CN105497960A - 一种具有促进伤口愈合功效的医用敷料及制法 - Google Patents
一种具有促进伤口愈合功效的医用敷料及制法 Download PDFInfo
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- CN105497960A CN105497960A CN201510994598.5A CN201510994598A CN105497960A CN 105497960 A CN105497960 A CN 105497960A CN 201510994598 A CN201510994598 A CN 201510994598A CN 105497960 A CN105497960 A CN 105497960A
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- wound healing
- herba
- medical dressing
- promoting wound
- polyurethane
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Abstract
本发明公开了一种具有促进伤口愈合功效的医用敷料，由下列主要原料制备而成，均为重量份：聚氨酯25-35；骨碎补4-8；黄芪5-9；岩笋6-11；细辛6-9；甘草10-14；陆英8-12；虎杖7-11；积雪草5-9；川芎6-9；荆芥10-12；聚乙烯醇9-13；醋酸淀粉酯6-10。本发明的优良效果还表现在：本发明所得医用敷料将聚氨酯与传统中草药相结合，配方合理，配伍精准，对创口无刺激性，有促进上皮长入，加速伤口愈合的作用。
Description
技术领域
本发明涉及医用材料领域，特别是涉及一种具有促进伤口愈合功效的医用敷料及制法。
背景技术
皮肤是人体的重要器官，具有十分重要的物理、化学及生物屏障功能，起着防止水分及电解质等物质的流失，以及免疫、传感等功能，对维持体内环境的稳定和阻止微生物入侵起着十分重要的作用。由于创伤、烧伤及皮肤溃烂等原因引起的皮肤损伤，会引起机体一系列的问题，比如细菌感染、新陈代谢加剧、水分和蛋白质过度流失、内分泌及免疫系统功能失调等，严重的可能危及生命。因此，皮肤损伤后，通常需要采用皮肤的替代品医用敷料来保护伤口，防止创面感染和严重脱水，提供有利于伤口愈合的湿润环境，促进创面愈合。
目前传统敷料如医用脱脂棉纱布、棉垫和凡士林纱布等，是临床上皮肤创伤应用最广的敷料。传统敷料具有网状编织结构，其价格低廉、制作工艺相对简单、原料来源广泛、质地柔软，有较强的吸收能力，能防止创面渗液积聚，对创面愈合有一定程度的保护作用，至今仍在皮肤创伤中广泛应用。但是传统敷料也有很明显的缺点，比如不能保持创面湿润，延迟创面愈合；创面肉芽组织容易长人敷料的网眼中，更换敷料时易与创面伤口粘连，损伤新生的肉芽组织并引起疼痛；敷料渗透后屏障作用差，容易引起外源性感染，止血效果差。
自20世纪50年代，聚氨酯首次应用于生物医学上算起，40多年来，聚氨酯弹性体在医学上的用途日益厂泛。1958年，聚氨酯首次用于骨折修复材料，而后又成功地应用于血管外科手术缝合用补充涂层。20世纪70年代开始，聚氯酯作为一种医用材料已倍受重视。到了20世纪80年代，用聚氨酯弹性体制造人工心脏移植手术获得成功，使聚氨酯材料在生物医学上的应用得到进一步的发展。目前在医学上，特别是在制造植入人体的各种医疗用品方面有着广泛的用途，应用领域包括人工心脏瓣膜、人工肺、骨粘合剂、人工皮肤与烧伤敷料、心脏起博器导线、缝线等。
