CN101085121A - 一种降血糖、降血脂的中药组合物及制法和应用 - Google Patents
一种降血糖、降血脂的中药组合物及制法和应用 Download PDFInfo
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Abstract
本发明公开了一种降血糖、降血脂的中药组合物，它是由山茱萸、决明子、泽泻、山楂、银杏叶按一定重量分配比所制成，其制法是将上述五味原药材用水煎煮，过滤，把滤液减压浓缩得稠膏，加入不同剂型相应的适量辅料，用常规的制剂方法制成口服液、片剂、胶囊剂、颗粒剂、丸剂或散剂，本中药组合物制剂经药效学试验结果表明具有显著的降血糖、降血脂的作用。
Description
一、技术领域：
本发明涉及一种降血糖、降血脂的中药组合物，属于中药制药领域。
二、背景技术：
据WHO有关资料表明，心血管疾病是人类的头号杀手，占总死亡人数的30％。而导致心血管疾病的主要因素就是高血压、高血脂、高血糖。当今世界有糖尿病患者1.3亿人，其中90％以上为2型糖尿病患者，而且每年以1％的速度递增，预计到2020年将猛增至2.3亿。我国的糖尿病患者总数已有6000万以上，预计每年发病增长率超过6％。此病不仅给患者带来极大的痛苦，生活质量受到很大影响，甚至威胁患者的生命，还给社会带来沉重的经济负担。高血压、高血脂与高血糖三者密切相关，高血脂可加重糖尿病，所以糖尿病患者除治疗高血糖外，还需要调节血脂，是减少糖尿病患者死亡率和致残率的关键。糖尿病合并高血脂更容易导致脑中风、冠心病、肢体坏死、眼底病变、肾脏病变、神经病变等，这些糖尿病的远期并发症是造成糖尿病患者残疾或过早死亡的主要原因。半数以上糖尿病患者合并高血脂，积极治疗高血脂对控制血糖、预防并发症大有好处。
目前临床上治疗高血糖的西药有磺酰脲类、双胍类、噻唑烷二酮类胰岛素增敏剂、非磺酰脲类胰岛素分泌剂以及α-葡萄糖苷酶抑制剂等。
磺酰脲类药物除首次治疗的失败率较高外，还易发生继发性失效以及不良反应发生率，如过敏、眩晕、肝损伤，主要是低血糖休克和体重增加，因此体重超重的病人不宜用此类药物；双胍类药物则易产生胃肠刺激和乳酸型中毒，很多国家已经禁用；胰岛素增敏剂类药物由于产生严重的肝功能衰竭而被撤出市场；α-葡萄糖苷酶抑制剂类药物拜糖平目前被公认为是治疗糖尿病的一线药物。
而祖国传统中医药则认为：人到中年以后，正气渐虚，肾精渐亏，阴虚阳亢，风阳上扰，而为头昏头胀，血压增高；阴虚阳亢，虚火灼津，津枯液燥，而为消渴；虚火内灼，木失滋养，津液膏脂聚为痰浊，血行涩滞，痰瘀阻络，而为高脂血症。因此，“三高”病症存在“肝肾下虚、痰瘀痹阻”的共同病理基础。治疗时大多用补益肝肾、健脾化湿、活血化瘀、清热通便、消食化痰这些药，如：补益肝肾的有何首乌、女贞子、枸杞、灵芝、虫草、刺五加叶、桑寄生、沙苑子等；健脾理气的有人参、绞股蓝、陈皮、甘草、薤白、山楂等；活血化瘀的有蒲黄、水蛭、当归、虎杖、牛膝、姜黄、三七、川芎、银杏叶等；清热解毒的有马齿苋、黄芩、黄连、柴胡、漏芦、菊花、熊胆、荷叶、葛根等；通便的有大黄、决明子、虎杖等；祛湿化痰的有半夏、海带、昆布、泽泻、月见草、沙棘等。复方中药制剂主要有健脾降脂灵、山丹芍药汤、百草降脂灵、降脂宁、血脂康、地赐康、地奥心血康等等。
三、发明内容：
本发明的目的是提供一种对降血糖、降血脂有良好功效的中药组合物，为心脑血管疾病和糖尿病患者带来福音。主要制成口服液、胶囊剂、片剂、颗粒剂、丸剂、散剂、膏剂等。
本发明中药组合物由以下重量份配比的原料所制成：
山茱萸1～4重量份、决明子1～3重量份、泽泻1～3重量份、山楂1～4重量份、银杏叶1～2重量份。
其制备方法如下：
按以上配比的山茱萸、决明子、泽泻、山楂、银杏叶五味中药，加水煎煮，第1次加水量为药材量的10倍，煎煮2-3小时，第2次加水8倍，煎煮1-2小时，煎液过滤，合并滤液，减压浓缩至相对密度为1.05-1.10(60℃测)，添加不同剂型相应的适量辅料，制成口服液、胶囊剂、片剂、颗粒剂、丸剂、散剂、膏剂等。
本发明中药组合物在制备治疗高血糖及高血脂疾病药物中的应用。
本发明来源于南京中医药大学科研配方，从山楂、枸杞子和决明子等近30种药物中通过严格的筛选而来，主要由山茱萸、决明子、泽泻、山楂、银杏叶等5种成分组成。本方滋养肝肾，化痰泄浊，祛瘀通络，标本兼顾，对高血糖症和高血脂症具有明显的疗效。
