CN105560763A - 中药组合物皮肤消毒液 - Google Patents
中药组合物皮肤消毒液 Download PDFInfo
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- CN105560763A CN105560763A CN201610105681.7A CN201610105681A CN105560763A CN 105560763 A CN105560763 A CN 105560763A CN 201610105681 A CN201610105681 A CN 201610105681A CN 105560763 A CN105560763 A CN 105560763A
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Abstract
本发明提供了一种用于皮肤消毒的消毒液,其原料包括黄连、黄柏、鱼腥草、紫花地丁、板蓝根、野菊花、蒲公英、木鳖子、土荆皮、蜂房、大蒜、硼砂、炉甘石、刺猬皮、白鲜皮、蛇床子、鹤虱、芜荑、皂角刺、儿茶和生甘草。用于皮肤消毒的中药成分、丙二醇、去离子水、无水乙醇、壬基酚聚氧乙烯醚和十二烷基硫酸钠。本发明提供的上述用于皮肤消毒的消毒液具有较强的杀菌作用,且对皮肤基本无刺激、无毒副作用,性能稳定,不易挥发,无难闻气味,不会产生耐药性,弥补了现行消毒液的不足,值得推广使用。
Description
技术领域
本发明涉及中医药技术领域,尤其涉及一种中药组合物皮肤消毒液。
背景技术
伤口皮肤感染是当前医学发展中的常见问题,越来越受到医学界的重视和关注。据文献报道,发生医院伤口皮肤感染的患者约占住院患者总数的5%~10%。我国每年因医院感染造成的损失约为10亿元。而防止皮肤感染一个非常重要的方式就是定期采用消毒液对伤口皮肤进行定期消毒。
目前虽然市面上消毒液及用品的种类很多,但大多为化学合成药剂,如烷基化物类消毒液、过氧化物类消毒液、酚类消毒液、胍类消毒液等。这些消毒液及其制品效果比较肯定,可是存在一些问题,如皮肤刺激性强、异味大、稳定性差等,采用这些化学合成类的皮肤消毒液可造成手部皮肤干涩、粗糙、脱皮甚至裂口,而其令人不悦的气味也影响其临床使用。有的产品还将用人工合成的激素作添加剂,当它们与人体皮肤长期或过量接触时就会对人体皮肤产生较大的副作用,同时使人体的皮肤患部病毒和细菌产生一定程度的耐药性,使得人体的皮肤患病部位病症反复频繁发作,难以根治。为了开发高效、低毒的消毒液新产品,从天然植物中寻找有灭菌、抑菌作用的药物成为一个重要课题。
本发明从天然植物中寻找具有灭菌、抑菌的中药成分,通过大量的实验研究,提供了一种中药组合物皮肤消毒液,其对金黄色葡萄球菌、绿脓杆菌、大肠杆菌、白色念株菌等病原微生物均有较强的杀灭作用,且对皮肤基本无刺激、无毒副作用,性能稳定,不易挥发,无难闻气味,不会产生耐药性,弥补了现行消毒液的不足,值得推广使用。
发明内容
本发明所要解决的技术问题是提供一种用于院内防治感染的纯中药皮肤消毒液,其具有较强的杀菌作用,且对皮肤基本无刺激、无毒副作用,性能稳定,不易挥发,无难闻气味,不会产生耐药性,弥补了现行消毒液的不足,值得推广使用。
为解决上述技术问题,本发明提供了一种用于皮肤消毒的消毒液的中药成分,其原料药包括黄连、黄柏、鱼腥草、紫花地丁、板蓝根、野菊花、蒲公英、木鳖子、土荆皮、蜂房、大蒜、硼砂、炉甘石、刺猬皮、白鲜皮、蛇床子、鹤虱、芜荑、皂角刺、儿茶和生甘草。
其中,所述中药成分中各原料药的重量分别为黄连35g~50g、黄柏25g~30g、鱼腥草10g~20g、紫花地丁10g~20g、板蓝根20g~25g、野菊花15g~25g、蒲公英10g~15g、木鳖子15g~20g、土荆皮10g~15g、蜂房10g~20g、大蒜15g~25g、硼砂10g~15g、炉甘石15g~20g、刺猬皮5g~10g、白鲜皮10g~20g、蛇床子15g~25g、鹤虱5g~10g、芜荑10g~20g、皂角刺10g~20g、儿茶15g~25g和生甘草15g~20g。
其中,所述中药成分中各原料药的重量分别为黄连40g~45g、黄柏25g~30g、鱼腥草15g~20g、紫花地丁10g~15g、板蓝根20g~25g、野菊花20g~25g、蒲公英10g~15g、木鳖子15g~20g、土荆皮10g~15g、蜂房15g~20g、大蒜20g~25g、硼砂10g~15g、炉甘石15g~20g、刺猬皮5g~10g、白鲜皮10g~15g、蛇床子20g~25g、鹤虱5g~10g、芜荑15g~20g、皂角刺10g~15g、儿茶20g~25g和生甘草15g~20g。
