CN106880826A - 一种治疗慢性心力衰竭的中药制剂及其制备方法 - Google Patents
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Abstract
本发明公开了一种治疗慢性心力衰竭的中药制剂,它是由生晒参、麦冬、五味子、干姜、制附子、桂枝、炙甘草、煅龙骨、煅牡蛎、紫贝齿、川芎、醋延胡索、郁金、当归、炙黄芪、红景天、赤灵芝、三七、龙眼肉、升麻、瓜蒌、薤白、丹参、赤芍、益母草按照一定的重量配比组成,具有补气回阳、温中散寒、活血祛瘀、养血安神的功效,能够有效治疗慢性心力衰竭。
Description
技术领域
本发明涉及一种中药制剂,具体涉及一种治疗慢性心力衰竭的中药制剂。本发明还涉及该中药制剂的制备方法。
背景技术
心力衰竭是由于心肌梗死、心肌病、血流动力学负荷过重、炎症等任何原因引起的心肌损伤,造成心肌结构和功能的变化,最后导致心室泵血或充盈功能低下。临床主要表现为呼吸困难、乏力和体潴留。慢性心力衰竭(CHF)是指持续存在的心力衰竭状态,可以稳定、恶化或失代偿。治疗心衰的目标不仅是改善症状、提高生活质量,而且针对心肌重构的机制,延缓和防止心肌重构的发展,降低心衰的住院率和死亡率。大多数患者有心脏病病史,针对病因治疗将显著改善心衰预后。冠心病、高血压和老年性退行性心瓣膜病是老年心衰患者的主要病因,风湿性心瓣膜病、扩张型心肌病、急性重症心肌炎等病是年轻者心衰的主要原因。收缩性心衰常见病因为冠心病,积极重建血运可防止心衰的发展和恶化;舒张性(或射血分数正常)心衰常见病因为高血压,控制血压极其重要,否则心衰进展迅速,也可诱发急性心衰。
目前西医对慢性心衰的治疗已从利尿、强心、扩血管等短期血流动力学/药理学措施,转为以神经内分泌抑制剂为主的长期的、修复性的策略,目的是改变衰竭心脏的生物学性质。但治疗效果都不是很理想,且有些方法的副作用很大,未能改善患者生存质量。
心衰在中医临床中属“心悸”、“怔忡”、“水肿”、“喘咳”、“痰饮”的范畴。中医学认为心衰初起病多在心肺两脏,病久则累及脾肾。其根本原因在于体虚,尤其与心脾肾阳虚有关。常由于感觉外邪、劳倦过甚、情志所伤、妊娠分娩而诱发。中医药在治疗慢性心力衰竭的方面有诸如副作用较少、疗效持久等优点。
发明内容
本发明的目的是提供一种中药制剂,该中药制剂对于治疗慢性心力衰竭具有治疗效果好,不易复发,价格低廉,治愈时间短,服用方便的特点。
本发明的另一目的是提供该治疗慢性心力衰竭的中药制剂的制备方法。
发明人在多年的临床医疗实践中,观察到慢性心力衰竭给患者带来的痛苦,根据该病症的发展规律,以及中药的配伍原则,并通过大量的临床验证,反复探索总结出一种治疗慢性心力衰竭的中药制剂的新配方,本发明选择生晒参、麦冬、五味子、干姜、制附子、桂枝、炙甘草、煅龙骨、煅牡蛎、紫贝齿、川芎、醋延胡索、郁金、当归、炙黄芪、红景天、赤灵芝、三七、龙眼肉、升麻、瓜蒌、薤白、丹参、赤芍、益母草进行组合,将这些药物组合使得各药物功效产生协同作用,使之具有补气回阳、温中散寒、活血祛瘀、养血安神的功效,从而能够有效治疗慢性心力衰竭。另外本发明中创造性的采用独特的治法治则,不仅仅是温阳利水的治疗方法,还注重温中散寒、活血祛瘀、养血安神的疗效,药物之间相互配合,加快药物到达病灶,促进患者的恢复。
本发明中药物的作用:
其中:
生晒参:为五加科植物人参Panax ginseng C. A. Mey的干燥根。性味平、甘、微苦,微温。栽培者为“园参”,野生者为“山参”。多于秋季采挖,洗净;园参经晒干或烘干,称“生晒参”。归脾、肺、心经。功效:大补元气,复脉固脱,补脾益肺,生津止渴,安神益智。人参能调节中枢神经系统兴奋过程和抑制过程的平衡。本品能补气安神,益智,与茯苓同用可用于脾肺气虚证。
