CN104258300A - 一种治疗中风后遗症之气虚血瘀型的中药制剂及其制备方法 - Google Patents
一种治疗中风后遗症之气虚血瘀型的中药制剂及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种治疗中风后遗症之气虚血瘀型的中药制剂及其制备方法,中药制剂中各种原料药材为:箭叶蓼、聚头蓟、山药、刺五加、葛藟、当归、瓜馥木、沙棘、紫河车、羊红膻、玫瑰花、扶桑、天仙藤、姜黄、过江藤、夏天无、驱风通、枫香脂、红花、奇蒿、鸡血藤、凌霄花、索骨丹、牛膝、薯莨、鹿茸、黄花苜蓿、杜仲、灰栒子、海马、列当、龙眼肉、刺蓼、南沙参和常春藤。本发明的有益效果是:本发明具有益气活血,扶正祛邪的功效,主治中风后遗症之气虚血瘀型;具有起效快、有效率高、疗效确切、安全性高、无毒副作用;还具有药效持久、无耐药性、适合长期服用,可明显降低病残率,提高患者的生活质量等优势。
Description
技术领域
本发明涉及中药制药技术领域,特别涉及一种治疗中风后遗症之气虚血瘀型的中药制剂及其制备方法。
背景技术
中风是中医学的疾病名称,也是人们对急性脑血管疾病的统称和俗称,本病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,又称脑卒中或脑血管意外,具有极高的病死率和致残率,主要分为出血性脑中风(脑出血或蛛网膜下腔出血)和缺血性脑中风(脑梗死、脑血栓形成)两大类。出血性脑中风早期死亡率很高,约有半数病人于发病数日内死亡,幸存者中多数留有不同程度的运动障碍、认知障碍、言语吞咽障碍等后遗症。缺血性脑中风患者临床上以偏瘫为主要后遗症。多发生于50岁以后,男性略多于女性。
中风后遗症的病因主要表现为:因为脑血管意外之后,脑组织缺血或受血肿压迫、推移、脑水肿等而使脑组织功能受损。急性期后,偏瘫逐渐成为痉挛性,上肢屈曲、内收, 下肢呈直伸,腱反射亢进,运动能力可有恢复。因此,患者不仅要积极到医院进行药物治疗,而且在平时也要注重中风后遗症的饮食疗法,以便加快缓解病情的步伐。
中风后遗症的临床症状主要有以下几个方面:1.出血性脑中风:(1)肢体功能障碍主要表现偏瘫侧感觉和运动功能障碍。(2)认知和精神较大范围或多次复发的脑出血,可留有精神和认知障碍:如人格改变、消极悲观、郁抑寡欢、精神萎靡、易激动等。(3)言语功能障碍。(4)吞咽功能障碍。(5)其他症状头疼、眩晕、恶心、失眠、多梦、注意力不集中、耳鸣、眼花、多汗、心悸、步伐不稳、颈项酸痛疲乏、无力、食欲不振、记忆力减退、痴呆、抑郁等。2.缺血性脑中风:(1)偏瘫是最常见的脑血栓后遗症。一侧肢体肌力减退、活动不利或完全不能活动。常伴有同侧肢体的感觉障碍如冷热不知、疼痛不觉等。有时还可伴有同侧的视野缺损。(2)失语运动性失语:表现为病人能听懂别人的话语,但不能表达自己的意思。感觉性失语:则无语言表达障碍,听不懂别人的话,也听不懂自己所说的话,表现为答非所问,“自说自话”。命名性失语则表现为看到一件物品,能说出它的用途,但却叫不出名称。(3)较大范围或多次复发也是脑血栓后遗症的症状,可留有精神和智力障碍:人格改变、消极悲观、郁抑寡欢、精神萎靡、易激动等。(4)其他症状头疼、眩晕、恶心、失眠、多梦、注意力不集中、耳鸣、眼花、多汗、心悸、步伐不稳、颈项酸痛疲乏、无力、食欲不振、记忆力减退、不能耐受噪声等。
中医学认为,中风后遗症主要是由于中风之后气虚血瘀,脉络瘀阻,风痰阻络,或肝肾二亏,精血不足,筋骨失养所致。分析中风后遗症的病因,故辨其临床证候分为:1、风痰瘀血,痹阻脉络型:半身不遂,口舌歪斜,舌强言謇或不语,偏身麻木,头晕目眩,舌质暗淡,舌苔薄白或白腻,脉弦滑。2、肝阳暴亢,风火上扰型:半身不遂,偏身麻木,舌强言謇或不语,或口舌歪斜,眩晕头痛,面红目赤,口苦咽干,心烦易怒,尿赤便干,舌质红或红绛,脉弦有力。3、痰热腑实,风痰上扰型:半身不遂,口舌歪斜,言语謇涩或不语,偏身麻木,腹胀便干便秘,头晕目眩,咯痰或痰多,舌质暗红或暗淡,苔黄或黄腻,脉弦滑或偏瘫侧脉弦滑而大。4、气虚血瘀型:半身不遂,口舌歪斜,口角流涎,言语謇涩或不语,偏身麻木,面色觥白,气短乏力,心悸,自汗,便溏,手足肿胀,舌质暗淡,舌苔薄白或白腻,脉沉细、细缓或细弦。5、肝阳上亢型:半身不遂,口舌歪斜,舌强言謇或不语,偏身麻木,烦躁失眠,眩晕耳鸣,手足心热,舌质红绛或暗红,少苔或无苔,脉细弦或细弦数。6、痰热内闭清窍(阳闭)型:起病骤急,神昏或昏愦,半身不遂,鼻鼾痰鸣,肢体强痉拘急,项背身热,躁扰不宁,甚则手足厥冷,频繁抽搐,偶见呕血,舌质红绛,舌苔黄腻或干腻,脉弦滑数。7、痰湿蒙塞心神(阴闭)型:素体阳虚,突发神昏,半身不遂,肢体松懈,瘫软不温,甚则四肢逆冷,面白唇暗,痰涎壅盛,舌质暗淡,舌苔白腻,脉沉滑或沉缓。8、元气败脱,神明散乱(脱证)型:突然神昏或昏愦,肢体瘫软,手撤肢冷汗多,重则周身湿冷,二便失禁,舌痿,舌质紫暗,苔白腻,脉沉缓、沉微。
西医治疗中风后遗症药物:抗血小板聚集类:阿司匹林、氯吡格雷,抑制血小板聚集,从而起到防止血液凝固,进而预防脑中风的作用。但是,西药治疗靶点单一,并且多数西药都有不同程度的耐药性,而绝大多数西药的副作用明显,对胃肠、肝肾造成不同程度的损伤;不适合在恢复期和二级预防期长期服用。
发明内容
本发明所要解决的技术问题在于,提供一种治疗中风后遗症之气虚血瘀型的中药制剂及其制备方法,本发明具有益气活血,扶正祛邪的功效,主治中风后遗症之气虚血瘀型;具有起效快、有效率高、疗效确切、安全性高、无毒副作用;还具有药效持久、无耐药性、适合长期服用,可明显降低病残率,提高患者的生活质量等优势。
为了解决上述技术问题,本发明提供一种治疗中风后遗症之气虚血瘀型的中药制剂,其中,包括以下原料药材:箭叶蓼、聚头蓟、山药、刺五加、葛藟、当归、瓜馥木、沙棘、紫河车、羊红膻、玫瑰花、扶桑、天仙藤、姜黄、过江藤、夏天无、驱风通、枫香脂、红花、奇蒿、鸡血藤、凌霄花、索骨丹、牛膝、薯莨、鹿茸、黄花苜蓿、杜仲、灰栒子、海马、列当、龙眼肉、刺蓼、南沙参和常春藤。
其中,所述中药制剂中各原料药材的重量份数比为:箭叶蓼15~30份、聚头蓟12~22份、山药10~20份、刺五加16~28份、葛藟15~30份、当归14~28份、瓜馥木17~32份、沙棘18~36份、紫河车10~25份、羊红膻12~22份、玫瑰花10~25份、扶桑10~22份、天仙藤13~27份、姜黄14~27份、过江藤10~20份、夏天无14~26份、驱风通14~25份、枫香脂13~27份、红花13~28份、奇蒿10~25份、鸡血藤10~25份、凌霄花16~32份、索骨丹5~7份、牛膝17~28份、薯莨14~32份、鹿茸10~32份、黄花苜蓿15~30份、杜仲10~26份、灰栒子10~24份、海马16~28份、列当14~26份、龙眼肉13~28份、刺蓼10~20份、南沙参11~23份和常春藤10~25份。
