CN105770692A - 一种治疗复发性流产的药物制剂及其制备方法 - Google Patents
一种治疗复发性流产的药物制剂及其制备方法 Download PDFInfo
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Abstract
本发明属于中医药技术领域,涉及一种治疗复发性流产的药物制剂及其制备方法。该药物制剂由干地黄、功劳叶、狗脊、桑寄生、补血草、砂仁、马鞭草、扶芳藤、丹参为药用原料按照一定的种类分比例制成。诸药合伍,滋阴补肾,益气养血,疏肝清热,活血化瘀,使肾气盛,冲任固,瘀热消,抑制或消除自身抗体,可使抗心磷脂抗体转为阴性,为受孕做准备。
Description
技术领域
本发明属于中医药技术领域,涉及一种治疗复发性流产的药物制剂及其制备方法,尤其是一种治疗抗心磷脂抗体阳性复发性流产的药物制剂及其制备方法。
背景技术
复发性流产(recurrentspontaneousabortion,RSA)是一种常见的妊娠并发症,是指与同一配偶发生2次或2次以上妊娠28周前的胎儿自然流产。RSA属于中医“滑胎”及“数堕胎”范畴,多为“肾气不足,冲任不固”所致。《叶氏女科证治》:“人身有三月而堕者,有六七月而堕者,有屡孕屡堕者,由于气血不足,名曰滑胎”。傅青主也指出:“胞胎虽系于带脉,而带脉实关乎脾肾。补先后二天之脾与肾,正所以固胞胎之气与血。”《医学衷中参西录》创制了“寿胎丸”,以肾为主防治滑胎,一直为后人所推崇。
现代医学研究表明,抗心磷脂抗体(ACA)是以血小板和内皮细胞膜上带负电荷的心磷脂作为靶抗原的自身抗体。ACA在不明原因复发性流产(RSA)患者的发病中起重要作用,但其确切机制尚不清楚。目前一般认为,抗ACA导致RSA涉及了免疫、内分泌、凝血功能、血液流变等机制。其机理可能有:ACA作用于滋养层表面的磷脂依赖抗原,影响其黏附、融合和分化过程,使合体滋养层细胞形成不足,造成子宫对胚胎可接受性明显降低,引起流产;ACA争夺胎盘血管的磷脂受体,导致蜕膜血管病变及胎盘栓塞造成胎盘血流量减少,致使胚胎缺血、缺氧、死亡;ACA可能阻止了前列环素的合成,使血栓素A2(TXA2)/前列环素比例升高,血栓素相对增多引起全身和胎盘血管痉挛缺血,形成血栓,引起胎盘梗死,造成不良妊娠结局。总之,ACA一方面导致血管内血栓栓塞,胚胎血供受阻从而导致流产,也可通过直接损伤滋养叶细胞使胚胎受损,引起自然流产、死胎等。据此,ACA阳性者于再次妊娠前应采取治疗,使抗体转阴性后再妊娠。国外文献报道多采用激素或阿斯匹林或肝素治疗,也有将上述几种药物结合起来应用,国内也有类似的报道,但上述药物在孕早期应用均有一定的副作用,宜尽量减少使用。
结合现代医学的病理研究我们不难发现,免疫失调与中医的“肾虚”不谋而和,ACA导致的多发性血栓症,与中医“血瘀”及“络病”非常吻合。免疫抑制剂治疗有效,为中医的补肾益气治疗取得较好的疗效提供了佐证,这也是本病的的本质。我们经过多年来的临床观察发现,ACA导致RSA的病机以肾虚为本,瘀血、湿热为标,属虚实夹杂之证。孕前本着“治未病”的思想,标本同治,调经祛病,为再次受孕做好准备。因此,利用中医药治疗该病渐为人们所推崇。
发明内容
为克服现有技术的不利因素,发明人在祖传治疗滑胎方的基础上,结合现代人的体质及现代医学理论,辨证与辨病相结合,提供了一种治疗复发性流产的药物制剂,尤其是一种治疗抗心磷脂抗体阳性复发性流产的药物制剂。
为实现上述目的,本发明采用的技术方案如下:
一种治疗复发性流产的药物制剂,其由干地黄、功劳叶、狗脊、桑寄生、补血草、砂仁、马鞭草、扶芳藤、丹参为药用原料制成。
