CN107158414A - 一种消毒杀菌抑菌润肤型医用超声耦合剂及其制备方法 - Google Patents
一种消毒杀菌抑菌润肤型医用超声耦合剂及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种消毒杀菌抑菌润肤型医用超声耦合剂及其制备方法,成分为:杀菌抗菌剂、丙二醇、润肤剂、性能调节剂、增稠剂、中和剂、蒸馏水。其制备步骤如下:第一步,按重量百分比称取增稠剂充分溶胀于部分蒸馏水中,备用;第二步,按重量百分比称取抗菌剂、丙二醇、润肤剂、性能调节剂,余量蒸馏水,混合均匀,然后在搅拌状态下加入第一步的溶胀液中,混合均匀,最后滴加中和剂,使溶液成凝胶。本发明制备的凝胶制备工艺简单,产品无色透明无气泡,超声分辨率高、图像清晰、声学性能稳定,对医疗器械无伤害,对皮肤和医疗器械杀菌抑菌效果好,涂覆后不流淌、无异味,对皮肤温和、润肤效果良好。
Description
技术领域
本发明属于医用领域,具体涉及一种消毒杀菌抑菌润肤型医用超声耦合剂及其制备方法。
背景技术
医用超声耦合剂是一种水溶性高分子胶体,它是用来排除探头和被测物体之间的空气,使超声波能有效地穿入被测物达到有效检测目的。传统的医用超声耦合剂仅仅是用来排除探头和被测物体之间的空气,使声波传导不受空气影响而衰减。随着医疗技术的进步及严格的要求,对所使用的医用用品要求更加严格。医用超声耦合剂除了要能具备传统超声耦合剂所有的基本功能外,还需要具备杀菌抗菌功能,使其能够减少超声检查过程中发生交叉感染的风险,并要求对人体皮肤温和而不具刺激,同时要能保护好探头不受损害。
有报道,CN100542615C公开了“具有消毒杀菌功能的医用超声耦合剂及其制备方法”,其制备的凝胶呈现中性白色或乳白色凝胶状态,此耦合剂在添加了杀菌剂后,外观为白色或乳白色凝胶状态,不是无色透明凝胶,对超声测定声学数据有影响,此复配体系制备的产品不能满足市场的需要。单纯的水-丙三醇体系(卡波姆不具有增溶抗菌剂的能力)是难以实现的无色透明状凝胶的。
复配消毒杀菌抑菌润肤型医用超声耦合剂的难点在于:安全高效广谱抗菌性的抗菌剂,如4,4'-二氯-2-羟基二苯醚在水中溶解度极低,如不添加合适的性能调节剂,就很难得到完全无色透明,且具有有效抗菌性能的水性凝胶产品。为了有效溶解诸如4,4'-二氯-2-羟基二苯醚这样的安全高效广谱抗菌剂,寻找合适的增溶体系是关键。医用耦合剂对于增溶体系的要求至少有以下三点:1)必须对诸如4,4'-二氯-2-羟基二苯醚这样的安全高效广谱抗菌剂有可观的增溶能力,能够溶解有效剂量的抗菌剂,同时还能得到无色透明的凝胶产品。2)增溶体系必须不对水凝胶体系产生破坏,即不因增溶体系的加入而影响水凝胶产品在超声检查中基本的使用性能,如声学性能、检测过程中易于涂布、凝胶性状稳定不流淌等。3)对人体皮肤必须温和、无刺激。
发明内容
发明目的:为了解决现有技术的不足,本发明提供一种消毒杀菌抑菌润肤型医用超声耦合剂,对超声探头无任何溶胀性和腐蚀性,能够在检测过程中对探头进行杀菌消毒,从而保护受检者身体健康,避免检测过程可能发生的交叉感染风险。获得产品外观为无色透明,赏心悦目,对人体皮肤无任何刺激性,无异味,易涂覆,不流淌,稳定性好。
本发明的技术解决方案:一种消毒杀菌抑菌润肤型医用超声耦合剂,第一步,按重量百分比称取增稠剂充分溶胀于部分蒸馏水中,备用;第二步,按重量百分比称取抗菌剂、丙二醇、润肤剂、性能调节剂,余量蒸馏水,混合均匀,然后在搅拌状态下加入第一步的溶胀液中,混合均匀,最后滴加中和剂,脱去气泡,使溶液成凝胶。
