CN104644646A - 地塞米松磷酸钠尿素乳膏及其制备方法 - Google Patents
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Abstract
本发明提供了一种用于皮炎和湿疹的地塞米松磷酸钠尿素乳膏及其制备方法。地塞米松磷酸钠尿素乳膏,按重量份数计,由以下组分组成:3-8份地塞米松磷酸钠、1800-2200份尿素,乳膏基质。地塞米松磷酸钠是糖皮质类激素,药理作用主要是抗炎、抗毒、抗过敏、抗风湿,临床使用较广泛。尿素能使皮肤角蛋白溶解变性,增进角质层的水合作用,从而使皮肤软化,从而减轻皮肤皲裂症状。本发明所述的地塞米松尿素乳膏可使皮肤软化,防止手足皲裂;同时加入微量的地塞米松磷酸钠,与单纯使用尿素或者激素药物相比,药效增强,而且将激素药物的副作用降至最低,同时消除了药效反复的问题。
Description
技术领域
本发明属于医学领域,具体涉及一种用于皮炎和湿疹的外用药物,尤其涉及一种含地塞米松磷酸钠和尿素的乳膏及其制备方法。
背景技术
皮炎、湿疹是常见的由多种内外因素引起的表皮及真皮浅层的炎症性皮肤病,其特点为自觉剧烈瘙痒,皮损多形性,对称分布,皮炎性湿疹有渗出倾向,慢性病程,易反复发作。目前多采用含皮质激素的药物外搽进行治疗,然而,这种治疗方法只适用于轻症或范围小的湿疹/皮炎。对面积大的湿疹或反复发作的湿疹,如果长期频繁或大量使用含皮质类激素的药物,不但会对全身或局部的皮肤有副作用,而且容易反复,难以治愈。
地塞米松磷酸钠为肾上腺皮质激素类药,具有抗炎、抗过敏、抗风湿、免疫抑制作用,其作用机理为:(1)抗炎作用:减轻和防止组织对炎症的反应,从而减轻炎症的表现;能够抑制炎症细胞,包括巨噬细胞和白细胞在炎症部位的集聚,并抑制吞噬作用、溶酶体酶的释放以及炎症化学中介物的合成和释放。(2)免疫抑制作用:包括防止或抑制细胞介导的免疫反应,延迟性的过敏反应,减少T淋巴细胞、单核细胞、噬酸性细胞的数目,降低免疫球蛋白与细胞表面受体的结合能力,并抑制白介素的合成与释放,从而降低T淋巴细胞向淋巴母细胞转化,并减轻情原发免疫反应的扩展。地塞米松磷酸钠还降低免疫复核物通过基底膜,并能减少补体成分及免疫球蛋白的浓度。地塞米松磷酸钠主要用于过敏性与自身免疫性炎症性疾病。多用于结缔组织病、活动性风湿病、类风湿性关节炎、红斑狼疮、严重支气管哮喘、严重皮炎、溃疡性结肠炎、急性白血病等,也用于某些严重感染及中毒、恶性淋巴瘤的综合治疗。
尿素,又称碳酰胺(carbamide),是一种白色晶体,分子式为H2NCONH2。哺乳动物和某些鱼类体内蛋白质代谢分解的主要含氮终产物。尿素是一种很好用的保湿成分,它存在于肌肤的角质层当中,属于肌肤天然保湿因子NMF的主要成分。对肌肤来说,尿素具有保湿以及柔软角质的功效,所以也能够防止角质层阻塞毛细孔,藉此改善粉刺的问题。常用于面膜、护肤水、膏霜以及护手霜等产品中保湿成份的添加。外用其软膏或乳膏可使皮肤软化,防止手足皲裂。
目前,临床上通常采用激素药物治疗,容易造成病程反复,难以治愈,给病人带来了很大的困扰。
发明内容
为了解决现有技术在皮炎、湿疹治疗方面的问题,本发明提供了一种用于皮炎和湿疹的地塞米松磷酸钠尿素乳膏及其制备方法。
本发明的技术方案:地塞米松磷酸钠尿素乳膏,按重量份数计,由以下组分组成:3-8份地塞米松磷酸钠、1800-2200份尿素,乳膏基质;所述乳膏基质由以下组分组成:
地塞米松磷酸钠是糖皮质类激素,药理作用主要是抗炎、抗毒、抗过敏、抗风湿,临床使用较广泛。尿素能使皮肤角蛋白溶解变性,增进角质层的水合作用,从而使皮肤软化,从而减轻皮肤皲裂症状。本发明所述的地塞米松尿素乳膏可使皮肤软化,防止手足皲裂;同时加入微量的地塞米松磷酸钠,与单纯使用尿素或者激素药物相比,药效增强,而且将激素药物的副作用降至最低,同时消除了药效反复的问题。