山茱萸性平味酸，入肝、肾经。具有补肝肾、涩精气、固虚脱之功效，为方中主药。与其它四药配伍后，可用于治疗糖尿病、阳痿精滑、腰酸眩晕、小便频数及大汗亡阳虚脱之证。
决明子苦甘咸，微寒，清肝明目，缓下通便，擅治肝阳上亢之高血压头痛头晕，与黄精相伍，治肝肾阴虚所致的视物昏花，且可治疗肠燥便秘。
泽泻甘淡，性寒，化痰除湿，利水通淋，治痰浊停聚，清阳不升之头晕。
山楂酸甘，微温，功擅消食化滞，为治积要药，尤善消油腻肉积，为治疗高血脂症、肥胖病的常用药物。与泽泻、决明子合用，泄浊降脂，共为方中辅药。
银杏叶甘苦而涩，功能活血化瘀，通行血脉。具有降压、降胆固醇和防治动脉粥样硬化之功用。为方中佐药，与泽泻、决明子、山楂合用，共开痰结瘀阻。
总之，该中药组合物依托于中医中药传统的医药和养生文化，“治未病”和“药食同源”是该产品开发研制的重要理论基础和有效的物质来源，同时也是本品的独特优势。该产品不仅安全无毒，而且同时具有降血糖和降血脂的双重功能，本产品的研制将会给高血脂、高血糖患者带来福音，同时给企业带来巨大的经济效益，亦将推动保健品产业的迅速发展。
四、具体实施方式
下面通过实施例进一步说明本发明中药组合物制剂的制备及降血糖、降血脂的功效。
实施例1 口服液取山茱萸3重量份、决明子2重量份、泽泻2重量份、山楂2重量份、银杏叶1重量份，第一次加10倍水，煎煮2小时，滤过；第二次加8倍水，煎煮1小时，滤过，合并滤液，减压浓缩(0.07Mpa、60-70℃)至相对密度为1.05-1.10(65℃)，加入1％阿斯巴甜，2％柠檬酸，搅匀，静置12小时以上，滤过，分装，灭菌，即得。
实施例2 颗粒剂取山茱萸2重量份、决明子2重量份、泽泻2重量份、山楂2重量份、银杏叶1重量份，第一次加10倍水，煎煮2小时，滤过；第二次加8倍水，煎煮1小时，滤过，合并滤液，减压浓缩(0.07Mpa、60-70℃)至相对密度为1.05-1.10(65℃)，加入2％阿斯巴甜，搅匀，喷雾干燥，干式制粒，以铝塑复合膜分装，即得。
实施例3 胶囊剂取山茱萸3重量份、决明子2重量份、泽泻2重量份、山楂3重量份、银杏叶1重量份，第一次加10倍水，煎煮2小时，滤过；第二次加8倍水，煎煮1小时，滤过，合并滤液，减压浓缩(0.07Mpa、60-70℃)至相对密度为1.05-1.10(65℃)，制软材，制颗粒，装入胶囊，即得。
实施例4 降血糖、降血脂药理作用初步研究
实验动物
昆明种小鼠，雄性，体重(20±2)g，南京中医药大学实验动物中心提供。
实验药物
本中药组合物口服液，规格：10ml/支(相当于含生药18g)，南京中医药大学自制，批号：070522。消渴丸，广州中一药业生产，批号：060520；脂必妥胶囊，由成都地奥九鸿制药厂生产，批号为0404021，规格：每粒装0.24g。高脂饲料：10％蛋黄粉、1.2％胆固醇，10％猪油、78％基础饲料。
主要试剂
四氧嘧啶，美国Sigma公司产品；血糖、总胆固醇(TC)、甘油三酯(TG)、高密度脂蛋白胆固醇(HDLOC)及低密度脂蛋白胆固醇(LDLOC)测定试剂盒，北京中生生物工程公司产品。
实验1.对四氧嘧啶糖尿病小鼠血糖的影响
选健康小鼠60只，随机分出10只作为正常对照组(生理盐水0.5ml·只-1)，其余50只小鼠禁食不禁水24h，各鼠均腹腔注射四氧嘧啶180mg/kg，其后72h眼眶采血测定血糖，血糖浓度高于11.1mmol·L-1者为糖尿病模型小鼠。将50只糖尿病模型小鼠随机分为5组：实验性糖尿病空白组(生理盐水0.5ml·只-1)，消渴丸组(5mg·kg-1)，高剂量组(800mg·kg-1)、中剂量组(400mg·kg-1)、低剂量组(200mg·kg-1)。每天上午8:00～9:00灌胃给药，连续30d。禁食12h从后小鼠眼眶后静脉丛取血测血糖值。结果见表1。
表1.本中药组合物对DM小鼠血糖水平的影响
| 组别 | 剂量(mg/kg) | n | 血糖(mmol/L) |
| 正常小鼠对照组糖尿病模型空白组高剂量组中剂量组低剂量组消渴丸组 | 8004002005 | 101010101010 | 6.72±1.4531.96±3.8824.85±4.24**△△25.36±4.47**△25.60±3.78*△25.43±3.26** |
注：同糖尿病模型空白组相比*p＜0.05**＜0.01；同消渴丸组相比△＜0.05△△＜0.01
实验2.对高脂小鼠血血脂的影响
