CN117503880A - 一种治疗慢性湿疹的中药组合物、制备方法及其应用 - Google Patents
一种治疗慢性湿疹的中药组合物、制备方法及其应用 Download PDFInfo
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Abstract
本发明提供一种治疗慢性湿疹的中药组合物、制备方法及其应用,其具有健脾调胃、清热化湿为主,兼凉血活血,最终祛除风、湿、热三邪以正安的中药组合物,其对缓解慢性湿疹患者病情、防止复发疗效显著,为临床治疗慢性湿疹的用药和药物使用方法提供了新的选择,该中药组合物由焦山楂20‑25重量份、神曲20‑25重量份、马齿苋15‑20重量份、连翘10‑15重量份、泽泻10‑15重量份、茯苓15‑20重量份、薏苡仁15‑20重量份、炒莱菔子10‑15重量份、白术10‑15重量份、生地黄15‑20重量份、牡丹皮15‑20重量份、紫荆皮10‑15重量份、地骨皮10‑15重量份、桑白皮10‑15重量份、生甘草6‑10重量份组成,将中药组合物制备成外用制剂。
Description
技术领域
本发明涉及慢性湿疹治疗领域,具体而言,涉及一种治疗慢性湿疹的中药组合物、制备方法及其应用。
背景技术
慢性湿疹以红斑、丘疹、水疱等多形性皮损为临床特征。目前,大多数采用激素类的外用药,但是长时间使用激素类外用药会导致涂药部分的皮肤异常或出现一些其他的不良反应。或是使用抗组织胺制剂,例如扑尔敏、息斯敏等,其具有口干嗜睡、头晕等毒副作用,甚则产生心肌毒性,长期使用糖皮质激素亦有激素依赖或反跳皮质功能亢进等反应,而治疗间断后,瘙痒迅速复发。
《诸病源候论·头面身体诸疮候》中提及“夫内热外虚,为风湿所乘,则生疮。……湿热相搏,故头面身体皆生疮……”,指出湿疹发病内因五脏失和、脾虚生湿化热,外有风、湿、热三邪,湿热相搏发于体表而成。
经过历代医家对湿疹的认识和总结,近现代医家提出湿疹病机为:
一则先天禀赋不耐,脾肺不足,脾虚湿盛,日久化热,加之外感风湿热邪,郁于肌表而发;
二则若病程缠绵,久治不愈则脾虚血弱,血虚生风而发;
三则母体食用过多辛辣刺激发物,遗热胎儿所致。中医多从脏腑、伤寒六经、温病卫气营血角度进行辨证论治湿疹。
常使用清热燥湿止痒、凉血解毒等功效的中药组合物进行治疗。例如,著名中医皮外科专家赵炳南教授提出卫、气、营、血四个病理发展阶段与湿疹病情的轻重深浅一一对应。赵老提出卫分证常夹杂外感,故宜解表清热,祛风止痒;邪侵气分,或由卫传气,湿热相博于气分故宜清热利湿;邪传营分,内陷较重,热毒蕴结常表现为心烦不寐,故宜清营解毒;血分证以动血伤阴为主,常表现为身热夜甚,烦躁不宁,故宜清热凉血。
又如专利申请号为201210590888.X的用于治疗慢性湿疹的中药组合物及其制备方法,其外用药包括艾叶、苦参、薄荷、威灵仙、徐长卿、黄芩、蜂房、浮萍、皂角刺、五倍子、土贝母、川楝子、三七、月季花、苦地丁,上述药物也是主要起到清热燥湿止痒、凉血解毒等功效的中药。
发明内容
本发明的目的在于提供一种治疗慢性湿疹的中药组合物、制备方法及其应用,其具有健脾调胃、清热化湿为主,兼凉血活血,最终祛除风、湿、热三邪以正安的中药组合物,其对缓解慢性湿疹患者病情、防止复发疗效显著,为临床用药和药物使用方法提供了新的选择。
