CN111840632A - 一种含止血微囊的液体敷料及其制备方法 - Google Patents
一种含止血微囊的液体敷料及其制备方法 Download PDFInfo
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Abstract
本发明涉及医疗材料领域，公开了一种含止血微囊的液体敷料及其制备方法，由以下重量份数的原料组成：微囊粉2‑30份，成膜剂1‑40份，保湿剂0.2‑2份，去离子水80‑96份。其所含微囊以环糊精为囊材，包裹具有止血作用的维生素K和酚磺乙胺以及抑菌作用的抑菌剂。按本发明的方法制备的液体伤口敷料，能够在表层的创口上形成一层保护层，具有快速止血、长效抑菌、保湿、护理创面的效果。
Description
技术领域
本发明涉及医疗材料领域，具体为一种含止血微囊的液体敷料及其制备方法。
背景技术
皮肤损伤是一种常见的疾病，传统的敷料如纱布、药棉、创口贴等敷料多为给伤口形成一种干性环境，待伤口自行结痂愈合，痊愈过程存在止血效果不佳、渗出液易滋生细菌、粘连伤口、更换二次损伤、等缺点。近年出现的新型生物流体敷料生物流体敷料主要是将成膜性的高分子材料和有利于伤口愈合成分相结合，以涂抹或喷雾的方式，在创口上形成一层透气保湿的隔离薄膜，隔离外界空气形成湿性环境，从而起到保护创面、促进伤口愈合的作用。这种敷料对各种形状的伤口都有良好的覆盖性，而且无需包扎。
目前的市面上的液体敷料有如下不足：1、功能局限单一，主要是起到杀菌抑菌的作用，无异于一般消毒液，无止血的作用或止血效果较差（如公开号CN201510591885.1的中国发明专利）；2、依靠银等重金属起到杀菌抑菌作用的液体敷料，若大面积伤口使用会有潜在的重金属中毒的风险（如申请号200610083191.8的中国发明专利）；3、已有的液体敷料多使用有机溶剂为溶剂，具有刺激性，可能引起过敏，或者使患者有疼痛感（如公开号CN201610553348.2的中国发明专利）。
发明内容
本发明专利在于克服现有技术存在的不足，提供一种能快速止血兼具长效抑菌、保湿等作用的液体敷料。
为实现上述目的，本发明采取的技术方案如下：
一种含止血微囊的液体敷料，由以下重量份数的原料组成：微囊粉2-30份，成膜剂1-40份，保湿剂0.2-2份，去离子水80-96份。
上述种含止血微囊的液体敷料，其所含微囊以环糊精为囊材，包裹具有止血作用的维生素K和酚磺乙胺以及抑菌作用的抑菌剂。环糊精的结构是一个类似截锥型的圆腔结构，在其空洞结构中，外侧上端(较大开口端)由C2和C3的仲羟基构成，羟丙基取代2，3位羟基H原子后增加了环糊精空腔的长度，下端(较小开口端)由C6的伯羟基构成，具有亲水性，而空腔内由于形成醚环为疏水区，能提高难溶性药物的稳定性、生物利用度和具有一定的控释作用。
优选的，所述的成膜剂为白芨胶、海藻酸钠、黄原胶、卡拉胶中的一种或多种。
优选的，所述的保湿为甘油、杏仁油、葡萄籽油中的一种或多种；
本发明一种含止血微囊的液体敷料的制备方法如下：
S1: 将环糊精粉末逐步加入到去离子水中搅拌均匀，得到环糊精的饱和溶液A溶液，将维生素K和酚磺乙胺溶解于80%乙醇中形成B溶液，将抑菌剂研细，过400目筛得到C粉末，将B溶液边搅拌边滴入A溶液中，持续搅拌并将C粉末加入A溶液中，得到混合液；
S2：在4-10℃温度下，以50-200r/min的转速对步骤S1所得混合液避光搅拌8-12小时后，减压干燥即得微囊粉；
S3：将微囊粉、成膜剂、保湿剂按比例溶解于去离子水中混匀即得液体敷料。
优选的，所述的环糊精为α-环糊精、β-环糊精、γ-环糊精或其酯衍生物、醚衍生物、交联聚合物中的一种或多种；
优选的，所述的抑菌剂为磺胺嘧啶、甲硝唑、诺氟沙星、左氧氟沙星中的一种或多种；
