CN109200162A - 一种治疗多囊卵巢综合征的中药制剂及制备方法 - Google Patents
一种治疗多囊卵巢综合征的中药制剂及制备方法 Download PDFInfo
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Abstract
本发明公开了一种治疗多囊卵巢综合征的中药组合物及其制备方法,由丹参、当归、赤芍、益母草、牛膝、苍术、茯苓、续断、熟地、柏子仁、香附、石菖蒲、泽兰和焦山楂14种中药材为原料制备而成,本发明所述中药组合物中各味中药相互影响,协同作用,在补肾祛瘀基础上,佐加化痰通络之品,从而助卵泡发育,促卵泡排出,同时可改善PCOS患者的卵巢局部异常的内分泌状态,降低雌激素水平,促进排卵,改善生殖机能,治疗PCOS疗效显著,且安全性高。本发明所述中药组合物的制备方法操作简便,生产成本低,效率高。
Description
技术领域
本发明公开一种治疗多囊卵巢综合征的中药制剂,全部选用天然中草药制成,同时还提供了该中药制剂的制备方法,具有明显的临床疗效,属于中医制药技术领域。
背景技术
多囊卵巢综合征是一种多起因、多态性的女性内分泌疾病,以雄激素过多和持续无排卵为特征,严重影响患者的身心健康和生殖健康,是妇科常见的疑难病症,目前的病因尚不清楚,近年来对 PCOS 的研究不断深入,治疗不断改良,但其病因复杂, 临床表现多样, 总体疗效不尽人意。目前西医多采用激素治疗以改善症状、促排卵及纠正代谢障碍或微创手术, 虽可在短期内显效, 但复发率极高,诊费昂贵,且易产生药物依赖及一系列不良反应(如肥胖、卵泡过度刺激综合征等),使其在临床上受到一定的限制。中医药治疗本病疗效显著,具有多靶点多环节作用的特点和优势,并且副作用小,因此,研究与开发服用疗效显著、安全性强的中药制剂对治疗多囊卵巢综合征具有重要意义。
发明内容
本发明提供了一种治疗多囊卵巢综合征的中药制剂及制备方法,具有临床症状缓解迅速,标本兼治的特点。
本发明的技术解决方案是基于我国中医学对多囊卵巢综合征的总体认识和现代医学对本症发病机理及治疗原则,在补肾祛瘀基础上,佐加化痰通络之品,而达到治疗多囊卵巢综合征之目的,为了达到这个目地提供的治疗多囊卵巢综合征的中药制剂,由以下药物按重量份数比制成的:
丹参15~25份、当归10~20份、赤芍10~20份、益母草15~25份、牛膝10~20份、苍术15~25份、茯苓10~20份、续断10~20份、熟地10~20份、柏子仁15~25份、香附5~15份、石菖蒲5~15份、泽兰10~20份、焦山楂10~20份。
本发明公开的治疗多囊卵巢综合征的中药制剂,其优选配比为:
丹参20份、当归15份、赤芍15份、益母草20份、牛膝15份、苍术20份、茯苓15份、续断15份、熟地15份、柏子仁20份、香附10份、石菖蒲10份、泽兰15份、焦山楂15份。
本发明所述的一种治疗多囊卵巢综合征的中药组合物的制备方法,按比例称取上述原料加4~6倍重量份数的水煎煮,煎液过滤,滤液浓缩即得。
优选的,所述加水煎煮为加水煎煮2~3次,每次0.5~1.0小时,合并煎液。
本发明还提供了所述制备方法制备的中药组合物。
本发明还提供了一种治疗多囊卵巢综合征的中药制剂,由所述治疗多囊卵巢综合征的中药组合物及药学上可接受的辅料制成。
优选的,其为口服制剂。
优选的,所述口服制剂片剂、丸剂、颗粒剂或口服液。
【用法用量】:每日两次口服;5-10g/次。
【适应症】:用于肾虚痰瘀所引起的月经后期或稀发、闭经,量少色紫黯有块,经行小腹胀痛或刺痛拒按,不孕。