本发明实施例一方面提供一种治疗慢性湿疹的中药组合物,该中药组合物由焦山楂20-25重量份、神曲20-25重量份、马齿苋15-20重量份、连翘10-15重量份、泽泻10-15重量份、茯苓15-20重量份、薏苡仁15-20重量份、炒莱菔子10-15重量份、白术10-15重量份、生地黄15-20重量份、牡丹皮15-20重量份、紫荆皮10-15重量份、地骨皮10-15重量份、桑白皮10-15重量份、生甘草6-10重量份组成,将中药组合物制备成外用制剂。
优选的,中药组合物由焦山楂20重量份、神曲20重量份、茯苓15重量份、薏苡仁15重量份、白术10重量份、炒莱菔子10重量份、连翘10重量份、泽泻10重量份、马齿苋15重量份、生地黄15重量份、牡丹皮15重量份、紫荆皮10重量份、地骨皮10重量份、桑白皮10重量份、白鲜皮10重量份、生甘草6重量份组成。
优选的,外用制剂包括栓剂、凝胶剂或膏剂。
本发明实施例的第二方面提供一种治疗慢性湿疹的中药组合物的应用,使用上述任一外用制剂制备中药肛栓剂,通过纳肛用药。
本发明实施例的第三方面提供一种治疗慢性湿疹的中药组合物的制备方法,使用上述任一中药组合物制备外用制剂,外用制剂的制备方法为:
按重量份称取焦山楂、神曲、马齿苋、连翘、泽泻、茯苓、薏苡仁、炒莱菔子、白术、生地黄、牡丹皮、紫荆皮、地骨皮、桑白皮、生甘草磨粉混合得到中药组合物粉末,加纯净水浸泡;
多次煎煮并获取中药组合物滤液;
浓缩中药组合物滤液至相对密度为1.18-1.20,冷却得到中药组合物浓缩液;
向中药组合物浓缩液中加入乙醇,保证含醇量为70%,搅拌静置2-3h后过滤,得到含醇中药组合物浓缩液;
回收含醇中药组合物浓缩液中的乙醇至无乙醇味,得到预备制剂;
减压蒸馏预备制剂,去除乙醇并浓缩成稠膏状,得到外用制剂;外用制剂的水分占比为16-20%。
优选的,每次加纯净水浸泡过程中,使用中药总重量份6-10倍水至少浸泡30min。
优选的,中药组合物滤液的获取步骤包括:煎煮3次中药组合物粉末,每次煎煮时间至少30min;取三次煎煮后的过滤液合并得到中药组合物滤液。
优选的,外用制剂为中药肛栓剂,以中药组合物结合可药用的栓剂辅料制备而成。
优选的,中药肛栓剂的制备方法为:
取10-20份麦淀粉、5-20份聚乙二醇、30-50份甘油混合,加热至融化,得到栓剂辅料;
分批加入至40-60份的外用制剂中,加热混合,均匀混合后趁热倒入至栓模内,冷却取出,得到治疗慢性湿疹的中药混合物栓剂。
优选的,加热温度为30-50℃。
本发明实施例的有益效果是:
1、本发明的中药组合物以山楂、神曲为君药。山楂消食化积,行气散瘀,为消化油腻肉食之要药;神曲消食健胃、和中止泻,两者均为“治脾圣药”。连翘、马齿苋、泽泻为臣药,以清热祛湿止痒,君臣共用,消补兼施,重在健脾。佐以莱菔子、茯苓、白术和薏苡仁,以健脾祛湿;血虚生风皮肤表现为瘙痒,血瘀难以濡养表现为干燥,故加生地黄、紫荆皮、牡丹皮取“除风先活血,血行风自灭”之意,祛风止痒、清热凉血;湿热犯肺,外泛肌肤而生湿疮,应重视肺脾同,故加地骨皮、白鲜皮、桑白皮入肺经,达“以皮治皮之效”;三药合用清泻肺热兼除湿止痒。甘草为使,调和诸药。本案配伍精当,各药味相辅相成,该方健脾调胃、清热化湿为主兼凉血活血,最终祛除风、湿、热三邪以正安。
2、使用本中药组合物制备中药肛栓剂,通过纳肛用药,药液经肠壁周围丰富的静脉丛和淋巴组织吸收入血,后通过直肠下静脉和(或)肛门静脉,经骼内静脉避开肝脏,从而进入下腔静脉,此途径避免了肝脏的首过消除效应,可最大限度地发挥药物疗效,达到刺激肠道蠕动、稀释肠腔内毒物、促进毒素排泄的治疗目的,提供了一种治疗慢性湿疹药物的新的应用方法;
