CN104147388B - 一种治疗偏头疼的中药组合物及其制备方法 - Google Patents
一种治疗偏头疼的中药组合物及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种治疗偏头痛的中药组合物，其特征是，由天麻、白芷、茯苓、黄芪、赤芍、蔓荆子、桂花等七味中药材制成。本发明以祛邪活络为主，祛风、散寒、化湿、清热，虚实夹杂，扶正祛邪并举，具有用药精简、见效快，有效率高，治愈后不复发等优点。
Description
技术领域
本发明涉及一种治疗偏头疼的中药组合物及其制备方法，属中药技术领域。
背景技术
偏头痛是一种发生在头部或左或右、是以头痛暴作、疼痛剧烈、反复发作为特征的搏动性头痛。发作前常有先兆，如眼前闪光、视物模糊、肢体麻木等，可伴恶心、呕吐，安静、黑暗环境内或睡眠后头痛缓解，反复发作特征相似。本病属中医学“头痛”、“头风”、“偏头痛”、“偏头风”等范畴。
欧美国家患病率为1500～2000/10万人口(1.5％～2％)。中国患病率为732.1/10万人口(0.73％)，发病率65.8/10万人口(0.06％)。国外患病年龄以25～45岁多见，45％病人在儿童和青春期起病，但1～12岁儿童不少见，首次发病<10岁占25％。男孩发病年龄小于女孩。中国患病年龄以20～45岁多见，10岁以下仅42.6/10万人口，14岁以下仅182/10万人口。国外女性较男性多2～3倍。中国患病率男性392.8/10万人口，女性1579.2/10万人口。
目前西医只能靠止痛药来缓解疼痛，并无特效药物，而吃止痛药，往往初期有效，吃久了止不住疼痛，或者加大药量，药物的副作用也会随之出现，常见的有胃炎、胃出血、胃溃疡、解热镇痛性肾炎等，甚至会引起药物性头痛。可以说，对于偏头疼，现代西医没有办法治愈。
中药治疗偏头疼具有独到之处，我国对头痛病认识，在殷商甲骨文就有“疾首”的记载，《内经》称本病为“脑风”、“首风”，《素问·风论》认为其病因乃外在风邪寒气犯于头脑而致。现常用的方剂有丹参息痛方、天麻头痛散、疏肝止痛方、清热止痛方等等，效果较好。
发明内容
本发明人在祖传秘方的基础上，经过改良，提供了一种治疗偏头疼的中药组合物。
本发明技术方案是：一种治疗偏头疼的中药组合物，其特征是，由天麻、白芷、茯苓、黄芪、赤芍、蔓荆子、桂花等七味中药材制成。
作为优选，本发明一种治疗偏头痛的中药组合物，其特征是，其组成原料的重量份为：天麻6-12、白芷3-6、茯苓3-6、黄芪1-3、赤芍1-3、蔓荆子4-8、桂花3-6。
作为最优技术方案，本发明一种治疗偏头痛的中药组合物，其特征是，其组成原料的重量份为：天麻8、白芷4、茯苓4、黄芪2、赤芍1、蔓荆子4、桂花4。
方中：
天麻：[性味]甘，平。[归经]归肝经。[功能主治]平肝息风止痉。用于头痛眩晕，肢体麻木，小儿惊风，癫痫抽搐，破伤风。
白芷：[性味]辛，温。[归经]归胃、大肠、肺经。[功能主治]散风除湿，通窍止痛，消肿排脓。用于感冒头痛，眉棱骨痛，鼻塞，鼻渊，牙痛，白带，疮疡肿痛。
茯苓：[性味]甘、淡，平。[归经]归心、肺、脾、肾经。[功能主治]利水渗湿，健脾宁心。用于水肿尿少，痰饮眩悸，脾虚食少，便溏泄泻，心神不安，惊悸失眠。
黄芪：[性味]甘，温。[归经]归肺、脾经。[功能主治]补气固表，利尿托毒，排脓，敛疮生肌。用于气虚乏力，食少便溏，中气下陷，久泻脱肛，便血崩漏，表虚自汗，气虚水肿，内热消渴等。
