CN105596662A - 一种治疗小儿湿疹的中药及其制备方法 - Google Patents
一种治疗小儿湿疹的中药及其制备方法 Download PDFInfo
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Abstract
本发明涉及一种治疗小儿湿疹的中药及其制备方法,所述中药中的原料药按重量配比为:土茯苓40-70份、地榆40-70份、苦参20-40份、桑白皮20-30份、地肤子10-20份、白鲜皮10-20份、浮萍5-15份、紫草5-15份、当归5-15份。制备方法为:按重量份称取各中药原料药材,将称取的药材切碎;将切碎后的药材用水煎煮两次,每次2-4h,合并煎煮液,滤过,加热浓缩,浓缩液灭菌,即得。本发明根据传统中医理论选用天然中药材为原料,未添加对皮肤有刺激的成分,治疗小儿湿疹具有疗效确切、无副作用,治愈后不复发等特点。
Description
技术领域
本发明属于医药技术领域,具体涉及一种小儿湿疹的中药及其制备方法。
技术背景
小儿湿疹是儿科常见的疾病,好发于头面、耳部、四肢及皮肤皱褶处,也可累及全身。其临床特点为皮肤瘙痒,多形性损害,对称性分布,浆液渗出,容易演变成慢性湿疹。现代医学认为本病是一种变态反应性皮肤病,主要由于对食物、颜色等的过敏作用,又因为婴儿的皮肤较薄,毛细血管网丰富而且内皮含水及氯化物比较多,对各种刺激因素较敏感。目前,关于小儿湿疹的制剂虽然很多,但仍缺乏有效药物,多采用肾上腺皮质激素类药物,但停药易复发,且累治累发,皮损面积不断扩大,婴幼儿皮肤薄,皮肤吸收能力较强,大面积长期使用激素类药物易导致激素副作用,关于中药治疗湿疹的方剂也有不少,但是达到理想效果却不多。
祖国医学对湿疹的认识由来已久,本病属于中医“浸淫疮”、“湿疮”、“绣球风”、“旋耳疮”等范畴。中医认为湿疹的主要病因为内有湿热,外受风邪入侵,充于腠理而致发病,热气郁于皮肤则作痒。在湿疹的治疗上,由于中药内服,小儿依从性较差,因此本发明特提供了一种通过外用治疗小儿湿疹的中药,本发明中药相对于上文所列的治疗湿疹的中药具有疗效确切、无副作用,治愈后不复发等特点。
发明内容
本发明的目的是提供一种治疗小儿湿疹的药物及其制备方法,为我科自拟复方(肖和印经验方),采用纯中药配方,具有清热化湿、祛风止痒功效,多年来取得良好疗效,用于治疗小儿湿疹疗效确切、无副作用,治愈后不复发。
本发明的目的通过以下技术方案实现。
一种治疗小儿湿疹的中药,其特征在于,该中药中的原料药按重量配比为:土茯苓40-70份、地榆40-70份、苦参20-40份、桑白皮20-30份、地肤子10-20份、白鲜皮10-20份、浮萍5-15份、紫草5-15份、当归5-15份。
所述治疗小儿湿疹的中药,优选:土茯苓50-60份、地榆50-60份、苦参30-40份、桑白皮20-25份、地肤子10-15份、白鲜皮10-15份、浮萍5-10份、紫草5-10份、当归5-10份。
所述治疗小儿湿疹的中药,更优选:土茯苓40份、地榆40份、苦参30份、桑白皮20份、地肤子10份、白鲜皮10份、浮萍5份、紫草5份、当归5份。
或:土茯苓50份、地榆50份、苦参30份、桑白皮20份、地肤子15份、白鲜皮15份、浮萍10份、紫草10份、当归10份。
上述的治疗小儿湿疹的中药的制备方法,包括如下步骤:
1)按上述重量份称取土茯苓、地榆、苦参、桑白皮、地肤子、白鲜皮、浮萍、紫草、当归,将称取的药材切碎;
2)将切碎后的药材用水煎煮两次,每次2-4h,合并煎煮液,滤过,加热浓缩,得浓缩液;
3)将步骤2)的浓缩液灭菌,即得本发明的治疗小儿湿疹的中药。
