CN116999612A - 一种用于止血并促进鼻粘膜修复的功能性液体敷料及制备工艺 - Google Patents
一种用于止血并促进鼻粘膜修复的功能性液体敷料及制备工艺 Download PDFInfo
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Abstract
本发明涉及一种医用敷料，具体涉及一种用于止血并促进鼻粘膜修复的功能性液体敷料及制备工艺，该功能性敷料按质量百分比计，由以下组分制备所得：海藻酸钾0.8‑0.9％、羟丙基甲基纤维素1.5‑1.8％、聚羧甲氨基多糖0.3‑0.4％、余量为氯化钠含量为0.9％的生理盐水。本发明的功能性敷料适用于鼻腔术后的渗血，鼻粘膜破损出血和促进鼻粘膜糜烂等创面的止血、修复、抗菌及保护，且降解完全，可以被身体吸收利用，对身体无毒副作用，使用安全。
Description
技术领域
本发明涉及一种医用敷料，具体涉及一种用于止血并促进鼻粘膜修复的功能性液体敷料及制备工艺。
背景技术
随着外界空气质量及气候的变化，鼻腔出血及鼻粘膜受损的患者日渐增多。引起鼻腔出血及鼻粘膜受损的原因有很多，比较常见的：
1、鼻腔干燥：如果长期处于干燥环境中，可能会导致鼻黏膜破损的情况，可遵医嘱使用复方薄荷油滴鼻液治疗；
2、鼻中隔偏曲：鼻中隔偏曲患者由于鼻黏膜比较薄弱，也有可能会导致鼻黏膜破损的症状，可在医生指导下使用盐酸赛洛唑啉鼻用喷雾剂缓解症状，如果保守治疗无效，可以做鼻中隔偏曲矫正术；
3、鼻炎：多由感染、过敏等原因造成，鼻炎患者在炎症刺激下也可能会导致鼻黏膜破损，可以用生理性海水冲洗鼻腔，配合用糠酸莫米松鼻喷雾剂、丙酸氟替卡松鼻喷雾剂等，同时可口服鼻炎片、阿莫西林胶囊等药物进行治疗；
4、鼻窦炎：鼻窦炎常继发于鼻炎，患者在炎症刺激下也可能导致鼻黏膜破损，可以口服克拉霉素缓释片、鼻渊舒口服液等药物治疗，鼻腔干燥的患者可以用复方薄荷油滴鼻液治疗；
5、其他：挖鼻损伤、鼻部外伤等原因也可造成鼻黏膜破损。
目前，多采用抗生素、激素类药品及鼻腔冲洗方法来解决，但效果均不是很理想。
发明内容
为解决上述问题，本发明提供了一种适用于鼻腔术后的渗血，鼻粘膜破损出血和促进鼻粘膜糜烂等创面的止血、修复、抗菌及保护的功能性敷料及制备工艺。
为实现上述目的，本发明采取的技术方案为：
一种用于止血并促进鼻粘膜修复的功能性液体敷料，按质量百分比计，由以下组分制备所得：
海藻酸钾0.8-0.9％、羟丙基甲基纤维素1.5-1.8％、聚羧甲氨基多糖0.3-0.4％、余量为氯化钠含量为0.9％的生理盐水。
本发明还提供了上述用于止血并促进鼻粘膜修复的功能性液体敷料的制备方法，包括如下步骤：
S1、在无菌条件下，取生理盐水800g加热至70～80℃，缓慢加入15～20g羟丙基甲基纤维素和8～10g海藻酸钾，经高速分散机充分搅拌均匀，使羟丙基甲基纤维素和海藻酸钾充分溶解后，得混合溶液，冷却至室温备用；
S2、取聚羧甲基氨基多糖3～5g在80℃下溶于100g生理盐水中，得聚羧甲基氨基多糖溶液；
S3、将所述的混合溶液和聚羧甲基氨基多糖溶液混合后，加入生理盐水补足到1000g，搅拌均匀，40目滤布过滤，用盐酸或冰醋酸调整pH值至4.5～6.5，包装灭菌入库。
进一步地，所述步骤S3中，搅拌时的转速不得大于900rpm,搅拌温度在80℃以下。
本发明的功能性敷料适用于鼻腔术后的渗血，鼻粘膜破损出血和促进鼻粘膜糜烂等创面的止血、修复、抗菌及保护，且降解完全，可以被身体吸收利用，对身体无毒副作用，使用安全。
附图说明
图1为ROS水平柱形图(x±s，n＝5)。
具体实施方式
