CN114533829A - 一种荆黄汤熏洗液及其制备方法 - Google Patents
一种荆黄汤熏洗液及其制备方法 Download PDFInfo
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- CN114533829A CN114533829A CN202210261166.3A CN202210261166A CN114533829A CN 114533829 A CN114533829 A CN 114533829A CN 202210261166 A CN202210261166 A CN 202210261166A CN 114533829 A CN114533829 A CN 114533829A
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- Prior art keywords
- soup
- vitex negundo
- decoction
- fumigation
- medicine
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Abstract
本发明公开了一种荆黄汤熏洗液及其制备方法,属于熏洗液技术领域,荆黄汤熏洗液包括药包和与其混合的水,所述荆黄汤熏洗液的药包由以下原料制成:包括黄柏、荆芥、苦参、苍术、地榆、薄荷、土茯苓、五倍子和甘草,所述荆黄汤熏洗液由以下质量克的原料制成,所述黄柏15克、荆芥10克、苦参20克、苍术15克、地榆15克、薄荷10克、茯苓15克、五倍子10克和甘草5克,制备时将药包置于煎药釜内部,向煎药釜内部添加水浸泡药包,加热煮沸并取头煎液,向煎药釜内部继续加水,加热煮沸并取二煎液,头煎液和二煎液混合备用,该荆黄汤熏洗液及其制备方法,可满足熏洗需要且制备简单。
Description
技术领域
本发明属于熏洗液技术领域,具体涉及一种荆黄汤熏洗液及其制备方法。
背景技术
痔瘘等肛门疾病是常见病多发病,单是痔的发病率在成年人群中就高达60~70%,严重影响社会劳动生产力和人们的生活质量,目前,手术仍然是治疗这类疾病的重要手段,然而由于肛门解剖部位特殊,肛门的神经丰富,痛觉敏锐,肌群复杂,受到刺激后易导致痉挛性疼痛,并影响到局部的血液循环,肛门部为污染环境,手术为有菌手术,现有的熏洗液很难为痔瘘等肛门疾病创造合适的治疗条件。
发明内容
本发明的目的在于提供一种荆黄汤熏洗液及其制备方法,以解决上述背景技术中提出的问题。
为实现上述目的,本发明提供如下技术方案:
一种荆黄汤熏洗液,包括药包和与其混合的水;
上述荆黄汤熏洗液的药包由以下原料制成:包括黄柏、荆芥、苦参、苍术、地榆、薄荷、土茯苓、五倍子和甘草。
上述荆黄汤熏洗液的药包由以下质量份的原料制成:上述黄柏15克、荆芥10克、苦参20克、苍术15克、地榆15克、薄荷10克、茯苓15克、五倍子10克和甘草5克。
一种制备方法,其用于荆黄汤熏洗液,包括以下步骤:
S1:将药包置于煎药釜内部;
S2:向煎药釜内部添加水浸泡药包;
S3:加热煮沸并取头煎液;
S4:向煎药釜内部继续加水;
S5:加热煮沸并取二煎液;
S6:头煎液和二煎液混合备用。
优选的,S2中药包的浸泡时间为30分钟,上述药包和与其混合的水的重量比例为1∶8。
优选的,S3中煮沸后取头煎液的时间为沸腾后五分钟。
优选的,S5中煮沸后取二煎液的时间为沸腾后十五分钟。
