CN106728835B - 一种治疗糖尿病的中药 - Google Patents
一种治疗糖尿病的中药 Download PDFInfo
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Abstract
本发明公开了一种治疗糖尿病的中药及其制备方法,所述中药由重量计的:丹参5‑15克、红花3‑10克、生地、山药各15‑25克;五味子、葛根各5‑15克;蛤粉、海浮石各10‑15克;天花粉10‑20克、鸡内金3‑7克、西瓜皮、冬瓜皮各10‑20克,桑螵蛸50‑70克、知母、麦冬、党参各5‑15克,生石膏25‑35克和元参10‑15克组成。本发明充分利用中药组方理论,药物之间彼此呼应,活血化瘀,肾水升心火降,分工明确,主次突出,相辅相成在治疗主证的同时兼顾兼证,治疗全面,疗效确切,经过临床验证效果显著,可以长期服用对糖尿病及由糖尿病导致的其他身体不适均有显著疗效。
Description
技术领域
本发明涉及中药技术领域,特别是一种治疗糖尿病的中药。
背景技术
糖尿病是一组由于胰岛素分泌缺陷和/或胰岛素作用障碍所致的以高血糖为特征的代谢性疾病。持续高血糖与长期代谢紊乱等可导致全身组织器官,特别是眼、肾、心血管及神经***的损害及其功能障碍和衰竭。严重者可引起失水,电解质紊乱和酸碱平衡失调等急性并发症酮症酸中毒和高渗昏迷。
口服药物主要用于治疗DM2,对于DM2患者而言,其本身胰腺功能已经受损,药物再进入胰腺细胞刺激B细胞分泌胰岛素,这样超负荷工作,只会加速胰腺B细胞的衰竭,最终导致药物治疗失效。此外,药物吸附在肠壁阻止葡萄糖吸收的同时,也阻止了营养物质的吸收,这将直接导致患者营养不良、机体免疫力下降,更易并发其它疾病。由于口服药物只能控制DM2的餐后血糖,对其他时段的血糖控制完全起不到作用,不能将全天24小时血糖控制平稳,所以并不能阻止或延缓并发症的发生。尤其是初发型DM2患者,如果一开始便选择口服药物治疗,不仅血糖控制不好,还失去了最佳的治疗时机。大部分这类DM2患者在长期服药的过程中,不但本身的疾病没得到有效控制,还导致肝脏和肾脏受到不可逆损伤,于是患病不久,他们就不能像正常人一样的生活。
多次皮下注射胰岛素治疗的弊端,每日2-5次定时进行皮下注射,不能完全满足DM患者自身的生理需要,无法应付不可预测的胰岛素需求量,对计划外事件亦不能应付自如;用笔一次注射大量胰岛素后,在皮下易形成“小水池”,胰岛素吸收入血速率不恒定,造成血糖较大的波动,不能将全天24小时血糖控制平稳;(3)不能阻断或减少胰岛素的持续吸收,一旦发生低血糖,就必须额外进食,对血糖控制不利;降糖速度较慢,胰岛素用量大,极易发生意外低血糖;每天注射,患者非常痛苦,也很不方便,并不能提高生活质量。
我国医学早在公元前两世纪《黄帝内经》就有关糖尿病的论述“属”消渴症范畴,消渴病即消瘦烦渴之意。消渴病的发病机制,以阴虚燥热为主要病机,阴虚为本,燥热为标,两者互为因果,贯穿整个病变过程中。
东汉末年,著名中医学家张仲景著《金匮要略》一书中立消渴专篇,提出了胃热、肾虚、肺胃津伤为消渴病的病因病机。
宋代赵佶著《圣济总录》中始有“三消”之说,提出消渴病:“原其本则一,推其标有三:一曰消渴,以渴而不利,引饮过甚而言之;二曰消中,以不渴而利,热气内消言之;三曰肾消,以渴而复利,肾燥不能制约言之,此久不愈,能为水肿痈疽之病”。
金元时期朱丹溪明确指出三消是指部位而言。“上消者,肺也……中消者,胃也……下消者,肾也……”强调消渴治疗应以“养阴、降火、生血”为主,创用藕汁饮养阴生津治疗消渴。
