CN104288424A - 一种治疗介入术后深静脉血栓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介入术后深静脉血栓的中药制剂,它是由丹参、炒桃仁、红花、水蛭、皂角刺、土鳖虫、川牛膝、黄芪、桂枝、白芍、川芎、香附、沉香、血竭、三七、玄参、太子参、生山楂、鸡内金、延胡索、川楝子、当归、木香按照一定的重量配比制成,具有活血化瘀,消栓通络的功效,能够有效治疗介入术后深静脉血栓。
Description
技术领域
本发明涉及一种中药制剂,具体涉及一种治疗介入术后深静脉血栓的中药制剂,本发明还涉及该中药制剂的制备方法。
背景技术
介入治疗是是利用现代高科技手段进行的一种微创性治疗--就是在医学影像设备的引导下,将特制的导管,导丝等精密器械,引入人体,对体内病态进行诊断和局部治疗。介入治疗应用数字技术,扩大了医生的视野,借助导管,导丝延长了医生的双手,它的切口(穿刺点),仅有米粒大小,不用切开人体组织,就可治疗许多过去无法治疗,必须手术治疗或内科治疗疗效欠佳的疾病,如肿瘤,血管瘤,各种出血等。介入治疗具有不开刀,创伤小,恢复快,效果好的特点。是未来医学的发展趋势。
深静脉血栓是指血液在深静脉腔内不正常的凝结,阻塞静脉管腔,导致静脉回流障碍,血栓的形成与手术中的操作、选择的方式、术后的加压包扎、病人的血液粘滞度都有很大的关系。而介入诊疗技术多采用的是穿刺、植入、插管等侵入性操作方法,手术后为避免穿刺点出血,需要严格卧床休息24小时,此时由于血流瘀滞或患者血液处于高凝状态,均易形成血栓,深静脉血栓一旦形成将会给病人造成巨大的痛苦,严重时会致残,长期慢性血栓开始表现为患肢肿胀、疼痛、乏力等症状,可后遗下肢水肿、继发性静脉曲张、皮炎、色素沉着、郁滞性溃疡等,后期因静脉瓣膜破坏导致患者肢肿胀、 淤积性皮炎、 顽固性小腿溃疡等后遗症严重影响患者生活质量。
目前,对于介入术后深静脉血栓的患者,一般会采用链激酶、尿激酶等溶栓疗法,或者是肝素等抗凝疗法,严重者甚至会再次进行手术,溶栓疗法、抗凝疗法易引起全身性溶栓效应,并引发出血,并有可能引发发热、皮疹、哮喘等并发症;手术疗法对患者的身体无疑又是一次严重的伤害,并且有一定的风险,治疗疗程长,费用高,患者不易接受,容易造成病情延误,对患者的身体造成不可恢复的损伤,同时给亲人和家庭带来沉重的精神负担和经济负担。
发明内容
本发明的目的在于提供一种治疗介入术后深静脉血栓的中药制剂,该中药制剂对于介入术后深静脉血栓具有疗效好,治愈率高,无毒副作用,服用方便,价格低廉,治愈时间短的特点。减轻了患者的痛苦,为患者及患者的家人减轻了心里负担以及经济压力。
发明人在多年的临床医疗实践中,观察到介入术后深静脉血栓的患者在治疗中的痛苦,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介入术后深静脉血栓的中药制剂的新配方,能够在较短的时间内使患者恢复正常。本发明具有疗效显著,见效快,治愈率高,无毒副作用,服用方便,价格低廉的特点。
本发明中药物的作用:
其中:
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。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。
炒桃仁:为蔷薇科植物桃Prunus persica (L.) Batsch 或山桃 Prunus davidiana (Carr.)Franch.的干燥成熟种子。性味:苦、甘,平。归心、肝、大肠经。功效:活血祛瘀,润肠通便,止咳平喘。桃仁祛瘀之力较强,又称破血药,用于治疗血瘀、癓瘕,常配红花、当归。
红花:为菊科植物红花Carthamus tinctorius L.的筒状花冠。性味温,辛。归心、肝经。功效:活血通经、散瘀止痛。红花辛散温通,专入血分,能活血祛瘀,通经调脉,常与桃仁、当归、川芎等相须为用。红花有扩张血管作用。红花黄色素可明显延长血浆复钙时间、凝血酶原时间和凝血时间。《本草衍义补遗》:红花,破留血,养血。多用则破血,少用则养血。
