CN117045717A - 一种治疗湿疹的外用复方精油组合物及其制备方法 - Google Patents
一种治疗湿疹的外用复方精油组合物及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种治疗湿疹的外用复方精油组合物,由以下重量份数的各组分组成:苍术精油8‑12份、洋甘菊精油5‑10份、荆芥精油10‑14份、金银花精油6‑10份、茉莉花精油4‑8份、乳香精油5‑9份、当归精油10‑20份、藿香精油6‑10份、陈皮精油10‑14份、卡波姆940 20‑30份、乙醇50‑100份、甘油30‑50份、三乙醇胺20‑40份,并公开了其制备方法,全方在清热利湿的基础上,注重疏风、凉血、活血、解毒,共同治疗湿热蕴结型湿疹效果显著。
Description
技术领域
本发明涉及医药领域,具体涉及一种治疗湿疹的外用复方精油组合物及其制备方法。
背景技术
湿疹是由多种内、外因素引起的真皮浅层及表皮的炎症。临床上急性期皮损以丘疱疹为主,有渗出、糜烂;慢性期苔藓样变为主;还有亚急性期,介于急性期和慢性期之间的皮肤病。早期症状:多因急性、亚急性湿疹反复发作演变而成,亦可开始即呈现慢性炎症。患处皮肤浸润增厚,变成暗红色及色素沉着。持久不愈时,皮损纹***大,表现干燥而易发生皲裂。常见于小腿、手、足、肘窝、外阴、***等处。湿疹中医辨证一般分为热毒型、湿热型、血燥型、湿阻型四型,晚期症状:为多数粟粒大红色丘疹、丘疱疹或水疱,尚有明显点状或小片状糜烂,渗液,结痂。损害境界不清。合并感染时可出现脓疱、脓性渗出及痂屑等。
湿邪属于中医传统五行理论中的水性物质,有滋润之势。但是,如果积聚过多,就会影响人体的正常代谢,以及脾胃功能的发挥。由于湿邪入侵人体会影响人体的正常代谢,从而导致水分代谢失调、又引起气血的产生,使气血瘀滞。湿邪进入人体表面时,会分为内湿和外湿两种类型。
当人体受凉、暴饮暴食、环境潮湿等情况时,容易引发外湿,表现为皮肤潮湿、出汗、皮肤发痒等症状。而内湿则与饮食习惯和生活方式有关,如暴食过多、拒绝运动等。长期存在的内湿不仅会影响人体的正常代谢,还会对脾胃功能造成影响,造成气血的瘀滞,从而导致湿疹的发生。
湿疹属于中医“湿疮”“湿疡”等范畴。中医学认为,本病多因湿热之邪蕴结体内,复因外感风、湿、热邪,内外两邪相合,溢于肌表而发为本病。且风湿热三邪可贯穿疾病始终,而在疾病的不同时期,表现有所不同,又因为湿为阴邪,湿性重浊,其性黏腻,缠绵难愈,且易耗伤阴血,日久化燥伤阴,虚风内生,反复发作。根据中医基础理论辨证,我们常给湿疹辨证为:湿热蕴结、脾虚湿蕴和血虚风燥三种类型,其中湿热蕴结最为常见。
发明内容
本发明的目的在于提供一种治疗湿疹的外用复方精油组合物,该复方精油针对的湿疹为湿热蕴结型。
一种治疗湿疹的外用复方精油组合物,由以下重量份数的各组分组成:苍术精油8-12份、洋甘菊精油5-10份、荆芥精油10-14份、金银花精油6-10份、茉莉花精油4-8份、乳香精油5-9份、当归精油10-20份、藿香精油6-10份、陈皮精油10-14份、卡波姆940 20-30份、乙醇50-100份、甘油30-50份、三乙醇胺20-40份。
所述治疗湿疹的外用复方精油组合物,由以下重量份数的各组分组成:苍术精油10份、洋甘菊精油8份、荆芥精油12份、金银花精油8份、茉莉花精油6份、乳香精油7份、当归精油15份、藿香精油8份、陈皮精油12份、卡波姆940 25份、乙醇70份、甘油40份、三乙醇胺30份。