下面结合具体实施例对本发明进行详细说明。以下实施例将有助于本领域的技术人员进一步理解本发明，但不以任何形式限制本发明。应当指出的是，对本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进。这些都属于本发明的保护范围。
实施例1
S1、在无菌条件下，取生理盐水800g加热至70℃，缓慢加入15g羟丙基甲基纤维素和8g海藻酸钾，经高速分散机充分搅拌均匀，使羟丙基甲基纤维素和海藻酸钾充分溶解后，得混合溶液，冷却至室温备用；
S2、取聚羧甲基氨基多糖(羧甲基氨基多糖)3g在80℃下溶于100g生理盐水中，得聚羧甲基氨基多糖溶液；
S3、将所述的混合溶液和聚羧甲基氨基多糖溶液混合后，加入生理盐水补足到1000g，搅拌均匀，搅拌时的转速不得大于900rpm,搅拌温度在80℃以下，搅拌时间控制在45min，40目滤布过滤，用盐酸或冰醋酸调整pH值至4.5，包装灭菌入库。
实施例2
S1、在无菌条件下，取生理盐水800g加热至80℃，缓慢加入20g羟丙基甲基纤维素和10g海藻酸钾，经高速分散机充分搅拌均匀，使羟丙基甲基纤维素和海藻酸钾充分溶解后，得混合溶液，冷却至室温备用；
S2、取聚羧甲基氨基多糖(羧甲基氨基多糖)5g在80℃下溶于100g生理盐水中，得聚羧甲基氨基多糖溶液；
S3、将所述的混合溶液和聚羧甲基氨基多糖溶液混合后，加入生理盐水补足到1000g，搅拌均匀，搅拌时的转速不得大于900rpm,搅拌温度在80℃以下，搅拌时间控制在65min，40目滤布过滤，用盐酸或冰醋酸调整pH值至6.5，包装灭菌入库。
实施例3
S1、在无菌条件下，取生理盐水800g加热至75℃，缓慢加入17.5g羟丙基甲基纤维素和9g海藻酸钾，经高速分散机充分搅拌均匀，使羟丙基甲基纤维素和海藻酸钾充分溶解后，得混合溶液，冷却至室温备用；
S2、取聚羧甲基氨基多糖(羧甲基氨基多糖)4g在80℃下溶于100g生理盐水中，得聚羧甲基氨基多糖溶液；
S3、将所述的混合溶液和聚羧甲基氨基多糖溶液混合后，加入生理盐水补足到1000g，搅拌均匀，搅拌时的转速不得大于900rpm,搅拌温度在80℃以下，搅拌时间控制在55min，40目滤布过滤，用盐酸或冰醋酸调整pH值至5.5，包装灭菌入库。
对比例1
将实施例1中的羟丙基甲基纤维素替换成等量的海藻酸钾；
对比例2
将实施例2中的聚羧甲基氨基多糖(羧甲基氨基多糖)替换成等量的羟丙基甲基纤维素。
对比例3
将实施例3中的海藻酸钾替换成等量的羟丙基甲基纤维素。
试验资料：
选取SPF级6～7周龄SD雄性大鼠80只，体重160～190g，适应性适应3d后，以卵清蛋白(OVA)诱导建立大鼠AR模型，造模方法：在第1、5、14、21天以含OVA 25μg、氢氧化铝凝胶[Al(OH)3]1mg、等渗盐水0.5ml的混悬液给予小鼠腹腔注射进行基础致敏，基础致敏后于第28天开始以500μg OVA加20μl等渗盐水给予小鼠双侧鼻腔滴注，连续进10d。
将造模成功的大鼠随机分为模型组、试验组1(每侧50μg，每天2次)、试验组2(每侧50μg，每天2次)、试验组3(每侧50μg，每天2次)、对照组1(每侧50μg，每天2次)、对照组2(每侧50μg，每天2次)、对照组3(每侧50μg，每天2次)和空白组，每组10只。各药物组大鼠给予相应药物，空白组和模型组大鼠给予等量生理盐水，连续4周。
末次给药结束4h后,从各组大鼠中随机抽取5只进行麻醉,处死后取鼻黏膜,置于40ng/L多聚甲醛中固定48h,脱水,石蜡包埋后切片(厚度3μm),进行HE染色，光镜下观察鼻黏膜病理改变,任选10个200倍视野观察黏膜上皮层、固有层、基底膜和黏膜下层的病理状况,并根据表1的标准计分量化，结果见表2。
表1大鼠鼻黏膜病理量化评分标准
