CN114569629A - 一种祛疤和皮肤修复的组合物及其制备方法 - Google Patents
一种祛疤和皮肤修复的组合物及其制备方法 Download PDFInfo
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- CN114569629A CN114569629A CN202210199331.7A CN202210199331A CN114569629A CN 114569629 A CN114569629 A CN 114569629A CN 202210199331 A CN202210199331 A CN 202210199331A CN 114569629 A CN114569629 A CN 114569629A
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Abstract
本发明公开了一种祛疤和皮肤修复的组合物及其制备方法,属于医药技术领域。该组合物由二甲基硅油、甘油、卡波姆、三乙醇胺、羟苯乙酯与纯化水混合获得。该组合物中二甲基硅油具有疤痕修复功能、甘油保湿性好、卡波姆和三乙醇胺的配合可保证组合物的稳定性,三乙醇胺有保湿和美白作用,淡化皮肤色素沉淀,同时可修复因晒伤引起皮肤损伤。羟苯乙酯有抗菌消炎,减轻疤痕的瘙痒和红肿。该组合物具有:1、快速成膜性;2、极强的抗菌消炎功效;3、改善红肿、止痛止痒效果极佳;4、滋养保湿、强力锁水、水化保湿、软化并修复疤痕;5、涂抹后能够与表皮紧密结合,显著改善疤痕色素沉着;6、具有美白改善疤红斑;7、具有快速自行风干的特性。
Description
技术领域
本发明属于医药技术领域,具体涉及一种祛疤和皮肤修复的组合物及其制备方法。
背景技术
硅酮是国际推荐的疤痕治疗的一线产品,医用硅酮采用国际进口原料,涂抹于皮肤表面快速形成一层疏水透气的薄膜,减少皮肤水分挥发,存进疤痕组织的封闭水合作用,协助分离坏死细胞,抑制胶原纤维增生。
但是,硅酮无法对疤痕表面的细菌及炎症反应如发红、发痒、发痛起到作用。目前市场上治疗或抑制疤痕的硅凝胶产品中多为单一的硅酮类物质,只有祛疤的功效,但是无法阻止细菌的侵袭疤痕导致的痒瘙痒、红肿和色素沉淀等现象,且功能较为单一。
发明内容
为了解决现有技术存在的仅使用硅酮对于疤痕进行处理过程中造成的皮肤问题以及功效单一的技术问题,本发明目的在于提供一种祛疤和皮肤修复的组合物及其制备方法。
本发明所采用的技术方案为:一种祛疤和皮肤修复的组合物,所述组合物主要由以下质量份数的原料制备得到:
医用硅酮1-10份,保湿剂1-10份,乳化剂1-5份,中和剂1-5份和杀菌防腐剂0.1-1份。
作为优选地,所述组合物主要由以下质量份数的原料制备得到:
医用硅酮3-8份,保湿剂3-8份,乳化剂2-4份,中和剂2-4份和杀菌防腐剂0.2-0.8份。
作为优选地,所述组合物主要由以下质量份数的原料制备得到:
医用硅酮6份,保湿剂6份,乳化剂3份,中和剂3.5份和杀菌防腐剂0.6份。
作为优选地,所述医用硅酮为硅油混合物;
所述硅油混合物为二甲基硅油、聚二甲基硅氧烷、聚二甲基硅氧烷交联聚合物和聚二甲基硅氧烷醇中的任意一种;
作为优选地,所述二甲基硅油为Q7-9120硅油。
作为优选地,所述保湿剂为甘油、丙二醇、1,3-丁二醇和聚乙二醇中的任意一种;
所述乳化剂为卡波姆、山梨酸醇脂肪酸酯类乳化剂中的任意一种。
作为优选地,所述中和剂为三乙醇胺。