所述治疗湿疹的外用复方精油组合物,由以下重量份数的各组分组成:苍术精油8份、洋甘菊精油10份、荆芥精油10份、金银花精油10份、茉莉花精油4份、乳香精油9份、当归精油10份、藿香精油10份、陈皮精油10份、卡波姆940 30份、乙醇50份、甘油50份、三乙醇胺20份。
所述治疗湿疹的外用复方精油组合物,由以下重量份数的各组分组成:苍术精油12份、洋甘菊精油5份、荆芥精油14份、金银花精油6份、茉莉花精油8份、乳香精油5份、当归精油20份、藿香精油6份、陈皮精油14份、卡波姆940 20份、乙醇100份、甘油30份、三乙醇胺40份。
所述治疗湿疹的外用复方精油组合物,苍术精油、洋甘菊精油、荆芥精油、金银花精油、茉莉花精油、乳香精油、当归精油、藿香精油、陈皮精油的提取方法为:分别取苍术、洋甘菊、荆芥、金银花、茉莉花、乳香、当归、藿香、陈皮药材,粉碎过10目筛,加入10倍重量药材的蒸馏水,浸泡1.5h后进行蒸馏,萃取温度90℃,冷凝管温度15-25℃,蒸馏时间2-4h,得精油纯露混合液,分离获得所述精油。
所述治疗湿疹的外用复方精油组合物,所述水蒸气蒸馏法的蒸馏时间为3h。
所述治疗湿疹的外用复方精油组合物,复方精油组合物的剂型为凝胶剂。
所述治疗湿疹的外用复方精油组合物,制备方法包括如下步骤:将苍术精油、洋甘菊精油、荆芥精油、金银花精油、茉莉花精油、乳香精油、当归精油、藿香精油、陈皮精油加入乙醇中,再加入甘油,搅拌均匀得精油液;加入卡波姆940,搅匀,加入三乙醇胺,再加适量蒸馏水即得。
所述治疗湿疹的外用复方精油组合物,湿疹的证型为湿热蕴结型。
洋甘菊一般指母菊,拉丁名为Matricaria chamomilla L.,菊科母菊属一年生草本植物。全株无毛,茎有沟纹,上部多分枝;下部分叶片为矩圆形或倒披针形,上部分叶片为卵形或长卵形;花冠黄色;果实为淡绿褐色,侧扁,略弯。花果期5—7月。
母菊原产于英国,欧洲、亚洲北部和西部都有种植,中国新疆北部和西部为主要产区,北京、南京、上海栽培于庭园或野生于旷野。喜光照、不耐热、不耐潮湿、喜微干燥的肥沃土壤,常生于河谷旷野、田边。母菊的繁殖常用分株和嫁接法繁殖,也可播种、扦插和压条繁殖。
《中国药用植物图鉴》记载母菊具有清热解毒、止咳平喘、祛风湿之功效,主治感冒发热,咽喉肿痛,肺热咳喘,热痹肿痛,疮肿。从母菊中提炼出的洋甘菊精油还常常被用来抑制皮肤发炎、促进伤口愈合,或者修复皮肤裂伤,治疗神经疼痛等问题。母菊可制成保健品,保湿、润泽、收敛毛孔的功效显著,
茉莉花精油调理皮肤,特别是干燥、敏感、老化、疤痕及妊娠纹等皮肤,保持皮肤的水份和弹性。
湿热蕴结型湿疹,起病急骤,皮疹多形态,红斑、丘疹、水疱、渗出等,伴瘙痒,心烦,口干,溲黄,便秘,舌质红,苔薄黄,脉滑。多见于急性湿疹、脂溢性湿疹以及慢性湿疹急性发作期。中医理论认为,湿热蕴结型湿疹由于血热脾湿,浸淫肌肤。本发明采用苍术精油燥湿健脾,为防止苍术过燥,采用洋甘菊精油、荆芥精油与之配伍,洋甘菊精油、荆芥精油具有疏风清热作用,苍术精油、洋甘菊精油、荆芥精油共为君药;金银花精油、茉莉花精油凉血解毒,为臣药;湿热蕴结型湿疹常常伴有脾虚湿困和血虚风燥夹瘀,故采用乳香精油、当归精油活血化瘀为佐药;采用藿香精油、陈皮精油健脾利湿,为使药,全方在清热利湿的基础上,注重疏风、凉血、活血、解毒,共同治疗湿热蕴结型湿疹效果显著。
