CN115054652B - 一种具有抗汗匀控功能的三伏贴及其制备方法 - Google Patents
一种具有抗汗匀控功能的三伏贴及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种具有抗汗匀控功能的三伏贴,所述三伏贴包括药膏,所述药膏包括质量比为(12~25):(75~90)的中药活性物质和抗汗匀控药膏基质,所述抗汗匀控药膏基质包括含有聚氨酯的高分子树脂。本发明使用上述原材料与药膏基质充分混合,可以避免皮肤与药物直接接触,防止药物成分短时间内大量输入皮肤导致皮肤受刺激甚至破损,可以长时间内稳定持续释放中药活性成分,使得血液中的药物浓度平稳,避免给药周期初段给药浓度过大带来毒副作用,防止给药周期后段药物释放水平较低,达不到治疗血药浓度。药膏基质以聚氨酯树脂为主要原料,与特种交联剂在60~90℃聚合6~8h而制得,为高分子医用树脂具有良好的药物控释能力。
Description
技术领域
本发明涉及中药配方技术领域,具体涉及一种用于三伏天的高分子材料缓控抗汗匀控三伏贴及其制备方法。
背景技术
中医认为虚寒疾病与肺、脾、肾三脏关系密切。夏季治疗则以补肾、健脾、养肺为主要法则,以改善神经内分泌功能,改善垂体—肾上腺皮质系统兴奋性使功能恢复平衡以增强机体免疫力,真正彻底改善体质。根据最新现代科学研究表明,夏季穴位贴敷能明显地提高机体免疫的各项指标,调节免疫蛋白的功能,减轻β受体的反应,改善机体的免疫状态。中医学理论观点“天人合一,天人相应”、“益火之源,以消阴翳”,从中医理论来说,“天阳”最强之时是引阳补虚、消阴散霾的最好时机,一年之中日照最长的是夏至,但一年中最热的时间却是夏至后第3个庚天起,即三伏天。三伏天是一年中最炎热的时期,也是人体阳气最为旺盛的时候,此时气血趋于机表,皮肤松弛,毛孔开张,有利于药物的渗透,有助于邪气的外驱。
“三伏贴”是利用夏季穴位开阖、经络疏松的原理在三伏天达到养阳的目的,在三伏天里进行穴位贴药,可通过经络内传,气候、穴位、药物三者共同作用,提高免疫抗病能力,对调节机体阴阳平衡,恢复脏腑功能,都有不可低估的效果。尤其是对缓解儿童以及老年人疾病,比如慢性咽炎、慢性鼻炎、过敏性鼻炎、过敏性咳嗽、慢性支气管炎、易感冒、急慢性腹泻、脾胃虚寒等。
现市场使用三伏贴种类繁多,但都困扰于夏季多汗易掉贴问题。三伏贴应用于夏季最炎热的时段,该时段人类体表有大量汗液,三伏贴使用在受者皮肤表面,市场三伏贴药托均为各类无纺布,无纺布厚度大,延展性差,与皮肤贴合性低,遇到夏季体表汗液较多时,易造成药贴脱落,这显然已经为整个三伏贴市场造成很大技术困扰,易脱落导致药贴贴敷时间短,药量供给不足,无法发挥正常药效。
而现阶段三伏贴的使用方法是:将配伍好的中药制备为药粉,然后制成直径三公分的圆形或者正方形药粉包贴于无纺布药托上。这样使用三伏贴药粉直接作用于皮肤,药效释放过于快速与集中很容易造成皮肤破损,不利于药效的吸收。
发明内容
本发明的目的在于克服现有三伏贴的不足,提供一种全新的高分子医用树脂抗汗匀控三伏贴。
