CN114748582A - 一种用于降血糖的中药组合物及其应用 - Google Patents
一种用于降血糖的中药组合物及其应用 Download PDFInfo
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- CN114748582A CN114748582A CN202110025440.2A CN202110025440A CN114748582A CN 114748582 A CN114748582 A CN 114748582A CN 202110025440 A CN202110025440 A CN 202110025440A CN 114748582 A CN114748582 A CN 114748582A
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Abstract
本发明提供了一种用于降血糖的中药组合物及其应用。该中药组合物由下列重量份的组分制成:金钗石斛1‑10份、葛根1‑10份、西洋参1‑10份和绞股蓝1‑10份。该中药组合物通过各组分之间的协同作用,能够起到更好的降血糖作用,且相对于单一组分及任三种组分的组合效果更好。由中药组合物制备而得的中药制剂具有降血糖功能,且疗效显著、便于服用、无明显毒副作用,可制备成用于降血糖的药物、食品或者保健品。
Description
技术领域
本发明涉及中药领域,具体涉及一种用于降血糖的中药组合物及其应用。
背景技术
糖尿病是一种多发病和常见病。据统计,目前我国糖尿病的患病人数已居全球之首。糖尿病患者机体中长期的高血糖状态会导致人体各种组织、器官的慢性损害、功能障碍,严重危害生命健康。并且长期用药对患者家庭及国家医保造成极大负担,因此,开发安全性高、疗效好的降糖药物及保健品具有重要的社会价值及经济价值。
虽然随着医疗技术的不断提高,糖尿病的治疗新药不断上市,但糖尿病的发病率在全世界范围内仍呈现上升趋势,其主要原因在于西药的治疗靶点过于单一,无法根治糖尿病,且具有较多的副作用。当前常用的用于治疗糖尿病的西药包括二甲双胍、磺酰脲类、格列奈类、α-糖苷酶抑制剂、胰岛素增敏剂、GLP-1受体激动剂、DPP-4抑制剂、SGLT-2抑制剂和胰岛素及其类似物等。
二甲双胍除了能有效降糖以外,还可降低体重、血压及血脂,具有心血管保护作用,显着改善长期预后,是超重或肥胖糖尿病患者的首选。但其胃肠道反应多见,长期应用可能会影响维生素B12的吸收。
磺酰脲类(例如格列喹酮(糖适平)、格列齐特(达美康)、格列本脲(优降糖)、格列吡嗪(美吡达)和格列美脲(亚莫利)等)疗效突出、价格便宜,是2型糖尿病一线用药,但其容易发生低血糖及体重增加,个别病人会出现皮肤过敏反应、白细胞减少等。
格列奈类(例如瑞格列奈(诺和龙)和那格列奈(唐力))餐时即服,方便灵活,病人依从性好,对于进餐不规律者或老年患者更适用。但其价格较高,使用不当也会引起低血糖。
α-糖苷酶抑制剂(例如阿卡波糖(拜唐平))降糖效果肯定,主要在肠道局部作用,仅2%吸收入血,肝肾等全身副作用少,不增加体重或能减轻体重,单用本药不引起低血糖,对心血管有保护作用,适合于老年糖尿病人和伴有肾功能损害患者。但由于本类药物阻碍碳水化合物在肠道的分解和吸收,使之滞留时间延长,因而导致细菌酵解产气增加。
胰岛素增敏剂(例如罗格列酮(文迪雅、太罗)和吡格列酮(艾可拓))不刺激胰岛素分泌,而是通过增强组织对胰岛素的敏感性来发挥降糖作用。这类药物适用2型糖尿病、糖耐量减低及有代谢综合征,可与双胍类、磺脲类药物或胰岛素合用可进一步改善血糖控制。单独使用不会引起低血糖。但其增加心衰风险,起效较慢,可导致水钠潴留,引起水肿及体重稍增。
GLP-1受体激动剂(例如艾塞那肽(百泌达)和利拉鲁肽(诺和力))除了能够显着降低血糖,还能减轻体重,降低血压、改善β细胞功能。但其半衰期短,有恶心、呕吐等消化道不良反应。价格昂贵,需注射用药,不推荐该药作为一线用药。
DPP-4抑制剂(例如西格列汀(捷诺维)、沙格列汀(安立泽)和维格列汀(佳维乐))增加内源性GLP-1水平,同时改善胰岛α和β细胞功能障碍,具有降糖疗效确切、低血糖风险小、不增加体重、无胃肠道反应,安全性及耐受性高等优点。但DPP-4是一种多效酶,其抑制剂还可能延长生长素释放激素、神经肽Y和P物质等激素的作用,可能产生神经源性炎症、血压升高、促发免疫反应等不良反应。
SGLT-2抑制剂(例如达格列净)极少发生低血糖,并对改善体重和血压有益处。但其可能与鼻咽炎、真菌感染以及泌尿生殖系统感染有关,长期用药的安全性有待于进一步观察。
