CN118217347A - 一种治疗乳痛症的中药组合物 - Google Patents
一种治疗乳痛症的中药组合物 Download PDFInfo
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Abstract
本发明涉及一种治疗乳痛症的中药组合物，所述中药组合物由蒲公英10‑30重量份、炒枳壳8‑20重量份、全瓜蒌8‑20重量份、连翘8‑20重量份、柴胡5‑15重量份、醋青皮5‑15重量份、醋香附5‑15重量份、当归5‑15重量份、乳香3‑12重量份和没药3‑12重量份制成。本发明的中药组合物制备方法简单，安全性高，外敷形式避免了手术创伤及内服寒凉损伤胃气的副作用，可以有效缓解乳房疼痛。
Description
技术领域
本发明涉及中药领域，具体涉及一种治疗乳痛症的中药组合物。
背景技术
乳痛症又称单纯性乳腺增生症，其突出症状是乳腺疼痛，以单侧或双侧乳腺胀痛、刺痛为主，多与月经周期有关，常见于青年女性。现代医学认为，乳痛症的发病与组织学异常、性激素异常、必需脂肪酸缺乏、精神因素等有关。雌激素能调节乳管组织的发育，扩张和延伸乳腺导管，孕激素在此基础上可以进一步促进乳腺小叶的发育。雌激素分泌过多，孕激素分泌过少，雌激素与孕激素的比率失衡时，会导致对靶器官乳腺的过度刺激，乳腺小叶实质及间质异常增生而又复旧不全。
乳痛症属中医“乳癖”、“经行乳房胀痛”范畴，与经前期脏腑功能失调有关。情志、饮食、劳倦是诱发乳痛症的重要因素。乳痛症病位在乳房、肝、脾胃、肾，病性属本虚标实，气滞痰凝血瘀为发病之标，肾精亏损、冲任失调为发病之本。
目前对于乳痛症的治疗无特效药物，西医多采用维生素类或激素类药物(例如他莫昔芬片)改善症状，而中医通过辨证治疗取得了一定的疗效，但是有效治疗乳痛症的中药组方报道仍较少。因此，发明一种用于治疗乳痛症，且副作用低的药物已成为亟待解决的技术问题。
发明内容
为解决上述技术问题，本发明包括以下几个方面：
本发明的第一方面提供一种治疗乳痛症的中药组合物，所述中药组合物由蒲公英、炒枳壳、全瓜蒌、连翘、柴胡、醋青皮、醋香附、当归、乳香和没药制成。
优选的，所述中药组合物由蒲公英10-30重量份、炒枳壳8-20重量份、全瓜蒌8-20重量份、连翘8-20重量份、柴胡5-15重量份、醋青皮5-15重量份、醋香附5-15重量份、当归5-15重量份、乳香3-12重量份和没药3-12重量份制成。
更优选的，所述中药组合物由蒲公英15-25重量份、炒枳壳10-15重量份、全瓜蒌10-15重量份、连翘10-15重量份、柴胡8-12重量份、醋青皮8-12重量份、醋香附8-12重量份、当归8-12重量份、乳香6-10重量份和没药6-10重量份制成。
最优选的，所述中药组合物由蒲公英20重量份、炒枳壳12重量份、全瓜蒌12重量份、连翘12重量份、柴胡10重量份、醋青皮10重量份、醋香附10重量份、当归10重量份、乳香9重量份和没药9重量份制成。
优选的，所述中药组合物进一步包括药学上可接受的辅料。
优选的，所述中药组合物为外用制剂。
优选的，所述中药组合物的剂型为贴剂、软膏剂、散剂或凝胶剂。
更优选的，所述中药组合物的剂型为贴剂。
优选的，所述中药组合物的制备方法包括如下步骤：取处方量的蒲公英、炒枳壳、全瓜蒌、连翘、柴胡、醋青皮、醋香附、当归、乳香和没药，分别粉碎后混匀，任选的加入药学上可接受的辅料，即得。
