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CN111888437A - 一种治疗湿疹的中药外用制剂 - Google Patents

一种治疗湿疹的中药外用制剂 Download PDF

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CN111888437A
CN111888437A CN202010874749.4A CN202010874749A CN111888437A CN 111888437 A CN111888437 A CN 111888437A CN 202010874749 A CN202010874749 A CN 202010874749A CN 111888437 A CN111888437 A CN 111888437A
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赵艳
王艳艳
段浩博
段素社
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Abstract

一种治疗湿疹的中药外用制剂,属于治疗皮肤疾病的中药制剂领域,按重量份数计,包括以下原料:地肤子30份,苦参15份,白鲜皮15份,土茯苓20份,徐长卿15份,穿山龙20份,细辛4份,防风15份,乌梅15份,五味子15份银柴胡15份,甘草10份。本发明中药外用制剂,治疗湿疹脱敏止痒效果好,费用低。

Description

一种治疗湿疹的中药外用制剂
技术领域
本发明属于治疗皮肤疾病的中药制剂领域,涉及一种治疗湿疹的中药外用制剂,脱敏止痒效果好,费用低。
背景技术
湿疹又称湿疮,是各种原因引起的过敏性、炎症性皮肤病。其特点为皮损形态多样,对称分布,剧烈瘙痒,有渗出倾向,反复发作,易形成慢性等。目前治疗中医实行内外兼治。仅内服药物中医就分四型,有湿热蕴肤证,治以清热利湿、解毒止痒,方药为龙胆泻肝汤合萆薢渗湿汤加减;脾虚湿蕴证,治法以健脾利湿止痒,方药为除湿胃苓汤或参苓白术散加减;阴虚湿热证,治法以滋阴养血,除湿止痒,方药为滋阴除湿汤;血虚风燥证,治法为养血润肤,祛风止痒,方药为当归饮子或四物消风饮加减。外治法更是种类繁多,如三黄洗剂、青黛膏、复方氧化锌、黑豆榴油软膏、5%硫磺膏等。传统湿疹治法常用内服兼外治的方法。内服药物辩证分型不统一,所用药物差异大,故疗效难以保证。外用药物组成简单,仅具有止痒作用,而无整体调理之效果,因而疗效不能持久,病情反复易见。
发明内容
本发明的目的是提供一种治疗湿疹的外用中药制剂,采用具备清热、燥湿、解毒的群药组成方剂。
本发明为实现其目的采用的技术方案是:
一种治疗湿疹的中药外用制剂,按重量份数计,包括以下原料:地肤子30份,苦参15份,白鲜皮15份,土茯苓20份,徐长卿15份,穿山龙20份,细辛4份,防风15份,乌梅15份,五味子15份银柴胡15份,甘草10份。
所述的中药外用制剂为软膏,由下述方法制备:将按原料总量与香油质量比为1:2的比例准备,浸泡72h,后用文火加热至油开,加热时间为10分钟,油开后,文火持续加热保持油温在200-220℃之间,至药呈深褐色时停火,时间为20min,滤掉药渣,加入黄蜡调成软膏。
本发明的有益效果:
本发明外用制剂通过12味具有清热解毒,燥湿止痒等作用的中药组合在一起,经香油炸取,保留有效成分于油中,加黄蜡调成软膏,外涂于病变部位,一日3次,涂抹1天内可止痒,7天皮疹消失,2周皮肤恢复正常颜色,疗效好,疗程短。
目前内服治疗湿疹的中药一般10-50元/日不等,而本发明外用中药制剂一天在3元之内,价格较传统内服加外治法,花费明显减少,还减少煎药之苦和服用的不适感。
