CN113499411A - 一种治疗缺血性脑卒中的中药组合物的制备方法及其应用 - Google Patents
一种治疗缺血性脑卒中的中药组合物的制备方法及其应用 Download PDFInfo
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Abstract
本发明涉及一种治疗缺血性脑卒中的中药组合物的制备方法及其应用，该中药组合物由下述重量份的原料药制备而成：黄芪29.3%‑43.9%、川12.8%‑23.8%、水蛭7.3%‑10.9%、蜈蚣2.1%‑3.6%、三棱12.8%‑20.1%、莪术9.1%‑12.8%、熟军3.6%‑7.3%。本发明以黄芪为君，逐五脏间恶血，诉其活血之用；以川芎为臣，取其行气活血之功；以水蛭、蜈蚣、三棱与莪术为使，水蛭具有破血、逐瘀、通经、消癥之效；蜈蚣有熄风通络之功；三棱、莪术均有破血行气，消积止痛的作用；还配伍少量熟军为佐药，破积血、下瘀血的同时通畅肠腑，使得瘀热与大便并下；全方益气活血通络，经临床观察，对气虚血瘀型中风病具有很好疗效。
Description
技术领域
本发明涉及一种治疗缺血性脑卒中的中药组合物的制备方法及其应用，属于中药领域。
背景技术
缺血性脑卒中(Cerebral Ischemic Stroke，简称CIS)，也称为脑梗死，是最常见的脑卒中类型，占全部脑卒中的60％～80％。该病主要由颈动脉血栓导致动脉狭窄，或不稳定斑块破碎导致脑部血管阻塞，进而导致脑部供血不足，脑组织发生缺血、缺氧性损伤引起，，并对血管供应区的脑组织产生不可逆的损害，出现神经损害症状、体征的一类综合征，脑卒中是严重危害人类生命安全的临床常见疾病，具有发病高率、致残率高和死亡率高的特点；根据临床流行病学统计信息，近年来我国青年人群中脑卒中的发病率也出现升高趋势，45岁以下成年人的发病率约为13.44％；是导致我国青、成、老年人死亡、残疾的第一病因根据缺血性脑卒中的主证特点。本病属于中医“中风病”的范畴，以猝然昏仆、不省人事、半身不遂、口眼歪斜、言语不利等为主症；本病基本病机属阴阳失调，气血逆乱；病理性质多属本虚标实。
中药在缺血性脑卒中治疗中已有长期的临床应用历史。临床证实疗效较好的单味中药包括葛根、三七、丹参、天麻、水蛭、刺蒺藜。药效物质基础研究显示，葛根中的葛根素、三七中的三七总皂苷、灯盏花中的黄酮类化合物、丹参中的丹参素、长春花中的长春西汀都具有良好的扩张脑血管、改善脑部微循环作用，对缺血性脑卒中具有一定的疗效；经过历代中医药大家经验的积累，目前临床常用的治疗缺血性脑卒中的中药复方主要为活血、补气/养阴活血或补肾活血类中药或中成药，包括补阳还五汤、桃红四物汤、血府逐瘀汤；在治疗缺血性脑卒中的中药复方中，黄芪、生地、当归、川芎、升麻、水蛭属于常用中药。然而，上述中药对后循环缺血性脑卒中的疗效仍然不理想；因此，对于中风解毒方仍需要进一步组方优化和改进。
发明内容
本发明的目的是针对上述现有技术存在的问题，为优化“中风病”的治疗效果，提供一种治疗缺血性脑卒中的中药组合物的制备方法及其应用。
为实现上述目的，本发明采用如下技术方案：一种治疗缺血性脑卒中的中药组合物，其特征在于：该中药组合物由下述重量百分比的原料药制备而成：黄芪29.3％-43.9％、川芎12.8％-23.8％、水蛭7.3％-10.9％、蜈蚣2.1％-3.6％、三棱12.8％-20.1％、莪术9.1％-12.8％、熟军3.6％-7.3％。
该中药组合物由下述重量份的原料药制备而成：黄芪100g、川芎50g、水蛭25g、蜈蚣8g、三棱45g、莪术30g、熟军15g。
利用一种治疗缺血性脑卒中的中药组合物制成任何一种临床上可接受的制剂。
所述制剂为合剂。
一种治疗缺血性脑卒中的中药组合物的制备方法，其特征在于：包括以下步骤：
S1：按以下重量百分比称取各原料组分：黄芪29.3％-43.9％、川芎12.8％-23.8％、水蛭7.3％-10.9％、蜈蚣2.1％-3.6％、三棱12.8％-20.1％、莪术9.1％-12.8％、熟军3.6％-7.3％，备用；
