CN114699494A - 一种抑菌消炎止痒中药乳膏及其制备方法 - Google Patents
一种抑菌消炎止痒中药乳膏及其制备方法 Download PDFInfo
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Abstract
一种抑菌消炎止痒中药乳膏,主要由中药组分和乳膏基质制备而成,其中,所述中药组分主要由独角莲、五倍子、皂角刺、土荆皮、白鲜皮、紫草、地肤子、金银花、野菊花、黄柏、百部、土茯苓、七星剑、铁冬青、狼毒、苦参、冰片、薄荷脑和蛇床子制备而成。本发明的抑菌消炎止痒中药乳膏可以清热燥湿,祛风杀虫止痒,可以有效地改善甚至消除皮肤病患者的临床症状,具有用药天然,治疗效果显著、治疗周期短、无毒副作用等特点。
Description
技术领域
本发明属于中药技术领域,尤其涉及一种抑菌消炎止痒中药乳膏及其制备方法。
背景技术
皮肤是人体的第一道生理防线和最大的器官,机体的异常情况也可以在皮肤表面反映出来,皮肤的生理功能受到损害就会引起皮肤病。皮肤病的种类繁多,多种内脏发生的疾病也可能在皮肤上有表现。常见的皮肤病有:银屑病(牛皮癣)、湿疹、痒疹、苔癣病、皮肤瘙痒症、糠疹、皮炎、手足皲裂、头癣、手癣、足癣、体癣、花斑癣和皮肌炎等。引起皮肤病的原因很多,部分皮肤病还具有传染性,皮肤病不仅影响自己的身体健康,还可能容易引起他人的恐慌与歧视。
目前治疗皮肤病的药物主要集中于单一病情治疗,这种治疗方式针对性较强,能够准确治愈某一种皮肤病,但是,却往往不适用于其他的皮肤病,无法满足人们生活中遭遇各种皮肤病的状况。为满足这种需要,市面上也出现了激素类外用膏,但是这些药都是西药成分,药物中含有大量激素,能够快速达到治愈的功效,但是无法长期改善皮肤的状况。药久用后易产生依赖,而且还可能导致过敏,造成患处皮肤出现干燥、粗糙、脱屑,甚至有浅细的裂纹,使皮肤瘙痒的病情加重,而且也不适合全身或大面积涂抹,难易控制皮肤疾病的复发,长期使用含有激素的药物会产生较大的副作用,比如幼儿采用激素类药物会出现肾上腺功能亢进综合症、钙流失增加、诱发其他皮肤病等。而且,目前市场上中成药没有疗效比较出色的产品,治疗适应症不明确,效果也不佳。
发明内容
本发明要解决的技术问题是克服现有技术的不足,提供一种抑菌消炎止痒中药乳膏及其制备方法。
为解决上述技术问题,本发明提出的技术方案之一是:
一种抑菌消炎止痒中药乳膏,主要由中药组分和乳膏基质制备而成,其中,所述中药组分主要由独角莲、五倍子、皂角刺、土荆皮、白鲜皮、紫草、地肤子、金银花、野菊花、黄柏、百部、土茯苓、七星剑、铁冬青、狼毒、苦参、冰片、薄荷脑和蛇床子制备而成。
优选的,所述中药组分主要由独角莲4-10重量份、五倍子3-10重量份、皂角刺3-10重量份、土荆皮10-30重量份、白鲜皮 5-10 重量份、紫草10-15重量份、地肤子9-15重量份、金银花9-35重量份、野菊花12-18重量份、黄柏7-13重量份、百部6-12重量份、土茯苓10-60重量份、七星剑 10-15重量份、铁冬青15-35重量份、狼毒2-5重量份、苦参5-11重量份、冰片0.15-0.3重量份、薄荷脑3-6重量份和蛇床子4-10重量份制备而成。
