CN116850256A - 一种治疗乳腺增生和乳腺结节的中药制剂及其制备方法 - Google Patents
一种治疗乳腺增生和乳腺结节的中药制剂及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种治疗乳腺增生和乳腺结节的中药组合物,涉及中药技术领域。按重量份计,所述中药组合物包括以下组分:夏枯草12‑17份、柴胡10‑14份、王不留行8‑12份、川芎9‑13份、石菖蒲5‑9份、郁金5‑9份、当归9‑11份、桂枝5‑9份、桃仁5‑9份、白芍10‑14份、茯苓10‑14份、红花7‑11份和薏苡仁10‑14份。本发明提供的中药组合物以疏肝解郁、清火理气和止痛祛瘀的中药为主要成分,对乳腺增生和乳腺结节具有良好的治疗效果,总有效率最高可达97.5%。
Description
技术领域
本发明涉及中药技术领域,特别是涉及一种治疗乳腺增生和乳腺结节的中药制剂及其制备方法。
背景技术
乳腺增生是发生于乳腺的一种良性疾病,主要表现为增生结节或乳腺纤维瘤,是乳腺上皮和纤维组织增生,乳腺组织导管和乳小叶结构上的退行性病变及进行性结缔组织的生长,其发病原因包括内分泌激素失调、饮食结构以及社会心理因素等。由于雌激素刺激乳腺上皮增生,会导致乳腺管的扩张,因此,一部分乳腺增生会形成局部结节脓肿,产生乳腺结节,其病症多以乳房胀痛为主,乳房内条索状结块或成性结节,多与经期前或情绪改变而变化,而70%~80%女性都有乳腺增生结节,如不及时治疗或长期迁延不愈,会发生乳腺良性肿瘤和恶性病变。临床常见的治疗方法包括激素类药物配合针灸、超声波或直接进行微创手术切除等方式,然而激素治疗有可能加剧人体激素间失衡,手术治疗增加了疼痛,而且恢复周期长,增加患者的痛苦。
乳腺结节的成因尚不明确,与多种遗传及环境因素相关。目前可能参与乳腺结节形成的病因包括内分泌激素水平、基因突变及环境影响等。虽然治疗乳增生的中药中医报道较多,但缺乏专门针对乳腺增生结节的有效中药方剂,临床上乳腺增生结节仍面临根治困难的问题。
发明内容
本发明的目的是提供一种治疗乳腺增生和乳腺结节的中药制剂及其制备方法,以解决上述现有技术存在的问题,该中药组合物可以有效治疗乳腺增生和乳腺结节,总有效率可达97.5%。
为实现上述目的,本发明提供了如下方案:
本发明提供一种治疗乳腺增生和乳腺结节的中药组合物,按重量份计,包括以下组分:夏枯草12-17份、柴胡10-14份、王不留行8-12份、川芎9-13份、石菖蒲5-9份、郁金5-9份、当归9-11份、桂枝5-9份、桃仁5-9份、白芍10-14份、茯苓10-14份、红花7-11份和薏苡仁10-14份。
优选地,按重量份计,包括以下组分:夏枯草15份、柴胡10份、王不留行8份、川芎11份、石菖蒲9份、郁金5份、当归9份、桂枝9份、桃仁7份、白芍12份、茯苓12份、红花9份和薏苡仁12份。
本发明还提供一种所述的中药组合物在制备治疗乳腺增生和乳腺结节的药物中的应用。
本发明还提供一种治疗乳腺增生和乳腺结节的药物,原料包括所述的中药组合物。
进一步地,所述药物还包括药学上可接受的辅料。
进一步地,所述药物的剂型包括粉剂、丸剂、颗粒剂、膏剂或片剂。
本发明还提供一种所述的药物的制备方法,包括利用溶剂提取得到所述的中药组合物中的有效成分,再制备得到所述药物的步骤。
进一步地,所述溶剂包括水。
本发明公开了以下技术效果:
在本发明的中药组合物中,夏枯草清肝泻火、散结消肿,可缓解乳痈、乳房胀痛等,起到散结消肿的作用;柴胡解表退热,梳理肝气,具有疏肝解郁的功效,此二者为君药,以疏肝解郁、清火理气为主要治则。王不留行、川芎、石菖蒲和郁金为臣药,其中,王不留行活血化瘀、消肿敛疮;川芎止痛祛瘀、行气开郁;石菖蒲开窍豁痰、醒神益智;郁金保肝利胆、祛瘀止血;当归、桂枝、桃仁、白芍、茯苓和红花为佐药,温通经脉;薏苡仁为使药,利湿健脾、舒筋除痹、清热排脓,调和诸药。该中药组合物以疏肝解郁、清火理气和止痛祛瘀的中药为主要成分,对乳腺增生和乳腺结节具有良好的治疗效果,总有效率最高可达97.5%。
具体实施方式
现详细说明本发明的多种示例性实施方式,该详细说明不应认为是对本发明的限制,而应理解为是对本发明的某些方面、特性和实施方案的更详细的描述。
应理解本发明中所述的术语仅仅是为描述特别的实施方式,并非用于限制本发明。另外,对于本发明中的数值范围,应理解为还具体公开了该范围的上限和下限之间的每个中间值。在任何陈述值或陈述范围内的中间值,以及任何其他陈述值或在所述范围内的中间值之间的每个较小的范围也包括在本发明内。这些较小范围的上限和下限可独立地包括或排除在范围内。
除非另有说明,否则本文使用的所有技术和科学术语具有本发明所述领域的常规技术人员通常理解的相同含义。虽然本发明仅描述了优选的方法和材料,但是在本发明的实施或测试中也可以使用与本文所述相似或等同的任何方法和材料。本说明书中提到的所有文献通过引用并入,用以公开和描述与所述文献相关的方法和/或材料。在与任何并入的文献冲突时,以本说明书的内容为准。
在不背离本发明的范围或精神的情况下,可对本发明说明书的具体实施方式做多种改进和变化,这对本领域技术人员而言是显而易见的。由本发明的说明书得到的其他实施方式对技术人员而言是显而易见得的。本发明说明书和实施例仅是示例性的。
关于本文中所使用的“包含”、“包括”、“具有”、“含有”等等,均为开放性的用语,即意指包含但不限于。
实施例1
原料:夏枯草12g、柴胡14g、王不留行10g、川芎9g、石菖蒲7g、郁金7g、当归10g、桂枝7g、桃仁5g、白芍14g、茯苓14g、红花7g和薏苡仁10g。
制备方法:
(1)按照上述原料配方,称取各原料后,按照料液比1:3加水后,煎煮1h,过滤,得到第一滤液和滤渣;
(2)步骤(1)得到的滤渣,按照料液比1:1.5加水后,再煎煮1h,过滤,得到第二滤液;
(3)第一滤液和第二滤液合并后,减压浓缩后真空干燥,得到中药提取物粉剂。
实施例2
原料:夏枯草15g、柴胡10g、王不留行8g、川芎11g、石菖蒲9g、郁金5g、当归9g、桂枝9g、桃仁7g、白芍12g、茯苓12g、红花9g和薏苡仁12g。
制备方法:
(1)按照上述原料配方,称取各原料后,按照料液比1:3加水后,煎煮1h,过滤,得到第一滤液和滤渣;
(2)步骤(1)得到的滤渣,按照料液比1:1.5加水后,再煎煮1h,过滤,得到第二滤液;
(3)第一滤液和第二滤液合并后,减压浓缩后真空干燥,得到中药提取物粉剂。
实施例3
原料:夏枯草17g、柴胡12g、王不留行12g、川芎13g、石菖蒲5g、郁金9g、当归11g、桂枝5g、桃仁9g、白芍10g、茯苓10g、红花11g和薏苡仁14g。
制备方法:
(1)按照上述原料配方,称取各原料后,按照料液比1:3加水后,煎煮1h,过滤,得到第一滤液和滤渣;
