CN116570700B - 一种具有抑菌、消炎、祛痘功效的中药制剂及其应用 - Google Patents
一种具有抑菌、消炎、祛痘功效的中药制剂及其应用 Download PDFInfo
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- Medicines Containing Plant Substances (AREA)
Abstract
本发明属于医药技术领域,具体涉及一种具有抑菌、消炎、祛痘功效的中药制剂及其应用。具体的,所述具有抑菌、消炎、祛痘功效的中药制剂,其药物活性成分包含以下重量份数的原料药:吴茱萸1‑5份,当归2‑10份,川芎1‑5份,茯苓1‑5份,桂枝2‑10份,白芍3‑15份,三棱1‑5份,莪术1‑5份,红花2‑10份,桃仁1‑5份,半夏1‑5份,麦冬2‑5份。进一步的,上述中药制剂还可以制备外用药品使用。经试验证明,上述产品具有高效快速祛痘、组织修复并提升肌肤免疫力、以及高安全性,因此具有良好的实际应用之价值。
Description
技术领域
本发明属于医药技术领域,具体涉及一种具有抑菌、消炎、祛痘功效的中药制剂及其应用。
背景技术
公开该背景技术部分的信息仅仅旨在增加对本发明的总体背景的理解,而不必然被视为承认或以任何形式暗示该信息构成已经成为本领域一般技术人员所公知的现有技术。
痤疮又称“痘痘”,是好发于人面部毛囊皮脂腺单位的一种慢性炎症性皮肤病,患病率在全球排名第8位。痘印的表现有皮肤局部屏障受损、炎症性色素沉着,严重的可导致痤疮瘢痕等。研究发现超过95%的人会有不同程度的痤疮发生,3%-7%的痤疮患者会遗留瘢痕,影响患者的容貌和身心健康。它的主要病因如下:①雄激素分泌异常引起的皮脂腺功能亢进;②毛囊异常角质化;③细菌的异常增生,常见的有痤疮丙酸杆菌(P. acnes)、金黄色葡萄球菌(S. aureus)等,最具危害性的是P. acnes;④炎症。痤疮可以是炎症性的也可以是非炎症性的。非炎症性皮损又称为粉刺,包括黑头粉刺(开放性粉刺)和白头粉刺(封闭性粉刺)。炎症性皮损多数是由粉刺发展而来,痤疮丙酸杆菌会诱发皮肤产生局部的炎症反应,导致粉刺壁破裂,并且其排出的内容物会进入到真皮中又再次产生局部的炎症反应,最终会破坏毛囊皮脂腺的结构,即使在炎症消退后也常出现红斑遗留、色素沉着或瘢痕。
临床上对痤疮患者的治疗手段主要有外用药物(如维A酸、过氧苯甲酰),口服药物(如抗生素、激素),物理治疗(如红蓝光、激光、射频),化学剥脱(如果酸、水杨酸),中医治疗(含内治法和外治法)等。虽然目前药物治疗痤疮疗效明显,但同时毒副作用也不容小觑,如过敏、肾脏功能损害、甚至导致畸形等。因而寻找安全、有效治疗痤疮的药物或化妆品成为研究热点。祛痘类外用药物是治疗痤疮较为普遍且有效的工具,而目前祛痘原料种类繁多,产品质量参差不齐,因此根据痤疮的发病机理、不同原料间的特性,在开发祛痘类制剂时,合理的挑选和复配原料具有重要的作用。
中药凭借其温和安全的特点,一直以来都是痤疮治疗研发的热潮。根据古典医籍所记载治疗痤疮的古方多以清热解毒、散结消肿、祛风除湿化瘀为主,而现代临床治疗痤疮的外用方药以清热解毒、活血通络、化痰除湿为主。
根据《黄帝内经•灵枢》:经脉篇第十胃足阳明之脉,起于鼻之交頞中,旁约太阳之脉,下循鼻外,上入齿中,还出挟口环唇,下交承浆,却循颐后下廉,出大迎,循颊车,上耳前,过客主人,循发际至额颅;其支者,从大迎前下人迎,循喉咙入缺盆,下膈属胃络脾;其直者,从缺盆下乳内廉,下挟脐,入气街中;其支者,起于胃口,下循腹里,下至气街中而合,以下髀关,抵伏兔,下膝膑中,下循胫外廉,下足跗,入中指内间;其支者,下廉三寸而别,下入中指外间;其支者,别跗上,入大指间,出其端。是动则病洒洒振寒,善呻数欠,颜黑,病至则恶人与火,闻木声则惕然而惊,心欲动,独闭户塞牖而处,甚则欲上高而歌,弃衣而走,贲响腹胀,是为骭厥。是主血所生病者,狂疟温淫,汗出鼽衄,口㖞唇胗,颈肿喉痹,大腹水肿,膝膑肿痛,循膺、乳、气街、股、伏兔、骭外廉、足跗上皆痛,中指不用。气盛则身已前皆热,其有馀于胃,则消谷善饥,溺色黄。气不足则身已前皆寒栗,胃中寒则胀满。为此诸病,盛则泻之,虚则补之,热则疾之,寒则留之,陷下则灸之,不盛不虚以经取之。盛者人迎大三倍于寸口,虚者人迎反小于寸口也。
足阳明胃经巡行人体面部,如胃经不降则人体前面起疙瘩即面部痤疮、青春痘等。是主血所生病,是主和是动好像两个人在打仗,强者打弱者,当强者出手还击弱者时这就是“是动”,自身正气攻击外来邪气,而当弱者受伤不断呻吟时这就是“是主”,当正气抵抗不住邪气,自身正气授勋。足阳明胃吸收吃进食物转化为气血,脾运化气血营养全身,阳明经以下降排出代谢,当正常新陈代谢不能排出时,气病在经,血也就淤积成疙瘩。当气血不能营养时也就造成面部色斑、痘印等。通过以上分析,面部痤疮、色斑等是和足阳明胃经有关,调足阳明胃经面部穴位也就能把面部痤疮、色斑攻破。通过药物加工成面部可吸收的膏体,刺激足阳明胃经穴位,改善经络气血的运行,让停留在面部的淤积排除体外,达到改善人体面部的痤疮、痘印、粉刺、色斑的目的。
