CN111494548A - 一种中药组合物及其应用 - Google Patents
一种中药组合物及其应用 Download PDFInfo
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- CN111494548A CN111494548A CN202010356483.4A CN202010356483A CN111494548A CN 111494548 A CN111494548 A CN 111494548A CN 202010356483 A CN202010356483 A CN 202010356483A CN 111494548 A CN111494548 A CN 111494548A
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Abstract
本发明公开了一种中药组合物及其应用,属于中药领域。本发明所述中药组合物用于治疗糖尿病,其由如下重量份的原料制成:熟地16‑24份、益母草16‑24份、地骨皮16‑24份、炒山药12‑18份、川牛滕12‑18份、天花粉12‑18份、金石斛12‑18份、桑螵蛸12‑18份、丹参12‑18份、葛根12‑18份、焦白术12‑18份、桑椹子12‑18份、番石榴叶12‑18份、绞股蓝12‑18份、人参10‑15份、麦冬8‑12份、枸杞8‑12份、灵芝8‑12份。本发明所述中药组合物治疗糖尿病效果好,可全面调理代谢紊乱,修复胰腺组织损伤,具有组方简单,治疗效果好,无副作用,疗程短的优点。
Description
技术领域
本发明属于中药技术领域,尤其涉及一种中药组合物及其应用。
背景技术
中医认为糖尿病属“消渴病”范畴,病理基础为阴虚燥热,以正虚阴亏为本,燥热虚火为标,故治疗宜养阴生津以扶正,清热润燥以治标。其临床可见燥热伤津、阴虚火旺、气阴两虚、阴阳两虚、气虚血瘀、痰湿内阻等证候,通常采用以下辨证论治:
1)肺热津伤证:表现为口渴多饮,咽干舌燥,尿频量多,怕热喜凉,心烦自汗,伴多食易饥,消瘦乏力等,治宜清热润肺,生津止渴;
2)胃热炽盛证:表现为多食易饥,形体消瘦,大便干燥,伴口渴喜饮,或口臭,口舌生疮等,治宜清胃泻火,养阴增液;
3)肾阴亏虚证:表现为尿频量多,混浊可如脂膏,或尿有甜味,口舌干燥,倦怠乏力,腰膝酸软,五心烦热等,治宜滋阴益肾,缩尿涩精;
4)阴阳两虚证:表现为小便频数且量多,或尿有余沥,面色黧黑,羸瘦体倦,形寒肢冷,耳轮焦干,腰膝酸软等,治宜温阳,滋肾,固精;
5)气阴两虚证:表现为食少溺多,渴欲饮水,但不欲饮冷,气息短促,语音低微,身倦乏力,自汗,五心烦热等,治宜益气养阴,生津润燥;
6)痰湿内阻证:表现为形体偏于肥胖,口干但饮水不多或不欲饮,胸脘痞闷,食后尤甚,气短乏力,懒动,或头部昏蒙,或头目眩晕等,治宜健脾益气,燥湿化痰。
目前,用于治疗糖尿病的中药较多,但药效差异化较大,故开发一种能够有效治疗糖尿病,且疗程短的中药具有极高的市场价值。
发明内容
有鉴于此,本发明提供一种中药组合物及其应用,该中药组合物的组方简单,治疗糖尿病效果好,无副作用且疗程短。
本发明采用如下技术方案:
本发明提供一种中药组合物,由以下组分制成:
优选地,所述的中药组合物由以下组分制成:
熟地20重量份、炒山药15重量份、川牛滕15重量份、麦冬10重量份、天花粉15重量份、金石斛15重量份、葛根15重量份、焦白术15重量份、地骨皮20重量份、桑椹子15重量份、桑螵蛸15重量份、丹参15重量份、益母草20重量份、番石榴叶15重量份、绞股蓝15重量份、枸杞10重量份、灵芝10重量份、人参12重量份。
本发明还提供一种中药制剂,由中药组合物及药学上可接受的辅料制成。
本发明还提供所述的中药组合物在制备治疗糖尿病的药物中的应用。
与现有技术相比,本发明的有益效果在于:
