CN106266152A - 一种治疗湿疹的药物组合物及其制备方法和用途 - Google Patents
一种治疗湿疹的药物组合物及其制备方法和用途 Download PDFInfo
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Abstract
本发明提供了一种治疗湿疹的药物组合物,它是由包含下述重量配比的原料药制备而成:苦参35‑40份、忍冬藤10‑15份、大血藤10‑15份、地肤子10‑15份、蛇床子10‑15份、花椒5‑10份、芒硝10‑15份、苍术10‑15份、蒲公英10‑15份、野菊花15‑20份、黄柏15‑20份。本发明还提供了该组合物的制备方法和用途。本发明提供的组合物,配伍精当,各药味相辅相成,对于治疗湿疹疗效显著,而且安全性好,使用方便,为临床提供了一种新的药物选择。
Description
技术领域
本发明属于药物领域,涉及一种治疗湿疹的药物组合物及其制备方法和用途。
背景技术
湿疹(eczema)是由多种内、外因素引起的真皮浅层及表皮炎症,是一种常见的过敏性、炎性皮肤病,以皮损形态多样、对称分布、瘙痒剧烈、有明显渗出倾向、反复发作、易成慢性等为显著特征,男女老幼皆可发病,无明显季节差异。本病缠绵难愈,临床治疗棘手,对患者身心健康造成极大影响。西医根据病程将其分为急性湿疹、亚急性湿疹和慢性湿疹三类,另外根据皮损形态、发病部位,也有各异名称。中医的辨证分型为湿热内蕴型、脾虚湿盛型和血虚风燥型三型。
湿疹的发病机制复杂,内部因素可由慢性感染病灶、内分泌及代谢改变、血液循环障碍、神经精神因素、遗传因素等,外部因素可由失误、吸入物、生活环境、动物皮毛、各种化学所诱发或加重,某些患者可能由迟发型超敏反应介导。
目前,西医治疗多采用注射钙剂、维生素C、硫代硫酸钠或普鲁卡因封闭,继发感染者加用抗生素,局部外用激素类药物,但都存在不同的副反应,不宜长期使用,且无法治其根本,停药后易复发。反观中医,则有系统的基础理论,以辨证论治为原则,从整体着眼,审证求因,审因论治,而且中药按方剂学理论合理配伍后,安全性好、疗效稳定,对治疗湿疹具有良好的临床应用前景。
发明内容
本发明的目的在于提供一种可以安全有效治疗湿疹的药物组合物及其制备方法和用途。
本发明提供了一种治疗湿疹的药物组合物,它是由包含下述重量配比的原料药制备而成:
苦参35-40份、忍冬藤10-15份、大血藤10-15份、地肤子10-15份、蛇床子10-15份、花椒5-10份、芒硝10-15份、苍术10-15份、蒲公英10-15份、野菊花15-20份、黄柏15-20份。
其中,它是由下述重量配比的原料制备而成:
苦参40份、忍冬藤15份、大血藤15份、地肤子15份、蛇床子15份、花椒10份、芒硝10份、苍术15份、蒲公英15份、野菊花15份、黄柏15份。
其中,它是由苦参、忍冬藤、大血藤、地肤子、蛇床子、花椒、芒硝、苍术、蒲公英、野菊花、黄柏的原生粉或水或有机溶剂提取物为活性成分,加入药学上可接受的辅料或辅助性成分制备而成的制剂。
其中,所述制剂为外用制剂。
其中,所述外用制剂为汤剂、膏剂、酊剂凝胶剂、洗剂、搽剂、气雾剂或喷雾剂。
本发明还提供了上述组合物的制备方法,它包括如下步骤:
a、称取各重量配比的原料;
b、将原料直接打粉,或加水或有机溶剂提取后,加入药学上可接受的辅料或辅助性成分制备而成。
本发明还提供了上述组合物在制备治疗湿疹的药物中的用途。
其中,所述湿疹为急性湿疹、亚急性湿疹和/或慢性湿疹。
其中,所述湿疹为湿热内蕴型、脾虚湿盛型和/或血虚风燥型的湿疹。