随着人们的健康理念不断增强,对安全且有效的祛痘产品需求也越来越高。目前大部分祛痘原料普遍存在有效率低、皮肤耐受性差、作用机理单一等问题,基于当前对痤疮病理的研究现状,立足于用新型天然复配祛痘原料调节足阳明胃经面部穴位,以期攻破面部痤疮、痘印、粉刺、色斑等皮肤问题。
发明内容
针对上述现有技术的不足,本发明的目的是提供一种具有抑菌、消炎、祛痘功效的中药制剂及其应用。在针对痤疮的治疗,基于中国传统中医理念并集合发明人多年的中医临床经验,开发出具有抑菌、消炎、祛痘功效的中药制剂,具有良好的实际应用之价值。
为实现上述目的,本发明采用以下技术方案:
本发明的第一个方面,提供一种具有抑菌、消炎、祛痘功效的中药制剂,其药物活性成分包含以下重量份数的原料药:
吴茱萸1-5份,当归2-10份,川芎1-5份,茯苓1-5份,桂枝2-10份,白芍3-15份,三棱1-5份,莪术1-5份,红花2-10份,桃仁1-5份,半夏1-5份,麦冬2-5份。
具体的,所述中药制剂除上述药物活性成分之外,还可以包含药学上可接受的辅料和/或载体。
更具体的,上述中药制剂,其制备方法包括:按质量份数称取相应各原料药,破碎成细粉后备用。
本发明的第二个方面,提供上述中药制剂在制备具有抑菌、消炎、祛痘功效产品中的应用。
所述产品可以为药品。
进一步的,所述药品为口服药或外用药,优选为外用药。
本发明的第三个方面,提供一种具有抑菌、消炎、祛痘功效的产品,所述产品至少包含上述第一方面所述中药制剂。
所述产品为药品。
在本发明的一个具体实施方式中,所述药品为口服药或外用药,优选为外用药。
具体的,所述外用药的剂型可以是溶液(即药物的水溶液)、粉剂、乳剂、软膏、糊(泥)膏、涂膜剂、气雾剂或者凝胶。比如将本发明上述第一方面中披露的中药制剂与药用辅料和/或载体混合,并使所得混合物形成所需的形状或状态。除本发明提到的除外,也可根据由沈阳药科大学主编的现代药物制剂丛书进行药物制剂的制备。以及,除本发明提到的以外,合适的药用辅料和/或载体是本领域已知的,例如参见2005年版的药用辅料手册(原著第四版),作者:R.C.罗;P.J.舍斯基。
在本发明的一个具体实施方式中,提供上述产品的使用方法,所述方法包括:将上述产品使用蛋清调匀后外敷于患处皮肤维持一段时间(如每天半小时),敷后温水清洗即可。
与现有技术相比,本发明的技术方案具有以下有益效果:
1. 上述中药制剂以吴茱萸、半夏为君药,温经散寒、燥湿散结、通降阳明,以当归、川芎、桃仁、红花、三棱、莪术为臣,协同君药加强活血化瘀、行气通络的作用,以茯苓、桂枝、白芍、麦冬为佐,在发汗利湿的同时,得白芍麦冬养阴滋润之性,反佐诸药以防温燥太过损伤津液,并以麦冬、半夏为使引药归经,行于足阳明胃经,可以显著抑制金黄色葡萄球菌、痤疮丙酸杆菌增殖,对多数试用者肌肤具有较好的改善肌肤炎症、祛痘的效果,发挥抑菌、消炎、祛痘的效用,稳定性良好,可以长期储藏,并已经临床用药证实其安全性和有效性,因此具有良好的实际应用之价值。
2. 高效快速祛痘:本发明纯天然中药成分可改善面部代谢慢,增强血流运行,使痤疮、痘印、粉刺、色斑等快速代谢。
3. 组织修复并提升肌肤免疫力:修复肌肤上皮层的受损组织,祛痘不留疤痕;同时提升肌肤免疫力,减少皮肤过敏和粉刺再生。
4. 高安全性:本发明最大限度采用天然成分,除痘不伤肤,无刺激,不过敏,不含抗生素和激素,长期使用,肌肤不会产生耐药性。针对皮肤的生理病理特点,通过杀菌消炎、修复再生和提升免疫力等对粉刺皮肤实现全程综合护理。
具体实施方式
应该指出,以下详细说明都是示例性的,旨在对本发明提供进一步的说明。除非另有指明,本文使用的所有技术和科学术语具有与本发明所属技术领域的普通技术人员通常理解的相同含义。
需要注意的是,这里所使用的术语仅是为了描述具体实施方式,而非意图限制根据本发明的示例性实施方式。如在这里所使用的,除非上下文另外明确指出,否则单数形式也意图包括复数形式,此外,还应当理解的是,当在本说明书中使用术语“包含”和/或“包括”时,其指明存在特征、步骤、操作和/或它们的组合。
正如背景技术所介绍的,现有技术中治疗痤疮的药物存在一定的不足,为了解决如上的技术问题,本发明立足于用新型天然复配祛痘原料调节足阳明胃经面部穴位,在针对痤疮的治疗,基于中国传统中医理念并集合发明人多年的临床经验,获得具有良好疗效的核心组方。
有鉴于此,在本发明的一个典型具体实施方式中,提供一种抑菌、消炎、祛痘的中药制剂,其药物活性成分包含以下重量份数的原料药:
吴茱萸1-5份,当归2-10份,川芎1-5份,茯苓1-5份,桂枝2-10份,白芍3-15份,三棱1-5份,莪术1-5份,红花2-10份,桃仁1-5份,半夏1-5份,麦冬2-5份。
本发明的又一具体实施方式中,所述药物活性成分包含以下重量份数的原料药:
吴茱萸1份,当归2份,川芎1份,茯苓1份,桂枝2份,白芍3份,三棱1份,莪术1份,红花2份,桃仁1份,半夏1份,麦冬2份。
在实际应用时,可对上述中药制剂进行临症加减,如在实际临床中,若皮肤干燥黄暗,色斑明显者可再增加桃仁1-2份,红花1-2份,麦冬2-5份。
若痤疮色红,痘印明显者可再增加三棱1-3份,莪术1-3份,半夏1-2份。
若粉刺较多,皮肤红痒者可再增加吴茱萸1-3份,当归1-3份,茯苓2-5份,桂枝1-3份,白芍1-3份。
此外,需要说明的是,上述各原料药可研成细末外用,也可煎煮内服,在此不做具体限定。
所述活性成分及原料药具体功效如下:
吴茱萸:《神农本草经》记载:“主温中下气,止痛,咳逆寒热,除湿,血痹,逐风邪,开腠理。”所含的吴茱萸次碱能抑制紫外线诱导的皮肤氧化反应,所含的基质金属蛋白酶(MMPs)是皮肤中降解胶原蛋白的主要酶类。皮肤经紫外线照射诱导氧自由基生成,后者可激活MMPs(主要是MMP2和MMP-9),导致胶原蛋白降解,从而产生皱纹(光老化)。吴茱萸次碱能抑制紫外线照射诱导的氧白由基生成,降低MMP2和MMP-9水平,对光老化有保护作用。
当归:《神农本草经》记载:“主咳逆上气,温虐,寒热,洗在皮肤中。妇人漏下绝子,诸恶创疡金创。煮饮之。一名干归。生川谷。”有补血养血、活血化瘀、调经止痛、润肤等多种功效。含有的大量维生素A、B、E以及各种有益微量元素能够被人体充分吸收,这些物质能够改善人体的新陈代谢功能,帮助及时排出体内多余的脂肪等垃圾,进而使肌肤得以焕发光彩。显著延缓肌肉萎缩,增加肌肉组织SOD的含量,其机理可能与当归促进肌肉血液循环、改善代谢有关。当归多糖有很好的抗衰老作用,ASP可拮抗脾脏的萎缩、增强血清和脑组织SOD活力、减少MDA含量、提高CSH-PX活性。
川芎:《日华子本草》记载:“治一切风,一切气,一切劳损,一切血。补五劳,壮筋骨,调众脉,破疗结宿血,养新血,长肉,鼻洪吐血及溺血,痔瘘,脑痈,发背,瘰沥,瘿赘,疮疥,及排脓,消瘀血。”具有活血行气祛风,驻颜消斑等功效,含川芎嗪等多种生物碱、阿魏酸等酚类物质、挥发油以及维生素等。川芎嗪能扩张血管,降低血管阻力,显著增加肢体血流量;对各种致病菌和病毒有抑制作用;有抗维生素E缺乏作用。川芎嗪对体外培养的黑素细胞有抑制细胞增殖、黑素合成、酪氨酸酶活性等作用。对微循环***有良好的调节作用,其水浸液对某些致病性皮肤真菌有较强的抑制力。还能抑制酪氨酸酶的活性,从而对黑斑、雀斑、老年斑能起到治疗作用。能增加皮肤新陈代谢、皮肤弹性和抗皱、抗衰老,使皮肤柔润;能抑制皮炎、增强皮肤的抵抗力;能中和释放的组织胺,具有防止过敏的能力。
茯苓:始载于《神农本草经》,味甘,性平,归心、脾、肺经,具有渗利水湿、补益脾胃、和中止呕、宁心益智、降冲逆之气、养阴生津等作用。其中的三萜类化合物是抗炎作用的主要成分,其通过抑制磷脂酶而达到抗炎效果,有效清除超氧阴离子自由基、羟自由基和过氧化氢,且清除率与质量浓度存在剂量依赖关系;进一步体外抗氧化实验表明,茯苓皮三萜具有抑制家鸡红细胞溶血作用,对小鼠肝脂质过氧化产生的MDA有较好的清除效果。茯苓多糖也具有抗氧化功能。可用于预防皮肤炎症,抗氧化,减缓衰老等。
桂枝:《神农本草经》记载:“味辛温。主上气咳逆,结气喉痹,吐吸,利关节,补中益气。久服通神,轻身不老。”具有解肌发汗、调和营卫的功效,能刺激汗腺分泌,增强血液循环,促进血液流向体表,扩张皮肤血管,促进发汗,在体外能抑制多种细菌,有效浓度为25mg/mL。如对金黄色葡萄球菌、伤寒杆菌、大肠杆菌、痢疾杆菌、霍乱弧菌、枯草杆菌、炭疽杆菌及皮肤真菌等都有一定的抑制作用。
白芍:《神农本草经》记载:“味苦平。主邪气腹痛,除血痹,破坚积寒热,疝瘕,止痛,利小便,益气。”有养血柔肝,缓中止痛,敛阴收汗的作用,有效改善血虚寒导致的皮肤粗糙、暗黄、黄褐斑、色素沉着等现象;白芍提取物TGP具有抗氧化和细胞膜稳定作用,对自由基有清除作用。醇提取物体外能抑制ADP、胶原、花生四烯酸诱导的家兔血小板聚集;同时有极强的抗菌作用。
三棱:首载于唐代陈藏器的《本草拾遗》。其味苦性平,归肝、脾两经。历代本草记载其能破血行气,消积止痛,可治症瘕积聚、气血凝滞、心腹疼痛、胁下胀痛、经闭、产后瘀血腹痛、跌打损伤、疮肿坚硬等。与莪术配伍能抑制ADP诱导的血小板聚集,降低全血黏度;三棱总黄酮具有较强的抗血小板聚集及抗血栓作用,三棱提取物在体外有一定的增进纤维蛋白溶解的作用,能够平衡肌肤的油脂分泌,疏通毛孔,清除皮肤内毒素杂质。
