CN112933237A - 一种治疗表皮增厚瘙痒性皮肤病的复合中药贴剂 - Google Patents
一种治疗表皮增厚瘙痒性皮肤病的复合中药贴剂 Download PDFInfo
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Abstract
一种治疗表皮增厚瘙痒性皮肤病的复合中药贴剂，属于外用中成药制剂，其采用白鲜皮、苦参、生地、当归、丹参、生甘草、乌梅等，经粉碎、萃取、渗漉、浓缩等工艺制成稠膏，再与冰片和基质羊毛脂混合为成膏，将该成膏与压敏胶丙烯酸聚氨酯胶粘剂混合、涂布于无纺布背衬、热烘、切割成块、覆盖保护纸、封装、钴60消毒等过程，制成本发明复合中药贴剂。针对外用药涂抹剂和贴剂用于治疗表皮增厚瘙痒性类别皮肤病{主要如神经性皮炎(局限性)、慢性湿疹(苔藓样变)和银屑病(寻常型)等}效果有限或因含激素有副作用，本品的研制采用纯中药组方并在工艺做了优选，并配合性能优良安全的压敏胶粘剂制成贴剂，以期为这类皮肤病的治疗提供效果更确切更安全的外用药品种。
Description
本发明涉及一种改进的治疗表皮增厚瘙痒性皮肤病的复合中药贴剂，属于外用药物制剂技术领域。
技术背景
表皮增厚瘙痒性皮肤病，是一类以显著的皮肤瘙痒和表皮增厚为主要表现的皮肤病，常见的有神经性皮炎、慢性湿疹、扁平苔藓和瘙痒症等。这类疾病有的仅以瘙痒为主要表现，而无原发性炎性病理改变如神经性皮炎(亦称为慢性单纯性苔癣)，但该病发展过程中一般出现炎性小型丘疹；也可有原发性变态反应病理基础如慢性湿疹、扁平苔癣和银屑病；以及单纯的瘙痒症等。在炎性表皮增厚性皮肤病类别，长期慢性皮肤瘙痒和表皮增厚是这些病的显著特点，除了单纯的瘙痒症，这类皮肤病另一个特点就是都存在病理性变态反应性炎症；而因反复搔抓刺激，皮损局部主要因表皮发生异常角化增厚。因皮损异常外观，尤其是迁延慢性瘙痒，往往给患者身心造成不同程度干扰。在人群中，这类皮肤病有些种类发病率相当高，如神经性皮炎发病率大约为12％【期刊Jingang An etc，.InternationalJournal of Medical Science，2013，10(5)】，湿疹发病率在欧美国家约为10％，美国为10.7％【期刊季娟等，中华皮肤科杂志2011，44(1)】。
神经性皮炎分为局限性和播散性两种，一般认为其病因主要与精神因素、和反复局部摩擦刺激有关；该病相当于中医“牛皮癣”“摄领疮”。慢性湿疹属中医湿疮范畴，根据临床不同特点可分为“旋耳疮”“浸淫疮”“血风疮”“四弯风”“粟疮”等，病程较长患者常出现皮损部位苔藓样变。银屑病分为几种，其中寻常型银屑病占多数为99％，中医称之为“白庀”“庀风”“松皮癣”“干癣”。这几类皮肤病致病因素较为复杂，一般认为是多因素导致发病，常见病因有不良生活方式如饮食不节、烟酒等不良嗜好、精神紧张、不良情绪、睡眠不足等等。中医一般认为与外感六淫、七情内伤、脏腑功能失调等有关。病理机理方面，西医方面，主要与变态反应(或/和过敏反应)炎症有关；中医方面，辩证呈现众说纷纭态势，而权威观点认为“血热”“血燥”“血瘀”应为这类皮肤病核心病机。
