CN108543044B - 一种治疗痤疮的联合用药物及其用途 - Google Patents

一种治疗痤疮的联合用药物及其用途 Download PDF

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CN108543044B
CN108543044B CN201810524286.1A CN201810524286A CN108543044B CN 108543044 B CN108543044 B CN 108543044B CN 201810524286 A CN201810524286 A CN 201810524286A CN 108543044 B CN108543044 B CN 108543044B
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黄蜀
罗霞
陈纯涛
许晓燕
张颜
李芳�
代庆娇
江南
万娟
甘宗容
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Traditional Chinese Medicine Research Institute Sichuan Academy Of Chinese Medicine Sciences
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Abstract

本发明公开了一种治疗痤疮的联合用药物及其用途，所述联合用药物是由内服产品和外用产品组成；所述内服产品是由肉桂、干姜、薏苡仁、当归、葛根、枸杞子、茯苓、桔梗制备而成；所述外用产品是由当归、黄芩、连翘、皂角刺、夏枯草、大黄、薏苡仁、金银花、丹参、赤芍、蒺藜、黄精、灵芝、三七、红花、桃仁制备而成。临床实验结果表明，本发明的产品使用前后痤疮症状具有显著差异，说明本发明产品组合具有疏风清热、解毒散结、活血化瘀的功用，对痤疮治疗及促进皮损恢复具有明显疗效。并且采用内外同治的方法，可以缩短痤疮治疗周期，增强痤疮治疗效果。

