CN106214787B - 一种治疗糖尿病的中药组合物及其制备方法与用途 - Google Patents
一种治疗糖尿病的中药组合物及其制备方法与用途 Download PDFInfo
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Abstract
本发明属于药品或保健品领域,具体涉及一种治疗糖尿病的中药组合物及其制备方法与用途。该中药组合物的原料药包括:乌梅5~120重量份、黄连10~240重量份、肉桂2~120重量份。本发明以厥阴立论,采用肝脾同治的方法治疗糖尿病;该中药组合物,充分考虑各中药的归经和性味,并选择各中药相互之间的配比,使得各中药相互配合、共同作用,调和肝脾,清热温寒,从而发挥对糖尿病的治疗作用;此外,该中药组合物,组成简单、成本较低。
Description
技术领域
本发明属于药品或保健品领域,具体涉及一种治疗糖尿病的中药组合物及其制备方法与用途。
背景技术
糖尿病(diabetes)是由遗传因素、免疫功能紊乱、微生物感染及其毒素、自由基毒素、精神因素等等各种致病因子作用于机体,导致胰岛功能减退、胰岛素抵抗等而引发的糖、蛋白质、脂肪、水和电解质等一系列代谢紊乱综合征,临床上以高血糖为主要特点,典型病例可出现多尿、多饮、多食、消瘦等症状。
如果糖尿病没有得到足够的控制,可以引起一些急性并发症,如低血糖症、酮症酸中毒、非酮高渗性昏迷;严重的长期并发症包括:心血管疾病、慢性肾衰竭(又称糖尿病肾病,是发展中国家成年人中血液透析的主要原因)、视网膜病变(又称糖尿病眼病,可致盲,是发展中国家非老龄成年人致盲的主要疾病)、神经病变及微血管病变;其中,微血管病变可能导致勃起功能障碍(阳痿)以及伤口难以愈合,而足部难以愈合的伤口则可能导致坏疽(俗称“糖尿病足”),进而导致患者截肢。
糖尿病总的治疗原则是:通过改变生活方式,包括饮食控制、体育锻炼、减轻体重、不吸烟及避免二手烟(这对预防及控制糖尿病也有一定的效果),并配合一定的药物治疗,以达到控制血糖、预防并发症的目的。
目前,治疗糖尿病的降血糖药物主要有:(1)双胍类药物:主要通过减少肝葡萄糖的输出和改善外周胰岛素抵抗而降低血糖;(2)磺脲类药物:属于促胰岛素分泌剂,主要通过刺激胰岛β细胞分泌胰岛素、增加体内的胰岛素水平而降低血糖;(3)噻唑烷二酮类药物(TZDs):主要通过增加靶细胞对胰岛素作用的敏感性而降低血糖;(4)格列奈类药物:为非磺脲类的胰岛素促泌剂,主要通过刺激胰岛素的早期分泌而降低餐后血糖;(5)α-糖苷酶抑制剂:通过抑制碳水化合物在小肠上部的吸收而降低餐后血糖;(6)二肽基肽酶-4(DPP-4)抑制剂:通过抑制DPP-4而减少GLP-1在体内的失活,增加GLP-1在体内的水平;以及注射胰岛素以及胰高糖素样多肽-1(GLP-1)受体激动剂等。
目前,由于糖尿病病理、病因研究等至今没有实质性的突破,现今医学界尚不能从根本上治愈糖尿病,各种治疗药物均有其不良反应:如低血糖事件和体重增加(如:胰岛素和胰岛素促分泌剂等),胃肠道反应(如:双胍类药物、糖苷酶抑制剂和GLP-1受体激动剂等),体重增加、水肿或不良心脏事件(如:噻唑烷二酮类药物TZDs)。