本发明进行总结及发展中医辨证论治,提出将枸杞、灵芝、人参、番石榴叶和克绞股蓝加入到现有处方,并按照君臣佐使进行组方。其中熟地、枸杞、桑葚子、桑螵蛸、川牛膝、炒山药为君药,功能为养阴、固肾益精、肝肾阴亏、腰膝酸软、遗精等;天花粉、金石斛、麦冬、番石榴叶、绞股蓝、地骨皮为臣药,功能为消心除烦,肺热咳嗽,清热消渴,骨蒸潮热等;人参、生白术、灵芝为佐药,功能为补气健脾胃,除湿安神,益气等;丹参、益母草、葛根为使药,功能为凉血消痛,脘腹肋痛,透疹,痈肿疮疡等。上述诸药进行配伍组方,各药相互作用,能够有效治疗糖尿病,全面调理代谢紊乱,修复胰腺组织损伤,具有组方简单,效果好,无副作用,并且疗程短的特点。
具体实施方式
为了进一步理解本发明,下面结合实施例对本发明优选实施方案进行描述,但是应当理解,这些描述只是为进一步说明本发明的特征和优点,而不是对本发明权利要求的限制。
本发明提供了一种中药组合物,由以下组分制成:
其中,本发明对所有原料的来源并没有特殊的限制,为市售即可。
所述熟地的用量优选为20重量份。熟地性温,味甘,有补血滋阴、益精填髓的作用。
所述益母草的用量优选为20重量份。益母草性微寒,味苦、辛,有活血调经、利尿消肿、清热解毒的作用。
所述地骨皮的用量优选为20重量份。地骨皮性寒,味甘,有凉血除蒸、清肺降火的作用。
所述炒山药的用量优选为15重量份。炒山药有补脾健胃的作用。
所述川牛膝的用量优选为15重量份。川牛膝性平,味甘、微苦,有逐瘀通经、通利关节、利尿通淋的作用。
所述天花粉的用量优选为15重量份。天花粉性微寒,味甘、微苦,有清热泻火、生津止渴、消肿排脓的作用。
所述金石斛的用量优选为15重量份。金石斛以茎入药,其性平,味甘、淡,有养阴清热的作用。
所述桑螵蛸的用量优选为15重量份。桑螵蛸性平,味甘、咸,有固精缩尿、补肾助阳的作用。
所述丹参的用量优选为15重量份。丹参性微寒,味苦,有活血祛瘀、通经止痛、清心除烦、凉血消痈的作用;同时促进组织修复和再生。
所述葛根的用量优选为15重量份。葛根性凉,味甘、辛,有解肌退热、生津止渴、透疹、升阳止泻、通经活络、解酒毒的作用。
所述焦白术的用量优选为15重量份。焦白术是白术炮制加工后的饮片,有健脾、止泻、补气的作用。
所述桑椹子的用量优选为15重量份。桑椹子性寒,味甘、酸,有滋阴养血、生津、润肠的作用。
所述番石榴叶的用量优选为15重量份。番石榴叶性平,味苦、涩,有燥湿健脾、清热解毒的作用。
所述绞股蓝的用量优选为15重量份。绞股蓝以根状茎入药,其性寒,味苦,有清热解毒、止咳祛痰的作用。
所述人参的用量优选为12重量份。人参性微温,味甘、微苦,有大补元气、复脉固脱、补脾益肺、生津养血、安神益智的作用;可对糖尿病患者自觉改善症状,还有轻微的降血糖作用,并与胰岛素有协同作用。
所述麦冬的用量优选为10重量份。麦冬性微寒,味甘、微苦,有养阴生津、润肺清心的作用。
所述枸杞的用量优选为10重量份。枸杞性平,味甘,有滋补肝肾、益精明目的作用。
所述灵芝的用量优选为10重量份。灵芝性平,味甘,有补气安神、止咳平喘的作用,还能促进血清、肝脏及骨髓的蛋白质与核酸的合成,加速骨髓细胞分裂、增殖。
在本发明提供的一些实施例中,所述中药组合物由如下组分制成:
熟地20重量份、炒山药15重量份、川牛滕15重量份、麦冬10重量份、天花粉15重量份、金石斛15重量份、葛根15重量份、焦白术15重量份、地骨皮20重量份、桑椹子15重量份、桑螵蛸15重量份、丹参15重量份、益母草20重量份、番石榴叶15重量份、绞股蓝15重量份、枸杞10重量份、灵芝10重量份、人参12重量份。
在本发明提供的一些实施例中,所述中药组合物由如下组分制成:
熟地16重量份、益母草16重量份、地骨皮16重量份、炒山药12重量份、川牛滕12重量份、天花粉12重量份、金石斛12重量份、桑螵蛸12重量份、丹参12重量份、葛根12重量份、焦白术12重量份、桑椹子12重量份、番石榴叶12重量份、绞股蓝12重量份、人参10重量份、麦冬8重量份、枸杞8重量份、灵芝8重量份。
