CN108403803B - 一种防治糖尿病心血管并发症的中药复方制剂 - Google Patents
一种防治糖尿病心血管并发症的中药复方制剂 Download PDFInfo
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Abstract
一种防治糖尿病心血管并发症的中药复方制剂,属于中药技术领域。其由以下重量份的中药组成:生白术20~40份、生山楂10~30份、丹参5~25份、天花粉5~25份、葛根20~40份、生牡蛎20~40份、灵芝5~25份、瓜蒌5~25份、土鳖虫5~25份、炒王不留行10~30份、南烛子5~25份。上述的一种防治糖尿病心血管并发症的中药复方制剂,配伍合理,具有运脾化浊、活血散结功效,且安全未见毒副作用,对防治糖尿病心血管并发症有很好的效果。
Description
技术领域
本发明属于中药技术领域,具体涉及一种防治糖尿病心血管并发症的中药复方制剂。
背景技术
糖尿病(diabetes mellitus,DM)是一组以慢性血葡萄糖水平增高为特征的代谢性疾病,是由胰岛素分泌和(或)作用缺陷所引起。长期碳水化合物以及脂肪、蛋白质代谢紊乱可引起多***损害,其中糖尿病心血管病变是糖尿病的常见并发症,也是导致糖尿病患者死亡的主要原因。研究表明,糖尿病患者与有心肌梗死既往史的非糖尿病患者发生心肌梗死的风险相当。高血糖和胰岛素抵抗等危险因素的存在,可降低一氧化氮的活性,影响血管的舒张功能,同时刺激血管产生大量细胞因子,促进炎症反应和氧化应激,提高血管渗透性,破坏血管内皮的完整性,导致血管内皮功能障碍的形成。在动脉粥样硬化(atherosclerosis,AS)形成的初期,血管内皮功能障碍仍具有可逆性,及早逆转血管内皮功能障碍对抑制AS 进展,从而防止心肌缺血性疾病的发生发展具有重要的临床意义。糖尿病心血管并发症是一种复杂的疾病,涉及多组织器官的病理改变,单一的控制血糖及抗血小板聚集等并不能有效防止胰岛素抵抗相关血管内皮功能障碍的发生发展。中医学将该病归于“消渴病”、“胸痹”、“心悸”等范畴,本发明对糖尿病心血管并发症发生和发展的干预作用是多角度多层面的,其在治疗糖尿病心血管病变这类复杂疾病方面具有独特优势。
发明内容
针对现有技术存在的问题,本发明的目的在于设计提供一种防治糖尿病心血管并发症的中药复方制剂的技术方案。
所述的一种防治糖尿病心血管并发症的中药复方制剂,其特征在于由以下重量份的中药组成:生白术20~40份、生山楂10~30份、丹参5~25份、天花粉5~25份、葛根20~40份、生牡蛎20~40份、灵芝5~25份、瓜蒌5~25份、土鳖虫5~25份、炒王不留行10~30份、南烛子5~25份。
所述的一种防治糖尿病心血管并发症的中药复方制剂,其特征在于由以下重量份的中药组成:生白术25~35份、生山楂15~25份、丹参10~20份、天花粉10~20份、葛根25~35份、生牡蛎25~35份、灵芝10~20份、瓜蒌10~20份、土鳖虫10~20份、炒王不留行15~25份、南烛子10~20份。
所述的一种防治糖尿病心血管并发症的中药复方制剂,其特征在于由以下重量份的中药组成:生白术30份、生山楂20份、丹参15份、天花粉15份、葛根30份、生牡蛎30份、灵芝15份、瓜蒌15份、土鳖虫15份、炒王不留行20份、南烛子15份。
生白术,甘、苦,温。归脾、胃经。具有健脾运脾的功效,可助脾气散精以灌四滂的作用,使清浊得分,湿浊不生。现代药理研究表明生白术水煎剂具有调节胃肠道功能及降血糖的作用。
生山楂,酸、甘,微温。归脾、胃、肝经。性温可入血分,能通行气血,活血祛瘀,且能化浊降脂。现代药理研究表明山楂中解脂酶促进脂肪分解,其提取物能扩张冠状动脉,增加冠脉血流量,又能降血脂和抗动脉粥样硬化。
丹参,苦,微寒。归心、肝经。功善活血化瘀、祛瘀生新,是治疗血行不畅,瘀血阻滞的要药,其有“小四物”之称而行血之中又兼补益之能。现代药理研究表明丹参具有扩张冠脉,增加冠脉血流量,调节血脂,降低血液粘度、抗动脉粥样硬化及抗炎镇痛的作用。
