CN106668566A - 治疗耳源性眩晕的中药制剂 - Google Patents
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Abstract
本发明提供了一种治疗耳源性眩晕的中药制剂,其原料包括川芎、天麻、龙胆草、夏枯草、葛根、丹参、银杏叶、白蒺藜、地龙、全蝎、生黄芩、麦门冬。本发明中药制剂就是临床中治疗眩晕的有效方剂,其组方配伍得当,药量精简,服用方便,对于眩晕有很好的治疗作用,适用于临床广泛应用于该病的治疗。
Description
技术领域
本发明涉及中医药技术领域,尤其涉及一种治疗耳源性眩晕的中药制剂。
背景技术
耳源性眩晕系指前庭迷路感受异常引起的眩晕。当发生迷路积水(梅尼埃综合征),晕动病(晕舟车病),迷路炎,迷路出血或中毒,前庭神经炎或损害,中耳感染等都可引起体位平衡障碍,发生眩晕。由于前庭核通过内侧束与动眼神经核之间有密切联系,因此,当前庭器受到病理性刺激时,常发生眼球震颤。当发生迷路积水(梅尼埃综合征),晕动病(晕舟车病),迷路炎,迷路出血或中毒,前庭神经炎或损害,中耳感染等都可引起体位平衡障碍,发生眩晕。
当发生迷路积水(梅尼埃综合征),晕动病(晕舟车病),迷路炎,迷路出血或中毒,前庭神经炎或损害,中耳感染等都可引起体位平衡障碍,发生眩晕。耳源性眩晕的主要表现为发作性眩晕,听力减退及耳鸣,重症常伴有恶心,呕吐,面色苍白,出汗等迷走神经刺激现象,可发生水平性或水平兼旋转性眼球震颤。一次发作的时间较短,病人常感物体旋转或自身旋转,行走可出现偏斜或倾倒,发作中神志清醒。
西医对于该病无较好的治疗方法,眩晕发作期中,患者应自选体位卧床休息。卧室保持极度安静,光线尽量暗些,但空气要流动通畅。戒绝刺激性饮食及烟、酒,宜用少盐饮食。消除病人紧张情绪及顾虑,对药物中毒引眩晕者应立即停药,多饮水。在间歇期不宜单独外出,防止突然发作,出现事故,对于位置性眩晕患者,可加强前庭锻炼,注意精神调理,保持心情舒畅。
近年来,中医药在耳源性眩晕的治疗中的优势越来越明显,特别是对反复发作的眩晕的调理,本发明中药制剂就是临床中治疗眩晕的有效方剂,其组方配伍得当,药量精简,服用方便,对于耳源性眩晕有很好的治疗作用,适用于临床广泛应用于该病的治疗。
发明内容
本发明所要解决的技术问题是提供一种用于治疗耳源性眩晕的中药制剂,是临床中治疗眩晕的有效方剂,有效的减轻发作症状,减少发作次数,其组方配伍得当,药量精简,服用方便,对于眩晕有很好的治疗作用,适用于临床广泛应用于该病的治疗。
为解决上述技术问题,本发明提供一种治疗耳源性眩晕的中药制剂,其原料药包括川芎、天麻、龙胆草、夏枯草、葛根、丹参、银杏叶、白蒺藜、地龙、全蝎、生黄芩和麦门冬。
其中,所述中药制剂中每份原料药材中的用量组合为川芎10g~15g、天麻10g~15g、龙胆草20g~25g、夏枯草30g~40g、葛根30g~35g、丹参25g~30g、银杏叶10g~15g、白蒺藜10g~15g、地龙10g~15g、全蝎15g~20g、生黄芩15g~20g、麦门冬30g~35g。
其中,所述中药制剂中每份原料药材中的最优用量组合为川芎10g、天麻15g、龙胆草30g、夏枯草30g、葛根30g、丹参30g、银杏叶15g、白蒺藜15g、地龙15g、全蝎20g、生黄芩15g、麦门冬30g。
其中,所述中药制剂的剂型为舌下含片。
本发明还提供了上述中药制剂的制备方法,其包括:
第一步,地龙和全蝎有效成分低温提取;
第二步,川芎、天麻和银杏叶乙醇提取;
第三步,其与成分的水提;
