CN114949134A - 一种用于提高先兆流产患者活产率的组合物及其制备方法 - Google Patents
一种用于提高先兆流产患者活产率的组合物及其制备方法 Download PDFInfo
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Abstract
本发明提供了一种用于提高先兆流产患者活产率的组合物及其制备方法,本发明组合物所选药材配伍相宜,组方精炼,在功能上相辅相成,以补肾健脾安胎为目的,集补肾、益精、行气、健脾、清热安胎、养心安神为一体,疗效显著,能显著提高先兆流产患者活产率;在药性上相制相佐,毒副反应少,并且本发明所提供制备方法制得的药物有效成分含量及纯度高,提高了药物中的实际有效成分浓度,有效提高提取效果,同时减少制剂制备所需辅料的使用,提高含药量和药物安全性,另外,本发明方法具有加工方便、生产效率高等优点,同时满足市场需求和生产要求。
Description
技术领域
本发明涉及一种用于提高先兆流产患者活产率的组合物及其制备方法,属于医药技术领域。
背景技术
先兆流产常表现为阴道流血及伴或不伴腹痛、宫颈口闭合和宫腔内胎儿可见。先兆流产是一种常见的妊娠并发症,在临床妊娠中该并发症发病率约为20%,而最终约50%患有该病的妇女最终发生流产。与自然流产发病的相关因素多种多样,如染色体、基因、解剖结构、免疫学、激素水平、感染及心理因素等,其他高危风险因素还包括父母年龄过大、母亲患有糖尿病或甲亢等全身性疾病。由于该病常发生于妊娠早期,并且约30%的早期妊娠很难判断,而由于适用人群特殊,为待产孕妇,孕妇对药物的敏感性和安全性要求极高,目前尚缺少效果确切安全可靠的用于提高先兆流产患者活产率的组合物。
因此,本发明课题组以健脾固肾、养血安胎、安全无毒为治疗原则,观察使用不同组方用于提高先兆流产患者活产率的组合物治疗效果、安全性的变化,比较不同组方间的效果差异,提供了一种新的用于提高先兆流产患者活产率的组合物及其制备方法,有效提高中医药临床治疗先兆流产患者活产率的能力。
发明内容
本发明针对现有技术存在的不足,提供一种用于提高先兆流产患者活产率的组合物及其制备方法,可以实现有效提高先兆流产患者活产率,满足实际生产要求和消费需求。
为解决上述问题,本发明所采取的技术方案如下:
一种用于提高先兆流产患者活产率的组合物,由以下各质量份的原料药按下述方法制成:
鹿角霜5-15份,巴戟天5-15份,菟丝子10-20份,淮山药10-30份,山茱萸5-15份,茯苓10-14份,人参10-20份,黄芪10-30份,桑寄生10-15份,黄芩5-15份,川芎3-10份,椿根白皮5-15份,砂仁3-10份,熟地3-10份,续断10-20份,当归10-20份,阿胶5-15份,白芍10-20份,白术5-15份,砂仁10-20份,甘草10-14份,地骨皮10-20份,淫羊藿5-15份;
本方所选药材配伍相宜,组方精炼,在功能上相辅相成,具有明显的增效作用,充分发挥了相须相使的配伍关系。以补肾安胎为目的,集补肾、益精、行气、健脾、养血柔肝,清热安胎、养心安神为一体,疗效显著;在药性上相制相佐,毒副反应少,服用安全。