其中,所述中药成分中各原料药的重量分别为黄连45g、黄柏30g、鱼腥草15g、紫花地丁15g、板蓝根20g、野菊花20g、蒲公英10g、木鳖子20g、土荆皮10g、蜂房15g、大蒜20g、硼砂10g、炉甘石15g、刺猬皮5g、白鲜皮15g、蛇床子20g、鹤虱5g、芜荑15g、皂角刺15g、儿茶20g和生甘草20g。
本发明还提供一种用于皮肤消毒的消毒液,其原料包括上述中药成分、丙二醇、去离子水、无水乙醇、壬基酚聚氧乙烯醚和十二烷基硫酸钠。
其中,所述消毒液中各原料的重量分别为上述中药成分10g~15g、丙二醇2g~3g、去离子水60g~80g、无水乙醇10g~15g、壬基酚聚氧乙烯醚0.3g~0.5g和十二烷基硫酸钠0.05g~0.2g。
本发明还提供了上述消毒液的制备方法,其包括:
第一步,将鱼腥草、木鳖子、土荆皮、蜂房、大蒜、硼砂、炉甘石、刺猬皮、白鲜皮、蛇床子、鹤虱和皂角刺混合在一起,将混合均匀后的混合物溶解于相对于其质量5~8倍量的醇浓度为85%~95%的乙醇中,浸渍24小时~36小时,随后采用渗漉法以每分钟1~2ml的速度缓缓渗漉,收集渗漉液,渗漉液静置过夜,过滤,过滤液除去溶剂,粉碎,过200目筛,获得第一粉末;
第二步,将余下原料药混合在一起,获得混合物,加入相对于混合物5~10倍量的醇浓度为70%~80%乙醇中浸泡1~2小时,加热提取2次,每次1~2小时,合并提取液,静置后去上清液,然后100~120目滤过,再经截流分子量为5000目~10000目的超滤柱超滤,超滤液减压浓缩获得干膏,粉碎,过200目筛,获得第二粉末,与第一粉末混合,获得中药成分;
第三步,按重量称取去离子水,将一半的去离子水加热到60~70℃后,加入反应釜中,然后加入上述重量的壬基酚聚氧乙烯醚和十二烷基硫酸钠搅拌均匀,等温度降到30~40℃时,加入上述重量的中药成分及剩余的去离子水和无水乙醇搅拌均匀,过滤,得到消毒液。
有益的技术效果
本发明提供的用于院内防治感染的纯中药皮肤消毒液,其具有较强的杀菌作用,且对皮肤基本无刺激、无毒副作用,性能稳定,不易挥发,无难闻气味,不会产生耐药性,弥补了现行消毒液的不足,值得推广使用。
具体实施方式
本发明提供了一种用于皮肤消毒的消毒液的中药成分,其原料药包括黄连、黄柏、鱼腥草、紫花地丁、板蓝根、野菊花、蒲公英、木鳖子、土荆皮、蜂房、大蒜、硼砂、炉甘石、刺猬皮、白鲜皮、蛇床子、鹤虱、芜荑、皂角刺、儿茶和生甘草。
院内感染是一直困扰医生治疗,也是患者护理的一个难题,常用消毒液皮肤刺激性强、异味大、稳定性差等,采用这些化学合成类的皮肤消毒液可造成手部皮肤干涩、粗糙、脱皮甚至裂口,有时会加重患者感染风险,因此本发明中药消毒液用于皮肤消毒使用,采用纯天然中药成分提取,通过临床结合实验研究,筛选出其中用于广谱杀毒、灭菌中药,也就是中医的清热解毒、杀虫疗癣的中药,对于普通的细菌具有很好的杀灭作用,对于院内感染金黄色葡萄球菌、铜绿假单胞菌、白色念珠菌等高度耐药菌,亦有很好的抑制作用。其组方思路如下:使用黄连、黄柏、鱼腥草、紫花地丁、板蓝根、野菊花、蒲公英,清热泻火、燥湿解毒,中医认为细菌等多外邪,又因其致病特性,多位火热毒邪,故用大剂量的清热泻火解毒药,迅速杀灭病菌;使用木鳖子、土荆皮、蜂房、大蒜、硼砂、炉甘石、刺猬皮、白鲜皮、蛇床子、鹤虱、芜荑、皂角刺、儿茶、生甘草,有很好的杀虫疗癣的作用,现代医学研究,上述药物及其提取物,具有很好的抑制细菌的作用,并且可以透皮吸收,如果采用雾化吸入的方式,对于因呼吸道感染的病菌亦具有很好的抑制作用。此外,通过对本发明中药制剂进行临床试验及体外抑制细菌实验,本发明中药消毒液对皮肤基本无刺激、无毒副作用,性能稳定,不易挥发,无难闻气味,不会产生耐药性,弥补了现行消毒液的不足,值得推广使用。
进一步优选,所述中药成分仅由上述原料药制备而成。
所述中药成分中各原料药的重量分别为黄连35g~50g、黄柏25g~30g、鱼腥草10g~20g、紫花地丁10g~20g、板蓝根20g~25g、野菊花15g~25g、蒲公英10g~15g、木鳖子15g~20g、土荆皮10g~15g、蜂房10g~20g、大蒜15g~25g、硼砂10g~15g、炉甘石15g~20g、刺猬皮5g~10g、白鲜皮10g~20g、蛇床子15g~25g、鹤虱5g~10g、芜荑10g~20g、皂角刺10g~20g、儿茶15g~25g和生甘草15g~20g。