胰岛素及胰岛素类似物是迄今为止控制血糖最强有力的武器,对肝肾无不良影响,所有不适合用口服降糖药的糖尿病人(如1型糖尿病、孕妇、糖尿病酮症酸中毒、肝肾功能不全患者等等)均可改用胰岛素治疗。早期使用胰岛素还可有助于保护和修复胰岛β细胞功能。但其低血糖风险相对较高,可致体重增加,个别患者注射部位出现皮肤过敏或脂肪萎缩,注射给药给患者带来不便,胰岛素类似物的价格较高。
因此,现有技术中的降血糖西药主要有以下几方面的缺陷:
缺陷一:低血糖风险相对较高。
缺陷二:易引起胃肠道不良反应。
缺陷三:价格昂贵影响药品可及性。
缺陷四:易引起水肿及体重增加。
缺陷五:易引起其它继发性症状和疾病,例如皮肤过敏反应、白细胞减少、心衰、神经源性炎症、血压升高、促发免疫反应、鼻咽炎、真菌感染以及泌尿生殖系统感染。
现有中药治疗糖尿病主要是通过滋补肝肾,生津止渴起到降糖的作用,而中医五行理论相生相克,是一个有机的整体,仅通过肝肾两经治疗具有局限性。本发明提供的治疗糖尿病速溶茶处方中金钗石斛归胃、肾经,西洋参归心、肺、肾经,葛根归脾、肺、胃经,绞股蓝归心、肺、胃经,改变了传统的以肝肾为主的治疗方法,以肺肾脾胃经治疗为主,中医认为肾为先天之本,脾胃为后天之本,肺主行水,通过肺气的宣发和肃降使经脾胃运化产生的水液输布到全身,滋养、润泽各组织器官;其次将代谢后的水液通过呼吸、皮肤汗孔蒸发排出体外,体现肺主皮毛的功能,减少肾的负担;再者通过肺气肃降,是体内代谢后的一部分水液下行到肾,经肾和膀胱的气化作用,生成尿液排出体外,体现肺的通调水道的生理功能。
其中,金钗石斛(Dendrobium nobile)为兰科石斛属多年生草本植物,是名贵中药材“石斛”的来源之一,具有益胃生津,滋阴清热的功效,能提高人体免疫能力,增强记忆力,补五脏虚劳,抗衰老。现代药理研究发现石斛碱具有促进免疫系统淋巴细胞产生移动抑制因子的作用,能够有效地抵消免疫抑制剂环磷酰胺加入所引起的提升移动抑制指数的副作用,从而提高机体的免疫功能。同时,石斛碱还具有抑制肿瘤的功能、抗突变作用、抗氧化和抗衰老等作用。
葛根(Pueraria lobata)为豆科植物野葛的干燥根,甘、辛,凉。有解肌退热,透疹,生津止渴,升阳止泻之功。野葛根的药用价值在我国始载于《神农本草经》,“主消渴、身大热、呕吐、诸痹、起阴气、解诸毒”。葛根素是葛根中主要活性成分,具有降血压、降血脂、抗氧化、清除自由基、增强免疫力,抗癌、抗肿瘤等。
西洋参(Panax quinquefolius)是五加科人参属多年生草本植物,别名花旗参、洋参、西洋人参,原产于加拿大的大魁北克与美国的威斯康辛州,具有补气养阴,清热生津之功效。用于气虚阴亏,内热,咳喘痰血,虚热烦倦,消渴,口燥喉干。西洋参皂苷是西洋参中最主要的有效成分之一,也是生理活性最显著的物质。迄今为止,人们已经在西洋参中提取了多种皂苷单体。西洋参皂苷单体的种类虽然不少,但主要是三萜类化合物,与人参皂苷结构有相似之处,但有些是西洋参所独有的。现代医学研究证明,西洋参具有抗疲劳、抗衰老、抗休克、提高思维、改善记忆及调节内分泌、增强人体免疫力及改善心血管功能等作用。
绞股蓝(Gynostemma pentaphyllum Makino.)又名七叶胆、福音草等,是葫芦科绞股蓝属植物。其中,绞股蓝总皂苷是绞股蓝中的主要活性成分。药理实验和临床应用表明,具有降血脂、抗肿瘤、抗衰老、保护肝脏及增强肌体免疫功能等作用,主要用于治疗肝癌、肺癌、子宫癌、皮肤癌等癌细胞的增殖,另外对人体有滋补、镇静、催眠、抗紧张、促食欲、降胆固醇、降转氨酶、延缓衰老等作用。
基于上述原因,需要对降血糖药物进一步研究,将中医药用于糖尿病治疗的创新,以解决常见的降血糖药物低血糖风险相对较高、易引起胃肠道不良反应、价格昂贵、易引起水肿及体重增加、易引起其它继发性症状和疾病的问题。
发明内容
基于此,本发明的主要目的在于提供了一种降血糖的中药组合物,以解决现有技术中常见的降血糖药物低血糖风险相对较高、易引起胃肠道不良反应、价格昂贵、易引起水肿及体重增加、易引起其它继发性症状和疾病的问题。
为了实现上述目的,根据本发明的一个方面,提供了一种用于降血糖的中药组合物,其由下列重量份的组分制成:金钗石斛1-10份、葛根1-10份、西洋参1-10份和绞股蓝1-10份。
本发明在对金钗石斛、葛根、西洋参、绞股蓝组合降血糖活性筛选过程中发现金钗石斛、葛根、西洋参、绞股蓝的特定配伍,具有优异的降血糖功能,并且上述中药特定配伍所组成的该中药组合物的降血糖功能活性是任一单一药材、或三味药材及其他更多药材复方所无法比拟的。
进一步地,该中药组合物由下列重量份的组分制成:金钗石斛1-10份、葛根3-10份、西洋参2-5份和绞股蓝1-10份。
进一步地,该中药组合物由下列重量份的组分制成:金钗石斛1-10份、葛根3-10份、西洋参2-5份和绞股蓝3-10份。
进一步地,该中药组合物由下列重量份的组分制成:金钗石斛1份、葛根3份、西洋参2份和绞股蓝3份。