水蛭:为水蛭科动物蚂蟥Whitmania pigra Whitman、水蛭Hirudo nipponica Whitman或柳叶蚂蟥Whit-mania acranulata Whitman 的干燥体。性味:咸、苦、平,有小毒。归肝经。具有破血,逐瘀,通经的功效,用于癥瘕痞块,血瘀经闭,跌扑损伤。水蛭咸苦入血分,善于破血逐淤,且力峻效宏,近代临床用治血小板增多症,短时煎服,有一定的疗效,治脑出血、颅内血肿,有较好的疗效。
皂角刺:为豆科植物皂荚Gleditsia sinensis Lam. 的干燥棘刺。性味:辛,温。归肺经,肝经。功效:消肿排脓,活血祛风。中医临床用于痈疽肿毒均有较好的治疗效果,一般表现为脓未成者可消,脓已成者可使之速溃。
土鳖虫:为鳖蠊科昆虫地鳖Eupolyphaga sinensis Walker或冀地鳖Stelephaga plancyi(Boleny)的雌虫全体。性味:寒,咸;有小毒。归肝经。功效:破瘀血,续筋骨,用于治疗跌打损伤,筋伤骨折,瘀肿疼痛。本品咸寒入血,主入肝经,性善走窜,能活血消肿止痛,续筋接骨疗伤,为伤科常用药,尤多用于骨折筋伤,瘀血肿痛。
川牛膝:为苋科植物川牛膝Cyathula officinalis Kuan 的干燥根。性味:甘、微苦、平。归肝、肾经。功效:逐瘀通经,通利关节,利尿通淋。用于经闭症瘕,胞衣不下,关节痹痛,足痿筋挛,尿血血淋,跌扑损伤。川牛膝偏于活血祛瘀。
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。黄芪擅长补中益气,补气以利尿,可以消水肿。
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。《长沙药解》载:“入肝家而行血分,定经络而达荣郁。善解风邪,最调木气。升清阳之脱陷,降浊阴之冲逆,舒筋脉之急挛;利关节之壅阻,散遏抑,止痛楚,通经络,开痹涩,甚去湿寒。止奔豚,更安惊悸。” 现代医学研究证实,桂枝能有效扩张血管、促进发汗,所含的桂皮醛、桂皮酸钠有解热、镇痛、镇静、抗惊厥作用,此外桂枝还有抗菌、抗病毒的功效。
白芍:为双子叶植物毛茛科植物芍药Paeonia lactiflora Pall. 的干燥根。性味:凉,苦酸,微寒。功效:补血柔肝、平肝止痛,敛阴收汗。研究表明:白芍中含有的芍药甙有抗菌、解热、抗炎、增加冠状动脉流量、改善心肌营养血流、扩张血管、对抗急性心肌缺血、抑制血小板聚集、镇静、镇痛、解痉、抗溃疡、调节血糖的作用。
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。
香附:为莎草科植物莎草Cyperus rotundus L. 的干燥根茎。性味:辛、微苦、微甘,平。归肝、脾、三焦经。功效:行气解郁,调经止痛,安胎,理气舒郁,调和肝胃。香附还可以调和诸药,起到使药的作用。香附和沉香配伍则升降诸气。
沉香:为瑞香科植物白木香Aquilaria sinensis (Lour.) Gilg 含有树脂的木材。性味:辛、苦,微温。归脾、胃、肾经。功效:行气止痛,温中止呕,纳气平喘。用于胸腹胀闷疼痛,胃寒呕吐呃逆,肾虚气逆喘急。《药品化义》:“沉香,纯阳而升,体重而沉,味辛走散,气雄横行,故有通天彻地之功,治胸背四肢诸痈及皮肤作痒。且香能温养脏腑,保和卫气。若寒湿滞于下部,以此佐舒经药,善驱逐邪气;若跌扑损伤,以此佐和血药,能散瘀定痛;若怪异诸病,以此佐攻痰药,能降气安神。总之,疏通经络,血随气行,痰随气转,凡属痛痒,无不悉愈”。
血竭:为棕榈科植物麒麟竭Daemonorops draco Blume.果实渗出的树脂经加工制成。性味:甘、咸,平。归心、肝经。功效:祛瘀定痛,止血生肌。用于跌扑折损,内伤瘀痛;外伤出血不止。《纲目》中记载:骐驎竭,木之脂液,如人之膏血,其味甘咸而走血,盖手足厥阴药也。肝与心包皆主血故尔。河间刘氏云,血竭除血痛,为和血之圣药是矣。乳香、没药,虽主血病,而兼入气分,此则专于血分者也。
