CN117137987A - 一种用于治疗糖尿病的药物组合物及其制备方法 - Google Patents
一种用于治疗糖尿病的药物组合物及其制备方法 Download PDFInfo
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Abstract
本发明属于中药技术领域,具体涉及一种用于治疗糖尿病的药物组合物及其制备方法。本发明提供了一种用于治疗糖尿病的药物组合物,原料包括:黄芪、枸杞、山药、桑葚、茯苓、白术、党参、当归、大黄、生地黄、牡丹皮、山茱萸、川芎、鸡血藤、泽泻、桂枝。本发明还提供了所述药物组合物的制备方法,步骤包括:按配方称取原料粉碎后混合;将粉碎后的混合物加水进行超声;超声完成后进行煎煮;煎煮完成后进行过滤,将滤液进行真空干燥后即得所述治疗糖尿病的药物组合物。在大鼠糖尿病模型中,本发明药物组合物能够有效降低血糖,无毒副作用,具有广阔的应用前景。
Description
技术领域
本发明涉及中药技术领域,更具体地说,涉及一种用于治疗糖尿病的药物组合物及其制备方法。
背景技术
糖尿病是一种以血浆葡萄糖升高为特征的内分泌代谢性疾病,长期的这种血糖升高会发生与心脑血管、神经、肾脏等疾病相关的并发症,这些并发症严重威胁着患者的生命。因此需要采取有效的方法来延缓糖尿病及其并发症的发生。
2型糖尿病(T2DM)是糖尿病中最常见的类型,占90%以上,其发病机制非常的错综复杂,包括遗传、环境因素等主要病因,发病机制可能与亚临床慢性炎症、氧化应激、肠道微生物群等有关。在治疗上主要通过促进胰岛素分泌和改善胰岛素抵抗等降糖药物或注射胰岛素,治疗期间患者的血糖可能波动明显。
糖尿病根据临床表现属于中医学中消渴病范畴,“消渴”一词首见于《素问·奇病论篇》载“肥者,令人内热,甘者令人中满,故其气上溢,转为消渴。”指出消渴为饮食不节,脾胃失运化所致。《金匮要略》立专篇讨论,并最早提出治疗方药。《圣济总录》载“消渴病久,肾气受伤,肾主水,肾气虚惫,气化失常,开阖不利,水液聚于体内而出现水肿。”指出消渴病为肾气不足,气化功能失常,津液聚集而发生水肿。
随着中医药的不断发展,越来越多的中医学者提出对2型糖尿病的诊治,中医学通过辨证论治,个体、整体化治疗以达到阴阳平衡、气血调和、气机调畅、脏腑协调,不仅能改善临床症状也能降低其血糖水平。
基于此,本发明提供了一种用于治疗糖尿病的药物组合物及其制备方法。
发明内容
为了克服现有技术中的问题,本发明提供了一种用于治疗糖尿病的药物组合物及其制备方法。
第一方面,本发明提供了一种用于治疗糖尿病的药物组合物,采用如下的技术方案:
一种用于治疗糖尿病的药物组合物,包括以下重量份原料:黄芪8-15份、枸杞3-8份、山药2-6份、桑葚2-6份、茯苓4-10份、白术4-10份、党参4-7份、当归2-5份、大黄3-6份、生地黄2-6份、牡丹皮3-8份、山茱萸3-8份、川芎3-8份、鸡血藤2-6份、泽泻2-8份、桂枝2-6份。
进一步地,包括以下重量份原料:黄芪10-12份、枸杞4-5份、山药2-3份、桑葚2-4份、茯苓6-8份、白术6-8份、党参5-6份、当归3-4份、大黄3-4份、生地黄3-4份、牡丹皮4-6份、山茱萸4-6份、川芎4-6份、鸡血藤3-5份、泽泻4-6份、桂枝3-4份。
进一步地,包括以下重量份原料:黄芪11份、枸杞4.5份、山药2.5份、桑葚3份、茯苓7份、白术7份、党参5.5份、当归3.5份、大黄3.5份、生地黄3.5份、牡丹皮5份、山茱萸6份、川芎6份、鸡血藤4份、泽泻5份、桂枝3.5份。
第二方面,本发明还提供另外一种用于治疗糖尿病的药物组合物的制备方法,采用如下的技术方案:
一种用于治疗糖尿病的药物组合物的制备方法,具体包括以下制备步骤:
步骤S1:按配方称取原料粉碎后混合;
步骤S2:将粉碎后的混合物加水进行超声;
步骤S3:超声完成后进行煎煮;
步骤S4:煎煮完成后进行过滤,将滤液进行真空干燥后即得所述治疗糖尿病的药物组合物。
进一步地,所述步骤S2包括将粉碎后的混合物加入相对于混合物粉料4-5倍重量份的水进行超声10-20min。
进一步地,所述步骤S3中煎煮时的加水量为混合物粉料重量的20-30倍,水分3-5次加入,煎煮时间为2-3h。
第三方面,本发明还提供了用于治疗糖尿病的药物组合物在制备降血糖药物或在制备用于辅助降血糖的保健食品中的应用。
第四方面,本发明还提供一种中药制剂,包括用于治疗糖尿病的药物组合物和药学可接受的辅料。
进一步地,所述辅料包括注射用水、药用载体、表面活性剂、稀释剂、赋形剂、抗氧剂、稳定剂、增溶剂中的一种或几种。
进一步地,所述药物组合物为胶囊剂、片剂、滴丸、口服液或者颗粒剂。
综上所述,本发明具有以下有益效果:
本发明在六味地黄丸(《小儿药证直诀》)经方组成(熟地黄、山茱萸、山药、泽泻、茯苓、牡丹皮)的基础上挖掘出了一种有效治疗糖尿病的中药组合物配方,为相关临床中药复方开发利用提供有力支持。
在糖尿病发生发展过程中,会产生气虚运血无力,血液运行不畅则生血瘀,阴虚内热灼伤脉道导致脉道涩滞不畅亦可成瘀,故佐以党参、生地黄、牡丹皮、川芎来活血祛瘀,祛瘀而不伤正,意在治标同时兼以扶正。
另外,本发明中以黄芪、茯苓、白术、泽泻等补虚药、利水渗湿药,益气健脾、淡渗利湿,兼之以前述党参、生地黄、牡丹皮、川芎等活血祛瘀药物合用,又做清热药之功效,以达到清热利湿泄浊的目的。治疗糖尿病还需要以寒温并用,补泻兼施,平衡阴阳。而其中的茯苓-泽泻组合是经典名方五苓散君药,配伍后可增强渗水利湿之功效,茯苓-党参组合同时又可提升益气健脾除湿之功效。
具体实施方式
下面通过具体实施方式来进一步说明本发明的技术方案。本领域技术人员应该明了,所述实施例仅仅是帮助理解本发明,不应视为对本发明的具体限制。
实施本发明的过程、条件、试剂、实验方法等,除以下专门提及的内容之外,均为本领域的普遍知识和公知常识,本发明没有特别限制内容。各实施例中未注明具体条件的实验方法,通常按照常规条件或按照制造厂商所建议的条件。
除非另有说明,本说明书中使用的全部专业术语和科学用语的含义均与本发明所属技术领域的技术人员一般理解的含义相同。但如有冲突,以包含定义的本说明书为准。
本发明提出的一种用于治疗糖尿病的药物组合物,包括以下重量份原料:黄芪8-15份、枸杞3-8份、山药2-6份、桑葚2-6份、茯苓4-10份、白术4-10份、党参4-7份、当归2-5份、大黄3-6份、生地黄2-6份、牡丹皮3-8份、山茱萸3-8份、川芎3-8份、鸡血藤2-6份、泽泻2-8份、桂枝2-6份。
所述用于治疗糖尿病的药物组合物的制备方法,包括以下步骤:
步骤S1:按配方称取原料粉碎后混合;
步骤S2:将粉碎后的混合物加入相对于混合物粉料4-5倍重量份的水进行超声10-20min;
步骤S3:超声完成后进行煎煮;煎煮时的加水量为混合物粉料重量的20-30倍,水分3-5次加入,煎煮时间为2-3h;
步骤S4:煎煮完成后进行过滤,将滤液进行真空干燥后即得所述治疗糖尿病的药物组合物。
下面结合具体实施例对本发明作进一步解说:
实施例1
本实施例用于治疗糖尿病的药物组合物,由以下重量份原料制成:黄芪11份、枸杞4.5份、山药2.5份、桑葚3份、茯苓7份、白术7份、党参5.5份、当归3.5份、大黄3.5份、生地黄3.5份、牡丹皮5份、山茱萸6份、川芎6份、鸡血藤4份、泽泻5份、桂枝3.5份。
所述药物组合物的制备方法包括:
步骤S1:按配方称取原料粉碎后混合;
步骤S2:将粉碎后的混合物加入相对于混合物粉料4.5倍重量份的水进行超声15min;
步骤S3:超声完成后进行煎煮;煎煮时的加水量为混合物粉料重量的25倍,水分5次加入,煎煮时间为2.5h;
步骤S4:煎煮完成后进行过滤,将滤液进行真空干燥后即得所述治疗糖尿病的药物组合物。
实施例2
本实施例用于治疗糖尿病的药物组合物,由以下重量份原料制成:黄芪10份、枸杞5份、山药2份、桑葚4份、茯苓6份、白术8份、党参6份、当归3份、大黄4份、生地黄3份、牡丹皮6份、山茱萸4份、川芎6份、鸡血藤3份、泽泻6份、桂枝3份。
所述药物组合物的制备方法包括:
步骤S1:按配方称取原料粉碎后混合;
步骤S2:将粉碎后的混合物加入相对于混合物粉料4倍重量份的水进行超声20min;
步骤S3:超声完成后进行煎煮;煎煮时的加水量为混合物粉料重量的30倍,水分5次加入,煎煮时间为3h;
步骤S4:煎煮完成后进行过滤,将滤液进行真空干燥后即得所述治疗糖尿病的药物组合物。
实施例3
本实施例用于治疗糖尿病的药物组合物,由以下重量份原料制成:黄芪12份、枸杞4份、山药3份、桑葚2份、茯苓8份、白术6份、党参6份、当归3份、大黄4份、生地黄3份、牡丹皮6份、山茱萸4份、川芎6份、鸡血藤3份、泽泻6份、桂枝4份。
所述药物组合物的制备方法包括:
步骤S1:按配方称取原料粉碎后混合;
步骤S2:将粉碎后的混合物加入相对于混合物粉料5倍重量份的水进行超声10min;
步骤S3:超声完成后进行煎煮;煎煮时的加水量为混合物粉料重量的20倍,水分4次加入,煎煮时间为2h;
步骤S4:煎煮完成后进行过滤,将滤液进行真空干燥后即得所述治疗糖尿病的药物组合物。
对比例1
现有技术中益糖康已证明其对T2DM有较好的防治作用,可以有效调节糖脂代谢,其原料组成为:黄芪14份、茯苓6份、白术6份、黄精12份、人参6份、枸杞子6份、黄连6份、丹参6份、三七3份、大黄3份、连翘6份、甘草4份。
所述药物组合物的制备方法包括:
步骤S1:按配方称取原料粉碎后混合;
步骤S2:将粉碎后的混合物加入相对于混合物粉料4.5倍重量份的水进行超声15min;
步骤S3:超声完成后进行煎煮;煎煮时的加水量为混合物粉料重量的25倍,水分5次加入,煎煮时间为2.5h;
步骤S4:煎煮完成后进行过滤,将滤液进行真空干燥后即得。
对比例2
本对比例用于治疗糖尿病的药物组合物,由以下重量份原料制成:黄芪15份、枸杞6.5份、山药3.5份、桑葚4份、党参8.5份、当归4.5份、大黄4.5份、生地黄4.5份、牡丹皮6份、山茱萸7份、川芎7份、鸡血藤5份、桂枝4.5份。
所述药物组合物的制备方法包括:
步骤S1:按配方称取原料粉碎后混合;
步骤S2:将粉碎后的混合物加入相对于混合物粉料4.5倍重量份的水进行超声15min;
步骤S3:超声完成后进行煎煮;煎煮时的加水量为混合物粉料重量的25倍,水分5次加入,煎煮时间为2.5h;
步骤S4:煎煮完成后进行过滤,将滤液进行真空干燥后即得所述治疗糖尿病的药物组合物。
对比例3
本对比例用于治疗糖尿病的药物组合物,由以下重量份原料制成:黄芪11份、枸杞4.5份、山药2.5份、桑葚3份、茯苓7份、白术7份、丹参5.5份、当归3.5份、大黄3.5份、黄精3.5份、牡丹皮5份、山茱萸6份、川芎6份、鸡血藤4份、泽泻5份、桂枝3.5份。
所述药物组合物的制备方法包括:
步骤S1:按配方称取原料粉碎后混合;
步骤S2:将粉碎后的混合物加入相对于混合物粉料4.5倍重量份的水进行超声15min;
步骤S3:超声完成后进行煎煮;煎煮时的加水量为混合物粉料重量的25倍,水分5次加入,煎煮时间为2.5h;
