CN107670056B - 一种医用超声抑菌耦合贴片及其制备方法 - Google Patents
一种医用超声抑菌耦合贴片及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种医用超声抑菌耦合贴片及其制备方法,涉及超声成像剂技术领域。按重量百分比计,由以下组分组成:凝结多糖或豆纤维蛋白胶原水凝基1%‑5%,甘油5%‑10%,胶原蛋白3%‑5%,三氯生或氯己定0.05%‑0.5%,色素0‑0.01%,防腐剂0.2%‑0.5%,余量为纯净水。该医用超声抑菌耦合贴片是一种透明、柔软、可弯曲、性能稳定、可降解水性高分子凝胶,具有高传导率、显像更清晰、有效延长超声探头使用寿命;自带消毒功能,防止交叉感染;保养皮肤、环保卫生,使用方便的特点。
Description
技术领域
本发明涉及超声成像剂技术领域,尤其是一种医用超声抑菌耦合贴片及其制备方法。
背景技术
超声检查是指运用超声波的原理对人体软组织的物理特性、形态结构与功能状态作出判断的一种非创伤性检查方法。它与X线、电子计算机体层扫描(CT)、核磁共振成像(MRI)和放射性核素扫描一样,是现代医学影像诊断的五项主要方法之一。
医用超声耦合剂对改善超声诊断技术的清晰度和分辨率发挥着极其重要的作用。医用超声耦合剂可以驱除超声探头与人体组织之间的空气,从而建立高效、保真的超声传播通道。
按照临床应用途径的不同,医用超声耦合剂可分为介入性耦合剂和非介入性耦合剂。前者指可供体腔及粘膜进行超声诊断及治疗用的无菌耦合剂,后者指仅供在皮肤上进行诊断用的耦合剂,而我国目前绝大多数为非介入性耦合剂。传统的超声耦合剂多为液体,以涂抹的方式应用,涂抹于超声探头或者检测部位皮上;检测完毕后用水清洗或者卫生纸直接擦拭以去除残余耦合剂,这样操作既不方便也不卫生。此外,该种医用超声耦合剂不适于接触破损皮肤,以及身体弯曲、曲折的部位,如手、关节等。另外,在超声诊断和治疗操作中,超声探头直接接触患者皮肤,使用后需要及时、定期进行消毒处理,操作繁琐。
因此,有必要开发一种安全、有效、使用方便、舒适、卫生、不用清洗,且具有消毒作用的超声耦合剂,具有重要意义。
发明内容
本发明要解决的技术问题是提供一种医用超声抑菌耦合贴片及其制备方法,该医用超声抑菌耦合贴片是一种透明、柔软、可弯曲、性能稳定、可降解水性高分子凝胶,具有高传导率、显像更清晰、有效延长超声探头使用寿命;自带消毒功能,防止交叉感染;保养皮肤、环保卫生,使用方便的特点。
为解决上述技术问题,本发明所采取的技术方案是:一种医用超声抑菌耦合贴片,按重量百分比计,由以下组分组成:
凝结多糖或豆纤维蛋白胶原水凝基1%-5%,
甘油5%-10%,
胶原蛋白3%-5%,
三氯生或氯己定0.05%-0.5%,
色素0%-0.01%,
防腐剂0.2%-0.5%,
余量为纯净水。
优选的,医用超声抑菌耦合贴片,按重量百分比计,由以下组分组成:
凝结多糖或豆纤维蛋白胶原水凝基1.5%-2.5%,
甘油5%-7%,
胶原蛋白3%-4%,
三氯生或氯己定 0.15%-0.3%,
色素0.005%-0.01%,
防腐剂0.2%-0.3%,
余量为纯净水。
优选的,防腐剂为卡松。
上述医用超声抑菌耦合贴片的制备方法,包括以下步骤:
(1)先称取甘油,再依次加入凝结多糖或豆纤维蛋白胶原水凝基、胶原蛋白进行混合,得混合物A;
(2)称取纯净水,加入三氯生或氯己定,色素,防腐剂,搅拌溶解,得混合物B;
(3)将混合物A加入到混合物B中,搅拌混合后,倒入真空加热搅拌锅内,先加热融化,至完全融化,再抽真空去气泡,得混合物C;
(4)将混合物C转入分装设备中,灌注成型,冷却密封,得到医用超声抑菌耦合贴片。
优选的,步骤(3)中,真空加热搅拌锅内,加热温度为70℃-90℃。
优选的,步骤(3)中,真空加热搅拌锅内,加热融化时间为1-1.5小时。
本发明医用超声抑菌耦合贴片各组分的作用如下:
凝结多糖是由微生物产生的,以β-(1→3)-糖苷键构成的水不溶性葡聚糖,是一类将其悬浊液加热后,能形成硬而有弹性的热不可逆性凝胶。凝胶多糖含膳食纤维98.6%,可用作低热、减肥、防止便秘等的功能性食品配料。
豆纤维蛋白胶原水凝基,系选用优质天然大豆经生物基因技术水解后高温瞬间干燥而成的粉末,具有胶原保护性、表面活性、保水性、粘结性、成膜性、乳化性等多方面特征。
甘油锁水、保湿、保润功能外,还具有高活性、抗氧化、促醇化等特殊功效。
胶原蛋白由动物皮提取,皮中除胶原蛋白外还含有透明质酸、硫酸软骨素等蛋白多糖,它们含有大量极性基团,是保湿因子,且有阻止皮肤中的酪氨酸转化为黑色素的作用,故胶原蛋白有纯天然保湿、美白、防皱、祛斑等作用。
三氯生是广谱抗菌剂,高效,安全,广泛用于化妆品,洗涤剂,医疗消毒及卫生保健产品的活性成分。
氯己定系阳离子表面活性剂,具有相当强的广谱抑菌、杀菌作用,是一种较好的杀菌消毒药,对革兰阳性和阴性菌的抗菌作用比苯扎溴铵强。
防腐剂:卡松,国际上公认的安全、高效、广谱性日化品限用防腐剂,不含任何重金属,能有效的抑制和灭除菌类和各种微生物。
医用超声抑菌耦合贴片成份中胶原蛋白与凝结多糖/豆纤维蛋白胶原水凝基,甘油的组合能增加凝胶的强度,同时具有保湿,美白皮肤的功效,三氯生/氯己定的添加更利于皮肤表面的消毒及对超声头的消毒。
本发明提供的医用超声抑菌耦合贴片可根据实际需要加工成不同的形状和尺寸,其中圆形规格可以为,直径100mm×5mm、直径120mm×5mm。
本发明提供的医用超声抑菌耦合贴片使用范围:超声影像领域(诊断系统),超声治疗领域,激光治疗领域,其他领域:如超声手术监控、超声聚焦治疗子宫肌瘤、体外冲击波疗法等。
适合领域:内脏的检查;眼部的检查;手指、腕、肘、肩、膝、踝、脚趾等小关节的检查;颈动脉、肌腱、乳腺、甲状腺、皮下肿瘤、皮肤癌等人体浅表部位的检查;手术的监控;人体敏感、隐私部位的检查;超声理疗和超声的治疗;妇女分娩时产程的监控等。
采用上述技术方案所产生的有益效果在于:
(1)本发明医用超声抑菌耦合贴片是一种透明、柔软、可弯曲、性能稳定、可降解水性高分子凝胶,不含硅油、各类矿物油以及其它导致硅橡胶膨胀和损坏的物质,生物稳定;对皮肤无刺激,无损伤;
(2)本发明医用超声抑菌耦合贴片对超声波有高传导率,因此获得的图像更清晰;而且自带消毒功能,无需探头消毒,有效防止交叉感染、环保卫生;
(3)本发明医用超声抑菌耦合贴片能有效延长超声探头使用寿命,有效避免超声波的“视觉盲区”;
(4)本发明医用超声抑菌耦合贴片使用时不粘皮肤和仪器探头,不粘污衣物,用后不用清理,使用方便、卫生;不磨损仪器探头,可节省其磨损修复的昂贵费用;
