CN115337219B - 皮肤修复组合物及其制备方法 - Google Patents
皮肤修复组合物及其制备方法 Download PDFInfo
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- CN115337219B CN115337219B CN202211104373.4A CN202211104373A CN115337219B CN 115337219 B CN115337219 B CN 115337219B CN 202211104373 A CN202211104373 A CN 202211104373A CN 115337219 B CN115337219 B CN 115337219B
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- parts
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- repair composition
- skin repair
- skin
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Abstract
本发明涉及一种皮肤修复组合物,其特征在于,由包括按质量份数计的如下组分的原料制备而成:海藻糖0.05份‑10份,聚丙烯酸盐/酯0.1份‑10份,保湿剂1份‑10份,大分子多糖0.5份‑10份,乳化剂0.5份‑8份,油脂1.5‑30份,水60‑90份。本发明的皮肤修复组合物在高温和低温下均具有良好的稳定性,且通过动物实验验证了本发明的皮肤修复组合物具有良好的皮肤修复效果。
Description
技术领域
本发明属于护肤品领域,更具体涉及一种皮肤修复组合物及其制备方法。
背景技术
随着社会观念的巨大转变和新的医学模式的建立,医美微创整形已经逐渐成为一种趋势。根据《2020年度医美行业网络关注度分析报告》显示,医美微创整形手术以风险相对较低、恢复期短等优势占据了整形行业总收入的38%。根据《2019年中国微整形行业深度研究报告》显示,微整形服务中最受消费者喜爱的项目前五名分别为:肉毒杆菌素注射、玻尿酸注射、激光脱毛、自体脂肪填充、光子嫩肤。但是,有时微创手术后会出现皮肤屏障受损现象,进而出现红、肿、热、痛等症状,困扰着这些爱美的人们。
相较于非无菌护肤品制剂,无菌护肤品制剂的生物负载低,安全性更高。但目前市面上,无菌配方的基质多为水溶性基质,乳化型基质甚少报道。如专利CN113975446A公开了涉及一种医用无菌敷贴配方及其制作方法,包括以下原料组成:主料0.1-0.3%、胶粘剂0.1-0.5%、保湿剂2-10%、防腐剂0.01-0.2%和杀菌剂1-5%,其余为纯化水。该专利提供了水溶性基质的配方,产品中缺乏油脂,保湿效果不强,修复效果差;且该专利仅通过添加防腐剂和杀菌剂控制微生物负载,并不能达到很好的无菌效果。
