CN105816599A - 一种治疗肝肾阳虚型发作性睡病的药物组合物 - Google Patents
一种治疗肝肾阳虚型发作性睡病的药物组合物 Download PDFInfo
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Abstract
本发明属于中医药领域，涉及一种治疗肝肾阳虚型发作性睡病的药物组合物及其制备方法。该药物组合物由隔山消、菟丝子、吴茱萸、桑寄生、细辛、沉香、茯苓、石菖蒲、合欢皮为药用原料，精心组方制成，全方伍用有温肾暖肝，醒脑开窍之效，针对肾阳亏虚，不能温煦肝脉，或寒邪直中，损伤肝阳，致肝阳亏虚，形成的肝肾阳虚型发作性睡病效果优异。
Description
技术领域
本发明属于中医药领域，涉及一种治疗肝肾阳虚型发作性睡病的药物组合物及其制备方法。
背景技术
发作性睡病(Narcolepsy)是一种慢性中枢神经系统功能障碍性疾病，主要临床特征是不可抗拒的白天过度嗜睡、夜间睡眠不安和病理性快速眼动睡眠(REM)症状(由强烈情感引发的发作性碎倒、睡眠瘫痪和入睡幻觉)。发作性睡病的发病原因不明，患病率约为0.03％-0.16％，不同国家报道略有差异，男女发病率无明显差别。发作性睡病常伴随终生，严重影响患者的生活质量，甚至会酿成意外事故而危及生命。例如儿童通常无法正常学习，不能从事体育活动；成人可出现机器操作事故，因工作能力下降而失业，骑自行车或在马路上行走时易出车祸等。
目前西药治疗主要适用于症状严重、发作频繁的患者。传统的中枢兴奋药因不良反应明显，目前已较少应用。新型中枢兴奋药如莫达非尼，安全性良好，但存在头痛、恶心、焦虑、紧张、口干、腹泻等不良反应；羟丁酸钠适应症多，运用范围较广，但亦有眩晕、共济失调、体重减轻、抑郁、胃肠功能紊乱等不良反应。抗抑郁药作为临床常用抗猝倒药，对睡瘫症和入睡前幻觉有一定的效果，但不良反应较其他药更多。
在古代中医文献中，没有“发作性睡病”的病名，但通过对文献记载资料的研究，并结合主要临床症状的分析，其应归属于“多寐”、“嗜睡”、“嗜卧”、等范畴。《灵枢·寒热病》曰：“阳气盛则瞋目，阴气盛则瞑目”。《类证治裁》云：“多寐者，阳虚阴盛之病”。《伤寒论》曰：“少阴之为病，脉微细，但欲寐也”。中医认为此类患者大多阴阳失调，阴盛阳虚，但发明人总结认为阳虚并不仅仅是脾肾阳虚，也包括常被忽视的肝阳虚。现代医家通过临床研究与观察，结合古代睡眠及多寐理论，在关于本病的病因病机上有了发展与深入，且进行了辨证分型，且从临床报道来看，有着很好的临床疗效和应用前景，且可避免或减轻药物的副反应，且复发率低。因此需要进一步开发治疗发作性睡病的中药。
发明内容
发明人善于将现代医学理论与传统医学理论相结合，辨证与辨病相结合，针对发作性睡病的病因病机，基于多年临床治疗经验，博采众长，苦心研究，为了克服现有技术的不足，本发明提供一种能够有效治疗肝肾阳虚型发作性睡病，而且具有较好的近、远期疗效的药物组合物。
为实现上述目的，本发明采用如下技术方案：
一种治疗肝肾阳虚型发作性睡病的药物组合物，其特征在于由如下药用原料制成：隔山消、菟丝子、吴茱萸、桑寄生、细辛、沉香、茯苓、石菖蒲、合欢皮。
更进一步优选如下技术方案：一种治疗肝肾阳虚型发作性睡病的药物组合物，其特征在于由下述重量份的药用原料制成：隔山消10-15份、菟丝子13-18份、吴茱萸6-11份、桑寄生5-8份、细辛4-7份、沉香7-12份、茯苓10-15份、石菖蒲8-13份、合欢皮10-15份。