一方面,本申请提供了一种具有抗汗匀控功能的三伏贴,所述三伏贴包括药膏,所述药膏包括质量比为(12~25):(75~90)的中药活性物质和抗汗匀控药膏基质,所述抗汗匀控药膏基质包括含有聚氨酯的高分子树脂。
优选的,所述抗汗匀控药膏基质采用医用的聚氨酯高分子树脂材料。
可选的,按质量份数计,所述中药活性物质包括:白术30-40份、茯苓25-35份、百合20-40份、麻黄15-25份、蜀椒15-25份、半夏20-40份。
可选的,所述三伏贴还包括用于承载所述药膏的药托,所述药托包括依次叠加的PU膜层、珠光膜层、药膏覆盖保护层和PU膜覆盖保护层,所述PU膜层的一面具有粘性,所述珠光膜层位于所述PU膜层粘性面的中部,所述药膏覆盖保护层与所述珠光膜层相连接,所述PU膜覆盖保护层用于将整张PU膜层、珠光膜层以及药膏覆盖保护层全部覆盖密封。
另一方面,本申请还提供了一种制备上述三伏贴的方法,包括如下步骤:
步骤一、按照重量份要求取原材料白术、茯苓、百合、麻黄、蜀椒、半夏,粉碎成粉末状;
步骤二、将抗汗匀控药膏基质加热融化,加入中药活性物质,混合搅拌均匀获得药膏。
可选的,所述加热温度为100~130℃。
可选的,还包括将所述药膏置于药托上的步骤,具体包括:
步骤三、将药膏涂于珠光膜层,用药膏覆盖保护层覆盖于药膏和珠光膜层上,并粘贴于PU膜层的粘性面;
步骤四、将PU膜覆盖保护层覆盖于步骤三的材料上,封装获得所述三伏贴。
本发明中,白术,中药名。味甘、微苦,入足阳明胃、足太阴脾经。补中燥湿,止渴生津,最益脾精,大养胃气,降浊阴而进饮食,善止呕吐,升清阳而消水谷,能医泄利。白术根茎含挥发油,油中主要成分为苍术酮、苍术醇、白术内酯等,对治疗肝硬化腹水、原发性肝癌、美尼尔氏综合症、慢性腰痛、急性肠炎及白细胞减少症等有一定疗效。白术用途广泛,除了医疗配方用药外,又是40多种中成药制剂的重要原料。
茯苓,中药名。味甘,气平,入足阳明胃、足太阴脾、足少阴肾、足太阳膀胱经。利水燥土,泻饮消痰,善安悸动,最豁郁满。除汗下之烦躁,止水饮之燥渴,淋癃泄痢之神品,崩漏遗带之妙药,气鼓与水胀皆灵,反胃共噎膈俱效。功标百病,效著千方。茯苓含有茯苓聚糖、茯苓酸、脂肪酸、卵磷脂、腺嘌呤、蛋白酶和三萜类等物质,能增强机体免疫功能,茯苓多糖有明显的抗肿瘤及保肝脏作用。
百合,中药名。气平,气甘,无毒。主邪气腹胀心痛,利大小便,补中益气。百合气平,禀天秋平之金气,入手太阴肺经;味甘无毒,得地中正之土味,入足太阴脾经。气降味和,阴也。肺主气,气逆则腹胀心痛,谓之邪者,盖非其位则为邪也;气平下降,所以主之。膀胱者州都之官,津液气化则出,肺主气,而与大肠为合,脾者又为胃行津液者也;百合甘平,平则气降,气化及于州都,则小便利。甘则脾润,脾行胃之津液,则大便利也。脾为中州,补中者味甘益脾也;肺主气,益气者气平肃肺也。
麻黄,中药名。气温,味苦,无毒。主中风伤寒头痛,温疟发表出汗,去邪热气,止咳逆上气,除寒热,破癥坚积聚。麻黄气温,禀天春和之木气,入足厥阴肝经;味苦无毒,得地南方之火味,入手少阴心经。气味轻升,阳也。心主汗,肝主疏泄,入肝入心,故为发汗之上药也。伤寒有五,中风伤寒者,风伤卫,寒伤营,营卫俱伤之伤寒也;麻黄温以散之,当汗出而解也。温疟,但热不寒之疟也,温疟而头痛,则阳邪在上,必发表出汗,乃可去温疟邪热之气,所以亦可主以麻黄也。肺主皮毛,皮毛受寒,则肺伤而咳逆上气之症生矣;麻黄温以散皮毛之寒,则咳逆上气自平。寒邪郁于身表,身表者,太阳经行之地,则太阳亦病而发热恶寒矣;麻黄温以散寒,寒去而寒热除矣。癥坚积聚者,寒气凝血而成之积也,寒为阴,阴性坚;麻黄苦入心,心主血,温散寒,寒散血活,积聚自破矣。
