CN105521158A - 一种治疗慢性子宫内膜炎致月经量少的药物制剂 - Google Patents
一种治疗慢性子宫内膜炎致月经量少的药物制剂 Download PDFInfo
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Abstract
本发明属于中药领域,公开了一种治疗慢性子宫内膜炎致月经量少的药物制剂。该药物制剂由叶底红、红毛七、川芎、牛马藤、菟丝子、枸杞子、通经草、白术、黄芪、牛膝、苏木、甘草为药用原料制成。全方合伍,养血行气,活血化瘀,温养冲任,培本复原之功效,标本同治使子宫内膜增生,从而修复受损的子宫内膜,故而疗效良好。
Description
技术领域
本发明属于中药领域,公开了一种治疗慢性子宫内膜炎致月经量少的药物制剂。
背景技术
正常情况下一次月经量约为60ml左右,低于30ml为过少,超过80ml为过多。月经过少与月经周期异常并见,月经过少一般是指连续发生二次以上,经量明显减少,甚或点滴即净,或经期缩短至不足两天,属月经病。该病发生于青春期和育龄期者可发展为闭经,发生于更年期者则往往进入绝经。
本病相当于西医的功能失调性子宫出血病、多囊卵巢综合征、卵巢早衰、内膜增生不良、宫腔粘连、慢性子宫内膜炎、子宫内膜结核、子宫内膜异位症、胎骨残留、未破裂卵泡黄素化、盆腔静脉淤血症、甲亢、体重下降、或人流手术后宫腔黏连等疾病。
祖国医学认为本病机理有虚有实。虚者多因精亏血少,冲任血海亏虚,经血乏源;实者多由瘀血内停,或痰湿阻滞,冲任壅塞,血行不畅而月经过少。临床上多以虚证和虚实夹杂多见,常见有肾虚血瘀、肝肾不足、肾虚肝郁、气滞血瘀等证型。近年来中医各种疗法在改善患者症状和体征,避免西药治疗的不良反应等方面取得较好疗效。
伴随着社会和自然环境的发展,女性的压力增加,妇科手术率的发生率和重复率升高,月经量少已成为临床常见病及多发病,其中不断升高的人工流产手术率是造成月经过少的主要原因,子宫内膜基底层会或多或少受到机械性损伤,加之机体抵抗力减弱,病原体可趁虚而入,逆行感染子宫内膜,其伤害机制共同作用可影响受体产生和作用在不同环节,引起细胞水平代谢和功能紊乱,导致细胞病变,加重子宫内膜的损伤,使子宫内膜间质纤维化,甚至钙化、骨化,宫腔内粘连形成。内膜及腺体部分或大部分被单层上皮所替代,其对性激素刺激不敏感,腺体变得稀疏,子宫内膜变薄或厚薄不均,部分功能层消失,子宫内膜血供减少最终经量减少。
中医治疗月经过少具有明显优势,既能达到治疗的目的,又能避免西药的毒副作用。近年来研究结果表明,中医药在治疗月经过少的同时,还可以改善卵巢功能,有显著的远期疗效优势。因此研制效果更为显著的治疗月经过少的药物制剂具有重大的意义。
发明内容
为了解决上述问题,本发明旨在提供一种治疗慢性子宫内膜炎致月经量少的药物制剂其制备方法。
本发明的一个目的是提供一种治疗慢性子宫内膜炎致月经量少的药物制剂。
发明人结合古今先贤的理论与自己的临床经验,将现代生理病理与中医病因病机、辨证与辨病有机结合起来,提供的一种治疗慢性子宫内膜炎致月经量少的药物制剂,由叶底红、红毛七、川芎、牛马藤、菟丝子、枸杞子、通经草、白术、黄芪、牛膝、苏木、甘草为药用原料制成。
为了药物中有效活性成分的协同作用,本发明人经过长期、大量的筛选组方试验,进一步优选如下技术方案:
一种治疗慢性子宫内膜炎致月经量少的药物制剂,其特征在于由以下重量份配比的药用原料制成:叶底红15-30份、红毛七10-18份、川芎6-12份、牛马藤10-25份、菟丝子15-30份、枸杞子10-30份、通经草10-15份、白术8-13份、黄芪10-20份、牛膝3-8份、苏木4-10份、甘草3-10份。
