CN117599124A - 一种治疗荨麻疹的中药组合物 - Google Patents
一种治疗荨麻疹的中药组合物 Download PDFInfo
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Abstract
本发明涉及一种治疗荨麻疹的中药组合物，所述中药组合物由5‑30重量份生地黄，5‑30重量份白芍，5‑30重量份荆芥，5‑30重量份苦参，5‑30重量份白鲜皮、5‑30重量份蛇蜕、1‑20重量份地肤子和1‑20重量份丹参制备而成。本发明的中药组合物制备方法简单，服用方便，安全性高，能够在荨麻疹临床治疗领域发挥重要作用。
Description
技术领域
本发明涉及中药领域，具体涉及一种治疗荨麻疹的中药组合物。
背景技术
荨麻疹是由于皮肤、黏膜小血管扩张及渗透性增加而出现的一种局限性水肿反应。荨麻疹由中心肿胀、大小可变，周围反射性红斑以及瘙痒或灼烧感3个典型特征组成。急性荨麻疹大多在24小时内消失，血管性水肿的典型特征是真皮下部和皮下组织突发明显肿胀，常常伴有疼痛感而非瘙痒感，其常累及黏膜，可能需要72小时才能消退，给患者皮肤带来明显不适，症状加重可累及呼吸道、消化道，出现胸闷、气短、呼吸困难，甚至发生喉头水肿或过敏性休克，如不及时救治有生命危险。
荨麻疹患者人群广，人数多，终生患病率达22％，时点患病率为1％。目前研究表明，约20％慢性自发性荨麻疹患者在3年才能消退，20％患者需要5-10年，但2％的患者甚至需要25年才能消退。该病病因复杂，多数患者病因不明，常见有食物或药物过敏、蚊虫叮咬、遗传因素、外界刺激、精神因素和内分泌改变等，病程长、反复发作，西医治疗常使用抗组胺药，治疗效果欠理想，服药时症状控制，停药后皮疹复发，临床治疗难度大，严重影响患者生活质量。
荨麻疹属于中医“瘾疹”范畴，荨麻疹是禀赋不耐，气血失和，外邪引动，卫气失固所致。内、外因交互亦可发为本病，内因多责之禀赋不足，气血虚弱，营卫失固；外因责之虚邪贼风外袭，或饮食不当，如食用鱼虾、辛辣、膏粱厚味等化热动风，或因七情变化等而导致内热生风。标象明显时则发病快，来势急骤；本虚突出时，则反复发作，缠绵难愈。
目前有效治疗荨麻疹的中药组方报道较少，因此从中药领域进一步发掘应用于治疗荨麻疹，且副作用低的药物已成为亟待解决的技术问题。
发明内容
为解决上述技术问题，本发明包括以下几个方面：
本发明的第一方面提供一种治疗荨麻疹的中药组合物，所述中药组合物由生地黄、白芍、荆芥、苦参、白鲜皮、蛇蜕、地肤子和丹参制备而成。
优选的，所述中药组合物由5-30重量份生地黄，5-30重量份白芍，5-30重量份荆芥，5-30重量份苦参，5-30重量份白鲜皮、5-30重量份蛇蜕、1-20重量份地肤子和1-20重量份丹参制备而成。
更优选的，所述中药组合物由5-15重量份生地黄，5-15重量份白芍，5-15重量份荆芥，5-15重量份苦参，5-15重量份白鲜皮、5-15重量份蛇蜕、1-10重量份地肤子和1-10重量份丹参制备而成。
进一步优选的，所述中药组合物由10重量份生地黄，10重量份白芍，10重量份荆芥，10重量份苦参，10重量份白鲜皮、10重量份蛇蜕、5重量份地肤子和5重量份丹参制备而成。
优选的，所述中药组合物进一步包括药学上可接受的辅料。
优选的，所述中药组合物为口服制剂。
优选的，所述中药组合物的剂型为汤剂、片剂、颗粒剂、胶囊剂。
更优选的，所述中药组合物的剂型为汤剂。
