CN105362698A - 一种治疗人工流产术后月经量少的药物制剂 - Google Patents
一种治疗人工流产术后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,涉及治疗月经不调的药物,尤其涉及一种治疗人工流产术后月经量少的药物制剂。该药物制剂由枸杞子、黄精、芡实、续断、手掌参、扶芳藤、鹿耳翎、红母鸡草、凤尾七、党参、陈皮、香附为药用原料按照一定的比例精心制成。诸药伍用,阴阳共调,攻补兼施,补肾养肝,活血化瘀,养血调经,针对引起人工流产术后月经量少的肾虚、血瘀、血虚等病因效果显著,标本兼治。
Description
技术领域
本发明属于中药领域,涉及治疗月经不调的药物,尤其涉及一种治疗人工流产术后月经量少的药物制剂。
背景技术
月经过少是指月经周期正常,月经量明显减少或行经时间不足2天,甚或点滴即净者,古籍有称“经水涩少”、“经水少”、“经量过少”等。人工流产手术是避孕失败后或因某种疾病而不适于继续妊娠者,或为预防遗传病及先天性畸形者的一种有效措施,其引起月经过少较为常见,亦是妇科临床常见的疑难病症。
西医认为可能与人流术后致生殖内分泌轴调节功能失调有关。现代研究表明人工流产术手术者手法不当或刮宫次数过多,在手术中可能伤及子宫内膜,造成子宫内膜血管损伤、硬化,影响子宫内膜的血流灌注或损伤了子宫内膜的基底层或导致宫腔黏连等,从而引起这些患者术后月经过少。
传统医学认为月经产生之机理十分复杂,根据《素问·上古天真论》:“女子七岁,肾气盛,齿更发长;二七而天癸至,任脉通,太冲脉盛,月事以时下”的记载,认为是在“肾气-天癸-冲任-胞宫”生殖轴的作用下而产生。《妇科玉尺·胎前·小产》有云:“是知正产者,正如果中粟熟,其壳自开,两无所损。半产者,则犹采研新粟,碎其肤壳,损其皮肤,然后取得其实。”人工流产术直接作用于胞宫,冲任二脉皆起于胞中;又胞脉系于肾,冲任之本在肾,人工流产术直接扰乱了肾-天癸-冲任-胞宫的生理,使冲任、胞宫直接受损,导致冲任、胞脉瘀滞,耗伤肾之元气精血,导致肾精亏虚。《傅青主女科》曰:“夫经水出诸肾”、“经本于肾”,经血为肾水所化,肾精亏损自然会月经量少,人工流产术使用吸刮器械直接伤及子宫,络脉损伤,亦如未熟之粟而强取之,必然会不可避免地损伤胞宫,胞脉瘀滞,耗伤肾之元气精血。现代医家多认为人流术后月经过少主要病机为肾虚、血虚、血瘀。目前,临床上现有的西医治疗往往毒副作用较大,且停药后易复发,治疗效果并不理想,人们常常求助于中药。
发明内容
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,总结认为人流是人为终止妊娠,似青藤摘瓜,导致冲任、胞宫直接受损,而人流术后失血,使血海空虚,肾精不足,冲任血海不充,故经来量少,属于虚实夹杂病证,据此,提供了一种治疗人工流产术后月经量少的药物制剂,其有补肾养肝,活血化瘀,养血调经之效,攻补兼施,疗效显著。
本发明采用的技术方案如下:
一种治疗人工流产术后月经量少的药物制剂,其由枸杞子、黄精、芡实、续断、手掌参、扶芳藤、鹿耳翎、红母鸡草、凤尾七、党参、陈皮、香附为药用原料按照一定的比例精心制成。
本发明在组方选择上多用补肝肾、补血、活血、化瘀,温经、行气之品,组方中的个别单味药具有治疗月经不调的作用,但均不足以具有良好的临床治疗效果。为了药物中有效活性成分的协同作用,本发明人在祖传秘方的基础上,经过长期、大量的筛选组方试验,进一步优选如下技术方案:一种治疗人工流产术后月经量少的药物制剂,其由下述重量份的药用原料制成:枸杞子20-40份、黄精10-20份、芡实20-40份、续断5-15份、手掌参10-15份、扶芳藤11-16份、鹿耳翎20-40份、红母鸡草10-20份、凤尾七14-20份、党参11-16份、陈皮5-15份、香附8-18份。
进一步优选地,一种治疗人工流产术后月经量少的药物制剂,其由下述重量份的药用原料制成:枸杞子30-36份、黄精14-20份、芡实25-30份、续断10-15份、手掌参10-15份、扶芳藤11-14份、鹿耳翎26-32份、红母鸡草13-17份、凤尾七14-18份、党参11-16份、陈皮8-13份、香附11-15份。
