CN117244035B - 一种用于治疗乳腺结节的药物组合物及其制备方法 - Google Patents
一种用于治疗乳腺结节的药物组合物及其制备方法 Download PDFInfo
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Abstract
本发明涉及一种用于治疗乳腺结节的药物组合物及其制备方法,所述药物组合物主要由柴胡、鳖甲、玄参、白芍、郁金、白薇、土贝母、浙贝母、牡丹皮制成。本发明药物组合物清热散结、疏肝凉血、育阴止痛,可适用于乳腺结节或乳癌(属中医肝郁气滞、热毒血瘀者)的标本兼治。
Description
技术领域
本发明属于中药领域,具体涉及一种用于治疗乳腺结节的药物组合物及其制备方法。
背景技术
乳腺结节多见于青中年妇女,近年来发病率逐渐升高,且存在癌变可能,已成为危害女性健康的主要疾病之一,常伴有疼痛不适, 对女性的工作、生活造成严重的困扰。针对乳腺结节,西医治疗常采用激素类、碘制剂或其他对症用药或利用手术治疗,但存在多毛、嗓音变粗等男性化表现,且手术也主要是切除了结节和扩张的腺体,体内的内分泌并未得到纠正,因此存在易复发等问题。
乳腺结节属于中医“乳癖证”,又名奶癖、乳痔、乳痞等,《诸病源候论》认为“癖者,癖侧在于两胁之间,有时而痛是也”;《疡科心得集·辨乳癖乳痰乳岩论》则记载了“有乳中结核,形如丸卵,不疼痛,不发寒热,皮色不变,其核随喜怒消长,此名乳癖”。《汤医大全》中引用陈实功将乳癖总结为“乳癖乃乳中结核,形如卵丸,或重坠作痛、或不痛,皮色不变,其核虽喜怒消长”。针对乳癖症的病因病机历代医家论述不痛,多认为其发生与肾虚冲任失调、肝气郁结、气滞血瘀、脾虚失运有关, 肾虚为病之本, 肝郁为病之标,当肾元不足时,冲任二脉即不充盛,再加上恼怒伤肝,肝气郁结、肝脾不和, 久之气滞血瘀、痰瘀互结、阻滞乳络而成该病。 基于此,临床治疗当以疏肝理气为主, 兼以活血化瘀、软坚散结为主,使用频率较高的药味包括了柴胡、当归、香附、鳖甲等,常用方剂包括了逍遥散化裁(柴胡、当归、白术、白芍、茯苓、橘核、路路通、鹿角霜、炙甘草、蒲公英、浙贝母、夏枯草、炮穿山甲),加减柴胡疏肝散(柴胡、郁金、当归、白芍、陈皮、茯苓、浙贝母、乳香、没药、仙茅、淫羊藿、甘草)、乳癖清热饮(当归、川芎、香附、延胡索、红花、黄连、栀子、夏枯草)。由于针对乳癖病因病机的认识上仍存在一定争议,目前中医治疗乳癖也未形成较为一致的方剂,缺乏统一的用药规范,方剂组成多样,不利于乳腺结节的规范化治疗。
本申请在对以往乳腺结节中医理论和中药方剂进行归纳总结的基础上,获得了一种组方简单、乳腺结节疗效确切的中药组合物,通过清热散结、疏肝凉血、育阴止痛而取得了标本兼治的治疗乳腺结节或乳癌(属中医肝郁气滞、热毒血瘀者)的效果。
发明内容
本发明的目的是提供一种用于治疗乳腺结节或乳癌(属中医肝郁气滞、热毒血瘀者)的药物组合物,其特征在于,主要由柴胡、鳖甲、玄参、白芍、郁金、白薇、土贝母、浙贝母、牡丹皮制成。
优选的,所述药物组合物由柴胡8-12份、鳖甲4-8份、玄参2-4份、白芍2-4份、郁金3-6份、白薇3-6份、土贝母2-4份、浙贝母2-4份、牡丹皮2-4份制成。
优选的,所述药物组合物由柴胡9-11份、鳖甲5-7份、玄参3-4份、白芍3-4份、郁金4-6份、白薇4-6份、土贝母3-4份、浙贝母3-4份、牡丹皮3-4份制成。
更优选的,所述药物组合物由柴胡10份、鳖甲6份、玄参3份、白芍3份、郁金5份、白薇5份、土贝母4份、浙贝母4份、牡丹皮3份制成。
