CN112220877B - 一种治疗脑中风恢复期的中药制剂及其制备方法 - Google Patents
一种治疗脑中风恢复期的中药制剂及其制备方法 Download PDFInfo
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Abstract
本发明涉及一种治疗脑中风恢复期的中药制剂及其制备方法，该中药制剂由下述重量配比的原料制成：葛根100～150份、三七70～140份、槐米70～100份、红花70～100份、地龙30～60份、川芎60～100份、豨签草70～100份、赤芍60～120份、水蛭30～50份、龙血竭50～80份。该中药制剂具有抑制血小板聚集，高效抗凝，降低血液粘度和血浆脂质过氧化物，使血液中的脂质物质不易在动脉堆积形成血栓的作用，保护血管内皮功能，稳定动脉粥样硬化斑块，使脑中风患者日益康复，远离复发，其疗程短，恢复快，是治疗脑中风的最佳药品。
Description
技术领域
本发明属于医药技术领域，具体涉及一种治疗脑中风恢复期的中药制剂及其制备方法。
背景技术
目前，随着我国人口老龄化加快，以中老年为主要对象的脑血管疾病明显增加。根据我国有关方面调查，我国脑血管病人约有6千万，每年新发病的脑血管病人约130万，每年因脑血管病死亡高大100万人，2018年公布的中国第三次居民死因抽样调查结果显示，脑血管病已在各种死亡原因中上升为第一位。
脑中风是一组以脑部缺血及出血性损伤症状为主要临床表现的疾病,其是神经系统的常见病和多发病，属于脑血管病中的一种。脑中风是我国成年人致死、致残的首位病因，具有发病率高、致残率高、死亡率高和复发率高的特点，即使在幸存者当中，四分之三的人却留下半身不遂等后遗症，使他们丧失了生活自理能力，该病疗程长，恢复慢，已成为严重危害中国居民健康和生命的主要疾病，该病给患者及其家庭和社会带来极大的经济、精神负担，所以该病的康复治疗是医患双方共同解决的头等大事。
现有治疗脑中风的药物主要以西药为主、部分患者会采用中药制剂；其中，口服西药主要包括抗血小板聚集的药物(阿司匹林肠溶片)、改善脑代谢的药物(吡拉西坦片)、抗凝药及控制危险因素的药物等。虽然西药治疗已多年，但一直未能解决疗效长、康复慢、副作用大的缺点，不能得到特别满意的疗效，而且有些西药口服不耐受，所以就得被迫中断治疗。利用中药制剂虽然能够解决西药副作用大的缺点，但同样存在疗程长，康复慢的问题，而且现有中药制剂对于脑中风急性期和恢复期的治疗都需要加服抗血小板聚集的药物，如脑中风恢复期单纯服用中药制剂复发率极高，尤其1年内复发的最多，而每复发一次，脑细胞受损加重一次，神经系统的功能损害也加重一次，因此针对曾发生脑中风的病人恢复期的治疗尤为重要，必须降低脑中风复发概率。
发明内容
鉴于上述技术问题，本发明的目的在于提供一种配方简单、无毒副作用，且能够治疗脑中风恢复期的中药制剂，该中药制剂具有抑制血小板聚集，高效抗凝，降低血液粘度和血浆脂质过氧化物，使血液中的脂质物质不易在动脉堆积形成血栓的作用，保护血管内皮功能，稳定动脉粥样硬化斑块，使脑中风患者日益康复，远离复发，其疗程短，恢复快，是治疗脑中风的最佳药品。
为实现上述目的，本发明是采用如下技术方案实现的：
一种治疗脑中风恢复期的中药制剂，该中药制剂由下述重量配比的原料制成：葛根100～ 150份、三七70～140份、槐米70～100份、红花70～100份、地龙30～60份、川芎60～100份、豨签草70～100份、赤芍60～120份、水蛭30～50份、龙血竭50～80份。