Description

一种治疗痤疮的联合用药物及其用途
技术领域
本发明涉及一种治疗痤疮的联合用药物及其用途。
背景技术
痤疮是毛囊皮脂腺单位的一种慢性炎症性皮肤病，从新生儿到成人，几乎所有年龄段的人均可患病，临床表现以好发于面部的粉刺、丘疹、脓疱、结节等多形性皮损为特点。全世界所有地区痤疮的患病率在70%-87%之间。
目前，治疗痤疮的西医疗法主要针对病因学采取如下几类方法，①抑制局部炎症：口服及外用抗菌素如四环素、美满霉素、甲硝唑等；②抗雄激素：口服雌激素、黄体酮、安体舒通等；③抑制皮脂腺分泌，改善毛囊口角化过度：如用维甲酸、硫酸锌等；以上疗法均具有一定的疗效，但采用西药治疗容易出现耐药性，出现许多副作用，如口干、口唇脱皮、皮肤干燥瘙痒，胃肠道反应等，育龄期妇女服用还会发生畸胎。
因此，现在急需一种能够有效治疗痤疮，并且安全无副作用的药物。
发明内容
本发明的目的在于提供一种治疗痤疮的联合用药物，它是由内服产品和外用产品组成；所述内服产品是由肉桂、干姜、薏苡仁、当归、葛根、枸杞子、茯苓、桔梗制备而成；所述外用产品是由当归、酒黄芩、连翘、皂角刺、夏枯草、酒大黄、薏苡仁、金银花、丹参、赤芍、炒蒺藜、制黄精、灵芝、三七、红花、桃仁制备而成。
进一步地，所述内服产品是由下述重量配比的原料制备而成：
肉桂5~30份、干姜10~27份、薏苡仁15~50份、当归1~10份、葛根10~60份、枸杞子10~40份、茯苓15~45份、桔梗9~36份、砂仁6~24份。
进一步地，所述内服产品是由下述重量配比的原料制备而成：
肉桂15份、干姜15份、薏苡仁30份、当归3份、葛根30份、枸杞子20份、茯苓30份、桔梗15份、砂仁10份。
进一步地，所述内服产品是由原料药的药粉、原料药的水提取物或有机溶剂提取物为活性成分，加上药学和/或食品上可接受的辅料制备而成的制剂。
进一步地，所述制剂为汤剂、散剂、胶囊剂、片剂、颗粒剂、羹剂。
进一步地，所述外用产品是由下述重量配比的原料制备而成：
当归11~55份、酒黄芩5~30份、连翘9~30份、皂角刺10~40份、夏枯草5~50份、酒大黄3~27份、薏苡仁10~60份、金银花3~35份、丹参5~50份、赤芍5~40份、炒蒺藜3~40份、制黄精6~36份、灵芝0.5~15份、三七10~40份、红花15~45份、桃仁10~50份。
进一步地，所述外用产品是由下述重量配比的原料制备而成：
当归30份、酒黄芩15份、连翘15份、皂角刺30份、夏枯草30份、酒大黄15份、薏苡仁30份、金银花15份、丹参30份、赤芍20份、炒蒺藜20份、制黄精20份、灵芝1份、三七30份、红花30份、桃仁30份。
进一步地，所述外用产品是由原料药的粉末、原料药的水提取物或有机溶剂提取物为活性成分，加上化妆品中可接受的辅料制备而成的化妆品。
进一步地，所述外用产品为净面巾、爽肤水、乳液、精华液、面霜、面膜、眼膜、啫喱等。
本发明还提供了上述联合用药物在制备治疗或改善痤疮的食品、保健品、药品或化妆品中的用途。
本发明内服产品以肉桂、干姜、葛根为君扶助脾阳以助化湿臣以茯苓、薏苡仁利水渗湿健脾，砂仁化湿行气，当归养血活血，枸杞子补肾益精血，佐以桔梗载药上升饮药直达病所，诸药合用共奏助阳化湿，活血行气之功。本发明外用产品以银花、连翘疏散风热，清热解毒，皂角刺托毒排脓，活血消痈，夏枯草清热泻火，散结消肿，以上四位为君，黄芩清热燥湿，泻火解毒，酒大黄泻下攻积、逐淤通经、清热泻火，当归补血调经，润肠通便，薏苡仁利水渗湿，健脾除痹，丹参、赤芍清热凉血、除烦安神，蒺藜平肝疏风，黄精消食健胃、益肺脾肾，灵芝补气健脾，三七、红花、桃仁活血化瘀、祛瘀止痛，以上十三位为臣，诸药合用共奏疏风清热、解毒散结、活血化瘀之功。
根据本实验结果可知，用药前后痤疮症状具有显著差异，说明本发明的产品具有疏风清热、解毒散结、活血化瘀的功用，对痤疮治疗及促进皮损恢复具有明显疗效。并且本发明采用内外同治的方法，可以缩短痤疮治疗周期，增强痤疮治疗效果。
本发明的外用产品和内服产品可以单独使用，也可以以任意比例组合使用。
显然，根据本发明的上述内容，按照本领域的普通技术知识和惯用手段，在不脱离本发明上述基本技术思想前提下，还可以做出其它多种形式的修改、替换或变更。
以下通过实施例形式的具体实施方式，对本发明的上述内容再作进一步的详细说明。但不应将此理解为本发明上述主题的范围仅限于以下的实例。凡基于本发明上述内容所实现的技术均属于本发明的范围。
具体实施方式
实施例1、本发明内服产品的制备
1.配方：肉桂15g、干姜15 g、薏苡仁30 g、当归3 g、葛根30 g、枸杞子20 g、茯苓30g、桔梗15 g、砂仁10 g。
2.制备方法：按配方称取原料药，加10-15倍水浸泡15分钟进行预处理；煎煮提取2-4次，每次15-30min，每次煎煮后过滤得滤液，混合所有滤液静止20h，将上清液浓缩至相对密度为1.15-1.3的稠膏；进风温度为180-200℃、出风温度为90-100℃，喷雾干燥得提取物。
将上述900g提取物，加入900g麦芽糊精，200g麦芽糖粉，240g 90%乙醇混合，置于摇摆制粒机中过20目筛，进行制粒，50℃干燥8h，干燥后物料经振荡筛选整粒，取20-60目之间颗粒，按20g/袋分装，即得本发明内服产品。
3.使用方法：每日服用两次，每次一袋，饭后温水冲服。
实施例2、本发明内服产品的制备
1.配方：肉桂30g、干姜27g、薏苡仁50g、当归10 g、葛根60 g、枸杞子40 g、茯苓45g、桔梗36g、砂仁24 g。
2.制备方法：按配方称取原料药，加10-15倍水浸泡15分钟进行预处理；煎煮提取2-4次，每次15-30min，每次煎煮后过滤得滤液，混合所有滤液静止20h，将上清液浓缩至相对密度为1.15-1.3的稠膏；进风温度为180-200℃、出风温度为90-100℃，喷雾干燥得提取物。
将上述450g提取物，加入450g麦芽糊精，100g麦芽糖粉， 120g 90%乙醇混合，置于摇摆制粒机中过20目筛，进行制粒，50℃干燥8h，干燥后物料经振荡筛选整粒，取20-60目之间颗粒，按20g/袋分装，即得本发明内服产品。
3.使用方法：同实施例1。
实施例3、本发明内服产品的制备
1.配方：肉桂5g、干姜10 g、薏苡仁15g、当归1 g、葛根10 g、枸杞子10 g、茯苓15g、桔梗9g、砂仁6 g。