其中,杀菌抗菌剂重量百分比为0.05%-3%,包括4,4'-二氯-2-羟基二苯醚、2,4,4'-三氯-2'-羟基二苯醚、4-氯-3,5-二甲基苯酚中的一种或多种,其作用是:杀灭霉菌,细菌和病毒。
其中,丙二醇重量百分比为2%-15%,其作用是:溶解抗菌剂。
其中,润肤剂重量百分比为1%-5%,包括丙三醇、聚乙二醇400、透明质酸、海藻酸钠、芦荟提取物中的一种或多种。其作用是:润肤保湿。
其中,性能调节剂重量百分比为0.05%-2%,包括肪醇醚聚氧乙烯醚硫酸钠、脂肪醇醚聚氧乙烯醚硫酸铵、烷基糖苷、醇醚糖苷、甜菜碱中的一种或多种。其作用是:调节诸如4,4'-二氯-2-羟基二苯醚这样的安全高效广谱抗菌剂在水凝胶体系中的溶解性。
其中,增稠剂重量百分比为0.1%-1.0%,包括卡波姆、羟丙基甲基纤维素、羟甲基纤维素钠、羧甲基纤维素钠中的一种或多种。其作用是:使产品成凝胶状物质。
其中,中和剂重量百分比为0.3%-2.0%,包括三乙醇胺、氢氧化钠、氢氧化钾、纯碱中的一种。其作用是:中和增稠剂,使耦合剂成品成凝胶状且是中性。
其中,蒸馏水重量百分比为72%-95%。
本发明的消毒抗菌抑菌润肤型医用耦合剂的制备方法,包括以下步骤:
第一步:将增稠剂加入部分蒸馏水中,于25℃-50℃搅拌3-5小时充分溶胀后,备用。
第二步:将杀菌抗菌剂、丙二醇、润肤剂、性能调节剂、余量蒸馏水混合,在25℃-50℃下充分搅拌2-3小时,得到均一的溶液。
第三步:将第二步所得的含杀菌抗菌剂的均一溶液,在搅拌状态下加入第一步所得的增稠剂溶胀液中后,在25℃-50℃下充分搅拌1-3小时,滴加中和剂,脱去其中的气泡,使溶液得无色透明的消毒杀菌抑菌润肤型医用超声耦合剂成品。
第四步,灌装。
有益效果:本发明制备的凝胶制备工艺简单,产品无色透明无气泡,超声分辨率高、图像清晰、声学性能稳定,对医疗器械无伤害,对皮肤和医疗器械杀菌抑菌效果好,涂覆后不流淌、无异味,对皮肤温和、润肤效果良好。
按照以上配方和制备方法制得的消毒抗菌抑菌润肤型医用耦合剂,对其性状、pH值、声学性能、卫生指标和杀菌抗菌率进行了抽样检测,性状、pH值、声学性能和符合《医用耦合剂》(YY0299-2008)、卫生指标、杀菌率和抑菌率符合《一次性使用卫生用品卫生标准》(GB15979-2002),检测结果表1。
表1 声学性能、卫生指标和杀菌抑菌率检测结果
具体实施方式:
下面结合具体实施例对本发明作进一步详细说明。应理解,这些实例只是为了举例说明本发明,而非以任何方式限制本发明的范围,任何熟悉该项技术的技术人员,在不脱离本发明的构思和范围内所作的更动与润饰,均应属于本发明的保护范围。
实施例1
制备总重量为1000克的消毒杀菌抑菌润肤型医用超声耦合剂。
第一步:将3克卡波姆940加入部分200克蒸馏水中,于30℃左右搅拌4小时充分溶胀,备用。
第二步:将3克4,4'-二氯-2-羟基二苯醚、100克丙二醇、30克聚乙二醇400、5克醇醚糖苷、656克蒸馏水于35℃左右搅拌2小时,得到均一的溶液。
第三步:将第二步所得的含4,4'-二氯-2-羟基二苯醚的均一溶解液,在搅拌状态下加入第一步所得的增稠剂溶胀液中后,于40℃左右继续搅拌1小时,滴加3克三乙醇胺,使溶液成凝胶,即可得无色透明的抗菌抑菌医用耦合剂成品。
第四步:包装。
实施例2
制备总重量为1000克的消毒杀菌抑菌润肤型医用超声耦合剂。
第一步:将3克羟甲基纤维素钠加入部分200克蒸馏水中,于25℃左右搅拌5小时充分溶胀,备用。
第二步:将3克2,4,4'-三氯-2-羟基二苯醚、120克丙二醇、20克丙三醇、5克烷基糖苷、648克蒸馏水于30℃左右搅拌3小时,得到均一的溶液。
第三步:将第二步所得的含2,4,4'-三氯-2'-羟基二苯醚的均一溶解液,在搅拌状态下加入第一步所得的增稠剂溶胀液中后,于35℃左右继续搅拌2小时,滴加1克三乙醇胺,使溶液成凝胶,即可得无色透明的抗菌抑菌医用耦合剂成品。
