CN111358899A - 一种治疗失眠多梦的中药组合物、制剂及其制剂的制备方法 - Google Patents
一种治疗失眠多梦的中药组合物、制剂及其制剂的制备方法 Download PDFInfo
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Abstract
本发明涉及中药领域，具体为一种治疗失眠多梦的中药组合物、制剂及其制剂的制备方法。按重量份数包括以下组分：灯芯草8～14份、百合4～11份、淮小麦10～16份、五味子5～14份、广木香5～11份、龙骨7～15份、睡草8～17份、北柴胡4～11份、牡蛎7～15份、夜交藤4～11份、生枣仁8～14份、茯苓7～14份、女贞子7～13份、旱莲草7～13份、石菖蒲6～14份、远志3～9份、浙麦冬4～12份。本发明公开了一种治疗失眠多梦的中药制剂及其制备方法，通过多种中草药的配伍，能够实现对于失眠多梦症状的治疗。
Description
技术领域
本发明涉及中药领域，具体为一种治疗失眠多梦的中药组合物、 制剂及其制剂的制备方法。
背景技术
失眠是常见的睡眠障碍，目前其患病率已超过32.1％。它是由 心神失养活不安而引起的，以经常不能获得正常睡眠为特征的一类病 症。主要表现为睡眠时间、深度的不足，以及不能消除疲劳、恢复体 力与精力。该症严重妨碍人的正常生活，并可加重或诱发心悸、胸痹、 眩晕、头晕、中风等病症。顽固性失眠，更给患者带来长期的痛苦。
随着现代生活节奏的加快，患有失眠和神经衰弱的人越来越多， 严重地困扰着人们的工作、学习及身体健康。目前，用于治疗失眠的 药物虽然很多，但都不能彻底根治。国内外治疗失眠的药物，以西药 为主，但是西药均有不同程度的成瘾性，依赖性和停药后失眠回跳等 副作用及不良反应；有的服后头晕、乏力、嗜睡及对心、肝、肾脏害 等。
因此，中医治疗失眠的中药制剂逐渐增多，但经临床使用证明， 大多效果不明显，有些还会引起不良副作用，无法很好地满足需求。
发明内容
为了解决以上的技术效果，本发明提供一种治疗失眠多梦的中药 组合物；
本发明是这样实现的：
一种治疗失眠多梦的中药组合物，按重量份数包括以下组分：灯 芯草8～14份、百合4～11份、淮小麦10～16份、五味子5～14份、 广木香5～11份、龙骨7～15份、睡草8～17份、北柴胡4～11份、 牡蛎7～15份、夜交藤4～11份、生枣仁8～14份、茯苓7～14份、 女贞子7～13份、旱莲草7～13份、石菖蒲6～14份、远志3～9份、 浙麦冬4～12份。
优选的，按重量份包括以下组分：灯芯草10～12份、百合6～9 份、淮小麦12～14份、五味子7～12份、广木香7～9份、龙骨9～ 13份、睡草10～15份、北柴胡6～9份、牡蛎9～13份、夜交藤6～ 9份、生枣仁10～12份、茯苓9～12份、女贞子9～11份、旱莲草9～ 11份、石菖蒲8～12份、远志5～7份、浙麦冬6～10份。
优选的，按重量份包括以下组分：灯芯草11份、百合8份、淮 小麦13份、五味子10份、广木香8份、龙骨11份、睡草12份、北 柴胡7份、牡蛎11份、夜交藤8份、生枣仁11份、茯苓10份、女 贞子10份、旱莲草10份、石菖蒲10份、远志6份、浙麦冬8份。
本发明还提供一种治疗失眠多梦的中药制剂，具体包括以下技术 方案：
该中药制剂的剂型为散剂、片剂、颗粒剂、口服液、丸剂和胶囊 剂中的任意一种。
此中药制剂的制备方法包括将上述任一项的中药组合物各组分 进行萃取得到萃取液，将萃取液沉淀得到沉淀物，将沉淀物与辅料混 合得到胶囊芯材颗粒物，将胶囊芯材颗粒物与胶囊壳按药物要求，装 粒，制得中药胶囊。
