CN113616627A - 一种治疗口腔溃疡的双层膜剂及其制备方法 - Google Patents
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Abstract
本发明公开一种治疗口腔溃疡的双层膜剂及其制备方法。该治疗口腔溃疡的双层膜剂为双层单向释药膜剂，包括多孔的载药内膜和防水外膜；所述载药内膜包括壳聚糖1‑60份，海藻酸钠1‑37份，聚乙烯醇1‑7份；所述防水外膜包括乙基纤维素、甲基丙烯酸羟乙酯、甲基丙烯酸甲酯共聚物、醋酸羟丙甲纤维素琥珀酸酯中的任意一种单独或多种组合经无水乙醇溶解后制成，浓度为1％～5％。本发明解决了OTC(Over The Count)中成药口腔溃疡散使用不方便，药物容易流失，一次用药作用时间短的问题。此外，本发明还提出了该治疗口腔溃疡的双层膜剂的制备方法。
Description
技术领域
本发明涉及医药制备技术领域，特别涉及一种治疗口腔溃疡的双层膜剂及其制备方法。
背景技术
口腔溃疡，又称为“口疮”，是一种十分常见的口腔粘膜疾病。
治疗口腔溃疡的口腔溃疡贴膜，并不是我们想象中的一张透明薄膜，它是一种涂了治疗口腔溃疡药物的一种微小贴膜，可以直接贴在口腔溃疡处，让药物充分运用于口腔溃疡处。根据患者的个人情况，可以选择不同的口腔溃疡贴膜，他们的成分也不尽相同，但是一般都会加入蜂胶和麻药，一来可以减少药物刺激口腔溃疡带来的疼痛，二来可以滋润口腔溃疡周围的口腔黏膜。因此，口腔溃疡贴膜是一种常用来治疗口腔溃疡的方式，如果想要无痛快速治疗口腔溃疡，口腔溃疡贴膜无疑是首选。
现有技术中，北京同仁堂股份有限公司同仁堂制药厂有一种口腔溃疡散的中成药，以青黛清热解毒，凉血疔疮，为主药；辅以冰片凉散清热，消肿止痛；白矾外用解毒杀虫，燥湿止痒，内服止血止泻，祛除风痰。诸药相合，共奏清火敛疮之功效。其用法是用清毒棉球蘸药擦患处，一日2-3次。其缺点是药物使用不方便，药粉涂于患处，药物易被唾液带走，影响药物作用时间，并且药物口感不好。因此，将中成药口腔溃疡散进行剂型改变很有必要。
发明内容
本发明的目的是克服中成药溃疡散使用不方便，药粉涂于患处，药物易被唾液带走，影响药物作用时间，并且药物口感不好的问题，提供了一种治疗口腔溃疡的双层膜剂及其制备方法。
本发明通过现有西药口腔贴膜剂的制备工艺，制备成为双层单向释药膜剂，其包括多孔状的载药内膜和防水外膜，载药内膜包括壳聚糖(CS)，海藻酸钠(ALG)、聚乙烯醇等，其中，壳聚糖(CS)占1-60份，海藻酸钠(ALG)占1-37份，聚乙烯醇占1-7份、矫味剂0.1～1份。载药内膜具有黏附性，能与黏膜紧密接触而不易滑动，其内膜有疏松小孔，有利于药物溶出析出，发挥药效。防水外膜主要包括乙基纤维素、甲基丙烯酸羟乙酯、甲基丙烯酸甲酯共聚物、醋酸羟丙甲纤维素琥珀酸酯中的任意一种或多种组合用无水乙醇溶解，浓度为1％～5％。所述双层膜剂的总厚度为0.3～0.5mm；每片双层膜剂长宽均为1～2cm，每片双层膜剂含药物1～2mg。
本发明中，所述载药内膜的药物是OTC(Over The Count)中成药口腔溃疡散。
本发明的一种治疗口腔溃疡的双层膜剂的制备方法，包括以下步骤：
内膜胶浆的制备：按照壳聚糖1-60份，海藻酸钠1-37份，聚乙烯醇1-7份的比例称取各组分，加水充分溶解，过滤得内膜胶浆；
载药内膜胶浆的制备：将治疗口腔溃疡的药物研细过200目筛，加入内膜胶浆，同时加入丙三醇和吐温80，搅拌充分后静置脱泡，匀浆，得含药内膜胶浆；
防水外膜胶浆的制备：无水乙醇加入高分子防水材料，配成1％～5％的浓度；所述高分子防水材料包括乙基纤维素、甲基丙烯酸羟乙酯、甲基丙烯酸甲酯共聚物、醋酸羟丙甲纤维素琥珀酸酯中的任意一种单独或多种组合；