S2：将称取的黄芪、川芎、水蛭、蜈蚣、三棱、莪术加水浸没药面，煎煮3次，每次煎煮时，先用武火煎开，再用文火煎煮，每次1小时；第一次煎煮时，熟军在煎煮半小时后加入；合并3次煎煮的滤液，过滤，浓缩，定容至250mL，灭菌，装瓶，即为成品。
步骤S1中，黄芪为100g，川芎为50g，水蛭为25g，蜈蚣为8g，三棱为45g，莪术为30g，熟军为15g。
含有黄芪的中药组合物在治疗缺血性脑卒中的应用。
本发明的有益效果：
1、本发明以黄芪为君，逐五脏间恶血，诉其活血之用。以川芎为臣，取其行气活血之功。以水蛭、蜈蚣、三棱与莪术为使，水蛭具有破血、逐瘀、通经、消癥之效。蜈蚣有熄风通络之功。三棱、莪术均有破血行气，消积止痛的作用，本方中还配伍少量熟军为佐药，破积血、下瘀血的同时通畅肠腑，使得瘀热与大便并下。全方益气活血通络，经临床观察，对气虚血瘀型中风病具有很好疗效。
2、采用天然动植物，在研究中并没有发现明显的毒副作用，安全性高，本品做成可以做成药学上的合剂。
3、黄芪具有行气功效，将其用于缺血性脑卒中患者，具有良好效益，尤其是调节血脂代谢和改善脑血管供血不足。
4、在以往行气活血方基础上，进行改良，以黄芪为君，重点为补气行气以活血，川芎为血中之气药，补而不滞，水蛭、蜈蚣、三棱与莪术，助黄芪活血破瘀，熟军破积血、下瘀血，兼顾通畅肠腑，使得瘀热与大便并下。
综上，本发明提供一种治疗缺血性脑卒中的中药及其制备方法与应用，为一种疗效显著，副作用小的治疗缺血性脑卒中的中药及其制备方法，解决现有西药的毒副作用大，种类单一及成本高昂等技术问题。本发明以方中以黄芪为君，逐五脏间恶血，诉其活血之用；以川芎为臣，取其行气活血之功；以水蛭、蜈蚣、三棱与莪术为使，水蛭具有破血、逐瘀、通经、消癥之效；蜈蚣有熄风通络之功；三棱、莪术均有破血行气，消积止痛的作用；本方中还配伍少量熟军为佐药，破积血、下瘀血的同时通畅肠腑，使得瘀热与大便并下。全方益气活血通络，经临床观察，对气虚血瘀型中风病具有很好疗效；采用天然动植物，在研究中并没有发现明显的毒副作用，安全性高，本品做成可以做成药学上的合剂、片剂、胶囊剂或颗粒剂。
具体实施方式
下面结合具体实施例对本发明做进一步说明。
本发明提供了一种治疗缺血性脑卒中的中药组合物，该中药组合物由下述重量份的原料药制备而成：黄芪29.3％-43.9％、川芎12.8％-23.8％、水蛭7.3％-10.9％、蜈蚣2.1％-3.6％、三棱12.8％-20.1％、莪术9.1％-12.8％、熟军3.6％-7.3％。
具体的，该中药组合物由下述重量份的原料药制备而成：黄芪100g、川芎50g、水蛭25g、蜈蚣8g、三棱45g、莪术30g、熟军15g。
黄芪：味甘，性微温；归脾、肺经；补气固表，托毒排脓，利尿，生肌；
川芎：味甘，性温；归肝、胆、心包经；活血行气，祛风止痛；
水蛭：味辛，性温；归肝、胆、心包经；活血祛瘀，祛风止痛；
蜈蚣：味辛，性温；归肝经；息风镇痉，通络止痛，攻毒散结；
三棱：味辛、苦，性平；归肝、脾经；破血行气，消积止痛；
莪术：味辛、苦，性温；归肝、脾经；行气破血，消积止痛；
熟军：味苦，性寒；归脾、胃、大肠、肝、心包经；泻热通肠，凉血解毒，逐瘀通经；
按常规方法制成任何一种临床上可接受的制剂。所述制剂为合剂。
一种治疗缺血性脑卒中的中药组合物的制备方法，包括以下步骤：
S1：按以下重量百分比称取各原料组分：黄芪29.3％-43.9％、川芎12.8％-23.8％、水蛭7.3％-10.9％、蜈蚣2.1％-3.6％、三棱12.8％-20.1％、莪术9.1％-12.8％、熟军3.6％-7.3％，备用；
S2：将称取的黄芪、川芎、水蛭、蜈蚣、三棱、莪术加水浸没药面，煎煮3次，每次煎煮时，先用武火煎开，再用文火煎煮，每次1小时；第一次煎煮时，熟军在煎煮半小时后加入；合并3次煎煮的滤液，过滤，浓缩，定容至250mL，灭菌，装瓶，即为成品。
实验样品：
