CN107412647A - 一种灭菌止痒留香的外用制剂 - Google Patents
一种灭菌止痒留香的外用制剂 Download PDFInfo
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- CN107412647A CN107412647A CN201710710689.0A CN201710710689A CN107412647A CN 107412647 A CN107412647 A CN 107412647A CN 201710710689 A CN201710710689 A CN 201710710689A CN 107412647 A CN107412647 A CN 107412647A
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Abstract
本发明提供了一种灭菌止痒留香的外用制剂，包括以下重量份的原料药：黄零草30、辛夷15、玫瑰花15、檀香18、川锦纹12、山奈9、白芷90、谷精草36、桑叶36、决明子36、白菊花36、青皮45、土荆皮15、紫荆皮15、苦楝根18、千金子50、斑蝥90、蜈蚣60、樟脑300。
Description
一技术领域
本发明涉及中药外用药领域，具体地说，本发明涉及一种灭菌止痒留香的外用中药制剂。
二背景技术
癣是皮肤科常见病，直接病因为皮肤癣菌感染皮肤而致的浅部真菌性皮肤病，一般认为其经常与免疫功能失调相关，并有一定的遗传倾向。临床以丘疹、水疱、浸渍糜烂、干燥脱屑伴瘙痒为主要表现，夏秋季发病率高，人群患病率可达一半以上。根据其临床表现将癣分为三型，即水疱型、浸渍糜烂型及鳞屑角化型。三型之间可相互转化。其中水疱型与浸渍糜烂型易继发细菌感染，引起丹毒、淋巴结炎、淋巴管炎、蜂窝织炎等。本病虽不危及患者生命，但极易复发，且易传染，对患者的生活质量和公共卫生都带来了诸多不利影响。
西医治疗癣多根据患者的皮损类型选用外用药物，如卡泊三醇，环吡酮胺软膏等，但这些药物经常有激素类成分或强刺激成分，疗效有限。市面上的多种中药治癣药物如黄肤乐软膏、癣要搞、顽癣净等疗效多不稳定确切，患者往往需要多次更换药物。而口服抗真菌药副作用较大，经常使患者中途停药，而且作用于浅表皮肤效率很低，疗效也不理想。
三发明内容
针对上述问题，本发明提供了一种灭菌止痒留香的外用制剂，其包含黄零草、土荆皮、千金子、斑蝥、蜈蚣等成分，通过科学配伍，使药物快速渗入皮肤，在杀灭多种癣菌、炎症细菌的同时调节局部免疫功能，实现除癣同时止痒的效果。并辅以玫瑰花、檀香、樟脑等成分，使药味芳香，经久不失，有效改善患者生理和心理感官。
一方面，本发明提供了一种灭菌止痒留香的外用制剂，包括以下重量份的原料药：黄零草20-50、玫瑰花10-20、檀香10-20、川锦纹10-20、白芷20-100、桑叶30-50、土荆皮 10-20、千金子20-60、斑蝥70-120、蜈蚣50-80、樟脑100-400。
进一步地，本发明的灭菌止痒留香的外用制剂包括以下重量份的原料药：黄零草20-50、辛夷10-20、玫瑰花10-20、檀香10-20、川锦纹10-20、山奈5-10、白芷20-100、谷精草20-50、桑叶30-50、决明子30-40、白菊花30-40、青皮40-50、土荆皮10-20、紫荆皮10-20、苦楝根15-30、千金子20-60、斑蝥70-120、蜈蚣50-80、樟脑100-400。
进一步地，本发明的灭菌止痒留香的外用制剂包括以下重量份的原料药：黄零草30、辛夷15、玫瑰花15、檀香18、川锦纹12、山奈9、白芷90、谷精草36、桑叶36、决明子36、白菊花36、青皮45、土荆皮15、紫荆皮15、苦楝根18、千金子50、斑蝥90、蜈蚣60、樟脑300。
本发明的外用制剂可以为擦剂、软膏剂、喷剂、涂膜剂等外用剂型。
另一方面，本发明提供了该外用制剂的擦剂剂型制备方法，包括以下步骤：
(1)按重量份称取原料药；
(2)将原料药研磨成10目的粗颗粒，将其装入容器中；