优选的,用于治疗乳腺结节或乳癌(属中医肝郁气滞、热毒血瘀者)的药物组合物还进一步包括鹿角霜、桑螵蛸中的一种或两种,具体的:所述用于治疗乳腺结节或乳癌(属中医肝郁气滞、热毒血瘀者)的药物组合物,由柴胡、鳖甲、玄参、白芍、郁金、白薇、鹿角霜、土贝母、浙贝母、牡丹皮制成;或所述用于治疗乳腺结节或乳癌(属中医肝郁气滞、热毒血瘀者)的药物组合物,由柴胡、鳖甲、玄参、白芍、郁金、白薇、桑螵蛸、土贝母、浙贝母、牡丹皮制成;或所述用于治疗乳腺结节或乳癌(属中医肝郁气滞、热毒血瘀者)的药物组合物,由柴胡、鳖甲、玄参、白芍、郁金、白薇、鹿角霜、桑螵蛸、土贝母、浙贝母、牡丹皮制成;
优选的,用于治疗乳腺结节或乳癌(属中医肝郁气滞、热毒血瘀者)的药物组合物由柴胡8-12份、鳖甲4-8份、玄参2-4份、白芍2-4份、郁金3-6份、白薇3-6份、鹿角霜3-6份、土贝母2-4份、浙贝母2-4份、牡丹皮2-4份制成;或所述用于治疗乳腺结节或乳癌(属中医肝郁气滞、热毒血瘀者)的药物组合物,由柴胡8-12份、鳖甲4-8份、玄参2-4份、白芍2-4份、郁金3-6份、白薇3-6份、桑螵蛸3-6份、土贝母2-4份、浙贝母2-4份、牡丹皮2-4份制成;或所述用于治疗乳腺结节或乳癌(属中医肝郁气滞、热毒血瘀者)的药物组合物,由柴胡8-12份、鳖甲4-8份、玄参2-4份、白芍2-4份、郁金3-6份、白薇3-6份、鹿角霜3-6份、桑螵蛸3-6份、土贝母2-4份、浙贝母2-4份、牡丹皮2-4份制成。
本发明用于治疗乳腺结节或乳癌(属中医肝郁气滞、热毒血瘀者)的药物组合物添加药学上可接受的辅料后可制备成口服药物组合物,所述口服药物组合物选自:汤剂、颗粒剂、冲剂、丸剂、散剂、片剂、胶囊剂等,优选的,所述用于治疗乳腺结节或乳癌(属中医肝郁气滞、热毒血瘀者)的药物组合物口服药物组合物选自汤剂、片剂、胶囊剂、丸剂或胶囊剂。
优选的,所述药学上可接受的辅料选自:填充剂、粘结剂、崩解剂、润滑剂、矫味剂中的一种或多种。
更优选的,所述填充剂选自淀粉、糊精、微晶纤维素等;所述粘结剂选自:淀粉浆、羟丙基甲基纤维素、羧甲基纤维素钠、聚维酮等;所述崩解剂选自羧甲基淀粉钠、交联聚维酮、交联羧甲基纤维素钠等;所述润滑剂选自:硬脂酸镁、滑石粉、微粉硅胶等。
本发明的再一个目的是提供一种用于治疗乳腺结节或乳癌(属中医肝郁气滞、热毒血瘀者)的药物组合物的制备方法,其特征在于包括以下步骤:
(1)备料:按照组方称取各原料药;
(2)粉碎:将鳖甲与任选的鹿角霜粉碎过20-40目筛,将剩余药味粉碎过10目筛,然后混合均匀得混合粉料备用;
(3)煎煮:在混合粉料中添加混合粉料重量3-5倍的纯净水后煎煮40-60分钟,过滤后滤液备用,滤渣中加入混合粉料重量2-4倍的纯净水后煎煮20-40分钟,过滤后合并两次滤液,任选的减压浓缩为比重1.1-1.2的浸膏;
(4)制剂:将步骤(3)所得的滤液或任选的浸膏,添加药学上可接受的辅料后,制得用于治疗乳腺结节或乳癌(属中医肝郁气滞、热毒血瘀者)的药物组合物。
优选的,所述步骤(2)中将鳖甲与任选的鹿角霜粉碎过30目筛;所述步骤(3)在混合粉料中添加混合粉料重量4倍的纯净水后煎煮50分钟,过滤后滤液备用,滤渣中加入混合粉料重量3倍的纯净水后煎煮30分钟,过滤后合并两次滤液。
本发明药物组合物中各原料的功效如下:
柴胡,味辛、苦,性微寒,归肝、胆、肺经。有和解表里,疏肝解郁,升阳举陷,退热截疟的功效。用于用于感冒发热,寒热往来,胸胁胀痛,月经不调,子宫脱垂,脱肛等的治疗。
