CN105963638A - 一种治疗月经过少的中药组合物及其制备方法 - Google Patents
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Abstract
本发明涉及一种治疗月经过少的中药组合物及其制备方法。该中药是由女贞子、熟地、当归、月季花、菟丝子、川芎、甘草、乌梅、郁金、北沙参、百合等中药原料制备而成的。本发明还提供了这种中药组合物的制备方法。本发明提供的中药组合物主要用于治疗月经过少,以及人流术后或清宫术后子宫内膜修复、轻度贫血、围绝经期综合症等疾病。
Description
技术领域
本发明涉及中药领域,具体涉及一种治疗月经过少的中药组合物及其制备方法。
背景技术
月经过少属于一种常见的月经失调,指月经周期基本正常,经量明显减少或点滴即净,或经期不足2天,经量少于正常,并且连续出现两个月经周期以上,或与以前相比明显减少,为原经量的30%-50%。发病率约为19.9%-63%。其危害是影响孕卵在子宫内膜种植,导致反复流产、不孕等,是闭经的前驱症状,长期月经过少可给患者带来心理压力。及早治疗,对维持正常的生理机能,保持生育能力具有积极的临床意义。
月经受垂体前叶和卵巢分泌的激素调节,而呈周期性子宫腔流血。月经过少可以由卵巢早衰、多囊卵巢综合征、子宫内膜增殖不充分、内膜过薄、幼稚子宫、子宫发育不良、子宫内膜结核、雌激素分泌不足、垂体-卵巢功能低下及盆腔手术损伤等所致。中医学认为,肾藏精主生殖,与月经的关系最为密切。肾气、天癸、冲任共同作用于胞宫,并在脏腑、气血、经络的协调作用下,使冲任二脉相资,血海充盈,故月经来潮。而天癸源于先天,藏之于肾,再次可见肾在女性月事中的重要地位。如《内经》所载:“肾气盛,天癸至,月事以时下。”月经过少的病因病机虽较为复杂,但不外乎虚、实两个方面。虚者可因久病体虚,阴血亏虚,或久病伤阳,运血无力,或饮食劳倦伤脾,经血亏少,血脉空虚,经血乏源。实者多因外感寒邪,寒凝血脉,或痰湿内生,或瘀血阻滞,或肝气郁结,致使血行不畅。《傅青主女科》:“经水出诸肾”、“肾气本虚,何能盈满而化经水外泄”。《医学正传·妇人传》云:“月经全借肾水施化,肾水既乏,则经血日以干涸”。因此肾虚应是本病的关键病因,月经过少的主要病机为肾虚精亏。故临床上应以补肾填精,滋阴补血调血为治疗原则。
发明内容
本发明的目的是提供一种治疗月经过少的中药组合物;
本发明的另一目的是提供一种治疗月经过少的中药组合物的制备方法。
本发明的目的是通过下列的技术方案实现的:
本发明所述的治疗月经过少的中药组合物,是由如下重量份的中药原料制备而成的:
女贞子10-40份、熟地3-20份、当归1-10份、月季花1-10份、菟丝子10-40份、川芎1-10份、甘草1-10份、乌梅3-20份、郁金1-10份、北沙参3-20份、百合8-30份。
优选地,是由如下重量份的中药原料制备而成的:
女贞子20-30份、熟地5-15份、当归3-7份、月季花3-7份、菟丝子20-30份、川芎3-7份、甘草3-7份、乌梅5-15份、郁金3-7份、北沙参8-15份、百合10-20份。
以下是本发明中药制剂的药材来源:
女贞子,为木犀科植物女贞Ligustrum lucidum Ait.的干燥成熟果实。【性味】甘、苦,凉。【归经】归肝、肾经。【功能主治】滋补肝肾,明目乌发。用于眩晕耳鸣,腰膝酸软,须发早白,目暗不明。
