CN114504619A - 一种治疗特应性皮炎的中药组合物 - Google Patents
一种治疗特应性皮炎的中药组合物 Download PDFInfo
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Abstract
本发明涉及一种治疗特应性皮炎的中药组合物，该中药组合物是由以下中药制备而成：野菊花、金银花、苦参、石菖蒲、黄柏、蛇床子、地肤子、白芷、马齿苋、甘草和牡丹皮。本发明中药组合物中的药物设计合理、相互配伍，对特应性皮炎的症状缓解率高，治愈率高，复发率低，其在减少药物对婴幼儿皮肤刺激的同时，增加了疗效。
Description
技术领域
本发明涉及中药领域，具体涉及一种治疗特应性皮炎的中药组合物。
背景技术
特应性皮炎(Atopic Dermatitis，AD)是一种常见的皮肤慢性炎症性复发性疾病。随着国内工业化水平的提高，气候改变和环境污染等影响，特应性皮炎患病率逐年上升，并以婴幼儿和青少年为主要患病人群，对青少年及儿童的身心健康成长造成影响。该病症是世界范围内最常见的炎性皮肤病，全球约有15％～30％的儿童和2％～10％的成人发病。特应性皮炎的治疗目的是缓解或消除临床症状，减少和预防复发，提高患者的生活质量。
现代医学治疗以局部应用类固醇激素或者钙调神经磷酸酶抑制剂配合润肤剂为主。糖皮质激素局部外用可以减轻局部炎症反应，减轻瘙痒症状。激素的选择应根据患者的年龄、皮损部位及病情严重程度，选用不同类型及强度的制剂。患者的皮损一旦控制，应及时将激素减量。钙调神经磷酸酶抑制剂类药物主要包括他克莫司和吡美莫司。两者均可用于糖皮质激素外用疗效欠佳，或拒绝应用糖皮质激素的患者。钙调神经磷酸酶抑制剂可与激素联合应用或序贯使用。这类药物是维持治疗的较好选择，每周使用2～3次，可以减少病情的复发。但是作为主要的西医外用治疗药物，糖皮质激素和钙调磷酸酶抑制剂都存在药物依赖、停药反跳、系统吸收影响儿童生长发育等副作用。
近年来大量的临床试验研究表明，中医药方法以其安全、有效的优势广泛应用于特应性皮炎的临床治疗。统计研究表明，中医外治方法治疗特应性皮炎的痊愈率和有效率均明显优于西医对照组，其不良反应发生率及复发率也相对较低，表明中医外治法治疗特应性皮炎有确切的疗效。
中医外治法分为中药洗渍、针灸、刺络拔罐、放血、推拿、中药外用制剂等多种类型。洗渍疗法是以中医的整体观念和辨证论治为指导，运用不同的治疗药物及方法达到治疗效果，具体方法是将药物置于体表皮肤、筋膜或患处，借助药物本身及一定的温度对机体发挥作用以达到疏经活络、调和气血的目的。
特应性皮炎属中医“奶藓”、“顽湿”等范畴，湿毒内生、外蕴皮肤为主要病机，苦参是清热解毒、燥湿止痒要药，历来被传统医家运用于瘙痒性皮肤病的治疗。临床报道苦参制剂治疗AD效果良好。现有研究推测，苦参可能通过拮抗角质形成细胞炎性反应，调节角质形成细胞增殖和凋亡稳态，进一步改善皮肤屏障功能，从而发挥治疗特应性皮炎的作用。
然而目前已有的治疗特应性皮炎的中药组方治疗效果均有限，因此从中药领域进一步发掘应用于治疗特应性皮炎的药物，为制定临床用药方案提供更加丰富的选择，成为亟待解决的技术问题。
发明内容
本发明的目的是提供一种能有效治疗特应性皮炎的中药组合物。
为实现上述目的，本发明采用以下技术方案：
本发明的第一方面是提供一种治疗特应性皮炎的中药组合物，该中药组合物由以下中药制备而成：野菊花、金银花、苦参、石菖蒲、黄柏、蛇床子、地肤子、白芷、马齿苋、甘草和牡丹皮。