这类表皮增厚性皮肤病在治疗上，西医多用抗组胺药、镇静剂、维生素类、钙剂等，外用主要是糖皮质激素类，软化除角质成分如水杨酸类、尿素、硫磺等，外用药剂型多为霜剂、膏剂、酊剂等；中医方面，内治呈现辨证论治观点不一，如从风、热、湿、血虚、血热、风燥等考虑组方，外治治则主要是清热解毒、祛风、杀虫、止痒、活血、养血润肤等，外用剂型有散剂、酒剂、搽剂、醋剂、熏蒸剂、油剂、酊剂、洗剂等。综上，中西医治疗这类病症方法众多包括各种药物，都有一定效果。但是，由于这类皮肤病具有表皮角质层异常增厚的特点，许多外用剂型药物如常用的膏霜剂、油乳剂等，一般实际效果并不很理想，而且很多品种对局部皮肤有刺激性、致敏性；甚至有些药物成分具有潜在其他危害，如配方含有毒性成分如汞、铅的轻粉、雄黄等，或有一定程度的毒性的中药如土槿皮、粗制硫磺等。近些年一些相关发明专利，主要在中药方面，剂型仅限于水煎剂、乙醇浸出液，内服或外用等，【专利申请号：201710359573.7；201410782402.1；201410319465.3；200910065404.8等】，仍不同程度存在上述缺陷。市场方面，效果比较确切有显著优势的品种有：如肤疾宁贴膏【药典，曲安奈德新霉素贴膏】、皮炎宁酊【药典，复方醋酸氟轻松酊】等，临床使用已有多年，近年有些新品种进入市场，如冰樟桉氟轻松贴膏等【药典 二部】。这些药都是复合配方，以西药为主，成分主要为糖皮质激素类、水杨酸类、抗生素等；主要功效是抗炎、止痒、软化溶解角质，尤其贴剂的形式，可以使皮损部位增厚的角质层水化增加药物渗透易度，角质容易剥脱，因而显示突出的效果。但缺陷在于，这些品种，如皮炎宁酊和此二贴剂容易出现过敏情况而致患者常不得已中断使用。分析其中原因，一是这些品种都含有水杨酸类成分，对皮肤有一定刺激性，也容易致敏皮肤；二是贴剂所含压敏胶黏贴成分里含有易致敏成分。还有，因这些品种都含有糖皮质激素，长期使用易出现局部和全身副作用如皮肤菲薄萎缩、毛细血管扩张等，患者对这类含激素外用药也有畏用心理。虽然较新的品种冰樟桉氟轻松贴膏，采用了几种中药原料如桉叶油、冰片、樟脑等，但这些原料药力显过于单薄，组方思路也过于简单，还因也加有激素和水杨酸类成分，使其缺陷较为明显。显然，针对这类皮肤病，市场也还需要效果更好、更确切、更安全的品种。
综合上述，值得尝试创制一种纯复合中药、更安全的原料配方制备的贴剂品种，其中弃用糖皮质激素和刺激类角质松解成分，以期实现对这类表皮增厚性瘙痒性皮肤病更确切、副作用更小、更安全的治疗效果。
发明内容
发明概述
配方和材料：本发明“一种治疗表皮增厚瘙痒性皮肤病的复合中药贴剂”，采用中药清热解毒、凉血活血、养血润肤类原料组方以达到抗炎止痒，促进皮肤组织恢复，加冰片增加效力并促进药物渗透，并选用贴膏剂型以软化角质、促进角质剥离。贴剂材料，背衬为透气性较好的医用无纺布，胶粘剂采用定制的医用压敏胶--丙烯酸聚氨酯压敏胶，后者无臭味、皮肤刺激小、粘着力低易剥离，适合护伤膏、经皮吸收带、长期用绷带等。
制备：本发明所用中药材原料通过粉碎、比例乙醇渗漉、减压浓缩后制成稠膏，加入羊毛脂基质和冰片加热混匀，再与医用压敏胶粘剂充分混匀后、涂展于无纺布背衬、短暂热烘、冷却后覆盖保护纸、切割成一定尺寸、封装、钴60消毒。
应用：本发明“一种改进的治疗表皮增厚瘙痒性皮肤病的复合中药贴剂”，主要用于表皮增厚类瘙痒性皮肤病，如局限性神经性皮炎、慢性湿疹、扁平苔癣和寻常型银屑病，以及瘙痒症等。
发明详述
鉴于上述分析，本人认为采用贴膏剂型复合中药配方制作的治疗表皮增厚性炎性皮肤病品种，比较他剂型更具优势，确定本发明配方不使用易于刺激皮肤或致敏成分，如水杨酸及其衍生物、尿素、硫磺、铅汞类及其他等等，而仅利用压敏胶的胶粘性能覆盖于皮损部位即可以水合软化表皮、松解角质，还利用了压敏胶载药性能掺入中药组分提取物稠膏，不仅有利于中药组分充分发挥抗炎止痒功效，更重要的可促进角质脱落，促使患部皮肤较快恢复正常(如局限性神经性皮炎、慢性湿疹、瘙痒症)，或至少显著好转(如扁平苔癣、银屑病)；而且同时也不使用糖皮质激素，以避免其引发副作用如激素的周身不良反应，局部皮肤菲薄萎缩、血管扩张、容易复发等等，也可避免患者对这类含激素药品的畏惧或排斥拒用心理。