天花粉,甘、微苦,微寒。归肺、胃经。既能清肺胃实热,又能生津止渴,具有清热不伤正,滋阴不碍脾的特点,是治疗消渴症的要药。现代药理研究表明天花粉凝集素粗品具有降低血糖的作用。
葛根,甘、辛,凉。归脾、胃、肺经。能鼓舞脾胃清阳之气上升,而有生津止渴之功,其味辛能行,具有通经活络之能。现代药理研究表明葛根总黄酮能扩张冠脉血管和脑血管,葛根所含的不同成分还具有降血糖、降血脂、抗氧化等作用。
生牡蛎,咸,微寒。归肝、胆、肾经。具有潜阳补阴、增气力及软坚散结的作用。现代药理研究表明牡蛎活性肽具有促进胰岛组织修复和恢复其分泌的功能,牡蛎提取液具有降低血糖的作用。
灵芝,甘,平。归心、肺、肝、肾经。能补心血、益心气、安心神,具有补气血不助热的特点。现代药理研究表明,灵芝能降低血液粘度,增加心肌收缩力,增加冠脉血流量,灵芝多糖可调节糖脂代谢途径。
瓜蒌,甘,微寒。归肺、胃、大肠经。具有清热化痰、宽胸散结的作用,又能利气开郁。现代药理研究表明瓜蒌具有扩张冠脉,增加冠脉血流量,抗凝血及降低血清胆固醇等多种活性,其水提取物可显著升高饥饿家兔血糖水平。
土鳖虫,咸,寒。归肝经。性善走窜,具有活血通经散结的作用。现代药理研究表明土鳖虫水提取液有调节脂质代谢、抗氧化自由基、保护血管内皮细胞的作用。
王不留行,苦,平。归肝、胃经。善于通利血脉,活血通经散结。现代药理研究表明王不留行能抗血管生成,其正丁醇提取物可抑制内皮细胞的增殖、迁移、粘附,对内皮细胞有良好的保护作用,王不留行与丹参配伍后可延长凝血时间、降低全血粘度。
南烛子,酸、甘,平。归肝、肾经。具有补肝肾,强筋骨,固精气的作用。中医认为“久病及肾”,故以此顾护肾精并益气。
制作方法:
一种防治糖尿病心血管并发症的中药复方制剂,所述制剂为下列之一的剂型:①汤剂;②颗粒剂;③丸剂;④胶囊。所述制剂由防治糖尿病心血管并发症的复方中药的水提取物和药物可接受的赋型剂组成。
所述的制剂为防治糖尿病心血管并发症汤剂,所述防治糖尿病心血管并发症汤剂按如下方法制得:准确称量后,纳入生牡蛎先煮30min,后入生白术,生山楂,丹参,天花粉,葛根,灵芝,瓜蒌,土鳖虫,炒王不留行,南烛子,武火煮沸后改用文火维持20min左右,将煎液倒出。再入清水,所有药物武火煮沸,改用文火维持,倒出煎液,将两次煎液混合即得防治糖尿病心血管并发症的中药汤剂。
所述的制剂为防治糖尿病心血管并发症颗粒剂,所述防治糖尿病心血管并发症颗粒剂按如下方法制得:准确称量生白术,生山楂,丹参,天花粉,生牡蛎,葛根,灵芝,瓜蒌,土鳖虫,炒王不留行,南烛子,适当的切碎或粉碎,置适宜煎煮容器中,加适量水使浸没药材,浸泡适当时间后,加热煮沸,一定时间后分离出煎液,药渣重复煎煮2~3次,收集各煎出液,离心分离或沉降滤过后,低温浓缩至规定浓度,将浓缩成一定比重的浸膏与辅料捏合,必要时加入适量的湿润剂,整粒,干燥,即得防治糖尿病心血管并发症的中药颗粒剂。
所述的制剂为防治糖尿病心血管并发症丸剂,所述防治糖尿病心血管并发症丸剂按如下方法制得:准确称量生白术,生山楂,丹参,天花粉,生牡蛎,葛根,灵芝,瓜蒌,土鳖虫,炒王不留行,南烛子,粉碎成细粉,过筛,混匀,炼蜜,合药,搓丸,干燥,即得防治糖尿病心血管并发症的中药丸剂。
所述的制剂为防治糖尿病心血管并发症胶囊剂,所述防治糖尿病心血管并发症胶囊剂按如下方法制得:准确称量生白术,生山楂,丹参,天花粉,生牡蛎,葛根,灵芝,瓜蒌,土鳖虫,炒王不留行,南烛子,适当的切碎或粉碎,置适宜煎煮容器中,加适量水使浸没药材,浸泡适当时间后,加热煮沸,一定时间后分离出煎液,药渣重复煎煮2~3次,收集各煎出液,离心分离或沉降滤过后,低温浓缩至规定浓度,加入或不加入药物可接受的赋型剂,即制得防治糖尿病心血管并发症的胶囊剂的内容物。
上述的一种防治糖尿病心血管并发症的中药复方制剂,配伍合理,具有运脾化浊、活血散结功效,且安全未见毒副作用,对防治糖尿病心血管并发症有很好的效果。
