CN103893722A - 一种治疗日光性皮炎的中药组合物及其制备方法 - Google Patents
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- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
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- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
Abstract
本发明属于医药技术领域，特别涉及一种治疗日光性皮炎的中药组合物及其制备方法。针对目前日光性皮炎的化学治疗药物肝毒性较大，疗效不佳的现有技术不足，本发明的提供一种治疗或预防日光性皮炎的中药组合物，其包括如下组分：马齿苋10-50份，羌活10-20份，槐花5-20份，黄芩5-15份，熟地5-10份，百合5-15份，金银花5-15份，蒲公英1-10份，枸杞5-15份，半枝莲9-15份，川芎9-15份，白芷5-15份，黄连素0.2-9份，白芍5.5-15份，干姜6-9份，甘草10-15份。该中药组合物在治疗或预防日光性皮炎方面均具有很好的治疗效果，且药物副作用低，具有显著的临床推广价值。
Description
技术领域
本发明属于医药技术领域，具体涉及一种治疗日光性皮炎的中药组合物及其制备方法。
背景技术
过敏是一种机体的变态反应。当过敏原(如化学物质、紫外线、粉尘等)进入体内后，与肥大细胞或者是嗜碱性粒细胞结合，产生白三烯，前列腺素等过敏因子，当机体第二次接受这种“过敏原”时，肥大细胞开始变形，产生过敏现象。研究表明，过敏性皮炎与自由基有直接关系。过敏性皮炎的本质是机体内产生大量的自由基对肥大细胞和嗜碱粒细胞的氧化破坏反应。所谓的自由基就是当机体进行代谢时，能夺去氧的一个电子，这样这个氧原子就变成自由基。自由基很不稳定，它要在身体组织细胞的分子中再夺取电子来使自己配对，当细胞分子动一个电子后，它也变成自由基，又要去抢夺细胞膜或或细胞核分子中的电子，这样又称会产生新的自由基。如，超氧化物阴离子自由基、羟自由基、氢自由基和甲基自由基，等等。过敏性皮炎(allergic dermatitis)是由于接触过敏性抗原(如化学物质、紫外线、花粉、粉尘、异体蛋白等几百种)引起的皮肤过敏反应，它主要是由IgE介导的I型变态反应。皮肤出现红肿、发痒、风团、脱皮等皮肤病症。主要的表现为皮炎、湿疹、荨麻疹等皮肤反应。
常见的过敏性皮炎主要有：接触性皮炎、日光性皮炎、化妆品皮炎、激素依赖性皮炎等。目前，治疗日光性皮炎的西药很多，但大多数药物治疗效果差，并且还有治疗成高、副作用大等缺点，严重时甚至影响患者健康。另外，还有很多治疗日光性皮炎的中药，但大多数具有治疗效果差、治愈率低和治疗周期长等缺点。本发明目的即在于提供一种作用全面，临床效果好的治疗日光性皮炎的中药组合物。
中医认为，日光性皮炎是由于机体禀赋不强，皮肤腠理不密，皮肤暴露部位经日光过度照射后，暑毒内侵，邪热与气血相搏而发病。多发于春夏季节，表现为身体暴露部位如颜面、颈部、手背等出现不同形状的红斑、丘疹、风团或水疱，伴局部瘙痒、灼热刺痛，严重者可致发热、头痛、恶心、呕吐等全身症状。其发病特点是日光照射后皮损明显加重，痒感加剧，避光后症状减轻。目前治疗日光性皮炎一股是目前主要依靠西药，副作用大，依赖性强，导致药量越来越大，造成恶性循环。
