CN113082029B - 一种伤口清洗消毒剂 - Google Patents
一种伤口清洗消毒剂 Download PDFInfo
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- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
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Abstract
本发明公开了一种伤口清洗消毒剂,所述伤口清洗消毒剂包括盐酸奥替尼定和阿地米屈。本发明意外发现,应用阿地米屈可以增加盐酸奥替尼定的溶解度,所配消毒液无需醇类物质增溶,且能长时间保持无沉淀。本发明的伤口清洗消毒剂,可用于治疗各种皮炎、湿疹、红肿、皮肤过敏和搔痒等,且对皮肤没有任何刺激作用,特别适合于伤口清洗及儿童皮肤消毒。
Description
技术领域
本发明涉及医疗外科用药技术领域,尤其涉及一种伤口清洗消毒剂。
背景技术
糖尿病和免疫抑制病人皮肤创伤很难愈合。为防止感染,伤口需要长期清洗和消毒。但是,大多数消毒剂会对伤口有伤害作用,比如:双氧水、过氧酸等;还有可能会对皮肤有刺激作用,比如:季铵盐类消毒剂(苯扎氯铵、苯扎溴铵、西曲氯铵)、有机酸类消毒剂等不能直接用于皮肤消毒和伤口清洗。氯己定、PHMB、碘等虽然可用于皮肤消毒,但是由于水溶性差,需要用高浓度乙醇作溶剂,由于乙醇对伤口也有强的刺激作用,这类消毒剂应用也受到一定的限制。此外,苯扎氯铵、氯己定等遇有血液的伤口时,由于不能穿透血膜,消毒效果也不理想。
近年来,欧洲上市了一种消毒剂,名称为盐酸奥替尼定,结构见结构式1:
该化合物能在广泛的PH值范围内保持高的灭菌作用,且抗菌活性不受血液、粘液等干扰物的影响,使用越来越普遍。由于盐酸奥替尼定在水中溶解度较差,单独使用需要5-15%的醇增溶,现有技术(Dissemond,J.,M.Augustin,S.A.Eming,T.Goerge,T.Horn,S.Karrer,H.Schumann,M.Stucker and G.S.D.DDG(2014)."Modern wound care-practical aspects of noninterventional topical treatment of patients withchronic wounds."Journal Der Deutschen Dermatologischen Gesellschaft12(7):541-553.)公开了将盐酸奥替尼定与苯氧乙醇合用,醇的用量可以适量减小,但仍然需要3-5%的醇;另外,苯氧乙醇也有一定的刺激作用。为克服这个缺点,Buckley等采用制备凝胶(Buckley,S.T.,K.J.Frank,G.Fricker and M.Brandl."Biopharmaceuticalclassification of poorly soluble drugs with respect to"enablingformulations"."European Journal of Pharmaceutical Sciences2013;50(1):8-16.),Kamila Szostak等采用制备纳米颗粒(Kamila Szostak,Aleksander Czogalla,Magdalena&Marek Langner.New Lipid Formulation of OctenidineDihydrochloride.Journal of Liposome Research.2016;DOI:10.1080/08982104.2016.1275678.)等的方法增加盐酸奥替尼定的溶解度,但均需用到昂贵的磷脂,且影响到灭菌效果。因此,迫切需要开发刺激性更小、工艺简单、成本低的含盐酸奥替尼定的消毒制剂。