熟地,为玄参科植物地黄或怀庆地黄的根茎,经加工蒸晒而成。【性味】甘,微温。【归经】归肝、肾经。【功能主治】滋阴补血,益精填髓。用于肝肾阴虚,腰膝酸软,骨蒸潮热,盗汗遗精,内热消渴,血虚萎黄,心悸怔忡,月经不调,崩漏下血,眩晕,耳鸣,须发早白。
当归,为伞形科植物当归Angelica sinensis(Oliv.)Diels的干燥根。【性味】甘、辛,温。【归经】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,跌扑损伤。
月季花,为蔷薇科植物月季Rosa chinensis Jacq.的干燥花,其根、叶也入药。【性味】甘,温。【归经】归肝经。【功能主治】活血调经,散毒消肿。花:用于月经不调,痛经,痈疖肿毒,淋巴结结核(未溃破)。叶:淋巴结结核,跌打损伤。根:跌打损伤,白带,遗精。
菟丝子,为旋花科植物菟丝子Cuscuta chinensis Lam.的干燥成熟种子。【性味】甘,温。【归经】归肝、肾、脾经。【功能主治】滋补肝肾,固精缩尿,安胎,明目,止泻。用于阳痿遗精,尿有余沥,遗尿尿频,腰膝酸软,目昏耳鸣,肾虚胎漏,胎动不安,脾肾虚泻;外治白癜风。
川芎,为伞形科植物川芎Ligusticum chuanxiong Hort.(或Ligusticum wallichiiFranch.)的干燥根茎。【性味】辛,温。【归经】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。
甘草,为豆科植物甘草Glycyrrhiza uralensis Fisch.、胀果甘草Glycyrrhiza inflataBat.或光果甘草Glycyrrhiza glabra L.的干燥根。【性味】甘,平。【归经】归心、肺、脾、胃经。【功能主治】补脾益气,清热解毒,祛痰止咳,缓急止痛,调和诸药。用于脾胃虚弱,倦怠乏力,心悸气短,咳嗽痰多,脘腹、四肢挛急疼痛,痈肿疮毒,缓解药物毒性、烈性。
乌梅,为蔷薇科植物梅Prunus mume(Sieh.)Sieb.et Zucc.的干燥近成熟果实。【性味】酸、涩,平。【归经】归肝、脾、肺、大肠经。【功能主治】敛肺,涩肠,生津,安蛔。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。
郁金,为姜科植物温郁金Curcuma wenyujin Y.H.Chen et C.Ling、姜黄Curcuma longaL.、广西莪术Curcuma kwangsiensis S.G.Lee et C.F.Liang或蓬莪术Curcuma phaeocaulisVal.的干燥块根。【性味】辛、苦,寒。【归经】归肝、心、肺经。【功能主治】行气化瘀,清心解郁,利胆退黄。用于经闭痛经,胸腹胀痛、刺痛,热病神昏,癫痫发狂,黄疸尿赤。
北沙参,为伞形科植物珊瑚菜Glehnia littoralis Fr.Schmidt ex Miq.的干燥根。【性味】甘、微苦,微寒。【归经】归肺、胃经。【功能主治】养阴清肺,益胃生津。用于肺热燥咳,劳嗽痰血,热病津伤口渴。
百合,为百合科植物卷丹Lilium lancifolium Thunb.、百合Lilium brownii F.E.Brownvar.viridulum Baker或细叶百合Lilium pumilum DC.的干燥肉质鳞叶。【性味】甘,寒。【归经】归心、肺经。【功能主治】养阴润肺,清心安神。用于阴虚久咳,痰中带血,虚烦惊悸,失眠多梦,精神恍惚。