更优选的，所述中药组合物的制备方法如下：取处方量的蒲公英、炒枳壳、全瓜蒌、连翘、柴胡、醋青皮、醋香附、当归、乳香和没药，分别粉碎后混匀，加入适量食醋调制成泥状，即得。
本发明的第二方面提供上述中药组合物的制备方法，包含以下步骤：取处方量的蒲公英、炒枳壳、全瓜蒌、连翘、柴胡、醋青皮、醋香附、当归、乳香和没药，分别粉碎后混匀，任选的加入药学上可接受的辅料，即得。
优选的，所述中药组合物的制备方法如下：取处方量的蒲公英、炒枳壳、全瓜蒌、连翘、柴胡、醋青皮、醋香附、当归、乳香和没药，分别粉碎后混匀，加入适量食醋调制成泥状，即得。
本发明的第三方面提供上述中药组合物在制备治疗乳痛症的药物中的应用。
优选的，所述乳痛症为哺乳期乳腺炎及浆液性乳腺炎引起的乳痛症。
本发明的第四方面提供上述中药组合物在制备治疗乳腺增生的药物中的应用。
本发明选用的中药原料在本领域的常见药理功效如下：
蒲公英：性寒，味苦、甘，归肝经、胃经。蒲公英清热解毒，利尿散结，消炎杀菌，用于治疗急性乳腺炎、淋巴腺炎、急性支气管炎、胃炎、肝炎、胆囊炎、痢疾、肠炎、尿路感染、盆腔炎、疔疮疡肿、目赤、肺痈、肠痈。
枳壳：性温，味苦、辛、酸，归脾经、胃经。枳壳理气宽中、行滞消胀，用于治疗胸胁气滞、胀满产痛、食积不化、痰饮内停、胃下垂、子宫脱垂、脱肛等。
全瓜蒌：性寒，味甘，微苦。全瓜蒌清热涤痰，宽胸散结，润燥滑肠，用于治疗肺热咳嗽，痰浊黄稠，胸痹心痛，结胸痞满，乳痈，肺痈，肠痈肿痛，大便秘结。
连翘：性微寒，味苦，归肺经、心经、小肠经。连翘清热解毒、消肿散结，用于治疗痈疽、瘰疬、乳痈、丹毒、风热感冒、温病初起、温热入营、高热烦渴、神昏发斑、热淋尿闭，具有镇吐、抗肝损伤、抗炎等功效。
柴胡：味辛、苦，性微寒，归肝、胆、肺经。柴胡和解表里，疏肝解郁，升阳举陷，退热截疟，用于治疗感冒发热、寒热往来、胸胁胀痛、月经不调、子宫脱垂、脱肛。
青皮：性温，味苦、辛，归肝经、胆经、胃经。青皮疏肝破气，消积化滞，用于治疗胸胁胀痛，疝气疼痛，食积气滞，脘腹胀痛，具有祛痰平喘，利胆保肝的功效。
香附：性平，味辛、微苦、微甘，归肝经、三焦经。香附行气解郁、调经止痛，用于治疗肝胃不和、气郁不舒、胸腹胁肋胀痛、痰饮痞满、月经不调、崩漏带下等。醋香附具有疏肝解郁，理气宽中，调经止痛之功效。
当归：味甘、辛、温，归肝、心、脾经。当归补血活血，调经止痛，润燥滑肠，用于治疗血虚诸证、月经不调、经闭痛经、症瘕结聚、崩漏、虚寒腹痛，痿痹、肌肤麻木、肠燥便难、赤痢后重、痈疽疮疡、跌扑损伤。
乳香：性温，味辛、苦，归心经、脾经、肝经。乳香调气活血、定痛、消肿、生肌，用于治疗气血瘀滞、心腹疼痛、痈疮肿毒、跌打损伤、风湿痹痛、痛经、产后瘀血刺痛。
没药：味辛、苦，性平，归心、肝、脾经。没药散瘀定痛，消肿生肌，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。
本发明的中药组合物中蒲公英清热解毒、消痈散结，柴胡疏肝解郁，醋青皮疏肝理气、消积化滞，醋香附疏肝理气、调经止痛，炒枳壳气宽中、化痰消积，全瓜篓清热涤痰，连翘清热解毒、消痈散结，当归、乳香和没药活血止痛，消肿生肌。方药联用，疏肝理气，缓解疼痛，特别适用于哺乳期乳腺炎及浆液性乳腺炎引起的乳痛。
本发明中药组合物的使用方法：将中药组合物中的各味中药研成粉末，由适量食醋调制成泥状，敷于圆形外敷贴下，贴乳房疼痛处。每贴含中药成分约110g，每天使用1次，连续治疗7天为一个疗程。