莪术:《日华子本草》记载:“治一切气,开胃消食,通月经,消瘀血,止扑损痛,下血及内损恶血等。”功能行气破血、消积止痛。与三棱配伍有抑菌、抗病毒的作用;莪术油、莪术醇有抗纤维组织增生作用;莪术油霜外用有抑制角质形成细胞增殖、促进角质形成细胞正常分化作用;莪术油有抑制白血病细胞生长、保护正常造血细胞作用;莪术不同提取物有抗血小板聚集、抗凝血及调节血液流变性作用。
红花:《本草正》记载:“达痘疮血热难出,散斑疹血滞不消。”《本草纲目》记载:“活血,润燥,止痛,散肿,通经。”具有活血通经,去瘀止痛的作用,可以润泽肌肤,软化皮肤角质层,扩张周围血管、抑制血小板聚集,增强纤维蛋白溶解,降低全血黏度。有抗炎作用,免疫抑制作用。抑制皮炎、增强皮肤的抵抗力防止过敏。
桃仁:《本草纲目》记载:“其功有四:治热入血室,一也;泄腹中滞血,二也;除皮肤血热燥痒,三也;行皮肤凝聚之血,四也。”具有活血行瘀,润燥滑肠的功效,主治痛经,闭经,症瘕积聚,跌打损伤,皮肤血热燥痒,血滞风痹。桃仁含有大量的脂肪油活血祛瘀、润肠通便、止咳平喘。具有抗炎、扩张血管、抑制血液凝固、抗血小板凝聚、降低血液黏稠度的作用,对于消除血流阻滞,改善血行障碍,使皮肤组织的机能恢复正常有一定的作用。具体机理是对血管壁有直接扩张作用,增加血流量,抑制血小板聚集,同时还有一定的溶血作用,其抗炎症作用对于皮肤溃疡化脓也有很好的疗效。
半夏:《药性论》记载:“消痰涎,开胃健脾,止呕吐,去胸中痰满,下肺气,主咳结。新生者摩涂痈肿不消,能除瘤瘿。”功能燥湿化痰、降逆止呕、消痞散结,外消痈肿;具有抗菌、抗炎、抗氧化等药理活性。含挥发油、有机酸等多种化合物成分。其含有的不饱和脂肪酸,可因其抗氧化作用而对黄褐斑起到较好的治疗作用;所含的氨基酸、油脂对皮肤具有营养作用,故能润肤增白。
麦冬:《本草新编》记载:“益精强阴,解烦止渴,美颜色,悦肌肤,退虚热。”功能养阴润肺,清心除烦、益胃生津。所含的黄酮类化合物,是一种有效的自由基清除剂,能减少细胞内脂褐素的蓄积,消除面部黑色素的沉着,改善皮肤弹性,减少或消除面部皱纹,使面部滋润、柔嫩,并使白发减少或返黑。所含的甾醇,对皮肤有很好的渗透性,可以保持皮肤表面的水分,促进皮肤新陈代谢,抑制皮肤炎症,防止日晒红斑及皮肤老化。所含的铁,能增强造血功能;所含的锰,能参与造血机能,皮肤从充足的血液中得到所需的营养而滋润毛发也因此正常生长。所含的锌,能促进组织再生,保护皮肤健康。并能治疗皮肤湿疹和痤疮。所含的铜,能维护皮肤和毛发正常的颜色和结构。对超氧自由基有较好的消除作用,是很好的自由基捕获剂;同时有极强的抗菌作用。
协同增效的中药组合物可使彼此的作用增强,吴茱萸性热可降逆散寒止痛,半夏性温可燥湿化痰,降逆止呕,消痞散结,二药配伍增强对于足阳明胃经的气血逆行导致经络阻塞的疏通;当归性温补血活血、川芎性温行气开郁,祛除风燥湿,活血止痛。三棱性平破血行气,消积止痛、莪术性温行气破血,消积止痛,红花性温活血通经,散瘀止痛、桃仁性温活血祛瘀,六者配伍能加强彼此活血化瘀的作用,将因痤疮、痘印、粉刺、色斑等造成的皮肤垃圾快速代谢;桂枝性温发汗解表、散寒止痛、通阳化气,茯苓性平利水渗湿,二药配伍能促进汗毛孔代谢功能,起到发汗利水的功效;白芍性温养血调经、敛阴止汗,麦冬性微寒养阴生津,二药配伍能敛阴养阴,锁住皮肤水分不过分流失;此外白芍与桂枝配伍还能起到调和营卫、营养肌肤,当归与桃仁配伍后其油性成分在与桂枝、白芍的协同作用下能充分滋润皮肤,川芎、三棱、莪术、红花、吴茱萸配伍能温通血脉、活血止痛,有效改善因痤疮、粉刺等引起的皮肤疼痛等不适,诸药共同配伍有效改善经络气血运行,使人体淤积排除体外。
因此,上述中药组合物可有效缓解痤疮、痘印、粉刺、色斑等,具备安全性和有效性。
为了使得本领域技术人员能够更加清楚地了解本发明的技术方案,以下将结合具体的实施例详细说明本发明的技术方案。
实施例1
一种治疗痤疮的中药组合物,其药物活性成分为:吴茱萸1份,当归2份,川芎1份,茯苓1份,桂枝2份,白芍3份,三棱1份,莪术1份,红花2份,桃仁1份,半夏1份,麦冬2份;将上述原料混合均匀,研磨成粉,形成祛痘中药组合物。
实施例2
一种治疗痤疮的中药组合物,其药物活性成分为:吴茱萸2份,当归3份,川芎1份,茯苓1份,桂枝2份,白芍3份,三棱1份,莪术1份,红花1份,桃仁2份,半夏1份,麦冬2份;将上述原料混合均匀,研磨成粉,形成祛痘中药组合物。
实施例3
一种治疗痤疮的中药组合物,其药物活性成分为:吴茱萸1份,当归3份,川芎1份,茯苓2份,桂枝2份,白芍2份,三棱3份,莪术3份,红花3份,桃仁1份,半夏2份,麦冬2份;将上述原料混合均匀,研磨成粉,形成祛痘中药组合物。
实施例4
