CN104436021A - 一种含牛蒡子的治疗糖尿病的中药组合物 - Google Patents
一种含牛蒡子的治疗糖尿病的中药组合物 Download PDFInfo
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Abstract
本发明属于医药技术领域，涉及一种中药组合物，具体涉及一种含牛蒡子的治疗糖尿病的中药组合物。本发明的治疗糖尿病的中药组合物是由以下重量配比的药用原料制备而成：赤芍5～20份、红景天5～15份、桑椹5～15份、牛蒡子2～9份、莪术1～5份、马兰1～5份。本发明治疗糖尿病的中药组合物，6味药用原料按配方比例组合治疗糖尿病具有协同增效功能，用于治疗糖尿病疗效显著且对患者身体无副作用。
Description
技术领域
本发明属于医药技术领域，涉及一种中药组合物，具体涉及一种含牛蒡子的治疗糖尿病的中药组合物。
背景技术
糖尿病是一组以高血糖为特征的代谢性疾病，是我国发病率高，危害严重的流行病之一。糖尿病时长期存在的高血糖，导致各种组织，特别是眼、肾、心脏、血管、神经的慢性损害、功能障碍，引发各种糖尿病并发症。据统计，糖尿病并发症的死亡率仅次于心血管病、脑血管病和肿瘤，居第四位。中国糖尿病患者数量已接近4000万人，居世界第三，与20世纪80年代的0.7％相比，增长了5倍。糖尿病可由遗传和环境因素相互作用而引起，常见症状有多饮、多尿、多食以及消瘦等。糖尿病可引起身体多系统的损害；引起胰岛素绝对或相对分泌不足以及靶组织细胞对胰岛素敏感性降低；引起蛋白质、脂肪、水和电解质等一系列代谢紊乱综合征，其中以高血糖为主要标志。目前治疗糖尿病的药很多，尤其是西药，但副作用大，而中成药效果不够显著。
发明内容
本发明的目的提供一种含牛蒡子的治疗糖尿病的中药组合物，该中药组合物疗效好、对人身体副作用小。
为了实现上述发明目的，本发明提供了以下技术方案：
一种含牛蒡子的治疗糖尿病的中药组合物，是由以下重量配比的药用原料制备而成：赤芍5～20份、红景天5～15份、桑椹5～15份、牛蒡子2～9份、莪术1～5份、马兰1～5份。所述各种药用原料均为符合国家或地方标准规定的中药材。
优选的，上述药用原料中，赤芍所占重量比例为9～15份。更优选的，赤芍所占重量比例为12份。
优选的，上述药用原料中，红景天所占重量比例为7～12份。更优选的，红景天所占重量比例为9份。
优选的，上述药用原料中，桑椹所占重量比例为7～12份。更优选的，桑椹所占重量比例为9份。
优选的，上述药用原料中，牛蒡子所占重量比例为4～7份。更优选的，牛蒡子所占重量比例为6份。
优选的，上述药用原料中，莪术所占重量比例为2～4份。更优选的，莪术所占重量比例为3份。
优选的，上述药用原料中，马兰所占重量比例为2～4份。更优选的，马兰所占重量比例为3份。
本发明的治疗糖尿病的中药组合物，可以按照常规的中药提取方法提取药用原料的活性组分，如加水煎煮，或用乙醇或乙醇的水溶液回流提取并收集提取液并浓缩；再加上药学上可接受的载体或/和辅料，如淀粉、糊精、微晶纤维、可压性淀粉、硬脂酸镁、微粉硅胶、蔗糖、羧甲基淀粉钠、羟丙基甲基纤维素、植物油、卵磷脂、聚乙二醇、丙二醇、尼泊金乙酯等，制成药剂学上适宜的剂型，如颗粒剂、片剂、硬胶囊、口服液、软胶囊、滴丸、水泛丸等。
与现有技术相比，本发明的有益效果：