具体实施方式
以下结合实施例来进一步说明本发明。
实施例1
一种防治糖尿病心血管并发症的中药复方制剂,其由以下重量的中药组成:生白术30 g、生山楂20 g、丹参15 g、天花粉15 g、葛根30 g、生牡蛎30 g、灵芝15 g、瓜蒌15 g、土鳖虫15 g、炒王不留行20 g、南烛子15g。
实施例2
一种防治糖尿病心血管并发症的中药复方制剂,其由以下重量的中药组成:生白术25 g、生山楂15 g、丹参10 g、天花粉10 g、葛根25 g、生牡蛎25 g、灵芝10 g、瓜蒌10 g、土鳖虫10 g、炒王不留行15 g、南烛子10g。
实施例3
一种防治糖尿病心血管并发症的中药复方制剂,其由以下重量的中药组成:生白术35 g、生山楂25 g、丹参20 g、天花粉15 g、葛根35 g、生牡蛎35 g、灵芝20 g、瓜蒌15 g、土鳖虫15 g、炒王不留行15 g、南烛子5g。
实施例4
一种防治糖尿病心血管并发症的中药复方制剂,其由以下重量的中药组成:生白术20 g、生山楂10 g、丹参5 g、天花粉5 g、葛根20 g、生牡蛎20 g、灵芝5 g、瓜蒌5 g、土鳖虫5 g、炒王不留行10 g、南烛子10g。
实施例5
一种防治糖尿病心血管并发症的中药复方制剂,其由以下重量的中药组成:生白术40 g、生山楂30 g、丹参25 g、天花粉15 g、葛根40 g、生牡蛎40 g、灵芝25 g、瓜蒌15g、土鳖虫15 g、炒王不留行25g、南烛子15g。
试验例1
1临床资料
1.1 一般资料
240例患者均为2016年1月至2017年12月在浙江中医药大学门诊部就诊的患者,根据计算机随机抽取数字分为对照组和治疗组,每组各120例。两组患者性别、年龄和病程的基线资料比较,差异无统计学意义(P>0.05),具有可比性。详见表1。
表1 两组患者基线资料比较
1.2 诊断标准
2型糖尿病患者符合《中国2型糖尿病防治指南(2010年版)》的诊断标准。
1.3 纳入标准
①符合上述诊断标准;②年龄35-70岁;③病程1年以上;④自愿参加并签署知情同意书者。
1.4 排除标准
①不符合上述诊断标准和纳入标准的患者;②酮症酸中毒、糖尿病足等严重糖尿病并发症患者;③合并心血管、神经、呼吸、消化、泌尿等***严重疾病及精神病患者;④I型糖尿病和其他继发性糖尿病;⑤妊娠和哺乳期妇女。
2 治疗方法
对照组予西医常规降糖治疗,治疗组在对照组治疗基础上治以运脾化浊、活血散结法,予自拟运脾活血散结方:生白术30g、生山楂20g、丹参15g、天花粉15g、葛根30g、生牡蛎30g、灵芝15g、瓜蒌15g、土鳖虫15g、王不留行20g、南烛子15g。每日1剂,水煎400mL,分早、晚两次温服。疗程为4周,治疗4周后进行疗效评价。在受试期间两组患者均进行糖尿病知识教育和糖尿病膳食指导。
3 疗效评价
3.1观察项目
①胰岛素抵抗相关指标,包括空腹血糖(FBG)、空腹胰岛素(FINS)及胰岛素抵抗指数(HOMA-IR);②血管炎性指标白介素-6(interleukin-6,IL-6),采用ELISA 试剂盒(GeneTech)检测。
3.2 统计工具和资料处理
采用SPSS16.0统计软件,计数资料采用χ 2 检验,计量资料采用t检验,等级资料采用秩和检验。
4 治疗结果
4.1 两组患者治疗前后胰岛素抵抗相关指标比较
由表2可见,两组糖尿病患者治疗前胰岛素抵抗相关指标比较,差异无统计学意义(P>0.05),具有可比性。治疗组治疗后FBG、FINS、HOMA-IR改善均优于对照组,差异具有统计学意义(P<0.05),提示治疗组治疗后胰岛素抵抗相关指标改善明显优于对照组。
注:与对照组治疗后比较,* P<0.05。
4.2 两组患者治疗前后IL-6水平比较
由表3可知,两组糖尿病患者治疗前IL-6的水平比较,差异无统计学意义(P>0.05),具有可比性。治疗组治疗后IL-6水平低于对照组,差异具有统计学意义(P<0.05),提示治疗组治疗后IL-6的水平改善明显优于对照组。
