CN103285093B - 一种治疗癫痫病的中药组合物 - Google Patents
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Abstract
本发明公开了一种治疗癫痫病的中药组合物，涉及中医药技术领域。其由如下中药材原料制备而成：茯苓30-40份、地龙30-40份、紫河车20-28份、牛蒡子20-28份、淫羊藿20-28份、牛黄12-18份、远志12-18份、全蝎12-18份、龙胆草12-18份、绿豆30-50份。本发明的药物对于癫痫病的治疗具有标本兼治、疗效特好、愈后复发率低的优势。
Description
技术领域
本发明属于医药技术领域，涉及一种药物配方，特别涉及一种治疗癫痫病的中药组合物。
背景技术
癫痫（epilepsy）俗称“羊癫疯、羊角风、羊羔疯或者羊痫风”，早在两千二百年前的《黄帝内经》中就有所记载，是大脑神经元突发性异常放电，导致短暂的大脑功能障碍的一种慢性疾病。
西医根据癫痫病因不同分成特发性癫痫和继发性（症状性）癫痫两大类。前者指这类患者的脑病并无可以解释症状的结构变化或代谢异常，而与遗传因素有较密切的关系。症状性癫痫因于多种脑部病损和代谢障碍，如先天性疾病、产前期和围生期疾病（产伤是婴儿期癫痫的常见病因）、高热惊厥后遗、难产、外伤、感染、中毒、颅内肿瘤、脑血管疾病、营养代谢性疾病等。癫痫的产生与神经元异常放电相关。人体休息时，一个大脑皮质锥体细胞的放电频率一般保持在1～10次/秒之间，而在癫痫病灶中，一组病态神经元的放电频率可高达每秒数百次。痫灶细胞群高频重复放电，使其轴突所直接联系的神经元产生较大的突触后电位，从而产生连续传播，直至抑制作用（包括痫性周围抑制性神经细胞的活动，胶质细胞对兴奋性物质的回收，以及病灶外抑制机构的参与）使发作终止。
由于传播途径及范围不同而引起各种形式发作。痫性活动可能仅牵涉一个区域的大脑皮质而不再扩散，引起单纯部分性发作；兴奋在前中央回或后中央回通过放电后细胞外钾离子的增多而传导到邻近神经元，造成杰克逊（Jackson）癫痫；痫性活动常由大脑皮质通过下行投射纤维传播到丘脑和中脑网状结构，引起意识丧失，再由弥散性丘脑投射系统传布到整个大脑皮质，产生继发的全面性强直一阵挛发作。另外，癫痫并发症包括：（1）晚期的外伤性特发性羊角风常伴有加重的趋势，可由局部性发作而演变为全身性发作，严重有记忆力减退，人格障碍智力低下等表现。（2）识别障碍：对事物的辨别能力差，的包括梦样状态，时间感知的歪曲，不真实感，分离状态。（3）情感障碍：表现为不愉快的状态，带有自卑感或伴有抑郁。（4）语言障碍：可产生部分失语或重复语言多。（5）记忆障碍：对熟悉事物产生没有体验过的感觉，或对过去经受过的事物的不能快速回忆。（6）错觉：表现在与物体的真实大小、距离、外型产生差异。（7）可并发穿透性颅脑损伤硬脑膜下血肿及脑内血肿脑挫伤颅骨骨折等疾病。（8）幻觉：在没有任何外界变化的情况下可产生视、听、味、空间感及物体成像等方面的变化和错觉。
作为一种难治之症，目前国内抗癫痫医学以及国际医学治疗癫痫的传统方式主要是药物和开颅手切除术，这两种治疗方法虽对病情有一定的控制作用，但却很难彻底根除病灶。
发明内容
鉴于现有技术的不足，本发明的目的在于提供一种治疗癫痫病的中药组合物。该中药组合物作为祖传秘方，具有标本兼治、疗效好、愈后复发率低的优点，经数十年临床应用后确定其是一种治疗癫痫病的特效药物。
本发明的目的是这样实现的：
本发明一种治疗癫痫病的中药组合物，由活性成分和药用辅料组成，按重量份计，所述的活性成分由含有茯苓30-40份、地龙30-40份、紫河车20-28份、牛蒡子20-28份、淫羊藿20-28份、牛黄12-18份、远志12-18份、全蝎12-18份、龙胆草12-18份和绿豆30-50份的中药材原料制备而成。
优选地，上述治疗癫痫病的中药组合物，其中所述的活性成分由茯苓36份、地龙36份、紫河车24份、牛蒡子24份、淫羊藿24份、牛黄15份、远志15份、全蝎15份、龙胆草15份和绿豆40份的中药材原料制备而成。
进一步优选地，上述治疗癫痫病的中药组合物，其中所述的药用辅料包括稀释剂和润滑剂，所述的稀释剂选自如下的一种或多种：淀粉、糊精、微晶纤维素、蔗糖；所述的润滑剂选自硬脂酸镁和/或滑石粉。