麦冬:为百合科植物麦冬(沿阶草)Ophiopogon japonicus (Thunb.)Ker-Gawl.的干燥块根。性味:甘、微苦、微寒。归心、肺、胃经。功效:益胃生津、润肺养阴、清心除烦。麦冬可以养阴清心,除烦安神。用治温热病热入心营、身热夜甚。
五味子:为木兰科植物五味子Schisandra chinensis (Turcz.)Baill.或华中五味子Schisandra sphenanthera Rehd. et Wils.的干燥成熟果实。性味:温、酸、甘。归肺、心、肾经。功能:收敛固涩,益气生津,补肾宁心。用于久嗽虚喘,梦遗滑精,遗尿尿频,久泻不止,自汗,盗汗,津伤口渴,短气脉虚,内热消渴,心悸失眠。
干姜:为姜科植物姜Zingiber officinale Rosc.的干燥根茎。性味:辛、热。归脾、胃、心、肺经。功效:温中散寒,回阳通脉,燥湿消痰,温肺化饮。用于脘腹冷痛,呕吐泄泻,肢冷脉微,痰饮喘咳。干姜外用治疗外伤化脓性感染。本品辛热燥烈、主入脾胃经,长于温暖中焦脾阳而散寒,故凡中焦寒证,无论外寒内侵之实寒证,还是阳气不足之虚寒证,均为要药。
制附子:为毛茛科植物乌头 Aconitum carmichaeli Debx. 的子根的加工品。性味:辛、甘,大热;有毒。归心、肾、脾经。功效:回阳救逆,补火助阳,散寒止痛。用于亡阳虚脱,肢冷脉微,阳萎,宫冷,心腹冷痛,虚寒吐泻,阴寒水肿,阳虚外感,寒湿痹痛。本品辛热燥烈,走而不守,能通行十二经,既能追复散失之亡阳,又能资助不足之元阳,与补益药同用,可治一身上下阳气衰微、阴寒内盛之证,能上助心阳以通脉,中温脾阳以健运,下温肾阳以益火。
桂枝:为樟科植物肉桂 Cinnamomum cassia Presl的干燥嫩枝。性味:辛、甘,温。归心、肺、膀胱经。功效:发汗解肌,温通经脉,助阳化气,平冲降气。桂枝性温,善通阳气,能化阴寒,温通经络,用于寒凝血滞诸痛证。桂枝常用于治疗痰饮、蓄水证,水为阴邪,得阳始化,桂枝入膀胱经,能温阳化气,以行水湿痰饮之邪,用治脾阳不运之痰饮证,常与茯苓、白术等同用。桂枝性温,善通阳气,能化阴寒,对阴寒遏阻阳气,津液不能输布,因而水湿停滞形成痰饮的病症。本品能温通经脉、散寒止痛,用于寒凝血滞等诸痛证。
炙甘草:为豆科植物甘草 Glycyrrhiza uralensis Fisch.,胀果甘草Glycyrrhiza Inflata Bat.或光果甘草Glycyrrhiza Glabra L.的干燥根及根茎。炙甘草为甘草的蜜烘制加工品。性味:甘,平。归心、肺、脾、胃经。功效:补脾和胃,益气复脉。《日华子本草》:安魂定魄。补五劳七伤,一切虚损、惊悸、烦闷、健忘。通九窍,利百脉,益精养气,壮筋骨,解冷热。
煅龙骨:龙骨为古代哺乳动物如象类、犀牛类、三趾马等的骨骼化石。煅龙骨是将刷净的龙骨,放坩锅内或其它容器中煅至红透,取出晾凉,碾碎得到。性味:甘、涩,平。入心、肝、肾、大肠经。功效:镇惊安神,敛汗固精,止血涩肠,生肌敛疮。治惊痫癫狂,怔忡健忘,失眠多梦,自汗盗汗,遗精淋浊,吐衄便血,崩漏带下,泻痢脱肛,溃疡久不收口。龙骨质重,有很好的镇惊安神的作用,可用治各种神志不安,失眠多梦,耳鸣等。
煅牡蛎:牡蛎为牡蛎科动物长牡蛎Ostrea gigas Thunberg、大连湾牡蛎Ostreatalienwhanensis Grosse或近江牡蛎Ostrea rivularis Gould等的贝壳。煅牡蛎是取净牡蛎,照明煅法煅至酥脆,性味:咸、微寒。归肝、胆、肾经。功效:平肝潜阳、软坚散结、收敛固涩。煅牡蛎收敛固涩。用于自汗盗汗,遗精崩带,胃痛吞酸。牡蛎煅制之后常与龙骨同用。
