CN105662996A - 治疗月经相关性痤疮的中药面膜 - Google Patents
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Abstract
本发明提供了一种治疗月经相关性痤疮的中药面膜，其原料药包括白矾、苦参、黄芩、黄连、黄柏、冰片、薄荷、马齿苋、蛇床子、皂角刺、土茯苓、白鲜皮、地肤子、刺蒺藜、地龙、柴胡、当归、白芍、延胡索、川楝子、牡丹皮、威灵仙、野菊花和蒲公英。本发明中药面膜对于痤疮新发的治疗，对于痤疮后期瘢痕修复、黑色素的清除具有良好的疗效，通过中药外用，透皮吸收，局部治疗，以局部影响全身，以求彻底治愈本病，本发明面膜通过了临床试验研究及动物实验研究，进行了安全性的系统评价，综合考量证实其安全有效，适用于临床推广。
Description
技术领域
本发明涉及中医药技术领域，尤其涉及一种治疗月经相关性痤疮的中药面膜。
背景技术
痤疮俗称“青春痘”，又叫“面疱”、“粉刺”、“酒刺”、“暗疮”等，是最常见的毛囊皮脂腺的慢性炎症性皮肤病。因皮脂腺管与毛孔的堵塞，皮脂外流不畅所致。自青春发育期后，几乎每个人都会在脸上或其他部位生过痤疮，只是有些人数量少，时间短，一般在25岁以后自然趋向痊愈，所以不必放在心上；有的人数量多，表现为丘疹、黑头、脓疱、脓肿、结节、囊肿，甚至瘢痕，常有碍美观。有的人胡乱求医或自己乱治，以致病情恶化，产生更多的瘢痕，遗恨终生。
痤疮是一种多因素引起的疾病，在有遗传因素的条件下，雄性激素分泌增多(尤其是皮肤组织中的双氢睾酮增多)和毛囊口内的痤疮棒状杆菌等微生物的作用是痤疮发病的两个主要因素。人体皮脂腺的发育与皮脂分泌直接受雄性激素的支配，青春期由于雄性激素水平显著提高，刺激皮脂腺，使皮脂分泌功能异常活跃，皮脂大量分泌，使皮肤油光发亮，毛囊口亦随之扩大，由于毛囊皮脂腺导管或毛囊口的角化堵塞，过多的皮脂不能及时排出，瘀积在毛囊内形成脂栓，即所谓粉刺。痤疮棒状杆菌所产生的溶脂酶、蛋白分解酶及透明质酸酶可分解皮脂中的三酸甘油脂，成为游离脂肪酸，它能破坏毛囊壁，使毛囊内含物进入和刺激真皮及毛囊周围组织，引起毛囊皮脂腺周围炎症反应，导致一系列痤疮症状。一部分脓疱是由于毛囊虫寄生或白色葡萄球菌的继发感染。
因个体的反应不同，痤疮造成的损害程度也有不同，其临床的表现也不一样。有些人只出现轻微的粉刺，有些人却是出现严重的囊肿，留下色素沉着和疤痕。因此，临床上根据症状的轻重又对痤疮进行了分级：
Ⅰ级：粉刺为主，少量丘疹、脓疱，总皮损小于30个；
Ⅱ级：粉刺和中等量丘疹、脓疱，总皮损数31～50个；
Ⅲ级：大量丘疹、脓疱，总皮损数50～100个，结节数小于3个；
Ⅳ级：结节/囊肿性痤疮或聚合性痤疮，总皮损大于100个，结节/囊肿大于3个。
对于本病的治疗，其预防胜于治疗，一定要强化预防意识。
预防方法：(1)瘢痕疙瘩继发于外伤、手术外，尚多见于预防接种、虫咬、痤疮及不明原因所致的皮肤损伤，一定要增强体质、强化个人卫生、增强安全意识，尽可能减少皮肤损伤。(2)一旦皮肤受到损伤，应选择正规单位和有经验的医师，积极采取措施，仍能减轻或减少瘢痕疙瘩的发生机会。此时，对瘢痕的预防主要是指上皮覆盖创面后瘢痕组织是否继续增生及其控制的措施；主要是指瘢痕形成前和形成间尚未成熟的阶段。
月经相关性痤疮临床中发病率极高，因其跟月经相关，发病呈现一定的规律性及难治性，用药需讲究阶段，本发明中药制剂在传统治疗痤疮的用药及思路基础上，提出月经前期敷用本发明中药面膜，本发明中药面膜对于痤疮新发的治疗，对于痤疮后期瘢痕修复、黑色素的清除具有良好的疗效，通过中药外用，透皮吸收，局部治疗，以局部影响全身，以求彻底治愈本病，本发明面膜通过了临床试验研究及动物实验研究，进行了安全性的系统评价，综合考量证实其安全有效，适用于临床推广。
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月经相关性痤疮的中药面膜，具有辨证论治的优势，克服了传统西药无法区分证型进行对证治疗，通过中药的外用，可以替代西药激素的使用量，可以降低药物依赖性及副作用等，或者采用中西医结合的治疗方法，具有更好的疗效和满意度。
