CN111494703B - 一种可促进皮肤屏障修复护理的保湿敷料及制备方法 - Google Patents
一种可促进皮肤屏障修复护理的保湿敷料及制备方法 Download PDFInfo
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
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- A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
- A61L26/0009—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form containing macromolecular materials
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- A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
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- A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
- A61L26/0061—Use of materials characterised by their function or physical properties
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Abstract
本发明提供一种可促进皮肤屏障修复护理的保湿敷料及制备方法,每1000g敷料包括:辛酸/癸酸甘油三酯90~110g、甘油65~95g、乳木果油8~12g、白油45~55g、戊二醇15~25g、羧甲基葡聚糖15~25g、硬脂酸45~55g、十六十八醇26~38g、透明质酸钠1~4g、鲸蜡硬脂醇聚醚‑25 7~12g、酵母精华10~20g、植物复合发酵滤液5~6g、丙烯酸(酯)类/丙烯酰胺共聚物10~20g和对羟基苯甲酸乙酯0.5~2g。本发明保湿敷料为创面伤口提供稳定的修复的屏闭环境,同时提高敷料的持续滋润、保湿和稳定皮肤良好状态的效果,稳定性高、保湿性好,阻隔外界干扰,加快创面伤口的愈合时间。
Description
技术领域
本发明涉及医用敷料技术领域,特别涉及一种可促进皮肤屏障修复护理的保湿敷料及制备方法。
背景技术
皮肤是人体抵御外界伤害的重要屏障。在日常生活中,皮肤损伤极为常见,如皮肤擦伤、挫伤、轻微割伤、轻微烫伤烧伤、晒伤、轻度医美术后等意外或疾病引起的皮肤局部的浅表创面伤害,皮肤屏障损伤后,抵御能力下降,容易感染外界细菌,引起炎症反应如瘙痒、红肿、刺痛等部分的皮肤屏障受损时会伴随少量出血和组织液渗出等现象。医用敷料作用于皮肤屏障的修复护理,可起到保护创面、防止感染、修复、促进创面愈合等重要作用。
现有的医用敷料多样,但容易因无法有效为创面形成良好的保护屏障环境,而导致皮肤创面二次污染,继而引发炎症,延长创面恢复和皮肤屏障修复时间。对于现有的乳膏体敷料而言,由于其乳状混合体系的配方组分复配的比例不同,采用的工艺不同等原因,导致所获得的乳膏体敷料的稳定性低,修复保湿效果差等,难以有效形成良好的创面伤口的屏闭环境,维持稳定的创面修复环境。本发明提出的一种可促进皮肤屏障修复护理的保湿敷料,能够为皮肤组织的创面修复提供稳定的屏闭环境,同时提高体敷料的持续滋润、保湿和稳定皮肤良好状态的效果,达到更好的帮助皮肤恢复的作用,减少创面伤口的愈合时间。
发明内容
鉴于此,本发明提出一种可促进皮肤屏障修复护理的保湿敷料及制备方法。
本发明的技术方案是这样实现的:
本发明提供一种可促进皮肤屏障修复护理的保湿敷料,每1000g敷料包括:辛酸/癸酸甘油三酯90~110g、甘油65~95g、乳木果油8~12g、白油45~55g、戊二醇15~25g、羧甲基葡聚糖15~25g、硬脂酸45~55g、十六十八醇26~38g、透明质酸钠1~4g、鲸蜡硬脂醇聚醚-25 7~12g、酵母精华10~20g、植物复合发酵滤液5~6g、丙烯酸(酯)类/丙烯酰胺共聚物10~20g和对羟基苯甲酸乙酯0.5~2g。
进一步说明,所述酸/癸酸甘油三酯、甘油、乳木果油、白油的复配质量比为:10:8:1:5。
进一步说明,所述酵母精华,按照质量百分比,包括:25~38%酿酒酵母细胞壁提取物、43~56%酿酒酵母溶胞产物、12~24%富锌酵母提取物、1~3%酵母精华素和0.5~0.8%覆膜酵母菌发酵产物滤液。
进一步说明,所述植物复合发酵滤液由紫薯发酵滤液、芦荟发酵滤液、糯米发酵滤液和银耳发酵滤液按体积比(5~15):(3~10):(1~2):(1~2)混合而成。
一种可促进皮肤屏障修复护理的保湿敷料的制备方法,包括如下步骤:
(1)预混溶液Ⅰ的配制:向配制罐中取配制总量40%水,按比例依次缓慢先加入透明质酸钠和对羟基苯甲酸乙酯,以60~90r/min的速度搅拌3~5min,静置0.5~1h,进行初次溶胀;在连续搅拌状态下加入羧甲基葡聚糖和酵母精华,于恒温20~23℃下充分搅拌5~7min,静置1~2h,使其充分浸润吸水溶胀后,得到预混溶液Ⅰ;
(2)预混溶液Ⅱ的配制:向真空均质乳化机油相锅中,按比例依次加入白油、乳木果油、辛酸/癸酸甘油三酯、硬脂酸、十六十八醇,搅拌加热至60~100℃,使其完全溶解,得到预混溶液Ⅱ;
(3)预混溶液Ⅲ的配制:向真空均质乳化机主锅中,称取剩余配制重量60%水、甘油、鲸蜡硬脂醇聚醚-25、戊二醇,加热搅拌至60~100℃,使其完全溶解,保温5~15min,得到预混溶液Ⅲ;
(4)均质乳化:将均质乳化机抽真空,将预混溶液Ⅱ抽入预混溶液Ⅲ中,进行初次搅拌3~8min后,进行高压均质3~5次,均质压力为100~150MPa,每次均质4~8min;降温至25~55℃,加入预混溶液Ⅰ、植物复合发酵滤液和丙烯酸(酯)类/丙烯酰胺共聚物,进行二次搅拌6~12min;加入三乙醇胺调节溶液pH值至5~8,搅拌均匀,抽真空排气泡,得到白色粘稠的乳状保湿敷料。
进一步说明,步骤(1)中,所述连续搅拌的速度为30~45r/min。
进一步说明,步骤(2)中,所述搅拌速度为120~150r/min。
进一步说明,步骤(3)中,所述搅拌速度为160~185r/min。
进一步说明,步骤(4)中,所述初次搅拌速度为850~950r/min,搅拌温度为80~105℃;所述再次搅拌的速度为300~400r/min。
进一步说明,步骤(4)中,所述均质压力为125MPa,均质4次,每次均质时间为6min。
与现有技术相比,本发明的有益效果是:本发明通过采用了辛酸/癸酸甘油三酯、甘油、乳木果油和白油复配而成的复合油脂,以十六十八醇和鲸蜡硬脂醇聚醚作为复合乳化剂,形成稳定的乳状混合体系,利用酵母精华联合羧甲基葡聚糖与透明质酸钠的复配,以可更好地诱发皮肤系统的免疫和皮肤屏障修复的功能,以及结合植物复合发酵液的良好的屏障作用,从而为创面伤口提供稳定的修复屏闭环境,有效减少创面伤口的修复时间和促进皮肤组织的恢复,加速受损细胞的修复,促进恢复皮肤屏障功能,减缓创面疼痛和缩短痛痒时间;同时,复合油脂有利于提高保湿敷料的持续滋润、保湿和稳定皮肤良好状态的效果,维持稳定的创面屏闭环境,促进创面愈合。本发明所获得的乳状保湿敷料与现有技术相比,具有稳定性高、保湿性好,在一定的湿润条件下起有效阻隔作用,减少外界干扰,快速形成稳定的屏闭环境,缩短创面伤口的愈合时间。另外,本发明通过采用四步法制备乳状保湿敷料,有利于提高酵母精华和植物复合发酵液等有效成分在乳状混合体系下的稳定性,实现敷料的持续滋润、保湿和稳定的效果,为创面伤口提供更加稳定的修复屏闭环境。