进一步优选地,一种治疗人工流产术后月经量少的药物制剂,其由下述重量份的药用原料制成:枸杞子30份、黄精16份、芡实26份、续断12份、手掌参10份、扶芳藤12份、鹿耳翎30份、红母鸡草15份、凤尾七17份、党参12份、陈皮10份、香附12份。
方中:枸杞子、黄精均为甘润平补之品,一善补滋补肝肾而主肝肾真阴不足,一善补气血而益精血,滋而不腻,补而不滞,最补肝肾,兼益脾肺,为君药。凤尾七甘苦平,善益肾养肝,活血调经,党参补中益气,健脾益肺,健运中气,养血而不偏滋腻,续断苦辛微温,补续血脉之药,善补肝肾,强筋骨,疏通气血筋骨而调气血,芡实甘涩平,补脾固肾,助气涩精,四药伍用补肝肾、健脾胃、益气血、通经络、散瘀滞为臣药。手掌参益肾健脾、理气和血;扶芳藤舒筋活络、益肾壮腰;鹿耳翎辛苦微温,除湿,化滞,散瘀,消肿,解毒;红母鸡草祛瘀调经,消瘀止痛,陈皮理气健脾,香附调和气血,具为佐使药。诸药伍用,阴阳共调,攻补兼施,补肾养肝,活血化瘀,养血调经,针对引起人工流产术后月经量少的肾虚、血瘀、血虚等病因效果显著,标本兼治。
本发明所用各药材的药理学研究现状如下所述。
芡实:本品为睡莲科植物芡EuryaleferoxSalisb.的干燥成熟种仁。秋末冬初采收成熟果实,除去果皮,取出种子,洗净,再除去硬壳(外种皮),晒干。【性味】甘、涩,平。【归经】归脾、肾经。【功能主治】益肾固精,补脾止泻,祛湿止带。用于梦遗滑精,遗尿尿频,脾虚久泻,白浊,带下。
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。《本草经疏》:枸杞子,润而滋补,兼能退热,而专于补肾、润肺、生津、益气,为肝肾真阴不足、劳乏内热补益之要药。老人阴虚者十之七八,故服食家为益精明日之上品。昔人多谓其能生精益气,除阴虚内热明目者。盖热退则阴生,阴生则精血自长,肝开窍于目,黑水神光属肾,二脏之阴气增益,则目自明矣。
续断:【性味】苦、辛,微温。【归经】归肝、肾经。【功能主治】补肝肾,强筋骨,续折伤,止崩漏。用于腰膝酸软,风湿痹痛,崩漏,胎漏,跌扑损伤。酒续断多用于风湿痹痛,跌扑损伤。盐续断多用于腰膝酸软。
手掌参:【性味】甘;平。【归经】肺;脾;胃经。【功能主治】止咳平喘;益肾健脾;理气和血;止痛。主肺虚咳喘;虚劳消瘦;神经衰弱;肾虚腰腿酸软;阳痿;滑精;尿频;慢性肝炎;久泻;失血;带下;乳少;跌打损伤。【用法用量】内服:煎汤,9-15g;或研末;或浸酒。
扶芳藤:【性味】苦;甘;微辛;微温。【归经】肝;脾;肾经。【功能主治】舒筋活络;益肾壮腰;止血消瘀。主肾虚腰膝酸痛;半身不遂;风湿痹痛;小儿惊风;咯血;吐血;血崩;有经不调;子宫脱垂;跌打骨折;创伤出血。【用法用量】内服:煎汤,15-30g;或浸酒,或入丸、散。外用:适量,研粉调敷,或捣敷,或煎水熏洗。
鹿耳翎:【性味】味辛;苦;性微温。【功能主治】祛风,除湿,化滞,散瘀,消肿,解毒。主感冒发热;肺热咳嗽;风湿关节炎;腹泻;肾炎水肿;经闭;跌打损伤;疔疮痈肿;瘰疬;毒蛇咬伤;湿疹瘙痒。
红母鸡草:【性味】甘辛;平。【归经】肝经。【功能主治】祛瘀调经,解毒,止痛。主跌打损伤,子宫脱垂,脱肛,闭经,牛皮癣,牙痛,头痛。
凤尾七:【性味】味甘;微苦;性平。【归经】肾;肝经。【功能主治】益肾养肝;调经活血。主劳热骨蒸;干血痨;头晕目眩;月经不调。
党参:【性味】甘,平。【归经】归脾、肺经。【功能主治】补中益气,健脾益肺。用于脾肺虚弱,气短心悸,食少便溏,虚喘咳嗽,内热消渴。《本草正义》:“党参力能补脾养胃,润肺生津,健运中气,本与人参不甚相远。其尤可贵者,则健脾运而不燥,滋胃阴而不湿,润肺而不犯寒凉,养血而不偏滋腻,鼓舞清阳,振动中气而无刚燥之弊。”
陈皮:【性味】苦、辛,温。【归经】归肺、脾经。【功能主治】理气健脾,燥湿化痰。用于胸脘胀满,食少吐泻,咳嗽痰多。