3、本发明在生产过程中,主要使用乙醇、纯净水等无毒物质,避免引用有毒的有机试剂等,并且乙醇使用后,还回收利用,不但在生产过程中安全无污染,无“三废”排放,还充分利用资源,进一步降低生产成本。
附图说明
为了更清楚地说明本发明实施例的技术方案,下面将对实施例中所需要使用的附图作简单地介绍,应当理解,以下附图仅示出了本发明的某些实施例,因此不应被看作是对范围的限定,对于本领域普通技术人员来讲,在不付出创造性劳动的前提下,还可以根据这些附图获得其他相关的附图。
图1为本发明实施例的I L-6(pg/mL)炎症状态组间比较图;
图2为本发明实施例的TNF-α(ng/L)炎症状态组件比较图;
图3为本发明实施例的I L-6(pg/mL)炎症状态灌肠前后比较图;
图4为本发明实施例的TNF-α(ng/L)炎症状态灌肠前后比较图。
具体实施方式
现详细说明本发明的多种示例性具体实施方式,该详细说明不应认为是对本发明的限制,而应理解为是对本发明的某些方面、特性和实施方案的更详细的描述。
应理解本发明中所述的术语仅仅是为描述特别的具体实施方式,并非用于限制本发明。另外,对于本发明中的数值范围,应理解为还具体公开了该范围的上限和下限之间的每个中间值。在任何陈述值或陈述范围内的中间值,以及任何其他陈述值或在所述范围内的中间值之间的每个较小的范围也包括在本发明内。这些较小范围的上限和下限可独立地包括或排除在范围内。
除非另有说明,否则本文使用的所有技术和科学术语具有本发明所述领域的常规技术人员通常理解的相同含义。虽然本发明仅描述了优选的方法和材料,但是在本发明的实施或测试中也可以使用与本文所述相似或等同的任何方法和材料。本说明书中提到的所有文献通过引用并入,用以公开和描述与所述文献相关的方法和/或材料。在与任何并入的文献冲突时,以本说明书的内容为准。
在不背离本发明的范围或精神的情况下,可对本发明说明书的具体实施方式做多种改进和变化,这对本领域技术人员而言是显而易见的。由本发明的说明书得到的其他具体实施方式对技术人员而言是显而易见得的。本发明说明书和实施例仅是示例性的。
关于本文中所使用的“包含”、“包括”、“具有”、“含有”等等,均为开放性的用语,即意指包含但不限于。
第一实施例
本实施例基于近代医家对湿疹的认识和总结,根据引发湿疹的3种类型病机,提供一种新的用于治疗慢性湿疹的中药组合物,该中药组合物由焦山楂20-25重量份、神曲20-25重量份、马齿苋15-20重量份、连翘10-15重量份、泽泻10-15重量份、茯苓15-20重量份、薏苡仁15-20重量份、炒莱菔子10-15重量份、白术10-15重量份、生地黄15-20重量份、牡丹皮15-20重量份、紫荆皮10-15重量份、地骨皮10-15重量份、桑白皮10-15重量份、生甘草6-10重量份组成,将中药组合物制备成外用制剂,外用制剂包括栓剂、凝胶剂或膏剂。
所述中药组合物中各原料药的重量份进一步优选为:焦山楂20重量份、神曲20重量份、茯苓15重量份、薏苡仁15重量份、白术10重量份、炒莱菔子10重量份、连翘10重量份、泽泻10重量份、马齿苋15重量份、生地黄15重量份、牡丹皮15重量份、紫荆皮10重量份、地骨皮10重量份、桑白皮10重量份、白鲜皮10重量份、生甘草6重量份组成。
