CN110742931A - 一种疤痕止痒软化乳膏及其制备方法 - Google Patents
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Abstract
本发明涉及一种疤痕止痒软化乳膏及其制备方法,所述药膏中含有以下物质:复方五倍子浸膏、薄荷脑、樟脑、冰片、水杨酸甲酯、硬脂酸、羊毛脂、凡士林、液体石蜡、司盘60、硬脂酸镁、甘油、吐温80、羟苯乙酯、羟苯丙酯和蒸馏水。跟现有技术相比,本发明改变了药膏的基质配方、比例并优化了制备工艺,显著提高了产品的稳定性。
Description
技术领域
本发明涉及一种中药乳膏。
背景技术
病理性瘢痕是由创伤等引起,以胶原等大量结缔组织基质的过度产生和沉积为特征的人类真皮区特有的纤维代谢性疾病,主要包括增生性疤痕和瘢痕疙瘩。病理性瘢痕的组织学特征为大量纤维细胞增生,细胞外基质中胶原、蛋白多糖、糖蛋白等过量沉积、胶原纤维排列紊乱(靖亚莎、刘刚,中国中西医结合皮肤性病学杂志,2009,8(4),262-265)。增生性疤痕主要是由于胶原蛋白合成代谢超长持续进行,超过分解代谢的速度,大量形成胶原纤维所致。胶原纤维素是疤痕形成的主要物质。当大量肌成纤维细胞收缩与肌细胞表面原纤维形成僵硬结构使疤痕萎缩变硬导致局部畸形或功能障碍,临床表现为感觉异样、瘤样增生并伴有不同程度的功能障碍。增生性疤痕与正常皮肤有四大差异,即:奇痒、增生、干燥和功能受限(林才、张鹏等,中国药师,2009,12(8),1133-1134)。
疤痕止痒软化乳膏为中药制剂,其主要成分为五倍子,对疤痕的增生具有较好的抑制作用。现代药理学研究表明,五倍子所含的鞣质通过沉淀蛋白来抑制纤维母细胞增生,促进小血管收缩,减少疤痕供血,从而达到减少疤痕的目的。其他均为辅药,有利于主药黏附、渗透等作用(林才、张鹏等,中国药师,2009,12(8),1133-1134)。但市场在售的疤痕止痒软化乳膏对储存条件要求较高,产品在较高温度下易破乳并发生油水分离,导致产品变质并影响最终的治疗效果,因此,需要提供一种新的技术方案来解决上述问题。
发明内容
为解决上述问题,本发明的目的是提供一种性质更加稳定、能保证疗效的疤痕止痒软化乳膏。
本发明提供了一种疤痕止痒软化乳膏,所述的疤痕止痒软化乳膏为W/O型中药乳膏剂并由以下组分构成:
复方五倍子浸膏10%-15%,薄荷脑2%-4%,樟脑2%-4%,冰片3%-5%,水杨酸甲酯2%-5%;
油相组分40%-50%,保湿剂3%-7%,乳化剂10%-25%,防腐剂0.1-0.3%,以及水3%-15%;
所述油相组分选自硬脂酸、羊毛脂、凡士林、液体石蜡、蜂蜡、高级脂肪醇中的一种或几种;
所述保湿剂选自甘油、丙二醇或山梨醇中的一种或几种;
所述乳化剂选自司盘60、硬脂酸镁、吐温80、三乙醇胺中的一种或几种;
所述防腐剂选自羟苯乙酯、羟苯丙酯中的一种或两种。
更进一步地,所述复方五倍子浸膏采用以下方法制备:
将五倍子85.7g、威灵仙85.7g、牡丹皮42.9g、泽兰42.9g,粉碎成细粉,用90%乙醇回流提取三次,每次加溶媒6倍量,每次回流1小时,滤过,合并滤液,回收乙醇,浓缩至120g,即得复方五倍子浸膏;
所述油相组分为硬脂酸、羊毛脂、凡士林和液体石蜡;
所述保湿剂为甘油;
所述乳化剂为司盘60、硬脂酸镁和吐温80;
所述防腐剂为羟苯乙酯和羟苯丙酯。
