CN110585473A - 含有新型抗菌剂的泡沫敷料及其制备方法 - Google Patents
含有新型抗菌剂的泡沫敷料及其制备方法 Download PDFInfo
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- CN110585473A CN110585473A CN201910871332.XA CN201910871332A CN110585473A CN 110585473 A CN110585473 A CN 110585473A CN 201910871332 A CN201910871332 A CN 201910871332A CN 110585473 A CN110585473 A CN 110585473A
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- alexidine
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Abstract
本发明涉及抗菌剂及抗菌泡沫敷料制造技术领域，具体地说是一种含有阿来西定(Alexidine)或带硅烷端有机季铵盐的含有新型抗菌剂的泡沫敷料及其制备方法，其特征在于含有带有机硅端的有机化合物和多链及高分子均包括在内，其质量百分比范围为0.01％至65％。优选地含有3‑(三甲氧基硅烷基)丙基二甲基十八烷基氯化铵或3‑(三羟基硅烷基)丙基二甲基十八烷基氯化铵或阿来西定。本发明与现有技术相比，具有广谱抗菌作用且抗菌性能持久，适用于各种伤口治疗以及负压引流用的敷料，对皮肤无刺激、无毒副作用、抗菌材料附着力强，不易迁移到体内等显著的优点。
Description
技术领域：
本发明属于生物材料、高分子材料等领域，具体地说是一种具有广谱抗菌作用且抗菌性能持久，应用于促进伤口愈合，防止伤口感染，对皮肤无刺激、无毒副作用、附着力强的含有新型抗菌剂的泡沫敷料及其制备方法。
背景技术：
医用泡沫敷料在急性慢性伤口治疗及流行的负压引流伤口治疗中起着重要作。泡沫敷料适用各种急性和慢性伤口治疗。尤其对于渗出液较多的伤口护理中，如臀尾部压疮、足腿部溃疡、各种程度烧伤、供皮区伤口、术后伤口和皮肤擦伤的护理。泡沫敷料与其它功能性敷料相比，具有以下优点：吸收伤口渗液量大，减少更换次数。避免伤口渗透液对周围皮肤的浸渍；为伤口提供湿润环境，使伤口不会形成结痂，加速伤口愈合。泡沫敷料的物理优越性在于其柔软舒适且透气性好，使患者感觉非常舒服，可以用于身体大多部位。
泡沫敷料主要用于伤口渗透液较多的地方，而这也是伤口易感染的情形，细菌会引发伤口发炎，伤口感染发炎严重影响伤口的愈合情况。因此有必要研究开发具有良好抗菌功能的泡沫敷料。普通泡沫敷料一般不具有抗菌功能，尽管目前也流行一些抗菌水泡沫敷料，但是它们大多是含有银离子的泡沫敷料产品，例如含有硝酸银，纳米银，银络合物等，而且这些抗菌泡沫敷料大多是在泡沫敷料的表面喷涂一层无机银抗菌剂，但是表面载银的泡沫敷料存在银离子释放过快且易脱落的问题，使敷料使用寿命短，在使用过程中银离子直接接触皮肤，可能会影响伤口的愈合，副作用明显，会产生色素沉淀。这类产品不能长期使用，对于治疗大面积烧伤及急慢性伤口深度感染的病人是具有极大的挑战性。因此研发含有新型抗菌功能抗菌材料附着力强的泡沫敷料，对于有效治疗各种急性慢性易感染性或已经感染的伤口，促进伤口愈合意义非常重要。
阿来西定和洗必泰(Chlorhexidine)都具有广谱抗菌功能，相比洗必泰，阿来西定抗菌速度快。阿来西定在化学结构上带有长链碳氢结构端，这种带长链的碳氢结构端的油性成分有利于分子渗透到亲油性的细菌的细胞壁结构，并迅速穿透，从而达到持久灭菌功能。此外，阿来西定还具有加速癌细胞死亡以及抗炎抗抗糖尿病性能，因此也可以加速伤口愈合速度。另外，阿来西定比洗必泰的致敏性小很多，而且其抗不同种菌剂量也小于或等于洗必泰抗菌剂量。
发明内容：