根据本发明的另一方面,提供了一种制备中药饮片的方法,该方法包括以下步骤:
(1)称取1-10份的金钗石斛、1-10份的葛根、1-10份的西洋参和1-10份的绞股蓝,加入适量的水从而得到混合物湿料,其中该混合物湿料的含水量在15%-30%之间;以及
(2)该混合物湿料经历一系列处理工艺从而得到中药饮片,其中该处理工艺包括杀菌以及选自以下中的一种和多种:熟化、膨化和干燥。
进一步地,该混合物湿料的含水量在20%-30%之间。
根据本发明的另一方面,提供了一种包含上述中药组合物和药学上可接受的辅料的中药制剂。
进一步地,该辅料选自稀释剂、助悬剂、抗氧化剂、乳化剂、崩解剂、黏合剂和防腐剂中的一种或多种。
进一步地,该中药制剂包含相对于中药制剂的重量计算总量为0.00001至99wt.%、0.00001至90wt.%、0.00001至80wt.%、0.00001至65wt.%、0.00001至50wt.%、或0.0001至10wt.%、或0.0001至5wt.%、或0.005至1wt.%、或0.1至20wt.%、或0.5至15wt.%、或1至5wt.%的至少一种辅料。
进一步地,该中药制剂进一步包含矫味剂。
进一步地,该中药制剂包含相对于中药制剂的重量计算总量为0.00001至99wt.%、0.00001至90wt.%、0.00001至80wt.%、0.00001至65wt.%、0.00001至50wt.%、或0.0001至10wt.%、或0.0001至5wt.%、或0.005至1wt.%、或0.1至20wt.%、或0.5至15wt.%、或1至5wt.%的至少一种矫味剂。
进一步地,该矫味剂为食用香精、甜味剂中一种或多种的组合。
进一步地,该甜味剂选自甜菊糖苷、罗汉果苷V、11-O-罗汉果苷V、罗汉果苷VI、赛门苷I、罗汉果苷IV、罗汉果苷III、甜菊苷、瑞鲍迪苷A、瑞鲍迪苷B、瑞鲍迪苷C、瑞鲍迪苷D、瑞鲍迪苷E、瑞鲍迪苷F、杜克苷A、甜茶苷、甜菊双糖苷、甘草甜素、奇异果甜蛋白(Thaumatin)、应乐果甜蛋白、马槟榔甜蛋白、仙茅甜蛋白、倍他丁(Pentadin)、布拉齐因(Brazzein)、三氯蔗糖、阿斯巴甜、阿力甜、糖精钠、纽甜、安赛蜜、甜蜜素、新橙皮苷二氢查耳酮、核糖、阿拉伯糖、木糖、脱氧核糖、阿洛酮糖、果糖、山梨糖、塔格糖、葡萄糖、甘露糖、半乳糖、塔罗糖、岩藻糖、鼠李糖、景天庚酮糖、甘露庚酮糖、水苏糖、棉籽糖、异麦芽酮糖、乳酮糖、低聚果糖、低聚木糖、低聚半乳糖、低聚异麦芽糖、大豆低聚糖、低聚壳聚糖、低聚甘露糖、海藻糖、黑曲霉低聚糖、菊粉、龙胆低聚糖、磷酸寡糖、赤藓糖醇、木糖醇、麦芽糖醇、异麦芽糖醇、山梨糖醇、甘露醇、乳糖醇、氢化淀粉水解物、白砂糖、黄砂糖、赤砂糖、绵白糖、单晶体冰糖、多晶体冰糖、红糖、黑糖、冰片糖和方糖中的一种或多种。
进一步地,该矫味剂为食用香精和赤藓糖醇按照重量比0.01-0.02:3的组合。
进一步地,该食用香精和该赤藓糖醇按照重量比0.01:3的组合。
进一步地,本发明的中药组合物可以根据临床应用需要,加入药学上可接受的载体或赋形剂制成不同剂型的产品。该中药制剂的剂型为贴片、膏剂、喷雾剂、气雾剂、粉雾剂、粉剂、片剂、凝胶剂、颗粒剂、硬胶囊、软胶囊、口服液、合剂、丸剂或滴丸。
进一步地,该中药制剂的剂型为片剂、颗粒剂、硬胶囊或软胶囊。
进一步地,该中药制剂可制备成速溶茶。
根据本发明的另一方面,提供了一种上述中药组合物或者上述中药制剂在制备用于降血糖的药物、食品或者保健品中的用途。
根据本发明的另一方面,提供了一种上述中药组合物或者上述中药制剂在制备用于治疗糖尿病的药物中的用途。
根据本发明的另一方面,提供了一种上述中药组合物与药物的组合或者上述中药制剂与药物的组合在制备用于治疗糖尿病的药物中的用途,其中所述药物选自二甲双胍、格列喹酮、格列齐特、格列本脲、格列吡嗪、格列美脲、瑞格列奈、那格列奈、阿卡波糖、罗格列酮、吡格列酮、艾塞那肽、利拉鲁肽、西格列汀、沙格列汀、维格列汀、达格列净、胰岛素和免疫抑制剂中的一种或多种。
本发明的有益效果:
本发明的中药组合物是以金钗石斛、葛根、西洋参、绞股蓝为有效成分,通过各组分之间的协同作用,起到更好的降血糖功能活性。该中药组合物的降血糖功能活性较单一组分效果更好。该中药组合物所生产的产品疗效显著、便于服用、无明显毒副作用。
具体实施方式
下面将结合本申请实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例是本申请一部分实施例,而不是全部的实施例。基于本申请中的实施例,本领域技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本申请保护的范围。