鳖甲,味咸,性微寒,归肝、肾经,具有滋阴潜阳,退热除蒸,软坚散结的功效,可用于阴虚发热,骨蒸劳热,阴虚阳亢,头晕目眩,虚风内动,经闭,癥瘕,久疟,疟母等的治疗。
玄参,味甘、苦、咸,性微寒,归脾、胃、肾经,具有清热凉血、滋阴降火,解读散结的功效,可用于温热病热入营血、身热、烦渴、舌绛、发斑、骨蒸劳嗽、虚烦不寤、津伤便秘、目涩昏花、咽喉肿痛、瘰疬痰核、痈疽疮毒等症的治疗。
白芍, 味苦、酸,性微寒,归肝、脾经,具有养血敛阴,柔肝止痛等功效,可用于头痛眩晕、胁痛、腹痛、四肢挛痛、血虚萎黄、月经不调、紫涵、盗汗等症的治疗。
郁金,味辛、苦,性寒,归肝、心、肺经,具有活血止痛、行气解郁、清心凉血、利胆退黄等功效,可用于胸胁刺痛、胸痹心痛、经闭痛经、乳房胀痛、热病神昏、癫痫发狂、血热吐衄,黄疸尿赤等症的治疗。
白薇,味苦咸,性寒,归肺、胃、肾经,有除虚烦、清热散肿、生肌止痛之的功效,可用于温邪伤营发热、阴虚发热、骨蒸劳热、产后血虚发热、热淋、血淋、痈疽肿毒、刀伤等症的治疗。
土贝母,味苦,性微寒,归肺、脾经,具有解毒、散结、消肿的功效,可用于乳痈,瘰疬,痰核等症的治疗。
浙贝母,味苦,性寒,归肺、心经,具有清热化痰止咳,解毒散结消痈的功效,可用于风热咳嗽,痰火咳嗽,肺痈,乳痈,瘰疬,疮毒等症的治疗。
牡丹皮,味苦、辛,性微寒,归心、肝、肾经,具有清热凉血、活血化瘀的功效,可用于热入营血、温毒发斑、吐血衄血、夜热早凉、无汗骨蒸、经闭痛经、跌扑伤痛、痈肿疮毒等症的治疗。
鹿角霜,味咸、涩,性温,归肝肾经,具有温肾助阳,收敛止血的功效,可用于脾肾阳虚,白带过多,遗尿尿频,崩漏下血,疮疡不敛等症的治疗。
桑螵蛸,味甘、咸,性平,归肝、肾经,具有固精缩尿,补肾助阳的功效,可用于遗精滑精,遗尿尿频,小便白浊等症的治疗。
本发明有益效果
1. 本发明药物组合物针对乳腺结节或乳癌(属中医肝郁气滞、热毒血瘀者)的病因病机,采用通过清热散结、疏肝凉血、育阴止痛而取得了标本兼治的治疗乳腺结节或乳癌(属中医肝郁气滞、热毒血瘀者)的效果。
2.本发明药物组合物的组方简单,各原料药配伍合理,乳腺结节的治疗效果明显优于同类药物。
具体实施方式
在下文中更详细地描述了本发明以有助于对本发明的理解。
实施例1: 一种治疗乳腺结节或乳癌(属中医肝郁气滞、热毒血瘀者)的汤剂
柴胡10份、鳖甲6份、玄参3份、白芍3份、郁金5份、白薇5份、土贝母4份、浙贝母4份、牡丹皮3份。
按照以下方法制备:
(1)备料:按照组方称取各原料药;
(2)粉碎:将鳖甲粉碎过30目筛,将剩余药味粉碎过10目筛,然后混合均匀得混合粉料备用;
(3)煎煮:在混合粉料中添加混合粉料重量4倍的纯净水后煎煮50分钟,过滤后滤液备用,滤渣中加入混合粉料重量3倍的纯净水后煎煮30分钟,过滤后合并两次滤液,即得本发明治疗乳腺结节或乳癌(属中医肝郁气滞、热毒血瘀者)的汤剂。
实施例2:一种治疗乳腺结节或乳癌(属中医肝郁气滞、热毒血瘀者)的胶囊剂
柴胡10份、鳖甲6份、玄参3份、白芍3份、郁金5份、白薇5份、鹿角霜5份、桑螵蛸5份、土贝母4份、浙贝母4份、牡丹皮3份。
(1)备料:按照组方称取各原料药;
(2)粉碎:将鳖甲与鹿角霜粉碎过30目筛,将剩余药味粉碎过10目筛,然后混合均匀得混合粉料备用;
(3)煎煮:在混合粉料中添加混合粉料重量4倍的纯净水后煎煮50分钟,过滤后滤液备用,滤渣中加入混合粉料重量3倍的纯净水后煎煮30分钟,过滤后合并两次滤液,减压浓缩为比重1.1-1.2的浸膏;
