CN111228367A - 一种治疗小儿过敏性紫癜的中药外用洗剂及其制备方法 - Google Patents
一种治疗小儿过敏性紫癜的中药外用洗剂及其制备方法 Download PDFInfo
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Abstract
一种治疗小儿过敏性紫癜的中药外用洗剂，其原料组成及重量份比为：大青叶4‐8、蝉蜕1‐5、鸡矢藤4‐8、牡丹皮4‐8、苦参3‐5、黄芪4‐8、薄荷1‐5，制备时，先将所有原料按所需比例混合，加水煎煮得到煎液，再将煎液兑入温水即可。本方不仅对小儿过敏性紫癜后期疗效显著，而且原料组成简单、无副作用。
Description
技术领域
本发明属于中医药领域，具体涉及一种治疗小儿过敏性紫癜的中药外用洗剂及其制备方法，适用于风热伤络、湿热伤络、血热伤络、脾不统血证型。
背景技术
过敏紫癜(HSP)又称亨-舒综合征，是儿童期最常见的血管炎，主要以小血管炎 为病理改变的全身综合征。该病是儿童免疫性疾病中最常见的类型之一，临床主要表 现为非血小板减少性可触性皮肤紫癜，常伴或不伴腹痛、关节肿痛、便血、尿血和(或) 蛋白尿等症状。该病发病率逐年增高，且儿童高于成人。过敏性紫癜可发生于任何年 龄，但90％发生于小于10岁的儿童，平均年龄6岁，多见于2～6岁。该病好发于秋 冬季。过敏性紫癜治疗的关键在于控制患儿急性症状及影响预后的因素，西医治疗原 则短期主要在于缓解消化道、关节症状，长期在于预防及治疗肾脏损害，总体措施为 支持、对症、免疫抑制及血液净化等[易著文.小儿过敏性紫癜的诊断与治疗[J].中国 实用儿科杂志，2009，24(11):827-830.]。但西医对于减轻皮疹，预防紫癜反复发作 尚无有效的方案。有研究证明，皮疹反复发作是引起肾损害的一个重要原因。
目前，治疗小儿过敏性紫癜的中药制剂多采用口服剂型，该类剂型存在患儿服药困难的问题，对此，外用洗剂开始研制使用，如中国专利：申请公布号CN104873800A、 申请公布日2015年9月2日的发明专利公开了一种治疗小儿皮肤型过敏性紫癜的外 洗药，其原料包括：净紫草、血余炭、炙元胡、青黛、鸡血藤、丹参、白鲜皮、茯苓 皮、冬瓜皮、地肤子、地骨皮、醋乳香、赤芍忍冬藤、蛇床子、苦参。虽然该配方用 于皮肤型过敏性紫癜引起的皮肤斑疹、关节肿痛、肌肉胀痛，可达到治标治本的目的， 但仍然存在以下缺陷：
1、该方的原料组成复杂，成本较高；
2、该方主要用于小儿过敏性紫癜早期的治疗，对于病情后期无明显疗效。
发明内容
本发明的目的是针对现有技术存在的原料组成复杂、对小儿过敏性紫癜后期无明显疗效的问题，提供一种原料组成简单、且对对小儿过敏性紫癜后期疗效显著的治疗 小儿过敏性紫癜的中药外用洗剂及其制备方法。
为实现以上目的，本发明提供了以下技术方案：
一种治疗小儿过敏性紫癜的中药外用洗剂，其原料组成及重量份比为：大青叶4 -8、蝉蜕1-5、鸡矢藤4-8、牡丹皮4-8、苦参3-5、黄芪4-8、薄荷1-5。
所述中药外用洗剂的组成及其重量份比为：大青叶6、蝉蜕3、鸡矢藤6、牡丹皮 6、苦参4、黄芪6、薄荷3。
一种治疗小儿过敏性紫癜的中药外用洗剂的制备方法，具体为：先将所有原料按所需比例混合，加水煎煮得到煎液，再将煎液兑入温水即可。
所述水的添加体积为所有原料重量之和的10-12倍，所述煎液与水的体积比为 1:(2-4)，所述煎液与温水的体积比为(1-2):(7.5-10)。
与现有技术相比，本发明的有益效果为：
