CN108578537A - 一种治疗失眠的肚脐贴 - Google Patents
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Abstract
本发明涉及一种治疗失眠的肚脐贴，该肚脐贴的药膏由有效成分和医学上可接受的辅料组成，其特征在于，所述的有效成分由以下重量百分比的中药饮片组成：延胡索14～18％，合欢花9～12％，石菖蒲14～18％，远志14～18％，当归10～14％，琥珀3～5％，三七花5～7％，珍珠母5～7％，五味子9～12％，冰片3～5％。经临床验证，本发明所述的治疗失眠的肚脐贴效果显著，总有效率达到91.18％，且没有出现任何临床不良反应。
Description
发明领域
本发明涉及医用配制品，具体涉及含有来自植物未确定结构的治疗失眠的中药制剂。
技术背景
失眠，通常指不能获得正常睡眠的一种病症。其临床表现有入睡困难、易醒、醒后不易入睡、多梦或早醒、严重者甚至彻夜不眠、日间伴有疲倦乏力、头昏思睡、精神萎靡等症状，严重影响人们的学习、工作和生活。西医多采用苯二氮卓类催眠药物或H1受体阻断药(马来酸氯苯那敏等)治疗失眠，药物起效较快，但长期服用，易产生药物依赖性。中医称失眠为“不寐”，失眠患者多因先天禀赋不足，肝血不足，肝体失养，血不舍魂，导致神魂不安，或长时间情志抑郁，造成肝气郁结，化火，灼伤心阴，出现失眠多梦，治疗的关键在于疏肝清热，补血解郁，宁心安神。随着社会生活环境等多种因素的影响，失眠患者的人数不断增多。目前治疗失眠的药物主要为口服药，治疗失眠效果有限。中医药治疗失眠历史悠久，具有独特的优势。因此，寻求一种治疗失眠效果显著的药物具有重要现实意义。
发明内容
本发明所要解决的技术问题是提供一种治疗失眠的肚脐贴，该肚脐贴疗效显著。
本发明解决上述技术问题的方案如下：
一种治疗失眠的肚脐贴，该肚脐贴的药膏由有效成分和医学上可接受的辅料组成，其特征在于，所述的有效成分由以下重量百分比的中药饮片组成：延胡索14～18％，合欢花9～12％，石菖蒲14～18％，远志14～18％，当归10～14％，琥珀3～5％，三七花5～7％，珍珠母5～7％，五味子9～12％，冰片3～5％。
上述肚脐贴中，所述的中药饮片的最佳重量百分比为：延胡索16％，合欢花10％，石菖蒲16％，远志16％，当归12％，琥珀4％，三七花6％，珍珠母6％，五味子10％，冰片4％。
本发明所述的肚脐贴的药膏由以下方法制备而成：取所述的中药饮片，粉碎成细粉，加入凡士林和羊毛脂，混匀即可。
中医认为，脐为先天之命蒂，后天之气舍，为经气之汇海，五脏六腑之本，从肚脐处给药可以更好的发挥疏肝解郁，补血平肝，宁心安神的作用。本发明所述的肚脐贴的有效成分由延胡索，合欢花，石菖蒲，远志，当归，琥珀，三七花，珍珠母，五味子，冰片组成，方中，石菖蒲具有宁神益智，祛痰开窍,化湿开胃的功效，延胡索具有安神止痛，行气活血的功效，共为君药；合欢花具有解郁安神，理气开胃，活络止痛的功效，当归具有补血活血，调经止痛，润肠通便的功效，远志具有养心安神，祛痰止咳的功效，五味子具有补肾宁心，收敛固涩，益气生津的功效，珍珠母具有平肝潜阳，定惊明目的功效，三七花具有清热生津，平肝降压，镇静催眠的功效，它们能起到舒肝解郁，补血平肝，宁心安神的作用，能助君药起到镇静催眠的作用，共为臣药；琥珀具有镇静，利尿，活血的功效，能助君药和臣药起到安神的作用，为佐药；冰片有促进其它药物吸收的作用，为使药。全方共奏疏肝解郁，补血平肝，宁心安神的功效，达到治疗失眠的目的。
为了更好的理解本发明，下面将通过临床实验来证明本发明所具有的技术效果。
一、临床资料
将52例失眠患者(年龄18～23岁)随机分为两组，治疗组为34例，对照组为18例。两组病例在年龄、性别、病程等方面经统计学分析无显著性差异(P＞0.05)，具有可比性。
二、诊断标准
参照中西医失眠诊断标准：①睡眠潜入期：入睡时间超过30分钟；②睡眠维持：夜间觉醒次数超过2次或凌晨早醒；③总的睡眠时间少于6小时；⑤日间残留效应：次日精神不振、白天思睡、乏力等。
三、排除标准
以下任一条件符合者：①身体器质性病变，如因胃痛等躯体痛以及瘙痒等躯体病造成的失眠；②怀孕或预备怀孕者以及哺乳期妇女；③拒绝签署知情同意书，违反试验方案者。
四、治疗方法
治疗组：取实施例1所述的肚脐贴，睡前3小时贴在神阙穴上，每日1贴，连续治疗7天。
对照组：口服马来酸氯苯那敏片(别名扑尔敏)，每日1粒，睡前半小时服用，连续服用7天。(参见郭佳土,马国精,高剑英.扑尔敏治疗原发性失眠65例疗效观察[J],福建医药杂志,1989,11(5):51-52.)
