CN113230274A - 一种祛疤软膏及其制备方法 - Google Patents
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Abstract
本发明公开了一种祛疤软膏及其制备方法。本发明的祛疤软膏包括以下质量百分比的组分:去细胞动物组织粉末或/和去细胞动物器官粉末:2%~10%;软膏基质:50%~93%;水:余量。本发明的祛疤软膏的制备方法包括以下步骤:1)将去细胞动物组织粉末或/和去细胞动物器官粉末加水分散,得到分散液;2)将软膏基质加热至50℃~70℃,再边搅拌边加入步骤1)的分散液,充分搅拌,冷却,即得祛疤软膏。本发明的祛疤软膏具有祛疤效果好、生物相容性好、天然无毒、成分简单、制备简单、原料来源丰富、成本低廉等优点,适合进行大面积推广应用。
Description
技术领域
本发明涉及生物医用技术领域,具体涉及一种基于去细胞动物组织粉末或/和去细胞动物器官粉末的祛疤软膏及其制备方法。
背景技术
外科皮肤切口、炎症、烧伤或创伤后的伤口愈合都会导致疤痕组织的形成,且易感人群的疤痕会变大、变红和变硬,引起瘙痒和疼痛,严重的甚至会导致严重的美容和功能问题,所以越来越多的人选择对疤痕进行美容治疗。祛除疤痕的手段多种多样,包括手术切除、放疗、压力治疗、冷冻治疗、局部硅胶贴片祛疤、病灶内注射皮质类固醇、病灶内注射干扰素等,但大都存在明显的局限性,实际效果一般,且无法保证不复发。实践表明,使用祛疤产品预防疤痕形成比对陈旧瘢痕进行治疗更重要。
目前,祛疤产品种类繁多,例如:CN 1389266A公开了一种治疗烧、烫伤的软膏剂及其制备方法,是将山莨菪碱、氢化可的松、α-干扰素和表皮生长因子与软膏基质混合,其可以用于烧伤和烫伤;CN 108938669A公开了一种用于治疗皮肤损伤的干细胞软膏及其制备方法,是将含干细胞团块的培养基与无生物毒性的凝胶基质混合制备而成的干细胞软膏,其可以用于皮肤损伤;CN 107184949A公开了一种表皮创伤修复软膏及其制备方法,是将来自罗非鱼皮的生物活性肽作为核心成分,将壳聚糖、琼胶和炉甘石粉混合作为软膏基质,其可以促进伤口愈合;CN 111067857A公开了一种含脐带提取物的祛疤膏及其制备方法,是将磷硅酸钠钙、脐带提取物、胎盘蛋白、胎盘酶和二裂酵母发酵产物溶胞物混合作为祛疤膏,其具有促进创伤加速愈合、伤口无痕修复的效果。以上4种祛疤产品虽然都具有一定的祛疤效果,但普遍存在实际祛疤效果一般、成分复杂、制备成本高、产品保质期短等问题,无法完全满足实际应用需求。
因此,亟需开发一种祛疤效果好、成分简单、制备简单、成本低廉的祛疤产品。
以上陈述仅仅是提供与本发明有关的背景信息,而不必然构成现有技术。
发明内容
本发明的目的在于提供一种祛疤软膏及其制备方法。
本发明所采取的技术方案是:
一种祛疤软膏,其包括以下质量百分比的组分:
去细胞动物组织粉末或/和去细胞动物器官粉末:2%~10%;
软膏基质:50%~93%;
水:余量。
优选的,所述去细胞动物组织粉末由动物组织经过脱细胞处理、冻干和粉碎得到。
优选的,所述动物组织为动物皮肤、动物肌腱中的至少一种。
进一步优选的,所述动物组织为猪皮、兔皮、鱼皮中的至少一种。
更进一步优选的,所述动物组织为猪皮(猪与人类具有同源性,接受度更高)。
优选的,所述去细胞动物器官粉末由动物器官经过脱细胞处理、冻干和粉碎得到。
优选的,所述动物器官为动物肝脏、动物肾脏中的至少一种。