本发明的用于提高先兆流产患者活产率组合物中,各原料组分是一个有机的整体,缺一不可。课题组在研发过程中发现,减少上述组合物中的任何一种原料组分,或以具有相似药性的原料药对本发明中药组合物的原料组分进行替换,则中药组合物整体的作用效果显著降低;在本发明的中药组合物的基础上再增加其他的原料组分,中药组合物的整体效果并未有明显的改善,甚至有中药组合物的整体效果降低的情况出现。
本发明第二方面,提供上述提高先兆流产患者活产率的组合物的制备方法:
步骤一、将鹿角霜,巴戟天,菟丝子,淮山药,山茱萸,茯苓,人参,黄芪,桑寄生,黄芩,川芎,椿根白皮,砂仁,熟地,续断,当归,白芍,白术,甘草,地骨皮,淫羊藿,超微粉碎,混合均匀,加90%乙醇浸泡40min,于40-50℃下超声40min后过滤,滤液用旋转蒸发仪减压浓缩成浸膏;
步骤二、步骤一中醇提后的药渣室温挥干溶剂,加10倍蒸馏水浸泡1小时后加热煎煮40min并趁热过滤,药渣再加5倍水煮沸保持1小时,趁热过滤,收集两次滤液旋转蒸发制成浸膏;
步骤三、合并步骤一和步骤二所得浸膏,加入阿胶,加水熬煮成稠膏;
步骤四、醇沉步骤三获得的稠膏,过滤取上清液;
步骤五、浓缩步骤四上清液至相对的清膏;
步骤六、上述清膏中加置制粒机中一步制粒,整粒,分装。
进一步的,步骤五清膏密度65℃为1.15-1.25;
中药成分复杂,同一种药材中既有水溶性成分,又有油溶性或醇溶性成分,且有些活性成分在高温下容易失活,因此通过选择合适的提取方法和提取工艺对中药有效成分进行提取分离,可以最大限度的提取出有效成分并保证有效成分的活性,从而保证产品的临床效果:例如上述方法将醇提、水提两种提取方法均使用,一同醇沉,采用上述制备方法,可以最大限度的提取出中药组合物中的有效成分并保证有效成分的纯度及活性,从而保证产品的临床效果,对于原料中的阿胶,采用“后下”的方式,能够减少阿胶中有效成分的挥发损耗,使其有效成分最大限度的保留在汤液中。
本发明第三方面,提供上述提高先兆流产患者活产率的组合物的制剂:上述药物制剂可以制成各种药物剂型,如丸剂、胶囊剂、片剂、散剂、颗粒剂或口服液等。
所述药学上可接受的辅料为药物制剂中的常规辅料,如:崩解剂、润滑剂、黏合剂等;优选为聚乙二醇、淀粉、乳糖、糊精、羧甲基纤维素钠中的一种或两种;
本发明第四方面,提供上述组合物在制备提高先兆流产患者活产率的组合物中的应用。
本发明的有益效果:
本发明的中药组合物所选药材配伍相宜,组方精炼,在功能上相辅相成,以补肾健脾安胎为目的,集补肾、益精、行气、健脾、清热安胎、养心安神为一体,疗效显著;在药性上相制相佐,毒副反应少,并且本发明所提供制备方法制得的药物有效成分含量及纯度高,提高了药物中的实际有效成分浓度,有效提高提取效果。
本发明药物选择鹿角霜,巴戟天,菟丝子,淮山药,山茱萸,茯苓,人参,黄芪,桑寄生,黄芩,川芎,椿根白皮,砂仁,熟地,续断,当归,阿胶,白芍,白术,砂仁,甘草,地骨皮,淫羊藿进行组合,将这些药物组合使得各药物功效产生协同作用,从而能够有效治疗先兆流产。其中:
鹿角霜:味咸,性温。有温肾助阳,收敛止血的功效,用于皮肾阴虚,遗尿尿频。
巴戟天:味辛,性微温。味补益、祛风药。有补肾助阳,强筋壮骨,祛风除湿的功效,用于肾虚,宫冷不孕。