在步骤3)之后还可进行如下操作,使得药物中的有效成分更加富集:将灭菌后的浓缩液加到D101大孔吸附树脂柱上,50%乙醇洗脱,收集5倍量柱体积洗脱液,减压回收乙醇至无醇味,滤过,得药物提取液,加热浓缩,得浓缩液;将浓缩液再次灭菌,即得。
本发明的治疗小儿湿疹的中药,由土茯苓、地榆、苦参、地肤子、白藓皮、桑白皮、浮萍制成。方中土茯苓和地榆为君药,臣以苦参、桑白皮、地肤子、白鲜皮,佐以浮萍、紫草、当归。药味精炼,疗效确切。土茯苓清热解毒利湿,地榆凉血止血收敛,发明人通过数十年临床病例的检验得出,本组方重用土茯苓和地榆组配而成的配方疗效能够达到最佳,方中大量使用的土茯苓和地榆发挥了清除流滋、渗液的重要作用;苦参清热解毒祛风,止痒;地肤子清热利湿,祛风止痒。白藓皮清热解毒祛湿,桑白皮清热祛风除湿,利水消肿,有修复受损组织细胞,淡化疤痕之功效;浮萍性轻浮,清燥,味辛而气清寒,入肺经,达皮肤,故上宣肺气,外达皮毛,发汗泄热,下通水道,能散皮肤之湿热。诸药合用清热化湿、祛风止痒、祛除湿疹而不留瘀痕。
本发明的治疗小儿湿疹的中药运用中药外用治疗婴幼儿湿疹患儿依从性好,疗效显著,避免长期使用西药激素引起局部毛细血管扩张、皮肤色素沉着等副作用;另中药制剂价格适中,使用后复发率较低,安全性高,在一定程度上可以减少患儿家长治疗费用。
具体实施例
实施例1
1)取土茯苓50g、地榆50g、苦参30g、桑白皮20g、地肤子15g、白鲜皮15g、浮萍10g、紫草10g、当归10g切碎;
2)将切碎后的药材用水煎煮两次,每次3h,合并煎煮液,滤过,加热浓缩,得浓缩液;
3)将步骤2)的浓缩液灭菌,即得本发明的治疗小儿湿疹的中药。
实施例2
1)取土茯苓50g、地榆50g、苦参30g、桑白皮20g、地肤子15g、白鲜皮15g、浮萍10g、紫草10g、当归10g切碎;
2)将切碎后的药材用水煎煮两次,每次3h,合并煎煮液,滤过,加热浓缩,得浓缩液;
3)将步骤2)的浓缩液灭菌;
4)将灭菌后的浓缩液加到D101大孔吸附树脂柱上,50%乙醇洗脱,收集5倍量柱体积洗脱液,减压回收乙醇至无醇味,滤过,得药物提取液,加热浓缩,得浓缩液;将浓缩液灭菌,即得。
实施例3
1)取土茯苓40g、地榆40g、苦参30g、桑白皮20g、地肤子10g、白鲜皮10g、浮萍5g、紫草5g、当归5g切碎;
2)将切碎后的药材用水煎煮两次,每次3h,合并煎煮液,滤过,加热浓缩,得浓缩液;
3)将步骤2)的浓缩液灭菌,即得本发明的治疗小儿湿疹的中药。
实施例4
1)取土茯苓40g、地榆40g、苦参30g、桑白皮20g、地肤子10g、白鲜皮10g、浮萍5g、紫草5g、当归5g切碎;
2)将切碎后的药材用水煎煮两次,每次3h,合并煎煮液,滤过,加热浓缩,得浓缩液;
3)将步骤2)的浓缩液灭菌;
4)将灭菌后的浓缩液加到D101大孔吸附树脂柱上,50%乙醇洗脱,收集5倍量柱体积洗脱液,减压回收乙醇至无醇味,滤过,得药物提取液,加热浓缩,得浓缩液;将浓缩液灭菌,即得。
本发明所述治疗小儿湿疹的中药的临床观察:
1、诊断及分型标准:
①西医诊断标准:参照赵辨《临床皮肤病学》第三版中急性湿疹的诊断标准;
皮疹为多数密集的粟粒大的小丘疹、丘疤疹或小水疤,基底潮红。由于搔抓,丘疹、丘疤疹或水疤顶端搔破后呈明显点状渗出及小糜烂面,浆液不断渗出,病变中心往往较重,而逐渐向周围蔓延,外围又有散在丘疹、丘疤疹,故境界不清。当合并有感染时,则炎症可更明显,并形成脓疤,脓液渗出或结黄绿色或污褐色痴。还可合并毛囊炎、疖、局部淋巴结炎等。
②中医辨证分型标准:(诊断和辨证分型是根据1994年国家中医药管理局发布的《中医病证诊断疗效标准》制定)