优选的,所述脱细胞处理为将动物组织或/和动物器官切块后依次用Triton X-100溶液、十二烷基硫酸钠(SDS)溶液、NaCl溶液和二次蒸馏水(ddH2O)进行浸泡。
优选的,所述Triton X-100溶液的体积浓度为1%~3%。
优选的,所述动物组织或/和动物器官在Triton X-100溶液中的浸泡时间为20h~30h。
优选的,所述十二烷基硫酸钠溶液的质量百分比浓度为0.1%~0.3%。
优选的,所述动物组织或/和动物器官在十二烷基硫酸钠溶液中的浸泡时间为40h~70h。
优选的,所述NaCl溶液的物质的量浓度为0.1mol/L~0.2mol/L。
优选的,所述动物组织或/和动物器官在NaCl溶液中的浸泡时间为40h~70h。
优选的,所述动物组织或/和动物器官在二次蒸馏水中的浸泡时间为20h~30h。
优选的,所述软膏基质的组成包括单硬脂酸甘油酯、羊毛脂、凡士林、液状石蜡、甘油、三乙醇胺、十八醇和水。
进一步优选的,所述软膏基质包括以下质量份的组分:
单硬脂酸甘油酯:30份~40份;
羊毛脂:10份~50份;
凡士林:5份~20份;
液体石蜡:60份~100份;
甘油:45份~55份;
三乙醇胺:3.5份~4.5份;
十八醇:8份~12份;
水:750份~850份。
优选的,所述软膏基质通过以下方法制备得到:
1)将单硬脂酸甘油酯、羊毛脂、凡士林和液状石蜡混合加热至70℃~90℃,得到油相;
2)将甘油、三乙醇胺、十八醇和水混合加热至70℃~90℃,得到水相;
3)将水相倒入搅拌状态的油相中,70℃~90℃搅拌至呈乳白色,冷却,即得软膏基质。
上述祛疤软膏的制备方法包括以下步骤:
1)将去细胞动物组织粉末或/和去细胞动物器官粉末加水分散,得到分散液;
2)将软膏基质加热至50℃~70℃,再边搅拌边加入步骤1)的分散液,充分搅拌,冷却,即得祛疤软膏。
本发明的有益效果是:本发明的祛疤软膏具有祛疤效果好、生物相容性好、天然无毒、成分简单、制备简单、原料来源丰富、成本低廉等优点,适合进行大面积推广应用。
具体而言:
1)本发明的祛疤软膏中添加有去细胞动物组织粉末或/和去细胞动物器官粉末,脱细胞处理在去除动物组织和动物器官中的细胞和遗传物质的同时,保留了细胞外基质(ECM)的复杂超微结构作为天然支架,ECM由原生细胞产生,可以作为众多分子成分和天然组织中发现的生长因子的储存和细胞生长的三维结构,是细胞迁移、附着、分化和功能化的微环境,ECM里面包含结构蛋白(胶原和弹性蛋白)、特化蛋白(原纤维蛋白、纤连蛋白和层粘连蛋白)、蛋白聚糖(硫酸肝素、硫酸软骨素和硫酸角蛋白)和各种生长因子等,能够促进组织结构重塑和组织再生,发挥出优异的祛疤效果;
2)本发明的祛疤软膏中添加有去细胞动物组织粉末或/和去细胞动物器官粉末,动物组织和动物器官来源丰富,价格低廉,天然无毒;
3)本发明的祛疤软膏成分简单,制备工艺简单,生产成本低,适合进行大面积推广应用。
附图说明
图1为实施例1的祛疤软膏对烫伤区域的祛疤效果测试结果。
图2为实施例1的祛疤软膏对切割伤口的祛疤效果测试结果。
图3为伤口横切的HE染色照片。
具体实施方式
下面结合具体实施例对本发明作进一步的解释和说明。
实施例1:
一种祛疤软膏,其制备方法包括以下步骤:
1)将新鲜猪皮切成小块,依次用体积浓度(v/v)2%的Triton X-100溶液浸泡24h、质量百分比浓度0.1%的十二烷基硫酸钠溶液浸泡48h、物质的量浓度0.1mol/L的NaCl溶液浸泡48h和二次蒸馏水浸泡24h,冻干,研磨成细粉,过200目筛,得到去细胞猪皮粉末;