在本发明提供的一些实施例中,所述中药组合物由如下组分制成:
熟地24重量份、益母草24重量份、地骨皮24重量份、炒山药18重量份、川牛滕18重量份、天花粉18重量份、金石斛18重量份、桑螵蛸18重量份、丹参18重量份、葛根18重量份、焦白术18重量份、桑椹子18重量份、番石榴叶18重量份、绞股蓝18重量份、人参15重量份、麦冬12重量份、枸杞12重量份、灵芝12重量份。
在本发明提供的另外一些实施例中,所述中药组合物由如下组分制成:
熟地18重量份、炒山药13.5重量份、川牛滕13.5重量份、麦冬9重量份、天花粉13.5重量份、金石斛13.5重量份、葛根13.5重量份、焦白术13.5重量份、地骨皮18重量份、桑椹子13.5重量份、桑螵蛸13.5重量份、丹参13.5重量份、益母草18重量份、番石榴叶13.5重量份、绞股蓝13.5重量份、枸杞9重量份、灵芝9重量份、人参10.5重量份。
在本发明提供的另外一些实施例中,所述中药组合物由如下组分制成:
熟地22重量份、炒山药16.5重量份、川牛滕16.5重量份、麦冬11重量份、天花粉16.5重量份、金石斛16.5重量份、葛根16.5重量份、焦白术16.5重量份、地骨皮22重量份、桑椹子16.5重量份、桑螵蛸16.5重量份、丹参16.5重量份、益母草22重量份、番石榴叶16.5重量份、绞股蓝16.5重量份、枸杞11重量份、灵芝11重量份、人参13.5重量份。
本发明是对现有处方的发展,其中以熟地、枸杞、桑葚子、桑螵蛸、川牛膝、炒山药为君药,功能为养阴、固肾益精、肝肾阴亏、腰膝酸软、遗精等;天花粉、金石斛、麦冬、番石榴叶、绞股蓝、地骨皮为臣药,功能为消心除烦,肺热咳嗽,清热消渴,骨蒸潮热等;人参、生白术、灵芝为佐药,功能为补气健脾胃,除湿安神,益气等;丹参、益母草、葛根为使药,功能为凉血消痛,脘腹肋痛,透疹,痈肿疮疡等。上述诸药进行配伍组方,各药相互作用,能够有效治疗糖尿病,全面调理代谢紊乱,修复胰腺组织损伤,具有治疗效果好,无副作用及疗程短的特点。
本发明还提供了一种中药制剂,由上述的中药组合物及药学上可接受的辅料制成。所述辅料优选为微晶纤维素、硬脂酸镁、交联羧甲基纤维素钠、甲基硅油、乳糖、蔗糖、甘露醇或山梨醇、玉米淀粉、小麦淀粉、稻米淀粉、马铃薯淀粉、明胶、黄芪胶、聚乙烯吡咯烷酮或磷酸钙。
本发明提供的中药制剂可以为颗粒剂、胶囊剂、片剂或丸剂。
本发明还提供了上述中药组合物在制备治疗糖尿病的药物中的应用。
为了进一步说明本发明,以下结合实施例对本发明提供的一种中药组合物及中药制剂进行详细描述。
以下实施例中所用的试剂均为市售。
实施例1-中药组合物的制备
将20克熟地、15克炒山药、15克川牛滕、10克麦冬、15克天花粉、15克金石斛、15克葛根、15克焦白术、20克地骨皮、15克桑椹子、15克桑螵蛸、15克丹参、20克益母草、15克番石榴叶、15克绞股蓝、10克枸杞、10克灵芝和12克人参混合,加入2760克水煎煮2次,每次1小时,合并提取液、滤过,搅匀,真空干燥后粉碎成80-100目细粉,即得。
实施例2-中药组合物的制备
将16克熟地、16克益母草、16克地骨皮、12克炒山药、12克川牛滕、12克天花粉、12克金石斛、12克桑螵蛸、12克丹参、12克葛根、12克焦白术、12克桑椹子、12克番石榴叶、12克绞股蓝、10克人参、8克麦冬、8克枸杞和8克灵芝混合,加入2140克水煎煮2次,每次1小时,合并提取液、滤过,搅匀,真空干燥后粉碎成80-100目细粉,即得。。
实施例3-中药组合物的制备
将24克熟地、24克益母草、24克地骨皮、18克炒山药、18克川牛滕、18克天花粉、18克金石斛、18克桑螵蛸、18克丹参、18克葛根、18克焦白术、18克桑椹子、18克番石榴叶、18克绞股蓝、15克人参、12克麦冬、12克枸杞和12克灵芝混合,加入3210克水煎煮2次,每次1小时,合并提取液、滤过,搅匀,真空干燥后粉碎成80-100目细粉,即得。
