CN108392620B - 一种治疗皮炎的联合用产品及其用途 - Google Patents
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Abstract
本发明公开了一种治疗皮炎的联合用康养产品,它是由内服产品和外用产品组成;所述内服产品是由薏苡仁、肉桂、桃仁、制黄精、马齿苋、当归、茯苓、生姜、红花、黄芩制备而成;所述外用产品是由人参、白鲜皮、乌梅、三七、川牛膝、黄芪、白及、马齿苋、白蒺藜、当归、赤芍、茯苓、紫草、酒川芎、白丁香、珍珠粉、白僵蚕、灵芝制备而成。实验结果表明,用药前后皮炎症状具有显著差异,说明本发明产品具有祛风止痒,利湿消肿,益气养血的功用,对皮炎治疗及促进皮损恢复具有明显疗效。并且本发明采用内外同治的方法,可以缩短皮炎治疗周期,增强皮炎治疗效果。
Description
技术领域
本发明涉及一种治疗皮炎的联合用康养产品及其用途。
背景技术
面部过敏性皮炎是皮肤科临床常见、多发性疾病,主要发病部位为面部的额头、眼睑、颧、颊等,有时双耳和头皮亦会出现皮肤病症。主要症状为皮肤瘙痒,水肿,大小不等的水泡,甚至渗液糜烂。不仅对患者正常学习和工作带来严重困扰,如不及时治疗还会因患者抓挠而出现继发性感染。
面部过敏性皮炎的发病率上升,与现代人饮食起居、生活方式等有一定的关联,如过食生冷,晚睡熬夜等,这些都会伤及人体脾、肾的阳气,导致寒湿内生。部分患者体内寒湿可蕴而化为湿热,加上外感风邪,使机体受风寒湿热的侵扰。或患者素体脾虚,对风、寒、湿诸邪易感,湿热风邪致病,面部皮肤出现红疹、红斑,和瘙痒不难理解;而寒湿风邪引起的,则要从中医基础理论的阴阳失调方面来分析:寒湿为阴邪阻滞于内,阳格于表或上,风邪外犯,又易于伤人上部,从而出现面部的真寒假热证,使面部亦出现红斑或红疹,以及瘙痒。风、寒、湿、热诸邪皆可阻滞人体气机,影响机体水液的代谢,则面部又可出现水肿或红肿,甚至水泡、渗液糜烂等。
目前,西医治疗过敏性皮炎多采用免疫抑制或调节疗法、抗组胺药、激素类药、钙剂及肥大胞膜稳定剂等。包括口服、外用、注射剂等多种剂型,常见的第一代抗组胺药氯苯敏(扑尔敏)、苯海拉明、赛海拉明、赛庚啶等,第二代抗组胺药阿斯咪唑(息斯敏)、特非那定、依巴斯丁等,激素氢化可的松、地塞米松等。化学药显效迅速,能在较短时间内减轻和控制症状。但长期使用易形成依赖,不良反应相对较多,愈后复发率高,长时间使用可导致头痛、抑郁、眩晕、疲乏等中枢神经系统副作用和心律不齐、心率失常等心血管系统副作用。另外,还有腹泻、便秘、定向力障碍、复视、鼻出血、肌痛、精神失常及男性乳房发育、精子减少、女性月经不调等不同的副作用。目前尚未见治疗过敏性皮肤病有效又无副作用的西药报道。
随着现代药理学和免疫学的发展,中药抗皮肤过敏研究愈来愈受重视,未见关于本发明治疗皮炎的联合用产品的报道。
发明内容
本发明的目的在于提供一种治疗皮炎的联合用康养产品,它是由内服产品和外用产品组成;所述内服产品是由薏苡仁、肉桂、桃仁、制黄精、马齿苋、当归、茯苓、生姜、红花、黄芩组成;所述外用产品是由人参、白鲜皮、乌梅、三七、川牛膝、黄芪、白及、马齿苋、白蒺藜、当归、赤芍、茯苓、紫草、酒川芎、白丁香、珍珠粉、白僵蚕、灵芝组成。
进一步地,所述内服产品是由下述重量配比的原料制备而成:
薏苡仁10~40份、肉桂3~21份、桃仁15~50份、制黄精5~40份、马齿苋9~36份、当归1~12份、茯苓7~49份、生姜9~36份、红花0.1~3份、黄芩1~10份。
进一步地,所述内服产品是由下述重量配比的原料制备而成:
薏苡仁30份、肉桂10份、桃仁30份、制黄精15份、马齿苋15份、当归3份、茯苓30份、生姜15份、红花1份、黄芩5份。