进一步优选,所述中药成分中各原料药的重量分别为黄连40g~45g、黄柏25g~30g、鱼腥草15g~20g、紫花地丁10g~15g、板蓝根20g~25g、野菊花20g~25g、蒲公英10g~15g、木鳖子15g~20g、土荆皮10g~15g、蜂房15g~20g、大蒜20g~25g、硼砂10g~15g、炉甘石15g~20g、刺猬皮5g~10g、白鲜皮10g~15g、蛇床子20g~25g、鹤虱5g~10g、芜荑15g~20g、皂角刺10g~15g、儿茶20g~25g和生甘草15g~20g。
最优选,所述中药成分中各原料药的重量分别为黄连45g、黄柏30g、鱼腥草15g、紫花地丁15g、板蓝根20g、野菊花20g、蒲公英10g、木鳖子20g、土荆皮10g、蜂房15g、大蒜20g、硼砂10g、炉甘石15g、刺猬皮5g、白鲜皮15g、蛇床子20g、鹤虱5g、芜荑15g、皂角刺15g、儿茶20g和生甘草20g。
各原料药药理如下:
黄连:味苦,性寒,入心、肺、胆、胃、大肠经,有清热燥湿,泻火解毒,凉血明目的作用,常用于治疗泻心经之火,心火旺之心烦不眠,及温热病之壮热神昏、心烦、口渴等证。
黄柏:拉丁名PhellodendriChinensisCortex,味苦,性寒,入肾、膀胱、大肠经,清热燥湿,泻火解毒,除骨蒸清虚热。用于湿热泻痢,黄疸,带下,热淋,脚气,痿辟,骨蒸劳热,盗汗,遗精,疮疡肿毒,湿疹瘙痒等证,黄柏对多种革兰氏阳性细菌具有良好的抗菌作用。
鱼腥草:拉丁名houttuyniaeherba,味辛,性微寒,入肺、膀胱经,具有清热解毒,排脓消痈,利尿通淋的功效,用于肺痈吐脓,痰热咳喘,热毒血痢,湿热淋证,热毒疮痈,蛇虫要上等证。
紫花地丁:味苦、辛,性寒,入心、肝经,具有清热解毒、凉血消肿的作用,主要用于治疗疔痈疮疖的治疗,对急性结膜炎、麦粒肿等也具有较好疗效,紫花地丁对黄金色葡萄球菌、肺炎杆菌、大肠杆菌、甲型链球菌、乙型链球菌、流感杆菌、白喉杆菌、绿脓杆菌、白色葡萄糖球菌、白色念珠菌有不同程度的抑制作用。
板蓝根:拉丁名IsatidisRadix,味苦、性寒,入心、肝、胆、胃经,有清热解毒、凉血利咽的作用,用于治疗温毒发斑;高热头痛;大头瘟疫;舌绛紫暗,烂喉丹痧;丹毒;痄腮;喉痹;疮肿、痈肿;水痘;麻疹;肝炎;流行性感冒,流脑,乙脑,肺炎,神昏吐衄,咽肿,火眼,疮疹;可防治流行性乙型脑炎、急慢性肝炎、流行性腮腺炎、骨髓炎等证。
野菊花:性微寒,味苦、辛,归肺、肝经,具有清热解毒、疏风平肝的功效,主治疔疮,痈疽,瘰疠、丹毒,湿疹,疥癣,风热感冒,咽喉肿痛,眩晕头痛,目赤热痛等证,野菊花对金黄色葡萄球菌、白喉杆菌、链球菌、绿脓杆菌、蒺疾杆菌、流感病毒,均有抑制作用。
蒲公英:味甘、苦,性寒,入肝、胃经,具有清热解毒、消痈散结、清肝明目、利尿通淋的作用,主要用于疮疡肿毒的治疗,对乳痈效果尤其显著,亦可用于肝火上炎之目赤肿痛等症状的治疗,此外,还具有利尿除湿的作用,用于治湿热黄疸、小便不利、泌尿系统感染等病症的治疗。
木鳖子:苦微甘,性温,有毒,入肝、脾、胃经,具有消肿散结,祛毒的功效,主治痈肿、疔疮、瘰疬、痔疮、无名肿毒、癣疮,风湿痹痛,筋脉拘挛,《开宝本草》:主折伤,消结肿恶疮,生肌,止腰痛,除粉刺酐蹭,妇人乳痈,肛门肿痛。
土荆皮:拉丁名PseudolaricisCortex,味辛,性温,归肺、脾经,具有杀虫,止痒的功效,主治疥癣瘙痒。
蜂房:味甘,性平,入胃经,具有祛风止痛,攻毒消肿,杀虫止痒的作用,用于风湿顽痹,风虫牙痛,痈疽疮毒,咽喉肿痛,风疹瘙痒,阳痿,遗尿等证。
大蒜:性温,味辛平;入脾、胃、肺经,具有温中消食、行滞气、暖脾胃、消积、解毒、杀虫的功效,主治饮食积滞、脘腹冷痛、水肿胀满、泄泻、痢疾、疟疾、百日咳、痈疽肿毒、白秃癣疮、蛇虫咬伤以及钩虫、蛲虫等病症。
硼砂:味甘、咸,性凉,归肺、胃经,外用清热解毒,消肿,防腐;内服清肺化痰。用于急性扁桃体炎,咽喉炎,咽喉肿痛,口舌生疮,口腔炎,齿龈炎,中耳炎,目赤肿痛,汗斑,为五官科疾患的常用药,内服用于痰热咳嗽,噎隔,但现代少用。
炉甘石:拉丁名Calamina,味甘,性平,归胃经,具有解毒明目退翳,收湿止痒敛疮的功效,用于目赤肿痛,眼缘赤烂,翳膜胬肉,溃疡不敛,脓水淋漓,湿疮,皮肤瘙痒等证。
刺猬皮:味苦、甘,性平,归胃、大肠、肾经,具有化瘀止痛,收敛止血,固精的功效。用于胃脘疼痛,子宫出血,便血,肠风下血,脱肛,痔疮,遗精,遗尿等证。
白鲜皮:拉丁名DictamniCortex,味苦,咸,性寒,归脾经;肺经;小肠经;胃经;膀胱经,具有清热燥湿;祛风止痒;解毒的功效,主治风热湿毒所致的风疹;湿疹;疥癣;黄疸;湿热痹痛等证。