脾胃虚弱是免疫网络表达异常,是“脾为之卫”作用失司,卫气不足以抗邪的表现,同样也是湿疹反复发作,迁延难愈的本质内因。脾失运化,又进一步导致水湿停聚,于内则郁久化热生风,于外则复感风邪。风、湿、热三邪蕴结于皮肤则发为湿疹。风、湿、热邪既为外因引发湿疹发作,又作为内因导致病程迁延。
基于《内经》“诸湿肿满皆属于脾”,本方案的中药组合物以“见湿非治湿,当以健脾为先”的治疗原则,认为“逐浊运脾”是治疗湿疹的核心环节。肺体合皮,故当以健脾以培土生金,肺脾同治,效如桴鼓。
慢性湿疹患者脾常不足,常出现胸腹胀满、口腻纳呆等症。本实施例中以焦山楂、神曲为君药。山楂消食化积,行气散瘀,为消化油腻肉食之要药;神曲消食健胃、和中止泻,两者均为“治脾圣药”,健脾养胃,调补中焦。
另外,湿性缠绵,易挟风、热,致病情反复难愈,本方案以连翘、马齿苋、泽泻为臣药,以清热祛湿止痒,君臣共用,消补兼施,重在健脾。连翘清热解毒、消肿散结、消炎,一则引心经热邪从小便而出,二则取其升浮宣散之力,托毒外出,缓解瘙痒。马齿苋清热解毒,凉血止血,止痢。泽泻入肾、膀胱经,具有利小便、清湿热。
佐以莱菔子、茯苓、白术和薏苡仁,以健脾祛湿。莱菔子入脾肺,消食除胀、降气化痰。茯苓入脾,利水消肿、健脾止泻、养心安神。白术入脾利尿消肿、固表止汗、燥湿健脾。薏苡仁入脾、肺、肾,利水渗湿、健脾止泻、除痹。
脾运化失常,则营血不足。一则无力推动血行致血瘀;二则无以化生气血致血少。血虚生风皮肤表现为瘙痒,血瘀难以濡养表现为干燥。故加生地黄、紫荆皮、牡丹皮取“除风先活血,血行风自灭”之意,祛风止痒、清热凉血。生地黄清热凉血、养阴生津。紫荆皮活血、通淋、解毒。牡丹皮清热凉血、活血化淤、退虚热。
湿热犯肺,外泛肌肤而生湿疮,应重视肺脾同,故加地骨皮、桑白皮、白鲜皮入肺经,达“以皮治皮之效”。地骨皮退热除蒸之效,凉血除蒸、清肺降火。桑白皮泻肺平喘,行水消肿。
佐以莱菔子、茯苓、白术和薏苡仁健脾祛湿,生地黄、紫荆皮、牡丹皮清热活血,祛风止痒,地骨皮、桑白皮、白鲜皮以皮治皮,三药合用健脾清泻肺热兼除湿止痒。
甘草为使,调和诸药。
本实施例中的药物组合物配伍精当,各药味相辅相成,该方健脾调胃、清热化湿为主,兼凉血活血,最终祛除风、湿、热三邪以正安。对缓解慢性湿疹患者病情、防止复发疗效显著,可以更为有效地治疗慢性湿疹患者,为临床用药提供了新的选择。
本实施例中将中药组合物制备成外用制剂,可选的外用制剂包括栓剂、凝胶剂或膏剂。优选的,使用上述外用制剂制备中药肛栓剂,通过纳肛用药,提供了一种新的治疗慢性湿疹的中药组合物的应用。
中药灌肠法是极具中医特色的外治法,利用大肠传导糟粕以降浊的功能特点,祛邪外达,调整阴阳,延缓疾病进展。解剖学和生理学发现,直肠周围具有丰富的动脉、静脉、淋巴丛,而且肠壁组织具有半透膜的特性,可选择透过性吸收,还可分泌细胞因子。针于此,本实施例中的外用制剂优选的制备成中药肛栓剂,栓剂中药组合物经肠壁周围丰富的静脉丛和淋巴组织吸收入血,后通过直肠下静脉和(或)肛门静脉,经骼内静脉避开肝脏,从而进入下腔静脉,此途径避免了肝脏的首过消除效应,可在脾、肺、肠道最大限度地发挥药物疗效,达到刺激肠道蠕动、稀释肠腔内毒物、促进毒素排泄的治疗目的。
一种治疗慢性湿疹的中药组合物的制备方法,使用上述中药组合物制备外用制剂,该外用制剂的制备方法为:
按重量份称取焦山楂、神曲、马齿苋、连翘、泽泻、茯苓、薏苡仁、炒莱菔子、白术、生地黄、牡丹皮、紫荆皮、地骨皮、桑白皮、生甘草磨粉混合得到中药组合物粉末,磨成细粉的粒径在1-50μm,加纯净水浸泡;可选的,加纯净水浸泡过程中,使用中药总重量份6-10倍水至少浸泡30min;