一种治疗痤疮的中药组合物,其药物活性成分为:吴茱萸1份,当归1份,川芎2份,茯苓2份,桂枝2份,白芍5份,三棱1份,莪术1份,红花4份,桃仁1份,半夏1份,麦冬3份;将上述原料混合均匀,研磨成粉,形成祛痘中药组合物。
对比例1
称取当归2份,川芎1份,茯苓1份,桂枝2份,白芍3份,三棱1份,莪术1份,红花2份,桃仁1份,半夏1份,麦冬2份;将上述原料混合均匀,研磨成粉,形成祛痘中药组合物。
对比例2
吴茱萸,将原料研磨成粉,形成祛痘中药组合物。
实施例5
一种治疗痤疮的中药组合物凝胶剂,中药有效成分采用如下方法进行提取,制剂按照下述步骤制备:
(1)用电子秤称取实施例1的祛痘中药组合物250g,用粉碎机粉碎成最粗粉过1号筛网,混合均匀,加入15倍量蒸馏水浸泡30min,减压低温回流提取3次,每次1h,提取温度70℃,合并3次提取液,浓缩,置于搅拌器中,控制转速40r/min,按照体积比5:1加入95%乙醇,低温(-4℃)静置12h,备用。
(2)将步骤(1)所得体系经4000r/min离心处理8min,分别收集上清液和沉淀,沉淀加入纯化水至生药含量0.3g/ml,进行喷雾干燥,得到多糖粉末,记作物料I。将上清液减压浓缩至含水量16%的药材浸膏,备用,记作物料II。
(3)按照质量百分比分别称取保湿剂5%,防腐剂0.095%,抗氧化剂1%,物料II药材浸膏20%,物料I多糖粉末1.5%,卡波姆-941 0.2%,余量纯化水。其中保湿剂为1 ,2-丙二醇与聚乙二醇-400质量比5:1的混合物;抗氧化剂为维生素C与无水亚硫酸钠质量比3:1的混合物,防腐剂为羟苯乙酯与羟苯丙酯质量比1:1的混合物。
(4)将物料I多糖粉末置于搅拌器中,加入纯化水制成浓度2%的多糖水溶液;将步骤(3)中卡波姆-941加入上述多糖水溶液中并加热至70℃持续静置3h,加入步骤(3)称取的保湿剂、防腐剂和抗氧化剂,保持搅拌速度40r/min,搅拌10min,调节pH值8.5,记作物料III备用。
(5)按照体积比4:1,将步骤(2)的物料II药材浸膏加入95%乙醇中超声溶解,记作物料IV,备用。
(6)将物料IV加入物料III中,搅拌速度30r/min,搅拌30min,温度40℃,即得治疗痤疮的中药组合物的凝胶剂,阴凉处存放。
实施例6
一种治疗痤疮的中药组合物涂膜剂,中药有效成分采用如下方法进行提取,制剂按照下述步骤制备:
称取实施例1的祛痘中药组合物250g,用粉碎机粉碎成最粗粉过1号筛网,混合均匀,用8倍量的45%乙醇回流提取3次,每次1h;合并乙醇提取液,过滤,减压回收乙醇至无乙醇味,浓缩成稠膏;称取30g聚乙烯醇-124,加入10倍体积纯化水浸泡膨胀后,置水浴上加热,使其完全溶解,搅匀备用;取稠膏用500ml水溶解,缓缓加入聚乙烯醇溶液中,搅匀;加入甘油、氮酮各15ml,补70%乙醇至1000ml,充分搅拌使其均匀呈黏胶状,分装,阴凉处存放。
实施例7
称取实施例1的祛痘中药组合物250g,研磨粉碎至极细粉,混合均匀,临用前加入蛋清液,充分搅拌成糊状,外敷面部备用。
试验一:抑菌作用评价
供试菌种:金黄色葡萄球菌、痤疮丙酸杆菌
培养基与培养条件:营养琼脂培养基,(36±1℃)温箱培养48±2h,用于金黄色葡萄球菌培养;疱肉培养基,(36±1℃)培养24-72h,用于痤疮丙酸杆菌培养。
分别取60g实施例1-4,对比例1-2中药组合物,用质量分数20%的丙二醇溶解至1000ml用于检测,空白样品为质量分数20%的丙二醇。
表1. 各实施例、对比例、空白样品纸片扩散法(K-B法)抑制细菌的抑菌圈直径(n=3,* p<0.05 , ** p<0.01, # p<0.05 , ## p<0.01 vs.空白样品)
从试验结果来看,实施例1-4及对比例1-2均可表现出抑制金黄色葡萄球菌、痤疮丙酸杆菌的作用,组方用药比单一用药吴茱萸的抑菌效果更好。
试验二:刺激性测试
将本发明实施例5-7制备的祛痘外用制剂送往第三方检测机构检测皮肤刺激性,对每种制剂均用鸡胚连续皮肤刺激性实验,试验组鸡胚出血、凝血和血管融解时间均高于5h。
试验三:本发明祛痘外用制剂人体评价按照“皮肤病药物临床研究指导原则”来进行分级判定:
痊愈:皮损消退;显效:皮损消退>60%,红斑的肿痛消失,粉刺消退;有效:皮损消退>20-60%,红斑的痛感减轻,粉刺部分消退或消失;无效:皮损消退<20%或加重,红斑的肿痛仍在,粉刺无改善。表2. 本发明祛痘外用制剂涂抹前后,试用者自我评估结果(n=75)
从试用者自我评估的结果表2可以看出,本发明实施例5-7所提供的祛痘外用制剂对多数试用者肌肤具有较好的改善肌肤炎症、祛痘的效果,发挥了抑菌、消炎、祛痘的作用。
试验四:稳定性测试
测试样品:实验组为实施例5-6制备的祛痘外用制剂及实施例7的粉末;对照组为未经温度试验的实施例5-6制备的祛痘外用制剂及实施例7的粉末,常温保存。