上述三乙醇胺不仅具有保湿美白、淡化色素的作用,和羟苯乙酯配合起到很好的成膜阻菌抑菌止痒的功效。
作为优选地,所述杀菌防腐剂为羟苯乙酯。
二甲基硅油为美国杜邦集团生产的道康宁Q7-9120硅油,12500cSt,又称硅酮、硅油,是一系列不同分子量的聚二甲基硅氧烷的总称,其单体数量由几个到几千个,数量越多,硅油的黏度越大。通式为(CH3)3SiO·[Si(CH3)2·O]n·Si(CH3)3,无色透明粘稠液体,具有优异的憎水防潮性,化学性质稳定,无毒,无味,无臭,耐光耐热,对皮肤、粘膜无刺激或过敏反应,以其为主要成分的国内已上市产品用于辅助治疗和预防增生性疤痕,如霜剂、凝胶剂、软膏剂、膜剂、喷雾剂等。临床研究显示,应用硅酮制品后可以改善增生性疤痕的颜色、柔顺性和厚度,有效抑制疤痕组织的形成,改善患者的症状和活动。二甲基硅油还可以减轻毛细血管充血,抑制疤痕组织内胶原纤维增生,从而预防病理性疤痕的形成。
甘油:化学名1,2,3-丙三醇,收载于《中国药典》四部,CAS号:56-81-5,分子式:C3H8O3,分子量:92.09。为无色、无臭、澄清的黏稠液体;味甜,具有引湿性,水溶液(1→10)为中性。本品与水或乙醇能任意混溶。甘油为重要的化工原料,常用作溶剂、保湿剂、防冻剂和甜味剂使用,广泛应用于食品、药品、化妆品及印染行业。在医药行业,常用作溶剂和保湿剂使用。本品无毒,对皮肤无过敏和刺激性。在本品中是利用其优良的引湿性,增强产品的保湿功能。
卡波姆:为丙烯酸键合烯丙基蔗糖或季戊四醇烯丙醚的高分子聚合物;收载于《中国药典》四部,CAS号:54182-57-9,有多种型号,型号不同其分子式、分子量也不同。卡波姆作为一种辅料已被英国、美国药典收载,并已广泛用于制药工业、日化工业及其它有关工业领域。在制剂中主要用作增稠剂、助悬剂和粘合剂,作缓释制剂的骨架材料和阻滞剂,固体制剂的薄膜衣材料,可与HPC或CMC合用作为粘膜粘贴剂基质。按干燥品计算,含羧酸基(—COOH)应为56.0%~68.0%。卡波姆是以季戊四醇等与丙烯酸交联得到的丙烯酸交联树脂,是一类非常重要的流变调节剂,中和后的卡波姆是优秀的凝胶基质,有增稠、悬浮等重要用途,工艺简单,稳定性好,广泛应用于乳液、膏霜、凝胶中。卡波姆为白色疏松状粉末;具酸性、吸湿性和微有特殊臭味,能溶于水、乙醇、甘油。常用浓度为0.1%~3.0%。由于其分子中含大量羧基,故水溶液应特别注意用碱中和后使用,以减少对皮肤、粘膜的刺激。卡波姆的中和剂可用氢氧化钠、氢氧化钾、碳酸氢钾、硼砂、氨基酸类、极性有机胺类如三乙醇胺。月桂胺和硬脂胺可在非极性系统中作中和剂。中和后的卡波姆水凝胶在pH6~11之间最粘稠,如pH<3或pH>12,粘稠度即降低,强电解质存在亦可降低粘度。本品选用卡波姆Carbomer940型号,分子结构:-[-CH2-CH-]N-COOH,利用本原料具有的高粘度及增粘效果好的优点,增加产品的稳定性,从而发挥本品的良好性能。在《中国药典》中作药用辅料,软膏基质和释放阻滞剂等。
三乙醇胺:本品为无色至微黄色的黏稠澄清液体,在水中或乙醇中极易溶解。收载于《中国药典》四部。CAS号:102-71-6,分子式:C6H15NO3,分子量:149.19。主要用于pH调节剂使用。三乙醇胺是含有卡波姆等酸性高分子凝胶的最常用中和剂,三乙醇胺通过与卡波姆的羧基中和,形成稳定的高分子结构。在本品中是通过调节产品的pH值,使卡波姆达到增稠、保湿美白、降低色素沉着的应用效果,对皮肤表面的晒伤有一定的修复作用。在《中国药典》中药用辅料,乳化剂和pH值调节剂等。