刘河间《三消论》云:“故治消渴者,补肾水阴寒之虚,而泻心火阳热之实,除肠胃燥热之甚,济身中津液之衰,使道路散而不结,津液生而不枯,气血利而不涩,则病日已矣。”
《医学心悟·三=消篇》指出:“治上消者,宜润其肺,兼清其胃,二冬汤主之;治中消者,宜清其胃,兼滋其肾,生地八物汤主之;治下消者,宜滋其肾,兼补其肺,地黄汤,生脉散并主之。夫上消清胃者,使胃火不得伤肺也;中消滋肾者,使相火不得攻胃也;下消清肺者,滋上源以生水也。三消之治,不必专执本经,而滋其化源,则病易痊矣。”
糖尿病属于中医“消渴”范畴,历代医家多以上消、中消、下消“三消”立论,论其治法,上消清肺润燥,中消清胃泻火,下消滋肾降火,例为常法。赵献可《医贯》中提倡“治消之法,无分上、中、下,当先治肾为急”,反对滥用苦寒克伐。
发明内容
针对现有的西医治疗糖尿病需要长期服药,且血糖容易反复,治疗不彻底的问题,本发明的目的是提供一种治疗糖尿病的中药配方,以消渴为根本,有效的治疗糖尿病。
本发明解决上述的技术问题的技术方案是,
一种治疗糖尿病的中药,由重量计的:丹参5-15克、红花3-10克、生地、山药各15-25克;五味子、葛根各5-15克;蛤粉、海浮石各10-15克;天花粉10-20克、鸡内金3-7克、西瓜皮、冬瓜皮各10-20克,桑螵蛸50-70克、知母、麦冬、党参各5-15克,生石膏25-35克和元参10-15克组成。
优选的,一种治疗糖尿病的中药,由重量计的:丹参8-10克、红花5-8克、生地、山药各18-22克;五味子、葛根各8-12克;蛤粉、海浮石各12-14克;天花粉13-18克、鸡内金4-6克、西瓜皮、冬瓜皮各12-18克,桑螵蛸55-65克、知母、麦冬、党参各8-12克,生石膏28-32克和元参12-14克组成。
优选的,一种治疗糖尿病的中药,由重量计的:丹参10克、红花6克、生地、山药各20克;五味子、葛根各10克;蛤粉、海浮石各12克;天花粉15克、鸡内金5克、西瓜皮、冬瓜皮各15克,桑螵蛸60克、知母、麦冬、党参各10克,生石膏30克和元参12克组成。
在上述组分中,
红花
活血通瘀类中药
性味归经:辛、温。归心、肝经。
功效:活血化瘀,通经。
主治:用于血滞经闭,产后瘀阻,癥瘕积滞,跌打伤痛,麻疹不透。
丹参
活血养血类中药
性味归经:苦,微寒。归心、心包、肝经。
功效:活血祛瘀,凉血消痈,养血安神。
主治:用于***,心腹疼痛,癥瘕积聚,风湿热痹,疮疡肿痛,烦躁不寐,心悸,失眠。
生地黄
清热凉血类中药
性味归经:甘、苦,寒。归心、肝、肾经。
功效:清热凉血,养阴生津。
主治:用于热病心烦,舌绛,血热吐衄,斑疹紫黑,热病伤阴,消渴多饮。
山药
补气类中药
性味归经:甘,平。归脾、肺、肾经。
功效:益气养阴,补益脾肺,补肾固精。
主治:用于脾虚食少、大便溏泄,肺虚咳喘,遗精尿频,阴虚消渴。
五味子
收涩类中药
性味归经:酸,温。归肺、肾、心经。
功效:敛肺滋肾,生津敛汗,涩精止泻,宁心安神。
主治:用于久咳虚喘,津伤口渴,自汗盗汗,肾虚遗精,脾肾虚泻,心悸失眠。
天花粉
清气泻火类中药
性味归经:苦、微甘,寒。归肺、胃经。
功效:清热生津,消肿排脓。
主治:用于热病津伤,口干,消渴,肺热咳嗽,肺燥咳血,热毒疮痈。
麦冬
补阴类中药
性味归经:甘、微苦,微寒。归肺、心、胃经。
功效:养阴润肺,益胃生津,清心除烦。
主治:用于燥咳痰稠,劳嗽咯血,口渴咽干,心烦失眠。
葛根
辛凉解表类中药
性味归经:甘、辛,凉。归肺、胃经。
