CN105770918A - 一种医用超声耦合剂 - Google Patents
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Abstract
本发明属于医药领域,涉及一种医用超声耦合剂。针对现有技术不足,本发明提供的医用超声耦合剂,其包括如下组分:当归、防风、女贞叶、忍冬藤、薄荷、冬瓜子和祖师麻。该医用超声耦合剂所选药材配伍相宜,具有更好的耦合作用,具有高效消毒杀菌、无细胞毒性、无皮肤致敏性、无刺激性的特性,避免了交叉感染;使用本发明医用超声耦合剂进行超声检查,透声效果更加显著,超声成像更加清晰。
Description
技术领域
本发明属于医药技术领域,具体涉及一种医用超声耦合剂。
背景技术
超声检查时,探头与病人皮肤之间的空气将阻碍超声波传入人体,为获得高质量的图像,需要液性传导介质来连接探头与病人体表,这种介质就是耦合剂。
在临床操作中,普通(外用)耦合剂需与皮肤、探头辐射面密切接触,并难以避免地沾染衣物,故除声学特性外,耦合剂还须满足不刺激皮肤、不损坏探头、不脏污衣物的要求。并且用于诊断患者时,有些对象皮肤可能会带有细菌或病毒,如果被沾染到探头上,很容易会传染给下一位患者,造成交叉感染,这是在超声诊断中最不想看到的,现有的手段一般是通过对探头进行消毒来实现,但这给超声诊断带来了额外的一些工作,可能会影响诊断的效率。
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。CN103751812B公开了一种超声耦合剂及其制备方法,其组方为何首乌、当归、酸藤木、大蓟、忍冬藤、竹叶蕉、薄荷、细叶桉、蜂房、纤冠藤、单条草、马鞭草、泽漆、紫云英、茄根和祖师麻。CN103977432A公开了一种心脏彩超用超声耦合剂,其组方为:薄荷30~60份,冰片20~40份,菊花30~40份,当归20~50份,穿心莲30~50份,狼把草20~60份,竹叶蕉30~50份,青叶胆35~60份,祖师麻20~40份,黄柏30~40份,射干20~30份,竹叶防风10~15份,甘油50~80份,无菌去离子水30~50份,淀粉15-30份。
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超声耦合剂,该医用超声耦合剂由以下原料药制得:当归、防风、女贞叶、忍冬藤、薄荷、冬瓜子和祖师麻。该医用超声耦合剂所选药材配伍相宜,具有更好的耦合作用,具有高效消毒杀菌、无细胞毒性、无皮肤致敏性、无刺激性的特性,避免了交叉感染;使用本发明医用超声耦合剂进行超声检查,透声效果更加显著,超声成像更加清晰。
优选的是,它由以下重量份的原料药制得:当归20-30份、防风10-15份、女贞叶10-15份、忍冬藤5-10份、薄荷20-40份、冬瓜子10-15份和祖师麻10-20份。
更优选的是,它由以下重量份的原料药制得:当归15份、防风13份、女贞叶12份、忍冬藤8份、薄荷30份、冬瓜子12份和祖师麻15份。
当归,甘、辛,温。归肝、心、脾经。补血活血,调经止痛,润肠通便。用于血虚萎黄,眩晕心悸,月经不调,经闭痛经,虚寒腹痛,肠燥便秘,风湿痹痛,跌扑损伤,痈疽疮疡。据《本草正》载:“其味甘而重,故专能补血,其气轻而辛,故又能行血,能养血,补气生精,安五脏,强形体,益神志,凡有形虚损之病,无所不宜。”现代医学研究证实,当归具有抗菌、消炎作用。
防风,辛、甘,温。归膀胱、肝、脾经。解表祛风,胜湿,止痉。用于感冒头痛,风湿痹痛,风疹瘙痒,破伤风。
女贞叶,苦;性凉,清热明目,解毒散瘀;消肿止咳。主头目昏痛;风热赤眼;口舌生疮;牙龈肿痛;疮肿溃烂,水火烫伤;肺热咳嗽。
忍冬藤,甘,寒。归肺、胃经。清热解毒,疏风通络。用于温病发热,热毒血痢,痈肿疮疡,风湿热痹,关节红肿热痛。
薄荷,辛,凉。归肺、肝经。宣散风热。清头目,透疹。用于风热感冒,风温初起,头痛,目赤,喉痹,口疮,风疹,麻疹,胸胁胀闷。现代医学研究证实,薄荷脑能够止痒,并具有微弱的局麻及对抗刺激剂,涂于局部由于刺激神经而引起凉感,并抑制痛觉神经。
冬瓜子,甘,寒。清肺、化痰、排脓。适用于肺热咳嗽、肺痈、肠痈等症。
祖师麻,味辛;苦;性温;小毒。肺;心经。祛风通络;散瘀止痛。主风湿痹痛;四肢麻木;头痛;胃痛;跌打损伤。《陕西中草药》载:“祛风除湿,温中散寒。治感冒,风湿疼痛,中风麻木,半身不遂,皮肤痒疹。”现代医学研究证实,祖师麻对皮肤、黏膜有穿透力。
本发明医用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。