瘙痒性皮肤病多存在变态反应性炎症，其病理机制主要环节在于变态反应引发局部微小循环障碍并产生的一些炎性介质引发瘙痒、继而反复搔抓致表皮增厚，因此对抗变态反应炎症和改善微小循环(亦即抗炎抗过敏)作为发明配方主要思路或技术路线。
本发明配方的中药部分：白鲜皮、苦参、丹参、生甘草清热解毒，抗炎止痒；生地、当归、丹参凉血活血，和血养阴，抗炎、促进皮肤愈复；辅以冰片加强清热抗炎作用，并促进众药透达皮肤炎性层发挥作用。迄今，这些中药的既往大量药理研究结果已经很明确揭示其上述药理功能【梅全喜，现代中药药理与临床应用手册，2019(第三版)】。
本发明采用的医用压敏胶主要成分为丙烯酸聚氨酯，可在常温条件与中药提取的稠膏高比例混合。定制的具体材料医用压敏胶【山东富乐新材有限公司】，具有良好的快粘力和粘基力、低粘度、对中药润湿性好、无苯溶剂、低细胞毒性刺激性等优点。
有关配方中药原料的详细资料(重点介绍与本发明有关内容)：
苦参：为豆科植物苦参的干燥根。性味：苦、寒。归经：入肝肾、大肠、小肠经。功能主治：清热、燥湿、杀虫。治热毒血痢、皮肤瘙痒、疥癞恶疮、阴疮湿痒、瘰疬、烫伤。《滇南本草》：″凉血，解热毒，疥癞，脓窠疮毒。疗皮肤瘙痒，血风癣疮，顽皮白屑，肠风下血，便血。消风，消肿毒，痰毒。″本发明利用其清热、燥湿、杀虫功能；以及治疗皮肤瘙痒、疥癞恶疮、湿疹湿疮、阴疮湿痒、血风癣疮，顽皮白屑等效果。现代药理研究：其有抗炎、抗过敏、抗菌作用。
白藓皮：为芸香科植物白鲜的根皮。性味苦、寒。归脾、胃、膀胱经。功能主治：清热燥湿，祛风解毒；用于湿热疮毒、黄水淋漓、湿疹、风疹、疥癣疮癞、风湿热痹、黄疸尿赤。《药性论》：″治一切热毒风，恶风，风疮、疥癣赤烂，眉发脱脆，皮肌急，壮热恶寒；主解热黄、酒黄、急黄、谷黄、劳黄等。″《本草原始》：″治一切疥癞、恶风、疥癣、杨梅、诸疮热毒。″本发明主要利用白鲜皮的清热燥湿、祛风解毒功能；以及治疗湿热毒疮、疥癣疮癞、风疮、湿疹、诸疮热毒等效果。现代药理研究：其有显著的抗炎、抗菌效果。
甘草：为豆科甘草属植物甘草的根和根状茎。性味：甘、平。归经：入脾、胃、肺经。功能主治：清热解毒、润肺止咳、和中缓急、调和诸药；生用，治咽喉肿痛、痈疽疮疡、解药毒及食物中毒。《本经》：″主五脏六府寒热邪气，坚筋骨，长肌肉，倍力，金疮肿，解毒。″《别录》：″温中下气，烦满短气，伤脏咳嗽，止渴，通经脉，利血气，解百药毒。″本发明主要利用生甘草的清热解毒、调和诸药、解毒功能，以及治疗痈疽疮疡效果。现代药理研究表明甘草有显著的抗炎抗过敏(变态反应)功效，显示糖皮质激素样作用，所含的甘草酸铵、甘草次酸抗炎强度接近可的松。
生地：为玄参科植物地黄的新鲜或干燥块根。性味：甘、寒。归经：归心、肝、肾经。功能主治：清热凉血、滋阴养血、生津；用于热病舌绛烦渴，阴虚内热，骨蒸劳热，内热消渴，吐血，衄血，发斑发疹《本经》：”主折跌绝筋，伤中，逐血痹，填骨髓，长肌肉，作汤除寒热积聚，除痹。生者尤良”。本发明主要利用其清热凉血、滋阴养血功能和主治发斑发疹效果。现代相关药理研究显显示，生地有显著抗炎和调节免疫作用；对湿疹、荨麻疹、神经性皮炎、等皮肤病都有较好效果。
