CN110841007A - 一种治疗脑中风后遗症的中药组合物及其应用 - Google Patents
一种治疗脑中风后遗症的中药组合物及其应用 Download PDFInfo
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Abstract
本发明公开了一种治疗脑中风后遗症的中药组合物及其应用,属于中药领域。该中药由全蝎18‑36份、天麻18‑36份、当归9‑18份、川芎7‑14份、桃仁7‑14份、地龙7‑14份、石决明12‑24份、丹参9‑18份、蜈蚣2条、羚羊角4‑7份、威灵仙9‑18份、土鳖虫7‑14份、桑枝9‑18份、赤芍6‑12份、秦芄6‑12份、伸筋草9‑18份、千年健6‑12份、玉竹9‑18份、黄芪12‑24份、甘草4‑7份制备成。本发明中药可快速、有效治疗脑中风后遗症,临床研究表明,本发明中药治疗脑中风后遗症的显效率达85.71%,并且治疗相同病症时所需时间缩短,治疗期间无复发病例。
Description
技术领域
本发明属于中药技术领域,尤其涉及一种治疗脑中风后遗症的中药组合物及其应用。
背景技术
脑中风又称脑卒中,是临床常见的心脑血管疾病。它是由诸多因素诱发而导致的脑血管狭窄或闭塞状况,进而造成脑部血液循环发生障碍的疾病,具有较高的致死率和致残率。近年来,随着老龄化程度不断加剧和社会压力增大,脑中风的发病率呈现高发势态,但伴随着医疗技术的发展和进步,脑中风患者发病后经及时救治,有较大几率挽救其生命。但由于患者脑部长时间缺血可引发局部脑组织环死,进而导致患者神经不同程度损伤,从而出现语言功能障碍、半身不遂以及口眼歪斜等后遗症,严重影响患者的生活质量。
目前,对于脑中风后遗症的治疗主要采取康复训练,但是临床疗效欠佳,患者及家属对治疗效果不满意。而中医治疗脑中风后遗症优势显著,可促进患者临床症状改善和提高生活质量,脑中风的治疗水平也有显著提高。但脑中风是难以根治的疾病,极易反复且伴有不同程度的后遗症,而现有中药治疗脑中风后遗症通常以气虚血瘀为主症,因而采用益气活血方进行治疗,如专利CN105796930A公开了一种治疗脑中风后遗症的中药制剂及其应用,该中药由黄芪25-35份、当归10-20份、川芎8-16份、桃仁8-16份、地龙8-16份、石决明25-35份、丹参10-20份、蜈蚣1-4条、羚羊角3-9份、天麻8-12份、威灵仙10-20份、土鳖虫8-16份、玉竹10-20份、甘草3-9份组成。然而该病多由风邪乘虚入侵引发肝风内动致使脏腑失和,进而引起气虚血瘀,因而采用益气活血方治疗虽能起到较好的治疗效果,但风邪多在经络窜走而不外泄,进而导致起效慢。
发明内容
本发明的目的在于:解决现有中药治疗脑中风后遗症起效慢的问题,从而提供一种治疗脑中风后遗症的中药组合物及其应用。
为了实现上述目的,本发明采用如下技术方案:
一种治疗脑中风后遗症的中药组合物,其包括如下重量份原料:全蝎18-36份、天麻18-36份、当归9-18份、川芎7-14份、桃仁7-14份、地龙7-14份、石决明12-24份、丹参9-18份、蜈蚣2条、羚羊角4-7份、威灵仙9-18份、土鳖虫7-14份、桑枝9-18份、赤芍6-12份、秦芄6-12份、伸筋草9-18份、千年健6-12份、玉竹9-18份、黄芪12-24份、甘草4-7份。
优选地,所述的中药组合物,其包括如下重量份原料:全蝎24-32份、天麻24-32份、当归12-16份、川芎10-13份、桃仁10-13份、地龙10-13份、石决明16-21份、丹参12-16份、蜈蚣2条、羚羊角5-6份、威灵仙12-16份、土鳖虫10-13份、桑枝12-16份、赤芍8-10份、秦芄8-10份、伸筋草12-16份、千年健8-10份、玉竹12-16份、黄芪16-21份、甘草5-6份。
