CN109420088A - 一种用于高泌乳素血症调理的中药方剂 - Google Patents
一种用于高泌乳素血症调理的中药方剂 Download PDFInfo
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- CN109420088A CN109420088A CN201810969637.XA CN201810969637A CN109420088A CN 109420088 A CN109420088 A CN 109420088A CN 201810969637 A CN201810969637 A CN 201810969637A CN 109420088 A CN109420088 A CN 109420088A
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Abstract
本发明公开了一种用于高泌乳素血症调理的中药方剂，涉及中药领域。其由含有下述重量配比的原料药制备而成：玫瑰花6‑15份，炒麦芽30‑90份，炒山楂20‑50份，佛手10‑20份，桃仁6‑15份，内金10‑20份。本发明方剂具有疏肝解郁，活血通经回乳的功效，适合用于高泌乳素血症的治疗和调养，效果显著，且口感适宜，药味安全，适合开发为调养类中药食品长期服用。
Description
技术领域
本发明涉及中药领域，为一种用于高泌乳素血症调理的中药方剂。
背景技术
高泌乳素血症（hyperprolactinemia），是一类由多种原因引起的、以血清泌乳素升高及其相关临床表现为主的下丘脑-垂体轴生殖内分泌紊乱综合征，是临床上常见的、可累及生殖、内分泌和神经系统的一类疾患的统称。目前，一般以血清泌乳素水平高于1.14nmol/L（25μg/L）为标准，因检测方法不一，各单位的正常值参考范围略有差异。患者在临床上常可表现为闭经、泌乳、月经频发、月经稀少、不孕、性功能减退、头痛、肥胖等症状，患者可因此就诊于妇产科、生殖医学科、男科、乳腺科、神经内科和神经外科。现代医学认为高泌乳素血症是由于多种因素引起垂体前叶嗜酸性细胞分泌过多的PRL所致。泌乳素升高可使下丘脑-垂体-性腺轴功能紊乱，从而使女性发生上述一系列症状。流行病学目前报道的人群发病率差异较大，最常见于生育年龄女性。一般而言，约占育龄妇女的0.4%，月经异常妇女的5%，生殖功能异常妇女的17%。高泌乳素血症目前仍以药物治疗为主，手术治疗及放疗为辅，根据个体化原则进行选择治疗。该病因复杂，常顽固难愈。目前，西医对本病的治疗的药物治疗主要包括麦角碱衍生物，最常用者是多巴胺受体激动剂，以及辅助的促排卵药物（欲生育患者）和激素替代治疗。最常用的多巴胺受体激动剂是溴隐停，但由于该药为进口药，药源少，副作用大，从而限制了其临床应用。且多多巴胺受体激动剂治疗都是可逆的，需要长期维持治疗。高泌乳素血症属中医“溢乳”、“不孕”、“闭经”等范畴，中医药对高泌乳血症有其独特的疗效，且无西药的诸多副作用。
本项发明的方剂为发明人从多年临床治疗妇科疾病经验的基础上总结出来用于高泌乳素血症调理的核心处方，发明人多年来临床以此方为基础加减变化用于高泌乳素血症调理，取得良好效果。本发明权利要求所主张的药材含量范围为专门针对于成药及食品开发而设计的处方量，其处方药材使用量构成变化情况从未公开外泄，本发明方剂的组方及用药剂量都非常精炼合理，使用安全，特别适合开发成用于高泌乳素血症调理的中药成药及相关食品。
发明内容
本项发明发明人认为高泌乳素血症的主要病机系肝郁血瘀。以此病机为基础，结合多年经验，推导出本发明用于高泌乳素血症调理的中药方剂，该方剂具有疗效确切，组方精炼安全，耐受性好，并因调理须长期服药而专程针对于育龄女性人群的口感进行组方设计以增强其服用的依从性，适合中药新药及食品开发的特点。
本发明采用的技术方案是：
一种用于高泌乳素血症调理的中药方剂。其特征是由以下重量份的中药制成：
玫瑰花6-15份，炒麦芽30-90份，炒山楂20-50份，佛手10-20份，桃仁6-15份，内金10-20份。
作为优选项：
