CN104306684A - 一种能改善睡眠、益智安神、补肾养心的外用药物及制备方法 - Google Patents
一种能改善睡眠、益智安神、补肾养心的外用药物及制备方法 Download PDFInfo
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Abstract
本发明涉及一种外用药品或保健用品,具体是一种能改善睡眠、益智安神、补肾养心的外用药物及制备方法。取丹参、白术2味中药材切制成10-15mm段,将酸枣仁(炒)、五味子、茯苓、麦冬、栀子、制何首乌、远志与上述2味中药材混合,置热回流提取罐内,加5倍量的水浸泡1小时,加热回流提取5小时,浓缩至比重1.15-1.20,80℃烘干,粉碎成细粉,制成颗粒,检验合格后,用药品包装用复合膜装袋,每袋装20g,每盒装3袋(或者5袋、6袋、7袋),装入大箱即得。保健功能:改善睡眠。适用于因神经衰弱、失眠健忘、心烦焦虑和更年期综合症等引起睡眠状况不佳的人群使用。
Description
技术领域
本发明涉及一种外用药品、保健用品及制备方法,具体是一种能改善睡眠、益智安神、补肾养心的外用药物及制备方法(商品名称:斯威牌解抑安神泡腿颗粒)。
背景技术
在已有技术中,治疗因神经衰弱、失眠健忘、心烦焦虑和更年期综合症等引起睡眠状况不佳的药物大多为口服制剂,过多服用不仅对肝、肾功能有影响,对胃也有很大的刺激性。中药材外用及加上适当使用方法,同样可以达到改善睡眠的未见报道。
发明内容
本发明的目的是针对上述不足而提供一种能改善睡眠、益智安神、补肾养心的外用药物及制备方法。
本发明的技术解决方案是:一种能改善睡眠、益智安神、补肾养心的外用药物,由以下重量份数的原料药制成:炒 酸枣仁10~15份、五味子10~15份、茯苓10~15份、丹参10~15份、麦冬8~12份、栀子8~12份、制 何首乌8~12份、白术8~12份、远志8~12份。使用方法:将塑料袋放入桶中,取本品一袋20 g倒入塑料袋中,加入35-45℃的温水2-2.5Kg使泡腿颗粒溶解,桶中再加入35-45℃的温水,双腿放入塑料袋中,塑料袋口封折于膝盖以上,使热气在膝盖以下的塑料袋内形成气蒸,泡腿时间30-35分钟。
优选:一种能改善睡眠、益智安神、补肾养心的外用药物,由以下重量份数的原料药制成颗粒:炒 酸枣仁10份、五味子10份、茯苓10份、丹参10份、麦冬12份、栀子12份、制 何首乌12份、白术12份、远志12份。
优选:一种能改善睡眠、益智安神、补肾养心的外用药物,由以下重量份数的原料药制成颗粒:炒 酸枣仁15份、五味子15份、茯苓15份、丹参15份、麦冬8份、栀子8份、制 何首乌8份、白术8份、远志8份。
药物剂型不限于此,按上述各药用原料与制药上常用的药用载体,如赋形剂或辅料可以混合制成颗粒剂、散剂、液体制剂或其它常规外用制剂。
一种能改善睡眠、益智安神、补肾养心的外用药物的制备方法,其步骤如下:
取丹参、白术2味中药材切制成10-15mm段,将酸枣仁(炒)、五味子、茯苓、麦冬、栀子、制何首乌、远志与上述2味中药材混合,置热回流提取罐内,加5倍量的水浸泡1小时,加热回流提取5小时,浓缩至比重1.15-1.20, 80℃烘干,粉碎成细粉,制成颗粒,检验合格后,用药品包装用复合膜装袋,每袋装20g,每盒装3袋(或者5袋、6袋、7袋),装入大箱即得。
酸枣仁:养心补肝,宁心安神,敛汗,生津。用于虚烦不眠,惊悸多梦,体虚多 汗,津伤口渴。酸枣仁(炒):取净酸枣仁,置炒制容器内,用文火炒至鼓起,色微变深。取出,放凉。本品炒后性温,治疗由胆虚寒引起的不眠;生用则导虚热,可治由胆实热引起的多睡症,所以本方采用炒酸枣仁。
五味子:收敛固涩,益气生津,补肾宁心。用于久嗽虚喘,梦遗滑精,遗尿尿频,久泻不止,自汗盗汗,津伤口渴,内热消渴,心悸失眠。