主症:发病急,皮损潮红灼热,瘙痒无休,渗液流汁。
兼症:伴身热、心烦口渴,大便干,尿短赤。
舌脉:舌质红,苔薄白或黄,脉滑或数。
(具备主症+次症2项,参考舌脉,即可辨证)
2、纳入标准:
①符合小儿急性湿疹诊断和湿疮湿热浸淫型辨证标准;②患儿为婴幼儿,年龄≧2个月≦3岁;③皮损受累面积一般选择为体表面积的5%-10%以内,最大皮损列为靶皮损,靶皮损面积及位置一般确定在直径2-10cm。
3、观察指标
建立统一的临床观察病历,观察并记录皮损形态、面积、瘙痒,进行症状分级评分。
(1)湿疹面积及严重指数评分标准
记分标准:无-0分轻度-1分中度-2分重度-3分,可记半级分,即0.5分。
a、皮损形态评分:
红斑:
轻度隐约可见,颜色微红;
中度比较明显,颜色淡红;
重度比较明显,颜色暗红。
丘疹:
轻度丘疹散在;
中度丘疹比较密集或相互融合;
重度丘疹非常密集,融合明显。
鳞屑、抓痕:
轻度较少细小鳞屑、抓痕;
中度明显白色细薄鳞屑、抓痕;
重度较多鳞屑、抓痕。
浸润、肥厚、苔藓化:
轻度略有浸润、肥厚及苔藓化不明显;
中度皮损较肥厚,轻度苔藓化;
重度皮损明显浸润、肥厚、苔藓化,触之较硬。
b、皮疹面积评分
使用烧伤手掌测量面积法,即患者五指并拢时,单手掌面积占体表面积1%,每一个手掌面积为一个记分单位,不足一个手掌面积按照半个记分单位计算。
面积评分标准
皮损面积(1%) | 计分 |
0 | 0 |
1-5 | 1 |
6-10 | 2 |
11-15 | 3 |
16-20 | 4 |
c、湿疹面积及严重度指数(改良EASI)计算
(红斑+丘疹+鳞屑+肥厚)×面积分数=面积及严重度指数分值
(2)瘙痒程度评分
无:记0分,无瘙痒;
轻:记1-3分,偶尔瘙痒,不用药,不影响工作学习生活;
中:记4-6分,阵发性瘙痒,时轻时重,影响睡眠工作学习生活,需要用药;
重:记7-10分,剧烈瘙痒,严重影响睡眠工作学习生活。
(3)中医证候
有无心烦、口渴、小便黄、大便干、食少乏力、腹胀便溏、小便清长或微黄、抓痕、脱屑,有记1分,无记0分。
疗效判定标准参照《中药新药治疗湿疮的临床研究指导原则》
(1)综合疗效判定标准
a、总分=(瘙痒程度分值+湿疹面积及严重度指数分值)×病期加权系数(慢性期2)
b、疗效判定标准
计算公式为(尼莫地平法):[(治疗前积分-治疗后积分)/治疗前积分]×100%
痊愈:皮损全部消退,症状消失,积分值减少≥95%
显效:皮损大部分消退,症状明显减轻,95%>积分值减少≥70%
有效:皮损部分消退,症状有所改善,70%>积分值减少≥50%
无效:皮损消退不明显,症状未见减轻或反见恶化,积分值减少不足50%
(2)主要疗效判定标准
瘙痒
临床痊愈:完全不痒
显效:评分等级降低两个等级
有效:评分等级降低一个等级
无效:评分等级未下降或加重
皮疹面积
痊愈:完全恢复正常皮肤或仅遗留色素沉着
显效:100%>皮疹面积(或个数)缩小≥70%
有效:70%>皮疹面积(或个数)缩小≥50%
无效:皮疹面积(或个数)<50%,或反见扩大
(3)中医证候疗效判定标准
痊愈:中医临床症状、体征消失或基本消失,证候积分减少≥95%
显效:中医临床症状、体征明显改善,95%>证候积分值减少≥70%
有效:中医临床症状、体征均有好转,70%>证候积分值减少≥50%
无效:中临床症状、体征无明显改善,证候积分值减少不足50%
4、施药方法:
分别以实施例1-4所得药液用纱布蘸取适量药液涂擦患处,无需清水再冲洗,每日3次,疗程7天。
选取来我院门诊就诊的湿疹患儿180例为研究对象,患者年龄在0-3岁,平均年龄为2岁,被随机分配进入9组,每组20人,每组患者性别、平均年龄、EASI评分比较差异无统计学意义。