再进一步地,本发明所提供的疤痕止痒软化乳膏由复方五倍子浸膏12%,薄荷脑3.4%,樟脑3.4%,冰片4.3%,水杨酸甲酯2.6%,硬脂酸11%,羊毛脂2%,凡士林27.3%,液体石蜡2%,司盘60 8%,硬脂酸镁5%,甘油5%,吐温80 10%,羟苯乙酯0.1%,羟苯丙酯0.1%及蒸馏水3.8%制成的W/O型中药乳膏剂。
具体而言,本发明提供的疤痕止痒软化乳膏通过以下方法进行制备(以1000g为例):
(1)称取硬脂酸110g、羊毛脂20g、凡士林273g、液体石蜡20g、司盘60 80g、硬脂酸镁50g、冰片43g、樟脑34g、薄荷脑34g,85℃搅拌熔融,为油相,保温备用;
(2)称取甘油50g、吐温80 100g、羟苯乙酯1g、羟苯丙酯1g、浸膏120g、纯化水38g,85℃搅拌溶解,为水相,保温备用;
(3)在搅拌下,将水相缓缓加至油相,85℃保温均质乳化1min,然后继续搅拌降温至55℃;
(4)称取水杨酸甲酯26g,55℃搅拌混合溶散均匀,加入上述乳液中,继续搅拌1min,降温至35℃,抽真空,灌装,即得疤痕止痒软化乳膏。
本发明中所述百分比均为重量百分比。
在研究中我们发现,跟现有技术相比,本发明提供的疤痕止痒软化乳膏,通过改进基质的配方、比例以及优化制备工艺,显著提高了产品的稳定性。
具体实施方式
以下通过具体实施方式的描述对本发明作进一步说明。应理解,这些实施例仅用于说明本发明而不用于限制本发明的范围。
实施例1
1.1复方五倍子浸膏的提取
称取五倍子85.7g、威灵仙85.7g、牡丹皮42.9g、泽兰42.9g,粉碎成细粉,用90%乙醇回流提取三次,每次加溶媒6倍量,每次回流1小时,滤过,合并滤液,回收乙醇,浓缩至120g,即得复方五倍子浸膏。
1.2疤痕止痒软化乳膏的制备
(1)称取硬脂酸110g、羊毛脂20g、凡士林273g、液体石蜡20g、司盘60 80g、硬脂酸镁50g、冰片43g、樟脑34g、薄荷脑34g,85℃搅拌熔融,为油相,保温备用;
(2)称取甘油50g、吐温80 100g、羟苯乙酯1g、羟苯丙酯1g、浸膏120g、纯化水38g,85℃搅拌溶解,为水相,保温备用;
(3)在搅拌下,将水相缓缓加至油相,85℃保温均质乳化1min,然后继续搅拌降温至55℃;
(4)称取水杨酸甲酯26g,55℃搅拌混合溶散均匀,加入上述乳液中,继续搅拌1min,降温至35℃,抽真空,灌装,即得疤痕止痒软化乳膏。
实施例2
2.1复方五倍子浸膏的提取
称取五倍子85.7g、威灵仙85.7g、牡丹皮42.9g、泽兰42.9g,粉碎成细粉,用90%乙醇回流提取三次,每次加溶媒6倍量,每次回流1小时,滤过,合并滤液,回收乙醇,浓缩至120g,即得复方五倍子浸膏。
2.2疤痕止痒软化乳膏的制备
(1)称取硬脂酸170g、羊毛脂20g、凡士林273g、液体石蜡20g、司盘60 130g,85℃-90℃搅拌熔融,作为油相,保温备用;
(2)称取甘油50g、三乙醇胺28g、羟苯乙酯1g、羟苯丙酯1g、复方五倍子浸膏120g、纯化水50g,85℃-90℃搅拌溶解,作为水相,保温备用;
(3)在搅拌下,将水相缓缓加入油相,85℃-90℃保温均质乳化5-15min,然后继续搅拌降温至50℃-55℃;
(4)称取冰片43g、樟脑34g、薄荷脑34g、水杨酸甲酯26g,50℃-55℃搅拌混合溶散均匀,加入上述乳液中,继续搅拌降温至30℃-35℃,抽真空5min,密闭静置10min,灌装,即得疤痕止痒软化乳膏。
实施例3
3.1复方五倍子浸膏的提取
