CN105641352A - 一种治疗面部色斑的药物制剂及其用途 - Google Patents
一种治疗面部色斑的药物制剂及其用途 Download PDFInfo
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Abstract
本发明涉及一种治疗面部色斑的药物制剂及其用途,按照重量分数比包括:当归10-20份,白芷10-20份,川芎20-30份,白蒺藜10-20份,白术10-20份,白茯苓10-20份,山药10-20份,白附子10-20份,白僵蚕10-20份,冬瓜仁10-20份,黄芩10-20份,绿豆20-30份,枸杞子5-10份,柿叶5-10份,芦荟5-10份。与现有技术相比,本发明注重中医理论,诸药合用,达到活血行气,养血祛斑的作用,标本兼治,愈后复发率低,且使用方便、无毒副作用、便于进一步推广应用。
Description
技术领域
本发明属于中医药领域,尤其是涉及一种用于治疗色斑的药物制剂及其用途。
背景技术
面部色斑为一种发病率极高的皮肤病,是由于黑色素细胞之色素障碍所产生的皮肤病,原因为黑色素活性增高,或黑色素不均匀沉积过度所导致,为色素代谢障碍性皮肤病,男女皆有可能致病。好发于颜面部,因而使患者的自尊心受到伤害,若发病严重者会障碍患者的社交活动。因此努力寻求和研发一种安全、高效,对人体无任何后遗症的治疗面部色素斑的方法,是目前医学界和美容界最重要的趋势。
传统医学认为气血淤阻、痰湿凝滞,则气血运行不畅,不能润养面部肌肤。色斑的形成有各种各样的原因,斑的种类不同则其形成的原因也不同,它不但和外界因素有关,也和情绪、饮食、内分泌及新陈代谢等因素有关,有些还来自遗传。近年来有研究表明,SOD是自由基强有力的清除剂,黑色素沉积可能与氧化与抗氧化失衡有关。研究提示,改善血液质量可能会使色斑问题得到缓解。
色斑的发病原因尚未完全明了,从中医的角度来看,血行瘀阻肌肤是其主要病理特点。面部雀斑、黄褐斑、老年斑属于常见的色素沉着皮肤病,其形成的主要原因是患者皮损部位黑色素细胞活性增强,黑素和黑素小体增加。黑色素的产生与排泄失去平衡,并过剩地聚集在表皮细胞内,就形成色素沉着。黑色素的生成是以酪氨酸为基质,在含铜的氧化酪氨酸酶的作用下,依次生成多巴、多巴醌及吲哚醌,最后自发形成黑色素,所以人为地阻止酪氨酸酶的形成,可有效地治疗黄褐斑。
发明内容
本发明根据传统中医理论及现代药理研究结果,反复筛选外用药,配制成中药祛斑制剂,具有温通血脉,活肤化瘀,养血祛斑,润泽肌肤的功效。能有效扩张末梢血管,改善面部微循环,软化角质,对色素沉着有一定的抑制作用。
具体而言,本发明的技术方案是这样实现的:
一种治疗面部色斑的药物制剂,按照重量分数比包括:当归10-20份,白芷10-20份,川芎20-30份,白蒺藜10-20份,白术10-20份,白茯苓10-20份,山药10-20份,白附子10-20份,白僵蚕10-20份,冬瓜仁10-20份,黄芩10-20份,绿豆20-30份,枸杞子5-10份,柿叶5-10份,芦荟5-10份。
为了进一步取得较好的技术效果,一种治疗面部色斑的药物制剂,以上各成分按照重量比为:当归15份,白芷15份,川芎25份,白蒺藜15份,白术15份,白茯苓15份,山药15份,白附子15份,白僵蚕15份,冬瓜仁15份,黄芩15份,绿豆25份,枸杞子8份,柿叶8份,芦荟8份。