进一步地，一种治疗肝肾阳虚型发作性睡病的药物组合物，其特征在于由下述重量份的药用原料制成：隔山消12份、菟丝子15份、吴茱萸8份、桑寄生6份、细辛5份、沉香8份、茯苓12份、石菖蒲10份、合欢皮10份。
进一步地，一种治疗肝肾阳虚型发作性睡病的药物组合物，其特征在于由下述重量份的药用原料制成：隔山消15份、菟丝子15份、吴茱萸10份、桑寄生5份、细辛5份、沉香12份、茯苓15份、石菖蒲12份、合欢皮15份。
方中：隔山消甘微苦微温，补肝肾，强筋骨，健脾胃；菟丝子甘温滋补肝肾，二药伍用，温肾暖肝为君药。吴茱萸辛苦热，散寒止痛，助阳止泻；细辛能补肝润燥，祛风散寒，通窍；桑寄生补肝肾，强筋骨，通经络，益肝血，三药为臣药，助君药温补肝肾，兼能通经活络，引药入窍。沉香纯阳而升，体重而沉，味辛走散，能疏通经络，使血随气行，能温养肝脏，保和卫气；茯苓利水渗湿，健脾宁心；石菖蒲化湿开胃，开窍豁痰，醒神益智；合欢皮主安五脏，和心志，令人欢乐无忧，为佐使药。诸药合伍有温肾暖肝，醒脑开窍之效，针对肾阳亏虚，不能温煦肝脉，或寒邪直中，损伤肝阳，致肝阳亏虚，形成的肝肾阳虚型发作性睡病而精心组方，效果优异。
本发明各组分的具体药理研究现状如下：
吴茱萸：【性味】辛、苦，热；有小毒。【归经】归肝、脾、胃、肾经。【功能主治】散寒止痛，降逆止呕，助阳止泻。用于厥阴头痛，寒疝腹痛，寒湿脚气，经行腹痛，脘腹胀痛，呕吐吞酸，五更泄泻，外治口疮；高血压。
细辛：【性味】辛，温。【归经】归心、肺、肾经。【功能主治】祛风散寒，通窍止痛，温肺化饮。用于风寒感冒，头痛，牙痛，鼻塞鼻渊，风湿痹痛，痰饮喘咳。【用法用量】1～3g；外用适量。
隔山消：【性味】味甘；微苦；性微温；【归经】脾；胃；肾经。【功能主治】补肝肾；强筋骨；健脾胃；解毒。主肝肾两虚；头昏眼花；失眠健忘；须发早白；阳痿；遗精；腰膝酸攀登；脾虚不运；脘腹胀满；仞欲不振；泄泻；产后乳少；鱼口疮毒。【用法用量】内服：煎汤，9-15g外用：鲜品适量，捣敷。
菟丝子：【性味】甘，温。【归经】归肝、肾、脾经。【功能主治】滋补肝肾，固精缩尿，安胎，明目，止泻。用于阳痿遗精，尿有余沥，遗尿尿频，腰膝酸软，目昏耳鸣，肾虚胎漏，胎动不安，脾肾虚泻；外治白癜风。【用法用量】6～12g；外用适量。
桑寄生：【性味】苦、甘，平。【归经】归肝、肾经。【功能主治】补肝肾，强筋骨，祛风湿，安胎元。用于风湿痹痛，腰膝酸软，筋骨无力，崩漏经多，妊娠漏血，胎动不安；高血压。
沉香：【性味】辛、苦，微温。【归经】归脾、胃、肾经。【功能主治】行气止痛，温中止呕，纳气平喘。用于胸腹胀闷疼痛，胃寒呕吐呃逆，肾虚气逆喘急。【用法用量】1.5～4.5g，入煎剂宜后下。
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。【用法用量】9～15g。
石菖蒲：【性味】辛、苦，温。【归经】归心、胃经。【功能主治】化湿开胃，开窍豁痰，醒神益智。用于脘痞不饥，噤口下痢，神昏癫痫，健忘耳聋。【用法用量】3～9g。
合欢皮：【性味】甘；平。【归经】心；肝经。【功能主治】安神解郁，活血消痈。主心神不安；忧郁，不眠，内外痈疡，跌打损伤。【用法用量】内服：煎汤，10-15g；或入丸、散。外用：适量，研末调敷。