优选的，所述的A溶液、B溶液、C粉末的比例为2-8：1：1。
本发明的有益效果为：
（1）维生素K和酚磺乙胺配合使用，能起到收缩血管、快速止血的作用。
（2）微生素K和酚磺乙胺有促进凝血的作用，甲硝唑有避免皮肤或粘膜组织感染的作用，但三者在水中溶解性差，将其包埋在环糊精中，以微囊形式能提高它们在液体敷料中的含量和生物利用度。
（3）维生素K和酚磺乙胺化学性质不稳定，微囊形式能对维生素K和酚磺乙胺和起到保护作用，可使其免受酸、碱、氧化剂和光的破坏。同时被微囊包裹的抑菌剂有一定缓释作用，起到长效抑菌。
（4）白芨胶能使液体敷料成膜，起到保护伤口作用，其自身也具有一定抑菌性能，能避免感染。
（5）本发明液体敷料具有止血、长效抑菌、保湿和有利于伤口愈合的效果。
具体实施方式
实施例一
一种含止血微囊的液体敷料，由以下重量份数的原料组成：微囊粉2份，成膜剂1份，保湿剂0.2份，去离子水80份。其制备方法如下：
S1:制备β-环糊精的饱和溶液A溶液，将维生素K和酚磺乙胺溶解于80%乙醇中形成B溶液，将甲硝唑研细，过400目筛为C粉末，将B溶液边搅拌边滴加进入的A溶液中，继续边搅拌边将C粉末加入A溶液中，A、B、C的比例为2：1：1；
S2：4℃温度下，以150r/min的转速避光搅拌10小时后，减压干燥即得微囊粉。
S3：将微囊粉、白芨胶、甘油按比例溶解于去离子水中混匀即得液体敷料。
实施例二
一种含止血微囊的液体敷料，由以下重量份数的原料组成：微囊粉10份，成膜剂12份，保湿剂1份，去离子水85份。其制备方法如下：
S1:制备α-环糊精的饱和溶液A溶液，将维生素K和酚磺乙胺溶解于80%乙醇中形成B溶液，将甲硝唑研细，过400目筛为C粉末，将B溶液边搅拌边滴加进入的A溶液中，继续边搅拌边将C粉末加入A溶液中，A、B、C的比例为3：1：1；
S2：4℃温度下，以150r/min的转速避光搅拌10小时后，减压干燥即得微囊粉。
S3：将微囊粉、白芨胶、甘油按比例溶解于去离子水中混匀即得液体敷料。
实施例三
一种含止血微囊的液体敷料，由以下重量份数的原料组成：微囊粉20份，成膜剂30份，保湿剂1.5份，去离子水90份。其制备方法如下：
S1:制备γ-环糊精的饱和溶液A溶液，将维生素K和酚磺乙胺溶解于80%乙醇中形成B溶液，将甲硝唑研细，过400目筛为C粉末，将B溶液边搅拌边滴加进入的A溶液中，继续边搅拌边将C粉末加入A溶液中，A、B、C的比例为4：1：1；
S2：4℃温度下，以150r/min的转速避光搅拌10小时后，减压干燥即得微囊粉。
S3：将微囊粉、白芨胶、甘油按比例溶解于去离子水中混匀即得液体敷料。
实施例四
一种含止血微囊的液体敷料，由以下重量份数的原料组成：微囊粉30份，成膜剂40份，保湿剂2份，去离子水6份。其制备方法如下：
S1:制备羟丙基-β-环糊精的饱和溶液A溶液，将维生素K和酚磺乙胺溶解于80%乙醇中形成B溶液，将甲硝唑研细，过400目筛为C粉末，将B溶液边搅拌边滴加进入的A溶液中，继续边搅拌边将C粉末加入A溶液中，A、B、C的比例为6：1：1；
S2：4℃温度下，以150r/min的转速避光搅拌10小时后，减压干燥即得微囊粉。
S3：将微囊粉、白芨胶、甘油按比例溶解于去离子水中混匀即得液体敷料。
实施例五
一种含止血微囊的液体敷料，由以下重量份数的原料组成：微囊粉28份，成膜剂36份，保湿剂1.8份，去离子水93份。其制备方法如下：
S1:制备羟丙基-β-环糊精的饱和溶液A溶液，将维生素K和酚磺乙胺溶解于80%乙醇中形成B溶液，将甲硝唑研细，过400目筛为C粉末，将B溶液边搅拌边滴加进入的A溶液中，继续边搅拌边将C粉末加入A溶液中，A、B、C的比例为8：1：1；
S2：4℃温度下，以150r/min的转速避光搅拌10小时后，减压干燥即得微囊粉。
S3：将微囊粉、白芨胶、甘油按比例溶解于去离子水中混匀即得液体敷料。