茯苓: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。
丹参:活血祛瘀,通经止痛,清心除烦,凉血消痈。用于胸痹心痛,脘腹胁痛,癥瘕积聚,热痹疼痛,心烦不眠,***,痛经经闭,疮疡肿痛。
麦冬:养阴生津,润肺清心。用于肺燥干咳。阴虚痨咳,喉痹咽痛,津伤口渴,内热消渴,心烦失眠,肠燥便秘。
栀子:泻火除烦,清热利湿,凉血解毒;外用消肿止痛。用于热病心烦,湿热黄疸,淋证涩痛,血热吐衄,目赤肿痛,火毒疮疡;外治扭挫伤痛。
制何首乌:补肝肾,益精血,乌须发,强筋骨,化浊降脂。用于血虚萎黄,眩晕耳鸣,须发早白,腰膝酸软,肢体麻木,崩漏带下,高脂血症。
白术:健脾益气,燥湿利水,止汗,安胎。用于脾虚食少,腹胀泄泻,痰饮眩悸,水肿,自汗,胎动不安。
远志:安神益智,交通心肾,祛痰,消肿。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,***肿痛。
该组方为中药制剂,采用酸枣仁、五味子、茯苓、丹参、麦冬等药物相互配伍,从而达到改善睡眠的保健或治疗功能。方中酸枣仁养心补肝、宁心安神、敛汗、生津,五味子收敛固涩、益气生津、补肾宁心,茯苓利水渗湿、健脾、宁心,丹参活血祛瘀、通经止痛、清心除烦、凉血消痈,麦冬养阴生津、润肺清心,加之栀子泻火除烦、清热利湿、凉血解毒、外用消肿止痛,制何首乌补肝肾、益精血、乌须发、强筋骨、化浊降脂,白术健脾益气、燥湿利水、止汗、安胎,远志安神益智、交通心肾、祛痰、消肿;借鉴传统中医理论,采用热回流提取技术,提取药物中的有效成分,制成颗粒,通过腿足浴疗法,用热水浸泡双腿和双脚,使药物快速吸收,促进全身组织新陈代谢,改善血液循环,活化全身各器官,达到改善睡眠的保健功能。
保健功能:改善睡眠、益智安神、补肾养心。
适宜人群:本品适用于因神经衰弱、失眠健忘、心烦焦虑和更年期综合症等引起睡眠状况不佳的人群使用。
使用方法:将塑料袋放入桶中,取本品一袋倒入塑料袋中,加入40℃左右的温水2—2.5Kg使泡腿颗粒溶解,桶中再加入40℃左右的温水,双腿放入塑料袋中,塑料袋口封折于膝盖以上,使热气在膝盖以下的塑料袋内形成气蒸,有利于促进膝关节的血液循环和皮肤吸收,泡腿时间30-35分钟为宜,连续使用效果更好。
本发明的优点:1、组方合理,效果明确。2、制成本发明产品的药材有效成分采用热回流提取技术,提取药物中的有效成份,具有收膏率高,能耗降低,提取物质量明显提高等优点。3、采用独特的外用使用方法,直接用于皮肤外用,提高了临床用药的安全性。如温水泡脚、塑料袋气蒸,有利于促进膝关节的血液循环和皮肤吸收,改善睡眠的效果更好。4、本发明的保健用品经吉林省卫生监测检验中心检测,对大鼠皮肤急性毒性试验LD50大于5000mg/kg,其毒性分级属于实际无毒级;对家兔皮肤多次刺激性试验为无刺激性;对豚鼠皮肤***反应试验为弱致敏性;根据《保健用品功能学评价程序与检验方法》中的判定标准判定:本品具有改善睡眠功能。5、斯威牌解抑安神泡腿颗粒在50例使用者中的显效率14%,总有效率为92%,结果表明,斯威牌解抑安神泡腿颗粒保健、治疗功效确切,且无不良反应事件。
具体实施方式
实施例1
一种能改善睡眠、益智安神、补肾养心的外用药物,其特征由以下重量份数的原料药制成颗粒:酸枣仁(炒)10份、五味子10份、茯苓10份、丹参10份、麦冬12份、栀子12份、制何首乌12份、白术12份、远志12份。
制备方法:取丹参、白术2味中药材切制成10-15mm段,将酸枣仁(炒)、五味子、茯苓、麦冬、栀子、制何首乌、远志与上述两味中药材混合,置热回流提取罐内,加5倍量的水浸泡1小时,加热回流提取5小时,浓缩至比重1.15-1.20, 80℃烘干,粉碎成细粉,制成颗粒,检验合格后,用药品包装用复合膜装袋,每袋装20g,每盒装3袋(或者5袋、6袋、7袋),装入大箱即得。