其中,所述中药制剂中各原料药材的重量份数比为:箭叶蓼17~26份、聚头蓟15~20份、山药12~20份、刺五加18~25份、葛藟17~25份、当归16~25份、瓜馥木18~26份、沙棘20~30份、紫河车13~22份、羊红膻13~17份、玫瑰花14~21份、扶桑14~20份、天仙藤14~25份、姜黄15~24份、过江藤13~18份、夏天无16~23份、驱风通18~22份、枫香脂14~24份、红花15~26份、奇蒿13~21份、鸡血藤16~23份、凌霄花18~30份、索骨丹4~6份、牛膝18~24份、薯莨15~28份、鹿茸12~27份、黄花苜蓿18~25份、杜仲14~24份、灰栒子15~20份、海马18~25份、列当15~25份、龙眼肉15~25份、刺蓼12~18份、南沙参15~20份和常春藤15~22份。
其中,所述中药制剂中各原料药材的重量份数比为:箭叶蓼20份、聚头蓟18份、山药14份、刺五加22份、葛藟24份、当归18份、瓜馥木25份、沙棘22份、紫河车15份、羊红膻16份、玫瑰花15份、扶桑16份、天仙藤22份、姜黄17份、过江藤15份、夏天无20份、驱风通20份、枫香脂17份、红花18份、奇蒿17份、鸡血藤22份、凌霄花19份、索骨丹5份、牛膝21份、薯莨24份、鹿茸19份、黄花苜蓿20份、杜仲21份、灰栒子18份、海马22份、列当23份、龙眼肉17份、刺蓼16份、南沙参17份和常春藤21份。
其中,所述中药制剂中各原料药材的重量份数比为:箭叶蓼24份、聚头蓟19份、山药13份、刺五加22份、葛藟24份、当归18份、瓜馥木25份、沙棘22份、紫河车16份、羊红膻15份、玫瑰花16份、扶桑17份、天仙藤22份、姜黄20份、过江藤14份、夏天无18份、驱风通20份、枫香脂22份、红花25份、奇蒿15份、鸡血藤18份、凌霄花21份、索骨丹6份、牛膝23份、薯莨24份、鹿茸22份、黄花苜蓿19份、杜仲21份、灰栒子16份、海马22份、列当17份、龙眼肉18份、刺蓼16份、南沙参19份和常春藤20份。
其中,所述中药制剂中各原料药材的重量份数比为:箭叶蓼18份、聚头蓟20份、山药17份、刺五加22份、葛藟21份、当归18份、瓜馥木24份、沙棘26份、紫河车22份、羊红膻15份、玫瑰花18份、扶桑17份、天仙藤20份、姜黄23份、过江藤16份、夏天无22份、驱风通20份、枫香脂14份、红花23份、奇蒿20份、鸡血藤21份、凌霄花23份、索骨丹4份、牛膝21份、薯莨25份、鹿茸14份、黄花苜蓿22份、杜仲20份、灰栒子18份、海马21份、列当24份、龙眼肉18份、刺蓼14份、南沙参18份和常春藤19份。
其中,所述中药制剂的剂型为胶囊剂时,其制备方法包括以下步骤:
第一步,将所述中药各原料药材按比例混合,加入相对于混合物质量3~5倍的醇浓度为85~90%的乙醇,加热回流1~3小时,提取,过滤获得第一提取液;过滤获得的药渣再加入相对于所述药渣质量1~2倍的醇浓度为85~95%的乙醇,加热回流1~3小时,提取,过滤获得第二提取液;将第一提取液和第二提取液合并,减压浓缩除去乙醇溶剂,干燥,获得干膏;
第二步,将第一步获得的干膏放置在超微粉碎机中粉碎1~2小时,粉碎,过筛,获得400目~500目的超微细粉;
第三步,在第二步获得的超微细粉中依次加入滑石粉、硬脂酸镁,进行混匀处理,即得胶囊内容物;所述超微细粉、硬脂酸镁和滑石粉的重量比为100∶0.1~0.5:0.1~0.5,将所述胶囊内容物装入胶囊壳体中,即得胶囊剂成品。
其中,所述中药制剂的剂型为口服液时,其制备方法包括以下步骤:
第一步,将索骨丹、牛膝、薯莨、鹿茸、黄花苜蓿、杜仲、灰栒子、海马和列当混合,加相对于混合物3倍~5倍量醇浓度为55%~65%的乙醇回流提取2次~4次,每次2小时~3小时,过滤,滤液合并,回收乙醇,浓缩至70℃相对密度为1.30~1.32的膏体,备用;
第二步,将箭叶蓼、聚头蓟、山药、刺五加、葛藟、当归、瓜馥木、沙棘、紫河车、羊红膻、玫瑰花、扶桑、天仙藤、姜黄、过江藤、夏天无、驱风通、枫香脂、红花、奇蒿、鸡血藤、凌霄花、龙眼肉、刺蓼、南沙参和常春藤按比例混合,加相对于混合物3~5倍量水,煮沸4~6小时,过滤,浓缩至80℃相对密度为1.20~1.27的膏体;第三步,将第一步、第二步获得的所述膏体混合,65℃~85℃减压真空干燥,得干膏粉;
第四步,将第三步获得的所述干膏粉中加入乙醇,得到含醇膏体,所述含醇膏体的含醇量为55%~75%;将所述含醇膏体依次进行冷藏处理、沉淀处理、过滤处理、回收乙醇处理,得到脱醇膏体,其中,冷藏处理时间为30~40小时;
第五步,将所述脱醇膏体中加入蔗糖粉、活性炭,依次进行加热处理、过滤处理、稀释处理,得到半成品;所述脱醇膏体与所述蔗糖粉的重量比为1∶0.1~0.3;所述脱醇膏体与所述活性炭的重量比为1∶0.001~0.002;所述加热处理的时间为20~40分钟,温度为100℃~110℃;
第六步,再将第五步获得的所述半成品依次进行过滤处理、灌封处理、灭菌处理,即得所述中药制剂口服液成品。
其中,所述中药的剂型为片剂时,其制备方法包括以下步骤:
第一步,将所述中药各原料药材按比例混合,加入相对于混合物质量3~5倍的醇浓度为85%~95%的乙醇,加热回流4~6小时,提取,过滤获得第一提取液;过滤获得的药渣再加入相对于所述药渣质量2~4倍的醇浓度为90%~95%的乙醇,加热回流1~3小时,提取,过滤获得第二提取液;将第一提取液和第二提取液合并,减压浓缩除去乙醇溶剂,干燥,获得干膏;
第二步,将第一步获得的干膏放置在超微粉碎机中粉碎1~3小时,粉碎,过筛,获得400目~500目的超微细粉;
第三步,将第二步获得的超微细粉,加入相对于其质量0.1~0.2倍的微晶纤维素、0.15~0.3倍乳糖、0.2~0.3倍的淀粉,过筛,混合均匀,制粒,干燥,加入相对于超微细粉质量0.025~0.04倍硬脂酸镁,整粒,压片,制成。
本发明的有益效果是:本发明具有益气活血,扶正祛邪的功效,主治中风后遗症之气虚血瘀型;具有起效快、有效率高、疗效确切、安全性高、无毒副作用;还具有药效持久、无耐药性、适合长期服用,可明显降低病残率,提高患者的生活质量等优势。
具体实施方式
中医学认为,中风后遗症主要是由于中风之后气虚血瘀,脉络瘀阻,风痰阻络,或肝肾二亏,精血不足,筋骨失养所致。
因此,本发明提供了一种治疗中风后遗症之气虚血瘀型的中药制剂,其中于,包括以下原料药材:箭叶蓼、聚头蓟、山药、刺五加、葛藟、当归、瓜馥木、沙棘、紫河车、羊红膻、玫瑰花、扶桑、天仙藤、姜黄、过江藤、夏天无、驱风通、枫香脂、红花、奇蒿、鸡血藤、凌霄花、索骨丹、牛膝、薯莨、鹿茸、黄花苜蓿、杜仲、灰栒子、海马、列当、龙眼肉、刺蓼、南沙参和常春藤。