双层膜剂的制备：按照贴膜剂的生产工艺均浆流延成膜法对载药内膜胶浆进行膜剂的铺膜，真空干燥，小心起膜，干燥后得载药内膜；将载药内膜平铺，量取防水外膜胶浆，再次利用均浆流延成膜法铺于载药内膜上，置于干燥通风阴凉处静置一小时，即得双层的单向释药膜剂，然后进行切割，灭菌，包装，即得治疗口腔溃疡的双层膜剂。制备过程中，载药内膜胶浆和防水外膜胶浆的加入重量比为(10～20)：(80～90)。
真空干燥的条件为50℃、-84kPa保存5小时。
本发明的上述技术方案的有益效果如下：
本发明通过现有西药口腔贴膜剂的制备工艺，将其制成双层单向释药膜剂，载药内膜有疏松小孔，有利于药物溶出析出，发挥药效；外膜不溶于水，起到保护内膜的作用，内膜可保持药物长期与溃疡面接触使疗效增强。贴膜能直接作用到溃疡患处，具有药物缓释效果，能够减轻疼痛、促进伤口愈合、缩短病程，且无副作用，粘附力强，能够牢固且持久的作用于口腔溃疡患处，患者进食和饮水时不易脱落，减少了患者进食或饮水时对口腔溃疡患处的刺激，提高患者使用舒适性。
附图说明
图1为本发明实施例的流程图。
具体实施方式
为使本发明要解决的技术问题、技术方案和优点更加清楚，下面将结合具体实施例进行详细描述。
一种治疗口腔溃疡的双层膜剂的制备方法，包括以下步骤：
内膜胶浆的制备：按照壳聚糖1-60份，海藻酸钠1-37份，聚乙烯醇1-7份，矫味剂0.1～1份的比例称取各组分，加水充分溶解，过滤得内膜胶浆；
载药内膜胶浆的制备：将治疗口腔溃疡的药物研细过200目筛，加入内膜胶浆，同时加入丙三醇和吐温80，搅拌充分后静置脱泡，匀浆，得含药内膜胶浆；
防水外膜胶浆的制备：无水乙醇加入高分子防水材料，配成1％～5％的浓度；所述高分子防水材料包括乙基纤维素、甲基丙烯酸羟乙酯、甲基丙烯酸甲酯共聚物、醋酸羟丙甲纤维素琥珀酸酯中的任意一种单独或多种组合；
双层膜剂的制备：按照贴膜剂的生产工艺均浆流延成膜法对载药内膜胶浆进行膜剂的铺膜，真空干燥，小心起膜，干燥后得载药内膜；将载药内膜平铺，量取防水外膜胶浆，再次利用均浆流延成膜法铺于载药内膜上，置于干燥通风阴凉处静置一小时，即得双层的单向释药膜剂，然后进行切割，灭菌，包装，即得治疗口腔溃疡的双层膜剂。
通过上述方法制备得到的治疗口腔溃疡的双层膜剂为双层单向释药膜剂，包括多孔的载药内膜和防水外膜。
优选实施例
如图1所示的基于口腔溃疡散治疗口腔溃疡的双层膜剂的制备方法，包括以下步骤：
(1)取无水乙醇50mL于研钵中，加入2.500g乙基纤维素，再注入无水乙醇50mL，使乙基纤维素在盛有无水乙醇的研钵中不贴壁并充分溶胀。在研钵中往同一方向匀速研磨30分钟，使乙基纤维素完全溶解，得100mL的2.5％乙基纤维素乙醇溶液。倒入100mL烧杯中，盖上盖子，静置待用；
(2)取口腔溃疡散于研钵，充分研磨后过200目药筛；
(3)量取100mL蒸馏水于250mL的烧杯中，置于恒温磁力搅拌器中10分钟加热到90℃。精密称取聚乙烯醇1.000g，边搅拌边缓慢加入蒸馏水中，搅拌10分钟至溶解完全，再精密称取壳聚糖0.720g，边搅拌边缓慢加入，待壳聚糖分散至在溶液中相对均匀，使用移液管加入0.7mL冰醋酸，搅拌十分钟，待壳聚糖溶解完全。最后精密称取海藻酸钠0.100g，边搅拌边加入，继续搅拌二十分钟至完全溶解。加入矫味剂糖精钠40mg，溶解，趁热通过放有两层纱布的布氏漏斗抽滤，得滤液、弃滤渣。
(4)将滤液置于恒温磁力搅拌器中，60℃搅拌，边搅拌边加入1.5mL丙三醇，加入0.100g口腔溃疡散，加入6滴吐温-80(约0.12mL)，继续搅拌10分钟；取出搅拌子，60℃保温静置脱泡；
(5)待脱泡完全，取25mL上述溶液，利用均浆流延成膜法铺于90mm玻璃培养皿，置于真空干燥箱，50℃、-84kPa保存5小时；小心起膜，于干燥处保存，得载药内膜；将所得载药内膜平铺于培养皿背面，量取2.5％乙基纤维素乙醇溶液4mL，利用均浆流延成膜法铺于所得载药内膜上，置于干燥通风阴凉处静置一小时，即得双层的单向释药膜剂。
