CN104840773A - 治疗椎动脉型颈椎病的中药组合物及制法 - Google Patents
治疗椎动脉型颈椎病的中药组合物及制法 Download PDFInfo
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Abstract
本发明公开了一种治疗椎动脉型颈椎病的中药组合物及制法,由下列原料药制备而成,均为重量份:葛根25-35;延胡索8-16;桂枝6-18;四棱杆8-12;甘草4-8;鸡血藤10-20;地锦6-10;赤芍10-14;白芍9-15;牛蒡根10-14;钩藤7-13;当归8-12;川芎9-11;天麻6-14;威灵仙5-15;赤胫散7-9。本发明的优良效果还表现在:本发明药物具有散寒疏风、活血化瘀等作用,能够有效解除或缓解椎动脉痉挛,增加血管壁弹性,从而改善椎-基底动脉血液循环,消除症状;药源易得,药材成本低廉,能够减轻患者负担。
Description
技术领域
本发明涉及中医中药领域,特别是涉及一种治疗椎动脉型颈椎病的中药组合物及制法。
背景技术
颈椎病是临床常见病,是由于颈椎退行性改变而影响脊髓、脊神经根、交感神经和椎支脉等结构,使椎间盘变性,髓核破裂突出及椎体后缘骨刺形成刺激,压迫神经根、椎动脉和脊髓等组织,产生水肿粘连、韧带肥厚变性、钙化等病理改变,而出现一系列临床症状。椎动脉型颈椎病是颈椎病中较为常见的一种类型,在颈椎病各个类型的发病率中仅次于神经根型颈椎病。本病是因各种机械性与动力性因素致使椎动脉遭受刺激或压迫,以致血管狭窄、折曲而造成以椎-基底动脉供血不全所致。本病的临床症状较为复杂,多以眩晕、头颈疼痛、植物神经功能紊乱为主,严重者可发生猝倒、昏厥等,严重困扰人们日常生活、学习和工作,甚至诱发意外事故,威胁生命健康和安全。
椎动脉型颈椎病属于祖国医学的“骨痹”、“颈筋急”等范畴。《素问·阴阳应象大论》越:“年四十,阴气自半也,起居衰矣。”“肝气养筋,肝衰致筋不能动,肾气养骨,肾衰则形体疲极。”从中医的病因、病机理论来看,肝肾阴虚、气血不足、经脉受损、外邪侵入等,是颈椎病发病的主要原因。对于本病的治疗,目前主要有手术治疗和保守治疗两种方法。由于手术治疗有严格的适应症和禁忌症,并且手术治疗有一定的风险和创伤性,术后容易出现并发症,且手术费用较高。故一般以保守治疗为主。
申请公布号CN 104127647 A(申请号201410405457.0)的中国发明专利文献公开了一种治疗椎动脉型颈椎病的中药汤剂,,由以下重量份数的原料药物制成:党参10-30份、鹿茸6-15份、骨碎补10-15份、葛根10-30份、山楂10-40份、苏木10-20份、龙血竭6-15份、鬼箭羽5-20份、鸡血藤10-30份、九龙藤5-20份和四方藤10-30份。申请公布号CN104306535 A(申请号201410501816.2)的中国发明专利文献公开了一种治疗椎动脉型颈椎病的膏药,;由以下重量份数的原料药制成:天花粉30-35份、九里香25-30份、牛膝25-30份、覆盆子20-25份、熟地15-20份、商陆9-12份、杜仲9-12份、川芎9-12份、木防己9-12份、丁公藤6-9份、七叶莲6-9份、黄柏6-9份、糜子20-25份、沙棘油70-90份、松香20-25份。申请公布号CN 102526367 A(申请号201210047276.6)的中国发明专利文献公开了一种治疗椎动脉型颈椎病的中药汤剂,由以下重量份的中药制成:黄芪15-25份、大枣10-15份、甘草10-20份、鹿茸10-15份、仙茅10-15份、龙眼肉15-25份、苏木10-20份、骨碎补10-15份、川芎15-25份、红花15-25份、泽兰10-15份、橘皮10-15份、苍术10-20份。
现代医学常采取口服抗动脉硬化药,血管扩张药物,应用颈围固定、牵引等非手术疗法治疗本病,虽有一定疗效,但由于疗法对疾病的治疗不全面,远期效果不佳,复发率较高等。中医治疗椎动脉型颈椎病具有疗效确切,简便易行,副作用小,易于被大多数患者接受,因而具有极大的临床意义。
发明内容
针对现有技术的不足,本发明的目的是提供一种制备简单、方便服用、安全有效的治疗椎动脉型颈椎病的中药组合物。该中药组合物疗效显著,无任何副作用。