为解决上述技术问题，本发明提供一种治疗月经相关性痤疮的中药面膜，其原料药包括白矾、苦参、黄芩、黄连、黄柏、冰片、薄荷、马齿苋、蛇床子、皂角刺、土茯苓、白鲜皮、地肤子、刺蒺藜、地龙、柴胡、当归、白芍、延胡索、川楝子、牡丹皮、威灵仙、野菊花和蒲公英。
所述中药面膜中各原料药的重量份分别为白矾10重量份～15重量份、苦参10重量份～20重量份、黄芩15重量份～25重量份、黄连25重量份～35重量份、黄柏15重量份～20重量份、冰片10重量份～15重量份、薄荷10重量份～20重量份、马齿苋10重量份～15重量份、蛇床子15重量份～25重量份、皂角刺10重量份～15重量份、土茯苓20重量份～25重量份、白鲜皮10重量份～15重量份、地肤子10重量份～20重量份、刺蒺藜10重量份～15重量份、地龙10重量份～15重量份、柴胡20重量份～30重量份、当归25重量份～35重量份、白芍10重量份～20重量份、延胡索10重量份～15重量份、川楝子15重量份～20重量份、牡丹皮10重量份～20重量份、威灵仙10重量份～15重量份、野菊花20重量份～35重量份和蒲公英20重量份～30重量份。
最优选，所述中药面膜中各原料药的重量份分别为白矾10重量份、苦参15重量份、黄芩20重量份、黄连30重量份、黄柏20重量份、冰片10重量份、薄荷15重量份、马齿苋10重量份、蛇床子20重量份、皂角刺10重量份、土茯苓20重量份、白鲜皮15重量份、地肤子15重量份、刺蒺藜10重量份、地龙10重量份、柴胡25重量份、当归30重量份、白芍15重量份、延胡索10重量份、川楝子20重量份、牡丹皮15重量份、威灵仙10重量份、野菊花30重量份和蒲公英25重量份。
进一步优选，所述中药面膜中各原料药的重量份分别为白矾10重量份～15重量份、苦参15重量份～20重量份、黄芩20重量份～25重量份、黄连30重量份～35重量份、黄柏15重量份～20重量份、冰片10重量份～15重量份、薄荷10重量份～15重量份、马齿苋10重量份～15重量份、蛇床子15重量份～20重量份、皂角刺10重量份～15重量份、土茯苓20重量份～25重量份、白鲜皮10重量份～15重量份、地肤子15重量份～20重量份、刺蒺藜10重量份～15重量份、地龙10重量份～15重量份、柴胡25重量份～30重量份、当归30重量份～35重量份、白芍10重量份～15重量份、延胡索10重量份～15重量份、川楝子15重量份～20重量份、牡丹皮15重量份～20重量份、威灵仙10重量份～15重量份、野菊花25重量份～30重量份和蒲公英25重量份～30重量份。
本发明还提供了上述中药面膜的制备方法，其包括：
第一步，将各原料药分别粉碎成粉末，按上述重量份配比，混合在一起，获得混合物，用相对于混合物质量5～8倍醇浓度为80～90％乙醇渗漉，静置24-36小时后，以2～4ml/min的速度收集渗漉液，调节pH为7，静置24小时，抽滤，滤液减压浓缩除去乙醇溶剂，干燥，干膏体碎成3000目的粉末；
第二步，将粉碎后的中药粉末，按照每10g原药粉末加入蒸馏水15ml，均匀搅拌成膏状，冷藏保存。
有益的技术效果
本发明提供一种用于治疗月经相关性痤疮的中药面膜，具有辨证论治的优势，克服了传统西药无法区分证型进行对证治疗，通过中药的外用，可以替代西药激素的使用量，可以降低药物依赖性及副作用等，或者采用中西医结合的治疗方法，具有更好的疗效和满意度。
具体实施方式
本发明提供一种治疗月经相关性痤疮的中药面膜，其原料药包括白矾、苦参、黄芩、黄连、黄柏、冰片、薄荷、马齿苋、蛇床子、皂角刺、土茯苓、白鲜皮、地肤子、刺蒺藜、地龙、柴胡、当归、白芍、延胡索、川楝子、牡丹皮、威灵仙、野菊花和蒲公英。