(6)最后进行切割，灭菌，包装，即得总厚度为0.3～0.5mm；单片双层膜剂长宽均为1～2cm，单片双层膜剂含药物1～2mg的治疗口腔溃疡的双层膜剂。
通过现有西药口腔贴膜剂的制备工艺，将其制成双层单向释药膜剂，载药内膜有疏松小孔，有利于药物溶出析出，发挥药效；外膜不溶于水，起到保护内膜的作用，内膜可保持药物长期与溃疡面接触使疗效增强。贴膜能直接作用到溃疡患处，具有药物缓释效果，能够减轻疼痛、促进伤口愈合、缩短病程，且无副作用，粘附力强，能够牢固且持久的作用于口腔溃疡患处，患者进食和饮水时不易脱落，减少了患者进食或饮水时对口腔溃疡患处的刺激，提高患者使用舒适性。
以上所述是本发明的优选实施方式，应当指出，对于本技术领域的普通技术人员来说，在不脱离本发明所述原理的前提下，还可以做出若干改进和润饰，这些改进和润饰也应视为本发明的保护范围。
Claims (10)
1.一种治疗口腔溃疡的双层膜剂，其特征在于，为双层单向释药膜剂，包括多孔的载药内膜和防水外膜；
其中，所述载药内膜包括壳聚糖1-60份，海藻酸钠1-37份，聚乙烯醇1-7份；
所述防水外膜包括乙基纤维素、甲基丙烯酸羟乙酯、甲基丙烯酸甲酯共聚物、醋酸羟丙甲纤维素琥珀酸酯中的任意一种单独或多种组合经无水乙醇溶解后制成，浓度为1％～5％。
2.根据权利要求1所述的一种治疗口腔溃疡的双层膜剂，其特征在于，所述载药内膜还包括矫味剂0.1～1份。
3.根据权利要求1所述的一种治疗口腔溃疡的双层膜剂，其特征在于，所述双层膜剂的总厚度为0.3～0.5mm；每片双层膜剂长宽均为1～2cm，每片双层膜剂含药物1～2mg。
4.如权利要求1所述的一种治疗口腔溃疡的双层膜剂，其特征在于，所述载药内膜的药物是中成药口腔溃疡散。
5.一种治疗口腔溃疡的双层膜剂的制备方法，其特征在于，包括以下步骤：
内膜胶浆的制备：按照壳聚糖1-60份，海藻酸钠1-37份，聚乙烯醇1-7份的比例称取各组分，加水充分溶解，过滤得内膜胶浆；
载药内膜胶浆的制备：将治疗口腔溃疡的药物研细过200目筛，加入内膜胶浆，同时加入丙三醇和吐温80，搅拌充分后静置脱泡，匀浆，得含药内膜胶浆；
防水外膜胶浆的制备：无水乙醇加入高分子防水材料，配成1％～5％的浓度；所述高分子防水材料包括乙基纤维素、甲基丙烯酸羟乙酯、甲基丙烯酸甲酯共聚物、醋酸羟丙甲纤维素琥珀酸酯中的任意一种单独或多种组合；
双层膜剂的制备：按照贴膜剂的生产工艺均浆流延成膜法对载药内膜胶浆进行膜剂的铺膜，真空干燥，小心起膜，干燥后得载药内膜；将载药内膜平铺，量取防水外膜胶浆，再次利用均浆流延成膜法铺于载药内膜上，置于干燥通风阴凉处静置一小时，即得双层的单向释药膜剂，然后进行切割，灭菌，包装，即得治疗口腔溃疡的双层膜剂。
6.根据权利要求5所述的一种治疗口腔溃疡的双层膜剂的制备方法，其特征在于，载药内膜和防水外膜的重量比为(10～20)：(80～90)。
7.根据权利要求5所述的一种治疗口腔溃疡的双层膜剂的制备方法，其特征在于，真空干燥的条件为50℃、-84kPa保存5小时。
8.根据权利要求5所述的一种治疗口腔溃疡的双层膜剂的制备方法，其特征在于，防水外膜胶浆的制备中，高分子防水材料优选为乙基纤维素。
9.根据权利要求5所述的一种治疗口腔溃疡的双层膜剂的制备方法，其特征在于，内膜胶浆的制备中，还加入了矫味剂，矫味剂的加入量为0.1～1份。
10.根据权利要求9所述的一种治疗口腔溃疡的双层膜剂的制备方法，其特征在于，所述矫味剂为糖精钠。
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