优选的，所述中药组合物的制备方法包括如下步骤：取处方量的生地黄、白芍、荆芥、苦参、白鲜皮、蛇蜕、地肤子和丹参，加入中药材总重量3-6倍的蒸馏水，浸泡0.5-1小时后大火煎煮至沸腾后，转小火煎煮，过滤药渣，取滤液加热浓缩至重量与最初加入的中药材总重量相同，即得。
优选的，所述制备方法中加入中药材总重量5倍的蒸馏水。
优选的，所述制备方法中浸泡中药材的时间为0.5小时。
优选的，所述制备方法中小火煎煮药材的时间为1小时。
本发明的第二方面提供一种上述中药组合物的制备方法，包含以下步骤：取处方量的生地黄、白芍、荆芥、苦参、白鲜皮、蛇蜕、地肤子和丹参，加入中药材总重量3-6倍的蒸馏水，浸泡0.5-1小时后大火煎煮至沸腾后，转小火煎煮，过滤药渣，取滤液加热浓缩至重量与最初加入的中药材总重量相同，即得。
优选的，所述制备方法中加入中药材总重量5倍的蒸馏水。
优选的，所述制备方法中浸泡中药材的时间为0.5小时。
优选的，所述制备方法中小火煎煮药材的时间为1小时。
本发明的第三方面提供上述中药组合物在制备治疗荨麻疹的药物中的应用。
优选的，所述荨麻疹为慢性荨麻疹或急性荨麻疹。
本发明的第四方面提供上述中药组合物在制备降低血清中组胺、IL-4含量和/或TNF-α含量的药物中的应用。
优选的，本发明提供上述中药组合物在制备同时降低血清中组胺、IL-4含量和TNF-α含量的药物中的应用。
本发明选用的中药原料在本领域的常见药理功效如下：
生地黄：性寒，味甘，归心经、肝经、肾经。生地黄清热凉血、养阴、生津，临床用于治热病舌绛烦渴、阴虚内热、骨蒸劳热、内热消渴、吐血衄血、发斑发疹。
白芍：性微寒，味苦、酸，归肝经、脾经，平肝止痛、养血调经、敛阴止汗。白芍有解痉、抗炎、抗菌、保肝、抗心肌缺血等功效。
荆芥：性辛，温，归肺、肝经。荆芥解表散风，透疹消疮，用于感冒、头痛、麻疹、风疹、疮疡初起。
苦参：味苦，性寒，归心、肝、胃、大肠、膀胱经。苦参有清热燥湿，杀虫，利尿之功，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、滴虫性阴道炎。
白鲜皮：性寒，味苦，归脾经、胃经。白鲜皮清热燥湿、祛风解毒，用于治疗湿热疮毒、黄水疮、湿疹、风疹、疥癣、疮癞、风湿痹、黄疸尿赤等症。
蛇蜕：为游蛇科动物黑眉锦蛇、锦蛇或乌梢蛇等蜕下的干燥表皮膜，味咸、甘，性平，归肝经。蛇蜕祛风定惊、退翳解毒，用于小儿惊风，抽搐痉挛，翳障，喉痹，疔肿，皮肤瘙痒。
地肤子：性寒，味甘、苦，归肾经、膀胱经。地肤子清利湿热、止痒，用于治疗皮肤瘙痒、荨麻疹、湿疹、小便不利。
丹参：苦，微寒，归心经、肝经。丹参祛瘀止痛，活血通经，清心除烦。用于治疗月经不调、经闭痛经、瘢癥积聚、胸腹刺痛、热痹疼痛、疮疡肿痛、心烦不眠、肝脾肿大、心绞痛。
本发明具有积极有益的效果：
1、本发明的中药组合物配伍合理，发明人通过优化中药的组分及含量配比，优选出了具有显著治疗荨麻疹，特别是慢性荨麻疹的中药组方。
2、本发明的中药组合物制备方法简单，服用方便，安全性高，能够在荨麻疹临床治疗领域发挥重要作用。
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
取生地黄10g、白芍10g、荆芥10g、苦参10g、白鲜皮10g、蛇蜕10g、地肤子5g和丹参5g，加入中药材总重量5倍的蒸馏水，浸泡0.5小时后大火煎煮至沸腾后，转小火煎煮1小时，过滤药渣，取滤液加热浓缩至70g，即得本发明的中药汤剂1。
实施例2