蛇床子:拉丁名cnidiifructus,味辛、苦,性温,入肾经,具有温肾壮阳、燥湿杀虫、祛风止痒的作用,用于肾阳虚衰引起的男子阳痿、女子宫冷不孕,寒湿带下或腰膝冷痛等症。
鹤虱:味苦、辛,性平,归脾、胃经,具有杀虫消积的功效,用于蛔虫病,蛲虫病,绦虫病,虫积腹痛,小儿疳积等证。
芜荑:味辛、苦,性温。归脾、胃经,具有杀虫消积的功效,用于小儿疳积,蛔虫病,蛲虫病。
皂角刺:味辛,性温,归肺经,主治痈疽肿毒,瘰疬,疮疹顽癣,产后缺乳,胎衣不下,疠风等证。
儿茶:味苦、涩,性微寒,归肺经,具有收湿生肌敛疮的功效,用于溃疡不敛,湿疹,口疮,跌扑伤痛,外伤出血等证。
生甘草:味甘,性平,入十二经,有清热解毒,调和药性,祛痰止咳的作用,并能健脾和中,缓急止痛,主要用于脾胃虚弱之腹胀纳呆,乏力;能缓解腹中拘挛性疼痛,缓和某些药物的烈性和毒性,减轻药物对机体的毒副作用或对胃肠道的刺激,通过加入甘草能起到补气中和,调和各组分的作用。
本发明还提供一种用于皮肤消毒的消毒液,其原料包括上述中药成分、丙二醇、去离子水、无水乙醇、壬基酚聚氧乙烯醚和十二烷基硫酸钠。
所述消毒液中各原料的重量分别为上述中药成分10g~15g、丙二醇2g~3g、去离子水60g~80g、无水乙醇10g~15g、壬基酚聚氧乙烯醚0.3g~0.5g和十二烷基硫酸钠0.05g~0.2g。
进一步优选,所述消毒液中各原料的重量分别为上述中药成分12g、丙二醇3g、去离子水70g、无水乙醇10g、壬基酚聚氧乙烯醚0.3g和十二烷基硫酸钠0.1g。
本发明还提供了上述消毒液的制备方法,其包括:
第一步,将鱼腥草、木鳖子、土荆皮、蜂房、大蒜、硼砂、炉甘石、刺猬皮、白鲜皮、蛇床子、鹤虱和皂角刺混合在一起,将混合均匀后的混合物溶解于相对于其质量5~8倍量的醇浓度为85%~95%的乙醇中,浸渍24小时~36小时,随后采用渗漉法以每分钟1~2ml的速度缓缓渗漉,收集渗漉液,渗漉液静置过夜,过滤,过滤液除去溶剂,粉碎,过200目筛,获得第一粉末;
第二步,将余下原料药混合在一起,获得混合物,加入相对于混合物5~10倍量的醇浓度为70%~80%乙醇中浸泡1~2小时,加热提取2次,每次1~2小时,合并提取液,静置后去上清液,然后100~120目滤过,再经截流分子量为5000目~10000目的超滤柱超滤,超滤液减压浓缩获得干膏,粉碎,过200目筛,获得第二粉末,与第一粉末混合,获得中药成分;
第三步,按重量称取去离子水,将一半的去离子水加热到60~70℃后,加入反应釜中,然后加入上述重量的壬基酚聚氧乙烯醚和十二烷基硫酸钠搅拌均匀,等温度降到30~40℃时,加入上述重量的中药成分及剩余的去离子水和无水乙醇搅拌均匀,过滤,得到消毒液。
本发明提供的伤口皮肤消毒液对人体皮肤表面的各种炎症具有消炎杀菌、活血化瘀、祛腐生肌、消肿止痒止痛的疗效,在消毒的同时,活血化瘀,祛腐生肌,可以有效地增强人体皮肤细胞蛋白酶的活性,改善人体皮肤表面组织的局部血液循环,促进人体表皮组织的新陈代谢和创面愈合。
以下采用实施例来详细说明本发明的实施方式,借此对本发明如何应用技术手段来解决技术问题,并达成技术效果的实现过程能充分理解并据以实施。
实施例1皮肤消毒中药成分1
将鱼腥草15g、木鳖子20g、土荆皮10g、蜂房15g、大蒜20g、硼砂10g、炉甘石15g、刺猬皮5g、白鲜皮15g、蛇床子20g、鹤虱5g和皂角刺15g混合在一起,将混合均匀后的混合物溶解于1kg的醇浓度为95%的乙醇中,浸渍30小时,随后采用渗漉法以每分钟2ml的速度缓缓渗漉,收集渗漉液,渗漉液静置过夜,过滤,过滤液除去溶剂,粉碎,过200目筛,获得第一粉末,将黄连45g、黄柏30g、紫花地丁15g、板蓝根20g、野菊花20g、蒲公英10g、芜荑15g、儿茶20g和生甘草20g混合在一起,获得混合物,加入1.5kg的醇浓度为80%乙醇中浸泡2小时,加热提取2次,每次2小时,合并提取液,静置后去上清液,然后100目滤过,再经截流分子量为10000目的超滤柱超滤,超滤液减压浓缩获得干膏,粉碎,过200目筛,获得第二粉末,与第一粉末混合,获得中药成分。
实施例2皮肤消毒中药成分2