具体实施方式
下面结合具体实施方式,进一步阐述本发明。应理解,这些实施例仅用于说明本发明而不用于限制本发明的范围。此外应理解,在阅读了本发明记载的内容之后,本领域技术人员可以对本发明作各种改动或修改,但这些等价形式同样落于本申请所附权利要求书所限定的范围。
实施例1
处方:苍术精油10g、洋甘菊精油8g、荆芥精油12g、金银花精油8g、茉莉花精油6g、乳香精油7g、当归精油15g、藿香精油8g、陈皮精油12g、卡波姆940 25g、乙醇70g、甘油40g、三乙醇胺30g,
制备方法:
1、分别取苍术、洋甘菊、荆芥、金银花、茉莉花、乳香、当归、藿香、陈皮药材,粉碎过10目筛,加入10倍重量药材的蒸馏水,浸泡1.5h后进行蒸馏,萃取温度90℃,冷凝管温度20℃,蒸馏时间3h,得精油纯露混合液,分离获得所述精油。
2、将处方量的苍术精油、洋甘菊精油、荆芥精油、金银花精油、茉莉花精油、乳香精油、当归精油、藿香精油、陈皮精油加入乙醇中,再加入甘油,搅拌均匀得精油液;加入卡波姆940,搅匀,加入三乙醇胺,再加适量蒸馏水即得。
实施例2
处方:苍术精油10g、洋甘菊精油8g、荆芥精油12g、金银花精油8g、茉莉花精油6g、乳香精油7g、当归精油15g、藿香精油8g、陈皮精油12g、卡波姆940 25g、乙醇70g、甘油40g、三乙醇胺30g,
制备方法:
1、分别取苍术、洋甘菊、荆芥、金银花、茉莉花、乳香、当归、藿香、陈皮药材,粉碎过10目筛,加入10倍重量药材的蒸馏水,浸泡1.5h后进行蒸馏,萃取温度90℃,冷凝管温度15℃,蒸馏时间4h,得精油纯露混合液,分离获得所述精油。
2、将处方量的苍术精油、洋甘菊精油、荆芥精油、金银花精油、茉莉花精油、乳香精油、当归精油、藿香精油、陈皮精油加入乙醇中,再加入甘油,搅拌均匀得精油液;加入卡波姆940,搅匀,加入三乙醇胺,再加适量蒸馏水即得。
实施例3
处方:苍术精油10g、洋甘菊精油8g、荆芥精油12g、金银花精油8g、茉莉花精油6g、乳香精油7g、当归精油15g、藿香精油8g、陈皮精油12g、卡波姆940 25g、乙醇70g、甘油40g、三乙醇胺30g,
制备方法:
1、分别取苍术、洋甘菊、荆芥、金银花、茉莉花、乳香、当归、藿香、陈皮药材,粉碎过10目筛,加入10倍重量药材的蒸馏水,浸泡1.5h后进行蒸馏,萃取温度90℃,冷凝管温度25℃,蒸馏时间2h,得精油纯露混合液,分离获得所述精油。
2、将处方量的苍术精油、洋甘菊精油、荆芥精油、金银花精油、茉莉花精油、乳香精油、当归精油、藿香精油、陈皮精油加入乙醇中,再加入甘油,搅拌均匀得精油液;加入卡波姆940,搅匀,加入三乙醇胺,再加适量蒸馏水即得。
实施例4:临床研究
1、病人来源:全部病例均来自南京中医药大学附属医院的门诊病人。
2、病例选择标准:
西医诊断标准:西医诊断标准参照(赵辨.临床皮肤病学[M].第三版.南京:江苏科学技术出版社,2009,604-605);中医诊断标准:参照《中华人民共和国国家标准·中医临床诊疗术语》GB/T13.20的诊断标准。起病急骤,皮疹多形态,红斑、丘疹、水疱、渗出等,伴瘙痒,心烦,口干,溲黄,便秘,舌质红,苔薄黄,脉滑。确诊为湿热蕴结型湿疹。无心肝肾等内脏疾病、无糖尿病史;非妊娠或哺乳期妇女;所有受试者均在1个月内未***使用糖皮质激素、非甾体类抗炎药及免疫抑制剂,1周内未局部外用糖皮质激素及非甾体类抗炎药。共100例,男58人,女42人,平均年龄为25.18±6.48岁,随机分为两组,分别为治疗组和对照组。