湿疮常由风湿热蕴肤、湿热浸淫肌肤、气血运行不畅而成。本发明组合物中的苦参、苍术清热燥湿,忍冬藤、黄柏透邪解毒,大血藤清热解毒、活血祛风,地肤子、蛇床子清热利湿、祛风止痒,蒲公英、野菊花清热祛风止痒,诸药合用共凑除湿止痒、活血祛风之用。
本发明提供的组合物,配伍精当,各药味相辅相成,对于治疗湿疹、防止湿疹复发疗效显著,临床治愈率和有效率好;而且本发明组合物安全性好,使用方便,为临床提供了一种新的药物选择。
显然,根据本发明的上述内容,按照本领域的普通技术知识和惯用手段,在不脱离本发明上述基本技术思想前提下,还可以做出其它多种形式的修改、替换或变更。
以下通过实施例形式的具体实施方式,对本发明的上述内容再作进一步的详细说明。但不应将此理解为本发明上述主题的范围仅限于以下的实例。凡基于本发明上述内容所实现的技术均属于本发明的范围。
具体实施方式
下面以实施例作进一步说明,但本发明不局限于这些实施例。
实施例1本发明组合物的制备
处方:苦参40g,忍冬藤15g,大血藤15g,地肤子15g,蛇床子15g,花椒10g,芒硝10g,苍术15g,蒲公英15g,野菊花15g,黄柏15g。
制备方法:按处方称取各原料药,煎煮2次。其中,每次加水2000ml,大火熬开后小火煎煮15分钟,将2次熬煮后的药水混匀使用。
使用方法:每日1剂,加清水煮开,先熏患处,水温适宜后再湿敷、浸泡患处、早晚各1次。
实施例2本发明组合物的制备
处方:苦参35g、忍冬藤10g、大血藤10g、地肤子10g、蛇床子10g、花椒5g、芒硝10g、苍术10g、蒲公英10g、野菊花20g、黄柏20g。
制备方法:同实施例1的制备方法。
实施例3本发明组合物的制备
处方:同实施例1的处方。
制备工艺:按处方称取各原料药,粉碎,混合均匀,即得。
以下用试验例的方式说明本发明的有益效果:
试验例1本发明组合物治疗湿疹的临床观察
一、收治患者及诊断标准
1、患者一般资料
患者性别及年龄范围:
本发明组合物的用药患者120例,年龄15-60岁,女性50例,男性70例,总病程最短半月,最长3年,治疗时间最短半月,最长半年。
对比例药物的用药患者120例,年龄15-62岁,女性65例,男性55例,总病程最短半月,最长3年,治疗时间最短半月,最长半年。
2、诊断标准:
瘙痒剧烈、多形性、对称性皮损,急性期有渗出倾向,慢性期苔藓样变皮损。其中:
急性湿疹好发于面、耳、手、足、前臂、小腿等暴露部位,严重者可弥漫全身,常对称分布。皮损多形性,常表现为红斑基础上的针头至粟粒大小丘疹、丘疱疹、严重者可出现小水疱,常融合成片,境界不清楚,皮损周边丘疱疹逐渐稀疏,常因搔抓形成点状糜烂面,有明显浆液性渗出。自觉瘙痒剧烈,搔抓、热水洗烫时可加重皮损。
亚急性湿疹是因急性湿疹炎症减轻或不适当处理后病程较久发展而来。表现为红肿及渗出减轻,但仍可有丘疹及少量丘疱疹,皮损成暗红色,可有少许鳞屑及轻度浸润。仍自觉有剧烈瘙痒。再次暴露于致敏原、新的刺激或处理不当可导致急性发作,如经久不愈,则可发展为慢性湿疹。
慢性湿疹是由急性湿疹或亚急性湿疹迁延而来,也可由于刺激轻微、持续而一开始就表现为慢性化。好发于手足小腿肘窝股部乳房、外阴、肛门等处,对对称发病。表现为患部皮肤浸润性暗红斑上有丘疹、抓痕及鳞屑,局部皮肤肥厚、表面粗糙,有不同程度苔藓样变、色素沉着获色素减退。自觉有明显瘙痒,常呈阵发性。病情时轻时重,延续数月或更久。
二、治疗标准
参照皮损面积及严重程度指数(EASI)对患者皮损渗出或结痂、肥厚、苔藓化、瘙痒程度以及皮损范围定级,按无、轻度、中度、重度、分别计为1-3分。疗效指数=[(治疗前积分-治疗后积分)/治疗前积分]×100%.