功效:发表解肌,透疹,升阳止泻,生津止渴。
主治:用于外感发热,项背强痛,麻疹不透,湿热泻痢,脾虚泄泻,热病烦渴,消渴证。
蛤粉
性味:味咸;性寒;
归经:肺;肾;肝经;
功能主治:清热;化痰利湿;软坚。主治胃痛;痰饮喘咳;水气浮肿;小便不通;遗精;白浊;崩中;带下;痈肿;瘿瘤;烫伤。
海浮石
类别:化痰止咳平喘药
性味归经:寒;咸;归肺经
功能主治:清肺化痰,软坚散结。用于痰热咳嗽,痰稠粘者,瘰疬,瘿瘤。
鸡内金
消食类中药
性味归经:甘,平。归脾、胃、小肠、膀胱经。
功效:健胃消食,固精止遗。
主治:用于食积不化,小儿疳积,遗尿遗精,石淋。
西瓜皮
清气泻火类中药
性味归经:味甘、淡,性凉。归心、胃、膀胱经。清凉解利。
功效:清暑除烦,解渴利尿。
主治:主治暑热烦渴,小便短少,水肿,口舌生疮。
冬瓜皮
利尿退肿类中药
性味归经:甘,微寒。归肺、小肠经。
功效:利水消肿。
主治:用于湿热水肿。
桑螵蛸
收涩类中药
性味归经:甘、咸,平。归肝、肾经。
功效:固精缩尿,补肾助阳。
主治:用于遗精,尿频,遗尿,阳痿。
知母
清气泻火类中药
性味归经:苦、甘,寒。归肺、胃、肾经。
功效:清热泻火,滋阴润燥。
主治:用于温热病壮热烦渴,肺热咳嗽,阴虚干咳,骨蒸潮热,内热消渴。
党参
补气类中药
性味归经:甘,平。归脾、肺经。
功效:补中益气,生津养血。
主治:用于中气不足,食少便溏,咳喘气短,津伤口渴,血虚萎黄,心悸头晕。
石膏
清气泻火类中药
性味归经:辛、甘,大寒。归肺、胃经。
功效:清热泻火,除烦止渴。
主治:用于温热病壮热烦渴,肺热咳喘,胃火头痛,牙龈肿痛;疮疡久溃,湿疹,烫伤。
元参
清热凉血类中药
性味归经:苦、甘、咸、寒。归肺、胃、肾经。
功效:清热凉血,解毒散结,滋阴生津。
主治:用于热入营分,身热夜甚,血热发斑,咽喉肿痛,痈肿疮毒,肠燥便秘。
本发明还提供了一种治疗糖尿病的中药的制备方法,包括如下步骤:
1)将蛤粉、海浮石和生石膏混合煎煮,过滤,取上清液;
2)将丹参、生地、山药、五味子、葛根、天花粉、西瓜皮、冬瓜皮、桑螵蛸、知母、麦冬、党参和元参清洗,粉碎加入乙醇水溶液回流30-50分钟,提取药物有效成分;
3)将红花粉碎后装入超临界CO2萃取釜中进行超临界CO2萃取,萃取的压力控制在萃取压力8-12MPa,萃取温度40-60℃,制得红花有效成分备用;
4)将鸡内金煎炒、粉碎,与步骤1)、步骤2)和步骤3)所得药物有效成分混合、浓缩成1.3-1.8g/ml的浸膏;
5)将步骤4)所得浸膏干燥、制剂。
优选的,步骤2)所述乙醇水溶液的重量分数为65wt-75wt%。
优选的,步骤5)所述干燥的条件是-78—-60℃冷冻干燥12-20小时。
优选的,步骤5)所述制剂,由所述浸膏和药学上的辅料混合制成,所述剂型包括口服液、颗粒剂、片剂、丸剂、散剂、胶囊剂、滴丸剂和注射剂。
本发明的有益效果是:
1、本发明提供了治疗糖尿病的中药的中药组方,充分利用中药组方理论,所选的药物,活血化瘀,肾水升心火降,分工明确,主次突出,相辅相成在治疗主证的同时兼顾兼证,充分体现了中药组方讲究的整体观、协调观,治疗全面,疗效确切,经过临床验证效果显著,副作用小,可以长期服用对糖尿病及由糖尿病导致的其他身体不适效果明显。
2、本发明还提供了一种治疗糖尿病的中药的制备方法,结合中药组方中特定组分的性质,与现有提取工艺相结合,既保证药物有效成分具有较高的溶出率,残留少,又能保证药物有效成分不被破坏。
3、本发明提供的治疗糖尿病的中药疗效突出,无毒副作用。
具体实施方式