发明的一种治疗小儿过敏性紫癜的中药外用洗剂的原料组成及其重量份比为：大青叶4-8、蝉蜕1-5、鸡矢藤4-8、牡丹皮4-8、苦参3-5、黄芪4-8、薄荷1 -5，方中大青叶具有清热凉血活血解毒，清营血之邪，蝉蜕祛风解表透疹的功效， 共为君药，牡丹皮清热凉血消瘀血，薄荷疏散风热，透疹解表，二药合之，共清卫分、 血分之邪，共为臣药，苦参清热燥湿止痒，鸡矢藤祛风除湿共清湿热之邪，黄芪扶正 固本，防正虚邪清，共为佐药，薄荷辛凉芳香开窍，促进皮肤药物的吸收，为使药， 全方的原料组成简单，与西药对症治疗，适用于小儿过敏性紫癜风热伤络、血热伤络、 湿热伤络证型，具有祛风清热、凉血透疹的功效，黄芪、鸡矢藤等在后期兼以补虚， 不仅能明显改善皮疹的反复发作，并缩短病程，减少并发症，而且无副作用，患儿依 从性好。因此，本发明不仅对小儿过敏性紫癜后期疗效显著，而且原料组成简单、无 副作用。
具体实施方式
下面结合实施例进一步说明本发明的实质性内容。
一种治疗小儿过敏性紫癜的中药外用洗剂，其原料组成及重量份比为：大青叶4 -8、蝉蜕1-5、鸡矢藤4-8、牡丹皮4-8、苦参3-5、黄芪4-8、薄荷1-5。
所述中药外用洗剂的组成及其重量份比为：大青叶6、蝉蜕3、鸡矢藤6、牡丹皮 6、苦参4、黄芪6、薄荷3。
一种治疗小儿过敏性紫癜的中药外用洗剂的制备方法，具体为：先将所有原料按所需比例混合，加水煎煮得到煎液，再将煎液兑入温水即可。
所述水的添加体积为所有原料重量之和的10-12倍，所述煎液与水的体积比为 1:(2-4)，所述煎液与温水的体积比为(1-2):(7.5-10)。
本发明的原理说明如下：
小儿过敏性紫癜早期多“责之于热、出之于风、风火致瘀”。患儿或因外感风邪, 蕴郁肌腠，从于火化；或素有伏火，受异气相激，炎上生风。风火相煽于脉络，迫 血妄行，溢于脉外，渗于皮下，发为紫癜，而离经之血皆为瘀血。故早期治疗强调治 风、治热、治瘀，其中清热泻火尤为关键，而病情后期则以虚为主。因此，本发明在 西医对症治疗过敏性紫癜的基础上给予疏风清热，凉血化瘀中药治疗，后期兼以补虚， 能明显改善皮疹反复发作。
实施例1：
一种治疗小儿过敏性紫癜的中药外用洗剂，其原料组成及重量份数为：大青叶4、蝉蜕1、鸡矢藤4、牡丹皮4、苦参3、黄芪4、薄荷1。
上述中药外用洗剂的制备方法为：先将所有原料按所需比例混合，加入230ml水煎煮得到煎液100ml，再将煎液兑入800ml温水即可。
实施例2：
与实施例1的不同之处在于：
所述中药外用洗剂的组成及其重量份比为：大青叶6、蝉蜕3、鸡矢藤6、牡丹皮 6、苦参4、黄芪6、薄荷3。
所述制备方法中，水的添加体积为所有原料重量之和的12倍，煎液与水的体积 比为1:3，所述煎液与温水的体积比为1:5。
实施例3：
与实施例1的不同之处在于：
所述中药外用洗剂的原料组成及重量份比为：大青叶8、蝉蜕5、鸡矢藤8、牡丹 皮8、苦参5、黄芪8、薄荷5。；
所述制备方法中，水的添加体积为所有原料重量之和的10倍，煎液与水的体积 比为1:2，所述煎液与温水的体积比为1.5:9。
实施例4：
与实施例1的不同之处在于：
所述中药外用洗剂的原料组成及重量份比为：大青叶5、蝉蜕2、鸡矢藤5、牡丹 皮5、苦参4、黄芪5、薄荷2。
所述制备方法中，水的添加体积为所有原料重量之和的10倍，煎液与水的体积 比为1:4，所述煎液与温水的体积比为1:10。
以下通过临床试验或具体药效学试验证明本发明的有益效果。
资料与方法
1.一般资料
病例来源：本研究病历来自湖北省中医院就诊的过敏性紫癜儿童，共60例。随 机分成对照组30例，治疗组30例。
上述病例大纳入标准为(符合以下所有条件)：
2岁≤年龄≤16岁；
符合过敏性紫癜诊断标准；
首诊时有皮疹；
尿检无异常(包含尿蛋白、尿红细胞、尿微量蛋白)；
皮疹反复发作(皮疹发作次数大于2次)；
排除标准(符合以下任何1条，需排除)：
年龄＜2岁或年龄＞16岁；
初诊时已无皮疹者；