作为本发明的优选，所述中药制剂剂由下述重量配比的原料制成：葛根120～140份、三七120～140份、槐米80～100份、红花80～100份、地龙40～60份、川芎60～80份、豨签草70～80份、赤芍60～80份、水蛭30～50份、龙血竭70～80份。
作为本发明的优选，所述中药制剂剂由下述重量配比的原料制成：葛根135份、三七 135份、槐米90份、红花90份、地龙45份、川芎70份、豨签草70份、赤芍60份、水蛭40份、龙血竭65份。
作为本发明的优选，该中药制剂的剂型包括胶囊剂、片剂、粉剂或丸剂。
本发明的另一个目的在于提供一种治疗脑中风恢复期的中药制剂的制备方法，该方法包括以下步骤：
(1)按组成原料的重量称取龙血竭粉成细粉，备用；
(2)取红花、川芎、槐米各一半量与三七、水蛭2味处方量中药饮片粉碎成细粉，过筛、混匀，备用；
(3)剩余红花、川芎、槐米各一半量与葛根、地龙、豨签草、赤芍4味处方量中药饮片加水煎煮二次，每次1小时，煎液过滤，合并滤液，滤液浓缩为相对密度为1.20—1.30(80℃)的清膏，备用；
(4)在步骤(3)的清膏加入步骤(2)的细粉，混匀，干燥，干燥后加入龙血竭粉碎成细粉，过筛，混匀。
作为本发明的优选，将步骤(4)获得的细粉装入胶囊制成胶囊剂，或压制成片剂，或制成丸剂，每粒或每片或每丸剂中含有0.4克药粉。
方解：方中以红花、赤芍、川芎、三七活血化瘀为君药；以龙血竭、水蛭、地龙破淤血通经络为臣药；以葛根配槐米有补脾益脑健神为佐药；以豨签草通经络使药；诸药配伍，主次得当，标本兼治，益气活血，化瘀通络。
本发明中药制剂的各味药材功效如下：
①葛根：味甘、辛，性平，无毒，归胃、脾，肺，膀胱经。具有解肌退热、生津止渴，通经活络，解酒毒。用于外感发热头痛，项背强痛，眩晕头痛，中风偏瘫，胸痹心痛，酒毒伤中。
②三七：味甘、微苦、温。归肝、胃经。具有散瘀止血，消肿定痛的功效。用于咯血，吐血，衄血，便血，崩漏，外伤出血，胸腹刺痛，跌扑肿痛效果是非常不错的。
③槐米：性微寒，味苦。[功能主治]凉血止血，清肝泻火。用于便血、痔血、血痢、崩漏、吐血、衄血、肝热目赤、头痛眩。
④红花：辛，温；归心、肝经。【功效】活血通经，散瘀止痛，用于胸痹心通，淤血腹痛，胸胁刺痛等病症，
⑤赤芍：苦，微寒。归肝经。有清热凉血，活血祛瘀的功效。
⑥川芎：辛，温。入肝、胆经。【功效】具有活血行气，祛风止痛的功效。
⑦地龙：地龙性寒味咸。其味咸，性寒。功能为清热、镇痉、止喘、利尿。
⑧水蛭：咸、苦，平；有小毒。归经归肝经。功能主治破血，逐瘀，通经。用于症瘕痞块，血瘀经闭，跌扑损伤。
⑨豨莶草：味辛、苦，性寒，归肝、肾经。可以祛除风湿、强健筋骨、清热解毒，
⑩龙血竭：性温、平，味甘、咸，无毒，入血分，归肺、脾、肾三经，具有活血化瘀、消肿止痛、收敛止血，软坚散结、生肌敛疮等显著功效。
用法用量：口服，每日3次，每次4粒，每粒中含有0.4克药粉。
本发明的优点和积极效果：
(1)本发明所述的一种治疗脑中风恢复期的中药制剂具有活血化瘀，舒展筋络，益脑健神的功效，用于血瘀阻络所致的中风，症见半身不遂，口眼歪斜，舌蹇语涩及头痛；急性、缺血性中风见上述证候者；该制剂配方及制备工艺简单，使用方便，治疗面广，且处方组成中药价格较低，无毒性药材，无紧缺药材；对脑中风急性期和恢复期治疗有确切疗效，疗程短，恢复快，复发率低，临床使用二十年，未出现副作用，可长期服用，安全稳定，是不可多得的中药制剂。
(2)本发明所述的一种治疗脑中风恢复期的中药制剂，因其具有抑制血小板聚集，高效抗凝，降低血粘度和血浆脂质过氧化物，使血液中脂质物质不易在动脉堆积形成血栓的作用，防止动脉粥样硬化形成，为脑组织创造一个良好的内环境，保护血管内皮细胞，使其不易受损，降低血脂，防止血栓形成，使脑中风患者远离复发。
