CN104547786B - 治疗高雄激素性痤疮的外用中药组合物及应用 - Google Patents
治疗高雄激素性痤疮的外用中药组合物及应用 Download PDFInfo
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Abstract
本发明提供一种用于治疗多囊卵巢综合征高雄激素性痤疮的外用中药组合物,由以下重量配比的原料药组成:蒲公英100‑300份,全蝎200‑500份,紫草150‑450份,土茯苓200‑500份,金银花150‑450份,蛇床子100‑300份,黄柏100‑300份。药物的制剂形式为洗剂。本发明药物组合物经临床研究验证了其治疗多囊卵巢综合征高雄激素性痤疮的安全性和有效性,组合物药味少,易于质量控制,同时成本低廉。可在制备用于治疗多囊卵巢综合征高雄激素性痤疮的外用药物中应用。
Description
技术领域
本发明属中药组合物,涉及一种用于治疗多囊卵巢综合征高雄激素性痤疮的外用中药组合物,及其药物用途。
背景技术
多囊卵巢综合征(Polycystic ovary syndrome,PCOS)是育龄妇女中最常见的妇科内分泌疾病。全球范围内5%-10%育龄妇女受此病困扰。PCOS最重要的内分泌特征即为高雄激素血症,卵巢局部和循环雄激素水平高,一方面可以阻碍卵泡的正常生长,造成无排卵或稀发排卵状态,表现为月经周期紊乱,通常为闭经或月经稀发,另一方面可引起多毛、痤疮、皮肤脂溢和/或脱发等临床症状。PCOS是女性高雄性激素血症最常见的原因,而PCOS患者多伴有雄激素升高,其临床表现以迟发性痤疮、多毛为多。目前临床多采用达英-35治疗,达英-35是唯一获准治疗PCOS的避孕药,具有抗雄激素及抗促性腺激素的作用。但由于其避孕药的特性和副作用,临床上并不容易被患者接受。
中医古籍中没有关于“多囊卵巢综合征”病名的记载。本病在古代医家的论著中被描述为“月经后期”、“闭经”、“崩漏”、“不孕症”等。肾为先天之本,主藏精,主导女性生殖器官的发育和生殖功能的形成。胞宫主行月经和孕育胎儿。PCOS常于天癸渐充时起病,在青春期,PCOS的主要表现是月经失调,在育龄期,PCOS的主要表现是不孕症。中医学认为“肺主皮毛”,痤疮发病系素体血热偏盛,饮食不节,外邪侵袭犯肺是致病的重要条件,若湿热夹痰,则会病程缠绵,病情加重。发病机制主要是肺胃积热,循经上熏,血随热行,上壅于胸面,气血郁滞,蕴积肌肤而致。
发明内容
本发明的目的是提供一种用于治疗多囊卵巢综合征高雄激素性痤疮的外用中药组合物,该中药组合物由以下重量配比的原料药组成:蒲公英100-300份,全蝎 200-500份,紫草150-450份,土茯苓200-500份,金银花150-450份,蛇床子100-300份,黄柏100-300份。以上组份的重量以生药计算。每1份可以是1g,也可以是公斤或吨,如果用克为单位,该配方组成可制成药物制剂1000剂。以上组成是按重量作为配比的,在生产时可按照相应比例增大或减小,如大规模生产可以以公斤为单位,或以吨为单位,小规模生产也可以毫克为单位,重量可以增大或减小,但各组成之间的生药材重量配比的比例不变。上述配比的中药组合物,根据需要加入适宜的赋形剂制成适合外用的洗剂。
本发明的另一个目的是提供所述的中药组合物在制备用于治疗多囊卵巢综合征高雄激素性痤疮的外用药物中的应用。
本发明的有益之处是:(1)本发明药物组合物有坚实的中医妇科经典理论支持,组分配比合理;(2)本发明药物组合物临床疗效确切,无毒副作用,使用安全,可在制备用于治疗多囊卵巢综合征高雄激素性痤疮的外用中药组合物中应用;(3)本发明药物组合物药味少,易于质量控制,同时成本低廉。
具体实施方式
本发明通过具体实施例作进一步的说明。
实施例1
药物组合物组成:蒲公英100g,全蝎 200g,紫草150g,土茯苓200g,金银花150g,蛇床子100g,黄柏100g。
制备方法:
(1)取蛇床子加水浸泡2小时,用水蒸汽蒸馏法收集的挥发油饱和水溶液,放入另一容器储存,备用。
(2)取蒲公英,全蝎,紫草,土茯苓,金银花,黄柏粉碎成粗粉,加入上述药渣,加水煎煮2次,每次1小时,合并上煎液,滤过,滤液浓缩至相对浓度为1.03-1.05(50℃)的清膏,放置24小时,加入上述挥发油饱和水溶液,混合均匀,即得。