本发明的技术方案是:
治疗椎动脉型颈椎病的中药组合物,由下列原料药制备而成,均为重量份:葛根25-35;延胡索8-16;桂枝6-18;四棱杆8-12;甘草4-8;鸡血藤10-20;地锦6-10;赤芍10-14;白芍9-15;牛蒡根10-14;钩藤7-13;当归8-12;川芎9-11;天麻6-14;威灵仙5-15;赤胫散7-9。
优选的方案中,葛根28-32;延胡索10-14;桂枝9-15;四棱杆9-11;甘草5-7;鸡血藤13-17;地锦7-9;赤芍11-13;白芍11-13;牛蒡根11-13;钩藤9-11;当归9-11;川芎9.5-10.5;天麻8-12;威灵仙7-13;赤胫散7.5-8.5。
更加优选的,葛根30;延胡索12;桂枝12;四棱杆10;甘草6;鸡血藤15;地锦8;赤芍12;白芍12;牛蒡根12;钩藤10;当归10;川芎10;天麻10;威灵仙10;赤胫散8。
治疗椎动脉型颈椎病的中药组合物,将其制成药学上可接受的稠膏剂,制备方法如下:
(1)赤芍洗净,置炒置炒制容器中,文火加热,炒至颜色加深,取出放凉,备用;延胡索净制后,置于米酒中浸泡15-30分钟(优选置于米酒中浸泡23分钟),然后转蒸锅中,蒸至上气为度,取出,切片备用;
(2)用竹刀将白芍表面的粗皮刮去,浸入蜂蜜水中,入蒸锅内蒸制1.3-2.5小时(优选入蒸锅内蒸制1.9小时),取出,切片,晒干,研磨成细粉备用(白芍∶蜂蜜∶水=40∶5∶16);天麻置姜汁中闷润,取出,入蒸锅内蒸至上气为度,取出,切1cm左右直片,干燥,粉碎成细粉,备用;
(3)将四棱杆和赤胫散置于中药干燥箱内,于52-60℃干燥20-30分钟(优选于56℃干燥25分钟),取出,粉碎成细粉,与步骤(2)处理后的细粉混合,过筛,置于通透袋中,备用;
(4)将葛根、桂枝、甘草、鸡血藤、地锦、牛蒡根、钩藤、当归、川芎和威灵仙一同置于中药锅中,加入纯净水浸泡2-4小时(优选加入纯净水浸泡3小时),然后加入步骤(1)处理后的赤芍和延胡索,武火加热煮沸5-10分钟(优选武火加热煮沸8分钟),转文火煎煮三次,第一次煎煮43-55分钟(优选第一次煎煮50分钟),第二次和第三次各煎煮22-46分钟(优选第二次和第三次各煎煮34分钟),第二次和第三次煎煮前补加纯净水至药面2-3cm,合并三次煎液,纱布过滤,得滤液,备用;
(5)步骤(3)所得通透袋置于上述滤液中,文火加热煎煮18-32分钟(优选文火加热煎煮25分钟),过滤,滤液减压浓缩至85℃相对密度为1.28-1.30的稠膏,灭菌,分装,即得。
上述治疗椎动脉型颈椎病的中药稠膏剂的制备方法,优选的方案是,步骤(3)中过40-80目筛(优选的过50-70目筛,更加优选的过60目筛)。
上述治疗椎动脉型颈椎病的中药稠膏剂的制备方法,优选的方案是,步骤(4)中加入8-14倍原料量的纯净水(优选的加入10-12倍原料量的纯净水,更加优选的11倍原料量的纯净水)。
所述颗粒剂的制备方法是:
(1)赤芍洗净,置炒制容器中,文火加热,炒至颜色加深,取出放凉,粉碎成粉,备用;延胡索净制后,置于米醋中浸泡25分钟,然后转蒸锅中,蒸至上气为度,取出,切片,干燥,粉碎成粉,备用;
(2)将四棱杆、赤胫散、桂枝、天麻和钩藤置于中药干燥箱内,先于75-85℃干燥11-18分钟(优选80℃干燥15分钟),然后于47-58℃干燥48-62分钟(优选于53℃干燥55分钟),取出,趁热粉碎成细粉,备用;
(3)将除赤芍、延胡索、四棱杆、赤胫散、桂枝、天麻和钩藤以外的原料药置于中药提取器中,加入4-8倍原料量的乙醇(优选加入6倍原料量的乙醇),加热回流提取三次,第一次回流提取1.0-1.4小时(优选第一次回流提取1.2小时),第二次回流提取45-60分钟(第二次回流提取53分钟),第三次回流提取12-34分钟(优选第三次回流提取18分钟),合并三次醇提液,过滤,滤液回收乙醇,减压浓缩至70℃密度为1.20g/mL的浸膏,备用
(4)将步骤(3)所得浸膏真空干燥,得干膏粉,与步骤(1)和步骤(2)处理后的原料药粉混合,加入质量分数为12%的糊精和质量分数为7.5%纤维素钠,制粒,干燥,整粒,按照25-35g/袋的计量(优选按照30g/袋的计量)包装,即得。