三七:为五加科植物三七Panax notoginseng (Burk.)F. H. Chen的干燥根。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”。
玄参:为玄参科植物玄参 Scrophularia ningpoensis Hemsl.的干燥根。性味甘、苦、咸,微寒。归肺、胃、肾经。功效:清热凉血,泻火解毒,滋阴。有轻微的降血糖作用。用于:温热病热入营血,热病伤阴之证。有清热凉血,解毒滋阴的功效。
太子参:为石竹科太子参属(Pseudostellaria)植物太子参的干燥根。性味:甘,微苦,微温。归肺、脾经。功效:补益脾肺,益气生津。治肺虚咳嗽,脾虚食少,心悸,怔忡,水肿,消渴,精神疲乏。
生山楂:为蔷薇科植物山里红Crataegus pinnatifida Bge.var.major N.E.Br.或山楂Crataegus pinnatifida Bge.的干燥成熟果实。性味:酸、甘、微温。归脾、胃、肝经。功效:消食健胃,行气散瘀。
鸡内金:为雉科动物家鸡Gallus gallus domesticus Brisson的干燥沙囊内壁。性味:甘,平。归脾、胃、小肠、膀胱经。功效:健胃消食,涩精止遗。用于食积不消,呕吐泻痢,小儿疳积,遗尿,遗精。《本草经疏》:肫是鸡之脾,乃消化水谷之所。其气通达大肠、膀胱二经。有热则泄痢遗溺,得微寒之气则热除,而泄痢遗溺自愈矣。烦因热而生,热去故烦自止也。今世又以之治诸疳疮多效。
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。本品辛温通散,能行血中气滞,气中血滞,活血行气止痛。
川楝子:为楝科植物川楝Melia toosendan Sieb. et Zucc.的干燥成熟果实。性味:苦,寒;有小毒。归肝、小肠、膀胱经。功效:舒肝行气止痛,驱虫。用于胸胁、脘腹胀痛,疝痛,虫积腹痛。
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。当归能活血消肿止痛,又能补血生肌,故为外科多常用,常与红花等同用。
木香:为菊科植物木香Aucklandia lappa Decne. 的干燥根。性味:辛、苦,温。归脾、胃、大肠、三焦、胆经。功效:行气止痛,健脾消食。
本发明的方解是:方中重用丹参不仅活血祛瘀,消栓通络消除患者病灶,而且清心除烦,养血安神从根本上调养身体,为君药之首,炒桃仁、红花配伍活血祛瘀,水蛭、皂角刺、土鳖虫活血通经,消肿排脓以上六味为此方中的君药,川牛膝、、桂枝助君药消栓通络,温通经脉。黄芪、白芍、川芎助君药利水消肿、补血柔肝、活血行气,香附、沉香舒肝理郁,行气中通,有助有血液流动,以上七味为此访中臣药。血竭、三七散瘀止痛、玄参、太子参补益健脾、清热凉血,生山楂、鸡内金行气散淤,延胡索、川楝子活血理气,当归、木香补血活血,舒经止痛,以上主要为此方中佐药,香附、沉香调和诸药,兼有使药的作用。方中诸药配伍、君臣协力、佐使共辅,使之具有活血化瘀,消栓通络的功效,能够有效治疗介入术后深静脉血栓。
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:丹参19-29份、炒桃仁7-17份、红花6-12份、水蛭6-12份、皂角刺19-29份、土鳖虫7-17份、川牛膝10-20份、黄芪25-35份、桂枝10-20份、白芍7-17份、川芎7-17份、香附7-17份、沉香3-9份、血竭1-5份、三七7-17份、玄参10-20份、太子参10-20份、生山楂19-29份、鸡内金10-20份、延胡索13-23份、川楝子10-20份、当归13-23份、木香6-12份。
其中优选为:丹参24份、炒桃仁12份、红花9份、水蛭9份、皂角刺24份、土鳖虫12份、川牛膝15份、黄芪30份、桂枝15份、白芍12份、川芎12份、香附12份、沉香6份、血竭3份、三七12份、玄参15份、太子参15份、生山楂24份、鸡内金15份、延胡索18份、川楝子15份、当归18份、木香9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,粒度为80-120目,将所得细粉投入混合药物搅拌机充分混匀,制成散剂温水冲服。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。