步骤S4:煎煮完成后进行过滤,将滤液进行真空干燥后即得所述治疗糖尿病的药物组合物。
药效学实验:
1、造模
将70只雄性SD大鼠适应性喂养1周后,体质量(200±20)g,购自辽宁长生生物技术有限公司,按体质量由低到高排序,用随机数字表抽取10只大鼠设为空白组,予普通饲料喂养,其他40只大鼠予高脂饲料喂养,均自由进食(约20g)饮水。其中,高脂饲料由辽宁中医药大学实验中心生产,组成:6%蛋黄粉,10%猪油,8%蔗糖,1%胆酸钠,1%胆固醇,74%普通饲料。
制备T2DM大鼠模型:60只大鼠经高脂饲料喂养4周后禁食不禁水12h,一次性腹腔注射链脲佐菌素(STZ)45mg/kg,注射时用柠檬酸缓冲液(pH 4.2~4.5)以1%的浓度溶解。72h后,连续3天同一时间尾静脉采血检测各组大鼠血糖水平,3次检测均大于16.7mmol/L认定为T2DM模型成功。
2、分组
60只大鼠均造模成功,按血糖水平由低到高排序,然后用随机数字表分为实施例组、对比例组、二甲双胍组和模型对照组,每组10只。
3、给药
实施例组和对比例组给予实施例1、对比例1-3制得的药物组合物制备冲剂56g/(kg·d)灌胃;
二甲双胍组给予盐酸二甲双胍片150mg/(kg·d)灌胃,该盐酸二甲双胍片为中美上海施贵宝制药有限公司生产,批号:1407082。
模型对照组和空白对照组大鼠均灌胃生理盐水0.1ml/10g。各组均每日1次,连续灌胃4周。给药期间空白组大鼠给予普通饲料喂养,其余各组予高脂饲料喂养。
4、血糖、血脂相关指标测量
应用酶联免疫吸附法(ELISA)测定大鼠血浆中糖化血红蛋白、胰岛素水平,生化法测血浆中甘油三酯、总胆固醇、高密度脂蛋白胆固醇和低密度脂蛋白胆固醇水平,具体操作严格按照试剂盒说明书进行。
其中,胰岛素(INS,批号:202101)、糖化血红蛋白(HbAlc,批号:202101)试剂盒,上海优选生物科技有限公司;甘油三酯(TG,批号:20210115)、总胆固醇(TC,批号:20210115)、高密度脂蛋白胆固醇(HDL-C,批号:20210115)、低密度脂蛋白胆固醇(LDL-C,批号:20210115)试剂盒,南京建成生物工程研究所。
5、统计学方法
采用SPSS25.0软件进行统计分析。计量资料符合正态分布者以平均值±标准差表示,多组间比较采用单因素方差分析,两两比较采用LSD法;不符合正态分布者用中位数和四分位数[M(Q1,Q3)]表示,多组间比较采用Kruskal-Wallis H检验,两两比较采用秩转换的方差分析。差异肠道菌群(基于门水平)与血糖、血脂的相关性采用Spearman相关分析。以P<0.05为差异有统计学意义。
6、各组大鼠血糖相关指标比较
如表1所示,与空白组比较,模型对照组血糖、胰岛素、糖化血红蛋白水平显著升高(P<0.01,P<0.001),提示造模成功;与模型对照组比较,二甲双胍组和实施例组血糖、胰岛素、糖化血红蛋白水平显著降低(P<0.01,P<0.001),且实施例组的实验结果与二甲双胍组接近,而对比例组各指标降低程度有限,大部分检测指标的差异无统计学意义(P>0.05)。
表1各组大鼠血糖相关指标比较
注:INS,胰岛素;HbAlc,糖化血红蛋白。与空白组比较,**表示P<0.01,***表示P<0.001;与模型对照组比较,#表示P<0.05,##表示P<0.01,###表示P<0.001。
治疗前制备T2DM大鼠模型中大鼠血糖数值在20-25mmol·L-1,对照组大鼠血糖数值在4-7mmol·L-1,经药物治疗后实施例组和对比例组相对于模型对照组血糖值均趋于正常血糖数值,且实施例组相对于对比例组血糖数值更趋于空白组(即正常血糖数值),因此本发明所提供的重要组合物能够有效降低血糖。