申请公布号CN105079857A（申请号201510521449.7）的中国发明专利文献公开了一种聚氨酯泡沫敷料，由以下重量配比的原料配制而成：聚醚多元醇100克，一缩乙二醇8克-10克，咪唑催化剂0.7克-1.0克，硅油稳定剂1克-2克，硼砂3克-5克，水2克-3克，海藻酸钙10克-15克。申请公布号CN105056279A（申请号201510490782.6）的中国发明专利文献公开了一种复合胶原的聚氨酯基双层敷料，包括内层胶原复合亲水性聚氨酯泡沫敷料和外层聚氨酯薄膜通过医用压敏胶粘接。所述胶原复合亲水性聚氨酯泡沫敷料由以下质量百分比计的组分混合后发泡而成：聚氨酯预聚物40-80%，起泡剂10-50%，交联剂5-40%，胶原蛋白0.1-3%。所述聚氨酯预聚物由0.1-1mol的聚醚多元醇与1-3mol的二异氰酸酯反应而得。申请公布号CN104906624A（申请号201510254239.6）的中国发明专利文献公开了一种复合海绵医用敷料及其制备方法，由以下重量份的原料配制而成：乙基纤维素50-70份，改性海蜇胶原粉体10-25份，桧木醇10-25份，壳聚糖10-25份，海藻酸钠5-15份，硫代硫酸钠15-30份，儿茶素1-10份，增粘剂4-16份，偶联剂0.1-10份及水50-80份。
伤口愈合问题始终与外科学的发展相伴随，现有的医用敷料对创面愈合无促进作用，无保湿作用，肉芽组织容易长入纱布网眼中致粘连结痂，且敷料渗透时易导致外源性感染等，难以满足患者的要求。
发明内容
为了弥补上述不足，本发明的目的在于提供一种具有促进伤口愈合功效的医用敷料，在药力渗透、透气性、促进伤口愈合等方面具有显著优势，且制备成本低、制备工艺简单等。
本发明的技术方案是：
一种具有促进伤口愈合功效的医用敷料，由下列主要原料制备而成，均为重量份：聚氨酯25-35；骨碎补4-8；黄芪5-9；岩笋6-11；细辛6-9；甘草10-14；陆英8-12；虎杖7-11；积雪草5-9；川芎6-9；荆芥10-12；聚乙烯醇9-13；醋酸淀粉酯6-10。
优选的方案是：聚氨酯28-32；骨碎补5-7；黄芪6-8；岩笋7-10；细辛7-8；甘草11-13；陆英9-11；虎杖8-10；积雪草6-8；川芎7-8；荆芥10.5-11.5；聚乙烯醇10-12；醋酸淀粉酯7-9。
更加优选的是：聚氨酯30；骨碎补6；黄芪7；岩笋8.5；细辛7.5；甘草12；陆英10；虎杖9；积雪草7；川芎7.5；荆芥11；聚乙烯醇11；醋酸淀粉酯8。
一种具有促进伤口愈合功效的医用敷料的制备方法，步骤如下：
（1）将虎杖、骨碎补和细辛置于容器中，加入白酒浸泡，每天摇动2-6次（优选每天摇动3-5次），过滤，滤液回收乙醇，得药液，备用；
（2）将步骤（1）所得药渣与黄芪、岩笋、甘草、陆英、积雪草、川芎和荆芥混合，置于药锅内，加二次蒸馏水，文火煎煮两次，第一次煎煮33-53分钟（优选第一次煎煮37-49分钟），第二次煎煮20-36分钟（优选第二次煎煮24-32分钟），合并两次煎液，过滤，滤液与步骤（1）所得药液混合，减压浓缩至75℃相对密度为1.18-1.20的清膏，加入香油拌匀，制成中药油膏，备用；
（3）将聚氨酯溶于DMF中配制成浓度为20%-40%的聚氨酯溶液（优选配制成浓度为25%-35%的聚氨酯溶液），置于三颈瓶中，向溶液中加入聚乙烯醇和醋酸淀粉酯，于恒温水浴锅中，沿顺时针磁力搅拌1-2小时（优选沿顺时针磁力搅拌1.2-1.8小时），得混合溶液，备用；
（4）向步骤（3）所得混合溶液中加入步骤（2）所得中药油膏、消泡剂、抗菌剂及透皮吸收剂，混匀，得铸膜液，备用；
（5）将步骤（4）所得铸膜液倒入平板玻璃板上，均匀刮制成膜，静置8-15分钟（优选静置10-13分钟），然后平行放入清水中凝胶45-65分钟（优选平行放入清水中凝胶50-60分钟），取出，置于浓度为0.2%羟丙甲基纤维素水溶液中浸泡10-24分钟（优选浸泡14-20分钟），取出，冷冻干燥，灭菌，封装，即得。
上述一种具有促进伤口愈合功效的医用敷料的制备方法，优选的方案是，步骤（1）中白酒的量为所述原料药量的3.8-5.6倍（优选的白酒的量为所述原料药量的4.4-5.0倍，更加优选的白酒的量为所述原料药量的4.7倍）。
上述一种具有促进伤口愈合功效的医用敷料的制备方法，优选的方案是，步骤（1）中浸泡的时间为3-7天（优选的浸泡的时间为4-6天，更加优选的浸泡的时间为5天）。
上述一种具有促进伤口愈合功效的医用敷料的制备方法，优选的方案是，步骤（3）中恒温水浴的温度为50℃-80℃（优选的恒温水浴的温度为60℃-70℃，更加优选的恒温水浴的温度为65℃）。