月经相关性痤疮，其发病除局部热毒壅盛外，更多由于肝经郁热，每至月经来潮之时，肝经血热，破血妄行，壅滞头面，发为痤疮，往往伴有湿邪，其治疗因与肝经有关，往往一味清热泻火，燥湿解毒其疗效不佳，而口服中药汤剂，特别是在月经期，服用大剂量的寒凉药，往往导致败伤脾胃，甚至因药性之偏导致经水断流，发为他病，本发明中药制剂针对本病的病因病机及临床治疗特点，以中药面膜局部使用，既可以迅速改善痤疮症状，又可以借透皮吸收的中药，通过经络作用于相应脏器，起到疏肝清肝的作用，达到治愈本病的目的。
本发明中药面膜使用白矾、苦参、黄芩、黄连、黄柏苦寒燥湿，泻火解毒，使用冰片、薄荷、马齿苋、野菊花、蒲公英清热解毒，其中冰片、薄荷寒而散，使泄热不留邪，散瘀不伤正，使用蛇床子、皂角刺、土茯苓、白鲜皮、地肤子、刺蒺藜杀虫疗癣，止痒，使用刺蒺藜、地肤子、地龙，有很好的抗过敏反应，使用柴胡、黄芩清肝疏肝，当归、白芍、延胡索养血柔肝，川楝子疏肝理气，牡丹皮、威灵仙、白芍凉血散血，诸药合用，共奏苦寒燥湿、杀虫止痒、疏肝养血之功效。本发明中药制剂在传统治疗痤疮的用药及思路基础上，提出月经前期敷用本发明中药面膜，本发明中药面膜对于痤疮新发的治疗，对于痤疮后期瘢痕修复、黑色素的清除具有良好的疗效，通过中药外用，透皮吸收，局部治疗，以局部影响全身，以求彻底治愈本病，本发明面膜通过了临床试验研究及动物实验研究，进行了安全性的系统评价，综合考量证实其安全有效，适用于临床推广。
所述中药面膜仅由上述原料药制备而成。
所述中药面膜中各原料药的重量份分别为白矾10重量份～15重量份、苦参10重量份～20重量份、黄芩15重量份～25重量份、黄连25重量份～35重量份、黄柏15重量份～20重量份、冰片10重量份～15重量份、薄荷10重量份～20重量份、马齿苋10重量份～15重量份、蛇床子15重量份～25重量份、皂角刺10重量份～15重量份、土茯苓20重量份～25重量份、白鲜皮10重量份～15重量份、地肤子10重量份～20重量份、刺蒺藜10重量份～15重量份、地龙10重量份～15重量份、柴胡20重量份～30重量份、当归25重量份～35重量份、白芍10重量份～20重量份、延胡索10重量份～15重量份、川楝子15重量份～20重量份、牡丹皮10重量份～20重量份、威灵仙10重量份～15重量份、野菊花20重量份～35重量份和蒲公英20重量份～30重量份。
进一步优选，所述中药面膜中各原料药的重量份分别为白矾10重量份～15重量份、苦参15重量份～20重量份、黄芩20重量份～25重量份、黄连30重量份～35重量份、黄柏15重量份～20重量份、冰片10重量份～15重量份、薄荷10重量份～15重量份、马齿苋10重量份～15重量份、蛇床子15重量份～20重量份、皂角刺10重量份～15重量份、土茯苓20重量份～25重量份、白鲜皮10重量份～15重量份、地肤子15重量份～20重量份、刺蒺藜10重量份～15重量份、地龙10重量份～15重量份、柴胡25重量份～30重量份、当归30重量份～35重量份、白芍10重量份～15重量份、延胡索10重量份～15重量份、川楝子15重量份～20重量份、牡丹皮15重量份～20重量份、威灵仙10重量份～15重量份、野菊花25重量份～30重量份和蒲公英25重量份～30重量份。
最优选，所述中药面膜中各原料药的重量份分别为白矾10重量份、苦参15重量份、黄芩20重量份、黄连30重量份、黄柏20重量份、冰片10重量份、薄荷15重量份、马齿苋10重量份、蛇床子20重量份、皂角刺10重量份、土茯苓20重量份、白鲜皮15重量份、地肤子15重量份、刺蒺藜10重量份、地龙10重量份、柴胡25重量份、当归30重量份、白芍15重量份、延胡索10重量份、川楝子20重量份、牡丹皮15重量份、威灵仙10重量份、野菊花30重量份和蒲公英25重量份。
各原料药药理如下：
白矾：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。
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，苦参对痢疾杆菌、大肠杆菌、变形杆菌、乙型链球菌以及金黄色葡萄球菌有明显的抑制作用。
