CN103041275B - 复方败酱草汤剂 - Google Patents
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Abstract
本发明涉及中药配方领域，具体地说是一种复方败酱草汤剂，其特征是原料组成以重量百分比计为：败酱草12～20％、垂盆草10～18％、红藤10～14％、地肤子8～10％、穿山甲6～8％、紫草3～4％、萹蓄6～8％、泽兰6～8％、皂刺5～7％、半边莲3～7％、栀子5～7％、白芷4～6％、砂仁3～5％、甘草3～6％，将上述14味中药用水浸泡，煎熬后去渣得滤液。本发明成本低、无明显毒副作用，能有效地治疗寻常型痤疮。
Description
技术领域
本发明涉及一种中成药制剂，具体地说是一种治疗寻常型痤疮的复方败酱草汤剂。
背景技术
众所周知，寻常型痤疮是一种毛囊及皮脂腺的慢性炎症性皮肤病，多发生于青年男女的面部及胸背部，是由于体内雄激素水平升高，导致皮脂分泌增强，加之皮脂腺导管角化，毛囊及皮脂腺阻塞，形成炎症性丘疹、脓胞、结节，所引发的一种慢性炎症性皮肤病。痤疮常常会导致面部的疤痕形成，严重影响了人们的容貌，使人形象大损，有碍仪容，而且自尊心也受到了极大的损害，给生活、工作和身心健康带来影响，对求职者来说，经常有人因此而不能通过面试关，甚至被革职，且这些人的婚恋也常受到影响。因此，很多痤疮患者都为之苦恼，据调查结果显示，在青春发育期，痤疮的发病率90％左右，如化脓感染性损害对身体确有一定威胁，如急性化脓性病变可有发热、畏寒、不适、淋巴结肿大，白细胞增多等全身症状；慢性化脓性病变则可形成感染灶，对身体影响虽然较隐匿，但也更深更广。几种重症型痤疮，皮损主要是大的结节、囊肿、脓肿和溃疡，并形成疤痕，对身体影响更大，有的尚伴有全身症状，治疗起来亦比较困难。目前西药治疗主要是抑制局部炎症、抗雄激素疗法、抑制皮脂腺分泌、光动力疗法等治疗，具有一定疗效，但存在耐药及毒副作用。
发明内容
本发明的目的就是为了克服上述现有的技术不足，提供一种无毒副作用、临床效果好的治疗寻常型痤疮的复方败酱草汤剂。
本发明解决上述技术问题采用的技术方案是：一种复方败酱草汤剂，其特征是原料组成以重量百分比计为：败酱草12～20％、垂盆草10～18％、红藤10～14％、地肤子8～10％、穿山甲6～8％、紫草3～4％、萹蓄6～8％、泽兰6～8％、皂刺5～7％、半边莲3～7％、栀子5～7％、白芷4～6％、砂仁3～5％、甘草3～6％，将上述14味中药用水浸泡，煎熬后去渣得滤液。
本发明的有益效果是，成本低、无明显毒副作用，能有效地治疗寻常型痤疮。
具体实施方式
下面结合实施例对本发明作进一步的描述：
实施例1：
采用败酱草、垂盆草、红藤、地肤子、穿山甲、紫草、萹蓄、泽兰、皂刺、半边莲、栀子、白芷、砂仁、甘草为原料制备而成，其组分(重量％)为败酱草18％、垂盆草16％、红藤10％、地肤子9％、穿山甲6％、紫草3％、萹蓄6％、泽兰6％、皂刺5％、半边莲5％、栀子5％、白芷4％、砂仁3％、甘草4％，取上述14种原料总重量56千克，精选洗净后在温室条件下用20000ml水浸泡20分钟左右，然后煎熬60分钟，常规去渣过滤，高压、灭菌工艺后，所得滤液共9000ml，袋分装，密封，每袋150ml。每日分2次口服，每次早晚空腹服150ml。