称取五倍子85.7g、威灵仙85.7g、牡丹皮42.9g、泽兰42.9g,粉碎成细粉,用90%乙醇回流提取三次,每次加溶媒6倍量,每次回流1小时,滤过,合并滤液,回收乙醇,浓缩至120g,即得复方五倍子浸膏。
3.2疤痕止痒软化乳膏的制备
(1)称取硬脂酸110g、羊毛脂20g、凡士林273g、液体石蜡20g、司盘60 130g、冰片21.5g,85℃搅拌熔融,作为油相,保温备用;
(2)称取甘油50g、三乙醇胺28g、羟苯乙酯1g、羟苯丙酯1g、浸膏120g、纯化水110g,85℃搅拌溶解,为水相,保温备用;
(3)在搅拌下,将水相缓缓加入油相,85℃保温均质乳化1min,然后继续搅拌降温至55℃;
(4)称取冰片21.5g、樟脑34g、薄荷脑34g、水杨酸甲酯26g,55℃搅拌混合溶散均匀并加入上述乳液中,继续搅拌1min,降温至35℃,抽真空,灌装,即得疤痕止痒软化乳膏。
实施例4
4.1复方五倍子浸膏的提取
称取五倍子85.7g、威灵仙85.7g、牡丹皮42.9g、泽兰42.9g,粉碎成细粉,用90%乙醇回流提取三次,每次加溶媒6倍量,每次回流1小时,滤过,合并滤液,回收乙醇,浓缩至120g,即得复方五倍子浸膏。
4.2疤痕止痒软化乳膏的制备
(1)称取硬脂酸110g、羊毛脂20g、凡士林273g、液体石蜡20g、司盘60 130g、冰片43g,85℃搅拌熔融,作为油相,保温备用;
(2)称取甘油50g、三乙醇胺14g、羟苯乙酯1g、羟苯丙酯1g、浸膏120g、纯化水124g,85℃搅拌溶解,为水相,保温备用;
(3)在搅拌下,将水相缓缓加入油相,85℃保温均质乳化1min,然后继续搅拌降温至55℃;
(4)称取樟脑34g、薄荷脑34g、水杨酸甲酯26g,55℃搅拌混合溶散均匀,加入上述乳液中,继续搅拌1min,降温至35℃,抽真空,灌装,即得疤痕止痒软化乳膏。
实施例5
5.1复方五倍子浸膏的提取
称取五倍子85.7g、威灵仙85.7g、牡丹皮42.9g、泽兰42.9g,粉碎成细粉,用90%乙醇回流提取三次,每次加溶媒6倍量,每次回流1小时,滤过,合并滤液,回收乙醇,浓缩至120g,即得复方五倍子浸膏。
5.2疤痕止痒软化乳膏的制备
(1)称取硬脂酸110g、羊毛脂20g、凡士林273g、液体石蜡20g、司盘60 70g、硬脂酸镁60g、樟脑34g、薄荷脑34g、冰片43g,85℃搅拌熔融,作为油相,保温备用;
(2)称取甘油50g、羟苯乙酯1g、羟苯丙酯1g、浸膏120g、纯化水110g,85℃搅拌溶解,为水相,保温备用;
(3)在搅拌下,将水相缓缓加入油相,85℃保温均质乳化1min,然后继续搅拌降温至55℃;
(4)称取水杨酸甲酯26g,55℃搅拌混合溶散均匀,加入上述乳液中,继续搅拌1min,降温至35℃,抽真空,灌装,即得疤痕止痒软化乳膏。
实施例6
6.1复方五倍子浸膏的提取
称取五倍子85.7g、威灵仙85.7g、牡丹皮42.9g、泽兰42.9g,粉碎成细粉,用90%乙醇回流提取三次,每次加溶媒6倍量,每次回流1小时,滤过,合并滤液,回收乙醇,浓缩至120g,即得复方五倍子浸膏。
6.2疤痕止痒软化乳膏的制备
(1)称取硬脂酸110g、羊毛脂20g、凡士林273g、液体石蜡20g、司盘60 130g、冰片43g,85℃搅拌熔融,作为油相,保温备用;
(2)称取甘油50g、吐温80 100g、羟苯乙酯1g、羟苯丙酯1g、浸膏120g、纯化水38g,85℃搅拌溶解,为水相,保温备用;