本发明的另一方面是提供了本发明中药组合物的活性成分的制备方法,该方法是采用水提或40-80%体积百分浓度的乙醇提取制备而成。具体制备方法如下:
方案一:取全部药材,混合后加水提取2-3次,每次加水量相当于药材总重量的6-12倍,每次提取时间为1-3小时,合并提取液,滤过,滤液浓缩至70-80℃时相对密度为1.15-1.20的清膏,即得活性成分。
方案二:取全部药材,混合后用40-80%乙醇回流提取2-3次,每次乙醇用量为药材总量的4-10倍,提取时间为1-4小时,合并提取液,过滤,滤液浓缩至70-80℃时相对密度为1.15-1.20的清膏,即得活性成分。
方案三:取全部药材,混合后加水提取2-3次,每次加水量相当于药材总重量的6-12倍,每次提取时间为1-3小时,合并提取液,滤过,滤液浓缩至70-80℃时相对密度为1.15-1.20的清膏,加入乙醇,使含醇量为40-70%,静置12-24小时,滤过,滤液浓缩至70-80℃时相对密度为1.10-1.25的浸膏,即得活性成分。
本发明所述的治疗月经过少的中药组合物,还可以与医药学上可接受的载体配合,制成各种口服制剂,如片剂、胶囊剂、口服液、糖浆剂、合剂等。
本发明的药学上可接受的载体包括但不限于以下:
口服制剂:
稀释剂:淀粉、糖粉、乳糖、糊精、微晶纤维素、无机盐、糖醇类等。
润湿剂与粘合剂:纯化水、乙醇、明胶、聚乙二醇、纤维素衍生物等。
崩解剂:淀粉、羧甲基淀粉钠、纤维素衍生物、交联聚维酮等。
润滑剂:硬脂酸镁、微粉硅胶、滑石粉、聚乙二醇等。
助溶剂:水、乙醇、甘油、丙二醇、液状石蜡、植物油等。
矫味剂:蔗糖、单糖、芳香剂等。
防腐剂:苯甲酸、山梨酸、甲酯、乙酯、丙酯等。
方法1:片剂
取方案一至方案三所得活性成分之一,加入片剂常用辅料,按常规生产方法制备得本发明片剂。
上述片剂常用辅料包括稀释剂、润湿剂、粘合剂、崩解剂、润滑剂之一或全部。
方法2:胶囊剂
取方案一至方案三所得活性成分之一,加入胶囊剂常用辅料,按常规生产方法制备得本发明胶囊剂。
上述胶囊剂常用辅料包括稀释剂、润湿剂、粘合剂、崩解剂、润滑剂之一或全部。
方法3:糖浆剂
取方案一至方案三所得活性成分之一,加入糖浆剂常用辅料,按常规生产方法制备得本发明糖浆剂。
上述糖浆剂常用辅料包括矫味剂、防腐剂、助溶剂之一或全部。
方法4:合剂
取方案一至方案三所得活性成分之一,加入合剂常用辅料,按常规生产方法制备得本发明合剂。
上述合剂常用辅料包括矫味剂、防腐剂之一或全部。
方法5:口服液
取方案一至方案三所得活性成分之一,溶解后净化、浓缩,加入口服液常用辅料,按常规生产方法制备得本发明口服液。
上述口服液常用辅料包括矫味剂、防腐剂、助溶剂之一或全部。
本申请人在研究传统中医辨证治疗的基础上参考现代药理研究成果,经过多年的试验,将多种配方进行筛选,找到了能有效治疗月经过少的中药配方,方中女贞子、熟地滋阴养血,当归补血、和血、调经;川芎活血行气,畅通气血;月季花、郁金活血调经;菟丝子补肝肾、益精血、调冲任;北沙参、绿萼梅、百合滋阴、益胃生津,使气血化生有源。全方具有补肾、滋阴、养血之功效,主要用于治疗月经过少,还可辅助治疗人流术后或清宫术后子宫内膜修复,此药物修复过程中可不抑制排卵;作为纠正贫血的辅助用药;改善围绝经期综合症所见头晕耳鸣、腰酸腿软、烘热汗出、五心烦热、失眠、口燥咽干等症状,提高围绝经期妇女的生活质量。本发明提供的一种治疗月经过少的中药组合物具有以下优点:
1、本发明提供的组合物制剂安全有效,具有补肾、滋阴、养血之功效,主要用于治疗月经过少,还可辅助治疗人流术后或清宫术后子宫内膜修复,纠正贫血的辅助用药,改善围绝经期综合症。
2、经临床试验证明,治疗组西药人工周期疗法基础上加用本发明中药组合物治疗月经过少,治疗组愈显率72%,对照组单纯西药人工周期治疗组愈显率46%,两组比较,差异具有统计学意义。治疗后,加用本发明中药组合物治疗组子宫内膜厚度显著优于对照组,两组比较差异具有统计学意义。
3、本发明提供的中药组合物制剂,配方科学合理,工艺简单,口感好,成本低。
具体实施方式
下面通过实施例进一步说明本发明。应该理解的是,本发明的实施例是用于说明本发明而不是对本发明的限制。根据本发明的实质对本发明进行的简单改进都属于本发明要求保护的范围。除非另有说明,本发明中的乙醇量的百分数是体积百分数,v/v表示溶液的体积比。
实施例1颗粒剂
称取女贞子10g、熟地3g、当归1g、月季花1g、菟丝子10g、川芎1g、甘草1g、乌梅3g、郁金1g、北沙参3g、百合8g。加水提取3次,三次加水量分别为药材总重量的12倍、8倍、6倍,三次提取时间分别为3小时、2小时、1小时,合并提取液,滤过,滤液浓缩至70℃时相对密度为1.25的清膏,加入淀粉、糊精,制粒、干燥、整粒即得。
实施例2片剂
称取女贞子40g、熟地20g、当归10g、月季花10g、菟丝子40g、川芎10g、甘草10g、乌梅20g、郁金10g、北沙参20g、百合30g。用乙醇回流提取2次,每次乙醇浓度分别为80%、60%,每次乙醇用量分别为药材总量的10倍、8倍,提取时间分别为4小时、3小时,合并提取液,过滤,滤液浓缩至80℃时相对密度为1.10的浸膏,加入辅料淀粉、乙醇、滑石粉,制得片剂。
实施例3片剂
称取女贞子20g、熟地5g、当归3g、月季花3g、菟丝子20g、川芎3g、甘草3g、乌梅5g、郁金7g、北沙参8g、百合10g。加水提取3次,三次加水量分别相当于药材总重量的12倍、8倍、6倍,每次提取时间分别3小时、2小时、1小时,合并提取液,滤过,滤液浓缩至70℃时相对密度为1.20的清膏,加入乙醇,使含醇量为40%,静置24小时,滤过,滤液浓缩至滤液浓缩至70℃时相对密度为1.10的浸膏,加入辅料淀粉、乙醇、滑石粉,制得片剂。
实施例4胶囊剂
称取女贞子30g、熟地15g、当归7g、月季花7g、菟丝子30g、川芎7g、甘草7g、乌梅15g、郁金7g、北沙参15g、百合20g。用40%乙醇回流提取3次,每次乙醇用量分别为药材总量的10倍、8倍、4倍,提取时间分别3小时、2小时、1小时,合并提取液,过滤,滤液浓缩60℃时相对密度为1.25的浸膏,在浸膏中加入辅料淀粉、乙醇、糊精、硬脂酸镁,按常规方法制成胶囊剂。
实施例5颗粒剂
称取女贞子15g、熟地4g、当归3g、月季花3g、菟丝子15g、川芎2g、甘草2g、乌梅4g、郁金2g、北沙参4g、百合10g。加水提取2次,每次加水量分别相当于药材总重量的12倍、10倍,每次提取时间分别为3小时、2小时,合并提取液,滤过,滤液浓缩至80℃下相对密度为1.05的清膏,加入乙醇,使含醇量为70%,静置12小时,滤过,滤液浓缩至70℃时相对密度为1.25的浸膏,加入淀粉、糊精,制粒、干燥、整粒即得。