黄精:【性味】甘,平。【归经】归脾、肺、肾经。【功能主治】补气养阴,健脾,润肺,益肾。用于脾胃虚弱,体倦乏力,口干食少,肺虚燥咳,精血不足,内热消渴。
香附:【性味】辛、微苦、微甘,平。【归经】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。《纲目》:“香附之气平而不寒,香而能窜,其味多辛能散,微苦能降,微甘能和。”
为了更好地表达本发明的药物制剂,本发明的药物制剂可由枸杞子、黄精、芡实、续断、手掌参、扶芳藤、鹿耳翎、红母鸡草、凤尾七、党参、陈皮、香附或其水或其有机溶剂提取物为活性成分,该成分单独或与药物可接受的载体混合,依照制剂学常规技术制成。
所述的药学上可接受的载体,如甘露醇、山梨醇、焦亚硫酸钠、亚硫酸氢钠、硫代硫酸钠、盐酸半胱氨酸、巯基乙酸、蛋氨酸、维生素C、EDTA二钠、EDTA钙钠,一价碱金属的碳酸盐、醋酸盐、磷酸盐或其水溶液、盐酸、醋酸、硫酸、磷酸、氨基酸、氯化钠、氯化钾、乳酸钠、木糖醇、麦芽糖、葡萄糖、果糖、右旋糖苷、甘氨酸、淀粉、蔗糖、乳糖、甘露糖醇、硅衍生物、纤维素及其衍生物、藻酸盐、明胶、聚乙烯吡咯烷酮、甘油、土温80、琼脂、碳酸钙、碳酸氢钙、表面活性剂、聚乙二醇、环糊精、β-环糊精、磷脂类材料、高岭土、滑石粉、硬脂酸钙、硬脂酸镁等等。
本发明药物制剂优选制成为口服剂型,如:片剂、糖衣片剂、薄膜衣片剂、肠溶衣片剂、胶囊剂、硬胶囊剂、软胶囊剂、口服液、口含剂、颗粒剂、冲剂、蜜丸剂、散剂、丹剂、溶液剂或硬膏剂等。进一步优选的是本发明所述药物制剂的口服剂型为片剂、胶囊剂或颗粒剂,最优选为胶囊剂。
本发明还提供了该一种本发明所述药物制剂的制备方法,本发明的发明人在研究中发现,通过优化制备方法,能够在保持有效药物的情况下,去除杂质或无药效的部分,减少杂质对治疗效果的干扰,使得该药物制剂更加有效,并且由此减少药物的用量。
本发明提供的一种治疗肝郁气滞型月经过少的药物制剂的制备方法,主要包括以下步骤:
取鹿耳翎、红母鸡草、陈皮、香附,加药材量4-8倍的50%的乙醇溶液,提取二次,每次1.5-2.0小时,(用6-8层纱布)趁热过滤,浓缩至无醇味得乙醇提取物浓缩液;取枸杞子、黄精、芡实、续断、手掌参、扶芳藤、凤尾七、党参连同鹿耳翎、红母鸡草、陈皮、香附乙醇提取后滤渣,加5-10倍水浸泡3-4小时,煎煮提取两次,每次1.5-2.0小时(从沸腾时开始计时);趁热过滤,浓缩至相对密度1.05-1.10(60℃测得),加乙醇使含醇量为30-35%(体积比),静置24小时后,离心20分钟,(转速为3000r/min),弃去下层沉淀物,得到上清液,浓缩至相对密度1.05-1.10(60℃测得)后与上述乙醇提取物浓缩液混合,在进风温度140~150℃,出风温度75~80℃条件下进行喷雾干燥,得到药物活性成分;该成分单独或与药物可接受的载体混合,依照制剂学常规技术制成本发明的药物制剂。
本发明是发明人经过反复研究,逐步改进,最后成功的一种疗效较好的药物制剂,并通过临床病例进一步验证了本发明药物制剂的疗效,详细资料如下所述:
1资料与方法
1.1一般资料:观察2013年8月至2014年8月就诊于我院妇科门诊确诊为月经量少的患者128例,观察组64例,对照组64例,采用随机分组,单盲方法,将病例按年龄、病情轻重不同分为观察组与对照组进行观察。观察组最大年龄40岁,最小年龄18岁,平均年龄27.7岁,对照组最大年龄39岁,最小年龄18岁,平均26.9岁;观察组病程最长6.5年,最短6个月,平均2.25年,对照组病程最长6.5年,最短7个月,平均2.06年;观察组病情轻度11例,中度32例,重度21例;对照组病情轻度10例,中度33例,重度21例,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。
中医辨证标准:参考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》的有关内容,制定中医辨证标准,肾虚、血瘀或血虚症。
