CN106266500A - 一种治疗乳腺增生的中药组合物 - Google Patents
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Abstract
本发明提供了一种治疗乳腺增生的中药组合物,其由以下重量份的原料药制成:白术3‑9、藿香3‑9、柴胡3‑9、草龙胆3‑9、鸡内金3‑9、瓜蒌3‑9、浙贝母3‑9、皂刺2‑6、醋制没药2‑6、知母2‑6、蜈蚣0.1‑3、全蝎0.1‑3、生血蛤皮0.1‑3、露蜂房焙半黑0.1‑3、壁虎0.1‑3、盆消0.1‑3、穿山甲0.1‑3。
Description
一技术领域
本发明涉及中药领域,具体地说,本发明涉及治疗乳腺增生的中药组合物。
二背景技术
乳腺增生病(Hyperplastic disease of breast,HDB)是乳腺导管和小叶在结构上的退行性和进行性变化。世界卫生组织统称“良性乳腺结构不良”,认为该病主要是由于内分泌系统失调所致,表现为机体内黄体酮、孕激素分泌过少,雌激素(特别是雌二醇)相对增多,致使雌激素长期刺激乳腺组织而发生的增生性病变。
除直接手术治疗外,西医治疗乳腺增生主要使用激素或激素受体(如三苯氧胺、雄性激素等)来达到减轻疼痛、缩小肿块的目的,但此类药物有多种不良反应,很多患者难以坚持用药,而且停药后极易复发,长期服用还有诱发子宫内膜癌的风险。
中药治疗从整体消除病因出发,可明显改善乳腺增生的症状,消除肿块(乳癖清胶囊云南通用善美制药有限责任公司等,主要成分包括柴胡、青皮、瓜蒌、土木香、贝母、冬虫夏草、重楼、当归等、乳核内消颗粒江西民济药业有限公司等主要成分包括贝母、当归、赤芍、漏芦、茜草、夏枯草、郁金、瓜蒌、甘草等),效果好,复发率低,且基本没有不良反应,已经是国内临床上常用的治疗方法。但中药治疗乳腺增生仍然存在起效缓慢,疗效不确切等缺点。
三发明内容
针对上述问题,在治疗乳腺增生的传统中药材,如柴胡、贝母、瓜蒌等的基础上,以健脾理气,活血化瘀,攻坚散结为机理,通过合理配伍,提供了一种疗效确切的治疗乳腺增生的中药组合物,能独立使用处理中轻度乳腺增生。
一方面,本发明提供了一种治疗乳腺增生的中药组合物,包括以下重量份的原料:白术3-9、藿香3-9、柴胡3-9、醋制没药2-6、蜈蚣0.1-3、全蝎0.1-3。
进一步的方面,本发明提供的治疗乳腺增生的中药组合物,由以下重量份的原料药制成:白术3-9、藿香3-9、柴胡3-9、草龙胆3-9、鸡内金3-9、瓜蒌3-9、浙贝母3-9、皂刺2-6、醋制没药2-6、知母2-6、蜈蚣0.1-3、全蝎0.1-3、生血蛤皮0.1-3、露蜂房焙半黑0.1-3、壁虎0.1-3、盆消0.1-3、穿山甲0.1-3。
进一步的方面,本发明提供的治疗乳腺增生的中药组合物,由以下重量份的原料药制成:白术8、藿香5、柴胡5、草龙胆3、鸡内金3、瓜蒌5、浙贝母3、皂刺2、醋制没药2、知母2、蜈蚣0.5、全蝎0.5、生血蛤皮1、露蜂房焙半黑0.5、壁虎0.5、盆消1、穿山甲1。
进一步的方面,本发明提供的治疗乳腺增生的中药组合物为粉末剂或丸剂。
另一方面,本发明提供了所述中药组合物粉末剂的制备方法,包括步骤:
按重量份称取各种药材;