一种祛疤和皮肤修复组合物的制备方法,所述方法包括如下步骤:
按照相应质量份数选取医用硅酮、甘油、乳化剂、中和剂、杀菌防腐剂和溶剂混匀。
作为优选地,所述溶剂为水;
所述混匀时搅拌速度为960-1000转/分钟,混匀时长为30~45分钟。
上述水在实际运用过程中可选用纯化水。
本发明的有益效果为:
本发明提供了一种祛疤和皮肤修复的组合物,该组合物是由二甲基硅油、甘油、卡波姆、三乙醇胺、羟苯乙酯与纯化水混合获得。该组合物中二甲基硅油具有修复功能、甘油具有保湿性能、卡波姆和三乙醇胺是一种弱碱性的有机物,具有一定保湿、中和脂肪酸的作用,做用于护肤品的乳化剂,具有一定温和保湿、美白的作用在甘油的配合下用于保证组合物的保湿、美白及降低色素沉着的功效,且具有稳定性,羟苯乙酯用于抗菌消炎防止细菌侵袭导致的瘙痒红肿等现象。
该组合物具有:1、快速成膜性防止细菌侵袭;2、极强的抗菌消炎功效;3、改善红肿、止痛止痒效果极佳;4、滋养保湿、强力锁水、水化保湿、软化并修复疤痕;5、涂抹后能够与表皮紧密结合,显著改善疤痕色素沉着;6、具有美白改善疤痕瘙痒和红斑;7、具有快速自行风干的特性。
附图说明
图1为病例1治疗前示意图;
图2为病例1治疗后示意图;
图3为病例2治疗前示意图;
图4为病例2治疗后示意图;
图5为病例3治疗前示意图;
图6为病例3治疗后示意图。
具体实施方式
下面结合具体实施例对本发明做进一步阐释。本领域技术人员将会理解,下列所描述的实施例是本发明一部分实施例,而不是全部的实施例,仅用于说明本发明,而不应视为限制本发明的范围。所用试剂均为可以通过市售购买获得的常规产品。
实施例1:
一种祛疤和皮肤修复组合物的制备方法,所述方法包括如下步骤:
按照相应质量份数选取Q7-9120硅油100克、甘油100克、卡波姆5克、三乙醇胺3.5克、羟苯乙酯0.6克,加水至1000克混匀,混匀时搅拌速度为960转/分钟,混匀时长为30分钟。该组合物为硅凝胶状。
实施例2:
一种祛疤和皮肤修复组合物的制备方法,所述方法包括如下步骤:
按照相应质量份数选取Q7-9120硅油100克、丙二醇100克、卡波姆50克、三乙醇胺50克、羟苯乙酯10克,加纯化水至10000克混匀,混匀时搅拌速度为1000转/分钟,混匀时长为45分钟。该组合物为硅凝胶状。
实施例3:
一种祛疤和皮肤修复组合物的制备方法,所述方法包括如下步骤:
按照相应质量份数选取Q7-9120硅油30克、1,3-丁二醇30克、卡波姆20克、三乙醇胺20克、羟苯乙酯2克,加纯化水至4000克混匀,混匀时搅拌速度为960转/分钟,混匀时长为45分钟。该组合物为硅凝胶状。
实施例4:
一种祛疤和皮肤修复组合物的制备方法,所述方法包括如下步骤:
按照相应质量份数选取Q7-9120硅油80克、甘油80克、卡波姆40克、三乙醇胺40克、羟苯乙酯8克,加纯化水至9000克混匀,混匀时搅拌速度为1000转/分钟,混匀时长为30分钟。该组合物为硅凝胶状。
实施例5:
一种祛疤和皮肤修复组合物的制备方法,所述方法包括如下步骤:
按照相应质量份数选取Q7-9120硅油60克、甘油60克、卡波姆30克、三乙醇胺35克、羟苯乙酯6克,加纯化水至5000克混匀,混匀时搅拌速度为1000转/分钟,混匀时长为45分钟。该组合物为硅凝胶状。
使用方法:伤口完全愈合、结痂脱落、无渗出液的疤痕方可使用,确保疤痕部位清洁干燥,取适量涂抹薄层,覆盖疤痕为准,每天涂抹3次或遵医嘱,干燥后其上可以使用防晒霜,化妆品,压力衣或压力器。