优选的，所述中药组合物由以下重量份的中药制备而成：野菊花1-5重量份、金银花1-5重量份、苦参1-5重量份、石菖蒲1-5重量份、黄柏1-5重量份、蛇床子1-5重量份、地肤子1-5重量份、白芷1-5重量份、马齿苋1-5重量份、甘草1-5重量份和牡丹皮1-5重量份。
更优选的，所述中药组合物由以下重量份的中药制备而成：野菊花2-4重量份、金银花2-4重量份、苦参2-4重量份、石菖蒲2-4重量份、黄柏2-4重量份、蛇床子2-4重量份、地肤子2-4重量份、白芷2-4重量份、马齿苋2-4重量份、甘草2-4重量份和牡丹皮2-4重量份。
最优选的，所述中药组合物由以下重量份的中药制备而成：野菊花3重量份、金银花3重量份、苦参3重量份、石菖蒲3重量份、黄柏3重量份、蛇床子3重量份、地肤子3重量份、白芷3重量份、马齿苋3重量份、甘草3重量份和牡丹皮3重量份。
优选的，所述中药组合物为外用制剂。
更优选的，所述外用制剂为软膏剂、溶液剂、洗剂、贴剂或汤剂。
本发明的第二方面是提供上述中药组合物的制备方法，包括以下步骤：
将上述处方量的野菊花、金银花、苦参、石菖蒲、黄柏、蛇床子、地肤子、白芷、马齿苋、甘草和牡丹皮放入煎药容器内，加2-4倍重量的水，浸泡30分钟后，武火煎煮沸腾，再用文火煎煮40-60分钟，过滤，即得。
优选的，上述制备方法中加入3倍重量的水。
优选的，上述制备方法中文火煎煮的时间为50分钟。
本发明的第三方面是提供上述中药组合物在制备治疗特应性皮炎的药物中的应用。
优选的，所述特应性皮炎为婴儿特应性皮炎。
本发明的第四方面是提供上述中药组合物在制备治疗湿疹的药物中的应用。
优选的，所述湿疹为婴儿湿疹。
本发明的第五方面是提供上述中药组合物在制备降低IgE水平和/或Th17细胞比例的药物中的应用。
本发明选用的中药原料在本领域的常见药理功效如下：
野菊花：性微寒，味苦、辛，归心经、肝经，具有清热解毒、消肿、凉肝明目之功效，临床上用于治疗疔疮痈肿、目赤肿痛、头痛眩晕。
金银花：性寒，味甘，归肺经、心经、胃经，具有清热解毒、凉散风热之功效，临床上用于治疗咽喉炎症、肺结核并发呼吸道感染、肺炎和细菌性痢疾、外科化脓性感染、子宫颈糜烂以及眼科急性炎症。
苦参：性寒，味苦，归心经、肝经、胃经、大肠经、膀胱经，具有清热燥湿、杀虫、利尿之功效，临床上用于治疗热痢、便血、黄疸尿闭、赤白带下、阴肿阴痒、湿疹、湿疮、皮肤瘙痒、疥癣麻风。
石菖蒲：味辛，性温，入心、胃经，具有化痰开窍，化湿行气，祛风利痹，消肿止痛之功效，临床上用于治疗痰蒙清窍，神志昏迷，健忘失眠，耳鸣耳聋。
黄柏：性寒，味苦，归肾经、膀胱经，具有清热燥湿、泻火除蒸、解毒疗疮之功效，临床上用于治疗湿热泻痢、黄疸、带下、热淋、骨蒸劳热、盗汗、遗精；疮疡肿毒、湿疹瘙痒。
蛇床子：性温，味辛、苦，归肾经，具有温肾壮阳、燥湿、祛风、杀虫之功效，临床上用于治疗阳痿、宫冷、寒湿带下、湿痹腰痛，外治外阴湿疹、妇人阴痒、滴虫性阴道炎。
地肤子：性寒，味甘、苦，归肾经、膀胱经，具有清利湿热、止痒之功效，临床上用于治疗皮肤瘙痒、荨麻疹、湿疹、小便不利。
白芷：味辛，性温，入肺、脾、胃经，具有解表散寒，祛风止痛，通鼻窍，燥湿止带，消肿排脓之功效，临床上用于治疗头痛，眉棱骨痛，齿痛，鼻渊，寒湿腹痛，肠风痔漏，赤白带下，痈疽疮疡，皮肤燥痒，疥癣。
马齿苋：味酸，性寒，归大肠经、肝经，具有清热解毒、凉血止血之功效，临床上用于治疗肠炎、菌痢、疔疮肿毒、蛇虫咬伤、痔疮肿痛、湿疹、丹毒、蛇虫咬伤、便血、痔血、崩漏下血急性皮炎、亚急性皮炎、带状疱疹、产后及功能性子官出血、阑尾炎、钩虫病。