当归：为伞形科植物当归的根。性味：甘、辛，温。归经：归肝、心、脾经。功能主治：补血和血，调经止痛，润燥滑肠。治月经不调，经闭腹痛，症瘕结聚，崩漏；血虚头痛，眩晕，痿痹；肠燥便难，赤痢后重；痈疽疮窃，跌扑损伤。《日华子本草》：″治一切风，一切血，补一切劳，破恶血，养新血及主癥癖。《本经》：″主咳逆上气，温疟寒热洗洗在皮肤中，妇人漏下，绝子，诸恶疮疡金疮，煮饮之。本发明主要利用其补血和血功能和主治症瘕结聚、痈疽疮疖效果。现代药理研究，显示当归有抗炎、调节免疫、改善微循环作用。″当归的抗炎作用机理主要涉及：降低毛细血管通透性；抑制PGE2的合成或释放；此外，降低豚鼠补体旁路的溶血活性，也可能是其抗炎机制之一。
丹参：为唇形科植物丹参的根。丹参性味：苦，微温。归经：入心、肝经。功能主治：活血祛瘀，安神宁心，凉血消痈，调经止痛。治心绞痛，月经不调，痛经，经闭，血崩带下，症瘕，积聚，瘀血腹痛，骨节疼痛，惊悸不眠，恶疮肿毒。《日华子本草》：″......排脓止痛，生肌长肉；破宿血，补新生血；......恶疮疥癣，瘿赘肿毒，丹毒。....″本发明主要利用其活血祛瘀、凉血消痈等功能及可主治恶疮癣疖效果。现代药理研究显示：丹参有抗炎，改善微循环作用，继而发挥促进组织修复和再生作用。
乌梅：为蔷薇科植物梅的干燥未成熟果实。性味：酸，温。归经：入肝、脾、肺、大肠经。功能主治：收敛生津，安蛔驱虫。治久咳，虚热烦渴，久疟，久泻，痢疾，便血，尿血，血崩，蛔厥腹痛、呕吐，钩虫病，牛皮癣，胬肉。《纲目》：乌梅、白梅所主诸病，皆取其酸收之义。《本草求真》：乌梅，酸涩而温，似有类于木瓜，但此入肺则收，入肠则涩，入筋与骨则软，入虫则伏，入于死肌、恶肉、恶痣则除，刺入肉中则拔，.....。本发明主要利用乌梅的收敛功能和主治牛皮癣效果。现代药理研究显示乌梅有明显的抗炎、抗氧化作用。根据上述古籍记载分析，乌梅对增厚的表皮角质层也应有软化剥脱作用，而且没有危害性。
冰片：为龙脑香科植物龙脑香树脂的加工品，或为樟脑、松节油等用化学方法合成的加工制成品。性味：辛、苦、凉。归经：入心、肺经。功能主治：清热、通诸窍，散郁火，去翳明目，消肿止痛。治中风口噤，热病神昏，惊痫痰迷，气闭耳聋，喉痹，口疮，中耳炎，痈肿，痔疮，目亦翳膜。本发明利用其清热、通窍、散郁火功能。现代药理研究表明，其有抗炎作用和促进药物吸收渗透作用。
本发明配方采用上述各药味，配伍以苦参、白鲜皮清热燥湿、祛风解毒、抗炎止痒为君药；以生地、当归、丹参清热凉血、活血祛瘀、滋阴养血、和血、抗炎止痒为臣药；佐以乌梅收敛皮损、软化剥脱角质层；甘草和冰片为使药，一是促进药物透达炎症部位，二是协调诸药发挥总合效果，二药本身的抗炎作用也有助于加强众药功效。总合众药，针对上述皮肤病在皮损部位发挥抗炎、抗过敏、止痒、促进角质脱落功效。
压敏胶：值得强调的是：本发明采用的压敏胶虽然比缺陷较多的胶粘剂如传统胶粘剂医用橡皮膏有许多优势(如前述)，后者含一定溶剂残留及其他潜在危害性成分，也是药典肤疾宁(曲安奈德新霉素)贴膏以前所用材料，但因目前在材料科学方面的局限性，作为贴剂的组成部分压敏胶和底层处理剂等成分相对复杂，本发明在贴剂的压敏胶材料部分，虽然主要采用了更安全、黏附效果更好的胶粘剂--丙烯酸聚氨酯压敏胶，但仍存在发生致敏的可能性。而本发明药物配方虽然未使用糖皮质激素，但本发明复合中药物组分的多重抗炎作用，应可有效对抗、降低或防止该贴剂中的压敏胶在本品种使用中可能发生的致敏性。
本发明的有益效果
针对以往相关产品或发明，很少有治疗表皮增厚性炎性皮肤病中药贴膏剂型，而且迄今这类皮肤病治疗药物在效果和安全性方面，仍存在诸多缺陷或不足，致使实际治疗中效果仍不很理想。本发明“一种改进的治疗表皮增厚瘙痒性皮肤病的复合中药贴剂”，在药物组分中药原料和胶粘材料做了优选。中药原料组方精简、治则明确、切中主要病机，兼顾了中医西医两个体系在表皮增厚瘙痒性皮肤病机理和药理；利用优选的中药成分抗炎、抗过敏、止痒优势，不仅使药物组分更容易透达皮肤炎性层发挥抗炎止痒作用，还可避免传统治疗相关皮肤病的药品使用激素的副作用和其他缺陷；在溶解角质方面，也避免使用有刺激性、致敏性的水杨酸类成分或其他具一定危害或刺激性成分如含汞铅的轻粉、雄黄、硫磺、尿素、苯甲酸等，而利用压敏胶覆盖皮损部位角质层水化、松解脱落角质的性能，并有利于药物渗透，即可促进病变皮肤恢复或显著好转。总合本发明上述综合作用，以期实现针对这类皮肤病，提供更安全、效果更好的治疗药物品种。
