CN104888098A - 一种用于关节置换后静脉血栓的中药制剂及制备方法 - Google Patents
一种用于关节置换后静脉血栓的中药制剂及制备方法 Download PDFInfo
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Abstract
本发明公开了一种用于关节置换后静脉血栓的中药制剂，它是以黄芪、川芎、丹参、附子、香附、延胡索、川牛膝、白芍、桂枝、威灵仙、红花、鸡血藤、羌活、独活、水蛭、土鳖虫、刘寄奴、乳香、没药、虻虫、三棱、莪术为原料，属于中药发明领域。根据每味中药的不同特性，以洗净切块预处理后，按比例配制，经特殊方法制作，具有活血化瘀、消栓通络作用，本发明产品组合及制作方法独特，经临床验证，该药治疗效果显著，治疗周期短，价格低廉，无不良反应和任何毒副作用，具有广阔的市场应用前景。
Description
技术领域
本发明涉及一种中药制剂，具体涉及一种用于关节置换后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
骨科大手术术后易发生深静脉血栓形成(DVT)，病人可以有腿肿、疼痛等临床症状，约50％-80％病人并没有任何症状，但可并发远期下肢深静脉功能不全而经常腿肿或出现静脉曲张，在少数病人则可并发肺栓塞(PE)而导致死亡，危害极大。主要是针对那些即将或已经接受全髋置换术、全膝关节置换术和髋关节骨折手术的病人。因为这些骨科大手术操作有时造成病人静脉壁损伤，术后早期卧床康复期间其静脉血流缓慢停滞，血液处于高凝状态，此时如果不采取有效的预防措施，将很容易发生静脉血栓形成。
目前，对于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用于关节置换后静脉血栓的中药制剂，该中药制剂对于治疗关节置换后静脉血栓具有治疗效果显著，治愈时间短，价格低廉，无不良反应和副毒作用的特点。
发明人在多年的临床医疗实践中，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，反复探索总结出用于治疗关节置换后静脉血栓的中药制剂的新配方。本发明具有治疗效果显著，治愈时间短，价格低廉，无不良反应和副毒作用的特点。
本发明中药物的作用：
其中：
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，温。归肺、脾经。功效：补气固表，利尿托毒，排脓，敛疮生肌。用于气虚乏力，食少便溏，中气下陷，久泻脱肛，便血崩漏，表虚自汗，气虚水肿，痈疽难溃，久溃不敛，血虚痿黄，内热消渴；慢性肾炎蛋白尿，糖尿病。
川芎：为伞形科植物川芎Ligusticum chuanxiong Hort.(或Ligusticum wallichiiFranch.)的干燥根茎。性味：辛，温。归肝、胆、心包经。功效：活血行气，祛风止痛。用于月经不调，经闭痛经，症瘕腹痛，胸胁刺痛，跌扑肿痛，头痛，风湿痹痛。《日华子本草》中记载：治一切风，一切气，一切劳损，一切血，补五劳，壮筋骨，调众脉，破癥结宿血，养新血，长肉，鼻洪，吐血及溺血，痔瘘，脑痈发背，瘰疬瘿赘，疮疥，及排脓消瘀血。
丹参：为唇形科植物丹参Salvia miltiorrhiza Bunge.的干燥根及根茎。性味：苦，微寒。归心、肝经。功效：祛瘀止痛，活血通经，清心除烦。用于月经不调，经闭痛经，症瘕积聚，胸腹刺痛，热痹疼痛，疮疡肿痛，心烦不眠；肝脾肿大，心绞痛。《滇南本草》中记载：补心定志，安神宁心。治健忘怔冲，惊悸不寐。
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，逐风寒湿邪。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。《别录》中记载：脚疼冷弱，腰脊风寒，心腹冷痛，霍乱转筋，下痢赤白，坚肌骨，强阴，又堕眙，为百药长。
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。用于肝郁气滞，胸、胁、脘腹胀痛，消化不良，胸脘痞闷，寒疝腹痛，乳房胀痛，月经不调，经闭痛经。《纲目》中记载：散时气寒疫，利三焦，解六郁，消饮食积聚，痰饮痞满，跗肿，腹胀，脚气，止心腹、肢体、头、目、齿、耳诸痛，痈疽疮疡，吐血，下血，尿血，妇人崩漏带下，月候不调，胎前产后百病。
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。《日华子本草》中记载：除风，治气，暖腰膝，破症癖，扑损瘀血，落胎，及暴腰痛。
