CN113318139A - 一种降血糖、降血脂的药食两用中药组合物 - Google Patents
一种降血糖、降血脂的药食两用中药组合物 Download PDFInfo
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Abstract
本发明涉及一种中药,具体是一种降血糖、降血脂的药食两用中药组合物。由以下重量份数的原料制备而成:菊苣10‑70份,茯苓30‑90份。以菊苣为核心成分,筛选经典药材茯苓与菊苣复配,起到疏肝利胆、健脾和胃益肾的作用,健脾运胃、祛湿泄浊、解毒通利。本配方的制定基于“肝脾相关”中医理论,合理组方,实现调整糖脂多种代谢疾病。复方制剂可以产生相互协同作用,这种协同作用可以明显降血脂、降血糖等,改善多种代谢疾病,“整合论治”老年人的一体多病状况。
Description
技术领域
本发明涉及一种中药,具体是一种降血糖、降血脂的药食两用中药组合物。
技术背景
中国国家***数据显示,截至2019年末,中国60岁及以上人口约有2.54亿,占总人口的18.1%。我国人口结构老龄化趋势明显,随着年龄的增长,老年人的各个脏器生理功能减退,心血管、糖尿病发病率明显升高,给患者和社会带来了沉重的负担,需要凝聚全社会共同的力量减缓糖、脂代谢性疾病的发展。老年人免疫力低下,易患高血压、糖尿病、冠心病、痛风及肿瘤等各种慢性疾病。老年患者一般是“共病老人”:一人身上常有两种以上的疾病。现有的数据显示:老年人有一个慢病的大约为90%,两个病共病的约70%,三个病以上的约有50%,65岁以上的老人有半数都有三个以上的疾病,一体多病十分常见,有的甚至一个脏器就同时存在几种病变。这些疾病致残率及病死率极高,对于一体多病,多种老年代谢综合征共存于一身的老年群体来说,常常面临需要多次挂号、多科看诊的繁琐流程,而其药物治疗也因多病混合,存在产生联合副作用的风险,导致病越看越多、越看越重。有调查显示,我国65岁以上的老年人中,25%左右的人在同时服用4—6种药物,由于用药不当带来的问题也比其他年龄的人要多。
因此,非常有必要开展非药物干预,研发一款安全有效、同时调整糖、脂等多种代谢紊乱、适合老年人一体多病特点的营养保健食品;“整合论治”、来满足老年人健康的特殊需求。
菊苣(Cichorium intybus L.)又名苦苣、法国苦苣、奇可力、咖啡草等,是菊科菊苣属多年宿根植物,原产于地中海、中亚和北非,早在古罗马和希腊时代己有栽培。菊苣在欧洲栽培甚多,多年来常被用作叶类蔬菜、牧草、制糖原料及咖啡的替代品。我国新疆、山东、内蒙古等地也有分布。菊苣是维吾尔族和蒙古族***滑肌张力。种子有非特异性植物血球凝集素”。国外亦有菊苣药用的研究报道。研究表明,菊苣提取物不仅是菊粉、菊苣酸、果糖等的重要来源,菊苣提取物的成分复杂,目前从菊苣中已分离得到多糖类、萜类(尤其是倍半萜类)、黄酮类、酚酸类化合物和多种维生素、金属元素等化学成分。而且它本身也具有许多的生理活性,比如增强免疫能力、抗炎作用、降尿酸、降低胆固醇和血糖等。
茯苓是多孔菌科真菌茯苓Poriacocos(Schw.)Wolf的干燥菌核;药食两用大宗中药材,临床运用最多的四大传统药材之一,有“十方九苓”之说,我国干茯苓年需求量达3万多吨,是我国中成药的主要原料药材,茯苓产业产值超过100亿元。茯苓主产于湖北、安徽、福建、云南、湖南、贵州、四川等省,味甘、淡,性平,无毒,具有利水渗湿、健脾、宁心的功效,主治水肿尿少、痰饮眩悸、脾虚食少、便溏泄泻、心神不安、惊悸失眠等,与适宜的药物配伍,不论寒、温、风、湿诸疾,均能发挥其独特功效。茯苓傍松根而生,古称茯菟,我国早在2000多年前的汉代即有茯苓的应用,《神农本草经》将其列入“轻身益气,不老延年”的“上品”。