CN115998828A - 一种治疗乳腺增生的中药组合物及其制备方法 - Google Patents
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Abstract
本发明涉及本发明公开了一种治疗乳腺增生的中药组合物,由下列中药原料制备而成:仙灵脾、当归、白芍、鹿角胶、柴胡、香附、青皮、陈皮、莪术等,并限定了制备方法,通过温补脾肾、疏肝理气、活血化瘀、舒经止痛、化痰解郁、疏通乳络,全方治疗脾肾阳虚,冲任失调型乳腺增生效果良好。
Description
技术领域
本发明属于中药制剂领域,具体涉及一种治疗乳腺增生的中药组合物及其制备方法。
背景技术
乳腺增生是以乳房有形状大小不一的肿块,疼痛,与月经周期有关为主要表现的乳腺组织的良性增生性疾病。本病是临床上最常见的乳房疾病,有一定的癌变危险,相当于西医的乳腺囊性增生症。
由于情志不遂,或受到精神刺激,导致肝气郁结,气机阻滞,思虑伤脾,脾失健运,痰浊内生,肝郁痰凝,气血瘀滞,阻于乳络而发;或因冲任失调,上则乳房痰浊凝结而发病,下则经水逆乱而月经失调。
目前申请的专利,如CN201710045731,一种治疗瘀阻郁热型乳腺增生的中药,CN202010495655,一种治疗女性乳腺增生的中药组合物及其制备方法,都是笼统地指出具有活血化瘀,通阳散结作用,没有针对具体的证型,由于乳腺增生表现各异,有时乳房疼痛以胀痛为主,常在月经前加剧,经后疼痛减轻,或疼痛随情绪波动而变化,痛甚者不可触碰,行走或活动时也有乳痛。乳痛主要以乳房肿块处为甚,常涉及胸胁部或肩背部。有些患者还可伴有乳头疼痛和作痒,乳痛重者影响工作或生活。脾肾阳虚,冲任失调型乳腺增生多见于乳腺增生中、晚期,常常表现为一侧或两侧乳腺出现肿块和疼痛,常伴有月经不调,前后不定期,经量减少,全身症状可见怕冷,腰膝酸软,神疲乏力,耳鸣。舌质淡胖,苔薄白,脉濡细。目前缺少一种标本兼治的治疗脾肾阳虚,冲任失调型乳腺增生的药物。
发明内容
鉴于现有技术的不足,本发明的目在于本发明是提供一种标本兼治的治疗脾肾阳虚,冲任失调型乳腺增生的中药组合物。
本发明的另一个目在于本发明的制备方法和应用。
本发明的目的是这样实现的:
一种治疗乳腺增生的中药组合物,由下列重量份的中药原料制备而成:仙灵脾18-22份、当归20-26份、白芍10-14份、鹿角胶8-12份、柴胡15-25份、香附10-14份、青皮8-12份、陈皮10-16份、莪术10-14份、郁金8-12份、桃仁6-10份、红花6-10份、乳香10-14份、没药8-12份、川楝子10-16份、夏枯草15-25份、白芷10-20份、羌活10-16份、秦艽10-16份、丝瓜络20-30份、木瓜8-10份、厚朴10-16份、枳壳8-12份。
所述一种治疗乳腺增生的中药组合物,由下列重量份的中药原料制备而成:仙灵脾18份、当归26份、白芍10份、鹿角胶12份、柴胡15份、香附14份、青皮8份、陈皮16份、莪术10份、郁金12份、桃仁6份、红花10份、乳香10份、没药12份、川楝子10份、夏枯草25份、白芷10份、羌活16份、秦艽10份、丝瓜络30份、木瓜8份、厚朴16份、枳壳8份。