为了进一步增加各原料之间的协同配合作用,发明人从提高药物疗效、降低副作用的角度出发,经过对中药成分进行筛选,优选出如下技术方案:一种治疗复发性流产的药物制剂,其由以下重量份配比的药用原料精心制成:干地黄13-18份、功劳叶10-15份、狗脊6-11份、桑寄生6-11份、补血草20-25份、砂仁4-7份、马鞭草5-8份、扶芳藤10-15份、丹参7-12份。
进一步优选地,一种治疗复发性流产的药物制剂,其特征在于由以下重量份配比的药用原料制成:干地黄15份、功劳叶10份、狗脊8份、桑寄生8份、补血草25份、砂仁6份、马鞭草6份、扶芳藤12份、丹参10份。
方中:干地黄甘寒滋阴补血,苦寒善清肝泻热,凉血止血,为治阴虚火旺之要药,功劳叶苦凉,补养阴气,清热养阴,平肝益肾,二药伍用补肾益肝,养阴清热为君药。狗脊苦能燥湿,甘能益血,温能养气,补而能走,桑寄生苦甘平补肝肾,强筋骨,通经络,益血,安胎元;补血草活血止血,温中健脾,滋补强壮;三药伍用补肾阳,温刚脏,健脾运,益气血,为臣药。君臣伍用补肾养肝,滋阴养血,阴阳并举,调理冲任,免疫系统才能发挥正常的免疫调节功能。砂仁辛温,补肺醒脾,养胃益肾,理元气,通滞气,理气安胎,助补药消化,生精生气;马鞭草苦凉,活血散瘀,清热解毒,利水消肿;丹参苦微寒,祛瘀止痛,活血通经,清心除烦;扶芳舒筋活络,益肾壮腰,止血消瘀,为佐使药。本方药性平和,散中有补,补中有散,具有祛邪而不伤正、滋补而不碍邪的特性,诸药合伍,滋阴补肾,益气养血,疏肝清热,活血化瘀,使肾气盛,冲任固,瘀热消,抑制或消除自身抗体,可使抗心磷脂抗体转为阴性,为受孕做准备。
本发明所用各药用原料的药理学研究现状如下:
干地黄:【性味】味甘;苦;微寒。【归经】归心;肝;肾经。【功能主治】滋阴清热;凉血补血。主热病烦渴;内热消渴;骨蒸劳热;温病发斑;血热所致的吐血;崩漏;尿血;便血;血虚萎黄;眩晕心悸;血少经闭。【用法用量】内服:煎汤,10-15g,大剂量可用至30g;赤可熬膏或入丸、散;或浸润后捣绞汁饮。外用:适量,捣敷。
桑寄生:【性味】苦、甘,平。【归经】归肝、肾经。【功能主治】补肝肾,强筋骨,祛风湿,安胎元。用于风湿痹痛,腰膝酸软,筋骨无力,崩漏经多,妊娠漏血,胎动不安;高血压。
砂仁:【性味】辛,温。【归经】归脾、胃、肾经。【功能主治】化湿开胃,温脾止泻,理气安胎。用于湿浊中阻,脘痞不饥,脾胃虚寒,呕吐泄泻,妊娠恶阻,胎动不安。
功劳叶:【性味】苦;凉。【归经】肝;肾经。【功能主治】清虚热;益肝肾;祛风湿。主阴虚劳热;咳嗽咯血;头晕目眩;腰膝酸软;风湿痹痛;白癜风。【用法用量】内服:煎汤,9-15g。外用:适量,捣汁或熬膏涂敷。
狗脊:【性味】苦、甘,温。【归经】归肝、肾经。【功能主治】补肝肾,强腰脊,祛风湿。用于腰膝酸软,下肢无力,风湿痹痛。【用法用量】6~12g。
马鞭草:【性味】苦,凉。【归经】归肝、脾经。【功能主治】活血散瘀,截疟,解毒,利水消肿。用于症瘕积聚,经闭痛经,疟疾,喉痹,痈肿,水肿,热淋。
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。
丹参:【性味】苦,微寒。【归经】归心、肝经。【功能主治】祛瘀止痛,活血通经,清心除烦。用于月经不调,经闭痛经,症瘕积聚,胸腹刺痛,热痹疼痛,疮疡肿痛,心烦不眠;肝脾肿大,心绞痛。
补血草:【性味】苦、咸,温。【功能主治】活血,止血,温中健脾,滋补强壮。用于月经不调,功能性子宫出血,痔疮出血,胃溃疡,脾虚浮肿。【用法用量】0.5~1两。
为了更好地表达本发明的药物制剂,本发明药物制剂是由干地黄、功劳叶、狗脊、桑寄生、补血草、砂仁、马鞭草、扶芳藤、丹参或其水或其有机溶剂提取物为活性成分,加入药物可接受的载体制备而成。
