CN105663561A - 一种防治复发性流产的药物组合物 - Google Patents
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Abstract
本发明属于中医药技术领域,涉及一种防治复发性流产的药物组合物及其制备方法。该药物组合物由以下原料药精心制成:菟丝子、女贞子、双参、白术、党参、缬草、黑皮跌打、莲须、刺五加、当归藤、玫瑰花、香附。本发明药物所选药材配伍相宜,组方精炼,在功能上相辅相成,疗效显著;在药性上相制相佐,毒副反应少;具有补肾健脾,益气补血,活血散瘀,调理冲任,培补其源之效,可保证胎孕物质基础,提高胎孕质量,促进宫体和胚胎的供血供氧。临床观察发现,治疗组使用本发明药物治疗后治愈率显著高于对照组,具有意料不到的技术效果。
Description
技术领域
本发明属于中医药技术领域,涉及一种防治复发性流产的药物组合物及其制备方法。
背景技术
复发性流产(RSA)又称反复自然流产,是指将连续2次或2次以上自然流产,是临床上较常见的妊娠并发症,约占育龄妇女的1%~5%。其病因复杂,复发风险随着流产次数的增加而增加,是妇科的顽症之一,临床表现是以流产妊娠期有腰酸腹痛或下腹坠胀,或伴有少量阴道出血为主要症状,中医称之为“滑胎”,具有反复发作,胚胎应期而下的特点。
现代医学认为,复发性流产的基本病理是胚胎及胎儿先死亡,底蜕膜出血,或胎盘后出血,形成胎盘后血肿,刺激子宫,使之收缩排出胚胎及胎儿。其与遗传因素、外界有毒物质影响、母体的疾病、免疫因素造成的排斥及母儿血型不合等有关。目前常见的治疗药物有镇静药、激素类药物、维生素类药物。其中较为常见的化学药有催眠镇静药如安定、雌激素如黄体酮、维生素E,但长期应用产生很大的不良反应。如早期妊娠时持续用镇静药,存在有可引起小儿唇裂的危险,孕妇长期服用大量的镇静药,会影响小儿的智力发育。妊娠期前3个月的妇女如果应用雌激素有可能使胎儿异化;妊娠3个月后服用雌激素,可使胎儿生殖器暂时性增大。大量的维生素E可使激素代谢紊乱,如经闭或月经过多,乳房增大肿胀,还可使血中胆固醇和甘油三酯升高,免疫功能减退等。
中医学认为,肾为先天之本,肾虚冲任不固是流产发生的基础。自然流产对患者的身心伤害颇大,而身体的损伤和心理的负担又影响着下次妊娠。国外的流行病学调查表明,自然流产的次数愈多,再次妊娠时流产的机率愈高。与中医学的认识相一致。中医认为,胎漏、胎动不安、滑胎均以肾虚冲任不固为主要病机,其次则与脾虚失摄、气血不足有关。胎元之形成,在于肾精之充盛,受孕之后,则有赖母体肾气之封藏、气血之充养、冲任之维系,故有“肾以载胎”和“任主胞胎”之说。肾虚的原因,常与孕后房事不节有直接关系,亦有素体禀赋虚弱者,胎孕频多而伤肾者,或跌仆闪挫而伤经络者,使肾失闭藏,则冲任不固。若劳力过度,饮食不调,或忧思不解,也可致脾虚气血虚弱,气虚失摄,胎元失养。根据中医理论,针对习惯性流产的发病机理,采用多进行辩证配伍组方,“预培其损”以达到标本兼治的目的。
发明内容
对于复发性流产的防治,发明人倡导治堕胎者,必当察此养胎之源,“预培其损”,孕前先查明引起流产的原因,再结合临证四诊资料辨证论治。据此供了一种治疗复发性流产的药物组合物,其具有比较突出的补气健脾、益肾安胎的功效,对脾肾两虚型滑胎有较好的防治疗效,并且无毒副作用。
本发明采用的技术方案如下:
一种防治复发性流产的药物组合物,其特征在于由以下原料药精心制成:菟丝子、女贞子、双参、白术、党参、缬草、黑皮跌打、莲须、刺五加、当归藤、玫瑰花、香附。