本发明针对现有技术中存在的缺点和不足，提出了一种具有广谱抗菌作用且抗菌性能持久，适用于各种急性慢性伤口治疗的含有阿来西定(Alexidine，1,1’-(1,6-Hexanediyl)bis{2-[N’-(2-ethylhexyl)carbamimidoy l]guanidine，}或带硅烷端有机季铵盐或带羟基硅烷端有机季铵盐含有新型抗菌剂的泡沫敷料及其制备方法。
一种含有新型抗菌剂的泡沫敷料，其特征在于含有以下成分的抗菌剂：阿来西定、有机硅烷端季铵盐、带羟基硅烷端有机季铵盐以及引生的低分子，高分子结构的带有机硅烷端季铵盐；所述抗菌剂占泡沫敷料质量百分比的0.01％至65％。
本发明所述抗菌剂中阿来西定占抗菌剂质量百分数的0.001％至5％、有机硅烷端季铵盐占抗菌剂质量百分数的0.001％至5％,0.01％-65％、带羟基硅烷端有机季铵盐以及引生的低分子占抗菌剂质量百分数的0.001％至5％,0.01％-65％。
本发明所述阿来西定泛指阿来西定及化合物，包括阿来西定(alexidine base)，阿来西定盐酸盐(alexidine hydrochloride),阿来西定二合盐酸盐(alexidinedihydrochloride)，阿来西定单乙酸酯(alexidine monoacetate),阿来西定双乙酸酯(alexidine diacetate),阿来西定葡萄糖酸盐(alexidine gluconate),阿来西定二葡萄糖酸盐(alexidine digluconate)。
本发明所述抗菌剂选用阿来西定和3-(三甲氧基硅烷基)丙基二甲基十八烷基氯化铵(3-(tri-methyloxysilyl propyldimethyloctadecyl ammonium)或3-(三羟基硅烷基)丙基二甲基十八烷基氯化铵(3-(tri-hydroxysilyl propyldimethyloctadecylammonium)组成，其中3-(三甲氧基硅烷基)丙基二甲基十八烷基氯化铵占比为0.01％-65％，3-(三羟基硅烷基)丙基二甲基十八烷基氯化铵占比为0.01％-65％，阿来西定占比为0.001％-5％。
本发明所述抗菌剂中含有3-(三甲氧基硅烷基)丙基二甲基十八烷基氯化铵与阿来西定，且二者的质量比例为5:0.1-0.1:5。
本发明所述泡沫敷料主要以高分子材料为主，例如，聚氨酯泡沫敷料以及以泡沫敷料为主外加一些辅助材料。
本发明还提出了一种含有新型抗菌剂的泡沫敷料的制备方法，其特征在于：配置含有0.01％-5％的抗菌剂溶液，溶液除了含有上述抗菌剂之外，还包括一些辅助材料例如0.1％-5％甘油，0.1％-10％壳聚糖，0.1％-10％藻酸盐，其余为水，然后经过下述任一方法获得泡沫敷料：
A.将抗菌剂溶液通过涂层或雾状喷雾器喷洒在泡沫敷料表面，经过化学或物理方式交联附着在泡沫表面，经烘箱干燥制从抗菌泡沫敷料；这种方法可以用于已经有成熟泡沫生产工艺技术，只要在原工艺基础上调整就可以制作成抗菌泡沫产品；
B.将医用泡沫敷料放入含有0.05％-10％抗菌剂溶液中，使医用泡沫敷料在反应槽中恒温浸泡，直至抗菌剂吸附在敷料0.05％-10％为止，温度为25～50℃，浸泡过后，将含抗菌剂的泡沫敷料取出，经烘箱干燥，干燥温度为35～80℃，干燥时间为1～24小时；
C.在生产泡沫工艺中直接将抗菌剂和其他医用泡沫制备原料一起混合制成含有抗菌剂的泡沫敷料。
经包装、灭菌后，即得到医用抗菌泡沫敷料成品。
本发明所获得的泡沫敷料采用的灭菌方式为钴-60辐照灭菌，电子束辐照或环氧乙烷灭菌方式的一种。
本发明与现有技术相比，通过在泡沫敷料制作中添加阿来西定或3-(三羟基硅烷基)丙基二甲基十八烷基氯化铵或3-(三甲氧基硅烷基)丙基二甲基十八烷基氯化铵，进而达到杀菌的作用，使所获得的泡沫敷料产品具有广谱抗菌作用，其中，通过复合阿来西定，不仅可以提高抗菌剂的抗菌作用，而且可以使泡沫敷料成品具有消炎以及快速杀菌的特性；通过采用带有机硅烷端季铵盐作为抗菌剂，使抗菌剂和泡沫基质通过化学或物理方式结合在一起，不会使抗菌剂迁移或脱落。本发明所提出的抗菌用泡沫敷料有助于溶解高分子组成的生物膜，穿透细胞壁的作用，增强有效抗菌作用(杀菌或抑制细菌生长等)。该泡沫敷料抗菌性能持久，适用于伤口治疗以及医用敷料领域。