川牛膝：为四川苋科植物牛膝Achyranthes bidentata Blume.的干燥根。性味：苦、酸，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。《四川中药志》中记载：祛风利湿，通经散血。治寒湿腰腿骨痛，足痿筋挛，妇女经闭及症瘕，淋病，尿血，阴痿、失溺。
白芍：为毛茛科植物芍药Paeonia lactiflora Pall.的干燥根。性味：苦、酸，微寒。归肝、脾经。功效：平肝止痛，养血调经，敛阴止汗。用于头痛眩晕，胁痛，腹痛，四肢挛痛，血虚萎黄，月经不调，自汗，盗汗。《本经》中记载：主邪气腹痛，除血痹，破坚积，治寒热疝瘕，止痛，利小便，益气。
桂枝：为樟科植物肉桂Cinnamomum cassia Presl的干燥嫩枝。春、夏二季采收，除去叶，晒干，或切片晒干。性味：辛、甘，温。归心、肺、膀胱经。主治发汗解肌，温通经脉，助阳化气，平冲降气。用于风寒感冒，脘腹冷痛，血寒经闭，关节痹痛，痰饮，水肿，心悸，奔豚。
威灵仙：为毛茛科植物威灵仙Clematis chinensis Osbeck、棉团铁线莲(山蓼)Clematis hexapetala Pall.或东北铁线莲(黑薇)Clematis manshurica Rupr.的干燥根及根茎。性味：辛、咸，温。归膀胱经。功效：祛风除湿，通络止痛。用于风湿痹痛，肢体麻木，筋脉拘挛，屈伸不利，骨哽咽喉。《唐本草》中记载：腰、肾、脚膝、积聚、肠内诸冷病，积年不瘥，服之效。
红花：为菊科植物红花Carthamus tinctorius L.的干燥花。性味：辛，温。归心、肝经。功效：活血通经，散瘀止痛。用于经闭，痛经，恶露不行，症瘕痞块，跌扑损伤，疮疡肿痛。《纲目》：活血，润燥，止痛，散肿，通经。
鸡血藤：为豆科植物密花豆Spatholobus suberectus Dunn的干燥藤茎。性味：苦、甘，温。归肝、肾经。主治活血补血，调经止痛，舒筋活络。用于月经不调，痛经，经闭，风湿痹痛，麻木瘫痪，血虚萎黄。
羌活：为伞形科植物羌活(背翅芹)Notopterygium incisum Ting ex H.T.Chang或宽叶羌活Notopterygium forbesii Boiss.的干燥根茎及根。性味：辛、苦，温。归膀胱、肾经。功能主治：散寒，祛风，除湿，止痛。用于风寒感冒头痛，风湿痹痛，肩背酸痛。《日华子本草》中记载：治一切风并气，筋骨拳挛，四肢赢劣，头旋眼目赤疼及伏梁水气。
独活：为伞形科植物重齿毛当归Angelica pubescens Maxim.f.biserrataShan et Yuan的干燥根。性味：辛、苦，微温。归肾、膀胱经。主治祛风除湿，通痹止痛。用于风寒湿痹，腰膝疼痛，少阴伏风头痛风寒挟湿头痛。
水蛭：为水蛭科动物蚂蟥Whitmania pigra Whitman、水蛭Hirudo nipponicaWhitman或柳叶蚂蟥Whit-mania acranulata Whitman的干燥体。性味：咸、苦，平；有小毒。归肝经。功效：破血，逐瘀，通经。用于症瘕痞块，血瘀经闭，跌扑损伤。
土鳖虫：为鳖蠊科昆虫地鳖Eupolyphaga sinensis Walker或冀地鳖Steleophaga plancyi(Boleny)的雌虫干燥体。性味：咸，寒；有小毒。归肝经。功效：破瘀血，续筋骨。用于筋骨折伤，瘀血经闭，症瘕痞块。
刘寄奴：为菊科植物奇蒿的全草。性味：苦，温。归心、脾经。功效：破血通经，敛疮消肿。治经闭症瘕，胸腹胀痛，产后血瘀，跌打损伤，金疮出血，痈毒焮肿。《唐本草》中记载：主破血，下胀。
乳香：为橄榄科乳香树属植物乳香树Boswellia carterii Birdw.[B.sacraFluek.]、药胶香树B.bhawdajiana Birdw.及野乳香树B.neglecta M.Moore等，其树干皮部伤口渗出的油胶树脂。性味：辛、苦，温。功效：活血止痛。用于心腹诸痛，筋脉拘挛，跌打损伤，疮痈肿痛；外用消肿生肌。《纲目》中记载：″消痈疽诸毒，托里护心，活血定痛，伸筋，治妇人难产，折伤。
没药：为橄榄科没药属植物没药树Commiphora myrrha Engl.[C.molmol Engl.]及同属他种植物的树干皮部渗出的油胶树脂。性味：苦，辛，平。归脾、肾、肝、心经。功效：散血去瘀，消肿定痛。主治胸腹瘀痛、痛经、经闭、症瘕、跌打损伤、痈肿疮疡、肠痈、目赤肿痛。有活血止痛、消肿生肌等功效。
虻虫：为虻科昆虫复带虻Tabanus bivittatus Matsumura或鹿虻T.chrysurus Loew.的干燥雌虻成虫。性味：苦，微寒。有毒。功效：破瘀散结，痛经堕胎。用于血瘀经闭，跌打损伤。