7、各组大鼠血脂相关指标比较
如表2所示,与空白组比较,模型对照组总胆固醇、甘油三酯、低密度脂蛋白胆固醇水平显著升高,高密度脂蛋白胆固醇水平显著降低(P<0.01,P<0.001),提示造模成功;与模型对照组比较,二甲双胍组和实施例组甘油三酯、低密度脂蛋白胆固醇水平显著降低,高密度脂蛋白胆固醇水平显著升高(##表示P<0.01,###表示P<0.001),且实施例组的实验结果与二甲双胍组接近。
表2各组大鼠血脂相关指标比较
注:TG,甘油三酯;TC,总胆固醇;HDL-C,高密度脂蛋白胆固醇;LDL-C,低密度脂蛋白胆固醇。与空白组比较,**表示P<0.01,***表示P<0.001;与模型对照组比较,##表示P<0.01,###表示P<0.001。
综上,前述结果表明本发明中制备得到的中药组合物能够降低T2DM模型大鼠血糖,调节血脂。
本具体实施例仅仅是对本发明的解释,其并不是对本发明的限制,本领域技术人员在阅读完本说明书后可以根据需要对本实施例做出没有创造性贡献的修改,但只要在本发明的权利要求范围内都受到专利法的保护。
Claims (10)
1.一种用于治疗糖尿病的药物组合物,其特征在于,包括以下重量份原料:黄芪8-15份、枸杞3-8份、山药2-6份、桑葚2-6份、茯苓4-10份、白术4-10份、党参4-7份、当归2-5份、大黄3-6份、生地黄2-6份、牡丹皮3-8份、山茱萸3-8份、川芎3-8份、鸡血藤2-6份、泽泻2-8份、桂枝2-6份。
2.根据权利要求1所述的一种用于治疗糖尿病的药物组合物,其特征在于,包括以下重量份原料:黄芪10-12份、枸杞4-5份、山药2-3份、桑葚2-4份、茯苓6-8份、白术6-8份、党参5-6份、当归3-4份、大黄3-4份、生地黄3-4份、牡丹皮4-6份、山茱萸4-6份、川芎4-6份、鸡血藤3-5份、泽泻4-6份、桂枝3-4份。
3.根据权利要求1所述的一种用于治疗糖尿病的药物组合物,其特征在于,包括以下重量份原料:黄芪11份、枸杞4.5份、山药2.5份、桑葚3份、茯苓7份、白术7份、党参5.5份、当归3.5份、大黄3.5份、生地黄3.5份、牡丹皮5份、山茱萸6份、川芎6份、鸡血藤4份、泽泻5份、桂枝3.5份。
4.权利要求1-3中任一项所述的用于治疗糖尿病的药物组合物的制备方法,其特征在于,包括以下步骤:
步骤S1:按配方称取原料粉碎后混合;
步骤S2:将粉碎后的混合物加水进行超声;
步骤S3:超声完成后进行煎煮;
步骤S4:煎煮完成后进行过滤,将滤液进行真空干燥后即得所述治疗糖尿病的药物组合物。
5.根据权利要求4所述的用于治疗糖尿病的药物组合物的制备方法,其特征在于,所述步骤S2包括将粉碎后的混合物加入相对于混合物粉料4-5倍重量份的水进行超声10-20min。
6.根据权利要求4所述的用于治疗糖尿病的药物组合物的制备方法,其特征在于,所述步骤S3中煎煮时的加水量为混合物粉料重量的20-30倍,水分3-5次加入,煎煮时间为2-3h。
7.权利要求1-3中任一项所述的用于治疗糖尿病的药物组合物在制备降血糖药物或在制备用于辅助降血糖的保健食品中的应用。
8.一种中药制剂,其特征在于,包括权利要求1-3中任一项所述的用于治疗糖尿病的药物组合物和药学可接受的辅料。
9.根据权利要求8所述的中药制剂,其特征在于,所述辅料包括注射用水、药用载体、表面活性剂、稀释剂、赋形剂、抗氧剂、稳定剂、增溶剂中的一种或几种。
10.根据权利要求8所述的中药制剂,其特征在于,所述中药制剂为胶囊剂、片剂、滴丸、口服液或者颗粒剂。
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