优选的,所述中药组分主要由独角莲5重量份、五倍子10重量份、皂角刺9重量份、土荆皮28重量份、白鲜皮9重量份、紫草15重量份、地肤子14重量份、金银花30重量份、野菊花15重量份、黄柏10重量份、百部11重量份、土茯苓50重量份、七星剑 14重量份、铁冬青34重量份、狼毒4.5重量份、苦参10重量份、冰片0.15重量份、薄荷脑5重量份和蛇床子9重量份制备而成。
优选的,按照质量百分比计,所述乳膏剂基质包括8.5%的凡士林、12%的硬脂酸、7%的单硬脂酸甘油酯、0.1%的尼泊金乙酯、1%的十二烷基硫酸钠、10%的甘油和余量的水。
本发明提出的技术方案之二是:
一种如上述的抑菌消炎止痒中药乳膏的制备方法,包括以下步骤:
(1)将独角莲、五倍子、皂角刺、土荆皮、白鲜皮、紫草、地肤子、 金银花、野菊花、黄柏、百部、土茯苓、七星剑、铁冬青、狼毒、苦参、蛇床子洗净,晾干,粉碎,过50-100目筛网,得到药物粉末;
(2)将步骤(1)制备的中药粉末中加入6-8倍的蒸馏水,浸泡12-24小时后煎煮,煎煮液过滤,得到药物提取液;
(3)在步骤(2)得到的药物提取液中加入乙醇溶液,浸泡提取;
(4)重复步骤(3)的浸泡提取,合并药液,过滤,然后将药液浓缩后,得到中药材的提取物;
(5)将步骤(4)得到的中药材提取物与乳膏基质加热搅拌混匀,待混合物温度降低至40℃以下时,加入冰片、薄荷脑,得到中药乳膏。
优选的,步骤(3)中,乙醇溶液的浓度为70-90%,乙醇溶液的加入量为药物提取液的10-15倍,浸泡提取的时间为0.5-2h。
优选的,步骤(5)中,中药材提取物与乳膏基质的质量比为1-3:1。
优选的,步骤(5)中,所述乳膏基质是通过以下制备方法制备获得的:将凡士林、硬脂酸、单硬脂酸甘油酯和尼泊金乙酯加热熔融制成均一的油相;将十二烷基硫酸钠、甘油和蒸馏水混合成水相,加热至80℃,然后将其加入到油相中,制成乳膏基质。
本发明的抑菌消炎止痒中药乳膏,主要独角莲、五倍子、皂角刺、土荆皮、白鲜皮、紫草、地肤子、金银花、野菊花、黄柏、百部、土茯苓、七星剑、铁冬青、狼毒、苦参、冰片、薄荷脑和蛇床子制备而成。冰片:有开窍醒神,清热散毒,明目退翳的功效,且芳香避秽驱邪杀虫止痒,去腐生新。蛇床子:祛风燥湿、杀虫止痒,用于湿疹、疥癣,瘙痒。土荆皮:杀虫止痒,治体藓、脚藓、疥疮、湿疹、神经性皮炎。独角莲:祛风止痉,解毒散结,燥湿化痰。紫草:凉血活血,解毒透疹。七星剑:发汗解暑、利湿解毒,可治疗慢性皮肤湿疹瘙痒,风痰疮等。地肤子:清热燥湿,祛风止痒,多用于皮肤风疹、湿疮、周身瘙痒等。白鲜皮:清热燥湿、祛风解毒,还可以用于一切热毒风,恶风,风疮、疥癣赤烂,具有明显的止痒、抗过敏作用。苦参:性味苦寒,具有清热燥湿,杀虫止痒,还具有抗菌、消炎、抗病毒的功效,减少皮肤受损和有效抑制病菌生长的效果,临床常用于治疗湿疹,湿疮,皮肤瘙痒,疥癣麻风,滴虫性阴道炎等,具有良好疗效。苦楝皮:杀虫、疗癣,用于治疗蛔虫病、钩虫病、蛲虫病、阴道滴虫病、疥疮、头癣。五倍子外用敛汗止血,收湿敛疮。百部杀虫灭虱,用用于头虱、体虱、蛲虫病;狼毒:散结、杀虫,外用于皮肤瘙痒、皮癣等,现代研究发现同时还有良好的抗菌、抗病毒作用。土茯苓、野菊花、金银花:清热解毒抗菌抗炎效果,土茯苓还可以除湿治疗痈肿、疥癣。薄荷脑,医药上用作刺激药,作用于皮肤或粘膜,有清凉止痒作用。清热药常与攻毒杀虫燥湿止痒药联用,故蛇床子常与苦参、白鲜皮、黄柏、土茯苓等联用共奏清热除湿、杀虫止痒、活血解毒之效。