注:与对照组治疗后比较,* P<0.05。
5 讨论
糖尿病心血管病变是糖尿病的常见并发症,高血糖和胰岛素抵抗等因素的存在,使血管的舒张功能受损,并伴随内皮细胞活化,使内皮源性活性物质的合成分泌受到影响,从而导致血管收缩痉挛、炎症反应持续、血小板激活、平滑肌细胞增生和血管重塑,动脉粥样硬化进行性加重,或不稳定斑块破裂而发生心肌梗死。中医学认为该病当归于“消渴病”、“胸痹”、“心悸”等范畴,生理情况下,血糖、血脂来源于水谷精微,由脾胃所化生,是人体必需的营养物质。但如果饮食不节,恣食膏粱厚味,或喜凉饮冷,或饥饱无常,日久损伤脾胃,脾胃运化失司,则水谷精微不能化生气血,清浊不能有效分别,导致湿聚成痰,浊气流溢脉中,此时血液中高水平的糖、脂即成为痰湿、浊气之属。如痰浊壅塞脉道,影响气血的运行,导致气血瘀滞;而痰浊留恋日久,则可成痰瘀互结之证。从以上分析可知糖尿病心血管病变主要涉及两个方面,一是脾失健运,二是痰瘀互结。故应以运脾化浊、活血散结为治疗法则,以达到标本兼治的目的。本实施例通过生白术、生山楂、丹参、天花粉、葛根、生牡蛎、灵芝、瓜蒌、土鳖虫、王不留行和天烛子合理配比,通过各个组分之间的相辅相成作用,到达了运脾化浊、活血散结的目的,能有效防治糖尿病心血管并发症。
以下是本发明的典型病例:
病例1:
李某,女,57岁。患有糖尿病病史3年,服盐酸二甲双胍片,一次0.5g(2片),每日3次口服。近日患者感心悸,空腹血糖10.8mmol/L,口干甚,小便多,胃纳可,大便粘,1~2日一行,舌红,苔薄白,脉结代。心电图示频发室性早搏。诊断:西医诊断:2型糖尿病 频发室性早搏 中医诊断:消渴病 心悸。给予所述中药汤剂治疗,2周后复诊心悸、口干、大便粘等症状明显减轻,空腹血糖7.5mmol/L,盐酸二甲双胍片减为一次2片,每日2次口服;4周后复诊心悸、口干等症状消失,大小便正常,空腹血糖7.1mmol/L,复查心电图示窦性心律 大致正常心电图。
病例2:
齐某,男,49岁。患有糖尿病病史1年余,服降糖药(盐酸二甲双胍片、瑞格列奈片等),效果不明显,空腹血糖9.2mmol/L,血压140~160/90~100mmHg。近月来出现心前区疼痛,伴胸闷,口渴,大便难,2~4日一行,舌红,有紫斑,苔白,脉弦。心电图示II、III、aVF,V2~4 ST段压低。诊断:西医诊断:2型糖尿病 冠心病 中医诊断:消渴病 胸痹心痛。给予所述中药汤剂治疗,2周后复诊患者胸痛、胸闷症状明显减轻,大便1日一行,空腹血糖8.7mmol/L,血压130~140/85~95mmHg。4周后复诊胸闷胸痛症状消失,大小便正常,空腹血糖7.0mmol/L,血压130~140/80~90mmHg,心电图示窦性心律,正常心电图。后于当地转方数次,血糖控制平稳,未再出现胸闷胸痛症状。
Claims (3)
1.一种防治糖尿病心血管并发症的中药复方制剂,其特征在于由以下重量份的中药组成:生白术20~40份、生山楂10~30份、丹参5~25份、天花粉5~25份、葛根20~40份、生牡蛎20~40份、灵芝5~25份、瓜蒌5~25份、土鳖虫5~25份、炒王不留行10~30份、南烛子5~25份。
2.如权利要求1所述的一种防治糖尿病心血管并发症的中药复方制剂,其特征在于由以下重量份的中药组成:生白术25~35份、生山楂15~25份、丹参10~20份、天花粉10~20份、葛根25~35份、生牡蛎25~35份、灵芝10~20份、瓜蒌10~20份、土鳖虫10~20份、炒王不留行15~25份、南烛子10~20份。
3.如权利要求1所述的一种防治糖尿病心血管并发症的中药复方制剂,其特征在于由以下重量份的中药组成:生白术30份、生山楂20份、丹参15份、天花粉15份、葛根30份、生牡蛎30份、灵芝15份、瓜蒌15份、土鳖虫15份、炒王不留行20份、南烛子15份。
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