本发明方中诸药或一味两用,或一药多用,为使诸药在功能上相辅相成,以增强疗效;在药性上相制相佐,以减低毒副反应,发明人进一步优选出以下方案:一种防治复发性流产的药物组合物,其特征在于由以下重量份的原料药精心制成:菟丝子13-18份、女贞子10-15份、双参30-35份、白术8-13份、党参10-15份、缬草6-9份、黑皮跌打10-15份、莲须7-11份、刺五加7-12份、当归藤12-17份、玫瑰花7-11份、香附5-9份。
进一步优选地,一种防治复发性流产的药物组合物,其特征在于由以下重量份的原料药精心制成:菟丝子15份、女贞子10份、双参33份、白术10份、党参12份、缬草8份、黑皮跌打12份、莲须9份、刺五加10份、当归藤15份、玫瑰花10份、香附8份。
方中:菟丝子甘温,补肾养肝,温脾助胃;但补而不峻,温而不燥;女贞子甘苦凉,养阴益肾,补气舒肝,通经和血;双参甘微苦平,健脾益肾,活血调经,三药伍用虚可以补,实可以利,寒可以温,热可以凉,湿可以燥,燥可以润,为补肾健脾为君药。白术健脾益气,燥湿利水;党参甘平,能补脾养胃,润肺生津,鼓舞清阳,健运中气,二药伍用补气健脾,补而不滞,为臣药。刺五加补肾强腰;益气安神;活血通络;缬草能安心神;黑皮跌打通经络,强筋骨,健脾温中;莲须清心通肾,固精气,益精血;当归藤补血活血,散瘀调经,强壮腰膝;玫瑰花理气解郁,和血散瘀,为佐药。香附平而不寒,香而能窜,其辛能散,微苦能降,微甘能和,调经和血,调理月经,使经期正常,为佐使药。诸药合伍有补肾健脾,益气补血,活血散瘀,调理冲任,培补其源之效,可保证胎孕物质基础,提高胎孕质量,促进宫体和胚胎的供血供氧,可有效治疗复发性流产患者。
本发明所用药用原料所涉及的药理药性与研究现状如下:
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。【用法用量】6~12g;外用适量。
女贞子:【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。
双参:【性味】甘、微苦,平。【功能主治】健脾益肾,活血调经,止崩漏,解毒。用于肾虚腰痛,贫血,咳嗽,遗精,阳萎,风湿关节痛,月经不调,倒经,崩漏,带下,不孕症。外用止血。
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。
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。
缬草:【性味】味辛;苦;性温。【归经】归心;肝经。【功能主治】安心神。主心神不安;心悸失眠;癫狂;脏躁;风湿痹痛;痛经;经闭;跌打损伤。
黑皮跌打:【性味】温;甘。【归经】肝;肾经。【功能主治】通经络;强筋骨;健脾温中。主跌打损伤;风湿性关节炎;类风湿性关节痛;感冒;月经不调。【用法用量】内服:煎汤,3-5钱;或浸酒。
莲须:【性味】甘、涩,平。【归经】归心、肾经。【功能主治】固肾涩精。用于遗精滑精,带下,尿频。《纲目》:“清心通肾,固精气,乌须发,悦颜色,益血,止血崩、吐血。”
刺五加:【性味】辛、微苦,温。【归经】归脾、肾、心经。【功能主治】益气健脾,补肾安神。用于脾肾阳虚,体虚乏力,食欲不振,腰膝酸痛,失眠多梦。
当归藤:【性味】苦;涩;性温。【归经】肝;肾经。【功能主治】补血;活血;强壮腰膝。主血虚诸证;月经不调;闭经;产后虚弱;腰腿酸痛;跌打骨折。【用法用量】内服:煎汤,15~30g。外用:适量,鲜品捣敷。
玫瑰花:【性味】甘、微苦,温。【归经】归肝、脾经。【功能主治】行气解郁,和血,止痛。用于肝胃气痛,食少呕恶,月经不调,跌扑伤痛。
