CN115068660A - 一种用于创面修复的湿性敷料及其制备方法 - Google Patents
一种用于创面修复的湿性敷料及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种用于创面修复的湿性敷料及其制备方法，包括海藻酸钠、褐藻胶寡糖、羟乙基纤维、氯化钠、纯化水。本发明与现有技术相比的优点在于：具有高安全性，无潜在细胞毒性、皮肤刺激、超敏反应、遗传毒性、急性毒性等优点，在烧伤科临床应用上，可根据烧烫伤创面的大小，灵活裁剪医用无菌棉片对创面进行湿敷，针对烧伤科临床上大面积的烧烫伤病人，采用本创面敷料进行湿润疗法，对创面进行修复，既可避免病人采用痛苦的植皮手术修复创面，又可显著降低病人医疗费用负担。
Description
技术领域
本发明涉及医用耗材及其制备方法技术领域，具体是指一种用于创面修复的湿性敷料及其制备方法。
背景技术
医用敷料，是创伤用品，用以覆盖压疮、伤口或其他损害的医用材料。
现有的海藻酸盐敷料(纤维型)是由海藻纤维制成的无纺布敷料，海藻酸盐能吸收伤口渗出液，形成凝胶状物质覆盖在创面上，维持湿性环境，促进创面愈合，但这类无纺布敷料临床上仅限用于小创面患者使用，且有着有异味，无黏性，外观与创面感染脓性分泌物不易区分，敷料容易发硬，与创面粘连，换药时引起创面再损伤等缺点，进而影响创面愈合。
发明内容
本发明要解决的技术问题是上述技术问题，提供一种配合医用无菌棉片进行使用，能够对不同大小的创面进行持续的湿敷、为创面提供湿润环境，促进创面愈合的湿性敷料。
为解决上述技术问题，本发明提供的技术方案为：一种用于创面修复的湿性敷料，包括海藻酸钠、褐藻胶寡糖、羟乙基纤维、氯化钠、纯化水；每1L所述纯化水中包含所述海藻酸钠0.5～10g、所述褐藻胶寡糖0.1～5g、所述羟乙基纤维素0.01～1g、所述氯化钠0.2～0.9g。一种用于创面修复的湿性敷料的制备方法，取所述海藻酸钠0.5～10g、所述褐藻胶寡糖0.1～5g、所述羟乙基纤维素0.01～1g、所述氯化钠0.2～0.9g添加1L所述纯化水溶解成溶液，将所述溶液加热至膜态沸腾，保持所述溶液处于膜态沸腾30min，冷却所述溶液，使用调节液将所述溶液的PH值调节至5.5～9.0，过滤所述溶液，分装所述溶液，对所述溶液进行分装，对分装后的所述溶液进行冷却。
本发明与现有技术相比的优点在于：本敷料具有高安全性，无潜在细胞毒性、皮肤刺激、超敏反应、遗传毒性、急性毒性等优点，在烧伤科临床使用上，可根据烧烫伤创面的大小，灵活裁剪医用无菌棉片对创面进行湿敷，针对烧伤科临床上大面积的烧烫伤病人，可采用本创面敷料进行湿润疗法，对创面进行修复，既可避免病人采用痛苦的植皮手术修复创面，又可显著降低病人医疗费用负担。
作为改进：所述调节液为稀氢氧化钠溶液，能够有效调节所述溶液的PH值。
作为改进：使用洗瓶对所述溶液进行分装，便于后期使用。
附图说明
图1是本发明一种用于创面修复的湿性敷料及其制备方法的制备方法示意图。
图2是消毒酒精(75％)与海藻酸盐液体敷料对大鼠烫伤模型的修复作用典型图。
图3是大鼠烫伤模型不同治疗后皮肤HE染色检测结果图。
具体实施方式
下面结合附图对本发明做进一步的详细说明。
结合附图1、附图2和附图3，一种用于创面修复的湿性敷料，包括海藻酸钠、褐藻胶寡糖、羟乙基纤维、氯化钠、纯化水；每1L所述纯化水中包含所述海藻酸钠0.5～10g、所述褐藻胶寡糖0.1～5g、所述羟乙基纤维素0.01～1g、所述氯化钠0.2～0.9g。一种用于创面修复的湿性敷料的制备方法，取所述海藻酸钠0.5～10g、所述褐藻胶寡糖0.1～5g、所述羟乙基纤维素0.01～1g、所述氯化钠0.2～0.9g添加1L所述纯化水溶解成溶液，将所述溶液加热至膜态沸腾，保持所述溶液处于膜态沸腾30min，冷却所述溶液，使用调节液将所述溶液的PH值调节至5.5～9.0，过滤所述溶液，分装所述溶液，对所述溶液进行分装，对分装后的所述溶液进行冷却。
本发明在具体实施时，海藻酸盐敷料(溶液型)，基于伤口湿性愈合理论，采用医用无菌棉片浸透本敷料覆盖于创面(并用纱布固定)，在创面表面形成柔软保护层，有效隔离外界各种病原菌入侵，止渗并防止体液流失，吸附坏死碎屑、细菌和微生物，从而持续保持创面清洁、无菌、湿润环境，有利于毛细血管再生，促进创面愈合的各种生长因子释放，刺激细胞增殖，有利于保持细胞活力和上皮细胞移行，从而促进创面愈合。