将鱼腥草15g、木鳖子15g、土荆皮10g、蜂房15g、大蒜20g、硼砂10g、炉甘石15g、刺猬皮5g、白鲜皮10g、蛇床子20g、鹤虱5g和皂角刺10g混合在一起,将混合均匀后的混合物溶解于1kg的醇浓度为95%的乙醇中,浸渍30小时,随后采用渗漉法以每分钟2ml的速度缓缓渗漉,收集渗漉液,渗漉液静置过夜,过滤,过滤液除去溶剂,粉碎,过200目筛,获得第一粉末,将黄连40g、黄柏25g、紫花地丁10g、板蓝根20g、野菊花20g、蒲公英10g、芜荑15g、儿茶20g和生甘草15g混合在一起,获得混合物,加入1.5kg的醇浓度为80%乙醇中浸泡2小时,加热提取2次,每次2小时,合并提取液,静置后去上清液,然后100目滤过,再经截流分子量为10000目的超滤柱超滤,超滤液减压浓缩获得干膏,粉碎,过200目筛,获得第二粉末,与第一粉末混合,获得中药成分。
实施例3皮肤消毒中药成分3
将鱼腥草20g、木鳖子20g、土荆皮15g、蜂房20g、大蒜25g、硼砂15g、炉甘石20g、刺猬皮10g、白鲜皮15g、蛇床子25g、鹤虱10g和皂角刺15g混合在一起,将混合均匀后的混合物溶解于1kg的醇浓度为95%的乙醇中,浸渍30小时,随后采用渗漉法以每分钟2ml的速度缓缓渗漉,收集渗漉液,渗漉液静置过夜,过滤,过滤液除去溶剂,粉碎,过200目筛,获得第一粉末,将黄连45g、黄柏30g、紫花地丁15g、板蓝根25g、野菊花25g、蒲公英15g、芜荑20g、儿茶25g和生甘草20g混合在一起,获得混合物,加入1.5kg的醇浓度为80%乙醇中浸泡2小时,加热提取2次,每次2小时,合并提取液,静置后去上清液,然后100目滤过,再经截流分子量为10000目的超滤柱超滤,超滤液减压浓缩获得干膏,粉碎,过200目筛,获得第二粉末,与第一粉末混合,获得中药成分。
实施例4皮肤消毒液
将40g的去离子水加热到70℃后,加入反应釜中,然后加入0.3g壬基酚聚氧乙烯醚和0.1g十二烷基硫酸钠搅拌均匀,等温度降到30℃时,加入4g实施例1制备的中药成分12g及30g的去离子水和无水乙醇10g搅拌均匀,过滤,得到消毒液。
实施例5消毒液急毒性试验
本发明皮肤消毒液包含中药黄连、黄柏、鱼腥草、紫花地丁、板蓝根、野菊花、蒲公英、木鳖子、土荆皮、蜂房、大蒜、硼砂、炉甘石、刺猬皮、白鲜皮、蛇床子、鹤虱、芜荑、皂角刺、儿茶和生甘草,通过对药物功效主治、毒理药理等进行检索,在常规用量下未见明显毒副作用,无中药配伍禁忌。因此进行本发明皮肤消毒液毒理实验研究。
实验动物:成年健康大鼠,40只,雌雄各半,实验前置动物于室内适应环境一周,自由摄食和摄水,室温18~22℃,相对湿度65~70%,照明昼夜明暗交替,给药前24h将动物背部脊柱两侧脱毛,去毛范围大约相当于体表面积的10%。
受试药物:高浓度本发明实施例1制备的中药组合物皮肤消毒液,处理成生药量1.25g/ml。
空白对照组:蒸馏水,实验室减压蒸馏制备,其余条件同本发明消毒液组。
对照组:成都中光洗消剂有限公司生产的碘伏消毒液(有效碘含量为4500~5500mg/L),其余条件同本发明消毒液组。
实验方法
根据大鼠体重,将大鼠分为空白对照组、对照组和实验组。
实验组:涂布本发明中药组合物皮肤消毒液,处理成给药剂量为1ml/cm2,即含生药1.25g/cm2,给药量为正常剂量168.17倍(使用本发明消毒液时,需要稀释使用,根据正常成人体表消毒液/面积计算,给药剂量为0.048g/cm2,人与小鼠换算为10.09:1)。分三次,将药物均匀地涂敷于动物背部去毛区。每日重复给药三次,每日观察,连续7天。
空白对照组:涂布蒸馏水,按1ml/cm2。分三次,将药物均匀地涂敷于动物背部去毛区。每日重复给药三次,每日观察,连续7天。
对照组:涂布碘伏消毒液,按1ml/cm2。分三次,将药物均匀地涂敷于动物背部去毛区。每日重复给药三次,每日观察,连续7天。
给药后要注意动物全身中毒表现和死亡情况,包括动物体重、皮肤、毛发、眼睛和粘膜的变化。呼吸、循环、中枢神经系统、四肢活动等变化。若遇有死亡动物则需进行尸检和肉眼观察,当有肉眼可见病变时,则需进行病理学检查。
结果与结论
通过急性毒理实验研究,观察7d大鼠涂药后情况,给药前,各组动物体重、进食、饮水情况无统计学差异,给药后,各组大鼠体重变化、进食饮水情况,无统计学差异。行为学无明显异常,未出现死亡及其他毒性反应。
本实验组剂量,是临床成人用药的168.17倍,现代药理学认为,对于药物急性毒性实验,最大耐受量相当于人临床日用剂量100倍以上而动物无死亡,无明显毒性反应情况出现时,该药是安全的。通过本急性毒性试验验证,无毒性反应,可以认定,本药品临床用药是安全的。
中药组合物皮肤消毒液长期毒性试验
实验动物:同急毒性试验
受试药物:实验组:本发明中药组合物皮肤消毒液,处理成生药量0.625g/ml,0.417g/ml,0.208g/ml。
空白对照组:蒸馏水,实验室减压蒸馏制备,其余条件同本发明消毒液组。