需要说明的是,在不冲突的情况下,本申请中的实施例及实施例中的特征可以相互组合。下面将结合实施例来详细说明本发明。
以下结合具体实施例对本发明作进一步详细描述,这些实施例不能理解为限制本申请所要求保护的范围。
正如背景技术部分所描述的,现有技术中常见的降血糖药物低血糖风险相对较高、易引起胃肠道不良反应、价格昂贵、易引起水肿及体重增加、易引起其它继发性症状和疾病的问题。为了解决上述问题,本发明提供了一种用于降血糖的中药组合物,其由下列重量份的组分制成:金钗石斛1-10份、葛根1-10份、西洋参1-10份和绞股蓝1-10份。
该中药组合物通过各组分之间的协同作用,能够起到更好的降血糖作用,且相对于单一组分及任三种组分的组合效果更好。由中药组合物制备而得的中药制剂具有降血糖功能,且疗效显著、便于服用、无明显毒副作用。
为进一步增强该中药组合物中四种组分的协同作用效果即增强该中药组合物的降血糖功效,在一种优选的实施方式中,该中药组合物由下列重量份的组分制成:金钗石斛1-10份、葛根3-10份、西洋参2-5份和绞股蓝1-10份。
为进一步增强该中药组合物中四种组分的协同作用效果即增强该中药组合物的降血糖功效,在一种优选的实施方式中,该中药组合物由下列重量份的组分制成:金钗石斛1-10份、葛根3-10份、西洋参2-5份和绞股蓝3-10份。
为进一步增强该中药组合物中四种组分的协同作用效果即增强该中药组合物的降血糖功效,在一种优选的实施方式中,该中药组合物由下列重量份的组分制成:金钗石斛1份、葛根3份、西洋参2份和绞股蓝3份。
根据本发明的另一方面,提供了一种制备中药饮片的方法,该方法包括以下步骤:
(1)称取1-10份的金钗石斛、1-10份的葛根、1-10份的西洋参和1-10份的绞股蓝,加入适量的水从而得到混合物湿料,其中该混合物湿料的含水量在15%-30%之间;以及
(2)该混合物湿料经历一系列处理工艺从而得到中药饮片,其中该处理工艺包括杀菌以及选自以下中的一种和多种:熟化、膨化和干燥。
该制备方法操作简便、能耗低,降低了有效成分的破坏,可适用于工业化大生产。
其中,本申请所指的熟化是指将混合物湿料置入高压容器内,在高温下热压处理一段时间,使中药材熟化。
其中,膨化是借助食品的膨化原理,结合中药材特点,对其进行科学处理的一种加工方法。其原理是将中药材置于膨化机中,随着加温加压的进行,中药材内部的水分子呈过热状态,当达到一定的高压后瞬间变成常压,中药材内部过热状态的水分子同时汽化而发生爆炸,巨大的膨化压力改变了中药材的外部形态和内部结构,使其膨胀疏松,形成海绵状空心网状结构。
为了进一步控制混合物湿料中的含水量、抑制微生物生长而优化工艺条件,在一种优选的实施方式中,该混合物湿料的含水量在20%-30%之间。
根据本发明的另一方面,提供了一种包含上述中药组合物和药学上可接受的辅料的中药制剂。
在一种优选的实施方式中,该辅料选自稀释剂、助悬剂、抗氧化剂、乳化剂、崩解剂、黏合剂和防腐剂中的一种或多种。
上述稀释剂包括植物油、聚乙二醇200-6000、丙二醉、丙三醇、山梨醇、D-木糖醇、甘油磷酸钙、交联聚维酮、肌醇、麦芽糖醇、乳糖酸、环糊精、乳糖、氧化钙、纤维素、葡萄糖、羧甲基纤维素、聚乙烯醇缩丁醛及矿物油中的一种或多种。
上述助悬剂包括蜂蜡、黄原胶、阿拉伯胶、干酪素、甲基纤维素、羟甲基纤维素钠、卡波姆、聚乙烯醇、羟乙基纤维素、海藻酸钠、甲壳素、甲壳糖、羟丙基甲基纤维素、乙基纤维素、琼脂、羟乙基甲基纤维素、羟丙纤维素中的一种或几种。
上述抗氧化剂包括二丁基羟基甲苯(BHT)、叔丁基对羟基茴香醚(BHA)、没食子酸丙酯、叔丁基对苯二酚(TBHQ)、苹果酸、谷胱甘肽、D-木糖、甘氨酸、α-生育酚、α-醋酸生育酚、亚硫酸钠、肌醇、抗坏血酸、植酸、抗坏血酸钠、卵磷脂、氢醌、木糖醇、琥珀酸、茶多酚中的一种或几种。
上述乳化剂包括乙基羟乙基纤维素、甲基纤维素、单硬脂酸甘油酯、羟化卵磷脂、乙酰化单甘油醋、三羟基甲烷、干酪素、乙二醇单硬脂酸酯、二乙酰单甘油酯、醋酸脂肪酸甘油酯、木糖醇酐单油酸酯、海藻酸丙二醇酯中的一种或几种。
上述粘合剂包括甲基纤维素(MC)、聚乙烯吡咯烷酮(PVP)、羟丙基纤维素(HPC)、羟丙基甲基纤维素(HPMC)、聚乙烯醇(PVA)、苯二甲酸醋酸纤维素(CAP)、聚维酮K30、乙基纤维素(EC)、微晶纤维素(CC)、丙烯酸树脂、桃胶、麦芽糖醇、泊洛沙姆;海藻酸钠、液体葡萄糖、转化糖、蔗糖单月桂酸酸中的一种或几种。
上述崩解剂包括胶体二氧化硅、硅酸铝镁、硬脂酸镁、预凝胶淀粉、交联羧甲基纤维素钠中的一种或几种。
上述防腐剂包括山梨酸、对羟基苯甲酸甲酯钠、苯甲酸、山梨酸甲酯、对羟基苯甲酸甲酯、对羟基苯甲酸苯酯、对羟基苯甲酸丁酯钙、丁香油、苯甲醇、对羟基苯甲酸丙酚钠中的一种或几种。