为了进一步取得较好的技术效果,一种治疗面部色斑的药物制剂,以上各成分按照重量比为:当归20份,白芷20份,川芎30份,白蒺藜20份,白术20份,白茯苓20份,山药20份,白附子20份,白僵蚕20份,冬瓜仁20份,黄芩20份,绿豆30份,枸杞子10份,柿叶10份,芦荟10份。
一种治疗面部色斑的药物制剂,所述药物制剂在治疗色斑药物或化妆品中的应用。
一种治疗面部色斑的药物制剂,所述药物制剂制备成面膜。
一种治疗面部色斑的药物制剂,所述药物制剂制备成外用制剂。
一种治疗面部色斑的药物制剂,所述药物制剂制备成颗粒剂,散剂,胶囊剂,丸剂,片剂以及临床上可接受的剂型。
本发明药物制备不同剂型仅所用的成型工艺和辅料不同,药物有效成分是一样的,治疗效果也相同或近似。且制剂首选外用制剂,颗粒剂的辅料可为庶糖粉、羟甲基纤维素钠、糊精及矫味剂等中进行选择;散剂可从淀粉、白陶土、磷酸钙、沉降碳酸钙等中选择;胶囊剂的辅料可从二氧化硅、蔗糖、HPC、微晶纤维素、预胶化淀粉、乳糖、糖粉、羧甲淀粉钠、羧甲纤维素钠、羟丙甲纤维素等中进行选择;丸剂的辅料可从淀粉、微晶纤维素、预胶化淀粉等中进行选择;片剂的辅料可从淀粉、糊精、微晶纤维素、预胶化淀粉、硬脂酸镁、乳糖、糖粉、羧甲淀粉钠等中进行选择。
本发明中所用到的中药的药理作用:
当归味甘而重,故专能补血,其气轻而辛,故又能行血,补中有动,行中有补,为血中之要药,因而,它既能补血,又能活血,既可通经,又能活络。川芎为血中之气药,具有活血行气的双向作用,现代药理研究其可扩张微小动、静脉,增加微循环血流,并有抗紫外线及分解黑色素的作用。白蒺藜味苦辛,性微温。入肝、肺经。主要功能为疏肝理郁、行气活血、平肝散风、祛风、明目。白蒺藜含有多种生物碱和甙类,有降血压、降血脂等作用,其中所含的过氧化物分解酶,具有明显的抗衰老作用,美容功效:久服可祛脸上瘢痕,并让肌肤柔嫩润滑。白术,健脾益气,燥湿利水,止汗,安胎的功效。白茯苓,能利水渗湿,而药性平和,利水而不伤正气,为利水渗湿要药。山药,味甘、性平,入肺、脾、肾经;不燥不腻具有健脾补肺、益胃补肾、固肾益精、聪耳明目、助五脏、强筋骨、长志安神、延年益寿的功效主治脾胃虚弱、倦怠无力、食欲不振、久泄久痢、肺气虚燥、痰喘咳嗽、肾气亏耗、腰膝酸软、下肢痿弱、消渴尿频、遗精早泄、带下白浊、皮肤赤肿、肥胖等病症。白附子祛汗斑、瘢痕疙瘩、粉刺等;并常常用于美容添加剂或防腐剂及护肤品中;白附子性热主升为阳明之要药,所以能荣于面,白附子具有燥湿化痰、祛风止痉、解毒散结作用;美容功效有润肤白面、灭瘢除黑。冬瓜仁,润肺,化痰,消痈,利水,治痰热咳嗽,肺痈,肠痈,淋病,水肿,脚气,痔疮,鼻面酒皶。绿豆,性味甘凉,有清热解毒之功。黄芩有清热燥湿,凉血安胎,解毒功效,主治温热病、上呼吸道感染、肺热咳嗽、湿热黄胆、肺炎、痢疾、咳血、目赤、胎动不安、高血压、痈肿疖疮等症。枸杞子,味甘、性平,具有滋阴补血,益精明目等作用,常用于治疗因肝肾阴虚或精血不足而引起的头昏、目眩腰膝酸软、阳痿早泄、遗精、白带过多及糖尿病等症。柿叶,含有很多丹宁酸,可以起到杀菌止痒的作用,对人体的皮肤不但有清洁杀菌,而且还可以帮助滋润皮肤。也含有丰富的维生素,还有相当数量蛋白质和氨基酸,祛斑润肤。芦荟,排毒养颜、美容护肤。白僵蚕,祛风定惊,化痰散结。冬瓜仁,净白肌肤,主治面色枯黄,容颜憔悴,面色晦暗等症状,可去除色斑、老年斑,增白。白芷,白芷粉能改善局部血液循环,消除色素在组织中过度堆积,促进皮肤细胞新陈代谢,进而达到美容美白的作用,能够破宿血,补新血,用于乳痈、发背、瘰疬、肠风、痔瘘,排脓,疮痍、疥癣等,能够止痛生肌,去面皯疵瘢。