对照组:成都中光洗消剂有限公司生产的碘伏消毒液(有效碘含量为4500~5500mg/L),其余条件同本发明消毒液组。
实验方法
实验组涂布本发明中药组合物皮肤消毒液,给药1ml/cm2,含生药为0.625g/cm2、0.417g/cm2、0.208g/cm2,药量为正常剂量105.11倍、70.07倍、35.04倍(使用本发明消毒液时,需要稀释使用,根据正常成人体表消毒液/面积计算,给药剂量为0.048g/cm2,人与小鼠换算为10.09:1)。分3次,将药物均匀地涂敷于动物背部去毛区。每日重复给药2次,每日观察,连续21天。
空白对照组:涂布蒸馏水,按1ml/cm2。分3次,将药物均匀地涂敷于动物背部去毛区。每日重复给药2次,每日观察,连续21天。
对照组:涂布碘伏消毒液,按1ml/cm2。分3次,将药物均匀地涂敷于动物背部去毛区。每日重复给药2次,每日观察,连续21天。
给药后要注意动物全身中毒表现和死亡情况,包括动物体重、皮肤、毛发、眼睛和粘膜的变化。呼吸、循环、中枢神经系统、四肢活动等变化。若遇有死亡动物则需进行尸检和肉眼观察,当有肉眼可见病变时,则需进行病理学检查。
结果与结论
通过长期毒理实验研究,观察21d大鼠涂药后情况,给药前,各组动物体重、进食、饮水情况无统计学差异,给药后,各组大鼠体重变化、进食饮水情况,无统计学差异。行为学无明显异常,未出现死亡及其他毒性反应。
通过本慢性毒性试验验证,无毒性反应,可以认定,本药品临床用药是安全的。
实施例6临床观察
一般资料:选择2014年1月~12月,采用成都中光洗消剂有限公司生产的碘伏消毒液(有效碘含量为4500~5500mg/L)进行术前髋关节置换手术301例患者的皮肤消毒为对照组;使用本发明实施例4制备的中药组合物皮肤消毒液进行术前髋关节置换手术325例患者的皮肤消毒为实验组,进行随机对照研究。
皮肤消毒范围及分组方法:对照组及实验组消毒范围均相同,按照美国对髋关节置换手术皮肤消毒范围为标准:即患者整个患侧下肢,上平肋缘,前为前正中线,后为后正中线。对照组用碘伏消毒液按常规消毒3遍;实验组用本发明实施例4制备的中药组合物皮肤消毒液常规消毒3遍。两组患者年龄、手术时间经统计学检验,差异无统计学意义(P>0.05),具有可比性。
采样与检验方法:用含相应中和剂的无菌洗脱液浸湿的棉拭子在消毒后切口部位的皮肤上来回均匀涂擦2次(面积10cm×5cm),涂擦过程中同时转动棉拭子,将剪去棉拭子手接触部位并放入装有10ml含相应中和剂的无菌洗脱液的试管内送检。将装有棉试子的试管充分振荡80次,取1.0ml接种于无菌平皿,内加入已熔化的45~48℃的营养琼脂15~18ml边倒边摇匀,待琼脂凝固,置于37℃温箱内培养48h,计菌落数。由手术台上的器械护士进行采样。
观察指标:观察两组患者皮肤消毒铺巾后,手术切口周围皮肤的无菌率(消毒合格的判断标准为消毒后皮肤细菌总数≤5cfu/cm2,并未检出致病菌为无菌)、伤口愈合情况、记录整个消毒操作所需时间。
统计学方法:数据以均数±标准差表示,采用SPSS13.0软件进行统计分析。两组消毒患者伤口愈合情况采用X2检验,两组消毒操作时间比较采用u检验。
结果
两组消毒剂消毒后患者切口感染情况比较
由表1可知,两组比较,差异无统计学意义(P>0.05)。表明手术切口感染的原因是多方面的,两种消毒液对患者术后切口感染无差异,本发明中药组合物皮肤消毒液的切口感染率低于对照组。
表1两组消毒剂消毒后患者切口感染情况
组别 | N | 切口感染例数 | 切口感染率 |
对照组 | 301 | 9 | 2.99%8 --> |
实验组 | 325 | 1 | 0.31% |
两组工作人员消毒操作时间比较
由表2可知,两组操作时间比较,差异有统计学意义(P<0.01)。提示两种工作人员消毒操作时间有显著差异,实验组消毒操作所需时间短。
表2两组工作人员消毒操作时间(min)
组别 | N | 工作人员消毒操作时间 |
对照组 | 301 | 13.1±1.3 |
实验组 | 325 | 4.8±0.9* |
与对照组比较,*P<0.01
讨论
碘伏与本发明中药组合物皮肤消毒液的比较,采用碘伏与本发明中药组合物皮肤消毒液消毒患者切口皮肤后,做切口细菌培养均无细菌生长,本发明中药组合物皮肤消毒液效果较好。无菌手术切口感染率<0.5%,两组差异无统计学意义(P>0.05),但采用本发明实施例1制备的中药组合物皮肤消毒液,用浸湿的小纱布涂擦皮肤,作用时间为1min,整个切口周围及患肢消毒一遍约需1.5min,而3遍消毒时间约需5min;而碘伏用同样的方法消毒术前皮肤,作用时间需要4min,整个切口周围及患肢需要5min,而对切口周围皮肤及患肢消毒,特别是关节置换手术,无菌要求高,一旦手术感染,给患者带来的将是灾难性的打击。因此,我院关节置换手术术前消毒患者皮肤均为3遍,总的消毒时间大约需要15min。
