CN116115702A - 一种加味蜂房丸组合物及其应用 - Google Patents
一种加味蜂房丸组合物及其应用 Download PDFInfo
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- CN116115702A CN116115702A CN202211645032.8A CN202211645032A CN116115702A CN 116115702 A CN116115702 A CN 116115702A CN 202211645032 A CN202211645032 A CN 202211645032A CN 116115702 A CN116115702 A CN 116115702A
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Abstract
本发明提供了一种加味蜂房丸组合物及其应用,属于中药技术领域。本发明所述加味蜂房丸组合物包括:蜂房、柴胡、青皮、香附、浙贝母、路路通、夏枯草、丝瓜络、法半夏、乳香、僵蚕、山慈菇和苦甘草。本发明组合物中,蜂房入阳明胃经,胃经过乳房,活血化瘀、止痛散结,为君药,柴胡、青皮疏肝理气共为臣药,山慈菇、香附、浙贝母、夏枯草、僵蚕、法半夏清热散结为佐药,路路通、丝瓜络、乳香、苦甘草调和诸药为使药。本发明组合物诸药合用,共奏活血理气散结之功,内外合用,能直达病所,药力迅速,以达到快速治疗乳腺疾病的效果。
Description
技术领域
本发明涉及中药技术领域,具体涉及一种加味蜂房丸组合物及其应用。
背景技术
乳腺增生是以乳腺肿块和疼痛为主要症状的育龄妇女发生的一种乳腺疾病。现代医学对乳腺增生的发病机制的研究主要集中在激素和信号通路方面。目前,乳腺增生的发病机制中主要以包括雌激素受体(ER)及孕激素受体(PR)紊乱方面、乳腺性激素受体异常、催乳素升高影响乳腺及下丘脑-垂体-性腺轴功能等激素方面得到了专家共识。由于部分非典型乳腺增生后期容易引发乳腺癌,故尽早、及时对乳腺增生进行治疗具有重要的意义。不同病理学表现的乳腺增生症发生乳腺癌的危险性也不相同,其中乳腺囊性增生的癌变率为1%-5%,只有活检证实为非典型增生时其发生乳腺癌的危险性才会明显增加。目前,非典型导管增生及外周型导管内乳透状瘤(导管内乳头状瘤病)被视为乳腺癌癌前病变。
目前,治疗乳腺增生的药物主要为中药治疗和西药治疗,其中西药主要为激素类的药物、碘制剂类以及三苯氧胺等,但是很容易出现体重加重、月经紊乱等副作用。在中药治疗方面,药力缓慢,疗效不明显,易复发,不能达到彻底治愈乳腺病的目的,给患者遭受不必要的痛苦。因此,亟需得到一种能够达到快速治疗乳腺疾病的中药。
发明内容
本发明的目的在于提供一种加味蜂房丸组合物及其应用,本发明提供的味蜂房丸组合物药力迅速,能够达到快速治疗乳腺疾病并不易复发的效果。
为了实现上述发明目的,本发明提供以下技术方案:
本发明提供了一种加味蜂房丸组合物,包括以下重量份的原料:蜂房5-25份、柴胡5-15份、青皮5-15份、香附5-20份、浙贝母5-15份、路路通7-20份、夏枯草7-20份、丝瓜络5-15份、法半夏5-25份、乳香2-18份、僵蚕5-15份、山慈菇5-20份和苦甘草5-20份。
优选的,所述组合物的剂型包括丸剂、片剂、胶囊剂、颗粒剂、膏剂。
