CN102688483B - 一种治疗皮肤病的组合物、含有该组合物的制剂及其制备方法 - Google Patents
一种治疗皮肤病的组合物、含有该组合物的制剂及其制备方法 Download PDFInfo
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Abstract
本发明提供了一种治疗皮肤病的组合物,包括不饱和脂肪酸、胶原蛋白、氨基酸、维生素和无机盐。本发明进一步提供了向所述组合物中加入赋形剂制成的各种制剂及其制备方法。本发明组合物及其制剂在临床实验中效果显著,对神经性皮炎(牛皮癣)、青春痘、手足癣、灰甲、鸡眼、甲沟炎等皮肤病在短时间内疗效显著。
Description
技术领域
本发明属于皮肤用化妆品或药品领域,具体地说涉及施用于皮肤的组合物,用于直接使用或以化妆品或药物制剂的形式局部施用于皮肤,改善和治疗皮肤病。还涉及含有该组合物的制剂及其制备方法。
背景技术
目前,随着社会的进步和人们生活水平的提高,强调生活质量,讲究身体健康、皮肤健美的保健意识也越来越深入人心,由此市场上各种化妆品如雨后春笋,层出不穷。目前,国内外的化妆品存在几个问题,治标不治本,绝大多数的化妆品仅有保湿功能,并不从根本上改变皮肤的生理状态;部分化妆品提取加工成本高,并且经常遇到原料易变质和产生异味,需要特殊的防腐剂等化学成分,这样往往达不到卫生标准,对皮肤没有益处反而会损伤皮肤,本产品主要通过天然抗氧化剂来防止产品变质。
皮肤是人体对抗外部的第一层保护,其在出现代谢缺陷、受外力磨擦或压迫、细菌入侵等情况时,出于保护本能,通过表皮增生加以对抗,形成鳞片状增生(牛皮癣)、老茧、裂片状增生(手足癣)、鸡眼等皮肤病变。人体细胞需要比较多的营养成分,例如人体必需的不饱和脂肪酸、必需的氨基酸等等,人体通过各种途径吸收利用这些营养成分,并运载至作为对抗外界的第一道屏障的皮肤细胞。一旦营养成分不足,就会出现免疫力降低,致使皮肤细胞老化、甚至出现病变。
在临床实践与日常生活中,很多患有上述皮肤疾病的患者,在皮肤表层出现病变的时候,使用药品或化妆品进行改善,反而导致护理不当造成皮肤内部水份与皮脂失去平衡。并且,在长期使用这类药品或化妆品后,会导致皮肤反馈性地刺激皮脂腺,使其分泌异常,进一步加重了皮肤对外界刺激的敏感性,导致皮肤破裂、增生、生斑,脓疮等症状。
在对已公开专利的检索中发现,在治疗皮肤疾病方面的专利都不可避免的含有刺激性成分,根据临床使用的经验,可以得知,长期使用这类药品或化妆品将导致耐药性和刺激性增加,降低皮肤的自身修复能力,并引起更多的副作用。
因此,研制一种对皮肤无刺激,集治疗和预防皮肤病和延缓皮肤衰老、修复皮肤功能等功效于一体的外用皮肤制剂是非常有必要的。
发明内容
本发明解决的技术问题是提供一种新的对皮肤无刺激,可直接使用或以化妆品或药物制剂的形式局部施用于皮肤,预防、改善和治疗皮肤相关疾病,修复皮肤功能的组合物,以及由该组合物制成的制剂及其制备方法。
本发明提供了一种新的治疗皮肤病的组合物,包括不饱和脂肪酸、胶原蛋白、氨基酸、维生素和无机盐。其中,所述不饱和脂肪酸可以是油酸、亚油酸、亚麻酸、花生四烯酸等人体必需不饱和脂肪酸中的一种或几种。本发明使用的不饱和脂肪酸优选精提后的植物不饱和脂肪酸,精提过程可以采用增溶、超临界流体萃取、超声提取等。植物不饱和脂肪酸的原料可以选用各种植物油,例如橄榄油、菜籽油、葵花油、茶油等。胶原蛋白是一类蛋白的总称,可以是从鱼、猪、牛等动物原料提取得到。胶原蛋白可以是生物技术提取的胶原蛋白,或是经过化学提取方法提取的胶原蛋白。所述氨基酸为人体必须氨基酸中的一种或几种,其中,人体必需氨基酸为赖氨酸、色氨酸、苯丙氨酸、蛋氨酸、苏氨酸、异亮氨酸、亮氨酸、缬氨酸8种氨基酸,也可以包括组氨酸、精氨酸。所述维生素优选维生素E和/或维生素A。所述无机盐优选钠盐和/或钾盐。