其中,上述原料药材的药理如下:
山药:味甘,性平,入肺、脾、肾经,具有健脾补肺、益胃补肾、固肾益精、聪耳明目、助五脏、强筋骨、长志安神、延年益寿的功效,主治脾胃虚弱、倦怠无力、食欲不振、久泄久痢、肺气虚燥、痰喘咳嗽、肾气亏耗、腰膝酸软、下肢痿弱、消渴尿频、遗精早泄、带下白浊、皮肤赤肿、肥胖等证。
刺五加:味辛、苦、微甘,性温,入脾、肾、心经,具有益气健脾,补肾安神,祛风除湿的功效,用于风寒湿痹、腰膝疼痛、筋骨痿软、行动迟缓、体虚羸弱、跌打损伤、骨折、水肿、脚气、阴下湿痒等证。刺五加甘A为胡萝卜素,人蔘中也含这类成分。在人体内能促进胆固醇的排泄,可防治血液中胆固醇含量过高症。刺五加甘B为紫丁香素( Syringin ),是刺五加的主要强壮成分,有促性腺、抗辐射、抗疲劳等作用,具有与人蔘皂素相似的生理活性。刺五加含超氧化歧化酵素SOD(Superoxide dimutase)复合物,SOD具有良好的抗氧化功能,可以增强人体免疫以及抵抗自由基攻击的效果,具有抗氧化作用,可增强人体免疫力、防止老化及促进健康。
当归:味辛、苦、微甘,性温,入脾、肾、心经,具有益气健脾,补肾安神,祛风除湿的功效,用于风寒湿痹、腰膝疼痛、筋骨痿软、行动迟缓、体虚羸弱、跌打损伤、骨折、水肿、脚气、阴下湿痒等证。
沙棘:沙棘果实中含有异鼠李素及其糖甙、槲皮素、山柰酚等7种黄桐物质,具有止咳、平喘祛痰、扩张冠状血管、降低胆固醇的效能,常用于治疗缺血性心脏病,对治疗心绞痛有效率达94%。沙棘中SOD活性成分丰富,每克沙棘鲜果SOD含量达到2746.0个酶单位,其含量是人参的4倍。它可以阻断因体内物质过氧化产生的自由基,而这种自由基与人体衰老、疾病的发生密切相关。
紫河车:甘、咸、温;入肺、心、肾经。《本草拾遗》:“主气血羸瘦,妇人劳损,面黩皮黑,腹内诸病渐瘦悴者。”现代医学研究认为,胎盘含蛋白质、糖、钙、维生素、免疫因子、女性激素、助孕酮、类固醇激素、促性腺激素、促肾上腺皮质激素等,能促进乳腺、子宫、阴道、睾丸的发育,对甲状腺也有促进作用,临床用于治疗子宫发育不全、子宫萎缩、子宫肌炎、机能性无月经、子宫出血、乳汁缺乏症等,均有显著疗效,对肺结核、支气管哮喘、贫血等亦有良效,研末口服或灌肠可预防麻疹或减轻症状。
羊红膻:味甘,辛,性温;归心、肾、肺、脾经。《陕西中草药》:“祛寒宣肺,祛风解毒,活血散瘀,消肿止痛。”《中药通报》:“治疗产后虚弱,阳痿不育,风寒感冒,痰饮咳嗽等。”温中散寒、温肾助阳,活血化瘀;健脾益气,养心安神,止咳祛痰。主治克山病,心改建,气短,咳喘。用于脾胃虚寒所致脘腹冷痛、呕吐、泄泻等。用治风寒袭肺、肺气失宣、咳嗽咳痰、胸闷喘息。
玫瑰花:性温,味甘微苦,归肝脾经。《本草纲目拾遗》:“和血,行血,理气。治风痹。”《本草再新》:“舒肝胆之郁气,健脾降火。治腹中冷痛,胃脘积寒,兼能破血。”利气、行血,治风痹,散疲止痛。玫瑰花及全株都有收敛性,可用于妇女月经过多,赤白带下以及肠炎、下痢、肠红半截出血等。理气解郁、和血散瘀。主治肝胃气痛,新久风痹,吐血咯血,月经不调,赤白带下,痢疾、乳痈,肿毒。玫瑰花中含有300多种化学成份,如芳香的醇、醛、脂肪酸、酚和含香精的油和脂,常食玫瑰制品中以柔肝醒胃,舒气活血,美容养颜,令人神爽。
天仙藤:苦,温;入肝、脾、肾经。《本草图经》:"解风劳。得麻黄则治伤寒发汗,与大黄同服堕胎气。"《本草再新》:"凉血活血,去风利湿,走经络,兼治腰腿肿疼。"行气化湿,活血止痛。治胃痛,疝气痛,妊娠水肿,产后血气腹痛,风湿疼痛。 行气活血,止痛,利尿。妊娠水肿,胸腹痛,疝痛,风湿痛。天仙藤,流气活血,治一切诸痛之药也。人身之气,顺则和平,逆则痛闷作矣。如杨氏《直指方》天仙藤治痰注臂痛,气留疝痛,瘕聚,奔豚腹痛,产后血气腹痛,他如妊娠水肿,面浮气促,男子风劳,久嗽不愈,悉以此药治之,无不寝安。盖谓其善于流行血气故也。观书所论主治,止属妊娠子肿、腹痛、风痨等症,而于他症则未及焉。即其所治之理,亦不过因味苦主于疏泄,性温得以通活,故能活血通道,而使水无不利,风无不除,血无不活,痛与肿均无不治故也。
姜黄:味辛、苦,性温,归肝、脾经,《本草纲目》:“姜黄,近时以扁如干姜形者为片子姜黄,圆如蝉腹形者为蝉肚郁金,并可浸水染色,蒁形虽似郁金,面色不黄也。”《本草求原》:“姜黄,益火生气,辛温这火化气,气生化则津液行于三阴三阳;清者注于肺,浊者注于经、溜于海,而血自行,是理气散结而兼泄血也。”具有破血行气,通经止痛的功效。用于血滞经闭,行经腹痛,胸胁剌痛,风湿痹痛,肩臂疼痛,跌扑损伤等证。
夏天无:苦、微辛,温。归肝经。《全国中草药汇编》:“祛风湿,降血压。主治风湿性关节炎、腰肌劳损,高血压病,脑血管意外引起偏瘫。”功能活血通络,行气止痛。用于中风偏瘫,跌扑损伤,风湿性关节炎,坐骨神经痛。夏天无生物碱可使麻醉犬脑与下肢血流量增加,血管阻力减低(经统计学处理均有显著差异),血压轻度下降,提示其有扩张脑血管和下肢血管的作用。枫香脂:辛,苦,平;归脾,肺,肝经。功用祛风活血,解毒止痛,止血生肌。用于痈疽,疮疹,瘰疬,齿痛,痹痛,瘫痪,吐血,衄血,咯血,外伤出血,皮肤皲裂。枫香脂及其挥发油体外实验可使兔血栓长度缩短和重量(湿重和干重)减轻,在体实验显示可明显抑制大鼠血栓形成;试管法实验表明可明显提高纤溶酶活性,显著提高血小板内cAMP含量。表明枫香脂及其挥发油抗血栓作用与促进纤溶活性和提高血小板cAMP有关,并提示挥发油可能是枫香脂的主要止血成分。
红花:性温,味辛,活血通经、散瘀止痛。用于经闭、痛经、恶露不行、症瘕痞块、跌打损伤。古人常有於血在体内时,常加红花一小把。纱布包煮开可用一天两次泡脚,适用各种静脉曲张,末梢神经炎,血液循环不好,腿脚麻木或青紫等淤血症。红花煎剂小剂量能使蟾蜍离体心脏及兔在体心脏轻度兴奋,使心跳有力,振幅加大;大剂量则对心脏有抑制作用,使心率减慢,心肌收缩力减弱,心搏出量减少。在兔、大鼠、犬等造成实验性心肌缺血或心肌梗塞的动物模型上,红花及其制剂均有不同程度的对抗作用。如先用含微量肾上腺素或去甲肾上腺素的洛氏液灌流血管,使动物离体血管平滑肌收缩保持一定的血管紧张性,造成可能类似人的血脉不通、血瘀状态。红花煎剂、红花黄色素及其他制剂对麻醉猫或犬均有不同程度的迅速降压作用,平均血压下降20毫米Hg左右,持续约30分钟后恢复。
鸡血藤:性味苦、甘,温。归肝、肾经。可活血舒筋;养血调经。主手足麻木;肢体瘫痪;风湿痹痛;妇女有经不调;痛经;闭经。功用:补血,活血,通络。用于月经不调,血虚萎黄,麻木瘫痪,风湿痹痛。本品含刺芒柄花素、芒柄花甙、樱黄素、阿弗罗莫辛、卡亚宁、甘草查耳酮、异甘草素、四羟基查耳酮、大豆黄素、苜蓿酚、9-O-甲氧基香豆雌酚、3,7-二羟基-6-甲氧基二氢黄酮醇、表儿茶精、原儿茶酸、无羁萜-3b-醇、b-谷甾醇、胡萝卜甾醇和7-酮基-b-谷甾醇。药理作用:对造血系统的作用;对凝血、纤溶的作用;抑制心脏和降低血压作用;抗癌作用;对脂质代谢的调节。