蜀椒,中药名。味辛,温、大热,有毒。主治邪气咳逆,温中,逐骨节皮肤死肌,寒湿痹痛,下气。除五脏六腑寒冷,伤寒,温疟,大风,汗不出,心腹留饮宿食,止肠澼下痢,泄精,女子字乳余疾,散风邪瘕结,水肿,黄疸,鬼疰,蛊毒,杀虫鱼毒。久服之头不白,轻身,增年。开腠理,通血脉,坚齿发,调关节,耐寒暑,可作膏药。
半夏,中药名。味辛,平、生微寒、熟温,有毒。主治伤寒寒热,心下坚,下气,喉咽肿痛,头眩,胸胀,咳逆,肠鸣,止汗。消心腹胸中膈痰热满结,咳嗽上气,心下急痛坚痞,时气呕逆,消痈肿,胎堕,治痿黄,悦泽面目。生令人吐,熟令人下。用之汤洗,令滑尽。
本申请的有益效果在于:
1、本发明利用上述配伍,配合药膏基质高分子医用树脂,能够长时间持续平稳释放中药活性成分,防止药物活性成分短时间内大量作用于皮肤,能有效避免皮肤受伤。高分子医用树脂为药膏基质使中药活性成分释放速度稳定,血药浓度平稳,防止血药谷峰现象,达到用药更安全有效。
2、本发明采用PU膜为药托,PU膜具有弹性佳,轻度高。厚度极薄仅有0.012mm,却有其他材料无法比拟之物性表现,可承受水压在10000mm水柱以上的压力,同时具有极佳的透湿性,人体汗气可以在薄膜间自由穿透,能够防止遇汗脱落问题。
附图说明
此处所说明的附图用来提供对本申请的进一步理解,构成本申请的一部分,本申请的示意性实施例及其说明用于解释本申请,并不构成对本申请的不当限定。在附图中:
图1是本发明三伏贴的结构示意图;
图2是本发明三伏贴的侧视结构示意图。
图中:1是药膏,2是珠光膜层,3是PU膜层,4是药膏覆盖保护层,5是PU膜覆盖保护层,6是药托。
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发明更为彻底的理解。然而,对于本领域技术人员来说显而易见的是,本发明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,为了避免与本发明发生混淆,对于本领域公知的一些技术特征未进行描述。
如未特殊说明,以下实施例中所采用的材料和仪器均为市售,可通过商业途径购得。
实施例1
本实施例提供了一种具有抗汗匀控功能的三伏贴,如图1和2所示,包括药托6和药膏1,药托6的结构是由PU膜层3、珠光膜层2、药膏覆盖保护层4、PU膜覆盖保护层5组成。PU膜层3一面具有粘性,另一面由可揭除保护层组成。珠光膜层2位于具有粘性面的PU膜层3中部,药膏覆盖保护层4覆盖于珠光膜层2上,PU膜覆盖保护层5和具有粘性面的PU膜层3相连接,将整张PU膜层3、珠光膜层2、药膏覆盖保护层4全部覆盖密封。
其中,药膏1由中药活性物质、药膏基质含有聚氨酯的高分子医用树脂组成。所述中药活性物质由一下重量份数的原材料制成:每1000重量份的药膏中,白术30份、茯苓25份、百合20份、麻黄15份、蜀椒15份、半夏20份。每1000重量份含有875重量份的药膏基质。