将上述各中药原料制成本发明中药颗粒剂优选的生产方法是:
步骤一:按本发明重量配比,称取丹参、炒桃仁、皂角刺、香附、沉香、血竭、玄参、太子参干燥粉碎至120目筛,备用;
步骤二:称取水蛭、土鳖虫、生山楂、鸡内金、川楝子风干粉碎至120目筛,备用;
步骤三:称取川牛膝、黄芪、桂枝、白芍、川芎、三七、延胡索、当归、木香加水煎煮两次,第一次2.5小时,第二次加入红花再煎煮1小时,合并两次煎液,滤过;将所得滤液浓缩至70-85℃时,加入75%乙醇,放置沉淀,过滤,弃沉淀,滤液回收乙醇,在70℃环境下相对密度1.13~1.18的清膏,备用;
步骤四:将步骤一、步骤二所得细粉加入清膏中搅拌混合均匀,干燥,粉碎成细粉,加入适量乳糖作为稀释剂,乙醇作为润湿剂以及微晶纤维素作为崩解剂,采用干法制粒,制成15g/袋,每袋含原料药5g的颗粒剂。
本发明药物具有活血化瘀,消栓通络的功效,且疗效显著,见效快,治愈率高,无毒副作用,服用方便,价格低廉,该中药制剂采用的方式治疗可以减少西药以及手术对患者造成的伤害,据对临床180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95%。
具体实施方式
实施例一、丹参19份、炒桃仁7份、红花6份、水蛭6份、皂角刺19份、土鳖虫7份、川牛膝10份、黄芪25份、桂枝10份、白芍7份、川芎7份、香附7份、沉香3份、血竭1份、三七7份、玄参10份、太子参10份、生山楂19份、鸡内金10份、延胡索13份、川楝子10份、当归13份、木香6份。
实施例二、丹参24份、炒桃仁12份、红花9份、水蛭9份、皂角刺24份、土鳖虫12份、川牛膝15份、黄芪30份、桂枝15份、白芍12份、川芎12份、香附12份、沉香6份、血竭3份、三七12份、玄参15份、太子参15份、生山楂24份、鸡内金15份、延胡索18份、川楝子15份、当归18份、木香9份。
实施例三、丹参29份、炒桃仁17份、红花12份、水蛭12份、皂角刺29份、土鳖虫17份、川牛膝20份、黄芪35份、桂枝20份、白芍17份、川芎17份、香附17份、沉香9份、血竭5份、三七17份、玄参20份、太子参20份、生山楂29份、鸡内金20份、延胡索23份、川楝子20份、当归23份、木香12份。
下面是患者使用本发明药物的临床统计资料:
一、一般资料
2011年11月至2013年10月治疗介入术后深静脉血栓患者360例。将患者随机分为观察组和对照组,其中男性187例,女性173例,男女比例1.1:1,两组患者年龄、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、治疗方法:
1、按照本发明药物实施例二,以及优选的制备方法制备的颗粒剂,一天三次,每次一袋,温服。7日为一个疗程。
2、对照组按照CN 102727615 A中治疗深静脉血栓的药及其制备方法的最佳重量配比制备后的颗粒剂,每次10g,每日两次,14天为一个疗程。
三、疗效评定标准:
1、治愈:患者症状、体征消失、超声波显示血栓消失、血流量、流速恢复正常;
2、好转:症状基本消失,体征明显好转,血栓明显缩小;
3、未愈:症状、体征无任何改善,超声波显示血栓无明显变化。
四、观察组结果统计
对照组结果统计
其中:总有效率=治愈率+好转率
服用两个疗程两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组,由此说明,本发明中药在治疗介入术后深静脉血栓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、张某,女,60岁,心血管手术后,患者感觉四肢有轻微疼痛,并伴有肿胀和水疱,当日行彩超发现深静脉血栓形成,立即给予溶栓治疗,治疗一周后未见好转,后采用本发明实施例二中所制颗粒剂,服用两个疗程后患者疼痛、肿胀现象减轻,彩超检查显示血栓缩小,血液粘度降低,继续服药两个疗程后,患者肿胀水疱、疼痛感完全消失,彩超检查未见血栓,痊愈,持续观察一周后未见复发。