目前,治疗糖尿病的新药的开发与研制成为目前药物研发的热点之一,中医药对糖尿病有相关文献记载迄今数千年,但是对中医药治疗糖尿病的药物开发突破性不够,亟待加强。比如:中国专利文献CN102266520A公开了:一种治疗糖尿病的中药组合物,由下列重量比的中药原料制成:人参20克,黄芪40克,当归20克,炒白术20克,茯苓30克,苍术30克,山药30克,麦冬40克,天冬30克,五味子20克,枸杞子20克,山萸肉30克,熟地30克,玉米须30克,川芎30克,丹参30克,鬼见羽50克,天花粉20克,鸡内金20克,马齿苋20克,红景天40克,白芍30克,姜半夏20克,陈皮20克,苦瓜80克,百部30克,黄连20克,黄柏10克,肉桂20克,芦荟10克,葫芦巴10克,甘草10克,金钱草5克,桑枝20克,葛根10克,夏枯草10克,蜂花粉50克,牛肾30克,木香20克,白僵蚕20克。然而,上述组合物存在组成复杂、成本较高等缺点,从而限制了其应用。
因此,研究新型的治疗效果好、毒副作用小、组成简单、成本较低的治疗糖尿病的药物具有重要意义。
发明内容
因此,本发明提供一种治疗治疗效果好、毒副作用小、组成简单、成本较低的治疗糖尿病的中药组合物,进而提供其制备方法与用途。
为解决上述技术问题,本发明是通过以下技术方案来实现的:
本发明提供一种治疗糖尿病的中药组合物,其原料药包括:
乌梅5~120重量份、黄连10~240重量份、肉桂2~120重量份。
优选地,本发明上述治疗糖尿病的中药组合物,其原料药包括:
乌梅5~55重量份、黄连10~110重量份、肉桂2~22重量份。
进一步优选地,本发明上述治疗糖尿病的中药组合物,其原料药包括:
乌梅15~45重量份、黄连30~90重量份、肉桂6~18重量份。
进一步优选地,本发明上述治疗糖尿病的中药组合物,其原料药包括:
乌梅30重量份、黄连60重量份、肉桂12重量份;或者
乌梅15重量份、黄连90重量份、肉桂6重量份;或者
乌梅45重量份、黄连30重量份、肉桂18重量份;或者
乌梅23重量份、黄连54重量份、肉桂17重量份;或者
乌梅19重量份、黄连48重量份、肉桂13重量份。
本发明提供一种上述治疗糖尿病的中药组合物的制备方法,包括以下步骤:
取选定重量份的乌梅、黄连和肉桂,以乌梅、黄连和肉桂的总重量为基准,加入至少2重量倍量的水加热回流至少1次,每次提取至少0.5小时,收集挥发油,然后过滤,合并滤液,浓缩至50℃相对密度为1.05-1.30,然后加入所述挥发油,即得;或者
取选定重量份的乌梅、黄连和肉桂,以乌梅、黄连和肉桂的总重量为基准,加入至少2重量倍量的体积分数至多为95%的乙醇水溶液加热回流至少1次,每次提取至少0.5小时,收集挥发油,然后过滤,合并滤液,浓缩至50℃相对密度为1.05-1.30,然后加入所述挥发油,即得;或者
取选定重量份的乌梅、黄连和肉桂,以乌梅、黄连和肉桂的总重量为基准,加入至少2重量倍量的体积分数至多为95%的甲醇水溶液加热回流至少1次,每次提取至少0.5小时,收集挥发油,然后过滤,合并滤液,浓缩至50℃相对密度为1.05-1.30,然后加入所述挥发油,即得。
优选地,本发明上述治疗糖尿病的中药组合物的制备方法,包括以下步骤:
取选定重量份的乌梅、黄连和肉桂,以乌梅、黄连和肉桂的总重量为基准,加入2~20重量倍量的水加热回流2次,每次提取0.5~3小时,收集挥发油,然后过滤,合并滤液,浓缩至50℃相对密度为1.10-1.25,然后加入所述挥发油,即得;或者
取选定重量份的乌梅、黄连和肉桂,以乌梅、黄连和肉桂的总重量为基准,加入至少2重量倍量的体积分数至多为60%的乙醇水溶液加热回流至少1次,每次提取至少0.5小时,收集挥发油,然后过滤,合并滤液,浓缩至50℃相对密度为1.05-1.30,然后加入所述挥发油,即得;或者
取选定重量份的乌梅、黄连和肉桂,以乌梅、黄连和肉桂的总重量为基准,加入至少2重量倍量的体积分数至多为60%的甲醇水溶液加热回流至少1次,每次提取至少0.5小时,收集挥发油,然后过滤,合并滤液,浓缩至50℃相对密度为1.05-1.30,然后加入所述挥发油,即得。