优选的,所述剂型为丸剂时,包括以下重量份的原料:蜂房6份、柴胡6份、青皮6份、香附6份、浙贝母12份、路路通9份、夏枯草9份、丝瓜络6份、法半夏6份、乳香3份、僵蚕9份、山慈菇6份、苦甘草6份。
优选的,所述丸剂的制备方法包括:将所述加味蜂房丸组合物粉碎,与蜂蜜混合搅拌,降温后搓成丸。
优选的,所述蜂蜜与所述加味蜂房丸组合物的重量比为(2-5):(2-5);所述蜂蜜的温度为110-120℃。
优选的,所述剂型为膏剂时,包括以下重量份的原料:蜂房20份、柴胡12份、青皮12份、香附15份、浙贝母20份、路路通15份、夏枯草15份、丝瓜络12份、法半夏20份、乳香15份、僵蚕12份、山慈菇15份和苦甘草12份。
优选的,所述膏剂的制备方法包括:将所述加味蜂房丸组合物粉碎,与水混合煎煮,过滤、静置后,将上清液减压浓缩得到相对密度1.3-1.5的膏状物,与炼蜜混合,得到所述膏剂。
优选的,所述水与所述加味蜂房丸组合物的质量比为(6-15):1;所述煎煮的次数为2-5次,每次时间为1-3h。
优选的,所述膏状物与炼蜜的质量比为(3-8):1。
本发明还提供了上述加味蜂房丸组合物在制备治疗乳腺增生和预防乳腺癌药物中的应用。
相对于现有技术,本发明具有如下有益效果:
本发明提供了一种加味蜂房丸组合物,包括:蜂房、柴胡、青皮、香附、浙贝母、路路通、夏枯草、丝瓜络、法半夏、乳香、僵蚕、山慈菇和苦甘草。本发明组合物中,蜂房入阳明胃经,胃经过乳房,活血化瘀、止痛散结,为君药,柴胡、青皮疏肝理气共为臣药,山慈菇、香附、浙贝母、夏枯草、僵蚕、法半夏清热散结为佐药,路路通、丝瓜络、乳香、苦甘草调和诸药为使药。本发明组合物诸药合用,共奏活血理气散结之功,内外合用,能直达病所,药力迅速,以达到快速治疗乳腺疾病并不易复发的效果。
具体实施方式
本发明提供了一种加味蜂房丸组合物,包括以下重量份的原料:蜂房5-25份、柴胡5-15份、青皮5-15份、香附5-20份、浙贝母5-15份、路路通7-20份、夏枯草7-20份、丝瓜络5-15份、法半夏5-25份、乳香2-18份、僵蚕5-15份、山慈菇5-20份和苦甘草5-20份。
在本发明中,所述组合物的剂型优选包括丸剂、片剂、胶囊剂、颗粒剂、膏剂。
在本发明中,所述剂型为丸剂时,优选包括以下重量份的原料:蜂房6份、柴胡6份、青皮6份、香附6份、浙贝母12份、路路通9份、夏枯草9份、丝瓜络6份、法半夏6份、乳香3份、僵蚕9份、山慈菇6份、苦甘草6份。在本发明中,所述剂型为膏剂时,优选包括以下重量份的原料:蜂房20份、柴胡12份、青皮12份、香附15份、浙贝母20份、路路通15份、夏枯草15份、丝瓜络12份、法半夏20份、乳香15份、僵蚕12份、山慈菇15份和苦甘草12份。
本发明所述蜂房味微甘微咸、性平,归肝、胃经,是一味攻毒疗疮、散肿止痛的佳药,根据中医“取象比类”的原理,露蜂房形态中空而多腔,与肺、子宫、卵巢、乳腺等中空脏器形似,可与各个脏器组织中的腺体形态中空比类,故常用之于肺、乳腺、子宫、卵巢及各个脏器腺病的治疗,因为蜂房入阳明胃经,胃经过乳房,活血化瘀、止痛散结,故蜂房治疗乳腺疾病效果很好,故为君药。
本发明所述柴胡、青皮皆有疏肝理气之功:柴胡香气馥郁,轻清上升,宣透疏达,调达肝气,善疏理上焦之郁;青皮味辛而温,其气峻烈,沉降下行,破肝经气结,善疏达下焦之郁。乳房位属胸胁,厥阴肝经所过之处。乳腺病日久,症状较重常规药物皆罔效,须用既入肝经理气行郁,又能消瘀散结、去湿升清之品方能起效。柴胡、青皮二者伍用,升降相宜,上下窜通,气郁可疏,气滞可行,气结可散,药力较一般的疏肝理气剂峻猛,故共同为臣药。