本发明的技术效果和优点:该荆黄汤熏洗液及其制备方法,通过临床应用发现,荆黄汤薰洗液可以减轻各种肛门肛管疾病术后的疼痛和水肿,有较好的抗感染作用,有明显的促进创面愈合的作用,未见明显的毒副反应,本熏洗液建立在逾万病例基础上,作了较系统的前瞻性随机对照临床研究,最终证明荆黄汤熏洗液在肛门疾病术后应用中,具有解毒消肿、活血止痛、促进创面愈合且安全可靠等特点。
具体实施方式
下面将结合本发明的内容,对本发明中的技术方案进行清楚、完整地描述,显然,所描述的内容仅仅是本发明一部分内容,而不是全部的内容。基于本发明中的内容,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他内容,都属于本发明保护的范围。
本发明提供了一种荆黄汤熏洗液,包括药包和与其混合的水;
荆黄汤熏洗液的药包由以下原料制成:包括黄柏、荆芥、苦参、苍术、地榆、薄荷、土茯苓、五倍子和甘草。
优选的,荆黄汤熏洗的药包由以下质量份的原料制成:黄柏15克、荆芥10克、苦参20克、苍术15克、地榆15克、薄荷10克、茯苓15克、五倍子10克和甘草5克。
一种制备方法,其用于荆黄汤熏洗液,包括以下步骤:
S1:将药包置于煎药釜内部;
S2:向煎药釜内部添加水浸泡药包;
S3:加热煮沸并取头煎液;
S4:向煎药釜内部继续加水;
S5:加热煮沸并取二煎液;
S6:头煎液和二煎液混合备用。
优选的,S2中药包的浸泡时间为30分钟,药包和与其混合的水的重量比例为1∶8。
优选的,S3中采用武火煮沸,取头煎液的时间为沸腾后五分钟。
优选的,S5中采用文火煮沸,取二煎液的时间为沸腾后十五分钟。
通过动物实验了解自拟荆黄汤薰洗液的安全性,特别是其多次给药后对皮肤和粘膜组织的刺激性和过敏性;
通过动物实验了解自拟荆黄汤薰洗液的药理学情况,研究其对抗炎、止痛、活血化瘀、促进伤口愈合的作用机理;
通过临床随机对照实验,了解自拟荆黄汤薰洗液对痔瘘疾病术后的伤口疼痛、肛门水肿、感染发生率及创面修复的影响,具体实验如下:
第一个实验为家兔皮肤刺激性实验,包括单次给药皮肤刺激性实验和多次给药皮肤刺激性实验。
单次给药皮肤刺激性实验:
家兔12只,随机分为两组,即完整皮肤组和破损皮肤组(用消毒针头划痕,以渗血为度),于给药前24小时将家兔背部两侧去毛,去毛面积约150cm2,将去毛部分分成四个区域,左侧分为上下2个区域,右侧2个区域,实验采用同体自身对比,左侧上半区涂抹低剂量,左侧下半区涂抹高剂量,右测上半区涂抹生理盐水,右侧下半区为正常区域,涂药后用无菌干纱布包扎涂药区域,24小时后用温水洗去残留薰洗液,去除薰洗液后1、24、48和72小时用肉眼观察并记录涂抹部位有无红斑和水肿等情况以及上述变化的恢复情况和时间,皮肤刺激分级参照卫生部《中药新药研究指南》。
结果显示:荆黄汤熏洗液高、低剂量组对家兔完整皮肤和破损皮肤用药部位均未见红斑、水肿等刺激反应,各组1~72小时内各个不同时间点刺激反应平均分值均为0,与空白对照组比较均无差异,结果见表1。
表1.荆黄汤熏洗液单次给药对家兔皮肤刺激性实验结果
多次给药皮肤刺激性实验:
家兔12只,分组及皮肤处理同单次给药,连续给药7天,停药后再观察72小时,每日观察并记录红斑、水肿、是否有色素沉着、有无出血点、皮肤粗糙或皮肤菲薄等情况,其它同上。
结果显示:荆黄汤熏洗液高、低剂量组对家兔皮肤连续涂抹1周,在给药期间及停药后72小时对家兔完整皮肤和破损皮肤用药部位均未见红斑、水肿等刺激反应,刺激反应平均分值均为0,涂药部位均无色素沉着、有无出血点、皮肤粗糙、皮肤菲薄等情况,与空白对照组比较均无差异,结果见表2。