消毒后皮肤的颜色碘伏消毒后皮肤的颜色接近未消毒皮肤的颜色,常常在大面积皮肤消毒的过程中,有时会分辨不清楚而遗漏;本发明中药组合物皮肤消毒液消毒后皮肤颜色接近碘酊消毒后皮肤的颜色,消毒皮肤后一目了然,在消毒的过程中,可以很仔细地观察到皮肤是否消毒,因而大大提高了工作效率。
本研究结果显示:本发明中药组合物皮肤消毒液,消毒效果确切,节省操作时间,提高了医护人员的工作效率,值得临床应用。
实施例7实验研究
药材及对照药品
实施例1制备的中药成分。
阳性对照药万古霉素、青霉素,由华英生物科技有限公司提供。
菌株及试剂
金黄色葡萄球菌、铜绿假单胞菌、白色念珠菌冻干菌株(山东中医药大学科研中心鉴定)
厌氧产气袋、厌氧指示剂(日本三菱瓦斯化学株式会社)
改良GAM肉汤培养基(山东中医药大学基础医学院制备)
琼脂条(天津市大茂化学试剂厂)。
实验方法
待测溶液的制备:本发明实施例4制备的中药组合物消毒液。
金黄色葡萄球菌、铜绿假单胞菌、白色念珠菌的复苏和菌悬液的制备:改良GAM肉汤培养基中加入10%羊血和2%琼脂,加热溶解,115℃高压灭菌15min,倾倒在平板培养皿内,以此用作冻干菌株的复苏平板和斜面培养基。利用平板划线法将冻干菌株接种至平板内,37℃厌氧培养72h后,挑取单个生长的菌落,转种至改良GAM肉汤培养基,继续培养24h,以此为菌悬液。
菌落计数
移取培养24h后的菌悬液500μL,加至装有4500μL生理盐水的试管中,得到稀释10倍的菌液。移取500μL稀释10倍的菌液至4500μL生理盐水中,得到稀释102倍的菌液。依次稀释,直至得到稀释107倍的菌液,取500μL至平板培养基上,均匀涂布,37℃厌氧培养48h,对生长的菌落进行计数。
琼脂稀释平板的制备
取9支无菌试管,第1管加入3mL提取液,2~9管加入3mL蒸馏水,第2管再加入3mL实施例1的中药成分获得的溶液,2~9管依次做倍比稀释。将含有2%琼脂的改良GAM培养基加热熔化,无菌操作吸取12mL培养基加至上述试管中,混匀倾注于平板中。使琼脂平板中药液倍比稀释度分别为1:5、1:10、1:20、1:40、1:80、1:160、1:320、1:640、1:1280,药物浓度分别为200、100、50、25、12.50、6.25、3.13、1.56、0.78mg/L。依照此法,分别制备本发明中药制剂的稀释平板,最终药物浓度分别为50、25、12.5、6.25、3.13、1.56、0.78、0.39、0.20mg/mL。对照组平板分别制备如下:制备相应浓度万古霉素丙酮溶液的药物平板、青霉素丙酮溶液的药物平板、空白平板(15mL培养基)、DMSO溶剂平板(12mL培养基+3mLDM-SO)、丙酮溶剂平板(12mL培养基+3mL丙酮)。
接种琼脂稀释平板
将制备好的菌悬液点种1μL于各个含药平板的表面,置厌氧环境中,37℃培养48h。
最小抑菌浓度(MIC)的判定将平板置于暗色、无反光物体表面,观察各药物提取液能够完全抑制细菌生长的最低药液浓度,为该药物对细菌的最低抑菌浓度(MIC)。
实验结果
细菌计数结果
平板上最终有3个菌落生长,因此待测菌悬液的浓度约为3×108mL-1。
MIC测定结果
通过对三种细菌对照平板的检测,未接种细菌的空白平板(空白-)均无细菌生长,接种细菌的空白平板(空白+)、DMSO溶剂平板、丙酮溶剂平板均有细菌生长,表明DMSO和丙酮作为溶剂,对抑菌效果的测定没有干扰。
各组药物对金黄色葡萄球菌的抑制效果测定结果
表3各组药物对金黄色葡萄球菌的抑制效果测定结果
+:菌株生长,-:菌株不生长(下同)
各组药物对铜绿假单胞菌的抑制效果测定结果
表4各组药物对铜绿假单胞菌的抑制效果测定结果
+:菌株生长,-:菌株不生长(下同)
各组药物对白色念珠菌的抑制效果测定结果
表5各组药物对白色念珠菌的抑制效果测定结果
+:菌株生长,-:菌株不生长(下同)
本次实验进行了本发明中药制剂全方的体外抑菌实验,通过多种药物配伍时的相互作用,对临床耐药菌株的抑制效果取得了较好的作用,本发明中药成分对于金黄色葡萄球菌具有很好的抑制作用,对于铜绿假单胞菌在3.13mg/ml浓度以上具有较好的抑制作用,对于白色念珠菌在6.25mg/ml浓度以上具有较好的抑制作用,综合评价其抑菌作用,其与广谱抗菌药青霉素以及万古霉素具有类似作用,因此本发明的临床推广使用具有非常大的潜力,应进行相应的临床研究进行验证。
