CN114191527A - 一种中正平和的提神醒脑中药组合物、医用固定贴及其制备方法 - Google Patents
一种中正平和的提神醒脑中药组合物、医用固定贴及其制备方法 Download PDFInfo
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Abstract
本申请公开了一种中正平和的提神醒脑中药组合物,包括可提神醒脑的温热性药物和寒凉性药物;按质量份数计,温热性药物包括:姜黄10~20份、当归60~100份、丁香油20~40份、柠檬桉5~15份和冷榨芝麻油5~15份;寒凉性药物包括:冬青油160~240份、桉叶油10~30份、山苍子油10~30份、樟脑油10~20份、薄荷脑80~120份和冰片10~20份。本申请中药组合物从益气温阳角度提神抗疲劳,辨证施治,不仅补虚扶正,也祛疲安神,据相畏相杀的配伍关系利用当归、冷榨芝麻油、丁香油、姜黄和柠檬桉的温热性来降低冰片、冬青油、山苍子油、樟脑油和薄荷脑的寒凉性,使提神中药组合物药性中正平和,避免了寒凉性提神药使人心率过快、体质虚寒的副作用,为虚寒人群的提神用药提供了新选择。
Description
技术领域
本申请涉及中药技术领域,尤其涉及一种中正平和的提神醒脑中药组合物、医用固定贴及其制备方法。
背景技术
随着社会的发展,人们生活节奏加快,职场竞争也愈发激烈,身体与精神长期处于紧张状态,慢性疲劳综合征也威胁着人们的健康。疲劳是身体在高强度或长时间活动后,产生的一种生理或心理现象,表现为身体困倦、精神倦怠,注意力减退,工作效率下降,经常处于疲劳状态就会发展为病理性损害。
现有技术中具有提神作用的药物多为大脑皮层兴奋药物,此类药物主要抗疲劳作用为兴奋大脑、消除睡意,可使服用者保持较长时间的连续工作状态。具有代表性的提神用药有冬青油、冰片、咖啡因、苯丙胺、哌甲酯哌、甲氯芬酯、吡拉西坦及莫达非尼等,但一方面会刺激心脏,另一方面冬青油、冰片等寒凉性较大,长期使用会使人心率过快、体质虚寒,对本身就为虚寒体质的人来说更是会加重虚寒体质。
现有的提神醒脑中药组合物的贴类产品多为将提神药物放置于强粘附力的胶布上贴敷,撕下时有较多膏体残留物,需要额外清洗,会损伤皮肤,撕掉的时候会粘连汗毛,而且不易撕掉。
发明内容
为了解决上述问题,本申请提供了一种中正平和的提神醒脑中药组合物,所述组合物包括可提神醒脑的温热性药物和寒凉性药物;
按质量份数计,所述温补性药物包括:姜黄10~20份、当归60~100份、丁香油20~40份、柠檬桉5~15份和冷榨芝麻油5~15份;
所述寒凉性药物包括:冬青油160~240份、桉叶油10~30份、山苍子油10~30份、樟脑油10~20份、薄荷脑80~120份和冰片10~20份。
进一步的,所述组合物包括可提神醒脑的温热性药物和寒凉性药物;
按质量份数计,所述温补性药物包括:姜黄15份、当归80份、丁香油30份、柠檬桉10份和冷榨芝麻油10份;
所述寒凉性药物包括:冬青油200份、桉叶油20份、山苍子油20份、樟脑油15份、薄荷脑100份和冰片15份。
另一方面,本申请还提供了如上述的中药组合物在制备医用固定贴、喷剂、口服药中的应用。
进一步的,所述医用固定贴包括载药层,所述载药层包括载体材料和所述中药组合物,所述中药组合物的用量占所述载药层质量分数的5~50%。