本发明所述山慈菇性甘、微辛,寒。有小毒,有清热解毒、消肿散结的功效。用于痈肿疔毒,淋巴结结核,蛇咬伤,为佐药。
本发明所述香附子开郁散结,多用于女子有心情抑郁,乳腺增生或乳房胀痛者。对于浮躁的心情导致心烦意乱,可以改善稳定情绪,安神宁心。香附子与山慈菇配伍,多用于乳腺增生或乳房胀痛者,为佐药。
本发明所述浙贝母味苦,性寒。归肺、心经。其苦寒较重,开泄力大,清火散结的作用较强,常用于治疗瘭病、痰核,为佐药。
本发明所述夏枯草可以清肝火、活血、散郁结,也可以消肿,从而辅助缓解乳腺胀痛和肿块的症状。此外,夏枯草还有清肝火、明目等作用,对于乳腺增生导致的其他症状,如目赤肿痛等,也有一定缓解作用,为佐药。
本发明所述僵蚕味辛、咸,性平。归胃、肺、肝经。有息风止痉,祛风止痛,化痰散结的作用,用治痰核、瘰疬,单用即效,或与浙贝母、夏枯草等配伍同用,为佐药。
本发明所述法半夏味辛,性温。归脾、胃、肺经。有燥湿化痰,降逆止呕,消痞散结的功效,入脾则可祛湿健脾,入胃则能顺气和胃,为佐药。
本发明所述路路通味苦,性平。归肝、肾经。能够通经脉,下乳汁,常可用来治疗女性乳汁不通,乳房胀痛等证,为使药。
本发明所述丝瓜络味甘,性平。归胃,肺,肝经。有祛风,通络,活血,下乳的功效。在乳汁的淤积引发的乳腺炎中,能很好的疏通乳汁、促进乳汁排泄的作用,为使药。
本发明所述乳香辛苦温、气香、辛苦发散、苦能破裂、温能通过、芳香逃跑、心肝脾经进入血分、活血行气止痛。乳香治疗乳房膨胀痛,如小叶增生和腺瘤有一定的效果。20世纪70年代,许多妇女患有乳房疾病,包括小叶增生。腺瘤和乳腺癌,通常在复方逍遥中加入乳香,消除乳房疼痛效果更好,为使药。
本发明所述苦甘草味苦,性寒。有清热解毒,燥湿杀虫的功效,外用于疮疖、肿痛,为使药。
本发明组合物中,蜂房入阳明胃经,胃经过乳房,活血化瘀、止痛散结,为君药,柴胡、青皮疏肝理气共为臣药,山慈菇、香附、浙贝母、夏枯草、僵蚕、法半夏清热散结为佐药,路路通、丝瓜络、乳香、苦甘草调和诸药为使药。本发明组合物诸药合用,共奏活血理气散结之功,内外合用,能直达病所,药力迅速,以达到快速治疗乳腺疾病并不易复发的效果。
在本发明中,所述丸剂的制备方法优选包括:将所述加味蜂房丸组合物粉碎,与蜂蜜混合搅拌,降温后搓成丸。所述粉碎的粒径优选为80-150目,更优选为100目;所述蜂蜜与所述加味蜂房丸组合物的重量比优选为(2-5):(2-5),更优选为3:3;所述蜂蜜的温度优选为110-120℃,更优选为115℃。
在本发明中,所述膏剂的制备方法优选包括:将所述加味蜂房丸组合物粉碎,与水混合煎煮,过滤、静置后,将上清液减压浓缩得到相对密度1.3-1.5的膏状物,与炼蜜混合,得到所述膏剂。所述粉碎的粒径优选为80-150目,更优选为100目;所述水与所述加味蜂房丸组合物的质量比优选为(6-15):1,更优选为10:1;所述煎煮的次数优选为2-5次,更优选为3次,每次时间优选为1-3h,更优选为2h,所述膏状物与炼蜜的质量比优选为(3-8):1,更优选为5:1。
在本发明中,若无特殊说明,所有的原料组分均为本领域技术人员熟知的市售商品。
本发明还提供了上述加味蜂房丸组合物在制备治疗乳腺增生和预防乳腺癌药物中的应用。
