CN1541676A - 一种产后补血保健药物及其制备方法和应用 - Google Patents
一种产后补血保健药物及其制备方法和应用 Download PDFInfo
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- CN1541676A CN1541676A CNA2003101031719A CN200310103171A CN1541676A CN 1541676 A CN1541676 A CN 1541676A CN A2003101031719 A CNA2003101031719 A CN A2003101031719A CN 200310103171 A CN200310103171 A CN 200310103171A CN 1541676 A CN1541676 A CN 1541676A
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- blood
- enriching blood
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- RZVAJINKPMORJF-UHFFFAOYSA-N p-acetaminophenol Chemical compound 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Abstract
Description
技术领域
本发明涉及一种补血药物及其制备方法和应用,尤其涉及一种产后补血保健药物及其制备方法和应用。
背景技术
全世界有数千万计的育龄女性在生产、人流、小产后,面临四大损伤:1)分娩、流产时,用力过度、耗时过久、失血过多而形成产后大虚;2)分娩、流产时,引起人体组织器官损伤;3)分娩、流产时,打破了正常的血液循环模式,气血滞逆或不足造成内分泌失调紊乱;4)人流、小产后体质虚弱、精神紧张引起周身不适。目前,市场现有的女性产后护理、保健品以补血类产品为主,如血尔、阿胶、红桃K等,但其功效单纯,不能解决产后诸多不适之症。
发明内容
本发明的目的是提供一种补血药物及其制备方法和应用,尤其提供一种产后补血保健药物及其制备方法和应用,克服了目前药物治疗产后诸多不适之症功效单纯,疗效不甚确切的缺点。
本发明的目的是通过以下技术方案完成的:一种产后补血保健药物,是由包括以下原料组分制成的制剂:桂圆肉、当归、人参、桃仁、甘草、红花、益母草、川芎。
所述组分可为以下重量份组分:桂圆肉6-18、当归8-30、人参2-6、桃仁2-6、甘草1-3、红花3-9、益母草3-9、川芎6-18。
所述组分优选为以下重量份组分:桂圆肉12、当归20、人参4、桃仁4、甘草2、红花6、益母草6、川芎12。
所述药物还包括加入适量黄酒,所述黄酒重量份为6-20,最好为12,本发明黄酒可从市场购得,符合食品标准,本发明药物原料合乎药典标准,均可从市场购得,选用优质原料。
所述保健药物还含有适量可药用的辅料,如矫味剂,红糖,尤其5-30重量份红糖,以及如赋型剂等。
所述保健药物可为任何一种药剂学上所说的剂型,优选为口服液、颗粒剂、胶囊剂。
一种产后补血保健药物的制备方法,包括以下步骤:取桂圆肉、当归、人参、桃仁、甘草、红花、益母草、川芎,按常规中药提取法提取,再按常规制剂法制成各种药用剂型;所述中药提取法为水提、醇提或水醇混合提取;还包括加入黄酒;所述制备方法还包括加入适量药用辅,如矫味剂,赋型剂。
本发明还提供了所述药物组合物在制备产后补血保健品或治疗产后诸症药物方面的应用。本发明的解决方案是基于祖国医学对治疗妇女产后疾病及全面调理人体机能机理的认识及治疗原则,参考现代药理研究成就,从祖国医药宝库中,筛选出滋肾阴、补气虚、化淤血、清浊滞、扶正培本的天然植物药,按中医理论之君臣佐使组方,提取精华,使其发挥补血滋阴、润燥止血、温补肝肾、益精养血之功效,增加生物活性和机体免疫力。
发明人认为产后因失血及疲劳导致产妇气血受损、正气虚弱、加之淤血未去、胞宫收缩、稍有护理调养不慎、感寒受冷、饮食不节或房劳所伤,极易引起产后诸病,故认为应以活血化瘀、温经止痛为主。