紫贝齿:为宝贝科动物蛇首眼球贝Erosaria (Ravitrona) caputserpentis(L.)、山猫宝贝Cypraca (Lyncina) lynx (L.)、绶贝Mauritia arabica (L.)或眼球贝(拟名)Erosaria (Ravitrona) helvola (L.)的贝壳入药。性味:咸,平。归脾、肝经。功效:清心安神,平肝明目。用于惊悸心烦不眠,小儿斑疹,目赤云翳。
川芎:为伞形科植物川芎Ligusticum chuanxiong Hort.的干燥根茎。性味:辛,温。归肝、胆、心经。功效:活血行气,祛风止痛。本品辛散温通,能上行巅顶,下达血海,外彻皮毛,旁通四肢,既能活血又能行气,昔人谓川芎为血中之气药,殆言其寓辛散、解郁、通达、止痛等功能。川芎有明显的镇静作用。抗菌作用等体外试验:川芎对大肠、痢疾(宋内氏)、变形、绿脓、伤寒、副伤寒杆菌及霍乱弧菌等有抑制作用。川芎水浸剂(1:3)在试管内对某些致病性皮肤真菌也有抑制作用。若心脉瘀阻,胸痹心痛,则常与桂枝、丹参等同用。本品含有川芎嗪能抑制血管平滑肌收缩,扩张冠状动脉,增加冠脉血流量,改善心肌缺氧状况及肠系膜微循环,增加脑及肢体血流量,降低外周血管阻力,还能抑制血小板聚集,可预防血栓的形成,对心脑血管疾病有很好的疗效。
醋延胡索:为罂粟科植物延胡索Corydalis yanhusuo W. T. Wang 的干燥块茎。性味:辛、苦、温。归肝、脾经。功效:活血,利气,止痛。用于胸胁、脘腹疼痛,经闭痛经,产后瘀阻,跌扑肿痛。本品辛散温通,能行血中气滞,气中血滞,活血行气止痛,善治血瘀气滞所致的多种疼痛,其止痛作用优良。《本草求真》中记载:“延胡索,不论是血是气,积而不散者,服此力能通达,以其性温,则于气血能行能畅,味辛则于气血能润能散,所以理一身上下诸痛,往往独行功多”。
郁金:为姜科植物温郁金Curcuma wenyujin Y. H. Chen et C. Ling、姜黄Curcuma longa L.、广西莪术Curcuma kwangsiensis S. G. Lee et C. F. Liang或蓬莪术Curcuma phaeocaulis Val.的干燥块根。性味:辛、苦,寒。归肝、心、肺经。功效:行气化瘀,清心解郁,利胆退黄,凉血破瘀。主治:胸腹胁肋诸痛,失心癫狂,热病神昏,吐血,衄血,尿血,血淋,妇女倒经,黄疸。本品辛散苦泄,性寒清热,能清心解郁开窍。郁金辛开苦降,芳香宣达,性寒又能清热。既入气分以行气解郁,又入血分以凉血祛瘀,为血中之气药,用于治疗气血郁滞的胸痛。
当归:为伞形科植物当归 Angelica sinensis (Oliv.) Diels 的干燥根。性味:甘、辛、苦,温。归肝、心、脾经。功效:补血;活血;调经止痛;润燥滑肠。当归对中枢神经系统有抑制作用,挥发油有镇静、催眠、镇痛、麻醉等作用。用于血虚萎黄、眩晕心悸、虚寒腹痛、风湿痹痛、跌扑损伤、痈疽疮疡。据《本草正》载:“其味甘而重,故专能补血,其气轻而辛,故又能行血,能养营养血,补气生精,安五脏,强形体,益神志,凡有形虚损之病,无所不宜”。
炙黄芪:为豆科植物蒙古黄芪 Astragalus membranaceus (Fisch.) Bge. var.mongholicus (Bge.)Hsiao 或膜荚黄芪 Astragalus membranaceus (Fisch.) Bge.的干燥根。性味:甘,微温。归肺、脾、肝、肾经。功效:补气升阳、固表敛汗、利水消肿、托疮排脓、通调水道。本品在体外对志贺氏痢疾杆菌、炭疽杆菌、甲型溶血性链球菌、乙型溶血性链球菌、白喉杆菌、假白喉杆菌、肺炎双球菌、金黄色葡萄球菌、柠檬色葡萄球菌、枯草杆菌等均有抑制作用。黄芪擅长补中益气,为补气升阳的要药,并且补气利尿,以消肿。
