CN112545756A - 一种医用臭氧油-硅酮泡沫敷贴的制备方法 - Google Patents
一种医用臭氧油-硅酮泡沫敷贴的制备方法 Download PDFInfo
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- CN112545756A CN112545756A CN202011336095.6A CN202011336095A CN112545756A CN 112545756 A CN112545756 A CN 112545756A CN 202011336095 A CN202011336095 A CN 202011336095A CN 112545756 A CN112545756 A CN 112545756A
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- ozone
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Abstract
本发明专利公开了一种医用臭氧油‑硅酮泡沫敷贴的制备方法，具体涉及医疗用品的技术领域。一种医用臭氧油‑硅酮泡沫敷贴的制备方法，包括如下步骤：将医用臭氧气体持续通入橄榄油中，得到臭氧油；将臭氧油、二甲基硅油、麻油、中药提取物、维生素A和维生素E搅拌混合均匀，同时加热融化制得臭氧油膏；将硅酮泡沫敷料浸泡在臭氧油膏内，从而得到臭氧油敷料；将臭氧油敷料用离心脱水机离心甩干；将臭氧油敷料设有超吸复合层、聚氨酯PU薄膜层和不透水的背衬层，臭氧油敷料设有离型纸层，从而制得医用臭氧油‑硅酮泡沫敷贴。采用本发明技术方案解决了现有的敷料伤口愈合慢的问题，可用于患者创伤的治疗。
Description
技术领域
本发明涉及医疗器械的技术领域，特别涉及一种医用臭氧油-硅酮泡沫敷贴的制备方法。
背景技术
创伤处理一直是医疗领域无法回避的问题，在日常生活中，人体的皮肤表面难免出现破损、擦伤、皮肤溃烂和烧伤等，对创面的有效处理不仅可以缓解痛苦、加速创面愈合、减少感染风险，愈合后也有利于外观的恢复。对于皮肤创伤的处理，通常采用局部清创消毒后用无菌敷料对伤口进行保护，同时每天更换敷料直至伤口愈合，借助敷料可防止伤口感染。
目前，国内各大医院所使用的创面敷料大多是由凡士林与棉纱布构成。虽然凡士林纱布具有一定的润滑保湿效果，但它会在创面表面形成一层不被人体吸收、不易清除的凡士林油层，而且也没有明显抑菌杀菌和促进伤口愈合的作用，敷料若不频繁更换，也容易滋生细菌而形成慢性伤口，导致伤口延迟愈合，增加病人的痛苦。并且棉纱布的缺陷也较为明显：1、伤口一旦干燥，纱布将与创面粘连，换药撕扯时会损伤新鲜肉芽组织；2、纱布一旦被创面渗液浸透，则需及时更换敷料，否则细菌可以通过润湿的纱布进入创面，造成感染；3、仅仅起到阻隔细菌，保护创面的作用，不具备促愈合、抑菌杀菌能力。因此迫切需要开发一种医用敷料来加快伤口愈合，降低感染风险。
发明内容
本发明意在提供一种医用臭氧油-硅酮泡沫敷贴的制备方法，解决了现有的敷料伤口愈合慢的问题。
为了达到上述目的，本发明的技术方案如下：一种医用臭氧油-硅酮泡沫敷贴的制备方法，包括如下步骤：
S102、将医用臭氧气体持续通入橄榄油中，使得橄榄油中臭氧含量为60-100g/L，即可得到臭氧油；
