CN109675068A - 一种具有消毒功能的医用超声耦合剂及其制备方法 - Google Patents
一种具有消毒功能的医用超声耦合剂及其制备方法 Download PDFInfo
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Abstract
本发明涉及一种具有消毒功能的医用超声耦合剂及其制备方法。该超声耦合剂,包括有效成分为:4‑氯‑3,5‑二甲基苯酚、丙烯酰胺二甲基牛磺酸铵/乙烯基吡咯烷酮共聚物、聚乙二醇、护肤剂和纯化水。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,选择对人体和环境无害、对硅橡胶制品无腐蚀性的消毒杀菌剂4‑氯‑3,5‑二甲基苯酚制备出透明凝胶状的具有杀菌消毒功能的医用超声耦合剂。
Description
技术领域
本发明涉及一种具有消毒功能的医用超声耦合剂及其制备方法,属于医药化工的技术领域。
背景技术
医用超声耦合剂是目前临床上广泛应用的试剂,其功能是加强超声探头和人体皮肤之间的耦合,隔绝超声探头和被检查部位皮肤之间的空气,使声波传导不受空气的影响而衰减,以达到准确清晰的检查结果,为医生的正确诊断提供依据。
超声检查过程中,超声探头在病人之间高频率反复使用,通常只是在病人使用后做简单擦拭,超声探头成为传播疾病的传播良好载体,容易使被检查者感染致病菌,存在很大的交叉感染的风险。目前的医用超声耦合剂中一般都添加有杀菌剂进行灭菌达到减少交叉感染的目的。
现有技术中具有消毒功能的耦合剂多以凝胶基质交联聚丙烯酸树脂、海藻酸钠、聚丙烯酸钠与消毒剂三氯生、醋酸氯己定、季铵盐等配伍,实现杀菌消毒功能。这些消毒剂或水溶性差,或与凝胶基质具有配伍禁忌,较高剂量使用会影响凝胶产品的透明度、安全性与稳定性。
因此,研究开发安全、稳定,满足临床使用要求的具有消毒功能的超声耦合剂,对于临床超声检查具有重要意义。
发明内容
针对现有技术的不足,本发明提供一种具有消毒功能的医用超声耦合剂。
本发明还提供一种上述具有消毒功能的医用超声耦合剂的制备方法。
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。
丙烯酰胺二甲基牛磺酸铵/乙烯基吡咯烷酮共聚物:白色粉末,用于透明体系的凝胶剂和水包油乳液的增稠剂。
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:
一种具有消毒功能的医用超声耦合剂,包括有效成分的重量百分比为:4-氯-3,5-二甲基苯酚0.1~2.0%、丙烯酰胺二甲基牛磺酸铵/乙烯基吡咯烷酮共聚物0.5~1.2%、聚乙二醇5.0~10.0%、护肤剂0.5~3.0%,余量为纯化水。
4-氯-3,5-二甲基苯酚的作用是杀灭细菌、霉菌和病毒;丙烯酰胺二甲基牛磺酸铵/乙烯基吡咯烷酮共聚物的作用是形成水溶性高分子凝胶;聚乙二醇的作用是作为溶剂溶解消毒剂;
根据本发明优选的,所述护肤剂为维生素E、尿囊素和D-泛醇中的一种或多种的复配;复配比例为任意比例。
一种具有消毒功能的医用超声耦合剂的制备方法,包括如下步骤:
1)按重量百分比称取丙烯酰胺二甲基牛磺酸铵/乙烯基吡咯烷酮共聚物,并加入至纯化水中,搅拌至完全溶解,得到溶液A,备用;
2)按重量百分比称取4-氯-3,5-二甲基苯酚,溶于相应重量百分比的聚乙二醇中,得到溶液B,备用;
3)按重量百分比称取护肤剂,并分散到纯化水中,得到溶液C,备用;
4)在搅拌状态下,依次将所述溶液B、溶液C加入到所述溶液A中,并按重量百分比补足纯化水,调节pH值至5.5~8.0,继续搅拌均匀,得到无色透明的凝胶,即超声耦合剂;
5)灌装。
根据本发明优选的,所述步骤4)中搅拌状态的搅拌速度控制在50~70r/min。速度太慢,混合不均匀;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,保持了传统医用超声耦合剂的性状和耦合功能,选择对人体和环境无害、对硅橡胶制品无腐蚀性的消毒杀菌剂4-氯-3,5-二甲基苯酚制备出透明凝胶状的具有杀菌消毒功能的医用超声耦合剂;