表2各组鼻黏膜病理得分
结果显示，模型组大鼠的鼻黏膜组织结构紊乱，固有层血管扩张，上皮大面积脱落化生，并可见大量的炎症细胞浸润；经各试验组药物干预4周后，大鼠鼻黏膜组织上皮排列整齐，固有层血管无明显扩张，上皮层结构恢复且炎症细胞浸润显著减少，鼻黏膜病理得分均较模型组显著下降；同时，经各对照组药物干预4周后，大鼠鼻黏膜组织上皮排列较整齐，固有层血管扩张，上皮层恢复情况一般，炎症细胞浸润较模型组略有减少，各试验组的鼻黏膜病理得分均显著低于各对照组，究其原因可能是海藻酸钾、羟丙基甲基纤维素、聚羧甲氨基多糖三者之间存在协同增效的关系。
取上述的各组5只大鼠的鼻黏膜组织适量，切成面积约1mm2的小片，用磷酸盐缓冲液清洗后，加入胶原酶1mL，37℃下孵育10min(每5min振摇1次)；待组织解离完全后，用3％胎牛血清终止消化，并用70μm滤网过滤；细胞加人磷酸盐级冲液10mL，离心。吸去上清液；细胞加入DCFH-DA工作液(用无血清RPMI-1640培养液制备，终浓度为10μmol/L)500μL,于37℃下孵有20min,以无血清RPMI-1640培养液清洗3次，再以磷酸盐缓冲液重悬，使用流式细胞仪检测其荧光强度，用以表示ROS水平(两者成正比)。
结果：如图1所示，与空白组比较，模型组的鼻粘膜组织中ROS水平显著升高(P＜0.05)，提示大鼠鼻黏膜组织损伤和炎症反应的加剧可能与ROS水平的升高有关；与模型组比较，各试验组和对照组的鼻粘膜组织中的ROS水平均显著下降(P＜0.05)，且各试验组的鼻粘膜组织中的ROS水平均显著低于对照组的鼻粘膜组织中的ROS水平(P＜0.05)，提示各试验组和对照组对大鼠鼻黏膜组织损伤和炎症反应的改善作用可能与其可以降低ROS水平有关，且海藻酸钾、羟丙基甲基纤维素、聚羧甲氨基多糖三者之间存在协同增效的关系。
综上所述，本发明的功能性敷料主要用于治疗鼻腔出血、渗血或鼻粘膜损伤引起的鼻腔炎症，其成分可以有效减轻鼻部不适感并促进伤口愈合，修复滋养鼻粘膜，并有清洁清洗鼻腔的功能，使鼻腔恢复理想的生理功能。
本具体实施使用时，以喷雾的形式直接喷洒在鼻腔出血点、术后或受创面、有炎症的鼻粘膜部位，根据其降解时间一般在间隔3-4个小时喷一次，每次每鼻孔喷3-4喷。
以上对本发明的具体实施例进行了描述。需要理解的是，本发明并不局限于上述特定实施方式，本领域技术人员可以在权利要求的范围内做出各种变形或修改，这并不影响本发明的实质内容。
Claims (3)
1.一种用于止血并促进鼻粘膜修复的功能性液体敷料，其特征在于：按质量百分比计，由以下组分制备所得：
海藻酸钾0.8-0.9％、羟丙基甲基纤维素1.5-1.8％、聚羧甲氨基多糖0.3-0.4％、余量为氯化钠含量为0.9％的生理盐水。
2.如权利要求1所述的一种用于止血并促进鼻粘膜修复的功能性液体敷料的制备方法，其特征在于：包括如下步骤：
S1、在无菌条件下，取生理盐水800g加热至70～80℃，缓慢加入15～20g羟丙基甲基纤维素和8～10g海藻酸钾，经高速分散机充分搅拌均匀，使羟丙基甲基纤维素和海藻酸钾充分溶解后，得混合溶液，冷却至室温备用；
S2、取聚羧甲基氨基多糖3～5g在80℃下溶于100g生理盐水中，得聚羧甲基氨基多糖溶液；
S3、将所述的混合溶液和聚羧甲基氨基多糖溶液混合后，加入生理盐水补足到1000g，搅拌均匀，40目滤布过滤，用盐酸或冰醋酸调整pH值至4.5～6.5，包装灭菌入库。
3.如权利要求2所述的制备方法，其特征在于：所述步骤S3中，搅拌时的转速不得大于900rpm,搅拌温度在80℃以下。
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