本发明产生的技术效果：
本发明的中药组合物配伍合理，发明人通过优化中药的组分及含量配比，优选出了具有显著治疗乳痛症的中药组方。本发明的中药组合物制备方法简单，安全性高，外敷形式避免了手术创伤及内服寒凉损伤胃气的副作用，可以有效缓解乳房疼痛。
具体实施方式
实施例1
取蒲公英20g、炒枳壳12g、全瓜蒌12g、连翘12g、柴胡10g、醋青皮10g、醋香附10g、当归10g、乳香9g和没药9g，分别粉碎后混匀，加入适量食醋调制成泥状，即得本发明中药组合物1。
实施例2
取蒲公英10g、炒枳壳12g、全瓜蒌20g、连翘12g、柴胡10g、醋青皮10g、醋香附10g、当归10g、乳香9g和没药9g，分别粉碎后混匀，加入适量食醋调制成泥状，即得本发明中药组合物2。
实施例3
取蒲公英12g、炒枳壳20g、全瓜蒌12g、连翘12g、柴胡10g、醋青皮10g、醋香附10g、当归10g、乳香9g和没药9g，分别粉碎后混匀，加入适量食醋调制成泥状，即得本发明中药组合物3。
对比例1(蒲公英替换为紫花地丁)
取紫花地丁20g、炒枳壳12g、全瓜蒌12g、连翘12g、柴胡10g、醋青皮10g、醋香附10g、当归10g、乳香9g和没药9g，分别粉碎后混匀，加入适量食醋调制成泥状，即得中药组合物对比例1。
对比例2(当归替换为川芎)
取蒲公英20g、炒枳壳12g、全瓜蒌12g、连翘12g、柴胡10g、醋青皮10g、醋香附10g、川芎10g、乳香9g和没药9g，分别粉碎后混匀，加入适量食醋调制成泥状，即得中药组合物对比例2。
试验例1、本发明中药组合物对雌性大鼠乳腺增生模型的抑制作用
1、试验方法
取80只SD大鼠肌内注射0.5mg·kg-1·d-1雌激素，持续25天，然后肌内注射5mg·kg-1·d-1孕激素，持续5天，建立大鼠乳腺增生模型。当大鼠乳头的高度和直径明显增加，表示乳腺增生模型大鼠建立成功。
选择60只造模成功的SD大鼠，随机分为模型组、本发明实施例1-3组和对比例1-2组，每组10只，另取10只未造模的SD大鼠作为空白组。试验开始后，本发明实施例1-3组和对比例1-2组大鼠分别在乳头附近以2g/kg体重的剂量涂抹本发明实施例1-3和对比例1-2制备的中药组合物，空白组和模型组均涂抹等体积的蒸馏水。各试验组大鼠每天给药1次，持续给药30天。最后一次给药12h后，大鼠腹腔注射2.5％戊巴比妥溶液，并经颈椎脱臼处死。然后从腹部主动脉采集血样，离心后分离血清。严格按照试剂盒说明书的步骤进行操作，用ELISA法检测各试验组大鼠血清中雌激素(estrogen，E2)、孕酮(progesterone，P)和黄体生成素(luteinizing hormone，LH)的浓度。
2、试验结果
乳腺增生模型大鼠给予本发明中药组合物后血清中性激素水平变化如下表1所示。
表1各试验组大鼠在给药后血清中性激素E2、P和LH表达水平比较
| 试验组 | E2(pg/mL) | P(pg/mL) | LH(pg/mL) |
| 空白组 | 30.26±5.68 | 82.81±12.24 | 3.82±0.58 |
| 模型组 | 92.14±8.34 | 25.60±5.14 | 18.29±1.42 |
| 实施例1组 | 42.35±5.83 | 69.28±9.32 | 5.57±0.86 |
| 实施例2组 | 55.73±6.41 | 54.31±10.44 | 8.42±0.79 |