凌霄花:甘、酸,寒;归肝、心包经。《本草纲目》:“凌雷花及根,甘酸而寒,茎叶带苦,行血分,能去血中伏火,故主产乳崩漏诸疾及血热生风之证也。”《本经逢原》:“凌雪花,额痛血闭,血气刺痛,厉风恶疮多用之,皆取其散恶血之功也。”《神农本草经》:“主妇人产乳余疾,崩中,症瘕,血闭,寒热羸瘦。”行血去瘀,凉血祛风。用于经闭癓瘕,产后乳肿,风疹发红,皮肤瘙痒,痤疮。
牛膝:味苦,酸,性平;归肝,肾经。《日华子本草》:“治腰膝软怯冷弱,破症结,排脓止痛,产后心腹痛并血运,落胎,壮阳。”《滇南本草》:“治疔疮、痈疽,敷患处。亦能打胎。同猪肉煨食之,能明目。”具有补肝肾,强筋骨,活血通经,引火(血)下行,利尿通淋的功效,怀牛膝功偏滋补肝肾,壮腰膝:用于肝肾不足引起的筋骨酸软、腰膝疼痛。
鹿茸:甘、咸,温。归肾、肝经。壮肾阳,补精髓,强筋骨,调冲任,托疮毒。主治肾虚、头晕、耳聋、目暗、阳痿、滑精、宫冷不孕、羸瘦、神疲、畏寒、腰脊冷痛、筋骨痿软、崩漏带下、阴疽不敛及久病虚损等症。鹿茸含有比人参更丰富的氨基酸、卵磷脂、维生素和微量元素等。鹿茸性温而不燥,具有振奋和提高机体功能,对全身虚弱、久病之后患者,有较好的保健作用。鹿茸可以提高机体的细胞免疫和体液免疫功能,促进淋巴细胞的转化,具有免疫促进剂的作用。它能增加机体对外界的防御能力,调节体内的免疫平衡而避免疾病发生和促进创伤愈合、病体康复,从而起到强壮身体、抵抗衰老的作用。
杜仲:味甘、微辛,性温,入肝、肾经。《玉楸药解》:"益肝肾,养筋骨,去关节湿淫。治腰膝酸痛,腿足拘挛。"《神农本草经》:“主腰脊痛、补中益精气、坚筋骨、强志、除阴下痒湿、小便余沥。”《药性论》:“治肾冷臀腰痛,腰病人虚而身强直,风也。腰不利加而用之。”杜仲具有补肝肾,强筋骨,清除体内垃圾,加强人体细胞物质代谢,防止肌肉骨骼老化,平衡人体血压,分解体内胆固醇,降低体内脂肪,恢复血管弹性,利尿清热,广谱抗菌,兴奋中枢神经,提高白血球药理作用。杜仲的叶和皮含有蛋白质、脂肪、维生素和矿物质等营养成分。杜仲游离氨基酸极少,含有的少量蛋白质,是和绝大多数食品类似的完全蛋白,即能够水解检出对人体必需的8种氨基酸。杜仲对免疫系统、内分泌系统、中枢神经系统、循环系统和泌尿系统都有不同程度的调节作用,杜仲能兴奋垂体-肾上腺皮质系统,增强肾上腺皮质功能。动物实验表明,杜仲含有一种可促进人体的皮肤、骨骼、肌肉中的蛋白质胶原的合成与分解的特殊成分,具有促进代谢、防止衰退的功能。
海马:甘温。具有补肾壮阳、温通血脉、镇静安神、散结消肿、舒筋活络、止咳平喘之功效。海马性温助阳,能温通经脉,又有活血作用,主治肾虚、阳痿、遗尿。海马是一种经济价值较高的名贵中药,具有强身健体、补肾壮阳、舒筋活络、消炎止痛、镇静安神、止咳平喘等药用功能,特别是对于治疗神经系统的疾病更为有效。海马除了主要用于制造各种合成药品外,还可以直接服用健体治病。海马能增强小鼠耐缺氧性,减少单胺氧化酶的活性,降低过氧化脂体在体内的含量。此外,各种海马提取物均有钙通道阻断剂的作用。通过阻断钙内流,达到保护神经元的功效。
龙眼肉:《滇南本草》:“养血安神,长智敛汗,开胃益脾。”《泉州本草》:“壮阳益气,补脾胃。治妇人产后浮肿,气虚水肿,脾虚泄泻。补益心脾,”养血安神。用于气血不足、心悸怔忡、健忘失眠、血虚萎黄。
南沙参:味甘、微苦,性微寒,入肺、胃经。清热养阴,有润肺止咳,养胃生津的作用,主要用于阴虚肺燥、干咳少痰、劳嗽痰血,胃阴不足、口感咽燥、气管炎,百日咳,肺热咳嗽,咯痰黄稠、大便秘结、舌红少苔等证。
箭叶蓼:性味: 酸、涩,平。主治:祛风除湿,清热解毒。用于风湿关节痛,毒蛇咬伤。
聚头蓟:性味:甘,苦。主治:凉血,消炎散肿。主治吐血,鼻出血,尿血,子宫出血,黄疸,疮痈。
葛藟:性味:甘,平。主治:补五脏,续筋骨,长肌肉,果实可食。
骨节酸痛,跌打损伤:根皮用甜酒捣烂敷患处。
瓜馥木:性味:微辛,温。主治:祛风活血,镇痛。主治坐骨神经痛,关节炎,跌打损伤。
扶桑:性味: 甘,平。主治:解毒,利尿,调经。根:用于腮腺炎,支气管炎,尿路感染,子宫颈炎,白带,月经不调,闭经;叶、花:外用治疔疮痈肿,乳腺炎,淋巴腺炎;花:月经不调。
过江藤:性味:微苦、辛,平。主治:清热解毒,散瘀消肿。用于痢疾,急性扁桃体炎,咳嗽咯血,跌打损伤;外用治痈疽疔毒,带状疱疹,慢性湿疹。
驱风通:性味:辛、微苦,温。主治:祛风除湿,活血散瘀,消肿止痛。风湿骨痛,感冒风寒,小儿麻痹后遗症:茎或枝3~8钱,水煎服。跌打骨折,外伤出血:叶捣烂外敷。烧烫伤:茎适量水煎外洗,并有叶研粉撒布患处。毒蛇咬伤:用干或鲜叶捣烂加酒或酒糟热敷患处,或用干粉加鲜薄荷叶加酒少许捣烂外敷。
奇蒿:性味:辛、苦,平。主治:清暑利湿,活血行瘀,通经止痛。用于中暑,头痛,肠炎,痢疾,经闭腹痛,风湿疼痛,跌打损伤;外用治创伤出血,乳腺炎。
索骨丹:性味:苦、涩,平。主治:凉血止血,消肿解毒。用于甲状腺肿,咽喉肿痛,衄血,吐血,咯血,崩漏,腹泻,痢疾,便血;外用治外伤出血,子宫脱垂。
薯莨:性味:苦、微酸、涩,平。主治:活血补血,收敛固涩。用于功能性子宫出血,产后出血,咯血,吐血,便血,尿血,腹泻;外用治烧伤。
黄花苜蓿:性味:苦,平。主治:降压利尿,消炎解毒。主治浮肿,各种恶疮。
灰栒子:性味:苦、涩,平。主治:凉血,止血。治鼻衄,牙龈出血,月经过多等症。
列当:性味:甘、咸,温。主治:补肾壮阳,润肠通便。用于肾虚阳痿,腰膝冷痛,肠燥便秘。
刺蓼:性味:酸、微辛,平。主治:解毒消肿,利湿止痒。用于湿疹,黄水疮,疔疮,痈疖,蛇咬伤。
常春藤:性味:苦、辛,温。主治:祛风利湿,活血消肿。用于风湿关节痛,腰痛,跌打损伤,急性结膜炎,肾炎水肿,闭经;外用治痈疖肿毒,荨麻疹,湿疹。
其中,所述中药制剂中各原料药材的重量份数比为:箭叶蓼15~30份、聚头蓟12~22份、山药10~20份、刺五加16~28份、葛藟15~30份、当归14~28份、瓜馥木17~32份、沙棘18~36份、紫河车10~25份、羊红膻12~22份、玫瑰花10~25份、扶桑10~22份、天仙藤13~27份、姜黄14~27份、过江藤10~20份、夏天无14~26份、驱风通14~25份、枫香脂13~27份、红花13~28份、奇蒿10~25份、鸡血藤10~25份、凌霄花16~32份、索骨丹5~7份、牛膝17~28份、薯莨14~32份、鹿茸10~32份、黄花苜蓿15~30份、杜仲10~26份、灰栒子10~24份、海马16~28份、列当14~26份、龙眼肉13~28份、刺蓼10~20份、南沙参11~23份和常春藤10~25份。