根据文献《化妆品用保湿剂的特点及应用》,修复受损的皮肤屏障需要从补水、保湿、修复三个角度出发,通过添加保湿剂、油脂和皮肤屏障修复成分,起到恢复皮肤屏障功能的作用。现有皮肤屏障修复产品主要通过添加保湿剂和修复成分来实现功能,根据文献《常用油脂对化妆品保湿效果的影响研究》,由于缺乏油脂成分,这样的产品往往保湿效果欠佳。除了添加防腐剂抑制微生物生长,现有技术中常使用的进一步杀灭微生物的方法还有湿热灭菌、辐照灭菌等。通常湿热灭菌需要温度大于115℃,持续时间长,一般化妆品生产设备并不能满足;而对于辐照灭菌,护肤品中的许多成分经辐照后易发生变色、气味刺激、酸碱度极端和料体性质改变等变化,且辐照为强氧化过程,会破坏产品的稳定性,对于乳化型基质产品来说,经辐照后产品低温和高温稳定性验证均会出现分层现象,这阻碍了乳化型基质的无菌制剂的开发。
针对现有技术中存在的问题,亟需研发一种无菌、稳定性好、且具有优秀皮肤修复功能的护肤产品。
发明内容
针对现有技术的上述缺陷和问题,本发明开发了一种乳化型基质的无菌皮肤修复组合物及其制备方法。
本发明第一方面提供了一种皮肤修复组合物,其特征在于,由包括按质量份数计的如下组分的原料制备而成:海藻糖0.05份-10份,聚丙烯酸盐/酯0.1份-10份,保湿剂1份-10份,大分子多糖0.5份-10份,乳化剂0.5份-8份,油脂1.5-30份,水60-90份。
可选地,所述大分子多糖选自黄原胶、海藻酸钠、可溶性淀粉中的一种或多种;优选地,所述大分子多糖为0.3-2.0份可溶性淀粉与0-1.3份海藻酸钠的组合物或0.3-2.0份可溶性淀粉与0-0.8份黄原胶的组合物。
优选地,所述大分子多糖的组分可以为以下几种组合:
(1)可溶性淀粉1.0-2.0份;
(2)可溶性淀粉0.5-1.5份,黄原胶0.3-0.8份;
(3)可溶性淀粉0.3-1.5份,海藻酸钠0.3-1.3份。
更优选地,所述大分子多糖的组分可以为以下几种组合:
(1)可溶性淀粉0.5-1.3份,黄原胶0.3-0.8份;
(2)可溶性淀粉0.3-1.3份,海藻酸钠0.3-1.3份。
可选地,所述乳化剂选自单脂肪酸甘油酯、聚乙二醇-7硬脂酸酯中的一种或多种。
可选地,所述组合物还包括中和剂0.1份-2份,优选地,所述中和剂选自氢氧化钠、三乙醇胺中的一种或多种。
可选地,所述油脂选自肉豆蔻酸异丙酯、凡士林、脂肪醇、石蜡、脂肪酸、硅油中的一种或多种;优选地,所述油脂为0.5-10份肉豆蔻酸异丙酯、0.5-5份凡士林、0.5-5份脂肪醇、1-10份石蜡的组合物;更优选地,所述脂肪醇为固态脂肪醇。固态脂肪醇可以是鲸蜡醇、十八醇、十六十八醇等用于化妆品保湿的油脂。
可选地,所述保湿剂选自甘油、丁二醇和丙二醇中的一种或多种。
可选地,所述组合物还包括防腐剂0.01份-1份,优选地,所述防腐剂选自羟苯甲酯、己二醇、苯氧乙醇、乙基己基甘油中的一种或多种。
本发明另一方面还提供了一种上述皮肤修复组合物的制备方法,其特征在于,包括如下步骤:
(1)按照重量份数称取海藻糖、聚丙烯酸盐/酯、保湿剂、水、大分子多糖,加热到70-90℃,搅拌均匀,得混合物1;
(2)按照重量份数称取油脂,加热到60-90℃,搅拌均匀,得混合物2;
(3)再将混合物2加入到混合物1中,保温搅拌至均匀;
(4)降温至30-55℃,出料,灌装;
(5)灌装完成后,Co60辐照灭菌,即得所述皮肤修复组合物。优选地,所述Co60辐照的强度范围为5-40Kgy。
优选地,步骤(4)为降温至30-55℃,按照重量份数称取中和剂,加入步骤(3)所得混合物中,搅拌至均匀,出料,灌装。
可选地,所述步骤(1)和/或(4)中还包括按照重量份数称取并添加防腐剂。