具体实施方式
为了更好理解本发明技术内容,下面提供具体实施例,对本发明做进一步的说明。
本发明实施例所用的实验方法如无特殊说明,均为常规方法。
本发明实施例所用的材料、试剂等,如无特殊说明,均可从商业途径得到。
实施例-一种可促进皮肤屏障修复护理的保湿敷料,根据下述的保湿敷料的制备方法,分别取如下组分原料的不同配比进行复配,制备1000g乳状保湿敷料:
其中,所述酵母精华,按照质量百分比,包括:25%酿酒酵母细胞壁提取物、43%酿酒酵母溶胞产物、12%富锌酵母提取物、1%酵母精华素和0.5%覆膜酵母菌发酵产物滤液;
所述植物复合发酵滤液由紫薯发酵滤液、芦荟发酵滤液、糯米发酵滤液和银耳发酵滤液按体积比5:3:1:1混合而成;
制备方法包括如下步骤:
(1)预混溶液Ⅰ的配制:向配制罐中取配制总量40%水,按比例依次缓慢先加入透明质酸钠和对羟基苯甲酸乙酯,以80r/min的速度搅拌4min,静置1h,进行初次溶胀;在连续搅拌状态下加入羧甲基葡聚糖和酵母精华,于恒温22℃下充分搅拌6min,静置1.5h,使其充分浸润吸水溶胀后,得到预混溶液Ⅰ;
(2)预混溶液Ⅱ的配制:向真空均质乳化机油相锅中,按比例依次加入白油、乳木果油、辛酸/癸酸甘油三酯、硬脂酸、十六十八醇,搅拌加热至80℃,使其完全溶解,得到预混溶液Ⅱ;
(3)预混溶液Ⅲ的配制:向真空均质乳化机主锅中,称取剩余配制重量60%水、甘油、鲸蜡硬脂醇聚醚-25、戊二醇,加热搅拌至80℃,使其完全溶解,保温10min,得到预混溶液Ⅲ;
(4)均质乳化:将均质乳化机抽真空,将预混溶液Ⅱ抽入预混溶液Ⅲ中,进行初次搅拌5min后,进行高压均质4次,均质压力为125MPa,每次均质6min;降温至40℃,加入预混溶液Ⅰ、植物复合发酵滤液和丙烯酸(酯)类/丙烯酰胺共聚物,进行二次搅拌9min;加入三乙醇胺调节溶液pH值至6,搅拌均匀,抽真空排气泡,得到白色粘稠的乳状保湿敷料,目视外观,为类白色粘稠流体,无异物。
实施例5-根据实施例4的一种可促进皮肤屏障修复护理的保湿敷料的制备,区别在于,所述酵母精华,按照质量百分比,包括:38%酿酒酵母细胞壁提取物、56%酿酒酵母溶胞产物、24%富锌酵母提取物、3%酵母精华素和0.8%覆膜酵母菌发酵产物滤液;所述植物复合发酵滤液由紫薯发酵滤液、芦荟发酵滤液、糯米发酵滤液和银耳发酵滤液按体积比15:10:2:2混合而成,其余参数及步骤均与实施例4相同。
对比例1-根据实施例4的一种可促进皮肤屏障修复护理的保湿敷料的制备,区别在于,保湿敷料配方中未添加酵母精华,其余参数及步骤均与实施例4相同。
对比例2-根据实施例4的一种可促进皮肤屏障修复护理的保湿敷料的制备,区别在于,保湿敷料配方中未添加植物复合发酵滤液,其余参数及步骤均与实施例4相同。
对比例3-根据实施例4中一种可促进皮肤屏障修复护理的保湿敷料的制备,区别在于,采用甜杏仁油和棕榈油替代乳木果油和白油,其余参数及步骤均与实施例4相同。
对比例4-根据实施例4中一种可促进皮肤屏障修复护理的保湿敷料的制备,区别在于,所述酸/癸酸甘油三酯、甘油、乳木果油、白油的复配质量比为:10:8:1:1,其余参数及步骤均与实施例4相同。
对比例5-根据实施例4中一种可促进皮肤屏障修复护理的保湿敷料的制备方法,区别在于,步骤(4)中,将预混溶液Ⅱ和预混溶液Ⅲ进行高压均质后,直接将透明质酸钠、对羟基苯甲酸乙酯、羧甲基葡聚糖、酵母精华、植物复合发酵滤液和丙烯酸(酯)类/丙烯酰胺共聚物按比例依次加入,进行二次搅拌,其余参数及步骤均与实施例4相同。
补充说明,上述紫薯发酵滤液、芦荟发酵滤液、糯米发酵滤液和银耳发酵滤液是分别于20℃下保温发酵后,并经超声处理后,离心分离,过滤而得的发酵产物滤液,具体步骤如下:
(1)分别将新鲜紫薯、芦荟、糯米、银耳的原料清洗干净后,分别以料液比为1:5的比例加水,于常温下浸泡12h;