主胸胁逆气,忧恚惊邪恐悸,心下结痛,寒热烦满,咳逆,口焦舌干,利小便;《本草纲目》记载,茯苓气味淡而渗,其性上行,生津液,开腠理,滋水源。而迄今为止,从茯苓中发现的化学成分主要有多糖类、三萜类、甾醇类、氨基酸、脂肪酸等,其中报道的具有生物活性的化合物主要集中在三萜类和多糖类化合物。目前共分离鉴定了三萜类成分84种,多糖类成分60余种。茯苓化学成分主要起作用的是茯苓多糖类和茯苓三萜类,其药效丰富。茯苓多糖具有抗肿瘤、保肝、利尿、降尿酸、抗衰老、抗炎、降血脂、降血糖、增强免疫、催眠等作用;茯苓三萜具有抗肿瘤、保肝、抗衰老、抗炎、增强免疫等作用。
发明内容
本发明的目的是提供一种降血糖、降血脂的药食两用中药组合物;
本发明是通过下列技术方案实现的:
一种降血糖、降血脂的药食两用中药组合物,由以下重量份数的原料制备而成:菊苣10-70份,茯苓30-90份。
进一步地,由以下重量份数的原料制备而成:菊苣25-55份,茯苓45-75份。进一步地,由以下重量份数的原料制备而成:菊苣34份,茯苓66份。
进一步地,所述中药组合物的制备方法包括如下步骤:
S1:按照重量份,菊苣、茯苓中加入4-30倍重量的水,采用煎煮法,煮沸后100℃回流提取5-8小时,提取液用滤布板框过滤,得到混合药液;
S2:浓缩:将得到的混合药液浓缩至相对密度1.0-1.3;
S3:制备药粉:将浓缩后的混合药液喷雾干燥,雾化器的频率为15HZ-20HZ,排风温度100℃,粉碎后过筛,得到中药组合物。
进一步地,所述中药组合物加入药学或生理学可接受的辅料,所述辅料为填充剂、矫味剂、润滑剂、崩解剂中的一种或多种。
进一步地,所述的中药组合物制成颗粒剂、粉剂、胶囊、片剂、丸剂、液体剂型。
本发明的优点:
发明人先后观察了菊苣提取物对多种代谢交互紊乱等的药理作用并进行机理研究。研究证实菊苣提取物可显著降低高甘油三酯、高尿酸并高血糖等交互紊乱大鼠血清TG、UA、Glu水平,其作用机理与抑制FAS及XO活性、增加Ins含量有关。
本配方的特点:设计以菊苣为核心成分,筛选经典药材茯苓与菊苣复配,起到疏肝利胆、健脾和胃益肾的作用,健脾运胃、祛湿泄浊、解毒通利。本配方的制定基于“肝脾相关”中医理论,合理组方,实现调整糖脂多种代谢疾病。复方制剂可以产生相互协同作用,这种协同作用可以明显降血脂、降血糖等,改善多种代谢疾病,“整合论治”老年人的一体多病状况。
基于中医“整合论治”策略筛选药性平和之品菊苣、茯苓组成配方,菊苣、茯苓均可健脾祛湿,菊苣还具有疏肝利胆、清热解毒、通利关节的功效,是张冰教授“整合论治”策略下标本兼治的药物组成。二药通过疏肝利胆、健脾运胃的作用整体调节代谢紊乱,利湿泄浊加速体内代谢废物的清除,兼能解毒通利、增强免疫力,选药精巧,独具匠心。
菊苣微苦、咸,凉。归肝、胆、胃经。《中国药典》(2020年版)载其功能清肝利胆,健胃消食,利尿消肿。可用于胃痛食少,水肿尿少。能协助茯苓增强健脾和胃、利水除湿之功,用作君药。茯苓甘、淡,平。归心、脾、肾经。《神农本草经》谓其:“利小便。久服安魂、养神、不饥、延年。”《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,健脾宁心之功。脾为后天之本。茯苓健运脾胃,兼能渗泄湿浊,用为臣药。
二药均可健脾祛湿,能导水下行通利膀胱,但茯苓性平偏于健脾渗湿;菊苣性寒善泻肾及膀胱之热以除下焦湿热。二药合用利水渗湿之功尤著且能胜热用于治疗水湿停滞下焦之水肿、小便不利、泄泻等证属偏热者。
具体实施方式
为使本发明的目的、技术方案和优点更加清楚,下面本发明中的技术方案进行清楚、完整地描述,显然,所描述的实施例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。