黄芩：拉丁名ScutellariaeRadix，味苦、性寒，入心、肺、胃、胆、大肠经，有清热燥湿，泻火解毒，安胎，止血的作用，主要用于湿热所致之腹泻、痢疾、黄疸、热淋；肺热咳嗽，口渴咽痛，还可用于胎热不安，热毒火邪侵淫皮肤之疮痈毒肿之证。
黄连：味苦，性寒，入心、肺、胆、胃、大肠经，有清热燥湿，泻火解毒，凉血明目的作用，常用于治疗泻心经之火，心火旺之心烦不眠，及温热病之壮热神昏、心烦、口渴等症状。
黄柏：拉丁名PhellodendriChinensisCortex，味苦，性寒，入肾、膀胱、大肠经，清热燥湿，泻火解毒，除骨蒸清虚热。用于湿热泻痢，黄疸，带下，热淋，脚气，痿辟，骨蒸劳热，盗汗，遗精，疮疡肿毒，湿疹瘙痒等证，黄柏对多种革兰氏阳性细菌具有良好的抗菌作用。
冰片：味辛、苦，性凉，归心、肺经，具有通诸窍，散郁火，去翳明目，消肿止痛的功效，主治中风口噤，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，蛲虫病等证。
薄荷：味辛、性凉，入肺，肝经，具有疏散风热、清利头目、利咽透疹、疏肝解郁的功效，用于外感风热或温病初起，风热头痛，赤木多泪，咽喉肿痛，麻疹透发不畅，风疹搔痒，肝气郁滞，胸闷不舒等证。
马齿苋：拉丁名Portulacaeherba，味酸，性寒，归大肠，肝经，具有清热解毒，利水去湿，散血消肿，除尘杀菌，消炎止痛，止血凉血的功效，主治痢疾，肠炎，肾炎，产后子宫出血，便血，乳腺炎等病症。
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。
土茯苓：味甘、淡，性平，肝经；胃经；脾经，具有解毒，除湿，利关节的功效，主治梅毒，淋浊，筋骨挛痛，脚气，疔疗疮，痈肿，瘰疬，梅毒及汞中毒所致的肢体拘挛，筋骨疼痛等证。
白鲜皮：拉丁名DictamniCortex，味苦，咸，性寒，归脾经；肺经；小肠经；胃经；膀胱经，具有清热燥湿；祛风止痒；解毒的功效，主治风热湿毒所致的风疹；湿疹；疥癣；黄疸；湿热痹痛等证。
地肤子：拉丁名KochiaeFructus，性寒，味辛、苦，具有清热利湿，祛风止痒的功效，主治小便涩痛、阴痒带下、风疹、湿疹、皮肤瘙痒等证。
刺蒺藜：拉丁名TribulusterrestrisL.辛、苦，微温。归肝经，平肝疏肝，祛风明目，治疗肝阳上亢，头晕目眩；胸胁胀痛，乳闭胀痛；风热上攻，目赤翳障；风疹瘙痒，白癜风等症。
地龙：味咸，性寒，归肝、脾、膀胱经，具有清热定惊，通络平喘，利尿的功效，主治高热神昏、关节痹痛，肢体麻木，半身不遂，肺热咳喘，水肿尿少的功效。
柴胡：拉丁名bupleuriradix，为伞形科植物柴胡或狭叶柴胡的干燥根，味苦，性微寒，归肝经、胆经，具有疏散退热、升阳舒肝的功效，用于感冒发热、寒热往来、疟疾，肝郁气滞，胸肋胀痛，脱肛，子宫脱落，月经不调等证。
当归：拉丁名angelicaesinensisradix，味甘、辛、苦，性温，入肝、心、脾经，有补血活血，调经止疼，润肠通便的作用。主要用于治疗心血不足之头目昏眩，倦怠乏力，心悸气短，及其他血虚证；血海空虚，冲任虚寒或淤血阻滞之月经不调，量少衍期等症状，当归有抗血小板凝聚和抗血栓、抗心肌缺血、扩张血管、降血脂等作用。
白芍：味苦、酸，性凉，入肝、脾经，具有养血柔肝，缓中止痛，敛阴收汗的作用，主治胸腹胁肋疼痛，泻痢腹痛，自汗盗汗，阴虚发热，月经不调，崩漏，带下等证。
延胡索：味苦、辛，性温，入肝、心、胃经，善行走散，可升可降，具有活血散瘀，行气止痛的作用，主治胸痹心痛，胁肋、脘腹诸痛，头痛、腰痛、疝气痛、筋骨痛、痛经、经闭，产后瘀腹痛，跌打损伤等证。
川楝子：味苦、性寒，归肝、小肠、膀胱经，具有疏肝泄热、行气止痛的功效，主治肝郁化火、胸胁、玩腹胀痛、疝气疼痛、虫积腹痛等证。
牡丹皮：拉丁名MoutanCortex，味苦、辛，性微寒，入心、肝、肾经，有清热凉血、活血化瘀的作用，用于热毒炽盛之阴虚发热、湿热结毒之肠痈、气结血瘀、口干、舌红绛等证；以及肝火目赤肿痛，胃火牙龈疼痛。