实施例2
一种能改善睡眠、益智安神、补肾养心的外用药物,其特征由以下重量份数的原料药制成颗粒:酸枣仁(炒)15份、五味子15份、茯苓15份、丹参15份、麦冬8份、栀子8份、制何首乌8份、白术8份、远志8份。
制备方法:取丹参、白术2味中药材切制成10-15mm段,将酸枣仁(炒)、五味子、茯苓、麦冬、栀子、制何首乌、远志与上述2味中药材混合,置热回流提取罐内,加5倍量的水浸泡1小时,加热回流提取5小时,浓缩至比重1.15-1.20, 80℃烘干,粉碎成细粉,制成颗粒,检验合格后,用药品包装用复合膜装袋,每袋装20g,每盒装3袋(或者5袋、6袋、7袋),装入大箱即得。
实验例1
工艺选择正交实验结果为:
因素水平表
正交试验设计表及结果
由上述试验结果选择最佳实验条件为:药材的提取时间5小时,溶媒的用量是药材的5倍。
实验例2
试验人群:年龄在32岁至64岁之间的知情受试者50例。
保健功能:改善睡眠。
适宜人群:本品适用于因神经衰弱、失眠健忘、心烦焦虑和更年期综合症等引起睡眠状况不佳的人群使用。
使用方案:将塑料袋放入桶中,取本品一袋20g倒入塑料袋中(实施例1),加入40℃左右的温水2—2.5Kg使泡腿颗粒溶解,桶中再加入40℃左右的温水,双腿放入塑料袋中,塑料袋口封折于膝盖以上,使热气在膝盖以下的塑料袋内形成气蒸,有利于促进膝关节的血液循环和皮肤吸收,泡腿时间30-35分钟为宜,,每天使用。
观察时间:14天
观察指标:改善睡眠的程度。
分以下几种类型:
入睡困难。
睡眠浅、易醒。
混合型失眠。
分析总结:
斯威牌解抑安神泡腿颗粒是通化斯威药业股份有限公司研制的中药保健用品之一,具有改善睡眠的保健功能,为评价其安全性和有效性,我们进行了50例使用人群抽样调查。
试验结果显示:
50例使用人群年龄在32岁至64岁之间,皆有因神经衰弱、失眠健忘、心烦焦虑和更年期综合症等引起各种不同程度的睡眠不佳,经过每日用该产品浸泡双腿、双脚30-35分钟,连续使用两周,其睡眠皆有不同程度的改善。
疗后完全好转的 0例。
疗后比疗前明显好转的 7例。
疗后比疗前略见好转的 39例。
疗后比疗前无改善的 4例。
从以上数据可知,斯威牌解抑安神泡腿颗粒的保健功效在50例抽样调查中的总有效率为92%,显效率14%,因引起睡眠不佳的原因不同,适用人群的体质差异,斯威牌解抑安神泡腿颗粒改善睡眠的功效体现不同。
抽样调查结果表明,斯威牌解抑安神泡腿颗粒治疗、保健功效确切,且无不良反应事件。
实验例3
经吉林省卫生监测检验中心检测,斯威牌解抑安神泡腿颗粒对大鼠皮肤急性毒性试验LD50大于5000mg/kg,其毒性分级属于实际无毒级;对家兔皮肤多次刺激性试验为无刺激性;对豚鼠皮肤***反应试验为弱致敏性。
实验例4
经吉林省卫生监测检验中心根据《保健用品功能学评价程序与检验方法》中的判定标准判定[吉卫检字第BJ201204032]:斯威牌解抑安神泡腿颗粒具有改善睡眠功能(实施例1)。
Claims (4)
1.一种能改善睡眠、益智安神、补肾养心的外用药物,其特征在于由以下重量份数的原料药制成颗粒剂:炒 酸枣仁10~15份、五味子10~15份、茯苓10~15份、丹参10~15份、麦冬8~12份、栀子8~12份、制 何首乌8~12份、白术8~12份、远志8~12份;使用方法:将塑料袋放入桶中,取本品一袋20 g倒入塑料袋中,加入35-45℃的温水2-2.5Kg使泡腿颗粒溶解,桶中再加入35-45℃的温水,双腿放入塑料袋中,塑料袋口封折于膝盖以上,使热气在膝盖以下的塑料袋内形成气蒸,泡腿时间30-35分钟。
2.按照权利要求1所述的一种能改善睡眠、益智安神、补肾养心的外用药物,其特征在于由以下重量份数的原料药制成颗粒:炒 酸枣仁10份、五味子10份、茯苓10份、丹参10份、麦冬12份、栀子12份、制 何首乌12份、白术12份、远志12份。