方解:本发明颗粒由柏子仁丸化裁而来,方中柏子仁,性平,味甘。归心、肾、大肠经。具有养心安神、润燥通便的功效。功用补心气养心血,交通心肾而安神,用于阴血不足、心神失养而出现心慌不安、经济失眠、夜间盗汗等。本方主要用于补益心肾,益精血之源。现代药理研究发现柏子仁脂肪油、挥发油以及柏子仁甙均有改善动物睡眠的作用;熟地,性微温,味甘、微苦。归肝、肾经。具用补血生津、滋肾养肝的功效。用于血虚萎黄,眩晕,心悸失眠,月经不调,崩漏,及肾阴不足的潮热骨蒸、盗汗、遗精、消渴,及肝肾精血亏虚的腰膝酸软,眩晕耳鸣,须发早白等。现代药理研究发现地黄寡糖通过多种途径激活机体组织,特别是造血微环境中的某些细胞,促进其分泌造血生长因子,增加DNA的合成来增强机体的造血功能;当归,性温,味辛甘、微苦。归肝、心、脾经。具有补血活血、养血调经、润肠通便的功效。用于血虚或血虚而兼有瘀滞的月经不调,痛经,经闭。现代药理研究发现当归中的多糖能刺激血红蛋白及红细胞的生成,并且能够刺激造血干细胞的生成,促进红细胞的分化,从而促进造血功能。柏子仁与熟地两药相伍补心脾而生血、滋肝肾而养阴,共益经血之源。当归补心肝血虚,熟地补血益精填髓,相配则补血填精之力犹强;续断,性微温,味苦、辛。归肝、肾经。具有补肝肾、续筋骨、通血脉、利关节、安胎的功效。用于肝肾不足,腰痛脚弱,风湿痹痛,及跌打损伤,骨折,肿痛,肝肾虚弱,冲任失调的胎动欲坠或崩漏经多等。现代药理研究发现续断总生物碱能显著制妊娠大鼠在体子宫平滑肌的自发收缩活动,降低其收缩幅度和张力;牛膝,性平,味苦、酸。归肝、肾经,具有补肝肾、强筋骨、散瘀血、引药下行的功效。用于血瘀之痛经、经闭、产后腹痛、胞衣不下及跌打损伤肝肾不足,腰膝酸软无力等证。本品能引药下行者,临床欲用药于下行者,常用本品为引经药,在此主补益肝肾,引血下行。牛膝与续断相配伍补肝肾、行血脉、引血下行;泽兰,性微温,味苦、辛。归肝、脾经。具有活血化瘀、通经、行血、利水的功效。用于血滞痛经,血滞经闭及产后瘀滞腹痛、恶露不尽等。现代药理研究发现泽兰对血液流变学的影响涉及改善血液流变性、抑制血小板聚集、抗血栓形成、作用于凝血和纤溶系统、改善微循环、降低血脂。对提取部分研究已确定了其活血化瘀作用的有效部位,泽兰可以从多途径、多环节起到改善血液流变学的作用。赤芍,性微寒,味苦。归肝经。清热凉血,散瘀止痛。用于热入营血,温毒发斑,吐血衄血,目赤肿痛,肝郁胁痛,经闭痛经,瘕瘕腹痛,跌扑损伤,痈肿疮疡。丹参,性微温,味苦,归心、肝经。活血祛瘀,通经止痛,清心除烦,凉血消痈。用于胸痹心痛,脘腹胁痛,瘕瘕积聚,热痹疼痛,心烦不眠,月经不调,痛经经闭,疮疡肿痛。现代药理研究发现丹参具有良好的血液循环系统改善作用,可以对血流动力学效应产生改善,还可以发挥有效的抗血栓作用,能有效地延长凝血时间。焦山楂,性微温,味酸、甘,归脾、胃、肝经。长于活血化瘀,常用于血瘀经闭,产后瘀阻,心腹刺痛,疝气疼痛。泽兰活血破瘀,行气通经;当归养血活血,两药合用,理气活血,行血祛瘀。泽兰、丹参、赤芍、焦山楂相配伍增强其活血化瘀通经、破癥散结;益母草,性微寒,味辛、苦,归心、肝、膀胱经。活血调经,利尿消肿,清热解毒。用于月经不调,痛经经闭,恶露不尽,水肿尿少,疮疡肿毒。现代药理研究发现益母草有促进微动脉血流恢复的作用,使闭锁的毛细血管重新开放,改善微循环功能状态,抗血小板聚集。香附,性平,味微苦、味甘,归肝经。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。现代药理研究发现香附对子宫有抑制作用,使其收缩力减弱、肌张力降低。行气药香附能增强益母草活血祛瘀的作用,同时有研究表明当归和香附配伍对离体子宫有明显的抑制其收缩的作用。苍术,性温,味辛、苦,归脾、胃经。燥湿健脾,祛风敖寒,明目。用于湿阻中焦,脘腹胀满,泄泻,水肿,风湿痹痛,风寒感冒,夜盲,眼目昏涩。现代药理研究发现苍术有明显促进胃肠运动的作用。石菖蒲,性温,味辛,归心、肝、脾经,开窍豁痰,醒神益智,化湿开胃。用于神昏癫痫,健忘失眠,耳鸣耳聋,脘痞不饥。茯苓,性温,味甘,平,归心、脾、肺经。利水渗湿,健脾,宁心。用于水肿尿少,痰饮眩悸,脾虚食少,便溏泄泻,心神不安,惊悸失眠。苍术与石菖蒲、茯苓等利水渗湿药配伍,以增强治湿之效,健脾除湿化痰;综观全方,诸药合用,不寒不温,不燥不腻,通补兼施,全方共奏补心肾而养血益精,行血脉而疏通胞脉之功。以调节生殖功能,促使冲任血海蓄溢协调。同时,肾的开合有度,水液代谢正常,气机通畅则瘀去经通,则肾-天癸-胞宫功能轴的阴阳平衡。现代药理研究发现补肾中药对卵巢功能及子宫内膜具有类激素样作用,可调整下丘脑-垂体-卵巢轴功能、促卵泡生长和排卵、调控相关细胞因子及其受体水平、整体调节性激素及其受体水平、改善子宫内膜促受孕等。由此可见本发明颗粒治疗肾虚血瘀型多囊卵巢综合征有充分的现代药理基础。