红景天:为景天科红景天属植物红景天Rhodiola saera (Prain) Fu,以全草入药。性味:甘、涩,寒。功效:补气清肺;益智养心;收涩止血;散瘀消肿。主气虚体弱;病后畏寒;气短乏力;肺热咳嗽;咯血;白带腹泻;跌打损伤;烫火伤;神经症;高原反应。
赤灵芝:为多孔菌科真菌赤芝Ganoderma lucidum(Leyss.ex Fr.)Karst.或紫芝Ganoderma sinense Zhao,Xu et Zhang的干燥子实体。性味:甘,平。归心、肺、肝、肾经。功效:补气安神,止咳平喘。用于眩晕不眠,心悸气短,虚劳咳喘。时珍尝疑:芝乃腐朽余气所生,正如人生瘤赘,而古今皆以为瑞草,又云服食可仙,诚为迂谬。近读成式之言,始知先得我所欲言,其揆一也。又方士以木积湿处,用药傅之,即生五色芝。嘉靖中王金尝生以献世宗。此昔人所未言者,不可不知。
三七:为五加科植物三七Panax notoginseng (Burk.)F. H. Chen的干燥根。取三七,洗净,干燥,碾细粉。性味:甘、微苦、温。归肝、胃经。功效:散瘀止血,消肿定痛。用于咯血,吐血,衄血,便血,崩漏,外伤出血,胸腹剌痛,跌扑肿痛。《本草求真》中记载:“三七,世人仅知功能止血住痛,殊不知痛因血瘀则疼作,血因敷散则血止。三七气味苦温,能于血分化其血瘀”。
龙眼肉:为无患子科龙眼属植物龙眼Dimocarpus longan Lour.的假种皮。性味:甘,温。归心、脾经。功效:补益心脾,养血安神。用于气血不足,心悸怔忡,健忘失眠,血虚萎黄。《纲目》:食品以荔枝为贵,而资益则龙眼为良,盖荔枝性热,而龙眼性和平也。严用和《济生方》治思虑劳伤心脾有归脾汤,取甘味归脾,能益人智之义。
升麻:为毛茛科植物大三叶升麻Cimicifuga heracleifolia Kom. 、兴安升麻Cimicifuga dahurica (Turcz.) Maxim . 或升麻 Cimicifuga foetida L. 的干燥根茎。性味辛、微甘,微寒。归肺、脾、胃、大肠经。功效:发表透疹,清热解毒,升举阳气。抗菌作用:在试管内升麻能抑制结核杆菌的生长.其变种绿叶升麻 Cimicifuga foetida L. var.simplex Huth.的水浸剂(1:4)在试管内对许兰黄癣菌、奥杜盎小芽胞癣菌、铁锈色小芽胞癣菌、红色表皮癣菌等皮肤真菌均有不同程度的抑制作用.有报告指出,升麻对金黄色葡萄球菌、炭疽杆菌有较强的抑制作用;对乙型链球菌、白喉杆菌、伤寒杆菌、绿脓杆菌、大肠杆菌、痢疾杆菌亦有不同程度的抑制作用。
瓜蒌:为葫芦科植物栝楼 Trichosanthes kirilowii Maxim. 或双边栝楼Trichosanthes rosthornii Harms 的干燥成熟种子。性味:甘、苦,寒。入肺、胃、大肠经。功效:润肺化痰,利气宽胸,散结,润肠。
薤白:为百合科植物小根蒜Allium macrostemon Bge.或薤Allium chinensis G.Don的干燥鳞茎。性味:辛、苦,温。归肺、胃、大肠经。功效:通阳散结,行气导滞。用于胸痹疼痛,痰饮咳喘,泄痢后重。药理学研究表明,有宽胸行气止痛作用,适用于冠心病之胸闷不舒或心绞痛,老年人慢性肠炎、菌痢。
丹参:为双子叶植物唇形科Labiatae鼠尾草属植物丹参Salvia /miltiorrhizaBge的干燥根及根茎。性味:苦,微寒。归经:入心、肝经。功效:活血调经,祛瘀止痛,凉血消痈,清心除烦,养血安神。用于胸肋胁痛,风湿痹痛,症瘕结块。《日华子本草》:养神定志,通利关脉。治冷热劳,骨节疼痛,四肢不遂;排脓止痛,生肌长肉;破宿血,补新生血;安生胎,落死胎;止血崩带下,调妇人经脉不匀,血邪心烦;恶疮疥癣,瘿赘肿毒,丹毒;头痛,赤眼,热温狂闷。丹参制剂中含有隐丹参酮、二氢丹参酮,对体外的葡萄球菌、大肠杆菌、变性杆菌有抑制作用。丹参能活血祛瘀,对消除肝脏纤维结缔组织的增生,也可能有一定的作用。近代医学实验证明,丹参还具有抗血小板凝聚、降低血液黏度及调节内外凝血系统的功能,是一种安全又可靠的治疗血栓疾病的天然中药。