病例二、吴某,女,48岁,突然腹部疼痛难忍,后确诊为腹主动脉夹层瘤三型,一周后进行了介入手术,术后2天左右患者出现小腿胀痛、疼痛,皮温、浅静脉充盈、腹股沟压痛、超声波检查确诊为深静脉血栓,采用本发明实施案例二中所制颗粒剂,服用三个疗程后患者疼痛、肿胀现象减轻,体温恢复正常,超声波检查显示血栓消失,痊愈,持续观察一周后未见复发。
Claims (4)
1.一种治疗介入术后深静脉血栓的中药制剂,其特征在于,该中药制剂是由以下重量份的药物制成:丹参19-29份、炒桃仁7-17份、红花6-12份、水蛭6-12份、皂角刺19-29份、土鳖虫7-17份、川牛膝10-20份、黄芪25-35份、桂枝10-20份、白芍7-17份、川芎7-17份、香附7-17份、沉香3-9份、血竭1-5份、三七7-17份、玄参10-20份、太子参10-20份、生山楂19-29份、鸡内金10-20份、延胡索13-23份、川楝子10-20份、当归13-23份、木香6-12份。
2.根据权利要求1所述的治疗介入术后深静脉血栓的中药制剂,其特征在于,由以下重量份的药物制成:丹参24份、炒桃仁12份、红花9份、水蛭9份、皂角刺24份、土鳖虫12份、川牛膝15份、黄芪30份、桂枝15份、白芍12份、川芎12份、香附12份、沉香6份、血竭3份、三七12份、玄参15份、太子参15份、生山楂24份、鸡内金15份、延胡索18份、川楝子15份、当归18份、木香9份。
3.根据权利要求1或2所述的治疗介入术后深静脉血栓的中药制剂,其特征在于:所述中药制剂为颗粒剂。
4.根据权利要求3所述的治疗介入术后深静脉血栓的中药制剂,其制备方法如下:
步骤一:按本发明重量配比,称取丹参、炒桃仁、皂角刺、香附、沉香、血竭、玄参、太子参干燥粉碎至120目筛,备用;步骤二:称取水蛭、土鳖虫、生山楂、鸡内金、川楝子风干粉碎至120目筛,备用;步骤三:称取川牛膝、黄芪、桂枝、白芍、川芎、三七、延胡索、当归、木香加水煎煮两次,第一次2.5小时,第二次加入红花再煎煮1小时,合并两次煎液,滤过;将所得滤液浓缩至70-85℃时,加入75%乙醇,放置沉淀,过滤,弃沉淀,滤液回收乙醇,在70℃环境下相对密度1.13~1.18的清膏,备用;步骤四:将步骤一、步骤二所得细粉加入清膏中搅拌混合均匀,干燥,粉碎成细粉,加入适量乳糖作为稀释剂,乙醇作为润湿剂以及微晶纤维素作为崩解剂,采用干法制粒,制成15g/袋,每袋含原料药5g的颗粒剂。
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CN104547595A (zh) * | 2015-02-05 | 2015-04-29 | 任景艳 | 一种血管介入治疗用的中药 |
CN104800657A (zh) * | 2015-05-14 | 2015-07-29 | 庄文华 | 一种用于动脉穿刺引起的皮下血肿的中药制剂及制备方法 |
CN104873948A (zh) * | 2015-06-18 | 2015-09-02 | 张金梅 | 一种治疗血管穿刺引起动脉血栓的中药制剂及其制备方法 |
CN104888098A (zh) * | 2015-05-04 | 2015-09-09 | 孙著叶 | 一种用于关节置换后静脉血栓的中药制剂及制备方法 |
CN105267535A (zh) * | 2015-11-20 | 2016-01-27 | 青岛金智高新技术有限公司 | 一种防治术后下肢深静脉血栓的药物 |
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CN105267535A (zh) * | 2015-11-20 | 2016-01-27 | 青岛金智高新技术有限公司 | 一种防治术后下肢深静脉血栓的药物 |
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