下面结合临床进一步说明本发明的积极效果:
疗效证明:
23日龄雌性SD大鼠60只,随机取出10只作为正常对照组,其余50只采用脱氢表雄酮(DHEA)法诱导PCOS模型。将PCOS大鼠随机分为中药高剂量组、中药低剂量组、二甲双胍组(阳性对照)、达英35组和模型组,每组10只。中药组每日给予 2ml 本发明方灌胃,二甲双胍和达英35组每日分别给予 2ml二甲双胍或达英35溶液(100mg/kg)(体重大约170g左右)灌胃,模型组和正常组均每日给予 2ml 1%羧甲基纤维素钠溶液灌胃,连续灌胃共28天。研究各治疗组及正常对照组大鼠体重、卵巢指数、子宫指数、血清激素及大鼠卵巢组织形态学等方面的差异。
实验结果:
1.本发明方对PCOS大鼠体重、卵巢和子宫指数的影响
与正常组比较,模型组大鼠体重大鼠体重、卵巢和子宫重量均显著增加(P<0.05)。与模型组比较,阳性药二甲双胍、达英35组和治疗药本发明方对大鼠体重、卵巢和子宫均具有显著改善功能,达英35组和本发明方本发明方高剂量组治疗效果更优(P<0.05)。
表1.本发明方对大鼠体重、卵巢和子宫指数的影响(n=10,±s)
组别 | 体重(g) | 卵巢(g) | 子宫(g) |
空白对照组 | 170.07±15.47 | 0.75±0.05 | 0.68±0.05 |
模型组 | 192.99±17.91** | 0.97±0.07** | 0.97±0.07** |
二甲双胍组 | 171.64±13.37## | 0.79±0.07## | 0.75±0.07# |
达英35组 | 173.94±14.37## | 0.79±0.07## | 0.61±0.07## |
本发明方(高) | 177.77±13.07## | 0.75±0.06## | 0.71±0.06# |
本发明方(低) | 181.91±19.41# | 0.77±0.06## | 0.80±0.07## |
注:与对照组比较**P<0.01;与模型组比较##P<0.01,#P<0.05
2.本发明方对PCOS大鼠卵巢组织形态学的影响
卵巢组织切片HE染色可见正常对照组卵巢镜下有多个黄体和处于不同发育阶段的卵泡,近成熟期卵泡可见卵细胞及放射冠,卵泡膜细胞层数较少。PCOS模型组大鼠黄体数量较正常对照组明显减少,卵巢可见多个初级卵泡及少量次级卵泡,近成熟期的卵泡内未见卵细胞,颗粒细胞排列疏松,层数减少,部分脱落,未见放射冠,卵泡膜细胞层较厚。与模型组比较,药物干预的四组大鼠卵巢病理得到明显改善,其卵巢内均可见黄体和多个发育不同阶段的卵泡,接近成熟期的卵泡可见卵细胞及放射冠,颗粒细胞排列较紧密,层数增多,卵泡膜细胞层较薄。
3.本发明方对PCOS大鼠血清激素包括:黄体生成激素(Luteinizing hormone,LH)、卵泡刺激素(FSH)、睾酮(Testosterone,T)、雌二醇(E2)、泌乳素(PRL)、孕酮(PRG)的影响:
表2.本发明方对PCOS大鼠血清激素的影响 (n=10,±s)
LH (pg/ml) | FSH (ng/ml) | T (pg/ml) | |
空白对照组 | 2371.86±121.05 | 25.89±1.99 | 1113.68±109.77 |
模型组 | 4306.97±219.87** | 31.60±3.07* | 1979.36±105.41** |