本发明的药物制剂可以是任何可药用的剂型,这些剂型包括: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、丸剂、散剂、膏剂、丹剂、混悬剂、粉剂、溶液剂、注射剂、栓剂、软膏剂、硬膏剂、霜剂、喷雾剂、滴剂、贴剂。本发明的制剂,优选的是口服剂型,如:软胶囊剂、胶囊剂、片剂、口服液、颗粒剂、丸剂、散剂、丹剂、膏剂,最优选的是本发明药物制剂制剂优选为片剂、胶囊剂或颗粒剂。
本发明的药物制剂,在制备成药剂时可选择性的加入适合的药物可接受的载体,所述药物可接受的载体选自: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。
本发明还提供了一种制备治疗复发性流产的药物制剂的方法,该方法包括以下步骤:
(1)按处方取补血草、砂仁、丹参加入2-10倍量75%乙醇,回流提取两次,每次1-3小时,滤过,合并两次滤液,减压回收乙醇至无醇味得乙醇提取物,备用;
(2)按处方取干地黄、功劳叶、狗脊、桑寄生、马鞭草、扶芳藤,与补血草、砂仁、丹参乙醇提取后滤渣合并,加2-10倍量水,煎煮提取1-3次,每次1-3小时,合并滤液,滤过,浓缩至相对密度1.05-1.20(60℃测),放置至室温,加入乙醇使含醇量达30%,搅匀,-5-0℃冷藏12小时,滤过,滤液减压回收乙醇至无醇味,与步骤(1)乙醇提取物合并,继续减压浓缩至干,得到药物活性成分;以该活性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。
本发明的制剂在使用时根据病人的情况确定用法用量。本发明的制剂在使用时根据病人的情况确定用法用量,可每日服1-3次,每次1-20剂,如:1-20袋或粒或片。
本发明抓住了疾病本质,进行针对治疗,所谓“有是证用是药”,从而保证了良好的临床疗效,并通过临床观察试验实施例9进一步说明了本发明的有益效果:本发明药物对降低或消除血清抗心磷脂抗体有确切的疗效,第1个疗程治疗结束后,治疗组、对照组患者ACA转阴分别为23、10例,ACA转阴率分别为35.94%、31.25%,治疗组ACA转阴率略高于对照组,差异无统计学意义(P>0.05);第2个疗程治疗结束后,治疗组、对照组患者ACA转阴总人数分别为58、22例,ACA转阴率分别为90.63%、68.75%,治疗组ACA转阴率明显高于对照组,差异有统计学意义(P<0.05)。同时,可以改善母胎免疫识别过度型反复自然流产患者的症状,2个疗程后,治疗组总转阴人数为58例,治疗后中医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);对照组总转阴人数为22例,与治疗前比较,中医症状积分差异无统计学意义(P>0.05);两组间比较,治疗组在改善中医症状方面优于对照组,治疗组症状积分减少更加明显,差异有统计学意义(P<0.01)。因此,本发明还请求保护上述药物制剂在制备治疗抗心磷脂抗体阳性复发性流产的药物中的用途,以及在制备治疗复发性流产的药物中的用途。
本发明相对与现有技术,有如下明显优势:首先,本发明药物制剂组方主要是依据复发性流产尤其是中医辩证属肾虚血热有瘀的病机特点研制而成,全方共奏滋阴补肾,益气养血,疏肝清热,活血化瘀之效,使肾气盛,冲任固,瘀热消,抑制或消除自身抗体,可使抗心磷脂抗体转为阴性,为受孕做准备,同时还可使血液黏度明显降低,增加循环流量,能抗血小板聚集和血栓形成,改善胎盘微循环,改善患者中医症候,克服单纯西药治疗的不利因素。
本发明组方精简,辨证与辨病相结合,配伍合理,成本低廉,经临床应用验证,其疗效确切,药性平和,未出现毒副作用及明显不良反应,安全系数高。