本发明目是这样实现的：
一种治疗表皮增厚瘙痒性皮肤病的复合中药贴剂，其采用若干中药、医用压敏胶粘剂和背衬无纺布材料组合，经一系列加工而成，其主要改进之处在于，药物配方所用中药为：
a清热解毒药：白鲜皮、苦参、生甘草等药中至少选择一种，每种含量为16-24重量单位(下同)；
b清热凉血、养阴、和血活血药：生地、当归、丹参等药中至少选择一种，每种含量为12-16；
c促进药物渗透：冰片0.6-1.4％(贴膏重量百分比，下同)；
d收敛、松解角质：乌梅，含量6-10
d基质：羊毛脂10-18％；
e压敏胶(定制)：配方成分主要为丙烯酸聚氨酯，可常温条件与中药稠膏或成膏混合。
上述a、b和d组分药材经粉碎成20目，之后用比例乙醇浸润、渗漉、浓缩为比重1.1-1.5的稠膏；在洁净环境车间，将稠膏按照0.7-1.3的比例再加入羊毛脂(即稠膏/羊毛脂＝0.7-1.3比例)，并加入冰片混匀，在均值乳化锅内，加热到65-80℃，进行均值乳化，之后冷却至48-60℃制成成膏，再与58-80％的压敏胶粘剂丙烯酸聚氨酯充分混合贴膏，涂布于无纺布上，再经短时(约2分钟)热烘(约80-120℃)后冷却、覆盖隔离保护纸，按一定尺寸切割成块状(如8cm x 10cm，每块含贴膏3g)，封装后钴60消毒即成贴剂成品。可利用全自动大规模生产线，各工艺环节均由机械自动完成。
具体实施方式
下面通过具体实例对本发明进一步阐述，应说明的是，下述实施实例具体内容仅是为了解释本发明，并不对其内容限定。
实施例一
一种治疗表皮增厚瘙痒性皮肤病的复合中药贴剂，各原料按以下重量份和重量百分比配制：白鲜皮、苦参每种含量为18重量单位(下同)；生地、丹参每种13；乌梅7；冰片0.8％(贴膏重量百分比，下同)；羊毛脂13％；压敏胶77.1％。将中药材组分(除冰片以外)经粉碎成20目之后，用比例乙醇浸润、渗漉、减压回收乙醇浓缩为比重1.1的稠膏；在洁净环境车间均质锅内，将稠膏与羊毛脂(按稠膏/羊毛脂＝0.7比例)和冰片置入均值乳化锅内，加热到65℃，进行均值乳化充分混匀成混悬状成膏，之后冷却至48℃，再与压敏胶充分混合成贴膏，涂布于含底层处理剂的无纺布上，再经短时1.8分钟热烘后冷却覆盖隔离纸，按一定尺寸切割成块状(如8cmx10cm，每块含贴膏3g)，封装后钴60消毒即成贴剂成品。
实施例二
一种治疗表皮增厚瘙痒性皮肤病的复合中药贴剂，优选地：各原料按以下重量份和重量百分比配制：白鲜皮、苦参、生甘草每种含量为21重量单位(下同)；生地、丹参、当归每种14.5，乌梅8.5；冰片1.1％(贴膏重量百分比，下同)；羊毛脂18％；压敏胶59.3％。将中药材组分(除冰片以外)经粉碎成20目之后，用比例乙醇浸润、渗漉、减压回收乙醇浓缩为比重1.2的稠膏；在洁净环境车间均质锅内，将稠膏与羊毛脂(按稠膏/羊毛脂＝1.2比例)和冰片置入均值乳化锅内，加热到75℃，进行均值乳化充分混匀成混悬状成膏，之后冷却至58℃，再与压敏胶充分混合成贴膏，涂布于无纺布上，再经短时2.2分钟热烘后冷却覆盖隔离纸，按一定尺寸切割成块状(如8cmx10cm，每块含贴膏3g)，封装后钴60消毒即成贴剂成品。