地塞米松磷酸钠尿素乳膏的制备方法,包括以下步骤:
(1)分别取基质中油相成分、水相成分加热至75-80℃;所述油相成分包括350-450份单硬脂酸甘油酯、900-1100份蓖麻油、800-1200份液状石蜡和900-1100份甘油,所述水相成分为800-1200份硬脂酸、80-120份三乙醇胺和40-60份10%尼泊金乙酯酊和5000份纯化水;
(2)采用适量纯化水溶解3-8份地塞米松磷酸钠后,缓缓加入至步骤(1)加热后的水相成分中;
(3)将步骤(1)加热后的油相成分缓缓加入步骤(2)得到的水相成分中,边加边顺向搅拌,至得到乳白色半固体状的半成品;
(4)当步骤(3)得到的半成品温度降至40-50℃时,加入1800-2200份尿素,边加边搅拌,得到均匀的乳白色乳膏,即为地塞米松磷酸钠尿素乳膏。
本发明的有益效果:地塞米松磷酸钠尿素乳膏为外用药物,局部涂抹;具有抗炎、抗过敏的功效,可用于萎缩性皮炎、接触性皮炎、神经性皮炎、脂溢性皮炎、肛门瘙痒以及湿疹的治疗。而且,本发明所述的地塞米松磷酸钠尿素乳膏药效好,防止反复,临床显效率100%,有效率85%。
具体实施方式
下面结合实施例对本发明做进一步的说明。
实施例1:
地塞米松尿素磷酸钠乳膏,按重量份数计,由以下组分组成:5g地塞米松磷酸钠、2000g尿素,乳膏基质;所述乳膏基质由以下组分组成:
地塞米松尿素磷酸钠乳膏的制备方法,包括以下步骤:
(1)分别取基质中油相成分、水相成分加热至75-80℃;所述油相成分包括单硬脂酸甘油酯、蓖麻油、液状石蜡和甘油,所述水相成分为硬脂酸、三乙醇胺和10%尼泊金乙酯酊和纯化水;
(2)采用适量纯化水溶解5g地塞米松磷酸钠后,缓缓加入至步骤(1)加热后的水相成分中;
(3)将步骤(1)加热后的油相成分缓缓加入步骤(2)得到的水相成分中,边加边顺向搅拌,至得到乳白色半固体状的半成品;
(4)当步骤(3)得到的半成品温度降至40-50℃时,加入2000g尿素,边加边搅拌,得到均匀的乳白色乳膏,即为地塞米松尿素乳膏。
治疗实施例1:
王某:男,50岁,双上肢局部呈红斑,淡红至鲜红色,稍有水肿,诊断接触性皮炎。使用地塞米松磷酸钠尿素乳膏对患处涂抹,每日3-5次,次日好转,3天后症状消失。半年后复诊,没有复发。
治疗实施例2:
赵某:女,36岁,面部针尖大丘疹密集,红,痒,诊断接触性皮炎。使用硼酸溶液冷敷,外用地塞米松磷酸钠尿素乳膏涂抹,每日3-5次,次日好转;3天后丘疹减少,褪红,5天后症状消失。1年后复诊,没有复发。
治疗实施例3:
李某,女,40岁,小腿肚丘疹样红斑,痒,诊断湿疹。使用地塞米松磷酸钠尿素乳膏涂抹患处,每日3-5次,当天见效,使用5天后,症状减轻,红斑颜色变浅,红斑面积减小。8个月后复诊,没有复发。
实施例2:
地塞米松尿素磷酸钠乳膏,按重量份数计,由以下组分组成:3g地塞米松磷酸钠、2200g尿素,乳膏基质;所述乳膏基质由以下组分组成:
地塞米松尿素磷酸钠乳膏的制备方法,包括以下步骤:
(1)分别取基质中油相成分、水相成分加热至75-80℃;所述油相成分包括单硬脂酸甘油酯、蓖麻油、液状石蜡和甘油,所述水相成分为硬脂酸、三乙醇胺和10%尼泊金乙酯酊和纯化水;
(2)采用适量纯化水溶解3g地塞米松磷酸钠后,缓缓加入至步骤(1)加热后的水相成分中;
(3)将步骤(1)加热后的油相成分缓缓加入步骤(2)得到的水相成分中,边加边顺向搅拌,至得到乳白色半固体状的半成品;
(4)当步骤(3)得到的半成品温度降至40-50℃时,加入2200g尿素,边加边搅拌,得到均匀的乳白色乳膏,即为地塞米松尿素乳膏。
治疗实施例4:
张某,男,12岁,面部局部呈红斑,淡红至鲜红色,稍有水肿,诊断接触性皮炎。使用硼酸溶液冷敷,外用地塞米松磷酸钠尿素乳膏涂抹,每日3-5次,次日好转;3天后症状消失。1年后复诊,没有复发。
治疗实施例5:
刘某,男,72岁,面颊部呈向心性分布的多发性红色斑块,皮肤干燥、有糠样鳞屑,毛细血管减少,诊断萎缩性皮炎。外用地塞米松磷酸钠尿素乳膏涂抹,每日3-5次,治疗2周,症状逐渐好转,1个月后症状消失。
治疗实施例6:
周某,男,26岁,3天前面部皮肤有瘙痒感,无原发皮损,由于搔抓及摩擦,皮肤逐渐出现绿豆大小的扁平丘疹,圆形,坚硬而有光泽,呈淡红色,散在分布,阵发性剧痒。之后颈部感觉局部瘙痒,后出现集簇的粟粒大正常皮色多角形扁平丘疹,稍具光泽,覆盖少量秕糠状鳞屑,患处皮损周围见抓痕,有血痂形成。诊断为神经性皮炎。外用地塞米松磷酸钠尿素乳膏涂抹,每日3-5次使用,瘙痒缓解,症状减轻,2周后症状消失。1年后复诊,没有复发。
实施例3:
地塞米松尿素磷酸钠乳膏,按重量份数计,由以下组分组成:8g地塞米松磷酸钠、1800g尿素,乳膏基质;所述乳膏基质由以下组分组成:
地塞米松尿素磷酸钠乳膏的制备方法,包括以下步骤:
(1)分别取基质中油相成分、水相成分加热至75-80℃;所述油相成分包括单硬脂酸甘油酯、蓖麻油、液状石蜡和甘油,所述水相成分为硬脂酸、三乙醇胺和10%尼泊金乙酯酊和纯化水;
(2)采用适量纯化水溶解8g地塞米松磷酸钠后,缓缓加入至步骤(1)加热后的水相成分中;
(3)将步骤(1)加热后的油相成分缓缓加入步骤(2)得到的水相成分中,边加边顺向搅拌,至得到乳白色半固体状的半成品;
(4)当步骤(3)得到的半成品温度降至40-50℃时,加入1800g尿素,边加边搅拌,得到均匀的乳白色乳膏,即为地塞米松尿素乳膏。
治疗实施例7:
刘某,女,32岁,面部眉弓部、面颊部出现炎症性丘疹,界限较清楚,其上覆盖油腻的鳞屑,自觉轻度瘙痒,诊断为脂溢性皮炎。外用地塞米松磷酸钠尿素乳膏涂抹,每日3-5次,1天后瘙痒缓解,3天后症状减轻,1周后症状消失。半年后复诊,没有复发。
治疗实施例8:
赵某某,男,76岁,肛门周围皮肤瘙痒,时轻时重,有时如虫行蚁走,夜间加重,肛周皮肤增厚,苔藓样变。外用地塞米松磷酸钠尿素乳膏涂抹,每日3-5次,用药当日瘙痒症状缓解,1周后症状消失。
表1.使用本发明的地塞米松磷酸钠尿素乳膏治疗病例的统计
治疗病例 | 治疗数 | 治愈数 | 显效率% | 治愈率% |
接触性皮炎 | 60 | 55 | 100 | 92 |
湿疹 | 40 | 32 | 100 | 80 |
萎缩性皮炎 | 10 | 7 | 100 | 70 |
神经性皮炎 | 10 | 8 | 100 | 80 |
脂溢性皮炎 | 20 | 16 | 100 | 80 |
肛门瘙痒 | 10 | 9 | 100 | 90 |
Claims (2)
1.地塞米松磷酸钠尿素乳膏,其特征在于:按重量份数计,由以下组分组成:3-8份地塞米松磷酸钠、1800-2200份尿素,乳膏基质;所述乳膏基质由以下组分组成:
2.如权利要求1所述的地塞米松磷酸钠尿素乳膏的制备方法,其特征在于:包括以下步骤:
(1)分别取基质中油相成分、水相成分加热至75-80℃;所述油相成分包括单硬脂酸甘油酯、蓖麻油、液状石蜡和甘油,所述水相成分包括硬脂酸、三乙醇胺、10%尼泊金乙酯酊和纯化水;
(2)采用适量纯化水溶解地塞米松磷酸钠后,缓缓加入至步骤(1)加热后的水相成分中;
(3)将步骤(1)加热后的油相成分缓缓加入步骤(2)得到的水相成分中,边加边顺向搅拌,至得到乳白色半固体状的半成品;
(4)当步骤(3)得到的半成品温度降至40-50℃时,加入尿素,边加边搅拌,得到均匀的乳白色乳膏,即为地塞米松尿素乳膏。
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刘萍 等: "复方醋酸地塞米松乳膏质量标准研究", 《医学信息》 * |
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