本发明另一方面还提供了上述皮肤修复组合物在制备用于修复皮肤屏障受损的化妆品、护肤品、药品或医疗器械中的用途;优选地,所述皮肤屏障受损为医美术后皮肤屏障受损。与之相对应地,本发明还提供了上述皮肤修复组合物用于治疗皮肤屏障受损的用途。
本发明的皮肤修复组合物为乳化型基质,具有良好的保湿和修复皮肤屏障作用;通过Co60辐照灭菌,使该组合物具有良好的无菌特性;且发明人通过大量实验找到了最合适的组分与配比,解决了乳化型基质在辐照下不稳定易分层的问题。通过实验验证,本发明的皮肤修复组合物在高温和低温下均具有良好的稳定性,具有良好的肤感,且通过动物实验验证了本发明的皮肤修复组合物具有良好的皮肤修复效果,与同类产品相比,本发明的皮肤修复组合物在安全性和有效性方面具有更佳的功效。
附图说明
为了更清楚地说明本发明实施例或现有技术中的技术方案,下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍。
图1为动物实验兔子背部试验区域各实验组具体分布示意图。
图2为兔皮肤修复试验对比结果。
图3为兔皮肤修复试验病理HE结果。
具体实施方式
下面结合实施例进一步说明本发明,应当理解,实施例仅用于进一步说明和阐释本发明,并非用于限制本发明。
除非另外定义,本说明书中有关技术术语和科学术语与本领域内的技术人员所通常理解的意思相同。虽然在实验或实际应用中可以应用与此间所述相似或相同的方法和材料,本文还是在下文中对材料和方法做了描述。在相冲突的情况下,以本说明书包括其中的定义为准。另外,材料、方法和例子仅供说明,而不具限制性。
本发明实施例中所采用的试验方法、检测方法和常规实验试剂配制方法,如无特别说明,均按照本领域常规操作。
原材料 | 级别 | 生产商 |
纯化水 | 符合2020版药典 | 公司自制 |
可溶性淀粉 | 药用辅料 | 山东聊城阿华制药股份有限公司 |
海藻酸钠 | 药用辅料 | 青岛海之林生物科技开发有限公司 |
海藻糖 | 药用辅料 | 江苏东南纳米材料有限公司 |
甘油 | 药用辅料 | 湖南尔康制药股份有限公司 |
黄原胶 | 药用辅料 | CP Kelco U.S.,Inc. |
羟苯甲酯 | 药用辅料 | 江西阿尔法高科药业有限公司 |
聚乙二醇-7硬脂酸酯 | 药用辅料 | Gattefosse SAS |
石蜡 | 药用辅料 | 湖南尔康制药股份有限公司 |
白凡士林 | 药用辅料 | 南昌白云药业有限公司 |
十六十八醇 | 药用辅料 | 湖南尔康制药股份有限公司 |
肉豆蔻酸异丙酯 | 药用辅料 | 浙江物美生物科技有限公司 |
氢氧化钠 | 药用辅料 | 成都华邑药用辅料制造有限责任公司 |
己二醇 | 药用辅料 | Finar Limited |
实施例1
本实施例提供一种皮肤修复组合物,该组合物的原料为:聚丙烯酸钠0.4g,甘油5g,羟苯甲酯0.1g,己二醇0.7g,聚乙二醇-7硬脂酸酯4g,肉豆蔻酸异丙酯7g,白凡士林3g,十六十八醇2g,石蜡3g,中和剂(氢氧化钠)0.8g,海藻糖0.03g,纯化水74g。
制备方法如下:
(1)按照上述重量称取海藻糖,聚丙烯酸钠,甘油,羟苯甲酯,纯化水,加热到80℃,搅拌均匀,得混合物1;
(2)按照上述重量称取聚乙二醇-7硬脂酸酯,十六十八醇,肉豆蔻酸异丙酯,白凡士林,石蜡,加热到80℃,搅拌均匀,得混合物2;