本发明药物的药理作用:功能主治:治疗妇女产后诸种不适,以温经止痛、活血化瘀、益气补血之法立方,治疗产后恶露、下肢坠痛、肢冷虚汗、奶少食差,该方有助于产后子宫女性尽快恢复到正常状态,并有祛斑养颜之功效,并增强免疫功能。
适应症:适用于产后体虚、受寒、淤血所致腹痛、恶露不下、点滴不畅或恶露不尽,甚则出血不止、恶寒发热,相当于现代医学宫缩不良、复旧不全、继发感染、子宫内膜炎、胎盘残留、产道裂伤、刮宫不净所致的产后出血、腹痛,对人流后腹痛、出血、发热有良好效果。
本发明选用名贵中草药,各成分功效如下:桂圆肉,为补血药,味甘,性平。入心、脾经。能补血养心安神。
当归,为补血药,味甘,辛,性温。入心、肝、脾经。能补血行血,为妇科调经要药,并有润燥、滑肠作用。还具有显著扩张冠脉、降低心肌耗氧量、对抗心肌缺血、提高免疫、抗炎、保肝、镇痛、刺激造血系统的活性,对子宫有兴奋和抑制“双向性”作用。
人参,为补气药,味甘,微苦,性微温。入脾、肺经。能大补元气、生津止渴。
桃仁,为理气药,味苦、甘,性平。入心、肝经。能活血祛瘀,并有润燥滑肠作用。
甘草,为补气药,味甘,性平。通行十二经。能益气、缓急、解毒、润肺。
红花,为理气药,味辛,性温。入心、肝经。能活血祛瘀。
益母草,为理气药,味辛,苦,性微寒。入肝、心包经。能活血祛瘀,具有利尿作用。
川芎,味辛,性温。入肝、胆心包经。能活血化瘀,祛风行气。研究证实有强心、增加心输出量和冠脉流量、抗血栓、抗心肌缺血、改善微循环、加强子宫平滑肌收缩等药理作用。
当归、人参、桂圆肉相须为用,气血双补,令脾胃气血充足,则乳汁生化有源,是为君药。桃仁、甘草、川芎理气补气活血祛瘀,是为臣药。红花、益母草活血通经,是为佐药。上述诸药合用,标本兼治,养血化瘀、温经止痛、使瘀去新生、寒散痛止。进而气血调和,乳脉畅通,祛斑养颜。
本发明药物原料均可从市场购得,选用优级原料。
本发明具有以下优点:1、疗效确切,治疗效果佳,本发明治疗妇女产后诸种不适,以温经止痛、活血化瘀、益气补血之法立方,有助于产后女性子宫尽快恢复到正常状态,具有缩宫、催乳作用,并有祛斑养颜之功效,增强免疫力,药理概念新颖,引导产妇保健新观念。
2、口感好,成本底。
3、选用天然植物药,无毒副作用。
为证明本发明的补血作用,进行了以下试验:对“虚”证动物模型的影响1.小鼠失血致“血虚”模型试验1.1试验目的用失血法造成“血虚”动物模型,以Hb、RBC为指标,观察受试药物对该模型有无补血作用。
1.2受试药物:本发明口服液,每100ml含原生药140g。阳性对照药:阿胶口服液,主要由阿胶组成,能补气养血,用于贫血、气虚体弱等血虚诸证。规格及用量:每盒10ml×12支,每日2次,每次1支。山东东阿阿胶药业公司生产。
1.3动物:昆明种小鼠,封闭群>30代,体重20-22g,由河南省中药研究所提供。
1.4试剂、仪器试剂:血红蛋白转化液,系河南医学检测研究所产品;注射用生理盐水,500ml/瓶,系太原药业股份有限公司产品。
仪器:日本岛津UV-730自动生化比色仪;日本岛津EB-3200D型精密电子天平。
1.5试验方法取雌性小鼠54只,经眶静脉取血0.5ml,同时测RBC和Hb,48h后再测RBC和Hb,按失血后的RBC和Hb数,将小鼠随机分为5组,即①蒸馏水空白对照组②本发明4g(生药量)/kg组、③本发明8g(生药量)/kg组、④本发明14g(生药量)/kg组、⑤阿胶口服液。每天分别按剂量施药本发明和阿胶口服液,0.1ml/10g体重,对照组给相应体积蒸馏水,连续6d,第6天给药后1h,取血测RBC和Hb,观察受试药物对RBC和Hb的影响。
1.6试验结果(见表1、表2)表1本发明对小鼠“血虚”模型Hb的影响(+±SD)组别 动物数 剂量 失血前 失血后给药前 失血后给药后(只) (g/kg×d) Hb(g/L) Hb(g/L) Hb(g/L)正常组 10 / 13.2±0.5 13.4±0.8 13.4±0.8模型组 8 / 14.2±0.4 10.2±1.2##△ 9.0±0.8##本发明 12 4×6 13.3±0.6 10.2±1.9△ 10.9±2.1*本发明 12 8×6 12.9±1.0 10.1±1.2△ 9.9±0.8*本发明 12 14×6 13.7±0.7 10.5±1.3△ 10.1±0.8**阿胶 10 0.15×6 14.3±0.4 10.2±2.2△ 10.7±0.4**与正常组比较:#表示P<0.05;##表示P<0.01。与对照组比较:*表示P<0.05;**表示P<0.01。与同组失血前比较(配对t检验),△P<0.01。
