CN102342993B - 一种皮肤抗敏修复外用制剂 - Google Patents
一种皮肤抗敏修复外用制剂 Download PDFInfo
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- CN102342993B CN102342993B CN2011103246673A CN201110324667A CN102342993B CN 102342993 B CN102342993 B CN 102342993B CN 2011103246673 A CN2011103246673 A CN 2011103246673A CN 201110324667 A CN201110324667 A CN 201110324667A CN 102342993 B CN102342993 B CN 102342993B
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Abstract
本发明涉及一种皮肤抗敏修复外用制剂,属中医药制剂技术领域。本发明是基于祖国中医学对敏感或过敏性皮肤多发皮炎,以及激素治疗敏感或过敏性皮炎导致患者皮肤受损加重顽疾发病机理的研究和治疗原则,同时辅以其他组份原料,使药剂中所含有效成分具有清热解毒、抗敏、修复、收敛、增加皮肤弹性和光泽的作用。本发明可制备成霜剂或水剂。该皮肤抗敏修复外用制剂直接作用于患者病灶部位,无毒副作用,疗效好,使用简单,解决了现有采用激素治疗敏感或过敏性皮肤炎症对患者造成更大的皮肤损害,且治疗困难、疗效差的问题。适合敏感、过敏性皮肤及用激光治疗皮炎导致皮肤损害的患者使用。
Description
技术领域
本发明涉及一种皮肤抗敏修复外用制剂,属中医药外用制剂技术领域。
背景技术
皮肤医学专家临床跟踪调查发现,中国现代成年女性每两个人中就有一个是敏感或过敏性皮肤。治疗敏感或过敏性皮肤多发的红斑、丘疹、脱屑、脓疮、瘙痒等病症,需要长期使用糖皮类激素;但使用激素时间长了会出现皮肤萎缩、毛细血管扩张、紫癜 、痤疮色素沉着异常、光过敏、多毛等症状,给现代爱美女性带来无尽的烦恼;激素依赖性皮肤病也成为现代爱美女性的一大顽敌,后续治疗困难,愈后总留有疤痕,治疗效果差。基于此,很多医学科研人员及医务工作者,不惜人力物力持续深入研究,反复试验,以期早日攻克激素依赖性皮炎及皮肤敏感或过敏顽症。
发明内容
本发明的目的在于,提供一种直接作用于患者病灶部位,无毒副作用,疗效好,操作简单;以解决现有采用激素治疗敏感或过敏性皮肤炎症对患者造成更大的皮肤损害,且治疗困难、疗效差等问题的皮肤抗敏修复外用制剂。
本发明是通过如下技术方案来实现上述目的的:
一种皮肤抗敏修复外用制剂,其特征在于:它是由下列重量百分比的原料制成的:
十六、十八烷基醇 2.2%, 甘油硬脂酸酯SE 2.2%,
16/18醇 1%, 角鲨烷 10%,
辛酸/癸酸甘油三酯 10%, 聚二甲基硅氧烷 2%,
维生素E 0.3%, 尼泊金甲酯 0.2%,
尼泊金丙酯 0.1%, 丁羟甲苯 0.1%,
甘油 5%, 丙二醇 5%,
芦芭胶油 3%, 尿囊素 0.3%,
增稠剂 0.5%, 甲基异噻唑啉酮 0.1%,
香料 0.02%, 透明质酸钠 0.05%,
抗敏修复剂 8%, 去离子水 49.93%。