实施例4-中药组合物的制备
将18克熟地、13.5克炒山药、13.5克川牛滕、9克麦冬、13.5克天花粉、13.5克金石斛、13.5克葛根、13.5克焦白术、18克地骨皮、13.5克桑椹子、13.5克桑螵蛸、13.5克丹参、18克益母草、13.5克番石榴叶、13.5克绞股蓝、9克枸杞、9克灵芝和10.5克人参混合,加入2400克水煎煮2次,每次1小时,合并提取液、滤过,搅匀,真空干燥后粉碎成80-100目细粉,即得。
实施例5-中药组合物的制备
将22克熟地、16.5克炒山药、16.5克川牛滕、11克麦冬、16.5克天花粉、16.5克金石斛、16.5克葛根、16.5克焦白术、22克地骨皮、16.5克桑椹子、16.5克桑螵蛸、16.5克丹参、22克益母草、16.5克番石榴叶、16.5克绞股蓝、11克枸杞、11克灵芝和13.5克人参混合,加入2940克水煎煮2次,每次1小时,合并提取液、滤过,搅匀,真空干燥后粉碎成80-100目细粉,即得。
实施例6-上述中药组合物的临床制剂
本发明实施例1-5所述的中药组合物,按照常规的药品生产工艺,加入适宜的矫味剂或甜味剂,制成颗粒剂;加入适宜的辅料,制成片剂、丸剂和胶囊剂。
实施例7-上述中药组合物临床疗效观察
1.临床资料及方法:选择2017年1月至今的76例临床确诊糖尿病患者随机分为实验组及对照组,实验组38例,对照组38例,分别服用实施例1制备的中药组合物和市售的二甲双胍,连续服用20天,在第10天、第20天时观察临床疗效结果见表1,治疗期间停止其他药物治疗。
2.诊断标准:参照以下标准评定疗效:
治愈:治疗后症状完全消失,3.9mmol/L<FPG(空腹血糖)<6.2mmol/L,P2hPG(餐后2小时血糖)<7.8mmol/L;
有效:治疗后症状明显改善,FPG<7.8mmol/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。
3.治疗效果
表1-本发明的中药组合物治疗糖尿病的临床疗效观察
从表1可以看出,本发明所述中药组合物在临床治疗糖尿病中取得了较好的疗效。在38例糖尿病患者中,服用本发明所述中药组合物10天后,治愈27例,治愈率占71.05%,有效11例,有效率占28.95%;服用本发明所述中药组合物20天后,治愈增至36例,治愈率达94.74%,剩余2例病情减轻,有效率占5.26%,病情减轻2例患者在继续服药7天后痊愈,治愈率达到100%。实施例2-5制备的中药组合物与实施例1制备的中药组合物的临床疗效相似,无统计学差异。
考察本发明中药组合物相比现有药物的疗效,其结果显示:
专利CN105770394A公开的药物在临床治疗糖尿病中,服用该中药组合物15天时,病情均显著好转,继续服药15天后全部治愈。可见,该中药组合物的治疗周期长达30天。
而本发明经总结和发展该中药组合物,得到本发明中药组合物,在第20天时治愈率达到94.74%,在第27天时全部治愈。可见,本发明中药组合物的治疗周期为20天,最长27天。
因此本发明所述中药组合物相比该药物明显缩短了疗程,取得了更好的治疗效果。
下面进一步提供三例更为详细的具体病例:
病例1
王XX,男,46岁,甘肃省天水市秦州区玉泉镇西十里村人。
于2017年11月3日发病,症见倦怠乏力,口干咽燥,手足心热,腰膝酸软,四肢无力,头晕脑胀,胸胀气短,疲乏无力,口渴多饮等,送往天水市第一人民医院救治,急性下壁心肌梗死,冠心病,心功能Ⅰ级,Ⅱ型糖尿病,血糖23.47等,14天出院。
2017年11月20日前来就诊,症见倦怠乏力,面浮肢肿,畏寒肢冷,四肢不温,口渴多尿,手脚麻木,腰酸腿软,性欲减退,消瘦,阴虚失调,阳虚失煦,舌质暗红,边有齿痕,苔白,脉细数等。血糖15.7mmol/L,尿蛋白(++),血肝酐230μmol/L,血压160/100mmHg。
症状分析:肝木失养,肝肾阴虚,阴伤不止,气随液耗,于致血虚,湿邪乃益,瘀血化热,瘀由虚生,血虚不荣,气虚不固,瘀阻肾络,久病入络等。