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。【用法用量】6~9g。
本发明所提供的防治复发性流产的药物组合物,可以直接将菟丝子、女贞子、双参、白术、党参、缬草、黑皮跌打、莲须、刺五加、当归藤、玫瑰花、香附粉碎,制备成粉散剂口服;也可以将各组分直接混合制成粗粉,萃取出粗粉中的有效成分制成浸膏,利用浸膏制备成口服剂型,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、溶液剂等,还可以制备成适于治疗复发性流产的其它剂型。
发明人综合考虑处方量、药物性质、用药对象、使用方便、制作成本等因素,优选制成胶囊剂、片剂、颗粒剂;最优选制成胶囊剂,即将各组分直接混合制成粗粉,萃取出粗粉中的有效成分制,该有效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备而成。
本发明还提供了一种上述所述药物组合物的制备方法,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,使得该药物组合物更加有效,并且由此减少药物的用量,本发明提供的该药物组合物的制备方法,它包括如下步骤:
按处方取缬草、黑皮跌打、当归藤、玫瑰花、香附用70%乙醇回流提取,收集乙醇回流提取液及滤渣;菟丝子、女贞子、双参、白术、党参、莲须、刺五加连同缬草、黑皮跌打、当归藤、玫瑰花、香附滤渣,加水4-10倍重量份的水煎煮2次,每次1.0-2.0小时,合并煎煮液,加乙醇至浓度为40%,放置8-12小时,过滤得醇沉液,醇沉液与乙醇回流提取液合并,减压回收乙醇,浓缩至浸膏,浸膏干燥成细粉,加药物可接受的载体混匀,用常规制剂方法制成临床所能接受的剂型。
上述所述的药物可接受的载体可选自如: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。
本发明还请求保护上述药物组合物在制备治疗复发性流产特别是在制备用于脾肾两虚型患者复发性流的药物中的用途。通过临床试验可知,两组患者治疗总疗效比较,治疗组成功保胎至正常分娩者达到为93.75%,对照组成功保胎至正常分娩者达到为81.25%,总有效率比较,治疗组明显高于对照组。通过对比中医证候疗效发现,经本发明药物治疗3个月经周期后,患者的临床症状显著改善;在安全性评价中,治疗组患者治疗前后血常规、尿常规、心电图等无异常变化,治疗过程中生命体征平稳且无恶心呕吐、过敏等不良反应,临床治疗结果显著。
与现有技术相比:本发明药物所选药材配伍相宜,组方精炼,在功能上相辅相成,疗效显著;在药性上相制相佐,毒副反应少;符合中医药学和现代医药学理论,具有补肾健脾,益气补血,活血散瘀,调理冲任,培补其源之效,可保证胎孕物质基础,提高胎孕质量,促进宫体和胚胎的供血供氧。临床观察发现,治疗组使用本发明药物治疗后治愈率显著高于对照组。
本发明药物组合物具有多靶点、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,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:菟丝子15份、女贞子10份、双参33份、白术10份、党参12份、缬草8份、黑皮跌打12份、莲须9份、刺五加10份、当归藤15份、玫瑰花10份、香附8份。
