CN119523887A - 一种治疗手足皲裂的药膏及其制备方法 - Google Patents
一种治疗手足皲裂的药膏及其制备方法 Download PDFInfo
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Abstract
本发明公开一种防治手足皲裂的药膏及其制备方法,所述药膏包括以下组分:纯化水、凡士林、甘油、单硬脂酸甘油酯、黄原胶、卡波姆、羟苯甲酯、8‑羟基喹啉硫酸盐。本药膏在NaOH溶液构建的大鼠皲裂模型中,能有效的改善皮肤裂口、肿胀和出血。本发明能够起到润肤护肤和促进手足裂口愈合等效果,在治疗手足皲裂方面有独特的显著优势,适合大面积推广使用。
Description
技术领域
本发明涉及药膏领域,特别涉及一种防治手足皲裂的药膏及其制备方法。
背景技术
手足皲裂是指因各种原因导致的手足皮肤干燥、出现裂隙,常伴有疼痛,是一种常见的手足部皮肤病。正常人体掌跖部位皮肤角质层较厚且无皮脂腺,缺乏皮脂保护,在外因刺激下,角质层会变脆变硬,一旦牵拉受压超过皮肤正常承受限度即可皲裂致病。常见的诱发因素有干燥、摩擦、外伤、酸碱物质、有机溶媒(肥皂洗洁精)等。手足皲裂需与手足湿疹、掌跖角化症、手足癣及鱼鳞病相鉴别,亦可合并手足癣、湿疹、鱼鳞病等。
手足皲裂不仅会造成疼痛和不适,还会使人的外表变得粗糙、难看,影响美观。由于皮肤破裂,容易收集尘埃和细菌,给感染带来机会,导致皮肤红肿、化脓、发痒、疼痛等。会限制手脚的运动能力,影响运动和日常生活。手足皲裂患者一般都会对自己的手脚感到不自信,影响心理健康。
单纯手足皲裂可遵医嘱使用维生素 E 乳膏外涂或维生素 B6 口服以改善症状。合并其他疾病若合并有湿疹、鱼鳞病的患者来说,则建议其积极治疗原发病,可在医生指导下使用氢化可的松乳膏等糖皮质激素制剂或口服维生素 A 等。对于合并有湿疹、鱼鳞病等疾病的患者,需要针对原发病进行治疗。氢化可的松乳膏等糖皮质激素制剂可以减轻炎症和瘙痒,促进皮肤的修复。维生素 A 可以调节皮肤的角化过程,改善皮肤的干燥和粗糙。但是目前针对手足皲裂的药剂临床药效均不能令人满意,或长期使用有刺激性作用,因此发明一种治疗手足皲裂的药膏是本发明目的所在。
发明内容
针对现有技术中对治疗手足皲裂的膏剂药效不佳、有刺激性等问题,本发明提供一种防治手足皲裂的药膏及其制备方法。
为了实现上述目的,本发明具体采取了以下技术方案:
一种防治手足皲裂的药膏(记为ZZ001),按照重量份数计,组成如下:纯化水70~90%、凡士林1~10%、甘油1~10%、单硬脂酸甘油酯1~10%、黄原胶0.1~1%、卡波姆0.1~1%、羟苯甲酯0.1~1% 、8-羟基喹啉硫酸盐0.1~1%。
所述的治疗皲裂药膏(ZZ001)的制备过程为:
(1)按比例称取凡士林、单硬脂酸甘油酯、甘油投入容器内加热至80~85℃,搅拌至完全溶解,作为油相;
(2) 按比例称取水、黄原胶、卡波姆、羟苯甲酯、8-羟基喹啉硫酸盐投入容器内加热至80~85℃,搅拌至完全溶解,作为水相;
(3)搅拌下将步骤(1)油相加入步骤(2)水相中,搅拌均匀;降温至室温即可。
优选地,步骤(3)中,先以20~100 r/min的搅拌速度将步骤(1)油相加入步骤(2)水相中,后再以5000~10000r/min的搅拌速度搅拌均匀(1~10分钟)。
上述防治手足皲裂的药膏作为防治手足皲裂药物的应用。
手足皲裂的动物模型中观察ZZ001的作用,发现可以缓解手足皲裂的临床症状。