进一步优选地,本发明上述治疗糖尿病的中药组合物的制备方法,包括以下步骤:
(1)取选定重量份的乌梅、黄连和肉桂,以乌梅、黄连和肉桂的总重量为基准,加入5~15重量倍量的水加热回流提取0.5~3小时,收集挥发油,然后过滤,得滤液A和药渣;
(2)取所述药渣,以乌梅、黄连和肉桂的总重量为基准,加入5~15重量倍量的水加热回流提取0.5~2小时,过滤,得滤液B;
(3)合并所述滤液A和所述滤液B,浓缩至50℃相对密度为1.10-1.25,然后加入所述挥发油,即得;或者
(1)取选定重量份的乌梅、黄连和肉桂,以乌梅、黄连和肉桂的总重量为基准,加入5~15重量倍量的体积分数为1%~50%的乙醇水溶液加热回流提取0.5~3小时,收集挥发油,然后过滤,得滤液A和药渣;
(2)取所述药渣,以乌梅、黄连和肉桂的总重量为基准,加入5~15重量倍量的体积分数为1%~50%的乙醇水溶液加热回流提取0.5~2小时,过滤,得滤液B;
(3)合并所述滤液A和所述滤液B,浓缩至50℃相对密度为1.10-1.25,然后加入所述挥发油,即得;或者
(1)取选定重量份的乌梅、黄连和肉桂,以乌梅、黄连和肉桂的总重量为基准,加入5~15重量倍量的体积分数为1%~50%的甲醇水溶液加热回流提取0.5~3小时,收集挥发油,然后过滤,得滤液A和药渣;
(2)取所述药渣,以乌梅、黄连和肉桂的总重量为基准,加入5~15重量倍量的体积分数为1%~50%的甲醇水溶液加热回流提取0.5~2小时,过滤,得滤液B;
(3)合并所述滤液A和所述滤液B,浓缩至50℃相对密度为1.10-1.25,然后加入所述挥发油,即得。
进一步优选地,本发明上述治疗糖尿病的中药组合物的制备方法,包括以下步骤:
(1)取选定重量份的乌梅、黄连和肉桂,以乌梅、黄连和肉桂的总重量为基准,加入10重量倍量的水加热回流提取1.5小时,收集挥发油,然后过滤,得滤液A和药渣;
(2)取所述药渣,以乌梅、黄连和肉桂的总重量为基准,加入10重量倍量的水加热回流提取1小时,过滤,得滤液B;
(3)合并所述滤液A和所述滤液B,浓缩至50℃相对密度为1.10-1.25,然后加入所述挥发油,即得;或者
(1)取选定重量份的乌梅、黄连和肉桂,以乌梅、黄连和肉桂的总重量为基准,加入10重量倍量的体积分数为5%的乙醇水溶液加热回流提取1.5小时,收集挥发油,然后过滤,得滤液A和药渣;
(2)取所述药渣,以乌梅、黄连和肉桂的总重量为基准,加入10重量倍量的体积分数为5%的乙醇水溶液加热回流提取1小时,过滤,得滤液B;
(3)合并所述滤液A和所述滤液B,浓缩至50℃相对密度为1.10-1.25,然后加入所述挥发油,即得;或者
(1)取选定重量份的乌梅、黄连和肉桂,以乌梅、黄连和肉桂的总重量为基准,加入10重量倍量的体积分数为5%的甲醇水溶液加热回流提取1.5小时,收集挥发油,然后过滤,得滤液A和药渣;
(2)取所述药渣,以乌梅、黄连和肉桂的总重量为基准,加入10重量倍量的体积分数为5%的甲醇水溶液加热回流提取1小时,过滤,得滤液B;
(3)合并所述滤液A和所述滤液B,浓缩至50℃相对密度为1.10-1.25,然后加入所述挥发油,即得。
本发明还提供包括上述治疗糖尿病的中药组合物的制剂、或者包括上述制备方法制备得到的治疗糖尿病的中药组合物的制剂,
所述中药组合物加入常规辅料,按照常规工艺,制成临床上可接受的片剂、胶囊剂、散剂、合剂、丸剂、颗粒剂、溶液剂、糖浆剂、煎膏剂、饮料、饼干、糖果、糕点或贴剂。
