CN1301123C - 一种用于治疗气滞血瘀型的女性月经失调的药物 - Google Patents
一种用于治疗气滞血瘀型的女性月经失调的药物 Download PDFInfo
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- CN1301123C CN1301123C CN 200410073078 CN200410073078A CN1301123C CN 1301123 C CN1301123 C CN 1301123C CN 200410073078 CN200410073078 CN 200410073078 CN 200410073078 A CN200410073078 A CN 200410073078A CN 1301123 C CN1301123 C CN 1301123C
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Abstract
本发明公开了一种治疗女性月经失调(气滞血瘀证)的药物，它以当归、赤芍、川芎、桃仁、红花、桔梗、牛膝、枳壳、柴胡、香附、乌药、丹参、延胡索、升麻、甘草共十五味中药材为原料制备而成。本发明药物具有疏肝理气，活血止痛的功效，临床用于治疗妇女月经过少，经期后错，行经不畅，经色暗红有血块，小腹或少腹疼痛，乳房胀痛或伴有黄褐斑等面部色素沉着等病症的效果显著，对人体无不良反应。
Description
所属技术领域本发明属于医药品的制备技术领域，涉及一种以中草药为原料制备的用于治疗女性月经失调(气滞血瘀证)的中成药。
背景技术
随着社会进步及妇女地位和社会生活水平的提高，女性健康越来越受到关注，关于妇科病的防治已成为当今医学界研究的一个重要课题。在以往针对妇科病的临床问诊中，月经失调(气滞血瘀证)类病症诸如常见的月经过少，经期后错，行经不畅，经色暗红有血块，小腹或少腹疼痛，乳房胀痛或伴有黄褐斑等面部色素沉着等病症通常都被医师认为是较难施治的疾病，它们至今仍是严重危及女性身心健康的重要疾病。现代治疗技术和西药的广泛应用，使上述疾病在治疗水平上有一定的提高，就医药市场而言，同类产品也较多。但目前西医临床用药大多仅限于单一疾患的对症治疗，其诊治方法往往是使用大量的抗菌消炎药物，一般只能达到缓解症状的作用，不能彻底治愈，治标不治本，兼之由于大剂量药物的作用，容易在患者体内产生副作用，造成体内分泌的严重失调，反而加重了患者病情；而迄今国内研制的一些妇科中药如痛经丸等亦存在有对疾病针对性不强或作用不明显的缺陷，有些产品服药时间也过长，造成患者心理上的痛苦，压力大，也容易因此导致患者体内的抗药性。
发明内容
本发明的目的在于对现有技术存在的问题加以解决，进而提供一种以中草药为原料制备的用于治疗女性月经失调(气滞血瘀证)的药物，以有效治疗妇女月经过少，经期后错，行经不畅，经色暗红有血块，小腹或少腹疼痛，乳房胀痛，或伴有黄褐斑等面部色素沉着等病症。
本发明所述的中药制剂是发明设计者以中医气血理论和妇科生理病理特点为依据，借鉴当代国内外中医药治疗妇科病的研究成果，经长期临床试验，反复筛选和验证而最后研制获得的。祖国医学早在两千年以前就提到气血治疗的重要性。中国传统医学理论中一个重要的组成部分气血理论认为，气血循环过程乃是人体一切组织器官进行生理活动的能量物质基础。气血以流畅和平衡为贵，如果气血失去流畅就会产生瘀血，瘀血阻于体内，反过来又会进一步导致气血循环内环境因素的恶化而造成更严重的瘀塞，故中医有以气血为纲、调气活血、而致平衡的祛病强身、养血美容的完整的理论体系。又中医观点认为，气血的活性能汲及生物属性对个体容光焕发和气质、情绪等的表达有直接影响。气血是维持人体生命机能的主要物质，二者相互依存，互相为用，气为血之帅，血随之而运行；血为气之守，气得之而静谧。气结则血凝，气虚则血脱，气迫则血走。气血和则俱和，病则俱病，二者只能相得，不能相失，相失则诸病丛生。《内经》对气血的论述，无论在生理、病理治疗上都很重视。如《至真要大论》曰：“谨守病机，各司其属有者求之，无者求之，盛者责之，心先五脏，疏其血气，令其条达，而臻和平”。而气血平和才能“长有天命”。强调治病主要关健之一是调理气血，使其正常。再如《阴阳应象大论》曰：“审其阴阳以别柔刚，阳病治阴，阴病治阳，定其气血，各守其乡……”，指出了治疗疾病的重点应气血。根据上述理论并针对妇科病证与气血正常与否密切相关的机理，本发明设计者精选出15味药效集中且易于为人体吸收的中药原料制备成复方，该方以活血化瘀、疏肝理气为立方原则，在对女性月经失调(气滞血瘀证)类病症的治疗和预防方面均具有极好的疗效。
构成本发明所述药物的各组分原料的重量配比为：当 归34～50；赤 芍34～50；川 芎34～50；桃 仁34～50；红 花27～40；桔 梗27～40；牛 膝22～33；枳 壳22～33；柴 胡27～40；香 附22～33；乌 药22～33；丹 参27～40；延胡索27～40；升 麻22～33；甘 草22～33。
上述药物剂方以活血化瘀、疏肝理气为立方原则，其中以当归、赤芍为君，加川芎有四物汤之意，具活血补血作用；以桃仁、红花破血祛瘀，合成桃红四物之义，攻中有补，以此行血分之瘀，柴胡、香附疏肝解郁，丹参活血祛瘀，延胡索理气止痛此七味为臣；佐以桔梗开利上焦之气；枳壳中消积以健脾，乌药、牛膝引诸药下行补肾；使以升麻引药上行以助诸药华颜面荣气血，加以甘草健脾调经共奏调和气血、止痛消斑之功效。