(3)再将混合物2加入到混合物1中,保温搅拌20min,至均匀;
(4)降温至50℃,按照上述重量称取氢氧化钠,己二醇,搅拌10min,至均匀,出料,灌装;
(5)灌装完成后,25Kgy Co60辐照灭菌,即得所述皮肤修复组合物。
实施例2
本实施例提供一种皮肤修复组合物,该组合物的原料为:聚丙烯酸钠0.4g,甘油5g,羟苯甲酯0.1g,己二醇0.7g,聚乙二醇-7硬脂酸酯4g,肉豆蔻酸异丙酯7g,白凡士林3g,十六十八醇2g,石蜡3g,中和剂(氢氧化钠)0.8g;海藻糖0.05g,纯化水74g。
制备方法与实施例1相同。
实施例3
本实施例提供一种皮肤修复组合物,该组合物的原料为:聚丙烯酸钠0.4g,甘油5g,羟苯甲酯0.1g,己二醇0.7g,聚乙二醇-7硬脂酸酯4g,肉豆蔻酸异丙酯7g,白凡士林3g,十六十八醇2g,石蜡3g,中和剂(氢氧化钠)0.8g;海藻糖0.08g,纯化水74g。
制备方法与实施例1相同。
实施例4
本实施例提供一种皮肤修复组合物,该组合物的原料为:聚丙烯酸钠0.4g,甘油5g,羟苯甲酯0.1g,己二醇0.7g,聚乙二醇-7硬脂酸酯4g,肉豆蔻酸异丙酯7g,白凡士林3g,十六十八醇2g,石蜡3g,中和剂(氢氧化钠)0.8g;海藻糖0.1g,纯化水74g。
制备方法与实施例1相同。
实施例5
本实施例提供一种皮肤修复组合物,该组合物的原料为:聚丙烯酸钠0.4g,甘油5g,羟苯甲酯0.1g,己二醇0.7g,聚乙二醇-7硬脂酸酯4g,肉豆蔻酸异丙酯7g,白凡士林3g,十六十八醇2g,石蜡3g,中和剂(氢氧化钠)0.8g;海藻糖0.05g,可溶性淀粉1.5g,纯化水74g。
制备方法如下:
(1)按照上述重量称取海藻糖,聚丙烯酸钠,甘油,羟苯甲酯,纯化水,可溶性淀粉,加热到80℃,搅拌均匀,得混合物1;
(2)按照上述重量称取聚乙二醇-7硬脂酸酯,十六十八醇,肉豆蔻酸异丙酯,白凡士林,石蜡,加热到80℃,搅拌均匀,得混合物2;
(3)再将混合物2加入到混合物1中,保温搅拌20min,至均匀;
(4)降温至50℃,按照上述重量称取氢氧化钠,己二醇,搅拌10min,至均匀,出料,灌装;
(5)灌装完成后,25Kgy Co60辐照灭菌,即得所述皮肤修复组合物。
实施例6
本实施例提供一种皮肤修复组合物,该组合物的原料为:聚丙烯酸钠0.4g,甘油5g,羟苯甲酯0.1g,己二醇0.7g,聚乙二醇-7硬脂酸酯4g,肉豆蔻酸异丙酯7g,白凡士林3g,十六十八醇2g,石蜡3g,中和剂(氢氧化钠)0.8g;海藻糖0.05g,海藻酸钠1.5g,纯化水74g。
制备方法如下:
(1)按照上述重量称取海藻糖,聚丙烯酸钠,甘油,羟苯甲酯,纯化水,海藻酸钠,加热到80℃,搅拌均匀,得混合物1;
(2)按照上述重量称取聚乙二醇-7硬脂酸酯,十六十八醇,肉豆蔻酸异丙酯,白凡士林,石蜡,加热到80℃,搅拌均匀,得混合物2;
(3)再将混合物2加入到混合物1中,保温搅拌20min,至均匀;
(4)降温至50℃,按照上述重量称取氢氧化钠,己二醇,搅拌10min,至均匀,出料,灌装;
(5)灌装完成后,25Kgy Co60辐照灭菌,即得所述皮肤修复组合物。
实施例7