所述中药原料重量份构成如下：玫瑰花9-12份，炒麦芽50-60份，炒山楂24-40份，佛手12-28份，桃仁9-12份，内金12-18份。
再优选所述中药原料重量份构成为：玫瑰花10份，炒麦芽60份，炒山楂30份，佛手15份，桃仁10份，内金15份。
本发明所述中药方剂的功能主治为：疏肝解郁，活血通经回乳。用于肝郁血瘀所致女性高泌乳素血症。其组方方解即作用机理为：
方中玫瑰花疏肝解郁，活血化瘀，针对主要病机而设；麦芽回乳，《中国药典》2005版一部记载“回乳炒用60g”，现代药理研究表明本品可显著减低血清PRL水平，两者共为君药；佛手疏肝解郁，炒山楂活血化瘀通经，桃仁破血逐瘀通经，三者共为臣药；内金消食和胃，为佐药。诸药合用，共奏疏肝解郁，活血通经回乳之功。
组方中各配伍中药的药理作用阐述如下：
玫瑰花：为蔷薇科植物玫瑰Rosa rugosa Thunb.的干燥花蕾。甘、微苦，温。归肝、脾经。功能行气解郁，和血，止痛。用于肝胃气痛，食少呕恶，月经不调，跌扑伤痛。含有挥发油、槲皮甙、苦味质、鞣质、脂肪油、有机酸（没食子酸）、红色素、黄色素、蜡质、β-胡萝卜素等。挥发油的主要成分有主要成分为香茅醇、牻牛儿醇、橙花醇、丁香油酚、苯乙醇等。
麦芽：为禾本科植物大麦Hordeum vulgare L. 的成熟果实经发芽干燥而得。将麦粒用水浸泡后，保持适宜温、湿度，待幼芽长至约0.5cm 时，晒干或低温干燥。麦芽有生麦芽，炒麦芽和焦麦芽。本发明用炒麦芽。味甘性平，归脾、胃经。麦芽含有α-及β-淀粉酶，催化酶，过氧化异构酶等。另含大麦芽碱，大麦芽胍碱A、B，腺嘌呤，胆碱，蛋白质，氨基酸，维生素D、D、E，细胞色素C等。功能行气消食，健脾开胃，退乳消胀。用于食积不消，脘腹胀痛，脾虚食少，乳汁郁积，乳房胀痛，妇女断乳。
山楂(炒）：为蔷薇科植物山里红Crataegus pinnatifida Bge.var.majorN.E.Br.或山楂Crataegus pinnatifida Bge.的干燥成熟果实，除去杂质及脱落的核，放锅内，炒至浅棕黄色。味辛、甘，性微温。入脾、胃、肝经。具有消食健胃，行气散瘀的功效。临床用于肉食积滞，胃脘胀满，泻痢腹痛，瘀血经闭，产后瘀阻，心腹刺痛，疝气疼痛；高脂血症等。现代研究主要有效成分为黄酮类成分和三萜类成分，有左旋儿表茶精，槲皮素，金丝桃甙，熊果酸，绿原酸，枸橼酸，枸橼酸单甲酯，枸橼酸二甲酯，枸橼酸三甲酯，黄烷聚合物等。药理证实具有促消化、强心、降血压、降血脂、抗氧化、提高免疫力等作用。
佛手：为芸香科柑橘属植物佛手Citrus medica L. var. sarcodactylisSwingle 的干燥果实。辛、苦、酸，性温。归肝、脾、肺经。功能舒肝理气，和胃止痛。含有柠檬油素，6，7-二甲氧基香豆精，3，5，8-三羟基-4＇，7-二甲氧基黄酮，柠檬苦素，胡萝卜甙，β-谷甾醇，对-羟基苯丙烯酸，棕榈酸，琥珀酸等。药理实验证明有抗炎、平喘、祛痰、抗心肌缺血、抑制消化道平滑肌痉挛等作用。临床常用于肝胃气滞，胸胁胀痛，胃脘痞满，食少呕吐等。
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。味甘苦，性平。入心、肝。大肠经。具有活血祛瘀，润肠通便的功效。临床用于经闭，痛经，癓瘕痞块，跌扑损伤，肠燥便秘等。现代研究其含有桃仁含苦杏仁甙，挥发油，脂肪油，葡萄糖，蛋白质，蔗糖等；油中主含油酸甘油酯和少量亚油酸甘油酯。另含苦杏仁酶等。药理证实具有扩张血管、降低血粘稠度、抗炎、抗过敏等作用。
内金：为雉科动物家鸡Gallus gallus domesticus Brisson的干燥沙囊内壁。味甘，性平。入脾、胃、小肠、膀胱经。具有健胃消食，涩精止遗的功效。临床用于食积不消，呕吐泻痢，小儿疳积，遗尿，遗精等。主要成分有胃激素、角蛋白、多种氨基酸胃蛋白酶、淀粉酶、多种维生素及微量元素等。药理证实具有促进胃液分泌量、酸度及消化力，促进胃蠕动等作用。
临床研究
本发明所述的中药方剂经多年的临床验证及36例高泌乳素血症妇科病人临床验证，以三个月为一疗程，结果显示所有病人的PRL（泌乳素）均有不同程度的下降，91.67%的病人PRL降到了25μg/L以下。所有病例均未见不良反应。坚持用本发明方减量进行食疗调养，随访一年，PRL均维持25μg/L以下。