治愈:瘙痒消失,疗效指数≥90%。
显效:瘙痒明显减轻,疗效指数为60%-89%。
好转:瘙痒减轻,疗效指数为20%-59%。
无效:症状体征无明显变化,疗效指数≤20%或者症状加重。
有效率=(治愈例数+显效例数+好转例数)/治疗总例数×100%。
三、治疗方法
1、给药方法:明确诊断后,120例患者均采用如下药物:
苦参40g,忍冬藤15g,大血藤15g,地肤子15g,蛇床子15g,花椒10g,芒硝10g,苍术15g,蒲公英15g,野菊花15g,黄柏15g。
每日1剂,水煎1次。早、晚分2次熏洗、湿敷、浸泡,连用2周。治疗期间,不配有其它西药和其它疗法。
治疗期间饮食清淡,忌肥甘厚味,忌甜食、辛辣、海鲜食物及热性水果,嘱多食蔬菜。
2、适用于无明显用药禁忌、无敏感性皮肤者。
3、对比例药物(即公开号为CN103463539A的专利组方):
明确诊断后,120例患者采用如下药物:
处方:苦参20g、蛇床子10g、花椒5g、黄柏10g、苍术10g、百部10g、地肤子10g、忍冬藤10g、蒲公英10g、白鲜皮10g、紫荆皮10g、大血藤10g、艾叶10g、芒硝5g。
制备方法、使用方法均同本发明药物。
四、治疗结果
治疗时间:2周。
1、疗效判定:结果如下。
表1患者经过本发明药物2周治疗后的疗效
治疗结果 | 病例数(例) | 有效率(%) |
治愈 | 30 | 25 |
显效 | 36 | 30 |
好转 | 40 | 33.3 |
无效 | 14 | 11.6 |
总计 | 120 | 88.33 |
表2患者经过对比例药物2周治疗后的疗效
治疗结果 | 病例数(例) | 有效率(%) |
治愈 | 21 | 17.5 |
显效 | 26 | 21.67 |
好转 | 55 | 45.83 |
无效 | 18 | 15.0 |
总计 | 120 | 85 |
将表1-2对比可知,与使用对比例药物相比,患者使用本发明药物组合物后,湿疹的治愈率、显效率、总有效率均有显著提高,说明本发明药物组合物对湿疹的治疗效果非常好,应用前景良好。
2、不良反应:用药期间未见不良反应,偶见部分患者治疗后期皮肤发红、有轻微烧灼感,嘱患者浸泡时水温微高于皮温为度。
说明本发明组合物毒副反应小,使用安全可靠。
因此,本发明组合物对湿疹的治疗效果显著,使用安全。
五、典型病例
患者刘某,女性,48岁。半年前,患者无明显诱因双手掌出现丘疹、水泡、脱屑、瘙痒剧烈,略见出水,服用开瑞坦治疗后可暂时缓解,停药易复发,多次配合糖皮质激素外用无明显疗效。近日患者手掌丘疹、水泡反复,瘙痒剧烈,刻诊:双手指缝见小水泡,少有渗液,白色丘疹,部分干燥脱屑,舌红,质干,苔腻,舌尖稍红,脉滑数。诊断为:湿疹。治宜除湿止痒祛风。使用本发明的具体实施方法,并建议患者饮食清淡,忌肥甘厚味,忌甜食、辛辣、海鲜食物及热性水果。按上述治疗1疗程(即2周),皮损减少,瘙痒明显减轻;再用药1疗程后,皮损、瘙痒完全消失。
上述实验表明,本发明药物组合物,对治疗湿疹患者疗效显著。
综上所述,本发明提供的组合物,配伍精当,各药味相辅相成,对于治疗湿疹疗效显著,临床治愈率和有效率好;而且本发明组合物安全性好,使用方便,为临床提供了一种新的药物选择。
Claims (9)
1.一种治疗湿疹的药物组合物,其特征在于:它是由包含下述重量配比的原料药制备而成:
苦参35-40份、忍冬藤10-15份、大血藤10-15份、地肤子10-15份、蛇床子10-15份、花椒5-10份、芒硝10-15份、苍术10-15份、蒲公英10-15份、野菊花15-20份、黄柏15-20份。
2.根据权利要求1所述的药物组合物,其特征在于:它是由下述重量配比的原料制备而成:
苦参40份、忍冬藤15份、大血藤15份、地肤子15份、蛇床子15份、花椒10份、芒硝10份、苍术15份、蒲公英15份、野菊花15份、黄柏15份。
3.根据权利要求1或2所述的组合物,其特征在于:它是由苦参、忍冬藤、大血藤、地肤子、蛇床子、花椒、芒硝、苍术、蒲公英、野菊花、黄柏的原生粉或水或有机溶剂提取物为活性成分,加入药学上可接受的辅料或辅助性成分制备而成的制剂。
4.根据权利要求3所述的组合物,其特征在于:所述制剂为外用制剂。
5.根据权利要求4所述的组合物,其特征在于:所述外用制剂为汤剂、膏剂、酊剂凝胶剂、洗剂、搽剂、气雾剂或喷雾剂。
6.权利要求1-5任意一项所述组合物的制备方法,其特征在于:它包括如下步骤:
a、称取各重量配比的原料;
b、将原料直接打粉,或加水或有机溶剂提取后,加入药学上可接受的辅料或辅助性成分制备而成。
7.权利要求1-5任意一项所述的组合物在制备治疗湿疹的药物中的用途。
8.根据权利要求7所述的用途,其特征在于:所述湿疹为急性湿疹、亚急性湿疹和/或慢性湿疹。
9.根据权利要求7所述的用途,其特征在于:所述湿疹为湿热内蕴型、脾虚湿盛型和/或血虚风燥型的湿疹。
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CN112755143B (zh) * | 2021-03-01 | 2022-06-24 | 复旦大学附属金山医院(上海市金山区核化伤害应急救治中心、上海市金山区眼病防治所) | 一种治疗湿疹的中药组合物及其应用 |
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