本实施例提供一种皮肤修复组合物,该组合物的原料为:聚丙烯酸钠0.4g,甘油5g,羟苯甲酯0.1g,己二醇0.7g,聚乙二醇-7硬脂酸酯4g,肉豆蔻酸异丙酯7g,白凡士林3g,十六十八醇2g,石蜡3g,中和剂(氢氧化钠)0.8g;海藻糖0.05g,黄原胶1.5g,纯化水74g。
制备方法如下:
(1)按照上述重量称取海藻糖,聚丙烯酸钠,甘油,羟苯甲酯,纯化水,黄原胶,加热到80℃,搅拌均匀,得混合物1;
(2)按照上述重量称取聚乙二醇-7硬脂酸酯,十六十八醇,肉豆蔻酸异丙酯,白凡士林,石蜡,加热到80℃,搅拌均匀,得混合物2;
(3)再将混合物2加入到混合物1中,保温搅拌20min,至均匀;
(4)降温至50℃,按照上述重量称取氢氧化钠,己二醇,搅拌10min,至均匀,出料,灌装;
(5)灌装完成后,25Kgy Co60辐照灭菌,即得所述皮肤修复组合物。
实施例8
本实施例提供一种皮肤修复组合物,该组合物的原料为:聚丙烯酸钠0.4g,甘油5g,羟苯甲酯0.1g,己二醇0.7g,聚乙二醇-7硬脂酸酯4g,肉豆蔻酸异丙酯7g,白凡士林3g,十六十八醇2g,石蜡3g,中和剂(氢氧化钠)0.8g;海藻糖0.05g,可溶性淀粉1g,海藻酸钠0.5g,纯化水74g。
制备方法如下:
(1)按照上述重量称取海藻糖,聚丙烯酸钠,甘油,羟苯甲酯,纯化水,可溶性淀粉,海藻酸钠,加热到80℃,搅拌均匀,得混合物1;
(2)按照上述重量称取聚乙二醇-7硬脂酸酯,十六十八醇,肉豆蔻酸异丙酯,白凡士林,石蜡,加热到80℃,搅拌均匀,得混合物2;
(3)再将混合物2加入到混合物1中,保温搅拌20min,至均匀;
(4)降温至50℃,按照上述重量称取氢氧化钠,己二醇,搅拌10min,至均匀,出料,灌装;
(5)灌装完成后,25Kgy Co60辐照灭菌,即得所述皮肤修复组合物。
实施例9
本实施例提供一种皮肤修复组合物,该组合物的原料为:聚丙烯酸钠0.4g,甘油5g,羟苯甲酯0.1g,己二醇0.7g,聚乙二醇-7硬脂酸酯4g,肉豆蔻酸异丙酯7g,白凡士林3g,十六十八醇2g,石蜡3g,中和剂(氢氧化钠)0.8g;海藻糖0.05g,可溶性淀粉1g,黄原胶0.5g,纯化水74g。
制备方法如下:
(1)按照上述重量称取海藻糖,聚丙烯酸钠,甘油,羟苯甲酯,纯化水,可溶性淀粉,黄原胶,加热到80℃,搅拌均匀,得混合物1;
(2)按照上述重量称取聚乙二醇-7硬脂酸酯,十六十八醇,肉豆蔻酸异丙酯,白凡士林,石蜡,加热到80℃,搅拌均匀,得混合物2;
(3)再将混合物2加入到混合物1中,保温搅拌20min,至均匀;
(4)降温至50℃,按照上述重量称取氢氧化钠,己二醇,搅拌10min,至均匀,出料,灌装;
(5)灌装完成后,25Kgy Co60辐照灭菌,即得所述皮肤修复组合物。
实施例10
本实施例提供一种皮肤修复组合物,该组合物的原料为:聚丙烯酸钠0.4g,甘油5g,羟苯甲酯0.1g,己二醇0.7g,聚乙二醇-7硬脂酸酯4g,肉豆蔻酸异丙酯7g,白凡士林3g,十六十八醇2g,石蜡3g,中和剂(氢氧化钠)0.8g;海藻糖0.05g,海藻酸钠1g,黄原胶0.5g,纯化水74g。
制备方法如下:
(1)按照上述重量称取海藻糖,聚丙烯酸钠,甘油,羟苯甲酯,纯化水,海藻酸钠,黄原胶,加热到80℃,搅拌均匀,得混合物1;
(2)按照上述重量称取聚乙二醇-7硬脂酸酯,十六十八醇,肉豆蔻酸异丙酯,白凡士林,石蜡,加热到80℃,搅拌均匀,得混合物2;