实施例六（对比例）
一种含止血微囊的液体敷料，其制备方法如下：
S1:制备羟丙基-β-环糊精的饱和溶液A溶液，再将薄荷油溶解于80%乙醇中形成B溶液，将甲硝唑研细，过400目筛为C粉末，将B溶液边搅拌边滴加进入的A溶液中，继续边搅拌边将C粉末加入A溶液中，A、B、C的比例为8：1：1；
S2：4℃温度下，以150r/min的转速避光搅拌10小时后，减压干燥即得微囊粉。
S3：将微囊粉、白芨胶、甘油按比例溶解于去离子水中混匀即得液体敷料。
实施例七
以上仅仅列出了本发明的部分实施例并进行了说明，将上述实施例一~五与实施例六所制备的液体敷料进行体外凝血实验和动物皮肤创口的止血实验。
实验方法如下：
1、凝血试验：将2ml各组实施例制备的液体敷料加入到试管，加入新鲜采集的新西兰兔静脉血8ml，每隔20s倾斜试管，观察并记录血液凝固的时间，每个实验组重复3次；
2、止血实验：健康成年体重约250g的SD大鼠，用相同的手术刀在背部同一部位划开一条长2cm深2mm的伤口，将各实施例制备的液体敷料喷涂于上面，用量以完全覆盖伤口为准，记录止血时间，每个样做三组平行实验。
实验结果如表1、表2所示：
表1凝血实验结果
| 实施例一 | 实施例二 | 实施例三 | 实施例四 | 实施例五 | 实施例六 | |
| 凝血时间（s） | 302±11.9 | 256±31.7 | 232±21.2 | 285±9.7 | 346±12.0 | 475±46.3 |
表2止血实验结果
由上述表1、表2结果来看，体外凝血实验和止血实验的结果基本一致。本发明能对伤口创面进行快速止血的效果，在经过多次的研究探索，实施例三为本发明的最优方案，即在步骤1中环糊精、维生素K-酚磺乙胺混合物和甲硝唑按照4：1的比例进行混合后，有更良好的包埋效果，对于创面有更快速的止血效果。
以上对本发明的特定实施例进行了说明，但本发明的保护内容不仅仅限定于以上实施例，在本发明的所属技术领域中，只要掌握通常知识，就可以在其技术要旨范围内进行多种多样的变更。
Claims (7)
1.一种含止血微囊的液体敷料，其特征在于，由以下重量份数的原料组成：微囊粉2-30份，成膜剂1-40份，保湿剂0.2-2份，去离子水80-96份。
2.根据权利要求1所述的一种含止血微囊的液体敷料，其特征在于，所述的成膜剂为白芨胶、海藻酸钠、黄原胶、卡拉胶中的一种或多种。
3.根据权利要求1所述的一种含止血微囊的液体敷料，其特征在于，所述的保湿为甘油、杏仁油、葡萄籽油中的一种或多种。
4.权利要求1至3任一所述的一种含止血微囊的液体敷料的制备方法，其特征在于，包括如下步骤：
S1: 将环糊精粉末逐步加入到去离子水中搅拌均匀，得到环糊精的饱和溶液A溶液，将维生素K和酚磺乙胺溶解于80%乙醇中形成B溶液，将抑菌剂研细，过400目筛得到C粉末，将B溶液边搅拌边滴入A溶液中，持续搅拌并将C粉末加入A溶液中，得到混合液；
S2：在4-10℃温度下，以50-200r/min的转速对步骤S1所得混合液避光搅拌8-12小时后，减压干燥即得微囊粉；
S3：将微囊粉、成膜剂、保湿剂按比例溶解于去离子水中混匀即得液体敷料。
5.根据权利要求4所述的一种含止血微囊的液体敷料的制备方法，其特征在于，所述的环糊精为α-环糊精、β-环糊精、γ-环糊精或其酯衍生物、醚衍生物、交联聚合物中的一种或多种。
6.根据权利要求4所述的一种含止血微囊的液体敷料的制备方法，其特征在于，所述的抑菌剂为磺胺嘧啶、甲硝唑、诺氟沙星、左氧氟沙星中的一种或多种。
7.根据权利要求4所述的一种含止血微囊的液体敷料的制备方法，其特征在于，所述的A溶液、B溶液、C粉末的比例为2-8：1：1。
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