湿疹的病机是湿热蕴阻,肤失濡养。治疗湿疹当以清热利湿为主,地肤子“能清除皮肤中之湿热与风邪而止痒”故为主药。苦参、白鲜皮、土茯苓、徐长卿清热燥湿,助主药祛除湿毒以止痒为辅药。穿山龙、细辛通络透表有助湿邪的代谢,且细辛有佐治其他药物寒凉凝滞的作用,故为佐药。甘草调和诸药为使药。以上组方经内服有效,但尽管有甘草,仍有一部分患者反映药苦难饮。湿疹本身也是过敏性疾病,过敏煎有抗过敏之作用,但过敏煎多用于治疗荨麻疹、过敏性鼻炎,用它来治疗湿疹并无临床性报道,于是我把过敏煎(防风、乌梅、五味子、银柴胡)加入原组方中,目的是提高临床疗效。然而,加药后的组方不管是内服还是外洗,疗效无明显提高。正当这时,我想把这个组方制成油膏外用,当时改变剂型的目的是解决煎药之苦及服药之苦的问题,把合方的药物制成油膏剂,外涂,一日3次,结果意外发现治疗作用明显增强,对急性、亚急性、慢性湿疹均有效,推测油提既保留了原来药效,又增加了香油的濡养作用。油膏的疗效好于内服和外洗,费用不及煎药的五分之一。
具体实施方式
下面结合具体实施例对本发明做进一步的说明。
一、具体实施例
实施例1
一种治疗湿疹的外用软膏,地肤子30g,苦参15g,白鲜皮15g,土茯苓20g,徐长卿15g,穿山龙20g,细辛4g,防风15g,乌梅15g,五味子15g,银柴胡15g,甘草10g。
软膏制备方法:以总量3斤中药,用6斤香油的比例,浸泡72小时,后用文火加热至油开,加热时间为10分钟,油开后,文火持续加热保持油温在200-220℃之间,至药呈深褐色时停火,时间为20min,滤掉药渣,加入黄蜡调成软膏,装盒备用。
二、临床试验
I、剂型及过敏煎的意外增效效果
过敏煎多用于治疗荨麻疹、过敏性鼻炎,本发明想过敏煎加入到本发明基础组方中,目的是提高临床疗效,但是加药后的组方不管是内服还是外洗,疗效无明显提高。具体临床试验如下:
1.一般资料
全部70例均为石家庄长城中西医结合医院门诊病历,按随机数字表法分为2组,第一组:35例,男21例,女14例,年龄6~59岁,病程3个月~4年。第二组:35例,男20例,女15例,年龄6~60岁,病程两个月~3年10个月;
2.诊断标准:
西医诊断标准(《常见疾病的诊断与疗效判断标准》,中国中医药出版社,1999年10月版)。《临床疾病诊断依据治愈好转标准》人民军医出版社,1998年6月版)
(1)急性湿疹急性过程,可发生于身体任何部位;全身泛发或局限于一处,常对称分布。皮疹呈多形性,集簇成片状,边界不清。病处轻度肿胀,红斑,丘疹,水疱,瘙痒明显,因搔抓常引起糜烂、结痂等,渗出明显。
(2)亚急性湿疹急性病变炎症减轻,渗液减少后,病程迁延,仍然瘙痒,皮疹以丘疹、鳞屑、结痂为主,仅有少数丘疱疹和糜烂,或有轻度浸润。
(3)慢性湿疹可由急性或亚急性期反复不愈而成,亦可一开始即为慢性湿疹。皮损多限局一处或多处,限局性或泛发性浸润肥厚,呈黯褐或棕色色素沉着,上覆以少量鳞屑或呈苔藓化。慢性病程,但常有急性发作。
2.2纳入标准:符合上述诊断标准,年龄5-65岁之间,男女不限。
2.3排除标准:不符合湿疹的诊断标准;年龄小于5岁或大于65岁者;妊娠或准备妊娠及哺乳期妇女;一周内使用抗组织胺药、激素类药物或正在用其它药治疗该病者。
3.治疗方法
第一组:地肤子30g,苦参15g,白鲜皮15g,土茯苓20g,徐长卿15g,穿山龙20g,细辛4g,防风15g,乌梅15g,五味子15g,银柴胡15g,甘草10g。
第二组:地肤子30g,苦参15g,白鲜皮15g,土茯苓20g,徐长卿15g,穿山龙20g,细辛4g,甘草10g。
均采用煎服法:将原料用水浸泡1小时,控制煎药时水没过药物2厘米,自水沸腾时开始计时,头煎30分钟,头煎结束后,取出煎汁150ml,然后再次向煎锅中加水,控制水没过药物1厘米,进行二煎,自水沸腾时开始计时,再煎20分钟,取出煎汁150ml,将两次的煎汁合并混匀,分两次服用。2周为一疗程。
4.疗效标准
