CN116808141A - 一种伤口护理软膏及其制备方法 - Google Patents
一种伤口护理软膏及其制备方法 Download PDFInfo
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- CN116808141A CN116808141A CN202310736178.1A CN202310736178A CN116808141A CN 116808141 A CN116808141 A CN 116808141A CN 202310736178 A CN202310736178 A CN 202310736178A CN 116808141 A CN116808141 A CN 116808141A
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Abstract
本发明公开了一种伤口护理软膏及其制备方法，属于医药制品技术领域，伤口护理软膏按照重量份的原料包括：白及65～80份、红花25～40份、龙胆苦苷5～10份、西洋参提取物25～30份、壳聚糖10～15份、维生素C 2～5份、软膏基质20～30份，最终制备得到的伤口护理软膏。该伤口护理软膏不仅能够止痛杀菌、而且通过抑制炎症反应、促进伤口局部血液循环，有利于肉芽组织及胶原纤维的形成，对伤口渗出物进行吸附，伤口愈合效果好。
Description
技术领域
本发明涉及医药制品技术领域，具体涉及一种伤口护理软膏及其制备方法。
背景技术
皮肤是一层覆盖于人体表面直接与外界环境相接触用于防护的组织。伤口是指正常皮肤在外界致伤因子(如外科手术、碰撞、摩擦、热、电流、化学物质等)，以及机体内在因素(如局部血液供应障碍等)作用下所导致的损伤。在伤口的护理过程中，医用敷料的应用越来越广泛，医用敷料不仅可以有效将破损皮肤与外界环境隔离开，从而阻止外界环境中的病原体接触伤口，减少伤口感染化脓的几率，还能通过添加药物活性成分而促进伤口的愈合。但目前用于伤口护理的医用敷料功能较为单一，往往仅能起到隔离、抗菌、止血等作用中的一种，促进伤口愈合的效果仍然不够理想，尤其是对于发生化脓性细菌感染的伤口治愈效果作用甚微，由于许多化脓性细菌产生一些毒素和酶，通过炎症反应能引起组织坏死，导致基质或胶原纤维溶解，加重局部组织损伤，并且伤口感染时渗出物很多，可增加局部伤口的张力，常使正在愈合的伤口或已缝合的伤口裂开，或者导致感染扩散加重损伤，从而伤口久治不愈、很难愈合，给受伤者带来痛苦。
发明内容
为了克服现有技术的不足，本发明的目的在于提供一种伤口护理软膏，该伤口护理软膏不仅能够止痛杀菌、而且通过抑制炎症反应、促进伤口局部血液循环，有利于肉芽组织及胶原纤维的形成，对伤口渗出物进行吸附，伤口愈合效果好。
本发明的目的之二在于提供一种伤口护理软膏的制造方法，该方法步骤简单，能够工业化生产伤口护理软膏。
本发明的目的之三在于提供一种伤口护理用敷料，能够对伤口进行包扎。
本发明的目的之一采用如下技术方案实现：
一种伤口护理软膏，按照重量份的原料包括：白及65～80份、红花25～40份、龙胆苦苷5～10份、西洋参提取物25～30份、壳聚糖10～15份、维生素C 2～5份、软膏基质20～30份。
进一步地，所述软膏基质选自羧甲基纤维素钠、聚乙二醇-20000、卡波姆940或其混合物的一种。
进一步地，按照重量份的原料为白及65份、红花28份、龙胆苦苷8份、壳聚糖12份、维生素C 5份、软膏基质20份。
本发明的目的之二采用如下技术方案实现：
本发明提供一种上述伤口护理软膏的制造工艺，包括以下步骤：
S1、按照配方量称取白及、红花、龙胆苦苷、壳聚糖、维生素C及软膏基质原料；
S2、将壳聚糖溶解于适量水中，搅拌均匀后添加维生素C，得混悬液，备用；
S3、将照配方量称取的白及、红花、龙胆苦苷混合均匀，然后加入软膏基质原料中，搅拌均匀，然后加入所述混悬液中，继续搅拌均匀，得到伤口护理药剂；
S4、将S3得到的所述伤口护理药剂装入模具成型，得所述伤口护理软膏。
本发明的目的之三采用如下技术方案实现：