上述一种具有促进伤口愈合功效的医用敷料的制备方法，优选的方案是，步骤（4）中所述消泡剂为质量分数为0.12%-0.20%的聚醚F68（优选的所述消泡剂为质量分数为0.14%-0.18%的聚醚F68，更加优选的所述消泡剂为质量分数为0.16%的聚醚F68）。
上述一种具有促进伤口愈合功效的医用敷料的制备方法，优选的方案是，步骤（4）中所述抗菌剂为质量分数为3.1%-3.7%的超微TiO2粉（优选的所述抗菌剂为质量分数为3.3%-3.5%的超微TiO2粉，更加优选的所述抗菌剂为质量分数为3.4%的超微TiO2粉）。
上述一种具有促进伤口愈合功效的医用敷料的制备方法，优选的方案是，步骤（4）中所述透皮吸收剂为质量分数为1%-3%的薄荷醇（优选的所述透皮吸收剂为质量分数为1.5%-2.5%的薄荷醇，更加优选的所述透皮吸收剂为质量分数为2%的薄荷醇）。
各主要原料的药理功效或理化性质分别为：
聚氨酯：全称为聚氨基甲酸酯，是主链上含有重复氨基甲酸酯基团的大分子化合物的统称。它是由有机二异氰酸酯或多异氰酸酯与二羟基或多羟基化合物加聚而成。聚氨酯的力学性能具有很大的可调性。通过控制结晶的硬段和不结晶的软段之间的比例，聚氨酯可以获得不同的力学性能。因此其制品具有耐磨、耐温、密封、隔音、加工性能好、可降解等优异性能。医用聚氨酯材料具有优良的生物相容性、可黏合性和抗血栓性，同时还具有优良的力学性能，在医用生物材料中扮演了十分重要的角色。
骨碎补：基原：为水龙骨科植物槲蕨、中华槲蕨、石莲姜槲蕨、崖姜、光亮密网蕨以及骨碎补科植物大叶骨碎补、海州骨碎补等的根茎。化学成份：槲蕨根茎含淀粉16.4％、葡萄糖5.37％，还含柚皮甙。性味：苦，温。归经：入肝、肾经。功能主治：补肾，活血，止血。治肾虚久泻及腰痛，风湿痹痛，齿痛，耳鸣，跌打闪挫、骨伤，阑尾炎，斑秃，鸡眼。
黄芪：基原：本品为豆科植物蒙古黄芪或膜荚黄芪的干燥根。性味：甘，温。归经：归肺、脾经。功效：补气固表，利尿托毒，排脓，敛疮生肌。主治：用于气虚乏力，食少便溏，中气下陷，久泻脱肛，便血崩漏，表虚自汗，气虚水肿，痈疽难溃，久溃不敛，血虚痿黄，内热消渴；慢性肾炎蛋白尿，糖尿病。
岩笋：基原：为兰科植物笋兰的全草。性味：甘；平。归经：肺；胃；肾经。功能主治：止咳平喘；活血祛瘀；接骨。主肺热喘咳；胃脘痛；跌打损伤；骨折。
细辛：基原：本品为马兜铃科植物北细辛、汉城细辛或华细辛的根及根茎。化学成份：辽细辛含挥发油约3％，挥发油的主要成分是甲基丁香油酚，其他有黄樟醚、β-蒎烯、优葛缕酮、酚性物质等。性味：辛，温。归经：归心、肺、肾经。药理作用：①局部麻醉作用，②解热、镇痛作用，③抑菌作用。功效：祛风散寒，通窍止痛，温肺化饮。主治：用于风寒感冒，头痛，牙痛。鼻塞鼻渊，风湿痹痛，痰饮喘咳。
甘草：基原：本品为豆科植物甘草、胀果甘草或光果甘草的干燥根及根茎。性味：甘，平。归经：归心。肺、脾、胃经。功效：补脾益气，清热解毒，祛痰止咳，缓急止痛，调和诸药。主治：用于脾胃虚弱，倦怠乏力，心悸气短，咳嗽痰多，院腹、四肢挛急疼痛，痈肿疮毒，缓解药物毒性、烈性。
陆英：基原：为忍冬科植物陆英的茎叶。化学成份：陆英全草含黄酮类、酚性成分、鞣质、糖类、绿原酸，种子含氰甙类。药理作用：1。镇痛：陆英煎剂70、120、140g/kg灌服，对小鼠热板法试验表明有镇痛作用，其镇痛成分体内半衰期为3.9h。2。抗肝损伤：陆英成分熊果酸100mg/kg皮下注射，对大鼠实验性肝损伤有保护作用，使肝中甘油三酯含量减少，并减轻肝细胞变性及坏死。3。其他作用：煎剂5g/kg灌胃，并加酒调外敷，对实验性骨折兔，有活血散瘀、增加磷的吸收、促进骨痂骨化的作用。性味：味甘；微苦；性平。功能主治：祛风；利湿；舒筋；活血。主风温痹痛；腰腿痛；水肿；黄疸；跌打扣损伤；产后恶露不行；风疹瘙痒；丹毒；疮肿。
虎杖：基原：为蓼科植物虎杖的根茎。化学成份：根和根茎含游离葸醌及蒽醌甙。主要为大黄素、大黄素甲醚和大黄酚，以及蒽甙A、蒽甙B。根中还含3，4’，5-三羟基芪-3-β-D-葡萄糖甙。另含鞣质和几种多糖。药理作用：①抗菌作用；②抗病毒作用。性味：苦，平。归经：肝；胆经。功能主治：活血散瘀；祛风通络；清热利湿；解毒。主妇女经闭；痛经；产后恶露不下；症瘕积聚；跌扑损伤；风湿痹痛；湿热黄疸；淋浊带下；疮疡肿毒；毒蛇咬伤；水火烫伤。