方中当归养血活血润肤祛斑,现代药理研究可抑制酪氨酸酶的活性,促进黑色素分解,改善微循环。白芷对致病真菌有一定的抑制作用,还可提高皮肤对紫外线的敏感性,白芷及其制品均有良好的长肌肤、润颜色的作用。白蒺藜可疏肝解郁,山药可补肾固精、补气养阴,白术、白茯苓可补气健脾、渗湿,白附子可解毒散结、敛疮生肌,黄芩、绿豆、白僵蚕可清热解毒、泻火燥湿,现代医学研究证明,白芷、川芎能抑制酪氨酸酶活性,阻止黑色素的生成;绿豆中含有30余种营养物质及微量元素,能减少血清中过氧化脂质形成紫褐素的量,同时对组织有修复再生作用,可增进皮肤弹性及活力,且与黄芩同用有抗菌、抗辐射作用,能消除黄竭斑的诱因;诸药合用,达到活血行气,养血祛斑的作用,标本兼治,愈后复发率低,且使用方便、无毒副作用、便于推广应用。
具体实施方式
对于本领域技术人员而言,显然本发明实施例的细节,而且在不背离本发明的精神或基本特征的情况下,能够以其他的具体形式实现本发明。均应将实施例看作是示范性的,而且是非限制性的,因此旨在将落在权利要求的等同要件的含义和范围内的所有变化囊括在本发明内。
实施例1:一种治疗面部色斑的药物制剂,各成分按照重量比为:
当归15份,白芷15份,川芎25份,白蒺藜15份,白术15份,白茯苓15份,山药15份,白附子15份,白僵蚕15份,冬瓜仁15份,黄芩15份,绿豆25份,枸杞子8份,柿叶8份,芦荟8份。
将以上药物制剂制备成中药面膜,制备方法如下:
(1)按上述重量比称取原料药盐城细末,过120目筛;无菌干燥处理后备用;(2)将中药粉末用蛋清或无菌水调成糊状即为祛斑面膜。
实施例2:一种治疗面部色斑的药物制剂,各成分按照重量比为:
当归20份,白芷20份,川芎30份,白蒺藜20份,白术20份,白茯苓20份,山药20份,白附子20份,白僵蚕20份,冬瓜仁20份,黄芩20份,绿豆30份,枸杞子10份,柿叶10份,芦荟10份。
将以上药物制剂制备成膏剂,制备方法如下:
(1)按上述重量比称取原料药加水煎煮两次,第1次煎煮1小时,第二次煎煮40分钟,合并滤液,过滤后,干燥成细粉,过100目筛;(2)将药液浓缩液加入作为乳化剂的聚乙二醇醚中,吐温-60搅匀,75℃保温。(3)将作为基质的鲸蜡醇,白凡士林加温至融,75℃保温,加入水相中,边加边搅拌。(4)甘油研细后,加入到已经成型的膏剂中(约45℃),搅匀即得。
实施例3:一种治疗面部色斑的药物制剂,各成分按照重量比为:
当归18份,白芷18份,川芎24份,白蒺藜18份,白术18份,白茯苓18份,山药17份,白附子12份,白僵蚕19份,冬瓜仁14份,黄芩18份,绿豆28份,枸杞子8份,柿叶8份,芦荟7份。
将以上药物制剂制备成胶囊剂,制备方法如下:
取以上量的中药按照实施例1中的方法进行煎熬,煎熬后药液进行浓缩,浓缩至一定浓度(比重为1:1左右),冷后加入1.1倍置的乙醇,充分混匀,放置过夜,使其沉淀,次日取其上清液(必要时滤过),沉淀物用少量52%乙醇洗净,洗液与滤液合并,减压回收乙醇后,待浓缩至一定浓度时加一定量水。混匀静置一定时间,使沉淀完全,率过,滤液低温蒸发至稠膏状,干燥浸膏粉末中加入适宜的糊精、预胶化淀粉等辅料,混匀后,加压逐步整到符合要求的粒度,装入胶囊壳,即得胶囊剂。
实施例4:一种治疗面部色斑的药物制剂,各成分按照重量比为:
当归16份,白芷16份,川芎22份,白蒺藜16份,白术16份,白茯苓16份,山药16份,白附子16份,白僵蚕16份,冬瓜仁12份,黄芩17份,绿豆27份,枸杞子9份,柿叶9份,芦荟9份。
将以上药物制剂制备成散剂,制备方法如下:
以上量的中药按照常规方法进行煎熬,煎熬后药液进行浓缩至比重为1:1.2的浓度,冷后加入1.5倍置的乙醇,充分混匀,放置过夜,使其沉淀,次日取其上清液,沉淀物用少量50%乙醇洗净,洗液与滤液合并,减压回收乙醇后,待浓缩至一定浓度时移置放冷处静置一定时间,使沉淀完全,率过,滤液低温蒸发至稠膏状,干燥浸膏粉末中加入适宜的淀粉和磷酸钙辅料,混匀后,过200目筛,即得散剂。
实施例5:动物模型试验
5.1、动物建模
取60只豚鼠适应性饲养1周,分别标记,一周后对各豚鼠背部进行脱毛。先用弯剪将长毛剪短,然后使用宠物专用电推剪将豚鼠背部毛发剃得更短,以便于毛发能够充分接触脱毛溶液,达到完全脱毛的目的。利用不同中波紫外线对豚鼠皮肤色素沉着及α-黑素细胞刺激表达的影响,将豚鼠眼部用面罩遮盖,盛放于敞口笼子中,充分暴露背部裸露皮肤,安抚后放置于光疗机中央,初始光照剂量为200mj/cm2,每次剂量增加20%,出现红斑则增加10%,出现清晰红斑暂停1次治疗,出现水疱、疼痛等,光照暂停至症状缓解。每周照射3次,共照射8周,豚鼠背部皮肤形成稳定而均匀的色素沉着。
5.2、分组及给药
将建模成功的兔子随机分为5组,每组10只,分别为模型组,西药组,中药外用组,中药内服组,中药内服+外用组,4周一个疗程,每组的治疗方法为:
空白对照组和模型组灌以等体积的生理盐水;
中药外用组,按照实施例2中膏剂的制备方法,每天用两次;
中药内服组,按照50mg.kg-1的剂量每日灌胃一次;
中药内服+外用组,按照30mg.kg-1的剂量每日灌胃一次,同时每日用膏剂一次;
西药组,外涂氢醌软膏,每日2次。
5.3、指标观察
5.3.1不良反应观察
在实验的开始,造模后,以及用药2周、4周和6周分别对豚鼠进行拍摄,观察并记录豚鼠背部裸露皮肤色素、红斑及脱屑情况,并及时完成实验记录。
疗效肉眼判定标准
依照其从浅到深依次分为:正常肤色(0分)、淡褐色(1分)、褐色(2分)、深褐色(3分)、黑色(4分)。
观察红斑情况并记录,依次分为:0分(无红斑)、1分(轻度红斑)、2分(中度红斑)、3分(红斑伴消肿、痂皮、坏死)。
观察鳞屑情况并记录,依次分为:0分(无鳞屑)、1分(少量鳞屑)、2分(中等量鳞屑)、3分(显著鳞屑)。
如果色素沉着、红斑、鳞屑情况介于不同分数级之间,则取两者平均数。
不良反应总积分=红斑总积分+鳞屑总积分。
5.3.2光镜下观察黑色素情况
待实验结束后处死动物,取豚鼠各区皮肤组织,做好标记并制成病理切片,进行常规HE染色和Masson-Fontana染色。黑素颗粒和嗜银细胞呈黑色,胶原纤维等呈红色。将制作成的病理片置于显微镜下读片并摄影。光学显微镜下观察HE染色各区皮肤组织病理切片中表皮细胞排列结构变化、表皮厚度及胶原纤维增生、淋巴细胞浸润情况等。对Masson-Fontana染色显示的黑素颗粒,高倍镜下取5个视野,计数表皮层每200个角质形成细胞中所含黑素颗粒数目,同时计算各组黑素颗粒数目的下降率,并进行拍照和记录。
5.4、实验结果
5.4.1肉眼观察对皮肤的不良反应情况
根空白组相比,各组均有不同程度的皮肤的不良反应,其中西药组的不良反应最大,而模型组最小,中药内服或外用均有不同程度的不良反应,内服组的不良反应最小,西药组以及中药各组与模型组相比均有统计学意义(见表1)。