在上述组合物中,不饱和脂肪酸的重量百分含量为65%~90%,其它组分的含量如下:胶原蛋白0.1%~15%,氨基酸0.1%~10%,维生素0.1%~10%,以及无机盐0.05%~1%。其中,不饱和脂肪酸可以是油酸、亚油酸、亚麻酸、花生四烯酸等中的一种或几种,多种不饱和脂肪酸可以不同比例进行混合。氨基酸可以是人体必须氨基酸中的一种或几种,氨基酸种类的选用及其组合比例可以根据具体情况进行选择。维生素优选维生素E和维生素A,优选含量为维生素E 0.1%~1%和维生素A 0.1%~1%。无机盐优选钠盐和钾盐,优选含量为钠盐0.05%~0.9%、钾盐0.05%~0.1%。其中,钠盐的形式可以是氯化钠,钾盐的形式可以是氯化钾。
本发明进一步提供了含有上述组合物的制剂,是在上述组合物中加入赋形剂来制备适于使用的不同剂型,例如,可加入药学上可成膏状的赋形剂来制备膏状涂剂,必要时还可加入药学上可接受的表面活性剂来达到更好的制剂效果,此外,也可加入药学上常用可成液体状的赋形剂来制备液体涂剂、液体喷雾剂以及由上述制剂进一步加工制成的面膜。需要说明的是,制备制剂是为了在某些环境下更方便的应用本发明组合物,在一些具体临床应用情况,也可以直接将本发明组合物不添加任何赋形剂(和/或表面活性剂)及香料,直接应用于患者皮肤患处。
所述制剂中不饱和脂肪酸的含量为50%~70%,胶原蛋白含量为0.1%~10%,氨基酸0.1%~6%,维生素0.1%~7%,无机盐0.05%~1%,赋形剂10%~25%和植物香料1%~5%。其中,维生素优选维生素E 0.1%~1%和维生素A 0.1%~1%,无机盐优选钠盐0.05%~0.9%、钾盐0.05%~0.1%。赋形剂可以是药学上接受的各种辅料或表面活性剂,还可以根据需要加入天然植物香料。
本发明还提供了上述制剂的制备方法,包括如下步骤:
(1)按所述制剂配方取料;
(2)将胶原蛋白及水溶性原料溶解得到水溶性凝胶基质,其中水溶性原料是指氨基酸、维生素以及无机盐;
(3)向不饱和脂肪酸中加入赋形剂及适量表面活性剂混匀,再缓缓加入步骤(2)中得到的水溶性凝胶基质匀浆,乳化均匀得到膏状制剂或液体制剂;
(4)成品并包装。
其中,不饱和脂肪酸可以选自油酸、亚油酸、亚麻酸、花生四烯酸中的一种或几种,为植物不饱和脂肪酸经过精提后得到,精提过程可以采用增溶、超临界流体萃取、超声提取等,优选凝固高速离心方法精提不饱和脂肪酸,该方法是利用饱和脂肪酸与不饱和脂肪酸凝固点的不同从而进行分离精制。植物不饱和脂肪酸的原料可以选用各种植物油例如橄榄油、菜籽油、葵花油、茶油等。胶原蛋白可以是生物技术提取的胶原蛋白,或是经过化学提取方法提取的胶原蛋白。
本发明组合物可以直接施用于皮肤,或制成化妆品或制剂施用于局部皮肤。所述制剂可以是用于皮肤的各种剂型,如膏状涂剂、液体涂剂、液体喷剂等剂型。也可以是与其它材料结合,如将膏状物或液体状物通过涂覆在一层薄膜背衬上做成面膜封装,面膜背衬材质采用纯棉、无纺布或合成纤维材料。
本发明组合物的药理分析如下:本发明组合物中的组分均为人体必需的营养成分,并且多数必须从外界补充。组成成分均可食用,安全性高。所有营养成分不必经过体循环,而是直接以透皮吸收的形式提供给皮肤细胞,保证皮肤细胞的营养,提高其免疫力,让皮肤恢复自身的能力,对抗细菌的入侵和病毒的侵害。