实施例1
一种治疗糖尿病的中药,由重量计的:丹参5克、红花3克、生地、山药各15克;五味子、葛根各5克;蛤粉、海浮石各10克;天花粉10克、鸡内金3克、西瓜皮、冬瓜皮各10克,桑螵蛸50克、知母、麦冬、党参各5克,生石膏25克和元参10克组成。
其制备方法,包括如下步骤:
1)将蛤粉、海浮石和生石膏混合煎煮,过滤,取上清液;
2)将丹参、生地、山药、五味子、葛根、天花粉、西瓜皮、冬瓜皮、桑螵蛸、知母、麦冬、党参和元参清洗,粉碎加入重量分数为65wt%乙醇水溶液30分钟,提取药物有效成分;
3)将红花粉碎后装入超临界CO2萃取釜中进行超临界CO2萃取,萃取的压力控制在萃取压力8MPa,萃取温度40℃,制得红花有效成分备用;
4)将鸡内金煎炒、粉碎,与步骤1)、步骤2)和步骤3)所得药物有效成分混合、浓缩成1.3g/ml的浸膏;
5)将步骤4)所得浸膏-78℃冷冻干燥12小时、和药学上的辅料混合制成口服液。
实施例2
一种治疗糖尿病的中药,由重量计的:丹参15克、红花10克、生地、山药各25克;五味子、葛根各15克;蛤粉、海浮石各15克;天花粉20克、鸡内金7克、西瓜皮、冬瓜皮各20克,桑螵蛸70克、知母、麦冬、党参各15克,生石膏35克和元参15克组成。
其制备方法,包括如下步骤:
1)将蛤粉、海浮石和生石膏混合煎煮,过滤,取上清液;
2)将丹参、生地、山药、五味子、葛根、天花粉、西瓜皮、冬瓜皮、桑螵蛸、知母、麦冬、党参和元参清洗,粉碎加入重量分数为75wt%乙醇水溶液50分钟,提取药物有效成分;
3)将红花粉碎后装入超临界CO2萃取釜中进行超临界CO2萃取,萃取的压力控制在萃取压力12MPa,萃取温度60℃,制得红花有效成分备用;
4)将鸡内金煎炒、粉碎,与步骤1)、步骤2)和步骤3)所得药物有效成分混合、浓缩成1.8g/ml的浸膏;
5)将步骤4)所得浸膏-60℃冷冻干燥20小时、和药学上的辅料混合制成颗粒剂。
实施例3
一种治疗糖尿病的中药,由重量计的:丹参10克、红花6克、生地、山药各20克;五味子、葛根各10克;蛤粉、海浮石各12克;天花粉15克、鸡内金5克、西瓜皮、冬瓜皮各15克,桑螵蛸60克、知母、麦冬、党参各10克,生石膏30克和元参12克组成。
其制备方法,包括如下步骤:
1)将蛤粉、海浮石和生石膏混合煎煮,过滤,取上清液;
2)将丹参、生地、山药、五味子、葛根、天花粉、西瓜皮、冬瓜皮、桑螵蛸、知母、麦冬、党参和元参清洗,粉碎加入重量分数为70wt%乙醇水溶液40分钟,提取药物有效成分;
3)将红花粉碎后装入超临界CO2萃取釜中进行超临界CO2萃取,萃取的压力控制在萃取压力10MPa,萃取温度500℃,制得红花有效成分备用;
4)将鸡内金煎炒、粉碎,与步骤1)、步骤2)和步骤3)所得药物有效成分混合、浓缩成1.5g/ml的浸膏;
5)将步骤4)所得浸膏-70℃冷冻干燥18小时、和药学上的辅料混合制成注射剂。
实施例4
一种治疗糖尿病的中药,由重量计的:丹参7克、红花4克、生地、山药各17克;五味子、葛根各8克;蛤粉、海浮石各11克;天花粉13克、鸡内金4克、西瓜皮、冬瓜皮各13克,桑螵蛸55克、知母、麦冬、党参各7克,生石膏28克(先煎)和元参11克组成。
其制备方法,包括如下步骤:
1)将蛤粉、海浮石和生石膏混合煎煮,过滤,取上清液;
2)将丹参、生地、山药、五味子、葛根、天花粉、西瓜皮、冬瓜皮、桑螵蛸、知母、麦冬、党参和元参清洗,粉碎加入重量分数为68wt%乙醇水溶液34分钟,提取药物有效成分;
