CN110840980A - 一种治疗女性不孕不育的中药组合物及其制备方法 - Google Patents

一种治疗女性不孕不育的中药组合物及其制备方法 Download PDF

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CN110840980A
CN110840980A CN201810867548.4A CN201810867548A CN110840980A CN 110840980 A CN110840980 A CN 110840980A CN 201810867548 A CN201810867548 A CN 201810867548A CN 110840980 A CN110840980 A CN 110840980A
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于金霞
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Abstract

本发明公开一种治疗女性不孕不育的中药组合物，原料药包括柴胡、当归、酒炙白芍、川芎、木香、羌活、益母草、香附、杜仲、肉桂、炒小茴香、枸杞、刘寄奴、泽兰、牛膝、胎盘，以理气活血、补肾为根本法则。兼证时，若输卵管阻塞者，可加穿山甲、鳖甲、全蝎；兼痰湿者去白芍，加茯苓、佩兰；兼经前乳胀者，加炒麦芽。

Description

一种治疗女性不孕不育的中药组合物及其制备方法
技术领域
本发明涉及中医药技术领域，具体为一种女性治疗不孕不育的药物及其制备方法。
背景技术
据国家权威部门的统计，目前，全国有育龄夫妇约2.3亿人，据分析不孕不育的发生率约占生育年龄妇女的15-20%，其中，女方因素约为60%左右，对于女性不孕不育的原因分类有很多种，比如性疾，糖尿病等疾病因素，个人心理因素，环境和工业毒物增加等。从女性病因学分类来看，排卵因素、输卵管因素、宫颈因素和内膜异位症是女性不孕症的主要原因。男性方面，主要包括精子成活率降低的因素、输精管因素、异常精液、性功能障碍等。中医认为受孕的机理主要是肾气旺盛，经血充沛，任脉通，冲脉盛，月事如期，两精相博，方能成孕。若先前肾气不足，冲任气血失调，即难受孕成胎。
中医治疗主要有调经促孕丸、培坤丸、保胎灵、妇科养荣丸等。西医治疗主要有：1、药物疗法：绒毛膜促腺性激素、睾丸酮的应用、克罗米酚、精氨酸、维生素类、硫酸锌糖浆等；2、对症治疗：精液不液化的治疗；死精症的治疗；不射精的治疗；免疫性不育的治疗；3、手术治疗：因精索静脉曲张所致的不育者，可施行精索内静脉高位结扎术；对输精管道X线造影发现某一段精道有梗阻者，可将梗阻病灶切除，把输精管与梗阻近端吻合，以恢复精子的通道。
发明内容
为了解决现有技术存在的上述问题，本发明提供了一种治疗女性不孕不育的中药组合物及其制备方法。
本发明所采用的技术方案为：
一种治疗女性不孕不育的中药组合物，包括如下重量份的原料制备而成：
柴胡10-40，当归10-30，酒炙白芍10-40，川芎8-15，木香8-15，羌活10-30，益母草10-40，香附10-40，杜仲10-40，肉桂10-30，炒小茴香8-20，枸杞10-40，刘寄奴10-30，泽兰10-30，牛膝8-15，胎盘8-15。兼证时，若输卵管阻塞者，可加穿山甲、鳖甲、全蝎10-20；兼痰湿者去白芍，加茯苓、佩兰10-20；兼经前乳胀者，加炒麦芽10-20份。
颗粒剂制备方法：
（1）按重量份数称取原料药，分别干燥、粉碎处理后，得到细粉，将细粉充分混合，待用；
（2）向步骤（1）所述混合原料加入乙醇并在40-80℃回流提取1-2h，回收乙醇后得到提取液；将提取液依次进行过滤、浓缩、干燥、粉碎处理，得到初步颗粒；
（3）将步骤（2）颗粒加入适量的糖粉与糊精，混合均匀，必要时再加入适量乙醇，调整湿度制成软材，然后过筛、干燥、最后整粒过筛即得颗粒剂。
汤剂制备方法：
（1）按重量份数称取原料药，混合后加入水没过药面1-2厘米，浸泡；
（2）在40-90℃条件下煎煮1-2h，煎煮2-4次，得煎煮液；
（3）合并煎煮液，过滤、浓缩、即得汤剂。
所述中药组合物还可以包括浸膏剂、酒剂、丸剂、散剂、胶囊或片剂；
优选颗粒剂、浸膏剂、口服液、酒剂。
配伍原则：
中医理论认为，妇女不孕症主要由于肾和气血的功能失调，故对肾和气血的调理尤为重要，因此本申请以理气活血、补肾为根本法则。以柴胡、香附、白芍、益母草为君药，注重理气活血，杜仲、枸杞胎盘为臣药，发挥补益肝肾之功；而加入肉桂、小茴香、羌活可以温暖子宫、卵泡，促进精子着床率。牛膝、川芎、木香等为使药进一步活血行气。兼证时，若输卵管阻塞者，可加穿山甲、鳖甲、全蝎；兼痰湿者去白芍，加茯苓、佩兰；兼经前乳胀者，加炒麦芽。
各原料药来源、功效如下：
