CN111643717B - 用于色素性皮肤病的医用敷料及其制备方法 - Google Patents

用于色素性皮肤病的医用敷料及其制备方法 Download PDF

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CN111643717B
CN111643717B CN202010454168.5A CN202010454168A CN111643717B CN 111643717 B CN111643717 B CN 111643717B CN 202010454168 A CN202010454168 A CN 202010454168A CN 111643717 B CN111643717 B CN 111643717B
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medical dressing
parts
glutathione
arbutin
hyaluronic acid
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CN111643717A (zh
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沈静飞
张文娅
陈懂勤
梁国锋
索玉龙
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Hainan Finsen Medical Devices Co ltd
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Abstract

本发明涉及医药领域,特别涉及用于色素性皮肤病的医用敷料及其制备方法。该医用敷料,包括:γ‑聚谷氨酸、透明质酸、熊果苷、谷胱甘肽和左旋VC磷酸酯。本发明利用聚谷氨酸的特性和功效,同时负载透明质酸、熊果苷、谷胱甘肽和左旋VC磷酸酯,在促进创面修复的同时,可以抑制酪氨酸酶活性、控制黑色素合成与分泌、抵御外界不良因子的刺激等多个途径,减少黑色素生产,以实现更好的治疗效果。

Description

用于色素性皮肤病的医用敷料及其制备方法
技术领域
本发明涉及医药领域,特别涉及用于色素性皮肤病的医用敷料及其制备方法。
背景技术
色素性皮肤病是由于黑素细胞和黑素生成异常造成,可由遗传及环境因素引起,它是皮肤病中的一类常见疾病。虽然大多数色素性皮肤病对健康不会构成重大危害,但有碍美容,由此对患者造成精神上的压力,影响其工作、学习、及日常生活。随着人们物质生活水平的提高,临床上,因色素性疾病前来就诊的病例越来越多。
黑色素皮肤病是指黑素生成增多所造成的色素性皮肤病,包括:雀斑、色素痣、咖啡斑、黄褐斑、雀斑样痣、黑变病、太田痣、色素性毛表皮痣、泛发黑子病、色素性玫瑰糠疹、斑痣、先天性色素痣等。医学上,目前对不同程度的黑色素皮肤病有不同的治疗方法。中国专利CN103495199A公开了一种治疗激光灼伤和烧烫伤的水凝胶伤口敷料及其制备方法,该水凝胶敷料其活性成分包括抗菌剂、保湿剂和稳定剂,抗菌剂抑制激光灼伤伤口及周围的细菌的黏附和生长,并能杀灭灼伤部位多种致病菌,有效促进灼伤伤口的愈合,且本发明中采用的抗菌剂不会产生耐药性;保湿剂可保持伤口的湿润,促进创伤面的愈合,预防疤痕的形成,减轻伤口疼痛;稳定剂可使水凝胶保持长时间的抗菌有效性。实验证明,本发明的水凝胶敷料具有效缓解伤口疼痛、控制局部感染、保持创面皮肤湿润、保护皮肤、加快促进创面和伤口愈合、预防疤痕形成的作用,可用于激光灼伤后的皮肤创面(如激光除痣等)及烧烫伤创面的治愈。中国专利CN108543106A公开了一种祛斑美白的皮肤护理敷料及其制备方法,其包含以下重量份的组分:透明质酸0.02-3份,苯乙烯-丙烯酸酯共聚物0.2-8份,卡波姆0.02-3份,甘油0.3-15份,尿囊素0.04-2份,熊果苷0.05-10份,维生素C乙基醚0.05-8份,藏红花提取物0.05-10份,辛酰羟肟酸0.01-1份,己二醇0.4-6份,pH调节剂0.01-1份,水33-99份;该发明的祛斑美白的皮肤护理敷料同时具有物理遮挡保护、加速皮肤代谢、抑制黑色素生成和抗菌消炎,消除皮肤炎症,防止色素沉着,多方位消除色斑,美白肌肤的功效。现有技术中虽然有对于皮肤色素的药用敷料,但往往成分复杂、成本高,且部分引入银离子作为抗菌剂,容易产生潜在危害。
发明内容
本发明旨在至少解决现有技术中存在的技术问题之一。为此,本发明提供了用于色素性皮肤病的医用敷料及其制备方法。
本发明的技术方案如下文所示。
本发明一方面提供了用于色素性皮肤病的医用敷料,包括:γ-聚谷氨酸、透明质酸、熊果苷、谷胱甘肽和左旋VC磷酸酯。