第四步,将第二步和三步获得的提取液混合在一起,在0℃下静止24小时,过滤,减压浓缩除去溶剂,粉碎成粉末,与第一步获得的粉末混合,加入相对于粉末质量的0.5%~1%的硬脂酸镁,压片,即得舌下含片。
其中,所述第一步中将地龙和全蝎分别放入水中浸泡3小时以上,在温度为-10~-20℃将全蝎和地龙杀死,冷冻干燥,粉碎成粉末。
其中,所述第二步中按重量称取川芎、天麻和银杏叶分别洗净,各自放入到醇浓度为80%的乙醇中浸泡,乙醇添加为各药材质量的5倍,浸泡1小时,随后加热提取2次,每次1~2小时,合并提取液,静置后取上清液,分别获得川芎提取液、天麻提取液和银杏叶提取液;
其中,所述第三步中将余下原料药成分混合在一起,分别洗净,用8倍这些药材质量质和的水煎煮4小时,过滤,得到第一次提取液,然后用6倍这些药材质量质和的水煎煮3小时,过滤,得到二次提取液,合并两次提取液。
有益的技术效果
本发明提供一种用于治疗耳源性眩晕的中药制剂,是临床中治疗眩晕的有效方剂,有效的减轻发作症状,减少发作次数,其组方配伍得当,药量精简,服用方便,对于眩晕有很好的治疗作用,适用于临床广泛应用于该病的治疗。
具体实施方式
本发明提供一种治疗耳源性眩晕的中药制剂,其原料药由川芎、天麻、龙胆草、夏枯草、葛根、丹参、银杏叶、白蒺藜、地龙、全蝎、生黄芩和麦门冬构成。
眩晕是临床常见症状之一,前庭、视觉和本体感觉系统(平衡三联)中的任一系统,不论是感受器还是与整合功能有关的区域有病变或受到刺激可出现眩晕,严重影响患者的生活质量。眩晕的发病机制非常复杂,但是内耳微循环障碍是常见耳源性眩晕疾病,如梅尼埃病、突发性聋伴眩晕、良性阵发性位置性眩晕(BPPV)发病的重要因素之一。对于眩晕的治疗提倡个体化综合治疗,即药物、手术以及前庭康复训练综合运用。药物治疗,尤其是改善微循环的药物在耳源性眩晕的治疗中占有非常重要的地位。中药针对耳源性眩晕的认识较西医丰富,综合其发病规律,瘀、虚、热、痰是其主要的病因病机,按照君臣佐使的组方思路,谴方用药,使其作用于人体具有活血化瘀、活络通脉之功效,传统中药药方中对于全蝎和地龙的使用一般是作为辅助成分使用,一份中药中全蝎和地龙的使用量一般在3~6g之间,而本发明中药制剂以相对用量最大的全蝎、地龙为君药,地龙10g~15g、全蝎15g~20g,本发明中药制剂以相对周量最大的全蝎、地龙为君药,其中全蝎息风镇痉,通络止痛,攻毒散结,地龙清热、平肝、止喘、通络,二药均为虫类药物,性走窜,既能息风止痉,又善清解高热,全蝎善于改善微循环而活血通络,地龙擅于散风热之邪而清热祛风通络,二药配合使用,针对该病发作时瘀、热、痰为主要病机具有很好的对证治疗作用,因此为君药,在该药的制备方法中,君药组因为是动物药,其有效成分多为蛋白质类,因此其加工工艺特殊,需要低温提取,高温或者酸碱的提取,会使其变性,非本发明中药制剂所述加工方法加工制备的药剂,使其有效成分破坏,导致方剂无效,因此从另一方面证实,全蝎和地龙为君药。中医讲究君臣佐使的配伍使用,当君药确定后,佐君行事的为臣药,本发明中药制剂以川芎、丹参、银杏叶、天麻、白蒺藜为臣药,其中川芎活血行气、祛风止痛,丹参祛瘀止痛,活血通经,清心除烦,银杏叶活血化瘀,通络止痛,敛肺平喘,化浊降脂,现代医学研究,上述中药有效组分或者有效单体成分,对于心脑血管微循环有很好的改善功能,抗血小板聚集,防止血栓形成,降低全血黏度,增强颈动脉血流量,减轻脑血管水肿,配合君药全蝎共行活血通络之功效;其中天麻平肝潜阳、熄风止痉,白蒺藜祛风明目、平肝解郁,二药合用配合君药地龙祛风除痰通络,风痰瘀一去,本病的基本病因已除,诸证速除,诸药合用行臣药之用。中医讲“诸风掉眩皆属于肝”,发作期肝风内动、肝阳上亢,本发明中药制剂使用龙胆草、夏枯草、生黄芩平抑肝阳、清热散风;针对本病有阴虚的并本,故加入麦门冬配合生黄芩,滋养肺胃之阴,同时坚阴清热。中医理论认为,“非风药无法到达巅顶”,因此本发明中药制剂中,风药川芎亦为使药,载药上达巅顶以求速效。综上是所述,该组方有利于脑缺血功能障碍的改善,抗血小板聚集,防止血栓形成,改善微循环,降低全血黏度,增强颈动脉血流量,其治疗常见耳源性眩晕疾病具有十分有效的作用。