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:干地黄15份、功劳叶10份、狗脊8份、桑寄生8份、补血草25份、砂仁6份、马鞭草6份、扶芳藤12份、丹参10份。
制备方法:(1)按处方取补血草、砂仁、丹参加入2-10倍量75%乙醇,回流提取两次,每次1-3小时,滤过,合并两次滤液,减压回收乙醇至无醇味得乙醇提取物,备用;
(2)按处方取干地黄、功劳叶、狗脊、桑寄生、马鞭草、扶芳藤,与补血草、砂仁、丹参乙醇提取后滤渣合并,加2-10倍量水,煎煮提取1-3次,每次1-3小时,合并滤液,滤过,浓缩至相对密度1.05-1.20(60℃测),放置至室温,加入乙醇使含醇量达30%,搅匀,-5-0℃冷藏12小时,滤过,滤液减压回收乙醇至无醇味,与步骤(1)的乙醇提取物合并,继续减压浓缩至干,得到药物活性成分;以该活性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胶囊剂。每粒含有生药1.5g。
实施例2胶囊剂
处方:干地黄15份、功劳叶12份、狗脊10份、桑寄生6份、补血草20份、砂仁6份、马鞭草5份、扶芳藤12份、丹参8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:干地黄13份、功劳叶15份、狗脊10份、桑寄生8份、补血草22份、砂仁5份、马鞭草8份、扶芳藤15份、丹参8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:干地黄18份、功劳叶15份、狗脊10份、桑寄生10份、补血草25份、砂仁7份、马鞭草6份、扶芳藤10份、丹参12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:干地黄15份、功劳叶12份、狗脊10份、桑寄生6份、补血草20份、砂仁6份、马鞭草6份、扶芳藤15份、丹参12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:干地黄16份、功劳叶12份、狗脊6份、桑寄生11份、补血草20份、砂仁5份、马鞭草8份、扶芳藤10份、丹参8份。
制备方法:参照实施例1的操作进行。
实施例7片剂
处方:干地黄16份、功劳叶10份、狗脊10份、桑寄生8份、补血草20份、砂仁6份、马鞭草7份、扶芳藤12份、丹参10份。
制备方法:(1)按处方取补血草、砂仁、丹参加入2-10倍量75%乙醇,回流提取两次,每次1-3小时,滤过,合并两次滤液,减压回收乙醇至无醇味得乙醇提取物,备用;
(2)按处方取干地黄、功劳叶、狗脊、桑寄生、马鞭草、扶芳藤,与补血草、砂仁、丹参乙醇提取后滤渣合并,加2-10倍量水,煎煮提取1-3次,每次1-3小时,合并滤液,滤过,浓缩至相对密度1.05-1.20(60℃测),放置至室温,加入乙醇使含醇量达30%,搅匀,-5-0℃冷藏12小时,滤过,滤液减压回收乙醇至无醇味,与步骤(1)的乙醇提取物合并,继续减压浓缩至干,得到药物活性成分;以该活性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片剂。每片含有生药1.0g。
实施例8颗粒剂
处方:干地黄15份、功劳叶10份、狗脊8份、桑寄生8份、补血草25份、砂仁6份、马鞭草6份、扶芳藤12份、丹参10份。
制备方法:(1)按处方取补血草、砂仁、丹参加入2-10倍量75%乙醇,回流提取两次,每次1-3小时,滤过,合并两次滤液,减压回收乙醇至无醇味得乙醇提取物,备用;