进一步优选地，上述治疗癫痫病的中药组合物，它为固体口服制剂；所述的固体口服制剂优选为胶囊剂。
需要说明的是，本发明所选用的中药材具有如下功能主治和来源：
茯苓：具有利水，渗湿利尿的功效。主治小便不利；水肿胀满；痰饮咳逆；呕吐；脾虚食少；泄泻；心悸不安；失眠健忘；遗精白浊。选用多孔菌科真菌茯苓Poria cocos （Schw.）Wolf 的干燥菌核。
地龙：具有清热、镇痉、止喘、利尿的功效。主治高热狂躁、惊风抽搐、头痛目赤、喘息痰热、中风、半身不遂等病证。
紫河车：性味甘、咸、温，入肺、心、肾经，有补肾益精，益气养血之功，主治虚损、羸瘦、咳血气喘、劳热骨蒸、遗精等症。选用健康产妇娩出之干燥胎盘。
牛蒡子：具有疏散风热、宣肺透疹、利咽散结、解毒消肿的功效，主治风热咳嗽、咽喉肿痛、斑疹不透、风疹瘙痒、疮疡肿毒。选自菊科植物牛蒡Arctium lappa L.的干燥成熟果实。
淫羊藿：补肾阳，强筋骨，祛风湿。用于阳痿遗精，筋骨痿软，风湿痹痛，麻木拘挛；更年期高血压。选用小檗科植物淫羊藿（Epimedium brevicornum Maxim.）的干燥叶。
牛黄：清心，豁痰，开窍，凉肝，息风，解毒。用于热病神昏，中风痰迷，惊痫抽搐，癫痫发狂，咽喉肿痛，口舌生疮，痈肿疔疮。选用牛科动物牛（Bos taurus domesticus Gmelin）干燥的胆结石。
远志：具有安神益智、祛痰、消肿的功能，用于心肾不交引起的失眠多梦、健忘惊悸，神志恍惚，咳痰不爽，疮疡肿毒，乳房肿痛。选用远志科植物远志Polygala tenuifolia Willd．和卵叶远志P.sibirica L.的干燥根。
全蝎：息风镇痉，攻毒散结，通络止痛。用于小儿惊风，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。选用钳蝎科动物东亚钳蝎Buthus martensii Karsch 的干燥体。
龙胆草：清热燥湿；泻肝定惊。湿热黄疸；小便淋痛；阴肿阴痒；湿热带下；肝胆实火之头胀头痛；目赤肿痛；耳聋耳肿；胁痛口苦；热病惊风抽搐。来源于龙胆科植物龙胆（Gentiana scabra Bge.）、条叶龙胆（Gentiana manshurica Kitag.）、三花龙胆（Gentiana triflora Pall.）和滇龙胆（Gentiana rigescens Franch.）的根和根茎。
绿豆：清热；消暑；利水；解毒。暑热烦渴；感冒发热；霍乱吐泻；痰热哮喘；头痛目赤；口舌生疮；水肿尿少；疮疡痈肿；风疹丹毒；药物及食物中毒。选用豆科植物绿豆的种子。
将上述各中药组分制备成本发明的复方制剂的制备方法为：称取处方量的茯苓30-40份、地龙30-40份、紫河车20-28份、牛蒡子20-28份、淫羊藿20-28份、牛黄12-18份、远志12-18份、全蝎12-18份、龙胆草12-18份和绿豆30-50份，加10-12倍量的水，浸泡12h-16h，然后煎煮三次，第一次煎1.5-2h，滤出药液待用；第二次加入8-10倍量的水，煎煮1-1.5h，滤出药液待用；第三次加入6-8倍量的水，煎煮0.8-1h，滤出药液待用；合并三次煎液，过滤，收集滤液；滤液浓缩至相对密度为1.25-1.35的稠膏，低温烘烤6-8h，得干膏粉；按干膏粉：糊精为1：0.5-1.5的重量比加入辅料，常规工艺制粒，整粒后分装于胶囊中，用60Co辐照源辐照灭菌，即得本发明的中药制剂。
发明人在临床上经过多年研究、治疗和观察，获得了本发明所述的中药组合物，该药物具有镇惊安神、祛痰解痉、消肿散结、理气、清热燥湿、泻火解毒、开窍提神、镇静、止痛作用，对于癫痫病的治疗具有标本兼治、疗效特好、愈后复发率低的优势。通过疗效观察，随访未发现明显不良反应，疗程短，其远期疗效满意。
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施例，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 中药胶囊剂的制备