威灵仙：拉丁名clematidisradixetrhizoma，味辛、咸，性温，有小毒，入膀胱经，具有祛风除湿，通络止痛，消痰水，散癖积的功效，主治痛风顽痹、风湿痹痛，肢体麻木，腰膝冷痛，筋脉拘挛，屈伸不利，脚气，疟疾，症瘕积聚，破伤风，扁桃体炎，诸骨鲠咽。
野菊花：性微寒，味苦、辛，归肺、肝经，具有清热解毒、疏风平肝的功效，主治疔疮，痈疽，瘰疠、丹毒，湿疹，疥癣，风热感冒，咽喉肿痛，眩晕头痛，目赤热痛等证，野菊花对金黄色葡萄球菌、白喉杆菌、链球菌、绿脓杆菌、蒺疾杆菌、流感病毒，均有抑制作用。
蒲公英：味甘、苦，性寒，入肝、胃经，具有清热解毒、消痈散结、清肝明目、利尿通淋的作用，主要用于疮疡肿毒的治疗，对乳痈效果尤其显著，亦可用于肝火上炎之目赤肿痛等症状的治疗，此外，还具有利尿除湿的作用，用于治湿热黄疸、小便不利、泌尿系统感染等病症的治疗。
本发明还提供了上述中药面膜的制备方法，其包括：
第一步，将各原料药分别粉碎成粉末，按上述重量份配比，混合在一起，获得混合物，用相对于混合物质量5～8倍醇浓度为80～90％乙醇渗漉，静置24-36小时后，以2～4ml/min的速度收集渗漉液，调节pH为7，静置24小时，抽滤，滤液减压浓缩除去乙醇溶剂，干燥，干膏体碎成3000目的粉末；
第二步，将粉碎后的中药粉末，按照每10g原药粉末加入蒸馏水15ml，均匀搅拌成膏状，冷藏保存。
使用时将本发明膏剂均匀涂布于面部，待水分蒸发后，形成面膜，约保留30分钟后，自然揭下面膜，颜面部残留中药用清水洗去即可。
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面膜1
将白矾10g、苦参15g、黄芩20g、黄连30g、黄柏20g、冰片10g、薄荷15g、马齿苋10g、蛇床子20g、皂角刺10g、土茯苓20g、白鲜皮15g、地肤子15g、刺蒺藜10g、地龙10g、柴胡25g、当归30g、白芍15g、延胡索10g、川楝子20g、牡丹皮15g、威灵仙10g、野菊花30g和蒲公英25g分别粉碎成粉末，混合在一起，获得混合物，用相对于混合物质量6倍醇浓度为90％乙醇渗漉，静置24小时后，以3ml/min的速度收集渗漉液，调节pH为7，静置24小时，抽滤，滤液减压浓缩除去乙醇溶剂，干燥，干膏体碎成3000目的粉末，将粉碎后的中药粉末，按照每10g原药粉末加入蒸馏水15ml，均匀搅拌成膏状，冷藏保存。
实施例2面膜2
将白矾10g、苦参15g、黄芩20g、黄连30g、黄柏15g、冰片10g、薄荷10g、马齿苋10g、蛇床子15g、皂角刺10g、土茯苓20g、白鲜皮10g、地肤子15g、刺蒺藜10g、地龙10g、柴胡25g、当归30g、白芍10g、延胡索10g、川楝子15g、牡丹皮15g、威灵仙10g、野菊花25g和蒲公英25g，分别粉碎成粉末，混合在一起，获得混合物，用相对于混合物质量6倍醇浓度为90％乙醇渗漉，静置24小时后，以3ml/min的速度收集渗漉液，调节pH为7，静置24小时，抽滤，滤液减压浓缩除去乙醇溶剂，干燥，干膏体碎成3000目的粉末，将粉碎后的中药粉末，按照每10g原药粉末加入蒸馏水15ml，均匀搅拌成膏状，冷藏保存。
实施例3面膜3
将白矾15g、苦参20g、黄芩25g、黄连35g、黄柏20g、冰片15g、薄荷15g、马齿苋15g、蛇床子20g、皂角刺15g、土茯苓25g、白鲜皮15g、地肤子20g、刺蒺藜15g、地龙15g、柴胡30g、当归35g、白芍15g、延胡索15g、川楝子20g、牡丹皮20g、威灵仙15g、野菊花30g和蒲公英30g分别粉碎成粉末，混合在一起，获得混合物，用相对于混合物质量8倍醇浓度为90％乙醇渗漉，静置24小时后，以3ml/min的速度收集渗漉液，调节pH为7，静置24小时，抽滤，滤液减压浓缩除去乙醇溶剂，干燥，干膏体碎成3000目的粉末，将粉碎后的中药粉末，按照每10g原药粉末加入蒸馏水15ml，均匀搅拌成膏状，冷藏保存。
实施例4本发明中药面膜急毒性试验