产品检验报告:
报告编号:ME(1)20210149,样品名称:自风干型祛疤硅凝胶。规格:20g/支。
检验结果:
实验例
本发明祛疤硅凝胶用于辅助预防和治疗皮肤病理性疤痕(如烧烫伤、创伤、手术和痤疮等造成的皮肤新旧疤痕),不用于未愈合伤口。
2021年3月至2021年10月,由郑州大学第一附属医院对本发明凝胶组合物进行了临床试验观察。具体如下:
一、资料与方法
选取112例瘢痕患者进行相关研究,其中烧烫伤21例,意外创伤48例,外科手术创伤43例。纳入标准:(1)符合瘢痕增生临床诊断标准;(2)处于瘢痕增生早期;(3)瘢痕增生伴有明显的变硬、红肿、瘙痒、疼痛等不适,将患者随机分为对照组(n=56)与治疗组(n=56)。年龄18~60岁,对照组男22例,女34例,治疗组男20例,女36例。治疗组患者先将患处用清水洗净拭干,检查确定无瘢痕破损、溃疡后,用上述实施例1制备得到的产品涂抹患处,3次/d,持续使用6个月后判断疗效。对照组用自粘性软聚硅酮敷贴于患处,关节部位或不易粘贴处用弹力绷带固定,连续使用12h/d即可,持续使用6个月。分别观察两组患者自觉症状、疤痕硬度、颜色和挛缩等。在观察治疗时,测定部位固定,测量的医护人员固定。
二、疗效评定标准
显效:痒痛症状消失或明显减轻,疤痕充血程度下降,色泽转淡或接近正常;厚度减少50%以上或变平,疤痕质地变软。
有效:痒痛症状减轻,疤痕色泽转淡;厚度和硬度明显改善,瘢痕皮肤趋于柔软。
无效:痒痛症状无明显变化,疤痕充血,质地坚韧,皮肤瘙痒、疼痛等不适感,瘢痕状态无明显改善甚至加重。
三、观察结果
两组患者治疗6个月后,治疗组2例患者失访,对照组3例患者失访,因此治疗组56例对照组53例进入结果分析,符合统计学分析要求。
疗效分析
采用Fisher精确概率法检验,两组主要有效性评价指标治疗总有效率,53例患者治疗两组对照总有效率分别为96.23%、66.04%。有效率明显提高,差异有统计学意义(P<0.05)。见表1。
表1两组患者疗效比较[n(%)]
根据上表的治疗效果可以看出,对术后瘢痕增生有明确的治疗效果,总体治疗效果和有效率均显著高于自粘性软聚硅酮敷贴(P<0.05)。
本实验各组用药前后血、尿常规及肝肾功能检查均无异常发现,用药后局部无皮疹及变态反应,尤为重要的是,治疗组使用实施例1制备得到的组合物后有清凉舒适的感觉,也无油腻感,绝大部分患者痒、痛症状减轻,能够显著改善疤痕色素沉着,所有病人用药后未发现任何不良反应。
对照组使用后至少1日更换一次,患者感觉操作不便,且感官上感觉不适,由上述试验结果可见本发明凝胶组合物相对于对照组产品更能止痒止痛,对改善疤痕硬度、颜色、患者感官等方面有着明显效果优势,且本发明使用方便,随时携带涂抹,经临床验证其疗效肯定,无毒副作用,使用方便,患者容易接受。
临床病例:
病例1:女。如图1所示为治疗前示意图,图2所示为治疗后示意图。
诊断科别:烧伤整形科,临床表现:线性瘢痕伴多处增生,有色素沉淀。
形成时间:1周,处理:使用上述实施例1制备得到产品,一日三次涂抹,每次1-3g克。
临床结论:使用三个月后,瘢痕平复,无色素沉淀,皮肤光滑。
病例2:如图3所示为治疗前示意图,图4所示为治疗后示意图。
诊断科别:皮肤科。临床表现:痘坑痘印形成萎缩性瘢痕。
形成时间:2年,处理:使用上述实施例1制备得到产品,一日三次涂抹,每次1-3克。