1.3纳入标准:符合疾病诊断标准;有人工流产病史,月经量少3个月以上病史;B超监测排卵日子宫内膜厚度>8mm;基础体温(BBT)双相。
1.4排除标准:有内分泌异常、黄体功能不全、宫腔器质性病变者;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。
1.5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2-4粒,服用至月经来潮时停服,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。
1.6治疗前后观察指标:
1.6.1月经情况的改变--月经量色、质,行经时间,月经周期。
1.6.2治疗前后症状评分,标准:轻度:8分以下,中度:8.5~11.5分;重度:12分以上。主要症状评分标准:月经减少1/3或不足2d,整个月经周期用7~10块纸垫5分;减少1/2,共用纸垫3~6块6分;月经点滴即净,用纸垫1~2块7分。
伴有痛经或少腹痛2分,腰骶酸痛1分,经色淡质稀薄1份,伴血块0.5分,头晕眼花或耳鸣0.5分,苔薄白或白腻0.5分,腰骶酸痛0.5分。
1.6.3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。
1.7统计学方法:采用SPSS16.0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%,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:上述128例患者治疗后,观察组治愈22例,显效28例,好转12例,无效2例,显效率78.1%,总有效率98.4%;对照组治愈13例,显效17例,好转21例,无效13例,显效率46.9%,总有效率79.7%,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),观察组效果更优异。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。
2.2.2两组症状积分比较:治疗后两组症状积分均比治疗前明显较少,与治疗前比较差异有统计学意义(P<0.01),治疗后两组间比较,差异有统计学意义(P<0.05),观察组症状积分减少更加明显。见表2。
表2治疗前后两组症状积分比较
注:与治疗前比较,*P<0.05,**P<0.01,治疗后与对照组比较,#P<0.05。
2.2.3用药期间药物不良反应的观察:对照组患者用药期间有1例患者出现轻度胃肠道反应。对照组患者用药期间有14例患者出现轻度胃肠道反应,如恶心、呕吐、上腹隐痛;有4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。
本发明药物制剂对于人工流产术后月经过少的患者,尤其是中医辨证属于肾虚、血瘀或血虚症患者,治疗效果明显,不良反应少,推测可能与中医药具有整体调控、多系统、多环节、多靶点的作用,通过整体辨证论治,能明显改善患者的临床症状,可能与调节下丘脑-垂体-卵巢轴,提高卵巢对FSH的反应性,改善卵巢储备功能以及促进卵巢局部的血液循环,改善卵巢血供,促进卵巢形成及排卵,同时还可能与提高子宫内膜的容受性有关。
总之,与现有技术相比,本发明具有以下有益效果:
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,共奏补肾养肝,活血化瘀,养血调经之功效,使肾精足,肾气盛,冲任二脉通,气血调和,则血海满盈充足;脾胃健运正常,无痰湿壅塞冲任,则精血下行无阻。化源充足,通路无阻,则月经量正常,月经如期而至。
本发明以辨证理论为基础,抓住患者肾虚、血虚之本,兼顾血瘀之标,阴阳并调,攻补兼施,扶正祛邪,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,而被广大患者认可。
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