更优选地,所述的中药组合物,其包括如下重量份原料:全蝎30份、天麻30份、当归15份、川芎12份、桃仁12份、地龙12份、石决明20份、丹参15份、蜈蚣2条、羚羊角6份、威灵仙15份、土鳖虫12份、桑枝15份、赤芍10份、秦芄10份、伸筋草15份、千年健10份、玉竹15份、黄芪20份、甘草6份。
优选地,所述中药组合物可与药品或食品辅料复合制备成中药制剂。
优选地,所述中药制剂是内服药物,其剂型包括泡腾片、分散片、胶囊剂、滴丸、丸剂、颗粒剂。
更优选地,所述中药制剂制备成分散片剂型。
本发明另一目的在于:提供一种所述分散片的制备方法,其步骤如下:
1)制备药物提取物
将所述药物混合后投罐,加8-10倍药物量水,在温度为68-75℃,真空度为0.04MPa的条件下煎煮1.8-2.0小时,滤出药液;药渣加5-7倍药物量水,在温度为58-65℃,真空度为0.05MPa的条件下煎煮1.2-1.5小时,滤出药液;药渣再加3-5倍药物量水,温度为45-55℃,真空度为0.07MPa的条件下煎煮0.5-1.0小时,滤出药液;合并三次药液,所述药液减压浓缩至相对密度为1.20-1.30的浸膏,喷雾干燥,得到水提药物;
2)制备分散片
药理分析:
本发明以肝风内动致使脏腑失和为病机,因而方中重用全蝎和天麻,全蝎息风镇痉、攻毒散结;天麻祛风止痉,平抑肝阳,且皆有通络作用,共为君药,奏逐湿除风、调和肝阳之功,使风邪湿毒外泄而脏腑功能恢复;当归活血通经;川芎活血行气、祛风止痛;桃仁活血祛瘀;丹参活血祛瘀、通经止痛、凉血;赤芍清热凉血、散瘀止痛;土鳖虫破血逐瘀,续筋接骨,共为臣药,有活血、行气、行散、祛瘀、破积之功,既使藏于经络、气血中的风邪湿毒排出,又为脏腑和脑部组织增加供血、供氧量,从而强化脏腑功能并促使受损神经恢复,同时避免风邪湿毒聚集和入侵,防止病症反复;地龙清热、通络、利尿;石决明平肝潜阳、清肝明目;蜈蚣息风镇痉、通络止痛、攻毒散结;羚羊角平肝息风、清肝明目、散血解毒;威灵仙祛风湿、通经络;秦艽祛风湿,清湿热,止痹痛,退虚热;桑枝祛风湿、利关节;千年健祛风湿;壮筋骨;伸筋草祛风除湿、舒筋活络,共为佐药,有平肝潜阳、息风镇痉、祛风散寒、舒筋通络、清肝明目之功,加速风邪湿毒排出,并使脏腑功能快速恢复;黄芪补气固表、托毒排脓、生肌养阴;玉竹养阴润燥、生津止渴、补脾益气;甘草清热解毒、调和诸药,共为使药,有补气固表、调和诸药之功。
全方共奏逐湿除风、行气活血、调和肝阳功效,能够快速引肝风湿毒外泄,从而使脏腑功能调和归位,脏腑调和则脑部组织气血充盈,脑部组织气血充盈则藏于其中的风邪湿毒不能久藏,因而能够快速治愈脑中风及其后遗症。
与现有技术相比,本发明的有益效果在于:
本发明中药针对脑中风后遗症的病因标实配伍成,具有逐湿除风、行气活血、调和肝阳功效,标实则逐湿除风,本虚则活血行气,故对标本虚实杂和之症实行标本兼治的治法,可快速、有效治疗脑中风后遗症。临床研究表明,本发明中药治疗脑中风后遗症的显效率达85.71%,并且治疗相同病症时所需时间缩短,治疗期间无复发病例。
具体实施方式
下面将结合实施例对本发明的实施方案进行详细描述,实施例中所用原药材均为2015版药典所收载的药材,经鉴定,各项指标均符合规定。
实施例1
本实施例提供一种治疗脑中风后遗症的中药汤剂,其具体步骤如下:
1)分别称取全蝎30g、天麻30g、当归15g、川芎12g、桃仁12g、地龙12g、石决明20g、丹参15g、蜈蚣2条、羚羊角6g、威灵仙15g、土鳖虫12g、桑枝15g、赤芍10g、秦芄10g、伸筋草15g、千年健10g、玉竹15g、黄芪20g、甘草6g;
2)将称取的药物合并投入电药罐,加10倍药物量水,在温度160℃下,煎煮35分钟,滤出药液;药渣加5倍药物量水,在温度120℃下,煎煮20分钟,滤出药液;将所述药液合并,即得治疗脑中风后遗症的中药汤剂。
实施例2
本实施例提供4种不同用量的所述中药汤剂,用量见下表1,炮制同实例1。
表1-治疗脑中风后遗症的中药汤剂
实施例3
本实施例提供一种治疗脑中风后遗症的分散片,其具体步骤如下:
1)分别称取全蝎30g、天麻30g、当归15g、川芎12g、桃仁12g、地龙12g、石决明20g、丹参15g、蜈蚣2条、羚羊角6g、威灵仙15g、土鳖虫12g、桑枝15g、赤芍10g、秦芄10g、伸筋草15g、千年健10g、玉竹15g、黄芪20g、甘草6g;
2)制备药物提取物
将称取的药物混合后投入电药罐,加10倍药物量水,在温度为68-75℃,真空度为0.04MPa的条件下煎煮1.8-2.0小时,滤出药液I;药渣加6倍药物量水,在温度为58-65℃,真空度为0.05MPa的条件下煎煮1.2-1.5小时,滤出药液;药渣再加4倍药物量水,温度为45-55℃,真空度为0.07MPa的条件下煎煮0.5-1.0小时,滤出药液;合并药液I、和,得到水提药液,所述水提药液减压浓缩至相对密度为1.20-1.30的浸膏,喷雾干燥,得到水提药物;
3)制备分散片
将所述水提药物和醇提药物分别研磨至粒径120-150目;
将研磨的水提药物和醇提药物按质量比为12-20:1的比例混合后,加入微晶纤维素Mcc、马铃薯淀粉、润滑剂PEG-600、Tween-80等分散片药学辅料,并按常规方法制成分散片,规格为0.25g/片。
为了验证本发明药物的疗效,下面结合具体临床资料予以说明。
1、毒性反应研究
1.1 急性毒性研究
将本发明药物汤剂按2 ml、3ml、4ml/kg对小鼠给药,给药后小鼠生理指标正常,未发生急性毒性反应;
将本发明药物分散片按0.5g、1g/kg对小鼠给药,给药后小鼠生理指标正常,未发生急性毒性反应;
1.2 长期毒性研究
将本发明药物汤剂按5ml/只/日、分散片0.2g/只/日对小鼠连续给药一个月,对小鼠的一般状况、血液学、血液生化学、尿常规、心电图、系统解剖、脏器系数和组织病理学均无明显影响,未发现毒性反应。
经毒性反应研究确定本发明药物无毒性后,用于临床治疗。
2、临床资料
2.1 一般资料
治疗组:自2016年4月至2019年8月份来我卫生室就诊的脑中风后遗症病例共42例,其中,男24例,女18例,年龄45-80岁,平均年齡57岁。均是脑中风病发后经住院治疗病情稳定,遗留有半身不遂或乏力或伴有语言不利、口眼咽斜的病例。病程1/2-1年。
对照组:选取2016年1月前已经治疗的脑中风后遗症病例共42例,其中,男24例,女18例,年龄45-80岁,平均年齡57岁。均是脑中风病发后经住院治疗病情稳定,遗留有半身不遂或乏力或伴有语言不利、口眼咽斜的病例。病程1/2-1年。
为方便观察疗效,对照组所选病例与治疗组病例的病情指数具有可比性。
2.2 治疗方法 本发明中药与针炙同时治疗。
2.2.1 中药治疗
治疗组:口服实施例1的中药汤剂,每天1剂,晚饭后温服;
对照组:处方:黄芪30g、当归15g、川芎12g、桃仁12g、地龙12g、石决明30g、丹参15g、蜈蚣2条、羚羊角6g、天麻10g、威灵仙15g、土鳖虫12g、玉竹15g、甘草6g,汤剂,每天1剂,晚饭后温服;