进一步优选地,一种治疗慢性子宫内膜炎致月经量少的药物制剂,其特征在于由以下重量份配比的药用原料制成:叶底红18-24份、红毛七12-16份、川芎6-10份、牛马藤15-20份、菟丝子20-26份、枸杞子14-20份、通经草10-15份、白术8-13份、黄芪11-16份、牛膝3-7份、苏木5-9份、甘草6-10份。
进一步优选地,一种治疗慢性子宫内膜炎致月经量少的药物制剂,其特征在于由以下重量份配比的药用原料制成:叶底红20份、红毛七15份、川芎7份、牛马藤18份、菟丝子25份、枸杞子16份、通经草12份、白术12份、黄芪15份、牛膝5份、苏木6份、甘草8份。
方解:君药:叶底红苦甘性凉,养血调经;红毛七辛苦温,活血散瘀,祛风除湿,行气止痛,二药配伍,苦凉辛温并举,行气养血,活血散瘀。
臣药:菟丝子甘温,补肾养肝,温脾助胃,温而不燥,虚可以补,实可以利,寒可以温,热可以凉,湿可以燥,燥可以润;枸杞子甘平,滋补肝肾,二药伍用补平补肝肾不足,生精化血;川芎活血行气,祛风止痛,为血中气药;牛马藤活血调经,补血舒筋;二药伍用,行气活血不伤正,舒筋通络。
佐药:通经草活血通经,利湿解毒,散瘀消肿;苏木行血祛瘀,消肿止痛;白术健脾益气,燥湿利水;黄芪补气固表,托毒排脓,生肌。
佐使药:牛膝补肝肾,强筋骨,逐瘀通经,引血下行;甘草补脾益气,清热解毒,祛痰止咳,缓急止痛,调和诸药。全方合伍,养血行气,活血化瘀,温养冲任,培本复原之功效,标本同治使子宫内膜增生,从而修复受损的子宫内膜,故而疗效良好。
进一步地,本发明所述的中药组合物中各原料药的功能及功能主治如下所述。
叶底红:【性味】味微苦;甘;性凉。【归经】归肝;心;膀胱经。【功能主治】养血调经。主血虚萎黄;月经不调;闭经;痛经;带下。
红毛七:【性味】辛;苦;性温。【归经】肝;胃经。【功能主治】活血散瘀;祛风除湿;行气止痛。主月经不调;痛经;产后血瘀腹痛;脘腹寒痛;跌打损伤,风湿痹痛。《陕西中草药》:活血散瘀,祛风止痛,降血压,止血,解草乌中毒。治月经不调,经期少腹疼痛,产后瘀血疼痛,关节炎,劳伤,扁桃体炎,高血压。
川芎:【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。
牛马藤:【性味】苦;微苦;性温。【归经】肝;胃经。【功能主治】活血调经;补血舒筋。主有经不调;痛经;闭经;产后血虚;贫血;风湿痹痛;四肢麻木;跌打损伤。【用法用量】内服:煎汤,15-30g,或浸酒。外用:适量,捣敷。
菟丝子:【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。
枸杞子:【性味】甘,平。【归经】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。【用法用量】6~12g。
通经草:【性味】辛;甘;平。【归经】肺;肝经。【功能主治】祛痰止咳;活血通经;利湿;解毒消肿。主咳嗽;月经不调;经闭腹痛;赤白带下;肺痨咳血;大便泄泻;小便涩痛;肺痈;乳痈;风湿关节痛;跌打损伤;肋间神经痛;暴发火眼;疮肿。【用法用量】内服:煎汤,9-15g。外用:适量,水煎熏洗;或捣敷。
白术:【性味】苦、甘,温。【归经】归脾、胃经。【功能主治】健脾益气,燥湿利水,止汗,安胎。用于脾虚食少,腹胀泄泻,痰饮眩悸,水肿,自汗,胎动不安。土白术健脾,和胃,安胎。用于脾虚食少,泄泻便溏,胎动不安。