纵观世界新药的研究方向，80年代以前主要是研究开发单一的化学药物及其制剂， 80年代以后开始发展生物技术和天然植物药物，药物研究方向趋于多样性。结合现代中医药发展理论，从提高药物疗效、降低副作用的角度出发，经过对中药成分进行筛选提取和/或配伍制得的制剂，其副作用小，安全性高，具有化学合成药不能比拟的优势。
发明内容
现有技术中化学药物治标不治本，且容易损伤胃肠道粘膜，药物毒副作用大，而中药则存在疗效不确定，缺少相应药物制剂。为了克服现有日光性皮炎化学治疗药物毒副作用大，日光性皮炎治疗效果难以持续的现有技术不足，本发明提供了一种治疗日光性皮炎的中药组合物，该中药组合物疗效好，副作用小，它主要由以下原料制得：马齿苋10-50份，羌活10-20份，槐花5-20份，黄芩5-15份，熟地5-10份，百合5-15份，金银花5-15份，蒲公英1-10份，枸杞5-15份，半枝莲9-15份，川芎9-15份，白芷5-15份，黄连素0.2-9份，白芍5.5-15份，干姜6-9份，甘草10-15份。
马齿笕有清热解毒、祛湿止带功效，适用于湿热下注、带下色黄、黏稠味臭、小便短黄、口渴口苦、舌红苔黄、脉滑者，亦可用于湿热泄泻、痢疾等。能驱虫功效，适用于小儿钩虫病。该品有清热解毒、止泻痢、除肠垢、益气补虚功效，适用于治疗久痢。
羌活为常用中药。药用历史悠久，始见于《神农本草经》，列于独活项下。羌活味苦、辛、性温。具有散表寒去风湿，利关节之功效。治外感风寒、头痛无汗、风寒湿痹、项强筋急、骨节酸痛、风水浮肿、痛肿疮毒等。现代分析表明，羌活主要含有菠烯，拧橡烯，话品烯醇和乙酸龙胆脑醋等成分。临床用于阳痿遗精，遗尿尿频，腰膝冷痛，肾虚作喘，五更泄泻；外用治白癜风，斑秃。解表散寒，祛风胜湿，止痛等症。现代药理学研究羌活具有显著的解热抗炎以及阵痛效果。
槐花又叫槐蕊，槐花的功效：凉血止血、清肝明目，槐花的的作用：治肠风便血、痔疮下血、尿血血淋、肝热头痛、目赤肿痛，槐花用药禁忌：脾胃虚寒者慎服槐花，槐花可以煎水代茶饮，槐花亦可与夏枯草、菊花、黄芩等同用，以增清肝泻火明目之效。临床主治：肠风便血；痔疮下血；血痢；尿血；血淋；崩漏；吐血；衄血；肝热头痛；目赤肿痛；痈肿疮疡。
黄芩别名山茶根、土金茶根。为唇形科植物黄芩(Scutellaria baicalensis Georgi)，以根入药。有清热燥湿，凉血安胎，解毒功效。主治温热病、上呼吸道感染、肺热咳嗽、湿热黄胆、肺炎、痢疾、咳血、目赤、胎动不安、高血压、痈肿疖疮等症。黄芩的临床应用抗菌比川芎还好，而且不产生抗药性。
熟地为玄参科植物地黄的块根，又名熟地黄或伏地，经加工炮制而成。熟地是一种上 好中药材，具有补血滋阴功效，可用于血虚萎黄，眩晕，心悸失眠，月经不调，崩漏等症，亦可用于肾阴不足的潮热骨蒸、盗汗、遗精、消渴等症，是虚证类非处方药药品六味地黄丸主要成分之一。熟地黄始见于《神农本草经》，临床使用有鲜、生、熟三种。均有养阴生津之功，而治阴虚津亏诸证。鲜地黄甘苦大寒，滋阴之力虽弱，但长于清热凉血，泻火除烦，多用于血热邪盛，阴虚津亏证；生(干)地黄甘寒质润凉血之力稍逊但长于养心肾之阴，故血热阴伤及阴虚发热者宜之；熟地黄性味甘温，入肝肾而功专养血滋阴，填精益髓，凡真阴不足，精髓亏虚者，皆可用之。熟地用于肾阳不足，命门火衰，畏寒肢冷，阳痿遗精，小便遗沥，或火不生土之食少便溏，多与附子、肉桂等温阳之品配用，此即所谓“善补阳者，必于阴中求阳”之意。用治阴疽寒凝，本品常与鹿角胶、肉桂、麻黄等配用以温经养血，散寒通脉。