本发明的治疗原则：寻常型痤疮俗称“青春痘”，属于中医“粉刺、面疱、酒刺、暗疮”等范畴，痤疮虽生长在皮肤表面，但与脏腑功能失调息息相关，中医认为引起痤疮的原因是由于面鼻及胸背部属肺，本病常由肺经风热阻于肌肤所致；或因过食肥甘、油腻、辛辣食物，脾胃蕴热，湿热内生，熏蒸于面而成；或因青春之体，血气方刚，肝阳上升，与风寒相搏，郁阻化热，瘀于肌肤；久病肾精亏损，气滞血瘀，痰瘀互结所致。临床上多表现实证为主，以热、湿、痰、瘀为标，痤疮虽病位在皮肤，但与肺、肝、脾、肾三脏功能失常密切相关。由肺有宿热，复感风邪，遂使肺热不得外泄引起；由情志内伤，气分郁滞，日久化热，热伏营血所致；由饮食不节，过食肥甘之物，使肠胃燥结，中焦积热，郁于面部皮肤而致。故拟定了清热解毒、凉血散结、消痈排脓、行气化痰、活血祛瘀、健脾化湿的治疗大法。本发明中方中败酱草性味辛苦微寒，具有清热解毒、消痈排脓、祛瘀止痛之功，本品既能泻热解毒，散结排脓，又能祛瘀止痛之功，可以治痤疮脓已形成者，亦可以治痤疮脓未成者，本品有消肿、止痛、生肌之功，《本经》：“败酱草，主暴热火疮，赤气，疥瘙唨痔，马鞍热气”，现代药理研究，败酱草对痤疮丙酸杆菌、金黄色葡萄球菌、绿脓杆菌、大肠杆菌等有抑制作用，能促进肝细胞再生，减少油脂分泌，对痤疮患者皮损有良好的修复作用；垂盆草性味甘淡微酸凉，归肝、胆、小肠经，具有清热解毒、利湿、散痈肿之功，本品能解毒，清热利湿，又能消痈散结功效。现代药理研究，垂盆草对痤疮丙酸杆菌、金黄色葡萄球菌、绿脓杆菌、大肠杆菌等有抑制作用，还有保肝等作用；二者共为君药。红藤性味苦平，归大肠经，具有清热解毒、活血止痛之功，本品既能清热解毒，消痈，又能活血散瘀、止痛等作用，现代药理研究，本品含鞣质，大血藤煎剂对痤疮丙酸杆菌、金黄色葡萄球菌、绿脓杆菌、大肠杆菌等有抑制作用；地肤子性味苦寒，具有清热利湿、止痒之功，《本草原始》“地肤子，去皮肤中积热，去皮肤外湿痒。”，《本草求真》“地肤子，利水，清热，功颇类于黄柏。但黄柏其味苦烈，此则味苦而甘，用此苦以入阴，寒以胜热，而使湿热尽从小便而出也。”地肤子煎剂对许兰氏黄癣菌、铁锈色小芽孢癣菌、羊毛状小芽孢癣菌等皮肤真菌，有不同程度的抑制作用；穿山甲性味咸寒，归肝肾经，本品有活血化瘀、消肿排脓之功，穿山甲善于走窜，性专行走散，能通经络而达病所，可使痤疮丘疹未成脓者消退，以托毒排脓；紫草有清润凉血及活血功效，又有解血分热毒的作用，多用于痤疮、湿疹、烫伤等证，紫草有缓和的退热作用及对金黄色葡萄球菌、绿脓杆菌、大肠杆菌等有抑制作用；萹蓄能清热利湿，收敛，杀虫止痒之功多用于痤疮、湿疮、痱子等皮肤病，对金黄色葡萄球菌、绿脓杆菌、大肠杆菌、羊毛状小芽孢癣菌、皮肤霉菌等有抑制作用，共为臣药。泽兰辛散温通，不寒不燥，性较温和，行而不峻，能疏肝气，具有祛瘀散结而不伤正气的特点，用于痤疮丘疹未消者；皂角刺活血消痈，托毒排脓，能减少油脂分泌；半边莲清热解毒，利湿消肿；栀子泻火，凉血解毒，清热利湿；白芷，本品芳香上达，祛风燥湿，消肿排脓，其白芷水煎剂对金黄色葡萄球菌、绿脓杆菌、大肠杆菌、羊毛状小芽孢癣菌、皮肤霉菌等有抑制作用；砂仁辛散温通，善于化湿、行气，为醒脾和胃之良药，其性温而不太燥，行气而不破气，调中而不伤中，佐治苦寒药物伤脾碍胃；共为佐药。甘草调和诸药，既能缓和药物烈性及减轻药物毒副作用，又可调和脾胃，健脾益气，以固后天之本，能防寒凉药物伤脾败胃为使药。本发明的组方，标本兼顾，从中医学整体观念出发，各个脏腑、形体和官窍在结构上不可分割，功能上相互协调、互相影响，并构成以五脏为中心的脏-腑-体-窍-华五个系统的理论，来辨证论治用药。本发明具有清热解毒、凉血散结、消痈排脓、行气化痰、活血祛瘀、健脾化湿之功，有效治疗寻常型痤疮。
