CN109675067A - 一种医用消毒超声耦合剂及其制备方法 - Google Patents
一种医用消毒超声耦合剂及其制备方法 Download PDFInfo
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Abstract
本发明涉及一种医用消毒超声耦合剂及其制备方法。所述医用消毒超声耦合剂，包括的有效成分为：4‑氯‑3,5‑二甲基苯酚，对羟基苯甲酸酯，交联聚丙烯酸树脂，丙三醇，聚乙二醇，三乙醇胺或氢氧化钠和纯化水。所述医用消毒超声耦合剂，对人体无毒、无致敏作用，对皮肤无刺激，对超声探头无腐蚀性、溶胀性，亦不需浸泡，且能实现医用超声探头消毒要求。
Description
技术领域
本发明涉及一种医用消毒超声耦合剂及其制备方法，属于医用超声耦合剂制备的技术领域。
背景技术
在超声检查诊疗中，超声波入射到两种不同媒质(空气和皮肤软组织)的分界面上时，由于二者阻抗相差大，反射系数大，导致穿过空气界面进入皮肤软组织的声能大幅度少。如果将超声探头与皮肤“干接触”，由于二者之间空气薄层的强烈反射作用，超声波将无法达到并进入人体皮肤软组织，无法实现诊断和治疗作用。医用超声耦合剂是一种充填或涂敷于皮肤与探头之间，用于透射声波的中介媒质，其声阻抗与人体软组织相近，形成使超声波顺畅和不失真的传播通道，避免超声波发生反射，图像更加清晰。
超声检查中的超声探头高频率反复在病人间使用，在病人使用后通常只是做简单擦拭，虽然不一定使病人感染致病菌，但依然存在很大的交叉感染的风险，同时也是易传播疾病良好的传播载体，因此，超声探头的消毒是一直困扰医用超声诊断与治疗的一大难题。
超声探头价格昂贵，检测频繁，每个患者都换一个新超声探头是不现实的；而且，超声探头材质及使用要求的特殊性，不能采用对塑料和橡胶具有腐蚀性和溶胀性的消毒剂，也不能使用常规的浸泡、高温高压等方法进行消毒；更不能实现受检者之间在有限的间隔时间内，完成消毒操作。
现有的消毒型超声耦合剂中的消毒剂配方单一，难以在短时间内(1分钟左右)杀灭病原微，杀菌效果具有局限性，无法在受检皮肤表面产生滞留杀菌作用。而且灭菌剂之间往往存在拮抗作用，共同使用可能互相消弱灭菌效果，无法实现抗菌谱的叠加，进而无法实现广谱杀菌的效果。
中国专利授权公告号101249268B公开了一种用于皮肤和腔道粘膜超声波检测与治疗时使用的具有杀菌功能的消毒杀菌型医用超声耦合剂及其制备方法。超声耦合剂包括羟乙基纤维素、卡波姆、羟丙基纤维素其中一种粘度调节剂，丙二醇和去离子水，其中还含有0.05～0.15％杀菌剂，所述杀菌剂组分选自聚六亚甲基双胍、苯扎氯铵、苯扎溴铵、醋酸氯己定、三氯苯氧基二苯醚、纳米银任意一种或它们的组合；上述消毒剂或水溶性差，或与凝胶基质具有配伍禁忌，使用较高剂量会影响凝胶产品的透明度、安全性与稳定性。
发明内容
针对现有技术的不足，本发明提供一种医用消毒超声耦合剂。
本发明还提供一种上述医用消毒超声耦合剂的制备方法。
发明概述：
本发明提供了一种多种消毒剂复合使用、对医用超声探头、皮肤具有消毒作用，同时具备良好声学性能、安全性和稳定性的水性医用超声探头消毒凝胶。它对超声探头无任何腐蚀性和溶胀性，无需浸泡即可达到消毒作用，杀菌时间短，能在整个检测过程中对超声探头进行杀菌消毒，使用方便；能减少医用超声检测过程中可能带来的交叉感染风险，保护受检者身体健康，而且不污染环境。