赤芍:为毛茛科植物芍药 Paeonia lactiflora Pall. 或川赤芍 Paeoniaveitchii Lynch 的干燥根。性味:苦,微寒。归肝经。功效:散瘀止痛,清热凉血,消肿。用于温毒发斑,吐血衄血,目赤肿痛,肝郁胁痛,经闭痛经,症瘕腹痛,跌扑损伤,痈肿疮疡。本品苦降,有活血通经、散瘀消癓、行滞止痛的功效。用于温热病热入血分,本品苦寒,主入肝经,善走血分,能清肝火,除血分郁热而有凉血、止血、散瘀消斑之功。
益母草:为唇形科一年生或两年生草本植物益母草Leonurus heterophyllusSweet. 的全草。性味:苦、辛,微寒。归肝、心包经。功效:活血调经,利水消肿。用于月经不调,痛经,经闭,恶露不尽,水肿尿少;急性肾炎水肿。本品苦泄辛散,主入血分,善于活血祛瘀调经,痿妇科经产要药。可以有效推迟女性闭经年龄。
本发明的方解是:方中生晒参补益元气、补脾益肺,麦冬润肺养阴、清心除烦,五味子益气生津、补肾宁心,干姜温中散寒、回阳通脉,制附子回阳救逆、散寒止痛,以上五味共为君药,君药注重补气回阳、温中散寒,具有很好的强心和改善心肌代谢的作用,增强患者体质,进而加快患者的康复,桂枝温通经脉、助阳化气,炙甘草补脾和胃、益气复脉,煅龙骨镇惊安神、敛汗固精,煅牡蛎平肝潜阳、软坚散结,紫贝齿清心安神,川芎、醋延胡索活血行气,郁金行气化瘀、清心解郁,当归补血活血,以上九味共为臣药,臣药不仅可以增强君药通经活络、活血行气的疗效,还具有温补肝肾、清热燥湿、软坚散结的效果,并且多味药还具有扩张血管,清理血管垃圾的功效,使得血液流畅,进而达到治疗的目的。炙黄芪补气升阳、利水消肿,红景天补气清肺、益智养心,赤灵芝补气安神、止咳平喘,三七散瘀止血、消肿定痛,龙眼肉补益心脾、养血安神,升麻清热解毒,瓜蒌理气散结,薤白通阳散结,丹参祛瘀止痛、养血安神,赤芍散瘀止痛、清热凉血,益母草活血调经,以上几味共为佐药,调理患者的身体,加强药物疗效,增强活血调经、散瘀止痛的效果,减少血液循环障碍,促进患者恢复。此方诸药合用,君臣协力,佐使共辅,具有补气回阳、温中散寒、活血祛瘀、养血安神的功效,能够有效治疗慢性心力衰竭。
本发明药物原料用量是经发明人进行大量摸索总结得出的,各原料用量为在下述重量份范围都具有较好的疗效:生晒参5-15份、麦冬10-20份、五味子7-17份、干姜10-20份、制附子7-17份、桂枝13-23份、炙甘草15-25份、煅龙骨19-29份、煅牡蛎19-29份、紫贝齿19-29份、川芎7-17份、醋延胡索15-25份、郁金7-17份、当归10-20份、炙黄芪25-35份、红景天15-25份、赤灵芝7-17份、三七4-14份、龙眼肉4-14份、升麻10-20份、瓜蒌15-25份、薤白10-20份、丹参19-29份、赤芍10-20份、益母草10-20份。
其中优选为:生晒参10份、麦冬15份、五味子12份、干姜15份、制附子12份、桂枝18份、炙甘草20份、煅龙骨24份、煅牡蛎24份、紫贝齿24份、川芎12份、醋延胡索20份、郁金12份、当归15份、炙黄芪30份、红景天20份、赤灵芝12份、三七9份、龙眼肉9份、升麻15份、瓜蒌20份、薤白15份、丹参24份、赤芍15份、益母草15份。