所述一种治疗乳腺增生的中药组合物,由下列重量份的中药原料制备而成:仙灵脾22份、当归20份、白芍14份、鹿角胶8份、柴胡25份、香附10份、青皮12份、陈皮10份、莪术14份、郁金8份、桃仁10份、红花6份、乳香14份、没药8份、川楝子16份、夏枯草15份、白芷20份、羌活10份、秦艽16份、丝瓜络20份、木瓜10份、厚朴10份、枳壳12份。
所述一种治疗乳腺增生的中药组合物,由下列重量份的中药原料制备而成:仙灵脾20份、当归23份、白芍12份、鹿角胶10份、柴胡20份、香附12份、青皮10份、陈皮13份、莪术12份、郁金10份、桃仁8份、红花8份、乳香12份、没药10份、川楝子13份、夏枯草20份、白芷15份、羌活13份、秦艽13份、丝瓜络25份、木瓜9份、厚朴13份、枳壳10份。
所述治疗乳腺增生的中药组合物,制备方法为:
(1)取香附、青皮、陈皮、莪术、郁金、桃仁、红花、乳香、没药,将其进行水蒸气蒸馏提取,从中提取挥发油,备用;
(2)取上述药材水蒸气蒸馏提取后的水溶液过滤,得蒸馏后的水溶液,加热浓缩,得蒸馏后的水浓缩液,备用;保留水蒸气蒸馏提取后的药渣,备用;
(3)将步骤(2)所得水蒸气蒸馏提取后的药渣,与其余药材混合,加水提取3次,三次加水量分别相当于药材总重量的12倍、8倍、6倍,每次提取时间分别3小时、2小时、1小时,合并提取液,滤过,滤液浓缩至70℃时相对密度为1.20的清膏,加入乙醇,使含醇量为40%,静置24小时,滤过,滤液加步骤(2)所得蒸馏后的水浓缩液,浓缩成流浸膏,加入步骤(1)所得挥发油,纯化水至总重量为药材总重量的3倍,灌装,即得本发明合剂。
所述治疗乳腺增生的中药组合物,制备方法为:
(1)取香附、青皮、陈皮、莪术、郁金、桃仁、红花、乳香、没药,将其进行水蒸气蒸馏提取,从中提取挥发油,备用;
(2)取上述药材水蒸气蒸馏提取后的水溶液过滤,得蒸馏后的水溶液,加热浓缩,得蒸馏后的水浓缩液,备用;保留水蒸气蒸馏提取后的药渣,备用;
(3)将步骤(2)所得水蒸气蒸馏提取后的药渣,与其余药材混合,加水提取3次,三次加水量分别相当于药材总重量的12倍、8倍、6倍,每次提取时间分别3小时、2小时、1小时,合并提取液,滤过,滤液浓缩至70℃时相对密度为1.20的清膏,加入乙醇,使含醇量为40%,静置24小时,滤过,滤液加步骤(2)所得蒸馏后的水浓缩液,浓缩成流浸膏,浓缩,减压浓缩干燥,喷入步骤(1)所得挥发油;
(4)添加辅料制备成片剂、胶囊剂、颗粒剂中的一种。
所述一种治疗乳腺增生的中药组合物在制备治疗乳腺增生药物中的应用。
所述一种治疗乳腺增生的中药组合物在制备治疗乳腺增生药物中的应用,乳腺增生为脾肾阳虚,冲任失调型。
仙灵脾又名淫羊藿,《神农本草经》列为中品,具有补肾阳、强筋骨、祛风湿功效,用于肾阳虚衰所致阳痿遗精、筋骨痿软、风湿痹痛、麻木拘挛。
当归为伞形科植物当归Angelica sinensis(Oliv.)Diels的干燥根。主产甘肃东南部,以岷县产量多,质量好,其次为云南、四川、陕西、湖北等省,均为栽培。具有补血活血,调经止痛,润肠通便之功效。常用于血虚萎黄,眩晕心悸,月经不调,经闭痛经,虚寒腹痛,风湿痹痛,跌扑损伤,痈疽疮疡,肠燥便秘。酒当归活血通经。用于经闭痛经,风湿痹痛,跌扑损伤。
鹿角胶温补肝肾,益精养血。用于血虚头晕,腰膝酸冷,虚劳消瘦。