2.制备方法：按配方称取原料药，加10-15倍水浸泡15分钟进行预处理；煎煮提取2-4次，每次15-30min，每次煎煮后过滤得滤液，混合所有滤液静止20h，将上清液浓缩至相对密度为1.15-1.3的稠膏；稠膏放入烘箱60-65℃进行烘干16h，干燥致不能流动；再置于减压干燥器(65℃，-0.1MPa)中进行减压干燥8小时，彻底干燥得提取物。将上述450g提取物，加入450g麦芽糊精，100g麦芽糖粉， 120g 90%乙醇混合制粒，干燥，按20g/袋分装，即得本发明内服产品。
3.使用方法：同实施例1。
实施例4、本发明外用产品的制备
1.配方：当归30g、酒黄芩15 g、连翘15 g、皂角刺30 g、夏枯草30 g、酒大黄15 g、薏苡仁30 g、金银花15 g、丹参30 g、赤芍20 g、炒蒺藜20 g、制黄精20 g、灵芝1 g、三七30g、红花30 g、桃仁30 g。
2.制备方法：将上述配方药材原料粉碎，按重量配比称取各中药材粉末，按料液比1:10加入蒸馏水，浸泡0.5h，加热回流提取1.5h，提取3次，合并提取液，提取液300目筛过滤，即得中药提取液。
将上述提取物40份，加入3份丙二醇，3份丁二醇，2份乳酸杆菌/豆浆发酵产物滤液，1.5份燕麦碱，0.35份丙烯酰二甲基牛磺酸铵/山嵛醇聚醚-25甲基丙烯酸酯交联聚合物，0.2份辛酰羟肟酸，0.15份透明质酸，0.1份甘草酸二钾，0.1份精氨酸；并以去离子水加至100；由此制备而成精华液，辅以天然绒丝（也叫棉籽绒丝）的布基（载体）成为面膜（洁面巾）。
3.使用方法：一片/日，外敷10分钟后取下。
实施例5、本发明外用产品的制备
1.配方：当归11g、酒黄芩5g、连翘9 g、皂角刺10 g、夏枯草5g、酒大黄27 g、薏苡仁10 g、金银花3g、丹参5 g、赤芍5 g、炒蒺藜3 g、制黄精6g、灵芝0.5 g、三七10 g、红花15 g、桃仁10g。
2.制备方法：同实施例4。
3.使用方法：同实施例4。
实施例6、本发明外用产品的制备
1.配方：当归55g、酒黄芩30 g、连翘30 g、皂角刺40 g、夏枯草50g、酒大黄27g、薏苡仁60g、金银花35g、丹参50 g、赤芍40 g、炒蒺藜40 g、制黄精36g、灵芝15 g、三七40 g、红花45 g、桃仁50g。
2.制备方法：同实施例4。
3.使用方法：同实施例4。
以下通过试验例的方式来说明本发明的有益效果。
试验例1
（1）患者来源
均为四川省第二中医医院门诊部以及社会招募的面部痤疮患者，共计120例，其中男性42例，女性78例，年龄15~45岁。
（2）诊断标准
参照《中国临床皮肤病学》（赵辨主编，江苏科学技术出版社，2009年12月第1版）拟定。
西医诊断及分级标准：
青春期开始发病，好发于面部、上胸及背部等皮脂腺发达部位，对称分布。皮损以丘疹、脓疱、黑头、结节、囊肿为主，伴有皮脂溢出呈慢性经过.临床轻重分级为:
①Ⅰ级：主要皮损为黑头粉刺，散发或多发，炎性丘疹散发。总病灶数10～30个。
②Ⅱ级：主要皮损为粉刺，并有中等数量的丘疹合浅在性脓疱，总病灶数31～50个，局限在面部。
中医证候诊断标准
①风热证
主症：黑头或白头粉刺居多，伴红色丘疹。
次症：颜面潮红，皮肤烘热或灼热，鼻息气热，可有痒痛。舌边尖红，苔薄黄，脉弦数或脉数。
②湿热证
主症：皮肤油腻，以疼痛性丘疹合脓庖为主。
次症：间有结节，或伴口臭，便秘、尿赤，舌质红，苔黄腻，脉滑。
具备以上主症及次症2项以上者，可诊断为该证候。
（3）受试者纳入标准
符合西医诊断及分级标准
符合中医证候诊断标准
符合入选年龄标准（16~45岁）
治疗前30日内未用过与本病相关的内服药物
7天内未用过与本病相关的外用药
签署知情同意书
（4）受试者排除标准
妊娠或哺乳期妇女
过敏体质或对本药及其中的药物成分过敏者
近30日内服用过与本病相关的内服药物
7天内用过治疗本病的药物
合并有心血管、脑血管、肝、肾严重原发性疾病
合并有造血系统疾病,精神病患者
化学物质所致的职业性痤疮，药物所致痤疮
不符合纳入标准的其他病例
（5）治疗方法
治疗组（60例）：口服实施例1制备的内服产品（2次/日，每次1包）与外用实施例4制备的外用产品（一片/日，外敷10分钟后取下）。
对照组（60例）：口服中药汤剂与外用中药汤剂洗剂（按药材配比，由病人自行抓药熬制）备注：中药来源于四川省中医药科学院中医研究所中药库房采购。
中药口服：肉桂15g、当归3 g、茯苓30 g、桔梗15 g、砂仁10 g。
中药洗剂：当归30g、连翘15 g、薏苡仁30 g、金银花15 g、夏枯草30、
赤芍20、制黄精20 g、桃仁30 g。
（6）临床观察指标
一月为一个疗程，观察服用一月后面部皮损情况，根据表1的症候评分，评定疗效
Figure DEST_PATH_IMAGE001
临床治愈：皮损全部消退，仅留有少许色素，皮损总积分为0分。
显效：皮损大部分消退，皮损总积分减少≥70％，＜100％。
有效：皮损部分消退，皮损总积分减少≥30％，＜70％。
无效：皮损消退不明显，皮损总积分减少＜30％。
（7）疗效判定标准
一月为一个疗程，使用一月后观察面部皮损情况，计算疗效指数=（治疗前积分和-治疗后积分和）/治疗前积分总和，以疗效指数≧30%判定为有效，实验组对照组相比较，两组皮损情况均整体减轻，且差异具有统计学意义(P<0.05），可判定该产品对痤疮治疗及促进皮损恢复有作用。
（8）统计学方法
采用SPSS22.0软件进行统计学分析，所有数据均采用均数±标准差（）表示，计量资料用非参数检验比较，Kruskal-Wallis检验,以P>0.05为差异无统计学意义，P<0.05为差异有统计学意义。
（9）治疗结果
Figure 447659DEST_PATH_IMAGE002
Figure DEST_PATH_IMAGE003
根据治疗前与治疗后积分和、疗效指数的比较，该病临床症状在用药前后具有显著差异，说明本产品具有疏风清热、解毒散结、活血化瘀的功用，对痤疮治疗及促进皮损恢复具有明显疗效。
综上，本发明的产品对痤疮治疗及促进皮损恢复具有明显疗效。并且本发明采用内外同治的方法，可以缩短痤疮治疗周期，增强痤疮炎治疗效果，为临床治疗痤疮提供了一种新的选择。