本发明药物可以采用中药制剂的常规制备工艺,可制成任何一种药剂学上所说的剂型,如丸剂、散剂、片剂、胶囊剂、颗粒剂、糖浆剂、口服液等。例如可以将这些原料药研成粉末状混合均匀制成散剂冲服;可以用水煎,经过滤得滤液,加入防腐剂制成口服液;必要时也可以直接服用汤剂。
本发明的一个重要特点是在中药制剂中含有丰富的营养成份和维生素,其中维生素B1和维生素C的0.1%-0.5%,远远超过蔬菜水果中维生素的含量,维生素B1和维生素C可以保护心肌,维持心肌的正常工作,可以促进患者的恢复,并且本中药制剂中蛋白质和热能的含量有所控制,两者含量都在5%以下,如果蛋白质含量过高会影响心衰的恢复,控制蛋白质和能量的摄入可以减轻患者的心脏负荷,促进患者好转,另外还含有多种氨基酸,特别是牛磺酸、乙酰半胱氨酸和组氨酸的作用最强,牛磺酸可以保护细胞膜的稳定性,预防心肌缺血,并且还具有双向调节钙离子的作用,进而起到保护心肌的作用,而乙酰半胱氨酸可以减少心肌梗塞以及心律失常,此外还可以加强其它抗心衰药物扩张外周血管和冠状动脉,抑制血小板聚集的作用,组氨酸还可以明显改善脑缺血所致的心功能障碍。本发明中各氨基酸组分含量见下表:
另外本发明中还有多种微量元素,例如钾、镁、钙、铁、锌等微量元素,这些微量元素是可以促进多种酶的合成,加快患者的恢复。钾元素有保护心脏的作用,可以缓解心律不齐,适当的增加钙量,也有利于增强心肌的功效,维持正常的心肌活动,为减轻水肿,药物中的钠含量很好,可以更好的控制心衰,本发明中各微量元素含量如下:
本发明的另一重要特点是含有丰富的水溶性纤维素,可以促进血液循环,减少胃肠胃淤血和红肿,以加快心脏病人的恢复。
本发明优选的制备方法是汤剂,其制备方法如下:
步骤一:按本发明重量配比,称取五味子、龙眼肉、瓜蒌用纱布包成药包,放于水中浸泡45分钟,过滤,备用;
步骤二:按本发明重量配比,称取煅龙骨、煅牡蛎、紫贝齿进行适当粉碎,然后在砂锅中加入步骤一中的冷水中,超过药面3~4厘米,用武火煎沸后,再用文火煎煮20~30分钟,然后加入生晒参、麦冬、干姜、郁金、升麻、丹参、赤芍继续煎煮20~30分钟,过滤,得滤液,在剩余药渣中加入3~5厘米的水,加入川芎、当归、薤白以及步骤一中的药包继续煎煮20分钟,最后加入桂枝、炙甘草、红景天、益母草煎煮10分钟,过滤,弃渣,备用;
步骤三:按本发明重量配比,称取制附子、醋延胡索、炙黄芪、赤灵芝、三七干燥,研磨粉碎至180目筛,备用;
步骤四:将步骤二中的两次滤液合并,趁热加入步骤三中的粉末,搅拌均匀,既得本发明所述治疗慢性心力衰竭的汤剂。
本发明药物具有补气回阳、温中散寒、活血祛瘀、养血安神等功效,且治疗效果好,不易复发,价格低廉,治愈时间短,服用方便,据对临床250例患者观察统计,使用本发明药物一个疗程总有效率90%,两个疗程总有效率96%。
具体实施方式
实施例一、生晒参5份、麦冬10份、五味子7份、干姜10份、制附子7份、桂枝13份、炙甘草15份、煅龙骨19份、煅牡蛎19份、紫贝齿19份、川芎7份、醋延胡索15份、郁金7份、当归10份、炙黄芪25份、红景天15份、赤灵芝7份、三七4份、龙眼肉4份、升麻10份、瓜蒌15份、薤白10份、丹参19份、赤芍10份、益母草10份。
步骤一:按本发明重量配比,称取五味子、龙眼肉、瓜蒌用纱布包成药包,放于水中浸泡45分钟,过滤,备用;
步骤二:按本发明重量配比,称取煅龙骨、煅牡蛎、紫贝齿进行适当粉碎,然后在砂锅中加入步骤一中的冷水中,超过药面3~4厘米,用武火煎沸后,再用文火煎煮20~30分钟,然后加入生晒参、麦冬、干姜、郁金、升麻、丹参、赤芍继续煎煮20~30分钟,过滤,得滤液,在剩余药渣中加入3~5厘米的水,加入川芎、当归、薤白以及步骤一中的药包继续煎煮20分钟,最后加入桂枝、炙甘草、红景天、益母草煎煮10分钟,过滤,弃渣,备用;