积雪草：基原：为双子叶植物伞形科积雪草的干燥全草或带根全草。成分：含多种α-香树脂醇型的三萜成分，其中有积雪草苷、参枯尼苷、异参枯尼苷，羟基积雪草苷，玻热模苷、破热米苷和破热米酸等，以及马达积雪草酸。药性：苦、辛，寒。归肝、脾、肾经。功用主治：清热解毒，利湿消肿。是东方人的长寿药，可益脑提神。研究表明具有滋补、消炎、愈合伤口、利尿通便和镇定作用。对麻风病、溃疡也有疗效，对血液净化及免疫力有激活作用，因其可刺激深层皮肤细胞的更替。它是神经滋补剂，能提高记忆力，减轻精神疲劳；还可降血压，治疗肝病等。
川芎：基原：本品为伞形科植物川穹的干燥根茎。性状：本品为不规则结节状拳形团块。表面黄褐色，粗糙皱缩，有多数平行隆起的轮节，顶端有凹陷的类圆形茎痕，下侧及轮节上有多数小瘤状根痕。质坚实，不易折断，断面黄白色或灰黄色，散有黄棕色的油室，形成层环呈波状。性味：辛，温。归经：归肝、胆、心包经。功效：活血行气，祛风止痛。主治：用于月经不调．经闭痛经，癥瘕腹痛，胸胁刺痛，跌扑肿痛，头痛。风湿痹痛。
荆芥：基原：为唇形科植物荆芥的全草。化学成份：含挥发油1。8％，油中主成分为右旋薄荷酮、消旋簿荷酮、少量右旋柠檬烯。药理作用：用人工发热的家兔，口服荆芥煎剂与浸剂2克（生药）／公斤，无甚解热作用。在体外，高浓度（1：100）有抗结核杆菌之作用。性味：辛，温。归经：入肺、肝经。功能主治：发表，祛风，理血；炒炭止血。治感冒发热，头痛，咽喉肿痛，中风口噤，吐血，衄血，便血；崩漏，产后血晕；痈肿，疮疥，瘰疬。荆芥穗效用相同，惟发散之力较强。
聚乙烯醇：白色片状、絮状或粉末状固体，无味。对人体皮肤无刺激性。PVA是唯一可被细菌作为碳源和能源利用的乙烯基聚合物，在细菌和酶的作用下，46天可降解75%，属于一种生物可降解高分子材料,可由非石油路线大规模生产，价格低廉，其耐油、耐溶剂及气体阻隔性能出众，在食品、药品包装方面具有独特优势。
醋酸淀粉酯：为白色粉末；特点是糊的凝沉性低，对酸、碱、热的稳定性高，糊的透明度高，冻溶稳定性好。主要用途：增稠剂、稳定剂、黏结剂、制食用淀粉膜。分子间不易形成氢键。低取代度的淀粉醋酸酯含乙酰0.5%-2.5%，在食品加工中用作增稠剂，其优点是黏度高，澄明度高，凝沉性弱，储存稳定。常将其进行复合变性，交联淀粉醋酸酯对于高温、强剪切力和低pH影响具有更高黏度稳定性，低温储存和冻融稳定性也高，适于罐头类食品应用，能在不同温度下储存。羟丙基淀粉醋酸酯，羟丙基取代度约3～6，乙酰基取代度约0.5～0.9，为口香糖的好基质，不溶于水，口嚼弹性好。
本发明提供的一种具有促进伤口愈合功效的医用敷料组方科学，制备方法简单，所得产品使用方便、便于携带。除此之外，本发明的优良效果还表现在：
1、本发明所得医用敷料稳定性好、透皮吸收快，对皮肤无刺激以及能够迅速促进伤口愈合；
2、本发明所得医用敷料将聚氨酯与传统中草药相结合，配方合理，配伍精准，对创口无刺激性，有促进上皮长入，加速伤口愈合的作用；
3、药源易得，药材成本低廉，能够减轻患者负担。
附图说明
图1是本发明所得医用敷料的降解性能示意图。
具体实施方式
下面结合实施例和实验例详细说明本发明的技术方案，但保护范围不被此限制。
实施例1一种具有促进伤口愈合功效的医用敷料，由下列主要原料制备而成，均为重量份（45g/份）：聚氨酯25份；骨碎补4份；黄芪5份；岩笋6份；细辛6份；甘草10份；陆英8份；虎杖7份；积雪草5份；川芎6份；荆芥10份；聚乙烯醇9份；醋酸淀粉酯6份。
一种具有促进伤口愈合功效的医用敷料的制备方法是：
（1）将虎杖、骨碎补和细辛置于容器中，加入3.8倍所述原料药量的白酒浸泡3天，每天摇动2次，过滤，滤液回收乙醇，得药液，备用；
（2）将步骤（1）所得药渣与黄芪、岩笋、甘草、陆英、积雪草、川芎和荆芥混合，置于药锅内，加二次蒸馏水，文火煎煮两次，第一次煎煮33分钟，第二次煎煮20分钟，合并两次煎液，过滤，滤液与步骤（1）所得药液混合，减压浓缩至75℃相对密度为1.18-1.20的清膏，加入香油拌匀，制成中药油膏，备用；
（3）将聚氨酯溶于DMF中配制成浓度为20%的聚氨酯溶液，置于三颈瓶中，向溶液中加入聚乙烯醇和醋酸淀粉酯，于50℃恒温水浴锅中，沿顺时针磁力搅拌1小时，得混合溶液，备用；
