CN105687517A - 一种用于治疗女性不孕症的药物 - Google Patents
一种用于治疗女性不孕症的药物 Download PDFInfo
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Abstract
本发明涉及一种用于治疗女性不孕症的药物，它是由以下重量配比的原料药材制备而成：阳桃根22份、羊红膻6份、地黄瓜12份、旋覆花6份、葫芦藓30份、红血藤12份、茺蔚子7份、王不留行8份、马鞭草22份。本发明运用：阳桃根祛风除湿，行气止痛，涩精止带；羊红膻健脾益气，养心安神，止咳祛痰；地黄瓜清热解毒，散瘀消肿，凉血止血；旋覆花消痰行水，降气止呕；葫芦藓祛风除湿，止痛止血；红血藤补血活血；茺蔚子活血调经，清肝明目；王不留行活血通经，不乳消痈；马鞭草清热解毒，活血通经，利水消肿，截疟。诸药合用，达到疏肝解郁、养血调经、温经散寒、活血益气之功效。临床实验证明，本发明能够安全有效治疗女性不孕症。
Description
技术领域
本发明涉及一种中药，具体涉及一种用于治疗女性不孕症的药物。
背景技术
凡生育年龄的妇女，婚后夫妇同居两年以上，配偶生殖功能正常，未避孕而未受孕者为女性不孕症。女性不孕症可分为原发不孕及继发不孕，从未怀孕者为原发性女性不孕症，曾有生育或流产后无避孕而两年以上不孕者为继发性女性不孕症。女性不孕症又可分为绝对不孕及相对不孕，绝对不孕指有先天性或后天性解剖上或功能上的缺陷，无法矫治而不能受孕者。相对性不孕指因某种因素阻碍受孕，产生暂时不孕。女性不孕症的原因很多，一类为不能排卵的女性不孕症，一类为不能怀孕的不育症，二者都可能是可逆的，也可能是不可逆的。根据统计，女性不孕约占60％，以输卵管及卵巢因素引起的女性不孕症占多数，本病的治疗，针对导致女性不孕症的原因进行治疗。本症发生的原因较多，主要为生殖器病变，如排卵障碍、输卵管闭阻、子宫内膜异位等。若是先天性的生理缺陷如无子富、无卵巢、无子宫内膜、实质性子宫和实质性输卵管等，则非药物所能解决。现代西医治疗本病无特殊药物。女性不孕症发病率为5％～10％，为妇科常见难治病之一。
不孕症，中医学称之“全不产”、“无子”、“断绪”等。
病因
①输卵管性不孕输卵管在捡拾卵子和运输卵子、精子和胚胎方面发挥着重要作用；输卵管也是精子获能，精卵相遇、受精的场所。感染和手术操作极易使输卵管黏膜受损，进而纤毛消失，蠕动障碍，以及阻塞或与周围组织粘连，影响输卵管的通畅性功能。因此，输卵管阻塞或通而不畅是女性不孕的重要原因。感染：盆腔感染是导致输卵管性不孕的主要因素。感染不仅引起输卵管阻塞，且因瘢痕形成，使输卵管壁僵硬和输卵管周围粘连，改变其与卵巢的关系，影响输卵管的拾卵及运送功能。感染的病原体可由需氧和厌氧菌所致，也可由衣原体、结核杆菌、淋病双球菌、支原体等所致。子宫内膜异位症：盆腔子宫内膜异位症、卵巢子宫内膜异位症可形成腹膜粘连带，使输卵管伞端外部粘连或卵巢周围粘连，使成熟卵不能被摄入输卵管；引起的广泛粘连还可影响受精卵的运行。输卵管结核：输卵管结核在生殖器结核中最常见，表现为输卵管增粗肥大、伞端外翻如烟斗状，甚至伞端封闭；输卵管僵直、结节状，部分可见干酪样团块或腹膜有粟粒样结节。约半数输卵管结核患者同时有子宫内膜结核。输卵管绝育：术后引起输卵管积水较常见，成为输卵管复通术后影响功能的重要因素。绝育术后输卵管近端组织和细胞的病变与绝育时间长短有关，因此绝育术后时间越长，复通成功率越低。