本发明提供一种伤口护理用敷料，将上述的一种伤口护理软膏固定于敷料衬层后，灭菌、分装，即得所述伤口护理用敷料。
相比现有技术，本发明的有益效果在于：
本发明提供的一种伤口护理软膏，白及能增强血小板第三因子活性，显著缩短凝血时间及凝血酶原形成时间，抑制纤维蛋白溶酶活性，对伤口局部出血有止血作用，且具有抗菌的作用，有效杀灭化脓性细菌，避免感染；龙胆苦苷具有抑制炎症反应，促进肉芽组织形成，而红花促进伤口局部血液循环，促进肉芽组织形成；西洋参提取物能激活上皮细胞，促进正常肉芽组织的形成，促进细胞活力，促进生成胶原蛋白，修复已受损的胶原纤维，同时壳聚糖也有杀菌作用，利用吸附作用，对伤口感染的渗透液进行吸附，有利于伤口快速愈合，不会裂开；维生素C不仅可以作为营养物质，具有催化羟化酶的作用，能够使α-多肽链中的两个主要氨基酸―脯氨酸及赖氨酸羟基化，形成前胶原分子，从而促进胶原纤维的形成，和西洋参提取物协同促进伤口快速愈合。
具体实施方式
下面，结合具体实施例，对本发明做进一步描述，需要说明的是，在不相冲突的前提下，以下描述的各实施例之间或各技术特征之间可以任意组合形成新的实施例。
实施例1
本实施例提供的伤口护理软膏按照重量份的原料为白及65份、红花28份、龙胆苦苷8份、西洋参提取物25份、壳聚糖12份、维生素C 5份、羧甲基纤维素钠20份。
实施例1提供的一种伤口护理软膏的制备方法，包括以下步骤：
S1、将白及、红花、龙胆苦苷分别超微振磨破壁得到粉末，过300目筛，备用，称取65重量份白及、28重量份红花、8重量份龙胆苦苷、12重量份壳聚糖、5重量份维生素C、20重量份羧甲基纤维素钠原料；
S2、将壳聚糖溶解于适量水中，搅拌均匀后添加维生素C，得混悬液，备用；
S3、将白及、红花、龙胆苦苷混合均匀，然后加入软膏基质原料中，搅拌均匀，然后加入混悬液中，继续搅拌均匀，得到伤口护理药剂；
S4、将S3得到的伤口护理药剂装入模具成型，得所述伤口护理软膏。
一种伤口护理用敷料，将本实施例所述的一种伤口护理软膏固定于敷料衬层后，灭菌、分装，即得所述伤口护理用敷料。
实施例2
本实施例提供的伤口护理软膏包括以下质量百分比的原料：白及70份、红花25份、龙胆苦苷10份、西洋参提取物28份、壳聚糖10份、维生素C 2份、聚乙二醇-20000 30份。
本实施例提供的一种伤口护理软膏的制备方法按照实施例1的制备方法制备即得。
一种伤口护理用敷料，将本实施例所述的一种伤口护理软膏固定于敷料衬层后，灭菌、分装，即得所述伤口护理用敷料。
实施例3
本实施例提供的伤口护理软膏包括以下质量百分比的原料：白及80份、红花40份、龙胆苦苷5份、西洋参提取物30份、壳聚糖15份、维生素C 3份、卡波姆940 25份。
本实施例提供的一种伤口护理软膏的制备方法按照实施例1的制备方法制备即得。
一种伤口护理用敷料，将本实施例所述的一种伤口护理软膏固定于敷料衬层后，灭菌、分装，即得所述伤口护理用敷料。
对比例1
与实施例1不同的是本对比例提供的伤口护理软膏包括红花28份、龙胆苦苷8份、西洋参提取物25份、壳聚糖12份、维生素C 5份、羧甲基纤维素钠20份。
本对比例提供的伤口护理软膏的制备方法按照实施例1的制备方法制备。
对比例2
与实施例1不同的是本对比例提供的伤口护理软膏包括白及65份、西洋参提取物25份、壳聚糖12份、维生素C 5份、羧甲基纤维素钠20份。
本对比例提供的伤口护理软膏的制备方法按照实施例1的制备方法制备。
对比例3
与实施例1不同的是本对比例提供的伤口护理软膏包括白及65份、红花28份、龙胆苦苷8份、壳聚糖12份、羧甲基纤维素钠20份。
本对比例提供的伤口护理软膏的制备方法按照实施例1的制备方法制备。
对比例4
与实施例1不同的是本对比例提供的伤口护理软膏包括白及65份、红花28份、龙胆苦苷8份、西洋参提取物25份、维生素C 5份、羧甲基纤维素钠20份。
本对比例提供的伤口护理软膏的制备方法按照实施例1的制备方法制备。
实施例4
本实施例提供7种伤口护理用敷料，分别是将实施例1～3、对比例1～4制备得到的伤口护理软膏分别固定于敷料衬层后，灭菌、分装，即得实施例1、对比例1～4提供的伤口护理用敷料共7种，每种伤口护理用敷料固定所使用的伤口护理软膏的量为5g。