三棱：为黑三棱科植物黑三棱Sparganium stoloniferum Buch.-Ham.的干燥块茎。性味：辛、苦，平。归肝、脾经。功效：破血行气，消积止痛。用于症瘕痞块，瘀血经闭，食积胀痛。《日华子本草》中记载：治妇人血脉不调，心腹痛，落胎，消恶血，补劳，通月经，治气胀，消扑损瘀血，产后腹痛、血运并宿血不下。
莪术：为姜科植物蓬莪术Curcuma phaeocaulis Val.、广西莪术CurcumaKwangsiensis S.G.Lee et C.F.Liang或温郁金Curcuma wenyujin Y.H.Chenet C.Ling的干燥根茎。性味：辛、苦，温。归肝、脾经。功效：行气破血，消积止痛。用于燀瘕痞块，瘀血经闭，食积胀痛；早期宫颈癌。
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，鸡血藤、红花配伍活血祛瘀，水蛭、刘寄奴、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、三棱舒肝理郁，行气中通，有助有血液流动，以上七味为此方中臣药。延胡索、威灵仙散瘀止痛，没药、附子补益健脾，莪术行气散淤，羌活、独活祛风止痛，乳香活血止痛，虻虫破瘀散结以上九味药为此方中佐药，香附调和诸药，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，能够有治疗防关节置换后静脉血栓。
本发明另一个重要特点是该中药制剂含有丰富的营养成分，富含氨基酸有17种以上，其中人体必需氨基酸有苏氨酸、缬氨酸、蛋氨酸、异亮氨酸、亮氨酸、赖氨酸和苯丙氨酸，含有人体必需的微量元素有铁、铬、铜、硼、锰、锶、和锌，另含钙、钾、镁、磷几种人体宏量元素。以上营养成分都是人体必需物质，能有效增强人体免疫力。
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：黄芪28-32份、川芎13-17份、丹参22-24份、附子10-14份、香附13-17份、延胡索18-22份、川牛膝16-20份、白芍13-17份、桂枝13-17份、威灵仙18-22份、红花7-11份、鸡血藤22-26份、羌活16-20份、独活16-20份、水蛭7-11份、土鳖虫10-14份、刘寄奴18-22份、乳香4-8份、没药4-8份、虻虫1-3份、三棱10-14份、莪术10-14份。
其中优选为：黄芪30份、川芎15份、丹参24份、附子12份、香附15份、延胡索20份、川牛膝18份、白芍15份、桂枝15份、威灵仙20份、红花9份、鸡血藤24份、羌活18份、独活18份、水蛭9份、土鳖虫12份、刘寄奴20份、乳香6份、没药6份、虻虫2份、三棱12份、莪术12份。
一种用于关节置换后静脉血栓的中药制剂的制备方法如下：
步骤一：按本发明重量份配比，取附子、水蛭、土鳖虫、虻虫置于砂锅中，加入2倍体积的水，武火熬煮55-60分钟，过滤，反复熬煮三次合并所得滤液，备用；
步骤二：按本发明重量配比，取黄芪、川芎、丹参、香附、延胡索、川牛膝、白芍、桂枝、威灵仙、羌活、独活、三棱、莪术药材置于砂锅中，加入8倍体积的水，武火熬煮25-30分钟后，加入红花、鸡血藤、刘寄奴武火熬煮15～20分钟，转文火熬煮20～30分钟过滤，再加入2倍体积的水，将乳香、没药投入砂锅中，文火熬煮15～20分钟得滤液，反复熬煮三次合并所得滤液，备用；
步骤三：合并步骤二和步骤一所得滤液，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℃环境下制成相对密度1.13～1.18的清膏，干燥，粉碎成120目细粉，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。
本发明使用方法：早晚各一次，每次一袋，温服。
本发明药物具有活血化瘀、消栓通络作用，且止痛效果好，价格低廉，无毒副作用，使用方便，能够减轻患者的病痛，具有广阔的市场应用前景。
具体实施方式
实施例一：黄芪30份、川芎15份、丹参24份、附子12份、香附15份、延胡索20份、川牛膝18份、白芍15份、桂枝15份、威灵仙20份、红花9份、鸡血藤24份、羌活18份、独活18份、水蛭9份、土鳖虫12份、刘寄奴20份、乳香6份、没药6份、虻虫2份、三棱12份、莪术12份。
实施例二：黄芪31份、川芎16份、丹参25份、附子12份、香附15份、延胡索21份、川牛膝19份、白芍16份、桂枝15份、威灵仙21份、红花10份、鸡血藤23份、羌活18份、独活18份、水蛭9份、土鳖虫12份、刘寄奴21份、乳香7份、没药7份、虻虫3份、三棱13份、莪术11份。