本发明治疗糖尿病的中药组合物，是发明人基于祖国医学对糖尿病的发病机理的认识，根据自己多年临床经验，先从众多中药中确定一系列对治疗糖尿病有效的中药，再经临床反复验证而筛选出来的。其中，赤芍,别名山芍药、草芍药；为毛茛科植物芍药或川赤芍的干燥根；苦，微寒；归肝经；具有清热凉血、散瘀止痛的作用；用于温毒发斑，吐血衄血，目赤肿痛，肝郁胁痛，经闭痛经，症瘕腹痛，跌扑损伤，痈肿疮疡等症。红景天，别名扫罗玛尔布(藏名)；为景天科植物全瓣红景天的全草；味甘涩，性寒；具有活血止血、清肺止咳的功效；用于咳血，咯血，肺炎咳嗽，妇女白带；外用治跌打损伤，汤火伤等症。桑椹，又名桑葚，为桑科植物桑的干燥果穗。甘、酸，寒；归心、肝、肾经；具有补血滋阴、生津润燥的功效；用于眩晕耳鸣，心悸失眠，须发早白，津伤口渴，内热消渴，血虚便秘等症。牛蒡子，别名大力子、恶实，为菊科植物牛蒡的干燥成熟果实；辛、苦，寒；归肺、胃经；具有疏散风热、宣肺透疹、解毒利咽的功效；用于风热感冒，咳嗽痰多，麻疹，风疹，咽喉肿痛，痄腮丹毒，痈肿疮毒等症。莪术，别名温莪术、蓬莪术、山姜黄、芋儿七、臭屎姜；为姜科植物蓬莪术、广西莪术或温郁金的干燥根茎；辛、苦，温；归肝、脾经；具有行气破血、消积止痛的功效；用于燀瘕痞块，瘀血经闭，食积胀痛；早期宫颈癌等症。马兰，别名鱼鳅串、泥鳅串、鸡儿肠、田边菊、路边菊、蓑衣草、脾草；为菊科马兰属植物马兰，以全草或根入药；辛、苦，寒；具有清热解毒，散瘀止血，消积的作用；用于感冒发烧，咳嗽，急性咽炎，扁桃体炎，流行性腮腺炎，传染性肝炎，胃、十二指肠溃疡，小儿疳积，肠炎，痢疾，吐血，崩漏，月经不调；外用治疮疖肿痛，乳腺炎，外伤出血等症。上述6味中草药按配方比例混合后，按照常规的中药提取方法提取药用原料的活性组分后得到本发明的治疗糖尿病的中药组合物。其中的6味药按配方比例组合后，治疗糖尿病具有协同增效的功能，能显著降低血糖、血脂浓度，提高血流量和抗氧化功效，治疗糖尿病效果显著且无毒副作用。
具体实施方式
下面结合试验例及具体实施方式对本发明作进一步的详细描述。但不应将此理解为本发明上述主题的范围仅限于以下的实施例，凡基于本发明内容所实现的技术均属于本发明的范围。
实施例1
本实施例的治疗糖尿病的中药组合物，是由以下重量配比的药用原料制备而成：赤芍12g、红景天9g、桑椹9g、牛蒡子6g、莪术3g、马兰3g。
上述药用原料的提取方法：按配方比例取药用原料，向药用原料中加水煎煮2次，2次煎煮的用水体积依次为药用原料体积的10倍和8倍，2次煎煮时间依次为1.5小时和1小时，每次煎煮后过滤并收集滤液；合并2次滤液，得到实施例1药用原料的提取液，将实施例1药用原料的提取液浓缩至相对密度1.20(80℃)，得实施例1的提取物。
向上述提取物中加入提取物2倍重量的可溶性淀粉，制粒、干燥，分装成袋，得到实施例1治疗糖尿病的中药组合物颗粒剂。
实施例2
本实施例的治疗糖尿病的中药组合物，是由以下重量配比的药用原料制备而成：赤芍20g、红景天5g、桑椹15g、牛蒡子2g、莪术1g、马兰5g。
上述药用原料的提取方法同实施例1。
实施例3
本实施例的治疗糖尿病的中药组合物，是由以下重量配比的药用原料制备而成：赤芍15g、红景天7g、桑椹8g、牛蒡子8g、莪术2g、马兰4g。
上述药用原料的提取方法同实施例1。
对比例
本实施例的治疗糖尿病的中药组合物，是由以下重量配比的药用原料制备而成：赤芍12g、红景天9g、桑椹9g、莪术3g、马兰3g。
上述药用原料的提取方法同实施例1。
药效学试验证明：
为了证实本发明药物的疗效和安全性，发明人进行了药效学和毒性试验考察。所采用的研究方法及试验结果如下：
1、试验材料
(1)药物及试剂：
根据实施例1制备的本发明中药组合物；
根据对比例制备的对比例中药组合物；
四氧嘧啶，SIGMA Co.生产；
葡萄糖测定试剂盒，由北京化工厂生产；
降糖灵，市售。
(2)动物：昆明种小鼠，由四川抗菌素研究所实验动物中心提供。
(3)仪器：VZS-723分光光度计，电子天平等。
2、试验方法与结果：
(一)本发明药物对四氧嘧啶性糖尿病小鼠高血糖的影响
(1)、造高血糖模型与分组
取体重25±1g昆明种雄性小鼠80只，禁食不禁水。3小时后，尾静脉注射四氧嘧啶生理盐水注射液85mg/kg(0.5ml/只)造成高血糖模型，另将15只体重25±1g昆明种雄性小鼠尾静脉注射等量生理盐水(0.5ml/只)，做为正常对照动物。72小时后，将上述小鼠禁食不禁水10小时；然后自其眼眶取血，葡萄糖氧化酶法测每只小鼠血糖浓度。