上述治疗椎动脉型颈椎病的中药颗粒剂的制备方法,优选的方案是,步骤(3)中所加乙醇的质量浓度为70%-90%(优选的所加乙醇的质量浓度为75%-85%,更加优选的所加乙醇的质量浓度为80%)。
所述丸剂的制备方法是:
(1)赤芍洗净,置炒置炒制容器中,文火加热,炒至颜色加深,取出放凉,备用;延胡索净制后,置于米醋中浸泡25分钟,然后转蒸锅中,蒸至上气为度,取出,切片备用;
(2)将步骤(1)处理后的赤芍、延胡索以及剩余原料药置于中药干燥箱中充分干燥,粉碎成细粉,备用;
(3)将步骤(2)处理后的原料药粉装入渗漉筒中,压实,盖上纱布,向渗漉筒中缓缓加入渗漉液(渗漉液为75%的乙醇∶水=1∶3),待渗漉液没过药面,封住筒口,浸泡15-30小时(优选浸泡23小时),加入渗漉液没过药面3-5cm,按照3-5mL/s的速度进行渗漉,收集渗漉液,渗漉过程中始终保持渗漉液在药面以上,待收集的渗漉液为原料量的8-12倍(优选待收集的渗漉液为原料量的10倍)时停止渗漉,将渗漉液减压浓缩至稠膏状,喷雾干燥,得干膏粉,备用;
(4)将上述干膏粉充分研磨,炼蜜为丸,制成黄豆大小的丸剂,即得。
所述粉剂的制备方法是:
(1)按比例称取各原料药,烘干,研末,过100-160目筛(优选过130目筛),得混合药粉;
(2)将上述混合药粉按照7-9g/袋的计量(优选按照8g/袋的计量)包装,即得。
本发明组方科学,制备方法简单,服用方便、效果显著。除此之外,本发明的优良效果还表现在:
1、本发明运用中医理论分析处方组成,根据各药味所含成分的理化性质与药理作用的研究结果,研究得到了合理、稳定的活性成分的制备方法;
2、本发明药物具有散寒疏风、活血化瘀等作用,能够有效解除或缓解椎动脉痉挛,增加血管壁弹性,从而改善椎-基底动脉血液循环,消除症状;
3、药源易得,药材成本低廉,能够减轻患者负担。
具体实施方式
下面结合实施例和实验例详细说明本发明的技术方案,但保护范围不限于此。
实施例1治疗椎动脉型颈椎病的中药组合物,由下列原料药制备而成,均为重量份(30g/份):葛根25份;延胡索8份;桂枝6份;四棱杆8份;甘草4份;鸡血藤10份;地锦6份;赤芍10份;白芍9份;牛蒡根10份;钩藤7份;当归8份;川芎9份;天麻6份;威灵仙5份;赤胫散7份。
治疗椎动脉型颈椎病的中药稠膏剂的制备方法是:
(1)赤芍洗净,置炒置炒制容器中,文火加热,炒至颜色加深,取出放凉,备用;延胡索净制后,置于米酒中浸泡15分钟,然后转蒸锅中,蒸至上气为度,取出,切片备用;
(2)用竹刀将白芍表面的粗皮刮去,浸入蜂蜜水中,入蒸锅内蒸制1.3小时,取出,切片,晒干,研磨成细粉备用(白芍∶蜂蜜∶水=40∶5∶16);天麻置姜汁中闷润,取出,入蒸锅内蒸至上气为度,取出,切1cm左右直片,干燥,粉碎成细粉,备用(天麻∶生姜∶水=30∶7∶15);
(3)将四棱杆和赤胫散置于中药干燥箱内,于52℃干燥20分钟,取出,粉碎成细粉,与步骤(2)处理后的细粉混合,过40目筛,置于通透袋中,备用;
(4)将葛根、桂枝、甘草、鸡血藤、地锦、牛蒡根、钩藤、当归、川芎和威灵仙一同置于中药锅中,加入8倍原料量的纯净水浸泡2小时,然后加入步骤(1)处理后的赤芍和延胡索,武火加热煮沸5分钟,转文火煎煮三次,第一次煎煮43-分钟,第二次和第三次各煎煮22分钟,第二次和第三次煎煮前补加纯净水至药面2-3cm,合并三次煎液,纱布过滤,得滤液,备用;
(5)步骤(3)所得通透袋置于上述滤液中,文火加热煎煮18分钟,过滤,滤液减压浓缩至85℃相对密度为1.28-1.30的稠膏,灭菌,分装,即得。
本发明所得稠膏剂的服用方法是:每天三次,每次3药匙,温水冲服,10天一个疗程。
典型病例:陈XX,女,43岁,患者自述:一年前无明显诱出现颈部疼痛,活动受限,时而出现眩晕症状,在当地医院检查为颈椎病,给予膏药进行治疗,治疗一个月后,颈部疼痛无明显缓解,后经朋友介绍来我院检查治疗。检查:患者颈部痛不能转,伴有头晕、恶心、心慌症状,患者舌苔黄燥,脉滑数,X线片及MRI显示:C3-5棘突两侧深压痛,椎间盘向后方突出。诊断为椎动脉型颈椎病。