菟丝子:为旋花科一年生寄生缠绕草本植物菟丝子的成熟种子。性甘、涩,温。归肾、肝、脾经。补肾阳,益肾精,明目,固精,缩尿,止带,止泻,安胎。平补肾之阴阳、固精益气、补肾益精,阴阳兼顾,补先天之脏以固胎;能促进卵巢黄体形成;为固肾安胎之主药,补而不燥,是补益肝肾之理想药物。
淮山药:为薯蓣科多年生蔓生草本植物薯蓣的根茎。性甘、平。归脾、肺、肾经。补脾肺肾气,益脾肺肾阴。
山茱萸:味酸,性微温。有补益肝肾,收敛固涩,固精缩尿,止痛的功效,用于腰膝酸软,月经不调。
茯苓:味甘淡、性平;归心、肺、脾经;具有健脾、安神、镇静、利尿,也能促进身体免疫能力,被誉为中药「四君八珍」之一,是多种方剂配伍的要药。
人参:人参性甘、微苦微温,有大补元气,补脾益肺,生津安神之功。《本草经疏》:“人参能回阳气于垂绝,却虚邪于俄顷。其主治也,则补五脏。现代药理研究人参含有多种人参皂甙,能促进蛋白质DNA.RNA的生物合成,增加机体的免疫功能,增强性腺功能,具有促性腺激素样作用。
黄芪:为豆科多年生草本植物黄芪的根。性甘,微温。归脾、肺经。补脾肺气,升阳举陷,益卫固表,益气摄血。
桑寄生:为桑寄生科小灌木植物桑寄生的带叶茎枝。性甘、辛、苦,平。归肝、肾经。祛风湿,通经络,补肝肾,养血安胎。
黄芩:为唇形科多年生草本植物黄芩的根。性苦,寒。归肺、脾、胃、肝、胆、大肠、膀胱经。清热燥湿,泻火解毒,凉血止血,清热安胎,以免热扰冲任、损伤胎元;对子宫平滑肌收缩有较强的抑制作用,且可对抗前列腺素收缩子宫的作用。
川芎:为伞形科多年生草本植物川芎的根茎。性辛,温。归心、肝经。具有活血行气,祛风止痛的功效。
椿根白皮:味苦,温,无毒。清热燥湿、收敛止带,止血,
砂仁:化湿开胃,温脾止泻,理气安胎,用于湿浊中阻,脾胃虚寒,呕吐泄泻,妊娠恶阻,胎动不安;
熟地:味甘,性微温。有补血养阴,填精益髓的功效,用于月经不调,血虚诸症,肝肾阴虚。
续断:为续断科多年生草本植物川续断的根。性甘、辛,微温。归肾、肝经。补肾阳,强筋骨,活血通络,续骨止痛,温补肝肾安胎,暖子宫,止胎漏兼壮筋骨,含有维生素E,能促进子宫和胚胎发育。
当归:为伞形科多年生草本植物当归的根。性甘、辛,温。归肝、辛、脾、大肠经。补血,活血,止痛,调经,润肠通便。
阿胶:为马科动物驴的皮经煎煮、浓缩制成的固体胶。性甘,平。归肺、肝、肾、心经。滋肾养胎、养血止血以荫胎,尤其阴道出血,血虚者。
白芍:为毛莨科多年生草本植物芍药的根。性甘、酸,微寒。归肝、心、脾经。补血,平抑肝阳,缓急止痛,止汗。
白术:为菊科多年生草本植物白术的根茎。性甘、苦,温。归脾、胃经。补脾气,固表止汗,安胎。
砂仁:为姜科植物阳春砂或缩砂的成熟果实或种子;辛,温,人脾、胃经。功能化湿行气,和胃醒脾,温脾止泻,安胎;主治脘腹痞痛、纳呆食滞、噎膈呕逆、泄泻及妊娠腹痛等。
甘草:为豆科多年生草本植物甘草的根茎。性甘,微寒。归心、肺、脾、胃经。补心脾气,缓急止痛,清热解毒,调和药性。
地骨皮:味甘,性寒。有凉血除蒸,清肺降火的功效,用于阴虚潮热,骨蒸盗汗,衄血。
淫羊藿:味辛、甘,性温,有补肾阳,强筋骨,祛风湿的功效,用于筋骨痿软,麻木拘谨,风湿痹痛。
具体实施方式
以下对本发明的优选实施例进行说明,应当理解,此处所描述的优选实施例仅用于说明和解释本发明,并不用于限定本发明。
实施例1
本发明所述用于提高先兆流产患者活产率的组合物是由下列重量份的原料药制成的:
鹿角霜15份,巴戟天15份,菟丝子18份,淮山药18份,山茱萸15份,茯苓14份,人参20份,黄芪30份,桑寄生15份,黄芩15份,川芎10份,椿根白皮15份,砂仁10份,熟地10份,续断18份,当归20份,阿胶15份,白芍20份,白术15份,砂仁20份,甘草14份,地骨皮20份,淫羊藿15份;
实施例2
本发明所述用于提高先兆流产患者活产率的组合物是由下列重量份的原料药制成的:
鹿角霜5份,巴戟天5份,菟丝子10份,淮山药10份,山茱萸5份,茯苓10份,人参10份,黄芪10份,桑寄生10份,黄芩5份,川芎3份,椿根白皮5份,砂仁3份,熟地3份,续断10份,当归10份,阿胶5份,白芍10份,白术5份,砂仁10份,甘草10份,地骨皮10份,淫羊藿5份;
实施例3
本发明所述用于提高先兆流产患者活产率的组合物是由以下方法制成的:
按实施例1-2称取原料,每份为1g,
步骤一、将除阿胶外的原料粉碎,混合均匀,加90%乙醇浸泡40min,于45℃下超声40min后过滤,滤液用旋转蒸发仪减压浓缩成浸膏;
步骤二、步骤一中醇提后的药渣室温挥干溶剂,加10倍蒸馏水浸泡1小时后加热煎煮40min并趁热过滤,药渣再加5倍水煮沸保持1小时,趁热过滤,收集两次滤液旋转蒸发制成浸膏;
步骤三、合并步骤一和步骤二所得浸膏,按实施例1-2称取并加入阿胶,加水熬煮成稠膏;
步骤四、醇沉步骤三获得的稠膏,过滤取上清液;
步骤五、浓缩步骤四上清液至相对的清膏,清膏密度65℃为1.2;
步骤六、上述清膏中加置制粒机中一步制粒,制粒机中还加入240g乳糖、120g糊精,整粒,分装,制成丸剂。
实施例4
按实施例1-2称取原料,每份为1g,
步骤一、将除阿胶外的原料粉碎,粉碎,混合均匀,加90%乙醇浸泡40min,于40℃下超声40min后过滤,滤液用旋转蒸发仪减压浓缩成浸膏;
步骤二、步骤一中醇提后的药渣室温挥干溶剂,加10倍蒸馏水浸泡1小时后加热煎煮40min并趁热过滤,药渣再加5倍水煮沸保持1小时,趁热过滤,收集两次滤液旋转蒸发制成浸膏;
步骤三、合并步骤一和步骤二所得浸膏,按实施例1-2称取并加入阿胶,加水熬煮成稠膏;
步骤四、醇沉步骤三获得的稠膏,过滤取上清液;
步骤五、浓缩步骤四上清液至相对的清膏,清膏密度65℃为1.15;
步骤六、上述清膏中加置制粒机中一步制粒,制粒机中还加入200g乳糖、200g糊精,整粒,分装,制成片剂。
实施例5
将实施例3步骤四所得上清液以常规方法制备成胶囊剂,规格为0.5g/粒。
实施例6
将实施例4步骤四所得上清液以常规方法制备成口服液。
实施例7
将实施例1的药物组方中熟地黄、阿胶、菟丝子、鹿角霜、茯苓、巴戟天替换为麦冬、木香、百合、首乌、锁阳、肉苁蓉;用量同实施例1,制备方法同实施例3。
以常规方法建立己烯雌酚所致流产模型,与本发明实施例1中药组合物流产模型的活产率进行比较,动物试验表明,本发明实施例1的组合物的活产率要显著优于实施例7。说明本发明的组合物符合中药的配伍关系,各组分之间具有协同促进作用,并非是具有相似药性的原料药的简单替换或组合。
实施例8
将实施例1中菟丝子的用量调整为5克,续断的用量调整为40克,桑寄生的用量调整为40克,阿胶的用量调整为40克,甘草的用量调整为2克,山药的用量调整为5克,砂仁的用量调整为50克,其他原料的用量同实施例1,并按实施例3的方法制备。