(4)制剂:将步骤(3)所得的浸膏,添加药学上可接受的辅料后,制得用于治疗乳腺结节或乳癌(属中医肝郁气滞、热毒血瘀者)的胶囊剂。
实施例3、一种治疗乳腺结节或乳癌(属中医肝郁气滞、热毒血瘀者)的片剂。
柴胡10份、鳖甲6份、玄参3份、白芍3份、郁金5份、白薇5份、桑螵蛸5份、土贝母4份、浙贝母4份、牡丹皮3份。
(1)备料:按照组方称取各原料药;
(2)粉碎:将鳖甲粉碎过30目筛,将剩余药味粉碎过10目筛,然后混合均匀得混合粉料备用;
(3)煎煮:在混合粉料中添加混合粉料重量4倍的纯净水后煎煮50分钟,过滤后滤液备用,滤渣中加入混合粉料重量3倍的纯净水后煎煮30分钟,过滤后合并两次滤液,减压浓缩为比重1.1-1.2的浸膏;
(4)制剂:将步骤(3)所得的浸膏,添加药学上可接受的辅料后,制得用于治疗乳腺结节或乳癌(属中医肝郁气滞、热毒血瘀者)的片剂。
实施例4、一种治疗乳腺结节或乳癌(属中医肝郁气滞、热毒血瘀者)的丸剂。
柴胡10份、鳖甲6份、玄参3份、白芍3份、郁金5份、白薇5份、鹿角霜5份、桑螵蛸5份、土贝母4份、浙贝母4份、牡丹皮3份,按照实施例2所述的方法制得治疗乳腺结节或乳癌(属中医肝郁气滞、热毒血瘀者)的丸剂。
效果例1:本发明药物组合物对乳腺增生大鼠的治疗效果
1.1实验药物
本发明中药提取物1:柴胡10份、鳖甲6份、玄参3份、白芍3份、郁金5份、白薇5份、土贝母4份、浙贝母4份、牡丹皮3份;
本发明中药提取物2:柴胡10份、鳖甲6份、玄参3份、白芍3份、郁金5份、白薇5份、鹿角霜5份、土贝母4份、浙贝母4份、牡丹皮3份;
本发明中药提取物3:柴胡10份、鳖甲6份、玄参3份、白芍3份、郁金5份、白薇5份、桑螵蛸5份、土贝母4份、浙贝母4份、牡丹皮3份;
本发明中药提取物4:柴胡10份、鳖甲6份、玄参3份、白芍3份、郁金5份、白薇5份、鹿角霜5份、桑螵蛸5份、土贝母4份、浙贝母4份、牡丹皮3份;
对比例1:柴胡10份、黄芩3份、白芍3份、郁金5份、陈皮3份、玄胡、3份、丹皮3份、红花3份、当归3份、荔枝核6份、桔核6份、连翘6份、夏枯草6份、鳖甲6份;
对比例2:柴胡10份、鳖甲6份、玄参3份、白芍3份、郁金5份、白薇5份、鹿茸5份、土贝母4份、浙贝母4份、牡丹皮3份;
对比例3:柴胡10份、鳖甲6份、玄参3份、白芍3份、郁金5份、白薇5份、鹿茸5份、肉苁蓉5份、土贝母4份、浙贝母4份、牡丹皮3份。
对比例4:柴胡10份、鳖甲6份、玄参8份、白芍3份、郁金5份、土贝母4份、浙贝母4份、牡丹皮3份
以上药物均按照实施例2方法制备成比重1.1-1.2的浸膏备用。
1.2实验模型的建立
10周龄雌性未孕SD大鼠100只,体重260-270g,随机分为正常组、空白组、本发明中药提取物1-4、对比例1-4组,每组10只,适应性饲养1d后,除正常组大鼠外其他大鼠均于后肢外侧肌肉注射苯甲酸雌二醇0.5mg/kg, 1次/d,连续20d,第21-25d肌注黄体酮,5mg/kg,1次/d,正常组大鼠则于第1d-第25d肌注等量生理盐水,1次/d。第26d-第55d灌胃给药各组相应浸膏,灌胃体积5mL/Kg体重,1次/d,正常组和空白组大鼠灌胃等体积生理盐水。末次灌胃后第24h,测量大鼠第2对乳头的高度。
1.3实验结果
应用统计软件SPSS的多因素方差分析模块进行数据分析,P<0.05表示差异有统计学意义。
表1本发明药物组合物对乳腺增生大鼠的治疗效果