2.2.2 针灸治疗 下肢取环跳、阳陵泉、足三里、解溪、昆仑等;上肢取肩偶、曲池、手三里、外关、合谷等;口眼喝斜加迎香、下关;流涎加承浆、地仓;多愁加内关等穴位。针刺患侧,每天1次。
2.3 疗效判定
2.3.1 显效:症状、体征明显改善,生活部分自理,患侧肢体肌力提高达II级以上;
2.3.2 有效:症状、体征有所改善,悲侧肢体肌力提高达I-II级;
2.3.3 无效:症状、体征无变化,甚至加重。
总有效率=(显效+有效)/总例数×100%。
2.4 治疗结果
治疗组总有效率100%,对照组100%;但治疗组显效率85.71%,高于对照组的71.43%,具体见表1。
表1-治疗组与对照组疗效比较
通过上述对比可知,虽然对照组和治疗组有效率均达到100%,但治疗组相比对照组具有更高的显效率,说明经研究和发展原处方获得的本发明药物相比对照方具有更好的治疗效果,尤其是显效率相比提高14.28%。
对比相同病情的恢复时间(平均值),以下具体结果如下:
治疗组的患者症状、体征明显改善,生活部分自理需20天,对照组的患者症状、体征明显改善,生活部分自理需22天;治疗组的患者口鼻歪斜恢复正常需12天;治疗组的患者口鼻歪斜恢复正常需15天。
通过相同病情的恢复时间对比,说明本发明药物相比对照组药物具有治疗快、时间短的优点。
2.5 典型病例
病例1
吴xx,男,57岁,甘肃省天水市秦州区玉泉镇吴家崖村人,患者于2019年2月16日上午9时突然发病,病症表现:吐字不清,右上肢、右下肢活动走路不便,发抖;血压测量结果:180/105(mmHg) ;P 72次/分钟、R 20次/分钟;脉弦数。
家人急送至秦州区人民医院做CT检查:左脑梗塞;住院治疗26天。
来我诊所,血糖测量结果:21 mmol/L;血脂:2.18 mmol/L;血压:165/100mmHg;右上肢、右下肢偏瘫;舌强言蹇;口眼歪斜;口角流涎;卧床不起;吞咽哽滞;吐字不清;
症状分析:疏通经络,祛除病邪,活血通筋,肝气郁滞,扶正祛邪,宣通诸窍,痰涎壅盛,心脉不通,气机不畅等;
主治:脑梗后遗症
治法:中药与针灸同时治疗。患者接受治疗10天,能下床走路;30天后,生活便可自理。血糖:8 mmol/L;血脂:1.86 mmol/L。
病例2
缑xx,男,64岁,甘肃省天水市秦州区牡丹镇缑家沟村人,患者于2019年4月19日晚3点突然昏倒,昏迷不醒30分钟。左上肢,左下肢软弱无力;口眼歪斜,口角流涎;头昏恶心;颈项强直;痰声漉漉;鼻鼾鼻鸣;
家人急送至第一人民医院救治,经CT检查:右脑大侧额颞顶叶,右侧基底节区多发梗死灶;右侧额叶软化灶;右侧大脑中动脉、左侧大脑中动脉、双侧大脑前动脉、右侧大脑后动脉信号缺失;左侧颈内动脉虹吸段纤细;血压测量结果:180/110 mmHg;住院治疗14天出院。
2019年5月8日来我诊所,患者当时表现:语言迟钝;口眼歪斜;说话时口角流涎;视力淡漠;左上肢无一点感觉;左下肢基本能动;头痛,颈项强直;心悸气短,头昏脑胀;血压测量结果:150/95 mmHg;P 76次/分钟、R 20次/分钟;
症状分析:气血阻滞,元气不足,胸阳不振;扶正祛邪,燔灼营血,平肝降逆,育阴潜阳,疏通经络等。
主治:多发性脑梗塞
治法:中药与针灸同时治疗。患者接受治疗5天,左上肢能伸直,手指无力,20天手指能活动。
病例3
李x,女,64岁,甘肃省天水市秦州区皂郊镇小寨村人,患者于2002年6月27日突然昏倒,不省人事,恶心呕吐,两手紧握,牙关紧闭,痰迷心窍,痰声如锯,大小便失禁,两目上窜,舌强言蹇,口眼歪斜,喉间漉漉,四肢撒开。