进一步地,所述内服产品是由原料药的药粉、原料药的水提取物或有机溶剂提取物为活性成分,加上药学和/或食品上可接受的辅料制备而成的制剂。
进一步地,所述制剂为汤剂、散剂、胶囊剂、片剂、颗粒剂、羹剂。
进一步地,所述外用产品是由下述重量配比的原料制备而成:
人参4~36份、白鲜皮10~50份、乌梅8~32份、三七10~50份、川牛膝15~65份、黄芪10~60份、白及10~50份、马齿苋15~50份、白蒺藜9~49份、当归5~35份、赤芍 5~40份、茯苓10~60份、紫草2~30份、酒川芎7~35份、白丁香6~36份、珍珠粉5~50 份、白僵蚕9~45份、灵芝0.3~3.0份。
进一步地,所述外用产品是由下述重量配比的原料制备而成:
人参10份、白鲜皮30份、乌梅15份、三七30份、川牛膝30份、黄芪30份、白及 30份、马齿苋30份、白蒺藜30份、当归15份、赤芍20份、茯苓30份、紫草10份、酒川芎15份、白丁香10份、珍珠粉30份、白僵蚕20份、灵芝1份。
进一步地,所述外用产品是由原料药的粉末、原料药的水提取物或有机溶剂提取物为活性成分,加上化妆品中可接受的辅料制备而成的化妆品。
进一步地,所述外用产品为净面巾、爽肤水、乳液、精华液、面霜、面膜、眼膜、啫喱等。
本发明还提供了上述联合用康养产品在制备治疗或改善皮炎的食品、保健品、药品或化妆品中的用途。
本发明内服产品以薏苡仁、茯苓利水渗湿健脾、桃仁活血祛瘀,臣以肉桂、生姜扶助脾阳以祛湿,制黄精健脾益胃,当归养血,红花活血祛瘀,马齿苋、黄芩清郁热;本发明外用产品以黄芪助阳益气,人参益气健脾,茯苓健脾祛湿,牛膝滋补肝肾,引热下行,三七活血化瘀、祛风止痛,马齿苋清热解毒,白蒺藜祛风止痒,臣以白及消肿生肌,白鲜皮燥湿去毒,当归补血调经,活血止痛,赤芍清热凉血,散瘀止痛,紫草清热凉血,川芎活血行气,祛风止痛,丁香温肾助阳,珍珠粉祛斑美白,白僵蚕息风止痉,祛风止痛,以上诸药合用共奏健脾祛湿,解毒止痒,清热消肿之功。
根据本实验结果可知,用药前后皮炎症状具有显著差异,说明本产品具有祛风止痒,利湿消肿,益气养血的功用,对皮炎治疗及促进皮损恢复具有明显疗效。并且本发明采用内外同治的方法,可以缩短皮炎治疗周期,增强皮炎治疗效果。
本发明的外用产品和内服产品可以单独使用,也可以以任意比例组合使用。
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
实施例1、本发明内服产品的制备
1.配方:薏苡仁30g、肉桂10g、桃仁30g、制黄精15g、马齿苋15g、当归3g、茯苓30g、生姜15g、红花1g、黄芩5g。
2.制备方法:按配方称取原料药,加10-15倍水浸泡15分钟进行预处理;煎煮提取2-4次,每次15-30min,每次煎煮后过滤得滤液,混合所有滤液静止20h,将上清液浓缩至相对密度为1.15-1.3的稠膏;进风温度为180-200℃、出风温度为90-100℃,喷雾干燥得提取物。
将480g提取物与320g麦芽糊精进行混合,混合均匀以后将物料置于摇摆制粒机中过 20目筛,进行制粒,50℃干燥8h,干燥后物料经振荡筛选整粒,取20-60目之间颗粒,按20g/袋分装,即得本发明内服产品。
3.使用方法:每日服用两次,每次一袋,饭后温水冲服。
实施例2、本发明内服产品的制备
1.配方:薏苡仁40g、肉桂21g、桃仁50g、制黄精40g、马齿苋36g、当归12g、茯苓49g、生姜36g、红花3g、黄芩10g。
2.制备方法:按配方称取原料药,加10-15倍水浸泡15分钟进行预处理;煎煮提取2-4次,每次15-30min,每次煎煮后过滤得滤液,混合所有滤液静止20h,将上清液浓缩至相对密度为1.15-1.3的稠膏;进风温度为180-200℃、出风温度为90-100℃,喷雾干燥得提取物。