在一种优选的实施方式中,该中药制剂包含相对于中药制剂的重量计算总量为0.00001至99wt.%、0.00001至90wt.%、0.00001至80wt.%、0.00001至65wt.%、0.00001至50wt.%、或0.0001至10wt.%、或0.0001至5wt.%、或0.005至1wt.%、或0.1至20wt.%、或0.5至15wt.%、或1至5wt.%的至少一种辅料。
在一种优选的实施方式中,该中药制剂进一步包含矫味剂。
本申请所指的矫味剂是指中药制剂中用以改善或屏蔽药物苦味,使病人难以觉察药物的强烈苦味(或其它异味如辛辣、刺激等等)的物质。迄今为止,药剂加工中已使用或正在使用的矫味剂包括:各种屏味剂、脂性物质(包括卵磷脂、表面活性剂)、亲水性药物包埋剂材料(如聚丙烯酸树脂类药用涂膜剂、改性淀粉类碳水化合物、环糊精类葡萄糖低聚物等等)以及离子交换树脂、蛋白质、沸石和其它各种本领域常规的矫味剂。
在一种优选的实施方式中,该中药制剂包含相对于中药制剂的重量计算总量为0.00001至99wt.%、0.00001至90wt.%、0.00001至80wt.%、0.00001至65wt.%、0.00001至50wt.%、或0.0001至10wt.%、或0.0001至5wt.%、或0.005至1wt.%、或0.1至20wt.%、或0.5至15wt.%、或1至5wt.%的至少一种矫味剂。
在一种优选的实施方式中,该矫味剂为食用香精、甜味剂中一种或多种的组合。
在一种优选的实施方式中,该甜味剂选自甜菊糖苷、罗汉果苷V、11-O-罗汉果苷V、罗汉果苷VI、赛门苷I、罗汉果苷IV、罗汉果苷III、甜菊苷、瑞鲍迪苷A、瑞鲍迪苷B、瑞鲍迪苷C、瑞鲍迪苷D、瑞鲍迪苷E、瑞鲍迪苷F、杜克苷A、甜茶苷、甜菊双糖苷、甘草甜素、奇异果甜蛋白(Thaumatin)、应乐果甜蛋白、马槟榔甜蛋白、仙茅甜蛋白、倍他丁(Pentadin)、布拉齐因(Brazzein)、三氯蔗糖、阿斯巴甜、阿力甜、糖精钠、纽甜、安赛蜜、甜蜜素、新橙皮苷二氢查耳酮、核糖、阿拉伯糖、木糖、脱氧核糖、阿洛酮糖、果糖、山梨糖、塔格糖、葡萄糖、甘露糖、半乳糖、塔罗糖、岩藻糖、鼠李糖、景天庚酮糖、甘露庚酮糖、水苏糖、棉籽糖、异麦芽酮糖、乳酮糖、低聚果糖、低聚木糖、低聚半乳糖、低聚异麦芽糖、大豆低聚糖、低聚壳聚糖、低聚甘露糖、海藻糖、黑曲霉低聚糖、菊粉、龙胆低聚糖、磷酸寡糖、赤藓糖醇、木糖醇、麦芽糖醇、异麦芽糖醇、山梨糖醇、甘露醇、乳糖醇、氢化淀粉水解物、白砂糖、黄砂糖、赤砂糖、绵白糖、单晶体冰糖、多晶体冰糖、红糖、黑糖、冰片糖和方糖中的一种或多种。
在一种优选的实施方式中,该矫味剂为食用香精和赤藓糖醇按照重量比0.01-0.02:3的组合。
在一种优选的实施方式中,该食用香精和该赤藓糖醇按照重量比0.01:3的组合。
在一种优选的实施方式中,本发明的中药组合物可以根据临床应用需要,加入药学上可接受的载体或赋形剂制成不同剂型的产品。该中药制剂的剂型为贴片、膏剂、喷雾剂、气雾剂、粉雾剂、粉剂、片剂、凝胶剂、颗粒剂、硬胶囊、软胶囊、口服液、合剂、丸剂或滴丸。
具体而言,包括上述中药组合物的中药制剂通常可给包括人在内的哺乳动物施用,其施用形式为常用的中药制剂的形式。
包括上述中药组合物的中药制剂可以全身用药,例如口服给药,组合物形式可为片剂、胶囊剂、糖浆、粉剂或颗粒剂;或者局部用药,例如皮肤局部用药,该药用组合物可为溶液剂、混悬剂、七氟烃烷气雾剂和干粉制剂;或者胃肠外给药,药物形式可为溶液剂或混悬剂,或者皮下给药或者栓剂直肠给药,或者透皮给药。
在一种优选的实施方式中,该中药制剂的剂型为片剂、颗粒剂、硬胶囊或软胶囊。
在一种优选的实施方式中,该中药制剂可制备成速溶茶。
为了将给药单元制成胶囊剂,可以将有效成分本发明化合物与稀释剂、助溶剂混合,将混合物直接置于硬胶囊或软胶囊中。也可将有效成分本发明化合物先与稀释剂、黏合剂、崩解剂制成颗粒或微丸,再置于硬胶囊或软胶囊中。用于制备本发明化合物片剂的各稀释剂、黏合剂、润湿剂、崩解剂、助溶剂品种也可用于制备本发明化合物的胶囊剂。
根据本发明的另一方面,提供了一种上述中药组合物或者上述中药制剂在制备用于降血糖的药物、食品或者保健品中的用途。
根据本发明的另一方面,提供了一种上述中药组合物或者上述中药制剂在制备用于治疗糖尿病的药物中的用途。
在本发明中,术语“治疗”也包括“预防”,除非存在与此相反的具体说明。术语“治疗(的)”和“治疗(地)”应该作相应的理解。
本发明还提供治疗糖尿病的方法,该方法包括给予所述患者治疗有效量的上述中药组合物。
本发明还提供治疗I型糖尿病的方法,该方法包括给予所述患者治疗有效量的上述中药组合物。
本发明还提供治疗II型糖尿病的方法,该方法包括给予所述患者治疗有效量的上述中药组合物。