(3)再将混合物2加入到混合物1中,保温搅拌20min,至均匀;
(4)降温至50℃,按照上述重量称取氢氧化钠,己二醇,搅拌10min,至均匀,出料,灌装;
(5)灌装完成后,25Kgy Co60辐照灭菌,即得所述皮肤修复组合物。
实施例11
本实施例提供一种皮肤修复组合物,该组合物的原料为:聚丙烯酸钠0.4g,甘油5g,羟苯甲酯0.1g,己二醇0.7g,聚乙二醇-7硬脂酸酯4g,肉豆蔻酸异丙酯7g,白凡士林3g,十六十八醇2g,石蜡3g,中和剂(氢氧化钠)0.8g;海藻糖0.05g,海藻酸钠1g,可溶性淀粉0.5g,纯化水74g。
制备方法如下:
(1)按照上述重量称取海藻糖,聚丙烯酸钠,甘油,羟苯甲酯,纯化水,海藻酸钠,可溶性淀粉,加热到80℃,搅拌均匀,得混合物1;
(2)按照上述重量称取聚乙二醇-7硬脂酸酯,十六十八醇,肉豆蔻酸异丙酯,白凡士林,石蜡,加热到80℃,搅拌均匀,得混合物2;
(3)再将混合物2加入到混合物1中,保温搅拌20min,至均匀;
(4)降温至50℃,按照上述重量称取氢氧化钠,己二醇,搅拌10min,至均匀,出料,灌装;
(5)灌装完成后,25Kgy Co60辐照灭菌,即得所述皮肤修复组合物。
实施例12
本实施例提供一种皮肤修复组合物,该组合物的原料为:聚丙烯酸钠0.4g,甘油5g,羟苯甲酯0.1g,己二醇0.7g,聚乙二醇-7硬脂酸酯4g,肉豆蔻酸异丙酯7g,白凡士林3g,十六十八醇2g,石蜡3g,中和剂(氢氧化钠)0.8g;海藻糖0.05g,黄原胶1g,可溶性淀粉0.5g,纯化水74g。
制备方法如下:
(1)按照上述重量称取海藻糖,聚丙烯酸钠,甘油,羟苯甲酯,纯化水,黄原胶,可溶性淀粉,加热到80℃,搅拌均匀,得混合物1;
(2)按照上述重量称取聚乙二醇-7硬脂酸酯,十六十八醇,肉豆蔻酸异丙酯,白凡士林,石蜡,加热到80℃,搅拌均匀,得混合物2;
(3)再将混合物2加入到混合物1中,保温搅拌20min,至均匀;
(4)降温至50℃,按照上述重量称取氢氧化钠,己二醇,搅拌10min,至均匀,出料,灌装;
(5)灌装完成后,25Kgy Co60辐照灭菌,即得所述皮肤修复组合物。
实施例13
本实施例提供一种皮肤修复组合物,该组合物的原料为:聚丙烯酸钠0.4g,甘油5g,羟苯甲酯0.1g,己二醇0.7g,聚乙二醇-7硬脂酸酯4g,肉豆蔻酸异丙酯7g,白凡士林3g,十六十八醇2g,石蜡3g,中和剂(氢氧化钠)0.8g;海藻糖0.05g,黄原胶1g,海藻酸钠0.5g,纯化水74g。
制备方法如下:
(1)按照上述重量称取海藻糖,聚丙烯酸钠,甘油,羟苯甲酯,纯化水,黄原胶,海藻酸钠,加热到80℃,搅拌均匀,得混合物1;
(2)按照上述重量称取聚乙二醇-7硬脂酸酯,十六十八醇,肉豆蔻酸异丙酯,白凡士林,石蜡,加热到80℃,搅拌均匀,得混合物2;
(3)再将混合物2加入到混合物1中,保温搅拌20min,至均匀;
(4)降温至50℃,按照上述重量称取氢氧化钠,己二醇,搅拌10min,至均匀,出料,灌装;
(5)灌装完成后,25Kgy Co60辐照灭菌,即得所述皮肤修复组合物。
实验例1低温和高温稳定性测试
实验方法:将实施例1-4获得的组合物取适量分别在-18℃和45℃下放置30天,恢复室温后,观察其外观并记录。结果如下表1所示。
表1