5、实验用药(1):
已有的治疗湿疹的中药复方并不少,例如:中国专利2008100159559公开了一种由苦参、当归、黄柏、土茯苓、白鲜皮、蛇床子、地肤子、凡士林制成的治疗慢性湿疹的药膏;2009100836737公开了一种解毒祛湿止痒汤,由苦参、白癣皮、黄柏、地肤子、蛇床子、土茯苓、杏仁、枯矾制备而成,其适应症包括湿疹;2012103015103公开了一种由黄柏、苦参、金银花、土茯苓、地肤子、地榆、白矾作为主要原料制备成的治疗渗出性小儿湿疹的中药复方洗剂;2011104600650公开了一种治疗湿疹的药物,由黄柏20-40,苦参20-40,紫草15-30,白癣皮20-40,地肤子20-40,蛇床子20-40,滑石20-40制成;2012105530630涉及由地肤子、蛇床子、大枫子、苦参、土茯苓、白鲜皮、紫草、荆芥制备而成的治疗出疹的外用制剂。
本发明中将本发明药物与上述治疗湿疹的复方进行疗效比较后发现,虽然已有的湿疹制剂并不少,但是达到理想效果却不多。
1组为本发明实施例1药物;2组为2008100159559中实施例2药物;3组为2009100836737中权利要求1药物;4组为2012103015103中实施例6药物;5组为2011104600650中实施例1药物;6组为2012105530630中实施例1药物。
用药期间按以下方法护理:
1.食物应清淡,易于吸收;2.保持病室的空气流通、湿度适宜,避免过敏原接触;3.与患儿身体接触的内衣应宽松、柔软,枕巾、褥单、被单经常换洗;4.患儿洗澡不应过勤,水温适宜,患处若伴有分泌物渗出,则以流水清洗;5.对已经出现湿疹的皮肤要注意保护、减少刺激,切忌抓挠、摩擦。
表11-6组药物治疗小儿湿疹疗效观察例(%)
分组 | 痊愈 | 显效 | 好转 | 无效 | 总有效 |
1组 | 15(75%) | 3(15%) | 2(10%) | 0(0%) | 18(90%) |
2组 | 10(50%) | 3(15%) | 6(30%) | 1(5%) | 13(65%)5 --> |
3组 | 9(45%) | 5(25%) | 3(15%) | 3(15%) | 14(70%) |
4组 | 11(55%) | 3(15%) | 5(25%) | 1(5%) | 14(70%) |
5组 | 8(40%) | 5(25%) | 3(15%) | 4(20%) | 13(65%) |
6组 | 8(40%) | 4(20%) | 6(30%) | 2(10%) | 12(60%) |
结果表明,本发明制备的治疗小儿湿疹的中药疗效显著,方中药物配伍得当、诸药合用清热化湿、祛风止痒、祛除湿疹而不留瘀痕。直接涂搽于发生湿疹的皮肤部位,使用方便,小儿的依从性好。
6、实验用药(2):
本发明方中土茯苓、地榆为君药,发明人经过实验发现重用土茯苓、地榆有助于湿疹的治疗,当渐少二者用量,效果明显降低,并且当降低二者用量同时增加方中其他中药(臣药、佐药)用量时,治疗效果仍比以土茯苓、地榆做为君药时显著降低。
表2中各组方情况如下:
1组:土茯苓50g、地榆50g、苦参30g、桑白皮20g、地肤子15g、白鲜皮15g、浮萍10g、紫草10g、当归10g
7组:土茯苓30g、地榆30g、苦参30g、桑白皮20g、地肤子15g、白鲜皮15g、浮萍10g、紫草10g、当归10g
8组:土茯苓30g、地榆30g、苦参50g、桑白皮20g、地肤子15g、白鲜皮15g、浮萍10g、紫草10g、当归10g
9组:土茯苓30g、地榆30g、苦参30g、桑白皮50g、地肤子15g、白鲜皮15g、浮萍10g、紫草10g、当归10g
