明显(P<0.05)下降,说明表明实施例样品可调节对单纯性肥胖小鼠的糖代谢功能恢复能量代谢的平衡。综合比较,实施例1组血糖和胰岛素下降效果较为明显。
3、样品对小鼠血脂水平的影响
给药结束后,摘除眼球进行取血,4℃,3500rpm条件下离心。测定血清中TC、HDL、LDL和VLDL的水平,结果见表3。
注:a与正常对照组相比,P<0.01;b与正常对照组相比,P<0.05;c与模型空白组相比,P<0.01;d与模型空白组相比,P<0.05。
由表3可见,模型空白组小鼠的血糖和胰岛素水平明显高于正常组,实施例组经对应的实施例样品治疗后,实施例组TC、HDL、LDL和VLDL的水平均有下降,并有显著性差异(P<0.05),说明表明该样品可调节单纯性肥胖小鼠的脂代谢。综合比较后,实施例1组对小鼠脂代谢调节效果较为明显。
通过上述针对小鼠的实验可知,采用本发明实施例提供的样品,对脾虚湿盛引起的单纯性肥胖有减肥、调节糖脂代谢的功能。而其余减方以及配比不在本申请范围内的配方,功效并不明显。
上述小鼠实验的给药量为4.0g/kg BW,推算出人体的服用量为26g/天(人体重按60kg计),按实施例1计,相当于薏苡仁6.24g、白扁豆3.12g、茯苓3.12g、莲子3.12g、山药3.12g、山楂3.12g、麦芽3.12g、芡实2.6g,低于《中国药典》的常规用量。综上,本发明所述健脾利湿的中药组合物具有很高的安全性。
最后应当说明的是,以上内容仅用以说明本发明的技术方案,而非对本发明保护范围的限制,本领域的普通技术人员对本发明的技术方案进行的简单修改或者等同替换,均不脱离本发明技术方案的实质和范围。
Claims (8)
1.一种具有健脾利湿功能的中药组合物,其特征在于,由下述重量配比的原料组成:薏苡仁10~30份、白扁豆5~15份、茯苓5~15份、莲子5~15份、山药5~15份、山楂5~15份、麦芽5~15份、芡实5~15份。
2.根据权利要求1所述的中药组合物,其特征在于,由下述重量配比的原料组成:薏苡仁20~24份、白扁豆8~12份、茯苓7~12份、莲子5~14份、山药5~12份、山楂5~15份、麦芽10~12份、芡实5~12份。
3.根据权利要求2所述的中药组合物,其特征在于,由下述重量配比的原料组成:薏苡仁24份、白扁豆12份、茯苓12份、莲子12份、山药12份、山楂12份、麦芽12份、芡实10份。
4.如权利要求1~3任一项所述的中药组合物在制备用于治疗单纯性肥胖的药品或保健食品中的应用。
5.根据权利要求4所述的应用,其特征在于,所述中药组合物对脾虚湿盛引起的单纯性肥胖有减肥和/或调节糖脂代谢的功能。
6.根据权利要求4所述的应用,其特征在于,所述用于治疗单纯性肥胖的药品或保健食品的形态为液态、固态或膏状。
7.如权利要求1~3任一项所述的中药组合物的制备方法,包括以下步骤:按照重量配比称取薏苡仁、白扁豆、茯苓、莲子、山药、山楂、麦芽和芡实,用水提取2~3次,每次0.5~2小时,过滤,合并滤液,浓缩或干燥即得。
8.根据权利要求7所述的制备方法,其特征在于,所述按照重量配比称取之后,用1000份的水提取2~3次,每次1~1.5小时,过滤,合并滤液,浓缩成稠膏或干燥成粉末,即得。
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