CN105688233A - 一种医用消毒超声耦合剂 - Google Patents
一种医用消毒超声耦合剂 Download PDFInfo
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Abstract
本发明属于医药领域，涉及一种医用超声耦合。针对现有技术不足，本发明提供的医用消毒超声耦合剂，其包括如下组分：浮萍、地锦草、半截叶、管仲、地皮消、赛金刚和泽泻。该医用消毒超声耦合剂所选药材配伍相宜，使用本发明医用消毒超声耦合剂进行超声检查，超声显像更加清晰，且具有良好的杀菌效果及使用安全性，具有很好的应用前景。
Description
技术领域
本发明属于医药技术领域，具体涉及一种医用消毒超声耦合剂。
背景技术
医用超声作为一种常规的影像学检查手段，超声探头会在检查工作中被频繁地应用，由于其对身体无损害、适用于多个年龄阶段，因此进行此项检查的人数众多。超声探头会频繁地同患者的皮肤或者黏膜进行直接接触，带菌量相对较多，且种类也比较繁杂，很可能成为引发医院感染的潜在危险因素。尽管医院感染无法根除，然通过有效的控制措施等可以降低感染的发生率，医用消毒超声耦合剂的应用便可以有效对在超声检查过程中所存在的感染高危因素进行避免，从而对因超声检查而发生的感染得到了有效的控制，避免了交叉感染，对降低医院感染的发生具有重要意义。同时，为了使图像清晰，在探头与皮肤或粘膜之间也需使用耦合剂。
现有技术中也公开了很多中药超声耦合剂，但是原料不易的、不精简、价格昂贵，增加了患者的就医成本。CN105343904A公开了一种医用彩超耦合剂及制备方法，其组方为：金盏草、白芷、茶油、地肤子、浮萍、油柑叶、梓叶、樟树叶、地皮消、红天葵、半截叶、管仲、樱桃、牛乳、海松子和芦荟，共计16味药物组成。
在进行超声检查的过程中，使用耦合剂对探头与人体组织之间的空气进行驱除，从而使高效、保真的超声传播通道得以建立，为现阶段超声技术在医药领域的一个进步。为此我们需要研发一种功效明确、配伍简单、原料易得的耦合剂，更好的为患者提供检查治疗服务。
发明内容
针对目前医用消毒超声耦合剂临床药物的不足，本发明的第一个目的在于提供一种医用消毒超声耦合剂，该医用消毒超声耦合剂由以下原料药制得：浮萍、地锦草、半截叶、管仲、地皮消、赛金刚和泽泻。该医用消毒超声耦合剂所选药材配伍相宜，具有更好的耦合作用，消毒杀菌好、无皮肤致敏性，避免了医源性的交叉感染；使用本发明医用消毒超声耦合剂进行超声检查，超声成像更加清晰。
优选的是，它由以下重量的原料药制得：浮萍20-30克、地锦草10-15克、半截叶10-15克、管仲5-10克、地皮消5-15克、赛金刚10-15克和泽泻10-20克。
更优选的是，它由以下重量的原料药制得：浮萍15克、地锦草13克、半截叶12克、管仲8克、地皮消10克、赛金刚12克和泽泻15克。
浮萍，辛，寒。归肺经。宣散风热，透疹，利尿。用于麻疹不透，风疹瘙痒，水肿尿少。《本经》载：“主暴热身痒，下水气，胜酒，长须发，止消渴。”
地锦草，辛，平。归肝、大肠经。清热解毒，凉血止血。用于痢疾，泄泻，咳血，尿血，便血，崩漏，疮疖痈肿。
半截叶，味微苦，性温。活血舒筋，燥湿杀虫。用于风湿性关节炎，跌打骨折，肝炎疟疾，蛔虫病。《云南中草药选》载：“燥湿，止血，消炎，生肌。治风湿腰痛，肝炎，肝硬化，肿瘤，跌打损伤，骨折。”
管仲，味苦，性平。清热消炎，凉血止血。用于赤白痢疾，肠炎胃痛，肺结核咯血，鼻衄便血，血崩，外伤出血，疔疮。《云南思茅中草药选》载：“清热止血，消炎收敛。治痢疾，肠炎，胃痛，咯血，吐血，外伤出血，痛经。”
地皮消，味甘、淡，性平；归肺、脾经。清热解毒，散瘀消肿。用于肺炎，扁桃体炎，腮腺炎，瘰疬，脓肿疮毒，骨折，创伤感染。《云南中草药》载：“清热解毒，消肿止痛。治骨折，淋巴结结核，腮腺炎，外伤出血。”