3)将红花粉碎后装入超临界CO2萃取釜中进行超临界CO2萃取,萃取的压力控制在萃取压力9MPa,萃取温度44℃,制得红花有效成分备用;
4)将鸡内金煎炒、粉碎,与步骤1)、步骤2)和步骤3)所得药物有效成分混合、浓缩成1.4g/ml的浸膏;
5)将步骤4)所得浸膏-74℃冷冻干燥16小时、和药学上的辅料混合制成片剂。
实施例5
一种治疗糖尿病的中药,由重量计的:丹参9克、红花7克、生地、山药各19克;五味子、葛根各9克;蛤粉、海浮石各13克;天花粉13克、鸡内金6克、西瓜皮、冬瓜皮各13克,桑螵蛸65克、知母、麦冬、党参各13克,生石膏32克和元参13克组成。
其制备方法,包括如下步骤:
1)将蛤粉、海浮石和生石膏混合煎煮,过滤,取上清液;
2)将丹参、生地、山药、五味子、葛根、天花粉、西瓜皮、冬瓜皮、桑螵蛸、知母、麦冬、党参和元参清洗,粉碎加入重量分数为71wt%乙醇水溶液38分钟,提取药物有效成分;
3)将红花粉碎后装入超临界CO2萃取釜中进行超临界CO2萃取,萃取的压力控制在萃取压力11MPa,萃取温度48℃,制得红花有效成分备用;
4)将鸡内金煎炒、粉碎,与步骤1)、步骤2)和步骤3)所得药物有效成分混合、浓缩成1.6g/ml的浸膏;
5)将步骤4)所得浸膏-70℃冷冻干燥17小时、和药学上的辅料混合制成丸剂。
实施例6
一种治疗糖尿病的中药,由重量计的:丹参13克、红花8克、生地、山药各23克;五味子、葛根各13克;蛤粉、海浮石各14克;天花粉14克、鸡内金4克、西瓜皮、冬瓜皮各17克,桑螵蛸68克、知母、麦冬、党参各14克,生石膏34克(先煎)和元参14克组成。
其制备方法,包括如下步骤:
1)将蛤粉、海浮石和生石膏混合煎煮,过滤,取上清液;
2)将丹参、生地、山药、五味子、葛根、天花粉、西瓜皮、冬瓜皮、桑螵蛸、知母、麦冬、党参和元参清洗,粉碎加入重量分数为73wt%乙醇水溶液42分钟,提取药物有效成分;
3)将红花粉碎后装入超临界CO2萃取釜中进行超临界CO2萃取,萃取的压力控制在萃取压力9MPa,萃取温度52℃,制得红花有效成分备用;
4)将鸡内金煎炒、粉碎,与步骤1)、步骤2)和步骤3)所得药物有效成分混合、浓缩成1.4g/ml的浸膏;
5)将步骤4)所得浸膏-68℃冷冻干燥18小时、和药学上的辅料混合制成丸剂。
实施例7
一种治疗糖尿病的中药,由重量计的:丹参14克、红花4克、生地、山药各16克;五味子、葛根各6克;蛤粉、海浮石各11克;天花粉11克、鸡内金4克、西瓜皮、冬瓜皮各11克,桑螵蛸52克、知母、麦冬、党参各6克,生石膏28克和元参11克组成。
其制备方法,包括如下步骤:
1)将蛤粉、海浮石和生石膏混合煎煮,过滤,取上清液;
2)将丹参、生地、山药、五味子、葛根、天花粉、西瓜皮、冬瓜皮、桑螵蛸、知母、麦冬、党参和元参清洗,粉碎加入重量分数为74wt%乙醇水溶液48分钟,提取药物有效成分;
3)将红花粉碎后装入超临界CO2萃取釜中进行超临界CO2萃取,萃取的压力控制在萃取压力9MPa,萃取温度56℃,制得红花有效成分备用;
4)将鸡内金煎炒、粉碎,与步骤1)、步骤2)和步骤3)所得药物有效成分混合、浓缩成1.5g/ml的浸膏;
5)将步骤4)所得浸膏-64℃冷冻干燥19小时、和药学上的辅料混合制成散剂。
实施例8
一种治疗糖尿病的中药,由重量计的:丹参8克、红花6克、生地、山药各17克;五味子、葛根各13克;蛤粉、海浮石各13克;天花粉17克、鸡内金6克、西瓜皮、冬瓜皮各17克,桑螵蛸68克、知母、麦冬、党参各14克,生石膏29克和元参14克组成。