多次煎煮并获取中药组合物滤液;可选的,煎煮3次中药组合物粉末,每次煎煮时间至少30min;取三次煎煮后的过滤液合并得到中药组合物滤液;
浓缩中药组合物滤液至相对密度为1.18-1.20,冷却得到中药组合物浓缩液;
向中药组合物浓缩液中加入乙醇,保证含醇量为70%,搅拌静置2-3h后过滤,得到含醇中药组合物浓缩液;
回收含醇中药组合物浓缩液中的乙醇至无乙醇味,得到预备制剂;减压蒸馏预备制剂,去除乙醇并浓缩成稠膏状,得到外用制剂;外用制剂的水分占比为16-20%。
在本实施例中制备中药肛栓剂,以中药组合物结合可药用的栓剂辅料制备而成。栓剂辅料的选择有多种,如可可豆油、香果脂基质、甘油明胶、聚乙二醇组合物等等。
可选的,中药肛栓剂的制备方法为:
取10-20份麦淀粉、5-20份聚乙二醇和30-50份甘油混合,30-50℃加热至融化,得到栓剂辅料;等分2份栓剂辅料,分批加入至40-60份的外用制剂中,在同温度下继续加热混合,均匀混合后趁热倒入至栓模内,冷却取出,得到治疗慢性湿疹的中药混合物栓剂。
以下通过实例具体说明。
(一)收治患者标准/诊断标准
研究病例均来源于在成都中医药大学附属医院(四川省中医院)皮肤科就诊的慢性湿疹患者。
慢性湿疹的诊断标准:
西医诊断标准:参照《皮肤性病学》及《中国临床皮肤病学》确定西医诊断标准。病程≥6个月,反复发作,瘙痒≥6周;皮损呈现对称分布,常在手足、四肢屈侧或二阴周围等部位发作。
中医诊断标准:中医证候诊断标准及中医症状分级量化评分标准参照《中药新药临床研究指导原则(试行)》中相关内容指定。主要包含3个证型。发病急,伴身热、心烦口渴、便干尿少,舌红苔黄腻,脉滑数为湿热浸淫证;发病缓,皮损颜色潮红、瘙痒、糜烂、鳞屑,伴纳呆、倦怠、腹胀、泄泻,舌淡白胖嫩、齿痕、苔白腻,脉濡缓为脾虚湿蕴证;病程长,反复发作,皮损暗淡、苔藓样变、剧痒、抓痕或脱屑,伴头晕、无力、腰膝酸软,舌淡苔白,脉弦细为血虚风燥证。
(二)治疗标准
参照2002年版《中药新药临床研究指导原则(试行)》中《中药新药治疗慢性肾功能衰竭的临床研究指导原则》相关内容指定。
表1.中医证候疗效评定标准表
疗效 | 评定标准 |
临床痊愈 | 临床症状、体征消失或基本消失,证候积分减少≥95% |
显效 | 临床症状、体征明显改善,证候积分减少≥70%,<95% |
有效 | 临床症状、体征均有好转,证候积分减少≥30%,<70% |
无效 | 临床症状、体征均无明显改善,甚或加重,证候积分减少<30% |
计算公式(尼莫地平法):(治疗前积分-治疗后积分)÷治疗前积分×100%;总有效率=(临床痊愈+显效+有效)病例数÷总病例数×100%;有效率=(痊愈+显效+有效)/n×100%。
(三)治疗方法
①治疗组:明确诊断后,67例患者均采用如下药物制备中药肛栓剂:
具体的制备中药肛栓剂方法为:
称取焦山楂20g、神曲20g、马齿苋15g、连翘10g、泽泻10g、茯苓15g、薏苡仁15g、炒莱菔子10g、白术10g、生地黄15g、牡丹皮15g、紫荆皮10g、地骨皮10g、桑白皮10g、白鲜皮10g、生甘草6g磨粉混合;加入1.5L浸泡30min,浸泡2次;
将浸泡后中药混合粉末煎煮3次,每次煮沸30min并过滤,合并滤液得到中药组合物滤液;
而后浓缩至相对密度1.18-1.20,放冷得到中药组合物浓缩液;
向中药组合物浓缩液加入浓度80%的乙醇,使含醇量为70%,搅拌,密闭静置2-3h,过滤得到含醇中药组合物浓缩液;