选取扬州市中医院脑病科门诊及住院缺血性脑卒中患者，按照平行对照研究，确定缺血性脑卒中患者共90人。根据病人就诊顺序及服药情况分为试验组(基础治疗+本发明方法制备的中风合剂组)、对照组(基础治疗+安慰组)，每组各45例。两组均按照各自组内治疗方案进行，观察周期为14天。14天后进行疗效评价，随访3个月。
①诊断标准：1.符合《中国急性缺血性脑卒中诊疗指南2018》及《中国脑卒中中西医结合诊治指南(2017)》；2.符合中医内科中风病及气虚血瘀证型诊断标准；3.年龄为40～80岁；4.无全身严重并发症；5.知情并同意参与该项试验。
②排除标准：1.不符合上述诊断及纳入标准者；2.年龄在40岁以下及85岁以上者；3.有短暂性脑缺血发作、脑出血、蛛网膜下腔出血病史者；4.聋，哑，盲，精神或智力障碍以及因其它原因导致的肢体残疾影响到肌力、神经功能缺损评分者；5.患有造成肢体活动受限的疾病，如外伤骨折、恶性肿瘤以及骨性关节炎等符合法律规定的残疾疾病；6.检查证实有心、肝、肺等器质性病变，合并炎症、肿瘤、血液病、免疫性疾病、脑外伤、脑寄生虫病，1个月内有手术史；7.有其他严重的内科疾病；8.妊娠或哺乳期妇女；9.对药物过敏者；近3个月内参与过其他临床试验者。
③病例的剔除和脱落：1.纳入后发现不符合纳入标准的病例,需予以剔除；2.受试者未按规定治疗、资料不全、发生严重不良事件或特殊生理变化不宜继续受试、自动退出者等均为脱落病例；3.观察中失访者。
④实验过程
(1)试验组：继续患者基础治疗方案，加服本发明方法制备的中风合剂。
(2)对照组：继续患者基础治疗方案，加服安慰剂。
(3)两组均以常规药物控制血压、血糖、血脂等其他指标以治疗个体患者原有基础疾病。
实验过程：
治疗后试验组患者NISS(患者神经功能缺损状况)评分显著低于对照组，差异具有统计学意义；试验组患者Barthel评分显著高于对照组，差异具有统计学意义；试验组患者凝血酶时间显著高于对照组，差异具有统计学意义。提示在基础治疗的基础上加服中风合剂能显著改善患者神经功能，提高患者的生活质量，使患者满意。
试验组患者治疗前后观察资料对比(n＝45)如下：
对照组患者治疗前后观察资料对比(n＝45)如下：
本发明已由上述相关实施例加以描述，然而上述实施例仅为实施本发明的范例。必需指出的是，已揭露的实施例并未限制本发明的范围。相反地，在不脱离本发明的精神和范围内所作的更动与润饰，均属本发明的专利保护范围。
Claims (7)
1.一种治疗缺血性脑卒中的中药组合物，其特征在于：该中药组合物由下述重量百分比的原料药制备而成：黄芪29.3%-43.9%、川芎12.8%-23.8% 、水蛭7.3%-10.9% 、蜈蚣2.1%-3.6% 、三棱12.8%-20.1%、莪术 9.1%-12.8%、熟军3.6%-7.3%。
2.根据权利要求1所述的一种治疗缺血性脑卒中的中药组合物，其特征在于：该中药组合物由下述重量份的原料药制备而成：黄芪100g、川芎50g 、水蛭25g 、蜈蚣8g 、三棱45g、莪术30g、熟军15g。
3.利用一种治疗缺血性脑卒中的中药组合物制成任何一种临床上可接受的制剂。
4.根据权利要求3所述的一种制剂，其特征在于：所述制剂为合剂。
5.一种治疗缺血性脑卒中的中药组合物的制备方法，其特征在于：包括以下步骤：
S1：按以下重量百分比称取各原料组分：黄芪29.3%-43.9%、川芎12.8%-23.8% 、水蛭7.3%-10.9% 、蜈蚣2.1%-3.6% 、三棱12.8%-20.1%、莪术 9.1%-12.8%、熟军3.6%-7.3%，备用；
S2：将称取的黄芪、川芎、水蛭、蜈蚣、三棱、莪术加水浸没药面，煎煮3次，每次煎煮时，先用武火煎开，再用文火煎煮，每次1小时；第一次煎煮时，熟军在煎煮半小时后加入；合并3次煎煮的滤液，过滤，浓缩，定容至250mL，灭菌，装瓶，即为成品。
6.根据权利要求5所述的方法，其特征是：步骤S1中，黄芪为100g，川芎为50g ，水蛭为25g ，蜈蚣为8g ，三棱为45g，莪术为30g，熟军为15g。
7.含有黄芪的中药组合物在治疗缺血性脑卒中的应用。
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