本发明制备的抑菌消炎止痒中药乳膏具有较好的抑菌止痒作用,尤其是冰片中的积雪草酸在体外和体内通过 NF- κB、TGF- β /Smad、MAPK、Wnt/ β -catenin 和 STAT 信号传导可对痤疮、烧伤、特应性皮炎和伤口等皮肤病发挥治疗作用;蛇床子素可通过修复皮肤屏障抑制Akt通路发挥消炎止痒的作用蛇床子素长期应用于皮肤瘙痒、湿疹等皮肤类疾病;土荆皮对我国常见的10种致病性皮肤真菌有一定的抗菌效用,主要的抗真菌成分包括有机酸、乙醇浸膏和苯浸膏通过各原料的协同作用,迅速缓解患者的瘙痒不适等症状,防止皮疹再次发生,复发率低;白鲜皮提取物腀酮具有抗炎活性,可以减轻由脂多糖刺激的巨噬细胞引发的炎症反应,其作用机制是通过减少巨噬细胞中IKK 和 和 ERK1/2(细胞外调节蛋白激酶)磷酸化,产生对 NF- κB抑制,减少iNOS和cox-2的mRNA 和蛋白表达,降低 NO的生成和前列腺素的合成,降低细胞的损伤,产生抗炎作用;地肤子中皂苷 Ic 及其苷元齐墩果酸是止痒、抗炎及抑制Ⅰ型变态反应的有效成分,作用的机理是地肤子甲醇提取物显著抑制脂多糖(LPS) 诱导的肿瘤坏死因子 α (TNF-α)、前列腺素 E2 (PGE2)、一氧化氮(NO)等炎性递质的释放。通过药理作用对中药组方的支持,本发明以冰片芳香避秽驱邪杀虫止痒,去腐生新,土荆皮杀虫止痒为君药发挥主要抑菌作用,白鲜皮、地肤子与蛇床子,常见有效的杀虫止痒的配伍,用以增强杀虫止痒的功效,相用为臣药,使其治疗作用显著增加,具有杀菌抗炎、修复皮肤、调节皮肤免疫和抗皮肤老化功效,能够有效防治皮炎、湿疹、手足体癣、毛囊炎等症。
与现有技术相比,本发明的优点在于:
本发明的抑菌消炎止痒中药乳膏可以清热燥湿,祛风杀虫止痒,可以有效地改善甚至消除皮肤病患者的临床症状,具有用药天然,治疗效果显著、治疗周期短、无毒副作用等特点。
具体实施方式
为了便于理解本发明,下文将结合较佳的实施例对本发明作更全面、细致地描述,但本发明的保护范围并不限于以下具体的实施例。
除非另有定义,下文中所使用的所有专业术语与本领域技术人员通常理解的含义相同。本文中所使用的专业术语只是为了描述具体实施例的目的,并不是旨在限制本发明的保护范围。
除有特别说明,本发明中用到的各种试剂、原料均为可以从市场上购买的商品或者可以通过公知的方法制得的产品。
实施例:
一种本发明的抑菌消炎止痒中药乳膏,主要由中药组分和乳膏基质制备而成,其中,中药组分主要由独角莲5重量份、五倍子10重量份、皂角刺9重量份、土荆皮28重量份、白鲜皮9重量份、紫草15重量份、地肤子14重量份、金银花30重量份、野菊花15重量份、黄柏10重量份、百部11重量份、土茯苓50重量份、七星剑 14重量份、铁冬青34重量份、狼毒4.5重量份、苦参10重量份、冰片0.15重量份、薄荷脑5重量份和蛇床子9重量份制备而成。
本实施例的抑菌消炎止痒中药乳膏的制备方法,包括以下步骤:
(1)将独角莲、五倍子、皂角刺、土荆皮、白鲜皮、紫草、地肤子、金银花、野菊花、黄柏、百部、土茯苓、七星剑、铁冬青、狼毒、苦参、蛇床子分别洗净,并于常温环境下晾干,然后采用超微粉碎机粉碎,过100目筛网,得到中药粉末;
(2)将步骤(1)制备的中药粉末中加入7倍的蒸馏水量,浸泡18小时后煎煮,煎煮3次,每次1小时,煎煮液过滤,得到药物提取液;
(3)在药物提取液中加入12倍的浓度为70%的乙醇溶液,浸泡一小时,然后重复提取1次,合并药液,过滤,浓缩,得到中药材的提取物;