γ-聚谷氨酸(γ-polyglutamic acid,γ-PGA)由L-谷氨酸或D-谷氨酸通过γ-酰胺键结合而成,是一种来自天然微生物发酵、环境友好、对人体安全无害的高分子聚合物。γ-PGA既有极强的保湿性、锁水性、水溶性、粘结性、增粘性、悬浮性、成膜性、缓释性、可生物降解性等卓越的理化性能,又有清除氧自由基、修复老化细胞、抑制酪氨酸酶活性、减少黑色素生成、减轻皮肤色素沉着等丰富的生物学功效。透明质酸(hyaluronic acidhyaluronan,HA)是一种由D-葡萄糖醛酸和N-乙酰氨基葡萄糖双塘重复单元交替构成的高级直链粘多糖。这种高分子聚合物具有高度黏弹性、可塑性、渗透性,良好的生物相溶性等特性。熊果苷又名熊果素,是一种天然存在的糖苷类物质,具有美白祛斑、保湿的作用,美白机制主要通过抑制黑色素细胞中酪氨酸酶、阻断多巴及多巴醌的合成,有效遏制黑色素的合成;然而,熊果苷不稳定,在偏酸或偏碱性以及较高温度下,存在一定程度的分解趋势,分解后会产生对苯二酚、葡萄糖。其中,对苯二酚虽然对黑色素的形成具有很强的抑制作用,但是,其对皮肤具有一定的刺激性,会引起过敏反应;同时,对苯二酚见光容易被氧化,生成红褐色物质,在皮肤表面会产生棕褐色斑点。谷胱甘肽是广泛分布于植物和微生物细胞内最主要、含量最丰富的含巯基的低分子肽,是一种由谷氨酸、半胱氨酸和甘氨酸组成的天然活性肽,谷胱甘肽通常含有还原型谷胱甘肽和氧化型谷胱甘肽两种存在形式;通常只有还原型谷胱甘肽才具有生物活性,因为还原型谷胱甘肽中的半胱氨酸侧链基团上的巯基可以保护重要的酶蛋白不被氧化,从而保证酶的生理活性;还原型谷胱甘肽可以作为抗氧化剂,在人体内不仅可以保护重要的蛋白质不被氧化,还可以清除人体新陈代谢过程中产生的自由基。VC磷酸酯(L-ascorbic acid-2-phosphate,APP)又名L-抗坏血酸-2-磷酸酯,左旋VC磷酸酯即左旋L-抗坏血酸-2-磷酸酯,是VC的稳定衍生物,主要构成成分是左旋VC和磷,左旋VC磷酸酯具有左旋VC的所有功效,但与左旋VC相比,更耐受高温、高压、高湿等恶劣条件。本发明人通过大量科学研究发现,将-聚谷氨酸、透明质酸、熊果苷、谷胱甘肽和左旋VC磷酸酯搭配后,使得各个组分之间具有了协同增效的功能,能够在一定程度上克服熊果苷和谷胱甘肽的不稳定性,使其更好的发挥功效,并且组合后对于色素性疾病有非常好的治愈效果,且缓解了治愈过程中的不适。
根据本发明的一些实施方式,所述医用敷料,以重量份计,包括:γ-聚谷氨酸20~35份、透明质酸30~50份、熊果苷6~18份、谷胱甘肽4~12份和左旋VC磷酸酯25~45份。
根据本发明的一些实施方式,所述医用敷料,以重量份计,包括:γ-聚谷氨酸25~30份、透明质酸35~45份、熊果苷10~14份、谷胱甘肽6~10份和左旋VC磷酸酯30~40份。
本发明人通过大量的科学研究,发现了各组分的最佳用量配比,使得各组分可以协同作用,共同发挥作用,避免色素的沉积,并降低愈合过程中的瘙痒和刺痛,提高舒适性。
根据本发明的一些实施方式,所述γ-聚谷氨酸的分子量为20~200万。
根据本发明的一些实施方式,所述透明质酸的分子量不大于20万。
特定分子量的γ-聚谷氨酸和透明质酸与本发明其它组分搭配时效果更佳。
根据本发明的一些实施方式,所述医用敷料为乳剂、凝胶剂或膏剂。
本发明对医用敷料的剂型没有特别的规定,可以根据实际需求,添加常规辅料制成常规剂型。
本发明另一方面还提供过一种上述医用敷料的制备方法,包括以下步骤:
1)将γ-聚谷氨酸和水混合,搅拌溶解,得到A液;
2)将透明质酸、谷胱甘肽、左旋VC磷酸酯和水,混合搅拌,得到B液;
3)将A液和B液混合均匀后,在搅拌状态下,加入熊果苷,混合均匀,得到医用敷料。
根据本发明的一些实施方式,步骤3)中,将A液和B液混合均匀后,调节pH值为6~8,并升温至40~60℃,在搅拌状态下,加入熊果苷,混合均匀,得到所述医用敷料。
根据本发明的一些实施方式,步骤1)中,所述γ-聚谷氨酸和水的质量比为1:30~60。
根据本发明的一些实施方式,所述A液和所述B液的体积比为1:6~9。
本发明通过调整物料的加入顺序,加入温度和pH,可以最大程度上避免熊果苷的氧化,并增加谷胱甘肽的稳定性。
本发明另一方面还提供一种如上所述的医用敷料或如上所述的制备方法在制备祛除色素的药物或护肤品中的应用。
本发明人通过大量的科学研究,发现将γ-聚谷氨酸、透明质酸、熊果苷、谷胱甘肽和左旋VC磷酸酯组合后,得到的医用敷料,对于愈合过程中减少黑色素的生成有非常好的效果,本发明利用聚谷氨酸的特性和功效,同时负载其它活性成分,在促进创面修复的同时,可以抑制酪氨酸酶活性、控制黑色素合成与分泌、抵御外界不良因子的刺激等多个途径,减少黑色素生产,以实现更好的治疗效果。本发明的准备方法通过特定的混合方式,可以避免制备过程中熊果苷和谷胱甘肽的氧化,最大程度的发挥其功效,且工艺步骤简单,易于质量控制和工业化生产。