制备方法:按处方取缬草、黑皮跌打、当归藤、玫瑰花、香附用70%乙醇回流提取,收集乙醇回流提取液及滤渣;菟丝子、女贞子、双参、白术、党参、莲须、刺五加连同缬草、黑皮跌打、当归藤、玫瑰花、香附滤渣,加水4-10倍重量份的水煎煮2次,每次1.0-2.0小时,合并煎煮液,加乙醇至浓度为40%,放置8-12小时,过滤得醇沉液,醇沉液与乙醇回流提取液合并,减压回收乙醇,浓缩至浸膏,浸膏干燥成细粉,加药物可接受的载体混匀,用常规制剂方法制成临床所能接受的剂型。本实施例胶囊每粒含有生药1.0g。
实施例2胶囊剂
处方:菟丝子13份、女贞子10份、双参35份、白术12份、党参10份、缬草6份、黑皮跌打10份、莲须7份、刺五加8份、当归藤12份、玫瑰花8份、香附6份。
制备方法:参照实施例1的操作进行。
实施例3胶囊剂
处方:菟丝子18份、女贞子12份、双参30份、白术8份、党参15份、缬草8份、黑皮跌打15份、莲须11份、刺五加12份、当归藤12份、玫瑰花7份、香附6份。
制备方法:参照实施例1的操作进行。
实施例4胶囊剂
处方:菟丝子15份、女贞子15份、双参30份、白术12份、党参10份、缬草6份、黑皮跌打10份、莲须10份、刺五加12份、当归藤17份、玫瑰花7份、香附9份。
制备方法:参照实施例1的操作进行。
实施例5胶囊剂
处方:菟丝子15份、女贞子12份、双参35份、白术8份、党参15份、缬草9份、黑皮跌打12份、莲须9份、刺五加7份、当归藤12份、玫瑰花8份、香附9份。
制备方法:参照实施例1的操作进行。
实施例6胶囊剂
处方:菟丝子13份、女贞子12份、双参30份、白术10份、党参10份、缬草8份、黑皮跌打15份、莲须8份、刺五加12份、当归藤12份、玫瑰花9份、香附8份。
制备方法:参照实施例1的操作进行。
实施例7片剂
处方:菟丝子15份、女贞子12份、双参33份、白术8份、党参12份、缬草8份、黑皮跌打15份、莲须8份、刺五加12份、当归藤15份、玫瑰花10份、香附8份。
制备方法:按处方取缬草、黑皮跌打、当归藤、玫瑰花、香附用70%乙醇回流提取,收集乙醇回流提取液及滤渣;菟丝子、女贞子、双参、白术、党参、莲须、刺五加连同缬草、黑皮跌打、当归藤、玫瑰花、香附滤渣,加水4-10倍重量份的水煎煮2次,每次1.0-2.0小时,合并煎煮液,加乙醇至浓度为40%,放置8-12小时,过滤得醇沉液,醇沉液与乙醇回流提取液合并,减压回收乙醇,浓缩至浸膏,浸膏干燥成细粉,加药物可接受的载体混匀,用常规制剂方法制成临床所能接受的剂型。本实施例片剂每片含有生药1.0g。
实施例8颗粒囊剂
处方:菟丝子15份、女贞子10份、双参33份、白术10份、党参12份、缬草8份、黑皮跌打12份、莲须9份、刺五加10份、当归藤15份、玫瑰花10份、香附8份。
制备方法:按处方取缬草、黑皮跌打、当归藤、玫瑰花、香附用70%乙醇回流提取,收集乙醇回流提取液及滤渣;菟丝子、女贞子、双参、白术、党参、莲须、刺五加连同缬草、黑皮跌打、当归藤、玫瑰花、香附滤渣,加水4-10倍重量份的水煎煮2次,每次1.0-2.0小时,合并煎煮液,加乙醇至浓度为40%,放置8-12小时,过滤得醇沉液,醇沉液与乙醇回流提取液合并,减压回收乙醇,浓缩至浸膏,浸膏干燥成细粉,加药物可接受的载体混匀,用常规制剂方法制成临床所能接受的剂型。本实施例颗粒剂每袋含有生药3.0g。
实施例9本发明药物组合物防治复发性流产的临床观察