柴胡为伞形科植物柴胡或狭叶柴胡的干燥根。春、秋二季采挖,除去茎叶及泥沙,干燥。柴胡是常用解表药。别名地熏、山菜、菇草、柴草,性味苦、微寒,归肝、胆经。有和解表里,疏肝升阳之功效。用于感冒发热、寒热往来、疟疾、肝郁气滞、胸肋胀痛、脱肛、子宫脱垂、月经不调。
香附为莎草科植物莎草的干燥根茎。秋季采挖,燎去毛须,置沸水中略煮或蒸透后晒干,或燎后直接晒干。性味辛、微苦、微甘,平。归肝、脾、三焦经。疏肝解郁,理气宽中,调经止痛。用于肝郁气滞,胸胁胀痛,疝气疼痛,乳房胀痛,脾胃气滞,脘腹痞闷,胀满疼痛,月经不调,经闭痛经。
青皮为芸香科植物橘Citrus reticulata Blanco及其栽培变种的干燥幼果或未成熟果实的果皮。5~6月收集自落的幼果,晒干,习称“个青皮”;7~8月采收未成熟的果实,在果皮上纵剖成四瓣至基部,除尽瓤瓣,晒干,习称“四花青皮”。性味苦、辛,性温。归肝、胆、胃经。有疏肝破气,消积化滞的功效。用于胸胁胀痛,疝气疼痛,乳癖,乳痈,食积气滞,脘腹胀痛。
陈皮为芸香科植物橘Citrus reticulata Blanco及其栽培变种的干燥成熟果皮。药材分为“陈皮”和“广陈皮”。采摘成熟果实,剥取果皮,晒干或低温干燥。性味苦、辛,性温。归肺、脾经。理气健脾,燥湿化痰。用于脘腹胀满,食少吐泻,咳嗽痰多。
莪术为姜科植物莪术Curcuma aeruginosa Roxb.[C.zedoaria non Rosc.]的根茎。莪术分布于广东、广西、四川、云南等地;广西莪术分布于广西;温郁金主产于浙江瑞安。具有行气破血,消积止痛之功效。常用于血气心痛,饮食积滞,脘腹胀痛,血滞经闭,痛经,癓瘕痞块,跌打损伤。
郁金为姜科植物温郁金Curcuma rcenyujin Y,H.Chenet C.Ling的干燥块根。冬季茎叶枯萎后采挖,除去泥沙和细根,蒸或煮至透心,干燥。性味辛、苦,寒。归肝、心、肺经。活血止痛,行气解郁,清心凉血,利胆退黄。用于胸胁刺痛,胸痹心痛,经闭痛经,乳房胀痛,热病神昏,癫痫发狂,血热吐衄,黄疸尿赤。
桃仁为蔷薇科植物桃Prunus persica(L.)Batsch或山桃Prunus davidiana(Carr.)Franch.的干燥成熟种子。果实成熟后采收,除去果肉和核壳,取出种子,晒干。全国各地普遍栽培。具有活血祛瘀,润肠通便,止咳平喘的功效。用于经闭痛经,症瘕痞块,肺痈肠痈,跌扑损伤,肠燥便秘,咳嗽气喘。
乳香为橄榄科植物乳香树Boswellia carterii Birdw.及同属植物Boswelliabhaurdajiana Birdw.树皮渗出的树脂。分为索马里乳香和埃塞俄比亚乳香,每种乳香又分为乳香珠和原乳香。性味辛、苦,温。归心、肝、脾经。活血行气止痛,消肿生肌。用于胸痹心痛,胃脘疼痛,痛经经闭,产后瘀阻,症瘕腹痛,风湿痹痛,筋脉拘挛,跌打损伤,痈肿疮疡。
没药为橄榄科植物地丁树Commiphora myrrha Engl.或哈地丁树Commiphoramolmol Engl.的干燥树脂。分为天然没药和胶质没药。分布于索马里、埃塞俄比亚及阿拉伯半岛南部等地。具有散瘀定痛,消肿生肌之功效。常用于胸痹心痛,胃脘疼痛,痛经经闭,产后瘀阻,癥瘕腹痛,风湿痹痛,跌打损伤,痈肿疮疡等病症的治疗。