步骤三:按本发明重量配比,称取制附子、醋延胡索、炙黄芪、赤灵芝、三七干燥,研磨粉碎至180目筛,备用;
步骤四:将步骤二中的两次滤液合并,趁热加入步骤三中的粉末,搅拌均匀,既得本发明所述治疗慢性心力衰竭的汤剂。
实施例二、生晒参10份、麦冬15份、五味子12份、干姜15份、制附子12份、桂枝18份、炙甘草20份、煅龙骨24份、煅牡蛎24份、紫贝齿24份、川芎12份、醋延胡索20份、郁金12份、当归15份、炙黄芪30份、红景天20份、赤灵芝12份、三七9份、龙眼肉9份、升麻15份、瓜蒌20份、薤白15份、丹参24份、赤芍15份、益母草15份。
制备和使用方法同实施例一。
实施例三、生晒参15份、麦冬20份、五味子17份、干姜20份、制附子17份、桂枝23份、炙甘草25份、煅龙骨29份、煅牡蛎29份、紫贝齿29份、川芎17份、醋延胡索25份、郁金17份、当归20份、炙黄芪35份、红景天25份、赤灵芝17份、三七14份、龙眼肉14份、升麻20份、瓜蒌25份、薤白20份、丹参29份、赤芍20份、益母草20份。
制备和使用方法同实施例一。
下面是患者使用本发明药物的临床统计资料:
一、一般资料
收治门诊患者1000例,将患者随机分为观察组和对照组,其中男性520例,女性480例,男女比例1.08:1,平均年龄65岁,两组患者年龄、性别、病程等各项基本资料基本相同,差异无统计学意义(P>0.05)。
二、诊断依据
1、符合冠心病,高血压性心脏病,左心衰的诊断标准及中医辨证者。
2、心功能分级II-III级。
3、符合中医气阴两虚血瘀水停的征候。参照《中药新药临床研究指导原则》关于心力衰竭的临床研究的指导原则中,中药新药治疗气虚血瘀中医辩证标准。
三、治疗方法
1、观察组按照本发明药物实施例二,以及优选的制备方法制备的汤剂,每日一剂,分两次服用,15天为一个疗程。
2、将对照组分为对照1组、对照2组和对照3组,对照1组按照西药中常规治疗慢性心力衰竭的方法,15天为一个周期;对照2组采用和本发明药方相同但是重量配比低于本发明最小数值进行治疗,(即:对照2组的配方为:生晒参2份、麦冬5份、五味子3份、干姜5份、制附子3份、桂枝6份、炙甘草7份、煅龙骨9份、煅牡蛎9份、紫贝齿9份、川芎3份、醋延胡索7份、郁金3份、当归5份、炙黄芪12份、红景天7份、赤灵芝3份、三七2份、龙眼肉2份、升麻5份、瓜蒌7份、薤白5份、丹参9份、赤芍5份、益母草5份。)对照3组采用和本发明药方相同但是重量配比高于本发明最大数值进行治疗(即:对照3组的配方为:生晒参20份、麦冬25份、五味子22份、干姜25份、制附子22份、桂枝28份、炙甘草30份、煅龙骨34份、煅牡蛎34份、紫贝齿34份、川芎22份、醋延胡索30份、郁金22份、当归25份、炙黄芪40份、红景天30份、赤灵芝22份、三七19份、龙眼肉19份、升麻25份、瓜蒌30份、薤白25份、丹参34份、赤芍25份、益母草25份。)。
四、疗效评定标准
疗效评定参照《中药新药研究指导原则》:
显效:心功能提高2个级别以上,但未达到Ⅰ级标准;
有效:心功能提高1个级别,但未达到Ⅰ级状态;
无效:心功能提高不足1个级别及慢性心衰症状未能控制。
五、疗效统计
观察组结果统计
对照1组结果统计
其中:总有效率=治愈率+好转率
使用两个疗程后观察组和对照1组患者的疗效对比情况
通过对比两组患者的治疗总有效率可以发现观察组明显高于对照1组。
对照2组统计结果
通过对观察组和对照2组进行对比,发现将药物的重量分数减少,药物的作用效果明显降低,不利于患者的恢复。
对照3组统计结果