实施例三
一种治疗表皮增厚瘙痒性皮肤病的复合中药贴剂，更优选地：各原料按以下重量份和重量百分比配制：白鲜皮、苦参、生甘草每种含量为20重量单位(下同)；生地、丹参、当归每种14，乌梅8；冰片1％(贴膏重量百分比，下同)；羊毛脂10％；压敏胶79％。将中药材组分(除冰片以外)经粉碎成20目之后，用比例乙醇浸润、渗漉、减压回收乙醇浓缩为比重1.3的稠膏；在洁净环境车间均质锅内，将稠膏与羊毛脂(按稠膏/羊毛脂＝1比例)和冰片置入均值乳化锅内，加热到80℃，进行均值乳化充分混匀成混悬状成膏，之后冷却至53-55℃，再与压敏胶充分混合成贴膏，涂布于无纺布上，经短时(2分钟)热烘后冷却覆盖隔离纸，按一定尺寸切割成块状(如8cmx10cm，每块含贴膏3g)，封装后钴60消毒即成贴剂成品。
实施例四
本发明一种治疗表皮增厚瘙痒性皮肤病的复合中药贴剂(以下用ZTJ表示)皮肤毒理试验：
观察ZTJ贴膏对兔皮肤刺激性和过敏性的影响，从而评价其安全性。方法：采用健康家兔进行完整皮肤和破损皮肤刺激性试验和皮肤过敏性实验。
药物和试剂：本发明贴剂ZTJ，每块8cmX10cm，含贴膏2g/块；空白无药压敏胶贴剂(WTJ)每块8cmX10cm；致敏剂2-4二硝基代苯(DNCB，上海试剂一厂)；硫化钠(莱阳化工实验厂)。动物：健康家兔，雌雄各半，体重(1500±30)g，由山西省中医药研究院实验动物中心提供。
1.皮肤刺激试验：将12只家兔随机分为完整皮肤组和破损皮肤组，每组六只雌雄各半。于给药前24小时，用8％的硫化钠溶液，将家兔脊柱两侧对称脱毛，不损伤皮肤，每侧面积约70cm2。24h后观察脱毛部位，观察脱毛部位是否有损伤，剔除皮肤受损兔。采用左右侧自身对照观察试验药物和试剂对皮肤的刺激性。完整皮肤用75％的乙醇消毒后，左侧脱毛处贴ZTJ贴膏，右侧贴敷的滴有生理盐水2ml的空白贴剂(WTJ)。破损皮肤组：用75％的乙醇消毒脱毛局部，并用消毒处理过的350号细砂纸在脱毛处摩擦，使皮肤出现密集出血点，以渗血为度，立即在左侧破损处贴贴剂ZTJ，右侧破损处贴无药WTJ(滴生理盐水2ml)，具体方法同完整皮肤组。每隔3天换贴一次，连续贴5次。每次去掉贴剂后，立即观察贴剂部位有红无红斑、水肿、色素沉着、出血点、皮肤粗糙、皮肤菲薄。实验结果按卫生部药政局《中药新药研究指南》【卫生部药政局，《中药新药研究指南(药学、药理学、毒理学)》，1994，209-212】中皮肤刺激性反应评分标准评分(对皮肤反应红斑、水泡、丘疹，范围、大小、数量等划分等级评分)，并计算平均分值进行刺激反应程度评价。结果见表一。
2皮肤过敏试验：将24只家兔随机分为三组即阴性对照组(生理盐水)、药物组(本发明药物贴剂ZTJ)、阳性对照组(DNCB)，每组八只，雌雄各半。①致敏接触：于给药前24小时，将家兔背部脊柱左侧脱毛，具体操作方法同皮肤刺激试验脱毛法，面积约为70cm2。75％酒精消毒后，阴性对照组滴加0.2ml生理盐水的压敏胶贴剂贴敷；阳性对照组贴敷滴加0.2ml浓度为1％的DBCB的压敏胶贴剂；药物组贴敷本发明贴剂ZTJ；三组均贴敷6h，取掉贴剂。试验第7天和第14天，以同样贴敷方法各重复一次。②激发接触：于致敏试验接触末次给药后第14d(第28d)，阴性对照组给与滴加0.2ml生理盐水的压敏胶贴剂；阳性对照组滴加0.1％的DNCB0.2ml的压敏胶贴剂；药物组给与贴敷本发明ZTJ。6h后，所有组去除贴剂，用温生理盐水洗净局部，及时观察并分别于于24h、48h、72h再次观察局部皮肤过敏反应情况。实验结果按卫生部药政局《中药新药研究指南》中皮肤过敏反应程度评分标准评分。按公式计算过敏反应均值和发生率，过敏反应平均值＝(红斑形成总分+水肿形成总分/动物总数，过敏反应发生率＝有过敏反应的动物数/动物总数X100％。结果见表二。