根据刘国华,张明岛.上海市中医病证诊疗常规[M].2版.上海:上海中医药大学出版社,2003:338-339.
治愈:症状消失,皮肤恢复正常;好转:症状及皮肤损害有改善;未愈:症状及体征均无变化。
5.结果:两组临床疗效比较结果详见表1。
表1
Figure BDA0002652297220000051
第一组与第二组比较,P>0.05,两组差异无统计学意义。
根据表1可以看出,上述加入过敏煎的方式,并没有达到预期提高治疗效果的预期。正当这时,想把这个组方制成油膏外用,当时改变剂型的目的是油膏方便、且药效保留时间长,可以解决煎药之苦及服药之苦的问题,把合方的药物制成油膏剂,外涂,一日3次,结果意外发现治疗作用明显增强,对急性、亚急性、慢性湿疹均有效,推测油提既保留了原来药效,又增加了香油的濡养作用。油膏的疗效好于内服和外洗,费用不及煎药的五分之一。具体临床试验如下:
II、本发明治疗湿疹的外用软膏的临床效果
1、临床资料
全部80例均为石家庄长城中西医结合医院中医科门诊病例。按随机数字表法分为2组,以炉甘石洗剂作为对照组进行观察,其中治疗组40例,男24例,女16例,年龄6~58岁,病程3个月~4年;对照组40例,男25例,女15例,年龄6~61岁,病程2个月~4年。
2.诊断标准:
西医诊断标准(《常见疾病的诊断与疗效判断标准》,中国中医药出版社,1999年10月版)。《临床疾病诊断依据治愈好转标准》人民军医出版社,1998年6月版)
(1)急性湿疹急性过程,可发生于身体任何部位;全身泛发或局限于一处,常对称分布。皮疹呈多形性,集簇成片状,边界不清。病处轻度肿胀,红斑,丘疹,水疱,瘙痒明显,因搔抓常引起糜烂、结痂等,渗出明显。
(2)亚急性湿疹急性病变炎症减轻,渗液减少后,病程迁延,仍然瘙痒,皮疹以丘疹、鳞屑、结痂为主,仅有少数丘疱疹和糜烂,或有轻度浸润。
(3)慢性湿疹可由急性或亚急性期反复不愈而成,亦可一开始即为慢性湿疹。皮损多限局一处或多处,限局性或泛发性浸润肥厚,呈黯褐或棕色色素沉着,上覆以少量鳞屑或呈苔藓化。慢性病程,但常有急性发作。
2.2纳入标准:符合上述诊断标准,年龄5-65岁之间,男女不限。
2.3排除标准:不符合湿疹的诊断标准;年龄小于5岁或大于65岁者;妊娠或准备妊娠及哺乳期妇女;一周内使用抗组织胺药、激素类药物或正在用其它药治疗该病者。
3.治疗方法
3.1治疗组:本发明治疗湿疹的中药外用制剂(实施例1),外涂,一日三次。
3.2对照组:炉甘石洗剂(1000ml内含甘油50ml,氧化锌50g,炉甘石150g)。
3.3疗程:2组均2周为一疗程,一疗程后统计疗效。
4.疗效标准
根据刘国华,张明岛.上海市中医病证诊疗常规[M].2版.上海:上海中医药大学出版社,2003:338-339.
治愈:症状消失,皮肤恢复正常;好转:症状及皮肤损害有改善;未愈:症状及体征均无变化。
5.结果
两组临床疗效比较表,详见表2。
表2两组临床疗效比较
Figure BDA0002652297220000071
与对照组比较P<0.05。
通过上述临床试验可以看出,过敏煎结合油膏剂型的创新,提高了临床治疗效果。

Claims (2)

1.一种治疗湿疹的中药外用制剂,其特征在于,按重量份数计,包括以下原料:地肤子30份,苦参15份,白鲜皮15份,土茯苓20份,徐长卿15份,穿山龙20份,细辛4份,防风15份,乌梅15份,五味子15份银柴胡15份,甘草10份。
2.根据权利要求1所述的一种治疗湿疹的中药外用制剂,其特征在于,所述的中药外用制剂为软膏,由下述方法制备:将按原料总量与香油质量比为1:2的比例准备,浸泡72h,后用文火加热至油开,加热时间为10分钟,油开后,文火持续加热保持油温在200-220℃之间,至药呈深褐色时停火,时间为20min,滤掉药渣,加入黄蜡调成软膏。
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