CN109420115A - 一种用于女性更年期综合征调理的中药方剂 - Google Patents
一种用于女性更年期综合征调理的中药方剂 Download PDFInfo
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Abstract
本发明公开了一种用于女性更年期综合征调理的中药方剂,涉及中药领域。其由含有下述重量配比的原料药制备而成:枸杞子10‑20份,杭菊花10‑20份,桑椹6‑15份,乌梅6‑15份,百合10‑20份,酸枣仁10‑20份,炙甘草10‑20份,淮小麦10‑30份,大枣6‑15份,砂仁3‑10份。本发明方剂具有滋补肝肾,生津止渴,养心安神的功效,适合用于女性更年期综合征的治疗与调养,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,为一种用于女性更年期综合征调理的中药方剂。
背景技术
女性更年期综合征为妇女在更年期出现的内分泌失调(性激素减少)和植物神经功能紊乱所致的一系列明显、严重的症状。更年期又称围绝经期,是妇女一生中从性成熟期进入老年期的一个过渡时期,此时卵巢功能逐渐消退至完全消失。更年期包括绝经前期(绝经前2~5年)、绝经期(更年期年龄绝经已达1年)、绝经后期(绝经1年后的生命时期,约为6~8年)。本病发病年龄大约在45~55岁之间,持续时间长短不一,约为2~10年,约2/3的妇女有症状表现。此外,年轻妇女由于行手术切除双卵巢或放射治疗后,也可出现类似症状。
更年期生理变化实际包括两个方面:卵巢功能衰退和机体老化。因卵巢功能衰退而使体内雌激素水平的降落在更年期综合征的诸多症状中起主要影响。更年期综合征的症状是多样化的,主要可归纳为三大类:
(1)阵发性烘热感、阵汗、皮肤潮红、心跳加快,还常有睡眠不佳、胸闷、头昏等,有的妇女还表现情绪不稳定、焦虑、抑郁、紧张、血压波动以及皮肤异样感觉等;
(2)外阴与内生殖器官萎缩、阴道干燥和性交痛,还易有膀胱炎与尿道炎;
(3)骨质疏松,常会引起周身疼痛,但骨折疏松到导致易骨折则在绝经若干年后(绝经后期)更为多见。
西医用于更年期综合征的药物主要是激素替代疗法,它抓住产生更年期综合征的根本原因是雌激素水平下降这一根本原因,通过外源补充激素的方法来治疗更年期综合征,往往见效较快,效果明显,但也存在明显不足。如:激素长期使用的耐药性,长期使用外源性激素会造成的严重的副作用,肝损害、子宫出血、增加子宫内膜癌、乳腺癌风险等。而采用中医中药进行调理,则可在改善更年期综合征各项症状的同时,避免这些不足。
中医认为,本病以肾阴虚为主,常累及心、肝、脾等脏,属于中医“不寐”、“脏躁”等病范畴。临床主要证型有肝肾阴虚、心肾不交。
本项发明的方剂为女性更年期综合征调理的核心处方,发明人多年来临床以此方为基础加减变化用于女性更年期综合征调理的病人逾千例,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女性更年期综合征调理的中药成药及相关食品。
发明内容
本项发明发明人总结多年经验,提供了一种专门应用于女性更年期综合征调理的中药方剂,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更年期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:
一种用于女性更年期综合征调理的中药方剂,其特征是由以下重量份的中药制成:
枸杞子10-20份,杭菊花10-20份,桑椹6-15份,乌梅6-15份,百合10-20份,酸枣仁10-20份,炙甘草10-20份,淮小麦10-30份,大枣6-15份,砂仁3-10份。
作为优选项:
所述中药原料重量份构成如下:枸杞子12-18份,杭菊花12-18份,桑椹9-12份,乌梅9-12份,百合12-18份,酸枣仁12-18份,炙甘草12-18份,淮小麦15-24份,大枣9-12份,砂仁3-6份。
再优选所述中药原料重量份构成为:枸杞子15份,杭菊花15份,桑椹10份,乌梅10份,百合15份,酸枣仁15份,炙甘草15份,淮小麦20份,大枣10份,砂仁6份。
本发明所述中药方剂的功能主治为:滋补肝肾,生津止渴,养心安神。用于女性更年期综合征,症见头面部烘热汗出,五心烦热,头晕耳鸣,心悸失眠,情志不宁,舌红少苔,脉细数等。
其组方方解即作用机理为:
方中枸杞滋补肝肾,菊花清热平肝,针对更年期综合征“阴常不足、阳常有余”基本病机而设,故为君药;桑椹滋补肝肾,兼生津止渴;百合养阴兼清心安神;酸枣仁补肝宁心用于虚烦不眠,敛汗生津用于多汗口渴;淮小麦养心安神,配伍甘草系《金匮要略》“甘麦大枣汤”之意,主治妇人脏躁,悲伤欲哭,精神恍惚等症;以上四药共为臣药;乌梅生津止渴,针对虚热烦渴而设,配甘草“酸甘化阴”;砂仁理气,配伍大队养阴药以滋阴不碍气;大枣养心安神;三药为佐药。甘草调和诸药,为使药。诸药相合,共奏滋补肝肾,生津止渴,养心安神之功。
组方中各配伍中药的药理作用阐述如下:
枸杞子:为茄科植物枸杞或宁夏枸杞的干燥成熟果实。味甘性平,归肝、肾经。功能滋补肝肾,益精明目。含有多糖,牛磺酸,γ-氨基丁酸,甜菜碱,阿托品,天仙子胺,玉蜀黍黄质,酸浆果红素,隐黄质,东莨菪素,胡萝卜素,硫胺素,核黄素,烟酸,维生素C等。种子含多种氨基酸、微量元素。现代药理证实有提高机体免疫力、降血糖、抗脂肪肝、抗疲劳等多种作用。临床常用于虚劳精亏,腰膝酸痛,眩晕耳鸣,内热消渴,血虚萎黄,目昏不明等。
菊花:为菊科植物菊的干燥头状花序。药材按产地和加工方法不同,分为“ 亳菊”、“滁菊”、“贡菊”、“杭菊”。甘、苦,微寒;归肺、肝经。功能散风清热,平肝明目。菊花含有含挥发油,腺嘌呤,胆碱,水苏碱,氨基酸,黄酮类等。挥发油主要含龙脑、樟脑、菊油环酮等。黄酮类有木犀草素-7-葡萄糖甙、大波斯菊甙、刺槐甙等。有一定的抗微生物、扩血管作用。
桑椹:为桑科植物桑的干燥果穗。甘酸性寒,归心、肝、肾经;功能补血滋阴,生津润燥。含有糖、糅酸、苹果酸及维生素B1、B2,C和胡萝卜素及黄酮等。用于眩晕耳鸣,心悸失眠,须发早白,津伤口渴,内热消渴,血虚便秘。
乌梅:为蔷薇科落叶乔木植物梅的未成熟果实。酸,涩,平。归肝,脾,肺,大肠经。功能敛肺止咳、涩肠止泻、生津止渴、安蛔。乌梅含柠檬酸、苹果酸、琥珀酸、碳水化合物、谷甾醇、蜡样物质及齐墩果酸样物质。有强杀菌性及提高肝脏功能的成分苦味酸及具有热镇痛作用的苦扁桃甙,果肉中尚含有较高活性的超氧化物歧化酶。临床常用于用于肺虚久咳,久痢滑肠,虚热消渴,蛔厥呕吐腹痛;胆道蛔虫症。
百合:为百合科植物百合、细叶百合、麝香百合及其同属多种植物鳞茎的鳞叶。味甘、微苦,性平。入心、肺经。具有润肺止咳、清心安神的功效。临床主治肺痨久嗽、咳唾痰血、热病后余热未清、虚烦惊悸、神志恍惚、脚气浮肿等。现代研究主要成分有秋水仙碱等多种生物碱及淀粉、蛋白质、脂肪、双磷脂酰甘油和磷脂肪酸等。药理证实具有止咳、祛痰、平喘、升高外周白细胞及抗过敏作用。