其中,所述中药制剂中各原料药材的重量份数比为:箭叶蓼17~26份、聚头蓟15~20份、山药12~20份、刺五加18~25份、葛藟17~25份、当归16~25份、瓜馥木18~26份、沙棘20~30份、紫河车13~22份、羊红膻13~17份、玫瑰花14~21份、扶桑14~20份、天仙藤14~25份、姜黄15~24份、过江藤13~18份、夏天无16~23份、驱风通18~22份、枫香脂14~24份、红花15~26份、奇蒿13~21份、鸡血藤16~23份、凌霄花18~30份、索骨丹4~6份、牛膝18~24份、薯莨15~28份、鹿茸12~27份、黄花苜蓿18~25份、杜仲14~24份、灰栒子15~20份、海马18~25份、列当15~25份、龙眼肉15~25份、刺蓼12~18份、南沙参15~20份和常春藤15~22份。
其中,所述中药制剂中各原料药材的重量份数比为:箭叶蓼20份、聚头蓟18份、山药14份、刺五加22份、葛藟24份、当归18份、瓜馥木25份、沙棘22份、紫河车15份、羊红膻16份、玫瑰花15份、扶桑16份、天仙藤22份、姜黄17份、过江藤15份、夏天无20份、驱风通20份、枫香脂17份、红花18份、奇蒿17份、鸡血藤22份、凌霄花19份、索骨丹5份、牛膝21份、薯莨24份、鹿茸19份、黄花苜蓿20份、杜仲21份、灰栒子18份、海马22份、列当23份、龙眼肉17份、刺蓼16份、南沙参17份和常春藤21份。
其中,所述中药制剂中各原料药材的重量份数比为:箭叶蓼24份、聚头蓟19份、山药13份、刺五加22份、葛藟24份、当归18份、瓜馥木25份、沙棘22份、紫河车16份、羊红膻15份、玫瑰花16份、扶桑17份、天仙藤22份、姜黄20份、过江藤14份、夏天无18份、驱风通20份、枫香脂22份、红花25份、奇蒿15份、鸡血藤18份、凌霄花21份、索骨丹6份、牛膝23份、薯莨24份、鹿茸22份、黄花苜蓿19份、杜仲21份、灰栒子16份、海马22份、列当17份、龙眼肉18份、刺蓼16份、南沙参19份和常春藤20份。
其中,所述中药制剂中各原料药材的重量份数比为:箭叶蓼18份、聚头蓟20份、山药17份、刺五加22份、葛藟21份、当归18份、瓜馥木24份、沙棘26份、紫河车22份、羊红膻15份、玫瑰花18份、扶桑17份、天仙藤20份、姜黄23份、过江藤16份、夏天无22份、驱风通20份、枫香脂14份、红花23份、奇蒿20份、鸡血藤21份、凌霄花23份、索骨丹4份、牛膝21份、薯莨25份、鹿茸14份、黄花苜蓿22份、杜仲20份、灰栒子18份、海马21份、列当24份、龙眼肉18份、刺蓼14份、南沙参18份和常春藤19份。
其中,所述中药制剂的剂型为胶囊剂时,其制备方法包括以下步骤:
第一步,将所述中药各原料药材按比例混合,加入相对于混合物质量3~5倍的醇浓度为85~90%的乙醇,加热回流1~3小时,提取,过滤获得第一提取液;过滤获得的药渣再加入相对于所述药渣质量1~2倍的醇浓度为85~95%的乙醇,加热回流1~3小时,提取,过滤获得第二提取液;将第一提取液和第二提取液合并,减压浓缩除去乙醇溶剂,干燥,获得干膏;
第二步,将第一步获得的干膏放置在超微粉碎机中粉碎1~2小时,粉碎,过筛,获得400目~500目的超微细粉;
第三步,在第二步获得的超微细粉中依次加入滑石粉、硬脂酸镁,进行混匀处理,即得胶囊内容物;所述超微细粉、硬脂酸镁和滑石粉的重量比为100∶0.1~0.5:0.1~0.5,将所述胶囊内容物装入胶囊壳体中,即得胶囊剂成品。
其中,所述当所述中药制剂的剂型为口服液时,其制备方法包括以下步骤:
第一步,将索骨丹、牛膝、薯莨、鹿茸、黄花苜蓿、杜仲、灰栒子、海马和列当混合,加相对于混合物3倍~5倍量醇浓度为55%~65%的乙醇回流提取2次~4次,每次2小时~3小时,过滤,滤液合并,回收乙醇,浓缩至70℃相对密度为1.30~1.32的膏体,备用;
第二步,将箭叶蓼、聚头蓟、山药、刺五加、葛藟、当归、瓜馥木、沙棘、紫河车、羊红膻、玫瑰花、扶桑、天仙藤、姜黄、过江藤、夏天无、驱风通、枫香脂、红花、奇蒿、鸡血藤、凌霄花、龙眼肉、刺蓼、南沙参和常春藤按比例混合,加相对于混合物3~5倍量水,煮沸4~6小时,过滤,浓缩至80℃相对密度为1.20~1.27的膏体;第三步,将第一步、第二步获得的所述膏体混合,65℃~85℃减压真空干燥,得干膏粉;
第四步,将第三步获得的所述干膏粉中加入乙醇,得到含醇膏体,所述含醇膏体的含醇量为55%~75%;将所述含醇膏体依次进行冷藏处理、沉淀处理、过滤处理、回收乙醇处理,得到脱醇膏体,其中,冷藏处理时间为30~40小时;
第五步,将所述脱醇膏体中加入蔗糖粉、活性炭,依次进行加热处理、过滤处理、稀释处理,得到半成品;所述脱醇膏体与所述蔗糖粉的重量比为1∶0.1~0.3;所述脱醇膏体与所述活性炭的重量比为1∶0.001~0.002;所述加热处理的时间为20~40分钟,温度为100℃~110℃;
第六步,再将第五步获得的所述半成品依次进行过滤处理、灌封处理、灭菌处理,即得所述中药制剂口服液成品。
其中,所述中药的剂型为片剂时,其制备方法包括以下步骤:
第一步,将所述中药各原料药材按比例混合,加入相对于混合物质量3~5倍的醇浓度为85%~95%的乙醇,加热回流4~6小时,提取,过滤获得第一提取液;过滤获得的药渣再加入相对于所述药渣质量2~4倍的醇浓度为90%~95%的乙醇,加热回流1~3小时,提取,过滤获得第二提取液;将第一提取液和第二提取液合并,减压浓缩除去乙醇溶剂,干燥,获得干膏;
第二步,将第一步获得的干膏放置在超微粉碎机中粉碎1~3小时,粉碎,过筛,获得400目~500目的超微细粉;
第三步,将第二步获得的超微细粉,加入相对于其质量0.1~0.2倍的微晶纤维素、0.15~0.3倍乳糖、0.2~0.3倍的淀粉,过筛,混合均匀,制粒,干燥,加入相对于超微细粉质量0.025~0.04倍硬脂酸镁,整粒,压片,制成。
实施例1 胶囊剂
本发明口服胶囊剂的制作过程为:取箭叶蓼200g、聚头蓟180g、山药140g、刺五加220g、葛藟240g、当归180g、瓜馥木250g、沙棘220g、紫河车150g、羊红膻160g、玫瑰花150g、扶桑160g、天仙藤220g、姜黄170g、过江藤150g、夏天无200g、驱风通200g、枫香脂170g、红花180g、奇蒿170g、鸡血藤220g、凌霄花190g、索骨丹50g、牛膝210g、薯莨240g、鹿茸190g、黄花苜蓿200g、杜仲210g、灰栒子180g、海马220g、列当230g、龙眼肉170g、刺蓼160g、南沙参170g和常春藤210g;