将药材粉碎成细粉,混合均匀,过120目筛,得粉末剂。
另一方面,本发明提供了所述中药组合物丸剂的制备方法,包括步骤:
按重量份称取各种药材;
将药材粉碎成细粉,混合均匀,过120目筛;
熬炼与药粉等重的蜂蜜;
将熬炼过的蜂蜜加入药粉中,调匀,和丸,得丸剂。
四具体实施方式
实施例1本发明中药组合物的制备
粉末剂:
按重量份称取各种药材:白术8、藿香5、柴胡5、草龙胆3、鸡内金3、瓜蒌5、浙贝母3、皂刺2、醋制没药2、知母2、蜈蚣0.5、全蝎0.5、生血蛤皮1、露蜂房焙半黑0.5、壁虎0.5、盆消1、穿山甲1;
将药材粉碎成细粉,混合均匀,过120目筛,得粉末剂;
丸剂:
按重量份称取各种药材:白术8、藿香5、柴胡5、草龙胆3、鸡内金3、瓜蒌5、浙贝母3、皂刺2、醋制没药2、知母2、蜈蚣0.5、全蝎0.5、生血蛤皮1、露蜂房焙半黑0.5、壁虎0.5、盆消1、穿山甲1;
将药材粉碎成细粉,混合均匀,过120目筛;
熬炼与药粉等重的蜂蜜;
将熬炼过的蜂蜜加入药粉中,调匀,和丸,得丸剂。
实施例2本发明中药组合物对大鼠乳腺增生模型的效果
造模方法:
取200-250g的SD大鼠50只,随机分为5组,每组10只,肌肉注射苯甲酸雌二醇0.5mg/Kg,每日1次,连续25天,既而用肌肉注射黄体酮4mg/Kg,每日1次,连续5天,制成大鼠乳腺增生模型。
给药方案:
造模同时开始灌胃给药,持续30天:
组1:实施例1制备的粉末剂,15mg/日,0.5ml生理盐水;
组2:乳癖清胶囊(云南通用善美制药有限责任公司)粉末,15mg/日,0.5ml生理盐水;
组3:乳核内消颗粒(江西民济药业有限公司)粉末,15mg/日,0.5ml生理盐水;
组4:三苯氧胺(扬子江制药)粉末,0.1mg/日,0.5ml生理盐水;
组5:0.5ml生理盐水
疗效评估方法:
第31天,将动物以3%戊巴比妥麻醉,腹主动脉取血,离心,取血清测定雌二醇(E2)、用8mm打孔器取第2、3对乳房称重。并在各组中取部分样本10%福尔马林固定,石蜡切片,HE染色,光镜检查。
实验结果:
组别 | E2(pg/ml) |
组1 | 24.04±3.95 |
组2 | 23.41±5.81 |
组3 | 33.70±9.10 |
组4 | 19.10±6.55 |
组5 | 50.54±6.20 |
注:组4小鼠死亡2只,组2小鼠死亡1只,原因不明。
组1至组4的乳腺组织病变较组5均有不同程度的好转,腺泡增多、增大,腺管上皮增厚,腺管内渗出,腺泡周围的炎性浸润程度均较模型组明显减轻。组1至组4中,组4明显好于其余各组,组1至组3仅凭肉眼观察无显著差异。
实验结果表明:本发明的中药组合物可以有效控制雌二醇水平,虽然效果不如雌激素受体抑制剂三苯氧胺,比临床上常用的乳癖清胶囊也略有不足,但在实际治疗效果上(控制乳房重量)明显超过了三苯氧胺、乳癖清胶囊和乳核内消颗粒,而且原理和实践上的不良反应率均低于三苯氧胺。
实施例3本发明中药组合物治疗乳腺增生的实际临床效果
病例选择:
出于保密隐私原因,患者的具体情况和来源不做公开。