②排卵障碍导致的不孕慢性排卵障碍是很多内分泌疾病的共同表现，占妇女的20％～25％。临床表现主要为月经不规则甚至闭经，周期短于26天或长于32天提示有排卵异常。病史还可反映多毛症、男性化、溢乳及雌激素过少等内分泌病紊乱的信号。1993年世界卫生组织(WHO)制定了无排卵的分类标准，共分为三大类。WHOⅠ型(低促性腺激素性无排卵)，WHOⅡ型(正常促性腺激素性无排卵)，WHOⅢ型(高促性腺激素性无排卵)。WHOⅠ型：包括下丘脑闭经(压力、减重、锻炼、神经性厌食及其他)、Kallmann综合征(促性腺激素释放激素前体细胞移行异常)和促性腺激素缺陷等。典型的表现是低促性腺激素性腺功能减退：FSH低、E2低而泌乳素和甲状腺素正常。WHOⅡ型：临床上所碰到的大部分患者。即具有正常促性腺激素的卵巢功能紊乱，伴有不同程度的无排卵或月经稀发。包括：PCOS，卵泡膜细胞增生症和HAIRAN综合征(多毛，无排卵，胰岛素抵抗和黑棘皮症)。典型表现是：FSH、E2和泌乳素正常，但LH/FSH常异常升高。WHOⅢ型：患者主要是终末器官的缺陷或抵抗，表现为高促性腺激素性腺功能减退，包括卵巢早衰和性腺发育不全(卵巢抵抗)。典型表现为FSH及LH升高，低E2。这类患者的特点是对诱发排卵的反应差，卵巢功能已减退。
③免疫性不孕目前与不孕有关的自身抗体分两类：非器官特异性自身抗体和器官特异性自身抗体。前者指针对存在于不同组织的共同抗原的抗体，如抗磷脂抗体(APA)、抗核抗体(ANA)、抗DNA抗体等；后者指只针对某个特异性器官组织自身抗原的抗体如抗精子抗体(ASAb)、抗卵巢抗体(AOVAb)、抗子宫内膜抗体(AEMAb)和抗绒毛膜促性腺激素抗体(AhCGAb)等。目前对非器官特异性自身抗体针对的抗原性质比较了解，检测APA和ANA的技术也较为成熟和标准，临床资料丰富；而器官特异性自身抗体针对的抗原成分复杂，检测的标准化程度低，它们与不孕的关系亦因检测数据分析、统计困难而不易明确，从而影响对自身抗体阳性的不孕患者的处理。
④不明原因的不孕一对不孕夫妇所检查的各项指标都正常，而不孕原因又无法解释的时候，即诊断为不明原因的不孕症。推测不明原因不孕症的病因可能有以下几方面：不良的宫颈分泌物影响；子宫内膜对早期胚胎的接受性较差；输卵管的蠕动功能不良；输卵管伞端拾卵功能缺陷；黄素化不破裂综合征；轻微的激素分泌欠佳，如黄体功能不足；精子和卵子受精能力受损；轻度子宫内膜异位症；免疫因素，如抗精子抗体、抗透明带抗体或抗卵巢抗体；腹膜巨噬细胞功能异常；腹腔液中抗氧化功能受损。
临床表现
①病史：注意婚龄，月经及性生活情况，以往有无盆腔感染或盆腔手术史。
②体检：注意体型、第二性征发育，甲状腺有无增大，乳房有否泌乳等。
③妇科检查：注意内外生殖器官有无发育不良，畸形、炎症及肿块。
治疗
①治疗器质性病变，如积极治疗炎症，宫口狭窄，阴道横隔，处女膜肥厚五曲中瘤等。
②调整卵巢功能
促排卵：可用氯芪酚胺，三苯氧胺，绒毛膜促性腺激素，人类更年期促注腺激素(HMG)。如甲状腺功能低可用甲状腺素，可促进全身及内分泌系统的代谢。
促进或补充黄体功能：于月经周期第15天开始每日肌肉注射HCG1000单位或使用黄体酮。
改善宫颈粘液：于月经周期第5-15天，口服已烯雌酚0.25mg，可使宫颈粘液变稀，利于精子通过。