第一步,将所述中药各原料药材按比例混合,加入相对于混合物质量5倍的醇浓度为90%的乙醇,加热回流2小时,提取,过滤获得第一提取液;过滤获得的药渣再加入相对于所述药渣质量1.5倍的醇浓度为85%的乙醇,加热回流3小时,提取,过滤获得第二提取液;将第一提取液和第二提取液合并,减压浓缩除去乙醇溶剂,干燥,获得干膏;
第二步,将第一步获得的干膏放置在超微粉碎机中粉碎2小时,粉碎,过筛,获得500目的超微细粉;
第三步,在第二步获得的超微细粉中依次加入滑石粉、硬脂酸镁,进行混匀处理,即得胶囊内容物;所述超微细粉、硬脂酸镁和滑石粉的重量比为100∶0.3:0.2,将所述胶囊内容物装入胶囊壳体中,即得胶囊剂成品。
实施例2 口服液
本发明口服液的制作过程为:取箭叶蓼240g、聚头蓟190g、山药130g、刺五加220g、葛藟240g、当归180g、瓜馥木250g、沙棘220g、紫河车160g、羊红膻150g、玫瑰花160g、扶桑170g、天仙藤220g、姜黄200g、过江藤140g、夏天无180g、驱风通200g、枫香脂220g、红花250g、奇蒿150g、鸡血藤180g、凌霄花210g、索骨丹60g、牛膝230g、薯莨240g、鹿茸220g、黄花苜蓿190g、杜仲210g、灰栒子160g、海马220g、列当170g、龙眼肉180g、刺蓼160g、南沙参190g和常春藤200g;
第一步,将索骨丹、牛膝、薯莨、鹿茸、黄花苜蓿、杜仲、灰栒子、海马和列当混合,加相对于混合物3倍量醇浓度为65%的乙醇回流提取3次,每次2小时,过滤,滤液合并,回收乙醇,浓缩至70℃相对密度为1.32的膏体,备用;
第二步,将箭叶蓼、聚头蓟、山药、刺五加、葛藟、当归、瓜馥木、沙棘、紫河车、羊红膻、玫瑰花、扶桑、天仙藤、姜黄、过江藤、夏天无、驱风通、枫香脂、红花、奇蒿、鸡血藤、凌霄花、龙眼肉、刺蓼、南沙参和常春藤按比例混合,加相对于混合物4倍量水,煮沸5小时,过滤,浓缩至80℃相对密度为1.25的膏体;第三步,将第一步、第二步获得的所述膏体混合,80℃减压真空干燥,得干膏粉;
第四步,将第三步获得的所述干膏粉中加入乙醇,得到含醇膏体,所述含醇膏体的含醇量为75%;将所述含醇膏体依次进行冷藏处理、沉淀处理、过滤处理、回收乙醇处理,得到脱醇膏体,其中,冷藏处理时间为35小时;
第五步,将所述脱醇膏体中加入蔗糖粉、活性炭,依次进行加热处理、过滤处理、稀释处理,得到半成品;所述脱醇膏体与所述蔗糖粉的重量比为1∶0.2;所述脱醇膏体与所述活性炭的重量比为1∶0.002;所述加热处理的时间为30分钟,温度为100℃~110℃;
第六步,再将第五步获得的所述半成品依次进行过滤处理、灌封处理、灭菌处理,即得所述中药制剂口服液成品。
实施例3 片剂
本发明口服片剂的制作过程为:取箭叶蓼180g、聚头蓟200g、山药170g、刺五加220g、葛藟210g、当归180g、瓜馥木240g、沙棘260g、紫河车220g、羊红膻150g、玫瑰花180g、扶桑170g、天仙藤200g、姜黄230g、过江藤160g、夏天无220g、驱风通200g、枫香脂140g、红花230g、奇蒿200g、鸡血藤210g、凌霄花230g、索骨丹40g、牛膝210g、薯莨250g、鹿茸140g、黄花苜蓿220g、杜仲200g、灰栒子180g、海马210g、列当240g、龙眼肉180g、刺蓼140g、南沙参180g和常春藤190g;
第一步,将所述中药各原料药材按比例混合,加入相对于混合物质量4倍的醇浓度为90%的乙醇,加热回流5小时,提取,过滤获得第一提取液;过滤获得的药渣再加入相对于所述药渣质量3倍的醇浓度为90%的乙醇,加热回流3小时,提取,过滤获得第二提取液;将第一提取液和第二提取液合并,减压浓缩除去乙醇溶剂,干燥,获得干膏;
第二步,将第一步获得的干膏放置在超微粉碎机中粉碎2小时,粉碎,过筛,获得500目的超微细粉;
第三步,将第二步获得的超微细粉,加入相对于其质量0.15倍的微晶纤维素、0.2倍乳糖、0.3倍的淀粉,过筛,混合均匀,制粒,干燥,加入相对于超微细粉质量0.03倍硬脂酸镁,整粒,压片,制成。
急性毒性实验:
急性毒性试验:应用NIH小鼠40只,SPF级,雌雄各半,体重18~25g,进行急性毒性试验。小鼠随机分为两组,每组20只,即对照组和给药组,实验前禁食12小时;将本发明的实施例1制备的胶囊剂溶解在水中,(浓度为5.74g生药/ml,最高浓度)灌胃,灌胃容积为5ml/kg(即单次给药剂量为28.7生药/kg),对照组给予等量生理盐水,一天给药2次,给药间隔时间6小时,给药后连续观察14天,并记录小鼠的的毒性反应及死亡数。实验结果表明:与对照组比较,给药后小鼠未见明显差异,实验连续观察14天,小鼠全身状况、饮食、饮水、体重增长均正常。小鼠口服灌胃本发明的胶囊剂LD50>28.7生药/kg,每日最大给药量为57.4生药/kg/日。本发明的中药临床用药量为4.6g生药/日/人,成人体重以60KG计,平均用药剂量为0.077g生药/kg/日。按体重计:小鼠(平均体重以21g计)口服灌胃本发明的中药的耐受量为临床用量的745倍。因此本发明的中药急性毒性低,临床用药安全。
长期毒性实验:将本发明实施例2的口服液对小鼠按6.43、15.72和36.41g生药/kg连续用药16周(1.0ml/100g体重,每天2次)及停药4周后,结果表明:本发明中药制剂对小鼠的毛发、行为、大小便、体重、脏器重量、血象、肝肾功能、血糖、血脂等指标均无明显影响,脏器肉眼没有发现异样变化和组织学检查结果表明,用药16周及停药4周后,小鼠各脏器均无明显改变。说明本发明中药制剂对小鼠长期用药后毒性小,停药后也没有异样反应,应用安全。
临床资料:
病例选择:取来源于我院2011年7月-2012年7月间神经内科门诊部收治的308例中风后遗症之气虚血瘀型患者,男172人,女136人;年龄50~79岁,病史5个月~7年;308例病人随机分为中药治疗组和中成药对照组,中药治疗组231人,男129人,女102人,年龄52-79岁,平均年龄为64.3岁;病程7-13月;脑栓塞65例,脑出血72例,脑梗死94例。中成药对照组77人,男43人,女34人;年龄50-77岁,平均年龄为65.1岁;病程6个月~7年;脑栓塞12例,脑出血21例,脑梗死44例;两组在性别、年龄、病种、病情程度、病程、病史等统计学处理,差异均无显著性意义(P>0.05),具有可比性;308例患者均经头颅CT或MR检查证实全部患者无精神或心理疾病。
诊断标准:西医诊断参考《各类脑血管疾病诊断要点》符合相关诊断标准且经头颅CT或MR确诊。中医诊断及辩证分型参考1996年制订的《中风病诊断与疗效评定标准试行》确诊为中风后遗症之气虚血瘀型。主要表现为:半身不遂,口舌歪斜,口角流涎,言语謇涩或不语,偏身麻木,面色觥白,气短乏力,心悸,自汗,便溏,手足肿胀,舌质暗淡,舌苔薄白或白腻,脉沉细、细缓或细弦。