黄芪:【性味】甘,温。【归经】归肺、脾经。【功能主治】补气固表,利尿托毒,排脓,敛疮生肌。用于气虚乏力,食少便溏,中气下陷,久泻脱肛,便血崩漏,表虚自汗,气虚水肿,痈疽难溃,久溃不敛,血虚痿黄,内热消渴;慢性肾炎蛋白尿,糖尿病。
牛膝:【性味】苦、酸,平。【归经】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。
苏木:【性味】甘、咸,平。【归经】归心、肝、脾经。【功能主治】行血祛瘀,消肿止痛。用于经闭痛经,产后瘀阻,胸腹刺痛,外伤肿痛。
甘草:【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。
本发明还提供了该药物制剂的制备方法,它包括如下步骤:将所述叶底红、红毛七、川芎、牛马藤、菟丝子、枸杞子、通经草、白术、黄芪、牛膝、苏木、甘草按处方比例混合,加入相对于混合物质量4~6倍的水,煎煮2~3小时,过滤获得第一提取液;过滤获得的药渣再加入相对于所述药渣质量2~4倍的水,煎煮1~2小时,过滤获得第二提取液;将第一提取液和第二提取液合并,减压浓缩,干燥,获得干膏,将膏放置在超微粉碎机中粉碎1~2小时,粉碎,过筛,获得100-200目的细粉,加入药学上可接受的辅料或辅助性成分按照药物制剂常规工艺制备得到。
所述的药学上可接受的载体或辅助性成分,如淀粉、糖粉、糊精、微晶纤维、可压性淀粉、硬脂酸镁、微粉硅胶、果糖、羧甲基淀粉钠、羧甲基纤维素钠、羟丙基甲基纤维素、植物油、卵磷脂、聚乙二醇、丙二醇、尼泊金乙酯等。
所述的药物制剂的剂型是口服剂型,比如,片剂、薄膜衣片剂、肠溶衣片剂、胶囊剂、硬胶囊剂、软胶囊剂、口服液、颗粒剂、蜜丸剂、散剂、丹剂、溶液剂或硬膏剂等。优选地,所述的药物制剂的剂型是片剂、胶囊剂或颗粒剂,最优选为胶囊剂。
本发明相对与现有技术,有如下明显优势:
发明药物所选药材配伍相宜,符合中医药学和现代医药学理论,立法全面,用药周到,发挥奇效,养血行气,活血化瘀,温养冲任,培本复原之功效,标本同治使子宫内膜增生,从而修复受损的子宫内膜,故而疗效良好。临床观察发现,观察组使用本发明制剂治疗后治愈率、有效率高,显著高于对照组。
本发明中药药物制剂具有多靶点、多环节、多层次的综合调控作用,副作用较小,患者依从性较好,服用方便,可有效地减轻病者负担和痛苦,能够达到标本兼治的目的,值得临床上广泛推广应用。
具体实施方式
以下通过具体实施例进一步描述本发明,本发明不仅仅限于以下实施例。在本发明的范围内或者在不脱离本发明的内容、精神和范围内,对本发明进行的变更、组合或替换,对于本领域的技术人员来说是显而易见的,且包含在本发明的范围之内。
实施例1胶囊剂
处方:叶底红20份、红毛七15份、川芎7份、牛马藤18份、菟丝子25份、枸杞子16份、通经草12份、白术12份、黄芪15份、牛膝5份、苏木6份、甘草8份。
制备方法:将所述叶底红、红毛七、川芎、牛马藤、菟丝子、枸杞子、通经草、白术、黄芪、牛膝、苏木、甘草按处方比例混合,加入相对于混合物质量4~8倍的水,煎煮2~3小时,过滤获得第一提取液;过滤获得的药渣再加入相对于所述药渣质量2~4倍的水,煎煮1~2小时,过滤获得第二提取液;将第一提取液和第二提取液合并,减压浓缩,干燥,获得干膏,将干膏放置在超微粉碎机中粉碎1~2小时,粉碎,过筛,获得100-200目的细粉,加入药学上可接受的辅料或辅助性成分按照药物制剂常规工艺制备得到。