当然,对于上述治疗用途,本发明的中药组合物的给药剂量依照所要预防或治疗疾病的性质和严重程度,患者或动物的个体情况,给药途径和剂型等可以有大范围的变化,这取决于医生的临床经验以及包括运用其它治疗手段的给药方案。
在一些优选的实施方式中,本文提供的中药组合物和医药用途与现有的常规抗糖尿病药物组合使用。糖尿病疗法的实例包括但不限于胰岛素、饮食管理、二甲双胍、磺酰脲、噻唑烷二酮、二肽基肽酶-4抑制剂、SGLT2抑制剂和胰高血糖素样肽-1类似物。因此,在某些实施方式中,还提供了将上述中药组合物与抗糖尿病药物组合使用,以用于在受试者中促进胰岛细胞生长、促进胰岛素产生和/或用于治疗糖尿病。
在一些优选的实施方式中,本文提供的中药组合物和医药用途与现有常规的一种或多种免疫抑制剂组合使用。因此,在某些实施方式中,还提供了与一种或多种免疫抑制剂组合使用的中药组合物,以用于促进胰岛细胞生长、促进胰岛素产生和/或用于治疗受试者的糖尿病。
免疫抑制剂将减少自身免疫介导的胰岛细胞退化。在某些实施方式中,一种或多种免疫抑制剂选自由以下组成的组:环孢菌素A;霉酚酸酯、维生素D3、抗CD3抗体、抗IL-21抗体、抗CD20抗体(例如利妥昔单抗)、抗CTLA4抗体、抗TNF-α抗体(例如英夫利昔单抗)、抗IL1α抗体、抗IL1β抗体、抗CD4抗体、抗CD45抗体、CTLA4分子(例如阿巴西普)、TNFα抑制剂(例如依那西普)、PD-L1分子、IL-1受体拮抗剂(例如阿纳金拉)、聚乙二醇化的粒细胞集落刺激因子(例如吡非司亭)、人重组IFN-α、IL-10、谷氨酸脱羧酶(GAD)-65、耐受性胰岛素肽(例如、胰岛素B:9-23、胰岛素原肽19-A3)、HSP60的DiaPep277、调节性T细胞(Tregs)和耐受性树突状细胞。例如,GAD-65和IL-10可以一起给药,例如作为表达两种分子的转基因细菌(例如乳球菌)。
中药组合物的制备实施例
【实施例1】中药组合物1的制备
取1kg金钗石斛、3kg葛根、2kg西洋参、3kg绞股蓝,将四种中药饮片加水过浸润,使之含水量控制在25%,然后用微波多用加工设备进行熟化、膨化、干燥、杀菌等工艺制成速溶中药饮片,即为本发明具有降血糖功能的中药组合物。
【实施例2】中药组合物2的制备
取1kg金钗石斛、10kg葛根、1kg西洋参、10kg绞股蓝,将四种中药饮片加水过浸润,使之含水量控制在15%,然后用微波多用加工设备进行熟化、膨化、干燥、杀菌等工艺制成速溶中药饮片,即为本发明具有降血糖功能的中药组合物。
【实施例3】中药组合物3的制备
取10kg金钗石斛、1kg葛根、5kg西洋参、1kg绞股蓝,将四种中药饮片加水过浸润,使之含水量控制在30%,然后用微波多用加工设备进行熟化、膨化、干燥、杀菌等工艺制成速溶中药饮片,即为本发明具有降血糖功能的中药组合物。
【实施例4】中药组合物4的制备
取1kg金钗石斛、3kg葛根、2kg西洋参,将三种中药饮片加水过浸润,使之含水量控制在25%,然后用微波多用加工设备进行熟化、膨化、干燥、杀菌等工艺制成速溶中药饮片,即为中药组合物4。
【实施例5】中药组合物5的制备
取1kg金钗石斛、3kg葛根、3kg绞股蓝,将三种中药饮片加水过浸润,使之含水量控制在25%,然后用微波多用加工设备进行熟化、膨化、干燥、杀菌等工艺制成速溶中药饮片,即为中药组合物5。
【实施例6】中药组合物6的制备
取1kg金钗石斛、2kg西洋参、3kg绞股蓝,将三种中药饮片加水过浸润,使之含水量控制在25%,然后用微波多用加工设备进行熟化、膨化、干燥、杀菌等工艺制成速溶中药饮片,即为中药组合物6。
【实施例7】中药组合物7的制备
取3kg葛根、2kg西洋参、3kg绞股蓝,将三种中药饮片加水过浸润,使之含水量控制在25%,然后用微波多用加工设备进行熟化、膨化、干燥、杀菌等工艺制成速溶中药饮片,即为中药组合物7。
【实施例8】中药组合物8的制备
取西洋参、枸杞子、五味子、续断、当归、牡丹皮各2.5kg,沙参、石斛、知母各3kg、黄芪12.5kg,绞股蓝、山药、玉竹、黄精、天花粉各5kg,山楂、葛根、山茱萸、鸡内金各3.8kg,生地、玄参各7.5kg,甘草、冬虫夏草、白豆蔻各0.8kg。将以上药物中西洋参、天花粉、冬虫夏草、白豆寇、牡丹皮、五味子粉碎成细末过80日筛备用,其余药材加水提取、浓缩,制成老膏,将老膏与上述粉末混合,搅拌均匀,制粒、干燥、整粒,即得中药组合物8。
【实施例9】中药组合物9的制备
取山茱萸15g、枸杞子20g、桑椹10g、制何首乌10g黑芝麻10g、女贞子12g、熟地黄15g、淫羊薇15g黑蚂蚁8g、杜仲15g、人参8g、西洋参10g黄芪8g、山药20g、茯苓15g、麦芽15g、苍术12g、自术12g、玉竹8g、黄精12g、石斛10g、绞股蓝10g、百合10g、地骨皮15g、牛蒡子12g知母10g、桑叶15g、紫草10g、马齿苋20g、生地黄15g、翻自草15g、三白草12g荔枝核30g、葛根12g、僵蚕10g、玉米须10g柿叶12g、丹参20g、大黄6g、鬼箭羽12g昆布12g、黄连6g、黄柏10g、灵芝15g、绞股蓝15g、银耳15g。将上述重量的原料药烘干后混合制粉,过120目筛,即得中药组合物9。