手足皲裂的动物模型是采用NaOH溶液涂抹的方式。采用此模型观察ZZ001对手足皲裂的治疗作用。结果显示ZZ001有效改善NaOH溶液涂抹导致的皮肤裂口,诱导伤口愈合。
附图说明
图1为ZZ001对皲裂大鼠模型治疗效果的大体形态观察;
图2为ZZ001对大鼠模型皮肤损伤的评分及统计学分析;
图3为ZZ001大鼠模型皮肤HYP(羟脯氨酸)的影响;
图2、图3中,*、**、*** 和 **** 分别表示p<0.05、p<0.01、p<0.001和p<0.0001。
具体实施方式
为了使本发明的技术目的、技术方案和有益效果更加清楚,下面结合具体实施例对本发明的技术方案作出进一步的说明,但所述实施旨在解释本发明,而不能理解为对本发明的限制,实施例中未注明具体技术或条件者,按照本领域内的文献所描述的技术或条件或者按照产品说明书进行。
实施例1、一种防治手足皲裂的药膏(记为ZZ001)及制备工艺
以质量百分比计,ZZ001配方如下:纯化水88.2%、凡士林2%、甘油3%、单硬脂酸甘油酯6%、黄原胶0.2%、卡波姆0.1%、羟苯甲酯0.2% 、8-羟基喹啉硫酸盐0.3%。
所述的治疗皲裂药膏的制备过程为:
(1)按比例称取凡士林、单硬脂酸甘油酯、甘油投入容器内加热至80~85℃,搅拌至完全溶解,作为油相;
(2)水、黄原胶、卡波姆、羟苯甲酯、8-羟基喹啉硫酸盐投入适当容器内加热至80~85℃,搅拌至完全溶解,作为水相;
(3)开启搅拌,搅拌速度为20r/min,将步骤(1) 80~85℃的油相缓缓加入步骤(2)80~85℃的水相中,将搅拌速度调为40r/min,搅拌20s~1min,开均质器, 8000r/min均质3min;
降温至室温即可。
实施例2、一种防治手足皲裂的药膏(记为ZZ001)及制备工艺
以质量百分比计,ZZ001配方如下:纯化水70%、凡士林10%、甘油10%、单硬脂酸甘油酯6%、黄原胶1%、卡波姆1%、羟苯甲酯1%、8-羟基喹啉硫酸盐1%。
所述的治疗皲裂药膏的制备过程为:
(1)按比例称取凡士林、单硬脂酸甘油酯、甘油投入容器内加热至80~85℃,搅拌至完全溶解,作为油相;
(2)水、黄原胶、卡波姆、羟苯甲酯、8-羟基喹啉硫酸盐投入适当容器内加热至80~85℃,搅拌至完全溶解,作为水相;
(3)开启搅拌,搅拌速度为20r/min,将步骤(1) 80~85℃的油相缓缓加入步骤(2)80~85℃的水相中,将搅拌速度调为40r/min,搅拌20s~1min,开均质器, 8000r/min均质5min;
降温至室温即可。
实施例3、一种防治手足皲裂的药膏(记为ZZ001)及制备工艺
以质量百分比计,ZZ001配方如下:纯化水90%、凡士林1%、甘油1%、单硬脂酸甘油酯7.6 %、黄原胶0.1%、卡波姆0.1%、羟苯甲酯0.1% 、8-羟基喹啉硫酸盐0.1%。
所述的治疗皲裂药膏的制备过程为:
(1)按比例称取凡士林、单硬脂酸甘油酯、甘油投入容器内加热至80~85℃,搅拌至完全溶解,作为油相;
(2)水、黄原胶、卡波姆、羟苯甲酯、8-羟基喹啉硫酸盐投入适当容器内加热至80~85℃,搅拌至完全溶解,作为水相;
(3)开启搅拌,搅拌速度为20r/min,将步骤(1) 80~85℃的油相缓缓加入步骤(2)80~85℃的水相中,将搅拌速度调为40r/min,搅拌20s~1min,开均质器, 8000r/min均质2min;
降温至室温即可。
应用例1、ZZ001对皲裂大鼠模型治疗效果的大体形态观察
