CN106215066A - 治疗慢性足癣急性发作期的中药泡脚液 - Google Patents
治疗慢性足癣急性发作期的中药泡脚液 Download PDFInfo
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Abstract
本发明提供了一种治疗慢性足癣急性发作期的中药泡脚液,其原料药包括天花粉、地骨皮、生甘草,金银花、荆芥、防风、红花、白蒺藜、蛇床子、皂角刺、百部、苦参、黄连、大枫子、地肤子、枯矾、大黄、藿香、乌贼骨和米醋。其有效减少足癣并发症的发生,降低其像体癣转化的发生率,综合疗效评价,优于单纯使用西药,通过一定的实验室研究及安全性评估后,适用于临床推广应用。
Description
技术领域
本发明涉及中医药技术领域,尤其涉及一种治疗慢性足癣急性发作期的中药泡脚液。
背景技术
足癣(俗名“香港脚”、脚气),系真菌感染引起,其皮肤损害往往是先单侧(即单脚)发生,数周或数月后才感染到对侧。水疱主要出现在趾腹和趾侧,最常见于三四趾间,足底亦可出现,为深在性小水疱,可逐渐融合成大疱。足癣的皮肤损害有一特点,即边界清楚,可逐渐向外扩展。因病情发展或搔抓,可出现糜烂、渗液,甚或细菌感染,出现脓疱等。
足癣是由致病性真菌引起的足部皮肤病,具有传染性。足癣在全世界广为流行,在热带和亚热带地区更为普遍。在我国,足癣的发病率也相当高。人的足底和趾间没有皮脂腺,从而缺乏抑制皮肤丝状真菌的脂肪酸,生理防御机能较差,而这些部位的皮肤汗腺却很丰富,出汗比较多,加之空气流通性差、局部潮湿温暖,有利于丝状真菌的生长。此外,足底部位皮肤角质层较厚,角质层中的角蛋白是真菌的丰富营养物质,有利于真菌的生长。
妇女在妊娠期间,由于内分泌的变化,引起皮肤抵抗真菌感染的能力下降,易患足癣。肥胖者因趾间潮湿,汗液浸渍易患足癣。足部皮肤受外伤,破坏了皮肤的防御功能,也是诱发足癣的因素之一。糖尿病患者由于缺乏胰岛素导致物质代谢紊乱,皮肤含糖量增加导致抵抗力下降,也易患足癣。滥用抗生素,长期使用皮质类固醇激素和免疫抑制剂等,使皮肤正常菌群失调,也会增加足癣的易感性。
足癣的发病还与生活习惯有关。有些人不注意足部清洁卫生和鞋袜的情况,为真菌提供了良好的孳生场所。
临床表现为脚趾间起水疱、脱皮或皮肤发白湿软,也可出现糜烂或皮肤增厚、粗糙、开裂,并可蔓延至足跖及边缘,剧痒。可伴局部化脓、红肿、疼痛,腹股沟淋巴结肿大,甚至形成小腿丹毒及蜂窝组织炎等继发感染。由于用手抓痒处,常传染至手而发生手癣(鹅掌风)。真菌在指(趾)甲上生长,则成甲癣(灰指甲)。真菌喜爱潮湿温暖的环境,夏季天热多汗,穿胶鞋、尼龙袜者更是为真菌提供了温床;冬季病情多好转,表现为皮肤开裂。
对该病的治疗有全身治疗和局部治疗两种情况。对重症足癣要考虑全应用抗真菌药物,如灰黄霉素0.2g,一天3次,但疗程不可过长,或酮康唑200mg,1次/d,一般不超过3周。Terbinafine 125mg,2次/d,3~5周后瘙痒,红斑消退,6~8周后脱屑及角化过度消失。
对于局部治疗,不同类型的足癣治疗方式有所不同:1.急性期足癣:渗液显著者先用3%硼酸液湿敷,待渗液停止后,局部涂复方雷锁辛溶液.待炎症减轻后,改用复方水杨酸软膏涂局部,或复方土槿皮酊;2.角化过度型足癣:选用复方水杨酸软膏涂局部,或中药浸泡.亦可选用抑菌作用较好的黄连,射干,丁香,土槿皮,半枝莲,金钱草,伸筋草,龙胆等8种中药等分研末混合,50g为1剂,加豆油100ml,煎后去渣油剂外用1%Terbinafine霜外用;3.鳞屑型及水疱型:局部外用复方水杨酸酊,复方土槿皮酊,1%益康唑霜,复方酮康唑霜或1%吡硫霉净酊(或霜);4.足癣并发细菌感染:可用1∶5000高锰酸钾液泡洗或0.1%雷夫诺诺尔液湿敷,伴有发发烧和淋同巴结肿大者,可全身应用抗生素。
