CN108126236B - 一种医药涂敷材料及其制备方法 - Google Patents

一种医药涂敷材料及其制备方法 Download PDF

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CN108126236B
CN108126236B CN201711384801.2A CN201711384801A CN108126236B CN 108126236 B CN108126236 B CN 108126236B CN 201711384801 A CN201711384801 A CN 201711384801A CN 108126236 B CN108126236 B CN 108126236B
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chitosan
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黄娟
王建伟
陆涛
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Jinhua Jingdi Medical Supplies Co ltd
Zhejiang Lover Health Science and Technology Development Co Ltd
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Zhejiang Lover Health Science and Technology Development Co Ltd
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Abstract

本发明涉及医疗卫生领域中的一种医药涂敷材料及其制备方法。将5～30质量份海藻酸钠、3～20质量份水溶性壳聚糖、5～50质量份氯化钠、20～100质量份甘油、0～100质量份丙二醇在搅拌下溶于100～1000份蒸馏水中得A；将50～600质量份乳化剂、300～700质量份硅氧烷树脂加入到300～800质量份挥发性硅氧烷中，混合均匀得B；将A缓慢加入到B溶液中乳化均匀，即得到一种医药涂敷材料。本发明的医药涂敷材料具有止血，加快皮肤创面愈合作用；有抗、抑菌功效，对创伤表面和外部的细菌抗、抑作用强；可主动、被动对皮肤保湿，对疤痕皮肤有水合作用，修复作用好。