现代医学研究证实,该组方有利于脑缺血功能障碍的改善,抗血小板聚集,防止血栓形成,改善微循环,降低全血黏度,增强颈动脉血流量,主要用于脑血管栓塞性疾病。由于其可改善微循环,故在临床中也常被应用于梅尼埃病、突发性聋伴眩晕、BPPV等常见耳源性眩晕疾病的治疗。
川芎:味辛,性温,归肝、胆、心包经,具有活血行气,祛风止痛的功效,主治月经不调;经闭痛经;产后瘀滞腥痛;症瘕肿块;胸胁疼痛;头痛眩晕;风寒湿痹;跌打损伤;痈疽疮疡等证。
天麻:味甘、性平,入肝经,有平肝熄风,解痉,通络止痛的作用,主要用于肝火上炎之眩晕头疼,肝阳上亢、肝风内动所致之劲风抽搐、癫痫等证。
龙胆草:味苦、性寒,入肝、胆经,有清热燥湿、降泄肝火和利胆的作用,主要用于肝经湿热所致之胸胁作痛,口苦耳聋,目赤肿痛;湿热黄疸;肝火上炎之头晕目肿;肝火化风之高热经抽;湿热下注之白带、小便不利等证.
夏枯草:味苦、辛,性寒,入肝、胆经,具有清火,明目,散结,消肿的功效,主治目赤肿痛,目珠夜痛,头痛眩晕,瘰疬,瘿瘤,肿痛;甲状腺肿大,淋巴结结核,乳腺增生,高血压、高血糖、高血脂和高血粘等证。
葛根:味甘、辛,性凉,入脾、胃经,有鼓舞胃气,清热生津,解肌发表,生阳,渗疹的作用,主要用于外感发热,头痛,项背强痛,热病口渴,消渴;脾虚泄泻,清阳不升等证。
丹参:味苦,性微寒,归心、肝经,具有活血调经,祛瘀止痛,凉血消痈,清心除烦,养血安神的功效,主治月经不调,经闭痛经,症瘕积聚,胸腹刺痛,热痹疼痛,疮疡肿痛,心烦不眠;肝脾肿大,心绞痛等证。
银杏叶:味甘、苦、涩,性平,入心、肺经,具有敛肺平喘,活血养心、涩肠止泻的功效,用于肺虚咳喘,胸闷心痛,头晕头痛,泄泻,痢疾等证。
白蒺藜:为蒺藜科蒺藜属植物的果实,味辛、苦,性微温;有小毒,归肝经,具有平肝解郁,活血祛风,明目,止痒的功效,用于头痛眩晕,胸胁胀痛,乳闭乳痈,目赤翳障,风疹瘙痒等证。
地龙:味成,性寒,归肝、脾、膀胱经,具有清热定惊,通络平喘,利尿的功效,主治高热神昏、关节痹痛,肢体麻木,半身不遂,肺热咳喘,水肿尿少的功效。
全蝎:味辛,性平,归肝经,具有息风镇痉,攻毒散结,通络止痛的功效,主治小儿惊风,抽搐痉挛,中风口歪,半身不遂,破伤风,风湿顽痹,偏正头痛,疮疡,瘰疬等证。
生黄芩:味苦、性寒,归心、肺、胃、胆、大肠经,有清热燥湿,泻火解毒,安胎,止血的作用,主要用于湿热所致之腹泻、痢疾、黄疸、热淋;肺热咳嗽,口渴咽痛,还可用于胎热不安,热毒火邪侵淫皮肤之疮痈毒肿之证。
麦门冬:味甘、微苦,性微寒,入心、肺、胃经,有养阴润肺、化痰止咳、清热养心的作用,主要用于燥邪伤肺或阴虚肺燥有热之干咳痰黏,劳嗽咳血,咽干鼻燥,肺痈,热伤胃阴或胃阴不足所致的口干咽燥,舌红少苔,胃脘隐痛,内热消渴,大便燥结,心阴虚及温病热邪扰及心营而致的心烦不眠,舌绛而干等证。
本发明提供的中药制剂为内服剂型,可以按照常规的制备方法在中药材有效提取成分的基础上添加各种辅料和载体,由于该病症发病时往往会发生呕吐,因此采用舌下含片效果最好。
本发明还提供了上述中药中有效成分的提取方法,其包括:
所述第一步中,将地龙和全蝎分别放入水中浸泡3小时以上,在温度为-10~-20℃将全蝎和地龙杀死,冷冻干燥,粉碎成粉末;