目前医院的临床治疗中,对于该病的治疗时较为麻烦,且效果不稳定,有些激素类的使用,对于皮肤有一定的损伤,会加重皮损,而中药的应用近年来发现其效果较为有效、可靠,无西药添加成分,对于真菌有很好的治疗作用,同时能够较好的修复皮损。本发明基于中医理论而研制,针对慢性足癣急性发作期具有滋阴润燥、清热解毒、燥湿止痒的功效,能够能有效遏制足癣的发展,针对多种真菌(如红色毛癣菌T.r、须癣毛癣菌T.m、白色念珠菌C.a菌株等)感染的患者都有治疗作用,有效减少足癣并发症的发生,降低其像体癣转化的发生率,综合疗效评价,优于单纯使用西药,通过一定的实验室研究及安全性评估后,适用于临床推广应用。
发明内容
本发明所要解决的技术问题是提供一种用于治疗慢性足癣急性发作期的中药泡脚液,具有滋阴润燥、清热解毒、燥湿止痒的功效,能够能有效遏制足癣的发展,针对多种真菌感染的患者都有治疗作用,有效减少足癣并发症的发生,降低其像体癣转化的发生率,综合疗效评价,优于单纯使用西药,通过一定的实验室研究及安全性评估后,适用于临床推广应用。
为解决上述技术问题,本发明提供了一种用于治疗慢性足癣急性发作期的中药泡脚液,其原料药包括天花粉、地骨皮、生甘草,金银花、荆芥、防风、红花、白蒺藜、蛇床子、皂角刺、百部、苦参、黄连、大枫子、地肤子、枯矾、大黄、藿香、乌贼骨和米醋。
其中,每剂所述中药泡脚液中苦参用量≥30g。
其中,每剂所述中药泡脚液中天花粉用量≥15g。
其中,每剂所述中药泡脚液中白蒺藜用量≥20g。
其中,所述中药泡脚液中各原料药的量分别为天花粉15g~25g、地骨皮25g~30g、生甘草20g~30g,金银花30g~35g、荆芥35g~40g、防风10g~15g、红花10g~15g、白蒺藜20g~30g、蛇床子25g~30g、皂角刺25g~30g、百部25g~30g、苦参30g~50g、黄连20g~25g、大枫子10g~15g、地肤子15g~20g、枯矾20g~25g、大黄30g~35g、藿香15g~20g和乌贼骨20g~25g。
其中,所述中药泡脚液中各原料药的量分别为天花粉15g、地骨皮30g、生甘草30g,金银花30g、荆芥40g、防风15g、红花10g、白蒺藜20g、蛇床子30g、皂角刺30g、百部30g、苦参40g、黄连25g、大枫子15g、地肤子15g、枯矾20g、大黄30g、藿香15g和乌贼骨20g。
本发明还提供上述中药泡脚液的制备方法,具体包括:
第一步,中草药成分提取;
第二步,第一步获得的中草药浓缩浸膏与米醋混合均匀,获得中药泡脚液,米醋的使用量为500ml。
其中,所述第一步进一步具体为按重量称取各原料药,混合到一起,加相对于混合物4~6倍的水,武火到煮沸,随后文火煎煮3小时,过滤,滤渣再次加入相对于混合物2~4倍的水,武火到煮沸,随后文火煎煮2小时,煎煮液过滤,合并两次煎煮液,浓缩成50℃下相对密度1.30~1.40的浸膏。
有益的技术效果
本发明提供的用于治疗足癣的中药泡脚液,具有滋阴润燥、清热解毒、燥湿止痒的功效,能够能有效遏制足癣的发展,针对多种真菌感染的患者都有治疗作用,有效减少足癣并发症的发生,降低其像体癣转化的发生率,综合疗效评价,优于单纯使用西药,通过一定的实验室研究及安全性评估后,适用于临床推广应用。
