CN106109473A - 一种复方维甲酸涂膜剂 - Google Patents
一种复方维甲酸涂膜剂 Download PDFInfo
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Abstract
本发明提供了一种复方维甲酸涂膜剂,包括以下重量百分比的成分:糖皮质激素类药物、维甲酸、成膜剂、渗透剂、分散剂和乙醇。将维甲酸与糖皮质激素类药物联用,疗效协同作用好;采用的涂膜剂口腔给药是一大剂型创新。经过临床测试,维甲酸和氢化可的松的配伍应用疗效要明显好于维甲酸的疗效。
Description
技术领域
本发明涉及药品领域,特别地,涉及一种复方维甲酸涂膜剂。
背景技术
口腔粘膜白斑是中老年人较常见的口腔黏膜病,在70岁以上男性中发病率高达8%,女性达2%以上,表现为上皮细胞由萎缩到增生直至异常增生的过程。和其他部位相比,发生在口腔底部、舌和软颚部位的白斑癌变率较高,报道为0.1~17%。目前,口腔粘膜白斑的发病机理尚不明确,普遍认为白斑癌变与理化因素长期作用、致癌剂损伤、遗传物质以及免疫功能不全有关。
口腔粘膜白斑的传统治疗方法包括预防治疗、药物治疗、理疗和手术治疗。预防疗法因白斑的致病因素尚不明了,故至今仍无重大突破;外科手术治疗一般主张只有在病理证实确有重度异常增生或癌变时才行切除术,包括传统手术、电烙术、激光切除和冷冻手术,但术后仍有较高的复发率,达10~35%。非手术疗法具有较好的患者顺应性,采取光敏疗法、β-胡萝卜素、番茄红素和维生素A等可达到50%以上的临床治愈。
维甲酸是口腔粘膜白斑局部治疗的主要药物,是维生素A的代谢中间产物,可促进上皮细胞增生、分化、角质溶解代谢,主要用于治疗寻常痤疮、银屑病、鱼鳞病、扁平苔癣、毛发红糠疹、毛囊角化病、鳞状细胞癌及黑色素瘤等疾病,临床研究其对口腔粘膜白斑治疗有效,可有效减小粘膜白斑的数量和大小,加速治疗进程。在治疗严重类型的皮肤病时,可与其他药物如皮质激素、抗生素等合并使用,增加疗效。
维甲酸及其衍生物被认为是最有开发前景的白斑治疗药物。目前该药的市售药品有维甲酸软膏和维甲酸乳膏,口腔给药存在误服风险,患者顺应性差,且乳膏剂药品目前已不推荐口腔给药,因此,维甲酸的临床用药剂型存在改进空间。涂膜剂工艺条件简单,操作性强,可起到药物局部缓释作用,和传统的乳膏剂相比,可进一步提高疗效,减少毒副作用,患者顺应性好。糖皮质激素抗炎抗过敏作用强大,采用维甲酸与氢化可的松配伍治疗粘膜白斑,将产生协同疗效。
发明内容
本发明目的在于提供一种复方维甲酸涂膜剂,以解决技术问题。
一种复方维甲酸涂膜剂,包括以下重量百分比的成分:糖皮质激素类药物0.1-0.3%、维甲酸0.08-0.15%、成膜剂4-6.5%、渗透剂4-5%、分散剂8-12%、乙醇余量。
优选的,所述的糖皮质激素类药物为氢化可的松或醋酸氢化可的松或泼尼松。
进一步优选的,所述的糖皮质激素类药物为氢化可的松。
优选的,所述的成膜剂为乙基纤维素或卡波姆或聚乙烯醇或聚乙烯吡咯烷酮。
进一步优选的,所述的成膜剂为乙基纤维素。
优选的,所述的渗透剂为氮酮或二甲基亚砜。
进一步优选的,所述的渗透剂为氮酮。
优选的,所述的分散剂为丙二醇或甘油或三乙酸甘油酯。
进一步优选的,所述的分散剂为丙二醇。
下面将维甲酸和氢化可的松的配伍应用临床疗效与维甲酸乳膏做对比:
考虑到本处方是已在临床应用多年的经验方,为了进一步确认疗效,由课题组提供复方维甲酸霜制剂(维甲酸和氢化可的松的配伍应用),牙周粘膜科医生设计了随机对照的临床研究病例收集,共分为两大组:实验组(两个亚组:0.05%复方维甲酸霜,0.1%复方维甲酸霜);对照组(市售阳性药组)0.05%维甲酸乳膏,0.1%维甲酸乳膏。
显效:粘膜病损消失;有效:白斑颜色变浅或病损面积缩小;无效:白斑颜色或病损面积无改变或变大。
由上表可见:维甲酸与氢化可的松配伍应用,疗效增强。
本发明具有以下有益效果:本发明的复方维甲酸涂膜剂,包括以下重量百分比的成分:糖皮质激素类药物、维甲酸、成膜剂、渗透剂、分散剂和乙醇。本发明的复方维甲酸涂膜剂将维甲酸与糖皮质激素类药物联用,疗效协同作用好;本发明采用的涂膜剂口腔给药是一大剂型创新,经过临床测试,维甲酸和氢化可的松的配伍应用疗效要明显好于维甲酸的疗效。
除了上面所描述的目的、特征和优点之外,本发明还有其它的目的、特征和优点。下面将对本发明作进一步详细的说明。