其制备方法,包括如下步骤:
1)将蛤粉、海浮石和生石膏混合煎煮,过滤,取上清液;
2)将丹参、生地、山药、五味子、葛根、天花粉、西瓜皮、冬瓜皮、桑螵蛸、知母、麦冬、党参和元参清洗,粉碎加入重量分数为65wt乙醇水溶液49分钟,提取药物有效成分;
3)将红花粉碎后装入超临界CO2萃取釜中进行超临界CO2萃取,萃取的压力控制在萃取压力12MPa,萃取温度58℃,制得红花有效成分备用;
4)将鸡内金煎炒、粉碎,与步骤1)、步骤2)和步骤3)所得药物有效成分混合、浓缩成1.7g/ml的浸膏;
5)将步骤4)所得浸膏-62℃冷冻干燥12-20小时、和药学上的辅料混合制成滴丸剂。
对比例1:将实施例3中的桑螵蛸的加入量变成30克,其他均不变。
对比例2:将实施例3中的桑螵蛸用海螵蛸替换,其他均不变。
本方的立方根本在于:一是津血同源,互为滋生,阴血不足,脉道不充;二是燥热可消烁津液,耗伤阴血,血行不畅,淤血停滞,此即“血如象舟,津如象水,水津充沛,舟始能行,若津液为所灼竭,则血液为之淤滞”;三是阴虚津亏,伤及阳气,鼓动无力,淤血内停;四是糖尿病多缠绵难愈,久虚入络,久病入络,气血不畅而成淤,此即“病久入深,营卫行涩”。淤血内结,郁久化热,热灼阴伤,则会导致或加重消渴。
唐容川在《血证论》中说:“淤血在里即渴……血与气本不相离,内有淤血,故气不得通,不能载水津上升,是以口渴……淤血去则不渴也”。
淤阻气滞,水液代谢障碍,津不得布,水谷精微不得濡养脏腑组织、四肢百骸,反随小便而去,发为消渴。阴虚燥热是糖尿病的主要病机,而淤血与阴虚燥热又互为因果,随着病情的发展,导致阴阳失衡,产生诸多并发症。
淤血既是一个致病因素,又是一个病理产物,淤血既可引起糖尿病,病后又易产生淤血,使病情加重,而且又容易引发各种并发症。所以淤血贯穿于糖尿病的整个过程。
证明,活血化淤药能改善微循环障碍,使微循环血流速度加快,降低血粘度,促使毛细血管网开放增加,对体内不同部位(心脑肾等)和不同类型(小动脉、小静脉、微动脉、微静脉毛细血管)的血管均有扩张作用,从而增加局部血流量;对于已经形成的血栓,活血化淤药物则是通过抑制血小板功能,抗凝血作用,增加纤维蛋白溶解活性,改善血液流变性,降低血粘度等环节达到治疗的效果。任继学名老中医认为,病邪入络,须活血化淤,淤血不行,新血断无生机,欲致新生,必先推陈,通补并行,每加行血药于补剂中,其功倍捷,祛淤不伤正由于“消渴”以阴虚为本,淤血是病理产物又是致病因素,在应用活血化淤的时候要注意顾护气血和滋养阴液,做到祛淤而不致耗气伤阴,养阴又不致留寇恋邪,以期达到较好疗效。糖尿病又是一个治疗周期较长的疾病,要制定一个长期的适合个体特征的治疗计划,达到祛淤不伤正、“以通为补”的效果。
提出活血化淤是治疗糖尿病的有效途径,应贯穿糖尿病治疗始终治疗用药原则,对于提高治疗效果具有积极意义、调整脏腑气血功能、标本兼治、祛淤不伤正。
临床药效试验
方法:将220例临床确诊糖尿病患者,患者个体之间的差异可忽略不计,将其随机分为实验组1-8、对照组1-2及二甲双胍组,每组20例,分别服用实施例1-8制备的中药组合物、对照组1-2制备的中药组合物和市售的二甲双胍,连续服用10天,观察临床疗效结果见表1,治疗期间停止其他中西药治疗。
诊断标准:参照***1993年制定的《中药新药临床研究指导原则》中的“治疗消渴病的临床研究指导原则”所规定的标准评定疗效。显效:治疗后症状基本消失,FPG(空腹血糖)<7.0mmol/L,P2hPG(餐后2小时血糖)<8.3mmol/L或血糖较前下降30%以上;有效:治疗后症状明显改善,FPG<8.3mmol/L,P2hPG<10.0mmol/L,或血糖较前下降10%~29%;无效:治疗后症状无明显改善,血糖下降未达到上述标准。