Description

一种医药涂敷材料及其制备方法
技术领域
本发明涉及一种医药涂敷材料及其制备方法，属于医疗卫生领域中的一种医用生物材料。
背景技术
目前，对人体的体表创伤、手术刀口、烧烫伤面，一般均采取涂敷消毒纱布、缠绷带等措施对患者进行治疗，因血液凝剧，往往使纱布附着于伤口创面上，换药物时伤口新生肉芽反复受损坏，延长了伤口愈合时间，有时会给患者带来难以忍受的痛苦，医护人员的操作亦很麻烦。而且传统纱布类敷材，贴敷伤口处透气性差，不易大面积使用，还有细菌易侵入的缺陷。
海藻酸盐是一种天然阴离子多糖，它与伤口渗出液接触后能形成凝胶，通过形成强亲水性凝胶而产生高吸收力，能锁住大量的水分，是一种很好的胶凝材料。同时海藻酸盐对人体新陈代谢具有独特的调节作用，并具有消炎、止血和散结等功能。壳聚糖是迄今所发现的唯一天然碱性多糖，不仅具有抗菌、止血功能，还能阻止血纤维蛋白素的形成，***细胞的增殖以及胶原蛋白的合成，因此可使伤口愈合后，结痴最小。在壳聚糖的C2-NH2，C6-OH上进行衍生引入酸根离子、羧甲基、季铵盐，或将壳聚糖降解成壳寡糖、提高脱乙酰度等方式得到的水溶性壳聚糖，因其提高了壳聚糖有效-NH3 +的暴露量以及壳聚糖向细胞的渗透能力，抗、抑菌性也显著增加。
由水溶性壳聚糖和海藻酸盐组成的壳聚糖/海藻酸盐敷料与渗出液、血液接触后，能快速吸取渗出液、血液，在接触面形成粘性凝胶状，附着于创面。但壳聚糖/海藻酸盐敷料因其分子结构中含有大量的羟基等亲水基团，具有抗水性差、吸湿性较强、透气性高等致命缺点。
发明内容
本发明的目的是针对现有技术存在的问题，通过引入具有阻水性、高透氧性和祛疤功效的硅氧烷，提高壳聚糖/海藻酸钠敷料的阻水性和透氧性。本发明将海藻酸钠、水溶性壳聚糖以10:1～1.5:1混合溶解在蒸馏水中，与硅氧烷树脂、表面活性剂、挥发性硅氧烷一起乳化，开发一种安全、有效、可喷涂的速效固化生物液体创口贴。海藻酸盐能够吸收伤口渗出液；壳聚糖能够抑制复合敷料上细菌的附着以及病原性微生物的增殖，即使长时间使用，也能够降低细菌感染的风险；硅氧烷树脂透气、不透水，通过对皮肤的封闭、水合，减少创伤处的水分散发，修复疤痕。挥发性硅氧烷迅速挥发，实现敷料的速效固化。
本发明公开了一种医药涂敷材料，由下述方法制成：将5～30质量份海藻酸钠、3～20质量份水溶性壳聚糖、5～50质量份氯化钠、20～100质量份甘油、0～100质量份丙二醇在搅拌下溶于100～1000份水中得A；将50～600质量份乳化剂、300～700质量份硅氧烷树脂加入300～800质量份挥发性硅氧烷中，混合均匀得B；将A缓慢加入到B溶液中乳化均匀，即得到一种医药涂敷材料。
优选的，所述水溶性壳聚糖为：类透明质酸壳聚糖、羧甲基壳聚糖、羟丙基三甲基氯化铵壳聚糖、壳聚糖乳酸盐、壳聚糖盐酸盐、壳聚糖醋酸盐或壳寡糖。
优选的，所述乳化剂为：油包水型乳化剂或油包水型乳化剂和水包油型乳化剂的混合乳化剂。
优选的，水包油型乳化剂的用量为1～100质量份。乳化剂以油包水性乳化剂为主，如span系列，可以加入少量水包油乳化剂，如tween系列，调整混合乳化剂整体的乳化能力。
优选的，所述硅氧烷树脂为三甲基硅氧基硅酸酯、三甲基硅氧基硅酸酯/聚丙基硅倍半氧烷、丙烯酸酯/聚三甲基硅氧烷-甲基丙烯酸酯共聚物、三甲基硅氧基硅酸酯/聚二甲基硅氧烷醇交联聚合物。
优选的，所述挥发性硅氧烷的粘度为0.65mPa.s/25℃，闪点低于-3℃。
优选的，所述的乳化方式为高速均质乳化、机械搅拌乳化或研磨乳化。
本发明的医药涂敷材料的制备方法步骤如下：将5～30质量份海藻酸钠、3～20质量份水溶性壳聚糖、5～50质量份氯化钠、20～100质量份甘油、0～100质量份丙二醇在搅拌下溶于100～1000份水中得A；将50～600质量份乳化剂、300～700质量份硅氧烷树脂加入300～800质量份挥发性硅氧烷中，混合均匀得B；将A缓慢加入到B溶液中乳化均匀，即得到一种医药涂敷材料。
通过将乳化后的溶液直接喷涂在伤口上，待溶剂挥发后，表面会形成一层能透气、防水、防尘、不受创口形状面积限制，不影响患者活动和清洁的保护层。该产品富有弹性、透气性，使用携带方便，使用时不影响外观，不引起不适感，能活动自如，对人体安全可靠，具有快速封闭伤口、抗菌、止血、促愈、淡疤、防水等优良性能。该产品不仅适合各类伤口，而且对临床长期困扰的一些难愈合伤口有特殊的疗效，消费者更加容易接受，市场需求巨大。
具体实施方式
下面通过具体实施例对本发明作进一步说明：
实例1
准确称取海藻酸钠20份、壳寡糖8份，氯化钠20份，甘油40份，加入蒸馏水852份，制成淡黄色液体A；称取span80 200份、三甲基硅氧基硅酸酯400份，加入六甲基二硅氧烷460份搅拌溶解得B。将A溶液缓慢加入B溶液中，高速均质乳化10min，灌装密封。直接涂布于伤口表面，30秒后干燥固化，外观光滑。
实例2
准确称取海藻酸钠15份、壳聚糖季铵盐10份，氯化钠25份，甘油20份，加蒸馏水至870份，制成淡黄色液体A；称取Emulsifier10(Dow corning)120份、丙烯酸酯/聚三甲基硅氧烷-甲基丙烯酸酯共聚物360份，加入六甲基二硅氧烷580份搅拌溶解得B。将A溶液缓慢加入B溶液中，高速均质乳化10min，灌装密封。直接涂布于伤口表面，30秒后干燥固化，外观光滑。
实例3
准确称取海藻酸钠20份、类透明质酸壳聚糖5份，氯化钠20份，甘油40份，丙二醇20份加入蒸馏水1035份，制成淡黄色液体A；称取span80 50份，tween80 10份，三甲基硅氧基硅酸酯300份，加入六甲基二硅氧烷500份搅拌溶解得B。将A溶液缓慢加入B溶液中，高速均质乳化10min，灌装密封。直接涂布于伤口表面，45秒后干燥固化，外观光滑。
实例4
准确称取海藻酸钠10份、壳寡糖20份，氯化钠8份，甘油40份，丙二醇60份，加蒸馏水至220份，制成淡黄色液体A；称取Emulsifier10(Dow corning)482份、三甲基硅氧基硅酸酯400份，加入六甲基二硅氧烷760份搅拌溶解得B。将A溶液缓慢加入B溶液中，高速均质乳化10min，灌装密封。距离创伤处15-20公分喷雾，30秒后干燥固化，外观光滑。
实例5
准确称取海藻酸钠5份、羧甲基壳聚糖5份，氯化钠10份，甘油40份，丙二醇60份，加蒸馏水至240份，制成淡黄色液体A；称取Emulsifier10(Dow corning)450份、三甲基硅氧基硅酸酯/聚丙基硅倍半氧烷440份，加入六甲基二硅氧烷750份搅拌溶解得B。将A溶液缓慢加入B溶液中，高速均质乳化10min，灌装密封。距离创伤处15-20公分喷雾，30秒后干燥固化，外观光滑。
本发明的涂敷材料具有很好的抑菌效果，其实验结果如下：
Figure BDA0001516396840000041
注：“+”表示有菌落生长，“-”表示无菌落生长。
最后，还需要注意的是，以上列举的仅是本发明的具体实施例子。显然，本发明不限于以上实施例子，还可以有许多变形。本领域的普通技术人员能从本发明公开的内容直接导出或联想到的所有变形，均应认为是本发明的保护范围。