典型临床病例
病例1：
张某，女，24岁，未婚。2010年6月*日初诊。 主诉：月经量少3个月。现病史：患者3个月来不明原因朋经量少，色暗红无血块，经前两侧乳胀痛，心烦急燥，月经周期正常。查体双侧乳房未触及明显包块，挤压乳晕可见少许白色水状物溢出。舌质暗，苔薄白，脉弦。内分泌查PRL80μg/L，头颅CT检查未见异常。诊断：高泌乳素血症，中医辨证肝郁血瘀。治疗方案为本发明方剂为基本方治疗。治疗三个月后，乳房胀痛及溢乳症状均消失，月经量恢复正常，内分泌查PRL23μg/L。坚持用本发明方减量进行食疗调养，随访一年，PRL均维持正常值。
病例2：
肖某，女，29岁，已婚。2011年10月*日初诊。 主诉：因工作紧张已闭经6个月，当前两侧乳胀痛，心烦急燥。查体双侧乳房未触及明显包块，挤压乳晕可见少许白色水状物溢出。舌质暗紫，苔薄，脉滑。内分泌查PRL88μg/L，头颅CT检查未见异常。诊断：高泌乳素血症（闭经），中医辨证肝气郁结，冲任不调。治疗方案为本发明方剂为基本方治疗。治疗三个月后，月经恢复，乳房胀痛及溢乳症状均消失，内分泌查PRL16μg/L。坚持用本发明方减量进行食疗调养，随访一年，PRL均维持正常值，月经正常。
综上所述本发明所述方剂对高泌乳素血症的调理，安全有效，非常适合开发成中药制剂。另外本发明方剂均为药食同源类药材，服用安全，口感适宜，患者使用的耐受性较其它药物更好，也非常开发成调理型中药类食品。
具体实施方式
以下结合实施例对本发明作进一步的说明。
实施例1
称取玫瑰花10份，炒麦芽60份，炒山楂30份，佛手15份，桃仁10份，内金15份。
制备步骤：
将所称取的各味中药，按传统工艺煎成汤剂或按常规的中成药制剂工艺加工成中国药典中所定义的片剂、丸剂、胶囊、颗粒剂、散剂或口服液等临床主要中成药制剂或依照常规食品加工工艺制成食品。
实施例2
称取玫瑰花6份，炒麦芽90份，炒山楂20份，佛手20份，桃仁15份，内金20份。
制备步骤同实施例1。
实施例3
称取玫瑰花15份，炒麦芽30份，炒山楂50份，佛手10份，桃仁6份，内金10份。
制备步骤同实施例1。
实施例4
称取玫瑰花9份，炒麦芽50份，炒山楂40份，佛手12份，桃仁12份，内金18份。
制备步骤同实施例1。
实施例5
称取玫瑰花12份，炒麦芽60份，炒山楂24份，佛手18份，桃仁9份，内金12份。
制备步骤同实施例1。
实施例6
称取玫瑰花10份，炒麦芽50份，炒山楂36份，佛手15份，桃仁9份，内金12份。
制备步骤同实施例1。
实施例7
称取玫瑰花9份，炒麦芽60份，炒山楂27份，佛手12份，桃仁9份，内金15份。
制备步骤同实施例1。
实施例8
称取玫瑰花10份，炒麦芽55份，炒山楂32份，佛手18份，桃仁12份，内金18份。
制备步骤同实施例1。
实施例9
称取玫瑰花9份，炒麦芽60份，炒山楂24份，佛手12份，桃仁10份，内金12份。
制备步骤同实施例1。
以上内容仅仅是对本发明如何实施所作的举例说明，而非本发明的保护范围，所属本技术领域的技术人员对所描述的具体实施例做的各种修改或补充或采用类似的方式替代，只要不偏离发明的结构或超越本权利要求书所定义的范围，均应属于本发明的保护范围。
Claims (4)
1.一种用于高泌乳素血症调理的中药方剂，其特征是由以下重量份的中药制成：
玫瑰花6-15份，炒麦芽30-90份，炒山楂20-50份，佛手10-20份，桃仁6-15份，内金10-20份。
2.根据权利要求1所述的用于高泌乳素血症调理的中药方剂，其特征是由以下重量份的中药制成：
玫瑰花9-12份，炒麦芽50-60份，炒山楂24-40份，佛手12-18份，桃仁9-12份，内金12-18份。
3.根据权利要求1所述的用于高泌乳素血症调理的中药方剂，其特征是由以下重量份的中药制成：
玫瑰花10份，炒麦芽60份，炒山楂30份，佛手15份，桃仁10份，内金15份。
4.根据权利要求1-3所述的用于高泌乳素血症调理的中药方剂在用于制备药品及食品主要制剂中的应用。
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