五、疗效评定标准
1、疗效评价：临床痊愈：睡眠时间恢复正常或夜间睡眠的时间在6小时以上,睡眠深沉,醒后精神充沛。显效:睡眠明显好转,睡眠的时间增加3小时以上,睡眠的深度增加。有效:症状减轻,睡眠的时间较前增加不足3小时。无效:治疗后失眠症状无明显改变或反而加重者。
2、症状积分评价标准：采用阿森斯失眠量表(AIS)评分：分为入睡时间(关灯后到睡着的时间)，夜间苏醒，比期望的时间早醒，总睡眠时间，总睡眠质量(无论睡多长)，白天情绪，白天身体功能(体力或精神：如记忆力、认知力和注意力等)，白天思睡八个问题评分,按照严重程度分为四个选项，选项由症状严重程度按0分，1分，2分，3分进行评分。
六、治疗结果
全部数据采用SPSS 17.0统计学软件进行统计分析。计数资料，以x±s表示，比较采用t检验，等级资料，以例数表示，比较采用秩和检验。P<0.05表示差异具有统计学意义。临床治疗效果比较见表1和表2。
表1两组治疗效果比较
注：※表示治疗组与对照组比较P＜0.05。
表2两组AIS积分比较
注：#表示同组治疗前后比较P＜0.05。
从表中的数据可以看出，治疗组与对照组比较总有效率高于对照组，差异具有统计学意义(P＜0.05)。治疗前，两组AIS积分差异不具有统计学意义；治疗后，同组治疗前后比较，积分差异显著(P＜0.05)；治疗后，治疗组与对照组积分差异不具有统计学意义(P＞0.05)。本发明肚脐贴治疗失眠的效果显著，总有效率高达91.18％，且没有出现任何临床不良反应。
具体实施方式
下述实施例中的延胡索，合欢花，石菖蒲，远志，当归，琥珀，三七花，珍珠母，五味子，冰片均为饮片。下述实施例所述的肚脐贴，每贴药膏的用量按生药量计均为0.6克。
实施例1
1、处方：延胡索48g，合欢花30g，石菖蒲48g，远志48g，当归36g，琥珀12g，三七花18g，珍珠母18g，五味子30g，冰片12g。
2、制备方法：将上述处方药饮片粉碎成80目细粉；取凡士林270g，羊毛脂30g与药粉混匀，得药膏；将药膏置于脱敏胶布上，覆盖上防粘层，即得所述的肚脐贴。
实施例2
1、处方：延胡索45g，合欢花28g，石菖蒲49g，远志52g，当归41g，琥珀12g，三七花19g，珍珠母16g，五味子28g，冰片10g。
2、制备方法：将上述处方药饮片粉碎成80目细粉；取凡士林210g，羊毛脂90g与药粉混匀，得药膏；将药膏置于脱敏胶布上，覆盖上防粘层，即得所述的肚脐贴。
实施例3
1、处方：延胡索51g，合欢花29g，石菖蒲47g，远志45g，当归32g，琥珀10g，三七花19g，珍珠母19g，五味子35g，冰片13g。
2、制备方法：将上述处方药饮片粉碎成80目细粉；取凡士林240g，羊毛脂60g与药粉混匀，得药膏；将药膏置于脱敏胶布上，覆盖上防粘层，即得所述的肚脐贴。
实施例4
1、处方：延胡索53g，合欢花31g，石菖蒲46g，远志44g，当归31g，琥珀12g，三七花16g，珍珠母19g，五味子34g，冰片14g。
2、制备方法：将上述处方药饮片粉碎成80目细粉；取凡士林250g，羊毛脂50g与药粉混匀，得药膏；将药膏置于脱敏胶布上，覆盖上防粘层，即得所述的肚脐贴。
Claims (3)
1.一种治疗失眠的肚脐贴，该肚脐贴的药膏由有效成分和医学上可接受的辅料组成，其特征在于，所述的有效成分由以下重量百分比的中药饮片组成：延胡索14～18％，合欢花9～12％，石菖蒲14～18％，远志14～18％，当归10～14％，琥珀3～5％，三七花5～7％，珍珠母5～7％，五味子9～12％，冰片3～5％。
2.根据权利要求1所述的一种治疗失眠的肚脐贴，其特征在于，所述的中药饮片的重量百分比为：延胡索16％，合欢花10％，石菖蒲16％，远志16％，当归12％，琥珀4％，三七花6％，珍珠母6％，五味子10％，冰片4％。
3.根据权利要求1或2所述的一种治疗失眠的肚脐贴，其特征在于，该肚脐贴的药膏由以下方法制得：取所述的中药饮片，粉碎成细粉，加入凡士林和羊毛脂，混匀即可。
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