具体实施方式
足癣是临床常见的一种皮肤病,现代医学认为是由足部真菌感染而致,中医又名“脚湿气”、“臭田螺”、“田螺疮”,因其以脚丫糜烂瘤痒伴有特殊臭味而得名。多因湿热停滞湿热下注或外感毒邪而致,-对于慢性足癣的病因辨证多为久病导致的阴虚内热、湿热留滞,以阴虚为主,而慢性足癣急性发作时,在阴虚为本的情况下,湿热加重,同时毒邪外扰,并发瘙痒,因此治疗时当以滋阴以治本,清热除湿、解毒止痒为标,标本兼治,本发明针对慢性足癣急性发作期用药,使用天花粉、地骨皮、生甘草,金银花、荆芥、防风、红花、白蒺藜、蛇床子、皂角刺、百部、苦参、黄连、大枫子、地肤子、枯矾、大黄、藿香、乌贼骨和米醋,该中药泡脚液通过改变外洗液的浓度,高浓度可以进行杀菌治病,低浓度可以预防疾病,是临床中难得的良方。现就全方组方思路解释如下:
本病的发生,在临床上有多种表现,而慢性足癣急性发作期的患者,以阴液损伤、湿热下注、毒邪外扰为主,其多见脱屑型或角化型,主要表现鳞屑不断发生于足趾间及足底跟部,自觉瘤痒,易致教裂。此多为外邪侵犯,伤阴化燥。治宜滋阴润燥、清热除湿、解毒止痒。故方中用主药天花粉味苦性寒,清热泻火,养阴润燥,排脓消肿,能滋养肺胃之阴,肺主皮毛,脾胃主四肢肌肉,故肺胃之阴得充,体表阴液得补,此外配地骨皮、红花,地骨皮甘寒入血分,清退虚热,滋阴润燥,佐红花血中之气药,活血润燥,更增润燥之功,金银花甘寒,清热解毒,杀菌抗病毒。荆芥、防风、白蒺藜三药合用,祛风止痒,与蛇床子、皂角刺合用,治一切风疮疥癣,皮肤瘙痒。本发明中药制剂使用苦参为另一主药,苦参甘寒入肝肾经,清热燥湿除下焦湿热治皮肤瘙痒疥癣,配合黄连,苦寒燥湿,清热解毒,使湿热不能相搏,势必孤矣,热邪易去,湿邪易散,用大风子,其辛能散风,苦能杀虫燥湿,温热能通行经络,用以治风癣疥癞诸疮。用百部、枯矾除疥癣湿疮,痈疽肿毒,地肤子清热解毒治皮肌瘙痒瘾疹。藿香解表散邪,芳香避秽,利湿除风,具有很好的祛湿止痒的功效,乌贼骨温而燥湿,治疮多脓汁,入药后有收敛收涩的功效。用大黄能抗多种菌类,抑菌试验证明大黄的抗菌作用强,抗菌谱广,其有效成分已证明为蒽醌衍生物,其中以大黄酸、大黄素和芦荟大黄素的抗菌作用最好。与金银花、黄连、蛇床子等药物合用,对痢疾杆菌、伤寒杆菌、霍乱弧菌、大肠杆菌、绿脓杆菌、葡萄球菌、链球菌、肺炎双球菌、白喉杆菌、炭疽杆菌及皮肤真菌等均有抗菌作用。使用生甘草清热解毒,同时可以佐制苦寒药物伤正,调和诸药,米醋对一般皮肤病具有良好的杀毒解毒作用,使以上诸药更有效的奏解毒止痒之功,全方合用,共奏清热解毒、养阴润燥、杀虫疗癣之功效,针对慢性足癣急性期各种表现有很好的治疗作用。
各原料药药理如下:
天花粉:拉丁名TrichosanthisRadix,味甘、微苦,性微寒,入肺、胃经,具有清热生津,消肿排脓的功效,用于热病烦渴,肺热燥咳,内热消渴,疮疡肿毒等证。
地骨皮:拉丁名LyciiCortex,性寒,味甘,具有凉血除蒸,清肺降火的功效,主治阴虚潮热、骨蒸盗汗、肺热咳嗽、咯血、衄血等证。
生甘草:拉丁名GlycyrrhizaeRadixetRhizoma,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。