所述的增稠剂为汉生胶、羟乙基纤维素或聚丙烯酰胺/C13-14异链烷烃/月桂醇聚醚-7(SEPIGEL 305)中的一种。
所述的香料为茉莉香、玫瑰香或薰衣草香中的一种。
所述的抗敏修复剂为马齿苋、五倍子、野菊花、栀子等份共混醇提取物。
该皮肤抗敏修复外用制剂是先将马齿苋、五倍子、野菊花、栀子等中药原料取相同份量洗净、烘干,共混后用乙醇提取,再真空浓缩、喷雾干燥后制成抗敏修复混醇物,再加入上述其他原料和去离子水,按制造工艺制备成霜剂直接涂覆患部;也可以制备成水剂直接擦洗患部。
组方剖析:
本发明是基于祖国中医学对敏感或过敏性皮肤多发皮炎、及激素治疗敏感或过敏性皮炎导致患者皮肤受损加重顽疾发病机理的研究和治疗原则,根据中医药理学组方,同时辅以其他组份原料,使药剂中所含有效成分具有很强的清热解毒、抗敏、修复、收敛、增加皮肤弹性和光泽的作用。其中:马齿苋、栀子和野菊花具有很好的凉血、清热解毒,清散痈肿的作用,五倍子能使皮肤、溃疡等局部的蛋白质凝固,具有收敛、止血、减少渗出、抗炎、止痛的作用。
本发明采用的维生素E起滋养、保护皮肤作用。尿囊素是化妆品的特效添加剂,能使皮肤保持水份、滋润、柔软,增加光泽;在药用方面,尿囊素具有促进细胞生长,加快伤口愈合,软化角质蛋白等药理功能,是皮肤创伤的良好愈合剂和抗溃疡药剂。丁羟甲苯其抗氧化能力较强,耐热及稳定性好,既没有特异臭,也没有遇金属离子呈色反应等缺点;丁羟甲苯以柠檬酸或其他有机酸为增效剂,我国规定可用于食用油脂、油炸食品、饼干、方便面、速煮米、果仁罐头、干鱼制品和腌腊肉制品中作抗氧化剂,最大使用量为0.2g/kg。
本发明的防腐剂采用尼泊金甲酯、尼泊金丙酯、甲基异噻唑啉酮;尼泊金甲酯和尼泊金丙酯又称为羟苯甲酯、羟苯丙酯,是国际上公认的广谱性高效食品防腐剂,美国、欧洲、日本、加拿大、韩国、俄罗斯等国都允许在食品中使用尼泊金甲酯和尼泊金丙酯。尼泊金甲酯和尼泊金丙酯是典型的生长抑制剂,通过抑制营养物质向细菌细胞转移,阻止细菌细胞生长而起防腐作用,对人体皮肤无危害。主要用作有机合成、食品、化妆品、医药的杀菌防腐剂,也用作于饲料防腐剂。甲基异噻唑啉酮是一种高效、耐热的水性杀菌剂、防腐剂,对于抑制细菌、真菌、霉菌及霉菌的生长具有很好的作用,可直接在个人护理用品、化妆品中使用。
本发明的硅油采用聚二甲基硅氧烷,是一种不同聚合度链状结构的聚有机硅氧烷,具有无嗅、无色、透明且对人体无毒等特性,聚二甲基硅氧烷用于清爽型膏霜、乳液、洗面奶、化妆水、彩妆、香水等中;添加在化妆品中能提高对皮肤的滋润和保护作用,增强药物对皮肤的渗透能力,提高药效。
本发明的增稠剂采用汉生胶、羟乙基纤维素或聚丙烯酰胺/C13-14异链烷烃/月桂醇聚醚-7中的一种;汉生胶又称黄原胶,溶于冷水和热水,具有高粘度,高耐酸、碱、盐特性、高耐热稳定性等,常被用作增稠剂、乳化剂、悬浮剂、稳定剂,广泛应用于日用化工、食品、医药等领域。羟乙基纤维素(HEC) 是一种白色或淡黄色无味、无毒的纤维状或粉末状固体,具有良好的增稠、悬浮、分散、乳化、粘合、成膜、保护水分和提供保护胶体等特性。聚丙烯酰胺/C13-14异链烷烃/月桂醇聚醚-7是SEPIGEL 305 聚丙烯酰胺聚合物,有增稠剂和乳化剂作用,PH范围3~11,包括在高度酸性介质,碱性介质和氧化介质中,是一种稳定的矿物质添加剂。能乳化所有的油相,不必担心植物油和硅油;能增稠所有的配方,即使是含大量溶剂,极度酸性或板度碱性的配方;具有稳定的乳化体和令人愉快的质感和手感,柔软,舒适,不留油腻感;