治疗方法:
中药治疗组中:
胶囊剂治疗组:服用本发明实施例1制备的胶囊剂,每日3次,一次1粒,每60天为1个疗程;
口服液治疗组:服用本发明实施例2制备的口服液,每日3次,30ml/次,每60天为一个疗程;
片剂治疗组:使用本发明实施例3制备的片剂,每日3次,每日3次,一次1片,每60天为一个疗程。
中成药对照组:服用三七通舒胶囊,每日3次,一次1粒,每60天为一个疗程。
疗效评价标准:
参照1996年制订的《中风病诊断与疗效评定标准试行》,以积分指数来评定疗效。积分指数=(治疗后积分-治疗前积分)/治疗前积分×100%。治愈积分指数>80%;显效:60%<积分指数≤80%;好转:10%<积分指数≤60%;无效:积分指数≤10%或死亡。
治疗结果:
参见表1和表2,从表1可以看出,采用本发明的中药治疗中风后遗症之气虚血瘀型,相对于中成药在治疗效果上,具有显著的改进;从表2可以看出,采用本发明的中药治疗中风后遗症之气虚血瘀型,相对于中成药,在治疗疗程上显著缩短。
表1各组分别治疗4个疗程后临床疗效比较 例
| 组别 | 例数 | 治愈数 | 显效数 | 好转数 | 无效数 | 总有效率(%) |
| 胶囊剂治疗组 | 77 | 34 | 37 | 5 | 1 | 98.7% |
| 口服液治疗组 | 77 | 35 | 36 | 6 | 0 | 100% |
| 片剂治疗组 | 77 | 32 | 38 | 7 | 0 | 100% |
| 中成药治疗组 | 77 | 7 | 13 | 36 | 21 | 72.7% |
表2 四组分别治疗4个疗程后治愈、显效和好转人数和时间比较 例(%)
| 组别 | 例数 | 第1个疗程 | 第2个疗程 | 第3个疗程 | 第4个疗程 |
| 胶囊剂治疗组 | 76 | 16(21.1%) | 19(25%) | 20(26.3%) | 21(27.6%) |
| 口服液治疗组 | 77 | 17(22.1%) | 19(24.7%) | 20(26%) | 21(27.3%) |
| 片剂治疗组 | 77 | 16(14%) | 18(24%) | 21(30%) | 22(32%) |
| 中成药治疗组 | 56 | 5(20.8%) | 9(16.2%) | 13(23.2%) | 29(51.8%) |
根据上述表格内的临床统计可知,本发明提供的中药具有起效快、有效率高、疗效确切、安全性高、无毒副作用;同时对治疗组治愈、显效和好转人数的230例以及中成药治疗组治愈、显效和好转的56例患者随访1年半,结果统计,胶囊剂治疗组76例中治愈34例和显效37例都无复发,好转的5例中复发1例,复发率为1.3%;口服液治疗组77例中治愈35例无复发,显效36例中复发1例,好转的6例中复发1例,复发率为2.6%;片剂治疗组77例中治愈32例无复发,显效38例中 复发1例,好转的7例中复发2例,复发率为3.9%;中成药治疗组治愈、显效和好转人数56例,治愈的5例患者中复发2例,显效的9例患者中复发6例,好转的13例中复发11例,复发率34%;上述复发是指患者治疗效果达到治愈、显效或好转后,在随访的1年半中明显出现治疗前的症状。
典型病例:王某,女性,57岁,因半身不遂,偏身麻木,面色觥白,气短乏力已9个月,另外还伴随口舌歪斜,口角流涎,言语謇涩或不语,心悸,自汗,便溏,手足肿胀,舌质暗淡,舌苔薄白或白腻,脉沉细、细缓或细弦;经检查初步判断为中风后遗症,经头颅CT或MR检查证实为中风后遗症之气虚血瘀型;且根据中医望、闻、问、切辨证进一步诊断为中风后遗症之气虚血瘀型。服用本发明中药制剂实施例2的口服液,每日3次,每次30ml/次,治疗2个疗程基本治愈,继续服药1个月治愈,随访1年半未复发。
以上所述仅为本发明的较佳实施例,并不用以限制本发明,凡在本发明的精神和原则之内,所作的任何修改、等同替换、改进等,均应包含在本发明的保护范围之内。
Claims (9)
1.一种治疗中风后遗症之气虚血瘀型的中药制剂,其特征在于,包括以下原料药材:箭叶蓼、聚头蓟、山药、刺五加、葛藟、当归、瓜馥木、沙棘、紫河车、羊红膻、玫瑰花、扶桑、天仙藤、姜黄、过江藤、夏天无、驱风通、枫香脂、红花、奇蒿、鸡血藤、凌霄花、索骨丹、牛膝、薯莨、鹿茸、黄花苜蓿、杜仲、灰栒子、海马、列当、龙眼肉、刺蓼、南沙参和常春藤。
2.根据权利要求1所述的治疗中风后遗症之气虚血瘀型的中药制剂,其特征在于,所述中药制剂中各原料药材的重量份数比为:箭叶蓼15~30份、聚头蓟12~22份、山药10~20份、刺五加16~28份、葛藟15~30份、当归14~28份、瓜馥木17~32份、沙棘18~36份、紫河车10~25份、羊红膻12~22份、玫瑰花10~25份、扶桑10~22份、天仙藤13~27份、姜黄14~27份、过江藤10~20份、夏天无14~26份、驱风通14~25份、枫香脂13~27份、红花13~28份、奇蒿10~25份、鸡血藤10~25份、凌霄花16~32份、索骨丹5~7份、牛膝17~28份、薯莨14~32份、鹿茸10~32份、黄花苜蓿15~30份、杜仲10~26份、灰栒子10~24份、海马16~28份、列当14~26份、龙眼肉13~28份、刺蓼10~20份、南沙参11~23份和常春藤10~25份。
3.根据权利要求1所述的治疗中风后遗症之气虚血瘀型的中药制剂,其特征在于,所述中药制剂中各原料药材的重量份数比为:箭叶蓼17~26份、聚头蓟15~20份、山药12~20份、刺五加18~25份、葛藟17~25份、当归16~25份、瓜馥木18~26份、沙棘20~30份、紫河车13~22份、羊红膻13~17份、玫瑰花14~21份、扶桑14~20份、天仙藤14~25份、姜黄15~24份、过江藤13~18份、夏天无16~23份、驱风通18~22份、枫香脂14~24份、红花15~26份、奇蒿13~21份、鸡血藤16~23份、凌霄花18~30份、索骨丹4~6份、牛膝18~24份、薯莨15~28份、鹿茸12~27份、黄花苜蓿18~25份、杜仲14~24份、灰栒子15~20份、海马18~25份、列当15~25份、龙眼肉15~25份、刺蓼12~18份、南沙参15~20份和常春藤15~22份。
4.根据权利要求1所述的治疗中风后遗症之气虚血瘀型的中药制剂,其特征在于,所述中药制剂中各原料药材的重量份数比为:箭叶蓼20份、聚头蓟18份、山药14份、刺五加22份、葛藟24份、当归18份、瓜馥木25份、沙棘22份、紫河车15份、羊红膻16份、玫瑰花15份、扶桑16份、天仙藤22份、姜黄17份、过江藤15份、夏天无20份、驱风通20份、枫香脂17份、红花18份、奇蒿17份、鸡血藤22份、凌霄花19份、索骨丹5份、牛膝21份、薯莨24份、鹿茸19份、黄花苜蓿20份、杜仲21份、灰栒子18份、海马22份、列当23份、龙眼肉17份、刺蓼16份、南沙参17份和常春藤21份。