所述第二步中,按重量称取川芎、天麻和银杏叶分别洗净,各自放入到醇浓度为80%的乙醇中浸泡,乙醇添加为各药材质量的5倍,浸泡1小时,随后加热提取2次,每次1~2小时,合并提取液,静置后取上清液,分别获得川芎提取液、天麻提取液和银杏叶提取液;
所述第三步中,将余下原料药成分混合在一起,分别洗净,用8倍这些药材质量质和的水煎煮4小时,过滤,得到第一次提取液,然后用6倍这些药材质量质和的水煎煮3小时,过滤,得到二次提取液,合并两次提取液。
所述第四步中,将第二步和三步获得的提取液混合在一起,在0℃下静止24小时,过滤,减压浓缩除去溶剂,粉碎成粉末,与第一步获得的粉末混合,加入相对于粉末质量的0.5%~1%的硬脂酸镁,压片,即得舌下含片。
每份原料药材中的用量组合为川芎10g~15g、天麻10g~15g、龙胆草20g~25g、夏枯草30g~40g、葛根30g~35g、丹参25g~30g、银杏叶10g~15g、白蒺藜10g~15g、地龙10g~15g、全蝎15g~20g、生黄芩15g~20g、麦门冬30g~35g。
每份原料药材中的最优用量组合为川芎10g、天麻15g、龙胆草30g、夏枯草30g、葛根30g、丹参30g、银杏叶15g、白蒺藜15g、地龙15g、全蝎20g、生黄芩15g、麦门冬30g。
综合分析,本发明中药制剂是临床中治疗眩晕的有效方剂,其组方配伍得当,药量精简,服用方便,对于眩晕有很好的治疗作用,适用于临床广泛应用于该病的治疗。
以下采用实施例来详细说明本发明的实施方式,借此对本发明如何应用技术手段来解决技术问题,并达成技术效果的实现过程能充分理解并据以实施。
实施例1舌下含片
将地龙15g和全蝎20g分别放入水中浸泡3小时以上,在温度为-20℃将全蝎和地龙杀死,冷冻干燥,粉碎成粉末;称取川芎10g、天麻15g和银杏叶15g分别洗净,各自放入到醇浓度为80%的乙醇中浸泡,乙醇添加为各药材质量的5倍,浸泡1小时,随后加热提取2次,每次2小时,合并提取液,静置后取上清液,分别获得川芎提取液、天麻提取液和银杏叶提取液,将龙胆草30g、夏枯草30g、葛根30g、丹参30g、白蒺藜15g、生黄芩15g、麦门冬30g混合在一起,分别洗净,用1.5kg的水煎煮4小时,过滤,得到第一次提取液,然后用1kg的水煎煮3小时,过滤,得到二次提取液,合并两次提取液,将前面获得的提取液混合在一起,在0℃下静止24小时,过滤,减压浓缩除去溶剂,粉碎成粉末,与地龙粉末、全蝎粉末混合,加入相对于粉末质量的0.5%的硬脂酸镁,压片,即得舌下含片。
舌下含片的毒理学检测
通过本发明中药药物急毒性(7天最大剂量给药)实验,长期毒性(30天连续给药)实验,在受试剂量范围内,该药物对大鼠每周体重、每周进食量、每周食物利用率、增重、总进食量、总食物利用率、血常规指标、生化指标、主要脏器湿重及脏/体比,经统计学分析,差异均无显著性;病理组织学检查也未见有意义的与受试动物有关的病理组织学改变。现将实验设计及结果详述于下:
实验动物:清洁级Wistar大鼠,40只,雌性。
饲养环境:实验前置动物于室内适应环境一周,自由摄食和摄水,室温18~23℃,相对湿度65~75%,照明昼夜明暗交替。
受试药物
本发明中药舌下含片配置成的水溶液,浓缩至生药浓度为1.08g/ml,0.6g/ml,0.5g/ml三种浓度水溶液,4℃保存,备用,使用时加热至36~39℃。
空白对照组:蒸馏水灌胃,其余条件同本发明药物组。
急毒性试验
实验方法
按照随机数字表,将大鼠分为对照组和实验组(灌胃本发明制剂水溶液,1.08g/ml)。灌胃量为20mL/kg,对照组灌胃蒸馏水20ml/kg。连续给药7天,停药观察3天。记录大鼠体重、进食、饮水情况,记录灌胃后大鼠各项反应,灌胃间期大鼠各项生理反应,以及死亡情况。