柴胡：来源：伞形科植物柴胡Bupleurumchinense DC.或狭叶柴胡BupleurumscorzonerifoliumWilld.的干燥根。性味：苦，微寒。归肝、胆经。功能主治：和解表里，疏肝，升阳。用于感冒发热，寒热往来，胸胁胀痛，月经不调，子官脱垂，脱肛。
当归：来源：伞形科植物当归Angelica sinensis（Oliv.） Diels 的干燥根。性味：甘、辛，温。归肝、心、脾经。功能主治：补血活血，调经止痛，润肠通便。用于血虚萎黄，眩晕心悸，月经不调，经闭痛经，虚寒腹痛，肠燥便秘，风湿痹痛，跌扑损伤，痈疽疮疡。酒当归活血通经。用于经闭痛经，风湿痹痛，跌打损伤。
白芍：来源：本品为毛茛科植物芍药Paeonialactiflora Pall. 的干燥根。性味：苦、酸，微寒。归肝、脾经。功能主治：平肝止痛，养血调经，敛阴止汗。用于头痛眩晕，胁痛，腹痛，四肢挛痛，血虚萎黄，月经不调，自汗，盗汗。酒炒白芍：取白芍片以酒拌匀，稍闷，待酒被吸尽，用文火炒至微黄色，取出摊凉。酒制后偏于养血活血，血虚兼寒凝血瘀之症最宜。
川芎：来源：伞形科植物川芎Ligusticum chuanxiong Hort.（或LigusticumwallichiiFranch.）的干燥根茎。性味：辛，温。归肝、胆、心包经。功能主治：活血行气，祛风止痛。用于月经不调，经闭痛经，症瘕腹痛，胸胁刺痛，跌扑肿痛，头痛，风湿痹痛。
木香：来源：菊科植物木香AucklandialappaDecne. 的干燥根。性味：辛、苦，温。归脾、胃、大肠、三焦、胆经。功能主治：行气止痛，健脾消食。用于胸脘胀痛，泻痢后重，食积不消，不思饮食。煨木香实肠止泻，用于泄泻腹痛。
羌活：来源：伞形科植物羌活（背翅芹）Notopterygiumincisum Ting ex H. T.Chang 或宽叶羌活NotopterygiumforbesiiBoiss. 的干燥根茎及根。性味：辛、苦，温。归膀胱、肾经。功能主治：散寒，祛风，除湿，止痛。用于风寒感冒头痛，风湿痹痛，肩背酸痛。
益母草：又叫坤草。来源唇形科植物益母草LeonurusjaponicusHoutt. 的新鲜或干燥地上部分。性味：苦、辛，微寒。归肝、心包经。功能主治：活血调经，利尿消肿。用于月经不调，痛经，经闭，恶露不尽，水肿尿少；急性肾炎水肿。
香附：又叫莎草、香附子、雷公头、三棱草、香头草、回头青、雀头香。来源：本品为莎草科植物莎草Cyperusrotundus L. 的干燥根茎。性味：辛、微苦、微甘，平。归肝、脾、三焦经。功能主治：行气解郁，调经止痛。用于肝郁气滞，胸、胁、脘腹胀痛，消化不良，胸脘痞闷，寒疝腹痛，乳房胀痛，月经不调，经闭痛经。
杜仲：来源：杜仲科植物杜仲EucommiaulmoidesOliv. 的干燥树皮。性味：甘，温。归肝、肾经。功能主治：补肝肾，强筋骨，安胎。用于肾虚腰痛，筋骨无力，妊娠漏血，胎动不安；高血压。杜仲炭：净杜仲丝用武火炒至黑褐色，内里丝断，存性，然后取出，用清水淋洒灭尽火星，晒干入药者。偏于止血
肉桂：来源：樟科植物肉桂Cinnamomum cassia Presl的干燥树皮。性味：辛、甘，大热。归肾、脾、心、肝经。功能主治：补火助阳，引火归源，散寒止痛，活血通经。用于阳痿，宫冷，腰膝冷痛，肾虚作喘，阳虚眩晕，目赤咽痛，心腹冷痛，虚寒吐泻，寒疝，奔豚，经闭，痛经。
小茴香：来源：伞形科植物茴香Foeniculum vulgare Mill.的干燥成熟果实；其根、叶和全草也可药用。性味：辛，温。归肝、肾、脾、胃经。功能主治：散寒止痛，理气和胃。用于寒疝腹痛，睾丸偏坠，痛经，少腹冷痛，脘腹胀痛，食少吐泻，睾丸鞘膜积液。盐炒小茴香暖肾散寒止痛。用于寒疝腹痛，睾丸偏坠，经寒腹痛。
枸杞子：来源：茄科植物宁夏枸杞Lyciumbarbarum L. 的干燥成熟果实。性味：甘，平。归肝、肾经。功能主治：滋补肝肾，益精明目。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。
刘寄奴：来源：为菊科植物奇蒿Artemisia anomala S. Moore的带花全草。性味：苦，温。归心、脾经。功能主治：破血通经，敛疮消肿。治经闭症瘕，胸腹胀痛，产后血瘀，跌打损伤，金疮出血，痈毒焮肿。
泽兰：来源：唇形科植物毛叶地瓜儿苗LycopuslucidusTurcz. var.hirtus Regel的干燥地上部分。性味：苦、辛，微温。归肝、脾经。功能主治：活血化瘀，行水消肿。用于月经不调，经闭，痛经，产后瘀血腹痛，水肿。
牛膝：来源：苋科植物牛膝Achyranthesbidentata Blume. 的干燥根。性味：苦、酸，平。归肝、肾经。功能主治：补肝肾，强筋骨，逐瘀通经，引血下行。用于腰膝酸痛，筋骨无力，经闭症瘕，肝阳眩晕。