本发明的基质采用16/18醇为油脂类化工原料,主要由碳十六醇以及碳十八醇组成。目前市场上销售的16/18醇主要有三个比例,即:
C16:C18=7:3、C16:C18=3:7以及C16:C18=5:5。其中C16:C18=3:7用途最为广泛,主要用途为适用于各类化妆品中作为基质,特别适合于膏霜及乳液;在医药中,可直接用于W/O乳化剂膏体,软膏基质等。
本发明的保湿剂采用甘油、丙二醇、芦芭胶油和透明质酸钠。
甘油是一种无色、无臭、有甜味、澄明的浓稠液体,化学名称为丙三醇。甘油具有很强的吸湿性,纯净的甘油能吸收40%的水分,所以搽在皮肤上能形成一层薄膜,有隔绝空气和防止水分蒸发的作用,还能吸收空气中的水分。冬季人们常用甘油搽于手和面部等暴露在空气中的皮肤表面,能使皮肤保持柔软,富有弹性,不受尘埃、气候等损害而干燥,起到防止皮肤冻伤的作用。
丙二醇像甘油一样,是一种水性的保湿剂,其粘性和吸湿性好,并且无毒,因而在食品、医药和化妆品工业中广泛用作吸湿剂、抗冻剂、润滑剂和溶剂。丙二醇与甘油的最大差别是,丙二醇渗透性更高,保湿度佳,不会有甘油的黏稠性,但对敏感肌肤的刺激性比甘油大,在保养品的配方中,通常是将丙二醇和甘油搭配使用,减小丙二醇使用量,一般丙二醇在5%浓度以下比较安全,可以被视作对皮肤无刺激性。
芦芭胶油主要成分为聚甲基丙烯酸甘油酯,是一种水溶性的不干润滑剂,保湿性能绝佳。芦芭胶油是透明的保湿基质,兼具水溶皮肤柔润剂和油润皮肤柔润剂的优点,具有锁水能力,是一种润湿平衡剂。
透明质酸钠是一种广泛存在于动物和人体的生理活性物质,在人的皮肤、关节滑膜液、脐带、房水及眼玻璃体中均有分布,其溶液具有高黏弹性及仿形性,具有良好的保湿和抗衰老作用。
本发明的油脂采用辛酸/癸酸甘油三酯和角鲨烷。辛酸/癸酸甘油三酯是一种高清爽度无味油脂,是棕榈油/椰子油的衍生物,经热分馏提取。是润滑剂和扩散剂,适合油性皮肤使用,不会堵塞毛孔。具有润滑和使肌肤柔软的效果,并有过滤紫外光的功能。角鲨烷是从深海鲨鱼肝脏中提取的角鲨烯经氢化制得的一种性能优异的烃类油脂,故又名深海鲨鱼肝油。是化学稳定性高,使用感极佳的动物油脂,对皮肤有较好的亲和性,不会引起过敏和刺激,并能加速配方中其他活性成分向皮肤中渗透;且纯净、无色、无异味,还可抑制霉菌的生长。
本发明的乳化剂采用十六、十八烷基醇和甘油硬脂酸酯 SE;十六、十八烷基醇是天然APG液晶型乳化剂,HLB值9.3,手感柔滑滋润,无刺激性,特别适用于功效产品及儿童产品。适用于各种油脂,尤其是植物油、硅油一起调配成稳定的乳液和膏霜。乳化能力强、稳定,保湿性能好,手感光滑。甘油硬脂酸酯 SE 可形成良好的界面膜,有柔软、润滑效果。
上述所有组份配伍后具有清热、凉血、解毒的协同作用,能消除皮肤炎症,收敛、滋润、光泽皮肤,修复受损部位,恢复皮肤弹性和本色,既能清散痈肿、活血化瘀、洁肤增色、修复创面,又能滋养、保护、美容皮肤,适合敏感、过敏性皮肤及用激光治疗皮炎导致皮肤损害的患者使用。
本发明上述的原料组份中,抗敏修复剂的中药原料的药性特点及功效如下:
马齿苋:
药性特点:马齿苋性寒滑利,味酸收敛,入大肠经,善清肠道热毒,又凉血止痢,为治湿热痢疾要药。入肝经,酸收有止血、止带。兼通利下焦,治热淋、血淋。
功效:清热解毒,凉血止血。