为了更好的表达本发明的药物组合物，本发明的药物组合物可由隔山消、菟丝子、吴茱萸、桑寄生、细辛、沉香、茯苓、石菖蒲、合欢皮或其水或其有机溶剂提取物为活性成分，依照制剂学常规技术制成各种剂型。
本发明的上述所述药物组合物可以加入制备不同剂型时所需的各种常规辅料或辅助性成分，以常规的中药制剂方法制备成任何一种常用的口服制剂，例如可以是片剂、糖衣片剂、薄膜衣片剂、肠溶衣片剂、胶囊剂、硬胶囊剂、软胶囊剂、口服液、颗粒剂、冲剂、丸剂、散剂、混悬剂、粉剂。
优选地，上述所述的口服剂型为胶囊剂、片剂、口服液、颗粒剂或丸剂。
最优选地，上述所述的口服剂型是胶囊剂。
上述所述的常规辅料或辅助性成分可为：甘露醇、山梨醇、焦亚硫酸钠、亚硫酸氢钠、硫代硫酸钠、盐酸半胱氨酸、巯基乙酸、蛋氨酸、维生素C、EDTA二钠、EDTA钙钠，一价碱金属的碳酸盐、醋酸盐、磷酸盐或其水溶液、盐酸、醋酸、硫酸、磷酸、氨基酸、氯化钠、氯化钾、乳酸钠、木糖醇、麦芽糖、葡萄糖、果糖、右旋糖苷、甘氨酸、淀粉、蔗糖、乳糖、甘露糖醇、硅衍生物、纤维素及其衍生物、藻酸盐、明胶、聚乙烯吡咯烷酮、甘油、土温80、琼脂、碳酸钙、碳酸氢钙、表面活性剂、聚乙二醇、环糊精、β-环糊精、磷脂类材料、高岭土、滑石粉、硬脂酸钙、硬脂酸镁等等。
本发明的另一个目的是提供一种制备治疗肝肾阳虚型发作性睡病的药物组合物的方法。
本发明提供的一种治疗肝肾阳虚型发作性睡病的药物组合物的制备方法，其特征在于包括以下步骤：
取细辛、沉香、石菖蒲、合欢皮粉碎成平均粒径为10-60μm的颗粒后加入5-10倍量的50％的乙醇水溶液，采用超声波提取，超声波提取完毕，取滤液，减压浓缩成稠膏得提取物A，备用，其中，提取条件包括：超声功率为130-160W，提取温度为30-50℃，提取时间为20-30min；
将隔山消、菟丝子、吴茱萸、桑寄生、茯苓加水煎煮两次，第一次煎煮1.5-2.0小时，加水量为煎煮药材总重量的6-10倍，第二次煎煮1.0-1.5小时，加水量为煎煮药材总重量的4-7倍，合并煎液，滤过，滤液减压浓缩，加入乙醇至浓度为30％，于-5～5℃冷藏12小时，滤过，滤液回收乙醇，浓缩得稠膏得提取物B，与提取物A混合均匀，加入辅料或辅助性成分混匀，按照本领域常规制剂工艺制成药剂学上适宜的剂型。如片剂、胶囊剂、口服液、颗粒剂、丸剂等。
本发明的制剂在使用时根据病人的情况确定用法用量。本发明的制剂在使用时根据病人的情况确定用法用量，可每日服1-3次，每次1-20剂，如：1-20袋或粒或片等。
本发明是发明人经过反复研究，逐步改进得到的一种疗效较好的治疗发作性睡病的药物，通过临床观察试验实施例10验证了本发明药物组合物药物对发作性睡病的治疗效果：治疗结束后近期总有效率为95.7％，治疗6个月后随访远期总有效率为88.9％，本发明采用辨病与辨证相结合，是从根本上治疗发作性睡病肝肾阳虚证的有效方法，所以取得了较好的近、远期疗效。因此，本发明还请求保护上述所述药物组合物在制备治疗发作性睡病药物中的用途。
总之，与现有技术相比本发明具有以下有益效果：本发明既遵循了中医辨证用药规律，又融入了现代药理，立法全面，按照君臣佐使原则配伍严谨组方，具有多靶点、多环节、多层次的综合调控作用，是治疗发作性睡病的理想中药复方；同时，临床疗效确切，取得了较好的近、远期疗效，可有效地减轻病者负担和痛苦，能够达到标本兼治的目的；本发明采用纯天然中草药，药源丰富，无毒副作用，且制备方法简单，服用方便，值得临床上广泛推广应用。
具体实施方式