实施例6糖浆剂
称取女贞子25g、熟地8g、当归5g、月季花5g、菟丝子25g、川芎5g、甘草5g、乌梅8g、郁金5g、北沙参6g、百合12g。加水提取2次,两次加水量分别为药材总重量的10倍、8倍,两次提取时间分别为2小时、1小时,合并提取液,滤过,滤液浓缩至80℃时相对密度为1.10的浸膏。在浸膏中加入糖浆剂辅料蔗糖、山梨酸、水搅拌均匀,制得糖浆剂。
实施例7口服液
称取女贞子35g、熟地12g、当归6g、月季花6g、菟丝子35g、川芎6g、甘草6g、乌梅12g、郁金6g、北沙参8g、百合15g。加水提取2次,两次加水量分别为药材总重量的10倍、8倍,两次提取时间分别为2小时、1小时,合并提取液,滤过,滤液浓缩至80℃时相对密度为1.10的浸膏,在浸膏中加入辅料甘露醇、山梨酸、水搅拌均匀,分装,制得口服液。
实施例8合剂
称取女贞子38g、熟地18g、当归8g、月季花8g、菟丝子38g、川芎8g、甘草8g、乌梅18g、郁金8g、北沙参18g、百合25g。加水提取3次,三次加水量分别相当于药材总重量的12倍、8倍、6倍,每次提取时间分别3小时、2小时、1小时,合并提取液,滤过,滤液浓缩至总重量为药材总重量的3倍,灌装,加入合剂辅料蔗糖、乙酯、水、山梨酸搅拌均匀,制得合剂。
实施例9粉剂
称取女贞子32g、熟地15g、当归7g、月季花6g、菟丝子28g、川芎4g、甘草9g、乌梅12g、郁金5g、北沙参12g、百合23g。粉碎,过筛,即得。
临床试验总结
1 一般资料
选择2015年12月至2016年12月于我院妇科就诊的患者100例,并将患者随机分成两组。
2 治疗方法
A组对照组:西药联合宫腔镜技术
宫腔粘连患者行宫腔粘连分离术或宫腔粘连电切术,手术结束时放置宫型环1枚;薄型子宫内膜者,仅行宫腔镜检。术后常规预防感染24小时。术后行雌孕激素进行人工周期治疗(戊酸雌二醇、黄体酮胶囊),连续3个疗程。
B组治疗组:在对照组基础上于术后配合本发明实施例5治疗,连续3个疗程。
所有患者治疗后3个月,月经干净3-7天,行宫腔镜了解宫腔情况,观察月经量,比较两组治疗前后的恢复情况。
3 临床疗效评定标准
月经量的临床疗效评价标准
治愈:经量≥50ml,维持3个月经周期以上;
显效:经量≥40ml,维持3个月经周期以上;或经量≥50ml,但不能维持3个月经周期以上;
好转:经量>30ml,或较原月经量增加50%,维持3个月经周期以上;
无效:经量无变化。
中医症状积分
治愈:中医症状积分减少≥95%;
显效:中医症状积分减少≥70%;
好转:中医症状积分减少≥30%;
无效:中医症状无改善。
4 结果
表1疗效结果
临床结果显示:治疗组西药人工周期疗法基础上加用本发明中药组合物治疗月经过少,治疗组愈显率72%,对照组单纯西药人工周期治疗组愈显率46%,两组比较,差异具有统计学意义。治疗后,加用本发明中药组合物治疗组子宫内膜厚度显著优于对照组,两组比较差异具有统计学意义。
典型病例
1、刘××,女,31岁。患者两年前顺产一女婴,产后8+月,月经复潮,出现月经后期,量少,多40~70天一潮,历2天干净,用卫生巾4~5条,未湿透,头晕乏力,心悸,腰酸,面色萎黄晦黯,舌质淡,苔薄白,脉细,检查内分泌五项提示卵巢功能早衰,诊为月经失调(过少),中医证属气血虚弱兼肾虚型。用本发明实施例3共治疗6个月,月经周期恢复正常,经量明显增多,历4~5天干净,用纸巾10条,复查内分泌五项正常。