2)将35质量份的单硬脂酸甘油酯、25质量份的羊毛脂、10质量份的凡士林和80质量份的液状石蜡混合,加热至80℃,保温至原料完全融化,得到油相,再将50质量份的甘油、4质量份的三乙醇胺、10质量份的十八醇和786质量份的蒸馏水混合,水浴加热至80℃,得到水相,再将水相缓慢倒入搅拌状态的油相中,80℃搅拌至呈乳白色,冷却,即得软膏基质;
3)将2质量份的去细胞猪皮粉末加5质量份的蒸馏水分散,得到分散液;
4)将93质量份的软膏基质加热至60℃,再边搅拌边缓慢加入步骤3)的分散液,充分搅拌,冷却,即得祛疤软膏。
性能测试:
1)烫伤皮肤的祛疤效果测试:在大鼠胸部两侧相同位置设置两块大小相同的烫伤区域,一块烫伤区域涂抹本实施例制备的祛疤软膏(实验组),另一烫伤区域不做任何处理(对照组),观察第1天、3天、7天和14天的祛疤效果,烫伤区域的祛疤效果测试结果如图1所示。
由图1可知:涂抹了本实施例制备的祛疤软膏的烫伤区域愈合更快,且疤痕明显更小。
2)切割伤口的祛疤效果测试:在大鼠胸部两侧相同位置切割出两块大小相同的伤口,一块切割伤口涂抹本实施例制备的祛疤软膏(实验组),另一切割伤口不做任何处理(对照组),观察第1天和14天的祛疤效果,切割伤口的祛疤效果测试结果如图2所示,伤口横切的HE染色照片如图3所示。
由图2可知:第14天涂抹了本实施例制备的祛疤软膏的切割伤口变的平复,两侧已不见刀痕,而未涂抹本实施例制备的祛疤软膏的切割伤口依然能看到很长的刀痕。
由图3可知:第14天涂抹了本实施例制备的祛疤软膏的切割伤口的切口瘢痕更小,且开始长出毛囊。
实施例2:
一种祛疤软膏,其制备方法包括以下步骤:
1)将新鲜猪皮切成小块,依次用体积浓度(v/v)2%的Triton X-100溶液浸泡24h、质量百分比浓度0.1%的十二烷基硫酸钠溶液浸泡48h、物质的量浓度0.1mol/L的NaCl溶液浸泡48h和二次蒸馏水浸泡24h,冻干,研磨成细粉,过200目筛,得到去细胞猪皮粉末;
2)将38质量份的单硬脂酸甘油酯、30质量份的羊毛脂、15质量份的凡士林和80质量份的液状石蜡混合,加热至80℃,保温至原料完全融化,得到油相,再将50质量份的甘油、4质量份的三乙醇胺、8质量份的十八醇和775质量份的蒸馏水混合,水浴加热至80℃,得到水相,再将水相缓慢倒入搅拌状态的油相中,80℃搅拌至呈乳白色,冷却,即得软膏基质;
3)将5质量份的去细胞猪皮粉末加15质量份的蒸馏水分散,得到分散液;
4)将80质量份的软膏基质加热至60℃,再边搅拌边缓慢加入步骤3)的分散液,充分搅拌,冷却,即得祛疤软膏。
参照实施例1的测试方法对本实施例制备的祛疤软膏的祛疤效果进行测试,测试发现其祛疤效果和实施例1制备的祛疤软膏十分接近。
实施例3:
一种祛疤软膏,其制备方法包括以下步骤:
1)将新鲜猪皮切成小块,依次用体积浓度(v/v)2%的Triton X-100溶液浸泡24h、质量百分比浓度0.1%的十二烷基硫酸钠溶液浸泡48h、物质的量浓度0.1mol/L的NaCl溶液浸泡48h和二次蒸馏水浸泡24h,冻干,研磨成细粉,过200目筛,得到去细胞猪皮粉末;
2)将40质量份的单硬脂酸甘油酯、45质量份的羊毛脂、15质量份的凡士林和80质量份的液状石蜡混合,加热至80℃,保温至原料完全融化,得到油相,再将45质量份的甘油、4质量份的三乙醇胺、8质量份的十八醇和753质量份的蒸馏水混合,水浴加热至80℃,得到水相,再将水相缓慢倒入搅拌状态的油相中,80℃搅拌至呈乳白色,冷却,即得软膏基质;