赛金刚，《云南思茅中草药选》：苦涩，寒。《云南思茅中草药选》：清热解毒，消炎杀菌，收敛止痛。治菌痢，急性肠胃炎，胃及十二指肠溃疡，脘腹痛，腹泻，尿路感染，高热，咽喉炎，扁桃体炎，便血，神经衰弱。
泽泻(根茎)又是传统的中药之一。中医理论认为其性寒，具有利水渗湿的功效；主治泄热通淋、小便不利、热淋涩痛、水肿胀满、泄泻、痰饮眩晕等症。现代医学研究，泽泻可降低血清总胆固醇及三酰甘油含量，减缓动脉粥样硬化形成；泽泻及其制剂现代还用于治疗内耳眩晕症、血脂异常、遗精、脂肪肝及糖尿病等。
本发明医用消毒超声耦合剂利用传统中药，配伍合理，诸药合用，不仅具有更好的耦合作用，还具有显著消毒杀菌之功效，避免了医源性交叉感染。可用于与皮肤、粘膜接触(包括阴道、眼部、食道、直肠和会阴部位)的超声操作。
制备本发明医用消毒超声耦合剂的方法，它包括以下步骤：
1)将处方量的中药材混合放入容器中，加药材重量的5-8倍的水，浸泡30分钟，煎煮2次，每次2小时，滤过，合并滤液，滤液减压浓缩至相对密度1.11-1.16的稠膏，该相对密度是在60℃下的检测结果，备用；
2)步骤1)所制稠膏中加入乙醇至含醇量为75％(v/v)，静置12小时，取上清液，回收乙醇，上清液浓缩，备用；
3)将上述步骤2)所制的上清液浓缩后，用常规工艺制成凝胶制剂，即为所述的医用消毒超声耦合剂。
本发明上述医用消毒超声耦合剂可以进一步制备成临床上常用的药物制剂。优选的是，所述医用消毒超声耦合剂可以制备成凝胶剂或水剂。
该消毒超声耦合剂原液对载体上金黄色葡萄球菌、白色念珠菌、大肠埃希菌、铜绿假单胞菌均作用5min，杀灭对数值均＞5.00。将该消毒超声耦合剂原液涂抹在病人皮肤上作用5min，对皮肤上自然菌的平均杀灭对数值＞2.00。该消毒超声耦合剂对人体皮肤无刺激性，图像清晰，对超声探头无腐蚀。然而，随意改变组方，不能达到本发明的效果。由此，该消毒超声耦合剂具有良好的杀菌效果及使用安全性。
总之，本发明与现有技术相比具有预料不到的显著效果，其有益效果具体是：具有更好的耦合作用、对人体无毒无害、无皮肤刺激性，无油腻性，具有较好的杀菌消毒作用，不损伤探头，不会污染衣物易清洗，且制备简单，原料易得、配伍简单、成本低，适于大众化使用，使用本发明的耦合剂进行超声检查，超声显像更加清晰，具有很好的应用前景。
具体实施方式
以下通过具体实施方式进一步描述本发明，但本发明不仅仅限于以下实施例。在本发明的范围内或者在不脱离本发明的内容、精神和范围内，对本发明所述的医用消毒超声耦合剂进行适当改进、替换功效相同的组分，对于本领域技术人员来说是显而易见的，它们都被视为包括在本发明的范围之内。
第一部分，本发明医用消毒超声耦合剂的制备
实施例1水剂
处方：浮萍15克、地锦草13克、半截叶12克、管仲8克、地皮消10克、赛金刚12克和泽泻15克。
制备方法：
1)将处方量的中药材混合放入容器中，加药材重量的6倍的水，浸泡30分钟，煎煮2次，每次2小时，滤过，合并滤液，滤液减压浓缩至相对密度1.11-1.16的稠膏，该相对密度是在60℃下的检测结果，备用；
2)步骤1)所制稠膏中加入乙醇至含醇量为75％(v/v)，静置12小时，取上清液，回收乙醇，上清液浓缩，备用；
3)将上述步骤2)所制的上清液浓缩后，用常规工艺制成凝胶制剂，即为所述的医用消毒超声耦合剂。
实施例2凝胶剂
处方：浮萍15克、地锦草13克、半截叶12克、管仲8克、地皮消10克、赛金刚12克和泽泻15克。
制备方法：
1)将处方量的中药材混合放入容器中，加药材重量的7倍的水，浸泡30分钟，煎煮2次，每次2小时，滤过，合并滤液，滤液减压浓缩至相对密度1.11-1.16的稠膏，该相对密度是在60℃下的检测结果，备用；
2)步骤1)所制稠膏中加入乙醇至含醇量为75％(v/v)，静置12小时，取上清液，回收乙醇，上清液浓缩，备用；