本实施例胶囊剂,每粒0.3g,含有生药1.6g。
实施例2胶囊剂
处方:叶底红18份、红毛七13份、川芎8份、牛马藤18份、菟丝子20份、枸杞子15份、通经草15份、白术10份、黄芪12份、牛膝4份、苏木5份、甘草7份。
制备方法:参照实施例1进行。
实施例3胶囊剂
处方:叶底红15份、红毛七12份、川芎7份、牛马藤15份、菟丝子20份、枸杞子10份、通经草10份、白术10份、黄芪10份、牛膝5份、苏木4份、甘草5份。
制备方法:参照实施例1进行。
实施例4胶囊剂
处方:叶底红25份、红毛七18份、川芎12份、牛马藤10份、菟丝子20份、枸杞子15份、通经草10份、白术10份、黄芪12份、牛膝8份、苏木4份、甘草6份。
制备方法:参照实施例1进行。
实施例5胶囊剂
处方:叶底红22份、红毛七12份、川芎9份、牛马藤15份、菟丝子26份、枸杞子18份、通经草10份、白术8份、黄芪12份、牛膝6份、苏木8份、甘草8份。
制备方法:参照实施例1进行。
实施例6胶囊剂
处方:叶底红24份、红毛七18份、川芎6份、牛马藤20份、菟丝子20份、枸杞子20份、通经草14份、白术13份、黄芪16份、牛膝5份、苏木6份、甘草8份。
制备方法:参照实施例1进行。
实施例7胶囊剂
处方:叶底红26份、红毛七18份、川芎10份、牛马藤22份、菟丝子20份、枸杞子25份、通经草12份、白术12份、黄芪12份、牛膝8份、苏木9份、甘草10份。
制备方法:参照实施例1进行。
实施例8片剂
处方:叶底红20份、红毛七15份、川芎7份、牛马藤18份、菟丝子25份、枸杞子16份、通经草12份、白术12份、黄芪15份、牛膝5份、苏木6份、甘草8份。
制备方法:将所述叶底红、红毛七、川芎、牛马藤、菟丝子、枸杞子、通经草、白术、黄芪、牛膝、苏木、甘草按处方比例混合,加入相对于混合物质量4~8倍的水,煎煮2~3小时,过滤获得第一提取液;过滤获得的药渣再加入相对于所述药渣质量2~4倍的水,煎煮1~2小时,过滤获得第二提取液;将第一提取液和第二提取液合并,减压浓缩,干燥,获得干膏,将干膏放置在超微粉碎机中粉碎1~2小时,粉碎,过筛,获得100-200目的细粉,加入药学上可接受的辅料或辅助性成分按照药物制剂常规工艺制备得到。
实施例9颗粒剂
处方:叶底红20份、红毛七15份、川芎7份、牛马藤18份、菟丝子25份、枸杞子16份、通经草12份、白术12份、黄芪15份、牛膝5份、苏木6份、甘草8份。
制备方法:将所述叶底红、红毛七、川芎、牛马藤、菟丝子、枸杞子、通经草、白术、黄芪、牛膝、苏木、甘草按处方比例混合,加入相对于混合物质量4~8倍的水,煎煮2~3小时,过滤获得第一提取液;过滤获得的药渣再加入相对于所述药渣质量2~4倍的水,煎煮1~2小时,过滤获得第二提取液;将第一提取液和第二提取液合并,减压浓缩,干燥,获得干膏,将干膏放置在超微粉碎机中粉碎1~2小时,粉碎,过筛,获得100-200目的细粉,加入药学上可接受的辅料或辅助性成分按照药物制剂常规工艺制备得到。
实施例10临床观察试验
1资料与方法
1.1一般资料:观察2014年4月至2014年12月就诊于我院妇科门诊,诊断为慢性子宫内膜炎致有月经过少证的患者108例,解脲支原体阳性44例,衣原体阳性12例,随机分为观察组与对照组进行观察,每组54例。观察组年龄18-32岁,平均年龄24.2±3.8岁,对照组年龄18-33岁,平均23.9±3.6岁;观察组病程最长4.5年,最短6个月,平均1.44±1.08年,对照组病程最长4.5年,最短5个月,平均1.36±1.01年;两组一般资料比较无统计学差异(P>0.05),具有可比性。