(3)本发明所述的一种治疗脑中风恢复期的中药制剂因疗效好，无毒副作用，需求量大，能够带动相关产业的发展，可建立本地区中草药材基地，尤其是对天然药物种植有极大的推动作用，有利于落后地区人民增收创利，繁荣经济；还可扩大本地区药业的生产规模，增加药厂生产量，增加税收，增加工人收入。
本发明所述药物的临床观察资料
1、病例选择
我们从本院住院患者按照顺序随机抽取病例400例，男、女性患者各200例，年龄在39-82 岁之间，平均年龄57岁，病人选择出现偏瘫、言语不清，或出现偏盲、偏身感觉障碍，或出现严重头晕、呕吐等颅高压的症状。颅脑CT检查，颅脑CT排除脑出血，诊断是脑中风发作的病人。随机分为治疗组(加服益脑康胶囊)和对照组(单纯西药组)，治疗组在使用西药的基础上加服“益脑康胶囊(实施例4)”，对照组给予盐酸倍他司汀片口服，静点抗血小板聚集，降纤、增加细胞代谢药物。
2、治疗方法
A.治疗组：益脑康胶囊每次4粒(每粒装0.4g)，口服3次，静点抗血小板聚集，降纤、增加细胞代谢药物(注射用血塞通一日400mg加250ml氯化钠注射液，静脉点滴；吡拉西坦注射液一次4-8g，用5％葡萄糖注射液一日1次，静脉点滴；)。B.对照组盐酸倍他司汀片每次2片，日服3次，静点抗血小板聚集，降纤、增加细胞代谢药物(注射用血塞通一日400mg 加250ml氯化钠注射液，静脉点滴；吡拉西坦注射液一次4-8g，用5％葡萄糖注射液一日1 次，静脉点滴)。
3、疗效评价标准
治疗组和对照组均观察治疗15天；指标及疗效判定标准：根据每个疗程患者的症状体征等指标，将疗效分为临床治愈、显效、有效、无效四个级别。
治愈：症状大部分消失，生活完全能自理；
显效：症状明显好转，瘫痪肢体肌力增进2级，生活能自理；
有效：症状好转，肢体肢体肌力增进1级；
无效：治疗前后症状和体征无明显变化。
4、治疗结果
本发明药物在治疗期间，对照组与治疗组对比，总有效率统计学处理存在显著差异(P ＜0.01),治疗组疗程比对照组疗程显著缩短(P＜0.01)。
本发明药物治疗期间接触的典型病例
病例1：王某某，男，65岁，居住梨树县蔡家镇，2017年9月30日入院，于入院前2 天无任何诱因自觉左侧肢体活动不灵，左上肢抬举无力，左手持物不能，左下肢不能独立行走，无头痛，头晕、呕吐、无意识障碍及二便失禁。查体：神情、构因困难，左侧鼻唇沟变浅，伸舌偏左，上下肢肌张力减退，肌力Ⅱ级，左下肢肌力Ⅲ级。左巴彬斯基氏阳性。门诊 CT诊断脑中风收住院。给予益脑康胶囊每次4粒，口服，日3次；静点抗血小板聚集、降纤、增加细胞代谢药物(注射用血塞通一日400mg加250ml氯化钠注射液，静脉点滴；吡拉西坦注射液一次4-8g，用5％葡萄糖注射液一日1次，静脉点滴)，入院十四天左侧上下肢肌力明显提高，好转出院，继续口服益脑康胶囊六个月，来院复查，语言流利，左侧上下肢活动较协调，能从事简单体力劳动，且一年内无复发。
病例2：张某某，女，57岁，居住梨树县万发镇，自述从2017年3月入院，半月前曾出现过左下肢活动无力、麻木、语言笨拙、经乡医生治疗症状消失，入院前4天晨起时自觉左上下肢因无力不能活动，语言笨拙，无意识障碍，经乡医生治疗无效，来本院门诊CT诊断脑中风收住院。查体：上下肢肌张力减弱，肌力Ⅱ级，左巴彬斯基氏阳性。给予益脑康胶囊每次4粒，口服，日3次；静点抗血小板聚集、降纤、增加细胞代谢药物(注射用血塞通一日 400mg加250ml氯化钠注射液，静脉点滴；吡拉西坦注射液一次4-8g，用5％葡萄糖注射液一日1次，静脉点滴)。入院9天，语言较前流利，左侧上下肌力Ⅳ+级，可独立行走，临床好转出院，继续口服益脑康6个月，来院复查，语言流利，左侧上下肢Ⅴ+，可从事家务，且一年内无复发。