取生地黄5g、白芍5g、荆芥10g、苦参10g、白鲜皮10g、蛇蜕10g、地肤子10g和丹参10g，加入中药材总重量5倍的蒸馏水，浸泡0.5小时后大火煎煮至沸腾后，转小火煎煮1小时，过滤药渣，取滤液加热浓缩至70g，即得本发明的中药汤剂2。
实施例3
取生地黄10g、白芍10g、荆芥5g、苦参5g、白鲜皮10g、蛇蜕10g、地肤子10g和丹参10g，加入中药材总重量5倍的蒸馏水，浸泡0.5小时后大火煎煮至沸腾后，转小火煎煮1小时，过滤药渣，取滤液加热浓缩至70g，即得本发明的中药汤剂3。
实施例4
取生地黄10g、白芍10g、荆芥10g、苦参10g、白鲜皮5g、蛇蜕5g、地肤子10g和丹参10g，加入中药材总重量5倍的蒸馏水，浸泡0.5小时后大火煎煮至沸腾后，转小火煎煮1小时，过滤药渣，取滤液加热浓缩至70g，即得本发明的中药汤剂4。
对比例1(蛇蜕替换成蝉蜕)
取生地黄10g、白芍10g、荆芥10g、苦参10g、白鲜皮10g、蝉蜕10g、地肤子5g和丹参5g，加入中药材总重量5倍的蒸馏水，浸泡0.5小时后大火煎煮至沸腾后，转小火煎煮1小时，过滤药渣，取滤液加热浓缩至70g，即得中药汤剂对比例1。
对比例2(白芍替换成当归)
取生地黄10g、当归10g、荆芥10g、苦参10g、白鲜皮10g、蛇蜕10g、地肤子5g和丹参5g，加入中药材总重量5倍的蒸馏水，浸泡0.5小时后大火煎煮至沸腾后，转小火煎煮1小时，过滤药渣，取滤液加热浓缩至70g，即得中药汤剂对比例2。
试验例1、本发明中药组合物对荨麻疹模型大鼠血清中组胺、IL-4和TNF-α含量的影响
1、试验方法
将80只大鼠随机分为空白组、模型组、本发明实施例1-4组以及对比例1-2组，每组10只。将卵清蛋白用生理盐水配成浓度为20mg/L的溶液，取该溶液1mg、Al(OH)310mg和1ml生理盐水混匀，制成混悬液，模型组和药物组(本发明实施例1-4组以及对比例1-2组)大鼠均予腹腔注射上述混悬液，空白组注射等量生理盐水。初次致敏10天后，选取距脊柱1.5cm范围内背中线两侧剃毛，用记号笔在该区域拟注射部位做标记。在模型组和药物组记点处皮内对称注射20mg/L的卵蛋白血清溶液0.1ml/点，诱发荨麻疹皮肤症状，创建荨麻疹Ⅰ型变态反应大鼠模型，空白组注射等量生理盐水。
首次致敏后的第7天，本发明实施例1-4组和对比例1-2组大鼠均按照2g汤剂/kg体重的剂量灌胃给予本发明实施例1-4和对比例1-2制备的汤剂，每天1次，模型组和空白组每天1次灌胃等量的生理盐水。连续给药10天后，于末次给药12小时后将所有大鼠断头处死，眼眶取血，血液以每分钟2000转进行离心，得上层清液，制得血清。
采用ELISA法测得各试验组大鼠血清中组胺和TNF-α的含量，采用放射免疫分析法测定IL-4含量，上述测定均严格按照试剂盒说明书步骤操作(组胺试剂盒购自南京建成生物工程研究所，IL-4试剂盒购自上海恒远生物科技有限公司，TNF-α蛋白ELISA试剂盒购自美国R&D公司)。
2、试验结果
荨麻疹模型大鼠给予本发明中药后血清中组胺、IL-4和TNF-α含量如下表1所示。
表1各试验组大鼠血清组胺、IL-4和TNF-α含量比较
| 试验组 | 组胺(ng/mL) | IL-4(ng/mL) | TNF-α(pg/mL) |
| 空白组 | 30.38±3.21 | 10.47±2.85 | 3.14±0.53 |
| 模型组 | 93.49±4.25 | 34.29±3.71 | 6.28±0.89 |
| 实施例1组 | 38.61±3.67 | 13.44±2.96 | 3.59±0.62 |