优选的，萃取液通过萃取剂与各组份混合后进行超声萃取得到。
进一步的，萃取剂包括表面活性剂溶液，萃取剂与各组份混合物 的比例为：2000mL：(200～300)g。
进一步的，表面活性剂溶液包括浓度为25.8×10-2～21.5× 10-2mol/L的十二烷基硫酸钠。
优选的，中药制剂的制备方法包括将权利要求上述任一项的中药 组合物的各组份与增溶剂进行混合得到混合物，对混合物提取得到提 取液，将提取液进行浓缩得到浓缩液，将浓缩液进行喷雾干燥，得到 混合粉体，将混合粉体加入淀粉，混合均匀，通过干法制粒进行压片 成型，即得中药含片。
进一步的，增溶剂包括β-环糊精；所述提取液通过在混合物中 加入乙醇，并在温度40～50℃的条件下，以100～130r/min的速度 进行搅拌得到。
上述方案的有益效果：
本发明公开了一种治疗失眠多梦的中药制剂及其制备方法，通过 多种中草药的配伍，能够实现对于失眠多梦症状的治疗。
具体实施方式
下面对本发明的技术方案进行清楚、完整地描述，显然，所描述 的实施例是本发明一部分实施例，而不是全部的实施例。基于本发明 中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获 得的所有其他实施例，都属于本发明保护的范围。
原料介绍：
灯芯草：味甘、淡，性微寒；用于清热利尿，小便不利，淋沥涩 痛之证。
百合：养阴润肺；清心安神。主阴虚久嗽；痰中带血；热病后期； 余热未清，或情志不遂所致的虚烦惊悸、失眠多梦、精神恍惚；痈肿； 湿疮。
淮小麦：甘，平；养心以宁神志，对于神志失常以及夜寐不安等 心神不宁之症，常常配合炙甘草、大枣等药同用，有养心安神作用。
五味子：敛肺，滋肾，生津，收汗，涩精。治肺虚喘咳，口干作 渴，自汗，盗汗，劳伤羸瘦，梦遗滑精，久泻久痢。
广木香：行气止痛，健脾消食。用于胸脘胀痛、泻痢后重、食积 不消、不思饮食。
龙骨：镇心安神，平肝潜阳，固涩，收敛。
睡草：含有生物碱、黄酮醇甙类、鞣质、脂肪油，具有良好的催 眠作用。
北柴胡：解表退热；疏肝解郁，升举阳气。主外感发热；寒热往 来；疟疾；肝郁胁痛乳胀；头痛头眩；月经不调；气虚下陷之脱肛； 子宫脱垂；胃下垂。
牡蛎：治虚弱、解丹毒、止渴。
夜交藤：养心安神，祛风，通络。
生枣仁：养肝，宁心，安神，敛汗。治虚烦不眠，惊悸怔忡，烦 渴，虚汗。
茯苓：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。
女贞子：养阴益气，抗痨。
旱莲草：凉血，止血，补肾，益阴。
石菖蒲：化湿开胃，开窍豁痰，醒神益智。
远志：安神益智，解郁。治惊悸，健忘，梦遗，失眠，咳嗽多痰， 痈疽疮肿。
浙麦冬：养阴、生津、润肺、止咳、清心、除烦。
本实施例提供一种治疗失眠多梦的中药组合物，按重量份数包括 以下组分：
灯芯草8～14份、百合4～11份、淮小麦10～16份、五味子5～ 14份、广木香5～11份、龙骨7～15份、睡草8～17份、北柴胡4～ 11份、牡蛎7～15份、夜交藤4～11份、生枣仁8～14份、茯苓7～ 14份、女贞子7～13份、旱莲草7～13份、石菖蒲6～14份、远志3～ 9份、浙麦冬4～12份。
实施例1
本实施例提供一种治疗失眠多梦的中药组合物，按重量份数包括 以下组分：
灯芯草8份、百合4份、淮小麦10份、五味子5份、广木香5 份、龙骨7份、睡草8份、北柴胡4份、牡蛎7份、夜交藤4份、生 枣仁8份、茯苓7份、女贞子7份、旱莲草7份、石菖蒲6份、远志 3份、浙麦冬4份。
本实施例还提供一种治疗失眠多梦的中药制剂，包括以上组分组 成的片剂，还提供一种中药制剂的制备方法，具体制备方法包括以下：