甘草：味甘、性平，具有益气补中、缓急止痛、润肺止咳、泻火解毒、调和诸药之功效，临床上用于治疗倦怠食少、肌瘦面黄、心悸气短、腹痛便溏、四肢挛急疼痛、脏躁、咳嗽气喘、咽喉肿痛痈疮肿痛、小儿胎毒及药物、食物中毒。
牡丹皮：辛，性微寒，归心经、肝经、肾经，具有清热凉血，活血化瘀之功效，临床上用于治疗温毒发斑，吐血衄血，夜热早凉，无汗骨蒸，经闭痛经，痈肿疮毒，跌扑伤痛。
本发明具有积极有益的效果：
1、本发明的中药组合物均采用天然的中药原料，其配制方法简单、原料药来源广泛、成本低，无激素刺激类毒副作用，适合特应性皮炎患者长期服用。
2、本发明的中药组合物配伍符合中药“君臣佐使”原则，组方科学合理，各原料药材作用各不相同却又相辅相成，对特应性皮炎的症状缓解率高，治愈率高，复发率低。
3、本发明的中药组合物根据婴儿及儿童的皮肤结构特点，设计了用于治疗婴儿及儿童期特应性皮炎的外用配方，增加了马齿苋、牡丹皮等药物，在减少药物对婴幼儿皮肤刺激的同时，增加了疗效。
具体实施方式
下面结合实施例对本发明作更进一步的说明，但本发明的实施方式不限于此。下述实施例中所使用的实验方法如无特殊说明，均为常规方法。
实施例1
分别称取野菊花3重量份、金银花3重量份、苦参3重量份、石菖蒲3重量份、黄柏3重量份、蛇床子3重量份、地肤子3重量份、白芷3重量份、马齿苋3重量份、甘草3重量份和牡丹皮3重量份，加3倍重量的水，浸泡30分钟后，武火煎煮沸腾，再用文火煎煮50分钟，过滤，即得本发明中药组合物1。
实施例2
分别称取野菊花5重量份、金银花3重量份、苦参3重量份、石菖蒲1重量份、黄柏3重量份、蛇床子3重量份、地肤子3重量份、白芷3重量份、马齿苋3重量份、甘草3重量份和牡丹皮3重量份，加3倍重量的水，浸泡30分钟后，武火煎煮沸腾，再用文火煎煮50分钟，过滤，即得本发明中药组合物2。
实施例3
分别称取野菊花3重量份、金银花5重量份、苦参3重量份、石菖蒲1重量份、黄柏3重量份、蛇床子3重量份、地肤子3重量份、白芷3重量份、马齿苋3重量份、甘草3重量份和牡丹皮3重量份，加3倍重量的水，浸泡30分钟后，武火煎煮沸腾，再用文火煎煮50分钟，过滤，即得本发明中药组合物3。
实施例4
分别称取野菊花3重量份、金银花3重量份、苦参5重量份、石菖蒲1重量份、黄柏3重量份、蛇床子3重量份、地肤子3重量份、白芷3重量份、马齿苋3重量份、甘草3重量份和牡丹皮3重量份，加3倍重量的水，浸泡30分钟后，武火煎煮沸腾，再用文火煎煮50分钟，过滤，即得本发明中药组合物4。
对比例1(省略牡丹皮)
分别称取野菊花3重量份、金银花3重量份、苦参3重量份、石菖蒲3重量份、黄柏3重量份、蛇床子3重量份、地肤子3重量份、白芷3重量份、马齿苋6重量份和甘草3重量份，加3倍重量的水，浸泡30分钟后，武火煎煮沸腾，再用文火煎煮50分钟，过滤，即得中药组合物对比例1。
对比例2(省略马齿苋)
分别称取野菊花3重量份、金银花3重量份、苦参3重量份、石菖蒲3重量份、黄柏3重量份、蛇床子3重量份、地肤子3重量份、白芷3重量份、甘草3重量份和牡丹皮6重量份，加3倍重量的水，浸泡30分钟后，武火煎煮沸腾，再用文火煎煮50分钟，过滤，即得中药组合物对比例2。
对比例3(将牡丹皮和马齿苋替换为白鲜皮)
分别称取野菊花3重量份、金银花3重量份、苦参3重量份、石菖蒲3重量份、黄柏3重量份、蛇床子3重量份、地肤子3重量份、白芷3重量份、白鲜皮6重量份和甘草3重量份，加3倍重量的水，浸泡30分钟后，武火煎煮沸腾，再用文火煎煮50分钟，过滤，