川楝子为楝科植物川楝MeLia toosendanSieb.et Zucc.的干燥成熟果实。冬季果实成熟时采收,除去杂质,干燥。性味苦,寒。归肝、小肠、膀胱经。疏肝泄热,行气止痛,杀虫。用于肝郁化火,胸胁、脘腹胀痛,疝气疼痛,虫积腹痛。
夏枯草为唇形科植物夏枯草的干燥果穗。性味辛、苦,寒。归肝、胆经。清肝泻火,明目,散结消肿。用于目赤肿痛,目珠夜痛,头痛眩晕,瘰疬,瘿瘤,乳痈,乳癖,乳房胀痛。
白芷为多年生高大草本,高1-2.5米,根圆柱形,茎基部径2-5厘米,基生叶一回羽状分裂,复伞形花序顶生或侧生,果实长圆形至卵圆形。主要变种有杭白芷、祁白芷、白芷(原变种)、台湾独活。以根入药,有祛病除湿、排脓生肌、活血止痛等功能。主治风寒感冒、头痛、鼻炎、牙痛。赤白带下、痛疖肿毒等症,亦可作香料。北方的一些省区有栽培,多自产自销,少数调省外。一般生于林下、林缘、溪旁、灌丛和山谷草地。
羌活别名羌青、护羌使者、胡王使者、羌滑、退风使者、黑药,伞形科、羌活属植物,多年生草本,高60-120厘米,根茎粗壮,伸长呈竹节状。根颈部有枯萎叶鞘。茎直立,圆柱形,中空,有纵直细条纹,带紫色。其性温,解表散寒、祛寒湿,用于外感风寒、头痛无汗、寒湿痹、上肢风湿疼痛。生长于海拔2000-4000米的林缘及灌丛内;分布于中国的陕西、四川、甘肃、青海、西藏。
秦艽为龙胆科植物秦艽Gentiana macrophμlla Pall.、麻花秦艽Gentianastraminea Maxim.、粗茎秦艽Gentiana cras-sicaulis Duthie ex Burk.或秦艽Gentianadahurica Fisch.的干燥根。前三种按性状不同分别习称“秦艽”和“麻花艽”,后一种习称“小秦艽”。春、秋二季采挖,除去泥沙;秦艽和麻花艽晒软,堆置“发汗”至表面呈红黄色或灰黄色时,摊开晒干,或不经“发汗”直接晒干;小秦艽趁鲜时搓去黑皮,晒干。性味辛、苦,性平。归胃、肝、胆经。有祛风湿,清湿热,止痹痛,退虚热的作用。用于风湿痹痛,中风半身不遂,筋脉拘挛,骨节酸痛,湿热黄疸,骨蒸潮热,小儿疳积发热。
丝瓜络为葫芦科植物丝瓜Luffa cylindrica(L.)Roem.的干燥成熟果实的维管束。夏、秋二季果实成熟、果皮变黄、内部干枯时采摘,除去外皮及果肉,洗净,晒干,除去种子。性味味甘,性平。归胃,肺,肝经。有祛风,通络,活血,下乳的功效。用于治疗痹痛拘挛、胸胁胀痛、乳汁不通,乳痈肿痛。
厚朴为木兰科植物厚朴Magnolia officinalis Rehd.et Wils.或凹叶厚朴Magnolia offinalis Rehd.et Wils.var.biloba Rehd.et Wils.的干燥干皮、根皮及枝皮。4~6月剥取,根皮和枝皮直接阴干;干皮置沸水中微煮后,堆置阴湿处,“发汗”至内表面变紫褐色或棕褐色时,蒸软,取出,卷成筒状,干燥。性味苦、辛,性温。归脾、胃、肺、大肠经。燥湿消痰,下气除满。用于湿滞伤中,脘痞吐泻,食积气滞,腹胀便秘,痰饮喘咳。
枳壳为芸香科植物酸橙Citrus aurantium L.及其栽培变种的干燥未成熟果实。7月果皮尚绿时采收,自中部横切为两半,晒干或低温干燥。具有理气宽中,行滞消胀之功效。常用于胸胁气滞,胀满疼痛,食积不化,痰饮内停,脏器下垂。