通过对观察组和对照3组进行对比,发现在增加了药物重量分数的情况下,一个疗程的作用效果差不多,但是两个疗程后作用效果甚至还要低于观察组,这就说明药物的用量并不是越多越好,药物用量增多不仅会造成药物的浪费,还会引起药物之间的相互作用,给患者带来副作用,甚至影响药物的治疗效果,不利于患者的恢复。
综上所述,本发明中药在治疗慢性心力衰竭具有良好的临床效果,能有效提高治疗的治愈率,值得在临床应用上推广。
典型病例及疗效:
病例一、王某,男,53岁,患者反复出现咳嗽、并伴有心悸乏力等症状,患者去医院检查,面色青紫,体温36.8℃,端坐呼吸,颈静脉明显怒张,心率齐,102次/分钟,两下肺有细小湿性啰音,肝于肋下二指可触及。心电图显示窦性心律;心脏扩大。舌黯淡,苔白, 脉沉细。诊断为:慢性心力衰竭,患者希望采用中药的治疗方法进行调理,采用本发明实施例二中所制制剂,以及所优选选的制备方法,服用两个疗程后,胸闷、心悸的现象有所好转,由于本病是一种慢性疾病,患者又坚持服用了三个多疗程,身体状况明显恢复,患者去医院复查,各种检查均正常,痊愈。
病例二、林某,女,64岁,患者半年前开始咳嗽气喘,近一周咯血痰,至医院检查。查体:端坐呼吸,神态疲倦,颈静脉怒张,心界向左稍扩大心率100次/分,律齐。X线胸部摄片:右心室段显著延长膨隆。舌黯红,苔薄,脉结代。诊断为:慢性心力衰竭。采用本发明实施例二中所制制剂,以及所优选选的制备方法,服用两个疗程后, 患者不再咯血痰;三个疗程后,咳嗽气喘症状消失,去医院检查,各项指标均正常,患者基本好转。
Claims (4)
1.一种治疗慢性心力衰竭的中药制剂,其特征在于,该中药制剂是由以下重量份的药物组成:生晒参5-15份、麦冬10-20份、五味子7-17份、干姜10-20份、制附子7-17份、桂枝13-23份、炙甘草15-25份、煅龙骨19-29份、煅牡蛎19-29份、紫贝齿19-29份、川芎7-17份、醋延胡索15-25份、郁金7-17份、当归10-20份、炙黄芪25-35份、红景天15-25份、赤灵芝7-17份、三七4-14份、龙眼肉4-14份、升麻10-20份、瓜蒌15-25份、薤白10-20份、丹参19-29份、赤芍10-20份、益母草10-20份。
2.根据权利要求书1所述的治疗慢性心力衰竭的中药制剂,其特征在于,由以下重量份的药物组成:生晒参10份、麦冬15份、五味子12份、干姜15份、制附子12份、桂枝18份、炙甘草20份、煅龙骨24份、煅牡蛎24份、紫贝齿24份、川芎12份、醋延胡索20份、郁金12份、当归15份、炙黄芪30份、红景天20份、赤灵芝12份、三七9份、龙眼肉9份、升麻15份、瓜蒌20份、薤白15份、丹参24份、赤芍15份、益母草15份。
3.根据权利要求1或2所述的治疗慢性心力衰竭的中药制剂,其特征在于:所述中药制剂为汤剂。
4.一种治疗慢性心力衰竭的中药制剂的制备方法,其特征在于,制备方法如下:步骤一:按本发明重量配比,称取五味子、龙眼肉、瓜蒌用纱布包成药包,放于水中浸泡45分钟,过滤,备用;步骤二:按本发明重量配比,称取煅龙骨、煅牡蛎、紫贝齿进行适当粉碎,然后在砂锅中加入步骤一中的冷水中,超过药面3~4厘米,用武火煎沸后,再用文火煎煮20~30分钟,然后加入生晒参、麦冬、干姜、郁金、升麻、丹参、赤芍继续煎煮20~30分钟,过滤,得滤液,在剩余药渣中加入3~5厘米的水,加入川芎、当归、薤白以及步骤一中的药包继续煎煮20分钟,最后加入桂枝、炙甘草、红景天、益母草煎煮10分钟,过滤,弃渣,备用;步骤三:按本发明重量配比,称取制附子、醋延胡索、炙黄芪、赤灵芝、三七干燥,研磨粉碎至180目筛,备用;步骤四:将步骤二中的两次滤液合并,趁热加入步骤三中的粉末,搅拌均匀,既得本发明所述治疗慢性心力衰竭的汤剂。
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