中医认为百合具有润肺止咳、清心安神的作用，尤其是鲜百合更甘甜味美。百合特别适合养肺、养胃的人食用，比如慢性咳嗽、肺结核、口舌生疮、口干、口臭的患者。百合不仅具有良好的营养滋补功效，而且对于病后虚症、结核病、神经官能症等患者大有裨益，对各种癌症都有较好的疗效。在肿瘤的预防和治疗方面，百合多用于治疗肺癌、鼻咽癌、皮肤癌等。在对上述癌症进行放射治疗后出现的体虚乏力、口干、心烦、干咳痰等症状时，用鲜百合与粳米一起煮粥，再调入适量的冰糖或蜂蜜后食用，对增强体质、抑制癌细胞生长、缓解放疗的反应，具有较好的效果。再如，将鲜百合与白糖适量共捣敷患处，对皮肤癌破溃出血、渗水者也有一定的治疗作用。
金银花性寒，味甘，入肺、心、胃经，具有清热解毒、抗炎、补虚疗风的功效，主治胀满下疾、温病发热，热毒痈疡和肿瘤等症。其对于头昏头晕、口干作渴、多汗烦闷、肠胃炎、菌痢、麻疹、肺炎、乙脑、流脑、急性乳腺炎、败血症、阑尾炎、皮肤感染、痈疽疔疮、丹毒、腮腺炎、化脓性扁桃体炎等病症均有一定疗效。同时金银花茶有独特的减肥功能，还能抑制与杀灭咽喉部的病原菌，对老人和儿童有抗感染功效。所以，经常服用金银花浸泡或煎剂有利于风火目赤、咽喉肿痛、肥胖症、肝热症和肝热型高血压的治疗与康复。
蒲公英具有清热解毒的作用，可用于热毒证，尤善清肝热，治疗肝热目赤肿痛，以及多种感染、化脓性疾病；消痈散结治疗热毒壅结于肌肉所致的痈肿疮毒，高热不退。对乳痈有良效，能解毒散结通乳，可内服或外敷，常配金银花等同用。另外还可配大黄、丹皮治疗肠痈。
枸杞(学名：Lycium chinense)是茄科枸杞属的多分枝灌木植物，高0.5-1米，栽培时可达2米多。国内外均有分布。枸杞全身是宝，明李时珍《本草纲目》记载：“春采枸杞 叶，名天精草；夏采花，名长生草；秋采子，名枸杞子；冬采根，名地骨皮”。枸杞嫩叶亦称枸杞头，可食用或作枸杞茶。现代研究，枸杞子有降低血糖、抗脂肪肝作用，并能抗动脉粥样硬化的效果。
半枝莲为唇形科植物半枝莲的干燥地上部分，具清热解毒、活血祛瘀、消肿止痛、抗癌等功能。现在主要与白花蛇舌草配合使用，用来延长肠癌患者的生存寿命。同时，半枝莲清热解毒，散瘀，止血，定痛，癌肿，跌打刀伤，蛇咬伤等。
川芎辛温香燥，走而不守，既能行散，上行可达巅顶；又入血分，下行可达血海。活血祛瘀作用广泛，适宜瘀血阻滞各种病症；祛风止痛，效用甚佳，可治头风头痛、风湿痹痛等症。昔人谓川芎为血中之气药，殆言其寓辛散、解郁、通达、止痛等功能。本品辛温升散，凡阴虚阳亢及肝阳上亢者不宜应用；月经过多、孕妇亦忌用。
白芷，性温，味辛微甘，具有祛风除湿；通窃止痛；消肿排脓的功效。主感冒头痛；眉棱骨痛；牙痛；鼻塞；鼻渊；湿胜久泻；妇女白带；痈疽疮疡；毒蛇咬伤。临床用于感冒头痛，眉棱骨痛，鼻塞，鼻渊，牙痛，白带，疮疡肿痛。也可用于解表散寒，祛风止痛，通鼻窍，燥湿止带，消肿排脓。治头痛，眉棱骨痛，齿痛，鼻渊，寒湿腹痛，肠风痔漏，赤白带下，痈疽疮疡，皮肤燥痒，疥癣。苍术具有燥湿健脾，祛风散寒，明目的功效，用于湿阻脾胃、脘腹胀满，寒湿白带，湿温病以及湿热下注、脚膝肿痛、痿软无力。治湿阻脾胃，而见脘腹胀满、食欲不振、倦怠乏力、舌苔白腻厚浊等症，常与厚朴、陈皮等配伍应用。