3、治疗方案:治疗组外用下述实施例1方法制备的凝胶剂涂患处,保留20~30分钟,用清水冲洗;一日2次,或遵医嘱,疗程为2周。对照组使用炉甘石洗剂(1000ml内含甘油50ml,氧化锌50g,炉甘石150g),涂患处,保留20~30分钟,用清水冲洗;一日2次,或遵医嘱,疗程为2周。
4、疗效评定标准:参考《中药新药临床指导原则》中对于“湿疹”的临床疗效评价标准判定,以皮疹面积及皮疹形态的减少,瘙痒程度减轻为主要指标。(1)痊愈:皮损全部消退,瘙痒症状消失,SSRI达95%以上。(2)显效:皮损大部分消退,瘙痒症状明显减轻,SSRI达70%以上。(3)有效:皮损部分消退,瘙痒症状有所改善,SSRI达30%以上。(4)无效:皮损消退不明显,瘙痒未见改善或反见恶化,或SSRI未达到有效标准。
注:症状积分下降指数(SSRI)=(治疗前总积分-治疗后总积分)÷治疗前总积分×100%。
5、观察指标:就诊时和治疗后第2周随访,记录患者皮疹面积、皮疹形态的变化,瘙痒程度的变化,按以下4级评分法记分。
①瘙痒程度:无:(0分):无瘙痒;轻度(1分):偶尔瘙痒,不用药,不影响正常生活工作;中度(2分):阵发性瘙痒,时轻时重,影响睡眠工作学习生活;重度(3分):剧烈瘙痒,严重影响睡眠工作学习生活。
②皮疹面积:0分:无皮疹;1分:皮疹面积<10%;2分:皮疹面积为10%~29%;3分:皮疹面积为30%~49%;4分:皮疹面积为50%~69%;5分:皮疹面积为70%~89%;6分:皮疹面积为90%~100%。
③皮疹形态:无(0分):无皮疹;轻度(1分):红斑、风团、丘疹、丘疱疹、水庖;中度(2分):渗出、糜烂;重度(3分):肥厚及苔藓样变;多形皮损:多形损害数皮疹评分相加。
各项指标相加为总分,依据其变化判断病人疗效。
6、结果:
从门诊就诊病人中筛选符合条件的湿热蕴结型湿疹患者,共纳入100例患者,随机分为治疗组和对照组,治疗组痊愈26例、显效14例、有效8例、无效2例,总有效率96%(48例),对照组痊愈15例、显效12例、有效7例、无效16例,总有效率68%(34例),说明本发明效果由于对照组。在本研究纳入的病例中,两组均未发现病人有任何不良反应报告,表明药物安全性。
实施例5:本发明对二甲苯所致小鼠耳廓肿胀的影响
实验材料
1、动物:昆明种小鼠,雌雄兼有,体重18~22g。
2、药物:本发明凝胶剂,涂抹给药。对照组使用炉甘石洗剂(1000ml内含甘油50ml,氧化锌50g,炉甘石150g)。
实验方法
昆明种小鼠40只,雌雄各半,体重18~22g,随机分成4组,每组10只。实验前24h,用硫化钠将小鼠背部脱毛,分别于小鼠背部涂抹给药,空白组涂抹等量的基质;本发明凝胶剂组和对照组分别涂抹给药,连续给药5d,每日1次,末次给药2h后,用100%二甲苯0.3ml/只涂于右耳内外两面,左耳作为对照,致炎4h后将小鼠***麻醉处死,减下双耳用9mm直径打孔器分别在小鼠的同一部位打下圆耳片,称重。计算出小鼠耳廓肿胀度(小鼠右耳片与左耳片的重量差)。
实验结果:见表1
表1本发明对二甲苯所致小鼠耳廓肿胀的影响
分组 | 动物(只) | 耳廓肿胀度(mg) |
空白组 | 10 | 22.86±5.32 |
本发明组 | 10 | 15.72±4.18**△ |
