CN107158051A - 一种治疗湿疹的鞣酸软膏及其制备方法 - Google Patents
一种治疗湿疹的鞣酸软膏及其制备方法 Download PDFInfo
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Abstract
本发明涉及一种鞣酸软膏及其制备方法,所述鞣酸软膏由鞣酸,甘油,枫香脂,甜菜碱,凡士林,吐温‑80,亚硫酸氢钠成份组成。所述鞣酸软膏的制备方法是用甘油溶解鞣酸,制得鞣酸甘油溶液,再加入甜菜碱、亚硫酸氢钠,加热并搅拌均匀制得组分A,将凡士林,枫香脂,吐温‑80加热并搅拌均匀,制得组分B;分别将组分A、组分B加热至75‑80℃,将组分A加入到组分B中,搅拌均匀,冷却至室温制得鞣酸软膏。本发明配方中的甜菜碱具有杀菌消炎、调节细胞渗透压、减少药物对皮肤的刺激等作用,枫香脂具有活血止痛、解毒、生肌等功效,可以增强鞣酸的治疗效果,且与甜菜碱具有较好的协同作用,二者联用降低药物对皮肤刺激作用的效果更显著。
Description
技术领域
本发明涉及一种鞣酸软膏及其制备方法,属于医药及制备技术领域,主要用于治疗湿疹,也可用于治疗褥疮、尿布疹等。
背景技术
鞣酸又名单宁酸、鞣质,是从五倍子中提取的一种黄色或淡棕色轻质无晶型粉末或鳞片的物质。无臭,微有特殊气味。易溶于水及乙醇,也易溶于甘油。鞣酸能沉淀蛋白质,皮肤、粘膜、溃疡接触鞣酸后,其组织蛋白质即被凝固,形成一层膜而具有收敛作用。局部使用可以治疗渗出性溃疡、褥疮、湿疹、烫伤等,亦用于解毒,可与生物碱、甙及重金属等均能形成不溶性复合物,故可以作为化学解毒剂。
甜菜碱化学名称是三甲基铵乙丙酯(C5H11NO2),系甘氨酸的三甲基衍生物。最早从甜菜中分离,是一种广泛分布于动植物组织中的季铵型水溶性生物碱。随着对甜菜碱的研究,甜菜碱许多优良的药理作用相继被发现,可用于对抗高同型半胱氨酸综合征,能保肝护肾、保持心脏与血管健康、抑瘤抗癌、降压镇静、解热镇痛、耐缺氧、促进脂肪代谢、杀菌消炎、保护细胞抵抗高渗等。
枫香脂为金缕梅科植物枫香的干燥树脂。枫香脂味辛、微苦,性平,归肺、脾经,具有活血止痛、解毒、生肌的功效,用于跌扑损伤、痈疽肿痛、吐血、衄血等。枫香脂目前在医药、香料、蜡染、卫生、有机合成中间体等方面均有广泛的应用。在闽南地区有用枫香树皮炖肉食用预防和治疗寒湿痹症的传统。研究表明,枫香脂可能含有萜类、黄酮类、酚酸类、苯丙素类、挥发油等化学成分,有扩张冠状动脉和血管、增加血流量、抗心肌缺氧、改善血液流变性、抗凝血、抗血栓形成和血小板聚集等药理作用。
湿疹是皮肤科常见病,是一种迟发型变态反应性皮肤病,病因较复杂。大部分患者易反复发作,使疾病转为慢性,皮损严重,瘙痒剧烈等特点,临床治疗比较困难。现有治疗湿疹的鞣酸软膏存在治疗效果不好,治愈时间长,长期使用对皮肤有刺激作用等问题。
发明内容
本发明是针对现有治疗湿疹的软膏制剂的缺点和不足,提供了一种鞣酸软膏及其制备方法。
一种鞣酸软膏,由下列重量份数的组分制成:鞣酸50-70份,甘油200-280份,枫香脂25-30份,甜菜碱25-30份,凡士林320-400份,吐温-80 20-28份,亚硫酸氢钠2份。
作为优选,上述鞣酸软膏,由下列重量份数的组分制成:鞣酸60份,甘油240份,枫香脂30份,甜菜碱30份,凡士林360份,吐温-80 24份,亚硫酸氢钠2份。
本发明的鞣酸软膏的制备方法具体按如下步骤进行:
(1)按照鞣酸50-70份,甘油200-280份,枫香脂25-30份,甜菜碱25-30份,凡士林320-400份,吐温-80 20-28份,亚硫酸氢钠2份的组分及其用量称量备用;
(2)用甘油溶解鞣酸,制得鞣酸甘油溶液,向所述的鞣酸甘油溶液中加入甜菜碱、亚硫酸氢钠,加热至70-75℃,搅拌混合均匀,保持温度在70-75℃,保温时间30-60分钟,制得组分A;