黄连素在临床中一直作为非处方药用于治疗腹泻，但是现代药理学研究证实黄连素具有显著的抗心力衰竭、抗心律失常、降低胆固醇、抗制血管平滑肌增殖、改善胰岛素抵抗、抗血小板、抗炎等作用，因而在心血管系统和神经系统疾病方面将可能有广泛、重要的应用前景，日益受到重视。黄连素是一种重要的生物碱，是我国应用很久的中药。可从黄连、黄柏、三颗针等植物中提取。它具有显著的抑菌作用。常用的盐酸黄连素又叫盐酸小檗碱。黄连素能对抗病原微生物，对多种细菌如痢疾杆菌、结核杆菌、肺炎球菌、伤寒杆菌及白喉杆菌等都有抑制作用，其中对痢疾杆菌作用最强，常用来治疗细菌性胃肠炎、痢疾等消化道疾病。临床主要用于治疗细菌性痢疾和肠胃炎，它无抗药性和副作用。
白芍为我国著名的传统常用中药材，应用历史悠久，芍药始载于东汉《神农本草经》，列为中品，记有“主邪气，白芍腹痛，除血痹，破坚积，寒热疝瘕，止痛，利小便，益气”。养血柔肝，缓中止痛，敛阴收汗。治胸腹胁肋疼痛，泻痢腹痛，自汗盗汗，阴虚发 热，月经不调，崩漏，带下等症。现代药理学研究显示，芍药甙对豚鼠、大鼠的离体肠管和在胃运动，以及大鼠子宫平滑机均表现抑制，并能拈抗催产素所引起的收缩；用醋酸注射于小鼠腹腔，以扭体反应作为疼痛的指标，芍药甙有显著的镇痛效果；芍药的浸膏能拈抗士的宁所引起的惊厥；白芍煎剂在试管内对志贺氏痢疾杆菌有抑菌作用，浸剂对某些致病性真菌亦有抑制作用。芍药甙对小白鼠正常体温有降温作用，对人工发热的小鼠也有解热作用。对大鼠实验性后足跖浮肿有抗炎作用；芍药甙在试管内或静脉注射时对二磷酸腺苷诱导的大鼠血小板聚集有抑制作用；芍药甙对由于紧张刺激而诱发的大鼠消化道溃疡有明显的抑制作用。
干姜《神农本草经》列为中品，生姜《名医别录》列为中品。陶弘景谓：“凡作干姜法：水淹三日，去皮置流水中六日，更乱去皮，然后晒干，置瓷缸中酿三日，乃成。”李时珍谓干姜以母姜造之，以白净结实者为良，凡入药并宜泡用。干姜用于暖脾阳，偏治脾寒腹痛泄泻。又能回阳通脉，温肺化饮，用治亡阳证，四肢厥逆，脉微欲绝，以及寒饮咳喘，形寒背冷，痰多清稀等症。
本发明中药组合物在中药组分选择上以除积痹、散风寒、祛风湿、强筋骨为主要标准，本发明中药组合物组合后具有显著的抗炎、镇痛和活血化淤效果。本发明对上述诸味中药的重量份数进行了优选，优选的条件是中西药配伍使用后药物对日光性皮炎治疗效果的增强。作为本发明的一个优选实施例，本发明中药组合物主要由以下重量份的原料制得：马齿苋30份，羌活15份，槐花15份，黄芩10份，熟地8份，百合10份，金银花10份，蒲公英6份，枸杞10份，半枝莲12份，川芎12份，白芷10份，黄连素5.5份，白芍10份，干姜8份，甘草12份。
优选地，本发明的中药组合物还进一步含有香橼5份，远志9份。香橼又名枸橼，为芸香科柑橘属植物，香橼味辛、微苦、酸，性温；归肝、肺、脾经；气香行散，可升可降；具有疏肝理气，宽胸化痰，除湿和中的效果，主治胸胁胀痛，咳嗽痰多，脘腹痞痛，食滞呕逆，水肿脚气。远志为常用中药，最早记载于《神农本草经》，列为上品，并被视为养命要药，性温，味苦、辛，具有安神益智、祛痰、消肿的功能，用于心肾不交引起的失眠多梦、健忘惊悸，神志恍惚，咳痰不爽，疮疡肿毒，乳房肿痛。
为了更好表达本发明的中药组合物，本发明可以制备成临床上常用的剂型。比如，粉状制剂、散剂、丸剂、丹剂、膏剂、颗粒剂、口服液、糖浆、片剂、胶囊剂等制剂。优选地，本发明中药组合物按照常规制备工艺制备成散剂、凝胶剂、片剂或胶囊剂。
本发明还提供了一种上述所述中药组合物的制备方法，包含下述步骤：取处方量上 述中药材碎成粗粉，按照粗粉总重量的4-9倍加入体积浓度为40％-95％的乙醇溶液，回流提取三次，回流时间为2-5h，滤过，滤液回收乙醇，冷却过滤，用水洗涤，干燥后即得中药浸膏；将其粉碎制成干膏粉后加入处方量的黄连素和蒲公英即可得到本发明中药组合物。本领域技术人员可在该制备方法技术上制备得到临床上常用中药药物剂型，如片剂、胶囊剂等。