进一步的,所述载体材料包括压敏胶;优选的,所述压敏胶为橡胶型热熔压敏胶。
进一步的,所述医用固定贴还包括用于固定载药层的固定膜层和可撕除的保护膜层;优选的,所述固定膜层为四面弹型弹力布,所述保护膜层为带硅油面的PET离型膜。
另一方面,本申请还提供了如上述的医用固定贴的制备方法,其特征在于,包括如下步骤:
步骤一:将压敏胶在微波融胶罐中用500~800W,2000~2600MHz微波加热60~120s后加入姜黄和当归;
步骤二:在所述微波融胶罐内温度降到70~90℃以下后,加入冬青油、桉叶油、丁香油、柠檬桉、山苍子油、樟脑油、薄荷脑、冰片和冷榨芝麻油,充入非活性气体加压,并控制所述融胶罐内压力为1.1~1.5bar,搅拌均匀;
步骤三:将所述压敏胶涂到离型膜上,再将弹力布复合到涂有所述压敏胶的所述离型膜上,复合完成后裁片,得到所述医用固定贴。
进一步的,在步骤一中,所述微波加热为700W,2450MHz微波加热90s。
进一步的,在步骤二中,所述非活性气体为氮气,所述融胶罐内压力为1.3bar。
进一步的,在步骤一中,所述姜黄、当归为120目的粉末。
本申请基于中医理论,用多味中草药配伍组成抗疲劳中药组合物;中药组合物中温补性药物姜黄,行气破瘀、通经止痛,归肝、胆、心经;当归,补血、活血,归肝、心、脾经;冬青油是从常绿植物鹿蹄草叶子萃取而得,入肝、肾二经,祛风湿,强筋骨,止血,止咳和促兴奋,与桉树油混合可以产生更好的效果;丁香油,暖胃、温肾,归脾、胃、肾经;柠檬桉,消肿散毒;山苍子油,扩张血管;樟脑油,归心、脾经,温散止痛、开窍辟秽;薄荷脑,疏风、清热,促透皮吸收;冰片,味辛、性寒,通诸窍、散郁火、消肿去翳,能延长组织耐缺氧时间,可改善血脑屏障的通透性,对感觉神经有刺激作用,为开窍醒神之品,但是容易导致脾虚肚泻、肝肾虚亏;冷榨芝麻油,是一味强壮剂,有补血等功效,适用于身体虚弱等症状,冷榨更是将芝麻素等营养物质完整保存,更能发挥其保肝护肾的功效;诸药共奏祛疲养神之功。
本申请具有如下有益效果:
1、本申请中药组合物从益气温阳角度提神,依据相畏、相杀的配伍关系利用当归、冷榨芝麻油、丁香油、姜黄和柠檬桉的温热性来降低冰片、冬青油、山苍子油、樟脑油和薄荷脑的寒凉性,使提神中药药性中正平和,避免了寒凉性提神药使人心率过快、体质虚寒的副作用,为虚寒人群的提神用药提供了新选择。
2、本申请使用特定频率的微波加热并控制微波功率和时间,使压敏胶在受热融化的同时,减少中药材的升温,从而避免高温对中药材药性的改变,稳定中药组方的药效。
3、本申请在将香味药材油提取物混入压敏胶时,充入非活性气体加压,并增大反应容器内压力,一方面避免了药材氧化,另一方面提高了香味药材油提取物的沸点,减少了香味物质的挥发,同时几乎不影响压敏胶的熔点,使压敏胶保持可流动状态,方便混入药材。
4、将本申请中药组合物使用本申请特定的制备方法制成医用固定贴后,在保持药性、药效的同时,降低了药物的挥发速度,提高了缓释效果,贴敷于穴位时更能在通过透皮作用发挥药效的同时避免对肠胃的刺激,也减少了脾胃消化对阳气的损耗。
具体实施方式:
为了更清楚的阐释本申请的整体构思,下面以实施例的方式进行详细说明,在下文的描述中,给出了大量具体的细节以便提供对本申请更为彻底的理解。然而,对于本领域技术人员来说显而易见的是,本申请可以无需一个或多个这些细节而得以实施。在其他的例子中,为了避免与本申请发生混淆,对于本领域公知的一些技术特征未进行描述。