a、按原料重量份数比准备称取各种原料，洗净，并在阳光下自 然干燥，备用；
b、将步骤a中所得的各干燥原料进行粉碎和过筛，将各原料粉 末与增溶剂混合均匀，然后置于提取罐中，并向提取罐中加入适量的 乙醇溶液并在温度为40℃的条件下，以100r/min的速度进行搅拌， 得提取液；
c、将步骤b中所得的提取液进行浓缩，所得浓缩液进行喷雾干 燥，得到混合粉体；
d、向混合粉体中加入适量的淀粉，混合均匀，采用干法制粒， 压片成型，即得成品。
在本实施例中，增溶剂选用β-环糊精。
在本实施例中，乙醇溶液中乙醇的体积分数为65％。
在本实施例中，步骤b中的乙醇溶液的加入量为各原料粉末总质 量的3倍。
在本实施例中，步骤b中的筛网的规格为160目筛。
在本实施例中，步骤d中的淀粉的加入量为混合粉体质量的3％。
实施例2
本实施例提供一种治疗失眠多梦的中药组合物，按重量份数包括 以下组分：
灯芯草11份、百合8份、淮小麦13份、五味子10份、广木香 8份、龙骨11份、睡草12份、北柴胡7份、牡蛎11份、夜交藤8 份、生枣仁11份、茯苓10份、女贞子10份、旱莲草10份、石菖蒲 10份、远志6份、浙麦冬8份。
本实施例还提供一种治疗失眠多梦的中药制剂，包括以上组分组 成的胶囊，还提供一种中药制剂的制备方法，具体制备方法包括以下：
(1)中药有效成分的萃取：
按照中药组方称取一定量的中药材，总重为200～300g于3000mL 的烧杯中，再加25.8×10-2～21.5×10-2mol/L的十二烷基硫酸钠 2000mL，不断搅拌下浸泡3～5h，然后使用TGCXZ-2B的超声循环提 取机中，打开超声波萃取电源，萃取30～40min，过滤，得第一道萃 取液及药渣，按照同样操作给药渣中加入萃取剂萃取2次，得二道、 三道萃取液，合并三道萃取液；
(2)中药有效成分的絮凝及富集：
取中药萃取液3000mL，不断搅拌下加入200～300mL质量分数为 1％～3％的壳聚糖或质量分数为1％～3％的聚合氯化铁，先快速搅拌 5～8min，混合均匀后，再慢速搅拌25～30min，待絮团完全形成后， 静置3～4h，在3000r/m下离心8～12min，收集絮状沉淀及上清液。
中药萃取液一般带负电荷，在水溶液中极易形成水化层，成为热 力学不稳定胶体体系，当与带正电荷的絮凝剂结合时，本身的负电被 中和，体系不带电，在重力及分子力的作用下形成沉淀，有效成分得 以富集；
(3)芯材制备：
按照用药需求，将絮状沉淀与辅料进行混合，在40～50℃的烘 箱中干燥10～15h，去除粉碎，得到中药芯材。
在本实施例中，辅料为淀粉。
(4)胶囊制备：
按照每个胶囊中原药量装入胶囊中，再按照30粒装/60粒装包 装。
实施例3
本实施例提供一种治疗失眠多梦的中药组合物，按重量份数包括 以下组分：
灯芯草14份、百合11份、淮小麦16份、五味子14份、广木香 11份、龙骨15份、睡草17份、北柴胡11份、牡蛎15份、夜交藤 11份、生枣仁14份、茯苓14份、女贞子13份、旱莲草13份、石 菖蒲14份、远志9份、浙麦冬12份。
本实施例还提供一种治疗失眠多梦的中药制剂，包括以上组分组 成的汤剂，还提供一种汤剂的制备方法，具体制备方法包括以下：
取以上组合物，并加500ml水，浸泡30分钟，加热煎煮30分钟， 过滤，将收集滤液转移至500ml容量瓶中，以水定容至刻度，0.45 μm微孔滤膜过滤，得到中药汤剂。
实验例1
请50名长期患有失眠症状的患者服用实施例1制备的中药含片， 每日三次，每次两片，坚持服用20天，20天后进行回访，发现43 人失眠症状消失，3人失眠症状有所减轻，4人失眠症状无明显改善。
实验例2