表2.荆黄汤熏洗液多次给药对家兔皮肤刺激性实验结果
第二个实验为家兔直肠粘膜刺激性实验,包括单次给药直肠粘膜刺激性实验和多次给药直肠粘膜刺激性实验。
单次给药直肠粘膜刺激性实验:
家兔18只,禁食16小时后,随机分为3组,即荆黄汤熏洗液低剂量组、荆黄汤熏洗液高剂量组和正常对照组(生理盐水),取受试物1ml,用导尿管注入家兔直肠中(约3cm),24小时后处死动物,取出直肠,肉眼观察粘膜有无充血,水肿等变化,取材后用10%福尔马林固定,做组织病理学检查,粘膜刺激分级参照卫生部《中药新药研究指南》。
结果显示:荆黄汤熏洗液高、低剂量组对家兔直肠粘膜均未见红斑、水肿等刺激反应,与空白对照组比较均无差异。组织病理学检查与空白对照组比较直肠组织结构未见异常改变,结果见表3。
表3.荆黄汤熏洗液单次给药对家兔直肠粘膜刺激性实验结果
多次给药直肠粘膜刺激性实验:
家兔18只,方法及分组同上,连续给药7日,每天观察动物的饮食、毛发、肛门、呼吸及四肢活动情况,于药后24小时处死动物,取出直肠,肉眼观察粘膜有无充血、水肿等变化,然后做组织病理学检查。
结果显示:荆黄汤熏洗液高、低剂量组对家兔直肠粘膜均未见红斑、水肿等刺激反应,与空白对照组比较均无差异,组织病理学检查与空白对照组比较直肠组织结构未见异常改变,结果见表4。
表4.荆黄汤熏洗液多次给药对家兔直肠粘膜刺激性实验结果
第三个实验为豚鼠过敏实验,包括致敏接触和激发接触;
致敏接触取受试药物0.2ml涂于豚鼠背部左侧脱毛区(阳性对照用1%2,4-二硝基氯苯,用1:1丙酮麻油配制),在7日和14日以同样的方法重复1次,激发接触于末次致敏后14日,将受试物0.2ml涂于豚鼠背部右侧脱毛区(阳性对照组用0.1%2,4-二硝基氯苯,用1∶1丙酮麻油配制),6小时后除去受试物,即刻观察,然后于24小时、48小时和72小时观察皮肤过敏反应情况,记录各时间过敏反应分值,致敏率(%)=出现皮肤红斑和水肿的动物数/受试动物总数,结果显示荆黄汤熏洗液对豚鼠皮肤未见过敏反应,结果见表5。
表5.荆黄汤熏洗液对豚鼠皮肤过敏实验结果
综上,研究结果表明,单次和多次给药后,荆黄汤熏洗液对家兔完整皮肤和破损皮肤用药部位均未见红斑、水肿等刺激反应,显示无明显皮肤刺激性;单次和多次给药,荆黄汤熏洗液对家兔直肠粘膜均未见红斑、水肿等刺激反应,表明无明显粘膜刺激性,荆黄汤熏洗液对豚鼠皮肤未见过敏反应。上述实验均显示出荆黄汤熏洗液局部外用较为安全。
通过动物药效学研究证实:荆黄汤薰洗液具有一定的抗炎作用、提高痛阈值、有较好的活血化瘀作用、有一定的促进伤口愈合作用。
第四个实验为对二甲苯所致小鼠耳廓肿胀的影响:
KM小鼠40只,雌雄各半,随机分成4组,即正常对照组(生理盐水)、阳性对照组(痔疮膏)、低剂量组和高剂量组,每天给药2次,连续给药3天,于末次给药1小时后,于一侧耳廓正反两面均匀涂抹二甲苯0.1ml/只,15min后处死,沿耳廓基线剪下双耳,于同一部位用打孔器打下直径9mm耳片称重,两耳片重量之差为肿胀度,结果显示,荆黄汤熏洗液高剂量组能明显减轻二甲苯致小鼠耳廓肿胀,与正常对照组比较,差异有显著性(P<0.05),结果见表6。
注:与正常对照组比较,*P<0.05,**P<0.01
第五个实验为对蛋清所致大鼠足跖肿胀的影响:
SD大鼠40只,雌雄各半,分组给药同上,于末次给药1小时后,用PV-200足趾容积测量仪测其正常右后足跖容积,并于大鼠右后足跖皮下注入新鲜鸡蛋清0.1ml/爪,然后分别于致炎后1小时、2小时、3小时、4小时、5小时、6小时测定其右后足跖容积,计算出肿胀值(致炎前后容积之差)。
结果显示,荆黄汤熏洗液高低剂量组在注射蛋清后2小时、3小时、4小时、5小时、6小时能减轻大鼠关节肿胀度,与正常对照组比较,差异有显著性(P<0.05或P<0.01);痔疮膏组在注射蛋清后5小时、6小时亦显示出一定抑制作用(P<0.05或P<0.01),但作用弱于荆黄汤熏洗液,结果见表7。
注:与正常对照组比较,*P<0.05,**P<0.01
第六个实验为对醋酸所致小鼠扭体反应的影响:
KM小鼠40只,雌雄各半,分组给药同上,于末次给药0.5小时后,腹腔注射0.5%冰醋酸0.2ml/只,观察并记录每只小鼠自致痛后至出现第一次扭体反应的时间和15分钟内出现扭体反应的次数,结果显示,荆黄汤熏洗液高剂量组和痔疮膏组在注射0.5%冰醋酸后能延长小鼠出现扭体反应的平均时间,减少扭体反应的平均次数,与正常对照组比较,差异有显著性(P<0.05或P<0.01),结果见表8。
注:与正常对照组比较,*P<0.05,**P<0.01
第七个实验为对小鼠热板性疼痛的影响:
KM小鼠,雌性,用YLS-6B智能热板仪测定痛阈值(调节热板温度使恒定于55±0.5℃,以小鼠自置于仪器上至出现舔后足所需时间作为该鼠的痛阈值),凡舔后足时间小于5s或大于30s或跳跃者弃之不用,筛选出合格的KM小鼠40只,分组给药同上,于末次给药后15、30、60min后分别测小鼠痛阈值,如60s仍无反应,则其痛阈值以60s计算,结果显示,荆黄汤熏洗液高剂量组和痔疮膏组在给药后15、30、60min均能提高小鼠的痛阈值,与正常对照组比较,差异有显著性(P<0.01),结果见表9。
注:与正常对照组比较,*P<0.05,**P<0.01
第八个实验为对小鼠凝血时间的影响:
KM小鼠40只,雌雄各半,分组给药同上,于末次给药1小时后用玻璃毛细管插入小鼠眼内眦球后静脉丛,深约4~5mm,轻轻转动再缩回,自血液流入管内开始计时,血液注满后取出毛细管,每隔30s折断毛细管约0.5cm,并缓慢向左右拉开,观察折断处是否有血凝丝,至血凝丝出现为止,所历时间即为凝血时间,结果显示,荆黄汤熏洗液高剂量组和痔疮膏组均能延长小鼠的凝血时间,与正常对照组比较,差异有显著性(P<0.05或P<0.01),结果见表10。
注:与正常对照组比较,*P<0.05,**P<0.01
第九个实验为对血瘀模型大鼠血流变指标的影响:
SD大鼠50只,雌雄各半,随机分为5组,即正常对照组(生理盐水),模型组(生理盐水),阳性对照组(痔疮膏)、荆黄汤熏洗液低剂量组(涂抹一次)和荆黄汤熏洗液高剂量组(连续涂抹两次,间隔20min),造模前5天开始涂抹给药,每天2次,给药4天后,除正常对照组外的其余4组均皮下注射盐酸肾上腺素,再放入4℃水中5min,造模后禁食,次日给药后2小时自颈动脉放血,用FASCO-3010型全自动血流变快测仪(重庆大学维多生物工程研究所)测定全血粘度、血浆粘度;用温氏法测定血沉、血球压积;采用PPP自动平衡电脑血小板聚集仪测定血小板聚集率,结果显示:荆黄汤熏洗液能明显降低“血瘀”模型大鼠的全血粘度、血浆粘度、血小板聚集率、红细胞压积和血沉,与模型组比较差异有显著性(P<0.05或P<0.01),结果见表11和表12。
注:与正常对照组比较,△P<0.01;与模型对照组比较,*P<0.05,**P<0.01
注:与正常对照组比较,△P<0.01;与模型对照组比较,*P<0.05,**P<0.01