表1.肉眼观察各组豚鼠实验干预过程中皮肤不良反应情况
注:
与模型组比较,#p<0.05,##p<0.01
根模型组相比,各治疗组的黑色素数目均有降低,西药组以及中药各组与模型组相比均有统计学意义(见表2)。
表2豚鼠背部各区皮肤黑素颗粒减少率的比较
组别 | 皮肤数目(块) | 黑素颗粒数目(个) |
空白对照组 | 2 | 9.36±2.01 |
模型组 | 10 | 19.36±2.77 |
西药组 | 10 | 13.60±2.35## |
中药外用组 | 10 | 12.74±1.90## |
中药内服组 | 10 | 13.38±2.39# |
中药内服+外用组 | 10 | 15.38±2.15# |
注:
与模型组比较,#p<0.05,##p<0.01
实施例6
临床实验
6.1、一般资料
2013年4月至2015年10月医院皮肤科和美容院收期间收治因色斑就诊的病人128例,其中男30例,女98例;年龄15~46岁,平均28岁;病程2个月~11年,平均5年。诊断符合《黄褐斑的临床诊断和疗效判定标准》(草案)川中黄褐斑诊断标准。患者用本发明中的药物制剂,未内服和外用其他相关药物及采用其他方法治疗本病。
6.2、治疗方案
该临床试验中的患者分为2组,分别为实验组和对照组,以30天为一个疗程。
实验组,为本发明组方的药物制剂,64例;
对照组,不含本发明中药成分的祛斑面膜,64例。
6.3、疗效标准
疗效标准参考《黄褐斑的现代诊治》相关标准拟定。
痊愈:皮损全部或基本消失,颜色正常或接近正常。
显效:皮损明显缩小,颜色明显变浅。
有效:皮损缩小,颜色变浅。
无效:皮损无明显改变,颜色略淡。
6.4、治疗结果
结果见表3,经统计学分析,两组进行比较,治疗组的显效率高于对照组(表3),具有显著性差异(P<0.05)。
表3两组药物的治疗结果
组别 | 治愈 | 显效 | 有效 | 无效 | 显效率 |
对照组(64例) | 7 | 18 | 16 | 23 | 64.1% |
治疗组(64例) | 35 | 23 | 3 | 3 | 95.3% |
6.5典型病例
病例1:刘某,女,36岁,白领,2014年6月25日来诊。面部色斑自6年前生育孩子后一直有但不明显,就诊时自诉因工作压力大,家中琐事多,且工作性质的改变,经常外出而导致色斑加重,在眼的外侧和鼻翼两侧色斑尤其明显,无其他皮肤方面的问题,开具本发明的面膜,每两日一次,睡前使用,平躺敷面膜30分钟后,用清水洗掉,做基本的护肤,白天在有色斑的部位适量涂抹膏剂,治疗1个月后复诊,色斑淡化很多,继续使用以上方法1个月,色斑基本消失,观察半年,没有复发。
病例2:郑某,男,29岁,快递员,2014年8月18日来医院就诊,因每日奔波于室外且没有防晒措施,色斑日渐形成,皮肤油腻尤其T型区,嘱咐注意清洁,要保持面部干净且干燥,内服本发明的胶囊制剂和膏剂,同时注意防晒,采取遮阳措施,治疗1个月有明显的效果,继续使用膏剂,2个月后再次复诊基本看不出色斑,观察半年,没有复发。
Claims (7)
1.一种治疗面部色斑的药物制剂,其特征在于,按照重量分数比包括:当归10-20份、白芷10-20份、川芎20-30份、白蒺藜10-20份、白术10-20份、白茯苓10-20份、山药10-20份、白附子10-20份、白僵蚕10-20份、冬瓜仁10-20份、黄芩10-20份、绿豆20-30份、枸杞子5-10份、柿叶5-10份、芦荟5-10份。