S104、将100份的S102中制得的所述臭氧油、1-3份的二甲基硅油、6-10份的麻油、3-5的份中药提取物、1份的维生素A和1-2份维生素E搅拌混合均匀，同时加热融化制得臭氧油膏，所述中药提取物由6份当归、3份甘草、1.5份白芷、1份紫草、1.2份血竭和1.2份轻粉构成；
S106、将硅酮泡沫敷料浸泡在S104中制得的所述臭氧油膏内，浸泡时间为60分钟，从而得到臭氧油敷料；
S108、将S106中得到的所述臭氧油敷料用离心脱水机离心甩干；
S110、将S108中的所述臭氧油敷料进行灭菌处理，灭菌后的臭氧油敷料的上侧依次设有超吸复合层、聚氨酯PU薄膜层和不透水的背衬层，所述臭氧油敷料的下侧设有离型纸层，所述离型纸层的两侧与背衬层贴附，所述离型纸层将聚氨酯PU薄膜层、臭氧油敷料和超吸复合层包覆在内，从而制得医用臭氧油-硅酮泡沫敷贴。
进一步的，步骤S102中制备臭氧油的温度控制在25℃。
通过上述设置，可降低臭氧自然分解率，增加橄榄油内臭氧含量及浓度。
进一步的，步骤S104中加热的温度不超过80℃。
通过上述设置，减少了维生素A、E及中药组合物在加热过程中的损失，也减少了臭氧油内臭氧因加热导致的流失。
进一步的，所述超吸复合层由脱脂棉布层和位于脱脂棉布层上的高吸水树脂颗粒层构成。
进一步的，步骤S106中硅酮泡沫敷料干重与臭氧油膏的质量比为(1-1.5):1。
通过上述设置，保证了硅酮泡沫敷料具有充足的吸水空间，又不至于过度丢失载药，同时手感触感较好。
与现有技术相比，本方案的有益效果：
1、本方案无任何化学添加和毒副作用，二甲基硅油、麻油的使用以及硅酮泡沫敷料本身的特性，可以润滑创面，有效防止伤口与敷料的粘连，解决了换药撕扯伤口的问题，中药混合物又具有促进伤口愈合，滋润保护创面、生肌等作用。
2、本方案制备的医用臭氧油-硅酮泡沫敷贴，所用的材料均有较好的透气性，在保证水蒸气透过的同时，又与外界阻隔，有效防止外界细菌进入创面内导致的感染。
3、本方案制备的医用臭氧油-硅酮泡沫敷贴具有良好的的抑菌作用，并提供湿润富氧环境，因此，臭氧油敷料层延缓了臭氧的自然分解，使得臭氧持续缓慢地释放，达到长效抑菌灭菌的效果。
4、本方案制备的医用臭氧油-硅酮泡沫敷贴具有显著的吸水优势，臭氧油敷料层、吸液层双层吸水，保证了创面湿度的适宜，也减少了换药频率，节约了医疗成本。聚氨酯PU薄膜层粘性好，使得敷料牢固贴合创面，此外它还具有防水特性十分可靠，一旦内层敷料渗透，也不至于导致整个敷料浸透，增加外界病原微生物侵入的风险。
5、本方案的医用臭氧油-硅酮泡沫敷贴结构分层设计合理，臭氧油敷料层负责持续向创面输送促愈杀菌药物，辅助超吸复合层吸收创面渗液；超吸复合层主要吸收创面内渗液；超吸复合层避免了水分过早接触聚氨酯PU薄膜层导致聚氨酯PU薄膜层失去粘性、变褶皱，并协同吸水；聚氨酯PU薄膜层主要用于固定敷料；背衬层负责保持敷料正常形状；超吸复合层的倒梯形结构起到轻度挤压臭氧油敷料层中央部位的作用，使臭氧油敷料层贴合创面的同时，挤压多余水分，保证在硅酮泡沫敷料的药液浓度。
附图说明
图1是实施例1中臭氧油-硅酮泡沫敷贴的结构示意图。
具体实施方式
下面通过具体实施方式对本发明作进一步详细的说明：
说明书附图中的附图标记包括：聚氨酯PU薄膜层1、背衬层2、脱脂棉布层3、高吸水树脂颗粒层4、臭氧油敷料5、离型纸层6。
实施例1
如附图1所示，一种医用臭氧油-硅酮泡沫敷贴的制备方法，包括如下步骤：