结果与结论
通过急性毒理实验研究,观察7天大鼠灌胃后情况,灌胃给药前,各组动物体重、进食、饮水情况无统计学差异,灌胃给药后,各组大鼠体重变化、进食饮水情况,无统计学差异。行为学无明显异常,未出现死亡及其他毒性反应。本实验组剂量是临床成人用药的114.31倍,现代药理学认为,对于药物急性毒性实验,最大耐受量相当于人临床日用剂量100倍以上而动物无死亡,无明显毒性反应情况出现时,该药是安全的。通过本急性毒性试验验证,无毒性反应,可以认定,本药品临床用药是安全的。
长期毒性试验
试验方法
按照随机数字表,将大鼠分为对照组和高剂量组(灌胃本发明中药制剂,0.6g/ml)、低剂量组(灌胃本发明中药制剂,0.5g/ml)。灌胃量为20mL/kg,对照组灌胃蒸馏水20mL/kg。连续给药21天,停药观察7天。记录大鼠体重、进食、饮水情况,记录灌胃后大鼠各项反应,灌胃间期大鼠各项生理反应,以及死亡情况。
结果与结论
实验中高低剂量分别为12g/kg/d,10g/kg/d,对应成人临床日拟用量的63.50倍、52.92倍,连续给药3周后,通过与对照组比较各项检测指标,如一般状态、体重、进食量、饮水量各组间无统计学差异。通过对各组大鼠进行组织病理学对比分析,未见明显的毒性敏感指标和毒性靶器官。停药观察1周后,高、低剂量组大鼠各项检测指标均属正常,未见迟发性毒性反应和蓄积性毒性反应。
综合各组长期毒性试验结果,本发明中药制剂应用对大鼠无明显毒副作用,临床成人拟用剂量和疗程处于安全范围。因此对应临床使用4周的疗程中,也是处于安全范围内。
比较例1
采用与实施例1相同的制备方法制备舌下含片,区别在于原料药材中没有使用全蝎和地龙。
比较例2
采用与实施例1相同的原料药材制备舌下含片,区别在于全蝎和地龙采用采用水提方式提取,具体为将20g全蝎和15g地龙浸泡在200g水中半小时,煮沸,随后文火煎煮2小时,过滤,得到提取液,浓缩除去溶剂,粉碎成粉末,在后面步骤中使用。
实验研究
药物及试剂
本发明实施例1制备的舌下含片1制备的水溶液0.2g/ml。
本发明比较例1制备的舌下含片2制备的水溶液0.2g/ml。
本发明比较例2制备的舌下含片3制备的水溶液0.2g/ml。
天麻素注射液,昆明制药集团公司提供
动物麻醉药物氨基甲酸乙酯(乌来糖)由上海山浦化工有限公司提供。
实验动物
Wistar大鼠,雌雄各半,体重220~240g。
实验方法
眩晕大鼠造模及血液流变学、脑血流量的检测
取Wistar大鼠60只(雌雄各半),随机分为6组,即正常对照组、模型组、天麻素注射液治疗组、实施例1组,比较例1组,比较例2组,每组10只。
正常对照组及模型组:5%羧甲基纤维素钠溶液5ml/d灌胃,每日1次连续7d。天麻素注射液治疗组:灌胃天麻素注射液(1.5g/kg),每日1次,连续7d;实施例1组:灌胃本发明实施例1制备的舌下含片1制备的水溶液,按1ml/100g体重给药,每日1次连续7d,实施例1组:灌胃本发明比较例1制备的舌下含片2制备的水溶液,按1ml/100g体重给药,每日1次连续7d,比较例2组:灌胃本发明比较例2制备的舌下含片3制备的水溶液,按1ml/100g体重给药,每日1次连续7d。
造模:于末次给药后0.5h,除正常对照组外,每只大鼠按10mg/kg体重皮下注射硝酸甘油,复制偏头痛动物模型。
血流量测试及相关指标检测:造摸2h后,全部大鼠用20%乌来糖麻醉,用手术剪剪开大鼠头皮暴露软脑膜组织,用“407”号多谱勒激光探头测试大鼠头部脑血流量。腹主动脉取血5ml于肝素钠抗凝试管内,用N6c全自动血液流变仪测定全血粘度、血浆粘度、红细胞聚集指数、红细胞刚性指数、红细胞变形指数等各项血液流变学指标。