金银花:拉丁名loniceraejaponicaeflos,味甘、性寒,入心、肺、胃、大肠经,有清热解毒的作用,兼能凉血止痢。主要用于外感风热、温热病热毒较盛,或温病初起热邪尚在上焦而未下行时;热毒下痢、大便下血;暑温证。
荆芥:味辛,性微温,入肺、肝经,具有祛风解表,宣毒透疹,理血止痉的功效,主治感冒寒热,头痛,目痒,咽痛,咳嗽,麻疹,风疹,痈疮,准将,吐血,血块血,便血,崩漏,产后中风、血晕等证。
防风:味辛、甘,性微温,入肺、肝、脾、膀胱经,有散寒解表,胜湿止痛,祛风止痉,止痒的作用,主要用于外感风寒证及寒邪郁闭,内热郁结之表寒里热证等。
红花:性温,味辛,入、心、肝经,具有活血通经,祛瘀止痛的作用,用于闭经,痛经,恶露不行,症瘕痞块,跌扑损伤,疮疡肿痛等证。
白蒺藜:为蒺藜科蒺藜属植物的果实,味辛、苦,性微温;有小毒,归肝经,具有平肝解郁,活血祛风,明目,止痒的功效,用于头痛眩晕,胸胁胀痛,乳闭乳痈,目赤翳障,风疹瘙痒等证。
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证。
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。
百部:味甘、苦,性微温,入肺经,具有润肺止咳,灭虱杀虫的作用,百部温润而不燥,性守而不走,又有开泄降气之功,主要用于新久诸咳,尤适于劳热久咳者,现代用于防治慢性支气管炎之咳嗽,肺结核之干咳,百日咳等证。
苦参:拉丁名SophoraeFlavescentisRadix,味苦,性寒,入心、胃、大肠、膀胱经,具有清热燥湿、祛风杀虫的作用,主要用于湿热泻痢,黄疸,淋证。
黄连:为五加科五加属植物细柱五加和无梗五加的根皮:拉丁名AcanthopanacisCortex,味辛、苦,性温,归肝、肾,具有祛风湿;补肝肾;强筋骨;活血脉的功效,主治风寒湿痹;腰膝疼痛;筋骨痿软;小儿行迟;体虚赢弱;跌打损伤;骨折;水肿;脚气;阴下湿痒等证。
大枫子:味辛,性热,有毒,入肺,肝经,具有祛风燥湿,攻毒杀虫的功效。主治麻风,疥癣,杨梅疮等证。
地肤子:味苦、性寒,入胃、大肠经,具有清热解毒、消痈、下乳、舒筋通脉的功效,用于乳痈肿痛,痈疽发背,瘰疬疮毒,乳汁不通,湿痹拘挛,骨节疼痛、热毒血痢、痔疮出血等证。
枯矾:味酸、涩,性寒,归肺;脾;肝;大肠;膀胱经,外用能解毒杀虫,燥湿止痒;内用止血,止泻,化痰。主治:中风;癫痫;喉痹;疥癣湿疮;痈疽肿毒;水火烫伤;口舌生疮;烂弦风眼;聤耳流脓;鼻中息肉;疮痔疼痛;崩漏;衄血;损伤出血;久泻玖痢;带下阴痒;脱肛;子宫下垂等证。
大黄:拉丁名RheiRadixetRhizoma,味苦,性寒,归胃经;大肠经;肝经;脾经,具有攻积滞;清湿热;泻火;凉血;祛瘀;解毒的功效,主治实热便秘;热结胸痞;湿热泻痢;黄疸;淋病;水肿腹满;小便不利;目赤;咽喉肿痛;口舌生疮;胃热呕吐;吐血;咯血;衄血;便血;尿血;蓄血;经闭;产后瘀滞腹痛;症瘕积聚;跌打损伤;热毒痈疡;丹毒;烫伤等证。
藿香:味辛,性微温,归肺、脾、胃经,具有祛暑解表,化湿和胃的功效。用于夏令感冒,寒热头痛,胸脘痞闷,呕吐泄泻,妊娠呕吐,鼻渊,手、足癣等证。
乌贼骨:拉丁名Cleistocactussepium,异名海螵蛸,味成、涩,性温,归脾、肾经。具有收敛止血,固精止带,制酸止痛,收湿敛疮的功效。主治溃疡病,胃酸过多,吐血衄血,崩漏便血,遗精滑精,赤白带下,胃痛吞酸;外治损伤出血,疮多脓汁等证。