实验动物：成年健康大鼠，40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％。
受试药物：本发明实施例1制备的中药面膜。
空白对照组：凡士林，其余条件同本发明药物组。
实验方法
按照随机数字表，将大鼠分为对照组和实验组。实验组给药3g/cm2，即生药1.95g/cm2，给药量为正常剂量327.925倍(正常人体给药，面膜0.06g/cm2，人与小鼠换算为10.09：1)。将药物均匀地涂敷于动物背部去毛区，并用无刺激性纱布、胶布加以固定。敷药物24小时后，可用温水，或适当溶别消除残留的药物或赋形剂，每日观察，连续7天。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7d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。
本实验组剂量，是临床成人用药的327.925倍，现代药理学认为，对于药物急性毒性实验，最大耐受量相当于人临床日用剂量100倍以上而动物无死亡，无明显毒性反应情况出现时，该药是安全的。通过本急性毒性试验验证，无毒性反应，可以认定，本药品临床用药是安全的。
实施例5本发明大鼠慢性毒性试验
实验动物：同急毒性试验
受试药物：
本发明中药面膜，通过添加蒸馏水调整成每1g膏剂含生药0.20g、0.15g、0.10g。
空白对照组：凡士林，其余条件同本发明药物组。
实验方法
按照随机数字表，将大鼠分为对照组和实验组。实验组给药2g/cm2，含生药为0.4g/cm2、0.30g/cm2、0.20g/cm2，药量为正常剂量67.27倍、50.45倍、33.63倍(正常人体给药，面膜0.06g/cm2，人与小鼠换算为10.09：1)。将药物均匀地涂敷于动物背部去毛区，并用无刺激性纱布、胶布加以固定。敷药物24小时后，可用温水，或适当溶别消除残留的药物或赋形剂，每日观察，连续21天。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
通过长期毒理实验研究，观察21d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。
通过本慢性毒性试验验证，无毒性反应，可以认定，本药品临床用药是安全的。
实施例6临床研究
一般资料：125例月经相关性痤疮患者均为我院门诊患者，临床症状和体征均符合痤疮的诊断，并且符合月经前痤疮加重，经行或经行后期减轻，其他时间无明显加重。治疗组63例，年龄18～42(25.2±5.7)岁；病程0.5～15(13.1±18.3个月)。对照组62例，年龄18～38(21±4.3)岁；病程8～17(10.8±13.9)。2组患者的年龄、性别、病程均无显著性差异(P均>0.05)，具有可比性。
治疗方法：2组均采用痤疮护理治疗，方法如下:①患者平躺在美容床上；②彻底清洁面部皮肤，用事先消毒好的粉刺挤压器挤出粉刺内容物；③粉刺清除完毕后，用中药(马齿苋)煎水纱布冷敷；④10～15min后取下纱布，予半导体红光照射，10min后治疗组予绿豆粉调拌本发明中药制剂所制面膜外涂，任其自行凝固，20～30min后取下，对照组使用异维A酸乳膏，薄层涂敷痤疮及周围，隔日1次，经前3天进行，行经前4天使用，共用药7天。2组均治疗3个月经周期，观察疗效。
在治疗期间，嘱两组患者均不要进食腥味、辛辣、各种酒类饮料及油炸、甜、腻之食品。
疗效判定标准：按痤疮的西医诊疗标准并参照《中医新药治疗粉刺的临床研究指导原则》，自拟痤疮治疗判定标准：治疗前及治疗后对患者的症状(粉刺、丘疹、脓疱、炎性结节)进行客观评分，评价疗效。
疗效指数＝(治疗前总皮损评分-治疗后总皮损评分)/(治疗前总皮损评分)×100％。临床疗效评价根据症状改善率分为痊愈、显效、好转、无效4级。
痊愈:皮损全部消失，仅留色素沉着及斑痕者；
显效:皮损消退70％以上；
好转:皮损消退30％以上；
无效:皮损消退30％以下。