1.耐热测试
耐热试验是将各处于室温的测试样品直接放入40±1℃的烘箱保持24h,恢复至室温后,观察测试样品是否与对照组无明显差异,结果见表3所示。
2.耐寒测试
耐寒试验是将各处于室温的测试样品直接放入-10℃的低温箱保持24h,恢复至室温后,观察测试样品是否与对照组无明显差异。结果见表3所示。
表3. 本发明祛痘外用制剂稳定性测试结果
结果表明,本发明实施例5-6制备的祛痘外用制剂及实施例7的粉末在耐热测试及耐寒测试恢复至室温后与相应对照组相比均无异常情况,说明含有本发明的中药制剂稳定性良好,可以长期储藏。
试验五:本发明中药制剂安全性评价
本发明中药制剂所有受试者治疗前后的生命体征稳定,肝脏功能、血常规、凝血功能安全性指标评价未发现明显异常改变,在用药期间患者均未出现过敏及严重的不良反应,临床用药安全可靠。
典型病例
病例1
陈某某,女,35岁,2020年8月13日就诊,症状:面部双颊处痤疮,颜色暗红,局部有粉刺色红,皮肤干燥,大便干,舌红苔厚,采用以下配方的中药组合物外用治疗,治疗方法:外用凝胶剂涂敷患处,每日半小时,敷后温水清洗面部,10日后患部范围明显缩小,皮肤润泽,20日后痊愈。
中药配方:
吴茱萸10g,当归20g,川芎10g,茯苓10g,桂枝20g,白芍30g,三棱10g,莪术10g,红花20g,桃仁10g,半夏10g,麦冬20g。
病例2
余某,女,16岁,2020年6月11日就诊,症状:额头、脸颊、下巴处痤疮,色暗红,伴面部发痒,大便3日一行,舌红苔厚腻,采用以下配方的中药组合物外用治疗,治疗方法:外用凝胶剂涂敷患处,每日半小时,敷后温水清洗面部,20日后痊愈。
中药配方:
吴茱萸10g,当归20g,川芎10g,茯苓20g,桂枝20g,白芍30g,三棱10g,莪术10g,红花20g,桃仁10g,半夏10g,麦冬20g,蝉蜕10g。
病例3
陈某,女,50岁,2020年3月20日就诊,症状:面部散在色斑,斑色暗棕,肤色暗淡,皮肤干枯,口渴,便干,舌红苔燥,采用以下配方的中药组合物外用治疗,治疗方法:外用凝胶剂涂敷患处,每日半小时,敷后温水清洗面部,6日后色斑逐渐变淡,皮肤润泽,30日后痊愈。
中药配方:
吴茱萸10g,当归20g,川芎10g,茯苓10g,桂枝30g,白芍30g,三棱10g,莪术10g,红花20g,桃仁10g,半夏10g,麦冬30g。
病例4
李某,男,20岁,2021年7月16日就诊,症状:脸颊部及颈部两侧脓包性痤疮,颜色暗红,局部颜色鲜红,皮肤干硬处偶有疼痛感,大便黏腻1-2日一行,舌红苔黄厚,采用以下配方的中药组合物外用治疗,治疗方法:外用涂膜剂涂敷患处,每日半小时,敷后温水清洗面部,3日后疼痛消失,皮肤***,脓包减退,20日后痊愈。
中药配方:
吴茱萸10g,当归20g,川芎10g,茯苓10g,桂枝20g,白芍30g,三棱20g,莪术20g,红花20g,桃仁10g,半夏10g,麦冬20g,干姜20g。
病例5
孟某某,男,16岁,2020年4月13日就诊,症状:面部白头粉刺,痘色鲜红,皮肤瘙痒伴皮脂溢出,大便黏腻,舌苔厚腻,采用以下配方的中药组合物外用治疗,治疗方法:外用凝胶剂涂敷患处,每日半小时,敷后温水清洗面部,18日后痊愈。
中药配方:
吴茱萸10g,当归20g,川芎10g,茯苓10g,桂枝20g,白芍30g,三棱10g,莪术10g,红花20g,桃仁10g,半夏10g,麦冬20g。
病例6
赵某某,女,33岁,2021年9月1日就诊,症状:脸颊色斑,伴有少量痘印,色暗,二便调,舌红苔厚,采用以下配方的中药组合物外用治疗,治疗方法:蛋清调匀外敷面部,每日半小时,敷后温水清洗面部,15日后痊愈。
中药配方:
吴茱萸10g,当归20g,川芎10g,茯苓10g,桂枝20g,白芍30g,三棱10g,莪术10g,红花20g,桃仁10g,半夏10g,麦冬20g。
病例7
孙某,女,60岁,2021年4月28日就诊,症状:面颊部及太阳穴处老年斑明显,肤色暗沉,便秘,舌淡苔裂,采用以下配方的中药组合物外用治疗,治疗方法:外用涂膜剂涂敷患处,每日半小时,敷后温水清洗面部,15日后老年斑色逐渐褪去,肤色转润,50日后痊愈。
中药配方:
吴茱萸10g,当归20g,川芎20g,茯苓30g,桂枝20g,白芍30g,三棱10g,莪术10g,红花20g,桃仁10g,半夏15g,麦冬30g。
病例8
李某某,女,35岁,2021年8月2日就诊,症状:额头及下巴处白头粉刺,色红,遇热及出汗后易痒,二便调,舌红苔厚,采用以下配方的中药组合物外用治疗,治疗方法:外用凝胶剂涂敷患处,每日半小时,敷后温水清洗面部,23日后痊愈。
中药配方:
吴茱萸10g,当归20g,川芎10g,茯苓30g,桂枝30g,白芍30g,三棱10g,莪术10g,红花20g,桃仁10g,半夏10g,麦冬20g。
