CN111803622A - 一种口腔溃疡液态修复膜 - Google Patents
一种口腔溃疡液态修复膜 Download PDFInfo
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Abstract
本发明公开一种口腔溃疡液态修复膜，属于口腔用药技术领域。本发明所述液态修复膜由以下原料制备得到，各原料及其质量百分比为：氯己定0.5％‑1％，地塞米松0.1％‑0.3％，苯佐卡因5％‑10％，美洲大蠊提取液72％‑82％，重组人表皮生长因子0.02％‑0.04％，维生素C 1％‑2％，水溶性蜂胶液10％‑15％。本发明所述口腔溃疡液态修复膜一次用药就可达到消炎、止痛、促进溃疡面愈合的作用，且药物附着牢固，保证了药效的充分发挥。
Description
技术领域
本发明涉及一种口腔溃疡液态修复膜，属于口腔用药技术领域。
背景技术
口腔溃疡也叫“口疮”，是指出现在口腔内唇、上颚、舌颊等部位黏膜上，呈圆形或椭圆形的疼痛溃疡点。可发生于任何年龄，一年四季均可发生。其确切病因尚不明确，但与多种因素相关，包括遗传因素、免疫因素、精神因素、饮食因素、创伤因素等。根据临床特征，分为原发性口腔溃疡、复发性口腔溃疡、创伤性口腔溃疡和伴发性口腔溃疡。其共同特点是局部疼痛明显，严重影响患者的日常工作及生活。
口腔溃疡的治疗原则为局部消炎、缓解疼痛、促进溃疡面愈合。因此多为局部用药。根据治疗原则，目前的口腔溃疡药物分为三类：局部消炎类、疼痛缓解类和促进愈合类。其共同特点是作用单一，单独使用时效果不佳，多种药物联合应用时，用药次数明显增加，使用不方便。
从药物的性状来看，可分为三类：(1)粉末状药物：多为中药粉末，喷涂面积大，使用不方便，难以准确喷涂到溃疡面，喷涂时由于粉末的刺激，疼痛感剧烈。同时，粉末易被唾液带走而咽下，在溃疡面附着时间较短。(2)液态/凝胶状药物：由于口腔不断产生唾液，液态药物很快被稀释、咽下，因而在溃疡面附着时间极短，作用有限。(3)固态膜状药物：对口腔深部的溃疡难以准确敷贴，对舌部和口底溃疡敷贴不牢固，容易脱落。
发明内容
本发明要解决的技术问题是：目前口腔溃疡药物作用单一、使用不便、在溃疡面附着时间短等不足。
本发明的目的在于提供一种口腔溃疡液态修复膜，该修复膜包含了局部消炎、缓解疼痛和促进溃疡面愈合的多种组分，一次使用就可达到单一药物交替多次使用的效果；液态修复膜由以下原料制备得到，各原料及其质量百分比为：氯己定0.5％-1％，地塞米松0.1％-0.3％，苯佐卡因5％-10％，美洲大蠊提取液72％-82％，重组人表皮生长因子0.02％-0.04％，维生素C1％-2％重量，水溶性蜂胶液10％-15％，所有原料质量百分比之和为100％。
本发明所述口腔溃疡液态修复膜中的各原料均为成品入药，将其按重量百分比直接混合后装入喷剂瓶即可使用。
本发明的有益效果：
(1)本发明所述口腔溃疡液态修复膜同时添加了氯己定、地塞米松、苯佐卡因、美洲大蠊提取液、重组人表皮生长因子、维生素C、水溶性蜂胶液。具有杀灭、抑制溃疡局部细菌、减轻炎症反应的作用，同时可明显减轻喷涂药物时的刺激性疼痛。添加美洲大蠊提取液具有抗炎、镇痛、促进组织修复、免疫调节作用；可明显促进局部肉芽组织的生长，加快溃疡面愈合；添加重组人表皮生长因子能促进创面组织修复过程中细胞DNA、RNA和羟脯氨酸的合成，加速创面肉芽组织的生成和上皮细胞的增殖，从而缩短创面的愈合时间，提高创面修复质量；添加维生素C具有抗氧化、抗自由基，促进伤口愈合的功效。
(2)本发明所述口腔溃疡液态修复膜加入了水溶性蜂胶液，可作为成膜材料，牢固的附着于溃疡面，使各组分有充分的作用时间。
(3)本发明所述口腔溃疡液态修复膜与现有药物相比，一次用药就可达到消炎、止痛、促进溃疡面愈合的作用，且药物附着牢固，保证了药效的充分发挥；同时，液态喷涂使用方便，不受溃疡位置的限制。
具体实施方式