生药处方：茯苓36公斤、地龙36公斤、紫河车24公斤、牛蒡子24公斤、淫羊藿24公斤、牛黄15公斤、远志15公斤、全蝎15公斤、龙胆草15公斤、绿豆40公斤。
制备工艺：称取处方量的上述中药材原料，粉碎，混匀，加12倍量的水，浸泡14h，然后煎煮三次，第一次煎1.5h，滤出药液待用；第二次加入9倍量的水，煎煮1.2h，滤出药液待用；第三次加入8倍量的水，煎煮0.8h，滤出药液待用；合并三次煎液，过滤，收集滤液；滤液浓缩至相对密度为1.3的稠膏，低温烘烤7h，得干膏粉；按干膏粉：糊精为1：1.2的重量比加入辅料，常规工艺制粒，整粒后分装于胶囊中，每粒胶囊按30克的生药量装药，用60Co辐照源辐照灭菌，即得胶囊制剂。
实施例2 中药胶囊剂的制备
生药处方：茯苓40公斤、地龙32公斤、紫河车20公斤、牛蒡子28公斤、淫羊藿28公斤、牛黄18公斤、远志12公斤、全蝎18公斤、龙胆草15公斤、绿豆50公斤。
制备工艺：称取处方量的上述中药材原料，粉碎，混匀，加11倍量的水，浸泡16h，然后煎煮三次，第一次煎2h，滤出药液待用；第二次加入9倍量的水，煎煮1.5h，滤出药液待用；第三次加入8倍量的水，煎煮1h，滤出药液待用；合并三次煎液，过滤，收集滤液；滤液浓缩至相对密度为1.3的稠膏，低温烘烤8h，得干膏粉；按干膏粉：糊精为1：1的重量比加入辅料，常规工艺制粒，整粒后分装于胶囊中，用60Co辐照源辐照灭菌，即得胶囊制剂。
实施例3 中药胶囊剂的制备
生药处方：茯苓31公斤、地龙40公斤、紫河车28公斤、牛蒡子25公斤、淫羊藿20公斤、牛黄12公斤、远志18公斤、全蝎12公斤、龙胆草18公斤、绿豆35公斤。
制备工艺：称取处方量的上述中药材原料，粉碎，混匀，加12倍量的水，浸泡15h，然后煎煮三次，第一次煎1.5h，滤出药液待用；第二次加入8倍量的水，煎煮1h，滤出药液待用；第三次加入8倍量的水，煎煮0.8h，滤出药液待用；合并三次煎液，过滤，收集滤液；滤液浓缩至相对密度为1.3的稠膏，低温烘烤7h，得干膏粉；按干膏粉：糊精为1：0.8的重量比加入辅料，常规工艺制粒，整粒后分装于胶囊中，用60Co辐照源辐照灭菌，即得胶囊制剂。
实施例4
64例癫痫病患者，属瘀阻清窍证，年龄5～45岁，男36例，女28例，病程,2～13年。同期内按病人接受治疗时间顺序随机分为两组，中药组32例口服本发明实施例1制备的胶囊。早中晚各服3粒（小儿2粒），3个月为一个疗程。对照组32例，口服卡马西平片治疗，成人剂量为每次100mg，3次／d，小儿剂量5～7mg(kg·d)，3次／d。两组临床资料统计学分析，无显著性差异(P＞0.05)，具有可比性。两组在治疗期问禁食羊肉、烟、酒等躁热之品和肥甘生冷之品，防止过度劳累、驾驶、高温、水上作业以免发作时发生意外，保持心情舒畅，避免精神刺激。
疗效标准：
近期治愈：治疗后与治疗前发作间歇时间比较延长1年以上；
好转：发作时症状比以前减轻，间歇期明显延长；
未愈：发作频繁或症状加重。
治疗结果：中药组32例中，治疗1个疗程痊愈5例，2个疗程痊愈8例，3个疗程愈14例；好转4例．无效的1例，总有效率96.9%。对照组32例中，治疗1个疗程治愈0例，2个疗程治愈4例，3个疗程治愈5例，好转17例，无效6例，总有效率为81.3%。由此可见，本发明的中药组合物治疗癫痫病的疗效优于西药的常规治疗，通过疗效观察，随访未发现明显不良反应，疗程短，其远期疗效满意。
Claims (4)
1.一种治疗癫痫病的中药组合物，其特征在于：由活性成分和药用辅料组成，按重量份计，所述的活性成分由茯苓36份、地龙36份、紫河车24份、牛蒡子24份、淫羊藿24份、牛黄15份、远志15份、全蝎15份、龙胆草15份和绿豆40份的中药材原料制备而成。
2.根据权利要求1所述治疗癫痫病的中药组合物，其特征在于：所述的药用辅料包括稀释剂和润滑剂，所述的稀释剂选自如下的一种或多种：淀粉、糊精、微晶纤维素、蔗糖；所述的润滑剂选自硬脂酸镁和/或滑石粉。
3.根据权利要求1所述治疗癫痫病的中药组合物，其特征在于：所述的中药组合物为固体口服制剂。
4.根据权利要求3所述治疗癫痫病的中药组合物，其特征在于：所述的固体口服制剂为胶囊。
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