根据中医皮肤渗透疗法理论,本产品富含大量活性营养物质及营养成分,能快速渗透皮肤,迅速补充皮肤细胞缺失的营养,从而增强细胞再生,清除阻塞毛孔的角质层及重金属和化学污染物,收缩毛孔,并且有助于对粉刺、脓包、疖疮,皮肤表面溃疡等症的治疗。
此外,本发明产品可以补充皮肤所需要的营养,改善皮肤的微循环,增强细胞自身的免疫力,维持皮肤生长和修复所需的正常生理成分,维持皮肤组织的正常形态和功能,增强自身抵御外界伤害的能力,保持皮肤组织表层的健康。
本发明组合物及其制剂在临床实验中效果显著,对神经性皮炎(牛皮癣)、青春痘、手足癣、灰甲、鸡眼、甲沟炎等皮肤病在短时间均显现出效果,疗效显著。
具体实施方式
下面结合实施例对本发明作进一步说明,以下实施例将有助于本领域的普通技术人员进一步理解本发明,但不以任何形式限制本发明。
实施例1:膏状制剂
按以下组分和比例取料:首先将橄榄油经凝固高速离心方法精提不饱和脂肪酸,取精提后的不饱和脂肪酸65克、赖氨酸、色氨酸、苯丙氨酸、蛋氨酸、苏氨酸、异亮氨酸、亮氨酸、缬氨酸混合物2克、精制鱼鳞胶原多肽5克、氯化钠0.9克、氯化钾0.1克、维生素E 0.1克、维生素A 0.1克,此外添加蜂胶25克、植物香料1.8克。先将胶原蛋白、氨基酸以及无机盐溶解于水中,得到水溶性凝胶基质匀浆,向溶解了维生素的不饱和脂肪酸中加入蜂胶25g混匀,再向其中缓缓加入上述水溶性凝胶基质匀浆,乳化均匀得到膏状物,成品并包装。
实施例2:膏状制剂
制备方法同实施例1所述,其中取料组分及含量如下:精提橄榄油 70g,鱼鳞胶原多肽0.1g,赖氨酸等八种氨基酸混合物0.1g,维生素A 0.05g,维生素E 0.05g,NaCl 0.05g,蜂胶25g,以及植物香料4.65g。
实施例3:膏状制剂
制备方法同实施例1所述,其中取料组分及含量如下:精提菜籽油65g,鱼鳞胶原多肽10g,赖氨酸等八种氨基酸混合物6g,维生素A 3.5g,维生素E 3.5g,NaCl 0.5g,KCl 0.1g,蜂胶10g,以及植物香料1.4g。
实施例4:膏状制剂
制备方法同实施例1所述,其中取料组分及含量如下:精提葵花油60g,鱼鳞胶原多肽5.5g,赖氨酸等八种氨基酸混合物1.5g,维生素A 2.0g,维生素E 1.5g,NaCl 0.4g,KCl 0.1g,凡士林24g,以及植物香料5g。
实施例5:膏状制剂
制备方法同实施例1所述,其中取料组分及含量如下:精提茶油 55g,鱼鳞胶原多肽8g,赖氨酸等八种氨基酸混合物3g,维生素A 3.0g,维生素E 2.0g,NaCl 0.9g,KCl 0.1g,凡士林25g,以及植物香料3g。
实施例6:膏状制剂
制备方法同实施例1所述,其中取料组分及含量如下:精提橄榄油 50g,鱼鳞胶原多肽10g,赖氨酸等八种氨基酸混合物6g,维生素A 3.5g,维生素E 3.5g,NaCl 0.9g,KCl 0.1g,凡士林22g,以及植物香料4.0g。
实施例7:液体制剂
按以下组分和比例取料:首先将橄榄油经凝固高速离心方法精提不饱和脂肪酸,取精提后的不饱和脂肪酸80克、赖氨酸、色氨酸、苯丙氨酸、蛋氨酸、苏氨酸、异亮氨酸、亮氨酸、缬氨酸混合物6克、鱼鳞胶原多肽10克、氯化钠0.9克、氯化钾0.1克、维生素E 1.5克、维生素A 1.5克。先将胶原蛋白、氨基酸以及无机盐溶解于水中,得到水溶性凝胶基质匀浆,向溶解了维生素的不饱和脂肪酸中缓缓加入上述水溶性凝胶基质匀浆,乳化均匀得到液体状物,成品并包装。
实施例8:面膜
将实施例1或实施例7中的产品通过涂覆在一层薄膜背衬上做成面膜封装。所说的面膜背衬材质采用纯棉、无纺布或合成纤维材料。
临床实验例