木瓜为蔷薇科植物贴梗海棠Chaenomeles speciosa(Sweet)Nakai的干燥近成熟果实。夏、秋二季果实绿黄时采收,置沸水中烫至外皮灰白色,对半纵剖,晒干。归肝、脾经。有舒筋活络,和胃化湿的功效。用于治疗湿痹拘挛,腰膝关节酸重疼痛,暑湿吐泻,转筋挛痛,脚气水肿。
白芍为毛茛科植物芍药Paeonia lactiflora Pall.[1]的干燥根。夏、秋二季采挖,洗净,除去头尾和细根,置沸水中煮后除去外皮或去皮后再煮,晒干。具有养血调经,敛阴止汗,柔肝止痛,平抑肝阳之功效。常用于血虚萎黄,月经不调,自汗,盗汗,胁痛,腹痛,四肢挛痛,头痛眩晕。
红花为菊科植物红花Carthamus tinctorius L.的干燥花。夏季花由黄变红时采摘,阴干或晒干。全国各地广有栽培。具有活血通经,散瘀止痛之功效。用于经闭,痛经,恶露不行,症瘕痞块,胸痹心痛,瘀滞腹痛,胸胁刺痛,跌扑损伤,疮疡肿痛。
有益效果:脾肾阳虚,冲任失调型乳腺增生多见于乳腺增生中、晚期,常常表现为一侧或两侧乳腺出现肿块和疼痛,常伴有月经不调,前后不定期,经量减少,全身症状可见怕冷,腰膝酸软,神疲乏力,耳鸣。舌质淡胖,苔薄白,脉濡细。本发明通过六个方面进行治疗,其一由于病程长久,脾肾亏损,为了直达药效,宜温补脾肾;其二由于患者常常烦躁易怒爱发脾气,采用疏肝理气;其三由于脾失健运,痰浊内生,肝郁痰凝,气血瘀滞,采用活血化瘀,其四由于乳房胀痛或刺痛,乳房肿块随喜怒消长,故舒经止痛;其五由于冲任失调,上则乳房痰浊凝结而发病,下则经水逆乱而月经失调,故采用化痰解郁;其六由于肝气郁结,气机阻滞,故疏通乳络。本发明以仙灵脾、当归、白芍、鹿角胶温补脾肾;柴胡、香附、青皮、陈皮疏肝理气,共为君药,莪术、郁金、桃仁、红花活血化瘀,乳香、没药、川楝子舒经止痛共为臣药,夏枯草、白芷、羌活、秦艽化痰解郁,丝瓜络、木瓜、厚朴、枳壳疏通乳络共为佐使药,全方治疗脾肾阳虚,冲任失调型乳腺增生效果良好。
具体实施方式
以下通过实施例形式,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。
实施例1:取仙灵脾18g、当归26g、白芍10g、鹿角胶12g、柴胡15g、香附14g、青皮8g、陈皮16g、莪术10g、郁金12g、桃仁6g、红花10g、乳香10g、没药12g、川楝子10g、夏枯草25g、白芷10g、羌活16g、秦艽10g、丝瓜络30g、木瓜8g、厚朴16g、枳壳8g,制备方法为:
(1)取香附、青皮、陈皮、莪术、郁金、桃仁、红花、乳香、没药,将其进行水蒸气蒸馏提取,从中提取挥发油,备用;
(2)取上述药材水蒸气蒸馏提取后的水溶液过滤,得蒸馏后的水溶液,加热浓缩,得蒸馏后的水浓缩液,备用;保留水蒸气蒸馏提取后的药渣,备用;
(3)将步骤(2)所得水蒸气蒸馏提取后的药渣,与其余药材混合,加水提取3次,三次加水量分别相当于药材总重量的12倍、8倍、6倍,每次提取时间分别3小时、2小时、1小时,合并提取液,滤过,滤液浓缩至70℃时相对密度为1.20的清膏,加入乙醇,使含醇量为40%,静置24小时,滤过,滤液加步骤(2)所得蒸馏后的水浓缩液,浓缩成流浸膏,加入步骤(1)所得挥发油,纯化水至总重量为药材总重量的3倍,灌装,即得本发明合剂。