米醋:能杀菌、去毒;可去腥臊、解油腻;在保健养生方面,可以醒脾开胃,增进食欲,促进唾液分泌和提高胃液酸度,有助于消化吸收;而且还是一味可口良药,外敷能疗烧烫伤、关节炎、腋臭和癣,内服可驱蛔虫。
每剂中药泡脚液苦参用量大于30g,苦参清热燥湿、解毒止痒,能够很好的杀灭真菌,若苦参用量少于30g,则无法有效实现治疗足癣的目的,天花粉滋阴润燥,解毒止痒,对于外邪侵袭,化燥伤阴导致的脱屑、角化等情况,有很好的治疗作用,若用量不到15g,则其治疗皮损的功效不足,难以全效,而白蒺藜有祛风止痒功效,用量亦应大于20g,若少于此剂量,则祛风力度减弱,因风邪善行而数变导致的瘙痒频发,难以有效止痒。
所述中药泡脚液中各原料药的量分别为天花粉15g~25g、地骨皮25g~30g、生甘草20g~30g,金银花30g~35g、荆芥35g~40g、防风10g~15g、红花10g~15g、白蒺藜20g~30g、蛇床子25g~30g、皂角刺25g~30g、百部25g~30g、苦参30g~50g、黄连20g~25g、大枫子10g~15g、地肤子15g~20g、枯矾20g~25g、大黄30g~35g、藿香15g~20g和乌贼骨20g~25g。
所述中药泡脚液中各原料药的量分别为天花粉15g、地骨皮30g、生甘草30g,金银花30g、荆芥40g、防风15g、红花10g、白蒺藜20g、蛇床子30g、皂角刺30g、百部30g、苦参40g、黄连25g、大枫子15g、地肤子15g、枯矾20g、大黄30g、藿香15g和乌贼骨20g。
本发明还提供上述中药泡脚液的制备方法,具体包括:
第一步,中草药成分提取;
第二步,第一步获得的中草药浓缩浸膏与米醋混合均匀,封装灭菌,获得中药泡脚液,米醋的使用量为500ml。
所述第一步进一步具体为按重量称取各原料药,混合到一起,加相对于混合物4~6倍的水,武火到煮沸,随后文火煎煮3小时,过滤,滤渣再次加入相对于混合物2~4倍的水,武火到煮沸,随后文火煎煮2小时,煎煮液过滤,合并两次煎煮液,浓缩成50℃下相对密度1.30~1.40的浸膏。
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中药泡脚液1
称取天花粉15g、地骨皮30g、生甘草30g,金银花30g、荆芥40g、防风15g、红花10g、白蒺藜20g、蛇床子30g、皂角刺30g、百部30g、苦参40g、黄连25g、大枫子15g、地肤子15g、枯矾20g、大黄30g、藿香15g和乌贼骨20g,混合到一起,加2.3kg的水,武火到煮沸,随后文火煎煮3小时,过滤,滤渣再次加入1.3kg的水,武火到煮沸,随后文火煎煮2小时,煎煮液过滤,合并两次煎煮液,浓缩成50℃下相对密度1.40的浸膏,加入500ml米醋混合均匀,获得中药泡脚液1。
毒理学检测
本发明中药泡脚液临床作用于慢性足癣急性期患者,一般一个疗程为7~10天左右,较少连续用药超过14日,因此,针对其主要应用方法,我们设置大鼠急毒性试验即可,通过验证短期内大量外用本发明中药泡脚液对大鼠可能产生的毒理作用,来进一步验证本发明中药泡脚液临床使用的安全用量,为临床转化该药物提供实验数据。
成年健康大鼠,36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%,在腿毛表面正中部位,用手术刀片横向划1cm切口,仅破损皮层,不到达肌肉及椎体,然后用无菌纱布止血。