（4）向步骤（3）所得混合溶液中加入步骤（2）所得中药油膏、消泡剂（所述消泡剂为质量分数为0.12%的聚醚F68）、抗菌剂（所述抗菌剂为质量分数为3.1%的超微TiO2粉）及透皮吸收剂（所述透皮吸收剂为质量分数为1%的薄荷醇），混匀，得铸膜液，备用；
（5）将步骤（4）所得铸膜液倒入平板玻璃板上，均匀刮制成膜，静置8分钟，然后平行放入清水中凝胶45分钟，取出，置于浓度为0.2%羟丙甲基纤维素水溶液中浸泡10分钟，取出，冷冻干燥，灭菌，封装，即得。
本发明所得医用敷料的使用方法是：将患处用温水擦拭干净，取适量大小的敷料贴合在患处，一天更换一次。
典型案例一：周XX，男，30岁，菏泽人。患者2012年8月17日左小腿以外被碰伤后出现一拇指大小的伤口，有血流出，疼痛剧烈。在附近诊所治疗后，伤口逐渐结痂，因结痂处痒痛难忍，患者多次抓挠导致痂皮掉落，三日后患处伤口周围皮肤溃烂，逐渐扩大，在当地某医院经抗生素治疗后，伤口未完全愈合。后经人介绍于2012年9月30日来我院就诊。检查：患处可见一5×5cm大小的环形溃疡，中间有黑色血痂和出血，溃疡边界清楚，上缘有增生，周围皮肤红肿。经患者同意使用本实施例所得一种具有促进伤口愈合功效的医用敷料贴合于患处，每天更换一次。治疗五天后，患者患处干燥，无出血症状，周围皮肤颜色基本恢复正常，继续治疗三天后，患者伤口无黑色血痂，创面干燥，无红肿，无疼痛症状。用药期间患者无其他不适反应。
实施例2一种具有促进伤口愈合功效的医用敷料，由下列主要原料制备而成，均为重量份（25g/份）：聚氨酯35份；骨碎补8份；黄芪9份；岩笋11份；细辛9份；甘草14份；陆英12份；虎杖11份；积雪草9份；川芎9份；荆芥12份；聚乙烯醇13份；醋酸淀粉酯10份。
一种具有促进伤口愈合功效的医用敷料的制备方法是：
（1）将虎杖、骨碎补和细辛置于容器中，加入5.6倍所述原料药量的白酒浸泡7天，每天摇动6次，过滤，滤液回收乙醇，得药液，备用；
（2）将步骤（1）所得药渣与黄芪、岩笋、甘草、陆英、积雪草、川芎和荆芥混合，置于药锅内，加二次蒸馏水，文火煎煮两次，第一次煎煮53分钟，第二次煎煮36分钟，合并两次煎液，过滤，滤液与步骤（1）所得药液混合，减压浓缩至75℃相对密度为1.18-1.20的清膏，加入香油拌匀，制成中药油膏，备用；
（3）将聚氨酯溶于DMF中配制成浓度为40%的聚氨酯溶液，置于三颈瓶中，向溶液中加入聚乙烯醇和醋酸淀粉酯，于80℃恒温水浴锅中，沿顺时针磁力搅拌2小时，得混合溶液，备用；
（4）向步骤（3）所得混合溶液中加入步骤（2）所得中药油膏、消泡剂（所述消泡剂为质量分数为0.20%的聚醚F68）、抗菌剂（所述抗菌剂为质量分数为3.7%的超微TiO2粉）及透皮吸收剂（所述透皮吸收剂为质量分数为3%的薄荷醇），混匀，得铸膜液，备用；
（5）将步骤（4）所得铸膜液倒入平板玻璃板上，均匀刮制成膜，静置15分钟，然后平行放入清水中凝胶65分钟，取出，置于浓度为0.2%羟丙甲基纤维素水溶液中浸泡24分钟，取出，冷冻干燥，灭菌，封装，即得。
本发明所得医用敷料的使用方法是：将患处用温水擦拭干净，取适量大小的敷料贴合在患处，一天更换一次。
实施例3一种具有促进伤口愈合功效的医用敷料，由下列主要原料制备而成，均为重量份（40g/份）：聚氨酯28份；骨碎补5份；黄芪6份；岩笋7份；细辛7份；甘草11份；陆英9份；虎杖8份；积雪草6份；川芎7份；荆芥10.5份；聚乙烯醇10份；醋酸淀粉酯7份。
一种具有促进伤口愈合功效的医用敷料的制备方法是：
（1）将虎杖、骨碎补和细辛置于容器中，加入4.4倍所述原料药量的白酒浸泡4天，每天摇动3次，过滤，滤液回收乙醇，得药液，备用；
（2）将步骤（1）所得药渣与黄芪、岩笋、甘草、陆英、积雪草、川芎和荆芥混合，置于药锅内，加二次蒸馏水，文火煎煮两次，第一次煎煮37分钟，第二次煎煮24分钟，合并两次煎液，过滤，滤液与步骤（1）所得药液混合，减压浓缩至75℃相对密度为1.18-1.20的清膏，加入香油拌匀，制成中药油膏，备用；
（3）将聚氨酯溶于DMF中配制成浓度为25%的聚氨酯溶液，置于三颈瓶中，向溶液中加入聚乙烯醇和醋酸淀粉酯，于60℃恒温水浴锅中，沿顺时针磁力搅拌1.2小时，得混合溶液，备用；