(2)按处方取干地黄、功劳叶、狗脊、桑寄生、马鞭草、扶芳藤,与补血草、砂仁、丹参乙醇提取后滤渣合并,加2-10倍量水,煎煮提取1-3次,每次1-3小时,合并滤液,滤过,浓缩至相对密度1.05-1.20(60℃测),放置至室温,加入乙醇使含醇量达30%,搅匀,-5-0℃冷藏12小时,滤过,滤液减压回收乙醇至无醇味,与步骤(1)的乙醇提取物合并,继续减压浓缩至干,得到药物活性成分;以该活性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颗粒剂。每袋含有生药4.0g。
实施例9本发明药物对抗心磷脂抗体阳性复发性流产的疗效观察试验
1资料与方法
1.1一般资料:共纳入临沂市中医院2013年8月-2014年12月诊治96例抗心磷脂抗体阳性致复发性流产患者作为研究对象,采用随机按数字表法以2:1分为治疗组和对照组,其中治疗组64例,年龄24~37岁,平均年龄(30.5±3.7)岁;流产次数2~6次,平均(2.8±1.2)次;对照组32例,年龄23~36岁,平均年龄(29.8±3.4)岁;流产次数2~6次,平均(2.4±0.9)次,两组患者年龄、流产次数比较,差异无统计学意义(P>0.05),具有可比性。
1.2诊断标准:
1.2.1复发性流产的诊断标准:参照《中医妇科学》(张玉珍)相关标准:与同一性伴侣连续遭受2次或2次以上的妊娠28周前胎儿丢失者;②抗心磷脂抗体(ACA)阳性。
1.2.2中医证型标准:参照《中药新药临床研究指导原则》、《中医妇科学》(张玉珍)及《中医病症诊断疗效标准》拟定“肾虚血热夹瘀”证型标准:屡孕屡堕或应期而堕,腰酸、乏力、潮热、心烦、手足心热、大便偏干、头晕耳鸣,月经周期基本规律,月经量偏少或正常,色黯红,有血块,或痛经,或行经不畅,舌质淡红或偏红或黯,苔薄黄或薄白,脉象细数或弦细。
1.3纳入、排除标准:
1.3.1纳入标准:符合上述诊断标准;年龄20~40岁的育龄妇女;夫妻双方染色体检查正常;男方精液检查正常;签署知情同意书并能按计划坚持治疗者。
1.3.2排除标准:妇科检查、盆腔B超除外生殖器器质性病变;生殖内分泌激素测定排除内分泌因素;输卵管造影排除输卵管不通者;宫颈分泌物检测排除生殖系统感染;除外合并严重心、脑血管,肝、肾及造血系统等原发性疾病和精神病患者;除外未按规定用药,依从性差,无法判断疗效或资料不全影响疗效者。
1.4治疗方法
治疗组: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,连续治疗2个月为1个疗程。对照组:服用阿司匹林肠溶片,50mg,每晚1次。以上2组均经期停药,服药期间严格应用避孕套避孕,2个月为1个疗程,连续观察2个疗程。每个疗程结束后均检测ACA抗体,并将2组检测结果进行对照。
1.5观察指标:
1.5.1两组患者治疗后ACA的转阴疗程及疗效;
1.5.2两组中医症状评分改善情况(按程度无、轻、中、重分级,其对应分值分别为0、1、2、3分)。
1.6疗效评定标准参照《中药新药临床研究指导原则》进行评定。痊愈:检测血ACA阴性,自觉症状消失;无效:化验血ACA阳性。
1.7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
2.1两组治疗后血清ACA变化:第1个疗程治疗结束后,治疗组、对照组患者ACA转阴分别为23、10例,ACA转阴率分别为35.94%、31.25%,治疗组ACA转阴率略高于对照组,差异无统计学意义(P>0.05);第2个疗程治疗结束后,治疗组、对照组患者ACA转阴总人数分别为58、22例,ACA转阴率分别为90.63%、68.75%,治疗组ACA转阴率明显高于对照组,差异有统计学意义(P<0.05)。见表1。
表1两组治疗后血清ACA变化
注:与对照组同期比较,*P<0.05.