按照随机数字表,将大鼠分为对照组和实验组。实验组给药3次/d,每1cm2给本发明实施例1制备的中药泡脚液1ml(将泡脚液浓缩成生药浓度2.73g/ml),反复涂擦,到全部晾干吸收,根据给药浓度计算,即生药给药量为2.73g/cm2,给药量为正常剂量112.17倍(人与大鼠的给药换算为1∶56,正常人体给药,外用本发明中药泡脚液,其中原药材含量为460g/d,2次/d,外用面积为225cm2),将药物均匀地涂敷于动物背部去毛区。每日观察,连续10d。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10d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。伤口愈合情况,给药组肉芽组织生长,无感染,其恢复程度显著优于对照组。
本实验组剂量,是临床成人用药的112.17倍,最大耐受量超过人临床日用剂量100倍以上,并且动物无死亡,该用药是安全的。
比较例1中药泡脚液2
称取地骨皮30g、生甘草30g,金银花30g、荆芥40g、防风15g、红花10g、白蒺藜20g、蛇床子30g、皂角刺30g、百部30g、苦参40g、黄连25g、大枫子15g、地肤子15g、枯矾20g、大黄30g、藿香15g和乌贼骨20g,混合到一起,加2.3kg的水,武火到煮沸,随后文火煎煮3小时,过滤,滤渣再次加入1.3kg的水,武火到煮沸,随后文火煎煮2小时,煎煮液过滤,合并两次煎煮液,浓缩成50℃下相对密度1.40的浸膏,加入500ml米醋混合均匀,获得中药泡脚液2。
临床研究
192例确诊的慢性足癣急性发作期患者均为在我院皮肤科门诊确诊,病程在6个月以上的患者,近2周发作加重,采用完全随机分组的方法,依就诊顺序将病例分入治疗组和对照组。治疗组101例,男49例,女52例;年龄19~54岁;病程7月至19年。对照组91例,男47例,女44例;年龄17~74岁;病程6月至20年。经统计学检验,两组患者在性别、年龄、病程、发病部位及症状体征严重程度各方面无显著差异,具有可比性。
排除妊娠及哺乳期妇女。所有患者治疗前1月内均未系统使用皮质激素类药物。
治疗组:采用本发明实施例1制备的中药泡脚液150mL,用温水稀释10~15倍,洗浴或浸泡患处,每次20~30min,2次/d。
对照组:用皮炎康外搽患处,2次/d。
治疗组与对照组均连续用药30d为1个疗程,观察期间停用其他内服或外用药。
观察方法
治疗前后分别对治疗组和对照组的症状和体征进行客观记录。症状、体征严重程度评分标准:
皮损面积:0=无,1=面积不足手或足的1/3,2=面积为手或足的1/3~2/3,3=面积大于手或足的2/3;
红斑:0=无,1=淡红,2=暗红,3=鲜红;
角化皲裂程度:0=无,1=干燥轻度角化,2=角化肥厚伴轻度皲裂,3=角化皲裂严重伴渗血;
瘙痒程度:0=无,1=轻度瘙痒,2=明显瘙痒,3=剧烈瘙痒。
疗效评定标准
痊愈:皮损完全消失,痒感消失,疗效指数为95%~100%;显效:皮损完全改善,痒感仍存在,疗效指数为60%~94%;有效:皮损有所改善,痒感仍重,疗效指数为20%~59%;无效:症状及体征无改进,疗效指数小于20%。
痊愈加显效合计有效率。两组均于1个疗程结束后判定疗效。
疗效指数(%)=(治疗前积分-治疗后积分)治疗前积分×100%。
统计学方法
使用spss15.0软件进行统计学分析,计量资料使用平均数±标准差配对t检验,计数资料采用卡方检验,以P<0.05为有显著统计学差异。
治疗结果
两组疗程前后积分比较,结果见表1。