总有效率＝(临床治愈数+显效数+好转数)/总病例数×100％。
统计学处理：采用SPSS13.0统计分析软件包进行计算。治疗前数据进行描述和均衡性比较，可比性比较主要采用μ2检验和t检验，P<0.05为有显著性差异。
结果
两组四个月经周期的治疗结果，见表1。
表1两组对于月经相关性痤疮的疗效
治疗组在4周内各阶段疗效均优于对照组，两组之间有显著性差异，P<0.05。不良反应及其它:治疗组、对照组均无一例毒副反应。
痤疮复发率情况
通过对两组患者停药后3个月的复发情况观察，对照组的复发率达33.87％，而治疗组复发率仅为6.35％，具有显著差异。
结论
通过使用本发明中药面膜治疗月经相关性痤疮临床疗效快于常用异维A酸乳膏，且整体治疗效果优于对照组，三个月的复发率观察，治疗组显著低于对照组，综合评价临床疗效观察，本发明中药面膜具有很好的临床疗效，适用于临床推广。
实施例7实验研究
药材及对照药品
本发明实施例1制备的中药面膜。
阳性对照药罗红霉素，由江苏恒瑞医药股份有限公司提供。
菌株及试剂
痤疮丙酸杆菌冻干菌株(ATCC11827，上海汉学贸易有限公司提供和鉴定)；
厌氧产气袋、厌氧指示剂(日本三菱瓦斯化学株式会社)；
改良GAM肉汤培养基(青岛海博生物技术有限公司)；
琼脂条(天津市大茂化学试剂厂)。
仪器与设备
BS110S型电子天平(北京赛多利斯天平有限公司)；
EvolutionRC型离心机(Sorvall)；
HH-2型水浴锅(金坛市奥瑞电器厂)；
710L厌氧盒(三菱瓦斯化学株式会社)；
HA-MIV型高压灭菌锅(Hirayama)；恒温培养箱(杭州蓝天化验仪器厂)。
实验方法
待测溶液的制备
本发明中药面膜制备过程中获得的3000目粉末，按照每10g粉末加入10mL水中(相当于原药材1g/mL)，至完全溶解，即为待测中药液。4℃保存，并在12h内使用完毕。
P.acne的复苏和菌悬液的制备
改良GAM肉汤培养基中加入10％羊血和2％琼脂，加热溶解，115℃高压灭菌15min，倾倒在平板培养皿内，以此用作冻干菌株的复苏平板和斜面培养基。利用平板划线法将冻干菌株接种至平板内，37℃厌氧培养72h后，挑取单个生长的菌落，转种至改良GAM肉汤培养基，继续培养24h，以此为菌悬液。
菌落计数
移取培养24h后的菌悬液500μL，加至装有4500μL生理盐水的试管中，得到稀释10倍的菌液。移取500μL稀释10倍的菌液至4500μL生理盐水中，得到稀释102倍的菌液。依次稀释，直至得到稀释107倍的菌液，取500μL至平板培养基上，均匀涂布，37℃厌氧培养48h，对生长的菌落进行计数。
琼脂稀释平板的制备
取9支无菌试管，第1管加入3mL提取液，2～9管加入3mL蒸馏水，第2管再加入3mL提取液，2～9管依次做倍比稀释。将含有2％琼脂的改良GAM培养基加热熔化，无菌操作吸取12mL培养基加至上述试管中，混匀倾注于平板中。使琼脂平板中药液倍比稀释度分别为1：5、1：10、1：20、1：40、1：80、1：160、1：320、1：640、1：1280，药物浓度分别为200、100、50、25、12.50、6.25、3.13、1.56、0.78mg/L。依照此法，分别制备本发明中药制剂的稀释平板，最终药物浓度分别为50、25、12.5、6.25、3.13、1.56、0.78、0.39、0.20mg/mL。对照组平板分别制备如下:制备相应浓度罗红霉素丙酮溶液的药物平板、空白平板(15mL培养基)、DMSO溶剂平板(12mL培养基+3mLDM-SO)、丙酮溶剂平板(12mL培养基+3mL丙酮)。
接种琼脂稀释平板
将制备好的菌悬液点种1μL于各个含药平板的表面，置厌氧环境中，37℃培养48h。
最小抑菌浓度(MIC)的判定将平板置于暗色、无反光物体表面，观察各药物提取液能够完全抑制细菌生长的最低药液浓度，为该药物对细菌的最低抑菌浓度(MIC)。
实验结果
细菌计数结果
平板上最终有3个菌落生长,因此待测菌悬液的浓度约为3×108mL- 1。
MIC测定结果