阿地米屈是一种内源性脂肪酸酰胺,能促进伤口愈合且对伤口没有刺激作用,结构见结构式2:
发明内容
本发明的目的是针对现有技术中的不足,提供一种伤口清洗消毒剂,该伤口清洗消毒剂对皮肤没有任何刺激作用。
为实现上述目的,本发明采取的技术方案是:
本发明第一方面提供一种伤口清洗消毒剂,所述伤口清洗消毒剂包括盐酸奥替尼定和阿地米屈。
优选地,所述盐酸奥替尼定和阿地米屈的质量比为1:1-200。
优选地,所述盐酸奥替尼定和阿地米屈的质量比为1:5-50。
优选地,所述盐酸奥替尼定和阿地米屈的质量比为1:20。
优选地,所述伤口清洗消毒剂包括以下质量百分比的组分:盐酸奥替尼定0.01-2.0%、阿地米屈0.1-20%。
优选地,所述伤口清洗消毒剂包括以下质量百分比的组分:盐酸奥替尼定0.05-0.5%、阿地米屈0.5-5%。
优选地,所述伤口清洗消毒剂包括以下质量百分比的组分:盐酸奥替尼定0.1-0.2%、阿地米屈1-3%。
优选地,所述伤口清洗消毒剂的剂型包括水溶液、油膏、乳膏、凝胶或混悬液。需要说明的是,现有技术中的醇溶液剂型同样适用于本发明的体系。
优选地,所述伤口清洗消毒剂的剂型为水溶液或乳膏。
本发明提供的伤口清洗消毒剂,除了盐酸奥替尼定和阿地米屈外,还可以根据需要加入其它活性成分,如抗氧剂、保湿剂、抗菌剂、消炎剂、伤口愈合剂等。
本发明第二方面提供采用上述伤口清洗消毒剂用于各种疾病皮肤和伤口的清洗与消毒灭菌。
本发明采用以上技术方案,与现有技术相比,具有如下技术效果:
本发明意外发现,应用阿地米屈可以增加盐酸奥替尼定的溶解度,所配消毒液无需醇类物质增溶,且能长时间保持无沉淀。本发明的伤口清洗消毒剂,可用于治疗各种皮炎、湿疹、红肿、皮肤过敏和搔痒等,且对皮肤没有任何刺激作用,特别适合于伤口清洗及儿童皮肤消毒。
具体实施方式
下面结合具体实施例对本发明作进一步说明,但不作为本发明的限定。
需要说明的是,在不冲突的情况下,本发明中的实施例及实施例中的特征可以相互组合。
实施例1
伤口清洗液包括以下组分:
盐酸奥替尼定 0.1g
阿地米屈 2g
水 97.9g。
实施例2
伤口清洗液包括以下组分:
盐酸奥替尼定 0.5g
阿地米屈 3g
水 96.5g。
实施例3
乳膏包括以下组分:
实施例4
乳膏包括以下组分:
实施例5
油膏包括以下组分:
对比例1
盐酸奥替尼定 0.1g
水 99.9g。
对比例2
盐酸奥替尼定 0.1g
苯氧乙醇 2g
水 97.9g。
对比例3
应用例
1、溶解度试验
取三支试管,各加入盐酸奥替尼定100mg,分别加入水、2%阿地米屈水溶液和4%阿地米屈水溶液各10ml,置振荡床,室温(20-30℃)振摇20小时,均有未溶物。过滤,滤除不溶物,滤液稀释25倍,用HPLC测浓度,结果如表1所示:
表1溶解度试验结果
溶液 | 峰面积 | 浓度(mg/ml) |
标准液 | 8039432 | 0.10064 |
水溶液 | 7805648 | 2.44 |
2%阿地米屈溶液 | 16284906 | 5.10 |
4%阿地米屈溶液 | 26361964 | 8.25 |
由表1中数据可知,应用阿地米屈可以增加盐酸奥替尼定的溶解度,且增溶作用随阿地米屈浓度的增加而增加。
2、稳定性试验
将实施例1、对比例1和对比例2放置冰箱2-5℃保藏,48小时后,对比例1和对比例2溶液变混浊,实施例1仍为清亮溶液。实施例1溶液在此条件下保存六个月,仍然清亮,未见混浊,说明阿地米屈增溶效果明显,溶液稳定。
3、皮肤刺激性试验
取家兔16只,试验前24小时在背部左右侧进行脱毛处理。去毛面积各3cm×3cm。经检查去毛皮肤无损伤。将此兔随机分成两组,每组8只,雌、雄各半。一组将实施例1样品0.5ml直接涂布于左侧已去毛的皮肤上,另一组将对比例2样品0.5ml直接涂布于左侧已去毛的皮肤上,然后用二层纱布(2.5cm×2.5cm)和一层玻璃纸覆盖,再用无刺激性胶布和绷带固定;两组动物的另一侧均涂布蒸馏水作对照。贴敷时间6小时。贴敷结束后,除去受试物并用温水清洁给药部位。