统计学处理方法
用SPSS14.0软件包进行统计学处理,实验数据以表示,组间比较采用t检验,以P<0.05为差异有统计学意义。
结果
各组大鼠脑血流量、血液流变学指标检测结果
经中药制剂灌胃治疗后,大鼠血液粘度显著性下降,全血低切、高切还原粘度明显下降(P<0.05);大鼠脑血流量得到了明显改善,与模型组比较差异有统计学意义(P<0.01);且从结果可见中药组与天麻素注射液组比较差异无统计学意义。见表1、2、3。
表1各组大鼠血液流变学指标的变化(n=10)
与模型对照组比较,*P<0.05;与阳性对照组比较,#P<0.05
表2各组大鼠红细胞特性指数
与模型对照组比较,*P<0.05
表3各组大鼠脑血流量变化(n=10)
组别 | 脑血流量(PU值) |
正常对照组 | 521.55±67.04 |
模型对照组 | 226.17±62.10 |
天麻素注射液组 | 362.74±33.07* |
实施例1组 | 429.48±62.57*# |
比较例1组 | 231.36±60.29 |
比较例2组 | 235.81±58.23 |
与模型组比较,*P<0.01;与阳性对照组比较,#P<0.05
结论
通过本发明中药制剂的实验研究,其对于大鼠脑血流量、血液流变学指标的研究,其效果优于对照组,P<O.05,综合分析,本发明中药制剂具有很好的改善耳源性眩晕的作用。
临床研究
资料与方法
一般资料
选取在我院2014年9月-2015年2月,在耳鼻喉科室就诊的被诊断为耳源性眩晕症患者,进行中医治疗与西医常规治疗方式疗效差异的对照研究。期间共记录患者184例,其中,治疗组90例采用本发明实施例1制备的中药舌下含片1进行治疗,对照组94例采取西医常规治疗方法。治疗组中,年龄33±3岁,男性47人,女性43人,对照组年龄33±3岁,男性48人,女性46人。两组患者在年龄、病程、性别等方面差异无统计学意义,具有可比性。
诊断依据
本文所采用的诊断标准根据中医病症的诊断疗效标准进行拟定:
①旋转性头晕眩,视物旋转,轻度患者闭目则止,重症眩晕如坐舟船;
②发病期间并无其他中枢神经系统症状出现,患者意识清醒;
③患者可能出现恶心、呕吐、耳鸣、耳聋、眼球震颤等症状;
④排除突发性耳聋伴眩晕、前庭神经炎等其引起眩晕的疾病,排除药物中毒和颅内占位性病变等因素导致的眩晕。
纳入及排除标准
在本试验中,将符合上述1.2所述诊断依据具有典型眩晕症状的患者纳入本次试验对象群体。本次试验的排除标准包括:
①患者有心血管、肝肾以及造血系统原发性疾病的需排除;
②药物过敏史,精神病患者需排除;
③由脑外伤、颅内占位性病变以及眼病引起的眩晕患者需排除;
④不符合上述纳入标准的患者,或未按标准服用药物以及资料不全无法给出判断,或安全性无法保障的患者需排除。
治疗方案
治疗组采用本发明实施例1的中药舌下含片1,发作时,舌下含服2片,静止期,舌下含服1片,2次每日,服药时须静卧30分钟。
对照组采取西医治疗方式,服用药物包括地芬尼多片25mg、谷维素20mg,每日均服用2次。
上述两组分别进行15d治疗后对其药效进行评估,随后进行1年的观察和随访调查。
疗效判定标准
对患者疗效的评判标准参照了美国美尼尔综合征学术会议所指定的相关标准。痊愈:患者恢复到正常人状态,体征和相应临床症状消失,并在1年内无复发。显效:患者恢复正常生活状态,临床症状及体征消失,1年以内偶有复发。有效:患者临床症状及相应体征消失,但遇疲劳及情绪变化时有复发迹象。无效:患者接受治疗后临床症状及体征并无明
结果