以下实施例中所采用的材料和仪器均为市售,如未特殊说明,以下实施例中的原料等级均为医用级,且均可通过商业途径购得。
另外,本申请中所述“水”包含去离子水、蒸馏水、离子交换水、双蒸水、高纯水、纯净水等医用领域能够使用的任何可行的水。
实施例1
该实施例提供了一种中正平和的提神醒脑中药组合物的医用固定贴的制备方法,具体步骤如下:
第一步,将姜黄15g、当归80g用磨粉机打成120目的粉末,将700g橡胶型热熔压敏胶在微波融胶罐中用700W,2000MHz微波加热90s后加入姜黄粉末和当归粉末,搅拌均匀;
第二步,在罐内温度降到80℃以下后,加入冬青油200g、桉叶油20g、丁香油30g、柠檬桉粉10g、山苍子油20g、樟脑油15g、薄荷脑100g、冰片15g和冷榨芝麻油10g,充入氮气加压,并控制融胶罐内压力为1.1bar,搅拌均匀;
第三步,用喷胶管将压敏胶涂到带硅油面的PET离型膜上,再将四面弹力布复合到涂有压敏胶的带硅油面的PET离型膜上,复合完成后裁片,得到便利贴。
实施例2~6
实施例2~6与实施例1的制备方法大致相同,区别仅在于,中药组合物组份及其质量份数不同,具体见表1。
对比例1
该对比例采用购自亿吉星医药的冰激牌提神醒脑贴。
对上述各实施例和对比例制备获得的便利贴或中药制剂对183位脉象虚寒(心气虚、脾肝肾虚弱,比普通人更易受提神的寒凉性药物刺激)的受试者进行测试。其中,每例测试时间为50天,期间记录受试者们用药后的平均提神持续时间,第50天时测量各受试者的心跳、脉象变化,同一受试者各例测试之间均间隔30天至受试者体征恢复测试前水平。所得结果见表1。
表1受试者用药后测量结果
由表1中的数据可知,当中药组合物组份及其质量份数为姜黄15份、当归80份、丁香油30份、柠檬桉10份、冷榨芝麻油10份、冬青油200份、桉叶油20份、山苍子油20份、樟脑油15份、薄荷脑100份和冰片15份时,能够使提神中药组合物药性中正平和,避免了寒凉性提神药使人心率过快、体质虚寒的副作用。其中,本申请实施例1的中药组合物的药性最为中正平和,但是用药后平均提神持续时间略短,固定实施例1的中药组合物组份及其质量份数,改变第一步中微波加热的频率和第二步中融胶罐内的压力来进一步提高本申请的中药组合物的用药后平均提神持续时间。
实施例7~12
与实施例1的制备方法大致相同,区别仅在于,第一步中微波加热的频率和第二步中融胶罐内的压力不同,具体见表2。
表2受试者用药后测量结果
由表2中的数据可知,当本申请中第一步中微波加热的频率为2450MHz,第二步中融胶罐内的压力为1.3bar时,能够在使提神中药组合物药性中正平和,避免了寒凉性提神药使人心率过快、体质虚寒的副作用的同时,使用药后平均提神持续时间也较长。其中,实施例7是本申请中的最优选实施例。
综上所述,本申请提供的一种中正平和的提神醒脑中药组合物、医用固定贴及其制备方法,采用中药植物来源,具有天然性好、无毒副作用、温和不刺激的优势。本申请中药组合物组份精妙,配合本申请特定的制备方法制成便利贴后,在保持药性、药效的同时,提高了缓释效果,贴敷于穴位时更能在通过透皮作用发挥药效的同时避免对肠胃的刺激、减少脾胃消化对阳气的损耗,从益气温阳角度提神抗疲劳,辨证施治,不仅补虚扶正,也祛疲安神,依据相畏、相杀的配伍关系利用当归、冷榨芝麻油、丁香油、姜黄和柠檬桉来降低冰片、冬青油、山苍子油、樟脑油和薄荷脑的副作用,避免了提神药物过度刺激心脏、加重虚寒的副作用,也为虚寒人群的提神抗疲劳提供了新的选择。