处方:枸杞子30份、黄精16份、芡实26份、续断12份、手掌参10份、扶芳藤12份、鹿耳翎30份、红母鸡草15份、凤尾七17份、党参12份、陈皮10份、香附12份。
制备方法:取鹿耳翎、红母鸡草、陈皮、香附,加药材量4-8倍的50%的乙醇溶液,提取二次,每次1.5-2.0小时,(用6-8层纱布)趁热过滤,浓缩至无醇味得乙醇提取物浓缩液;取枸杞子、黄精、芡实、续断、手掌参、扶芳藤、凤尾七、党参连同鹿耳翎、红母鸡草、陈皮、香附乙醇提取后滤渣,加5-10倍水浸泡3-4小时,煎煮提取两次,每次1.5-2.0小时(从沸腾时开始计时);趁热过滤,浓缩至相对密度1.05-1.10(60℃测得),加乙醇使含醇量为30-35%(体积比),静置24小时后,离心20分钟(离心转速为3000r/min),弃去下层沉淀物,得到上清液,浓缩至相对密度1.05-1.10(60℃测得)后与上述乙醇提取物浓缩液混合,在进风温度140~150℃,出风温度75~80℃条件下进行喷雾干燥,得到药物活性成分;依照制剂学常规技术制成胶囊剂。
本实施例制备的胶囊每粒含有生药2.02g。
实施例2
处方:枸杞子35份、黄精17份、芡实25份、续断10份、手掌参15份、扶芳藤11份、鹿耳翎28份、红母鸡草15份、凤尾七15份、党参10份、陈皮12份、香附12份。
制备方法:参照实施例1的操作进行。
实施例3
处方:枸杞子33份、黄精18份、芡实30份、续断10份、手掌参12份、扶芳藤14份、鹿耳翎25份、红母鸡草10份、凤尾七15份、党参16份、陈皮8份、香附15份。
制备方法:参照实施例1的操作进行。
实施例4
处方:枸杞子25份、黄精20份、芡实36份、续断5份、手掌参10份、扶芳藤16份、鹿耳翎25份、红母鸡草15份、凤尾七16份、党参11份、陈皮12份、香附10份。
制备方法:参照实施例1的操作进行。
实施例5
处方:枸杞子25份、黄精14份、芡实25份、续断10份、手掌参12份、扶芳藤12份、鹿耳翎20份、红母鸡草20份、凤尾七14份、党参11份、陈皮10份、香附16份。
制备方法:参照实施例1的操作进行。
实施例6
处方:枸杞子20份、黄精20份、芡实30份、续断15份、手掌参15份、扶芳藤11份、鹿耳翎35份、红母鸡草16份、凤尾七15份、党参12份、陈皮5份、香附18份。
制备方法:参照实施例1的操作进行。
实施例7
处方:枸杞子32份、黄精18份、芡实36份、续断8份、手掌参10份、扶芳藤14份、鹿耳翎26份、红母鸡草17份、凤尾七15份、党参15份、陈皮10份、香附15份。
制备方法:参照实施例1的操作进行。
实施例8
处方:枸杞子35份、黄精20份、芡实30份、续断15份、手掌参12份、扶芳藤14份、鹿耳翎26份、红母鸡草14份、凤尾七14份、党参12份、陈皮8份、香附16份。
制备方法:参照实施例1的操作进行。
实施例9
处方:枸杞子30份、黄精16份、芡实26份、续断12份、手掌参10份、扶芳藤12份、鹿耳翎30份、红母鸡草15份、凤尾七17份、党参12份、陈皮10份、香附12份。
制备方法:取鹿耳翎、红母鸡草、陈皮、香附,加药材量4-8倍的50%的乙醇溶液,提取二次,每次1.5-2.0小时,(用6-8层纱布)趁热过滤,浓缩至无醇味得乙醇提取物浓缩液;取枸杞子、黄精、芡实、续断、手掌参、扶芳藤、凤尾七、党参连同鹿耳翎、红母鸡草、陈皮、香附乙醇提取后滤渣,加5-10倍水浸泡3-4小时,煎煮提取两次,每次1.5-2.0小时(从沸腾时开始计时);趁热过滤,浓缩至相对密度1.05-1.10(60℃测得),加乙醇使含醇量为30-35%(体积比),静置24小时后,离心20分钟(离心转速为3000r/min),弃去下层沉淀物,得到上清液,浓缩至相对密度1.05-1.10(60℃测得)后与上述乙醇提取物浓缩液混合,在进风温度140~150℃,出风温度75~80℃条件下进行喷雾干燥,得到药物活性成分;依照制剂学常规技术制成片剂。
实施例10