观察两组患者用药后的眩晕及伴随性症状发病频次,并显改善。随访患者在日常生活中发生不良反应的总体状况,重点关注随访患者眩晕发作间歇的长短。治疗结果见表4、表5。
表4两组症状改善情况比较(%)
与对照组比较,*P<0.05
表5两组患者疗效比较(n)
组别 | N | 痊愈 | 显效 | 有效 | 无效 | 总有效率 |
治疗组 | 90 | 21 | 39 | 27 | 3 | 97%* |
对照组 | 94 | 14 | 25 | 43 | 12 | 87% |
与对照组比较,*P<0.05
结论
通过本发明中药含片与西药对照研究发现,本发明中药制剂对于耳源性眩晕的临床症状改善优于对照组,其综合疗效亦优于对照组,不良反应少于西药。本发明中药含片临床使用方便,易于保存,通过科学的制剂工艺,能够保证药效最大的被人体利用,因此,本发明中药制剂适用于临床推广。
以上所述,仅是本发明的较佳实施例而已,并非是对本发明作其它形式的限制,任何熟悉本专业的技术人员可能利用上述揭示的技术内容加以变更或改型为等同变化的等效实施例。但是凡是未脱离本发明技术方案内容,依据本发明的技术实质对以上实施例所作的任何简单修改、等同变化与改型,仍属于本发明技术方案的保护范围。
Claims (9)
1.一种治疗耳源性眩晕的中药制剂,其特征在于:原料药包括川芎、天麻、龙胆草、夏枯草、葛根、丹参、银杏叶、白蒺藜、地龙、全蝎、生黄芩和麦门冬。
2.如权利要求1所述的治疗耳源性眩晕的中药制剂,其特征在于:每份原料药材中的用量组合为川芎10g~15g、天麻10g~15g、龙胆草20g~25g、夏枯草30g~40g、葛根30g~35g、丹参25g~30g、银杏叶10g~15g、白蒺藜10g~15g、地龙10g~15g、全蝎15g~20g、生黄芩15g~20g、麦门冬30g~35g。
3.如权利要求1或2所述的治疗耳源性眩晕的中药制剂,其特征在于:每份原料药材中的最优用量组合为川芎10g、天麻15g、龙胆草30g、夏枯草30g、葛根30g、丹参30g、银杏叶15g、白蒺藜15g、地龙15g、全蝎20g、生黄芩15g、麦门冬30g。
4.如权利要求1至3所述的治疗耳源性眩晕的中药制剂,其特征在于:所述中药制剂的剂型为舌下含片。
5.权利要求1至4所述中药制剂的制备方法,其特征在于,包括:
第一步,地龙和全蝎有效成分低温提取;
第二步,川芎、天麻和银杏叶乙醇提取;
第三步,其与成分的水提;
第四步,将第二步和三步获得的提取液混合在一起,在0℃下静止24小时,过滤,减压浓缩除去溶剂,粉碎成粉末,与第一步获得的粉末混合,加入相对于粉末质量的0.5%~1%的硬脂酸镁,压片,即得舌下含片。
6.如权利要求5所述中药制剂的制备方法,其特征在于:所述第一步中将地龙和全蝎分别放入水中浸泡3小时以上,在温度为-10~-20℃将全蝎和地龙杀死,冷冻干燥,粉碎成粉末。
7.如权利要求5或6所述中药制剂的制备方法,其特征在于:所述第二步中按重量称取川芎、天麻和银杏叶分别洗净,各自放入到醇浓度为80%的乙醇中浸泡,乙醇添加为各药材质量的5倍,浸泡1小时,随后加热提取2次,每次1~2小时,合并提取液,静置后取上清液,分别获得川芎提取液、天麻提取液和银杏叶提取液。
8.如权利要求5至7所述中药制剂的制备方法,其特征在于:所述第三步中将余下原料药成分混合在一起,分别洗净,用8倍这些药材质量质和的水煎煮4小时,过滤,得到第一次提取液,然后用6倍这些药材质量质和的水煎煮3小时,过滤,得到二次提取液,合并两次提取液。
9.权利要求1至3所述中药制剂在制备治疗耳源性眩晕的药物中的应用。
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