第十个实验为对创面模型家兔伤口愈合的影响:
家兔24只,背部去毛,在背部头侧1/3,脊柱旁1.5cm处,左右对称设计成3cm×4cm大小,长轴与脊柱平行的矩形创面,用1%普鲁卡因局麻后,按设计完整切除皮肤、浅筋膜组织,直至深筋膜浅面,创面用无菌干纱布包扎,随机分成4组,即正常对照组(生理盐水)、阳性对照组(痔疮膏)、低剂量组和高剂量组,每天给药2次,连续给药10天,每次换药时测量创面大小,计算术后10天的创面面积及愈合速度,以创面愈合95%为愈合标准,记录每个创面的愈合天数,结果显示:与正常对照组比较,荆黄汤熏洗液高低剂量组及阳性对照组动物术后10天的创面大小、愈合速度和平均愈合时间差异均有显著性(P<0.05或P<0.01),荆黄汤熏洗液能加速创面模型家兔伤口的愈合,结果见表13。
注:与正常对照组比较,*P<0.05,**P<0.01
第十一个实验为对溃疡模型家兔创口愈合的影响:
家免24只,后背臀部去毛,面积为4cm×4cm大小,消毒后于其中心部注射无菌松节油0.7ml,24小时后以注射中心为圆心环形切开皮肤,半径为1cm,术后用无菌纱布包扎,1周后形成溃疡模型,表面用无菌干纱布包扎,分组给药同上,每天换药一次,以创面愈合95%为愈合标准,记录创面的愈合天数,结果显示:与正常对照组比较,荆黄汤熏洗液高、低剂量组及阳性对照组家兔术后10日的平均愈合时间差异有显著性(P<0.05或P<0.01),荆黄汤熏洗液能加速溃疡模型家兔伤口的愈合,结果见表14。
注:与正常对照组比较,*P<0.05,**P<0.01
综上,通过动物药效学研究结果显示,荆黄汤熏洗液能明显减轻二甲苯致小鼠耳廓肿胀和蛋清所致大鼠足跖肿胀,具有一定的抗炎作用;荆黄汤熏洗液能延长小鼠出现扭体反应的平均时间,减少扭体反应的平均次数,提高小鼠对热痛阈值,显示出一定的镇痛作用;荆黄汤熏洗液能延长小鼠的凝血时间,降低“血瘀”模型大鼠的全血粘度、血浆粘度、血小板聚集率、红细胞压积和血沉,具有较好的活血化瘀作用;荆黄汤熏洗液能缩短创面和溃疡模型家兔伤口的平均愈合时间,具有一定的促进伤口愈合作用。
荆芥辛温解表,薄荷辛凉解表,常用于风寒或风热感冒引起的头痛发热,或麻疹初起有表证者,民间也有用荆芥煎汤外洗治疗疱疹及湿热性皮肤疹子的。古方有用荆芥烧烟熏治疗痔疮的记载,近代将荆芥(及薄荷)作为外用的则鲜见,我们在临床实践中发现将其外用有良好的舒适感和止痛作用,试用于痔瘘术后效果良好,再根据肛门疾病的特点,结合川南气候多湿多热、湿热胶结、湿热下注等因素,组合加入大黄、黄桷、苦参、苍术、地榆、土茯苓等,收到良好疗效。经临床对比性研究及动物实验证明荆黄汤薰洗液有显著的抗炎止痛、促进伤口愈合的作用,国内虽有学者用中药汤剂坐浴分别治疗痔疮、肛瘘、肛裂等的报导,但都未见用于多种肛门疾病的报导。
熏洗坐浴法是痔瘘等肛门疾病常用的治疗手段,特别是手术后更是重要的辅助治疗措施,中医或中西结合的肛肠工作者常选用中药组方熏洗,相关专业期刊也时有报导,但缺乏相对集中的大宗病例,亦鲜见临床系统的对比性研究,更未见实验性研究,本研究通过了严密、系统的动物实验,验证了荆黄汤熏洗液的有效性和局部应用的安全性,为其大量、系统的运用于临床提供了实验和理论依据,本研究是建立在逾万病例基础上,作了较系统的前瞻性随机对照临床研究,最终证明荆黄汤熏洗液在肛门疾病术后应用中,具有解毒消肿、活血止痛、促进创面愈合且安全可靠等特点。
工作原理:
该荆黄汤熏洗液及其制备方法:通过临床应用发现,荆黄汤薰洗液可以减轻各种肛门肛管疾病术后的疼痛和水肿,有较好的抗感染作用,有明显的促进创面愈合的作用,未见明显的毒副反应。
将2178例肛门肛管疾病患者随机分为单日手术者为荆黄汤坐浴组(治疗组)1100例,双日手术者为1/5000高锰酸钾液坐浴组(对照组)1078例。见表15。
表15 荆黄汤坐浴组与高锰酸钾液坐浴组一般临床资料比较(例)
具体的荆黄汤薰洗液的制备为选取荆芥、黄柏、大黄、苦参、地榆、薄荷等按1:5加水浸泡30分钟,武火煎煮,沸后5分钟取头煎,药渣再加水,文火煎煮,沸后15分钟取二煎液,将两次所得薰洗液混合备用,治疗组患者术后每次排便后,先在浴盆内放600~700ml的70℃~80℃热水,置一特别的塑料盆套套于热水上,套内放煎好的荆黄汤薰洗液500毫升(下面的热水将薰洗液加温并将薰洗液托起,这样可以反复加热水以维持所需的温度同时可节省用药量),待薰洗液温度合适时(约50℃左右)开始坐浴,每次15~20min。对照组患者术后每次排便后用1/5000高锰酸钾溶液坐浴,方法同上。
观察术后肛门(伤口)疼痛、水肿、感染、治愈时间,其中便后疼痛经坐浴消除或减轻程度按“五指评分法”评判,中度以上的疼痛降至轻度疼痛及以下,有明显舒适感者属优;自觉疼痛显著减轻,舒适为良;坐浴后疼痛无改善或改善不明显者为差。
从本研究疗效对比的统计资料得知治疗组:疼痛减轻优良率达97.99%,较对照组的75.51%高22.48个百分点;感染率较对照组的2.7%低1.3个百分点;术后水肿发生率较对照组的7.05%低3.37个百分点,且中重度水肿显著少于对照组;术后两周痊愈率为98.54%,较对照组的64.93%高33.61个百分点,疗效显著,结果见表16。
表16 荆黄汤坐浴与高锰酸钾坐浴的疗效对比[例(×10-2)]
最后应说明的是:以上仅为本发明的优选实施例而已,并不用于限制本发明,尽管参照前述实施例对本发明进行了详细的说明,对于本领域的技术人员来说,其依然可以对前述各实施例所记载的技术方案进行修改,或者对其中部分技术特征进行等同替换,凡在本发明的精神和原则之内,所作的任何修改、等同替换、改进等,均应包含在本发明的保护范围之内。
Claims (6)
1.一种荆黄汤熏洗液,包括药包和与其混合的水,其特征在于:
所述荆黄汤熏洗液的药包由以下原料制成:包括黄柏、荆芥、苦参、苍术、地榆、薄荷、土茯苓、五倍子和甘草。
2.根据权利要求1所述的一种荆黄汤熏洗液,其特征在于:所述荆黄汤熏洗液的药包由以下质量份的原料制成:所述黄柏15克、荆芥10克、苦参20克、苍术15克、地榆15克、薄荷10克、茯苓15克、五倍子10克和甘草5克。
3.一种制备方法,其用于根据权利要求1~2任一项所述的一种荆黄汤熏洗液,其特征在于,包括以下步骤:
S1:将药包置于煎药釜内部;
S2:向煎药釜内部添加水浸泡药包;
S3:加热煮沸并取头煎液;
S4:向煎药釜内部继续加水;
S5:加热煮沸并取二煎液;
S6:头煎液和二煎液混合备用。
4.根据权利要求3所述的一种荆黄汤熏洗液的制备方法,其特征在于:S2中药包的浸泡时间为30分钟,所述药包和与其混合的水的重量比例为1∶8。
5.根据权利要求3所述的一种荆黄汤熏洗液的制备方法,其特征在于:S3中煮沸后取头煎液的时间为沸腾后五分钟。
6.根据权利要求3所述的一种荆黄汤熏洗液的制备方法,其特征在于:S5中煮沸后取二煎液的时间为沸腾后十五分钟。
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