(2)步骤(1)得到的滤渣,按照料液比1:1.5加水后,再煎煮1h,过滤,得到第二滤液;
(3)第一滤液和第二滤液合并后,减压浓缩后真空干燥,得到中药提取物粉剂。
对比例1
同实施例2,区别仅在于,原料去除王不留行。
对比例2
同实施例2,区别仅在于,将王不留行替换为炮穿山甲。
对比例3
同实施例2,区别仅在于,将王不留行替换为鸡血藤。
对比例4
同实施例2,区别仅在于,将石菖蒲替换为麝香。
效果验证
1.1一般资料
2021年1月至2022年12月在天津市北辰区中医医院就诊的乳腺增生和乳腺结节患者280例,年龄24-65岁,随机分为7组,每组40例。
1.2诊断标准
(1)一侧或两侧乳房有单个或多个肿块,大多伴有周期性乳房疼痛,与情绪和月经周期有明显关系,月经前一周左右症状加重,月经后肿块疼痛明显减轻,连续三个月无法缓解;
(2)临床检查乳房可触及单个或多个不规则结节,质量韧性,多位于外部和上部,结节不粘附于周围组织,可推动,有轻微疼痛,腋窝淋巴结不大;
(3)B超高频图像显示乳腺内出现增生。
1.3排除标准
生理性乳房疼痛、初潮前小儿乳房发育症、男性乳房发育症以及乳房良性或恶性肿瘤等疾病。
1.4治疗
试验组1-7分别口服实施例1-3和对比例1-4制备得到的中药提取物粉剂,每日3次,每次10mg。
1.5疗效判定标准
显效:全部或主要症状明显消除,疼痛和不适感明显消失,但还会出现轻微的症状,大部分正常生活恢复;
有效:症状、体征均有好转,疼痛和不适感减轻,但还会出现轻微的症状,部分正常生活恢复;
无效:症状、体征均无明显改善,甚或加重。
2.结果
各试验组的治疗效果如表1所示。根据表1可以看出,本发明的中药组合物可以有效治乳腺增生和乳腺结节,总有效率最高可达97.5%。
表1
以上所述的实施例仅是对本发明的优选方式进行描述,并非对本发明的范围进行限定,在不脱离本发明设计精神的前提下,本领域普通技术人员对本发明的技术方案做出的各种变形和改进,均应落入本发明权利要求书确定的保护范围内。
Claims (8)
1.一种治疗乳腺增生和乳腺结节的中药组合物,其特征在于,按重量份计,包括以下组分:夏枯草12-17份、柴胡10-14份、王不留行8-12份、川芎9-13份、石菖蒲5-9份、郁金5-9份、当归9-11份、桂枝5-9份、桃仁5-9份、白芍10-14份、茯苓10-14份、红花7-11份和薏苡仁10-14份。
2.根据权利要求1所述的中药组合物,其特征在于,按重量份计,包括以下组分:夏枯草15份、柴胡10份、王不留行8份、川芎11份、石菖蒲9份、郁金5份、当归9份、桂枝9份、桃仁7份、白芍12份、茯苓12份、红花9份和薏苡仁12份。
3.一种如权利要求1或2所述的中药组合物在制备治疗乳腺增生和乳腺结节的药物中的应用。
4.一种治疗乳腺增生和乳腺结节的药物,其特征在于,原料包括权利要求1或2所述的中药组合物。
5.根据权利要求4所述的药物,其特征在于,所述药物还包括药学上可接受的辅料。
6.根据权利要求5所述的药物,其特征在于,所述药物的剂型包括粉剂、丸剂、颗粒剂、膏剂或片剂。
7.一种如权利要求4所述的药物的制备方法,其特征在于,包括利用溶剂提取得到权利要求1或2所述的中药组合物中的有效成分,再制备得到所述药物的步骤。
8.根据权利要求7所述的制备方法,其特征在于,所述溶剂包括水。
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