在治疗时,本发明组合物采用内服和外用两种形式,内服一次一粒,每粒9-11g,一日1-2次,外用膏剂,每片膏剂15-20g,膏剂贴于患处,每日更换一次,7日为一个疗程。
下面将结合本发明中的实施例,对本发明中的技术方案进行清楚、完整地描述。显然,所描述的实施例仅仅是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。
实施例1
准确称量蜂房25g、柴胡15g、青皮15g、香附20g、浙贝母15g、路路通20g、夏枯草20g、丝瓜络15g、法半夏25g、乳香18g、僵蚕15g、山慈菇20g和苦甘草20g后,混合。
实施例2
准确称量蜂房5g、柴胡5g、青皮5g、香附5g、浙贝母5g、路路通7g、夏枯草7g、丝瓜络5g、法半夏5g、乳香2g、僵蚕5g、山慈菇5g和苦甘草5g后,混合。
实施例3
准确称量蜂房6g、柴胡6g、青皮6g、香附6g、浙贝母12g、路路通9g、夏枯草9g、丝瓜络6g、法半夏6g、乳香3g、僵蚕9g、山慈菇6g、苦甘草6g后,混合。
实施例4
准确称量蜂房20g、柴胡12g、青皮12g、香附15g、浙贝母20g、路路通15g、夏枯草15g、丝瓜络12g、法半夏20g、乳香15g、僵蚕12g、山慈菇15g和苦甘草12g后,混合。
实施例5
丸剂的制备
将实施例3称量得到的混合物粉碎100目,与90g 115℃蜂蜜混合充分搅拌,降至室温后,按照每丸10g搓成丸。
实施例6
丸剂的制备
将实施例3称量得到的混合物粉碎150目,与90g 110℃蜂蜜混合充分搅拌,降至室温后,按照每丸9g搓成丸。
实施例7
丸剂的制备
将实施例3称量得到的混合物粉碎80目,与90g 120℃蜂蜜混合充分搅拌,降至室温后,按照每丸11g搓成丸。
实施例8
膏剂的制备
将实施例4称量得到的混合物粉碎100目,与1950g水混合煎煮2h,过滤,将滤渣按照上述步骤重复煎煮2次,合并滤液,静置后,将上清液减压浓缩得到相对密度1.4的膏状物,加入膏状物质量1/5的炼蜜,充分混合后,得到所述膏剂。
实施例9
膏剂的制备
将实施例4称量得到的混合物粉碎80目,与2925g水混合煎煮3h,过滤,将滤渣按照上述步骤重复煎煮1次,合并滤液,静置后,将上清液减压浓缩得到相对密度1.5的膏状物,加入膏状物质量1/8的炼蜜,充分混合后,得到所述膏剂。
实施例10
膏剂的制备
将实施例4称量得到的混合物粉碎150目,与1170g水混合煎煮1h,过滤,将滤渣按照上述步骤重复煎煮4次,合并滤液,静置后,将上清液减压浓缩得到相对密度1.3的膏状物,加入膏状物质量1/3的炼蜜,充分混合后,得到所述膏剂。
实验例1
动物实验
1、乳腺增生大鼠模型的建立及分组
取雌性未孕SD大鼠,75-85日龄,体重200±10g,饲养于标准动物房,每日12h白天和黑夜循环,自由进食、进水。随机选取8只作为空白对照组,按模型组注射同体积苯甲酸雌二醇注射量生理盐水。其余按0.5mL·kg-1肌内注射苯甲酸雌二醇注射液,持续25天;0.5mL·kg-1肌内注射黄体酮注射液,持续5天,造模结束。随机取空白对照组大鼠2只,造模大鼠2只进行组织病理学检查,确定造模成功后余下的大鼠进行随机分组。
随机将成模大鼠分为模型对照组、实施例5内服组、实施例8外用组、综合组(实施例5+实施例8)、乳消癖片组共5个处理组,每组8只大鼠。
2、给药方法
内服组:服用本发明实施例5丸剂,服用剂量10g/kg,每日1次;