表1治疗组疗程前后积分比较
注:治疗组疗程前后积分相比,*P<0.05,与对照组比较,#P<0.05
从表1可以看出,本发明提供的中药泡脚液疗程结束后各临床观察指标积分均有明显改善,经配对t检验,治疗前后各积分的差异有显著性意义。
两组药物疗效比较,结果见表2。
表2两种药物治疗足癣疗效比较(例)
组别 | n | 痊愈 | 显效 | 有效 | 无效 | 总有效率(%) |
治疗组 | 101 | 33 | 36 | 29 | 3 | 97.03* |
对照组 | 91 | 19 | 27 | 29 | 16 | 82.42 |
注:经χ2检验,*P<0.05。
统计学处理表明,本发明提供的中药泡脚液对慢性足癣的疗效均优于相应部位对照组的疗效(P<0.05),中药泡脚液对慢性足癣的疗效明显优于对照组,两组总有效率比较有显著性差异(P<0.05)。两组患者治疗过程中均无明显不良反应。
经过上述临床研究看出,本发明中药泡洗液对于足癣具有很好的疗效,效果优于对于对照组,适用于临床推广。
实验研究
菌株:红色毛癣菌T.r、絮状表皮癣菌E.f、白色念珠菌C.a菌株各2株。
药物:本发明实施例1制备的中药泡脚液1,经过处理得到相当于含生药浓度0.1g/ml的中药过滤液;本发明比较例1制备的中药泡脚液2,经过处理得到相当于含生药浓度0.1g/ml的中药过滤液。
培养基:马铃薯葡萄糖琼脂基(PDA),葡萄糖蛋白膝琼脂基(SDA),改良沙氏液体培养基(真菌肉汤)。
实验方法
药物稀释
液基法:本发明提供的实施例1制备的中药泡脚液1和比较例1制备的中药泡脚液2,用沙氏液基以微量稀释法-系列倍比稀释,倍比稀释法制作成100%,50%,25%,12.5%,6.25%,3.125%,1.563%,0.781%,0.391%,0.195%等10个浓度的药基。-20℃保存备用。
菌悬液制备
红色毛癣菌T.r、絮状表皮癣菌E.f需在马铃薯葡萄糖琼脂基(PDA)上37℃培养14天;白色念珠菌在葡萄糖蛋白陈琼脂基(SDA)上25℃培养48小时。将受试菌种在培养基上活化2次,以保证其纯度和活力;皮肤癣菌菌悬液配制:用生理盐水搔刮冲洗菌落,加入组织研磨器中研磨,所得菌悬液用15~20um孔径的无菌滤器过滤,滤液用血球计数板计数抱子数,并调整抱子密度为5×106个/ml;白色念珠菌菌悬液配制:挑取直径>1mm的菌落5个,混悬于5ml生理盐水中,混匀后用分光光度计在530nm下校正浊度至0.5麦氏浊度,使每ml菌量相当于1×106cfu/ml~5×106cfu/ml,然后用血球计数板调整菌量至5×106cfu/ml。
接种
采用试管液基法,取20ul菌液(含菌105cfu)于药基混液(4ml),并设沙氏液基(4ml)直接接种相同量菌液做空白对照。念珠菌液基置恒温箱中25℃培养48h;皮肤癣菌置恒温箱中37℃培养14d实验均重复2次。
结果
皮肤癣菌培养14天后在试验组和对照组所有试管中均见到菌落生长,白念珠菌培养48h后在试验组和对照组的所有试管中均见到试管底部沉淀,血球计数板显示生长。
皮肤癣菌组试管菌液加入组织研磨器中研磨,所得菌悬液用15~20um孔径的无菌滤器过滤,滤液用血球计数板计数抱子数,计算浓度;白色念珠菌组菌液震荡,加入血球计数板计算抱子数,计算浓度。
本发明中药制剂对于菌培养的抑制作用,结果见表3。
表3液基法孢子浓度(单位:106fu/ml)
与对照组比较,*P<0.05。