与正常组比较:△△△ P<0.001;与空白组比较:P<0.05,/> P<0.01。
表1实验结果显示,空白组大鼠与正常组大鼠相比第2对乳头的平均高度明显增大,并具有统计学差异,证明了本申请中大鼠乳腺增生模型造模成功。灌胃本发明药物组合物和对比例1-4药物的大鼠相对于空白组均显示了一定的乳腺增生治疗效果,其中本发明中药提取物1-4组大鼠第2对乳头高度相对于空白组均具有统计学差异,其中尤其以本发明中药提取物4组乳腺增生治疗效果最为优异,第2对乳头平均高度已接近正常大鼠水平。而对比例1-4组大鼠虽然第2对乳头平均高度相对于空白组均显示了一定程度的降低,但与空白组相比均不具有统计学差异,其中仅将鹿角霜与桑螵蛸替换为补肾效果更强的鹿茸与肉苁蓉后乳腺增生治疗效果均呈现了明显的减弱。另外,需要强调的是仅仅将具有清热散结功效的白薇替换同样具有解毒散结功效的玄参后,乳腺增生治疗效果也出现了明显减弱,替换后第2对乳头高度与空白组大鼠不具有统计学差异。以上实验结果均证明了本发明治疗乳腺结节或乳癌(属中医肝郁气滞、热毒血瘀者)的药组合物的原料药配伍合理,乳腺结节的治疗效果明显优于同类药物,且并非简单的同样或类似功效的中药药味的替换、添加所能得到的。
以上描述了本发明优选实施方式,然其并非用以限定本发明。本领域技术人员对在此公开的实施方案可进行并不偏离本发明范畴和精神的改进和变化。
Claims (9)
1.一种用于治疗乳腺增生的药物组合物,其特征在于,由柴胡、鳖甲、玄参、白芍、郁金、白薇、土贝母、浙贝母、牡丹皮制成。
2.根据权利要求1所述的用于治疗乳腺增生的药物组合物,其特征在于,柴胡8-12份、鳖甲4-8份、玄参2-4份、白芍2-4份、郁金3-6份、白薇3-6份、土贝母2-4份、浙贝母2-4份、牡丹皮2-4份制成。
3.根据权利要求1或2所述的用于治疗乳腺增生的药物组合物,其特征在于,还进一步包括鹿角霜、桑螵蛸中的一种或两种。
4.根据权利要求3所述的用于治疗乳腺增生的药物组合物,其特征在于,进一步包括鹿角霜为3-6份、桑螵蛸3-6份中的一种或两种。
5.根据权利要求4所述的用于治疗乳腺增生的药物组合物,其特征在于,所述药物组合物为口服药物组合物。
6.根据权利要求5所述的用于治疗乳腺增生的药物组合物,其特征在于,所述口服药物组合物选自:汤剂、颗粒剂、冲剂、丸剂、散剂、片剂或胶囊剂。
7.权利要求3-6任一项所述的用于治疗乳腺增生的药物组合物的制备方法,其特征在于,包括以下步骤:
(1)备料:按照组方称取各原料药;
(2)粉碎:将鳖甲与任选的鹿角霜粉碎过20-40目筛,将剩余药味粉碎过10目筛,然后混合均匀得混合粉料备用;
(3)煎煮:在混合粉料中添加混合粉料重量3-5倍的纯净水后煎煮40-60分钟,过滤后滤液备用,滤渣中加入混合粉料重量2-4倍的纯净水后煎煮20-40分钟,过滤后合并两次滤液,任选的减压浓缩为比重1.1-1.2的浸膏;
(4)制剂:将步骤(3)所得的滤液或任选的浸膏,添加药学上可接受的辅料后,制得用于治疗乳腺增生的药物组合物。
8.根据权利要求7所述的制备方法,其特征在于:所述步骤(2)中将鳖甲与任选的鹿角霜粉碎过20-40目筛;所述步骤(3)在混合粉料中添加混合粉料重量4倍的纯净水后煎煮50分钟,过滤后滤液备用,滤渣中加入混合粉料重量3倍的纯净水后煎煮30分钟。
9.权利要求1-6任一项所述的药物组合物在制备治疗乳腺增生的药物组合物中的用途。
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