下面结合具体实施例本发明作进一步的详细说明，但本发明的保护范围并不限于所述内容。
实施例1
一种口腔溃疡液态修复膜，所述液态修复膜由以下原料制备得到，各原料及其质量百分比为：氯己定0.66％，地塞米松0.3％，苯佐卡因10％，美洲大蠊提取液72％，重组人表皮生长因子0.04％，维生素C 2％重量，水溶性蜂胶液15％，所有原料质量百分比之和为100％。
实施例2
一种口腔溃疡液态修复膜，所述液态修复膜由以下原料制备得到，各原料及其质量百分比为：氯己定1％，地塞米松0.1％，苯佐卡因5％，美洲大蠊提取液82％，重组人表皮生长因子0.02％，维生素C1.88％重量，水溶性蜂胶液10％，所有原料质量百分比之和为100％。
实施例3
一种口腔溃疡液态修复膜，所述液态修复膜由以下原料制备得到，各原料及其质量百分比为：氯己定0.5％，地塞米松0.2％，苯佐卡因8％，美洲大蠊提取液78％，重组人表皮生长因子0.03％，维生素C1％重量，水溶性蜂胶液12.27％，所有原料质量百分比之和为100％。
对实施例1～3所制备的口腔溃疡液态修复膜和对比例1～4进行使用效果评价，比较其平均愈合时间和溃疡疼痛评分。平均愈合时间越短，说明其治疗效果越好。溃疡疼痛评分分为即时评分和当日评分。即时评分越低，说明药物使用时对溃疡面的刺激越小，患者的体验越好。当日评分越低，说明药物缓解疼痛的效果越好；对比例1使用氯己定含漱液+口服维生素C；对比例2喷涂美洲大蠊提取液；对比例3：使用苯佐卡因凝胶；对比例4使用冰硼散。
试验方法：140名受试者参加试验，年龄20～65岁，其中男性64例，女性76例，均为口腔溃疡初发第一天患者。将所有受试者随机分成7组，每组20人。7组受试者在性别、年龄、口腔溃疡大小等一般资料方面无明显差异。实施例1～3、对比例1～4均为喷或涂于溃疡表面，对比例1为氯己定含漱液含漱5分钟，并口服维生素C 100mg/次。各组药物使用均为每天3次。直至溃疡完全愈合。计算每组的平均愈合时间。溃疡疼痛评分采用《疼痛程度数字评估量表》进行评价，用0-10代表不同程度的疼痛，0:表示无痛；1-3:轻度疼痛；4-6:中度疼痛；7-10，重度疼痛，10表示无法忍受的剧烈疼痛，患者在量表上标示出相应的疼痛评分。即时评分在药物使用后即刻进行，取当天3次评分的平均值进行比较；当日评分在当日最后一次用药结束后1小时进行。
评价效果如表1所示。
从表1可以看出，实施例1～3所有病例均在4天内痊愈，平均愈合时间3.1～3.3天，即时疼痛评分和当日疼痛评分均明显低于对比例；经统计学分析，实施例1～3之间的治疗效果及缓解疼痛的效果差异无统计学意义(p>0.05)；实施例1～3与对比例1～4之间的治疗效果及缓解疼痛的效果差异有非常显著的统计学意义(p<0.01)，实施例的疗效明显优于对比例。
本发明美洲大蠊提取液、重组人表皮生长因子及维生素C联合应用，对溃疡面和创面的修复具有协同作用，能明显促进肉芽组织及上皮细胞生长，从而提高疗效、缩短病程；地塞米松与美洲大蠊提取液或重组人表皮生长因子联合应用，可在抑制局部炎症反应的同时，促进溃疡修复，使各有效成分的作用增强；氯己定广谱抗菌素，能抑制细菌导致的炎症反应，与地塞米松抗炎作用相协同。此外，蜂胶有明显的抑菌作用，与氯己定合用可以增强抗菌效果；同时，蜂胶的抗炎效果与地塞米松合用后增强；蜂胶的麻醉作用可增强苯佐卡因的局部麻醉效果，加入蜂胶可以使口腔溃疡在用药时疼痛明显减轻。
Claims (1)
1.一种口腔溃疡液态修复膜，其特征在于：所述液态修复膜由以下原料制备得到，各原料及其质量百分比为：氯己定0.5％-1％，地塞米松0.1％-0.3％，苯佐卡因5％-10％，美洲大蠊提取液72％-82％，重组人表皮生长因子0.02％-0.04％，维生素C1％-2％，水溶性蜂胶液10％-15％。
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