(3)在搅拌下,将水相缓缓加入油相,85℃保温均质乳化1min,然后继续搅拌降温至55℃;
(4)称取薄荷脑34g、樟脑34g、水杨酸甲酯26g,55℃搅拌混合溶散均匀,加入上述乳液中,继续搅拌1min,降温至35℃,抽真空,灌装,即得疤痕止痒软化乳膏。
实施例7
通过观察以上实施例1-6制备的疤痕止痒软化乳膏的外观并通过稳定性试验、室温放置实验和离心试验考察实施例1-6制备的疤痕止痒软化乳膏的物理稳定性,具体指标如下:
综上所述,对比现有技术,本发明所制备的疤痕止痒软化乳膏膏体细腻均匀,稠度合适;通过稳定性试验、室温放置试验和离心试验考察其物理稳定性,发现通过本发明所制备的疤痕止痒软化乳膏具有更好的稳定性。
Claims (8)
1.一种疤痕止痒软化乳膏,其特征在于,所述的疤痕止痒软化乳膏为W/O型中药乳膏剂并由以下组分构成:
复方五倍子浸膏10%-15%,薄荷脑2%-4%,樟脑2%-4%,冰片3%-5%,水杨酸甲酯2%-5%;
油相组分40%-50%,保湿剂3%-7%,乳化剂10%-25%,防腐剂0.1-0.3%,以及水3%-15%;
所述油相组分选自硬脂酸、羊毛脂、凡士林、液体石蜡、蜂蜡、高级脂肪醇中的一种或几种;
所述保湿剂选自甘油、丙二醇或山梨醇中的一种或几种;
所述乳化剂选自司盘60、硬脂酸镁、吐温80、三乙醇胺中的一种或几种;
所述防腐剂选自羟苯乙酯、羟苯丙酯中的一种或两种。
2.如权利要求1所述的疤痕止痒软化乳膏,其特征在于,所述复方五倍子浸膏采用以下方法制备:
将五倍子85.7g、威灵仙85.7g、牡丹皮42.9g、泽兰42.9g,粉碎成细粉,用90%乙醇回流提取三次,每次加溶媒6倍量,每次回流1小时,滤过,合并滤液,回收乙醇,浓缩至120g,即得复方五倍子浸膏。
3.如权利要求1所述的疤痕止痒软化乳膏,其特征在于,所述油相组分为硬脂酸、羊毛脂、凡士林和液体石蜡。
4.如权利要求1所述的疤痕止痒软化乳膏,其特征在于,所述保湿剂为甘油。
5.如权利要求1所述的疤痕止痒软化乳膏,其特征在于,所述乳化剂为司盘60、硬脂酸镁和吐温80。
6.如权利要求1所述的疤痕止痒软化乳膏,其特征在于,所述防腐剂为羟苯乙酯和羟苯丙酯。
7.如权利要求1-6任一所述的疤痕止痒软化乳膏,其特征在于,该疤痕止痒软化乳膏由复方五倍子浸膏12%,薄荷脑3.4%,樟脑3.4%,冰片4.3%,水杨酸甲酯2.6%,硬脂酸11%,羊毛脂2%,凡士林27.3%,液体石蜡2%,司盘60 8%,硬脂酸镁5%,甘油5%,吐温8010%,羟苯乙酯0.1%,羟苯丙酯0.1%及蒸馏水3.8%制成的W/O型中药乳膏剂。
8.如权利要求7所述的疤痕止痒软化乳膏,其特征在于,1000g疤痕止痒软化乳膏的制备方法为:
(1)称取硬脂酸110g、羊毛脂20g、凡士林273g、液体石蜡20g、司盘60 80g、硬脂酸镁50g、冰片43g、樟脑34g、薄荷脑34g,85℃搅拌熔融,为油相,保温备用;
(2)称取甘油50g、吐温80 100g、羟苯乙酯1g、羟苯丙酯1g、浸膏120g、纯化水38g,85℃搅拌溶解,为水相,保温备用;
(3)在搅拌下,将水相缓缓加至油相,85℃保温均质乳化1min,然后继续搅拌降温至55℃;
(4)称取水杨酸甲酯26g,55℃搅拌混合溶散均匀,加入上述乳液中,继续搅拌1min,降温至35℃,抽真空,灌装,即得疤痕止痒软化乳膏。
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