请50名长期患有失眠症状的患者服用实施例2制备的中药胶囊， 每日三次，每次两片，坚持服用20天，20天后进行回访，发现41 人失眠症状消失，6人失眠症状有所减轻，3人失眠症状无明显改善。
实验例3
请50名长期患有失眠症状的患者服用实施例3制备的中药汤剂， 每日三次，每次两片，坚持服用20天，20天后进行回访，发现45 人失眠症状消失，3人失眠症状有所减轻，2人失眠症状无明显改善。
以上所述仅为本发明的优选实施例而已，并不用于限制本发明， 对于本领域的技术人员来说，本发明可以有各种更改和变化。凡在本 发明的精神和原则之内，所作的任何修改、等同替换、改进等，均应 包含在本发明的保护范围之内。
Claims (10)
1.一种治疗失眠多梦的中药组合物，其特征在于，按重量份数包括以下组分：灯芯草8～14份、百合4～11份、淮小麦10～16份、五味子5～14份、广木香5～11份、龙骨7～15份、睡草8～17份、北柴胡4～11份、牡蛎7～15份、夜交藤4～11份、生枣仁8～14份、茯苓7～14份、女贞子7～13份、旱莲草7～13份、石菖蒲6～14份、远志3～9份、浙麦冬4～12份。
2.根据权利要求1所述的治疗失眠多梦的中药组合物，其特征在于，按重量份包括以下组分：灯芯草10～12份、百合6～9份、淮小麦12～14份、五味子7～12份、广木香7～9份、龙骨9～13份、睡草10～15份、北柴胡6～9份、牡蛎9～13份、夜交藤6～9份、生枣仁10～12份、茯苓9～12份、女贞子9～11份、旱莲草9～11份、石菖蒲8～12份、远志5～7份、浙麦冬6～10份。
3.根据权利要求1所述的治疗失眠多梦的中药组合物，其特征在于，按重量份包括以下组分：灯芯草11份、百合8份、淮小麦13份、五味子10份、广木香8份、龙骨11份、睡草12份、北柴胡7份、牡蛎11份、夜交藤8份、生枣仁11份、茯苓10份、女贞子10份、旱莲草10份、石菖蒲10份、远志6份、浙麦冬8份。
4.一种治疗失眠多梦的中药制剂，其特征在于，该中药制剂的剂型为散剂、片剂、颗粒剂、口服液、丸剂和胶囊剂中的任意一种。
5.根据权利要求4所述的治疗失眠多梦的中药制剂，其特征在于，所述中药制剂的制备方法包括将权利要求1～3任一项所述的中药组合物各组分进行萃取得到萃取液，将所述萃取液沉淀得到沉淀物，将所述沉淀物与辅料混合得到胶囊芯材颗粒物，将所述胶囊芯材颗粒物与胶囊壳按药物要求，装粒，制得中药胶囊。
6.根据权利要求5所述的治疗失眠多梦的中药制剂，其特征在于，所述萃取液通过萃取剂与各组份混合后进行超声萃取得到。
7.根据权利要求6所述的治疗失眠多梦的中药制剂，其特征在于，所述萃取剂包括表面活性剂溶液，所述萃取剂与所述各组份混合物的比例为：2000mL：(200～300)g。
8.根据权利要求7所述的治疗失眠多梦的中药制剂制备方法，其特征在于，所述表面活性剂溶液包括浓度为25.8×10-2～21.5×10-2mol/L的十二烷基硫酸钠。
9.根据权利要求4所述的治疗失眠多梦的中药制剂，其特征在于，所述中药制剂的制备方法包括将权利要求1～3任一项所述的中药组合物的各组份与增溶剂进行混合得到混合物，对所述混合物提取得到提取液，将所述提取液进行浓缩得到浓缩液，将所述浓缩液进行喷雾干燥，得到混合粉体，将所述混合粉体加入淀粉，混合均匀，通过干法制粒进行压片成型，即得中药含片。
10.根据权利要求9所述的治疗失眠多梦的中药制剂，其特征在于，所述增溶剂包括β-环糊精；所述提取液通过在混合物中加入乙醇，并在温度40～50℃的条件下，以100～130r/min的速度进行搅拌得到。
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