对照组 | 10 | 19.45±6.43 |
与空白组相比**P<0.01;*P<0.05;与对照组比△P<0.05。
结果表明:本发明凝胶剂组与空白组相比较,有显著性差异,说明本发明可明显抑制二甲苯所致小鼠耳廓的肿胀。本发明凝胶剂组与对照组相比较,有显著性差异,说明本发明凝胶剂效果明显由于对照组炉甘石洗剂。
尽管已经示出和描述了本发明的实施例,对于本领域的普通技术人员而言,可以理解在不脱离本发明的原理和精神的情况下可以对这些实施例进行多种变化、修改、替换和变型,本发明的范围由所附权利要求及其等同物限定。
Claims (9)
1.一种治疗湿疹的外用复方精油组合物,其特征在于,由以下重量份数的各组分组成:苍术精油8-12份、洋甘菊精油5-10份、荆芥精油10-14份、金银花精油6-10份、茉莉花精油4-8份、乳香精油5-9份、当归精油10-20份、藿香精油6-10份、陈皮精油10-14份、卡波姆94020-30份、乙醇50-100份、甘油30-50份、三乙醇胺20-40份。
2.根据权利要求1所述治疗湿疹的外用复方精油组合物,其特征在于,由以下重量份数的各组分组成:苍术精油10份、洋甘菊精油8份、荆芥精油12份、金银花精油8份、茉莉花精油6份、乳香精油7份、当归精油15份、藿香精油8份、陈皮精油12份、卡波姆940 25份、乙醇70份、甘油40份、三乙醇胺30份。
3.根据权利要求1所述治疗湿疹的外用复方精油组合物,其特征在于,由以下重量份数的各组分组成:苍术精油8份、洋甘菊精油10份、荆芥精油10份、金银花精油10份、茉莉花精油4份、乳香精油9份、当归精油10份、藿香精油10份、陈皮精油10份、卡波姆940 30份、乙醇50份、甘油50份、三乙醇胺20份。
4.根据权利要求1所述治疗湿疹的外用复方精油组合物,其特征在于,由以下重量份数的各组分组成:苍术精油12份、洋甘菊精油5份、荆芥精油14份、金银花精油6份、茉莉花精油8份、乳香精油5份、当归精油20份、藿香精油6份、陈皮精油14份、卡波姆940 20份、乙醇100份、甘油30份、三乙醇胺40份。
5.根据权利要求1所述治疗湿疹的外用复方精油组合物,其特征在于,苍术精油、洋甘菊精油、荆芥精油、金银花精油、茉莉花精油、乳香精油、当归精油、藿香精油、陈皮精油的提取方法为:分别取苍术、洋甘菊、荆芥、金银花、茉莉花、乳香、当归、藿香、陈皮药材,粉碎过10目筛,加入10倍重量药材的蒸馏水,浸泡1.5h后进行蒸馏,萃取温度90℃,冷凝管温度15-25℃,蒸馏时间2-4h,得精油纯露混合液,分离获得所述精油。
6.根据权利要求5所述治疗湿疹的外用复方精油组合物,其特征在于,所述水蒸气蒸馏法的蒸馏时间为3h。
7.根据权利要求1所述治疗湿疹的外用复方精油组合物,其特征在于,复方精油组合物的剂型为凝胶剂。
8.根据权利要求7所述治疗湿疹的外用复方精油组合物,其特征在于,制备方法包括如下步骤:将苍术精油、洋甘菊精油、荆芥精油、金银花精油、茉莉花精油、乳香精油、当归精油、藿香精油、陈皮精油加入乙醇中,再加入甘油,搅拌均匀得精油液;加入卡波姆940,搅匀,加入三乙醇胺,再加适量蒸馏水即得。
9.根据权利要求1所述治疗湿疹的外用复方精油组合物,其特征在于,湿疹的证型为湿热蕴结型。
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