以下通过具体实施例进一步描述本发明，本发明不仅仅限于以下实施例。在本发明的范围内或者在不脱离本发明的内容、精神和范围内，对本发明进行的变更、组合或替换，对于本领域的技术人员来说是显而易见的，且包含在本发明的范围之内。
实施例1胶囊剂
处方：隔山消12份、菟丝子15份、吴茱萸8份、桑寄生6份、细辛5份、沉香8份、茯苓12份、石菖蒲10份、合欢皮10份。
制备方法：取细辛、沉香、石菖蒲、合欢皮粉碎成平均粒径为40-50μm的颗粒后加入8倍量的50％的乙醇水溶液，采用超声波提取，超声波提取完毕，取滤液，减压浓缩成稠膏得提取物A，备用，其中，提取条件包括：超声功率为130-160W，提取温度为30-50℃，提取时间为20-30min；
将隔山消、菟丝子、吴茱萸、桑寄生、茯苓加水煎煮两次，第一次煎煮1.5-2.0小时，加水量为煎煮药材总重量的8倍，第二次煎煮1.0-1.5小时，加水量为煎煮药材总重量的5倍，合并煎液，滤过，滤液减压浓缩，加入乙醇至浓度为30％，于-5～5℃冷藏12小时，滤过，滤液回收乙醇，浓缩成稠膏得提取物B，与提取物A混合均匀，按照本领域常规制剂工艺制成胶囊，每粒装量0.33g，相当于生药0.9g。
实施例2胶囊剂
处方：隔山消15份、菟丝子15份、吴茱萸10份、桑寄生5份、细辛5份、沉香12份、茯苓15份、石菖蒲12份、合欢皮15份。
制备方法：取细辛、沉香、石菖蒲、合欢皮粉碎成平均粒径为30-40μm的颗粒后加入7倍量的50％的乙醇水溶液，采用超声波提取，超声波提取完毕，取滤液，减压浓缩成稠膏得提取物A，备用，其中，提取条件包括：超声功率为130-160W，提取温度为30-50℃，提取时间为20-30min；
将隔山消、菟丝子、吴茱萸、桑寄生、茯苓加水煎煮两次，第一次煎煮1.5-2.0小时，加水量为煎煮药材总重量的7倍，第二次煎煮1.0-1.5小时，加水量为煎煮药材总重量的6倍，合并煎液，滤过，滤液减压浓缩，加入乙醇至浓度为30％，于-5～5℃冷藏12小时，滤过，滤液回收乙醇，浓缩成稠膏得提取物B，与提取物A混合均匀，按照本领域常规制剂工艺制成胶囊，每粒装量0.33g，相当于生药1.0g。
实施例3胶囊剂
处方：隔山消12份、菟丝子13份、吴茱萸10份、桑寄生8份、细辛5份、沉香7份、茯苓10份、石菖蒲8份、合欢皮12份。
制备方法：取细辛、沉香、石菖蒲、合欢皮粉碎成平均粒径为10-30μm的颗粒后加入8倍量的50％的乙醇水溶液，采用超声波提取，超声波提取完毕，取滤液，减压浓缩成稠膏得提取物A，备用，其中，提取条件包括：超声功率为130-160W，提取温度为30-50℃，提取时间为20-30min；
将隔山消、菟丝子、吴茱萸、桑寄生、茯苓加水煎煮两次，第一次煎煮1.5-2.0小时，加水量为煎煮药材总重量的10倍，第二次煎煮1.0-1.5小时，加水量为煎煮药材总重量的5倍，合并煎液，滤过，滤液减压浓缩，加入乙醇至浓度为30％，于-5～5℃冷藏12小时，滤过，滤液回收乙醇，浓缩成稠膏得提取物B，与提取物A混合均匀，按照本领域常规制剂工艺制成胶囊。
实施例4胶囊剂
处方：隔山消15份、菟丝子18份、吴茱萸10份、桑寄生8份、细辛6份、沉香8份、茯苓15份、石菖蒲8份、合欢皮15份。
制备方法：参照实施例1-3的操作进行。
实施例5胶囊剂
处方：隔山消10份、菟丝子15份、吴茱萸11份、桑寄生5份、细辛5份、沉香8份、茯苓10份、石菖蒲12份、合欢皮12份。