酸枣仁:为鼠李科植物酸枣的干燥成熟种子。甘、酸,平。归肝、胆、心经。功能养心补肝,宁心安神,敛汗,生津。用于虚烦不眠,惊悸多梦,体虚多汗,津伤口渴。酸枣仁含有脂肪油,蛋白质,生物碱,三萜皂苷,黄酮类化合物,氨基酸,甾醇,维生素C和多种微量元素。多种实验证明其有镇静催眠,强心抗心肌缺血,抗氧化,增强免疫等多种作用。
甘草:为豆科植物甘草. 胀果甘草和光果甘草的干燥根及根茎。其中炙甘草为取甘草片,照蜜炙法炒至黄色至深黄色,不粘手时取出,晾凉。味甘,性平。入心、肺、脾、胃经。具有补脾益气、和中缓急、润肺、解毒、调和诸药的功效。临床主治咽喉肿痛、消化性溃疡、痈疽疮疡,解药毒及食物中毒等。现代研究甘草主要含三萜类、黄酮类、生物碱类和多糖类物质。药理证实具有抗炎、抗过敏、解毒、解热镇痛、镇咳及肾上腺皮质激素样作用等作用。
小麦:为禾本科植物小麦的种子。味甘;性凉,归心、脾、肾经。功能养心;益肾;除热;止渴。主脏躁;烦热;消渴;泄利;痈肿;外伤出血;烫伤。
大枣:为鼠李科枣属植物枣的干燥成熟果实。味甘性温,归脾、胃经。功能补中益气,养血安神。用于脾虚食少,乏力便溏,妇人脏躁。
砂仁:为姜科植物阳春砂、绿壳砂或海南砂的干燥成熟果实。味辛性温。归脾、胃、肾经。具有化湿开胃,温脾止泻,理气安胎的功效。临床用于湿浊中阻,脘痞不饥,脾胃虚寒,呕吐泄泻,妊娠恶阻,胎动不安等。主含挥发油等。
临床研究
本发明所述的中药方剂经多年的临床验证及90例更年期综合征重症患者的临床试验资料统计显示,使用以本发明方剂为基本方治疗更年期综合征,经1疗程(90天)治疗后,采用更年期Kupperman评分分值减少程度作为主要疗效指标判定,本发明治疗组有效率为90%,西药激素替代疗法对照组为93.3%,中成药对照组为93.3%,经统计学分析,差异无统计学意义(P>0.05),三组疗效相当。但坚持随访一年后,能坚持使用原有方案进行治疗的,本发明治疗组为90%,西药组为46.67%,中成药对照组为66.7%,患者对本发明方的耐受性明显示优于其它两组对照组。本发明组所有病例未见不良反应。
典型临床病例
病例1:
李某,女,52岁。2013年7月*日初诊。 主诉:更年期综合征1年。现病史:绝经3年,潮热出汗2年,骨密度检查提示骨量减少。症见心烦易怒,失眠,烘热汗出,悲伤欲哭,大便干,舌质紫暗,苔黄厚,脉滑数。诊断:中医:绝经前后诸症。西医:更年期综合征。
治疗方案为本发明方剂为基本方治疗。治疗三个月后临床症状明显改善。潮热出汗已较前减轻,由原来的4~5次/d,降到0~1次/d,心烦及失眠症状消失。更年期Kupperman评分由初诊时的35分降至16分。随访一年,坚持用本发明方减量进行调养,诸症未再复发。
病例2:
朱某,女,52岁。2014年1月*日初诊。患者于二年前(50岁)绝经,绝经后即出现潮热、多汗、心烦、易激惹、乏力、睡眠障碍,并伴心慌、气短等不适症状,日渐加重,有时无法正常生活和工作,上述症状持续达两年时间,就诊**三甲医院妇科门诊,诊断为:更年期综合征。服替勃龙等激素治疗2月效果不明显。舌质紫暗,苔黄厚,脉滑数。中医诊断:脏躁(肾阴虚)。西医诊断:更年期综合征。
治疗方案为本发明方剂为基本方治疗。治疗三月后,更年期综合征症状明显减轻,更年期Kupperman评分由初诊时的40分降至14分。续服三月,诸症消失。坚持用本发明方减量进行调养,随访一年,诸症未再复发。