(3)向容器中加入重量为原料药15倍的75％乙醇后封闭；
(4)浸泡10日，期间每日摇动1次；
(5)50目滤布过滤收集滤液；
(6)分装至擦剂容器。
另一方面，本发明提供了该外用制剂的软膏剂剂型制备方法，包括以下步骤：
(1)按重量份称取原料药；
(2)将原料药以75％的乙醇提取2次，每次加乙醇量分别为原料药重量的10倍，每次提取时间为2小时，合并提取液，浓缩至半固体状；
(3)将适量黑醋与蜂蜜混合，加热到80-100℃，在80-100℃保温1分钟，形成基质；
(4)当基质冷却到60℃时，将步骤(2)得到的半固体提取物与基质混合，搅拌均匀，冷却成软膏剂。
(5)分装至软膏剂容器。
本发明的外用制剂可以治疗各种皮肤癣症、炎症，并具有止痒效果。
四附图说明
无
五具体实施方式
实施例1本发明外用制剂的制备
擦剂剂型制备
(1)按以下重量份称取原料药：黄零草30、辛夷15、玫瑰花15、檀香18、川锦纹12、山奈9、白芷90、谷精草36、桑叶36、决明子36、白菊花36、青皮45、土荆皮15、紫荆皮 15、苦楝根18、千金子50、斑蝥90、蜈蚣60、樟脑300；
(2)将原料药研磨成10目的粗颗粒，将其装入玻璃缸中；
(3)向容器中加入重量为原料药15倍的75％乙醇后封闭；
(4)浸泡10日，期间每日摇动1次；
(5)50目滤布过滤收集滤液；
(6)分装至擦剂容器。
软膏剂剂型制备
(1)按以下重量份称取原料药：黄零草30、辛夷15、玫瑰花15、檀香18、川锦纹12、山奈9、白芷90、谷精草36、桑叶36、决明子36、白菊花36、青皮45、土荆皮15、紫荆皮 15、苦楝根18、千金子50、斑蝥90、蜈蚣60、樟脑300；
(2)将原料药以75％的乙醇提取2次，每次加乙醇量分别为原料药重量的10倍，每次提取时间为2小时，合并提取液，浓缩至半固体状；
(3)将30重量份黑醋与70重量份蜂蜜混合，加热到80-100℃，在80-100℃保温1分钟，形成基质；
(4)当基质冷却到60℃时，将步骤(2)得到的半固体提取物与基质混合，搅拌均匀，冷却成软膏剂。
(5)分装至软膏剂容器。
实施例2本发明外用制剂的抗菌效果
实验药品：
冰黄肤乐软膏(西藏芝芝药业有限公司)。
按实施例1的方法制备的本发明中药外用软膏剂。
实验菌株：
陕西省人民医院皮肤科分离的常见皮肤癣菌代表菌株：
红色毛癣菌(T.rubrum)、絮状表皮癣菌(E.floccosum)、石膏样小孢子菌(M.gypseum)。实验培养基：
沙堡氏吐温80液体、沙堡氏吐温80琼脂培养基(沙堡氏培养基加入5‰吐温80)。
最低抑菌浓度(MIC)和最低杀菌浓度(MBC)计算：
用沙堡氏吐温80液体培养基稀释实验药品，使其终浓度分别为100、80、60、40、20、15、10、8、4、2、1、0.5、0mg/ml。每管加入3×104细菌/ml菌液0.2ml，置30摄氏度培养箱内培养10日，以无癣菌生长的最高药物稀释倍数为该药品的最低抑菌浓度(MIC)。
取最低抑菌浓度以上不长菌的培养物分别转种于琼脂平板上，30摄氏度培养7日，以不长菌的最高稀释倍数的药物浓度为该药的最低杀菌浓度(MBC)。
杀菌时间测量：
即取20mg/ml浓度的药液2ml，将3×104细菌/ml菌液0.2ml加入至药液试管内，并立即计时，分别于10、30、60min时取出0.1ml置于沙堡氏吐温80琼脂培养基30摄氏度培养7日，观察是否存在菌落(有菌落为+，无菌落为-)。
实验结果：
冰黄肤乐软膏
| 菌株 | MIC(mg/ml) | MBC(mg/ml) | 10min杀菌 | 30min杀菌 | 60min杀菌 |
| 红色毛癣菌 | 1 | 1 | + | - | - |
| 絮状表皮癣菌 | 2 | 4 | - | - | - |
| 石膏样小孢子菌 | 8 | 8 | + | + | - |
本发明中药外用软膏剂
| 菌株 | MIC(mg/ml) | MBC(mg/ml) | 10min杀菌 | 30min杀菌 | 60min杀菌 |
| 红色毛癣菌 | 1 | 1 | + | - | - |