(4)将凡士林、硬脂酸、单硬脂酸甘油酯和尼泊金乙酯加热至熔融制成均一的油相;将十二烷基硫酸钠、甘油和蒸馏水,制成水相,加热至80℃,然后将其加入到油相中,制成乳膏基质;
(5)将中药材的提取物与乳膏基质按质量比为2:1比例加热混合搅拌15分钟,制得乳膏;
(6)待乳膏温度降低至40℃以下,加入冰片 (95%乙醇溶化)、薄荷脑 (95%乙醇溶化),制成中药乳膏。
刺激性试验、过敏性实验
将30只小白鼠背部剪去毛,分别涂抹实施例中制备的中药乳膏于剪去毛的部位和没涂部位进行比较,结果未发现刺激性和过敏反应。
取实施例制备的乳膏适量涂于志愿者(16-65岁,25人)手面上,20分钟后观察,均未出现发红、发疹、起疤现象。
对磷酸组胺所致瘙痒的影响实验:
实验方法及分组:昆明小鼠36只,雌雄各半,随机分为3组,分别为模型对照组、阳性对照组(复方醋酸地塞米松乳)、实施组(涂实施例1的中药乳膏)。
于实验前一天先在小鼠颈背部脱毛2cm*3cm大小,用细砂纸打磨小鼠右后足背部皮肤,以皮肤发红渗血而不出血为度,24小时后,抽取0.02%的磷酸组胺50μL滴于打磨过的皮肤之上,马上观察记录15min内小鼠的瘙痒次数及持续时间。瘙痒的指征为小鼠回头舔啃右后足背皮肤为一次瘙痒并记录。
将乳膏涂抹于小鼠右后足背部皮肤并轻柔片刻至吸收,30min后造模,观察记录15min内舔体次数及舔体反应持续时间,比较组间差异,结果见表1。
表 1 抑菌止痒乳膏对磷酸组胺所致瘙痒的止痒作用
注:与模型组比较,** P<0.01
组织胺是一种可以引起皮肤瘙痒的重要递质,小鼠在普通环境下受抗原刺激后,其皮损、病理和免疫等的特征与人类异位皮损相一致。所以通过实验,与模型组相比,阳性对照组和实验组皮肤瘙痒次数明显减少(P<0.01),皮肤瘙痒持续时间明显缩短(P<0.01),结果表明抑菌止痒乳膏具有明显的治疗皮肤瘙痒的作用。虽然本发明的中药乳膏的止痒效果相比于激素类复方醋酸地塞米松乳的止痒效果略差,但是本发明纯中药乳膏用药天然,无毒副作用,更易控制皮肤疾病的复发。
案例1:
陈某某,19岁,女性,上肢尺侧患有湿疹2年,临床表现为丘疹,丘疱疹,有渗液,结痂等,曾接受多种外用药物治疗,效果不明显,使用本发明抑菌止痒乳膏,每天涂覆患处3次,并且避免可能致敏和刺激性食物,如辣椒、浓茶、咖啡、酒类。24h内症状缓解,2个月天后皮疹完全清除,随访半年后未复发。
案例2:
杨某,男36岁,司机,患有股癣3年,常反复发作,发作时常伴剧烈瘙痒,有时可波及到阴囊和阴茎,严重时可向前后上方蔓延,曾至医院治疗,使用过达克宁的硝酸咪唑软膏和百川止痒液,也用过盐酸特比萘芬乳膏,瘙痒仍无明显改善,使用本发明的抑菌止痒中药乳膏,一天二至三次,均匀涂抹在患处,且患者保持经常换洗贴身衣物,如内裤,床单等。经常清洗阴股部。保持阴股部干爽洁净,24h内症状缓解,2个月后股癣症状消除,随访一年未复发。
案例3:
方某,67岁,女性,诊断为老年性皮肤瘙痒,自觉全身瘙痒,但以下肢最明显,夜间入睡前瘙痒尤甚,一般为阵发性,严重时为持续性瘙痒,阵发性加剧,有时难以忍耐。使用本发明抑菌止痒乳膏均匀涂抹于下肢患处,24h瘙痒症状缓解,2个月下肢瘙痒症状消除。
案例4:
刘某,男43岁,诊断为牛皮癣,后颈部斑块伴瘙痒1年,自觉阵发性瘙痒,反复搔抓,常常由于局部刺激精神烦躁加剧,皮损及其周围常见抓痕或血痂,就诊处方西药药膏,无明显改善此症状,患者在使用本发明的抑菌止痒纯中药乳膏,一天二至三次,均匀涂抹在患处,嘱咐保持充足睡眠和良好心情,避免刺激,少食辛辣,2天瘙痒症状缓解,2月后瘙痒症状消除。