3.按照权利要求1所述的一种能改善睡眠、益智安神、补肾养心的外用药物,其特征在于由以下重量份数的原料药制成颗粒:炒 酸枣仁15份、五味子15份、茯苓15份、丹参15份、麦冬8份、栀子8份、制 何首乌8份、白术8份、远志8份。
4.按照权利要求1-3任一所述的一种能改善睡眠、益智安神、补肾养心的外用药物的制备方法,其特征在于步骤如下:
取丹参、白术两味中药材切制成10-15mm段,将炒酸枣仁、五味子、茯苓、麦冬、栀子、制何首乌、远志与上述两味中药材混合,置热回流提取罐内,加5倍量的水浸泡1小时,加热回流提取5小时,浓缩至比重1.15-1.20, 80℃烘干,粉碎成细粉,制成颗粒,检验合格后,用药品包装用复合膜装袋。
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Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN106177398A (zh) * | 2015-05-05 | 2016-12-07 | 刘宽明 | 一种治慢性神经衰弱的配方 |
CN106177823A (zh) * | 2015-05-06 | 2016-12-07 | 刘宽明 | 一种治夏日饮冷、呕吐腹泻的配方 |
CN106177167A (zh) * | 2015-05-06 | 2016-12-07 | 刘宽明 | 一种治冠心病的配方 |
Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1456238A (zh) * | 2003-02-12 | 2003-11-19 | 毛友昌 | 安神片的制备方法 |
CN101653553A (zh) * | 2009-08-10 | 2010-02-24 | 黄山 | 一种益心安神颗粒 |
CN102283999A (zh) * | 2011-08-08 | 2011-12-21 | 许建成 | 一种治疗失眠的中药制剂 |
-
2014
- 2014-10-18 CN CN201410558495.XA patent/CN104306684B/zh not_active Expired - Fee Related
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1456238A (zh) * | 2003-02-12 | 2003-11-19 | 毛友昌 | 安神片的制备方法 |
CN101653553A (zh) * | 2009-08-10 | 2010-02-24 | 黄山 | 一种益心安神颗粒 |
CN102283999A (zh) * | 2011-08-08 | 2011-12-21 | 许建成 | 一种治疗失眠的中药制剂 |
Non-Patent Citations (1)
Title |
---|
张旭明: "安神胶囊治疗慢性失眠症的对照研究", 《现代中西医结合杂志》 * |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN106177398A (zh) * | 2015-05-05 | 2016-12-07 | 刘宽明 | 一种治慢性神经衰弱的配方 |
CN106177823A (zh) * | 2015-05-06 | 2016-12-07 | 刘宽明 | 一种治夏日饮冷、呕吐腹泻的配方 |
CN106177167A (zh) * | 2015-05-06 | 2016-12-07 | 刘宽明 | 一种治冠心病的配方 |
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