病例3：吴刚，男，53岁。住梨树镇，于2017年2月4日住院。于住院前3天休息时自觉右侧上下肢活动不灵活，语言不清，右上肢抬举不力，右下肢不能独立行走，门诊CT诊断脑中风收住院。查体：右侧肢体不能独立行走，右侧鼻唇沟变浅，伸舌偏右，右侧上下肢张力减弱，近端肌力Ⅱ级，远端肌力0级，右侧巴彬斯基氏阳性，给予益脑康胶囊每次4粒，口服，日3次；静点抗血小板聚集、降纤、增加细胞代谢药物(注射用血塞通一日400mg 加250ml氯化钠注射液，静脉点滴；吡拉西坦注射液一次4-8g，用5％葡萄糖注射液一日1 次，静脉点滴)，入院十一天右侧面瘫明显减轻，右侧上下肢远端能自主轻微活动，语言较住院前流利，好转出院，继续口服益脑康胶囊12个月，来院复查，语言流利，四肢肌力Ⅴ级，能从事体力劳动，回归社会，且一年内无复发。
附图说明
图1为本发明中药制剂的制备流程图。
具体实施方式
实施例1
一种治疗脑中风恢复期的中药制剂，该中药制剂由下述重量配比的原料制成：葛根150 份、三七100份、槐米70份、红花70份、地龙30份、川芎90份、豨签草100份、赤芍100份、水蛭40份、龙血竭50份。
一种治疗脑中风恢复期的中药制剂的制备方法，该方法包括以下步骤：
(1)以上十味原料，龙血竭粉成细粉，备用；
(2)取红花、川芎、槐米各一半量与三七、水蛭2味处方量中药饮片粉碎成细粉，过筛、混匀；
(3)剩余红花、川芎、槐米各一半量与葛根、地龙、豨签草、赤芍4味处方量中药饮片加水煎煮二次，每次1小时，煎液过滤，合并滤液，滤液浓缩为相对密度为1.20～1.30(80℃)的清膏；
(4)在步骤(3)的清膏加入步骤(2)的细粉，混匀，干燥，干燥后加入龙血竭粉碎成细粉，过筛，混匀，装入胶囊，制成1000粒，每粒含有0.4克药粉。
本申请将红花、川芎、槐米一半用于直接粉碎药粉备用；另一半与葛根、地龙、豨签草、赤芍煎煮提取浓缩液，目的是符合制备工艺流程要求，提取的浓缩液需要与药粉拌膏的量相符，另装胶囊的重量达到每粒0.4克药粉，达到治疗剂量。
实施例2
一种治疗脑中风恢复期的中药制剂，该中药制剂由下述重量配比的原料制成：葛根100 份、三七100份、槐米100份、红花100份、地龙40份、川芎100份、豨签草70份、赤芍80份、水蛭30份、龙血竭80份。
一种治疗脑中风恢复期的中药制剂的制备方法，该方法包括以下步骤：
(1)以上十味原料，龙血竭粉成细粉，备用；
(2)取红花、川芎、槐米各一半量量与三七、水蛭2味处方量中药饮片粉碎成细粉，过筛、混匀；
(3)剩余红花、川芎、槐米各一半量与葛根、地龙、豨签草、赤芍4味处方量中药饮片加水煎煮二次，每次0.5小时，煎液过滤，合并滤液，滤液浓缩为相对密度为1.20～1.30(80℃) 的清膏；
(4)在步骤(3)的清膏加入步骤(2)的细粉，混匀，干燥，干燥后加入龙血竭粉碎成细粉，过筛，混匀，装入胶囊，制成1000粒，每粒含有0.4克药粉。
实施例3
一种治疗脑中风恢复期的中药制剂，该中药制剂由下述重量配比的原料制成：葛根135 份、三七70份、槐米100份、红花80份、地龙55份、川芎60份、豨签草100份、赤芍120份、水蛭30份、龙血竭50份。
一种治疗脑中风恢复期的中药制剂的制备方法，该方法包括以下步骤：
(1)以上十味原料，龙血竭粉成细粉，备用；
(2)取红花、川芎、槐米各一半量量与三七、水蛭2味处方量中药饮片粉碎成细粉，过筛、混匀；
(3)剩余红花、川芎、槐米各一半量与葛根、地龙、豨签草、赤芍4味处方量中药饮片加水煎煮二次，每次2小时，煎液过滤，合并滤液，滤液浓缩为相对密度为1.20～1.30(80℃)的清膏；