1.1病例资料:选取我院于2012年03月-2014年02月收治的96例脾肾两虚型复发性流产的患者,年26-39岁,平均年龄(30.9±3.5)岁,流产2-6次,平均流产(2.5±1.3)次。根据治疗方式的不同将其分为两组。其中研究组48例,年龄25-35岁,平均年龄(28.4±3.3)岁,平均流产(2.4±1.2)次;对照组48例,年龄26-37岁,平均年龄(30.2±3.8)岁,平均流产(2.7±1.4)次;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:
1.2.1RAS的诊断标准:依据乐杰主编的《妇产科学(第7版)》中复发性流产诊断标准拟定:2次或2次以上发生在妊娠20周之前的自然流产,封闭抗体阴性,排除以下情况:1)合并严重缺血缺氧性疾病、精神病及血液系统疾病;2)妊娠组织物或夫妇双方染色体检查异常;3)常规妇检、B超等检查提示生殖道解剖结构异常;4)白带常规、细菌性阴道病、衣原体、支原体、淋菌及β-溶血性链球菌培养等提示生殖道感染;5)抗心磷脂抗体阳性,抗子宫内膜抗体阳性,抗精子抗体阳性;6)夫妇血型及Rh因子提示母儿血型不合;7)男方精液常规异常。
1.2.2中医症候辨证标准:参照《中药新药临床研究指导原则》、《中医妇科学》有关内容拟定脾肾两虚证:头晕耳鸣,腰酸膝软,神疲肢倦,气短懒言,纳少便溏,夜尿频多,眼眶黯黑或面有黯斑。舌质淡,苔薄,脉沉弱。
主证:既往自然流产2胎以上;
次证:①神疲乏力;②面色萎黄或晦暗;③头晕耳鸣;④夜尿频多;⑤眼眶暗黑或面有暗斑;⑥舌淡,或有齿痕,苔白润,脉沉细弱。
以上主证必备,次证具备至少3项时,可做为临床拟诊。
1.2.3中医症状评分:主要症状评分标准参照《中医临床病症诊断疗效标准》,脾肾两虚证按无、轻度、中度、重度分别计0、1、2、3分。自拟评分标准:各项体征进行评分累加,0-5分为轻度;6-10分为中度;累积分数在11分以上者为重度。
1.3治疗方法
对照组:于自然月经或撤退性出血第5天开始服用滋肾育胎丸一天三次,饭后淡盐水口服,患者需服药1-3个月,以服药后临床症状消除为原则,但服至3个月后停药。
治疗组:于自然月经或撤退性出血第5天开始口服本发明实施例1制备的胶囊,每日2次,每次2-4粒,饭后半小时服用,至少连续服用4周,以服药后临床症状消除为原则,症状未消除服用至3个月后停药。
于第4个月开始监测卵泡发育:监测月经第五天的窦卵泡数,并与月经周期第10天开始监测有无卵泡发育以及是否成熟和排卵,指导同房,通过基础体温、血HCG监测,一旦生化妊娠即进行西医常规疗法,两组均治疗至既往流产时间1月以上,患者孕期禁性生活,避免过度劳累,特别阴道出血者卧床休息。随访至正常分娩后进行疗效评定。
1.4观察指标及疗效判定标准:
1.4.1服药治疗前后中医症状疗效:痊愈:症状积分降低不低于95%,症状消失;显效:症状积分降低超过70%而低于95%,症状明显减轻;有效:症状积分降低超过30%而低于70%,症状有所改善;无效:症状积分降低低于30%,症状加重或无改善。
1.4.2妊娠结局疗效:治愈:阴道流血停止,妊娠继续,胎儿发育正常,B超检查胎儿发育及孕周与子宫大小相符,腰酸、胀痛及小腹疼痛症状明显缓解或消失;未愈:阴道流血未停止,胚胎发育不良或停止发育,甚至流产,B超检查子宫大小小于孕周或与孕周基本相符,腰酸胀痛及小腹疼痛加重或未减轻。
1.5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
治疗过程中无剔除和脱落及终止病例,均完成临床观察。
2.1两组妊娠结局疗效评价:治疗组与对照组痊愈率分别为93.75%和81.25%,两组痊愈率比较差异有统计学意义(P<0.05),治疗组的疗效明显优于对照组。见表1。