Claims (5)

1.一种治疗痤疮的联合用药物，其特征在于：它是由内服产品和外用产品组成；所述内服产品是由肉桂、干姜、薏苡仁、当归、葛根、枸杞子、茯苓、桔梗、砂仁制备而成；所述外用产品是由当归、酒黄芩、连翘、皂角刺、夏枯草、酒大黄、薏苡仁、金银花、丹参、赤芍、炒蒺藜、制黄精、灵芝、三七、红花、桃仁制备而成；
所述内服产品是由下述重量配比的原料制备而成：
肉桂15份、干姜15份、薏苡仁30份、当归3份、葛根30份、枸杞子20份、茯苓30份、桔梗15份、砂仁10份；
所述外用产品是由下述重量配比的原料制备而成：
当归30份、酒黄芩15份、连翘15份、皂角刺30份、夏枯草30份、酒大黄15份、薏苡仁30份、金银花15份、丹参30份、赤芍20份、炒蒺藜20份、制黄精20份、灵芝1份、三七30份、红花30份、桃仁30份。
2.根据权利要求1所述的联合用药物，其特征在于：所述内服产品是由原料药的药粉、原料药的水提取物或有机溶剂提取物为活性成分，加上药学上可接受的辅料制备而成的制剂。
3.根据权利要求2所述的联合用药物，其特征在于：所述制剂为颗粒剂。
4.根据权利要求1所述的联合用药物，其特征在于：所述外用产品是由原料药的粉末、原料药的水提取物或有机溶剂提取物为活性成分，加上化妆品中可接受的辅料制备而成的化妆品。
5.根据权利要求4所述的联合用药物，其特征在于：所述外用产品为面膜。
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