赤芍：[性味]苦，微寒。[归经]归肝经。[功能主治]清热凉血，散瘀止痛。用于温毒发斑，吐血衄血，目赤肿痛，肝郁胁痛，经闭痛经，症瘕腹痛，跌扑损伤，痈肿疮疡。
蔓荆子：[性味]辛、苦，微寒。[归经]归膀胱、肝、胃经。[功能主治]疏散风热，清利头目。用于风热感冒头痛，齿龈肿痛，目赤多泪，目暗不明，头晕目眩。
桂花：[性味]花：辛，温。[功能主治]花：散寒破结，化痰止咳。用于牙痛，咳喘痰多，经闭腹痛。
优选地，本发明治疗偏头痛的中药组合物可以为片剂、分散片、颗粒剂、胶囊剂或汤剂。可以采用本领域技术人员熟知的方法来进行药剂的制备。根据需要，可以加入各种药学上可接受的载体。所述的载体包括药学领域常规的稀释剂、赋形剂、填充剂、粘合剂、湿润剂、崩解剂、吸收促进剂、表面活性剂、吸附载体、润滑剂等。本发明的药剂在制备时，可选择的填充剂有：淀粉、糖粉、磷酸钙、糊精、微晶纤维素、乳糖、预胶化淀粉、甘露醇等；可选择的粘合剂有：羧甲基纤维素钠、PVP-K30、羟丙基纤维素、淀粉浆、甲基纤维素、乙基纤维素、羟丙基甲基纤维素、胶化淀粉等；可选择的崩解剂有：干淀粉、交联聚维酮、交联羧甲基纤维素钠、羧甲基淀粉钠、低取代羟丙基纤维素等；可选择的润滑剂有：硬脂酸镁、滑石粉、十二烷基硫酸钠、微粉硅胶等。
本发明优选为片剂、胶囊剂、颗粒剂。
进一步优选为胶囊剂。
本发明还提供了一种治疗偏头痛中药组合物胶囊剂的制备方法，包含如下步骤：按照本发明重量份称取干燥后的天麻、白芷、茯苓、黄芪、赤芍、蔓荆子、桂花等七味中药材，混合均匀，粉碎成过80-100目的细粉，灭菌装入0号胶囊中即得本发明胶囊剂。当然本发明胶囊剂也可以根据现有的制剂工艺，加入其他辅料，如矫味剂。
本发明胶囊剂用法用量：每天2次，每次4-6粒，每粒含药量0.4g。7天一疗程。
本发明以祛邪活络为主，祛风、散寒、化湿、清热，虚实夹杂，扶正祛邪并举。本发明组方具有用药精简、原料药材来源易得、制剂制备工艺简单、价格低廉，见效快，有效率高，治愈后不复发等优点。并且本发明中药组合物全部药材都是药食同源材料，且服用剂量低，无胃肠刺激，安全性较好，适于在临床上大规模推广。
具体实施方式
以下通过实施例形式，对本发明的上述内容再作进一步的详细说明，但不应将此理解为本发明上述主题的范围仅限于以下的实例，凡基于本发明上述内容所实现的技术均属于本发明的范围。
实施例1
本治疗偏头痛的中药组合物颗粒剂，采用下述的重量配比制备：
天麻8重量份，白芷4重量份，茯苓4重量份，黄芪2重量份，赤芍1重量份，蔓荆子4重量份，桂花4重量份。
制备方法：对各原料进行严格筛选，净选、烘干、称取、粉碎成过80目的细粉，加入适量β环糊精，加95％乙醇制粒，60℃以下干燥，整粒，即得颗粒剂。
实施例2
本治疗偏头痛的中药组合物胶囊剂，采用下述的重量配比制备：
天麻8重量份，白芷4重量份，茯苓4重量份，黄芪2重量份，赤芍1重量份，蔓荆子4重量份，桂花4重量份。
制备方法：对各原料进行严格筛选，净选、烘干、称取然后粉碎成过80目的细粉，灭菌装入0号胶囊中即得本发明胶囊剂。
实施例3
本治疗偏头痛的中药组合物胶囊剂，采用下述的重量配比制备：
天麻10重量份，白芷4重量份，茯苓6重量份，黄芪3重量份，赤芍2重量份，蔓荆子8重量份，桂花6重量份。