服用本实施例所得治疗椎动脉型颈椎病的中药稠膏剂,服用方法:每天三次,每次3药匙,温水冲服,10天一个疗程。用药两个疗程后,患者颈部疼痛明显减轻,其他体征明显缓解,继续用药两个疗程,患者可颈部活动正常,X线显示:突出部位明显回缩,其他症状全部消失,患者自感痊愈,三个月后随访,无复发。
实施例2治疗椎动脉型颈椎病的中药组合物,由下列原料药制备而成,均为重量份(10g/份):葛根35份;延胡索16份;桂枝18份;四棱杆12份;甘草8份;鸡血藤20份;地锦10份;赤芍14份;白芍15份;牛蒡根14份;钩藤13份;当归12份;川芎11份;天麻14份;威灵仙15份;赤胫散9份。
治疗椎动脉型颈椎病的中药颗粒剂的制备方法是:
(1)赤芍洗净,置炒制容器中,文火加热,炒至颜色加深,取出放凉,粉碎成粉,备用;延胡索净制后,置于米醋中浸泡25分钟,然后转蒸锅中,蒸至上气为度,取出,切片,干燥,粉碎成粉,备用;
(2)将四棱杆、赤胫散、桂枝、天麻和钩藤置于中药干燥箱内,先于80℃干燥15分钟,然后于53℃干燥55分钟,取出,趁热粉碎成细粉,备用;
(3)将除赤芍、延胡索、四棱杆、赤胫散、桂枝、天麻和钩藤以外的原料药置于中药提取器中,加入6倍原料量的质量浓度为80%的乙醇,加热回流提取三次,第一次回流提取1.2小时,第二次回流提取53分钟,第三次回流提取18分钟,合并三次醇提液,过滤,滤液回收乙醇,减压浓缩至70℃密度为1.20g/mL的浸膏,备用
(4)将步骤(3)所得浸膏真空干燥,得干膏粉,与步骤(1)和步骤(2)处理后的原料药粉混合,加入质量分数为12%的糊精和质量分数为7.5%纤维素钠,制粒,干燥,整粒,按照30g/袋的计量包装,即得。
本发明所得颗粒剂的服用方法是:每天三次,每次1袋,温水冲服,10天一个疗程。
实施例3治疗椎动脉型颈椎病的中药组合物,由下列原料药制备而成,均为重量份(25g/份):葛根28份;延胡索10份;桂枝9份;四棱杆9份;甘草5份;鸡血藤13份;地锦7份;赤芍11份;白芍11份;牛蒡根11份;钩藤9份;当归9份;川芎9.5份;天麻8份;威灵仙7份;赤胫散7.5份。
治疗椎动脉型颈椎病的中药丸剂的制备方法是:
(1)赤芍洗净,置炒置炒制容器中,文火加热,炒至颜色加深,取出放凉,备用;延胡索净制后,置于米醋中浸泡25分钟,然后转蒸锅中,蒸至上气为度,取出,切片备用;
(2)将步骤(1)处理后的赤芍、延胡索以及剩余原料药置于中药干燥箱中充分干燥,粉碎成细粉,备用;
(3)将步骤(2)处理后的原料药粉装入渗漉筒中,压实,盖上纱布,向渗漉筒中缓缓加入渗漉液(渗漉液为75%的乙醇∶水=1∶3),待渗漉液没过药面,封住筒口,浸泡23小时,加入渗漉液没过药面3-5cm,按照3-5mL/s的速度进行渗漉,收集渗漉液,渗漉过程中始终保持渗漉液在药面以上,待收集的渗漉液为原料量的10倍时停止渗漉,将渗漉液减压浓缩至稠膏状,喷雾干燥,得干膏粉,备用;
(4)将上述干膏粉充分研磨,炼蜜为丸,制成黄豆大小的丸剂,即得。
本发明所得丸剂的服用方法是:每天三次,每次10丸,温水送服,10天一个疗程。
典型病例:赵XX,男,50岁,患者自述:半年前在一次散步中,听到背后有人呼喊自己,转身查看时突然出现眩晕症状,立即停下,扶住额头,眩晕仍未停止,随后跌倒在地,被周围人扶起,此后又出现偏头痛以及记忆力减退症状,家人恐慌,遂于2010年9月17日来我院检查治疗。检查:患者有头发头晕症状,视物旋转,甚至出现猝倒,TCD检测发现患者椎动脉血流速度异常,血管壁增厚,管腔狭窄,X线片显示钩锥关节骨质增生。诊断为椎动脉型颈椎病。
服用本实施例所得治疗椎动脉型颈椎病的中药丸剂,服用方法是:每天三次,每次10丸,温水送服,10天一个疗程。服用两个疗程后,患者眩晕症状明显减轻,其他体征明显好转,继续服用两个疗程后,X线显示:增生部位明显回缩,其他症状全部消除。患者自感痊愈,半年后随访,患者无复发。
实施例4治疗椎动脉型颈椎病的中药组合物,由下列原料药制备而成,均为重量份(15g/份):葛根32份;延胡索14份;桂枝15份;四棱杆11份;甘草7份;鸡血藤17份;地锦9份;赤芍13份;白芍13份;牛蒡根13份;钩藤11份;当归11份;川芎10.5份;天麻12份;威灵仙13份;赤胫散8.5份。
治疗椎动脉型颈椎病的中药粉剂的制备方法是:
(1)按比例称取各原料药,烘干,研末,过130目筛,得混合药粉;