3)将10质量份的去细胞猪皮粉末加40质量份的蒸馏水分散,得到分散液;
4)将50质量份的软膏基质加热至60℃,再边搅拌边缓慢加入步骤3)的分散液,充分搅拌,冷却,即得祛疤软膏。
参照实施例1的测试方法对本实施例制备的祛疤软膏的祛疤效果进行测试,测试发现其祛疤效果和实施例1制备的祛疤软膏十分接近。
上述实施例为本发明较佳的实施方式,但本发明的实施方式并不受上述实施例的限制,其他的任何未背离本发明的精神实质与原理下所作的改变、修饰、替代、组合、简化,均应为等效的置换方式,都包含在本发明的保护范围之内。
Claims (10)
1.一种祛疤软膏,其特征在于,其包括以下质量百分比的组分:
去细胞动物组织粉末或/和去细胞动物器官粉末:2%~10%;
软膏基质:50%~93%;
水:余量。
2.根据权利要求1所述的祛疤软膏,其特征在于:所述去细胞动物组织粉末由动物组织经过脱细胞处理、冻干和粉碎得到;所述去细胞动物器官粉末由动物器官经过脱细胞处理、冻干和粉碎得到。
3.根据权利要求2所述的祛疤软膏,其特征在于:所述动物组织为动物皮肤、动物肌腱中的至少一种;所述动物器官为动物肝脏、动物肾脏中的至少一种。
4.根据权利要求2或3所述的祛疤软膏,其特征在于:所述脱细胞处理为将动物组织或/和动物器官切块后依次用Triton X-100溶液、十二烷基硫酸钠溶液、NaCl溶液和二次蒸馏水进行浸泡。
5.根据权利要求4所述的祛疤软膏,其特征在于:所述Triton X-100溶液的体积浓度为1%~3%;所述十二烷基硫酸钠溶液的质量百分比浓度为0.1%~0.3%;所述NaCl溶液的物质的量浓度为0.1mol/L~0.2mol/L。
6.根据权利要求4所述的祛疤软膏,其特征在于:所述动物组织或/和动物器官在Triton X-100溶液中的浸泡时间为20h~30h,在十二烷基硫酸钠溶液中的浸泡时间为40h~70h,在NaCl溶液中的浸泡时间为40h~70h,在二次蒸馏水中的浸泡时间为20h~30h。
7.根据权利要求1或2所述的祛疤软膏,其特征在于:所述软膏基质的组成包括单硬脂酸甘油酯、羊毛脂、凡士林、液状石蜡、甘油、三乙醇胺、十八醇和水。
8.根据权利要求7所述的祛疤软膏,其特征在于:所述软膏基质包括以下质量份的组分:单硬脂酸甘油酯:30份~40份;
羊毛脂:10份~50份;
凡士林:5份~20份;
液体石蜡:60份~100份;
甘油:45份~55份;
三乙醇胺:3.5份~4.5份;
十八醇:8份~12份;
水:750份~850份。
9.根据权利要求7所述的祛疤软膏,其特征在于:所述软膏基质通过以下方法制备得到:
1)将单硬脂酸甘油酯、羊毛脂、凡士林和液状石蜡混合加热至70℃~90℃,得到油相;
2)将甘油、三乙醇胺、十八醇和水混合加热至70℃~90℃,得到水相;
3)将水相倒入搅拌状态的油相中,70℃~90℃搅拌至呈乳白色,冷却,即得软膏基质。
10.权利要求1~9中任意一项所述的祛疤软膏的制备方法,其特征在于,包括以下步骤:
1)将去细胞动物组织粉末或/和去细胞动物器官粉末加水分散,得到分散液;
2)将软膏基质加热至50℃~70℃,再边搅拌边加入步骤1)的分散液,充分搅拌,冷却,即得祛疤软膏。
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