(2)将其粉碎成浆状后,按照浆液质量的4%进行复合微生物,于密闭发酵罐的湿度为90%,温度为26℃下保温复合发酵15d,得到发酵初液;复合微生物包括酿酒酵母菌、胚牙乳杆菌、短乳杆菌、发酵乳杆菌、干酪乳杆菌和保加利亚乳杆菌;
(3)将发酵初液进行超声60KHz处理15min,经离心分离后,收集上清液,过滤而得的发酵产物滤液;
(4)将制得的紫薯发酵滤液、芦荟发酵滤液、糯米发酵滤液和银耳发酵滤液按一定的体积比混合得到植物复合发酵滤液。
根据上述实施例4~5和对比例1~5制备获得的皮肤屏障伤口护理的液体敷料,进行安全性实验、抑菌实验和创面修复实验。
一、安全性实验
将实施例4~5、对比例1-5的液体敷料分别进行动物皮肤刺激试验、皮肤致敏试验、体外细胞毒性试验,结果表明安全无毒。
二、抑菌实验
根据2015年版中国药典《抑菌效力检查法》进行抑菌效力测定,测定供试液沙氏葡萄液体培养基中,24h存活的菌落数,试验菌为:铜绿假单胞菌、金黄色葡萄球菌、大肠埃希菌、白色念珠菌,实施例4~5和对比例1~5的抑菌率如下表:
试验菌 | 铜绿假单胞菌 | 金黄色葡萄球菌 | 大肠埃希菌 | 白色念珠菌 |
实施例4 | >99.9% | >99.9% | >99.9% | >99.9% |
实施例5 | >99.9% | >99.9% | >99.9% | >99.9% |
对比例1 | 93% | 92% | 93% | 96% |
对比例2 | 69% | 62% | 73% | 80% |
对比例3 | 89% | 88% | 90% | 92% |
对比例4 | 98% | 96% | 96% | 99% |
对比例5 | >99.9% | >99.9% | >99.9% | >99.9% |
由上表的抑菌率结果可知,本发明制得的保湿敷料对铜绿假单胞菌、金黄色葡萄球菌、大肠埃希菌、白色念珠菌的抑制率均能够大于>99.9%;而在对比例2中未添加植物复合发酵滤液,其屏障作用明显降低,影响其修复效果;对比例3中,采用甜杏仁油和棕榈油替代乳木果油和白油,其乳化稳定性降低,影响创面伤口的屏闭环境形成,使修复效果下降;其次由对比例1和4可以看出,酵母精华和复合油脂的配比对敷料的屏障作用也具有一定影响。
三、稳定性试验
将实施例4~5和对比例1~5中分别进行等量取样,置于恒温箱中存放观察,定期观察保湿敷料并记录其分层情况,其结果如下表:
根据上表统计情况可以看出,由本发明实施例4~5制得的保湿敷料具有良好的稳定性,而在对比例3~5中的保湿敷料,随着时间的延长,其出现了析出分层的情况,则将影响敷料对为创面伤口提供稳定的修复屏闭环境的稳定性,且对比例5中析出分层情况最为明显,表明了,本发明采用四步法制备乳状保湿敷料,有利于提高酵母精华和植物复合发酵液等有效成分在乳状混合体系下的稳定性。
四、创面修复实验
选择210例以切伤、裂伤、擦伤、烧烫伤、缝合伤口等创面面积<5cm2的皮肤浅表损伤的志愿者,随机分成7个实验组,每实验组30例,评价实施例4~5和对比例1~5的液体敷料,治疗皮肤浅表损伤的有效性,观察伤口的有无不良反应、平均疼痛消失天数、平均痛痒消失天数、创面愈合情况和时间,其结果如下表:
根据上表的创面修复情况可知,本发明制得的保湿敷料明显减缓了创面疼痛和缩短了创面痛痒的时间,创面伤口的修复效果好,降低了创面渗出液的分泌,保持敷料的持续滋润、保湿、和稳定的效果,促进皮肤组织的重建,加速受损细胞的修复,促进恢复皮肤屏障功能,加快创面伤口的愈合。
对比例1和2的保湿敷料对创面愈合时间明显延长,表明了本发明将酵母精华-羧甲基葡聚糖联合复配透明质酸钠,可更好地诱发皮肤系统的免疫和皮肤屏障修复的功能,并在结合植物复合发酵液良好的屏障作用,有利于提高创面伤口的修复效果和促进皮肤组织的恢复,促进细胞增生,加快损细胞的修复,缩短创面伤口的愈合时间。在对比例3和对比例4中,其创面出现了少量渗出液,影响了愈合效果和延长创面愈合时间,表明本发明采用了辛酸/癸酸甘油三酯、甘油、乳木果油和白油复配而成的复合油脂,有利于提高敷料的持续滋润、保湿和稳定皮肤良好状态的效果,维持稳定的创面屏闭环境,加快创面伤口的愈合。