所述常规辅料为:填充剂、崩解剂、润滑剂、助悬剂、粘合剂、甜味剂、矫味剂、防腐剂、基质等。填充剂包括:淀粉、预胶化淀粉、乳糖、甘露醇、甲壳素、微晶纤维素、蔗糖等;崩解剂包括:淀粉、预胶化淀粉、微晶纤维素、羧甲基淀粉钠、交联聚乙烯吡咯烷酮、低取代羟丙纤维素、交联羧甲基纤维素纳等;润滑剂包括:硬脂酸镁、十二烷基硫酸钠、滑石粉、二氧化硅等;助悬剂包括:聚乙烯吡咯烷酮、微晶纤维素、蔗糖、琼脂、羟丙基甲基纤维素等;粘合剂包括,淀粉浆、聚乙烯吡咯烷酮、羟丙基甲基纤维素等;甜味剂包括:糖精钠、阿斯帕坦、蔗糖、甜蜜素、甘草次酸等;矫味剂包括:甜味剂及各种香精;防腐剂包括:尼泊金类、苯甲酸、苯甲酸钠、山梨酸及其盐类、苯扎溴铵、醋酸氯乙定、桉叶油等;基质包括:PEG6000、PEG4000、虫蜡等。
本发明还提供上述中药组合物、上述制备方法制备得到的中药组合物、或上述中药组合物的制剂在制备治疗糖尿病的药品或保健品中的应用。
本发明的技术方案具有如下优点:
本发明认为,厥阴疏泄不利,气机失调,肝气逆乱,犯胃侮脾;肝胆风木相火上冲为热,脾胃阳衰阴寒不化为寒,寒热错杂,肝脾为病,而致消渴。因此,本发明以厥阴立论,采用肝脾同治的方法治疗糖尿病。
【乌梅】性平,味酸、涩,归肝经、脾经、肺经、大肠经,具有敛肺、涩肠、安蛔、生津的功效,主要用于肺虚久咳、久痢滑肠、虚热消渴、蛔厥呕吐腹痛、道蛔虫症的治疗。
【黄连】性寒,味苦,归心经、肝经、脾经、胆经、胃经、大肠经,具有清热燥湿、泻火解毒的功效,主要用于湿热痞满、呕吐吞酸、泻痢、黄疽、高热神昏、心火亢盛、心烦不寐、血热吐衄、目赤、牙痛、消渴、痈肿疗疮的治疗,外治湿疹、湿疮、耳道流脓。
【肉桂】性大热,味辛、甘,归心经、肝经、脾经、肾经,具有补火助阳、引火归源、散寒止痛、活血通经的功效,主要用于阳痿、宫冷、腰膝冷痛、肾虚作喘、阳虚眩晕、目赤咽痛、心腹冷痛、虚寒吐泻、寒疝、奔豚、经闭、痛经的治疗。
(1)本发明治疗糖尿病的中药组合物,充分考虑各中药乌梅、黄连和肉桂的归经和性味,并选择各中药相互之间的配比,乌梅味酸入肝,补厥阴肝体,酸敛助厥阴之合,复其疏泄之职;黄连味苦性寒以清热,直折阳气外越之势,使阳气内敛;肉桂辛热温阳散寒以治虚寒,三药共用,调和肝脾,清热温寒,从而发挥对糖尿病的治疗作用;
(2)本发明所述中药组合物,组成简单、成本较低。
附图说明
为了使本发明的内容更容易被清楚的理解,下面根据本发明的具体实施例并结合附图,对本发明作进一步详细的说明,其中:
图1是实验例1中对2型糖尿病模型小鼠血糖值的影响;
图2是实验例1中对2型糖尿病模型小鼠糖耐量的影响;
图3是实验例1中总胆固醇含量测定标准曲线;
图4是实验例1中对2型糖尿病模型小鼠总胆固醇水平的影响;
图5是实验例1中胰岛素含量测定标准曲线;
图6是实验例1中对2型糖尿病KK/Upj-AY小鼠胰岛素水平的影响;
图7是实验例1中正常对照组的C57BL/6J小鼠;
图8是实验例1中模型对照组的KK/Upj-AY小鼠;
图9是实验例1中实验组小鼠的肝脏解剖图;
图10是实验例1中模型对照组小鼠的肝脏解剖图。
具体实施方式
实施例1
本实施例治疗糖尿病的中药组合物的原料药组成为:
乌梅30g、黄连60g、肉桂12g;
该中药组合物的制备方法,包括以下步骤:
(1)取选定重量份的乌梅、黄连和肉桂,以乌梅、黄连和肉桂的总重量为基准,加入1020g水加热回流提取1.5小时,收集挥发油,然后过滤,得滤液A和药渣;
(2)取所述药渣,以乌梅、黄连和肉桂的总重量为基准,加入1020g水加热回流提取1小时,过滤,得滤液B;
(3)合并所述滤液A和所述滤液B,减压浓缩至50℃相对密度为1.10-1.25,然后加入所述挥发油,即得。
本实施例治疗糖尿病的中药组合物加入常规辅料,按照常规工艺,制成颗粒剂。
实施例2
本实施例治疗糖尿病的中药组合物的原料药组成为:
乌梅15g、黄连90g、肉桂6g;
该中药组合物的制备方法,包括以下步骤:
(1)取选定重量份的乌梅、黄连和肉桂,以乌梅、黄连和肉桂的总重量为基准,加入555g水加热回流提取3小时,收集挥发油,然后过滤,得滤液A和药渣;
(2)取所述药渣,以乌梅、黄连和肉桂的总重量为基准,加入555g水加热回流提取02小时,过滤,得滤液B;
(3)合并所述滤液A和所述滤液B,减压浓缩至50℃相对密度为1.10-1.25,然后加入所述挥发油,即得。
本实施例治疗糖尿病的中药组合物加入常规辅料,按照常规工艺,制成胶囊剂。
实施例3
本实施例治疗糖尿病的中药组合物的原料药组成为:
乌梅45g、黄连30g、肉桂18g;
该中药组合物的制备方法,包括以下步骤:
(1)取选定重量份的乌梅、黄连和肉桂,以乌梅、黄连和肉桂的总重量为基准,加入1395g水加热回流提取0.5小时,收集挥发油,然后过滤,得滤液A和药渣;
(2)取所述药渣,以乌梅、黄连和肉桂的总重量为基准,加入465g水加热回流提取0.5小时,过滤,得滤液B;
(3)合并所述滤液A和所述滤液B,减压浓缩至50℃相对密度为1.10-1.25,然后加入所述挥发油,即得。
本实施例治疗糖尿病的中药组合物加入常规辅料,按照常规工艺,制成糖浆剂。
实施例4
本实施例治疗糖尿病的中药组合物的原料药组成为:
乌梅23g、黄连54g、肉桂17g;
该中药组合物的制备方法,包括以下步骤:
(1)取选定重量份的乌梅、黄连和肉桂,以乌梅、黄连和肉桂的总重量为基准,加入752g水加热回流提取2小时,收集挥发油,然后过滤,得滤液A和药渣;
(2)取所述药渣,以乌梅、黄连和肉桂的总重量为基准,加入846g水加热回流提取0.8小时,过滤,得滤液B;
(3)合并所述滤液A和所述滤液B,减压浓缩至50℃相对密度为1.10-1.25,然后加入所述挥发油,即得。
本实施例治疗糖尿病的中药组合物加入常规辅料,按照常规工艺,制成散剂。
实施例5
本实施例治疗糖尿病的中药组合物的原料药组成为:
乌梅19g、黄连48g、肉桂13g;
该中药组合物的制备方法,包括以下步骤:
(1)取选定重量份的乌梅、黄连和肉桂,以乌梅、黄连和肉桂的总重量为基准,加入960g水加热回流提取1小时,收集挥发油,然后过滤,得滤液A和药渣;
(2)取所述药渣,以乌梅、黄连和肉桂的总重量为基准,加入960g水加热回流提取1小时,过滤,得滤液B;
(3)合并所述滤液A和所述滤液B,减压浓缩至50℃相对密度为1.10-1.25,然后加入所述挥发油,即得。
本实施例治疗糖尿病的中药组合物加入常规辅料,按照常规工艺,制成片剂。
实验例1本发明中药组合物的对糖尿病治疗效果的研究
1、实验目的
以KK/Upj-AY小鼠给予高脂饲料进行2型糖尿病模型造模,研究本发明制备的中药组合物对2型糖尿病小鼠的降血糖作用。
2实验试剂、动物与仪器
盐酸吡格列酮片(15mg×7片,批号:120202,生产日期2012年1月31日,有效期至2014年12月,北京太洋药业有限公司生产);
SPF级KK/Upj-AY小鼠40只、C57BL/6J小鼠10只(均由北京华阜康生物科技股份有限公司提供;均为10-13周龄,均为雄性;实验动物许可证:KK/Upj-AY小鼠SCXK(京)2009-0004;C57BL/6J小鼠SCXK(京)2009-0007;合格证编号:KK/Upj-AY小鼠11401300000486;C57BL/6J小鼠11401300000487);
高脂饲料(购于北京华阜康生物科技股份有限公司);
免条码拜安康血糖测定仪,注册号:[国食药监械(进)字2008第2403659,出口产品注册标准:YZD/USA4991-2008],型号Contour TS;检测试纸:拜安康检测试纸;甲醛。
3、实验方法