以常规方法建立己烯雌酚所致流产模型,与本发明实施例1组合物对流产模型的活产率进行比较,动物试验表明,本发明实施例1的组合物活产率要显著优于实施例8。说明本发明的组合物中各原料药的用量并非是常规的调整所能得到的,本发明的中药组方中,各原料药材的用量配比是根据其药材特性、君臣佐使配伍等各种考虑因素决定的,对于中药组合物的整体药效起到非常重要的作用。
实施例9
安全性试验
(1)急性毒性试验:急性毒性试验:将健康小白鼠70只,雌雄各半,随机分为7组,每组10只,设剂量组7个,试验前禁食16小时,分别分4次灌服给药(本发明实施例3的方法制备的实施例1组方的组合物),给药后观察各组反应情况,此后连续观察7天,灌胃给药后观察一周,均未发现动物死亡;因此本发明的中药组合物急性毒性低,临床用药安全。
(2)长期毒性试验:
将80只健康大白鼠(雌雄各半,体重均在123g~142g由卫生部长春生物制品所动物室提供)随机分成4组,三个剂量组(实验药物均为本发明实施例3的方法制备的实施例1组方的组合物)一个空白对照组,每组20只,三个剂量组为第一组2.0g/kg/天、第二组5.0g/kg/天,第三组10.0g/kg/天,分别灌胃,连续给药2个月,第四组为对照组不给药。给药1个月后,高剂量组和对照组分别处死1/3动物,测定各项指标;给药2个月后,各剂量组除分别留1/3动物作恢复期观察外,其余全部处死,测定各项指标。观察和测定项目包括如外观体症和行为活动、分泌物、粪便性状;血液的常规指标和生化指标;系统尸检及脏器系数和组织学检查等内容。
结果表明:用不同剂量给小鼠连续口服,对小鼠的进食量和体重增长均无影响。对肝肾功能均未发现明显毒性作用;说明本发明的中药组合物安全无毒性。
(3)特殊毒性试验:
致畸敏感期毒性试验对胚胎形成、胎鼠的生长发育、胎鼠外观及内脏、骨骼发育,与对照组相比均无显著性差异。
一般生殖毒性试验对受孕率、胚胎形成,胎鼠生长发育、胎鼠外观及内脏、骨骼发育均无影响。说明本发明的中药组合物无毒性反应,无致畸胎作用,长期用药安全可靠。
实施例10
中药组合物对大白鼠血液生理指标的影响
各组利用自动分析仪进行测定,红细胞(RBC)、白细胞(WBC)、血红蛋白(HCTb)、血细胞比容(HCT%)、血小板(PLT)、淋巴细胞百分比(Ly%)、淋巴细胞总数(Ly)均在正常范围内变动,与对照组比较差异不显著(P>0.05,其中P为剂量组与对照组差异参数),说明该发明提供的中药组合物制剂对实验动物造血功能无不良影响,未见毒性反应,
实施例11
对正常孕鼠离体子宫平滑肌的影响
(1)试验方法:
取成年雌性大鼠30只,体重250-350克,分为试验组、阳性对照组和空白对照组,每组均为10只,各组大鼠的体重和健康状况无明显差别。
大鼠交配受孕7d后,击昏,剖腹取出2.0cm长的一段子宫,置于洛氏液中,恒温(35±0.5℃),通入O2,将张力换能器与XWT-164平衡记录仪相连接,静息张力1g,平衡10min后给药,试验组的给药实施例1的中药组合物,使浴槽内药物的最终浓度为16mg/ml;阳性对照组给药市售的黄体酮注射液,使浴槽内药物的最终浓度为16mg/ml;空白对照组加入等量的生理盐水。记录给药10min后子宫平滑肌的变化,结果见表1。