病例9
王某,女,30岁,2022年1月10日就诊,症状:脸颊处痤疮,色红,局部触之有硬结和疼痛感,并有肥厚性瘢痕可见,大便干结,舌红苔厚,采用以下配方的中药组合物外用治疗,治疗方法:外用涂膜剂涂敷患处,每日半小时,敷后温水清洗面部,5日后,疼痛感消失,硬结处软化,30日后痊愈。
中药配方:
吴茱萸10g,当归20g,川芎20g,茯苓30g,桂枝30g,白芍30g,三棱10g,莪术10g,红花20g,桃仁10g,半夏10g,麦冬20g。
病例10
张某,女,19岁,2022年3月2日就诊,症状:面部及胸背粉刺,色红,面部伴皮脂溢出,舌苔厚腻,采用以下配方的中药组合物外用治疗,治疗方法:外用凝胶剂涂敷患处,每日半小时,敷后温水清洗,25日后痊愈。
中药配方:
吴茱萸15g,当归20g,川芎10g,茯苓30g,桂枝30g,白芍30g,葛根60g,三棱10g,莪术10g,红花10g,桃仁10g,半夏10g,麦冬20g。
病例11
孔某某,男,23岁,2022年4月13日就诊,症状:额头处黑头粉刺,伴有少量丘疹,痘疹色红,偶有痒感,大便黏腻,舌红苔黄,采用以下配方的中药组合物外用治疗,治疗方法:外用凝胶剂涂敷患处,每日半小时,敷后温水清洗,13日后痊愈。
中药配方:
吴茱萸10g,当归20g,川芎10g,茯苓20g,桂枝15g,白芍30g,三棱10g,莪术10g,红花20g,桃仁10g,半夏10g,麦冬20g。
病例12
宋某,男,28岁,2021年12月3日就诊,症状:面颊部痤疮严重,常有皮脂溢出,患部皮肤坚硬伴有疼痛感,大便2-3日一行,便溏,舌红苔腻,采用以下配方的中药组合物外用治疗,治疗方法:外用涂膜剂涂敷患处,每日半小时,敷后温水清洗面部,3日后,硬结处软化无疼痛感,20日后痊愈。
中药配方:
吴茱萸10g,当归20g,川芎15g,茯苓15g,桂枝30g,白芍30g,三棱15g,莪术15g,红花20g,桃仁10g,半夏15g,麦冬20g。
病例13
郭某,男,24岁,2021年6月20日就诊,症状:面部痤疮,下颌处丘疹明显,伴有少量脓疱,局部有瘢痕形成,大便2日一行便干,舌红苔黄厚,采用以下配方的中药组合物外用治疗,治疗方法:外用凝胶剂涂敷患处,每日半小时,敷后温水清洗面部,4日后,脓疱消退,28日后痊愈。
中药配方:
吴茱萸10g,当归30g,川芎10g,茯苓30g,桂枝30g,白芍30g,三棱10g,莪术10g,红花20g,桃仁20g,半夏10g,麦冬20g。
病例14
李某,女,16岁,2020年8月2日就诊,症状:左侧面部痤疮,粉刺红痒,面色偏白,舌淡胖大有齿痕,苔厚腻,采用以下配方的中药组合物外用治疗,治疗方法:外用凝胶剂涂敷患处,每日半小时,敷后温水清洗面部,10日后患部范围明显缩小,20日后痊愈。
中药配方:
吴茱萸10g,当归20g,川芎20g,茯苓10g,桂枝20g,白芍30g,三棱10g,莪术10g,红花20g,桃仁10g,半夏10g,麦冬20g,干姜20g。
病例15
赵某某,女,36岁,2022年3月3日就诊,症状:额头痘疹色红伴有痒感,下颌痘印明显,口渴口苦,大便干结,舌红苔黄,采用以下配方的中药组合物外用治疗,治疗方法:外用凝胶剂涂敷患处,每日半小时,敷后温水清洗面部,9日后额头痘疹消食,22日后痘印消褪。
中药配方:
吴茱萸10g,当归20g,川芎10g,茯苓30g,桂枝20g,白芍30g,三棱10g,莪术10g,红花15g,桃仁10g,半夏10g,麦冬20g。
病例16
王某,女,22岁,2021年12月13日就诊,症状:脸颊及颈部散在暗红色痤疮,皮肤干燥,脱屑,大便可,小便黄,舌淡苔厚,采用以下配方的中药组合物外用治疗,治疗方法:外用凝胶剂涂敷患处,每日半小时,敷后温水清洗面部,10日后患部范围明显缩小,皮肤润泽,30日后痊愈。
中药配方:
吴茱萸10g,当归20g,川芎10g,茯苓10g,桂枝15g,白芍30g,三棱10g,莪术10g,红花20g,桃仁20g,半夏10g,麦冬30g。
病例17
陈某某,女,56岁,2021年4月15日就诊,症状:面部暗褐色色斑,皮肤黝黑无光泽,舌红苔燥,采用以下配方的中药组合物外用治疗,治疗方法:蛋清调匀外敷面部,每日半小时,敷后温水清洗面部,20日后色斑转淡,皮肤润泽,45日后痊愈。
中药配方:
吴茱萸10g,当归20g,川芎20g,茯苓30g,桂枝20g,白芍50g,三棱10g,莪术10g,红花20g,桃仁20g,半夏10g,麦冬20g。
病例18
孙某,女,16岁,2020年8月22日就诊,症状:右面部痤疮明显,左侧较少,颜色暗红,皮肤干燥,大便干,舌红苔厚,采用以下配方的中药组合物外用治疗,治疗方法:外用凝胶剂涂敷患处,每日半小时,敷后温水清洗面部,12日后患部范围明显缩小,皮肤润泽,30日后痊愈。