本发明所述的用于治疗女性月经失调(气滞血瘀证)的药物可以制成药剂学上所说的多种剂型，如胶囊剂、片剂等剂型。胶囊剂或片剂的实际制法是将上述重量配比的十五味中药原料，粉碎成细粉，过筛，混匀，装胶囊或压片，即制得本发明胶囊剂或片剂。
本发明提供的是一种治疗女性月经失调(气滞血瘀证)的天然药物，用于妇女月经过少，经期后错，行经不畅，经色暗红有血块，小腹或少腹疼痛，乳房胀痛，或伴有黄褐斑等面部色素沉着。为证明其治疗效果及安全性，发明者使用按上述提供的处方制备得到的胶囊剂进行了毒理学、药效学和临床试验，研究结果如下：1、与功能主治有关的药效学研究经对本发明胶囊剂试验结果表明，该药对老龄大鼠性激素有一定的促进分泌作用；可以明显提高老龄小鼠血清超氧化物歧化酶(SOD)活性，降低肝组织过氧化脂质(LPO)，降低心肌脂褐素含量，具有明显的抗衰老作用；可显著提高小鼠碳粒廓清速率，提示对小鼠单核巨噬细胞系统的吞噬功能有一定的提高作用；能加速正常小鼠肠系膜微循环血流速度，有一定改善微循环作用。
2、毒理研究动物急性毒性实验表明本发明胶囊剂药液小白鼠灌胃给药的半数致死量大于37.5g/kg，属于无毒级药物；最大耐受量为每日37.5g/kg，相当于临床人用量468倍。本发明胶囊剂不同剂量对大鼠灌胃60天的长期毒性实验结果表明，大白鼠外观体征、行为活动、食量及体重均无异常，血液常规及血液生化学指标检测结果正常；脏体系数无明显异常，系统尸解和病理组织学检查表明无明显病理改变；未发现毒性反应，大鼠无毒性反应剂量为8g/kg/日，相当于临床人用量100倍。
3、临床研究本发明药物由当归、赤芍、川芎、桃仁、红花、丹参等组成，具有疏肝理气、活血止痛的功能，适用于妇女月经过少，经期后错，经行不畅，经色黯红有血块，小腹或少腹疼痛，乳房胀痛，或伴有黄褐斑等面部色素沉着。临床试验疗程为12周，采用随机盲法分治疗组和对照组，验证组入组315例，服用本发明药物胶囊剂，每次4粒(每粒装0.4g)，每日3次；对照组入组105例，服用逍遥丸，每次8粒，每日3次。在陕西省中医医院等三家医院同时进行临床验证工作，其中试验组完成312例，脱落3例(0.95％)，对照组完成103例(1.9％)。可比性分析结果表明治疗前，在性别、年龄、病程、病情、中医症状、血常规、肝肾功能检查和尿粪常规检查、心电图、妇科检查和B超检查等方面，组间差异无统计学意义，提示可比性合格。疗效分析结果表明验证组愈显率62.2％，总有效率88.1％；对照组愈显率52.4％，总有效率75.7％，两组比较无统计学意义(P＞0.05)。疗效影响因素分析结果表明年龄、病程、病情对两组疗效无明显影响(P＞0.05)。安全性分析结果表明临床验证期间，未发生明显不良反应。经血、尿、便常规、心电图及肝肾功能检测说明本发明胶囊剂对血、尿、便常规及心、肝、肾功能均无不良影响。
Claims (1)
1.一种用于治疗气滞血瘀型的女性月经失调的药物，其特征在于它是由下述重量配比的中药原料制成的药剂学所说的药剂：当归34～50； 赤芍34～50； 川芎34～50； 桃仁34～50；红花27～40； 桔梗27～40； 牛膝22～33； 枳壳22～33；柴胡27～40； 香附22～33； 乌药22～33； 丹参27～40；延胡索27～40；升麻22～33； 甘草22～33。
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| CN100998722B (zh) * | 2006-12-28 | 2010-04-21 | 王玉秀 | 一种治疗月经后期痛经的内服中药 |
| CN1994417B (zh) * | 2006-12-28 | 2010-05-12 | 王玉秀 | 一种治疗月经量多型痛经的内服中药 |
| CN102716294A (zh) * | 2012-06-28 | 2012-10-10 | 舒佰成 | 一种治疗妇科痛经病的中药散剂 |
| CN103251769B (zh) * | 2013-05-03 | 2015-03-11 | 吉林万通药业集团梅河药业股份有限公司 | 一种妇科调经片及其制备方法 |
| CN104069274A (zh) * | 2014-04-10 | 2014-10-01 | 黄红妹 | 一种治疗月经失调的中药组合物 |
| CN104606395A (zh) * | 2014-12-11 | 2015-05-13 | 青岛佰众化工技术有限公司 | 一种治疗经行发热的中药方剂 |
| CN105194059A (zh) * | 2015-11-09 | 2015-12-30 | 济南新时代医药科技有限公司 | 一种治疗人工流产术后月经过少的中药 |
| CN105194192A (zh) * | 2015-11-10 | 2015-12-30 | 叶建斌 | 一种治疗月经后期的中药口服液及制备方法 |
| CN105381141A (zh) * | 2015-11-18 | 2016-03-09 | 杜英凤 | 治疗痛经的浸液片的制备方法 |
| CN105687600A (zh) * | 2016-04-06 | 2016-06-22 | 王保安 | 一种治疗更年期综合症的中药组合物及其制备方法与应用 |
| CN105748813A (zh) * | 2016-04-06 | 2016-07-13 | 王保安 | 一种预防/治疗子宫肌瘤的中药组合物及其制备方法与应用 |
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