本发明制剂曾大量应用于临床,得到了有效的信息反馈,临床应用中具有改善皮肤血液循环、增强肌肤免疫力与皮肤营养状态,起到软化角质层、悦泽面容和促进色素吸收等作用,能够清除堵塞毛孔的的角质层及种技术和化学污染物,预防辐射,营养皮肤;富含大量活性营养物质及营养成分,能快速渗透皮肤,补充皮肤细胞缺失的营养,起效快;可以收缩毛孔,增强细胞再生,补充皮肤所需要的营养,增强细胞自身的免疫力。本发明制剂用于治疗皮肤病的临床观察实验如下。
临床观察实验一:治疗牛皮癣。
1、一般资料:牛皮癣患者共40例,全部病例随机分为对照组和研究组,每组20例患者。
2、研究方法:
对照组患者外涂临床常用糖皮质激素,每日早晚各1次,七天后,开始外涂阿奇霉素膏剂,每日3次。研究组患者使用本发明实施例1中的膏状制剂,每日早晚各1次,涂覆患处,分别于7天、1个月、2个月观察两组患者皮肤恢复情况。
3、治疗效果如下:
对照组患者在使用糖皮质激素7天后,皮肤有所改善,开始变得光滑;7天后换用阿奇霉素膏剂,继续治疗3周,即治疗1个月后,观察到牛皮癣部分鳞片开始变软、脱落。在用药治疗2个月后,情况与用药1个月时差别不大,患者牛皮癣得到改善,但没有痊愈的。
研究组患者在使用本发明制剂7天后,皮肤有所改善,开始变得光滑,但不如对照组明显;在使用1个月后,牛皮癣部分鳞片开始变软、脱落,与对照组比较差别不大;在使用2个月后,20名患者中有18名患者基本痊愈,1名患者明显改善,1名患者没有改善。
临床疗效显示,在开始使用初期,本发明制剂对牛皮癣的治疗效果没有激素和抗生素起效快,但是在使用2个月后,本发明制剂对牛皮癣的治疗效果明显优于临床常用激素类和抗生素类药物。以上结果说明,使用本发明制剂能有效治疗牛皮癣等皮肤疾病,缩短皮肤再生时间,减少副作用。
临床观察实验二:治疗青春痘。
1、一般资料:青春痘患者共50例,全部病例随机分为对照组和研究组,每组25例患者。
2、研究方法:对照组患者口服临床常用药异维A酸胶,每日2次。研究组患者使用本发明制剂,每日早晚各1次,涂覆患处,分别于使用2天、7天、2个星期后观察两组患者皮肤恢复情况。
3、治疗效果如下:
对照组患者口服异维A酸胶2天后,皮肤有所改善;服用7天后,皮肤改善与此前相比不明显;服用2个星期后,情况与用药1个星期时差别不大,患者青春痘得到改善,但是没有痊愈的。
研究组患者使用本发明制剂2天后,皮肤有所改善,开始变得光滑,一天前新长青春痘开始去脓包,优于对照组;使用7天后,9名患者所有青春痘脓包消失,13名患者部分消失,3名患者改善不明显,明显优于对照组;使用2个星期后,25名患者中有22名患者痊愈,2名患者明显改善,1名患者没有改善。
临床疗效显示,使用本发明制剂2天后,治疗效果即显示出优于对照组;使用7天后,治疗效果明显优于对照组;使用本发明制剂2个星期后,本发明制剂对青春痘的治疗效果与对照组相比,效果显著。以上结果显示,使用本发明制剂治疗青春痘患者,能明显缩短皮肤再生时间,减少副作用。
此外,提供几例典型临床病例进行效果说明,具体如下:
临床病例1:李××,男,61岁,由于常年开车,脚步长有鸡眼,使用本产品两周后,鸡眼开始软化,两月后脱落,痊愈。同时也使用本产品,在老人斑,一个月后,大部分老人斑变浅,少部分消失。
临床病例2:白××,男,60岁,由于早年从事体力工作,脚部的老家较厚,每两天必须进行去角质层,使用本产品一周后,角质层软化,不再需要用刀去除角质层,一个月后,老茧变薄,类似一般皮肤,同时脚部的皮肤变得细滑,粉嫩。
临床病例3:常××,女,58岁,得湿疹,使用本产品后一周,即痊愈。