中药配方:
吴茱萸10g,当归10g,川芎10g,茯苓30g,桂枝20g,白芍30g,三棱10g,莪术10g,红花20g,桃仁10g,半夏10g,麦冬20g。
病例19
韩某某,女,40岁,2020年8月13日就诊,症状:面部散在痤疮,颜色偏红,偶有痒感,皮肤易出油,舌红苔腻,采用以下配方的中药组合物外用治疗,治疗方法:蛋清调匀外敷面部,每日半小时,敷后温水清洗面部,6日后患部范围明显缩小,出油减轻,20日后痊愈。
中药配方:
吴茱萸10g,当归20g,川芎10g,茯苓30g,桂枝20g,白芍30g,三棱10g,莪术10g,红花20g,桃仁10g,半夏20g,麦冬20g。
病例20
刘某某,女,22岁,2022年1月6日就诊,症状:面部少量白头粉刺,食生冷刺激食物后面部红痒,大便溏,舌苔白腻有齿痕,采用以下配方的中药组合物外用治疗,治疗方法:外用凝胶剂涂敷患处,每日半小时,敷后温水清洗面部,10日后粉刺消退,23日后粉刺已无,未在出现红痒反应。
中药配方:
吴茱萸10g,当归20g,川芎20g,茯苓20g,桂枝15g,白芍30g,三棱10g,莪术10g,红花10g,桃仁10g,半夏10g,麦冬20g。
病例21
刘某,女,35岁,2021年2月16日就诊,症状:面部痤疮伴红痒,颧骨处尤甚,大便黏腻,舌苔厚腻,采用以下配方的中药组合物外用治疗,治疗方法:外用凝胶剂涂敷患处,每日半小时,敷后温水清洗面部,7日后痤疮、红痒减轻,25日后痊愈。
中药配方:
吴茱萸10g,当归20g,川芎20g,茯苓30g,桂枝30g,白芍30g,三棱10g,莪术10g,红花10g,桃仁10g,半夏10g,麦冬20g。
病例22
周某,女,35岁,2020年1月11日就诊,症状:额头及右侧脸颊痤疮暗斑,皮肤干燥,口渴,小便清长,舌淡苔白,采用以下配方的中药组合物外用治疗,治疗方法:外用凝胶剂涂敷患处,每日半小时,敷后温水清洗面部,10日后患部范围明显缩小,皮肤润泽,20日后痊愈。
中药配方:
吴茱萸10g,当归20g,川芎10g,茯苓30g,桂枝30g,白芍30g,三棱10g,莪术10g,红花20g,桃仁10g,半夏10g,麦冬10g。
病例23
欧某某,女,15岁,2021年7月15日就诊,症状:唇周及下巴粉刺反复,严重时伴有疼痛感,皮肤易出油,肢冷便溏,舌苔薄白,采用以下配方的中药组合物外用治疗,治疗方法:蛋清调匀外敷面部,每日半小时,敷后温水清洗面部,4日后粉刺减少,20日后痊愈。
中药配方:
吴茱萸15g,当归20g,川芎30g,茯苓30g,桂枝30g,白芍30g,三棱10g,莪术10g,红花20g,桃仁10g,半夏30g,麦冬20g。
病例24
公某,女,60岁,2021年3月22日就诊,症状:面部色斑暗沉,肤色较暗,皮肤干燥,口渴口淡,大便2-3日一行量少,舌淡苔白有裂痕,采用以下配方的中药组合物外用治疗,治疗方法:蛋清调匀外敷面部,每日半小时,敷后温水清洗面部,15日后皮肤润泽,色斑变浅,50日后痊愈。
中药配方:
吴茱萸10g,当归20g,川芎20g,茯苓10g,桂枝10g,白芍30g,三棱10g,莪术10g,红花20g,桃仁20g,半夏10g,麦冬20g。
病例25
孟某,女,38岁,2022年1月6日就诊,症状:面部红色痤疮及背部粉刺,伴有痒感,皮肤偏干,大便秘结,舌红苔厚,采用以下配方的中药组合物外用治疗,治疗方法:外用凝胶剂涂敷面部、背部患处,每日半小时,敷后温水清洗,5日后痤疮及粉刺减少,瘙痒已无,20日后痊愈。
中药配方:
吴茱萸10g,当归20g,川芎10g,茯苓10g,桂枝10g,白芍30g,三棱15g,莪术15g,红花20g,桃仁10g,半夏10g,麦冬20g。
以上所述仅为本发明的优选实施例,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 (3)
1.一种具有抑菌、消炎、祛痘功效的中药制剂在制备具有抑菌、消炎、祛痘功效药品中的应用,其特征在于,所述中药制剂的药物活性成分为以下重量份数的原料药:
吴茱萸1-5份,当归2-10份,川芎1-5份,茯苓1-5份,桂枝2-10份,白芍3-15份,三棱1-5份,莪术1-5份,红花2-10份,桃仁1-5份,半夏1-5份,麦冬2-5份;
所述药品为外用药。
2.如权利要求1所述的应用,其特征在于,其药物活性成分包含以下重量份数的原料药:
吴茱萸1份,当归2份,川芎1份,茯苓1份,桂枝2份,白芍3份,三棱1份,莪术1份,红花2份,桃仁1份,半夏1份,麦冬2份。
3.如权利要求1所述的应用,其特征在于,所述中药制剂还包含药学上可接受的辅料和/或载体。
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