滤液回收乙醇至无乙醇味,得到预备制剂;
减压蒸馏除乙醇浓缩至稠膏状,测定水分控制在16-20%,得到稠膏状外用制剂;
取10-20份麦淀粉、5-20份聚乙二醇和30-50份甘油混合,30-50℃加热至熔化,分批加入上述稠膏状产物,同温继续加热至充分混匀,趁热倾入栓模内,放冷,取出,即得。
中药肛栓剂的使用方法为:戴上指套或者手套;嘱患者张口深呼吸,尽量放松;将中药肛栓剂插入肛门,并用示指将栓剂沿直肠壁朝前脐部方向送入6-7cm;置入中药肛栓剂后,保持侧卧位15Mi n;观察是否产生预期药效,若栓剂滑脱肛门外,给予重新插入;擦净肛周皮肤。
患者每天早晚各使用中药肛栓剂1次,每周5天,共4周。
②对照组:给予安慰剂灌肠。
对照药物:灌肠安慰剂,含:92.2%氯化钠溶液、食品添加剂(5%麦芽糊精、2%焦糖色素、0.5%柠檬黄色素、0.3%日落黄色素)。氯化钠溶液和食品添加剂的可以是任一相关产品的生产产家获取得到。
灌肠操作步骤包括:
患者准备:了解灌肠的目的和操作程序,消除紧张情绪,排尽大小便,配合操作。
物品准备:灌肠药物、注射器、治疗碗、肛管(16~18号)、温水(38~40°C)10mL、止血钳、润滑剂、水温计、棉签、一次性乳胶手套、弯盘、卫生纸、塑料单、治疗巾、小垫枕、免洗手消毒液、便盆、生活垃圾桶、医用垃圾桶。
体位准备:左/右侧卧位;抬高臀部,将小垫枕、塑料单和治疗巾垫于臀下,使臀部抬高约10cm,防止药液溢出。
护士操作步骤:插入肛管,佩戴乳胶手套,润滑肛门及肛管前段,用止血钳夹闭肛管,充分暴露肛门后轻柔插入肛门15~20cm。注入药液,测量药液温度,用注射器抽吸药液75mL,松开止血钳缓慢注入药液。拔出肛管,药液注入完毕,再注入温水5~10mL,抬高肛管尾端,使管内药液全部注完,拔出肛管,卫生纸擦净肛门,脱手套,双手消毒,嘱受试者依次交替取左侧卧位、仰卧位、右侧卧位休息,尽量保留药液1小时以上,使药液充分吸收。清理用物,填写灌肠记录表。
患者每天早晚各灌肠1次,每周5天,共4周。
治疗期间饮食清淡,忌肥甘厚味,忌甜食、辛辣、海鲜食物,忌吸烟饮酒,禁用或禁食某些对机体致敏的药物或食物;嘱多食蔬菜,避免接触致敏物质,注意气温变化,调摄寒温,加强锻炼。避免强烈搔抓皮疹,避免用热水烫洗,同时疏导患者的心理压力,以取得患者信任和配合。
③指标检测:两组治疗结束后,分别检测肠道微炎症状态指标、疗效评定。
(四)治疗结果:
本研究计划纳入134例受试者,实际纳入116例,经区组随机法分为安慰剂灌肠组(PEG)和中药栓剂组(HEG)各58例,各种原因导致脱落37例,最终两组分别有38例、41例纳入统计。表3-14所示,两组间的年龄、BM I经独立样本t检验,p>0.05;两组间的性别经卡方检验,p>0.05;以上均表明PEG和HEG组间基线资料均衡,具有可比性。
表2.人口学基线资料表
项目 | PEG | HEG | 统计量 | p |
样本量(n,%) | 38,48.1% | 41,51.9% | ||
年龄(岁,M±SD) | 59.50±10.61 | 57.07±14.49 | 0.844a | 0.401 |
男(n,%) | 23,60.5% | 23,56.1% | 0.159b | 0.690 |
女(n,%) | 15,39.5% | 18,43.9% | ||
BMI(M±SD) | 23.31±3.01 | 23.42±2.82 | -0.162a | 0.871 |