(2)试验结果:
本发明的中药组合物对正常孕大鼠离体子宫平滑肌的影响结果见表1。
结果表明:试验组和阳性对照组都能降低孕鼠子宫平滑肌的收缩力,减慢其收缩频率,与空白对照组相比,均有显著性差异;试验组和阳性对照组相比,具有显著性差异,说明本发明的中药组合物较阳性对照药物(黄体酮注射液)相比,其提高活产率作用更强。
实施例12
对己烯雌酚所致流产模型的活产率效果
(1)试验方法:
选取2个月的昆明小鼠,体重在30-40g,按雌:雄(2:1)的比例合笼交配。检出阴栓之日为妊娠第1日,随机将80只阴栓鼠按孕期分为4组,每组20只。
对照组和模型组灌胃相同体积的生理盐水;
试验组灌胃给药本发明实施例3方法制备的实施例组方的丸剂;阳性对照组给药市售黄体酮;
上述各组,每天灌胃1次,连续给药10d。除对照组外,于妊娠第7日连续皮下注射己烯雌酚2d,对照组皮下注射等体积的生理盐水2d,各组于妊娠第18日处死,解剖,观察各组活胎数。
(2)试验结果:试验结果见表2。
实施例13
临床效果试验
选择120位先兆流产症状的孕妇进行治疗,使用本发明实施例3按实施例1组方制备的丸剂,早晚各服一次,每次一袋,7天为一个疗程,持续服药至妊娠满12周(84天)其中治愈105例,显效10,好转5例,无效0例,总有效率100%表明该发明中药治疗先兆流产效果显著,达到了临床治疗目的,并且在治疗过程中,未见明显不良反应。
为了更详细的说明治疗情况,以下给出典型病例及治疗的疗效情况:
病例1:杨某,33岁,自述曾有2次自然流产史,均在孕50天左右,现停经47天,阴道少量出血1天。彩超结果为宫内早孕,见胎心,化验尿HCG(+),感腰腹坠痛,有少量阴道出血伴轻微恶心、舌暗有明显齿痕,表明胎动不安,服本申请药物3周后症状全无,后访顺产健康一男婴。
病例2:李某,27岁,自诉曾有3次自然流产史,均在孕50天左右,其月经周期为平均45天上下,此次妊娠已停经55天,目前阴道少量出血2天,妊娠试验阳性,B超提示早孕,有胎心。服用本申请中药7日后,阴道出血减少,下腹痛明显减轻。继续服用本申请中药至妊娠3个月,B超检查提示胎儿发育正常。停药,后访顺产一健康女婴。
病例3:王某,35岁,自述曾有3次自然流产史,均在孕50天左右,现停经38天,化验尿HCG(+),B超提示宫内孕。诊断:滑胎。给予本发明药物口服,服至妊娠3个月,B超检查提示胎儿发育正常。停药,后访顺产一健康男婴。
病例4:周某,40岁,自述曾有4次自然流产,均在孕60天左右,现停经49d,妊娠试验阳性,现出现阴道出血。服用本申请药物4周后,阴道出血量明显减少,继续服用本申请药物至妊娠2个半月后停药,后访顺产一健康男婴。
病例5:孙某,32岁,自述曾有5次自然流产,均在孕50天左右,停经48d后,化验尿HCG(+),B超提示宫内孕现,目前出现阴道少量出血。服用本申请药物4周后,阴道出血量明显减少,继续服用本申请药物至妊娠3个月后停药,服药期间未出现阴道出血、恶心等,后访顺产一健康女婴。
由上述情况表明,本发明是用于提高先兆流产患者活产率的有效药物,使肾气旺盛,有利于胎儿的生长发育,有效提高了保胎的成功率。无毒副作用,疗效稳定,安全可靠,临床意义巨大。