表1本发明所述治疗糖尿病的中药组合物、对照组治疗糖尿病的中药组合物和二甲双胍治疗糖尿病临床疗效结果统计。
其中,表中总有效病例数=(显效+有效)。从表1可以看出,本发明所述中药组合物在临床上,取得了较好的疗效,所选择糖尿病患者中,服用本发明实施例1-8所述中药组合物10天后,显效率高达80.0%,总有效率高达95%;特别是实施例3,总有效率高达100%。对比例2组和二甲双胍组临床疗效相似。说明本发明提供的治疗糖尿病的中药疗效较为突出,同时,通过对比,实施例3和对比例1、2说明本发明配方中各药物之间的配伍和重量比是影响本发明药物疗效的重要因素。
最后说明的是,以上实施例仅用以说明本发明的技术方案而非限制,本领域普通技术人员对本发明的技术方案所做的其他修改或者等同替换,只要不脱离本发明技术方案的精神和范围,均应涵盖在本发明的权利要求范围当中。
Claims (7)
1.一种治疗糖尿病的中药,其特征在于:由重量计的:丹参5-15克、红花3-10克、生地、山药各15-25克;五味子、葛根各5-15克;蛤粉、海浮石各10-15克;天花粉10-20克、鸡内金3-7克、西瓜皮、冬瓜皮各10-20克,桑螵蛸50-70克、知母、麦冬、党参各5-15克,生石膏25-35克和元参10-15克组成。
2.根据权利要求1所述的一种治疗糖尿病的中药,其特征在于:由重量计的:丹参8-10克、红花5-8克、生地、山药各18-22克;五味子、葛根各8-12克;蛤粉、海浮石各12-14克;天花粉13-18克、鸡内金4-6克、西瓜皮、冬瓜皮各12-18克,桑螵蛸55-65克、知母、麦冬、党参各8-12克,生石膏28-32克和元参12-14克组成。
3.根据权利要求1所述的一种治疗糖尿病的中药,其特征在于:由重量计的:丹参10克、红花6克、生地、山药各20克;五味子、葛根各10克;蛤粉、海浮石各12克;天花粉15克、鸡内金5克、西瓜皮、冬瓜皮各15克,桑螵蛸60克、知母、麦冬、党参各10克,生石膏30克和元参12克组成。
4.一种根据权利要求1-3任一项所述的治疗糖尿病的中药的制备方法,其特征在于:包括如下步骤:
1)将蛤粉、海浮石和生石膏混合煎煮,过滤,取上清液;
2)将丹参、生地、山药、五味子、葛根、天花粉、西瓜皮、冬瓜皮、桑螵蛸、知母、麦冬、党参和元参清洗,粉碎加入乙醇水溶液30-50分钟,提取药物有效成分;
3)将红花粉碎后装入超临界CO2萃取釜中进行超临界CO2萃取,萃取的压力控制在萃取压力8-12MPa,萃取温度40-60℃,制得红花有效成分备用;
4)将鸡内金煎炒、粉碎,与步骤1)、步骤2)和步骤3)所得药物有效成分混合、浓缩成1.3-1.8g/ml的浸膏;
5)将步骤4)所得浸膏干燥、制剂。
5.根据权利要求4所述的制备方法,其特征在于:步骤2)所述乙醇水溶液的重量分数为65wt-75wt%。
6.根据权利要求4所述的制备方法,其特征在于:步骤5)所述干燥的条件是-78—-60℃冷冻干燥12-20小时。
7.根据权利要求4所述的制备方法,其特征在于:步骤5)所述制剂,由所述浸膏和药学上的辅料混合制成,所述剂型包括口服液、颗粒剂、片剂、丸剂、散剂、胶囊剂、滴丸剂和注射剂。
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