本发明还请求保护上述中药组合物在制备治疗日光性皮炎药物中的用途。本发明药物组合物在治疗日光性皮炎时，显示出显著的抗炎镇痛、活血化淤活性。本发明药效实施例19显示，与模型组比较，本发明中药组合物低中高三个剂量组均可以显著降低二甲苯所致小鼠的耳肿胀值(P＜0.01)，表明本发明中药组合物具有显著抑制二甲苯诱导的小鼠耳肿胀的作用，且其对耳肿胀的降低效果存在显著的量效关系。同样实验条件下，阳性对照药扑尔敏组也显著降低耳肿胀值(P＜0.05)，但其抗炎效果明显不及本发明中药组合物。
总之，本发明药物组合物在治疗日光性皮炎方面，与现有技术相比具有如下优势：
1)与阳性对照药相比，本发明药物组合物中药物成分不仅在抗炎和镇痛方面更为显著，而且在活血化淤方面也显著优于阳性药物，这表明本发明组合物在日光性皮炎治疗中具有显著的协同作用，不仅能够显著改善日光性皮炎的症状，还能延缓日光性皮炎的发展，有助于日光性皮炎患者的痊愈过程；
2)与当前治疗日光性皮炎的化学治疗药物相比，本发明中药组合物为天然纯中药制剂，不良反应和副作用显著降低，特别是其对于肠道黏膜不产生任何破坏作用，且本发明中药组合物作用全面，药物治疗效果更佳，显著提高了日光性皮炎患者的用药依从性，并提高了患者的生活质量。
具体实施方式
以下通过具体实施例进一步描述本发明，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，对本发明进行的变更、组合或替换，对于本领域的技术人员来说是显而易见的，且包含在本发明的范围之内。
第一部分本发明中药组合物制剂、制备及其使用方法
实施例1-6中药组合物散剂
表1本发明中药组合物散剂处方
实施例1制备方法：取组合物中各药材，按照常规工艺研磨成粉状，过100目筛，小火烘干备用，即得散剂。使用时，用水溶解后直接冲服。实施例2-6制备方法同实施例1。
实施例7-12中药组合物凝胶剂
表2本发明中药组合物凝胶剂处方
实施例7制备方法：取处方中各药材，按照常规中药煎煮工艺操作，滤除药渣后加入适量的单硬脂酸甘油酯和二甲基硅油即得。该凝胶剂(或称汤剂)用于日光性皮炎治疗时，每日涂抹2-3次。实施例8-12制备方法和使用方法同实施例7。
实施例13-18本发明中药组合物片剂/胶囊剂
表3本发明中药组合物片剂/胶囊剂处方
实施例13制备工艺：取处方量的各中药材粉碎成粗粉，按照粗粉总重量的5倍加入体积浓度为80％的乙醇溶液，回流提取三次，回流时间每次3h，滤过，滤液回收乙醇，冷却过滤，用水洗涤，干燥后即得中药浸膏；将中药浸膏经干燥、粉碎制成干膏粉，再加入常规辅料成分利用现有技术制备成片剂或胶囊剂。
实施例14-18制备工艺同实施例13。
第二部分本发明中药组合物药效学研究
实施例19本发明中药组合物对二甲苯致小鼠耳肿胀的影响
取健康ICR小鼠72只，♀♂各半，分6组，12只/组，即模型组、氢化可的松(海南三叶制药厂有限公司，下同)、扑尔敏组(海口康力元制药有限公司)、本发明中药组合物(按实施例1所述中药组合物处方和制备工艺制得)低剂量组、中剂量组和高剂量组。每只ig给药1次/d；给药14d，末次药后60min，小鼠右耳均匀涂抹二甲苯0.03mL/只致肿，2h后剪下双耳打耳片称重，计算耳肿胀值(mg)。肿胀值＝右耳重量-左耳重量。