通过上述实验,研究人员发现:加入一定量的海藻糖之后,解决了组合物的低温稳定性问题,但高温稳定性分层。为解决高温稳定性,研究人员在配方中进一步加入不同种类和量的大分子多糖,验证其高温稳定性,并验证了产品的使用感。结果如下表2所示。
表2
从以上数据可以看出,实施例8、9和11具有良好的高温稳定性,且兼顾了良好肤感。故选择大分子多糖为可溶性淀粉1份、黄原胶为0.5份或可溶性淀粉1份、海藻酸钠为0.5份或海藻酸钠1份、可溶性淀粉0.5份作为本发明的优选配方。
实验例2有效性测试(动物实验)
实验动物来源:成都达硕实验动物有限公司
(1)实验分组
将兔子背部的毛脱掉,然后用温水清洗局部,棉球擦干备用。脱毛部位左右对称分六个2cm×2cm大小的区域:1#、2#、3#、4#、5#、6#六个区域。六个区域中,左上为试验组1(实验组-实施例8),其代号为1#;左中为试验组2(实验组-实施例9),其代号为2#;左下试验组3(实验组-实施例11),其代号为3#;右上为同类产品对照组(海藻酸钠修护敷料,品牌为安亦佳),其代号为4#;右中为阴性对照组(生理盐水),其代号为5#;右下为空白对照组(不处理),其代号为6#。具***置如图1所示。
(2)试验造模及治疗方法
用2.5%的戊巴比妥钠按lmL/kg,沿耳缘静脉给家兔麻醉。用微针在1#、2#、3#、4#、5#五个区域进行造创,微针频率300次/min,单次处理30s,共处理3~5次,直至兔子皮肤呈较严重红斑、形成浅性疤痕。
根据《中药外用药理实验技术规范(草案)》,粉末或膏状原则上以均匀涂覆在给药区一层,厚度约1~2mm为度;液体可直接湿敷,选用纱布定量吸附液体。将样品直接涂抹于试验组区域完全覆盖该区域创伤面,用无菌生理盐水浸透无菌纱布后覆盖至阴性对照组区域。再用绷带覆盖实验部位至少4h,去除纱布块和绷带,用持久性墨水对接触性部位进行标记,并用温水清洗掉残留试验材料并擦干。所有区域每天给药2次(早上、晚上各一次),连续给药7天,在造模成功第3、7天对修复皮肤拍照并取样。
(3)评价方法
①皮肤表面观察:修复护理后,肉眼观察兔皮肤表面微损伤、浅性疤痕组织形成情况。
效果判定标准:显效:肉眼视红斑、疤痕面积消退>50%,好转:肉眼视红斑、疤痕面积消退>30%,无效:肉眼视红斑、疤痕面积消退<30%。总有效率以显效加好转计。
统计学方法:采用χ2检验及方差分析,统计分析使用SPSS软件。
②取创面组织做病理HE检查:随机抽取一只兔子在第3天分别取试验组、同类产品对照组、阴性对照组创面组织做病理HE检查;随机抽取一只兔子在第7天分别取试验组、同类产品对照组、阴性对照组创面组织做病理HE检查。
(4)动物试验结果
①皮肤表面观察
兔皮肤修复试验对比结果见图2、表3、图3。
表3兔皮肤修复疗效评定表
试验结果观察统计可知,使用实验组-实施例8区域显效22例,好转8例,无效0例;使用实验组-实施例9区域显效22例,好转8例,无效0例;使用实验组-实施例11区域显效27例,好转3例,无效0例;同类产品对照组(海藻酸钠修护敷料)显效20例,好转7例,无效3例;阴性对照区域(生理盐水)显效4例,好转5例,无效21例;使用产品与使用生理盐水具有显著性差异(P<0.01)。通过观察创面的修复情况可以看出,连续使用产品7天之后,创面红斑明显减轻,且创面区域基本恢复正常皮肤结构。