具体实施方式
以下结合具体的实施例对本发明的技术方案做进一步说明,但本发明并不限于这些具体实施方式。实施例中所使用的试验方法如无特殊说明,均为常规方法;所使用的材料、试剂等,如无特殊说明,均可从商业途径得到的试剂和材料。
实施例中,γ-聚谷氨酸的分子量为100万;透明质酸的分子量10万。
实施例1医用敷料的制备
组成:
γ-聚谷氨酸30g、透明质酸40g、熊果苷12g、谷胱甘肽8g和左旋VC磷酸酯35g。
制备:
1)将γ-聚谷氨酸和900g水混合,搅拌溶解,得到A液;
2)将透明质酸、谷胱甘肽、左旋VC磷酸酯和8000g水,混合搅拌,得到B液;
3)将A液和B液混合均匀后,调节pH值为7,并升温至50℃,在搅拌状态下,加入熊果苷,混合均匀,得到所述医用敷料。
实施例2医用敷料的制备
组成:
γ-聚谷氨酸25g、透明质酸45g、熊果苷10g、谷胱甘肽6g和左旋VC磷酸酯40g。
制备:
1)将γ-聚谷氨酸和1000g水混合,搅拌溶解,得到A液;
2)将透明质酸、谷胱甘肽、左旋VC磷酸酯和9000g水,混合搅拌,得到B液;
3)将A液和B液混合均匀后,调节pH值为7,并升温至50℃,在搅拌状态下,加入熊果苷,混合均匀,得到所述医用敷料。
实施例3医用敷料的制备
组成:
γ-聚谷氨酸30g、透明质酸35g、熊果苷14g、谷胱甘肽10g和左旋VC磷酸酯30g。
制备:
1)将γ-聚谷氨酸和1000g水混合,搅拌溶解,得到A液;
2)将透明质酸、谷胱甘肽、左旋VC磷酸酯和9000g水,混合搅拌,得到B液;
3)将A液和B液混合均匀后,调节pH值为7,并升温至50℃,在搅拌状态下,加入熊果苷,混合均匀,得到所述医用敷料。
实施例4医用敷料的制备
组成:
γ-聚谷氨酸20g、透明质酸50g、熊果苷18g、谷胱甘肽12g和左旋VC磷酸酯25g。
制备:
1)将γ-聚谷氨酸和1200g水混合,搅拌溶解,得到A液;
2)将透明质酸、谷胱甘肽、左旋VC磷酸酯和7200g水,混合搅拌,得到B液;
3)将A液和B液混合均匀后,调节pH值为7,并升温至50℃,在搅拌状态下,加入熊果苷,混合均匀,得到所述医用敷料。
实施例5医用敷料的制备
组成:
γ-聚谷氨酸35g、透明质酸30g、熊果苷6g、谷胱甘肽4g和左旋VC磷酸酯45g。
制备:
1)将γ-聚谷氨酸和1100g水混合,搅拌溶解,得到A液;
2)将透明质酸、谷胱甘肽、左旋VC磷酸酯和8900g水,混合搅拌,得到B液;
3)将A液和B液混合均匀后,调节pH值为7,并升温至50℃,在搅拌状态下,加入熊果苷,混合均匀,得到所述医用敷料。
对比例1
组成:
γ-聚谷氨酸30g、透明质酸40g、熊果苷12g和左旋VC磷酸酯35g。
制备:同实施例1。
对比例2
组成:
透明质酸40g、熊果苷12g、谷胱甘肽8g和左旋VC磷酸酯35g。
制备:同实施例1。
对比例3
组成:
γ-聚谷氨酸30g、透明质酸40g、熊果苷12g、谷胱甘肽8g和左旋VC磷酸酯35g。
制备:
1)将γ-聚谷氨酸、透明质酸、谷胱甘肽、左旋VC磷酸酯和8900g水混合,搅拌溶解,调节pH值为7,常温,在搅拌状态下,加入熊果苷,混合均匀,得到所述医用敷料。
实验例1
选取80名志愿者,其中,男性35名,女性45名,年龄18~42岁,志愿者患有痤疮,表皮存在浅性疤痕并有色素沉积。
将志愿者随机分为8组,每组10人,各组志愿者的基线资料对比差异无统计学意义(P>0.05);各组志愿者分别施用实施例1~5和对比例1~3制备得到的瘢痕护理敷料;每日涂抹两次,14天为一个疗程。
志愿者根据皮损形态进行评分,按红斑/色素程度从0分~5分进行评分,其中0分表示自然光线下观察,无肉眼可见红斑/色素沉着;3分表示自然光线下观察,中度红斑/色素沉着,颜色较红/黄褐色;5分表示自然光线下观察,重度红斑/色素沉着,颜色鲜红/深揭色。
志愿者的治疗效果如表1所示,其中分值为平均分。可以看出,本发明的医用敷料可以非常好修复痤疮导致的色素沉积和浅性疤痕。
表1志愿者的治疗效果
敷料 治疗前 治疗第7天 治疗第14天 治疗第21天
实施例1 5 2.5 1.3 0.5
实施例2 4.9 2.9 1.1 0.2
实施例3 4.8 2.4 1.2 0.4
实施例4 4.9 2.6 1.4 0.6
实施例5 4.8 2.8 1.3 0.3
对比例1 4.9 3.8 3.4 2.3
对比例2 4.8 3.8 3.0 1.9
对比例3 4.9 4.1 3.9 3.0
本领域技术人员应该理解的是,本发明的使用不受限于上述特定应用。就本文描述或描绘的特定元素和/或特征而言,本发明也不局限于其优选实施方案。应当理解的是,本发明不限于所公开的实施方案例或各个实施方案,且在不脱离由以下权利要求所阐述和限定的本发明的范围的情况下能够进行许多重新布置、修改和替换。