3统计学处理：试验结果数据均以X±S表示，采用统计学分析软件SPSS13.0进行方差分析，P＜0.05即为差异有统计学意义。
4实验结果：①皮肤刺激试验：根据皮肤刺激强度评价标准，刺激反应分值＜0.5即为无刺激性，实验结果显示各组分值均＜0.5，表明本发明中药贴剂对家兔完整与破损皮肤均无刺激性。②皮肤过敏试验：实验结果显示阳性对照组红斑和水肿都非常明显，分值1-2.6，而空白和试验药物(ZTJ)组则皮肤光滑、无红斑、无水肿，分值均为0分，未见任何过敏反应。综上结果显示：ZTJ贴膏对家兔的完整皮肤和破损皮肤无刺激性、无过敏性反应。
表一 表皮增厚性皮肤病复合中药贴剂皮肤刺激试验结果
表二 表皮增厚性皮肤病复合中药贴剂皮肤过敏试验结果
实施例五
本发明ZTJ贴剂对三种皮肤增厚瘙痒性皮肤病的临床应用观察
药物：本发明ZTI贴剂，阳性对照药肤疾宁(曲安奈德新霉素)贴剂(FJN)。
病人及分组：选择于2014年3月-2019年5月就诊于本研究所门诊部的表皮增厚瘙痒性皮肤病人152例，病程由9个月至13年不等。其中包括神经性皮炎(局限型)56例，慢性湿疹49例，银屑病(寻常型)45例；男86例，女66例，年龄27-52岁。入选标准按照各病诊断标准【吴少祯等，常见疾病的诊断与疗效判定(标准)，1999】，入选病人均排除严重心、肝、肾功能疾病，药物过敏，以及无法配合治疗和随访患者。用药分组：按照不同病人和/或不同皮损标注号码，同一病人有不同部位皮损，给以两个不同标号分别做为实验组(以ZTJ表示，下同)和阳性对照用药组(以FJN表示，下同)；各病种不同病人，也随机分为该病种ZTJ组和对照FJN组。按此方法，共计：①神经性皮炎皮损共83个号，分为ZTJ组42个，FJN组41个；②慢性湿疹皮损共96个号，分为ZTJ组和FJN组各48个；③银屑病共93个号皮损，分为ZTJ组46个，FJN组47个。入选的各类皮肤病的ZTJ组和FJN组，患者和皮损一般情况(年龄、性别、病程、皮损部位、皮损严重程度等)无统计意义差别(P＞0.05)，具有可比性.
方法：按照观察组皮损号给与贴敷ZTJ，对照组皮损号给与贴敷FJN，每隔三天换一次药，并即时观察记录皮损局部皮肤变化(包括皮肤颜色、粗糙程度、表皮厚度、角质剥离程度以及是否贴敷局部及周边出现过敏等)，并记录患者瘙痒症状程度变化。连续治疗观察3周，共换药6次。
疗效及判定标准：(参考前述文献“诊断与疗效判定标准”)，治疗将该三种表皮增厚瘙痒性皮肤病治疗效果分为3个等级。痊愈：皮损完全消退、瘙痒消失、仅有少量色素沉着；显效：与用药前相比，皮损明显消退变薄＞60％，瘙痒明显减轻；有效：与用药前相比，皮损消退变薄＜60％、＞30％，瘙痒有所减轻；无效：皮损消退＜20％，瘙痒无明显变化，或用药局部皮损处出现红斑、丘疹、水泡等，瘙痒加重等贴剂过敏表现。总有效率＝(痊愈+显效+有效)/总皮损号数X 100％。
结果统计方法：采用SPSS17.0统计学软件进行统计分析。对得到的数据进行统计学处理，P＜0.05即为差别有统计学意义。
观察结果见表三：
表三 本发明ZTJ贴剂和阳性对照FJN贴剂治疗表皮增厚性皮肤病疗效对比
*＝P＜0.05，**＝P＜0.01