3.1实验条件
40只SPF级自发性2型糖尿病KK/Upj-AY小鼠单笼喂养于SPF级实验室中,饲以KK/Upj-AY小鼠专用的高脂饲料,自由进食饮水;10只C57BL/6J小鼠饲以普通鼠料,自由进食饮水。
环境温度:20-25℃,湿度:40%-70%。
3.2实验分组
10只C57BL/6J小鼠作为正常对照组;
40只KK/Upj-AY小鼠进行2型糖尿病模型造模,选取造模成功的30只KK/Upj-AY小鼠随机分为3组,分别为模型对照组、阳性对照组和实验组,每组10只。
3.3给药方法
正常对照组灌胃给予放冷的蒸馏水5mg/kg,每天1次,连续灌胃5周;
模型对照组灌胃给予放冷的蒸馏水5mg/kg,每天1次,连续灌胃5周;
阳性对照组灌胃给予盐酸吡格列酮片10mg/kg,每天1次,连续灌胃给药5周;
实验组灌胃给予实施例1制备的中药组合物4.5g/kg,每天1次,连续灌胃给药5周。
4、实验数据检测与处理
4.1检测指标
实验期间,各组小鼠禁食不禁水,每4小时测血糖1次;末次给药后第2天,各组小鼠禁食不禁水4小时,测量体重、血糖值,作为末次给药后的血糖值;同时进行糖耐量实验,各组小鼠禁食4小时所测血糖值做为0分钟血糖值,然后分别灌胃给予2.5g/kg的葡萄糖,随后分别于第30分钟、第60分钟和第120分钟测定各组小鼠的血糖值,并按照如下公式计算曲线下面积AUC:AUC=(0h+30h)*0.25+(30h+60h)*0.25+(60h+120h)*0.5。
实验最后1天,处死小鼠,并取材做为指标检测,备用。
具体实验步骤如下:
(1)早7:00开始给予小鼠禁食,自由饮水;
(2)11:00开始取材;
(3)摘除眼球,取眶静脉血,室温放置约20分钟,离心取血清,将血清分成每份50-60μL,转移至-80℃冰箱中冷冻保存;
(4)处死小鼠,测量体长,腹围,并记录数值;
(5)摘取脂肪称重,后浸入30倍以上10%福尔马林溶液中,待做病理切片;
(6)摘取胰腺浸入Bouin s固定液,24小时后,转入70%乙醇中保存,待做病理切片;
(7)摘取肝脏称重,拍照,分取肝大叶,浸入30倍以上10%福尔马林溶液中,待做病理切片,其余肝脏切成每份约50mg,投入液氮速冻后转入-80℃冰箱冷冻保存备用;
(8)摘取肾脏,称重,纵向2/3处剖开,投入30倍以上10%福尔马林溶液,待做病理切片;
(9)取大腿骨骼肌,一部分投入10%福尔马林溶液供做病理切片,另一部分投入液氮速冻后转移至-80℃冰箱冻存,备用;
(10)摘取脑、肠道,浸入10%福尔马林溶液中,待做病理切片;
(11)取回盲部位肠内容物,先投入液氮速冻,然后转移至-80℃冰箱,冻存,备用。
此外,用间接法测定小鼠血清中总胆固醇(TC)含量,用夹心法测定小鼠血清中胰岛素(Insulin)含量。
5、实验结果
各组的具体实验结果如表1-2、图1-10所示。
表1各组小鼠的血糖值的实验结果(X±SD,mmol/L)
与模型对照组比较,*P<0.05,**P<0.01;与正常对照组比较,##P<0.01
由表1可知,(1)给药0周时,与正常对照组相比,模型对照组小鼠的血糖值显著升高(P<0.01),有统计学意义;这表明,2型糖尿病模型造模成功;
(2)给药1周、2周、3周、4周或5周,与模型对照组相比,实验组小鼠的血糖值显著降低(P<0.01),有统计学意义。
表2各组小鼠的糖耐量的实验结果(X±SD,mmol/L)
与模型对照组比较,*P<0.05,**P<0.01;与正常对照组比较,##P<0.01
由表2可知,在糖耐量实验中,与正常对照组相比,模型对照组各时间点的血糖值及曲线下面积(AUC)值均显著升高(P<0.01),有统计学意义;这表明,2型糖尿病模型造模成功;