(2)将上述混合药粉按照8g/袋的计量包装,即得。
本发明所得粉剂的服用方法是:每天三次,每次1袋,热水冲服,10天一个疗程。
实施例5治疗椎动脉型颈椎病的中药组合物,由下列原料药制备而成,均为重量份(20g/份):葛根30份;延胡索12份;桂枝12份;四棱杆10份;甘草6份;鸡血藤15份;地锦8份;赤芍12份;白芍12份;牛蒡根12份;钩藤10份;当归10份;川芎10份;天麻10份;威灵仙10份;赤胫散8份。
治疗椎动脉型颈椎病的中药稠膏剂的制备方法是:
(1)赤芍洗净,置炒置炒制容器中,文火加热,炒至颜色加深,取出放凉,备用;延胡索净制后,置于米酒中浸泡23分钟,然后转蒸锅中,蒸至上气为度,取出,切片备用;
(2)用竹刀将白芍表面的粗皮刮去,浸入蜂蜜水中,入蒸锅内蒸制1.9小时,取出,切片,晒干,研磨成细粉备用(白芍∶蜂蜜∶水=40∶5∶16);天麻置姜汁中闷润,取出,入蒸锅内蒸至上气为度,取出,切1cm左右直片,干燥,粉碎成细粉,备用(天麻∶生姜∶水=30∶7∶15);
(3)将四棱杆和赤胫散置于中药干燥箱内,于56℃干燥25分钟,取出,粉碎成细粉,与步骤(2)处理后的细粉混合,过60目筛,置于通透袋中,备用;
(4)将葛根、桂枝、甘草、鸡血藤、地锦、牛蒡根、钩藤、当归、川芎和威灵仙一同置于中药锅中,加入11倍原料量的纯净水浸泡3小时,然后加入步骤(1)处理后的赤芍和延胡索,武火加热煮沸8分钟,转文火煎煮三次,第一次煎煮50分钟,第二次和第三次各煎煮34分钟,第二次和第三次煎煮前补加纯净水至药面2-3cm,合并三次煎液,纱布过滤,得滤液,备用;
(5)步骤(3)所得通透袋置于上述滤液中,文火加热煎煮25分钟,过滤,滤液减压浓缩至85℃相对密度为1.28-1.30的稠膏,灭菌,分装,即得。
本发明所得稠膏剂的服用方法是:每天三次,每次3药匙,温水冲服,10天一个疗程。
本发明所用主要中药原料的药理如下:
葛根:基原:本品为豆科植物野葛的干燥根。性状:本品呈纵切的长方形厚片或小方块。外皮淡棕色,有纵皱纹,粗糙。切面黄白色,纹理不明显。质韧,纤维性强。性味:甘、辛,凉。归经:归脾、胃经。功效:解肌退热,生津,透疹,升阳止泻。主治:用于外感发热头痛、项背强痛,口渴,消渴,麻疹不透,热痢,泄泻;高血压颈项强痛。
延胡索:基原:为罂粟科植物延胡索的块茎。性味:辛苦,温。归经:入肝、胃经。功能主治:活血,散瘀,理气,止痛。治心腹腰膝诸痛,月经不调,症瘕,崩中,产后血晕,恶露不尽,跌打损伤。
桂枝:基原:本品为樟科植物肉桂的干燥嫩枝。性味:辛、甘,温。归经:归心、肺、膀胱经。功效:发汗解肌,温通经脉,助阳化气,平冲降气。主治: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。药理作用:1、抗菌作用,2、抗病毒作用,3、利尿作用。
四棱杆:基原:为唇形科植物毛叶香茶菜的叶。化学成份:叶主含萜类成分,已经确证的有:毛叶香茶菜素A、B、C,延命草醇,表诺多星,表诺多星,毛果香茶有贝壳松素,冬凌草甲素,毛果香茶菜贝壳松醇,毛叶酯,毛叶醇,诺多星,毛果香茶菜醛H,大叶香茶菜素B,希柯勘宁,毛叶香茶菜素,香茶菜属醛,香茶菜属醇等。还含剂墩果酸。药理作用:1、抗肿瘤作用:分离出的苦味成分延命草素有抗肿瘤和抑菌作用。2、对免疫系统的影响;3、抗菌作用,试篮球赛法表明,醇提物对金黄色葡萄球菌、甲型链球菌、乙型链球菌、肺炎链球菌均有明显抑菌作用,对流感杆菌有一定作用,对其他杆菌几无作用。性味:味苦;性凉。功能主治:清热解毒;活血消肿。主治肝炎;胃炎;乳腺炎;闭经;跌打损伤;关节疼痛;蛇虫咬伤。
甘草:基原:本品为豆科植物甘草、胀果甘草或光果甘草的干燥根及根茎。性味:甘,平。归经:归心。肺、脾、胃经。功效:补脾益气,清热解毒,祛痰止咳,缓急止痛,调和诸药。主治:用于脾胃虚弱,倦怠乏力,心悸气短,咳嗽痰多,院腹、四肢挛急疼痛,痈肿疮毒,缓解药物毒性、烈性。
鸡血藤:基原:本品为豆科植物密花豆的干燥藤茎。性状:本品为椭圆形、长矩圆形或不规则的斜切片,厚0.3-1cm。栓皮灰棕色,有的可见灰白色斑,栓皮脱落处显红棕色。性味:苦、甘,温。归经:归肝、肾经。功效:补血,活血,通络。主治:用于月经不调,血虚萎黄,麻木瘫痪,风湿痹痛。