制备方法：对各原料进行严格筛选，净选、烘干、称取然后粉碎成过80目的细粉，灭菌装入0号胶囊中即得本发明胶囊剂。
实施例4
本治疗偏头痛的中药组合物胶囊剂，采用下述的重量配比制备：
天麻6重量份，白芷6重量份，茯苓4重量份，黄芪5重量份，赤芍6重量份，蔓荆子6重量份，桂花4重量份。
制备方法：对各原料进行严格筛选，净选、烘干、称取然后粉碎成过100目的细粉，灭菌装入0号胶囊中即得本发明胶囊剂。
本发明药物的临床观察资料
1、一般资料
门诊患者200例。随机分为两组，各100例，两组性别、年龄、症状等均无显著性差异。
2、诊断标准
发作性中度到重度搏动性头痛，伴恶心、呕吐或畏光。体力活动使头痛加剧。发作开始时仅为轻到中度的钝痛或不适感，几分钟到几小时后达到严重的搏动性痛或跳痛。约2/3为一侧性头痛，也可为双侧头痛，有时疼痛放射至上颈部及肩部。
3、治疗方法
治疗组：口服本发明最优技术方案制得的胶囊剂，每天2次，每次4-6粒，7天一疗程，连续服用2个疗程。
对照组：口服盐酸氟桂嗪片10mg，每天3次，7天为一个疗程，连续服用2个疗程。
4、疗效标准
(1)治愈：症状消失无复发，相关实验室检查正常；
(2)显效：症状消失，颈颅多普勒超声检查正常，半年以内无复发；
(3)有效：症状减轻，实验室检查有所改善；
(4)无效：症状及实验室检查均无改善。
5、实验结果
治疗结果治疗两周后统计疗效，治疗组100例，其中治愈72例(72.0％)，显效18例(20.0％)，有效6例(6.0％)，无效2例(2.0％)；总有效率98.0％；对照组100例，其中治愈36例(36.0％)，显效24例(24.0％)，有效18例(18.0％)，无效22例(22.0％)，总有效率78.0％。
典型病例：
某男，29岁。患者自诉6年前开始出现偏头痛，每次发作持续6-12小时不等，头痛时伴有畏光、烦躁、恶心呕吐等症状，睡眠稍有不足，偏头疼就发作。以前常吃止痛药止痛，但进来越发严重，发作更为频繁。来本院治疗后，给予本发明药物治疗2个疗程，头痛消失，随访1年，偏头痛没有复发。
某女，33岁。患者自诉4年前开始出现偏头痛，发作时疼痛剧烈，每次发作持4-24小时不等，同时伴有恶心，呕吐，情绪紧张或睡眠不足，则发作更频繁，曾服用去痛片、布洛芬等，服药后可暂时缓解，进来发作频率增高，来本院治疗后，给予本发明药物治疗2个疗程，头痛消失，随访1年，偏头痛没有复发。
Claims (5)
1.一种治疗偏头疼的中药组合物，其特征是，其组成原料的重量份为：天麻6-12、白芷3-6、茯苓3-6、黄芪1-3、赤芍1-3、蔓荆子4-8、桂花3-6。
2.如权利要求1所述的一种治疗偏头痛的中药组合物，其特征是，其组成原料的重量份为：天麻8、白芷4、茯苓4、黄芪2、赤芍1、蔓荆子4、桂花4。
3.如权利要求1-2任一所述的一种治疗偏头痛的中药组合物，其特征是，其为片剂、颗粒剂、胶囊剂或汤剂。
4.如权利要求3所述的一种治疗偏头痛的中药组合物，其特征是，其为胶囊剂。
5.如权利要求4所述的一种治疗偏头痛的中药组合物的制备方法，包含如下步骤：按照本发明重量份称取干燥后的天麻、白芷、茯苓、黄芪、赤芍、蔓荆子和桂花等七味中药材，混合均匀，粉碎成过80-100目的细粉，灭菌装入0号胶囊中即得本发明胶囊剂。
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