(2),与模型对照组相比,实验组在各时间点的血糖值及AUC值均显著降低(P<0.01),有统计学意义。
由图1-10可知,与模型对照组相比,实验组小鼠的血糖显著降低,糖尿病的症状显著改善。
6、实验结论
本发明制备的中药组合物对2型糖尿病小鼠的高血糖具有显著的改善调节作用,具有显著的降血糖作用,对糖尿病具有显著的治疗作用。
显然,上述实施例仅仅是为清楚地说明所作的举例,而并非对实施方式的限定。对于所属领域的普通技术人员来说,在上述说明的基础上还可以做出其它不同形式的变化或变动。这里无需也无法对所有的实施方式予以穷举。而由此所引伸出的显而易见的变化或变动仍处于本发明创造的保护范围之中。
Claims (9)
1.一种中药组合物,其特征在于,其原料药由如下组分组成:
乌梅5~120重量份、黄连10~240重量份、肉桂2~120重量份;
所述中药组合物的制备方法如下:
取选定重量份的乌梅、黄连和肉桂,以乌梅、黄连和肉桂的总重量为基准,加入至少2重量倍量的水加热回流至少1次,每次提取至少0.5小时,收集挥发油,然后过滤,合并滤液,浓缩至50℃相对密度为1.05-1.30,然后加入所述挥发油,即得;或者
取选定重量份的乌梅、黄连和肉桂,以乌梅、黄连和肉桂的总重量为基准,加入至少2重量倍量的体积分数至多为95%的乙醇水溶液加热回流至少1次,每次提取至少0.5小时,收集挥发油,然后过滤,合并滤液,浓缩至50℃相对密度为1.05-1.30,然后加入所述挥发油,即得;或者
取选定重量份的乌梅、黄连和肉桂,以乌梅、黄连和肉桂的总重量为基准,加入至少2重量倍量的体积分数至多为95%的甲醇水溶液加热回流至少1次,每次提取至少0.5小时,收集挥发油,然后过滤,合并滤液,浓缩至50℃相对密度为1.05-1.30,然后加入所述挥发油,即得。
2.根据权利要求1所述的中药组合物,其特征在于,其原料药由如下组分组成:
乌梅5~55重量份、黄连10~110重量份、肉桂2~22重量份。
3.根据权利要求2所述的中药组合物,其特征在于,其原料药由如下组分组成:
乌梅15~45重量份、黄连30~90重量份、肉桂6~18重量份。
4.根据权利要求3所述的中药组合物,其特征在于,其原料药由如下组分组成:
乌梅30重量份、黄连60重量份、肉桂12重量份;或者
乌梅15重量份、黄连90重量份、肉桂6重量份;或者
乌梅45重量份、黄连30重量份、肉桂18重量份;或者
乌梅23重量份、黄连54重量份、肉桂17重量份;或者
乌梅19重量份、黄连48重量份、肉桂13重量份。
5.根据权利要求1所述的中药组合物的制备方法,其特征在于,包括以下步骤:
取选定重量份的乌梅、黄连和肉桂,以乌梅、黄连和肉桂的总重量为基准,加入2~20重量倍量的水加热回流2次,每次提取0.5~3小时,收集挥发油,然后过滤,合并滤液,浓缩至50℃相对密度为1.10-1.25,然后加入所述挥发油,即得;或者
取选定重量份的乌梅、黄连和肉桂,以乌梅、黄连和肉桂的总重量为基准,加入至少2重量倍量的体积分数至多为60%的乙醇水溶液加热回流至少1次,每次提取至少0.5小时,收集挥发油,然后过滤,合并滤液,浓缩至50℃相对密度为1.05-1.30,然后加入所述挥发油,即得;或者
取选定重量份的乌梅、黄连和肉桂,以乌梅、黄连和肉桂的总重量为基准,加入至少2重量倍量的体积分数至多为60%的甲醇水溶液加热回流至少1次,每次提取至少0.5小时,收集挥发油,然后过滤,合并滤液,浓缩至50℃相对密度为1.05-1.30,然后加入所述挥发油,即得。
6.根据权利要求5所述的中药组合物的制备方法,其特征在于,包括以下步骤:
(1)取选定重量份的乌梅、黄连和肉桂,以乌梅、黄连和肉桂的总重量为基准,加入5~15重量倍量的水加热回流提取0.5~3小时,收集挥发油,然后过滤,得滤液A和药渣;
(2)取所述药渣,以乌梅、黄连和肉桂的总重量为基准,加入5~15重量倍量的水加热回流提取0.5~2小时,过滤,得滤液B;
(3)合并所述滤液A和所述滤液B,浓缩至50℃相对密度为1.10-1.25,然后加入所述挥发油,即得;或者
(1)取选定重量份的乌梅、黄连和肉桂,以乌梅、黄连和肉桂的总重量为基准,加入5~15重量倍量的体积分数为1%~50%的乙醇水溶液加热回流提取0.5~3小时,收集挥发油,然后过滤,得滤液A和药渣;
(2)取所述药渣,以乌梅、黄连和肉桂的总重量为基准,加入5~15重量倍量的体积分数为1%~50%的乙醇水溶液加热回流提取0.5~2小时,过滤,得滤液B;
(3)合并所述滤液A和所述滤液B,浓缩至50℃相对密度为1.10-1.25,然后加入所述挥发油,即得;或者
(1)取选定重量份的乌梅、黄连和肉桂,以乌梅、黄连和肉桂的总重量为基准,加入5~15重量倍量的体积分数为1%~50%的甲醇水溶液加热回流提取0.5~3小时,收集挥发油,然后过滤,得滤液A和药渣;
(2)取所述药渣,以乌梅、黄连和肉桂的总重量为基准,加入5~15重量倍量的体积分数为1%~50%的甲醇水溶液加热回流提取0.5~2小时,过滤,得滤液B;
(3)合并所述滤液A和所述滤液B,浓缩至50℃相对密度为1.10-1.25,然后加入所述挥发油,即得。
7.根据权利要求6所述的中药组合物的制备方法,其特征在于,包括以下步骤:
(1)取选定重量份的乌梅、黄连和肉桂,以乌梅、黄连和肉桂的总重量为基准,加入10重量倍量的水加热回流提取1.5小时,收集挥发油,然后过滤,得滤液A和药渣;
(2)取所述药渣,以乌梅、黄连和肉桂的总重量为基准,加入10重量倍量的水加热回流提取1小时,过滤,得滤液B;
(3)合并所述滤液A和所述滤液B,浓缩至50℃相对密度为1.10-1.25,然后加入所述挥发油,即得;或者
(1)取选定重量份的乌梅、黄连和肉桂,以乌梅、黄连和肉桂的总重量为基准,加入10重量倍量的体积分数为5%的乙醇水溶液加热回流提取1.5小时,收集挥发油,然后过滤,得滤液A和药渣;
(2)取所述药渣,以乌梅、黄连和肉桂的总重量为基准,加入10重量倍量的体积分数为5%的乙醇水溶液加热回流提取1小时,过滤,得滤液B;
(3)合并所述滤液A和所述滤液B,浓缩至50℃相对密度为1.10-1.25,然后加入所述挥发油,即得;或者
(1)取选定重量份的乌梅、黄连和肉桂,以乌梅、黄连和肉桂的总重量为基准,加入10重量倍量的体积分数为5%的甲醇水溶液加热回流提取1.5小时,收集挥发油,然后过滤,得滤液A和药渣;
(2)取所述药渣,以乌梅、黄连和肉桂的总重量为基准,加入10重量倍量的体积分数为5%的甲醇水溶液加热回流提取1小时,过滤,得滤液B;
(3)合并所述滤液A和所述滤液B,浓缩至50℃相对密度为1.10-1.25,然后加入所述挥发油,即得。
8.包括权利要求1-4任一项所述的中药组合物的制剂、或者包括权利要求5-7任一项所述的制备方法制备得到的中药组合物的制剂,其特征在于,所述中药组合物加入常规辅料,按照常规工艺,制成临床上可接受的片剂、胶囊剂、散剂、合剂、丸剂、颗粒剂、溶液剂、糖浆剂或煎膏剂。
9.权利要求1-4任一项所述的中药组合物、权利要求5-7任一项所述的制备方法制备得到的中药组合物、或权利要求8所述的中药组合物的制剂在制备治疗糖尿病的药品中的应用。
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