病程(年,M(P25,P75)) | 2.05(1.00,5.35) | 3.10(1.15,6.50) | -1.007c | 0.314 |
其中,BM I为身体质量指数;PEG为安慰剂灌肠组;HEG为中药灌肠组(下同);a表示独立样本t检验;b表示卡方检验,c表示Mann-Whitney U检验。
表3.临床EASI评分与瘙痒VAS评分
PEG和HEG组间临床EAS I评分与VAS评分比较见表3,并结合图1-4。图表所示:经秩和检验,两组受试者前基线的EAS I差异无统计意义(p=0.883);两组受试者治疗后的EASI差异有统计意义(p<0.001);两组受试者基线的VAS评分差异无统计意义(p=0.686);两组受试者治疗后的VAS评分差异有统计意义(p<0.001)。
结果表明:与安慰剂灌肠相比,中药栓剂能够降低受试者的EAS I评分和瘙痒VAS评分水平。
表4.微炎症状态指标比较M(P25,P75)
PEG和HEG组间微炎症状态比较见表4和图1-2。图表所示:经秩和检验,两组受试者基线的I L-6差异无统计意义(p=0.084);两组受试者治疗后的I L-6差异有统计意义(p<0.001);两组受试者基线的TNF-α差异无统计意义(p=0.934);两组受试者治疗后的TNF-α差异无统计意义(p=0.887)。
表5.炎症状态治疗前后比较M(P25,P75)
PEG和HEG治疗前后微炎症状态比较见表表5、图3和4。图表所示:经秩和检验,PEG治疗前后I L-6差异无统计意义(p=0.065);HEG治疗前后I L-6差异有统计意义(p=0.034);PEG治疗前后TNF-α差异无统计意义(p=0.057);HEG治疗前后TNF-α差异无统计意义(p=0.184)。
结果表明:与安慰剂灌肠相比,中药肛栓剂能够降低受试者的I L-6水平,但对受试者TNF-α水平没有影响。
表6.中医证候疗效评定
疗效 | PEG | HEG | χ2 | p |
痊愈 | 0 | 0 | 6.348 | 0.012 |
显效 | 0 | 0 | ||
有效 | 9(23.7%) | 21(51.2%) | ||
无效 | 29(76.3%) | 20(48.8%) |
如表6中的治疗慢性湿疹的疗效评定所示,PEG总有效率为23.7%,HEG总有效率为51.2%;经卡方检验,两组总有效率差异有统计意义。结果表明:与安慰剂灌肠相比,中药栓剂治疗慢性湿疹的总有效率更高。其中,总有效率=(临床痊愈+显效+有效)病例数÷总病例数×100%。
根据上述实验结果表明,本发明中的药物组合物制备出来的中药肛栓剂,与安慰剂灌肠相比,中药直肠栓剂可降低慢性湿疹患者I L-6水平,减轻微炎症状态,对缓解慢性湿疹患者病情疗效显著。
本说明书描述了本发明的实施例的示例,并不意味着这些实施例说明并描述了本发明的所有可能形式。应理解,说明书中的实施例可以多种替代形式实施。附图无需按比例绘制;可放大或缩小一些特征以显示特定部件的细节。公开的具体结构和功能细节不应当作限定解释,仅仅是教导本领域技术人员以多种形式实施本发明的代表性基础。本领域内的技术人员应理解,参考任一附图说明和描述的多个特征可以与一个或多个其它附图中说明的特征组合以形成未明确说明或描述的实施例。说明的组合特征提供用于典型应用的代表实施例。然而,与本发明的教导一致的特征的多种组合和变型可以根据需要用于特定应用或实施。