组织学观察:兔皮肤修复试验病理HE结果见图3。
根据HE病理检查可以看出,在第3天时,试验组表皮不连续,结构较清晰,表皮中有炎细胞浸润;生理盐水组表皮不连续,结构欠清晰,表皮中有较多炎细胞浸润;同类产品(海藻酸钠修护敷料)组表皮不连续,表皮有炎细胞浸润。第7天时,试验组创面基本恢复正常皮肤结构,而同类产品(海藻酸钠修护敷料)组表皮仍有炎细胞浸润。
总结:通过观察创面的修复情况可以看出,连续使用7天之后,产品创面红斑明显减轻,浅性疤痕明显减少,且创面区域基本恢复正常皮肤结构,说明产品对动物皮肤并没有刺激作用,并且能够通过在创面表面形成保护层,为创面愈合提供微环境,能够有效的保护创面,促进创面愈合恢复。本发明产品和同类产品(例如海藻酸钠修护敷料)相比,在安全性和有效性方面具有更佳的功效。
应该理解到披露的本发明不仅仅限于描述的特定的方法、方案和物质,因为这些均可变化。还应理解这里所用的术语仅仅是为了描述特定的实施方式方案的目的,而不是意欲限制本发明的范围,本发明的范围仅受限于所附的权利要求。
本领域的技术人员还将认识到,或者能够确认使用不超过常规实验,在本文中所述的本发明的具体的实施方案的许多等价物。这些等价物也包含在所附的权利要求中。
Claims (9)
1.一种皮肤修复组合物,其特征在于,由包括按质量份数计的如下组分的原料制备而成:海藻糖0.05份,聚丙烯酸钠0.4份,甘油5份,大分子多糖,聚乙二醇-7硬脂酸酯4份,肉豆蔻酸异丙酯7份,白凡士林3份,十六十八醇2份,石蜡3份,水74份;所述大分子多糖的组分为以下几种组合:
(1)可溶性淀粉0.5~1.3份,黄原胶0.3~0.8份;
(2)可溶性淀粉0.3~1.3份,海藻酸钠0.3~1.3份;
所述皮肤修复组合物的制备方法包括如下步骤:
(1)按照重量份数称取海藻糖、聚丙烯酸钠、甘油、水、大分子多糖,加热到70~90℃,搅拌均匀,得混合物1;
(2)按照上述重量称取聚乙二醇-7硬脂酸酯,十六十八醇,肉豆蔻酸异丙酯,白凡士林,石蜡,加热到80℃,搅拌均匀,得混合物2;
(3)再将混合物2加入到混合物1中,保温搅拌至均匀;
(4)降温至30~55℃,出料,灌装;
(5)灌装完成后,Co60辐照灭菌,即得所述皮肤修复组合物。
2.权利要求1所述的皮肤修复组合物,其特征在于,所述组合物还包括中和剂0.1份~2份。
3.权利要求2所述的皮肤修复组合物,其特征在于,所述中和剂选自氢氧化钠、三乙醇胺中的一种或多种。
4.权利要求1所述的皮肤修复组合物,其特征在于,所述组合物还包括防腐剂0.01份~1份。
5.权利要求4所述的皮肤修复组合物,其特征在于,所述防腐剂选自羟苯甲酯、己二醇、苯氧乙醇、乙基己基甘油中的一种或多种。
6.权利要求1所述的皮肤修复组合物,其特征在于,步骤(4)为降温至30~55℃,按照重量份数称取中和剂,加入步骤(3)所得混合物中,搅拌至均匀,出料,灌装。
7.权利要求1所述的皮肤修复组合物,其特征在于,所述步骤(1)和/或(4)中还包括按照重量份数称取并添加防腐剂。
8.权利要求1所述的皮肤修复组合物在制备用于修复皮肤屏障受损的化妆品、护肤品、药品或医疗器械中的用途。
9.权利要求8所述的用途,其中所述皮肤屏障受损为医美术后皮肤屏障受损。
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