CN105687758A - 一种治疗抗心磷脂抗体阳性先兆流产的药物制剂 - Google Patents
一种治疗抗心磷脂抗体阳性先兆流产的药物制剂 Download PDFInfo
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Abstract
本发明属于中医药领域，涉及一种治疗抗心磷脂抗体阳性先兆流产的药物制剂及其制备方法。该药物制剂由菟丝子、覆盆子、续断、刺五加、牛奶浆根、手掌参、丹参、苎麻根为药用原料制成。全方合伍攻补兼施，标本同治，祛邪而不伤正，活血而不伤胎，共奏补肾益气，和血安胎、安子益母之功效，治疗ACA阳性所致先兆流产疗效安全可靠，对母婴未发现有明显毒副作用，显示了中医药在治疗先兆流产方面的巨大优势。
Description
技术领域
本发明属于中医药领域，涉及一种治疗抗心磷脂抗体阳性先兆流产的药物制剂及其制备方法。
背景技术
早期先兆流产是以妊娠12周以前，出现阴道少量流血，伴阵发性下腹痛或腰背痛为主要症状，妇科检查宫颈口未开，胎膜未破、与停经周数相符，妊娠尚有希望继续者。属于中医“胎漏、胎动不安”等范畴。如不及时正确治疗，常可发展为堕胎、小产或并发胎萎不长，直接影响着胎儿的正常发育和孕妇的身心健康。
近年来，国内外大量的主动免疫及被动免疫动物模型证明，抗心磷脂抗体(Anticardiolipinantibody，ACA)对早期先兆流产患者具有直接的致病作用，抗心磷脂抗体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。目前一般认为，ACA一方面能干扰机体磷脂依赖性凝血功能，从而损伤血管内皮而触发内源性凝血系统，改变血栓素/前列腺素水平，促进血小板聚集，血栓形成，造成胎盘缺血，导致胎儿宫内发育迟缓、死胎以致流产。另一方面，孕早期ACA可干扰细胞滋养层与合体滋养层的融合及羊膜的生长发育，从而导致流产。
目前ACA引起的先兆流产的治疗，国内外多采用免疫抑制剂(强的松或泼尼松等)联合抗凝药物(阿司匹林或肝素等)治疗，但长期应用可引起血糖升高、骨质疏松、感染、血小板减少、出血等副反应。因此如何应用安全、有效的药物使其异常增高的抗心磷脂抗体转阴，从而使妊娠能顺利完成是国内外学者研究的主要课题。中医认为肾主生殖，中医多以补肾、养血、清热为治则。现代医学研究证明，中医学中的“肾”与现代医学之机体生殖免疫有密切关系，补肾药可调节机体生殖内分泌-免疫网络。同时中医“未孕先防、预培其损”、“既孕防病，已病早治”治疗原则，可以克服了单纯应用西药可能出现的不良反应，并且降低了复发率，疗效确切。因此需要提出一种治疗先兆性流产的药物制剂。
发明内容
为克服现有技术的不利因素，发明人在祖传方药的基础上，结合现代人的体质及现代医学理论，辨证与辨病相结合，认为肾虚固摄无权，胎元不固，气化不利，血运不畅，离经之血滞而成瘀，均可使胎失所养引发，证属肾虚血瘀，据此，提供了一种疗效确定、副作用小的治疗抗心磷脂抗体阳性先兆流产的药物制剂，尤其适用于肾虚血瘀型先兆流产抗心磷脂抗体阳性患者。
为实现上述目的，本发明采用的技术方案如下：
一种治疗抗心磷脂抗体阳性先兆流产的药物制剂，其由菟丝子、覆盆子、续断、刺五加、牛奶浆根、手掌参、丹参、苎麻根为药用原料制成。
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：
一种治疗抗心磷脂抗体阳性先兆流产的药物制剂，其由以下重量份配比的药用原料精心制成：菟丝子20-26份、覆盆子8-13份、续断10-15份、刺五加8-13份、牛奶浆根20-25份、手掌参15-20份、丹参7-12份、苎麻根5-8份。
进一步优选地，一种治疗抗心磷脂抗体阳性先兆流产的药物制剂，其由以下重量份配比的药用原料精心制成：菟丝子25份、覆盆子12份、续断15份、刺五加10份、牛奶浆根20份、手掌参18份、丹参10、苎麻根7份。
发明人有多年的临床保胎实践，准确的审因辩证，灵活应用补肾、益气、和血安胎之药，方药选用菟丝子、覆盆子、续断、刺五加、牛奶浆根、手掌参、丹参、苎麻根，临床应用于肾虚血瘀型抗心磷脂抗体阳性所致先兆流产患者，对ACA有转阴作用，并促进胎盘微循环，增加胎盘血量，提高免疫功能达到保胎的作用。方中：菟丝子甘温，平补肾阴肾阳，补肝益肾，固精安胎；覆盆子甘酸温补益肾气，强阴建阳固精，二药伍用补肾益精，为君药。续断苦辛微温，补续血脉，调气血，通经络，补而不滞，行而不泄，刺五加辛微苦温，补肾强腰，益气安神，活血通络；牛奶浆根甘辛温，补中益气，健脾化湿，强筋壮骨，活血解毒，三药伍用，既补肾固任调冲，又益气活血，行瘀安胎，取“养胎者血也，护胎者气也”这一理论，为臣药。手掌参甘平益肾健脾，理气和血，安神镇惊，丹参祛瘀止痛，活血通经，清心除烦；苎麻根凉血止血，清热安胎，利尿解毒，具为佐使药。全方合伍攻补兼施，标本同治，祛邪而不伤正，活血而不伤胎，共奏补肾益气，和血安胎之功效。
进一步地，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。