制备本发明医用超声耦合剂的方法,它包括以下步骤:
1)将当归、防风、女贞叶、忍冬藤、冬瓜子和祖师麻混合放入容器中,加药材重量的10-15倍的水,浸泡30-60分钟,煎煮2-4次,每次2-3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65℃下的检测结果,备用;
2)取薄荷加入3倍量的蒸馏水,搅拌均匀后,过滤,取滤液备用;
3)将上述步骤1)、2)所制的稠膏和滤液混合,用常规工艺制成凝胶制剂,即为所述的超声耦合剂。
本发明上述医用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,所述医用超声耦合剂可以制备成凝胶剂或水剂。
本发明还公开上述医用超声耦合剂的一种用途,本发明医用超声耦合剂经统计发现,实验组与对照Ⅰ、Ⅱ在检查后的细菌培养结果有明显差异(P<0.05)。且随意改变组方,并不能达到本发明耦合剂的效果。试验组标本培养的微生物未检测出微生物菌落,避免了交叉感染。毒性试验进一步表明,本发明耦合剂安全无刺激。
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,本发明医用超声耦合剂的制备
实施例1水剂
处方:当归15份、防风13份、女贞叶12份、忍冬藤8份、薄荷30份、冬瓜子12份和祖师麻15份。
制备方法:
1)将当归、防风、女贞叶、忍冬藤、冬瓜子和祖师麻混合放入容器中,加药材重量的12倍的水,浸泡60分钟,煎煮3次,每次3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65℃下的检测结果,备用;
2)取薄荷加入3倍量的蒸馏水,搅拌均匀后,过滤,取滤液备用;
3)将上述步骤1)、2)所制的稠膏和滤液混合,用常规工艺制备成水剂,即为所述的超声耦合剂。
实施例2凝胶剂
处方:当归15份、防风13份、女贞叶12份、忍冬藤8份、薄荷30份、冬瓜子12份和祖师麻15份。
制备方法:
1)将当归、防风、女贞叶、忍冬藤、冬瓜子和祖师麻混合放入容器中,加药材重量的12倍的水,浸泡60分钟,煎煮3次,每次3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65℃下的检测结果,备用;
2)取薄荷加入3倍量的蒸馏水,搅拌均匀后,过滤,取滤液备用;
3)将上述步骤1)、2)所制的稠膏和滤液混合,用常规工艺制成凝胶制剂,即为所述的超声耦合剂。
实施例3凝胶剂
处方:当归30份、防风15份、女贞叶15份、忍冬藤10份、薄荷40份、冬瓜子15份和祖师麻20份。
制备方法:
1)将当归、防风、女贞叶、忍冬藤、冬瓜子和祖师麻混合放入容器中,加药材重量的15倍的水,浸泡60分钟,煎煮4次,每次3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65℃下的检测结果,备用;
2)取薄荷加入3倍量的蒸馏水,搅拌均匀后,过滤,取滤液备用;
3)将上述步骤1)、2)所制的稠膏和滤液混合,用常规工艺制成凝胶制剂,即为所述的超声耦合剂。
实施例4凝胶剂
处方:当归20份、防风10份、女贞叶10份、忍冬藤5份、薄荷20份、冬瓜子10份和祖师麻10份。
制备方法:
1)将当归、防风、女贞叶、忍冬藤、冬瓜子和祖师麻混合放入容器中,加药材重量的10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65℃下的检测结果,备用;
2)取薄荷加入3倍量的蒸馏水,搅拌均匀后,过滤,取滤液备用;
3)将上述步骤1)、2)所制的稠膏和滤液混合,用常规工艺制成凝胶制剂,即为所述的超声耦合剂。
对比实施例1凝胶剂
处方:当归35份、防风10份、女贞叶12份、忍冬藤12份、薄荷45份、射干25份和祖师麻25份。
制备方法同实施例2。
第二部分,本发明医用超声耦合剂的药效学考察
试验例1本发明医用超声耦合剂的临床治疗效果
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300例临床观察,病人随机分成三组,实验组100例,其中男性64例,女性36例,年龄15-63岁,平均年龄41.6岁;对照Ⅰ组100例,其中男性56例,女性44例,年龄14-63,平均年龄43.1岁。对照Ⅱ组100例,其中男性60例,女性40例,年龄13-65,平均年龄44.0岁。三组资历基本一致,无显著差异,具有可比性。