二甲双胍组 | 2471.47±171.65## | 28.47±2.87 | 1161.94±111.37## |
达英35组 | 2736.51±197.05## | 24.16±2.94## | 1108.24±98.21## |
本发明方(高) | 2356.75±129.01## | 26.86±2.17## | 1311.38±101.45## |
本发明方(低) | 2499.61±123.37## | 25.46±2.31## | 1451.23±118.46## |
表3.本发明方对PCOS大鼠血清激素的影响 (n=10,±s)
PRL(ng/ml) | E2 (pg/ml) | PRG (mIU/ml) | |
空白对照组 | 2.11±0.27 | 11.41±1.37 | 47.33±3.54 |
模型组 | 4.37±0.31** | 5.11±0.41** | 19.73±10.37** |
二甲双胍组 | 2.49±0.15## | 8.41±0.71# | 41.33±3.21## |
达英35组 | 2.97±0.25## | 10.44±0.84## | 48.21±3.77## |
本发明方(高) | 2.49±0.21## | 6.86±0.87 | 33.71±3.13## |
本发明方(低) | 2.71±0.37## | 4.46±0.77 | 30.46±24.16## |
一、诊断标准:
参照《中药新药临床研究指导原则》中治疗月经不调、闭经、不孕的疗效评定标准制定
二、用药方法:
每日两次;5-10g/次。
疗效判定标准:
治愈:月经恢复正常周期,停药后月经规则连续3个周期以上,或受孕者。各种症状明显减轻,血中激素值基本正常,B超示卵巢恢复正常大小。
有效:月经周期恢复正常,但停药后不到3个周期病情复发者。各种症状有所减轻,血中激素值趋于正常,B超显示卵巢比治疗前缩小。
无效:月经紊乱无改善,各种症状无减轻,血中激素值无明显变化,卵巢大小无变化。
本发明用于临床治疗本发明经临床疗效观察,在72例多囊卵巢综合征的患者中,治疗组服用本发明所述中药制剂3个月经周期即有明显的效果,1个疗程后,治愈8例,有效24例,无效4例,总有效率占88.89%;对照组:治愈5例,有效24例,无效7例,总有效率占80.56%。
本发明的积极效果在于:
所述中药组合物中各味中药相互影响协同作用,在补肾祛瘀基础上,佐加化痰通络之品,从而助卵泡发育,促卵泡排出,同时可改善PCOS患者的卵巢局部异常的内分泌状态,降低雌激素水平,促进排卵,改善生殖机能,治疗PCOS疗效显著,且安全性高;所述中药组合物的制备方法操作简便,生产成本低,效率高。
具体实施方式
通过以下实施例进一步举例描述本发明,并不以任何方式限制本发明,在不背离本发明的技术解决方案的前提下,对本发明所作的本领域普通技术人员容易实现的任何改动或改变都将落入本发明的权利要求范围之内。
实施例1
取丹参20g、当归15g、赤芍15g、益母草20g、牛膝15g、苍术20g、茯苓15g、续断15g、熟地15g、柏子仁20g、香附10g、石菖蒲10g、泽兰15g、焦山楂15g,加原料总重量4倍的水煎煮为加水煎煮2次,每次0.5~1.0小时,合并煎液,煎液过滤,滤液浓缩即得。
实施例2
称取丹参15g、当归10g、赤芍10g、益母草15g、牛膝10g、苍术15g、茯苓10g、续断10g、熟地10g、柏子仁15g、香附5g、石菖蒲5g、泽兰10g、焦山楂10g,加原料总重量5倍的水煎煮3次,每次0.5~1.0小时,合并煎液,煎液过滤,滤液浓缩即得。
实施例3
称取丹参25g、当归20g、赤芍20g、益母草25g、牛膝20g、苍术25g、茯苓20g、续断20g、熟地20g、柏子仁25g、香附15g、石菖蒲15g、泽兰20g、焦山楂20g,加原料总重量6倍的水煎煮3次,每次0.5~1.0小时,合并煎液,煎液过滤,滤液浓缩即得。