外用组:外用本发明实施例8膏剂,将膏剂外敷于乳房;
综合组:服用本发明实施例5丸剂,服用剂量10g/kg,外用本发明实施例8膏剂,将膏剂外敷于乳房;
乳消癖片:服用乳消癖片,服用剂量10g/kg;
空白对照组和模型对照组每日灌服与实施例5给药组等量的生理盐水。连续灌胃给药30d,期间观察记录大鼠的表观学特征变化。
3、药效学研究方法
(1)肉眼观察:对大鼠的第2对乳腺进行局部脱毛处理,测量给药30d后乳头直径,记录数据,如表1所示。
表1各组大鼠乳头直径
组别 | 乳头直径(mm) | 乳头高度(mm) |
空白对照 | 0.93 | 1.23 |
模型组 | 1.57 | 1.77 |
内服组 | 1.38 | 1.45 |
外用组 | 1.35 | 1.49 |
综合组 | 1.12 | 1.20 |
乳消癖片组 | 1.45 | 1.43 |
由表1可知,本发明内服和外用加味蜂房综合使用时,相对于其他组更能显著降低模型对大鼠乳腺带来的影响。
(2)测量乳头参数后,眼眶取血,静置30min后,离心(3000r/min,10min)取血清。用ELISA检测各组血清中雌二醇(estrogen,E2)、孕酮(progestogen,P)、睾酮(testosterone,T)和催乳素(prolactin,PRL)。各组试验结果见表2。
表2各组血清激素水平(μg/L)
组别 | <![CDATA[E<sub>2</sub>]]> | P | T | PRL |
空白对照 | 15.43 | 8.72 | 153.27 | 2.09 |
模型组 | 70.36 | 3.58 | 78.24 | 4.25 |
内服组 | 22.67 | 7.79 | 139.18 | 2.54 |
外用组 | 25.48 | 7.69 | 140.26 | 2.77 |
综合组 | 16.04 | 8.52 | 151.12 | 2.28 |
乳消癖片组 | 24.31 | 7.62 | 135.63 | 3.03 |
由表2可知,本发明内服和外用加味蜂房综合使用时,相对于其他组更能显著降低模型对大鼠血清性激素带来的影响,能达到治疗乳腺疾病的效果。
实验例2
临床试验
1、患者及分组
选取内蒙古医科大学附属医院2020年10月-2021年10月收治的乳腺增生患者240例,平均分为两组,本发明加味蜂房3组(内服组、外用组和内服+外用)和乳消癖片组,两组间的年龄、病程、病症严重程度间没有统计学差异。
2、诊断标准
均经彩色多普勒超声检查确诊。中医诊断标准:参考《中医病证诊断疗效标准》中乳癖的相关诊断标准。
(1)纳入标准和排除标准
纳入标准:1)符合上述中西医诊断标准者;2)年龄20~50岁;3)月经周期规律者;3)患者本人签署知情同意书。
(2)排除标准:1)妊娠期、哺乳期妇女;2)接受其他治疗者;3)心肝肾及造血系统严重疾病者;4)合并其他乳房疾病者;5)精神疾病患者;6)对使用药物过敏者。
3、治疗方法
内服组:一次一粒,每粒9-11g,一日1-2次;
外用组:每片膏剂15-20g,膏剂贴于患处,每日更换一次;
内服+外用组:内服,一次一粒,每粒9-11g,一日1-2次;外用膏剂,每片膏剂15-20g,膏剂贴于患处,每日更换一次;
乳消癖片组:口服,一次5-6片,一天3次;乳消癖片来自肾阳红阳制药。
4、疗效标准