覆盆子：【性味】甘、酸，温。【归经】归肾、膀胱经。【功能主治】益肾，固精，缩尿。用于肾虚遗尿，小便频数，阳痿早泄，遗精滑精。
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。
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。【用法用量】9～27g。
牛奶浆根：【性味】甘；辛；性温。【归经】肺；脾；肾经。【功能主治】益气健脾；活血通络；祛风除湿。主劳倦乏力；食少；乳汁不下；脾虚白带；脱肛；月经不调；头风疼痛；跌打损伤；风湿性关节痛。【用法用量】内服：煎汤，30-60g。外用：适量，捣敷。
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。
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。
苎麻根：【性味】性寒，味甘。【归经】归肝经、心经、膀胱经。【功效与作用】凉血止血，清热安胎，利尿，解毒。主治血热妄行所致的咯血、吐血、衄血、血淋、便血、崩漏、紫癜，胎动不安，胎漏下立，小便淋沥，痈疮肿毒，虫蛇咬伤。【临床应用】内服：煎汤，用量5～30克，或捣汁。外用：适量，鲜品捣敷，或煎汤熏洗。
为了更好地表达本发明的药物制剂，本发明药物制剂可由菟丝子、覆盆子、续断、刺五加、牛奶浆根、手掌参、丹参、苎麻根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，最优选为胶囊剂。
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抗心磷脂抗体阳性先兆流产的药物制剂的方法，该方法包括以下步骤：
(1)按处方取刺五加、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)按处方取菟丝子、覆盆子、续断、奶浆根、手掌参、苎麻根，与刺五加、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1.10-1.15(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。
本发明还请求保护上述药物制剂在制备治疗抗心磷脂抗体阳性先兆流产的药物中的用途，尤其是在制备治疗抗心磷脂抗体阳性先兆流产肾虚血瘀证的药物中的用途。通过临床观察试验实施例9可知：(1)两组临床总疗效的比较：治疗组与对照组总有效率分别为91.1％和63.0％，两组总有效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；(2)两组ACA转阴疗效比较：治疗组与对照组总有效率分别为91.1％和60.9％，两组总有效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；(3)两组治疗前后中医症状积分比较：治疗组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)，对照组与治疗前比较，差异有统计学意义(P＜0.05)；治疗后两组间比较，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)；(4)治疗组患者治疗后均未见异常反应，随访结果令人满意。
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先兆流产患者抗心磷脂抗体阳性的病机特点研制而成，全方伍攻补兼施，标本同治，祛邪而不伤正，活血而不伤胎，共奏补肾益气，和血安胎，安子益母之功效，治疗ACA阳性所致先兆流产疗效安全可靠，对母婴未发现有明显毒副作用，显示了中医药在治疗先兆性流产方面的巨大优势。
本发明组方精简，辨证与辨病相结合，基于“养胎者血也，护胎者气也”这一理论，打破了习俗用药，药性平和，未出现毒副作用及明显不良反应，安全系数高。本发明中药来源广泛，价格较低，制成的剂型适合患者携带和使用。
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25份、覆盆子12份、续断15份、刺五加10份、牛奶浆根20份、手掌参18份、丹参10份、苎麻根7份。
制备方法：(1)按处方取刺五加、丹参加入8倍量75％乙醇，回流提取两次，每次2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)按处方取菟丝子、覆盆子、续断、奶浆根、手掌参、苎麻根，与刺五加、丹参乙醇提取后滤渣合并，加6倍量水，煎煮提取2次，每次1.5小时，合并滤液，滤过，浓缩至相对密度1.13(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；依照制剂学常规技术制成胶囊。每粒含有生药1.0g。
实施例2胶囊剂
处方：菟丝子20份、覆盆子10份、续断15份、刺五加10份、牛奶浆根20份、手掌参18份、丹参10份、苎麻根5份。