马齿苋的化学成分与药理:马齿苋全草含大量去甲肾上腺素和多量钾盐(包括硝酸钾、氯化钾、硫酸钾和其他钾盐)等;马齿苋提取物对痢疾杆菌、伤寒杆菌、绿脓杆菌、大肠杆菌、金黄色葡萄球菌均有不同程度的抑制作用。
栀子:
药性特点:栀子苦寒清降,上清心肺之热,下泄肝胆湿热,通泄三焦之火。清热兼能凉血、解毒、消肿止痛。治热病心烦、高热神昏、湿热黄疸、血热妄行、火毒疮痈等。
功效:泄火除烦,清热利湿,凉血解毒,消肿止痛。
栀子的化学成分与药理:栀子含栀子甙、藏红花素、胆碱、山梨醇、果胶、鞣质、挥发油等;栀子水浸膏和醇浸膏均有利胆作用促进胆汁分泌,降低血清胆红素的含量;还能促进胰腺分泌,有降低胰淀粉酶活性的作用;对金黄色葡萄球菌、脑膜炎双球菌、卡他球菌、多种皮肤真菌均有抑制作用。栀子煎剂有解热、镇静、镇痛、降压、止血、抗炎和加速软组织愈合等作用。
野菊花:
药性特点:野菊花苦寒清泻,味辛发散,归心经,长于清热解毒、清散痈肿。入肝经,清肝火而明目。凡热毒诸证及肝热目疾多可选用。
功效:清热解毒。
野菊花的化学成分与药理:野菊花含野菊花内酯、野菊花三醇、野菊花醇、野菊花酮、木犀草素、矢车菊甙、亚油酸、正二十八烷醇、挥发油等;野菊花水剂在试管内对金黄色葡萄球菌、兔肌胶原诱导的大鼠血小板聚集有明显的抑制作用。其煎剂对金黄色葡萄球菌、大肠杆菌、痢疾杆菌等有一定抑制作用。对多种皮肤真菌、疱疹病毒、流感病毒等也有抑制作用。野菊花还有解热、降压、调整血流动力学和抗心肌缺血的作用,能增强吞噬细胞的吞噬功能。
五倍子:
药性特点:五倍子酸涩收敛,寒能清热,以收中兼泄见长,适用于多种正气不固,滑脱不禁。
功效:敛肺降火,涩肠止泻,固精止遗,敛汗止血。
五倍子的化学成分与药理:五倍子含五倍子鞣质约60%~70%,有的高达80%;鞣质的一般药理作用是:能使皮肤、粘膜、溃疡等局部的蛋白质凝固,而起收敛、止血、减少渗出、抗炎、止痛等作用。
本发明的有益效果在于:
该皮肤抗敏修复外用制剂可制成霜剂和水剂,直接涂抹于患处,对人体皮肤无毒无害。其中的抗敏修复混合物具有很强的清热解毒、抗敏、修复、收敛、增加皮肤弹性和光泽的作用;其他辅佐添加组份均选用能使皮肤柔嫩、光滑、清爽、去角质、且对皮肤无刺激的保湿剂、防腐剂、抗氧化剂、乳化剂、增稠剂、硅油、油脂等,使用方便,达到保湿、止痒、清洁皮肤、修复创面、还原肤色的目的,适合敏感、过敏性皮肤及用激光治疗皮炎导致皮肤损害的患者使用。本发明治疗过程简单方便,疗效显著,制造成本低廉。
本发明的制剂与规格:本品规格可根据市场情况而定,每瓶净含量应符合国家有关规定。
霜剂:20g/瓶、30g/瓶、50g/瓶。
水剂:100ml/瓶、120ml/瓶。
本发明的用法与用量:
霜剂:
每天早晚各一次,使用时需彻底清洁使用部位,直接用该霜剂涂擦患处,15天为1疗程,一般病情2~3个疗程,重症病情5~6个疗程。
水剂:
每天三次(可根据需要使用),用该水剂擦洗患处,15天为1疗程,一般病情3~4个疗程,重症病情7~8个疗程。
注意事项:
(1)、外用,严禁内服。
(2)、停用其他不必要的化妆品和药品。
具体实施方式:
(以100kg原料制取该皮肤抗敏修复外用制剂为例)
该皮肤抗敏修复外用制剂的制备工艺如下:
(1)首先按上述表格中的原料名称和原料重量称取各原料。
(2)将A相的十种原料加热至85℃并搅拌至完全溶解。
(3)将B相的四种原料和去离子水加热至85℃并搅拌至完全溶解。
(4)在搅拌条件下将搅拌至完全溶解的A相加入B相中,并高速均质4分钟,再在85℃恒温下搅拌15分钟后冷却至45~48℃。