临床病例4:王××,女,21岁,青春痘情况比较严重,使用本产品,用本品薄涂患处2-3次/日,新长青春痘,当天使用,两天后红肿消退,时间长的青春痘,两个星期后内红肿消退,毛囊内的脓球消失,患处平滑,余下的色素一个月后消失,达到了观感标准。
临床病例5:吴××,男,35岁,冬天,得牛皮癣,吃药打针多次,不见改善,使用该产品,用本品薄涂患处2-3次/日,即时止痒,两周后鳞片状患皮脱落,患处变得平滑,一个月后余下的红色新皮及色素沉着,消失,达到了观感标准。
临床病例6:尹××,男,36岁,脚部甲沟炎,适用本产品,一个月后,即有明显改善。
以上病例说明本发明组合物及其制剂对于临床常见皮肤疾病都具有很好的治疗功效。
Claims (4)
1.一种局部施用于皮肤的治疗皮肤病的制剂,其特征在于,由如下重量百分含量的组分组成:不饱和脂肪酸50%~70%、胶原蛋白0.1%~10%、氨基酸0.1%~6%、维生素0.1%~7%、无机盐0.05%~1%、赋形剂10%~25%和植物香料1%~5%;所述无机盐为钠盐和/或钾盐;
所述不饱和脂肪酸为花生四烯酸、油酸、亚麻酸和亚油酸中的一种或几种;
所述氨基酸为赖氨酸、色氨酸、苯丙氨酸、蛋氨酸、苏氨酸、异亮氨酸、亮氨酸、缬氨酸的混合物;
所述维生素为维生素E和维生素A。
2.如权利要求1所述的制剂,其特征在于,所述维生素含有维生素E0.1%~1%和维生素A0.1%~1%。
3.如权利要求1所述的制剂,其特征在于,所述无机盐含有钠盐0.05%~0.9%和钾盐0.05%~0.1%。
4.权利要求1所述制剂的制备方法,包括如下步骤:
(1)按所述制剂配方取料;
(2)将胶原蛋白及水溶性原料溶解,得到水溶性凝胶基质匀浆;
(3)向不饱和脂肪酸中加入赋形剂混匀,再缓缓加入其它原料,乳化均匀得到制剂;
(4)成品并包装。
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HK12102381.9A HK1161510A2 (en) | 2011-03-22 | 2012-03-08 | A composition for treating skin diseases |
KR1020120027771A KR101445730B1 (ko) | 2011-03-22 | 2012-03-19 | 피부병을 치료하기 위한 조성물, 상기 조성물을 함유하는 제제 및 그 제조 방법 |
JP2012064489A JP5622775B2 (ja) | 2011-03-22 | 2012-03-21 | 皮膚病の治療用組成物、並びにそれを用いた製剤及びその調製方法 |
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CN106902388A (zh) * | 2015-12-22 | 2017-06-30 | 上海邦中高分子材料有限公司 | 一种3d打印生物纸及其制备方法和用途 |
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CN108355130A (zh) * | 2018-05-22 | 2018-08-03 | 界首市菁华科技信息咨询服务有限公司 | 一种治疗牛皮癣的温敏型胶原复合消炎凝胶喷剂及其制备方法 |
CN114177348B (zh) * | 2021-12-14 | 2023-02-10 | 华北理工大学 | 一种医用液体敷料及其制备方法和应用 |
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