实施例2:取仙灵脾22g、当归20g、白芍14g、鹿角胶8g、柴胡25g、香附10g、青皮12g、陈皮10g、莪术14g、郁金8g、桃仁10g、红花6g、乳香14g、没药8g、川楝子16g、夏枯草15g、白芷20g、羌活10g、秦艽16g、丝瓜络20g、木瓜10g、厚朴10g、枳壳12g;制备方法为:
(1)取香附、青皮、陈皮、莪术、郁金、桃仁、红花、乳香、没药,将其进行水蒸气蒸馏提取,从中提取挥发油,备用;
(2)取上述药材水蒸气蒸馏提取后的水溶液过滤,得蒸馏后的水溶液,加热浓缩,得蒸馏后的水浓缩液,备用;保留水蒸气蒸馏提取后的药渣,备用;
(3)将步骤(2)所得水蒸气蒸馏提取后的药渣,与其余药材混合,加水提取3次,三次加水量分别相当于药材总重量的12倍、8倍、6倍,每次提取时间分别3小时、2小时、1小时,合并提取液,滤过,滤液浓缩至70℃时相对密度为1.20的清膏,加入乙醇,使含醇量为40%,静置24小时,滤过,滤液加步骤(2)所得蒸馏后的水浓缩液,浓缩成流浸膏,浓缩,减压浓缩干燥,喷入步骤(1)所得挥发油;
(4)添加淀粉制备成片剂。
实施例3:取仙灵脾20g、当归23g、白芍12g、鹿角胶10g、柴胡20g、香附12g、青皮10g、陈皮13g、莪术12g、郁金10g、桃仁8g、红花8g、乳香12g、没药10g、川楝子13g、夏枯草20g、白芷15g、羌活13g、秦艽13g、丝瓜络25g、木瓜9g、厚朴13g、枳壳10g;制备方法为:
(1)取香附、青皮、陈皮、莪术、郁金、桃仁、红花、乳香、没药,将其进行水蒸气蒸馏提取,从中提取挥发油,备用;
(2)取上述药材水蒸气蒸馏提取后的水溶液过滤,得蒸馏后的水溶液,加热浓缩,得蒸馏后的水浓缩液,备用;保留水蒸气蒸馏提取后的药渣,备用;
(3)将步骤(2)所得水蒸气蒸馏提取后的药渣,与其余药材混合,加水提取3次,三次加水量分别相当于药材总重量的12倍、8倍、6倍,每次提取时间分别3小时、2小时、1小时,合并提取液,滤过,滤液浓缩至70℃时相对密度为1.20的清膏,加入乙醇,使含醇量为40%,静置24小时,滤过,滤液加步骤(2)所得蒸馏后的水浓缩液,浓缩成流浸膏,浓缩,减压浓缩干燥,喷入步骤(1)所得挥发油;
(4)添加糊精制备成颗粒剂。
实施例4:取仙灵脾20g、当归23g、白芍12g、鹿角胶10g、柴胡20g、香附12g、青皮10g、陈皮13g、莪术12g、郁金10g、桃仁8g、红花8g、乳香12g、没药10g、川楝子13g、夏枯草20g、白芷15g、羌活13g、秦艽13g、丝瓜络25g、木瓜9g、厚朴13g、枳壳10g;制备方法为:
(1)取香附、青皮、陈皮、莪术、郁金、桃仁、红花、乳香、没药,将其进行水蒸气蒸馏提取,从中提取挥发油,备用;
(2)取上述药材水蒸气蒸馏提取后的水溶液过滤,得蒸馏后的水溶液,加热浓缩,得蒸馏后的水浓缩液,备用;保留水蒸气蒸馏提取后的药渣,备用;
(3)将步骤(2)所得水蒸气蒸馏提取后的药渣,与其余药材混合,加水提取3次,三次加水量分别相当于药材总重量的12倍、8倍、6倍,每次提取时间分别3小时、2小时、1小时,合并提取液,滤过,滤液浓缩至70℃时相对密度为1.20的清膏,加入乙醇,使含醇量为40%,静置24小时,滤过,滤液加步骤(2)所得蒸馏后的水浓缩液,浓缩成流浸膏,浓缩,减压浓缩干燥,喷入步骤(1)所得挥发油;
(4)添加糊精制备成胶囊剂。
实施例5:临床试验