Claims (9)
1.一种抑菌消炎止痒中药乳膏,其特征在于,主要由中药组分和乳膏基质制备而成,其中,所述中药组分主要由独角莲、五倍子、皂角刺、土荆皮、白鲜皮、紫草、地肤子、金银花、野菊花、黄柏、百部、土茯苓、七星剑、铁冬青、狼毒、苦参、冰片、薄荷脑和蛇床子制备而成。
2.如权利要求1所述的抑菌消炎止痒中药乳膏,其特征在于,所述中药组分主要由独角莲4-10重量份、五倍子3-10重量份、皂角刺3-10重量份、土荆皮10-30重量份、白鲜皮 5-10重量份、紫草10-15重量份、地肤子9-15重量份、金银花9-35重量份、野菊花12-18重量份、黄柏7-13重量份、百部6-12重量份、土茯苓10-60重量份、七星剑 10-15重量份、铁冬青15-35重量份、狼毒2-5重量份、苦参5-11重量份、冰片0.15-0.3重量份、薄荷脑3-6重量份和蛇床子4-10重量份制备而成。
3.如权利要求2所述的抑菌消炎止痒中药乳膏,其特征在于,所述中药组分主要由独角莲5重量份、五倍子10重量份、皂角刺9重量份、土荆皮28重量份、白鲜皮9重量份、紫草15重量份、地肤子14重量份、金银花30重量份、野菊花15重量份、黄柏10重量份、百部11重量份、土茯苓50重量份、七星剑 14重量份、铁冬青34重量份、狼毒4.5重量份、苦参10重量份、冰片0.15重量份、薄荷脑5重量份和蛇床子9重量份制备而成。
4.如权利要求1-3中任一项所述的抑菌消炎止痒中药乳膏,其特征在于,按照质量百分比计,所述乳膏剂基质组成包括:8.5%的凡士林、12%的硬脂酸、7%的单硬脂酸甘油酯、0.1%的尼泊金乙酯、1%的十二烷基硫酸钠、10%的甘油及余量的蒸馏水。
5.一种如权利要求1-4中任一项所述的抑菌消炎止痒中药乳膏的制备方法,其特征在于,包括以下步骤:
(1)将独角莲、五倍子、皂角刺、土荆皮、白鲜皮、紫草、地肤子、金银花、野菊花、黄柏、百部、土茯苓、七星剑、铁冬青、狼毒、苦参、蛇床子洗净,晾干,粉碎,过50-100目筛网,得到中药粉末;
(2)将步骤(1)制备的中药粉末中加入6-8倍的蒸馏水,浸泡12-24小时后煎煮,煎煮液过滤,得到药物提取液;
(3)在步骤(2)得到的药物提取液中加入乙醇溶液,浸泡提取;
(4)重复步骤(3)的浸泡提取,合并药液,过滤,然后将药液浓缩后,得到中药材的提取物;
(5)将步骤(4)得到的中药材提取物与乳膏基质加热搅拌混匀,待混合物温度降低至40℃以下时,加入冰片、薄荷脑,得到中药乳膏。
6.如权利要求5所述的制备方法,其特征在于,步骤(3)中,乙醇溶液的浓度为70%-90%,乙醇溶液的加入量为药物提取液的10-15倍,浸泡提取的时间为0.5-2h。
7.如权利要求5所述的制备方法,其特征在于,步骤(5)中,中药材提取物与乳膏基质的质量比为1-3:1。
8.如权利要求5所述的制备方法,其特征在于,步骤(5)中,所述乳膏基质是通过以下制备方法制备获得的:将凡士林、硬脂酸、单硬脂酸甘油酯和尼泊金乙酯加热熔融制成均一的油相;将十二烷基硫酸钠、甘油和蒸馏水混合成水相,加热至80℃,然后将其加入到油相中,制成乳膏基质。
9.如权利要求5所述的制备方法,其特征在于,步骤(2)中,煎煮的次数为3次,每次1小时。
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