制备方法：参照实施例1-3的操作进行。
实施例6胶囊剂
处方：隔山消15份、菟丝子15份、吴茱萸6份、桑寄生8份、细辛7份、沉香12份、茯苓15份、石菖蒲10份、合欢皮10份。
制备方法：参照实施例1-3的操作进行。
实施例7口服液
处方：隔山消12份、菟丝子15份、吴茱萸8份、桑寄生6份、细辛5份、沉香8份、茯苓12份、石菖蒲10份、合欢皮10份。
制备方法：取细辛、沉香、石菖蒲、合欢皮粉碎成平均粒径为10-60μm的颗粒后加入5-10倍量的50％的乙醇水溶液，采用超声波提取，超声波提取完毕，取滤液，减压浓缩成稠膏得提取物A，备用，其中，提取条件包括：超声功率为130-160W，提取温度为30-50℃，提取时间为20-30min；
将隔山消、菟丝子、吴茱萸、桑寄生、茯苓加水煎煮两次，第一次煎煮1.5-2.0小时，加水量为煎煮药材总重量的6-10倍，第二次煎煮1.0-1.5小时，加水量为煎煮药材总重量的4-7倍，合并煎液，滤过，滤液减压浓缩，加入乙醇至浓度为30％，于-5～5℃冷藏12小时，滤过，滤液回收乙醇，浓缩成稠膏得提取物B，与提取物A混合均匀，按照本领域常规制剂工艺制成，每瓶装量10ml，相当于生药3.0g。
实施例8颗粒剂
处方：隔山消12份、菟丝子15份、吴茱萸8份、桑寄生6份、细辛5份、沉香8份、茯苓12份、石菖蒲10份、合欢皮10份。
制备方法：取细辛、沉香、石菖蒲、合欢皮粉碎成平均粒径为10-60μm的颗粒后加入5-10倍量的50％的乙醇水溶液，采用超声波提取，超声波提取完毕，取滤液，减压浓缩成稠膏得提取物A，备用，其中，提取条件包括：超声功率为130-160W，提取温度为30-50℃，提取时间为20-30min；
将隔山消、菟丝子、吴茱萸、桑寄生、茯苓加水煎煮两次，第一次煎煮1.5-2.0小时，加水量为煎煮药材总重量的6-10倍，第二次煎煮1.0-1.5小时，加水量为煎煮药材总重量的4-7倍，合并煎液，滤过，滤液减压浓缩，加入乙醇至浓度为30％，于-5～5℃冷藏12小时，滤过，滤液回收乙醇，浓缩成稠膏得提取物B，与提取物A混合均匀，按照本领域常规制剂工艺制成颗粒剂，每袋装量10g，相当于生药3.0g。
实施例9丸剂
处方：隔山消12份、菟丝子15份、吴茱萸8份、桑寄生6份、细辛5份、沉香8份、茯苓12份、石菖蒲10份、合欢皮10份。
制备方法：取细辛、沉香、石菖蒲、合欢皮粉碎成平均粒径为10-60μm的颗粒后加入5-10倍量的50％的乙醇水溶液，采用超声波提取，超声波提取完毕，取滤液，减压浓缩成稠膏得提取物A，备用，其中，提取条件包括：超声功率为130-160W，提取温度为30-50℃，提取时间为20-30min；
将隔山消、菟丝子、吴茱萸、桑寄生、茯苓加水煎煮两次，第一次煎煮1.5-2.0小时，加水量为煎煮药材总重量的6-10倍，第二次煎煮1.0-1.5小时，加水量为煎煮药材总重量的4-7倍，合并煎液，滤过，滤液减压浓缩，加入乙醇至浓度为30％，于-5～5℃冷藏12小时，滤过，滤液回收乙醇，浓缩成稠膏得提取物B，与提取物A混合均匀，加入辅料或辅助性成分混匀，按照本领域常规制剂工艺制成丸剂，每10丸重2.0g，相当于生药3.0g。
实施例10临床观察试验
1资料与方法
1.1一般资料：50例研究对象来自2014年1-12月我院睡眠医学专题门诊的发作性睡病患者，中医诊断为肝肾阳虚证。其中男32例，女18例；年龄9～46岁；病程1年～12年，平均(3.3±4.2)年；有家族史6例。