从80只注射四氧嘧啶生理盐水注射液的小鼠中选择血糖高于200mg/dL且血糖值相近的60只，随机分为4组，即模型组、本发明药物组、对照组1及降糖灵组，每组15只。
(2)、给药、测血糖浓度
五组小鼠分别按下述方法灌胃给药和生理盐水：对本发明药物组灌胃本发明实施例1制备的中药组合物，用药总剂量：7g/kg(生药材)；对降糖灵组灌胃降糖灵，用药总剂量：80mg/kg；对对照组1灌胃本发明对比例制备的中药组合物，用药总剂量：7g/kg(生药材)；对模型组灌服等溶媒量的生理盐水；生理盐水组灌服等溶媒量的生理盐水。
连续给药10天，给药期间及前后观察各组的小鼠的摄食、活动及排泄情况均无异常情况发生。于第10天给药1小时后，眼眶取血，测空腹血糖浓度(禁食不禁水10小时，方法同前述)。比较对照组1与模型组之间，各给药组之间差异，结果见表1。
表1
注：表1中，与模型组比较:▲▲▲P＜0.001,▲▲P＜0.05，▲P＞0.05。
表1中实验结果表明：小鼠静脉注射四氧嘧啶72小时后，小鼠高血糖造模成功，其血糖浓度显著高于生理盐水组。本发明药物组连续给药10天后，小鼠血糖浓度降为395.4±31.3mg/dL，比模型组的小鼠血糖浓度448.5±45.2mg/dL低53mg/dL左右。且本发明药物组的统计结果相对于模型组的的统计结果P＜0.05，具有显著性差异，本发明的药物组对四氧嘧啶性糖尿病小鼠高血糖的降血糖治疗效果好；且小鼠给药期间及前后无不良反应，本发明的治疗糖尿病的中药组合物治疗糖尿病对患者身体副作用小。
而对照组1连续给药10天后，小鼠血糖浓度为421.5±101.7mg/dL，比模型组的小鼠血糖浓度448.5±45.2mg/dL低27mg/dL左右；比本发明药物组小鼠血糖浓度的统计值395.4±31.3mg/dL高26mg/dL左右；且对照组1的统计结果相对于模型组的统计结果P＞0.05，无显著性差异。故得知，对比例制备的中药组合物对四氧嘧啶性糖尿病小鼠高血糖的降血糖治疗效果差。
综上，本发明治疗糖尿病的中药组合物，治疗糖尿病疗效好、见效快且对身体无副作用，6味药用原料按配方比例组合后，具有协同增效功能；缺少任意组分，中药组合物治疗糖尿病的疗效都会明显降低，如上述药效学试验中，对照组1的治疗效果相对于本发明药物组的疗效明显降低，且本发明的治疗糖尿病的中药组合物治疗糖尿病对患者身体副作用小。
Claims (10)
1.一种含牛蒡子的治疗糖尿病的中药组合物，其特征在于：它是由以下重量配比的药用原料制成：赤芍5～20份、红景天5～15份、桑椹5～15份、牛蒡子2～9份、莪术1～5份、马兰1～5份。
2.根据权利要求1所述的治疗糖尿病的中药组合物，其特征在于：赤芍所占重量比例为9～15份。
3.根据权利要求1所述的治疗糖尿病的中药组合物，其特征在于：红景天所占重量比例为7～12份。
4.根据权利要求1所述的治疗糖尿病的中药组合物，其特征在于：桑椹所占重量比例为7～12份。
5.根据权利要求1所述的治疗糖尿病的中药组合物，其特征在于：牛蒡子所占重量比例为4～7份。
6.根据权利要求5所述的治疗糖尿病的中药组合物，其特征在于：牛蒡子所占重量比例为6份。
7.根据权利要求1所述的治疗糖尿病的中药组合物，其特征在于：莪术所占重量比例为2～4份。
8.根据权利要求7所述的治疗糖尿病的中药组合物，其特征在于：莪术所占重量比例为3份。
9.根据权利要求1所述的治疗糖尿病的中药组合物，其特征在于：马兰所占重量比例为2～4份。
10.根据权利要求9所述的治疗糖尿病的中药组合物，其特征在于：马兰所占重量比例为3份。
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