出现腹痛及关节疼痛；
尿检异常(尿蛋白、尿红细胞或尿微量蛋白出现异常者)；
合并有心、脑血管、肝、内分泌系统、造血系统、精神方面或严重的胃肠道疾病， 需行外科手术等疾病；
因患儿退出或失访而脱落者；
观察过程中，患儿继发严重感染或发生其他疾病，影响疗效和安全性判断者；
有严重合并症的HSP患者(如中枢神经系统症状)。
2.治疗方法
饮食生活注意：予常规治疗包括隔离过敏源(花粉、蛋类、奶类、海鲜、粉尘)， 饮食清淡，以高营养、易消化食物为主，禁食生冷油腻及海鲜、虾蟹等水产品，着棉 质衣物，避免接触化纤等材质衣物。
对照组：(1)一般治疗：对症治疗，西药常规治疗(芦丁片、双密达莫片)；(2) 使用青衣洗剂。
治疗组：(1)一般治疗：对症治疗，西药常规治疗(芦丁片、双密达莫片)。
观察指标：观察2周内皮疹的发作情况
3.诊断标准
参考国家中医药管理局发布的《中医病证诊断疗效标准》[21]中HSP部分拟定：
临床治愈:皮肤紫癜消退或基本消退；
好转:皮肤紫癜部分消退70％以上；
有效:皮肤紫癜减少30％，或有部分新发紫癜；
无效:皮肤紫癜及其它临床症状无减少。
4.统计学处理数据
采用SPSS22.0软件包统计，计数资料用卡方检验，疗效指标用采用t检验统计 学方法处理。P＜0.05为差异有显著性意义；P＞0.05为无显著性差异。
5.治疗结果
两组病例总疗效比较(见表1)
表1两组临床疗效比较
通过上表能够看出，两组疗效比较存在显著性差异(P＜0.05)，且治疗组的疗效明显优于对照组。因此，本发明所述外用洗剂配合西药治疗小儿过敏性紫癜可以显著 提高皮疹的治愈率且能改善皮疹反复发作。
两组均未见不良反应。
典型病例
熊某，男，14岁，主因“反复皮疹2月余”就诊；患儿2月前无明显诱因出现双 下肢皮疹，无腹痛及关节疼痛，于当地人民医院诊断为“过敏性紫癜”，于抗过敏、 抗血小板聚集药物治疗后，皮疹消褪，出院后皮疹反复发作3次，遂来我院就诊。刻 下症：双下肢皮疹，伴皮肤瘙痒，二便可，食欲可，寐安；查体：一般可，双下肢可 见绿豆大小，密集分布的皮疹，呈对称性分布，高出皮面，压之不褪色，咽红，扁桃 体Ⅱ°肿大，舌红苔薄白，脉滑数。诊断:过敏性紫癜。
处理：1.饮食生活指导；2.青衣洗剂7付，足浴兼洗浴患处，日1次；3.芦丁片1#qdpo。
二诊：使用实施例2所述外用洗剂，皮疹2天后消褪，后无皮疹，无身痒，大便 日一次，不成型。查体：双下肢可见少于陈旧性皮疹，咽稍红，扁桃体Ⅰ°，舌稍红， 苔薄白，脉小滑；
处理：1.饮食生活指导；2.青衣洗剂继用7付；3；芦丁片继用；
三诊：家长诉近一周无皮疹发作，无其他不适。
处理：1.饮食生活指导；2.芦丁继用；3.不适随诊。
Claims (4)
1.一种治疗小儿过敏性紫癜的中药外用洗剂，其特征在于：
所述中药外用洗剂的原料组成及其重量份比为：大青叶4-8、蝉蜕1-5、鸡矢藤4-8、牡丹皮4-8、苦参3-5、黄芪4-8、薄荷1-5。
2.根据权利要求1所述的一种治疗小儿过敏性紫癜的中药外用洗剂，其特征在于：
所述中药外用洗剂的组成及其重量份比为：大青叶6、蝉蜕3、鸡矢藤6、牡丹皮6、苦参4、黄芪6、薄荷3。
3.一种权利要求1所述的治疗小儿过敏性紫癜的中药外用洗剂的制备方法，其特征在于：
所述制备方法为：先将所有原料按所需比例混合，加水煎煮得到煎液，再将煎液兑入温水即可。
4.根据权利要求3所述的一种治疗小儿过敏性紫癜的中药外用洗剂的制备方法，其特征在于：所述水的添加体积为所有原料重量之和的10-12倍，所述煎液与水的体积比为1:(2-4)，所述煎液与温水的体积比为(1-2):(7.5-10)。
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