“糖脂代谢性疾病”是指以糖、脂代谢紊乱为特征,以肥胖、高血糖、高血脂、脂肪肝和动脉粥样硬化等疾病单一或合并出现为临床特点的疾病。临床上对于多种代谢紊乱,常常同时给予两种或两种以上的药物进行治疗,以分别降低甘油三酯(TG)和血糖(Glu)等指标含量,这种用药方式既不经济,也可能产生许多意想不到的副作用。
中医学无“糖脂代谢性疾病”的病名,多将其归属于“消渴”“痰浊”和“瘀血”等范畴,是一组由于脏腑功能失调,津液失于输化导致的综合症。现代学者研究认为,血糖、血脂与营血津液颇为相似,是水谷精微所化生的精微物质。病理状态下各种原因所致的气血运行不畅,水谷精微输布失常,生成痰浊血瘀阻遏脏腑经络是糖脂代谢性疾病发生的基本中医病机。现代人嗜食肥甘厚味,饮食不节是糖脂代谢疾病发病的始动因素。如《素问·通评虚实论》所言:“肥贵人,则高粱之疾也”。《素问·奇病论篇》曰:“肥者,令人内热,甘者令人中满,故其气上溢,转为消渴”。李杲在《脾胃论》中亦提到:“至于五味,口嗜而欲食之,必自裁制,勿使过焉,过则伤其正也”。过食肥甘厚味,损伤脾胃,水谷精微运化失司,精微物质不能正常布散,肝气失于濡养则致肝气不足或肝气失司有进一步加重脾失运化。由此可见,肝失疏泄、脾失健运是其发生的关键病机。因此,在中医“肝脾相关”理论指导下,深入探讨疏肝健脾法对糖脂代谢性疾病的防治作用,将有助于开辟中西医结合防治糖脂代谢性疾病的新思路。
实施例1:
降血糖、降血脂的药食两用中药组合物,由以下重量份数的原料制备而成:菊苣35份,茯苓65份,每份5kg。
实施例2:
降血糖、降血脂的药食两用中药组合物,由以下重量份数的原料制备而成:菊苣30份,茯苓70份,每份5kg。
实施例3:
降血糖、降血脂的药食两用中药组合物,由以下重量份数的原料制备而成:菊苣40份,茯苓60份,每份5kg。
实施例4:制备方法
(一)提取
按上述各实施例配比称取菊苣和茯苓,投入罐中,加10倍的水,煮沸,在100℃回流提取5小时,提取液用滤布板框过滤,不能有黑渣,浓缩至相对密度1.05。
(二)喷雾干燥
开启离心风机,检查风机类设备的运行情况:包括是否有高速离心喷雾干燥机振动、异声、异味等,电机及轴承的温度是否正常,地脚螺丝是否有松动。
(先开蒸汽加热)开启电加热器(电加热是起辅助加热作用),并检查是否漏电(如果漏电,控制柜会自动跳掉)。进行筒身预热,预热温度在150-250℃之间。
打开风机进风温度控制在150-250℃。
放置离心喷雾头,开启离心喷头,将雾化器的频率慢慢调到一定的频率(根据实际情况确定15HZ-20HZ),让喷头达到该频率条件下的最高转速时,开启进料泵,打开进料泵的出口阀门。同时打开筒身底部和旋风分离器底部的授粉器,接受料物。连续生产的时候不需要每批物料都清洗,需要根据物料的腐蚀性来确定,洗离心喷头时一般不需要拆卸,用螺杆泵打清水清洗。
慢慢打开离心喷头的阀门,使下料量由小到大,否则将产生粘壁现象,直到调节到适当的要求,以保持排风温度为一个常数80-100℃。
干燥后的成品被收集,在塔体下部和旋风分离器下部的授粉器内,在授粉器未经充满前就应调换,在调换授粉器时,必须先将上面的蝶阀关换方可进行。
使用完毕后,应喷水清洗。
在拆装时,应注意不能把主轴弄弯,装喷雾盘时要用塞片来控制盘和壳体的间隙,固定喷雾盘的螺母一定要拧紧,防止松动落
(先关蒸汽加热和电加热降温,同时关掉供料泵(螺杆泵)降温)当进口温度降到80℃-100℃关闭,雾化器在温度为80-100℃以下时可关闭,循环风机在温度为50-80℃以下时可关闭。
喷料完毕后,将原料液切换至溶剂,并且将雾化器频率调至40-70HZ,并喷雾8-20分钟左右,慢慢减速雾化器转速至10-30HZ左右,关闭离心喷头的电源。
保持离心风机运转,使旋风喷雾干燥塔内的温度降至30-60℃,然后关闭风机电源。
用螺杆泵打清水清洗离心喷雾干燥机。