以上所述仅为本申请的实施例而已,并不用于限制本申请。对于本领域技术人员来说,本申请可以有各种更改和变化。凡在本申请的精神和原理之内所作的任何修改、等同替换、改进等,均应包含在本申请的权利要求范围之内。
Claims (10)
1.一种中正平和的提神醒脑中药组合物,其特征在于,所述组合物包括可提神醒脑的温热性药物和寒凉性药物;
按质量份数计,所述温热性药物包括:姜黄10~20份、当归60~100份、丁香油20~40份、柠檬桉5~15份和冷榨芝麻油5~15份;
所述寒凉性药物包括:冬青油160~240份、桉叶油10~30份、山苍子油10~30份、樟脑油10~20份、薄荷脑80~120份和冰片10~20份。
2.根据权利要求1所述的一种中正平和的提神醒脑中药组合物,其特征在于,所述组合物包括可提神醒脑的温热性药物和寒凉性药物;
按质量份数计,所述温热性药物包括:姜黄15份、当归80份、丁香油30份、柠檬桉10份和冷榨芝麻油10份;
所述寒凉性药物包括:冬青油200份、桉叶油20份、山苍子油20份、樟脑油15份、薄荷脑100份和冰片15份。
3.如权利要求1或2所述的中药组合物在制备提神醒脑、缓解疲劳药物的应用,所述药物的剂型包括贴剂、喷剂、口服剂。
4.一种包含如权利要求1或2所述的中药组合物的医用固定贴,其特征在于,所述医用固定贴包括载药层,所述载药层包括载体材料和所述中药组合物,所述中药组合物的用量占所述载药层质量分数的5~50%。
5.根据权利要求4所述的医用固定贴,其特征在于,所述载体材料包括压敏胶;优选的,所述压敏胶为橡胶型热熔压敏胶。
6.根据权利要求4所述的医用固定贴,其特征在于,所述医用固定贴还包括用于固定载药层的固定膜层和可撕除的保护膜层;优选的,所述固定膜层为四面弹型弹力布,所述保护膜层为带硅油面的PET离型膜。
7.如权利要求3-6任一所述的医用固定贴的制备方法,其特征在于,包括如下步骤:
步骤一:将压敏胶在微波融胶罐中用500~800W,2000~2600MHz微波加热60~120s后加入姜黄和当归;
步骤二:在所述微波融胶罐内温度降到70~90℃以下后,加入冬青油、桉叶油、丁香油、柠檬桉、山苍子油、樟脑油、薄荷脑、冰片和冷榨芝麻油,充入非活性气体加压,并控制所述融胶罐内压力为1.1~1.5bar,搅拌均匀;
步骤三:将所述压敏胶涂到离型膜上,再将弹力布复合到涂有所述压敏胶的所述离型膜上,复合完成后裁片,得到所述医用固定贴。
8.根据权利要求7所述的一种提神醒脑缓解疲劳的便利贴的制备方法,其特征在于,在步骤一中,所述微波加热为700W,2450MHz微波加热90s。
9.根据权利要求7所述的一种提神醒脑缓解疲劳的便利贴的制备方法,其特征在于,在步骤二中,所述非活性气体为氮气,所述融胶罐内压力为1.3bar。
10.根据权利要求7所述的一种提神醒脑缓解疲劳的便利贴的制备方法,其特征在于,在步骤一中,所述姜黄、当归为120目的粉末。
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