试验例1、本发明中药组合物对特应性皮炎小鼠的治疗效果
1、试验方法
1.1、动物模型制备
在小鼠背部选取2.5cm×2.5cm面积的皮肤，涂抹0.8％Na2S溶液剔除背部毛发，配制体积比为3：1的丙酮和橄榄油的混合液，添加DNFB至其浓度为0.5％。次日于背部涂抹0.5％DNFB混合液，每日于背部剃毛区涂抹100μL，连续涂抹2d，3-6d不进行任何处理，第7天后每隔2d涂抹一次70μL 0.5％DNFB混合液，直至第28天，观察小鼠背部是否出现脱屑、红斑等情况，若出现则代表模型制备成功，最终选择造模成功小鼠共80只，另取10只未造模的小鼠作为空白对照组，共计90只进入后续试验。
1.2、试验分组及给药方法
分别取实施例1-4和对比例1-3制备的中药组合物，加热浓缩至相对密度1.20的浸膏，各中药浸膏加入蒸馏水配成200mg/ml的药液，备用。
除空白对照组以外，将制备好的模型小鼠随机分为8组，即模型组、本发明中药组合物1-4组以及中药组合物对比例1-3组，每组10只小鼠。本发明中药组合物1-4组和中药组合物对比例1-3组在模型制备后，在背部病灶处皮肤上涂抹200μL的上述中药组合物1-4和中药组合物对比例1-3，每天3次，连续涂抹3周；模型组小鼠涂抹与药液相同体积的蒸馏水，每天3次，连续3周。
1.3、观测指标与测定方法
1.3.1、小鼠背部皮损评分
参照特应性皮炎积分评定标准：末次给药结束后，根据背部出现红斑、表皮脱落、鳞屑、水肿情况分为4个等级无、轻、中、重，标记0、1、2、3分，总分为症状评分总和，评分越高表明皮肤受损程度越严重。
1.3.2、样本采集
末次给药结束后称重，记录小鼠体重，麻醉后，采用采血管进行心脏取血2mL，3000r/min离心5min，保留血清。打开腹腔，获得脾脏组织，将脂肪以及结缔组织去除后清洗干净，用滤纸包裹吸干后备用。
1.3.3、IgE水平检测
严格参照ELISA试剂盒进行，配制梯度稀释标准品溶液，加入待测样品轻柔混匀后置于37℃水浴锅中温育30min，加入IgE抗体稀释液，37℃水浴锅中孵育30min，添加亲和素过氧化物酶复合物37℃孵育30min，洗涤液清洗、甩干后，显色反应后添加终止液终止反应，在酶标仪中450nm波长下测定待测样品吸光度A值，建立标准品回归曲线，根据待测样品A值算出浓度。
1.3.4、小鼠脾脏淋巴液中Th17细胞检测
将脾脏组织剪碎后，加入淋巴细胞分离液进行研磨获得脾淋巴细胞悬液，用200目钢网过滤后进行离心，丢弃上清，加入预冷红细胞裂解液，离心后获得淋巴细胞悬液。添加CD4+抗体，4℃孵育30min，PBS清洗后添加IL-17抗体以及对照，4℃孵育30min，PBS清洗后重悬细胞，上机检测。采用Cellsquest软件分析检测结果。
2、试验结果
使用本发明中药组合物治疗特应性皮炎模型小鼠3周后，各试验组小鼠受损皮肤评分、血清中IgE水平以及脾脏淋巴液中Th17细胞含量如表1所示。
表1使用各中药组合物后受损皮肤评分、IgE水平和Th17细胞含量比较(n＝10)
| 试验组 | 受损皮肤评分 | IgE(ng/mL) | Th17细胞比例 |
| 空白对照组 | 0 | 20.32±0.76 | 6.89±0.38 |
| 模型组 | 8.8±1.8 | 123.29±13.83 | 33.22±4.37 |
| 中药组合物1组 | 2.8±0.3 | 42.87±4.38 | 9.14±0.79 |