实验例
将实施例1、对比例1～4提供的伤口护理用敷料用于促进伤口愈合的实验。
1.1测试药物：实施例1、对比例1～4提供的伤口护理用敷料。
1.2试验方法：8周龄雄性Wister大鼠35只，体重290～310g，单笼饲养，大鼠体质及健康状况均不会对本实验产生差异化干扰，大鼠麻醉后于背部两侧对称性备皮约2×2cm区域，使用手术刀于备皮区域中间位置剥离1×1cm的皮肤至暴露肌肉层，手术后大鼠随机分为7组，具体为：实施例1～3组、对比例1～4组，每组5只，相应地使用实施例1、对比例1～4提供的伤口护理用敷料覆盖伤口，并使用纱布外部固定。大鼠正常饲喂相同饲料，每隔3天更换一次敷料，同时观察伤口感染情况，更换敷料时使用无菌生理盐水对伤口进行清创清洗。手术后第7d开始，每天观察伤口愈合情况，记录各组大鼠伤口愈合所需时间，其中所述感染是指伤口红肿，有脓性分泌物，所述伤口愈合是指伤口闭合，上皮覆盖，伤口无裂开，无破溃，无出血，具体实验结果见表1。
1 .3实验结果：表1 实施例1、对比例1～4提供的伤口护理用敷料促进伤口愈合的效果
从表中可以看出，和对比例1～4相比较，使用实施例1提供的伤口护理用敷料的10处手术伤口在愈合过程中有1处出现了感染，伤口愈合时间平均为10.25天，而对比例1提供的伤口护理用敷料不含有白及组分， 10处手术伤口在愈合过程中有9处出现了感染，伤口愈合时间平均为35.20，说明白及在伤口护理过程中防止感染，促进伤口的愈合很重要，证实了其抗菌和缩短凝血时间及凝血酶原形成时间，抑制纤维蛋白溶酶活性的功效；对比例2提供的伤口护理用敷料不含有红花、龙胆苦苷组分，10处手术伤口在愈合过程中有2处出现了感染，伤口愈合时间平均为20.15，说明龙胆苦苷组分抑制炎症反应和促进肉芽组织形成、以及红花促进伤口局部血液循环和促进肉芽组织形成能够促进伤口的愈合；对比例3提供的伤口护理用敷料不含有西洋参提取物、维生素C组分，10处手术伤口在愈合过程中有3处出现了感染，伤口愈合时间平均为30.45，说明促进肉芽组织形成能够促进伤口的愈合，说明胶原纤维修复和形成对于伤口尽快愈合很重要，对比例4提供的伤口护理用敷料不含有壳聚糖组分，10处手术伤口在愈合过程中有1处出现了感染，伤口愈合时间平均为15.35，说明促进肉芽组织形成能够促进伤口的愈合，说明壳聚糖利用吸附作用，对伤口感染的渗透液进行吸附，有利于伤口快速愈合。
上述实施方式仅为本发明的优选实施方式，不能以此来限定本发明保护的范围，本领域的技术人员在本发明的基础上所做的任何非实质性的变化及替换均属于本发明所要求保护的范围。
Claims (5)
1.一种伤口护理软膏，其特征在于，按照重量份的原料包括：白及65～80份、红花25～40份、龙胆苦苷5～10份、西洋参提取物25～30份、壳聚糖10～15份、维生素C 2～5份、软膏基质20～30份。
2.如权利要求1所述的一种伤口护理软膏，其特征在于，按照重量份的原料为白及65份、红花28份、龙胆苦苷8份、西洋参提取物25份、壳聚糖12份、维生素C 5份、软膏基质20份。
3.如权利要求1-2任一项所述的一种伤口护理软膏，其特征在于，所述软膏基质选自羧甲基纤维素钠、聚乙二醇-20000、卡波姆940或其混合物的一种。
4.权利要求1～3任一项所述的一种伤口护理软膏的制备方法，其特征在于，包括以下步骤：
S1、按照配方量称取白及、红花、龙胆苦苷、壳聚糖、维生素C、软膏基质原料；
S2、将壳聚糖溶解于适量水中，搅拌均匀后添加维生素C，得混悬液，备用；
S3、将照配方量称取的白及、红花、龙胆苦苷混合均匀，然后加入软膏基质原料中，搅拌均匀，然后加入所述混悬液中，继续搅拌均匀，得到伤口护理药剂；
S4、将S3得到的所述伤口护理药剂装入模具成型，得所述伤口护理软膏。
5.一种伤口护理用敷料，其特征在于，将权利要求1～3任一项所述的一种伤口护理软膏固定于敷料衬层后，灭菌、分装，即得所述伤口护理用敷料。
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