1.2诊断标准:按照张玉珍等编著《中医妇科学》和中华人民共和国卫生部2002年颁布的《中药新药治疗月经不调的临床研究指导原则》的月经过少的诊断标准。
月经过少:月经过少是指月经周期正常,月经血量较常量明显减少,甚至点滴即净,或经行时间不足2天,经量亦少的月经病。
1.3排除标准:有内分泌异常、黄体功能不全;有甲状腺功能亢进、结核、严重贫血等慢性消耗性疾病者;3个月内有口服激素、使用避孕药者;服药过程中出现不良反应者;未按规定用药,无法判断疗效或资料不全等影响疗效或统计处理者。
1.4治疗方法:
观察组:月经第5天开始使用本发明实施例1制备的胶囊剂,每日两次,每次2-4粒,月经来潮时停服,以3个月为一个疗程,连续服用3个月。
对照组:使用西药行人工周期雌孕激素序贯疗法,从月经第5天开始,患者口服补佳乐1mg,1次/d,连服21d;自第15天开始,加用黄体酮胶丸100mg,2次/d,服至第21天与补佳乐同时停药。连续治疗3个月经周期。
1.5观察指标:
1.5.1观察两组治疗前后月经情况的改变--月经量色、质,行经时间,月经周期,子宫内膜厚度(月经周期第24d时B超监测)。
1.5.2观察两组患者的治疗效果。
1.5.3用药期间药物不良反应的观察:观察用药期间有无出现不良反应并记录,如胃肠道不适、过敏反应、阴道出血时间延长等。如出现严重不良反应者,立即停止用药,退出本研究。
1.5.4随访性观测:治疗结束后第三次月经来潮后随访,记录相关症状观察。
1.6统计学方法:采用SPSS15.0统计软件进行计算。各数值以表示,计量资料采用t检验,计数资料采用χ2检验,以P<0.05为差异有统计学意义。
2结果
2.1疗效标准:根据《中药新药治疗月经不调的临床研究指导原则》,拟定以下疗效标准:痊愈:治疗后月经周期、经量恢复正常,其他症状消失,停药3个月经周期未复发者。显效:月经量增加1/3,其他症状消失减轻,积分较治疗前减少70%以上,停药3个月经周期无复发者。有效:治疗后月经周期、经量、经期较治疗前改善,其他症状较治疗前减轻,积分较治前减少30~69%。无效:治疗后月经周期、经量及经期无改善,积分较治疗前减少30%以下。
2.2疗效观察
2.2.1两组患者疗效比较:观察组痊愈20例,显效25例,有效8例,无效1例,显效率83.33%,总有效率98.15%;对照组痊愈10例,显效13例,有效17例,无效14例,显效率42.59%,总有效率74.07%,观察组与对照组显效率、总有效率比较,差异有统计学意义(P<0.05),说明观察组较对照组可以明显的提高月经过少的临床治愈率及显效率。见表1。
表1两组患者疗效比较(n%,例)
注:与对照组比较,*P<0.05。
2.2.2治疗前后子宫内膜厚度比较:两组治疗后黄体期子宫内膜厚度与治疗前比较也有增厚,差异有统计学意义(P<0.01),治疗后两组间比较,差异有统计学意义(P<0.05),治疗组效果更优。见表2。
表2治疗前后子宫内膜厚度及经期时间比较
注:与治疗前比较,*P<0.05,**P<0.01;与治疗后对照组比较,#P<0.05。
2.2.3两组治疗后随访结果比较:在治疗结束后对显效患者随访时,观察组45例患者月经正常,有1例患者在随访时,月经过少,而对照组23例患者中,有16例患者月经正常,有6例患者月经过少,1例患者闭经,说明对照组的患者在停药后临床症状有反弹。据此可以说明观察组与对照组比较具有更好的远期疗效,并且患者的临床症状不易复发,也证明了本发明药物制剂可以治疗由慢性子宫内膜炎引起的月经过少,使机体得到良好的恢复。