选健康小鼠60只，随机分出10只作为正常对照组，其余50只小鼠，饲以高脂饲料，正常饮水，造模14d，得到模型组。模型造成后，随机分成5组：模型组、大剂量组(200mg/kg)、中剂量组(100mg/kg)、小剂量组(50mg/kg)、阳性药脂必妥组(340mg/kg)，其中3个剂量组、脂必妥组按上述剂量灌胃给药，空白对照组和药理模型组给同体积的水，每天上午1次，连续30d，取血测定各鼠TC、TG、HDL-C、LDL-C，各组数据以均值±标准差表示，组间进行t测验。结果见表2。
表2.本中药组合物对DM小鼠血酯水平的影响
| 组别 | 正常小鼠对照组 | 实验性模型对照组 | 样品组 | 脂必妥组 | ||
| 高剂量组 | 中剂量组 | 低剂量组 | ||||
| 剂量(mg/kg) | 800 | 400 | 200 | 5 | ||
| n | 10 | 10 | 10 | 10 | 10 | 10 |
| TG水平(mol/L) | 0.76±0.20 | 2.42±0.78 | 1.54±0.45** | 1.57±0.53** | 1.60±0.56* | 1.35±0.42** |
| TC水平(mmol/L) | 1.90±0.57 | 3.45±0.42 | 2.61±0.70** | 2.63±0.75** | 2.67±0.78* | 2.54±0.66** |
| HDLC水平(mmol/L) | 0.89±0.25 | 1.15±0.28 | 0.90±0.34** | 0.93±0.30* | 0.92±0.36* | 0.89±0.27** |
| LDL-C水平(mmol/L) | 0.66±0.24 | 1.24±0.25 | 0.81±0.26**△ | 0.84±0.21* | 0.85±0.28* | 0.83±0.27** |
注：同模型对照组相比*p＜0.05**＜0.01；同脂必妥组相比△＜0.05△△＜0.01
Claims (6)
1.一种降血糖、降血脂的中药组合物，其特征在于它是由以下重量份配比的原药材所制成：山茱萸1～4重量份、决明子1～3重量份、泽泻1～3重量份、山楂1～4重量份、银杏叶1～2重量份。
2.根据权利要求1所述的中药组合物，其特征在于该组合物按中药常规的制剂方法制成口服液、片剂、胶囊剂、颗粒剂、丸剂、膏剂或散剂。
3.一种制备权利要求1所述中药组合物的方法，其特征在于制备方法如下：
取山茱萸1～4重量份、决明子1～3重量份、泽泻1～3重量份、山楂1～4重量份、银杏叶1～2重量份，加水2次，煎煮，滤过，合并滤液，减压浓缩至相对密度为1.05～1.10，65℃测，添加不同剂型相应的适量辅料制成口服液、片剂、胶囊剂、颗粒剂、丸剂、膏剂或散剂。
4.根据权利要求3所述的中药组合物的制备方法，其特征在于第一次加水量为药材量的10倍，煎煮2～3小时，第二次加水为药材量的8倍，煎煮1～2小时。
5.如权利要求1所述的中药组合物在制备治疗高血糖疾病药物中的应用。
6.如权利要求1所述的中药组合物在制备治疗高血脂疾病药物中的应用。
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| CN101341915B (zh) * | 2008-08-18 | 2011-02-09 | 廖翊敏 | 多功能保健茶 |
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| CN103055056A (zh) * | 2011-12-14 | 2013-04-24 | 西安泰科迈医药科技有限公司 | 一种辅助降血脂中药药物组合及其制备方法 |
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| CN103055056A (zh) * | 2011-12-14 | 2013-04-24 | 西安泰科迈医药科技有限公司 | 一种辅助降血脂中药药物组合及其制备方法 |
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| CN112316037A (zh) * | 2020-11-25 | 2021-02-05 | 王红卫 | 降高血脂的口服药物 |
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