对比用药结果分析：本发明ZTJ组，在三种皮肤病(神经性皮炎，慢性湿疹，银屑病)总有效率分别为97.61％，95.83％和95.65％，显著高于对照FJN组(**P＜0.01)；ZTJ无效级别皮损号主因患者未能坚持配合观察而中断用药；各组有效级别少数几例皮损号主因观察期间不慎将贴剂脱落。FJN组无效级别皮损号，大多因皮肤刺激过敏反应明显，中途停止用FJN贴敷而改用其他药，因此把这些皮损号记为无效(％)级别。治疗观察结果还显示，ZTJ组痊愈级别效果：对神经性皮炎要明显好于ZTJ组慢性湿疹和银屑病(*P＜0.05，**P＜0.01)；而且对三种皮肤病效果都显著比FJN组好(**P＜0.01)。分析在痊愈级别，慢性湿疹组和银屑病组效果较差的原因是，除了外用药治疗，还必须配合内治等综合方法，才可能实现更好效果；包括神经性皮炎也还需要配合其他治疗保健综合方法，如内服中药、全面改善不良生活方式，尤其在精神、心理、情绪方面积极改善，才有望实现更满意效果。
Claims (6)
1.一种治疗表皮增厚瘙痒性皮肤病的复合中药贴剂，其采用若干中药、医用压敏胶粘剂和背衬无纺布材料组合，经一系列加工而成，其特征在于，药物配方所用中药、附加材料和工艺为：
a.清热解毒药：白鲜皮、苦参、生甘草等药中至少选择一种，每种含量为16-24重量单位(下同)；
b.清热凉血、养阴、和血活血药：生地、当归、丹参等药中至少选择一种，每种含量为12-16；
c.促进药物渗透：冰片0.6-1.4％(贴膏重量百分比，下同)；
d.收敛、松解角质：乌梅，含量6-10；
e.基质：羊毛脂10-18％；
f.压敏胶(定制)：配方成分主要为丙烯酸聚氨酯，可常温条件与中药稠膏或成膏混合。
上述a、b和d组分药材经粉碎成20目，之后用比例乙醇浸润、渗漉、浓缩为比重1.1-1.5的稠膏；在洁净环境车间，将稠膏按照0.7-1.3的比例再加入羊毛脂(即稠膏/羊毛脂＝0.7-1.3)，并加入冰片混匀，在均值乳化锅内，加热到65-80℃，进行均值乳化，之后冷却至48-60℃制成成膏，再与58-80％的压敏胶粘剂丙烯酸聚氨酯充分混合成贴膏，涂布于无纺布上，再经短时(约2分钟)热烘(约80-120℃)后冷却、覆盖隔离纸，按一定尺寸切割成块状(如8cmX 10cm，每块含成膏3g)，封装后钴60消毒即成贴剂成品。可利用全自动大规模生产线，各工艺环节均由机械自动完成。
2.根据权利要求1所述的一种治疗表皮增厚瘙痒性皮肤病的复合中药贴剂，其特征在于，重要粉碎工艺是将中药原料粉碎成20目，
3.根据权利要求1和2所述的“本发明复合中药贴剂”，其工艺过程特征在于：是中药经粉碎后，用比例乙醇浸润、渗漉、浓缩为比重1.1-1.5的稠膏；在洁净环境车间，将稠膏按照0.7-1.3的比例再加入羊毛脂(即稠膏/羊毛脂＝0.7-1.3)，并加入冰片混匀，在均值乳化锅内，加热到65-80℃，进行均值乳化，之后冷却至48-60℃制成成膏。
4.根据权利要求3所述，进一步工艺特征是：将成膏与58-80％的压敏胶粘剂丙烯酸聚氨酯(包括但不限该压敏胶类别)充分混合成贴膏，涂布于无纺布上，再经短时(约2分钟)热烘(约80-120℃)后冷却、覆盖隔离纸，按一定尺寸切割成块状(如8cm x 10cm，每块含贴膏3g)，封装后钴60消毒即成贴剂成品。
5.根据权利要求1-4所述制成的本发明“一种治疗表皮增厚瘙痒性皮肤病的复合中药贴剂”，主要用于表皮增厚瘙痒性皮肤病，包括(但不限于)局限性神经性皮炎、慢性湿疹(皮损苔藓样变)、寻常型银屑病、瘙痒症等。
6.根据权利要求1-5，本发明一种治疗表皮增厚瘙痒性皮肤病的复合中药贴剂，关键特征是将复合中药配方制成的成膏，与丙烯酸聚氨酯压敏胶粘剂结合制成纯复合中药贴剂，用于治疗表皮增厚变态反应性皮肤病。
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