在去除药物后30分钟、24小时、48小时和72小时时间点,在自然光线下观察皮肤反应。按表2给出的评分标准对皮肤红斑和水肿进行评分:
表2刺激性试验评分表
刺激反应 | 分值 |
红斑 | |
无红斑 | 0 |
轻度红斑(勉强可见) | 1 |
中度经斑(明显可见) | 2 |
重度红斑 | 3 |
紫红色红斑到轻度焦痂形成 | 4 |
水肿 | |
无水肿 | 0 |
轻度水肿(勉强可见) | 1 |
中度水肿(明显隆起) | 2 |
重度水肿(皮肤隆起1mm,轮廓清楚) | 3 |
严重水肿(皮肤隆起1mm以上并有扩大) | 4 |
总分(皮肤红斑和水肿) | 8 |
统计各组平分值,按动物数进行平均,依表3标准,判断样品的刺激性:
表3刺激性评价表
试验结果表明:实施例1组仅一只轻度红斑,其余均无红斑,所有动物无水肿,评分为0.125,属无刺激性。对照组五只有轻度红斑,三只无红斑,均无水肿,评分为0.625,属轻度刺激性。说明实施例1样品比对比例2样品刺激性小。
4、抑菌试验
将供试菌种划线接入相应的试管斜面培养基上,细菌于37℃恒温培养箱中培养24h,真菌于28℃恒温培养箱中培养5d,4℃冰箱中冷藏备用。
供试菌株菌悬浮液的制备:分别用接种环挑取少许细菌或真菌孢子于装有玻璃珠和10mL无菌生理盐水的三角瓶中,振荡,采用活菌计数法测定菌数,制成菌体或孢子浓度为106-107CFU/mL的均匀菌悬浮液或孢子悬液。
取灭菌烘干的牛津杯(外径8mm、内径6mm、高10mm)置于已用0.1mL菌悬液涂布均匀的培养皿中,用无菌微量移液器分别注入200μL空白对照液,每种菌做3个平行。细菌恒温培养24h,真菌培养5d,测量抑菌圈直径,计算抑菌率。结果如表4所示:
表4
由表4中数据可知,实施例1和对比例2无明显抑菌差别。
以上所述仅为本发明较佳的实施例,并非因此限制本发明的实施方式及保护范围,对于本领域技术人员而言,应当能够意识到凡运用本发明说明书内容所作出的等同替换和显而易见的变化所得到的方案,均应当包含在本发明的保护范围内。
Claims (10)
1.一种伤口清洗消毒剂,其特征在于,所述伤口清洗消毒剂包括盐酸奥替尼定和阿地米屈;阿地米屈可以增加盐酸奥替尼定的溶解度。
2.根据权利要求1所述的伤口清洗消毒剂,其特征在于,所述盐酸奥替尼定和阿地米屈的质量比为1:1-200。
3.根据权利要求2所述的伤口清洗消毒剂,其特征在于,所述盐酸奥替尼定和阿地米屈的质量比为1:5-50。
4.根据权利要求3所述的伤口清洗消毒剂,其特征在于,所述盐酸奥替尼定和阿地米屈的质量比为1:20。
5.根据权利要求1所述的伤口清洗消毒剂,其特征在于,所述伤口清洗消毒剂包括以下质量百分比的组分:盐酸奥替尼定0.01-2.0%、阿地米屈0.1-20%。
6.根据权利要求5所述的伤口清洗消毒剂,其特征在于,所述伤口清洗消毒剂包括以下质量百分比的组分:盐酸奥替尼定0.05-0.5%、阿地米屈0.5-5%。
7.根据权利要求6所述的伤口清洗消毒剂,其特征在于,所述伤口清洗消毒剂包括以下质量百分比的组分:盐酸奥替尼定0.1-0.2%、阿地米屈1-3%。
8.根据权利要求1所述的伤口清洗消毒剂,其特征在于,所述伤口清洗消毒剂的剂型包括水溶液、油膏、乳膏、凝胶或混悬液。
9.根据权利要求8所述的伤口清洗消毒剂,其特征在于,所述伤口清洗消毒剂的剂型为水溶液或乳膏。
10.采用权利要求1-9任一项所述的伤口清洗消毒剂在制备用于各种疾病皮肤和伤口的清洗与消毒灭菌的产品中的用途。
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