3)将上述步骤2)所制的上清液浓缩后，用常规工艺制成凝胶制剂，即为所述的医用消毒超声耦合剂。
实施例3凝胶剂
处方：浮萍30克、地锦草15克、半截叶15克、管仲10克、地皮消15克、赛金刚15克和泽泻20克。
制备方法：
1)将处方量的中药材混合放入容器中，加药材重量的8倍的水，浸泡30分钟，煎煮2次，每次2小时，滤过，合并滤液，滤液减压浓缩至相对密度1.11-1.16的稠膏，该相对密度是在60℃下的检测结果，备用；
2)步骤1)所制稠膏中加入乙醇至含醇量为75％(v/v)，静置12小时，取上清液，回收乙醇，上清液浓缩，备用；
3)将上述步骤2)所制的上清液浓缩后，用常规工艺制成凝胶制剂，即为所述的医用消毒超声耦合剂。
实施例4凝胶剂
处方：浮萍20克、地锦草10克、半截叶10克、管仲5克、地皮消5克、赛金刚10克和泽泻10克。
制备方法：
1)将处方量的中药材混合放入容器中，加药材重量的5倍的水，浸泡30分钟，煎煮2次，每次2小时，滤过，合并滤液，滤液减压浓缩至相对密度1.11-1.16的稠膏，该相对密度是在60℃下的检测结果，备用；
2)步骤1)所制稠膏中加入乙醇至含醇量为75％(v/v)，静置12小时，取上清液，回收乙醇，上清液浓缩，备用；
3)将上述步骤2)所制的上清液浓缩后，用常规工艺制成凝胶制剂，即为所述的医用消毒超声耦合剂。
对比实施例1凝胶剂
处方：浮萍75克、地锦草10克、半截叶55克、管仲53克、地皮消60克、白芷75克和泽泻45克。
制备方法同实施例2。
第二部分，本发明医用消毒超声耦合剂的药效学考察
试验例1本发明医用消毒超声耦合剂的临床消毒效果
1)临床资料
作为辅助超声诊疗的耦合剂，选择超声诊疗患者100例临床观察，所有患者检查部位的皮肤均完整无病变、溃烂。其中男性57例，女性43例，年龄18-69岁，平均年龄51.3岁。病人随机分为两组，且两组患者资历基本一致，无显著差异，具有可比性。
2)皮肤消毒现场实验
检查前在其腹部，用无菌棉拭子沾湿采样液涂抹采样10cm×3cm范围作为消毒前对照。然后取医用超生消毒超声耦合剂原液3～5ml均匀涂抹于腹部，按探头检查顺序均匀涂抹5min后，用无菌棉拭子沾湿采样液按上述方法涂抹采样作为试验组。将采样棉拭头无菌剪入装有10ml中和剂(中和剂为D/E中和肉汤，为美国BD公司生产)的试管内，经充分震荡洗脱，取洗脱液接种培养，作活菌计数，计算杀灭对数值。
3)安全性观察
在每个被检查者使用该耦合剂之后，收集不良反应(刺激或瘙痒等)，观察皮肤变化(红疹、斑块、起泡等局部反应)；同时观察超声探头是否出现腐蚀、溶胀情况及声像图效果。
4)结果
结果表明，将该消毒超声耦合剂原液涂抹在病人皮肤上作用5min，对皮肤上自然菌的平均杀灭对数值2.06，消毒前平均检出菌数为189cfu/cm2。该消毒超声耦合剂对人体皮肤无刺激性，对超声探头无腐蚀，图像清晰。
同条件下，对照Ⅱ组(本发明对比实施例1制备的医用消毒超声耦合剂)耦合剂原液涂抹在病人皮肤上作用5min，对皮肤上自然菌的平均杀灭对数值1.03，消毒前平均检出菌数为186cfu/cm2。该消毒超声耦合剂对人体皮肤无刺激性，对超声探头腐蚀较小，也可长期使用，图像较为清晰。
由此说明，该消毒超声耦合剂具有良好的杀菌效果及使用安全性。
试验例2
1)试验菌株
试验菌株为金黄色葡萄球菌(ATCC6538)、大肠杆菌(8099)、铜绿假单胞菌(ATCC15442)、白色念珠菌(ATCC10231)，由医院检验科提供。
2)载体定量杀菌试验方法
(1)菌悬液及染菌载体制备
将各试验菌经分离纯化培养，取单个典型菌落接种营养琼脂培养基斜面，培养24h用其新鲜斜面培养物。用营养肉汤洗下斜面上菌苔，经充分震荡混匀并用浓度为1000mg/L的胰蛋白胨生理盐水(TPS)稀释成含菌量1.0×108～5.0×108cfu/ml试验菌液。分别取20菌悬液滴染在lcm×1cm无菌布片上，经37℃温箱烘烤15min，即制成染菌载体，回收菌量范围5.0×105～5.0×106cfu/片。