(4)将A相和B相的混合液冷却至45~48℃后,加入C相、C1相和D相的原料搅拌均匀,然后冷却至38℃时即可得到本发明的霜剂。
(5)分装后即为成品。
该皮肤抗敏修复外用制剂经耐寒耐热试验证明,稳定性良好。试用实验表明,每天早晚各一次(使用时需彻底清洁使用部位),持续使用15天左右,肉眼即可见抗敏修复有明显的改善。
为了表明本发明对治疗敏感或过敏性皮肤炎症及激素治疗后皮肤炎症的疗效,本发明经过对78例患者的临床观察,其临床数据如下:
(1)、一般资料:78例皮肤炎症患者均为门诊患者,年龄在25~58岁之间,自觉皮肤瘙痒、灼热、疼痛、干燥、脱屑、紧绷感的36例;面部潮红、皮肤萎缩变薄、间断性丘疹反复发作、毛细血管扩张的23例;痤疮似症状泛发、紫癜、酒渣鼻样改变、口周皮炎严重、色素沉着(熟称锅底脸)、皮肤已出现萎缩纹、毛囊炎性脓疮的19例。78例随诊结果统计如下:
(2)、疗效判断标准:
痊愈或显效:自觉症状及体症全部或大部分消失;
有效:自觉症状及体症部分消失或减轻;
无效:自觉症状及体症稍有改变或无改变。
(3)、治疗结果:见下表。
从上表所示可看出,痊愈或显效72例,有效13例,无效6例,总有效率为92.3%,痊愈率为48.7%,显效率为43.6%。从以上治疗结果可以看出,对痤疮似症状泛发、紫癜、酒糟鼻样改变、口周皮炎严重、色素沉着(熟称锅底脸)、皮肤已出现萎缩纹、毛囊炎性脓疮有一定疗效;对潮红、皮肤萎缩变薄、间断性丘疹反复发作、毛细血管扩张疗效好;对皮肤瘙痒、灼热、疼痛、干燥、脱屑、紧绷感治疗效果尤佳。
(4)、典型病例:
病例1:湖南,李梅,女, 25岁;皮肤干燥紧绷并带有脱屑。使用其它产品症状经常反复。使用本产品5天,症状减轻不在有脱屑,8天后明显好转不在有紧绷感,皮肤明显水嫩,13天皮肤不良症状完全消失,皮肤水嫩并红润有弹性。
病例2:广东,项庚妹,女,34岁;皮肤出现萎缩纹并带有色素沉着。用过很多产品,并就医无明显效果。使用本产品3天萎缩纹有好转,7天萎缩纹好转明显、色素沉着肉眼可见变淡。12天萎缩纹消除已不显,色素沉着部分已经淡化不显,皮肤明显有润感。17天皮肤症状消失已无色素沉着。
Claims (3)
1.一种皮肤抗敏修复外用制剂,其特征在于:它是由下列重量百分比的原料制成的:
HLB值9.3的天然APG液晶型乳化剂 2.2%,
甘油硬脂酸酯SE 2.2%,
16/18醇 1%, 角鲨烷 10%,
辛酸/癸酸甘油三酯 10%, 聚二甲基硅氧烷 2%,
维生素E 0.3%, 尼泊金甲酯 0.2%,
尼泊金丙酯 0.1%, 丁羟甲苯 0.1%,
甘油 5%, 丙二醇 5%,
芦芭胶油 3%, 尿囊素 0.3%,
增稠剂 0.5%, 甲基异噻唑啉酮 0.1%,
香料 0.02%, 透明质酸钠 0.05%,
抗敏修复剂 8%, 去离子水 49.93%;
所述的抗敏修复剂为马齿苋、五倍子、野菊花、栀子等份共混醇提取物。
2.根据权利要求1所述的一种皮肤抗敏修复外用制剂,其特征在于:所述的增稠剂为汉生胶、羟乙基纤维素或聚丙烯酰胺/C13-14异链烷烃/月桂醇聚醚-7中的一种。
3.根据权利要求1所述的一种皮肤抗敏修复外用制剂,其特征在于:所述的香料为茉莉香、玫瑰香或薰衣草香中的一种。
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