第四步:包装。
实施例3
制备总重量为1000克的消毒杀菌抑菌润肤型医用超声耦合剂。
第一步:将3克羟丙基甲基纤维素加入部分200克蒸馏水中,于40℃左右搅拌3小时充分溶胀,备用。
第二步:将3克4-氯-3,5-二甲基苯酚、100克丙二醇、30克透明质酸、5克甜菜碱、5克肪醇醚聚氧乙烯醚硫酸钠、651克蒸馏水于40℃左右搅拌3小时,得到均一的溶液。
第三步:将第二步所得的含4-氯-3,5-二甲基苯酚的均一溶解液,在搅拌状态下加入第一步所得的增稠剂溶胀液中后,于45℃左右继续搅拌1小时,滴加3克三乙醇胺,使溶液成凝胶,即可得无色透明的抗菌抑菌医用耦合剂成品。
第四步:包装。
实施例4
制备总重量为1000克的消毒杀菌抑菌润肤型医用超声耦合剂。
第一步:将3克卡波姆U20加入部分200克蒸馏水中,于25℃左右搅拌5小时充分溶胀,备用。
第二步:将3克2,4,4'-三氯-2-羟基二苯醚、100g丙二醇、30g聚乙二醇400、5g烷基糖苷、5g肪醇醚聚氧乙烯醚硫酸钠、651克蒸馏水于35℃左右搅拌2小时,,得到均一的溶液。
第三步:将第二步所得的含2,4,4'-二氯-2-羟基二苯醚的均一溶解液,在搅拌状态下加入第一步所得的增稠剂溶胀液中后,于40℃左右继续搅拌2小时,滴加3克三乙醇胺,使溶液成凝胶,即可得无色透明的抗菌抑菌医用耦合剂成品。
第四步:包装。
Claims (7)
1.一种消毒杀菌抑菌润肤型医用超声耦合剂,其特征是:含有效成分的重量百分比为:杀菌抗菌剂0.05%~3%,丙二醇2%~15%,润肤剂1%~5%,性能调节剂0.05%~2%,增稠剂0.1%~1.0%,中和剂0.3%~2.0%,蒸馏水72%~95%;把抗菌剂、丙二醇、润肤剂、性能调节剂、蒸馏水充分混合后的溶液加入到溶胀于蒸馏水中的增稠剂体系中,再滴加中和剂,脱去气泡,使溶液成凝胶状,得到超声耦合剂。
2.根据权利要求1所述的消毒杀菌抑菌润肤型医用超声耦合剂,其特征是:所述抗菌剂为4,4'-二氯-2-羟基二苯醚、2,4,4'-三氯-2'-羟基二苯醚、4-氯-3,5-二甲基苯酚中的一种或多种。
3.根据权利要求1所述的消毒杀菌抑菌润肤型医用超声耦合剂,其特征是:所述润肤剂为丙三醇、聚乙二醇400、透明质酸、海藻酸钠、芦荟提取物中的一种或多种。
4.根据权利要求1所述的抗菌抑菌型医用超声耦合剂,其特征是:所述性能调节剂为脂肪醇醚聚氧乙烯醚硫酸钠、脂肪醇醚聚氧乙烯醚硫酸铵、烷基糖苷、醇醚糖苷、甜菜碱中的一种或多种。
5.根据权利要求1所述的消毒杀菌抑菌润肤型医用超声耦合剂,其特征是:所述增稠剂为卡波姆、羟丙基甲基纤维素、羟甲基纤维素钠、羧甲基纤维素钠中的一种或多种。
6.根据权利要求1所述的消毒杀菌抑菌润肤型医用超声耦合剂,其特征是:所述中和剂为三乙醇胺、氢氧化钠、氢氧化钾、纯碱中的一种或多种。
7.一种根据权利要求1所述的消毒杀菌抑菌润肤型医用超声耦合剂的制备方法,其特征是:包括以下步骤:
第一步:将增稠剂加入部分蒸馏水中,于25℃-50℃搅拌3-5小时充分溶胀后,备用;
第二步:将杀菌抗菌剂、丙二醇、润肤剂、性能调节剂、余量蒸馏水混合,在25℃-50℃下充分搅拌2-3小时,得到均一的溶液;
第三步:将第二步所得的含杀菌抗菌剂的均一溶液,在搅拌状态下加入第一步所得的增稠剂溶胀液中后,在25℃-50℃下充分搅拌1-3小时,滴加中和剂,脱去其中的气泡,使溶液得无色透明的消毒杀菌抑菌润肤型医用超声耦合剂成品;
第四步,灌装。
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