上述三伏贴的制备方法包括如下步骤:
步骤1、按照所述重量份数要求取原材料白术、茯苓、百合、麻黄、蜀椒、半夏,以及高分子医用树脂;
步骤2、将白术、茯苓、百合、麻黄、蜀椒、半夏一起用设备破壁粉碎机制成粉末,备用;
步骤3、将药膏基质放入反应釜中加热至110°融化为液态,备用;
步骤4、将步骤2制备好的中药活性成分放入步骤3融化后的药膏基质中,充分加热搅拌20分钟混合均匀后制得药膏1;
步骤5、将步骤3制备的药膏1均匀涂于珠光膜层2上备用;
步骤6、将药膏覆盖保护层4覆盖于步骤5制备的药膏1和珠光膜层2上备用;
步骤7、将步骤6制备的材料放置于PU膜层3具有粘性面中间;
步骤8、将PU膜覆盖保护层5覆盖于步骤7制备的材料上,封袋装盒,得成品三伏贴。
实施例2
本实施例的三伏贴与实施例1大致相同,区别在于中药活性物质不同,具体的,本实施例的中药活性物质由以下重量份数的原材料制成:每1000重量份的药膏中,白术40份、茯苓35份、百合40份、麻黄25份、蜀椒25份、半夏40份。每1000重量份含有795重量份的药膏基质。
实施例3
本实施例的三伏贴与实施例1大致相同,区别在于中药活性物质不同,具体的,本实施例的中药活性物质由以下重量份数的原材料制成:每1000重量份的药膏中,白术35份、茯苓30份、百合35份、麻黄20份、蜀椒20份、半夏30份。每1000重量份含有830重量份的药膏基质。
使用方法
本发明取出后可以直接使用,首先,将装盒的三伏贴取出,其次,将PU膜覆盖保护层5揭掉,将药膏覆盖保护层4揭掉,然后,将药托6贴敷于使用者皮肤上,最后,将PU膜层3不带粘性一面的保护层揭掉。
使用注意事项
1、对贴敷有效成分过敏者禁止使用;
2、怀孕者、半岁内婴儿、高血压患者、糖尿病患者、心脏病患者禁止使用;
3、贴敷位置皮肤破损禁止使用。
抗汗匀控效果实验
本申请采用对虚寒型慢性咳嗽治疗的临床观察,评价所制备的三伏贴的抗汗匀控效果,具体的实验方法如下:
病例选取:选取2020年6月至2021年12月在山东省某中医院治疗的200例虚寒型慢性咳嗽患者,采用随机、单盲法分为穴贴组和对照组,其中三伏贴穴贴组180人,西药对照组20人,每组男女性人数各半,平均年龄约42岁,平均病程约3.5年。所有患者参与本研究前未接受过贴敷治疗,患者病例资料完整,自愿参与本研究,并签署知情同意书。各组患者一般资料比较,差异均无统计学意义(p>0.05),具有可比性。
治疗方法:(1)西药对照组:给予西药治疗。复方氢溴酸右美沙芬糖浆(湖北凤凰白云山药业有限公司,国药准字H2006647)口服,每次10ml,每日3次,治疗1周。(2)三伏贴穴贴组:在西药治疗的同时加用三伏贴。贴敷取穴:初伏、末伏取大椎、定喘(双)、脾俞(双)、天突、至阳,二伏取膻中、风门(双)、肺俞(双)、身柱、命门。隔10天贴一次,贴敷时间8h。注意事项:发热在37.5℃以上者及贴敷处有皮损者暂缓贴敷;贴敷当日饮食以清淡为主,尽量避免有刺激性的沐浴乳接触穴位局部皮肤。