地锦:基原:为葡萄科植物爬山虎的根及茎。化学成份:叶含矢车菊素。种子含油28%。其中含软脂酸、硬脂酸、油酸、棕榈油酸,亚油酸。地锦的冠瘿含羧乙基赖氨酸及羧乙基鸟氨酸。性味:甘,温。归经:肝经。功能主治:活血,祛风,止痛。治产后血瘀,腹中有块,赤白带下,风湿筋骨疼痛,偏头痛。
赤芍:基原:本品为毛茛科植物芍药或川赤芍的干燥根。性味:苦,微寒。归经:归肝经。功能主治:清热凉血,散瘀止痛。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。
白芍:基原:本品为毛莨科植物芍药的干燥根。化学成份:根含芍药甙、牡丹酚、芍药花甙,苯甲酸约1.07%、挥发油、脂肪油、树脂、鞣质、糖、淀粉、粘液质、蛋白质、β-谷甾醇和三萜类。性味:苦、酸,微寒。归经:归肝、脾经。功效:平肝止痛,养血调经,敛阴止汗。主治: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。
牛蒡根:基原:菊科植物牛蒡的根。性味:苦,寒。归经:《得配本草》:“入手太阴经。”功能主治:祛风热,消肿毒。治风毒面肿,头晕,咽喉热肿,齿痛,咳嗽,消渴,痈疽疮疥。
钩藤:基原:为茜草科植物钩藤或华钩藤及其同属多种植物的带钩枝条。化学成份:带钩茎枝叶含钩藤碱、异钩藤碱、柯诺辛因碱、异柯诺辛因碱、柯楠因碱、二氢柯楠因碱、硬毛帽柱木碱、硬毛帽柱木因碱。性味:甘,凉。归经:入肝、心经。药理作用:①镇静作用;②降压作用。功能主治:清热平肝,熄风定惊。治小儿惊痫瘈疭,大人血压偏高,头晕、目眩,妇人子痫。
当归:基原:本品为伞形科植物当归的干燥根。化学成份:根含挥发油,甘肃岷县产者含0.4%,四川汶县产者含0.7%。挥发油的主要成分有:亚丁基苯酞、邻羧基苯正戊酮及Δ2,4-二氢酞酐。性味:甘、辛,温。归经:归肝、心、脾经。功效:补血活血,调经止痛,润肠通便。主治:用于血虚萎黄,眩晕心悸,月经不调,经闭痛经,虚寒腹痛,肠燥便秘,风湿痹痛,跌扑损伤,痈疽疮疡。酒当归活血通经。用于经闭痛经,风湿痹痛,跌扑损伤。
川芎:基原:本品为伞形科植物川穹的干燥根茎。性状:本品为不规则结节状拳形团块。表面黄褐色,粗糙皱缩,有多数平行隆起的轮节,顶端有凹陷的类圆形茎痕,下侧及轮节上有多数小瘤状根痕。质坚实,不易折断,断面黄白色或灰黄色,散有黄棕色的油室,形成层环呈波状。性味:辛,温。归经:归肝、胆、心包经。功效:活血行气,祛风止痛。主治:用于月经不调.经闭痛经,癥瘕腹痛,胸胁刺痛,跌扑肿痛,头痛。风湿痹痛。
天麻:基原:为天科天麻属植物天麻的块茎。成分:天麻含酚类:天麻苷即称天麻素,天麻醚苷,4-乙氧甲基苯酚,对羟基苯甲醛,3,4-二羟基苯甲醛;芳香族化合物:4-羟苄基甲醚等。药性:甘、辛,平。归肝经。功用主治:熄风止痉,平肝阳,祛风通络。主治急慢惊风,抽搐拘挛,破伤风,眩晕,头痛,半身不遂,肢麻,风湿痹痛。
威灵仙:基原:为毛莨科植物威灵仙的根。化学成份:①威灵仙的根含白头翁素、白头翁内酯、甾醇、糖类、皂甙、内酯、酚类、氨基酸。叶含内酯、酚类、三萜、氨基酸、有机酸。药理作用:①对循环系统的作用;②对平滑肌的影响;③抗利尿作用;④降血糖作用。性味:辛咸,温,有毒。归经:入膀胱经。功能主治:祛风湿,通经络,消痰涎,散癖积。治痛风、顽痹、腰膝冷痛,脚气,疟疾,症瘕积聚,破伤风,扁桃体炎,诸骨鲠咽。
赤胫散:基原:为蓼科植物缺腰叶蓼或华缺腰叶蓼的全草。性味:酸苦微辛,寒。功能主治:清热解毒,活血消肿。治痢疾,白带,血热头痛,崩漏,经闭,乳痈疮疖,跌打损伤。
试验例1本发明所得治疗椎动脉型颈椎病的中药组合物(实施例5)的临床应用:
1、资料和方法
1.1一般资料
选取2010年4月-2013年7月在来我院治疗的诊断为椎动脉型颈椎病患者共330例。其中男性患者143例,女性患者187例。年龄在22-70岁,平均年龄48.5±3.5岁。所有患者随机分为实验组210例和对照组120例,两组患者在性别、年龄、病情方面经统计学处理,无统计意义(P>0.05),具有可比性。
1.2诊断标准:
(1)有椎-基底动脉缺血征(以眩晕为主)和(或)曾有猝倒病史;(2)伴随症状:头痛、肩上肢麻痛,胸痛,心慌,消化道症状,失眠,记忆力下降等;(3)旋颈诱发试验阳性;(4)X线片显示椎体间关节失稳或钩椎关节骨质增生;(5)一般均有较明显的交感神经症状;(6)排除外眼源性和耳源性眩晕、外神经官能症与颅内肿瘤等。
1.3治疗方法
实验组服用本发明的产品,服用方法:每天三次,每次3药匙,温水冲服,10天一个疗程。对照组服用其他药品(如颈腰康胶囊、布洛芬、氯唑沙宗片颗粒等常规药品)。共观察治疗三个疗程。
1.4疗效判断标准
治愈:眩晕等临床症状及体征完全消失,能正常工作喝生活;显效:眩晕等临床症状及体征基本消失,基本可以正常工作;好转:眩晕等临床症状及体征明显减轻;无效:治疗后症状无明显改善。
1.5治疗结果
实验组和对照组的治疗结果,如表1所示
表1:实验组和对照组的治疗结果比较
治疗效果:治愈151例(71.9%),显效38例(18.1%),好转18例(8.6%),无效3例(1.4%),总有效率98.6%。效果明显优于对照组。
两组患者自感症状及其精神变化如表2所示。
表2:两组患者自感症状及其精神变化
本发明选择葛根、延胡索、桂枝、四棱杆、甘草、鸡血藤、地锦、赤芍、白芍、牛蒡根、钩藤、当归、川芎、天麻、威灵仙和赤胫散共16味主要原料配制而成。方中,葛根具有解肌退热,生津,透疹,升阳止泻的功效;延胡索活血,散瘀,理气,止痛;桂枝温通经脉,助阳化气;四棱杆清热解毒;活血消肿;鸡血藤活血,通络;地锦活血,祛风,止痛;白芍平肝止痛,养血调经;牛蒡根祛风热,消肿毒;钩藤热平肝,熄风定惊;当归补血活血,调经止痛,润肠通便;川芎活血行气,祛风止痛;赤胫散清热解毒,活血消肿;甘草补脾益气,清热解毒,祛痰止咳,缓急止痛,调和诸药。全方配伍,共奏活血通络、祛风止痛,滋补肝肾之功。治疗三个疗程,有效率可达98.3%,而对照组仅为78.3%。
应当指出的是,具体实施方式只是本发明比较有代表性的例子,显然本发明的技术方案不限于上述实施例,还可以有很多变形。本领域的普通技术人员,以本发明所明确公开的或根据文件的书面描述毫无异议的得到的,均应认为是本专利所要保护的范围。
Claims (10)
1.治疗椎动脉型颈椎病的中药组合物,其特征在于,由下列原料药制备而成,均为重量份:葛根25-35;延胡索8-16;桂枝6-18;四棱杆8-12;甘草4-8;鸡血藤10-20;地锦6-10;赤芍10-14;白芍9-15;牛蒡根10-14;钩藤7-13;当归8-12;川芎9-11;天麻6-14;威灵仙5-15;赤胫散7-9。
2.如权利要求1所述的治疗椎动脉型颈椎病的中药组合物,其特征在于,由下列原料药制备而成,均为重量份:葛根28-32;延胡索10-14;桂枝9-15;四棱杆9-11;甘草5-7;鸡血藤13-17;地锦7-9;赤芍11-13;白芍11-13;牛蒡根11-13;钩藤9-11;当归9-11;川芎9.5-10.5;天麻8-12;威灵仙7-13;赤胫散7.5-8.5。
3.如权利要求1所述的治疗椎动脉型颈椎病的中药组合物,其特征在于,由下列原料药制备而成,均为重量份:葛根30;延胡索12;桂枝12;四棱杆10;甘草6;鸡血藤15;地锦8;赤芍12;白芍12;牛蒡根12;钩藤10;当归10;川芎10;天麻10;威灵仙10;赤胫散8。
4.如权利要求1-3所述的治疗椎动脉型颈椎病的中药组合物,其特征在于,将其制成药学上可接受的稠膏剂,制备方法如下:
(1)赤芍洗净,置炒置炒制容器中,文火加热,炒至颜色加深,取出放凉,备用;延胡索净制后,置于米酒中浸泡15-30分钟(优选置于米酒中浸泡23分钟),然后转蒸锅中,蒸至上气为度,取出,切片备用;
(2)用竹刀将白芍表面的粗皮刮去,浸入蜂蜜水中,入蒸锅内蒸制1.3-2.5小时(优选入蒸锅内蒸制1.9小时),取出,切片,晒干,研磨成细粉备用(白芍∶蜂蜜∶水=40∶5∶16);天麻置姜汁中闷润,取出,入蒸锅内蒸至上气为度,取出,切1cm左右直片,干燥,粉碎成细粉,备用:
(3)将四棱杆和赤胫散置于中药干燥箱内,于52-60℃干燥20-30分钟(优选于56℃干燥25分钟),取出,粉碎成细粉,与步骤(2)处理后的细粉混合,过筛,置于通透袋中,备用;