收集的膏粉双袋密封避免吸潮。
检查膏粉的流动性,如果膏粉太细,可以加大喷料频率。
开始收集的膏粉应先溶于水检查是否有黑点异物。确认后再开始大生产。
(三)总混
膏粉粉碎过60-100目筛,加入填充剂一并过筛。
投料加入润滑剂,总混时间为45分钟,
双袋密封,避免吸潮。
(四)干法制粒
干法前确认设备清洁干净,14-40目颗粒100%,40目以下粉末重新干法制粒。注意减少损耗保证收率。
上述粉末或颗粒加入适宜辅料制成颗粒剂、粉剂、胶囊、片剂、丸剂、液体等剂型进行成品包装。
实施例5:将实施例4中水的加入量调整为20倍,100℃提取8小时,混合药液浓缩至相对密度1.07,然后喷雾干燥、粉碎、造粒得到产品。
实施例6:将实施例4中水的加入量调整为5倍,100℃提取6小时,混合药液浓缩至相对密度1.1,然后喷雾干燥、粉碎、造粒得到产品。
病例1:陈某,女,75岁,于半年前检查空腹血糖为:7.01mmol/L,总胆固醇5.16mmol/L,诊断为“T2DM”,患者否认家族高血压、糖尿病家族史。予以生活方式干预和口服菊苣茯苓汤(菊苣12g,茯苓22g)每日1剂,水煎服,分早晚2次服用,未接受其他药物治疗。嘱低脂低糖饮食。3个月后空腹血5.67mmol/L,总胆固醇4.44mmol/L。嘱坚持低脂、低糖饮食。定期复诊、复查血脂血糖水平。随访3个月血糖血脂水平稳定。
病例2:李某,男,48岁于2020年12月检查总胆固醇为7.19mmol/L,低密度脂蛋白为4.84,空腹血糖为4.93mmol/L。诊断为混合型高脂血症。予以生活方式干预和口服菊苣茯苓汤(菊苣10g,茯苓20g)每日1剂,水煎服,分早晚2次服用,未接受其他药物治疗。嘱低脂低糖饮食。3个月后总胆固醇为3.5mmol/L,低密度脂蛋白为1.58,空腹血糖为4.51mmol/L。嘱坚持低脂、低糖饮食。定期复诊、复查血脂血糖水平。随访3个月血糖血脂水平稳定。
以上所述实施例仅举例表达本发明的具体实施方式,其描述较具体详细,但并不能因此而理解为对本发明专利应用范围的限制;应当指出的是,对于本领域的普通技术人员来说,在不脱离本发明构思的前提下,还可以做出若干变形和改进,这些都属本发明的保护范围。因此,本发明专利的保护范围应以所附权利要求为准。
Claims (6)
1.一种降血糖、降血脂的药食两用中药组合物,其特征在于:由以下重量份数的原料制备而成:菊苣10-70份,茯苓30-90份。
2.根据权利要求1所述的降血糖、降血脂的药食两用中药组合物,其特征在于:由以下重量份数的原料制备而成:菊苣25-55份,茯苓45-75份。
3.根据权利要求1所述的降血糖、降血脂的药食两用中药组合物,其特征在于:由以下重量份数的原料制备而成:菊苣34份,茯苓66份。
4.根据权利要求1-3任一项所述的降血糖、降血脂的药食两用中药组合物,其特征在于:所述中药组合物的制备方法包括如下步骤:
S1:按照重量份,菊苣、茯苓中加入4-30倍重量的水,采用煎煮法,煮沸后100℃回流提取5-8小时,提取液用滤布板框过滤,得到混合药液;
S2:浓缩:将得到的混合药液浓缩至相对密度1.0-1.3;
S3:制备药粉:将浓缩后的混合药液喷雾干燥,雾化器的频率为15HZ-20HZ,排风温度80-100℃,粉碎后过筛60-100目,得到中药组合物。
5.根据权利要求1-3任一项所述的降血糖、降血脂的药食两用中药组合物,其特征在于:所述中药组合物加入药学或生理学可接受的辅料,所述辅料为填充剂、矫味剂、润滑剂、崩解剂等中的一种或多种。
6.根据权利要求5所述的降血糖、降血脂的药食两用中药组合物,其特征在于,所述的中药组合物制成颗粒剂、粉剂、胶囊、片剂、丸剂、液体剂型。
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