| 絮状表皮癣菌 | 0.5 | 1 | - | - | - |
| 石膏样小孢子菌 | 2 | 2 | + | - | - |
数据表明本发明外用制剂的抗炎杀菌效果，特别是对絮状表皮癣菌和石膏样小孢子菌的杀菌效果明显好于现有的治癣外用药物。杀菌时间类似，起效较快。
实施例3本发明外用制剂的止痒效果
实验药品：
卡泊三醇软膏/达力士(爱尔兰利奥制药)
冰黄肤乐软膏(西藏芝芝药业有限公司)。
按实施例1的方法制备的本发明中药外用擦剂。
实验对象：
健康豚鼠40只，雌雄各半，随机分为4组，每组10只。分别为空白对照组、冰黄肤乐软膏组、本发明外用擦剂组，卡泊三醇软膏组。
实验过程：
实验前1日，各试验组豚鼠右后足背部剃毛，随后在剃毛区涂药1次。实验日，以砂纸擦伤右后足背剃毛区，面积约1cm2，局部再涂药1次，每次每只豚鼠涂药量约为0.15g/本发明外用擦剂2ml。各组在末次涂药后10min，开始在右后足背创面处滴0.01％磷酸组织胺0.05mL/只，此后每隔3min依0.01％、0.02％、0.03％、0.04％……递增浓度，每次均为0.05mL/ 只，直至出现豚鼠回头舔右后足，以最后出现豚鼠回头舔右后足时所给予的磷酸组织胺总量 (μg)为致痒阈。依据各组豚鼠的致痒阈评价该受试药物的止痒作用。
实验结果：
| 组别 | 各组平均磷酸组织胺总量(μg)/致痒阈 |
| 空白对照组 | 65.2±34.5 |
| 卡泊三醇软膏组 | 164.8±89.5 |
| 冰黄肤乐软膏组 | 90.2±70.3 |
| 本发明外用擦剂组 | 180.4±77.1 |
数据表明，本申请的外用制剂有着良好的止痒作用，不低于临床上常用的疗效确切的卡泊三醇，好于常见的中药制剂冰黄肤乐软膏。
实施例4本发明外用制剂的实际临床效果
实验药品：
环吡酮胺软膏/环利(北京双吉制药有限公司)。
冰黄肤乐软膏(西藏芝芝药业有限公司)。
按实施例1的方法制备的本发明中药外用擦剂。
实验对象：
参照《临床皮肤性病学》、、《中华人民共和国中医药行业标准·中医皮肤科病证诊断疗效标准》、《中药新药临床研究指导原则》制定足癣病例纳入标准如下：
1.年龄18～65岁。
2.符合足癣的西医诊断标准(水疱型或浸渍糜烂型，皮屑直接镜检可见到真菌菌丝、孢子，或真菌培养阳性)。
3.符合中医脚湿气，辨证为湿热浸淫证(患处叠起针尖大小的半透明水疱，疱壁坚实，搔破流津水，或湿烂浸淫，蔓延成片，上叠白皮，疱底鲜红，瘙痒剧烈，舌红，苔黄腻，脉滑数)。
4.近2个月内未接受过全身抗真菌药物治疗，2周内未接受过外用抗真菌药物治疗。
实验过程：
在陕西省人民医院皮肤科的协助下共纳入足癣病例60例，平均分为4组，分别为空白对照组、环吡酮胺软膏组、冰黄肤乐软膏组、本发明中药外用擦剂组。
环吡酮胺软膏组、冰黄肤乐软膏根据患者情况按照说明书使用(每日2-3次)，本发明中药外用擦剂根据患者情况每日施用2-3次，空白对照组除正常清洗，保持干燥外不施用任何药物。治疗共4周
疗效评价：
临床指标包括症状和体征，主要有红斑、丘疹、水疱、渗出、糜烂、瘙痒，按0-3
级评分，0＝无，1＝轻，2＝中，3＝重。
红斑：无(0分)无红斑、轻(1分)淡红斑、中(2分)鲜红斑、重(3分)红斑伴水肿；
丘疹：无(0分)无丘疹、轻(1分)数量少于5个、中(2分)数量大于5个少于10个重(3分)数量大于10个；
水疱：无(0分)无水疱、轻(1分)数量少于5个、中(2分)数量大于5个少于10个重(3分)数量大于10个；
渗出：无(0分)无渗出、轻(1分)渗出较少，伴点状浆痂、中(2分)渗出伴片状浆痂重(3分)渗出严重，滋水淋漓；
糜烂：无(0分)无皮损、轻(1分)皮肤白软起皱、中(2分)表皮脱落，色红湿润、重 (3分)皮肤糜烂，伴有渗液；
瘙痒：无(0分)无明显痒感、轻(1分)痒感很轻，偶有搔抓，不影响情绪及生活、中(2分)痒感较重，经常搔抓，但可耐受，不影响睡眠、重(3分)痒重，难以忍受，影响睡眠。
以停药后1周的疗效作为最终疗效，疗效指数＝(治疗前积分-治疗后积分)/治疗前积分×100％。
治愈：症状、体征完全消失，疗效指数等于100％；