S102、将医用臭氧气体持续通入橄榄油中，使得橄榄油中臭氧含量为60g/L，并且过程中温度控制在25℃，从而得到臭氧油；
S104、将100份的S102中制得的臭氧油、2份的二甲基硅油、10份的麻油、3的份中药提取物、1份的维生素A和1份维生素E搅拌混合均匀，同时加热融化制得臭氧油膏，上述加热过程中温度不超过80℃，同时上述的中药提取物由6份当归、3份甘草、1.5份白芷、1份紫草、1.2份血竭和1.2份轻粉构成；
S106、将硅酮泡沫敷料浸泡在S104中制得的臭氧油膏内，浸泡时间为60分钟，从浸泡的容器中，从而得到臭氧油敷料5；
S108、将S106中得到的所述臭氧油敷料5用离心脱水机离心甩干，至硅酮泡沫敷料干重与臭氧油膏的重量比为1：1.5时停止；
S110、将S108中的臭氧油敷料5进行灭菌处理，灭菌后的臭氧油敷料5的上侧依次设有超吸复合层、聚氨酯PU薄膜层和不透水的背衬层2，超吸复合层由脱脂棉布层3和位于脱脂棉布层3下的高吸水树脂颗粒层4构成，脱脂棉布层3臭氧油敷料5连接在一起，超吸复合层采用倒梯形设计，并且其面积小于臭氧油敷料5的面积，聚氨酯PU薄膜层的面积大于臭氧油敷料5的面积，聚氨酯PU薄膜层粘付在背衬层2上，聚氨酯PU薄膜层的尺寸与背衬层2的尺寸相同，背衬层2由医用PVC材质制成，具有防水效果，同时借助背衬层2确保了臭氧油敷料5的外形稳定，同时可防止臭氧油敷料5出现褶皱的情况，臭氧油敷料5的下侧设有离型纸层6，离型纸层6的两侧与背衬层2贴附，离型纸层6将聚氨酯PU薄膜层、臭氧油敷料5和超吸复合层包覆在内，从而制得医用臭氧油-硅酮泡沫敷贴。
上述的臭氧油敷料5中所用载体材料为硅酮泡沫，其吸水性强。当创面渗液被臭氧油敷料5吸收时，高吸水树脂颗粒层4的极强吸水性能将液体及时从臭氧油敷料5清除，避免了创面被液体持续渗液浸泡的情况。而聚氨酯PU薄膜层虽然它具有良好的防水性，但是与水过长时间接触会导致薄膜变形，甚至还将失去粘性，所以设计脱脂棉布层3与聚氨酯PU薄膜直接接触，只有当高吸水树脂颗粒和臭氧油敷料5吸收的液体量超载时，渗液才会流向脱脂棉布层3，这将有利于保护聚氨酯PU薄膜层。同时三种吸水材料的设计也将增大渗液吸收量，减少换药次数。而脱脂棉布层3和位于脱脂棉布层3上的高吸水树脂颗粒层4采用倒梯形的设计将使得臭氧油敷料5中央区域受到的压力大于周围部位，同时起到一个轻微挤压臭氧油敷料5的作用，有利于创面产生的渗液被超吸复合层及时吸收。
本方案的工作过程：本医用臭氧油-硅酮泡沫敷贴工作时需将离型纸死开，将臭氧油敷料5贴敷于患者的创面上，然后按压背衬层2和超吸复合层，使得超吸复合层牢固的粘贴在患者创面周边的皮肤上，最后揭开背衬层2；当创面渗液较多时，患者可自行挤压臭氧油-硅酮泡沫敷贴，从而促进超吸复合层对渗液进行吸收处理。
与传统敷料相比，医用臭氧油-硅酮泡沫敷贴的优势在于：硅酮泡沫敷料具有透气性好，吸湿性好，抗感染的特性。其作用有：1、可以吸收创面渗液，减少创面分泌物，它可以吸收其同等体重的20倍水分。2、能在创面表面形成湿润环境，减少敷料与创面肉芽组织粘连，有利于组织增生和创面修复。3、对受压部位皮肤起到保洁、保温的作用，隔绝外界污染，保护创面裸露的神经末梢，缓解疼痛。4、泡沫敷料软硬适中，能有效缓解创面压力，减少卧床病人褥疮的发生率。臭氧油主要由臭氧与不饱和脂肪酸构成的。适当浓度的臭氧具有抗炎、促成局部组织再生、清除自由基，抗肿瘤等作用。同时臭氧油中的臭氧对各种细菌、真菌、病毒、霉菌、支原体、衣原体、阴道滴虫等病原微生物都有杀灭作用；它可以破坏细胞膜,导致细胞膜的通透性增加,也可以使细胞活动必需的酶失去活性，而臭氧杀灭病毒是通过直接破坏核糖核酸或脱氧核酸完成的。