（4）向步骤（3）所得混合溶液中加入步骤（2）所得中药油膏、消泡剂（所述消泡剂为质量分数为0.14%的聚醚F68）、抗菌剂（所述抗菌剂为质量分数为3.3%的超微TiO2粉）及透皮吸收剂（所述透皮吸收剂为质量分数为1.5%的薄荷醇），混匀，得铸膜液，备用；
（5）将步骤（4）所得铸膜液倒入平板玻璃板上，均匀刮制成膜，静置10分钟，然后平行放入清水中凝胶50分钟，取出，置于浓度为0.2%羟丙甲基纤维素水溶液中浸泡14分钟，取出，冷冻干燥，灭菌，封装，即得。
本发明所得医用敷料的使用方法是：将患处用温水擦拭干净，取适量大小的敷料贴合在患处，一天更换一次。
实施例4一种具有促进伤口愈合功效的医用敷料，由下列主要原料制备而成，均为重量份（30g/份）：聚氨酯32份；骨碎补7份；黄芪8份；岩笋10份；细辛8份；甘草13份；陆英11份；虎杖10份；积雪草8份；川芎8份；荆芥11.5份；聚乙烯醇12份；醋酸淀粉酯9份。
一种具有促进伤口愈合功效的医用敷料的制备方法是：
（1）将虎杖、骨碎补和细辛置于容器中，加入5.0倍所述原料药量的白酒浸泡6天，每天摇动5次，过滤，滤液回收乙醇，得药液，备用；
（2）将步骤（1）所得药渣与黄芪、岩笋、甘草、陆英、积雪草、川芎和荆芥混合，置于药锅内，加二次蒸馏水，文火煎煮两次，第一次煎煮49分钟，第二次煎煮32分钟，合并两次煎液，过滤，滤液与步骤（1）所得药液混合，减压浓缩至75℃相对密度为1.18-1.20的清膏，加入香油拌匀，制成中药油膏，备用；
（3）将聚氨酯溶于DMF中配制成浓度为35%的聚氨酯溶液，置于三颈瓶中，向溶液中加入聚乙烯醇和醋酸淀粉酯，于70℃恒温水浴锅中，沿顺时针磁力搅拌1.8小时，得混合溶液，备用；
（4）向步骤（3）所得混合溶液中加入步骤（2）所得中药油膏、消泡剂（所述消泡剂为质量分数为0.18%的聚醚F68）、抗菌剂（所述抗菌剂为质量分数为3.5%的超微TiO2粉）及透皮吸收剂（所述透皮吸收剂为质量分数为2.5%的薄荷醇），混匀，得铸膜液，备用；
（5）将步骤（4）所得铸膜液倒入平板玻璃板上，均匀刮制成膜，静置13分钟，然后平行放入清水中凝胶60分钟，取出，置于浓度为0.2%羟丙甲基纤维素水溶液中浸泡20分钟，取出，冷冻干燥，灭菌，封装，即得。
本发明所得医用敷料的使用方法是：将患处用温水擦拭干净，取适量大小的敷料贴合在患处，一天更换一次。
典型案例二：刘XX，男，43岁，泰安人。患者是一名出租车司机，2013年8月17日，刘先生在送一名客户去机场的路上，被对面逆行而来的车辆撞伤，身体多处骨折及软组织挫伤，被值班交警紧急送往我院进行治疗手术治疗。术后第三天换药时发现患者左手臂处伤口出现感染，伤口纱布被液体浸湿，患处不断渗血，有少量脓液流出，纱布与伤口发生粘连。后经患者及家属同意，在伤口进行消毒处理后，使用本实施例所得一种具有促进伤口愈合功效的医用敷料贴敷于伤口，两天后换药时发现伤口感染症状消失，细菌培养呈阴性，患处干燥无菌，皮肤颜色恢复正常，一周后检查发现患处伤口已基本恢复正常，患者无任何不适反应。
实施例5一种具有促进伤口愈合功效的医用敷料，由下列主要原料制备而成，均为重量份（25g/份）：聚氨酯30份；骨碎补6份；黄芪7份；岩笋8.5份；细辛7.5份；甘草12份；陆英10份；虎杖9份；积雪草7份；川芎7.5份；荆芥11份；聚乙烯醇11份；醋酸淀粉酯8份。
一种具有促进伤口愈合功效的医用敷料的制备方法是：
（1）将虎杖、骨碎补和细辛置于容器中，加入4.7倍所述原料药量的白酒浸泡5天，每天摇动4次，过滤，滤液回收乙醇，得药液，备用；
（2）将步骤（1）所得药渣与黄芪、岩笋、甘草、陆英、积雪草、川芎和荆芥混合，置于药锅内，加二次蒸馏水，文火煎煮两次，第一次煎煮43分钟，第二次煎煮28分钟，合并两次煎液，过滤，滤液与步骤（1）所得药液混合，减压浓缩至75℃相对密度为1.18-1.20的清膏，加入香油拌匀，制成中药油膏，备用；
（3）将聚氨酯溶于DMF中配制成浓度为30%的聚氨酯溶液，置于三颈瓶中，向溶液中加入聚乙烯醇和醋酸淀粉酯，于65℃恒温水浴锅中，沿顺时针磁力搅拌1.5小时，得混合溶液，备用；