(2)中和剂鉴定实验
以金黄色葡萄球菌、白色念珠菌为试验菌，设计6组，按载体定量杀菌试验方法进行。结果第1组有极少量菌生长或无菌生长；第2组有菌生长且明显少于3、4、5组，但多于第1组；第3、4、5组菌数接近且符合阳性对照组菌数要求，第6组无菌生长。符合上述条件，试验重复3次结果一致，判定所选中和剂及其浓度适宜。
(3)杀菌试验
采用载体定量杀菌试验方法，在20％条件下进行试验。按每个菌片5.0ml用量将试验用消毒剂分装在无菌平皿内，将菌片完全浸泡在消毒超声耦合剂内(分三组，阳性对照用TPS)。作用至规定时间，取出菌片投人到装有5.0ml中和剂的试管内，中和作用10min后经充分震荡洗脱，取洗脱液接种培养，进行活菌计数，计算平均杀灭对数值。所有试验至少重复3次。
三组分别是实验组、对照Ⅰ组、对照Ⅱ组。其中实验组为本发明实施例2制备的医用消毒超声耦合剂；对比Ⅰ组为阳性对照用TPS；对照Ⅱ组为本发明对比实施例1制备的医用消毒超声耦合剂。
3)试验结果
经3次试验结果表明，用D/E中和肉汤作为该消毒超声耦合剂的中和剂，可有效中和其对试验菌的残留作用，中和剂本身及其中和产物对试验菌生长及培养基无影响(表1)。
表1.耦合剂中和剂鉴定结果
载体浸泡定量杀菌试验结果表明，用受试剂作用5min，对金黄色葡萄球菌、大肠埃希菌、铜绿假单胞菌、白色念珠菌的平均杀灭对数值均＞5.00。而对照Ⅱ组用受试剂作用5min，对金黄色葡萄球菌、大肠埃希菌、铜绿假单胞菌、白色念珠菌的平均杀灭对数值均≥4.00。具体杀菌试验结果见表2。
表2.耦合剂杀菌试验结果
同时，本发明在涂布性能、分辨率、超声图形清晰程度比较：试验组的耦合剂均质地细腻均匀，不含气泡，稠度适宜、使用时不会流淌、易挤出，涂布性能良好，不易干燥，探头滑动良好，分辨率高，超声图像清晰，但是对照Ⅱ组，出现少量气泡。另外，试验组和对照Ⅱ组均无明显皮肤黏膜刺激；长期使用后，对探头也没有明显腐蚀。
综上，本发明提供了一种含中药成分的医用消毒超声耦合剂及其制备方法，该耦合剂所选中药材组方精简，配伍合理，具有耦合及抗菌消毒的显著功效，无毒副作用，安全可靠，值得临床推广应用。另外，本发明提供的制备中药组合物的方法，利用现代制备工艺快速提取该组合物的有效成分，该方法简单易行，适合大批量推广生产。
Claims (5)
1.一种医用消毒超声耦合剂，其特征在于，它由以下原料药制得：浮萍、地锦草、半截叶、管仲、地皮消、赛金刚和泽泻。
2.如权利要求1所述的医用消毒超声耦合剂，其特征在于，它由以下重量的原料药制得：浮萍20-30克、地锦草10-15克、半截叶10-15克、管仲5-10克、地皮消5-15克、赛金刚10-15克和泽泻10-20克。
3.如权利要求1所述的医用消毒超声耦合剂，其特征在于，它由以下重量的原料药制得：浮萍15克、地锦草13克、半截叶12克、管仲8克、地皮消30克、赛金刚10克和泽泻15克。
4.如权利要求1-3所述的组合物，其特征在于所述医用消毒超声耦合剂优选为凝胶剂或水剂。
5.一种制备如权利要求4所述的医用消毒超声耦合剂的方法，其特征在于，它包括以下步骤：
1)将处方量的中药材混合放入容器中，加药材重量的5-8倍的水，浸泡30分钟，煎煮2次，每次2小时，滤过，合并滤液，滤液减压浓缩至相对密度1.11-1.16的稠膏，该相对密度是在60℃下的检测结果，备用；
2)步骤1)所制稠膏中加入乙醇至含醇量为75％(v/v)，静置12小时，取上清液，回收乙醇，上清液浓缩，备用；
3)将上述步骤2)所制的上清液浓缩后，用常规工艺制成凝胶制剂，即为所述的医用消毒超声耦合剂。
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