试验结果显示当本发明泡脚液浓度低于12.5%时,其抑制真菌生长的作用降低,与对照组相比较差别不大;药液对皮肤癣菌的抑制作用明显,对白念珠菌抑制作用较差,说明本发明中药泡脚液按照原方剂量外洗,有抑制真菌生长的作用。
去掉天花粉后,比较例1制备的中药泡脚液2对于菌培养的抑制作用,结果见表4。
表4液基法孢子浓度(单位:106fu/ml)
与对照组比较,*P<0.05。
试验结果显示当本发明中药去天花粉泡脚液浓度低于50%时,其抑制真菌生长的作用降低,与对照组相比较差别不大;与本发明中药泡脚液同浓度、同菌种的抑制结果进行比较,其效果较差,有统计学差异。
结论
经过实验研究,本发明中药制剂对于真菌的有很好的抑制作用,在临床使用保证有效浓度的情况下,对于足癣有好的治疗作用,在较低浓度泡脚液的作用下,能起到很好的预防足癣的作用;此外,我们通过实验研究证实,本发明中药制剂中天花粉的去除,对于该泡脚液的作用效果减少较为明显,因此可以说明君药天花粉在足癣的治疗中具有较显著的作用,综合分析,本发明中药泡脚液适用于进行临床验证。
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)
1.一种用于治疗慢性足癣急性发作期的中药泡脚液,其特征在于:原料药包括天花粉、地骨皮、生甘草,金银花、荆芥、防风、红花、白蒺藜、蛇床子、皂角刺、百部、苦参、黄连、大枫子、地肤子、枯矾、大黄、藿香、乌贼骨和米醋。
2.如权利要求1所述的用于治疗足癣的中药泡脚液,其特征在于:每剂所述中药泡脚液中苦参用量≥30g。
3.如权利要求1或2所述的用于治疗足癣的中药泡脚液,其特征在于:每剂所述中药泡脚液中天花粉用量≥15g。
4.如权利要求1至3所述的用于治疗足癣的中药泡脚液,其特征在于:每剂所述中药泡脚液中白蒺藜用量≥20g。
5.如权利要求1至4所述的用于治疗足癣的中药泡脚液,其特征在于:各原料药的量分别为天花粉15g~25g、地骨皮25g~30g、生甘草20g~30g,金银花30g~35g、荆芥35g~40g、防风10g~15g、红花10g~15g、白蒺藜20g~30g、蛇床子25g~30g、皂角刺25g~30g、百部25g~30g、苦参30g~50g、黄连20g~25g、大枫子10g~15g、地肤子15g~20g、枯矾20g~25g、大黄30g~35g、藿香15g~20g和乌贼骨20g~25g。
6.如权利要求1至5所述的用于治疗足癣的中药泡脚液,其特征在于:各原料药的量分别为天花粉15g、地骨皮30g、生甘草30g,金银花30g、荆芥40g、防风15g、红花10g、白蒺藜20g、蛇床子30g、皂角刺30g、百部30g、苦参40g、黄连25g、大枫子15g、地肤子15g、枯矾20g、大黄30g、藿香15g和乌贼骨20g。
7.权利要求1至6所述中药泡脚液的制备方法,其特征在于,包括:
第一步,中草药成分提取;
第二步,第一步获得的中草药浓缩浸膏与米醋混合均匀,获得中药泡脚液,米醋的使用量为500ml。
8.如权利要求7所述中药泡脚液的制备方法,其特征在于:所述第一步进一步具体为按重量称取各原料药,混合到一起,加相对于混合物4~6倍的水,武火到煮沸,随后文火煎煮3小时,过滤,滤渣再次加入相对于混合物2~4倍的水,武火到煮沸,随后文火煎煮2小时,煎煮液过滤,合并两次煎煮液,浓缩成50℃下相对密度1.30~1.40的浸膏。
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