依照《最新国内外疾病诊疗标准》中诊断标准对患者的疗效进行判定:疼痛消失、乳腺肿块消退为治愈;疼痛显著减轻、肿块消退50%以上为显效;疼痛显著减轻、但肿块消失50%以下或疼痛减轻不显著、肿块消失在50%以上为有效;临床症状在3个月后重新出现者,疼痛无显著改善,肿块无消退,为无效。总有效率=(治愈率+显效率+有效率)/总患者×100%。
按照各组的服用方法,1个月后,统计4组临床疗效具体结果如表3所示。
表3各组临床效果
组别 | 治愈(例) | 显效(例) | 有效(例) | 无效(例) | 总有效率(%) |
内服 | 8 | 18 | 27 | 7 | 88.3 |
外用 | 6 | 17 | 31 | 6 | 90 |
内服+外用 | 15 | 20 | 25 | 0 | 100 |
乳消癖片 | 7 | 15 | 28 | 10 | 85 |
由表3可知,患者服用本发明加味蜂房丸相对于乳消癖片在治疗乳腺增生方面,效果更好。并且,采用本发明加味蜂房组合物内服和外用后,总有效率达到100%。
以上所述仅是本发明的优选实施方式,应当指出,对于本技术领域的普通技术人员来说,在不脱离本发明原理的前提下,还可以做出若干改进和润饰,这些改进和润饰也应视为本发明的保护范围。
Claims (10)
1.一种加味蜂房丸组合物,其特征在于,包括以下重量份的原料:
蜂房5-25份、柴胡5-15份、青皮5-15份、香附5-20份、浙贝母5-15份、路路通7-20份、夏枯草7-20份、丝瓜络5-15份、法半夏5-25份、乳香2-18份、僵蚕5-15份、山慈菇5-20份和苦甘草5-20份。
2.根据权利要求1所述的加味蜂房丸组合物,其特征在于,所述组合物的剂型包括丸剂、片剂、胶囊剂、颗粒剂、膏剂。
3.根据权利要求2所述的加味蜂房丸组合物,其特征在于,所述剂型为丸剂时,包括以下重量份的原料:蜂房6份、柴胡6份、青皮6份、香附6份、浙贝母12份、路路通9份、夏枯草9份、丝瓜络6份、法半夏6份、乳香3份、僵蚕9份、山慈菇6份、苦甘草6份。
4.根据权利要求3所述的加味蜂房丸组合物,其特征在于,所述丸剂的制备方法包括:将所述加味蜂房丸组合物粉碎,与蜂蜜混合搅拌,降温后搓成丸。
5.根据权利要求4所述的加味蜂房丸组合物,其特征在于,所述蜂蜜与所述加味蜂房丸组合物的重量比为(2-5):(2-5);所述蜂蜜的温度为110-120℃。
6.根据权利要求2所述的加味蜂房丸组合物,其特征在于,所述剂型为膏剂时,包括以下重量份的原料:蜂房20份、柴胡12份、青皮12份、香附15份、浙贝母20份、路路通15份、夏枯草15份、丝瓜络12份、法半夏20份、乳香15份、僵蚕12份、山慈菇15份和苦甘草12份。
7.根据权利要求6所述的加味蜂房丸组合物,其特征在于,所述膏剂的制备方法包括:将所述加味蜂房丸组合物粉碎,与水混合煎煮,过滤、静置后,将上清液减压浓缩得到相对密度1.3-1.5的膏状物,与炼蜜混合,得到所述膏剂。
8.根据权利要求7所述的加味蜂房丸组合物,其特征在于,所述水与所述加味蜂房丸组合物的质量比为(6-15):1;所述煎煮的次数为2-5次,每次时间为1-3h。
9.根据权利要求7所述的加味蜂房丸组合物,其特征在于,所述膏状物与炼蜜的质量比为(3-8):1。
10.权利要求1-9任意一项所述加味蜂房丸组合物在制备治疗乳腺增生和预防乳腺癌药物中的应用。
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