本发明配方所有原料在使用范围内经验证均是对人体和环境安全、无害的产品;生产的超声耦合剂符合YY0299-2016《医用超声耦合剂》的行业标准,对人体无毒、无致敏作用,对皮肤无刺激,对医用超声探头无腐蚀性与溶胀性,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,在杀菌同时又能对超声探头随时进行消毒,使用方便,有效降低医用超声诊疗过程中可能带来的交叉感染风险;
2.本发明所述医用消毒超声耦合剂,所需原料常见易得,制造设备为普通容器、搅拌装置,自动罐装机等,制备工艺简单。
附图说明
图1为本发明所述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
一种具有消毒功能的医用超声耦合剂,100g中包括有效成分的重量为:4-氯-3,5-二甲基苯酚1g、丙烯酰胺二甲基牛磺酸铵/乙烯基吡咯烷酮共聚物1g、聚乙二醇10g、护肤剂2g,余量为纯化水。
4-氯-3,5-二甲基苯酚的作用是杀灭细菌、霉菌和病毒;丙烯酰胺二甲基牛磺酸铵/乙烯基吡咯烷酮共聚物的作用是形成水溶性高分子凝胶;聚乙二醇的作用是作为溶剂溶解消毒剂;
其中,所述护肤剂为维生素E、尿囊素和D-泛醇按1:1:2比例的复配。
实施例2
如图1所示。
实施例1所述具有消毒功能的医用超声耦合剂的制备方法,包括如下步骤:
1)称取丙烯酰胺二甲基牛磺酸铵/乙烯基吡咯烷酮共聚物1g,并加入至纯化水中,搅拌至完全溶解,得到溶液A,备用;
2)称取4-氯-3,5-二甲基苯酚1g,溶于10g聚乙二醇中,得到溶液B,备用;
3)称取护肤剂2g,并分散到纯化水中,得到溶液C,备用;
4)在搅拌状态下,依次将所述溶液B、溶液C加入到所述溶液A中,并按重量百分比补足纯化水,调节pH值至5.5~8.0,继续搅拌均匀,得到无色透明的凝胶,即超声耦合剂;
5)灌装。
其中,所述步骤4)中搅拌状态的搅拌速度控制在50~70r/min。速度太慢,混合不均匀;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了抽样检测,检测结果符合要求。检测结果见下表:
通过上述数据可以得出,按《消毒技术规范》(2002年版)和YY0299-2016医用超声耦合剂的要求进行测定,产品性能测试的指标都符合要求。
Claims (4)
1.一种具有消毒功能的医用超声耦合剂,其特征在于,包括有效成分的重量百分比为:4-氯-3,5-二甲基苯酚0.1~2.0%、丙烯酰胺二甲基牛磺酸铵/乙烯基吡咯烷酮共聚物0.5~1.2%、聚乙二醇5.0~10.0%、护肤剂0.5~3.0%,余量为纯化水。
2.根据权利要求1所述的具有消毒功能的医用超声耦合剂,其特征在于,所述护肤剂为维生素E、尿囊素和D-泛醇中的一种或多种的复配;复配比例为任意比例。
3.一种如权利要求1或2所述的具有消毒功能的医用超声耦合剂的制备方法,其特征在于,包括如下步骤:
1)按重量百分比称取丙烯酰胺二甲基牛磺酸铵/乙烯基吡咯烷酮共聚物,并加入至纯化水中,搅拌至完全溶解,得到溶液A,备用;
2)按重量百分比称取4-氯-3,5-二甲基苯酚,溶于相应重量百分比的聚乙二醇中,得到溶液B,备用;
3)按重量百分比称取护肤剂,并分散到纯化水中,得到溶液C,备用;
4)在搅拌状态下,依次将所述溶液B、溶液C加入到所述溶液A中,并按重量百分比补足纯化水,调节pH值至5.5~8.0,继续搅拌均匀,得到无色透明的凝胶,即超声耦合剂;
5)灌装。
4.根据权利要求3所述的医用超声耦合剂的制备方法,其特征在于,所述步骤4)中搅拌状态的搅拌速度控制在50~70r/min。
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