实施例2
药物组合物组成:蒲公英150g,全蝎 275g,紫草225g,土茯苓275g,金银花225g,蛇床子150g,黄柏150g。
制备方法:
(1)取蛇床子加水浸泡2小时,用水蒸汽蒸馏法收集的挥发油饱和水溶液,放入另一容器储存,备用。
(2)取蒲公英,全蝎,紫草,土茯苓,金银花,黄柏粉碎成粗粉,加入上述药渣,加水煎煮2次,每次1小时,合并上煎液,滤过,滤液浓缩至相对浓度为1.03-1.05(50℃)的清膏,放置24小时,加入上述挥发油饱和水溶液,混合均匀,即得。
实施例3
药物组合物组成:蒲公英200g,全蝎 350g,紫草300g,土茯苓350g,金银花300g,蛇床子200g,黄柏200g。
制备方法:
(1)取蛇床子加水浸泡2小时,用水蒸汽蒸馏法收集的挥发油饱和水溶液,放入另一容器储存,备用。
(2)取蒲公英,全蝎,紫草,土茯苓,金银花,黄柏粉碎成粗粉,加入上述药渣,加水煎煮2次,每次1小时,合并上煎液,滤过,滤液浓缩至相对浓度为1.03-1.05(50℃)的清膏,放置24小时,加入上述挥发油饱和水溶液,混合均匀,即得。
实施例4
药物组合物组成:蒲公英250g,全蝎 425g,紫草375g,土茯苓425g,金银花375g,蛇床子250g,黄柏250g。
制备方法:
(1)取蛇床子加水浸泡2小时,用水蒸汽蒸馏法收集的挥发油饱和水溶液,放入另一容器储存,备用。
(2)取蒲公英,全蝎,紫草,土茯苓,金银花,黄柏粉碎成粗粉,加入上述药渣,加水煎煮2次,每次1小时,合并上煎液,滤过,滤液浓缩至相对浓度为1.03-1.05(50℃)的清膏,放置24小时,加入上述挥发油饱和水溶液,混合均匀,即得。
实施例5
药物组合物组成:蒲公英300g,全蝎 500g,紫草450g,土茯苓500g,金银花450g,蛇床子300g,黄柏300g。
制备方法:
(1)取蛇床子加水浸泡2小时,用水蒸汽蒸馏法收集的挥发油饱和水溶液,放入另一容器储存,备用。
(2)取蒲公英,全蝎,紫草,土茯苓,金银花,黄柏粉碎成粗粉,加入上述药渣,加水煎煮2次,每次1小时,合并上煎液,滤过,滤液浓缩至相对浓度为1.03-1.05(50℃)的清膏,放置24小时,加入上述挥发油饱和水溶液,混合均匀,即得。
实施例6
1.病例收集与分组:
选取57例多囊卵巢综合征高雄激素性痤疮的患者。分为中药治疗组(31例)和西药对照组(26例)。两组患者在年龄、性激素水平、生育情况等方面无显著性差异,具有可比性。排出标准:合并有乳腺、心脑血管、肝、肾和造血系统疾病、精神疾病等其他疾病者;未按规定用药或未能定时随访,无法判断疗效,或资料不全影响疗效判断者;入组前3个月内曾服用或外用各种激素类药物者;患有其他引起痤疮的疾病者。
2.治疗方法
中药治疗组病人使用本药物组合物(组成:蒲公英20g,全蝎 35g,紫草30g,土茯苓35g,金银花30g,蛇床子20g,黄柏20g),每日1剂外洗,每日2次,连续治疗14天。西药对照组病人使用甲硝唑凝胶(江苏圣宝罗药业有限公司生产),每日1剂外涂,每日2次,连续治疗14天。
3. 疗效观察:参照《中医药新药临床研究指导原则》制定:
痊愈:皮损消退率≥95%,或仅遗留少许色素沉着,症状消失;
显效:皮损大部分消退,消退率70%~95%,症状明显减轻;
有效:皮损部分消退,消退率50%~70%,症状改善;
无效:皮损消退不明显或者加重,消退率<50%,症状未见变化。
4. 结果:治疗结束后中药治疗组总有效率93.5%,显著高于西药对照组(P<0.05)。治疗过程中未见任何不良反应发生。结果参见表1。
Claims (2)
1.一种治疗多囊卵巢综合征高雄激素性痤疮的外用中药组合物,其特征在于,该中药组合物由以下重量配比的原料药组成:蒲公英100-300份,全蝎 200-500份,紫草150-450份,土茯苓200-500份,金银花150-450份,蛇床子100-300份,黄柏100-300份。
2.根据权利要求1所述的一种治疗多囊卵巢综合征高雄激素性痤疮的外用中药组合物在制备用于治疗多囊卵巢综合征高雄激素性痤疮的外用药物中应用。
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