(3)将凡士林,枫香脂,吐温-80加热至75-80℃,搅拌混合均匀,并保持温度在75-80℃,保温时间20-40分钟,制得组分B;
(4)分别将组分A、组分B加热至75-80℃,将所述组分A加入到所述组分B中,边加边搅拌均匀,并保持温度在75-80℃,保温时间30分钟。冷却至室温制得鞣酸软膏。
进一步,步骤(2)中,优选所述的保温时间40-60分钟。
进一步,步骤(3)中,优选所述的保温时间30-40分钟。
本发明的鞣酸软膏主要用于治疗湿疹,也可用于治疗褥疮、尿布疹等。
与现有技术相比,本发明的有益效果在于:
(1)本发明制备工艺简单,原料简单易得,成本低。
(2)本发明配方中的甜菜碱,具有杀菌消炎、调节细胞渗透压、减少药物对皮肤的刺激等作用。
(3)本发明配方中的枫香脂,具有活血止痛、解毒、生肌的功效,可以增强鞣酸的治疗效果,且与甜菜碱具有较好的协同作用,二者联用降低药物对皮肤刺激作用的效果更显著。
(4)本发明所制得软膏均匀细腻,易于涂抹,治疗效果好,对皮肤无刺激作用。
具体实施方式
实施例1药物刺激性试验
处方1-8软膏的制备方法具体按如下步骤进行:
(1)按表一所述组分及其用量称量备用;
(2)用甘油溶解鞣酸,制得鞣酸甘油溶液,向所述的鞣酸甘油溶液中加入甜菜碱、亚硫酸氢钠,加热至75℃,搅拌混合均匀,保持温度在75℃,保温时间为40分钟,制得组分A;
(3)将凡士林,枫香脂,吐温-80加热至80℃,搅拌混合均匀,并保持温度在80℃,保温时间为30分钟,制得组分B;
(4)分别将组分A、组分B加热至80℃,将所述组分A加入到所述组分B中,边加边搅拌均匀,并保持温度在80℃,保温时间为30分钟。冷却至室温制得鞣酸软膏。
表1各组处方
试验方法:取家兔20只,雌雄各半,随机分为A、B、C、D四组。将家兔脊柱两侧毛剪短后,用10%硫化钠脱毛,每侧一处,面积约为4cm×4cm,采用同体左右侧自身对比。24小时后,每只家兔按每侧涂抹0.5g软膏,涂抹位置及对应处方如表4所示,每日一次,连续用药14天,停药后观察7天。肉眼观察局部有无红斑、水肿等情况,按表2、表3进行评分并分别计算各组的反应平均分值,作刺激性强度评价。
表2皮肤刺激性反应评分标准
红斑 | 分值 | 水肿 | 分值 |
无红斑 | 0 | 无水肿 | 0 |
勉强可见 | 1 | 勉强可见 | 1 |
明显可见 | 2 | 可见(边缘高出周围皮肤) | 2 |
中度到严重红斑 | 3 | 皮肤隆起约1mm,轮廓清楚 | 3 |
紫红色红斑并有焦痂形成 | 4 | 水肿隆起1mm以上并范围扩大 | 4 |
表3皮肤刺激性强度评价标准
平均分值 | 评价 | 平均分值 | 评价 |
0~0.49 | 无刺激性 | 3.0~5.99 | 中度刺激性 |
0.5~2.99 | 轻度刺激性 | 6.0~8.00 | 强刺激性 |
表4持续给药皮肤刺激性试验结果
试验结果:如表4所示,A、B、C、D各组家兔接触软膏处右侧刺激反应平均分值分别为3.8、3.6、4.0、3.6,属于中度刺激性。A、C两组左侧刺激反应平均分值分别为1.8、1.6,属于轻度刺激性。B、D两组左侧刺激反应平均分值都为0,属于无刺激性。
试验结果表明,处方组成没有甜菜碱的处方2、4、6、8对皮肤有中度刺激作用。处方组成有甜菜碱,但没有枫香脂的处方1、5对皮肤有轻度刺激作用。处方组成既有甜菜碱,又有枫香脂的处方3、7对皮肤无刺激作用。说明在本配方中,甜菜碱可以降低药物对皮肤的刺激作用,枫香脂与甜菜碱联用降低刺激作用的效果更显著,而单独加入枫香脂,并没有降低刺激作用的效果,表明枫香脂与甜菜碱具有较好的协同作用。