5.根据权利要求1-4任一项所述的治疗中风后遗症之气虚血瘀型的中药制剂,其特征在于,所述中药制剂中各原料药材的重量份数比为:箭叶蓼24份、聚头蓟19份、山药13份、刺五加22份、葛藟24份、当归18份、瓜馥木25份、沙棘22份、紫河车16份、羊红膻15份、玫瑰花16份、扶桑17份、天仙藤22份、姜黄20份、过江藤14份、夏天无18份、驱风通20份、枫香脂22份、红花25份、奇蒿15份、鸡血藤18份、凌霄花21份、索骨丹6份、牛膝23份、薯莨24份、鹿茸22份、黄花苜蓿19份、杜仲21份、灰栒子16份、海马22份、列当17份、龙眼肉18份、刺蓼16份、南沙参19份和常春藤20份。
6.根据权利要求1-4任一项所述的治疗中风后遗症之气虚血瘀型的中药制剂,其特征在于,所述中药制剂中各原料药材的重量份数比为:箭叶蓼18份、聚头蓟20份、山药17份、刺五加22份、葛藟21份、当归18份、瓜馥木24份、沙棘26份、紫河车22份、羊红膻15份、玫瑰花18份、扶桑17份、天仙藤20份、姜黄23份、过江藤16份、夏天无22份、驱风通20份、枫香脂14份、红花23份、奇蒿20份、鸡血藤21份、凌霄花23份、索骨丹4份、牛膝21份、薯莨25份、鹿茸14份、黄花苜蓿22份、杜仲20份、灰栒子18份、海马21份、列当24份、龙眼肉18份、刺蓼14份、南沙参18份和常春藤19份。
7.根据权利要求1-6任一项所述的治疗中风后遗症之气虚血瘀型的中药制剂,其特征在于,所述中药制剂的剂型为胶囊剂时,其制备方法包括以下步骤:
第一步,将所述中药各原料药材按比例混合,加入相对于混合物质量3~5倍的醇浓度为85~90%的乙醇,加热回流1~3小时,提取,过滤获得第一提取液;过滤获得的药渣再加入相对于所述药渣质量1~2倍的醇浓度为85~95%的乙醇,加热回流1~3小时,提取,过滤获得第二提取液;将第一提取液和第二提取液合并,减压浓缩除去乙醇溶剂,干燥,获得干膏;
第二步,将第一步获得的干膏放置在超微粉碎机中粉碎1~2小时,粉碎,过筛,获得400目~500目的超微细粉;
第三步,在第二步获得的超微细粉中依次加入滑石粉、硬脂酸镁,进行混匀处理,即得胶囊内容物;所述超微细粉、硬脂酸镁和滑石粉的重量比为100∶0.1~0.5:0.1~0.5,将所述胶囊内容物装入胶囊壳体中,即得胶囊剂成品。
8.根据权利要求1-6任一项所述的治疗气虚血瘀型中风后遗症的中药制剂的制备方法,其特征在于,所述中药制剂的剂型为口服液时,其制备方法包括以下步骤:第一步,将索骨丹、牛膝、薯莨、鹿茸、黄花苜蓿、杜仲、灰栒子、海马和列当混合,加相对于混合物3倍~5倍量醇浓度为55%~65%的乙醇回流提取2次~4次,每次2小时~3小时,过滤,滤液合并,回收乙醇,浓缩至70℃相对密度为1.30~1.32的膏体,备用;
第二步,将箭叶蓼、聚头蓟、山药、刺五加、葛藟、当归、瓜馥木、沙棘、紫河车、羊红膻、玫瑰花、扶桑、天仙藤、姜黄、过江藤、夏天无、驱风通、枫香脂、红花、奇蒿、鸡血藤、凌霄花、龙眼肉、刺蓼、南沙参和常春藤按比例混合,加相对于混合物3~5倍量水,煮沸4~6小时,过滤,浓缩至80℃相对密度为1.20~1.27的膏体;第三步,将第一步、第二步获得的所述膏体混合,65℃~85℃减压真空干燥,得干膏粉;
第四步,将第三步获得的所述干膏粉中加入乙醇,得到含醇膏体,所述含醇膏体的含醇量为55%~75%;将所述含醇膏体依次进行冷藏处理、沉淀处理、过滤处理、回收乙醇处理,得到脱醇膏体,其中,冷藏处理时间为30~40小时;
第五步,将所述脱醇膏体中加入蔗糖粉、活性炭,依次进行加热处理、过滤处理、稀释处理,得到半成品;所述脱醇膏体与所述蔗糖粉的重量比为1∶0.1~0.3;所述脱醇膏体与所述活性炭的重量比为1∶0.001~0.002;所述加热处理的时间为20~40分钟,温度为100℃~110℃;
第六步,再将第五步获得的所述半成品依次进行过滤处理、灌封处理、灭菌处理,即得所述中药制剂口服液成品。
9.根据权利要求1-6任一项所述的治疗中风后遗症之气虚血瘀型的中药制剂,其特征在于,所述中药的剂型为片剂时,其制备方法包括以下步骤:
第一步,将所述中药各原料药材按比例混合,加入相对于混合物质量3~5倍的醇浓度为85%~95%的乙醇,加热回流4~6小时,提取,过滤获得第一提取液;过滤获得的药渣再加入相对于所述药渣质量2~4倍的醇浓度为90%~95%的乙醇,加热回流1~3小时,提取,过滤获得第二提取液;将第一提取液和第二提取液合并,减压浓缩除去乙醇溶剂,干燥,获得干膏;
第二步,将第一步获得的干膏放置在超微粉碎机中粉碎1~3小时,粉碎,过筛,获得400目~500目的超微细粉;
第三步,将第二步获得的超微细粉,加入相对于其质量0.1~0.2倍的微晶纤维素、0.15~0.3倍乳糖、0.2~0.3倍的淀粉,过筛,混合均匀,制粒,干燥,加入相对于超微细粉质量0.025~0.04倍硬脂酸镁,整粒,压片,制成。
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| CN104721582A (zh) * | 2015-03-27 | 2015-06-24 | 李佃场 | 一种治疗肾虚型月经过少的药物及其制备方法 |
| CN105963609A (zh) * | 2016-05-11 | 2016-09-28 | 烟台民望机电技术有限公司 | 一种治疗温热在肺型牛流行热的药物组合物及其制备方法 |
| CN116251151A (zh) * | 2022-12-08 | 2023-06-13 | 成都中医药大学 | 一种中药活性成分组合物及其用途 |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN104721582A (zh) * | 2015-03-27 | 2015-06-24 | 李佃场 | 一种治疗肾虚型月经过少的药物及其制备方法 |
| CN105963609A (zh) * | 2016-05-11 | 2016-09-28 | 烟台民望机电技术有限公司 | 一种治疗温热在肺型牛流行热的药物组合物及其制备方法 |
| CN116251151A (zh) * | 2022-12-08 | 2023-06-13 | 成都中医药大学 | 一种中药活性成分组合物及其用途 |
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