Claims (5)

1.一种医药涂敷材料，其特征在于由下述方法制成：将5~30质量份海藻酸钠、3~20质量份水溶性壳聚糖、5~50质量份氯化钠、20~100质量份甘油、0~100质量份丙二醇在搅拌下溶于100~1000份水中得A；将50~600质量份乳化剂、300~700质量份硅氧烷树脂加入300~800质量份挥发性硅氧烷中，混合均匀得B；将A缓慢加入到B溶液中乳化均匀，即得到一种医药涂敷材料；
所述硅氧烷树脂为三甲基硅氧基硅酸酯、三甲基硅氧基硅酸酯/聚丙基硅倍半氧烷、丙烯酸酯/聚三甲基硅氧烷-甲基丙烯酸酯共聚物、三甲基硅氧基硅酸酯/聚二甲基硅氧烷醇交联聚合物；
所述挥发性硅氧烷的粘度为0.65mPa.s/25℃，闪点低于-3℃。
2.根据权利要求1 所述的一种医药涂敷材料，其特征在于所述水溶性壳聚糖为：类透明质酸壳聚糖、羧甲基壳聚糖、羟丙基三甲基氯化铵壳聚糖、壳聚糖乳酸盐、壳聚糖盐酸盐、壳聚糖醋酸盐或壳寡糖。
3.根据权利要求1 所述的一种医药涂敷材料，其特征在于所述乳化剂为：油包水型乳化剂或油包水型乳化剂和水包油型乳化剂的混合乳化剂。
4.根据权利要求3所述的一种医药涂敷材料，其特征在于水包油型乳化剂的用量为1~100质量份。
5.根据权利要求1 所述的一种医药涂敷材料，其特征在于所述的乳化方式为高速均质乳化、机械搅拌乳化或研磨乳化。
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