2.2.4用药期间药物不良反应的观察:观察组患者用药期间有1例患者出现轻度胃肠道反应。对照组患者用药期间有12例患者出现轻度胃肠道反应,如恶心、呕吐、上腹隐痛;有3例患者出现不规则阴道流血,观察组与对照组比较,差异有统计学意义,观察组不良反应更少,患者依从性更好。
我们推测,本发明药物制剂有多靶点、多环节、多层次的综合调控作用,可能是改善子宫内膜的螺旋动脉的血流,提高子宫内膜的血流灌注,促进微循环、子宫内膜的生长、修复;还可能提高子宫内膜的雌、孕激素受体含量,多种因素同作用改善月经。
治疗结果显示:观察组较对照组可以明显提高由慢性子宫内膜炎引起的月经过少的临床治愈率及显效率;具有更好的远期疗效,并且患者的临床症状不易复发,不良反应少,是一种安全有效的药物制剂,为中医药治疗月经过少提供新的方法,值得进一步研究并推广应用。
Claims (10)
1.一种治疗慢性子宫内膜炎致月经量少的药物制剂,其特征在于由叶底红、红毛七、川芎、牛马藤、菟丝子、枸杞子、通经草、白术、黄芪、牛膝、苏木、甘草为药用原料制成,各药用原料的重量份配比如下:叶底红15-30份、红毛七10-18份、川芎6-12份、牛马藤10-25份、菟丝子15-30份、枸杞子10-30份、通经草10-15份、白术8-13份、黄芪10-20份、牛膝3-8份、苏木4-10份、甘草3-10份。
2.如权利要求1所述的药物制剂,其特征在于由以下优选重量份配比的药用原料制成:叶底红18-24份、红毛七12-16份、川芎6-10份、牛马藤15-20份、菟丝子20-26份、枸杞子14-20份、通经草10-15份、白术8-13份、黄芪11-16份、牛膝3-7份、苏木5-9份、甘草6-10份。
3.如权利要求2所述的药物制剂,其特征在于由以下优选重量份配比的药用原料制成:叶底红20份、红毛七15份、川芎7份、牛马藤18份、菟丝子25份、枸杞子16份、通经草12份、白术12份、黄芪15份、牛膝5份、苏木6份、甘草8份。
4.如权利要求1-3所述的药物制剂,其特征在于其制备方法包括如下步骤:将所述叶底红、红毛七、川芎、牛马藤、菟丝子、枸杞子、通经草、白术、黄芪、牛膝、苏木、甘草按处方比例混合,加入相对于混合物质量4~8倍的水,煎煮2~3小时,过滤获得第一提取液;过滤获得的药渣再加入相对于所述药渣质量2~4倍的水,煎煮1~2小时,过滤获得第二提取液;将第一提取液和第二提取液合并,减压浓缩,干燥,获得干膏,将干膏放置在超微粉碎机中粉碎1~2小时,粉碎,过筛,获得100-200目的细粉,加入药学上可接受的辅料或辅助性成分按照药物制剂常规工艺制备得到。
5.如权利要求1-3任一所述的药物制剂,其特征在于所述药物制剂的剂型是口服剂型。
6.如权利要求5所述的药物制剂,其特征在于所述口服剂型为片剂、薄膜衣片剂、肠溶衣片剂、胶囊剂、硬胶囊剂、软胶囊剂、口服液、颗粒剂、蜜丸剂、散剂、丹剂、溶液剂或硬膏剂等。
7.如权利要求6所述的药物制剂,其特征在于所述口服剂型优选为片剂、胶囊剂、颗粒剂。
8.如权利要求7所述的药物制剂,其特征在于所述口服剂型最优选为胶囊剂。
9.权利要求1-3任一所述的药物在制备治疗月经量少的药物的用途。
10.权利要求1-3任一所述的药物在制备治疗慢性子宫内膜炎致月经量少的药物的用途。
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