所有上述的首要实施这一知识产权,并没有设定限制其他形式的实施这种新产品和/或新方法。本领域技术人员将利用这一重要信息,上述内容修改,以实现类似的执行情况。但是,所有修改或改造基于本发明新产品属于保留的权利。
以上所述,仅是本发明的较佳实施例而已,并非是对本发明作其它形式的限制,任何熟悉本专业的技术人员可能利用上述揭示的技术内容加以变更或改型为等同变化的等效实施例。但是凡是未脱离本发明技术方案内容,依据本发明的技术实质对以上实施例所作的任何简单修改、等同变化与改型,仍属于本发明技术方案的保护范围。
Claims (8)
1.一种用于皮肤消毒的消毒液的中药成分,其特征在于:原料药包括黄连、黄柏、鱼腥草、紫花地丁、板蓝根、野菊花、蒲公英、木鳖子、土荆皮、蜂房、大蒜、硼砂、炉甘石、刺猬皮、白鲜皮、蛇床子、鹤虱、芜荑、皂角刺、儿茶和生甘草。
2.如权利要求1所述用于皮肤消毒的消毒液的中药成分,其特征在于:各原料药的重量分别为黄连35g~50g、黄柏25g~30g、鱼腥草10g~20g、紫花地丁10g~20g、板蓝根20g~25g、野菊花15g~25g、蒲公英10g~15g、木鳖子15g~20g、土荆皮10g~15g、蜂房10g~20g、大蒜15g~25g、硼砂10g~15g、炉甘石15g~20g、刺猬皮5g~10g、白鲜皮10g~20g、蛇床子15g~25g、鹤虱5g~10g、芜荑10g~20g、皂角刺10g~20g、儿茶15g~25g和生甘草15g~20g。
3.如权利要求1或2所述用于皮肤消毒的消毒液的中药成分,其特征在于:各原料药的重量分别为黄连40g~45g、黄柏25g~30g、鱼腥草15g~20g、紫花地丁10g~15g、板蓝根20g~25g、野菊花20g~25g、蒲公英10g~15g、木鳖子15g~20g、土荆皮10g~15g、蜂房15g~20g、大蒜20g~25g、硼砂10g~15g、炉甘石15g~20g、刺猬皮5g~10g、白鲜皮10g~15g、蛇床子20g~25g、鹤虱5g~10g、芜荑15g~20g、皂角刺10g~15g、儿茶20g~25g和生甘草15g~20g。
4.如权利要求1至3所述用于皮肤消毒的消毒液的中药成分,其特征在于:各原料药的重量分别为黄连45g、黄柏30g、鱼腥草15g、紫花地丁15g、板蓝根20g、野菊花20g、蒲公英10g、木鳖子20g、土荆皮10g、蜂房15g、大蒜20g、硼砂10g、炉甘石15g、刺猬皮5g、白鲜皮15g、蛇床子20g、鹤虱5g、芜荑15g、皂角刺15g、儿茶20g和生甘草20g。
5.一种用于皮肤消毒的消毒液,其特征在于:原料包括权利要求1至4所述中药成分、丙二醇、去离子水、无水乙醇、壬基酚聚氧乙烯醚和十二烷基硫酸钠。
6.权利要求5所述用于皮肤消毒的消毒液,其特征在于:所述消毒液中各原料的重量分别为上述中药成分10g~15g、丙二醇2g~3g、去离子水60g~80g、无水乙醇10g~15g、壬基酚聚氧乙烯醚0.3g~0.5g和十二烷基硫酸钠0.05g~0.2g。
7.权利要求1至6所述消毒液的制备方法,其特征在于,包括:
第一步,制备所述中药成分;
第二步,按重量称取去离子水,将一半的去离子水加热到60~70℃后,加入反应釜中,然后加入上述重量的壬基酚聚氧乙烯醚和十二烷基硫酸钠搅拌均匀,等温度降到30~40℃时,加入上述重量的中药成分及剩余的去离子水和无水乙醇搅拌均匀,过滤,得到消毒液。
8.权利要求7所述消毒液的制备方法,其特征在于:
所述第一步进一步具体包括,
第a步,将鱼腥草、木鳖子、土荆皮、蜂房、大蒜、硼砂、炉甘石、刺猬皮、白鲜皮、蛇床子、鹤虱和皂角刺混合在一起,将混合均匀后的混合物溶解于相对于其质量5~8倍量的醇浓度为85%~95%的乙醇中,浸渍24小时~36小时,随后采用渗漉法以每分钟1~2ml的速度缓缓渗漉,收集渗漉液,渗漉液静置过夜,过滤,过滤液除去溶剂,粉碎,过200目筛,获得第一粉末;
第b步,将余下原料药混合在一起,获得混合物,加入相对于混合物5~10倍量的醇浓度为70%~80%乙醇中浸泡1~2小时,加热提取2次,每次1~2小时,合并提取液,静置后去上清液,然后100~120目滤过,再经截流分子量为5000目~10000目的超滤柱超滤,超滤液减压浓缩获得干膏,粉碎,过200目筛,获得第二粉末,与第一粉末混合,获得中药成分。
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