1一般资料:选取医院确诊的2018年1月-2020年12月收治的100例乳腺增生患者,年龄25~52岁,病程5个月至5年,单侧乳腺增生10例,双侧乳腺增生90例。
2纳入标准:参照国家中医药管理局《中医病证诊断疗效标准》为诊断依据。(1)乳房有扁平肿块,与周围组织无黏连,边界欠清;(2)乳房胀痛、刺痛,与心情不佳、月经周期有关;(3)B超、红外线乳透均显示乳腺增生征象,钼钯X线正常。(4)均签定知情同意书。(5)符合中医辨证:一侧或两侧乳腺出现肿块和疼痛,常伴有月经不调,前后不定期,经量减少,全身症状可见怕冷,腰膝酸软,神疲乏力,耳鸣。舌质淡胖,苔薄白,脉濡细。
3排除标准:①排除乳腺癌、乳腺纤维瘤等疾病;②排除3个月内接受激素治疗;③排除合并心脑血管,肝、肾,造血系统等原发性疾病。
4试验方法
临床分组:将100例患者随机分为消乳散结胶囊对照组、本发明中药治疗组,每组50例,2组在病程、病情、年龄等方面差异无统计学意义性。
5治疗方案
本发明中药治疗组:服用本发明实施例1中药,每日早晚各一次,每次200-300ml,每个疗程6日,治疗5个疗程,再巩固治疗3个月,统计疗效。消乳散结胶囊对照组:消乳散结胶囊(国药准字Z20055636),山东步长神州制药有限公司,10粒/次,3次/日,口服,治疗4个月,统计疗效。
6疗效评价标准:按照全国中医外科学会的乳腺增生疗效标准进行评价。①痊愈:临床症状及肿块完全消失,乳透、B超显示正常;②显效:治疗后临床症状及肿块基本消失,停药后半年无复发;或肿块最大直径缩小1/2以上,临床症状明显改善,乳透、B超基本正常;③有效:肿块直径缩小不足1/2,疼痛减轻,乳透及B超稍有改变;④无效:疼痛等临床症状无好转,甚至加重,肿块无缩小或反而增大变硬,或单纯乳痛缓解而肿块不缩小者。将痊愈、显效及有效之和作为总有效。见表1。
表1临床疗效评价比较
组别 | 痊愈 | 显效 | 有效 | 无效 | 有效率(%) |
对照组 | 12 | 20 | 6 | 12 | 76 |
治疗组 | 18 | 16 | 12 | 4 | <![CDATA[92<sup>**</sup>]]> |
与对照组比较*p<0.05**p<0.01
结论:本发明治疗乳腺增生具有良好的温补脾肾、疏肝理气、活血化瘀、舒经止痛、化痰解郁、疏通乳络之功效。临床上用于脾肾阳虚,冲任失调乳腺增生疗效确切,且不良反应少。
当然,本发明创造并不局限于上述实施方式,熟悉本领域的技术人员在不违背本发明精神的前提下还可作出等同变形或替换,这些等同的变型或替换均包含在本申请权利要求所限定的范围内。
Claims (8)
1.一种治疗乳腺增生的中药组合物,其特征在于:由下列重量份的中药原料制备而成:仙灵脾18-22份、当归20-26份、白芍10-14份、鹿角胶8-12份、柴胡15-25份、香附10-14份、青皮8-12份、陈皮10-16份、莪术10-14份、郁金8-12份、桃仁6-10份、红花6-10份、乳香10-14份、没药8-12份、川楝子10-16份、夏枯草15-25份、白芷10-20份、羌活10-16份、秦艽10-16份、丝瓜络20-30份、木瓜8-10份、厚朴10-16份、枳壳8-12份。