2.2两组ACA转阴后中医症状积分比较:2个疗程后,治疗组总转阴人数为58例,治疗后中医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);对照组总转阴人数为22例,与治疗前比较,中医症状积分差异无统计学意义(P>0.05);两组间比较,治疗组在改善中医症状方面优于对照组,治疗组症状积分减少更加明显,差异有统计学意义(P<0.01)。见表2。
表2两组治疗前后中医症状积分比较(分)
注:与治疗前比较,*P<0.01,与对照组同期比较,#P<0.01。
2.3安全性情况:治疗2个疗程后,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。
本发明药物对降低或消除血清抗心磷脂抗体有确切的疗效。同时,可以改善母胎免疫识别过度型反复自然流产患者的中医症候,且疗效显著,无副作用,为研究中医药治疗免疫性反复自然流产的机理。
典型病例:
肖某,29岁,公务员,2013年10月2日初诊。以先后二次自然流产为主诉。患者既往身体健康,月经周期正常,经量多,色黯红有血块,腰酸、乏力、心烦、手足心热、大便偏干;2013年1月孕40多天,无任何原因而自然流产,一月前又孕两月余阴道少许出血,行B超检查提示:早孕,宫内妊娠,胚胎停止发育,宫腔内少许积血,即行清宫术。现术后二月,化验血优生优育系列均正常,血ACA阳性。自感腰酸困疼,夜眠不佳,手足心热,饮食一般,乏力易疲倦。舌淡,苔薄白,脉细,中医辩证肾虚血热血瘀,服用本发明实施例1制备的胶囊剂,每日2次,每次4粒。11月3日复诊,服药后诸症均有好转,舌脉同前,复查血AcA,阴性,继续用药一个疗程,痊愈。2014年3月妊娠,胚胎发育良好。现顺娩一健康男婴。
Claims (10)
1.一种治疗复发性流产的药物制剂,其特征在于由干地黄、功劳叶、狗脊、桑寄生、补血草、砂仁、马鞭草、扶芳藤、丹参为药用原料制成。
2.如权利要求1所述的药物制剂,其特征在于由以下重量份配比的药用原料制成:干地黄13-18份、功劳叶10-15份、狗脊6-11份、桑寄生6-11份、补血草20-25份、砂仁4-7份、马鞭草5-8份、扶芳藤10-15份、丹参7-12份。
3.如权利要求2所述的药物制剂,其特征在于由以下重量份配比的药用原料制成:干地黄15份、功劳叶10份、狗脊8份、桑寄生8份、补血草25份、砂仁6份、马鞭草6份、扶芳藤12份、丹参10份。
4.如权利要求1-3任一所述的药物制剂,其特征在于制备方法包括以下步骤:
(1)按处方取补血草、砂仁、丹参加入2-10倍量75%乙醇,回流提取两次,每次1-3小时,滤过,合并两次滤液,减压回收乙醇至无醇味得乙醇提取物,备用;
(2)按处方取干地黄、功劳叶、狗脊、桑寄生、马鞭草、扶芳藤,与补血草、砂仁、丹参乙醇提取后滤渣合并,加2-10倍量水,煎煮提取1-3次,每次1-3小时,合并滤液,滤过,浓缩至相对密度1.05-1.20(60℃测),放置至室温,加入乙醇使含醇量达30%,搅匀,-5-0℃冷藏12小时,滤过,滤液减压回收乙醇至无醇味,与步骤(1)的乙醇提取物合并,继续减压浓缩至干,得到药物活性成分;以该活性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。
5.如权利要求4所述的药物制剂,其特征在于所述药物制剂为口服剂型。
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优选为软胶囊剂、胶囊剂、片剂、口服液、颗粒剂、丸剂、散剂、丹剂、膏剂中的一种或多种。
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胶囊剂、片剂或颗粒剂。
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优选为胶囊剂。
9.权利要求1-3任一所述的药物制剂在制备治疗复发性流产的药物中的用途。
10.权利要求1-3任一所述的药物制剂在制备治疗抗心磷脂抗体阳性复发性流产的药物中的用途。
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