显然,本领域的技术人员可以对本发明进行各种改动和变型而不脱离本发明的精神和范围。这样,倘若本发明的这些修改和变型属于本发明权利要求及其等同技术的范围之内,则本发明也意图包含这些改动和变型在内。
Claims (9)
1.一种用于提高先兆流产患者活产率的组合物,其特征在于,所述药物由以下各质量份的原料药制成:鹿角霜5-15份,巴戟天5-15份,菟丝子10-20份,淮山药10-30份,山茱萸5-15份,茯苓10-14份,人参10-20份,黄芪10-30份,桑寄生10-15份,黄芩5-15份,川芎3-10份,椿根白皮5-15份,砂仁3-10份,熟地3-10份,续断10-20份,当归10-20份,阿胶5-15份,白芍10-20份,白术5-15份,砂仁10-20份,甘草10-14份,地骨皮10-20份,淫羊藿5-15份。
2.如权利要求1所述的用于提高先兆流产患者活产率的组合物,其特征在于,所述药物由以下各质量份的原料药制成:鹿角霜15份,巴戟天15份,菟丝子18份,淮山药18份,山茱萸15份,茯苓14份,人参20份,黄芪30份,桑寄生15份,黄芩15份,川芎10份,椿根白皮15份,砂仁10份,熟地10份,续断18份,当归20份,阿胶15份,白芍20份,白术15份,砂仁20份,甘草14份,地骨皮20份,淫羊藿15份。
3.如权利要求1所述的用于提高先兆流产患者活产率的组合物,其特征在于,所述药物由以下各质量份的原料药制成:鹿角霜5份,巴戟天5份,菟丝子10份,淮山药10份,山茱萸5份,茯苓10份,人参10份,黄芪10份,桑寄生10份,黄芩5份,川芎3份,椿根白皮5份,砂仁3份,熟地3份,续断10份,当归10份,阿胶5份,白芍10份,白术5份,砂仁10份,甘草10份,地骨皮10份,淫羊藿5份。
4.如权利要求1所述的用于提高先兆流产患者活产率的组合物的制备方法,其特征在于,所述制备方法包括以下步骤:
步骤一、将鹿角霜,巴戟天,菟丝子,淮山药,山茱萸,茯苓,人参,黄芪,桑寄生,黄芩,川芎,椿根白皮,砂仁,熟地,续断,当归,白芍,白术,甘草,地骨皮,淫羊藿,超微粉碎,混合均匀,加90%乙醇浸泡40min,于40-50℃下超声40min后过滤,滤液用旋转蒸发仪减压浓缩成浸膏;
步骤二、步骤一中醇提后的药渣室温挥干溶剂,加10倍蒸馏水浸泡1小时后加热煎煮40min并趁热过滤,药渣再加5倍水煮沸保持1小时,趁热过滤,收集两次滤液旋转蒸发制成浸膏;
步骤三、合并步骤一和步骤二所得浸膏,加入阿胶,加水熬煮成稠膏;
步骤四、醇沉步骤三获得的稠膏,过滤取上清液;
步骤五、浓缩步骤四上清液至相对的清膏;
步骤六、上述清膏中加置制粒机中一步制粒,整粒,分装。
5.如权利要求4所述的制备方法,其特征在于,步骤五清膏密度65℃为1.15-1.25。
6.如权利要求4所述的制备方法,其特征在于,步骤六制粒机中还加入乳糖、糊精中的一种或两种。
7.如权利要求4所述的制备方法,其特征在于,所述乳糖和糊精的质量比为1:1-2。
8.如权利要求4所述的制备方法,其特征在于,所述步骤六可进一步制成丸剂、胶囊剂、片剂、散剂、颗粒剂或口服液。
9.如权利要求1所述的组合物的在制备提高先兆流产患者活产率的药物中的应用。
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