具体实施方式：
以下通过具体实施方式的描述对本发明作进一步说明，但这并非是对本发明的限制，本领域技术人员根据本发明的基本思想，可以做出各种修改或改进，但是只要不脱离本发明的基本思想，均在本发明的范围之内。
实施例1
把6克甲醇加到50克HYPOL Hydrogel(polyurethane prepolymer,W.R.Grace&Co商标名)预聚体中(NCO含量0.5-1.2meg/g)，在几秒钟确保完全混合均匀；然后将44克水和1.8克3-(三甲氧基硅烷基)丙基二甲基十八烷基氯化铵和0.2克阿来西定迅速加到HYPOLHydrogel预聚体混合液中，强烈搅拌；然后把泡沫溶液到入模具厚度为2.2毫米中发泡，经37-55度熟化2小时，100-120度30分钟除去水分，冷却后获得抗菌泡沫敷料其密度为0.38g/cm3，拉长断裂为930％，吸液量为10.7g/g。
实施例2
将0.5mol真空干燥过的聚乙丙三醇(PPG6000 triol)与2.5mol六亚甲基二异氰酸酯(HDI)在80度混合反应一小时之后，0.85mol聚乙二醇(PEG1000)，0.85mol聚乙二醇(PE2000)和0.1mol透明质酸加入到反应容器中继续在80度交联反应6小时，获取预聚体A1。将0.1mol碳酸氢钠，0.4mol水，0.5mol表面活性剂L64，0.1Mol稳泡剂，0.1Mol三亚乙基二胺,0.1mol辛酸锌,0.02mol 3-(三羟基硅烷基)丙基二甲基十八烷基氯化铵和0.001mol阿来西定，混合搅拌溶解形成无色透明溶液，获得发泡剂B1。
将预聚体A1在高速分散机迅速搅拌加人发泡剂B1，继续搅拌分散10S，混合物倒入模具中发泡，然后经55-60度度熟化2小时，100-120度30分钟除去水分，冷却后获得抗菌泡沫敷料。
实施例3
A、预聚体的制备：将8份壳聚糖、40份脱水聚乙二醇、2份甘油，30份甲苯二异氰酸酯混合，搅拌，80℃保温反应1小时得到粘稠状的预聚体；
B、发泡：称取0.5份阿来西定、0.5份3-(三甲氧基硅烷基)丙基二甲基十八烷基氯化铵、15份聚醚多元醇、l份辛酸锌、1份二甲基乙醇胺、3份海藻酸钠、3份硅表面活性剂，混合均匀，快速搅拌均匀，加入步骤A所得预聚体，立即高速搅拌1小时，混合均匀后迅速倒入发泡模具进行发泡，熟化25小时，即得抗菌聚氨酯敷料。
实施例4
将医用泡沫敷料放入含0.5％阿来西定和有2％3-(三羟基硅烷基)丙基二甲基十八烷基氯化铵季铵盐的水溶液的反应槽中恒温浸泡到季铵盐吸附在敷料上，温度为30～32℃；
浸泡过后，将医含机季铵盐或有机硅烷季用泡沫敷料取出，经烘箱干燥，干燥温度为35～50℃，最后30分钟100-110度。干燥总时间为1～24小时。
实施例5
将含有2％浓度的3-(三甲氧基硅烷基)丙基二甲基十八烷基氯化铵溶液通过雾状喷雾器到医用泡沫敷料A(MS-50PW 3mm厚,吸液量47.5g/100cm2)片上，经烘箱干燥，干燥温度为35～50℃30分钟，最后30分钟80-100度，经过交联灭菌得到抗菌泡沫敷料。
实施例6
将含有2％浓度的3-(三甲氧基硅烷基)丙基二甲基十八烷基氯化铵溶液通过雾状喷雾器到医用泡沫敷料B(MS-SS-60P,3mm厚,吸液量52.2g/100cm2)片上，经烘箱干燥，干燥温度为35～50℃30分钟，最后30分钟80-100度，经过交联灭菌得到抗菌泡沫敷料。
实施例7
对实施例2、5、6及参考含纳米银标准样品的泡沫敷料进行杀灭金黄色葡萄球菌，大肠杆菌实验，检测在不同时间的杀菌率。
根据本发明实施例1、5、6和参考含银标准样品提供的聚氨酯海绵敷料的检测结果显示，本发明所提供的抗菌的聚氨酯敷料具有良好的杀菌性能，其杀菌性能超过或等同于含银离子泡沫敷料。