将240g提取物与160g麦芽糊精进行混合,混合均匀以后将物料置于摇摆制粒机中过 20目筛,进行制粒,50℃干燥8h,干燥后物料经振荡筛选整粒,取20-60目之间颗粒,按20g/袋分装,即得本发明内服产品。
3.使用方法:同实施例1。
实施例3、本发明内服产品的制备
1.配方:薏苡仁10g、肉桂3g、桃仁15g、制黄精5g、马齿苋9g、当归1g、茯苓7g、生姜9g、红花0.1g、黄芩1。
2.制备方法:按配方称取原料药,加10-15倍水浸泡15分钟进行预处理;煎煮提取2-4次,每次15-30min,每次煎煮后过滤得滤液,混合所有滤液静止20h,将上清液浓缩至相对密度为1.15-1.3的稠膏;稠膏放入烘箱60-65℃进行烘干16h,干燥致不能流动;再置于减压干燥器(65℃,-0.1MPa)中进行减压干燥8小时,彻底干燥得提取物。
将120g提取物与80g麦芽糊精进行混合,干燥,按20g/袋分装,即得本发明内服产品。
3.使用方法:同实施例1。
实施例4、本发明外用产品的制备
1.配方:人参10g、白鲜皮30g、乌梅15g、三七30g、川牛膝30g、黄芪30g、白及30g、马齿苋30g、白蒺藜30g、当归15g、赤芍20g、茯苓30g、紫草10g、酒川芎 15g、白丁香10g、珍珠粉30g、白僵蚕20g、灵芝1g。
2.制备方法:将上述配方药材原料粉碎,按重量配比称取各中药材粉末,按料液比1:10 加入蒸馏水,浸泡0.5h,加热回流提取1.5h,提取3次,合并提取液,提取液300目筛过滤,即得中药提取液。
将上述提取物40份,加入3份丙二醇,3份丁二醇,2份乳酸杆菌/豆浆发酵产物滤液,1.5份燕麦碱,0.35份丙烯酰二甲基牛磺酸铵/山嵛醇聚醚-25甲基丙烯酸酯交联聚合物,0.2份辛酰羟肟酸,0.15份透明质酸,0.1份甘草酸二钾,0.1份精氨酸;并以去离子水加至100;由此制备而成精华液,辅以天然绒丝(也叫棉籽绒丝)的布基(载体)成为面膜(洁面巾)。
3.使用方法:每日使用面膜一次,净面,湿敷10分钟。
实施例5、本发明外用产品的制备
1.配方:人参4g、白鲜皮10g、乌梅8g、三七10g、川牛膝15g、黄芪10g、白及10g、马齿苋15g、白蒺藜9g、当归5g、赤芍5g、茯苓10g、紫草2g、酒川芎7g、白丁香6g、珍珠粉5g、白僵蚕9g、灵芝0.3g。
2.制备方法:同实施例4。
3.使用方法:同实施例4。
实施例6、本发明外用产品的制备
1.配方:人参36g、白鲜皮50g、乌梅32g、三七50g、川牛膝65g、黄芪60g、白及 50g、马齿苋50g、白蒺藜49g、当归35g、赤芍40g、茯苓60g、紫草30g、酒川芎35g、白丁香36g、珍珠粉50g、白僵蚕45g、灵芝3g。
2.制备方法:同实施例4。
3.使用方法:同实施例4。
试验例1
(1)患者来源
均为四川省第二中医医院门诊部以及社会招募的面部过敏性皮炎患者,共计120例,其中男性42例,女性78例,年龄15~45岁。
(2)诊断标准
西医诊断标准:
①皮疹集中在面部;
②近期面部无激素类或刺激性物质接触史;
③面部瘙痒,灼热,疼痛,排除其他原发性或继发性皮肤疾病;
④面部粉刺、丘疹、脓疱或红斑,排除其他原发性或继发性皮肤疾病;
⑤面部发红,干燥脱屑;
⑥通常无全身症状。
中医诊断标准:
湿热证:
主症:瘙痒,灼热或疼痛,面部红肿,可见红斑,丘疹,皮肤干燥,脱屑,粗糙,皮肤萎缩变薄,毛细血管扩张等;
其他症状:首次发病或复发,心烦,口渴,息粗,大便干结,小便黄赤,舌红苔黄腻,脉洪数。
(3)受试者纳入标准
符合中医湿热证诊断标准
符合入选年龄标准(15~45岁)
病程在1-15天之内
治疗前2周内未使用过皮质类固醇激素或免疫抑制剂
治疗前7天内未用过与本病相关的治疗药物
签署知情同意书
(4)受试者排除标准