中药组合物的降血糖活性实验
【实施例10】中药组合物1-9降血糖活性
1、实验目的:观察实施例1-9配伍的中药组合物在动物模型中的降血糖作用。
2、实验材料:
2.1药物与试剂
2.1.1供试品:各中药组合物根据实施例1~9的方法制备。
2.1.2对照药:罗格列酮钠片,葛兰素史克(天津)有限公司。
2.1.3试剂:血糖试纸为三诺生物传感股份有限公司产品。
2.2实验动物:SPF级C57BL/6J雄性小鼠,来源:北京华阜康生物科技股份有限公司。
2.3给药方法:灌胃给药。
2.4试验方法:
取C57BL/6J小鼠,适应性喂养一周后,随机取10只小鼠作为空白组,并测定小鼠体重、空腹血糖值;其余小鼠禁食24小时(自由饮水),腹腔注射四氧嘧啶130mg/kg造模,自由饮食7天后,测定空腹血糖值,血糖值大于10mmol/L的为造模成功小鼠。选取110只成膜小鼠根据血糖值随机分为11组,每组10只。加之空白组,共12组:(1)空白组;(2)模型组;(3)阳性对照品组(5mg/kg/天);(4)中药组合物1组(50mg/kg/天);(5)中药组合物2组(50mg/kg/天);(6)中药组合物3组(50mg/kg/天);(7)中药组合物4组(50mg/kg/天);(8)中药组合物5组(50mg/kg/天);(9)中药组合物6组(50mg/kg/天);(10)中药组合物7组(50mg/kg/天);(11)中药组合物8组(50mg/kg/天);(12)中药组合物9组(50mg/kg/天);每天灌胃给药1次,连续给药30天。测定小鼠空白血糖值、体重,结果如下表:
表1中药组合物对四氧嘧啶致小鼠糖尿病模型血糖的影响
注:模型组与空白组相比较,###P<0.001;阳性对照组或中药组合物组与模型组比较,*P<0.05。
表1数据结果显示,各中药组合物对四氧嘧啶引起的小鼠血糖升高均具有一定的降低作用,但是中药组合物1-3组对血糖的降低作用较其他组合物效果更好,与模型组比较(*P<0.05)。其中,中药组合物1组的降血糖效果最佳,效果甚至好于阳性药物组。
表2中药组合物对四氧嘧啶致小鼠糖尿病模型体重的影响
注:模型组与空白组相比较,##P<0.01,#P<0.05;阳性对照组或中药组合物组与模型组比较,*P<0.05。
表2数据结果显示,造模后小鼠体重对比空白组显著下降(##P<0.01,#P<0.05)。与模型组相比较,中药组合物1-3组给药30天后对体重的缓解较其他组合物效果更好,与模型组比较(*P<0.05)。其中,中药组合物1组对体重的缓解最佳,效果甚至好于阳性药物组。
【实施例11】中药组合物治疗糖尿病临床疗效观察
根据1999年世界卫生组织糖尿病诊断标准,收治按诊断标准确诊糖尿病患者500例,其中轻度324例,中度176例。分别给患者服用本发明实施例1制备的中药组合物速溶茶5个疗程,疗效判定有效标准为:①空腹血糖水平明显下降;②OGTT试验2小时PG水平明显下降;③糖尿病症状或并发症减轻。未达到以上标准者判定无效。经统计,治疗有效率90.5%。该结果表明本发明中药组合物速溶茶对糖尿病及其并发症具有显著的治疗效果。
中药制剂的制备实施例
【实施例12】中药制剂制备
1、片剂
以重量份数计,包括的组方为:金钗石斛1份、葛根3份、西洋参2份、绞股蓝3份、山梨糖醇300份、硬脂酸镁10份。将各种物料进行过80目筛,然后混合均匀,压片,分装即可。
用法用量:一日2次,一次1片。
2、颗粒剂
以重量份数计,包括的组方为:金钗石斛1份、葛根3份、西洋参2份、绞股蓝3份、山梨糖醇200份、麦芽糊精500份、二氧化硅20份、甜菊糖苷10份。将各种物料进行过80目筛,然后混合均匀,制粒,分装即可。
用法用量:一日2次,一次1袋。
3、胶囊剂
以重量份数计,包括的组方为:金钗石斛1份、葛根3份、西洋参2份、绞股蓝3份、山梨糖醇300份、硬脂酸镁10份。将各种物料进行过80目筛,然后混合均匀,装胶囊即可。
用法用量:一日2次,一次1粒。
以上所述的仅是本发明的实施例,方案中公知的具体结构及特性等常识在此未作过多描述。应当指出,对于本领域的技术人员来说,在不脱离本发明的前提下,还可以作出若干变形和改进,这些也应该视为本发明的保护范围,这些都不会影响本发明实施的效果和专利的实用性。本申请要求的保护范围应当以其权利要求的内容为准,说明书中的具体实施方式等记载可以用于解释权利要求的内容。