| 中药组合物2组 | 4.0±0.5 | 59.27±5.90 | 17.45±2.07 |
| 中药组合物3组 | 4.2±0.6 | 62.15±6.71 | 18.42±1.92 |
| 中药组合物4组 | 4.4±0.8 | 65.28±6.24 | 19.52±2.24 |
| 中药对比例1组 | 6.1±1.0 | 84.92±8.12 | 24.33±2.49 |
| 中药对比例2组 | 6.2±1.1 | 88.25±7.39 | 25.91±2.28 |
| 中药对比例3组 | 6.4±0.9 | 94.23±7.90 | 27.49±2.62 |
由上表试验结果可知，与空白对照组相比，模型组小鼠受损皮肤评分显著升高，背部出现红斑、脱屑、结痂皮损表现，小鼠血清IgE水平显著升高，淋巴液中Th17细胞比例显著升高。使用本发明各中药组合物1-4组治疗3周，小鼠皮肤明显好转，结痂逐渐减少，小鼠皮肤受损皮肤评分、小鼠血清中IgE水平以及脾脏淋巴液中Th17细胞含量明显低于模型对照组和中药组合物对比例1-3组(差异具有统计学意义)，证实本发明的中药组合物对于特应性皮炎的治疗具有显著的效果。值得注意的是，中药组合物1组的治疗效果最佳，产生了预料不到的技术效果。
Claims (10)
1.一种治疗特应性皮炎的中药组合物，其特征在于，该中药组合物由以下中药制备而成：野菊花、金银花、苦参、石菖蒲、黄柏、蛇床子、地肤子、白芷、马齿苋、甘草和牡丹皮。
2.根据权利要求1所述的中药组合物，其特征在于，所述中药组合物由以下重量份的中药制备而成：野菊花1-5重量份、金银花1-5重量份、苦参1-5重量份、石菖蒲1-5重量份、黄柏1-5重量份、蛇床子1-5重量份、地肤子1-5重量份、白芷1-5重量份、马齿苋1-5重量份、甘草1-5重量份和牡丹皮1-5重量份。
3.根据权利要求2所述的中药组合物，其特征在于，所述中药组合物由以下重量份的中药制备而成：野菊花2-4重量份、金银花2-4重量份、苦参2-4重量份、石菖蒲2-4重量份、黄柏2-4重量份、蛇床子2-4重量份、地肤子2-4重量份、白芷2-4重量份、马齿苋2-4重量份、甘草2-4重量份和牡丹皮2-4重量份。
4.根据权利要求3所述的中药组合物，其特征在于，所述中药组合物由以下重量份的中药制备而成：野菊花3重量份、金银花3重量份、苦参3重量份、石菖蒲3重量份、黄柏3重量份、蛇床子3重量份、地肤子3重量份、白芷3重量份、马齿苋3重量份、甘草3重量份和牡丹皮3重量份。
5.根据权利要求1-4任一项所述的中药组合物，其特征在于，所述中药组合物为外用制剂。
6.权利要求1-5任一项所述中药组合物的制备方法，其特征在于，包括以下步骤：
将处方量的野菊花、金银花、苦参、石菖蒲、黄柏、蛇床子、地肤子、白芷、马齿苋、甘草和牡丹皮放入煎药容器内，加2-4倍重量的水，浸泡30分钟后，武火煎煮沸腾，再用文火煎煮40-60分钟，过滤，即得。
7.根据权利要求6所述的制备方法，其特征在于，所述制备方法中加入3倍重量的水。
8.根据权利要求6所述的制备方法，其特征在于，所述制备方法中文火煎煮的时间为50分钟。
9.权利要求1-5任一项所述的中药组合物在制备治疗特应性皮炎的药物中的应用。
10.权利要求1-5任一项所述的中药组合物在制备治疗湿疹的药物中的应用。
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