显效：症状、体征明显改善，疗效指数≥60％；
好转：症状、体征有改善，疗效指数为20％～59％；
无效：症状、体征改善不明显或恶化，疗效指数＜20％；
实验结果：
| 药物 | 治愈 | 显效 | 好转 | 无效 |
| 空白对照 | 0 | 0 | 3 | 10 |
| 环吡酮胺软膏 | 6 | 5 | 3 | 1 |
| 冰黄肤乐软膏 | 2 | 7 | 4 | 1 |
| 本发明中药外用擦剂 | 7 | 5 | 3 | 0 |
注：空白组有2例，冰黄肤乐软膏有1例实验中脱组。
数据表明，本发明的中药外用擦剂在治疗常见的皮肤癣症-足癣时效果明显优于冰黄肤乐软膏，不亚于甚至优于疗效确切的西药-环吡酮胺软膏(治愈和有效率略好)，而且两种中药制剂在实验中没有报告任何不良反应(环吡酮胺软膏有3个病例报告用药后数小时内红肿和发痒加剧)。临床实验单位认为此药物有进一步研究、投产、用于临床的价值。
Claims (10)
1.一种灭菌止痒留香的外用制剂，包括以下重量份的原料药：黄零草20-50、玫瑰花10-20、檀香10-20、川锦纹10-20、白芷20-100、桑叶30-50、土荆皮10-20、千金子20-60、斑蝥70-120、蜈蚣50-80、樟脑100-400。
2.权利要求1所述的外用制剂，包括以下重量份的原料药：黄零草20-50、辛夷10-20、玫瑰花10-20、檀香10-20、川锦纹10-20、山奈5-10、白芷20-100、谷精草20-50、桑叶30-50、决明子30-40、白菊花30-40、青皮40-50、土荆皮10-20、紫荆皮10-20、苦楝根15-30、千金子20-60、斑蝥70-120、蜈蚣50-80、樟脑100-400。
3.权利要求2所述的外用制剂，包括以下重量份的原料药：黄零草30、辛夷15、玫瑰花15、檀香18、川锦纹12、山奈9、白芷90、谷精草36、桑叶36、决明子36、白菊花36、青皮45、土荆皮15、紫荆皮15、苦楝根18、千金子50、斑蝥90、蜈蚣60、樟脑300。
4.权利要求1-3任一项的外用制剂，其为擦剂。
5.权利要求1-3任一项的外用制剂，其为软膏剂。
6.制备权利要求4的外用制剂的方法，包括以下步骤：
(1)按重量份称取原料药；
(2)将原料药研磨成10目的粗颗粒，将其装入容器中；
(3)向容器中加入重量为原料药15倍的75％乙醇后封闭；
(4)浸泡10日，期间每日摇动1次；
(5)50目滤布过滤收集滤液；
(6)分装至擦剂容器。
7.制备权利要求5的外用制剂的方法，包括以下步骤：
(1)按重量份称取原料药；
(2)将原料药以75％的乙醇提取2次，每次加乙醇量分别为原料药重量的10倍，每次提取时间为2小时，合并提取液，浓缩至半固体状；
(3)将适量黑醋与蜂蜜混合，加热到80-100℃，在80-100℃保温1分钟，形成基质；
(4)当基质冷却到60℃时，将步骤(2)得到的半固体提取物与基质混合，搅拌均匀，冷却成软膏剂。
(5)分装至软膏剂容器。
8.权利要求1-5任一项的外用制剂，其用于治疗皮肤癣症。
9.权利要求1-5任一项的外用制剂，其用于治疗皮肤炎症。
10.权利要求8或9任一项的外用制剂，其还可用于止痒。
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| CN105963596A (zh) * | 2016-06-21 | 2016-09-28 | 登封市科技企业孵化服务中心 | 土槿皮中药酒 |
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| CN101199646A (zh) * | 2007-12-18 | 2008-06-18 | 周松申 | 治疗牛皮癣的外用擦剂 |
| CN101224252A (zh) * | 2007-12-29 | 2008-07-23 | 耿树德 | 一种治疗癣病的外用中成药 |
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