具体实施方式
以下对本发明的实施例进行详细说明,但是本发明可以根据权利要求限定和覆盖的多种不同方式实施。
实施例1
一种复方维甲酸涂膜剂,包括以下重量百分比的成分:糖皮质激素类药物0.2%、维甲酸0.1%、成膜剂5%、渗透剂4.32%、分散剂9.71%、乙醇余量。
所述的糖皮质激素类药物为氢化可的松。
所述的成膜剂为乙基纤维素。
所述的渗透剂为氮酮。
所述的分散剂为丙二醇。
实施例2
一种复方维甲酸涂膜剂,包括以下重量百分比的成分:糖皮质激素类药物0.1%、维甲酸0.15%、成膜剂4%、渗透剂5%、分散剂8%、乙醇余量。
所述的糖皮质激素类药物为氢化可的松。
所述的成膜剂为卡波姆。
所述的渗透剂为氮酮。
所述的分散剂为甘油。
实施例3
一种复方维甲酸涂膜剂,包括以下重量百分比的成分:糖皮质激素类药物0.3%、维甲酸0.08%、成膜剂6.5%、渗透剂4%、分散剂12%、乙醇余量。
所述的糖皮质激素类药物为泼尼松。
所述的成膜剂为聚乙烯醇。
所述的渗透剂为二甲基亚砜。
所述的分散剂为三乙酸甘油酯。
实施例4
一种复方维甲酸涂膜剂,包括以下重量百分比的成分:糖皮质激素类药物0.15%、维甲酸0.08%、成膜剂4.9%、渗透剂4.3%、分散剂12%、乙醇余量。
所述的糖皮质激素类药物为醋酸氢化可的松。
所述的成膜剂为乙基纤维素。
所述的渗透剂为二甲基亚砜。
所述的分散剂为三乙酸甘油酯。
实施例5
一种复方维甲酸涂膜剂,包括以下重量百分比的成分:糖皮质激素类药物0.12%、维甲酸0.12%、成膜剂5.5%、渗透剂4%、分散剂8%、乙醇余量。
所述的糖皮质激素类药物为氢化可的松。
所述的成膜剂为聚乙烯吡咯烷酮。
所述的渗透剂为氮酮。
所述的分散剂为丙二醇。
实施例6
一种复方维甲酸涂膜剂,包括以下重量百分比的成分:糖皮质激素类药物0.18%、维甲酸0.1%、成膜剂5.2%、渗透剂4.2%、分散剂10.8%、乙醇余量。
所述的糖皮质激素类药物为醋酸氢化可的松。
所述的成膜剂为聚乙烯吡咯烷酮。
所述的渗透剂为氮酮。
所述的分散剂为甘油。
实施例7
一种复方维甲酸涂膜剂,包括以下重量百分比的成分:糖皮质激素类药物0.25%、维甲酸0.14%、成膜剂4%、渗透剂5%、分散剂11.2%、乙醇余量。
所述的糖皮质激素类药物为泼尼松。
所述的成膜剂为乙基纤维素。
所述的渗透剂为二甲基亚砜。
所述的分散剂为丙二醇。
实施例8
一种复方维甲酸涂膜剂,包括以下重量百分比的成分:糖皮质激素类药物0.12%、维甲酸0.15%、成膜剂5.9%、渗透剂4.7%、分散剂10%、乙醇余量。
所述的糖皮质激素类药物为醋酸氢化可的松。
所述的成膜剂为聚乙烯醇。
所述的渗透剂为二甲基亚砜。
所述的分散剂为三乙酸甘油酯。
以上所述仅为本发明的优选实施例而已,并不用于限制本发明,对于本领域的技术人员来说,本发明可以有各种更改和变化。凡在本发明的精神和原则之内,所作的任何修改、等同替换、改进等,均应包含在本发明的保护范围之内。
Claims (10)
1.一种复方维甲酸涂膜剂,其特征在于,包括以下重量百分比的成分:糖皮质激素类药物0.1-0.3%、维甲酸0.08-0.15%、成膜剂4-6.5%、渗透剂4-5%、分散剂8-12%、乙醇 余量。
2.如权利要求1所述的复方维甲酸涂膜剂,其特征在于,所述的糖皮质激素类药物为氢化可的松或醋酸氢化可的松或泼尼松。
3.如权利要求1所述的复方维甲酸涂膜剂,其特征在于,所述的成膜剂为乙基纤维素或卡波姆或聚乙烯醇或聚乙烯吡咯烷酮。
4.如权利要求1所述的复方维甲酸涂膜剂,其特征在于,所述的渗透剂为氮酮或二甲基亚砜。
5.如权利要求1所述的复方维甲酸涂膜剂,其特征在于,所述的分散剂为丙二醇或甘油或三乙酸甘油酯。
6.如权利要求2所述的复方维甲酸涂膜剂,其特征在于,所述的糖皮质激素类药物为氢化可的松。
7.如权利要求3所述的复方维甲酸涂膜剂,其特征在于,所述的成膜剂为乙基纤维素。
8.如权利要求4所述的复方维甲酸涂膜剂,其特征在于,所述的渗透剂为氮酮。
9.如权利要求5所述的复方维甲酸涂膜剂,其特征在于,所述的分散剂为丙二醇。
10.如权利要求1所述的复方维甲酸涂膜剂,其特征在于,包括以下重量百分比的成分:氢化可的松0.2%、维甲酸0.1%、乙基纤维素5%、氮酮4.32%、丙二醇9.71%、乙醇 余量。
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