2、方法
进行超声诊疗时:
实验组患者使用本发明实施例2制备的超声耦合剂,将产品直接涂于检查部位,将探头按压到耦合剂上进行检查,检查完毕后擦除。
对照Ⅰ组使用MIBO医用耦合剂,将产品直接涂于检查部位,将探头按压到耦合剂上进行检查,检查完毕后擦除。
对照Ⅱ组使用对比实施例1制备的超声耦合剂,将产品直接涂于检查部位,将探头按压到耦合剂上进行检查,检查完毕后擦除。
在每次超声检查前、结束后,使用表面自然菌采样规格板和浸有无菌PBS的棉拭子,对受试者皮肤上涂有耦合剂范围内5cm×5cm进行采样。根据《医疗机构消毒技术规范2012版》将采样棉拭子头用无菌操作的方式放入装有10mLPBS的无菌试管中,用电动混匀器混匀20s,形成菌悬液进行活菌培养并计数,检测微生物总数。
3、结果
经统计发现,实验组在检查前超声探头和受检皮肤的细菌培养结果分别为(281±26)CFU/cm2和(239±22)CFU/cm2;在检查后超声探头和受检皮肤的细菌培养结果分别为(2±1)CFU/cm2和(1±1)CFU/cm2。显然检查前后超声探头和受检皮肤的细菌培养结果存在很大差异(P<O.05)。
对照Ⅰ组在检查前超声探头和受检皮肤的细菌培养结果分别为(269±26)CFU/cm2和(251±22)CFU/cm2;在检查后超声探头和受检皮肤的细菌培养结果分别为(56±12)CFU/cm2和(52±10)CFU/cm2。对照Ⅰ组检查前后的细菌培养结果未见明显差异(P<0.05)。
对照Ⅱ组在检查前超声探头和受检皮肤的细菌培养结果分别为(280±25)CFU/cm2和(242±23)CFU/cm2;在检查后超声探头和受检皮肤的细菌培养结果分别为(45±10)CFU/cm2和(32±9)CFU/cm2。对照Ⅱ组检查前后的细菌培养结果未见明显差异(P<0.05)。
以上各组间检查前、各组内检查前后的细菌培养结果未见明显差异(P>0.05),但实验组与对照Ⅰ、Ⅱ在检查后的细菌培养结果有明显差异(P<0.05)。特别的是,治疗组与对照Ⅱ组比较,差异显著,具有统计学意义(P<0.05),表明随意改变组方,尽管优于对照Ⅰ组,但是仍不能达到本发明耦合剂的效果。
试验组标本培养的微生物未检测出微生物菌落。对照Ⅰ组微生物菌落经培养鉴定,确定有金黄色葡萄球菌、大肠杆菌、铜绿假单胞菌、白色念珠菌等,可引起院内感染,引起腹泻等消化道疾病和皮肤病等。对照Ⅱ组微生物菌落经培养鉴定,确定有金黄色葡萄球菌、大肠杆菌和白色葡萄球菌等被检出。
毒性试验结果:一次完整皮肤刺激试验结果表明,试验组耦合剂对家兔皮肤刺激反应积分为0,属无刺激性。变态反应试验评分为0,属无刺激性。对比Ⅰ组出现16例变态反应,对照Ⅱ组出现6例变态反应。表明本发明耦合剂安全可靠。
本发明在涂布性能、分辨率、超声图形清晰程度比较:对照Ⅱ组和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Ⅰ组,出现少量气泡。另外,三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)
1.一种医用超声耦合剂,其特征在于,它由以下原料药制得:当归、防风、女贞叶、忍冬藤、薄荷、冬瓜子和祖师麻。
2.如权利要求1所述的医用超声耦合剂,其特征在于,它由以下重量份的原料药制得:当归20-30份、防风10-15份、女贞叶10-15份、忍冬藤5-10份、薄荷20-40份、冬瓜子10-15份和祖师麻10-20份。
3.如权利要求1所述的医用超声耦合剂,其特征在于,它由以下重量份的原料药制得:当归15份、防风13份、女贞叶12份、忍冬藤8份、薄荷30份、冬瓜子12份和祖师麻15份。
4.如权利要求1-3所述的组合物,其特征在于所述医用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所述的医用超声耦合剂的方法,其特征在于,它包括以下步骤:
1)将当归、防风、女贞叶、忍冬藤、冬瓜子和祖师麻混合放入容器中,加药材重量的10-15倍的水,浸泡30-60分钟,煎煮2-4次,每次2-3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65℃下的检测结果,备用;
2)取薄荷加入3倍量的蒸馏水,搅拌均匀后,过滤,取滤液备用;
3)将上述步骤1)、2)所制的稠膏和滤液混合,制成凝胶制剂,即为所述的超声耦合剂。
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