以上所述仅为本发明的较佳实施例而已,并不用以限制本发明,凡在本发明的精神和原则之内,所作的任何修改、等同替换、改进等,均应包含在本发明的保护范围之内。
Claims (7)
1.一种可促进皮肤屏障修复护理的保湿敷料,其特征在于:每1000g敷料包括:辛酸/癸酸甘油三酯90~110g、甘油65~95g、乳木果油8~12g、白油45~55g、戊二醇15~25g、羧甲基葡聚糖15~25g、硬脂酸45~55g、十六十八醇26~38g、透明质酸钠1~4g、鲸蜡硬脂醇聚醚-25 7~12g、酵母精华10~20g、植物复合发酵滤液5~6g、丙烯酸(酯)类/丙烯酰胺共聚物10~20g和对羟基苯甲酸乙酯0.5~2g;
所述植物复合发酵滤液由紫薯发酵滤液、芦荟发酵滤液、糯米发酵滤液和银耳发酵滤液按体积比(5~15):(3~10):(1~2):(1~2)混合而成;
所述辛酸/癸酸甘油三酯、甘油、乳木果油、白油的复配质量比为:10:8:1:5;
所述酵母精华,按照质量百分比,包括:25~38%酿酒酵母细胞壁提取物、43~56%酿酒酵母溶胞产物、12~24%富锌酵母提取物、1~3%酵母精华素和 0.5~0.8%覆膜酵母菌发酵产物滤液。
2.一种如权利要求1所述的可促进皮肤屏障修复护理的保湿敷料的制备方法,其特征在于:包括如下步骤:
(1)预混溶液Ⅰ的配制:向配制罐中取配制总量40%水,按比例依次缓慢先加入透明质酸钠和对羟基苯甲酸乙酯,以60~90r/min的速度搅拌3~5min,静置0.5~1h,进行初次溶胀;在连续搅拌状态下加入羧甲基葡聚糖和酵母精华,于恒温20~23℃下充分搅拌5~7min,静置1~2h,使其充分浸润吸水溶胀后,得到预混溶液Ⅰ;
(2)预混溶液Ⅱ的配制:向真空均质乳化机油相锅中,按比例依次加入白油、乳木果油、辛酸/癸酸甘油三酯、硬脂酸、十六十八醇,搅拌加热至60~100℃,使其完全溶解,得到预混溶液Ⅱ;
(3)预混溶液Ⅲ的配制:向真空均质乳化机主锅中,称取剩余配制重量60%水、甘油、鲸蜡硬脂醇聚醚-25、戊二醇,加热搅拌至60~100℃,使其完全溶解,保温5~15min,得到预混溶液Ⅲ;
(4)均质乳化:将均质乳化机抽真空,将预混溶液Ⅱ抽入预混溶液Ⅲ中,进行初次搅拌3~8min后,进行高压均质3~5次,均质压力为100~150MPa,每次均质4~8min;降温至25~55℃,加入预混溶液Ⅰ、植物复合发酵滤液和丙烯酸(酯)类/丙烯酰胺共聚物,进行二次搅拌6~12min;加入三乙醇胺调节溶液pH值至5~8,搅拌均匀,抽真空排气泡,得到白色粘稠的乳状保湿敷料。
3.根据权利要求2所述的一种可促进皮肤屏障修复护理的保湿敷料的制备方法,其特征在于:步骤(1)中,所述连续搅拌的速度为30~45r/min。
4.根据权利要求2所述的一种可促进皮肤屏障修复护理的保湿敷料的制备方法,其特征在于:步骤(2)中,所述搅拌速度为120~150r/min。
5.根据权利要求2所述的一种可促进皮肤屏障修复护理的保湿敷料的制备方法,其特征在于:步骤(3)中,所述搅拌速度为160~185r/min。
6.根据权利要求2所述的一种可促进皮肤屏障修复护理的保湿敷料的制备方法,其特征在于:步骤(4)中,所述初次搅拌速度为850~950r/min,搅拌温度为80~105℃;所述二次搅拌的速度为300~400r/min。
7.根据权利要求2所述的一种可促进皮肤屏障修复护理的保湿敷料的制备方法,其特征在于:步骤(4)中,所述均质压力为125MPa,均质4次,每次均质时间为6min。
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