结果显示，与模型组比较，本发明中药组合物低中高三个剂量组均可以显著降低二甲苯所致小鼠的耳肿胀值(P＜0.01)，表明本发明中药组合物具有显著抑制二甲苯诱导的小鼠耳肿胀的作用，且其对耳肿胀的降低效果存在显著的量效关系。同样实验条件下，阳性对照药扑尔敏组也显著降低耳肿胀值(P＜0.05)，但其抗炎效果明显不及本发明中药组合物。
表4本发明中药组合物对二甲苯所致小鼠耳肿胀的影响
注：与模型组比较，*P＜0.05，**P＜0.01。
实施例20本发明中药组合物对紫外线造成的皮肤光老化和皮肤水肿的影响
20.1本发明中药组合物对紫外线造成的皮肤光老化的保护作用
将小鼠随机分为6组：模型组给予凝胶基质，实施例7制备的本发明组合物凝胶分为高、低剂量组，阳性对照组1给予维生素E；阳性对照组2给予扑尔敏；阳性对照组3给予阿达帕林凝胶。实验前小鼠背部脱毛，暴露面积4cm×3cm，各组预防性涂抹3d。小鼠置于紫外灯下(40W UVA虹管5根，UVB灯管2根)，距离皮肤35cm处进行照射，照射期间用纸扳遮住动物头部。初始照射时间为4h/d，逐渐增加到12h/d，连续照射4周，在照射的过程中肉眼观察并记录皮肤的变化情况。
20.2本发明中药组合物对紫外线造成的皮肤水肿的影响
将小鼠随机分为6组：模型组给予凝胶基质，实施例1制备的本发明组合物凝胶分为高、低剂量组，阳性对照组1给予醋酸泼尼松软膏(天津药业集团有限公司)；阳性对照组2给予扑尔敏；阳性对照组3给予阿达帕林凝胶。于实验前小鼠背部脱毛，暴露面积4cm×3cm；各组预防性涂抹7d。将小鼠水平固定在铁架上，与紫外灯(40WUVA灯管4根，UVB灯管1根6垂直距离10cm，连续照射6h，照射期间用纸板遮住动物头部。照射后40h，断脊处死小鼠，分别取两耳(d＝0.7cm)及背部(d＝2cm)经照射的圆形皮片，精确称取耳重、皮重及体重，计算耳指数和皮指数：{耳(皮)指数＝耳(皮)重(mg)/体重(g)×100}。
20.2.1结果
20.2.1.1肉眼观察
照射4d后，模型组小鼠被照射皮肤出现严重的大红肿、脱屑；维生素E与本发明组合物 凝胶组、扑尔敏组、阿达帕林凝胶组皮肤损伤情况较模型组轻，脱屑现象较少。其中本发明组合物凝胶组红肿、脱屑现象比扑尔敏组和阿达帕林凝胶组轻。
照射15d后，模型组小鼠被照射皮肤出现大面积片状红斑、溃烂、结痂、皮肤局部增厚；维生素E、本发明组合物凝胶组及扑尔敏组皮肤损伤情况较模型组轻，红斑少、破溃较轻。其中本发明组合物凝胶组效果优于扑尔敏组和阿达帕林凝胶组。
照射24d后，模型组小鼠被照射皮肤呈现片状红斑、溃烂、水疱、增厚、失去光泽与弹性，老化明显；维生素E、本发明组合物凝胶组及扑尔敏组、阿达帕林凝胶组皮肤损伤情况较模型组轻，红斑少、破溃轻、水疱数量少、皮肤增厚不明显。其中本发明组合物凝胶组较扑尔敏组、阿达帕林凝胶组破溃轻微，水疱数量少，水疱小。
20.2.1.2皮肤水肿的影响
从表5可以看出：本发明组合物凝胶组可以降低小鼠耳指数、皮指数，差异有非常显著性意义(P＜0.01)，且其效果优于扑尔敏组。
表5对小鼠耳指数、皮指数的影响
与模型组比较**P＜0.01，*P＜0.05，与扑尔敏组比较△△P＜0.01，△P＜0.05；
与阿达帕林凝胶组比较☆☆P＜0.01，☆P＜0.05，与醋酸泼尼松组比较▲▲P＜0.01，▲P＜0.05。
结果表明，本发明组合物制剂的治疗效果优于扑尔敏和阿达帕林凝胶。
Claims (6)
1.一种治疗日光性皮炎的中药组合物，其特征在于它主要由以下重量份的原料制得：马齿苋10-50份，羌活10-20份，槐花5-20份，黄芩5-15份，熟地 5-10份，百合5-15份，金银花5-15份，蒲公英 1-10份，枸杞5-15份，半枝莲 9-15份，川芎9-15份，白芷5-15份，黄连素0.2-9份，白芍5.5-15份，干姜6-9份，甘草10-15份。