疗效评定标准:痊愈:咳嗽、神疲乏力、气短等症状消失或基本消失,咳嗽症状积分降低≥90%;有效:咳嗽症状减轻,神疲乏力、气短等症状较治疗前缓解,30%≤咳嗽症状积分降低<90%;无效:咳嗽无明显缓解,神疲乏力、气短等症状无明显改善,咳嗽症状积分降低<30%。治疗有效率=(痊愈例数+有效例数)/总例数×100%。其中,咳嗽症状积分的计算方法如下:统计日间咳嗽症状积分:无咳嗽,计0分;偶有短暂咳嗽,计1分;频繁咳嗽,轻度影响日常生活,计2分;频繁咳嗽,严重影响日常生活,计3分;统计夜间咳嗽症状积分:无咳嗽,计0分;夜间阵咳或入睡咳,计1分;因咳嗽轻度影响夜间睡眠,计2分;因咳嗽严重影响夜间睡眠,计3分。统计并计算治疗前后的平均分值,计算治疗前后的积分降低百分比。
抗汗匀控效果评定标准:优秀:正常生活状态下,连续贴敷8h无脱落,贴敷处不易出汗,无任何红肿过敏现象;一般:正常生活状态下连续贴敷8h出现翘边、部分膏体裸露,贴敷处轻微出汗发红;较差:贴敷处出汗较多,脱落时长小于8h,贴敷处出现发红过敏现象。抗汗匀控优秀率=优秀例数/总例数×100%。
贴敷治疗一个疗程结束后统计结果,所得结果如表1和表2所示:
表1
表2
结合表1和表2的数据可知,本申请实施例提供的三伏贴,在与西药的配合作用下,能够显著改善虚寒型慢性咳嗦的治疗,并且,相对于常用的医用防水抗汗基材(例如凡士林)或目前市场上常用的贴剂高分子材料(例如商品化的的退热贴采用的聚丙烯酸树脂或亲水性丙三醇高分子凝胶),采用医用聚氨酯高分子材料的膏体基质再与药物以特定比例混合制备药膏,在实际应用中能够起到很好的抗汗匀控效果,进而能够在药物组成一致或近似的情况下,更好的发挥药物作用,与此同时,还能够显著改善传统三伏贴的中药药物对皮肤的刺激性,降低三伏贴的副作用。
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 (1)
1.一种具有抗汗匀控功能的三伏贴,其特征在于,所述三伏贴包括药膏,所述药膏包括质量比为(12~25):(75~90)的中药活性物质和抗汗匀控药膏基质,所述抗汗匀控药膏基质采用医用的聚氨酯高分子树脂材料;
所述中药活性物质包括:白术30-40份、茯苓25-35份、百合20-40份、麻黄15-25份、蜀椒15-25份、半夏20-40份;
所述三伏贴还包括用于承载所述药膏的药托,所述药托包括依次叠加的PU膜层、珠光膜层、药膏覆盖保护层和PU膜覆盖保护层,所述PU膜层的一面具有粘性,所述珠光膜层位于所述PU膜层粘性面的中部,所述药膏覆盖保护层与所述珠光膜层相连接,所述PU膜覆盖保护层用于将整张PU膜层、珠光膜层以及药膏覆盖保护层全部覆盖密封;
所述三伏贴的制备方法包括:
步骤一、按照重量份要求取原材料白术、茯苓、百合、麻黄、蜀椒、半夏,粉碎成粉末状;
步骤二、将抗汗匀控药膏基质加热融化,加热温度为100~130℃,加入中药活性物质,混合搅拌均匀获得药膏;
步骤三、将药膏涂于珠光膜层,用药膏覆盖保护层覆盖于药膏和珠光膜层上,并粘贴于PU膜层的粘性面;
步骤四、将PU膜覆盖保护层覆盖于步骤三的材料上,封装获得所述三伏贴。
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