(4)在步骤(3)的清膏加入步骤(2)的细粉，混匀，干燥，干燥后加入龙血竭粉碎成细粉，过筛，混匀，装入胶囊，制成1000粒，每粒含有0.4克药粉。
实施例4
一种治疗脑中风恢复期的中药制剂，该中药制剂由下述重量配比的原料制成：葛根135 份、三七135份、槐米90份、红花90份、地龙45份、川芎70份、豨签草70份、赤芍60份、水蛭40份、龙血竭65份。
一种治疗脑中风恢复期的中药制剂的制备方法，参照实施例1。
实施例5
一种治疗脑中风恢复期的中药制剂，该中药制剂由下述重量配比的原料制成：葛根150 份、三七100份、槐米70份、红花70份、地龙30份、川芎90份、豨签草100份、赤芍100份、水蛭40份、龙血竭50份；
一种治疗脑中风恢复期的中药制剂的制备方法，参照实施例1。
实施例6
一种治疗脑中风恢复期的中药制剂，该中药制剂由下述重量配比的原料制成：葛根100 份、三七100份、槐米100份、红花100份、地龙40份、川芎100份、豨签草70份、赤芍80份、水蛭30份、龙血竭80份。
一种治疗脑中风恢复期的中药制剂的制备方法，参照实施例1。
实施例7
一种治疗脑中风恢复期的中药制剂，该中药制剂由下述重量配比的原料制成：葛根135份、三七70份、槐米100份、红花80份、地龙55份、川芎60份、豨签草100份、赤芍120 份、水蛭30份、龙血竭50份。
一种治疗脑中风恢复期的中药制剂的制备方法，参照实施例1。
本发明在研究开发此中药制剂过程中对组方原料的选择以及配比关系做了大量实验，成功的发明了上述组方和制备工艺，上述中药制剂的中药饮片缺一不可，重量配比非常重要，每个组分多、少对整体治疗效果都会有一定的影响，且工艺流程也对药效和药品质量稳定有一定影响。
Claims (5)
1.一种治疗脑中风恢复期的中药制剂，其特征在于，该中药制剂由下述重量配比的原料制成：葛根100～150份、三七70～140份、槐米70～100份、红花70～100份、地龙30～60份、川芎60～100份、豨签草70～100份、赤芍60～120份、水蛭30～50份、龙血竭50～80份；
具体制备方法为：
(1)按组成原料的重量称取龙血竭粉成细粉，备用；
(2)取红花、川芎、槐米各一半量与三七、水蛭2味处方量中药饮片粉碎成细粉，过筛、混匀，备用；
(3)剩余红花、川芎、槐米各一半量与葛根、地龙、豨签草、赤芍4味处方量中药饮片加水煎煮，煎液过滤，合并滤液，滤液浓缩得清膏，备用；
(4)在步骤(3)的清膏加入步骤(2)的细粉，混匀，干燥，干燥后加入龙血竭粉碎成细粉，过筛，混匀。
2.根据权利要求1所述的一种治疗脑中风恢复期的中药制剂，其特征在于，所述中药制剂由下述重量配比的原料制成：葛根120～140份、三七120～140份、槐米80～100份、红花80～100份、地龙40～60份、川芎60～80份、豨签草70～80份、赤芍60～80份、水蛭30～50份、龙血竭70～80份。
3.根据权利要求1所述的一种治疗脑中风恢复期的中药制剂，其特征在于，所述中药制剂由下述重量配比的原料制成：葛根135份、三七135份、槐米90份、红花90份、地龙45份、川芎70份、豨签草70份、赤芍60份、水蛭40份、龙血竭65份。
4.根据权利要求1至3任意一项所述的一种治疗脑中风恢复期的中药制剂，其特征在于，该中药制剂的剂型包括胶囊剂、片剂、粉剂或丸剂。
5.根据权利要求1所述的一种治疗脑中风恢复期的中药制剂，其特征在于，步骤(3)加水煎煮二次，每次1小时；将步骤(4)获得的细粉装入胶囊制成胶囊剂，或压制成片剂，或制成丸剂，每粒或每片或每丸剂中含有0.4克药粉。
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