2.根据权利要求1所述一种治疗面部色斑的药物制剂,其特征在于,以上各成分按照重量比为:当归15份、白芷15份、川芎25份、白蒺藜15份、白术15份、白茯苓15份、山药15份、白附子15份、白僵蚕15份、冬瓜仁15份、黄芩15份、绿豆25份、枸杞子8份、柿叶8份、芦荟8份。
3.根据权利要求1所述一种治疗面部色斑的药物制剂,其特征在于,以上各成分按照重量比为:当归20份、白芷20份、川芎30份、白蒺藜20份、白术20份、白茯苓20份、山药20份、白附子20份、白僵蚕20份、冬瓜仁20份、黄芩20份、绿豆30份、枸杞子10份、柿叶10份、芦荟10份。
4.根据权利要求1-3所述一种治疗面部色斑的药物制剂,其特征在于,所述药物制剂在制备治疗色斑药物或化妆品中的应用。
5.根据权利要求1所述一种治疗面部色斑的药物制剂,其特征在于,所述药物制剂制备成面膜。
6.根据权利要求1中所述一种治疗面部色斑的药物制剂,其特征在于,所述药物制剂制备成外用制剂。
7.根据权利要求6所述一种治疗面部色斑的药物制剂,其特征在于,所述药物制剂制备成颗粒剂、散剂、胶囊剂、丸剂、片剂以及临床上可接受的剂型。
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CN106176406A (zh) * | 2016-08-18 | 2016-12-07 | 丽容堂(深圳)化妆品有限公司 | 身体美白配方及其用途 |
CN106924164A (zh) * | 2017-04-15 | 2017-07-07 | 刘东泰 | 驻颜润肤精华液及其制备方法 |
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CN102670907A (zh) * | 2012-03-26 | 2012-09-19 | 展继军 | 一种治疗面部色斑的纯中药制剂 |
CN104491058A (zh) * | 2014-11-29 | 2015-04-08 | 柯利佳 | 一种治疗面部色斑的制作方法 |
CN104740321A (zh) * | 2015-03-31 | 2015-07-01 | 成都中医药大学附属医院 | 一种祛斑中药组合物及其制备方法 |
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CN102670907A (zh) * | 2012-03-26 | 2012-09-19 | 展继军 | 一种治疗面部色斑的纯中药制剂 |
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CN104740321A (zh) * | 2015-03-31 | 2015-07-01 | 成都中医药大学附属医院 | 一种祛斑中药组合物及其制备方法 |
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CN106176406A (zh) * | 2016-08-18 | 2016-12-07 | 丽容堂(深圳)化妆品有限公司 | 身体美白配方及其用途 |
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