胎盘：又叫胞衣、衣胞、紫河车、胎衣、胎膜。胎盘（placenta）是哺乳动物妊娠期间由胚胎的胚膜和母体子宫内膜联合长成的母子间交换物质的过渡性器官，为健康产妇娩出之胎盘。性味：甘咸、温。功能主治：补气，养血，益精。用于虚损、羸瘦、咳血气喘、劳热骨蒸、遗精等症。
具体实施方式
一种治疗女性不孕不育的中药组合物，包括如下重量份的原料制备而成：按重量份数柴胡10-40，当归10-30，酒炙白芍10-40，川芎8-15，木香8-15，羌活10-30，益母草10-40，香附10-40，杜仲10-40，肉桂10-30，炒小茴香8-20，枸杞10-40，刘寄奴10-30，泽兰10-30，牛膝8-15，胎盘8-15。兼证时，若输卵管阻塞者，可加穿山甲、鳖甲、全蝎10-20；兼痰湿者去白芍，加茯苓、佩兰10-20；兼经前乳胀者，加炒麦芽10-20份。
颗粒剂制备方法：
（1）按重量份数称取原料药，分别干燥、粉碎处理后，得到细粉，将细粉充分混合，待用；
（2）向步骤（1）所述混合原料加入乙醇并在40-80℃回流提取1-2h，回收乙醇后得到提取液；将提取液依次进行过滤、浓缩、干燥、粉碎处理，得到初步颗粒；
（3）将步骤（2）颗粒加入适量的糖粉与糊精，混合均匀，必要时再加入适量乙醇，调整湿度制成软材，然后过筛、干燥、最后整粒过筛即得颗粒剂。
汤剂制备方法：
（1）按重量份数称取原料药，混合后加入水没过药面1-2厘米，浸泡；
（2）在40-90℃条件下煎煮1-2h，煎煮2-4次，得煎煮液；
（3）合并煎煮液，过滤、浓缩、即得汤剂。
所述中药组合物还可以包括浸膏剂、酒剂、丸剂、散剂、胶囊或片剂；
该中药组合物还可以为浸膏剂、片剂、丸剂。
一种治疗女性不孕不育的中药组合物，包括如下重量份的原料制备而成：按重量份数优选柴胡20，当归15，酒炙白芍20，川芎10，木香10，羌活15，益母草20，香附20，杜仲20，肉桂15，炒小茴香10，枸杞20，刘寄奴15，泽兰15，牛膝10，胎盘10。兼证时，若输卵管阻塞者，可加穿山甲、鳖甲、全蝎15；兼痰湿者加茯苓、佩兰15；兼经前乳胀者，加炒麦芽15。
颗粒剂制备方法：
（1）按重量份数称取原料药，分别干燥、粉碎处理后，得到细粉，将细粉充分混合，待用；
（2）向步骤（1）所述混合原料加入乙醇并在40-80℃回流提取1-2h，回收乙醇后得到提取液；将提取液依次进行过滤、浓缩、干燥、粉碎处理，得到初步颗粒；
（3）将步骤（2）颗粒加入适量的糖粉与糊精，混合均匀，必要时再加入适量乙醇，调整湿度制成软材，然后过筛、干燥、最后整粒过筛即得颗粒剂。
汤剂制备方法：
（1）按重量份数称取原料药，混合后加入水没过药面1-2厘米，浸泡；
（2）在40-90℃条件下煎煮1-2h，煎煮2-4次，得煎煮液；
（3）合并煎煮液，过滤、浓缩、即得汤剂。
前后共收治58例不孕不育患者，其中排除男方因素，年龄最小20岁，最大33岁，以22~30岁居多；病程最短2-4年。中医辨证患者以肾虚，肝郁，血瘀为主，服用本发明的中药组合物，服用颗粒剂或汤剂，每日早晚两次，治疗期间不要服用其他药物，禁烟酒、生冷、油腻、辛辣食物。
治疗效果标准：
服用后3-6个月，女方怀孕为显效；
服用后6-12个月，女方怀孕为有效；
服用后12个月，女方依旧不孕为无效。
表1
效果 显效 有效 无效
人数 25 28 5
百分比（%） 43.1 48.3 8.6
服用后，观察患者情况，均未发生严重不良反应，部分患者出现轻微腹泻，停药后症状即消失。其中，无效8.6％、有效48.3％，显效43.1％，即本发明提供的治疗女性不孕不育的药物总有效率为91.4％。
典型病例：
病例1：张某，女，27岁，结婚3年未能授孕，精神状态不佳。去当地人民医院检查，排卵不畅。服用克罗米酚2个月后，症状未见好转，仍未怀孕。遂去看中医，诊断为肾虚所致排卵异常。服用本发明中药颗粒剂，半年后就怀孕了。
病例2：赵某，女，27岁。2016年3月18日来我处初诊。婚后2年未孕，服用好多西药无效，也经部分中药治疗，仍无效。妇科检查子宫发育不良。证见经期小腹、乳房胀痛，素有情志不畅，腰膝酸软，脉弦，四肢冰凉畏寒，诊断为肝郁肾阳虚型不孕。治宜疏肝理气、温补肾阳。服用本发明药物半年，情致舒畅，经期正常，服用本发明药物1年后，就怀孕了，后来喜得男宝一名。
病例3：黄某，女，30岁。25岁结婚，婚后于2015年3月生1女婴，想要2胎。至2017年3月9日来诊仍未怀孕。月经期间，右腹疼痛，带下黄稠，舌红苔黄腻，脉细滑。证属肾虚、气血不和、冲任失调，在基本方基础上，加茯苓、佩兰。服用半年有余，回访，怀有身孕。
以上所述，仅为本发明的具体实施方式，但本发明的保护范围并不局限于此，任何熟悉本技术领域的技术人员在本发明揭露的技术范围内，可轻易想到变化或替换，都应涵盖在本发明的保护范围之内。因此，本发明的保护范围应以所述权利要求的保护范围为准。