而中药组合物是由当归、甘草、白芷、紫草、血竭、轻粉构成的粉末混合物，是中成药“生肌膏”的重要成分之一，将其混合后熬制成的膏药具有显著的促愈、消腐、生肌作用，将臭氧油与中药膏制成外用敷料混合使用，既可以达到灭菌和促愈的双重疗效，又可以延缓在常温常压的臭氧的半衰期，增加药膏的作用时间，使之持续作用创面。此外，部分人群对臭氧油具有不耐受性，使用后可能导致皮肤的瘙痒不适，在其中加入适量的维生素A和E，可以减轻这种副反应，维生素A和E本身也可以治疗粉刺、脓包、疖疮，皮肤表面溃疡等皮肤疾病。
实施例2
本实施例与实施例1的区域仅在于：步骤S102中橄榄油中臭氧的含量为80g/L，以及步骤S108：将S106中得到的所述臭氧油敷料5用离心脱水机离心甩干，至硅酮泡沫敷料干重与臭氧油膏的重量比为1：1时停止。
实施例3
本实施例与实施例2的区域仅在于：步骤S102中橄榄油中臭氧的含量为100g/L。
以上的仅是本发明的实施例，方案中公知的具体结构和/或特性等常识在此未作过多描述。应当指出，对于本领域的技术人员来说，在不脱离本发明结构的前提下，还可以作出若干变形和改进，这些也应该视为本发明的保护范围，这些都不会影响本发明实施的效果和专利的实用性。本申请要求的保护范围应当以其权利要求的内容为准，说明书中的具体实施方式等记载可以用于解释权利要求的内容。
Claims (5)
1.一种医用臭氧油-硅酮泡沫敷贴的制备方法，其特征在于：包括如下步骤：
S102、将医用臭氧气体持续通入橄榄油中，使得橄榄油中臭氧含量为60-100g/L，即可得到臭氧油；
S104、将100份的S102中制得的所述臭氧油、1-3份的二甲基硅油、6-10份的麻油、3-5的份中药提取物、1份的维生素A和1-2份维生素E搅拌混合均匀，同时加热融化制得臭氧油膏，所述中药提取物由6份当归、3份甘草、1.5份白芷、1份紫草、1.2份血竭和1.2份轻粉构成；
S106、将硅酮泡沫敷料浸泡在S104中制得的所述臭氧油膏内，浸泡时间为60分钟，从而得到臭氧油敷料；
S108、将S106中得到的所述臭氧油敷料用离心脱水机离心甩干；
S110、将S108中的所述臭氧油敷料进行灭菌处理，灭菌后的臭氧油敷料的上侧依次设有超吸复合层、聚氨酯PU薄膜层和不透水的背衬层，所述臭氧油敷料的下侧设有离型纸层，所述离型纸层的两侧与背衬层贴附，所述离型纸层将聚氨酯PU薄膜层、臭氧油敷料和超吸复合层包覆在内，从而制得医用臭氧油-硅酮泡沫敷贴。
2.根据权利要求1所述的一种医用臭氧油-硅酮泡沫敷贴的制备方法，其特征在于：步骤S102中制备臭氧油的温度控制在25℃。
3.根据权利要求1所述的一种医用臭氧油-硅酮泡沫敷贴的制备方法，其特征在于：步骤S104中加热的温度不超过80℃。
4.根据权利要求1-3中任意一项所述的一种医用臭氧油-硅酮泡沫敷贴的制备方法，其特征在于：所述超吸复合层由脱脂棉布层和位于脱脂棉布层上的高吸水树脂颗粒层构成。
5.根据权利要求1所述的一种医用臭氧油-硅酮泡沫敷贴的制备方法，其特征在于：步骤S106中硅酮泡沫敷料干重与臭氧油膏的质量比为(1-1.5):1。
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