实验动物为6周龄的雌性SD大鼠,购自斯贝福(北京)生物技术有限公司。待大鼠适应1周后,留取5只大鼠作为空白组,其余大鼠作为模型组建模。所有大鼠用水合氯醛麻醉后用脱毛膏脱去背部毛发,退毛面积约3*3cm。退完毛的建模大鼠用0.5M浓度的NaOH溶液涂抹背部皮肤,每次涂抹约1mL。该操作每天进行1次。5-7天后大鼠背部皮肤开裂、肿胀、结痂后作为建模成功的标志,空白组大鼠仅退毛不做任何处理。
建模成功后大鼠随机分为3组,每组5只。分别是模型组、ZZ001组(实施例1制得)和阳性药组,阳性药采用市售的马应龙尿素软膏。ZZ001组和尿素软膏组每天涂抹两次,每次0.3g,模型组每天涂抹生理盐水,每次1mL。
结果如图1所示,与空白对照组相比,模型组显示出典型的皲裂特征,如皮肤裂口,出血,肿胀,组织液渗出,结痂等,给药组与阳性药组均显示出能显著缓解这些皮肤损伤,只表现出个别出血点和结痂。
应用例2、ZZ001对大鼠模型皮肤损伤的评分及统计学分析
每天目测评价皮损修复情况,记录数据。皮损评分标准如下: 0 分:皮损完全消失;1 分:皮损修复面积达 1/2~1;2 分:皮损修复面积达 1 /4 ~ 1 /2;3 分:皮损修复面积达 0~1 /4。
结果如图2所示,模型组显示出较高的皮肤损伤,皮损面积较大,且自体恢复能力极差,而ZZ001组和阳性药组能极大的缓解NaOH诱导的皮肤损伤。
应用例3、ZZ001对皲裂大鼠模型皮肤羟脯氨酸(HYP)含量的影响
试验结束后收取大鼠背部皮肤样本,每组每只大鼠剪取涂药处皮肤50mg,采用南京建成生物科技有限公司的羟脯氨酸(HYP)测定试剂盒(碱水解法)测定大鼠背部皮肤羟脯氨酸(Hyp)含量。结果如图3显示,与正常(空白对照)组小鼠相比,在NaOH溶液的持续刺激下,模型对照组大鼠皮肤的HYP显著下降,皮肤表层出现较大损伤,且皮肤的愈合能力和愈合速度显著下降,而给药组和阳性对照组的HYP则显著升高,接近空白组的含量,说明在ZZ001和阳性药的处理下,皮肤愈合速度增加,在试验结束时已经接近正常皮肤,ZZ001的HYP含量高于阳性药尿素软膏的HYP含量。说明ZZ001的效果要好于阳性对照。
综上结果表明,ZZ001具有缓解手足皲裂的临床症状,改善皮肤裂口,诱导伤口愈合的作用。在治疗手足皲裂病方面显示了良好的应用前景。
Claims (4)
1.一种防治手足皲裂的药膏,其特征在于,按照重量份数计,组成如下:纯化水70~90%、凡士林1~10%、甘油1~10%、单硬脂酸甘油酯1~10%、黄原胶0.1~1%、卡波姆0.1~1%、羟苯甲酯0.1~1% 、8-羟基喹啉硫酸盐0.1~1%。
2.根据权利要求1所述的防治手足皲裂的药膏的制备方法,其特征在于,过程如下:
(1)按比例称取凡士林、单硬脂酸甘油酯、甘油投入容器内加热至80~85℃,搅拌至完全溶解,作为油相;
(2) 按比例称取水、黄原胶、卡波姆、羟苯甲酯、8-羟基喹啉硫酸盐投入容器内加热至80~85℃,搅拌至完全溶解,作为水相;
(3)搅拌下将步骤(1)油相加入步骤(2)水相中,搅拌均匀;降温至室温即可。
3.根据权利要求1所述的防治手足皲裂的药膏的制备方法,其特征在于,步骤(3)中,先以20~100 r/min的搅拌速度将步骤(1)油相加入步骤(2)水相中,后再以5000~10000r/min的搅拌速度搅拌均匀。
4.权利要求1所述防治手足皲裂的药膏作为防治手足皲裂药物的应用。
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