（4）向步骤（3）所得混合溶液中加入步骤（2）所得中药油膏、消泡剂（所述消泡剂为质量分数为0.16%的聚醚F68）、抗菌剂（所述抗菌剂为质量分数为3.4%的超微TiO2粉）及透皮吸收剂（所述透皮吸收剂为质量分数为2%的薄荷醇），混匀，得铸膜液，备用；
（5）将步骤（4）所得铸膜液倒入平板玻璃板上，均匀刮制成膜，静置12分钟，然后平行放入清水中凝胶55分钟，取出，置于浓度为0.2%羟丙甲基纤维素水溶液中浸泡17分钟，取出，冷冻干燥，灭菌，封装，即得。
本发明所得医用敷料的使用方法是：将患处用温水擦拭干净，取适量大小的敷料贴合在患处，一天更换一次。
试验例1：本发明所得一种具有促进伤口愈合功效的医用敷料（实施例5）的降解性能试验：
取面积为5×5cm2的本发明所得一种具有促进伤口愈合功效的医用辅料置于pH为7.4的PBS缓冲溶液中，培养7周，每周取出，水洗、干燥，称重。计算降解率。公式如下：DR（%）=（W1-W2）/W1×100，其中，W1为降解前样品质量，W2为降解后样品质量。结果如图1所示。
由图1数据可知，本发明所得一种具有促进伤口愈合功效的医用辅料在开始的1-2周内降解速率较缓慢，在3周后其降解率明显增加达到15%，此后降解率逐渐加快，到第7周时其降解率接近70%。
试验例2：本发明所得一种具有促进伤口愈合功效的医用敷料（实施例5）的应用研究：
选取2012年5月-2014年5月来我院治疗的300例患者，其中男性178例，女性122例，年龄最大67岁，年龄最小9岁。所有患者皮肤均有不同程度的创伤，其中机械性损伤患者158例，疾病感染损伤患者93例，烧烫伤患者49例。所有患者随机分为实验组和对照组，两组患者在年龄、病情等方面差异无统计学意义（P＞0.05），具有可比性。其中实验组使用本发明所得一种具有促进伤口愈合功效的医用敷料，使用方法：将患处用温水擦拭干净，取适量大小的敷料贴合在患处，一天更换一次。对照组使用无菌敷贴（厂商：青岛海氏海诺医疗用品有限公司）。共观察治疗7天。疗效评定标准：痊愈：创口完全愈合；显效：创口基本愈合或结痂；有效：创口明显缩小，炎症等表现减轻；无效：创口没有明显的改善或加重。总有效率=（痊愈例数+显效例数+有效例数）/总观察病例数×100%。结果如表1所示。
表1实验组和对照组患者的治疗效果
由表1数据可知，使用本发明所得一种具有促进伤口愈合功效的医用敷料的实验组痊愈122例（67.8%），显效39例（21.7%），有效15例（8.3%），无效4例（2.2%），总有效率为97.8%。而对照组的痊愈率为47.5%，总有效率仅79.2%。由此表明，本发明所得医用敷料具有显效快，治愈率高的显著效果。
最后应说明的是，实施例只是本发明最优的具体实施方式而已，并不用于限制本发明，尽管参照前述实施例对本发明进行了详细的说明，对于本领域的技术人员来说，其依然可以对前述各实施例所记载的技术方案进行修改，或者对其中部分技术特征进行等同替换。凡在本发明的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。
Claims (10)
1.一种具有促进伤口愈合功效的医用敷料，其特征在于，由下列主要原料制备而成，均为重量份：聚氨酯25-35；骨碎补4-8；黄芪5-9；岩笋6-11；细辛6-9；甘草10-14；陆英8-12；虎杖7-11；积雪草5-9；川芎6-9；荆芥10-12；聚乙烯醇9-13；醋酸淀粉酯6-10。
2.如权利要求1所述的一种具有促进伤口愈合功效的医用敷料，其特征在于，由下列主要原料制备而成，均为重量份：聚氨酯28-32；骨碎补5-7；黄芪6-8；岩笋7-10；细辛7-8；甘草11-13；陆英9-11；虎杖8-10；积雪草6-8；川芎7-8；荆芥10.5-11.5；聚乙烯醇10-12；醋酸淀粉酯7-9。
3.如权利要求1所述的一种具有促进伤口愈合功效的医用敷料，其特征在于，由下列主要原料制备而成，均为重量份：聚氨酯30；骨碎补6；黄芪7；岩笋8.5；细辛7.5；甘草12；陆英10；虎杖9；积雪草7；川芎7.5；荆芥11；聚乙烯醇11；醋酸淀粉酯8。
4.如权利要求1-3任一所述的一种具有促进伤口愈合功效的医用敷料的制备方法，其特征在于，步骤如下：