2、曾××,女,29岁。患者月经周期延后,40~50天一潮,经量少,色淡黯,经行小腹冷痛,得热痛减,腰膝酸疼,口淡,大便烂,舌质淡黯,苔白,脉沉细,诊为月经失调,中医证属肾虚血寒型月经后期,用本发明实施例8治疗,用药两个月,月经30~35天一潮,经量增加,经行腹痛消失,嘱忌生冷寒凉之品调理。
3、黄XX,女,22岁,未婚。月经量少1年余,经量少2天即净(护垫即可),夹血块,色淡红,平素月经基本规律,伴腰脊酸软,头晕耳鸣,纳眠可,二便调,舌质淡,苔薄白,脉沉细尺弱。妇科B超检查未见异常。给予本发明实施例1治疗1个月,月经按时来潮,经量较前增多,不伴腰脊酸软,头晕耳鸣,舌红润,纳眠可,二便调。如此治疗3个月经周期,经量明显增多,诸症消失。
虽然,上文中已经用一般性说明、具体实施方式及试验,对本发明作了详尽的描述,但在本发明基础上,可以对之作一些修改或改进,这对本领域技术人员而言是显而易见的。因此,在不偏离本发明精神的基础上所做的这些修改或改进,均属于本发明要求保护的范围。
Claims (7)
1.一种治疗月经过少的中药组合物,其特征在于它是由如下重量份的中药原料制备而成的:女贞子10-40份、熟地3-20份、当归1-10份、月季花1-10份、菟丝子10-40份、川芎1-10份、甘草1-10份、乌梅3-20份、郁金1-10份、北沙参3-20份、百合8-30份。
2.如权利要求1所述的治疗月经过少的中药组合物,其特征在于它是由包括如下重量份的中药原料制备而成的:女贞子20-30份、熟地5-15份、当归3-7份、月季花3-7份、菟丝子20-30份、川芎3-7份、甘草3-7份、乌梅5-15份、郁金3-7份、北沙参8-15份、百合10-20份。
3.如权利要求1或2所述的治疗月经过少的中药组合物,其特征在于它的活性成分是采用水提或40-80%体积百分浓度的乙醇提取制备而成。
4.如权利要求3所述的治疗月经过少的中药组合物,其特征在于它的活性成分是通过以下方法制备而成的:取全部药材,混合后加水提取2-3次,每次加水量相当于药材总重量的6-12倍,每次提取时间为1-3小时,合并提取液,滤过,滤液浓缩至70-80℃时相对密度为1.15-1.20的清膏,即得活性成分。
5.如权利要求3所述的治疗月经过少的中药组合物,其特征在于它的活性成分是通过以下方法制备而成的:取全部药材,混合后用40-80%乙醇回流提取2-3次,每次乙醇用量为药材总量的4-10倍,提取时间为1-4小时,合并提取液,过滤,滤液浓缩至70-80℃时相对密度为1.15-1.20的清膏,即得活性成分。
6.如权利要求3所述的治疗月经过少的中药组合物,其特征在于它的活性成分是通过以下方法制备而成的:取全部药材,混合后加水提取2-3次,每次加水量相当于药材总重量的6-12倍,每次提取时间为1-3小时,合并提取液,滤过,滤液浓缩至70-80℃时相对密度为1.15-1.20的清膏,加入乙醇,使含醇量为40-70%,静置12-24小时,滤过,滤液浓缩至70-80℃时相对密度为1.10-1.25的浸膏,即得活性成分。
7.一种治疗月经过少的制剂,由权利要求1-6所述的治疗月经过少的中药组合物与医药学上可接受的载体配合制备而成。
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