家人急送至第一人民医院救治,CT检查:脑溢血30ml。经历6天住院救治无效,送回家中。
于2019年7月5日到我诊所,患者当时表现:不省人事,两手紧握,牙关紧闭,舌强言蹇,颈项强直,鼻鼾鼻鸣,二便失禁,口歪眼斜,肌肤不仁,两颊带红,痰迷心窍,四肢发软。
血压测量结果:210/115 mmHg;P 98次/分钟、R 23次/分钟;
症状分析: 通络醒神,闭塞神明,痰湿蒙塞,心脉不通,镇灼开窍,神昏谵语,宣通开窍,邪入心包。
主治:脑溢血
治法:中药与针灸同时治疗。患者接受治疗3天能起床坐;10天说话通畅,20天痊愈;该病是特殊病,至今无后遗症。
应当理解,虽然本说明书按照实施方式加以描述,但并非每个实施例仅包含一个独立的技术方案,说明书的这种叙述方式仅仅是为清楚起见,本领域技术人员应当将说明书作为一个整体,各实施例中的技术方案也可以经适当组合,形成本领域技术人员可以理解的其他实施方式。
Claims (8)
1.一种治疗脑中风后遗症的中药组合物,其特征在于:以重量份计,采用包括如下中药原料制备成:全蝎18-36份、天麻18-36份、当归9-18份、川芎7-14份、桃仁7-14份、地龙7-14份、石决明12-24份、丹参9-18份、蜈蚣2条、羚羊角4-7份、威灵仙9-18份、土鳖虫7-14份、桑枝9-18份、赤芍6-12份、秦芄6-12份、伸筋草9-18份、千年健6-12份、玉竹9-18份、黄芪12-24份、甘草4-7份。
2.如权利要求1所述的中药组合物,其特征在于:采用包括如下中药原料制备成:全蝎24-32份、天麻24-32份、当归12-16份、川芎10-13份、桃仁10-13份、地龙10-13份、石决明16-21份、丹参12-16份、蜈蚣2条、羚羊角5-6份、威灵仙12-16份、土鳖虫10-13份、桑枝12-16份、赤芍8-10份、秦芄8-10份、伸筋草12-16份、千年健8-10份、玉竹12-16份、黄芪16-21份、甘草5-6份。
3.如权利要求1或2所述的中药组合物,其特征在于:采用包括如下中药原料制备成:全蝎30份、天麻30份、当归15份、川芎12份、桃仁12份、地龙12份、石决明20份、丹参15份、蜈蚣2条、羚羊角6份、威灵仙15份、土鳖虫12份、桑枝15份、赤芍10份、秦芄10份、伸筋草15份、千年健10份、玉竹15份、黄芪20份、甘草6份。
4.如权利要求1-3任意一项所述的治疗脑中风后遗症的中药组合物在制备治疗脑中风后遗症的药物中的应用。
5.一种治疗脑中风后遗症的中药制剂,其特征在于:包含权利要求1-3任意一项所述的治疗脑中风后遗症的中药组合物及药品上或保健食品上可接受的辅料。
6.如权利要求5所述的中药制剂,其特征在于:所述中药制剂是内服药物,其剂型包括泡腾片、分散片、胶囊剂、滴丸、丸剂、颗粒剂。
7.如权利要求6所述的中药制剂,其特征在于:所述中药制剂制备成分散片剂型。
8.如权利要求7所述的中药制剂,其特征在于:所述分散片的制备方法如下:
1)制备药物提取物
将所述药物混合后投罐,加8-10倍药物量水,在温度为68-75℃,真空度为0.04MPa的条件下煎煮1.8-2.0小时,滤出药液;药渣加5-7倍药物量水,在温度为58-65℃,真空度为0.05MPa的条件下煎煮1.2-1.5小时,滤出药液;药渣再加3-5倍药物量水,温度为45-55℃,真空度为0.07MPa的条件下煎煮0.5-1.0小时,滤出药液;合并三次药液,所述药液减压浓缩至相对密度为1.20-1.30的浸膏,喷雾干燥,得到水提药物;
2)制备分散片
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