Claims (7)

1.一种治疗女性不孕不育的中药组合物，按重量份数计算，组方：包括柴胡10-40，当归10-30，酒炙白芍10-40，川芎8-15，木香8-15，羌活10-30，益母草10-40，香附10-40，杜仲10-40，肉桂10-30，炒小茴香8-20，枸杞10-40，刘寄奴10-30，泽兰10-30，牛膝8-15，胎盘8-15。
2.如权利要求1所述的中药组合物，按重量份数计算，兼证时，若输卵管阻塞者，可加穿山甲、鳖甲、全蝎各10-20。
3.如权利要求1所述的中药组合物，按重量份数计算，兼证时，痰湿者去白芍，加茯苓、佩兰各10-20。
4.如权利要求1所述的中药组合物，按重量份数计算，兼证时，经前乳胀者，加炒麦芽10-20。
5.如权利要求1所述的中药制剂，按重量份数计算，组方：包括柴胡20，当归15，酒炙白芍20，川芎10，木香10，羌活15，益母草20，香附20，杜仲20，肉桂15，炒小茴香10，枸杞20，刘寄奴15，泽兰15，牛膝10，胎盘10。
6.如权利要求1-5任一中药组合物制备成颗粒剂的制备方法，其包括以下步骤：
（1）按重量份数称取原料药，分别干燥、粉碎处理后，得到细粉，将细粉充分混合，待用；
（2）向步骤（1）所述混合原料加入乙醇并在40-80℃回流提取1-2h，回收乙醇后得到提取液；将提取液依次进行过滤、浓缩、干燥、粉碎处理，得到初步颗粒；
（3）将步骤（2）颗粒加入适量的糖粉与糊精，混合均匀，必要时再加入适量乙醇，调整湿度制成软材，然后过筛、干燥、最后整粒过筛即得颗粒剂。
7.如权利要求1-5任一中药组合物制备成汤剂的制备方法，其包括以下步骤：
（1）按重量份数称取原料药，混合后加入水没过药面1-2厘米，浸泡；
（2）在40-90℃条件下煎煮1-2h，煎煮2-4次，得煎煮液；
（3）合并煎煮液，过滤、浓缩、即得汤剂。
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CN1385207A (zh) * 2002-06-05 2002-12-18 石景田 得生丹
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CN1385207A (zh) * 2002-06-05 2002-12-18 石景田 得生丹
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