对照平板中,未接种细菌的空白平板无细菌生长,接种细菌的空白平板、DMSO溶剂平板、丙酮溶剂平板均有细菌生长,表明DMSO和丙酮作为溶剂,对抑菌效果的测定没有干扰。
各组药物对P.acne的抑制效果测定结果
表2各组药物对P.acne的抑制效果测定结果
+：菌株生长，-：菌株不生长
本次实验进行了本发明中药制剂全方的体外抑菌实验，通过多种药物配伍时的相互作用，对临床耐药菌株的抑制效果取得了较好的作用，其与抗生素具有类似作用，因此本发明的临床推广使用具有非常大的潜力，应进行相应的临床研究进行验证。
Claims (5)
1.一种治疗月经相关性痤疮的中药面膜，其特征在于：原料药包括白矾、苦参、黄芩、黄连、黄柏、冰片、薄荷、马齿苋、蛇床子、皂角刺、土茯苓、白鲜皮、地肤子、刺蒺藜、地龙、柴胡、当归、白芍、延胡索、川楝子、牡丹皮、威灵仙、野菊花和蒲公英。
2.如权利要求1所述的治疗月经相关性痤疮的中药面膜，其特征在于：所述中药面膜中各原料药的重量份分别为白矾10重量份～15重量份、苦参10重量份～20重量份、黄芩15重量份～25重量份、黄连25重量份～35重量份、黄柏15重量份～20重量份、冰片10重量份～15重量份、薄荷10重量份～20重量份、马齿苋10重量份～15重量份、蛇床子15重量份～25重量份、皂角刺10重量份～15重量份、土茯苓20重量份～25重量份、白鲜皮10重量份～15重量份、地肤子10重量份～20重量份、刺蒺藜10重量份～15重量份、地龙10重量份～15重量份、柴胡20重量份～30重量份、当归25重量份～35重量份、白芍10重量份～20重量份、延胡索10重量份～15重量份、川楝子15重量份～20重量份、牡丹皮10重量份～20重量份、威灵仙10重量份～15重量份、野菊花20重量份～35重量份和蒲公英20重量份～30重量份。
3.如权利要求1或2所述的治疗月经相关性痤疮的中药面膜，其特征在于：所述中药面膜中各原料药的重量份分别为白矾10重量份、苦参15重量份、黄芩20重量份、黄连30重量份、黄柏20重量份、冰片10重量份、薄荷15重量份、马齿苋10重量份、蛇床子20重量份、皂角刺10重量份、土茯苓20重量份、白鲜皮15重量份、地肤子15重量份、刺蒺藜10重量份、地龙10重量份、柴胡25重量份、当归30重量份、白芍15重量份、延胡索10重量份、川楝子20重量份、牡丹皮15重量份、威灵仙10重量份、野菊花30重量份和蒲公英25重量份。
4.如权利要求1至3所述的治疗月经相关性痤疮的中药面膜，其特征在于：所述中药面膜中各原料药的重量份分别为白矾10重量份～15重量份、苦参15重量份～20重量份、黄芩20重量份～25重量份、黄连30重量份～35重量份、黄柏15重量份～20重量份、冰片10重量份～15重量份、薄荷10重量份～15重量份、马齿苋10重量份～15重量份、蛇床子15重量份～20重量份、皂角刺10重量份～15重量份、土茯苓20重量份～25重量份、白鲜皮10重量份～15重量份、地肤子15重量份～20重量份、刺蒺藜10重量份～15重量份、地龙10重量份～15重量份、柴胡25重量份～30重量份、当归30重量份～35重量份、白芍10重量份～15重量份、延胡索10重量份～15重量份、川楝子15重量份～20重量份、牡丹皮15重量份～20重量份、威灵仙10重量份～15重量份、野菊花25重量份～30重量份和蒲公英25重量份～30重量份。
5.权利要求1至4所述中药面膜的制备方法，其特征在于，包括：
第一步，将各原料药分别粉碎成粉末，按上述重量份配比，混合在一起，获得混合物，用相对于混合物质量5～8倍醇浓度为80～90％乙醇渗漉，静置24-36小时后，以2～4ml/min的速度收集渗漉液，调节pH为7，静置24小时，抽滤，滤液减压浓缩除去乙醇溶剂，干燥，干膏体碎成3000目的粉末；
第二步，将粉碎后的中药粉末，按照每10g原药粉末加入蒸馏水15ml，均匀搅拌成膏状，冷藏保存。
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