表1两组妊娠结局疗效评价,n%
注:与对照组比较,*P<0.05。
2.2治疗后3个月经期后两组患者中医证候疗效比较:治疗后治疗组痊愈21例,显效18例,有效8例,无效1例,总有效率97.9%;对照组痊愈11例,显效15例,有效14例,无效8例,总有效率66.7%,治疗组与对照组总有效率比较,差异有统计学意义(P<0.05),说明治疗组较对照组中医证候疗效优势明显。见表2。
表2两组患者中医证候疗效比较,例
注:与对照组比较,*P<0.05。
2.3安全性情况:治疗3个月后,治疗组患者治疗前后血常规、尿常规、心电图无异常变化,治疗过程中生命体征平稳且无恶心呕吐、过敏等不良反应,说明本方的临床运用是安全可靠的。
虽然引起患者复发性流产的机制还不十分明确,但本发明药物治疗脾肾两虚型复发性流产患者取得了较好效果,推测本发明中药可能具有调节患者下丘脑-垂体-卵巢轴的作用,可能与改善机体功能,保证胎孕物质基础,促进宫体和胚胎的供血供氧有关。本药用于治疗滑胎症疗效显著、价格低廉、无副作用,值得临床推广和应用。
总之:通过对比妊娠结局及中医证候疗效发现,本发明药物能显著提高了脾肾两虚型复发性流产患者的妊娠成功率,明显改善了患者的临床症状,且应用安全,无明显不良反应。由此说明使用本发明所述药物组合物治疗复发性流产特别是防治属于脾肾两虚证型,取得了显著的疗效,临床应用安全可靠。
Claims (9)
1.一种防治复发性流产的药物组合物,其特征在于由以下原料药精心制成:菟丝子、女贞子、双参、白术、党参、缬草、黑皮跌打、莲须、刺五加、当归藤、玫瑰花、香附。
2.如权利要求1所述的药物组合物,其特征在于由以下重量份的原料药精心制成:菟丝子13-18份、女贞子10-15份、双参30-35份、白术8-13份、党参10-15份、缬草6-9份、黑皮跌打10-15份、莲须7-11份、刺五加7-12份、当归藤12-17份、玫瑰花7-11份、香附5-9份。
3.如权利要求2所述的药物组合物,其特征在于由以下重量份的原料药精心制成:菟丝子15份、女贞子10份、双参33份、白术10份、党参12份、缬草8份、黑皮跌打12份、莲须9份、刺五加10份、当归藤15份、玫瑰花10份、香附8份。
4.如权利要求1-3任一所述的药物组合物,其特征在于所述药物组合物优选制成为口服剂型,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、溶液剂等。
5.如权利要求4所述的药物组合物,其特征在于所述口服剂型优选为胶囊剂、片剂、颗粒剂。
6.如权利要求5所述的药物组合物,其特征在于所述口服剂型优选为胶囊剂。
7.如权利要求1-3任一所述的药物组合物,其特征在于所述药物组合物的制备方法包括如下步骤:
按处方取缬草、黑皮跌打、当归藤、玫瑰花、香附用70%乙醇回流提取,收集乙醇回流提取液及滤渣;菟丝子、女贞子、双参、白术、党参、莲须、刺五加连同缬草、黑皮跌打、当归藤、玫瑰花、香附滤渣,加水4-10倍重量份的水煎煮2次,每次1.0-2.0小时,合并煎煮液,加乙醇至浓度为40%,放置8-12小时,过滤得醇沉液,醇沉液与乙醇回流提取液合并,减压回收乙醇,浓缩至浸膏,浸膏干燥成细粉,加药物可接受的载体混匀,用常规制剂方法制成临床所能接受的剂型。
8.如权利要求1-3任一所述的药物组合物在制备防治复发性流产的药物中的用途。
9.如权利要求1-3任一所述的药物组合物在制备防治脾肾两虚型复发性流产的药物中的用途。
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