术语说明：
4-氯-3,5-二甲基苯酚：分子式，C8H9ClO，用于乳剂、化妆品、皮革、油墨、胶合板等作防霉防腐剂,医药上常用皮肤消毒剂。
交联聚丙烯酸树脂：商品名称卡波姆，是一种优秀的凝胶基质，有增稠、悬浮等重要用途，广泛应用于乳液、膏霜、凝胶中。
纯化水：饮用水经蒸馏法、离子交换法、反渗透法或其他适宜的方法制得的供药用的水，不含任何添加剂。
本发明的技术方案为：
一种医用消毒超声耦合剂，包括的有效成分重量百分比为：4-氯-3,5-二甲基苯酚0.1～2.0％，对羟基苯甲酸酯0.1～1.0％，交联聚丙烯酸树脂0.3～1.2％，丙三醇4.0～10.0％，聚乙二醇4.0～10.0％，三乙醇胺或氢氧化钠0.2～1.5％，余量为纯化水。
4-氯-3,5-二甲基苯酚和对羟基苯甲酸酯的作用是杀灭细菌、霉菌和病毒；交联聚丙烯酸树脂的作用是形成水溶性高分子凝胶；丙三醇作为保湿剂，具有保水和润滑皮肤的功效；聚乙二醇作为杀菌剂的溶剂，也作为保湿剂，与丙三醇混合使用，其保湿效果更好；三乙醇胺或氢氧化钠作用是中和交联聚丙烯酸树脂，调节耦合剂产品pH值；
一种上述医用消毒超声耦合剂的制备方法，包括如下步骤：
1)按重量百分比称取定量的4-氯-3,5-二甲基苯酚、对羟基苯甲酸酯和聚乙二醇；将4-氯-3,5-二甲基苯酚和对羟基苯甲酸酯溶解在聚乙二醇溶液中，制得溶液A，备用；
2)按重量百分比称取定量的丙三醇，将所述溶液A加入到丙三醇中，搅拌均匀，制得溶液B，备用；
3)按重量百分比称取交联聚丙烯酸树酯，将其分散到纯化水中，搅拌至溶解，制得溶液C，备用；
4)将溶液B在搅拌状态下加入到溶液C中，并按重量百分比补足纯化水，继续搅拌均匀，制得溶液D；
5)按重量百分比称取三乙醇胺或氢氧化钠，搅拌状态下，滴加到溶液D中，调节pH值至5.5～8.0，得到无色透明的凝胶，即杀菌消毒型医用超声耦合剂；
6)灌装。
根据本发明优选的，所述步骤4)和步骤5)中搅拌状态的搅拌速度控制在50～70r/min。如果速度太慢，混合不均匀；如果速度太快，容易产生气泡，从而影响产品的性状。
本发明的有益效果为：
1.本发明所述医用消毒超声耦合剂，对人体无毒、无致敏作用，对皮肤无刺激，对超声探头无腐蚀性、溶胀性，亦不需浸泡，且能实现医用超声探头消毒要求；其中的杀菌消毒剂4-氯-3,5-二甲基苯酚和对羟基苯甲酸酯共同使用过程中不会相互削弱灭菌效果，抗菌谱叠加，实现广谱杀菌和快速高效杀菌消毒，并实现整个超声诊疗过程中对超声探头进行杀菌消毒，有效降低超声检测过程中交叉感染风险，保护受检者身体健康；
2.本发明所述医用消毒超声耦合剂，保持了传统医用超声耦合剂的性状和耦合功能，符合YY0299-2016《医用超声耦合剂》的行业标准，同时具有杀灭细菌、霉菌、病毒等病原微生物的功能；在超声诊疗过程中，既可作为耦合剂使用，又能在杀菌同时对超声探头进行随时消毒，使用方便，能有效地降低医用超声诊疗过程中交叉感染的风险；
3.本发明所述医用消毒超声耦合剂所使用的消毒剂与凝胶基质具有很好的配伍性能，能以任意比例添加，在许多杀菌应用中能高效且无毒性的发挥作用；
4.本发明所述医用消毒超声耦合剂，制备工艺简单，原料易得，制造设备为普通容器、搅拌装置、自动罐装机等，设备投资少，操作成本低，利于工业化生产。
附图说明
图1为本发明所述医用消毒超声耦合剂的制备流程图。
具体实施方式
下面结合实施例和说明书附图对本发明做进一步说明，但不限于此。