(5)本发明医用超声抑菌耦合贴片固态、长时超声,影像清晰,一次性,长时使用;可用于“凹凸部位,弯曲部位、浅表部位”的超声使用。
(6)本发明医用超声抑菌耦合贴片的制备方法简单,成本低,包括:配料、混料、加热抽真空、分装,即得成品。
具体实施方式
下面结合具体实施方式对本发明作进一步详细的说明;
本发明实施例中所使用的组分,均为市售产品。如:凝结多糖购自上海冠英生物科技发展有限公司 ;胶原蛋白购自郑州郑亚化工产品有限公司;甘油购自河南通商进出口有限公司;三氯生购自天津市百灵消毒剂有限责任公司;色素购自郑州红星化工有限公司;防腐剂购自郑州红星化工有限公司。
实施例1
一种医用超声抑菌耦合贴片,按重量百分比计,由以下组分组成:凝结多糖2%,甘油7%,胶原蛋白4%,三氯生0.1%,色素0.005%,防腐剂0.2%,余量为纯净水。
上述医用超声抑菌耦合贴片的制备方法,包括以下步骤:
(1)先称取相应量的甘油在搅拌桶内,再依次加入凝结多糖、胶原蛋白进行混合,得混合物A;
(2)称取所需纯净水,加入三氯生,色素,防腐剂,搅拌溶解,得混合物B;
(3)将混合物A加入到混合物B中,再次搅拌混合后,倒入真空加热搅拌锅内,加热融化1-1.5小时至完全融化,抽真空去气泡,得混合物C;
(4)将混合物C转入分装设备中,灌注成型,冷却密封,得到医用超声抑菌耦合贴片。
其中,所用设备可以是:步骤(1)和(2)使用分散机(普通螺旋桨搅拌机);步骤(3)使用真空双行星动力搅拌机;步骤(4)使用全自动固化分装一体机。
实施例2
一种医用超声抑菌耦合贴片,按重量百分比计,由以下组分组成:豆纤维蛋白胶原水凝基2%,甘油5%,胶原蛋白3%,三氯生0.2%,防腐剂0.3%,余量为纯净水。
上述医用超声抑菌耦合贴片的制备方法,包括以下步骤:
(1)先称取相应量的甘油在搅拌桶内,再依次加入豆纤维蛋白胶原水凝基、胶原蛋白进行混合,得混合物A;
(2)称取所需纯净水,加入三氯生,防腐剂,搅拌溶解,得混合物B;
(3)将混合物A加入到混合物B中,再次搅拌混合后,倒入真空加热搅拌锅内,加热融化1-1.5小时至完全融化,抽真空去气泡,得混合物C;
(4)将混合物C转入分装设备中,灌注成型,冷却密封,得到医用超声抑菌耦合贴片。
其中,所用设备可以是:步骤(1)和(2)使用分散机(普通螺旋桨搅拌机);步骤(3)使用真空双行星动力搅拌机;步骤(4)使用全自动固化分装一体机。
实施例3
一种医用超声抑菌耦合贴片,按重量百分比计,由以下组分组成:凝结多糖5%,甘油10%,胶原蛋白5%,三氯生0.3%,色素0.001%,防腐剂0.5%,余量为纯净水。
上述医用超声抑菌耦合贴片的制备方法同实施例1。
实施例4
一种医用超声抑菌耦合贴片,按重量百分比计,由以下组分组成:凝结多糖3.5%,甘油8%,胶原蛋白4.5%,氯己定0.5%,色素0.008%,防腐剂0.4%,余量为纯净水。
上述医用超声抑菌耦合贴片的制备方法,包括以下步骤:
(1)先称取相应量的甘油在搅拌桶内,再依次加入凝结多糖、胶原蛋白进行混合,得混合物A;
(2)称取所需纯净水,加入氯己定,色素,防腐剂,搅拌溶解,得混合物B;
(3)将混合物A加入到混合物B中,再次搅拌混合后,倒入真空加热搅拌锅内,加热融化1-1.5小时至完全融化,抽真空去气泡,得混合物C;