临床结论:使用六个月后,皮肤光滑平整,无色素沉淀。
病例3:如图5所示为治疗前示意图,图6所示为治疗后示意图。
诊断科别:外科(甲乳),临床表现:线性增生性瘢痕。
形成时间:2个月,处理:使用上述实施例1制备得到产品,一日三次涂抹,每次0.2-0.5克。
临床结论:使用六个月后,瘢痕平复,无色素沉淀。
本发明不局限于上述可选的实施方式,任何人在本发明的启示下都可得出其他各种形式的产品,均属于本发明的保护范围。上述具体实施方式不应理解成对本发明的保护范围的限制,本领域的普通技术人员应当理解,在不背离本发明的范围下,可对前述各实施例所记载的技术方案进行修改,或对其中部分或者全部技术特征进行等同替换,与此同时这些修改或者替换,并不会使相应的技术方案的本质脱离本发明各实施例技术方案的范围。
Claims (9)
1.一种祛疤和皮肤修复的组合物,其特征在于,所述组合物主要由以下质量份数的原料制备得到:
医用硅酮1-10份,保湿剂1-10份,乳化剂1-5份,中和剂1-5份和杀菌防腐剂0.1-1份。
2.根据权利要求1所述的祛疤和皮肤修复的组合物,其特征在于,所述组合物主要由以下质量份数的原料制备得到:
医用硅酮3-8份,保湿剂3-8份,乳化剂2-4份,中和剂2-4份和杀菌防腐剂0.2-0.8份。
3.根据权利要求2所述的祛疤和皮肤修复的组合物,其特征在于,所述组合物主要由以下质量份数的原料制备得到:
医用硅酮6份,保湿剂6份,乳化剂3份,中和剂3.5份和杀菌防腐剂0.6份。
4.根据权利要求1-3任一项所述的祛疤和皮肤修复的组合物,其特征在于,所述医用硅酮为硅油混合物;
所述硅油混合物为二甲基硅油、聚二甲基硅氧烷、聚二甲基硅氧烷交联聚合物和聚二甲基硅氧烷醇中的任意一种;
优选地,所述二甲基硅油为Q7-9120硅油。
5.根据权利要求1-3任一项所述的祛疤和皮肤修复的组合物,其特征在于,所述保湿剂为甘油、丙二醇、1,3-丁二醇和聚乙二醇中的任意一种;
所述乳化剂为卡波姆和山梨酸醇脂肪酸酯类乳化剂中的任意一种。
6.根据权利要求1-3任一项所述的祛疤和皮肤修复的组合物,其特征在于,所述中和剂为三乙醇胺。
7.根据权利要求1-3任一项所述的祛疤和皮肤修复的组合物,其特征在于,所述杀菌防腐剂为羟苯乙酯。
8.一种如权利要求1-7任一项所述的祛疤和皮肤修复组合物的制备方法,其特征在于,所述方法包括如下步骤:
按照相应质量份数选取医用硅酮、甘油、乳化剂、中和剂、杀菌防腐剂和溶剂混匀。
9.根据权利要求8所述的祛疤和皮肤修复组合物的制备方法,其特征在于,所述溶剂为水;
所述混匀时搅拌速度为960-1000转/分钟,混匀时长为30~45分钟。
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祛疤分享: "润好 - 自风干型祛疤硅凝胶", pages 1, Retrieved from the Internet <URL:https://www.sohu.com/a/523204239_121320780> * |
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CN116869921B (zh) * | 2023-07-12 | 2024-04-16 | 上海森博生物科技有限公司 | 一种疤痕修复乳膏组合物及其制备方法和应用 |
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