表2药味用量筛选试验例(%)
分组 | 痊愈 | 显效 | 好转 | 无效 | 总有效 |
1组 | 15(75%) | 3(15%) | 2(10%) | 0(0%) | 18(90%) |
7组 | 8(40%) | 6(30%) | 6(30%) | 0(0%) | 14(70%) |
8组 | 9(45%) | 6(30%) | 4(20%) | 1(5%) | 15(75%) |
9组 | 11(55%) | 2(10%) | 6(30%) | 1(5%) | 13(65%) |
实验表明,本发明方中以土茯苓、地榆为君药能够取得最佳疗效,降低二者用量或降低二者用量的同时增加其他药味用量,治疗的总有效率均呈现显著降低。
典型治疗病例:
张某某,23个月,望诊所见:患儿精神状态疲倦、营养一般、全身起针尖状丘疹,色红,并部分融合为红斑、伴有渗出液,有结痂。以本发明实施例1药物外用治疗。三日后,望诊见患儿精神较初诊时大为好转,大片红斑已消退,无渗出液,丘疹干。继续用药一个疗程之后,患儿全部皮疹消失,治愈,皮肤光滑。
刘某,18个月,望诊所见:患儿头面、耳后均有潮红样丘疹,伴有渗出液,有结痂,其母曾以母乳在皮疹区涂抹,未愈。以本发明实施例2药物外用治疗。三日后,患儿红色丘疹已消退,无渗出,丘疹变干,七日后全部皮疹消失,治愈。
Claims (8)
1.一种治疗小儿湿疹的中药,其特征在于,主要由下列原料药制成:茯苓、地榆、苦参。
2.根据权利要求1所述治疗小儿湿疹的中药,其特征在于,该中药中的原料药按重量配比为:土茯苓40-70份、地榆40-70份、苦参20-40份。
3.根据权利要求1所述治疗小儿湿疹的中药,其特征在于,该中药中的原料药按重量配比为:土茯苓40-70份、地榆40-70份、苦参20-40份、桑白皮20-30份、地肤子10-20份、白鲜皮10-20份、浮萍5-15份、紫草5-15份、当归5-15份。
4.根据权利要求3所述治疗小儿湿疹的中药,其特征在于,该中药中的原料药按重量配比为:土茯苓50-60份、地榆50-60份、苦参30-40份、桑白皮20-25份、地肤子10-15份、白鲜皮10-15份、浮萍5-10份、紫草5-10份、当归5-10份。
5.根据权利要求4所述治疗小儿湿疹的中药,其特征在于,该中药中的原料药按重量配比为:土茯苓50份、地榆50份、苦参30份、桑白皮20份、地肤子15份、白鲜皮15份、浮萍10份、紫草10份、当归10份。
6.根据权利要求4所述治疗小儿湿疹的中药,其特征在于,该中药中的原料药按重量配比为:土茯苓40份、地榆40份、苦参30份、桑白皮20份、地肤子10份、白鲜皮10份、浮萍5份、紫草5份、当归5份。
7.根据权利要求1至6所述的治疗小儿湿疹的中药的制备方法,包括如下步骤:
1)按重量份称取土茯苓、地榆、苦参、桑白皮、地肤子、白鲜皮、浮萍、紫草、当归,将称取的药材切碎;
2)将切碎后的药材用水煎煮两次,每次2-4h,合并煎煮液,滤过,加热浓缩,得浓缩液;
3)将步骤2)的浓缩液灭菌,即得本发明的治疗小儿湿疹的中药。
8.根据权利要求7所述的治疗小儿湿疹的中药的制备方法,其特征在于:在步骤3)之后还可进行如下操作,使得药物中的有效成分更加富集:将灭菌后的浓缩液加到D101大孔吸附树脂柱上,50%乙醇洗脱,收集5倍量柱体积洗脱液,减压回收乙醇至无醇味,滤过,得药物提取液,加热浓缩,得浓缩液;将浓缩液再次灭菌,即得本发明的治疗小儿湿疹的中药。
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