所述调节液为稀氢氧化钠溶液。
使用洗瓶对所述溶液进行分装。
对比例
采用SD大鼠烫伤模型，以消毒酒精(75％)为阳性对照，评价海藻酸盐液体敷料对烧烫伤治疗的功效。
烫伤模型：
SD大鼠(200～220g)12只，饲养于动物房中，自由饮食，待其适应1周后，称其体重，先用电动理发器小心地剔除大鼠背部的毛，然后使用适量薇婷脱毛膏将剩余短毛脱除干净。
用温水蘸湿棉球，轻轻地擦除背部残余的脱毛膏，以防过敏。
将这12只大鼠随机分为3组，做好标记。分别为正常对照组(Control，n＝2)、烫伤模型消毒酒精(Reference，n＝5)、烫伤模型海藻酸盐液体敷料(Test，n＝5)。
24h后腹腔注射10％水合氯醛0.1ml/20g麻醉，用棉线的一端将麻醉后的大鼠四肢绑好，另一端固定在四角带有钉子的木板上。
大鼠烫伤模型的建立：空用面积为6.0cm2控温100℃的烙铁平头，持续接触大鼠背部脱毛的皮肤30s，建立烫伤大鼠模型。
烫伤治疗与效果观测：
烫后24h，开始治疗与效果比较观测。
正常对照组不进行任何治疗。
消毒酒精组：每日消毒酒精(75％)创面清洁一次，共处理16次。
海藻酸盐液体敷料组：用适宜面积医用棉卷，浸透海藻酸盐液体敷料后粘贴于创面，每日一次，共处理16次。
每日一次创面处理时，记录创面修复状态，并拍照。
试验结果：
对大鼠烫伤模型的修复作用，对比观察典型结果见附图2。
试验组：连续给药3次(4天)后，创面颜色加深，出血点面积扩大；给药7次(8天)后，创面伤口边缘有结痂趋势；给药12次(13天)后，创面局部结痂并有脱离；给药15次(16天)后，痂体脱落，有明显新鲜组织生长，且伤口面积缩小。
对照组：创面处理前7次(8天)后，除了伤口稍变硬，无明显变化；处理12次(13天)后，伤口仍然没有明显变化；给药15次(16天)后，痂体边缘翘起。
大鼠皮肤HE染色检测其烫伤创面病理组织学：
分别在烫伤治疗后8和16天，每组各取2只大鼠，切取创面组织标本用4％多聚甲醛进行固定、脱水、浸腊、包埋、切片，制成石蜡切片，HE染色，脱水封固。
然后在高倍显微镜下拍照并观察组织形态变化。确定不同时间点创伤皮肤表皮再生、真皮中汗腺、炎细胞浸润、肉芽组织中毛细血管及成纤维细胞生长情况。
大鼠皮肤HE染色检测结果：
大鼠烫伤后，表皮缺失、毛囊及皮脂腺全部未见，大片皮下组织溶解、脱落，形成烫伤模型。
对比空白对照组大鼠皮肤的病理观察见附图3。
给药8天后，试验组皮下局部组织轻度受损、胶原排列有序；
75％酒精对照组胶原纤维断裂真皮深层局部肌纤维坏死。
给药16天后，试验组皮下大量胶原纤维、毛细血管增生，伤口愈合明显。75％酒精组表皮坏死、胶原纤维稀疏断裂。
以上对本发明及其实施方式进行了描述，这种描述没有限制性，附图中所示的也只是本发明的实施方式之一，实际的结构并不局限于此。总而言之如果本领域的普通技术人员受其启示，在不脱离本发明创造宗旨的情况下，不经创造性的设计出与该技术方案相似的结构方式及实施例，均应属于本发明的保护范围。
Claims (4)
1.一种用于创面修复的湿性敷料，其特征在于：包括海藻酸钠、褐藻胶寡糖、羟乙基纤维、氯化钠、纯化水；
每1L所述纯化水中包含所述海藻酸钠0.5～10g、所述褐藻胶寡糖0.1～5g、所述羟乙基纤维素0.01～1g、所述氯化钠0.2～0.9g。
2.根据权利要求1所述的一种用于创面修复的湿性敷料的制备方法，其特征在于：取所述海藻酸钠0.5～10g、所述褐藻胶寡糖0.1～5g、所述羟乙基纤维素0.01～1g、所述氯化钠0.2～0.9g添加1L所述纯化水溶解成溶液，将所述溶液加热至膜态沸腾，保持所述溶液处于膜态沸腾30min，冷却所述溶液，使用调节液将所述溶液的PH值调节至5.5～9.0，过滤所述溶液，分装所述溶液，对所述溶液进行分装，对分装后的所述溶液进行冷却。
3.根据权利要求1所述的一种用于创面修复的湿性敷料的制备方法，其特征在于：所述调节液为稀氢氧化钠溶液。
4.根据权利要求1所述的一种用于创面修复的湿性敷料的制备方法，其特征在于：使用洗瓶对所述溶液进行分装。
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