主治:Ⅱ型糖尿病与冠心病等。
治法:服用本发明所述实施例1制备的中药组合物10天,血糖11.46mmol/L,尿蛋白(+),血压130/95mmHg;继续服药10天,血糖:7.46mmol/L,血压120/90mmHg;继续服药7天,血糖:5.91mmol/L,血压120/80mmHg。
病例2
常XX,男,50岁,甘肃省天水市秦州区太京镇师家崖村人。
于2017年3月19日,症见口干舌燥,腰膝酸软,五心烦热,头晕耳鸣,多饮,尿量频繁,畏寒肢冷,面浮肢肿,倦怠乏力,腹胀纳差等。急送至秦城区人民医院诊救,化验血糖:21.67mmol/L,果糖胺3.98mmol/L,治疗11天出院后,血糖14.58mmol/L,果糖胺3.69mmol/L,血压130/80mmHg,尿蛋白(+++)。
于2017年5月7日前来就诊,口渴多尿,面浮肢肿,腰酸乏力,性欲减退,消瘦,腹胀纳差,夜尿多,多食,睡眠不佳,烦躁不安,梦多,舌质暗红,边有齿痕,苔白,脉细数等,血糖14.62mmol/L,果糖胺3.68mmol/L,血压120/80mmHg。
症状分析:气阴两虚,益气养阴,温肾利水,气随液耗,湿邪乃盛,瘀血化热,湿热瘀结,瘀血湿热,滋养肝肾,清热明目,阴损及阳,阴阳两虚等。
主治:Ⅱ型糖尿病。
治法:服用本发明所述实施例1制备的中药组合物10天,血糖10.09mmol/L,果糖胺3.48mmol/L,血压120/80mmHg;继续服药10天,血糖5.87mmol/L,果糖胺3.31mmol/L。
病例3
张XX,男,54岁,甘肃省天水市秦州区玉泉镇西十里村人。
于2019年6月16日,症见头晕耳鸣,视物模糊,五心烦热,口干舌燥,腰膝酸软,口渴多尿等。急送至秦州区人民医院救治,化验血糖:19.63mmol/L,果糖胺3.69mmol/L,甘油三脂3.72mmol/L,经治疗13天后出院,血糖16.52mmol/L,果糖胺3.87mmol/L,甘油三脂3.58mmol/L,血压150/100mmHg等症。
2019年7月8日前来就诊,症见面浮肢肿,腹胀纳差,四肢不温,腰膝酸软,口渴多尿,消瘦,头晕耳鸣,心烦急躁,胸胀气短,血压150/95mmHg,血糖14.68mmol/L,果糖胺3.69mmol/L,甘油三脂3.42mmol/L,舌质紫暗,脉沉弱等症。
症状分析:肺虚不调,脾虚不运,肾虚不化,曷生内湿,由于气虚不固,血虚不荣,阴虚失调,阳虚失煦等。
主治:Ⅱ型糖尿病。
治法:服用本发明实施例1制备的中药组合物10天,血糖10.68mmol/L,果糖胺3.48mmol/L,甘油三脂2.68mmol/L,血压130/90mmHg;继续服药10天后,血糖5.79mmol/L,果糖胺3.30mmol/L,甘油三脂2.08mmol/L。
以上实施例的说明只是用于帮助理解本发明的方法及其核心思想。应当指出,对于本技术领域的普通技术人员来说,在不脱离本发明原理的前提下,还可以对本发明进行若干改进和修饰,这些改进和修饰也落入本发明权利要求的保护范围内。
Claims (5)
2.根据权利要求1所述的中药组合物,其特征在于,由以下组分制成:
熟地20重量份、炒山药15重量份、川牛滕15重量份、麦冬10重量份、天花粉15重量份、金石斛15重量份、葛根15重量份、焦白术15重量份、地骨皮20重量份、桑椹子15重量份、桑螵蛸15重量份、丹参15重量份、益母草20重量份、番石榴叶15重量份、绞股蓝15重量份、枸杞10重量份、灵芝10重量份、人参12重量份。
3.一种中药制剂,其特征在于,由权利要求1或2所述的中药组合物及药学上可接受的辅料制成。
4.根据权利要求3所述的中药制剂,其特征在于,其剂型为颗粒剂、胶囊剂、片剂或丸剂。
5.根据权利要求1或2所述的中药组合物在制备治疗糖尿病的药物中的应用。
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