以上所述仅为本发明的优选实施例而已,并不用于限制本发明,对于本领域的技术人员来说,本发明可以有各种更改和变化。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 (10)
1.一种治疗慢性湿疹的中药组合物,其特征在于,所述中药组合物由焦山楂20-25重量份、神曲20-25重量份、马齿苋15-20重量份、连翘10-15重量份、泽泻10-15重量份、茯苓15-20重量份、薏苡仁15-20重量份、炒莱菔子10-15重量份、白术10-15重量份、生地黄15-20重量份、牡丹皮15-20重量份、紫荆皮10-15重量份、地骨皮10-15重量份、桑白皮10-15重量份、生甘草6-10重量份组成,将所述中药组合物制备成外用制剂。
2.根据权利要求1所述的治疗慢性湿疹的中药组合物,其特征在于,所述中药组合物由焦山楂20重量份、神曲20重量份、马齿苋15重量份、连翘10重量份、泽泻10重量份、茯苓15重量份、薏苡仁15重量份、炒莱菔子10重量份、白术10重量份、生地黄15重量份、牡丹皮15重量份、紫荆皮10重量份、地骨皮10重量份、桑白皮10重量份、生甘草6重量份组成。
3.根据权利要求1所述的治疗慢性湿疹的中药组合物,其特征在于,所述外用制剂包括栓剂、凝胶剂或膏剂。
4.一种治疗慢性湿疹的中药组合物的应用,其特征在于,使用权利要求1或3任一所述的外用制剂制备中药肛栓剂,通过纳肛用药。
5.一种治疗慢性湿疹的中药组合物的制备方法,其特征在于,使用权利要求1或3任一所述的中药组合物制备外用制剂,所述外用制剂的制备方法为:
按重量份称取焦山楂、神曲、马齿苋、连翘、泽泻、茯苓、薏苡仁、炒莱菔子、白术、生地黄、牡丹皮、紫荆皮、地骨皮、桑白皮、生甘草磨粉混合得到中药组合物粉末,加纯净水浸泡多次;
多次煎煮并获取中药组合物滤液;
浓缩所述中药组合物滤液至相对密度为1.18-1.20,冷却得到中药组合物浓缩液;
向所述中药组合物浓缩液中加入乙醇,保证含醇量为70%,搅拌静置2-3h后过滤,得到含醇中药组合物浓缩液;
回收所述含醇中药组合物浓缩液中的乙醇至无乙醇味,得到预备制剂;
减压蒸馏所述预备制剂,去除乙醇并浓缩成稠膏状,得到所述外用制剂;所述外用制剂的水分占比为16-20%。
6.根据权利要求5所述的治疗慢性湿疹的中药组合物的制备方法,其特征在于,所述加纯净水浸泡过程中,每次使用中药总重量份6-10倍水至少浸泡30min。
7.根据权利要求5所述的治疗慢性湿疹的中药组合物的制备方法,其特征在于,所述中药组合物滤液的获取步骤包括:煎煮3次中药组合物粉末,每次煎煮时间至少30min;取三次煎煮后的过滤液合并得到中药组合物滤液。
8.根据权利要求5所述的治疗慢性湿疹的中药组合物的制备方法,其特征在于,所述外用制剂为中药肛栓剂,以所述中药组合物结合可药用的栓剂辅料制备而成。
9.根据权利要求8所述的治疗慢性湿疹的中药组合物的制备方法,其特征在于,所述中药肛栓剂的制备方法为:
取10-20份麦淀粉、5-20份聚乙二醇、30-50份甘油混合,加热至融化,得到栓剂辅料;
栓剂辅料分批加入至40-60份的所述外用制剂中,加热混合,均匀混合后趁热倒入至栓模内,冷却取出,得到治疗慢性湿疹的中药混合物栓剂。
10.根据权利要求9所述的治疗慢性湿疹的中药组合物的制备方法,其特征在于,所述加热温度为30-50℃。
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