（1）将虎杖、骨碎补和细辛置于容器中，加入白酒浸泡，每天摇动2-6次（优选每天摇动3-5次），过滤，滤液回收乙醇，得药液，备用；
（2）将步骤（1）所得药渣与黄芪、岩笋、甘草、陆英、积雪草、川芎和荆芥混合，置于药锅内，加二次蒸馏水，文火煎煮两次，第一次煎煮33-53分钟（优选第一次煎煮37-49分钟），第二次煎煮20-36分钟（优选第二次煎煮24-32分钟），合并两次煎液，过滤，滤液与步骤（1）所得药液混合，减压浓缩至75℃相对密度为1.18-1.20的清膏，加入香油拌匀，制成中药油膏，备用；
（3）将聚氨酯溶于DMF中配制成浓度为20%-40%的聚氨酯溶液（优选配制成浓度为25%-35%的聚氨酯溶液），置于三颈瓶中，向溶液中加入聚乙烯醇和醋酸淀粉酯，于恒温水浴锅中，沿顺时针磁力搅拌1-2小时（优选沿顺时针搅拌1.2-1.8小时），得混合溶液，备用；
（4）向步骤（3）所得混合溶液中加入步骤（2）所得中药油膏、消泡剂、抗菌剂及透皮吸收剂，混匀，得铸膜液，备用；
（5）将步骤（4）所得铸膜液倒入平板玻璃板上，均匀刮制成膜，静置8-15分钟（优选静置10-13分钟），然后平行放入清水中凝胶45-65分钟（优选平行放入清水中凝胶50-60分钟），取出，置于浓度为0.2%羟丙甲基纤维素水溶液中浸泡10-24分钟（优选浸泡14-20分钟），取出，冷冻干燥，灭菌，封装，即得。
5.根据权利要求4所述的一种具有促进伤口愈合功效的医用敷料的制备方法，其特征在于，步骤（1）中白酒的量为所述原料药量的3.8-5.6倍（优选的白酒的量为所述原料药量的4.4-5.0倍，更加优选的白酒的量为所述原料药量的4.7倍）。
6.根据权利要求4所述的一种具有促进伤口愈合功效的医用敷料的制备方法，其特征在于，步骤（1）中浸泡的时间为3-7天（优选的浸泡的时间为4-6天，更加优选的浸泡的时间为5天）。
7.根据权利要求4所述的一种具有促进伤口愈合功效的医用敷料的制备方法，其特征在于，步骤（3）中恒温水浴的温度为50℃-80℃（优选的恒温水浴的温度为60℃-70℃，更加优选的恒温水浴的温度为65℃）。
8.根据权利要求4所述的一种具有促进伤口愈合功效的医用敷料的制备方法，其特征在于，步骤（4）中所述消泡剂为质量分数为0.12%-0.20%的聚醚F68（优选的所述消泡剂为质量分数为0.14%-0.18%的聚醚F68，更加优选的所述消泡剂为质量分数为0.16%的聚醚F68）。
9.根据权利要求4所述的一种具有促进伤口愈合功效的医用敷料的制备方法，其特征在于，步骤（4）中所述抗菌剂为质量分数为3.1%-3.7%的超微TiO2粉（优选的所述抗菌剂为质量分数为3.3%-3.5%的超微TiO2粉，更加优选的所述抗菌剂为质量分数为3.4%的超微TiO2粉）。
10.根据权利要求4所述的一种具有促进伤口愈合功效的医用敷料的制备方法，其特征在于，步骤（4）中所述透皮吸收剂为质量分数为1%-3%的薄荷醇（优选的所述透皮吸收剂为质量分数为1.5%-2.5%的薄荷醇，更加优选的所述透皮吸收剂为质量分数为2%的薄荷醇）。
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| CN108498843A (zh) * | 2018-06-13 | 2018-09-07 | 暨南大学 | 一种三维打印抗菌水凝胶敷料及其制备方法 |
| CN109811468A (zh) * | 2019-03-01 | 2019-05-28 | 杭州鹏图化纤有限公司 | 一种复合型无纺布及其制备方法 |
| CN115006312A (zh) * | 2022-07-08 | 2022-09-06 | 重庆登康口腔护理用品股份有限公司 | 一种抗炎抑菌组合物和应用及其含该组合物的制品和制备方法 |
| CN115006312B (zh) * | 2022-07-08 | 2023-08-22 | 重庆登康口腔护理用品股份有限公司 | 一种抗炎抑菌组合物和应用及其含该组合物的制品和制备方法 |
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