③输卵管堵塞
输卵管注药，当输卵管有轻度粘连或不完全阻塞时，可由宫腔、输卵管注入药液，药物可用抗菌素，地塞米松，透明质酸酶溶于生理盐水中，人液量随通畅程度而定，一般在月经干内后3天，每2-3天注人一次至排卵前，可连续2-3周期，无效者腹腔镜检查。
输卵管成形术，输卵管炎经保守治疗后无效者，可根据子宫输卵管碘油造影结果，根据阻塞不同部位，作输卵管成形术，分四种：输卵管粘连分离术，造口术，阻塞部分切除端与端吻合术，输卵管宫角植人术等。
④中药治疗
以髓入手，全身治疗，使病症开始好转，人体恢复正常生理机能。
本发明所涉及药材均可见记载于《中华本草》。
发明内容
本发明旨在提供一种用于治疗女性不孕症的药物，通过选择合适的药材及其配比，达到安全有效治愈女性不孕症的目的。
为了达到上述目的，本发明采用以下技术方案：
一种用于治疗女性不孕症的药物，其特征在于，它是由以下重量配比的原料药材制备而成：阳桃根22份、羊红膻6份、地黄瓜12份、旋覆花6份、葫芦藓30份、红血藤12份、茺蔚子7份、王不留行8份、马鞭草22份。
下面结合中药学理论说明本发明有益效果：
发明人认为，女性不孕症的病因，主要是先天不足，肾气虚弱，冲任失调或寒凝，或劳伤气血；其次是内伤七情而使肝气郁结，外感六淫而邪伢冲任以及瘀血停积，阴阳气血失调，致使月经紊乱而难于受孕。肾气虚弱，气滞血瘀是产生不孕症的重要机理。肾气虚弱：禀赋素虚，肾气不充，冲任失调或房事不节，损伤肾气。肾主藏元阴元阳，肾虚元阳不足，命门火衰，不能温煦冲任，胞宫因之不能摄精成孕。肝郁气滞：情怀不畅，善感多怒，肝气郁结，疏泄失常，致气机不利，血运不畅，冲任不得相资，难以摄精成孕。痰湿内阻：素体肥胖，恣食厚味，脾虚不运，痰湿内生，气机不畅，胞络受阻，以致胞宫不能摄精成孕。寒凝血瘀：素体阳虚，阴寒内生，胞宫失于温煦，或经期感受寒邪，寒凝胞宫，胞脉阻滞，气机不利，血运受阻，任脉不通以致不孕。血虚：体质素弱，阴血不足，或因失血伤阴，以致冲任空虚，血少不能摄精成孕。故治疗则采取养血补肾，调补冲任，健脾燥湿，化痰调经。
本发明运用：阳桃根祛风除湿，行气止痛，涩精止带；羊红膻健脾益气，养心安神，止咳祛痰；地黄瓜清热解毒，散瘀消肿，凉血止血；旋覆花消痰行水，降气止呕；葫芦藓祛风除湿，止痛止血；红血藤补血活血；茺蔚子活血调经，清肝明目；王不留行活血通经，不乳消痈；马鞭草清热解毒，活血通经，利水消肿，截疟。诸药合用，达到疏肝解郁、养血调经、温经散寒、活血益气之功效。
下面结合临床实验数据说明本发明的有益效果：
1、一般资料
发明人2012年7月-2014年11月间共收集60例女性不孕症患者。随机分为：治疗组30例，对照组30例。其中治疗组年龄23～33岁，病程2～8年；对照组年龄22～32岁间，病程2～7年。两组性别、年龄、病程等资料无显著性差异，具有可比性。
诊断标准
①婚后同居未避孕2年以上不孕者；
②妇科常规体检无异常者；
③月经稀发、基础体温(BBT)单相型或不典型双相体温；
④血清泌乳素(PRL)>21ng/ml。
纳入标准①符合诊断标准；②年龄18～70岁；③依从性好；④自愿签署知情同意书。
排除标准①妊娠、哺乳期妇女；②患有严重心、肺、肝、肾脏疾病患者；③有精神系统疾病，不能配合治疗者；④发病后经其他药物治疗的患者。
2、治疗方法