(4)将葛根、桂枝、甘草、鸡血藤、地锦、牛蒡根、钩藤、当归、川芎和威灵仙一同置于中药锅中,加入纯净水浸泡2-4小时(优选加入纯净水浸泡3小时),然后加入步骤(1)处理后的赤芍和延胡索,武火加热煮沸5-10分钟(优选武火加热煮沸8分钟),转文火煎煮三次,第一次煎煮43-55分钟(优选第一次煎煮50分钟),第二次和第三次各煎煮22-46分钟(优选第二次和第三次各煎煮34分钟),第二次和第三次煎煮前补加纯净水至药面2-3cm,合并三次煎液,纱布过滤,得滤液,备用;
(5)步骤(3)所得通透袋置于上述滤液中,文火加热煎煮18-32分钟(优选文火加热煎煮25分钟),过滤,滤液减压浓缩至85℃相对密度为1.28-1.30的稠膏,灭菌,分装,即得。
5.根据权利要求4所述的治疗椎动脉型颈椎病的中药稠膏剂的制备方法,其特征在于,步骤(3)中过40-80目筛(优选的过50-70目筛,更加优选的过60目筛)。
6.根据权利要求4所述的治疗椎动脉型颈椎病的中药稠膏剂的制备方法,其特征在于,步骤(4)中加入8-14倍原料量的纯净水(优选的加入10-12倍原料量的纯净水,更加优选的11倍原料量的纯净水)。
7.如权利要求1-3所述的治疗椎动脉型颈椎病的中药组合物,其特征在于,将其制成药学上可接受的颗粒剂,制备方法如下:
(1)赤芍洗净,置炒制容器中,文火加热,炒至颜色加深,取出放凉,粉碎成粉,备用;延胡索净制后,置于米醋中浸泡25分钟,然后转蒸锅中,蒸至上气为度,取出,切片,干燥,粉碎成粉,备用;
(2)将四棱杆、赤胫散、桂枝、天麻和钩藤置于中药干燥箱内,先于75-85℃干燥11-18分钟(优选80℃干燥15分钟),然后于47-58℃干燥48-62分钟(优选于53℃干燥55分钟),取出,趁热粉碎成细粉,备用;
(3)将除赤芍、延胡索、四棱杆、赤胫散、桂枝、天麻和钩藤以外的原料药置于中药提取器中,加入4-8倍原料量的乙醇(优选加入6倍原料量的乙醇),加热回流提取三次,第一次回流提取1.0-1.4小时(优选第一次回流提取1.2小时),第二次回流提取45-60分钟(第二次回流提取53分钟),第三次回流提取12-34分钟(优选第三次回流提取18分钟),合并三次醇提液,过滤,滤液回收乙醇,减压浓缩至70℃密度为1.20g/mL的浸膏,备用
(4)将步骤(3)所得浸膏真空干燥,得干膏粉,与步骤(1)和步骤(2)处理后的原料药粉混合,加入质量分数为12%的糊精和质量分数为7.5%纤维素钠,制粒,干燥,整粒,按照25-35g/袋的计量(优选按照30g/袋的计量)包装,即得。
8.根据权利要求7所述的治疗椎动脉型颈椎病的中药颗粒剂的制备方法,其特征在于,步骤(3)中所加乙醇的质量浓度为70%-90%(优选的所加乙醇的质量浓度为75%-85%,更加优选的所加乙醇的质量浓度为80%)。
9.如权利要求1-3所述的治疗椎动脉型颈椎病的中药组合物,其特征在于,将其制成药学上可接受的丸剂,制备方法如下:
(1)赤芍洗净,置炒置炒制容器中,文火加热,炒至颜色加深,取出放凉,备用;延胡索净制后,置于米醋中浸泡25分钟,然后转蒸锅中,蒸至上气为度,取出,切片备用;
(2)将步骤(1)处理后的赤芍、延胡索以及剩余原料药置于中药干燥箱中充分干燥,粉碎成细粉,备用;
(3)将步骤(2)处理后的原料药粉装入渗漉筒中,压实,盖上纱布,向渗漉筒中缓缓加入渗漉液(渗漉液为75%的乙醇∶水=1∶3),待渗漉液没过药面,封住筒口,浸泡15-30小时(优选浸泡23小时),加入渗漉液没过药面3-5cm,按照3-5mL/s的速度进行渗漉,收集渗漉液,渗漉过程中始终保持渗漉液在药面以上,待收集的渗漉液为原料量的8-12倍(优选待收集的渗漉液为原料量的10倍)时停止渗漉,将渗漉液减压浓缩至稠膏状,喷雾干燥,得干膏粉,备用;
(4)将上述干膏粉充分研磨,炼蜜为丸,制成黄豆大小的丸剂,即得。
10.如权利要求1-3所述的治疗椎动脉型颈椎病的中药组合物,其特征在于,将其制成药学上可接受的粉剂,制备方法如下:
(1)按比例称取各原料药,烘干,研末,过100-160目筛(优选过130目筛),得混合药粉;
(2)将上述混合药粉按照7-9g/袋的计量(优选按照8g/袋的计量)包装,即得。
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