实施例三：黄芪32份、川芎16份、丹参23份、附子12份、香附15份、延胡索21份、川牛膝19份、白芍15份、桂枝15份、威灵仙20份、红花10份、鸡血藤23份、羌活18份、独活18份、水蛭9份、土鳖虫12份、刘寄奴21份、乳香6份、没药7份、虻虫2份、三棱11份、莪术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月关节置换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一，以及优选的制备方法制备的颗粒剂，一天二次，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，静脉造影检查显示血栓消失、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
| 组别 | 例数 | 治愈[n(％)] | 好转[n(％)] | 未愈[n(％)] | 总有效率(％) |
| 观察组 | 180 | 126(70) | 45(25) | 9(5) | 95.0 |
| 对照组 | 180 | 63(35) | 81(45) | 36(20) | 80.0 |
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，本发明中药在关节置换后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，全膝关节置换手术后，患者感觉四肢有轻微疼痛，并伴有肿胀和水疱，静脉造影检查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一中所制颗粒剂，服用两个疗程后患者疼痛、肿胀现象减轻，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，全膝关节置换术后1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，静脉造影检查确诊为深静脉血栓，采用本发明实施案例一中所制颗粒剂，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)
1.一种用于关节置换后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：黄芪28-32份、川芎13-17份、丹参22-24份、附子10-14份、香附13-17份、延胡索18-22份、川牛膝16-20份、白芍13-17份、桂枝13-17份、威灵仙18-22份、红花7-11份、鸡血藤22-26份、羌活16-20份、独活16-20份、水蛭7-11份、土鳖虫10-14份、刘寄奴18-22份、乳香4-8份、没药4-8份、虻虫1-3份、三棱10-14份、莪术10-14份。
2.根据权利要求1所述的用于关节置换后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：黄芪30份、川芎15份、丹参24份、附子12份、香附15份、延胡索20份、川牛膝18份、白芍15份、桂枝15份、威灵仙20份、红花9份、鸡血藤24份、羌活18份、独活18份、水蛭9份、土鳖虫12份、刘寄奴20份、乳香6份、没药6份、虻虫2份、三棱12份、莪术12份。
3.根据权利要求1或2所述的用于关节置换后静脉血栓的中药制剂，其特征在于：所述中药制剂为颗粒剂。
4.一种用于关节置换后静脉血栓的中药制剂的制备方法，其特征在于，制备方法如下：步骤一：按本发明重量份配比，取附子、水蛭、土鳖虫、虻虫置于砂锅中，加入2倍体积的水，武火熬煮55-60分钟，过滤，反复熬煮三次合并所得滤液，备用；步骤二：按本发明重量配比，取黄芪、川芎、丹参、香附、延胡索、川牛膝、白芍、桂枝、威灵仙、羌活、独活、三棱、莪术药材置于砂锅中，加入8倍体积的水，武火熬煮25-30分钟后，加入红花、鸡血藤、刘寄奴武火熬煮15～20分钟，转文火熬煮20～30分钟过滤，再加入2倍体积的水，将乳香、没药投入砂锅中，文火熬煮15～20分钟得滤液，反复熬煮三次合并所得滤液，备用；步骤三：合并步骤二和步骤一所得滤液，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℃环境下制成相对密度1.13～1.18的清膏，干燥，粉碎成120目细粉，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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