处方:枸杞子30份、黄精16份、芡实26份、续断12份、手掌参10份、扶芳藤12份、鹿耳翎30份、红母鸡草15份、凤尾七17份、党参12份、陈皮10份、香附12份。
制备方法:取鹿耳翎、红母鸡草、陈皮、香附,加药材量4-8倍的50%的乙醇溶液,提取二次,每次1.5-2.0小时,(用6-8层纱布)趁热过滤,浓缩至无醇味得乙醇提取物浓缩液;取枸杞子、黄精、芡实、续断、手掌参、扶芳藤、凤尾七、党参连同鹿耳翎、红母鸡草、陈皮、香附乙醇提取后滤渣,加5-10倍水浸泡3-4小时,煎煮提取两次,每次1.5-2.0小时(从沸腾时开始计时);趁热过滤,浓缩至相对密度1.05-1.10(60℃测得),加乙醇使含醇量为30-35%(体积比),静置24小时后,离心20分钟(离心转速为3000r/min),弃去下层沉淀物,得到上清液,浓缩至相对密度1.05-1.10(60℃测得)后与上述乙醇提取物浓缩液混合,在进风温度140~150℃,出风温度75~80℃条件下进行喷雾干燥,得到药物活性成分;依照制剂学常规技术制成颗粒剂。
Claims (10)
1.一种治疗人工流产术后月经量少的药物制剂,其特征在于由枸杞子、黄精、芡实、续断、手掌参、扶芳藤、鹿耳翎、红母鸡草、凤尾七、党参、陈皮、香附为药用原料制成。
2.如权利要求1所述的药物制剂,其特征在于由下述优选重量份的药用原料制成:枸杞子20-40份、黄精10-20份、芡实20-40份、续断5-15份、手掌参10-15份、扶芳藤11-16份、鹿耳翎20-40份、红母鸡草10-20份、凤尾七14-20份、党参11-16份、陈皮5-15份、香附8-18份。
3.如权利要求2所述的药物制剂,其特征在于由下述优选重量份的药用原料制成:枸杞子30-36份、黄精14-20份、芡实25-30份、续断10-15份、手掌参10-15份、扶芳藤11-14份、鹿耳翎26-32份、红母鸡草13-17份、凤尾七14-18份、党参11-16份、陈皮8-13份、香附11-15份。
4.如权利要求3所述的药物制剂,其特征在于由下述重量份的药用原料制成:枸杞子30份、黄精16份、芡实26份、续断12份、手掌参10份、扶芳藤12份、鹿耳翎30份、红母鸡草15份、凤尾七17份、党参12份、陈皮10份、香附12份。
5.如权利要求1-4任一所述的药物制剂,其特征在于其制备方法包括以下步骤:
取鹿耳翎、红母鸡草、陈皮、香附,加药材量4-8倍的50%的乙醇溶液,提取二次,每次1.5-2.0小时,(用6-8层纱布)趁热过滤,浓缩至无醇味得乙醇提取物浓缩液;
取枸杞子、黄精、芡实、续断、手掌参、扶芳藤、凤尾七、党参连同鹿耳翎、红母鸡草、陈皮、香附乙醇提取后滤渣,加5-10倍水浸泡3-4小时,煎煮提取两次,每次1.5-2.0小时(从沸腾时开始计时);趁热过滤,浓缩至相对密度1.05-1.10(60℃测得),加乙醇使含醇量为30-35%(体积比),静置24小时后,离心20分钟(离心转速为3000r/min),弃去下层沉淀物,得到上清液,浓缩至相对密度1.05-1.10(60℃测得)后与上述乙醇提取物浓缩液混合,在进风温度140~150℃,出风温度75~80℃条件下进行喷雾干燥,得到药物活性成分;该成分单独或与药物可接受的载体混合,依照制剂学常规技术制成本发明的药物制剂。
6.如权利要求1-5任一所述的药物制剂,其特征在于所述药物制剂优选制成口服剂型。
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为片剂、糖衣片剂、薄膜衣片剂、肠溶衣片剂、胶囊剂、硬胶囊剂、软胶囊剂、口服液、口含剂、颗粒剂、冲剂、蜜丸剂、散剂、丹剂、溶液剂或硬膏剂等。
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为片剂、胶囊剂或颗粒剂。
9.如权利要求8所述的药物制剂,其特征在于所述口服剂型为胶囊剂。
10.权利要求1-9任一所述的药物制剂在制备治疗人工流产术后月经量少的药物中的应用。
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