表2本发明对小鼠“血虚”模型RBC的影响(+±SD)组别 动物数 剂量 失血前 失血后给药前 失血后给药后(只) (g/kg×d) RBC(1012/L) RBC(1012/L) RBC(1012/L)正常组 10 / 7.0±0.3 7.0±0.4 7.1±0.5模型组 8 / 6.7±0.6 4.3±1.0##△ 6.2±0.9##本发明 12 4×6 6.8±0.7 3.7±1.0△ 6.5±0.3*本发明 12 8×6 6.9±0.2 4.2±0.9△ 6.9±0.4*本发明 12 14×6 7.0±0.6 3.9±0.7△ 6.8±0.6*阿胶 10 10×6 7.1±0.5 4.2±1.1△ 6.7±0.5*与正常对照组比较:#表示P<0.05;##表示P<0.01。与模型对照组比较:*表示P<0.05;**表示P<0.01。与同组失血前比较(配对t检验),△P<0.01。
1.7试验结论试验结果表明,本发明对失血造成的“血虚”模型RBC和Hb均有明显的改善作用。
2、临床观察妇女产后缺乳的改善根据《中医病诊断疗效标准》、《新药(中药)临床研究指导原则》制定临床病例观察。
1)临床诊断标准产后缺乳是妇女产后哺乳期,乳汁分泌量少或全无,不能满足喂养婴儿的需要。
2)中医证候标准主证:气血亏虚证 产后乳少,甚少或全无,乳汁清稀,无胀感。伴面色少华,神疲食少。舌淡,少苔,脉虚细。
兼证:肝气郁滞证产后乳少,甚少或全无,乳汁稠,而乳房胀硬而痛。情志抑郁不乐,胸肋胀痛,食欲减退,或有微热。舌质暗红或尖边红,苔薄黄,脉弦细。
3)疗效判定标准痊愈:乳汁分泌正常,能正常哺乳。
有效:乳汁分泌增多,或乳汁分泌正常,但不够喂养婴儿。
无效:乳汁分泌无改变。
4)病例,从1998年2月至2000年11月观察门诊和住院病例240例,随机双盲对照,其中本发明口服液180例,空白对照60例。
5)疗程 本发明实施例1口服液一日两次,每次20ml,7天为一疗程。
6)疗效结果痊愈120人,占67%,有效170例,占95%,无效10例占5%。统计对照组比较:P<0.05。
具体实施方式
实施例1口服液按以下配比称取各组分(kg):桂圆肉12、当归20、人参4、桃仁4、甘草2、红花6、益母草6,红糖18,黄酒12L。
制备方法:取上述原料,加水熬制,初始温火至100℃后,再猛火熬制2小时,熬制压力为1.5个大气压。红糖熬制,熬制时间为1小时。120目筛过滤机过滤,过滤液经温火浓缩,加入黄酒,调整使含水量为50%,灌封于20ml或10ml口服液瓶中,以100℃30分钟流通蒸汽灭菌,即得。
用法:口服,一日两次,每次10ml-20ml。
实施例2口服液原料和制备方法同实施例1,不同在于加入黄酒20L,调整使含水量为70%。
实施例2口服液原料和制备方法同实施例1,不同在于加入黄酒6L,调整使含水量为40%。
实施例3颗粒剂按以下配比称取各组分(kg):桂圆肉6、当归8、人参2、桃仁2、甘草1、红花3、益母草3,黄酒6L。
制备方法:取上述原料,加水熬制,初始温火至100℃后,再猛火熬制3小时,熬制压力为2个大气压。120目筛过滤机过滤,过滤液经温火浓缩,浓缩为湿块,用60%浓度黄酒浸润制粒干燥,20目过筛,装袋,2.5克/袋,1000袋,紫外灭菌30分钟,即得。
实施例4胶囊剂按以下配比称取各组分(kg):桂圆肉18、当归30、人参6、桃仁6、甘草13、红花9、益母草9、红糖30。
制备方法:取上述原料加水熬制,初始温火至100℃后,再猛火熬制1.5小时,熬制压力为1个大气压。加入红糖熬制,熬制时间为1.5小时。120目筛过滤机过滤,过滤液经温火浓缩,浓缩为含水量为15%的湿块,干燥,紫外灭菌30分钟,即得。
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