以上对本申请实施例进行了详细介绍,本文中应用了具体个例对本申请的原理及实施方式进行了阐述,以上实施例的说明仅用于帮助理解本申请的方法及其核心思想。同时,本领域技术人员依据本申请的思想,基于本申请的具体实施方式及应用范围上做出的改变或变形之处,都属于本申请保护的范围。综上所述,本说明书内容不应理解为对本申请的限制。
Claims (10)
1.一种用于降血糖的中药组合物,其特征在于,由下列重量份的组分制成:金钗石斛1-10份、葛根1-10份、西洋参1-10份和绞股蓝1-10份。
2.根据权利要求1所述的中药组合物,其特征在于,由下列重量份的组分制成:金钗石斛1-10份、葛根3-10份、西洋参2-5份和绞股蓝1-10份;优选地,由下列重量份的组分制成:金钗石斛1-10份、葛根3-10份、西洋参2-5份和绞股蓝3-10份;最优选地,由下列重量份的组分制成:金钗石斛1份、葛根3份、西洋参2份和绞股蓝3份。
3.一种制备中药饮片的方法,其特征在于,所述方法包括以下步骤:
(1)称取1-10份的金钗石斛、1-10份的葛根、1-10份的西洋参和1-10份的绞股蓝,加入适量的水从而得到混合物湿料,其中所述混合物湿料的含水量在15%-30%之间;以及
(2)所述混合物湿料经历一系列处理工艺从而得到中药饮片,其中所述处理工艺包括杀菌以及选自以下中的一种和多种:熟化、膨化和干燥。
4.根据权利要求3所述的方法,其特征在于,所述混合物湿料的含水量在20%-30%之间。
5.一种包含权利要求1或2所述的中药组合物和药学上可接受的辅料的中药制剂。
6.根据权利要求5所述的中药制剂,其特征在于,所述辅料选自稀释剂、助悬剂、抗氧化剂、乳化剂、崩解剂、黏合剂和防腐剂中的一种或多种;优选地,所述中药制剂包含相对于中药制剂的重量计算总量为0.00001至50wt.%、或0.0001至10wt.%、或0.0001至5wt.%、或0.005至1wt.%、或0.1至20wt.%、或0.5至15wt.%、或1至5wt.%的至少一种辅料。
7.根据权利要求5所述的中药制剂,其特征在于,所述中药制剂进一步包含矫味剂;优选地,所述中药制剂包含相对于中药制剂的重量计算总量为0.00001至99wt.%、0.00001至90wt.%、0.00001至80wt.%、0.00001至65wt.%、0.00001至50wt.%、或0.0001至10wt.%、或0.0001至5wt.%、或0.005至1wt.%、或0.1至20wt.%、或0.5至15wt.%、或1至5wt.%的至少一种矫味剂;更优选地,所述矫味剂为食用香精、甜味剂中一种或多种的组合;最优选地,所述甜味剂选自甜菊糖苷、罗汉果苷V、11-O-罗汉果苷V、罗汉果苷VI、赛门苷I、罗汉果苷IV、罗汉果苷III、甜菊苷、瑞鲍迪苷A、瑞鲍迪苷B、瑞鲍迪苷C、瑞鲍迪苷D、瑞鲍迪苷E、瑞鲍迪苷F、杜克苷A、甜茶苷、甜菊双糖苷、甘草甜素、奇异果甜蛋白、应乐果甜蛋白、马槟榔甜蛋白、仙茅甜蛋白、倍他丁、布拉齐因、三氯蔗糖、阿斯巴甜、阿力甜、糖精钠、纽甜、安赛蜜、甜蜜素、新橙皮苷二氢查耳酮、核糖、阿拉伯糖、木糖、脱氧核糖、阿洛酮糖、果糖、山梨糖、塔格糖、葡萄糖、甘露糖、半乳糖、塔罗糖、岩藻糖、鼠李糖、景天庚酮糖、甘露庚酮糖、水苏糖、棉籽糖、异麦芽酮糖、乳酮糖、低聚果糖、低聚木糖、低聚半乳糖、低聚异麦芽糖、大豆低聚糖、低聚壳聚糖、低聚甘露糖、海藻糖、黑曲霉低聚糖、菊粉、龙胆低聚糖、磷酸寡糖、赤藓糖醇、木糖醇、麦芽糖醇、异麦芽糖醇、山梨糖醇、甘露醇、乳糖醇、氢化淀粉水解物、白砂糖、黄砂糖、赤砂糖、绵白糖、单晶体冰糖、多晶体冰糖、红糖、黑糖、冰片糖和方糖中的一种或多种;特别优选地,所述矫味剂为食用香精和赤藓糖醇按照重量比0.01-0.02:3的组合;最优选地,所述食用香精和所述赤藓糖醇按照重量比0.01:3的组合。
8.根据权利要求5至7中任一项所述的中药制剂,其特征在于,所述中药制剂的剂型为贴片、膏剂、喷雾剂、气雾剂、粉雾剂、粉剂、片剂、凝胶剂、颗粒剂、硬胶囊、软胶囊、口服液、合剂、丸剂或滴丸;优选地,所述中药制剂的剂型为片剂、颗粒剂、硬胶囊或软胶囊。
9.根据权利要求1或2所述的中药组合物或者根据权利要求5至8中任一项所述的中药制剂在制备用于降血糖的药物、食品或者保健品中的用途或者在制备用于治疗糖尿病的药物中的用途。
10.根据权利要求1或2所述的中药组合物与药物的组合或者根据权利要求5至8中任一项所述的中药制剂与药物的组合在制备用于治疗糖尿病的药物中的用途,其中所述药物选自二甲双胍、格列喹酮、格列齐特、格列本脲、格列吡嗪、格列美脲、瑞格列奈、那格列奈、阿卡波糖、罗格列酮、吡格列酮、艾塞那肽、利拉鲁肽、西格列汀、沙格列汀、维格列汀、达格列净、胰岛素和免疫抑制剂中的一种或多种。
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