Claims (5)

1.一种用于色素性皮肤病的医用敷料的制备方法,其特征在于,以重量份计,所述医用敷料由以下组分构成:γ-聚谷氨酸20~35份、透明质酸30~50份、熊果苷6~18份、谷胱甘肽4~12份和左旋VC磷酸酯25~45份;所述透明质酸的分子量为10万;
所述医用敷料的制备方法包括以下步骤:
1)将γ-聚谷氨酸和水混合,搅拌溶解,得到A液;
2)将透明质酸、谷胱甘肽、左旋VC磷酸酯和水,混合搅拌,得到B液;
3)将A液和B液混合均匀后,调节pH值为6~8,并升温至40~60℃,在搅拌状态下,加入熊果苷,混合均匀,得到所述医用敷料。
2.根据权利要求1所述的医用敷料的制备方法,其特征在于,以重量份计,所述医用敷料由以下组分构成:γ-聚谷氨酸25~30份、透明质酸35~45份、熊果苷10~14份、谷胱甘肽6~10份和左旋VC磷酸酯30~40份。
3.根据权利要求1或2所述的医用敷料的制备方法,其特征在于,所述医用敷料为乳剂、凝胶剂或膏剂。
4.根据权利要求1所述的医用敷料的制备方法,其特征在于,所述A液和所述B液的体积比为1:6~9。
5.如权利要求1或2中所述的医用敷料的制备方法或如权利要求4中所述的医用敷料的制备方法在制备祛除色素的药物或护肤品中的应用。
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