2.如权利要求1所述的治疗日光性皮炎的中药组合物，其特征在于它主要由以下重量份的原料制得：马齿苋30份，羌活15份，槐花15份，黄芩10份，熟地8份，百合10份，金银花10份，蒲公英6份，枸杞10份，半枝莲12份，川芎12份，白芷10份，黄连素5.5份，白芍10份，干姜8份，甘草12份。
3.如权利要求2所述的治疗日光性皮炎的中药组合物，其特征在于它还含有如下重量份的原料：香橼5份和远志9份。
4.如权利要求1-3任一所述的治疗日光性皮炎的中药组合物，其特征在于：它是散剂、凝胶剂、片剂或胶囊剂。
5.一种制备如权利要求4所述的治疗日光性皮炎的中药组合物的方法，其特征在于它包括以下步骤：取处方量上述中药材碎成粗粉，按照粗粉总重量的4-9倍加入体积浓度为40%-95%的乙醇溶液，回流提取三次，回流时间为2-5h，滤过，滤液回收乙醇，冷却过滤，用水洗涤，干燥后即得中药浸膏，将其粉碎制成干膏粉后加入处方量的黄连素和蒲公英即可得到本发明中药组合物。
6.如权利要求1-3任一所述的中药组合物在制备治疗日光性皮炎药物中用途。
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| CN104740566A (zh) * | 2015-03-26 | 2015-07-01 | 鼎旺生物科技有限公司 | 一种减轻皮肤炎症的制剂、制备方法及其应用 |
| CN104984046A (zh) * | 2015-06-25 | 2015-10-21 | 湖北中医药大学 | 一种治疗过敏性皮肤病的中药外用制剂及其制备方法 |
| CN105168532A (zh) * | 2015-07-23 | 2015-12-23 | 青岛蓝盛洋医药生物科技有限责任公司 | 一种治疗日光性皮炎的药物组合物及其制备方法 |
| CN105213570A (zh) * | 2015-09-29 | 2016-01-06 | 罗奕珺 | 一种治疗日光性皮炎的药物组合物及其制备方法 |
| CN105232758A (zh) * | 2015-10-10 | 2016-01-13 | 临沂草之美医药科技有限公司 | 一种治疗日光性皮炎的药物组合物及其制备方法 |
| CN105311427A (zh) * | 2015-11-18 | 2016-02-10 | 暨南大学 | 一种用于治疗日光性皮炎的含有艾叶的药物组合物 |
| CN105327032A (zh) * | 2015-11-26 | 2016-02-17 | 王辉 | 一种治疗日光性皮炎的中药组合物、制备方法及其使用方法 |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108815303A (zh) * | 2018-09-03 | 2018-11-16 | 文勇 | 一种治疗前列腺炎症的组合物及其制备方法 |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102488791A (zh) * | 2011-12-11 | 2012-06-13 | 王英婷 | 一种用于湿疹、皮炎的中药颗粒剂 |