通过以下典型病例进一步表明本发明药物的治疗效果:
病例1
曾某,36岁,女,因“停经6个月”而就诊。病史:既往月经不规则,周期45-60天,经期4-6天,量中到少,色暗红,有血块,无痛经。B超:子宫内膜:5.1mm,双侧卵巢内可见卵泡数大于12个,提示双侧卵巢多囊样改变。查示六项激素示:E2113pmol/L、T1.96nmol/L、P2.50nmol/L、PRL165.19uIU/mL、LH6.45mIU/mL、FSH1.82mIU/mL、LH/FSH3.54,诊断为多囊卵巢综合征;使用本发明药物(实施例3)口服1个月月经来潮,3个月月经周期正常,症状明显好转,1年后随访,未复发。
病例 2
张某,25岁,女,因“月经后期1年”而就诊。病史:既往月经规则,周期40-60天,经期4-6天,量中,色暗红,有血块,无痛经。B超:子宫内膜:4.5mm,双侧卵巢内可见卵泡数大于12个,提示双侧卵巢多囊样改变。查示六项激素示:E2166pmol/L、T2.01nmol/L、P2.10nmol/L 、PRL258.01uIU/mL LH6.62mIU/mL、FSH3.29mIU/mL 、LH/FSH2.01,诊断为多囊卵巢综合征;使用本发明药物(实施例1)口服1个月月经来潮,3个月月经周期正常,症状明显好转,1年后随访,未复发。
病例3
冯某,30岁,女,因“月经失调10余年,结婚4年不孕”而就诊。病史:既往月经不规则,周期45-100天,经期4-6天,量一般,色红,有血块,无痛经。B超:子宫内膜:5.4mm,双侧卵巢内可见卵泡数大于12个,提示双侧卵巢多囊样改变。查示六项激素示:E2124pmol/L、T2.15nmol/L 、P0.29nmol/L、PRL285.17uIU/mL 、LH21.18mIU/mL、FSH6.24mIU/mL LH/FSH3.39,诊断为多囊卵巢综合征;使用本发明药物(实施例2)口服1月月经来潮,3个月月经周期正常,症状明显好转,1年后随访,未复发。
病例4
李某,28岁,女,因“月经后期2年”而就诊。病史:既往月经规则,周期45-60天,经期5-6天,量少,色暗红,有血块,无痛经。B超:子宫内膜:6.8mm,双侧卵巢内可见卵泡数大于12个,提示双侧卵巢多囊样改变。查示六项激素示:E2236pmol/L、T2.95nmol/L、P2.22nmol/L 、PRL195.21uIU/mL、LH9.91mIU/mL、FSH3.71mIU/mL LH/FSH2.67,诊断为多囊卵巢综合征;使用本发明药物(实施例3)口服1个月月经来潮,3个月月经周期正常,症状明显好转,1年后随访,未复发。
Claims (4)
1.一种治疗多囊卵巢综合征的中药制剂,其特征在于是由以下重量份数比的原料制成的:
丹参15~25份、当归10~20份、赤芍10~20份、益母草15~25份、牛膝10~20份、苍术15~25份、茯苓10~20份、续断10~20份、熟地10~20份、柏子仁15~25份、香附5~15份、石菖蒲5~15份、泽兰10~20份、焦山楂10~20份。
2.权利要求1所述一种治疗多囊卵巢综合征的中药制剂,其特征在于,优选配比为:
丹参20份、当归15份、赤芍15份、益母草20份、牛膝15份、苍术20份、茯苓15份、续断15份、熟地15份、柏子仁20份、香附10份、石菖蒲10份、泽兰15份、焦山楂15份。
3.如权利要求1或2所述的一种治疗多囊卵巢综合征的中药制剂的制备方法,其特征在于:
按比例称取上述原料加4~6倍重量份数的水煎煮,煎液过滤,滤液浓缩即得。
4.权利要求3所述的一种治疗多囊卵巢综合征的中药制剂的制备方法,其特征在于:
所述加水煎煮为加水煎煮2~3次,每次0.5~1.0小时,合并煎液。
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