| 实施例3组 | 56.29±6.55 | 52.16±9.58 | 9.17±0.95 |
| 对比例1组 | 65.82±7.36 | 43.52±8.14 | 12.98±1.03 |
| 对比例2组 | 68.24±7.45 | 45.28±8.33 | 12.54±1.17 |
上表试验结果表明，与空白组相比，模型组大鼠雌激素和黄体生成素表达水平显著上调，孕激素表达水平显著下调，证实雌性大鼠乳腺增生模型构建成功。与模型组和对比例1-2组相比，本发明实施例1-3组大鼠经本发明中药治疗后雌激素和黄体生成素表达水平显著下调，孕激素表达水平显著上调(差异均具有统计学意义)，证实本发明中药组合物对乳腺增生大鼠的性激素水平具有显著调节作用。令人意外的是，本发明实施例1的中药组合物对模型大鼠的性激素调节作用最强，产生了难以预期的优异效果。上述试验结果表明，本发明的中药组合物具有显著改善模型大鼠性激素水平的效果，预期临床上可以用于乳痛症或乳腺增生患者的治疗。
虽然已经对本发明的具体实施方案进行了描述，但是本领域技术人员应认识到，在不偏离本发明的范围或精神的前提下可以对本发明进行多种改变与修饰。因而，本发明意欲涵盖落在附属权利要求书及其同等物范围内的所有这些改变与修饰。
Claims (10)
1.一种治疗乳痛症的中药组合物，其特征在于，所述中药组合物由蒲公英、炒枳壳、全瓜蒌、连翘、柴胡、醋青皮、醋香附、当归、乳香和没药制成。
2.根据权利要求1所述的中药组合物，其特征在于，所述中药组合物由蒲公英10-30重量份、炒枳壳8-20重量份、全瓜蒌8-20重量份、连翘8-20重量份、柴胡5-15重量份、醋青皮5-15重量份、醋香附5-15重量份、当归5-15重量份、乳香3-12重量份和没药3-12重量份制成。
3.根据权利要求2所述的中药组合物，其特征在于，所述中药组合物由蒲公英15-25重量份、炒枳壳10-15重量份、全瓜蒌10-15重量份、连翘10-15重量份、柴胡8-12重量份、醋青皮8-12重量份、醋香附8-12重量份、当归8-12重量份、乳香6-10重量份和没药6-10重量份制成。
4.根据权利要求3所述的中药组合物，其特征在于，所述中药组合物由蒲公英20重量份、炒枳壳12重量份、全瓜蒌12重量份、连翘12重量份、柴胡10重量份、醋青皮10重量份、醋香附10重量份、当归10重量份、乳香9重量份和没药9重量份制成。
5.根据权利要求1-4任一项所述的中药组合物，其特征在于，所述中药组合物进一步包括药学上可接受的辅料。
6.根据权利要求1-4任一项所述的中药组合物，其特征在于，所述中药组合物为外用制剂。
7.根据权利要求6所述的中药组合物，其特征在于，所述中药组合物的剂型为贴剂、软膏剂、散剂或凝胶剂。
8.权利要求1-7任一项所述中药组合物的制备方法，其特征在于，包含以下步骤：取处方量的蒲公英、炒枳壳、全瓜蒌、连翘、柴胡、醋青皮、醋香附、当归、乳香和没药，分别粉碎后混匀，任选的加入药学上可接受的辅料，即得。
9.根据权利要求8所述的制备方法，其特征在于，取处方量的蒲公英、炒枳壳、全瓜蒌、连翘、柴胡、醋青皮、醋香附、当归、乳香和没药，分别粉碎后混匀，加入适量食醋调制成泥状，即得。
10.权利要求1-7任一项所述中药组合物在制备治疗乳痛症的药物中的应用。
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