治疗组口服本发明按照具体实施例3制得的胶囊，每日3次。治疗3个月。
对照组口服溴隐亭片，每次2.5mg，每日2次。治疗3个月。
3、疗效标准与治疗结果
3.1疗效标准
①痊愈：PRL<21ng/ml，临床症状消失并妊娠，尿HCG(人绒毛膜促性腺激素)试验阳性，BBT高温相持续21天以上；
②有效：PRL明显下降，但仍>21ng/ml，临床症状好转，BBT仍为单相或不典型双相体温；
③无效：PRL下降不明显，临床症状有所好转，BBT仍为单相或不典型双相体温。
3.2治疗统计结果见表1。
表1两组疗效比较
可见，本发明制得的药物能够安全有效治疗女性不孕症，治愈率高。
具体实施方式
为了更好地理解和实施本发明，下面结合具体实施例进一步说明本发明。
实施例1
称取：阳桃根22克、羊红膻6克、地黄瓜12克、旋覆花6克、葫芦藓30克、红血藤12克、茺蔚子7克、王不留行8克、马鞭草22克；加8倍量水，煎煮1.5小时，过滤；滤渣加6倍量水，煎煮1小时，过滤；合并滤液，浓缩至120克，即得符合正常成人一天用量的煎剂。
用于治疗女性不孕症。口服，每日服用一次。
实施例2
称取：阳桃根22克、羊红膻6克、地黄瓜12克、旋覆花6克、葫芦藓30克、红血藤12克、茺蔚子7克、王不留行8克、马鞭草22克；加10倍量水，煎煮2小时，过滤；滤渣加8倍量水，煎煮1.5小时，过滤；合并滤液，浓缩，干燥，包装，即得符合正常成人一天用量的散剂。
用于治疗女性不孕症。口服，每日分早晚两次服用。
实施例3
称取：阳桃根22克、羊红膻6克、地黄瓜12克、旋覆花6克、葫芦藓30克、红血藤12克、茺蔚子7克、王不留行8克、马鞭草22克；加6倍量水，煎煮3次，每次煎煮1小时，合并煎煮液，浓缩，干燥，装入胶囊壳，即得符合正常成人一天用量的胶囊剂。
用于治疗女性不孕症。口服，每日分早中晚三次服用。
Claims (4)
1.一种用于治疗女性不孕症的药物，其特征在于，它是由以下重量配比的原料药材制备而成：阳桃根22份、羊红膻6份、地黄瓜12份、旋覆花6份、葫芦藓30份、红血藤12份、茺蔚子7份、王不留行8份、马鞭草22份。
2.如权利要求1所述的一种用于治疗女性不孕症的药物，其特征在于，其制备方法为：称取：阳桃根22份、羊红膻6份、地黄瓜12份、旋覆花6份、葫芦藓30份、红血藤12份、茺蔚子7份、王不留行8份、马鞭草22份；加8倍量水，煎煮1.5小时，过滤；滤渣加6倍量水，煎煮1小时，过滤；合并滤液，浓缩至120份，即得煎剂；上述份均是指重量份。
3.如权利要求1所述的一种用于治疗女性不孕症的药物，其特征在于，其制备方法为：称取：阳桃根22份、羊红膻6份、地黄瓜12份、旋覆花6份、葫芦藓30份、红血藤12份、茺蔚子7份、王不留行8份、马鞭草22份；加10倍量水，煎煮2小时，过滤；滤渣加8倍量水，煎煮1.5小时，过滤；合并滤液，浓缩，干燥，包装，即得散剂；上述份均是指重量份。
4.如权利要求1所述的一种用于治疗女性不孕症的药物，其特征在于，其制备方法为：称取：阳桃根22份、羊红膻6份、地黄瓜12份、旋覆花6份、葫芦藓30份、红血藤12份、茺蔚子7份、王不留行8份、马鞭草22份；加6倍量水，煎煮3次，每次煎煮1小时，合并煎煮液，浓缩，干燥，装入胶囊壳，即得胶囊剂；上述份均是指重量份。
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