2.如权利要求1所述一种治疗乳腺增生的中药组合物,其特征在于:由下列重量份的中药原料制备而成:仙灵脾18份、当归26份、白芍10份、鹿角胶12份、柴胡15份、香附14份、青皮8份、陈皮16份、莪术10份、郁金12份、桃仁6份、红花10份、乳香10份、没药12份、川楝子10份、夏枯草25份、白芷10份、羌活16份、秦艽10份、丝瓜络30份、木瓜8份、厚朴16份、枳壳8份。
3.如权利要求1所述一种治疗乳腺增生的中药组合物,其特征在于:由下列重量份的中药原料制备而成:仙灵脾22份、当归20份、白芍14份、鹿角胶8份、柴胡25份、香附10份、青皮12份、陈皮10份、莪术14份、郁金8份、桃仁10份、红花6份、乳香14份、没药8份、川楝子16份、夏枯草15份、白芷20份、羌活10份、秦艽16份、丝瓜络20份、木瓜10份、厚朴10份、枳壳12份。
4.如权利要求1所述一种治疗乳腺增生的中药组合物,其特征在于:由下列重量份的中药原料制备而成:仙灵脾20份、当归23份、白芍12份、鹿角胶10份、柴胡20份、香附12份、青皮10份、陈皮13份、莪术12份、郁金10份、桃仁8份、红花8份、乳香12份、没药10份、川楝子13份、夏枯草20份、白芷15份、羌活13份、秦艽13份、丝瓜络25份、木瓜9份、厚朴13份、枳壳10份。
5.如权利要求1-4中任一所述治疗乳腺增生的中药组合物,其特征在于:制备方法为:
(1)取香附、青皮、陈皮、莪术、郁金、桃仁、红花、乳香、没药,将其进行水蒸气蒸馏提取,从中提取挥发油,备用;
(2)取上述药材水蒸气蒸馏提取后的水溶液过滤,得蒸馏后的水溶液,加热浓缩,得蒸馏后的水浓缩液,备用;保留水蒸气蒸馏提取后的药渣,备用;
(3)将步骤(2)所得水蒸气蒸馏提取后的药渣,与其余药材混合,加水提取3次,三次加水量分别相当于药材总重量的12倍、8倍、6倍,每次提取时间分别3小时、2小时、1小时,合并提取液,滤过,滤液浓缩至70℃时相对密度为1.20的清膏,加入乙醇,使含醇量为40%,静置24小时,滤过,滤液加步骤(2)所得蒸馏后的水浓缩液,浓缩成流浸膏,加入步骤(1)所得挥发油,加纯化水至总重量为药材总重量的3倍,灌装,即得本发明合剂。
6.如权利要求1-4中任一所述治疗乳腺增生的中药组合物,其特征在于:制备方法为:
(1)取香附、青皮、陈皮、莪术、郁金、桃仁、红花、乳香、没药,将其进行水蒸气蒸馏提取,从中提取挥发油,备用;
(2)取上述药材水蒸气蒸馏提取后的水溶液过滤,得蒸馏后的水溶液,加热浓缩,得蒸馏后的水浓缩液,备用;保留水蒸气蒸馏提取后的药渣,备用;
(3)将步骤(2)所得水蒸气蒸馏提取后的药渣,与其余药材混合,加水提取3次,三次加水量分别相当于药材总重量的12倍、8倍、6倍,每次提取时间分别3小时、2小时、1小时,合并提取液,滤过,滤液浓缩至70℃时相对密度为1.20的清膏,加入乙醇,使含醇量为40%,静置24小时,滤过,滤液加步骤(2)所得蒸馏后的水浓缩液,浓缩成流浸膏,浓缩,减压浓缩干燥,喷入步骤(1)所得挥发油;
(4)添加辅料制备成片剂、胶囊剂、颗粒剂中的一种。
7.如权利要求1所述一种治疗乳腺增生的中药组合物在制备治疗乳腺增生药物中的应用。
8.如权利要求1所述一种治疗乳腺增生的中药组合物在制备治疗乳腺增生药物中的应用,乳腺增生为脾肾阳虚,冲任失调型。
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