本发明各原料还可按下表所列比例(重量百分比)混合的实施例来实现，其煎熬程序、口服方法与实施例1相同，其含量如下表所示。
下面结合我院，即山东省威海市文登中心医院进行的临床预试验对本发明作进一步、详细地描述：
1、病例选择：临床随机选择65例患者，男31例，女34例，年龄16-39岁，平均21.2±3.8岁，病程2个月-10年，平均3.7±2.8年；。排除病例①合并严重的心脑血管病者，②严重肝肾功能不全者，③妊娠或哺乳期妇女者，④对本药过敏者，⑤硬结性、囊肿性痤疮者，分级达IV度(重度)之痤疮⑥未按规定用药或资料不全等影响疗效或安全性判断者。⑦脾胃虚寒易腹泻者。
2、诊断标准：西医诊断标准参照《临床皮肤病学》制定的诊断标准拟定：(1)患者多为青壮年；(2)好发于面部、上胸及背部等皮脂腺发达部位；(3)损害为多数散在性的黑头粉刺、丘疹、脓疱、结节，对称分布。临床轻重分级：参考Pillsbury分类法。(1)I度：黑头粉刺散发至多发，炎症性皮疹散发；(2)II度：I度+浅在性脓疱，炎症性皮疹数目增加，局限于颜面；(3)III度：II度+深在炎症性皮疹，发于颜面、颈部、胸背部；(4)IV度：III度+囊肿，易形成瘢痕，发生于上半身；临床选入患者为I度至III度分级标准。中医辨证分型标准：参照《中药新药治疗痤疮(粉刺)的临床研究指导原则》，中医辨证为湿热蕴毒结瘀证。主症：颜面或胸背部皮色或红色丘疹为主，散在脓疱小结节、油脂多；次症：口渴，大便干，小便黄，女性可月经前加重，或月经有血块，舌质红或暗红，苔薄或黄腻，脉弦滑或滑数，凡具备以上主症1项、次症3项者，辨证即可成立。
3、疗效标准：包括临床治愈、显效、有效、无效，治疗结束评价总疗效。疗效标准参照《中药新药治疗痤疮(粉刺)的临床研究指导原则》中有关疗效标准拟定。治愈：皮损全部消退，仅留有色素沉着，无新疹出现；显效：皮疹消退70％以上，偶有新疹出现；有效：皮疹消退30％以上，但少于70％，偶有新疹出现；无效：经过1疗程治疗后，皮损消退少于30％，或反增不减。
4、治疗方法：每次服用复方败酱草合剂150ml，每日早、晚两次饭后服用，20天为1疗程，每个疗程隔三天，连续服用本发明治疗三个疗程。
5、治疗结果：本发明治疗65例，治愈16例(24.6％)，显效21例(32.3％)，有效22例(33.9％)，无效6例(9.2％)，总有效率90.8％。
Claims (1)
1.一种治疗寻常型痤疮的复方败酱草汤剂，其特征是：原料药组成以重量百分比计为，败酱草12～20％、垂盆草10～18％、红藤10～14％、地肤子8～10％、穿山甲6～8％、紫草3～4％、萹蓄6～8％、泽兰6～8％、皂刺5～7％、半边莲3～7％、栀子5～7％、白芷4～6％、砂仁3～5％、甘草3～6％，将上述14味中药用水浸泡，煎熬后去渣得滤液。
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