1.2诊断标准：
1.2.1参照《国际睡眠障碍分类》(第二版)制定发作性睡病诊断标准。
伴猝倒症的发作性睡病诊断标准：白天睡眠过多至少持续3个月；明确存在情感触发的猝倒症；多次睡眠潜伏期试验发现，平均睡眠潜伏期≤8min，并且入睡直接进入快速动眼(rem)睡眠2次以上，或者脑脊液下丘脑分泌素-1≤110ng/L，或不足正常对照平均水平的1/3。
不伴猝倒症的发作性睡病诊断标准：白天睡眠过多至少持续3个月；尽管可能报告猝倒症样症状，但无典型的猝倒；多次睡眠潜伏期试验发现，平均睡眠潜伏期≤8min，并且入睡直接进入rem睡眠2次以上，或者脑脊液下丘脑分泌素-1≤110ng/L，或不足正常对照平均水平的1/3。
1.2.2中医诊断标准：参照《中药新药临床研究指导原则》并结合临床症状，制定：精神不振，嗜睡多寐，形寒肢冷，腰膝酸软，爪甲不荣，意志消沉，惊恐惕惧，夜间多梦易惊，面白而青，纳呆便溏，舌淡苔白而滑，脉沉迟无力。
1.3纳入及排除标准：纳入符合上述诊断标准且数据完整者。排除因自身免疫性疾病、脑部肿瘤、头部外伤、神经变性疾病等引起的继发性发作性睡病者。
1.4治疗方法：口服本发明实施例1制备的胶囊，每日2次，成人每次4-6粒，饭前半小时服用，治疗1个月为1个疗程，治疗3个疗程后评定疗效。治疗期间不用其他方法治疗。
1.5观察指标及方法：
1.5.1观察治疗前后及随访时患者症状，包括白天嗜睡、猝倒、睡瘫、多梦、幻觉、睡语、吐舌的发生例数，评价疗效。
1.5.2比较治疗前后评价嗜睡改善程度，采用Epworth嗜睡量表(ESS)评分法。
1.6疗效判定标准：参照贾建平第6版《神经病学》拟定。治疗后，根据患者嗜睡发作次数、程度和时间对近期疗效作出判断；并随访6个月观察远期疗效。
近期疗效标准：①显效：患者临床特征消失，能正常生活和学习；②有效：嗜睡发作次数和时间缩短50％以上，基本能正常生活和学习；③无效：症状和体征无改变，不能坚持正常生活和学习。
远期疗效标准：①显效：患者临床特征消失，能正常生活和学习，治疗后6个月内无发作；②有效：嗜睡发作次数和时间缩短50％以上，基本能正常生活和学习，6个月内嗜睡发作次数和时间缩短50％以上；③无效：症状和体征无改变，不能坚持正常学习。
1.7统计学方法：采用SPSS15.0统计软件进行计算。各数值以表示，计量资料采用t检验，计数资料采用χ2检验，以P＜0.05为差异有统计学意义。
2结果
纳入研究的50例研究对象中，未能坚持治疗脱落3例，符合近期疗效评价的患者47例；对治疗有效的患者进行随访时，失访2例。
2.1临床疗效评价：治疗结束后，显效32例，有效13例，无效2例，近期总有效率为95.7％；治疗6个月后对治疗有效的45例患者进行随访，显效27例，有效13例，无效5例，其中复发的患者猝倒、肢体无力症状也较治疗前明显改善，远期总有效率为88.9％。见表1。
表1临床综合疗效评价
注：与对照组比较，*P＜0.05。
2.2治疗前后及随访时Epworth嗜睡量表(ESS)积分比较：疗程结束后，患者积分较治疗前均有下降，差异有统计学意义(P＜0.05)；随访时，患者积分未见明显升高与治疗后比较差异无统计学意义(P＞0.05)。见表2。
表2患者治疗前后及随访时积分比较分
注：与治疗前比较：*P＜0.05；与治疗后比较：#P＞0.05。