口感适应性研究:10名患更年期综合征女性,分别服用已上市治疗更年期综合征的成药更年安、更年灵、更年欣与本发明方剂的处方煎剂后,进行盲法评价,均认为本发明方煎剂的口感远优于其它叁种,长期服用更令人易于接受。
综上所述本发明所述方剂对更年期综合征的治疗安全有效,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
称取枸杞子15份,杭菊花15份,桑椹10份,乌梅10份,百合15份,酸枣仁15份,炙甘草15份,淮小麦20份,大枣10份,砂仁6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
称取枸杞子20份,杭菊花10份,桑椹6份,乌梅15份,百合10份,酸枣仁20份,炙甘草10份,淮小麦30份,大枣6份,砂仁10份。
制备步骤同实施例1。
实施例3
称取枸杞子10份,杭菊花20份,桑椹15份,乌梅6份,百合20份,酸枣仁10份,炙甘草20份,淮小麦10份,大枣15份,砂仁3份。
制备步骤同实施例1。
实施例4
称取枸杞子12份,杭菊花18份,桑椹9份,乌梅12份,百合12份,酸枣仁18份,炙甘草12份,淮小麦24份,大枣9份,砂仁5份。
制备步骤同实施例1。
实施例5
称取枸杞子18份,杭菊花12份,桑椹12份,乌梅9份,百合18份,酸枣仁12份,炙甘草18份,淮小麦15份,大枣12份,砂仁3份。
制备步骤同实施例1。
实施例6
称取枸杞子12份,杭菊花15份,桑椹10份,乌梅10份,百合18份,酸枣仁18份,炙甘草12份,淮小麦18份,大枣9份,砂仁6份。
制备步骤同实施例1。
实施例7
称取枸杞子18份,杭菊花18份,桑椹9份,乌梅12份,百合15份,酸枣仁15份,炙甘草18份,淮小麦24份,大枣10份,砂仁3份。
制备步骤同实施例1。
实施例8
称取枸杞子15份,杭菊花18份,桑椹12份,乌梅9份,百合12份,酸枣仁18份,炙甘草15份,淮小麦20份,大枣12份,砂仁6份。
制备步骤同实施例1。
实施例9
称取枸杞子12份,杭菊花18份,桑椹10份,乌梅12份,百合18份,酸枣仁12份,炙甘草18份,淮小麦18份,大枣9份,砂仁5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)
1.一种用于女性更年期综合征调理的中药方剂,其特征是由以下重量份的中药制成:
枸杞子10-20份,杭菊花10-20份,桑椹6-15份,乌梅6-15份,百合10-20份,酸枣仁10-20份,炙甘草10-20份,淮小麦10-30份,大枣6-15份,砂仁3-10份。
2.根据权利要求1所述的用于女性更年期综合征调理的中药方剂,其特征是由以下重量份的中药制成:
枸杞子12-18份,杭菊花12-18份,桑椹9-12份,乌梅9-12份,百合12-18份,酸枣仁12-18份,炙甘草12-18份,淮小麦15-24份,大枣9-12份,砂仁3-6份。
3.根据权利要求1所述的用于女性更年期综合征调理的中药方剂,其特征是由以下重量份的中药制成:
枸杞子15份,杭菊花15份,桑椹10份,乌梅10份,百合15份,酸枣仁15份,炙甘草15份,淮小麦20份,大枣10份,砂仁6份。
4.根据权利要求1-3所述的用于女性更年期综合征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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