| 实施例2组 | 56.42±4.18 | 19.62±3.04 | 4.61±0.69 |
| 实施例3组 | 60.02±4.25 | 21.73±3.25 | 4.85±0.71 |
| 实施例4组 | 62.56±3.74 | 23.55±3.57 | 4.98±0.75 |
| 对比例1组 | 74.24±4.05 | 30.25±4.18 | 5.41±0.77 |
| 对比例2组 | 72.37±3.77 | 29.58±4.09 | 5.26±0.82 |
由上表1可知，与空白组比较，模型组大鼠血清组胺、IL-4和TNF-α含量明显上升(差异均具有统计学意义)。与模型组和对比例1-2组相比，本发明实施例1-4组大鼠血清组胺、IL-4和TNF-α含量均明显降低(差异均具有统计学意义)。令人意外的是，本发明实施例1的中药汤剂降低血清中组胺、IL-4和TNF-α含量的幅度最高，产生了难以预期的优异效果。上述试验结果表明，本发明的中药组合物具有显著治疗荨麻疹的作用。
虽然已经对本发明的具体实施方案进行了描述，但是本领域技术人员应认识到，在不偏离本发明的范围或精神的前提下可以对本发明进行多种改变与修饰。因而，本发明意欲涵盖落在附属权利要求书及其同等物范围内的所有这些改变与修饰。
Claims (10)
1.一种治疗荨麻疹的中药组合物，其特征在于，所述中药组合物由生地黄、白芍、荆芥、苦参、白鲜皮、蛇蜕、地肤子和丹参制备而成。
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5-30重量份生地黄，5-30重量份白芍，5-30重量份荆芥，5-30重量份苦参，5-30重量份白鲜皮、5-30重量份蛇蜕、1-20重量份地肤子和1-20重量份丹参制备而成。
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5-15重量份生地黄，5-15重量份白芍，5-15重量份荆芥，5-15重量份苦参，5-15重量份白鲜皮、5-15重量份蛇蜕、1-10重量份地肤子和1-10重量份丹参制备而成。
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10重量份生地黄，10重量份白芍，10重量份荆芥，10重量份苦参，10重量份白鲜皮、10重量份蛇蜕、5重量份地肤子和5重量份丹参制备而成。
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，所述中药组合物进一步包括药学上可接受的辅料。
6.根据权利要求1-4任一项所述的中药组合物，其特征在于，所述中药组合物为口服制剂。
7.根据权利要求1-4任一项所述的中药组合物，其特征在于，所述中药组合物的剂型为汤剂、片剂、颗粒剂、胶囊剂。
8.权利要求1-4任一项所述中药组合物的制备方法，其特征在于，所述制备方法包含以下步骤：取处方量的生地黄、白芍、荆芥、苦参、白鲜皮、蛇蜕、地肤子和丹参，加入中药材总重量3-6倍的蒸馏水，浸泡0.5-1小时后大火煎煮至沸腾后，转小火煎煮，过滤药渣，取滤液加热浓缩至重量与最初加入的中药材总重量相同，即得。
9.权利要求1-7任一项所述中药组合物在制备治疗荨麻疹的药物中的应用。
10.权利要求1-7任一项所述中药组合物在制备降低血清中组胺、IL-4含量和/或TNF-α含量的药物中的应用。
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