不符合面部过敏性皮炎诊断的患者
年龄<15岁,或者>45岁的患者
妊娠及哺乳期的患者
对本产品成分过敏者合并心脑血管、肝、肾、及造血功能严重疾病,精神病患者
不能按照实施计划完成治疗过程者
中断治疗及未按照要求用药者,无法判断疗效或资料不全等影响疗效或安全判断
(5)治疗方法
治疗组(60例):口服实施例1制备的内服产品(2次/日,每次1包)与外用实施例 4制备的产品(一片/日,外敷10分钟后取下)。
对照组(60例):口服中药汤剂与外用中药汤剂洗剂(按药材配比,由病人自行抓药熬制)备注:中药来源于四川省中医药科学院中医研究所中药库房采购。
中药口服:薏苡仁30g、肉桂10g、制黄精15g、马齿苋15g、当归3g、红花1g、
中药外洗剂:白蒺藜30g、茯苓30g、三七30g、黄芪30g、白及30g、赤芍20g、酒川芎15g、白丁香10g
(6)临床观察指标
一月为一个疗程,观察服用一月后面部皮损情况,根据表1中的症候评分及疗效指数,评定疗效。
表1项目临床观察表
临床痊愈: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%。
(7)疗效判定标准
一月为一个疗程,使用一月后观察面部皮损情况,计算疗效指数=(治疗前积分和- 治疗后积分和)/治疗前积分总和,以疗效指数≧50%判定为有效。实验组对照组相比较,两组皮损情况均整体减轻,且差异具有统计学意义(P<0.05),可判定该产品对皮炎治疗及促进皮损恢复有作用。
(8)统计学方法
(9)治疗结果
表2疗效评价*组别
根据治疗前与治疗后积分和、疗效指数的比较,该病临床症状在用药前后具有显著差异,说明本产品具有祛风止痒,利湿消肿,益气养血的功用,对皮炎治疗及促进皮损恢复具有明显疗效。
综上,本发明的产品对皮炎治疗及促进皮损恢复具有明显疗效。并且本发明采用内外同治的方法,可以缩短皮炎治疗周期,增强皮炎治疗效果,为临床治疗皮炎提供了一种新的选择。
Claims (6)
1.一种治疗皮炎的联合用产品,其特征在于:它是由内服产品和外用产品组成;所述内服产品是由薏苡仁、肉桂、桃仁、制黄精、马齿苋、当归、茯苓、生姜、红花、黄芩制备而成;所述外用产品是由人参、白鲜皮、乌梅、三七、川牛膝、黄芪、白及、马齿苋、白蒺藜、当归、赤芍、茯苓、紫草、酒川芎、白丁香、珍珠粉、白僵蚕、灵芝制备而成;所述内服产品是由下述重量配比的原料制备而成:
薏苡仁30份、肉桂10份、桃仁30份、制黄精15份、马齿苋15份、当归3份、茯苓30份、生姜15份、红花1份、黄芩5份;
所述外用产品是由下述重量配比的原料制备而成:
人参10份、白鲜皮30份、乌梅15份、三七30份、川牛膝30份、黄芪30份、白及30份、马齿苋30份、白蒺藜30份、当归15份、赤芍20份、茯苓30份、紫草10份、酒川芎15份、白丁香10份、珍珠粉30份、白僵蚕20份、灵芝1份。
2.根据权利要求1所述的联合用产品,其特征在于:所述内服产品是由原料药的药粉、原料药的水提取物或有机溶剂提取物为活性成分,加上药学和/或食品上可接受的辅料制备而成的制剂。
3.根据权利要求2所述的联合用产品,其特征在于:所述制剂为汤剂、散剂、胶囊剂、片剂、颗粒剂、羹剂。
4.根据权利要求1~3任一项所述的联合用产品,其特征在于:所述外用产品是由原料药的粉末、原料药的水提取物或有机溶剂提取物为活性成分,加上化妆品中可接受的辅料制备而成的化妆品。
5.根据权利要求4所述的联合用产品,其特征在于:所述外用产品为净面巾、爽肤水、乳液、精华液、面霜、面膜、眼膜或啫喱。
6.权利要求1~5任一项所述联合用产品在制备治疗或改善皮炎的药品或化妆品中的用途。
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