实施例2:治疗湿疹的鞣酸软膏由下属重量配比的原料制成:鞣酸60份,甘油240份,枫香脂30份,甜菜碱30份,凡士林360份,吐温-80 24份,亚硫酸氢钠2份。
(1)用甘油溶解鞣酸,制得鞣酸甘油溶液。再加入甜菜碱、亚硫酸氢钠,加热至75℃,搅拌混合均匀,保持温度在75℃,保温时间40分钟,制得组分A。
(2)将凡士林,枫香脂,吐温-80加热至80℃,搅拌混合均匀,并保持温度在80℃,保温时间30分钟,制得组分B。
(3)分别将组分A、组分B加热至80℃,将组分A加入到组分B中,边加边搅拌均匀,并保持温度在80℃,保温时间30分钟。冷却至室温制得鞣酸软膏。
实施例3:治疗湿疹的鞣酸软膏由下属重量配比的原料制成:鞣酸60份,甘油240份,甜菜碱30份,凡士林360份,吐温-80 24份,亚硫酸氢钠2份。
制备方法同实施例2不同之处仅在于:不加入枫香脂。
用皮肤损伤或溃疡的家兔,豚鼠进行试验研究,结果表明,实施例2、3所述的鞣酸软膏都能减少伤口处的血浆渗出,促进受损皮肤的结痂愈合。
用实施例2、3所述的鞣酸软膏试用于临床500例湿疹患者,根据患者治疗情况反馈,发现实施例2的鞣酸软膏治疗效果较好,疗效快,一般用药一周,病状明显好转,并且治愈周期短,一般为4-5周。而实施例3的鞣酸软膏,疗效较慢,治愈时间较长,一般为6-8周。结果表明,配方中的枫香脂,有明显增强鞣酸治疗效果的作用。
典型病例
病例1:孙某,男54岁。手部湿疹,经多种方法治疗无效,奇痒钻心,根本无法正常工作,精神几近崩溃。后使用本发明实施例2的鞣酸软膏,用药一周后,症状明显好转,患者感觉痒痛减轻。一个月后,患者手部破溃处已愈合,红色湿疹基本消失。
病例2:5岁小男孩李某某面颈部、手部处大面积红色湿疹伴皮肤破损。小男孩表示身体瘙痒难忍,晚上难入睡。后使用本发明实施例2的鞣酸软膏,一周后,患者感觉瘙痒明显减轻,晚上可以正常睡觉。又持续用药三周后,患儿手部破溃处已愈合,红色湿疹基本消失,面颈部症状也基本痊愈。
病例3:王某,女46岁。患有湿疹多年,经常出差,生活没有什么规律,导致她的病症反复发作。虽然多次去大医院及皮肤专科医院治疗,可每次治都没有完全治愈。后使用本发明实施例2的鞣酸软膏,用药一个月后,患者皮损基本消退,也没有痒痛的感觉了,又持续用药一周,病症已完全消失,至今未见复发。
Claims (5)
1.一种鞣酸软膏,其特征在于:由下列重量份数的组分制成:鞣酸50-70份,甘油200-280份,枫香脂25-30份,甜菜碱25-30份,凡士林320-400份,吐温-80 20-28份,亚硫酸氢钠2份。
2.如权利要求1所述鞣酸软膏,其特征在于:由下列重量份数的组分制成:鞣酸60份,甘油240份,枫香脂30份,甜菜碱30份,凡士林360份,吐温-80 24份,亚硫酸氢钠2份。
3.一种如权利要求1所述鞣酸软膏的制备方法,其特征在于:所述方法按如下步骤进行:
(1)按照权利要求1所述组分用量称量备用;
(2)用甘油溶解鞣酸,制得鞣酸甘油溶液,向所述的鞣酸甘油溶液中加入甜菜碱、亚硫酸氢钠,加热至70-75℃,搅拌混合均匀,保持温度在70-75℃,保温时间30-60分钟,制得组分A;
(3)将凡士林,枫香脂,吐温-80加热至75-80℃,搅拌混合均匀,并保持温度在75-80℃,保温时间20-40分钟,制得组分B;
(4)分别将组分A、组分B加热至75-80℃,将所述组分A加入到所述组分B中,边加边搅拌均匀,并保持温度在75-80℃,保温时间30分钟。冷却至室温制得鞣酸软膏。
4.如权利要求3所述鞣酸软膏的制备方法,其特征在于:步骤(2)中,所述的保温时间为40-60分钟。
5.如权利要求3所述鞣酸软膏的制备方法,其特征在于:步骤(3)中,所述的保温时间为30-40分钟。
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