本发明与现有技术相比，通过在制作泡沫敷料中加入阿来西定或带硅烷端有机季铵盐，具体地说明通过添加3-(三甲氧基硅烷基)丙基二甲基十八烷基氯化铵，3-(三羟基硅烷基)丙基二甲基十八烷基氯化铵季铵盐或阿来西定，或把泡沫敷料放在含有3-(三甲氧基硅烷基)丙基二甲基十八烷基氯化铵，或3-(三羟基硅烷基)丙基二甲基十八烷基氯化铵季铵盐或阿来西定的溶液中0.1-24小时直到达到预期指标为止，或通过涂层或雾状喷涂泡沫敷料表面，经过干燥除去溶剂，进而达到杀菌的作用，使所获得的泡沫敷料产品具有广谱抗菌作用，本发明所提出的抗菌泡沫敷料有助于溶解高分子组成的生物膜，穿透细胞壁的作用，增强有效抗菌作用(杀菌或抑制细菌生长等)。该泡沫敷料抗菌性能持久，适用于伤口治疗以及医用敷料领域。
Claims (8)
1.一种含有新型抗菌剂的泡沫敷料，其特征在于含有以下成分的抗菌剂：阿来西定、有机硅烷端季铵盐、带羟基硅烷端有机季铵盐以及引生的低分子，高分子结构的带有机硅烷端季铵盐；所述抗菌剂占泡沫敷料质量百分比的0.01％至65％。
2.根据权利要求1所述的一种含有新型抗菌剂的泡沫敷料，其特征在所述抗菌剂中阿来西定占抗菌剂质量百分数的0.001％至5％、有机硅烷端季铵盐占抗菌剂质量百分数的0.001％至5％,0.01％-65％、带羟基硅烷端有机季铵盐以及引生的低分子占抗菌剂质量百分数的0.001％至5％,0.01％-65％。
3.根据权利要求1所述的一种含有新型抗菌剂的泡沫敷料，其特征在所述阿来西定泛指阿来西定及化合物，包括阿来西定(alexidine base)，阿来西定盐酸盐(alexidinehydrochloride),阿来西定二合盐酸盐(alexidine dihydrochloride)，阿来西定单乙酸酯(alexidine monoacetate),阿来西定双乙酸酯(alexidine diacetate),阿来西定葡萄糖酸盐(alexidine gluconate),阿来西定二葡萄糖酸盐(alexidine digluconate)。
4.根据权利要求1所述的一种含有新型抗菌剂的泡沫敷料，其特征在所述抗菌剂选用阿来西定和3-(三甲氧基硅烷基)丙基二甲基十八烷基氯化铵(3-(tri-methyloxysilylpropyldimethyloctadecyl ammonium)或3-(三羟基硅烷基)丙基二甲基十八烷基氯化铵(3-(tri-hydroxysilyl propyldimethyloctadecyl ammonium)组成，其中3-(三甲氧基硅烷基)丙基二甲基十八烷基氯化铵占比为0.01％-65％，3-(三羟基硅烷基)丙基二甲基十八烷基氯化铵占比为0.01％-65％，阿来西定占比为0.001％-5％。
5.根据权利要求1所述的一种含有新型抗菌剂的泡沫敷料，其特征在所述抗菌剂中含有3-(三甲氧基硅烷基)丙基二甲基十八烷基氯化铵与阿来西定，且二者的质量比例为5:0.1-0.1:5。
6.根据权利要求1所述的一种含有新型抗菌剂的泡沫敷料，其特征在所述泡沫敷料主要以高分子材料为主，例如，聚氨酯泡沫敷料以及以泡沫敷料为主外加一些辅助材料。
7.一种含有新型抗菌剂的泡沫敷料的制备方法，其特征在于：配置含有0.01％-5％的抗菌剂溶液，溶液除了含有如权利要求1-6中任意一项所述的抗菌剂之外，还包括辅助材料例如0.1％-5％甘油，0.1％-10％壳聚糖，0.1％-10％藻酸盐，其余为水，然后经过下述任一方法获得泡沫敷料：
A.将抗菌剂溶液通过涂层或雾状喷雾器喷洒在泡沫敷料表面，经过化学或物理方式交联附着在泡沫表面，经烘箱干燥制从抗菌泡沫敷料；这种方法可以用于已经有成熟泡沫生产工艺技术，只要在原工艺基础上调整就可以制作成抗菌泡沫产品；
B.将医用泡沫敷料放入含有0.05％-10％抗菌剂溶液中，使医用泡沫敷料在反应槽中恒温浸泡，直至抗菌剂吸附在敷料0.05％-10％为止，温度为25～50℃，浸泡过后，将含抗菌剂的泡沫敷料取出，经烘箱干燥，干燥温度为35～80℃，干燥时间为1～24小时；
C.在生产泡沫工艺中直接将抗菌剂和其他医用泡沫制备原料一起混合制成含有抗菌剂的泡沫敷料。
经包装、灭菌后，即得到医用抗菌泡沫敷料成品。
8.根据权利要求7所述的一种含有新型抗菌剂的泡沫敷料的制备方法，其特征在于所获得的泡沫敷料采用的灭菌方式为钴-60辐照灭菌，电子束辐照或环氧乙烷灭菌方式的一种。
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