(4)将混合物C转入分装设备中,灌注成型,冷却密封,得到医用超声抑菌耦合贴片。
其中,所用设备可以是:步骤(1)和(2)使用分散机(普通螺旋桨搅拌机);步骤(3)使用真空双行星动力搅拌机;步骤(4)使用全自动固化分装一体机。
实施例5
一种医用超声抑菌耦合贴片,按重量百分比计,由以下组分组成:凝结多糖4%,甘油6%,胶原蛋白4%,三氯生0.2%,色素0.003%,防腐剂0.25%,余量为纯净水。
上述医用超声抑菌耦合贴片的制备方法同实施例1。
实施例6
一种医用超声抑菌耦合贴片,按重量百分比计,由以下组分组成:凝结多糖1.5%,甘油6%,胶原蛋白3.5%,三氯生0.15%,色素0.006%,防腐剂0.25%,余量为纯净水。
上述医用超声抑菌耦合贴片的制备方法同实施例1。
本发明医用超声抑菌耦合贴片,依照下述标准进行试验,完全合格。
依据YY/0299-2008《医用超声耦合剂》标准,对该产品的生物相容性、稳定性、性能等进行试验。抑菌作用依据GB/15979-2002《一次性使用卫生用品卫生标准》。
1、皮肤的刺激与迟发反应:依据GB/T 16886.10-2005 医疗器械生物学评价 第10部分:刺激与迟发型超敏反应试验 。
2、稳定性:依据YY/0299-2008.6.3项试验方法进行试验。
3、性能指标:依据YY/0299-2008.6.2项试验方法进行试验。
4、抑菌作用:依据GB/15979-2002《一次性使用卫生用品卫生标准》附录C产品抑菌杀菌性能与稳定性测试方法进行试验。
检验报告1
检验报告2
Claims (6)
1.一种医用超声抑菌耦合贴片,其特征在于:按重量百分比计,由以下组分组成:豆纤维蛋白胶原水凝基1%-5%,
甘油5%-10%,
胶原蛋白3%-5%,
三氯生或氯己定0.05%-0.5%,
色素0%-0.01%,
防腐剂0.2%-0.5%,
余量为纯净水。
2.根据权利要求1所述的医用超声抑菌耦合贴片,其特征在于:按重量百分比计,由以下组分组成:
豆纤维蛋白胶原水凝基1.5%-2.5%,
甘油5%-7%,
胶原蛋白3%-4%,
三氯生或氯己定 0.15%-0.3%,
色素0.005%-0.01%,
防腐剂0.2%-0.3%,
余量为纯净水。
3.根据权利要求1所述的医用超声抑菌耦合贴片,其特征在于:防腐剂为卡松。
4.根据权利要求1-3任一项所述的医用超声抑菌耦合贴片的制备方法,其特征在于,包括以下步骤:
(1)先称取甘油,再依次加入豆纤维蛋白胶原水凝基、胶原蛋白进行混合, 得混合物A;
(2)称取纯净水,加入三氯生或氯己定,色素,防腐剂,搅拌溶解,得混合物B;
(3)将混合物A加入到混合物B中,搅拌混合后,倒入真空加热搅拌锅内,先加热融化,至完全融化,再抽真空去气泡,得混合物C;
(4)将混合物C转入分装设备中,灌注成型,冷却密封,得到医用超声抑菌耦合贴片。
5.根据权利要求4所述的医用超声抑菌耦合贴片的制备方法,其特征在于,步骤(3)中,真空加热搅拌锅内,加热温度为70℃-90℃。
6.根据权利要求4所述的医用超声抑菌耦合贴片的制备方法,其特征在于,步骤(3)中,真空加热搅拌锅内,加热融化时间为1-1.5小时。
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