实施例1
100g医用消毒超声耦合剂，包括的有效成分重量为：4-氯-3,5-二甲基苯酚2g，对羟基苯甲酸酯0.5g，交联聚丙烯酸树脂1g，丙三醇5g，聚乙二醇5g，三乙醇胺1g，余量为纯化水。
4-氯-3,5-二甲基苯酚和对羟基苯甲酸酯的作用是杀灭细菌、霉菌和病毒；交联聚丙烯酸树脂的作用是形成水溶性高分子凝胶；丙三醇作为保湿剂，具有保水和润滑皮肤的功效；聚乙二醇作为杀菌剂的溶剂，也作为保湿剂，与丙三醇混合使用，其保湿效果更好；三乙醇胺或氢氧化钠作用是中和交联聚丙烯酸树脂，调节耦合剂产品pH值；
实施例2
如图1所示。
实施例1所述医用消毒超声耦合剂的制备方法，包括如下步骤：
1)称取4-氯-3,5-二甲基苯酚2g、对羟基苯甲酸酯0.5g和聚乙二醇5g；将4-氯-3,5-二甲基苯酚和对羟基苯甲酸酯溶解在聚乙二醇溶液中，制得溶液A，备用；
2)称取丙三醇5g，将所述溶液A加入到丙三醇中，搅拌均匀，制得溶液B，备用；
3)称取交联聚丙烯酸树酯1g，将其分散到纯化水中，搅拌至溶解，制得溶液C，备用；
4)将溶液B在搅拌状态下加入到溶液C中，并按重量百分比补足纯化水，继续搅拌均匀，制得溶液D；
5)称取三乙醇胺1g，搅拌状态下，滴加到溶液D中，调节pH值至5.5～8.0，得到无色透明的凝胶，即杀菌消毒型医用超声耦合剂；
6)灌装。
其中，所述步骤4)和步骤5)中搅拌状态的搅拌速度控制在50～70r/min。如果速度太慢，混合不均匀；如果速度太快，容易产生气泡，从而影响产品的性状。
对本实施例制得的医用消毒超声耦合剂的性能指标、卫生指标和功能指标进行抽样检测，检测结果符合要求，检测结果见下表：
将实施例2制得的医用消毒超声耦合剂与市场购买的耦合剂进行微生物杀灭对比试验，实施例2制得的医用消毒超声耦合剂作用1分钟，上述四种菌的杀灭率可达到99.99％，而市场购买的耦合剂经过半个小时的作用后只对细菌繁殖体的杀灭率达到99.99％，对真菌的杀灭率达不到要求。
Claims (3)
1.一种医用消毒超声耦合剂，其特征在于，包括的有效成分重量百分比为：4-氯-3,5-二甲基苯酚0.1～2.0％，对羟基苯甲酸酯0.1～1.0％，交联聚丙烯酸树脂0.3～1.2％，丙三醇4.0～10.0％，聚乙二醇4.0～10.0％，三乙醇胺或氢氧化钠0.2～1.5％，余量为纯化水。
2.一种如权利要求1所述的医用消毒超声耦合剂的制备方法，其特征在于，包括如下步骤：
1)按重量百分比称取定量的4-氯-3,5-二甲基苯酚、对羟基苯甲酸酯和聚乙二醇；将4-氯-3,5-二甲基苯酚和对羟基苯甲酸酯溶解在聚乙二醇溶液中，制得溶液A，备用；
2)按重量百分比称取定量的丙三醇，将所述溶液A加入到丙三醇中，搅拌均匀，制得溶液B，备用；
3)按重量百分比称取交联聚丙烯酸树酯，将其分散到纯化水中，搅拌至溶解，制得溶液C，备用；
4)将溶液B在搅拌状态下加入到溶液C中，并按重量百分比补足纯化水，继续搅拌均匀，制得溶液D；
5)按重量百分比称取三乙醇胺或氢氧化钠，搅拌状态下，滴加到溶液D中，调节pH值至5.5～8.0，得到无色透明的凝胶，即杀菌消毒型医用超声耦合剂；
6)灌装。
3.根据权利要求2所述的医用消毒超声耦合剂的制备方法，其特征在于，所述步骤4)和步骤5)中搅拌状态的搅拌速度控制在50～70r/min。
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