诊断标准按照中华全国中医外科学会乳腺病专题组制定的诊断标准,经临床体检和红外线扫描确诊。具体表现包括:乳房胀痛和肿块,部分患者具有周期性,月经前疼痛加重,月经来潮后减轻或消失,部分患者整个月经周期都有疼痛;体检发现一侧或双侧乳腺有弥漫性增厚,可局限于乳腺一部分,也可分散于整个乳腺,肿块呈颗粒状、结节状或片状,大小不一,质韧不硬,常为多发性,可见于一侧,肿块与周围组织分界不清;超声检查:乳腺体结构紊乱,回声不均。
共选取确诊的乳腺增生患者60名,患者年龄20~55岁,平均34.2岁;其中双侧增生58例,单侧增生2例。将60例患者随机分成4组。
治疗方案:
组1:实施例1制备的粉末剂,每日2次,每次5g口服;同时醋调10g粉末,涂于患处和肝俞处,每日1次;
组2:乳癖清胶囊(云南通用善美制药有限责任公司),每次3粒,每日3次;
组3:乳核内消颗粒(江西民济药业有限公司),每次10g,每日2次;
组4:安宫黄体酮(浙江仙琚制药股份有限公司)、三苯氧胺(扬子江制药)各10mg,每日2次;维生素E、B6各10mg,每日2次;
连续治疗3个月
疗效评价:
参照中华全国中医外科学会乳腺病专题组制定的疗效评定标准:
临床治愈:肿块消失,乳痛消失;
显效:肿块最大直径缩小1/2以上,乳痛消失;
有效:肿块最大直径缩小不足1/2,乳痛减轻或肿块缩小1/2以上,乳痛减轻不明显;
无效:肿块未缩小或反而增大变硬,或单纯乳痛缓解。
实验效果:
组别 | 治愈 | 显效 | 有效 | 无效 |
组1 | 3 | 9 | 2 | 1 |
组2 | 2 | 7 | 4 | 2 |
组3 | 2 | 5 | 4 | 4 |
组4 | 4 | 8 | 2 | 0 |
注:组4有一病例因出血在第一个月退出实验。
实验结果表明,本发明的中药组合物的实际临床效果,在有效率、显效率上明显优于常用的乳癖清胶囊,接近激素治疗方案,而且没有激素治疗带来的诸多不便和不良反应,中轻度乳腺增生时可以作为激素治疗的有效替代方案。
Claims (6)
1.一种治疗乳腺增生的中药组合物,包括以下重量份的原料:白术3-9、藿香3-9、柴胡3-9、醋制没药2-6、蜈蚣0.1-3、全蝎0.1-3。
2.权利要求1所述的中药组合物,由以下重量份的原料药制成:白术3-9、藿香3-9、柴胡3-9、草龙胆3-9、鸡内金3-9、瓜蒌3-9、浙贝母3-9、皂刺2-6、醋制没药2-6、知母2-6、蜈蚣0.1-3、全蝎0.1-3、生血蛤皮0.1-3、露蜂房焙半黑0.1-3、壁虎0.1-3、盆消0.1-3、穿山甲0.1-3。
3.权利要求2所述的中药组合物,由以下重量份的原料药制成:白术8、藿香5、柴胡5、草龙胆3、鸡内金3、瓜蒌5、浙贝母3、皂刺2、醋制没药2、知母2、蜈蚣0.5、全蝎0.5、生血蛤皮1、露蜂房焙半黑0.5、壁虎0.5、盆消1、穿山甲1。
4.权利要求1-3任一项的中药组合物,其为粉末剂或丸剂。
5.权利要求4的中药组合物的粉末剂制备方法,包括步骤:
按重量份称取各种药材;
将药材粉碎成细粉,混合均匀,过120目筛,得粉末剂。
6.权利要求4的中药组合物的丸剂制备方法,包括步骤:
按重量份称取各种药材;
将药材粉碎成细粉,混合均匀,过120目筛;
熬炼与药粉等重的蜂蜜;
将熬炼过的蜂蜜加入药粉中,调匀,和丸,得丸剂。
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