2.3安全性及随访情况：各组患者在治疗前后进行肝肾功能、血尿常规检查均未见明显异常，亦未见明显不良反应。本发明采用辨病与辨证相结合，是从根本上治疗发作性睡病的有效方法，所以取得了较好的近、远期疗效。
典型病例：患者，刘某，男，11岁，2014年3月7日初诊。患者3年前出现白天发作性睡眠，伴有猝倒，经某儿童医院诊断为“儿童发作性睡病”，经用补中益气汤、二陈汤、香砂六君子汤治疗1年余，未见明显好转。诊见萎顿困倦，嗜睡难抑，肢体震颤，重则猝倒，淡漠懒言，意志消沉，思维迟钝，夜间多梦易惊，畏寒怕冷，四肢欠温，面白而青，纳呆便溏，舌淡苔白而滑，脉沉迟无力。证属肝肾阳虚。服用本发明按实施例1制得的药物，2个疗程后，症状即基本消失，后又服用1个疗程进行了巩固治疗，痊愈。痊后随访半年没有复发过。
Claims (10)
1.一种治疗肝肾阳虚型发作性睡病的药物组合物，其特征在于由如下药用原料制成：隔山消、菟丝子、吴茱萸、桑寄生、细辛、沉香、茯苓、石菖蒲、合欢皮。
2.如权利要求1所述的药物组合物，其特征在于由下述重量份的药用原料制成：隔山消10-15份、菟丝子13-18份、吴茱萸6-11份、桑寄生5-8份、细辛4-7份、沉香7-12份、茯苓10-15份、石菖蒲8-13份、合欢皮10-15份。
3.如权利要求2所述的药物组合物，其特征在于由下述重量份的药用原料制成：隔山消12份、菟丝子15份、吴茱萸8份、桑寄生6份、细辛5份、沉香8份、茯苓12份、石菖蒲10份、合欢皮10份。
4.如权利要求2所述的药物组合物，其特征在于由下述重量份的药用原料制成：隔山消15份、菟丝子15份、吴茱萸10份、桑寄生5份、细辛5份、沉香12份、茯苓15份、石菖蒲12份、合欢皮15份。
5.如权利要求1-4任一所述的药物组合物，其特征在于述所述药物组合物制备成口服制剂。
6.如权利要求5所述的药物组合物，其特征在于述所述口服制剂优选为片剂、糖衣片剂、薄膜衣片剂、肠溶衣片剂、胶囊剂、硬胶囊剂、软胶囊剂、口服液、颗粒剂、冲剂、丸剂、散剂、混悬剂、粉剂。
7.如权利要求6所述的药物组合物，其特征在于述所述口服制剂优选为胶囊剂、片剂、口服液、颗粒剂或丸剂。
8.如权利要求7所述的药物组合物，其特征在于述所述口服制剂优选为胶囊剂。
9.如权利要求1-8任一所述的药物组合物，其特征在于述所述药物组合物的制备方法包括以下步骤：
取细辛、沉香、石菖蒲、合欢皮粉碎成平均粒径为10-60μm的颗粒后加入5-10倍量的50％的乙醇水溶液，采用超声波提取，超声波提取完毕，取滤液，减压浓缩成稠膏得提取物A，备用，其中，提取条件包括：超声功率为130-160W，提取温度为30-50℃，提取时间为20-30min；
将隔山消、菟丝子、吴茱萸、桑寄生、茯苓加水煎煮两次，第一次煎煮1.5-2.0小时，加水量为煎煮药材总重量的6-10倍，第二次煎煮1.0-1.5小时，加水量为煎煮药材总重量的4-7倍，合并煎液，滤过，滤液减压浓缩，加入乙醇至浓度为30％，于-5～5℃冷藏12小时，滤过，滤液回收乙醇，浓缩得稠膏得提取物B，与提取物A混合均匀，加入辅料或辅助性成分混匀，按照本领域常规制剂工艺制成药剂学上适宜的剂型，如片剂、胶囊剂、口服液、颗粒剂、丸剂等。
10.权利要求1-4任一所述的药物组合物在制备治疗肝肾阳虚型发作性睡病药物中的用途。
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