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- 2014-03-25 CN CN201610155352.3A patent/CN105688160A/zh not_active Withdrawn
- 2014-03-25 CN CN201410113112.8A patent/CN103893722B/zh active Active
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Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102488791A (zh) * | 2011-12-11 | 2012-06-13 | 王英婷 | 一种用于湿疹、皮炎的中药颗粒剂 |
Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104740566A (zh) * | 2015-03-26 | 2015-07-01 | 鼎旺生物科技有限公司 | 一种减轻皮肤炎症的制剂、制备方法及其应用 |
| CN104740566B (zh) * | 2015-03-26 | 2018-05-29 | 鼎旺生物科技有限公司 | 一种减轻皮肤炎症的制剂、制备方法及其应用 |
| CN104984046A (zh) * | 2015-06-25 | 2015-10-21 | 湖北中医药大学 | 一种治疗过敏性皮肤病的中药外用制剂及其制备方法 |
| CN104984046B (zh) * | 2015-06-25 | 2019-02-26 | 湖北中医药大学 | 一种治疗过敏性皮肤病的中药外用制剂及其制备方法 |
| CN105168532A (zh) * | 2015-07-23 | 2015-12-23 | 青岛蓝盛洋医药生物科技有限责任公司 | 一种治疗日光性皮炎的药物组合物及其制备方法 |
| CN105213570A (zh) * | 2015-09-29 | 2016-01-06 | 罗奕珺 | 一种治疗日光性皮炎的药物组合物及其制备方法 |
| CN105232758A (zh) * | 2015-10-10 | 2016-01-13 | 临沂草之美医药科技有限公司 | 一种治疗日光性皮炎的药物组合物及其制备方法 |
| CN105878560A (zh) * | 2015-10-10 | 2016-08-24 | 烟台市蓝洋之草医药生物科技有限公司 | 一种制备治疗日光性皮炎的药物组合物的方法 |
| CN105311427A (zh) * | 2015-11-18 | 2016-02-10 | 暨南大学 | 一种用于治疗日光性皮炎的含有艾叶的药物组合物 |
| CN105327032A (zh) * | 2015-11-26 | 2016-02-17 | 王辉 | 一种治疗日光性皮炎的中药组合物、制备方法及其使用方法 |
Also Published As
| Publication number | Publication date |
|---|---|
| CN105688160A (zh) | 2016-06-22 |
| CN105688159A (zh) | 2016-06-22 |
| CN103893722B (zh) | 2016-06-01 |
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