菟丝子20-26份、覆盆子8-13份、续断10-15份、刺五加8-13份、牛奶浆根20-25份、手掌参15-20份、丹参7-12份、苎麻根5-8份。
制备方法：(1)按处方取刺五加、丹参加入5倍量75％乙醇，回流提取两次，每次2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)按处方取菟丝子、覆盆子、续断、奶浆根、手掌参、苎麻根，与刺五加、丹参乙醇提取后滤渣合并，加5倍量水，煎煮提取3次，每次1.5小时，合并滤液，滤过，浓缩至相对密度1.10(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；依照制剂学常规技术制成胶囊。
实施例3胶囊剂
处方：菟丝子26份、覆盆子12份、续断10份、刺五加12份、牛奶浆根20份、手掌参20份、丹参8份、苎麻根7份。
制备方法：(1)按处方取刺五加、丹参加入-10倍量75％乙醇，回流提取两次，每次1.5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)按处方取菟丝子、覆盆子、续断、奶浆根、手掌参、苎麻根，与刺五加、丹参乙醇提取后滤渣合并，加10倍量水，煎煮提取2次，每次1.5小时，合并滤液，滤过，浓缩至相对密度1.12(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；依照制剂学常规技术制成胶囊。
实施例4胶囊剂
处方：菟丝子20份、覆盆子10份、续断10份、刺五加8份、牛奶浆根25份、手掌参15份、丹参8份、苎麻根7份。
制备方法：(1)按处方取刺五加、丹参加入4倍量75％乙醇，回流提取两次，每次2.5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)按处方取菟丝子、覆盆子、续断、奶浆根、手掌参、苎麻根，与刺五加、丹参乙醇提取后滤渣合并，加10倍量水，煎煮提取3次，每次1小时，合并滤液，滤过，浓缩至相对密度1.15(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；依照制剂学常规技术制成胶囊。
实施例5胶囊剂
处方：菟丝子25份、覆盆子12份、续断12份、刺五加13份、牛奶浆根25份、手掌参15份、丹参12份、苎麻根5份。
制备方法：(1)按处方取刺五加、丹参加入8倍量75％乙醇，回流提取两次，每次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)按处方取菟丝子、覆盆子、续断、奶浆根、手掌参、苎麻根，与刺五加、丹参乙醇提取后滤渣合并，加8倍量水，煎煮提取3次，每次1.0时，合并滤液，滤过，浓缩至相对密度1.10(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；依照制剂学常规技术制成胶囊。
实施例6胶囊剂
处方：菟丝子25份、覆盆子8份、续断15份、刺五加12份、牛奶浆根25份、手掌参15份、丹参8份、苎麻根8份。
制备方法：(1)按处方取刺五加、丹参加入8倍量75％乙醇，回流提取两次，每次1.5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)按处方取菟丝子、覆盆子、续断、奶浆根、手掌参、苎麻根，与刺五加、丹参乙醇提取后滤渣合并，加8倍量水，煎煮提取2次，每次2小时，合并滤液，滤过，浓缩至相对密度1.12(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；依照制剂学常规技术制成胶囊。
实施例7片剂
处方：菟丝子25份、覆盆子12份、续断10份、刺五加10份、牛奶浆根20份、手掌参18份、丹参10份、苎麻根7份。
制备方法：(1)按处方取刺五加、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)按处方取菟丝子、覆盆子、续断、奶浆根、手掌参、苎麻根，与刺五加、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1.10-1.15(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；依照制剂学常规技术制成片剂。
实施例8颗粒剂
处方：菟丝子20份、覆盆子12份、续断15份、刺五加10份、牛奶浆根20份、手掌参18份、丹参10份、苎麻根5份。
制备方法：(1)按处方取刺五加、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)按处方取菟丝子、覆盆子、续断、奶浆根、手掌参、苎麻根，与刺五加、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1.10-1.15(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；依照制剂学常规技术制成颗粒剂。
实施例9临床观察试验
1临床资料
1.1一般资料：2013年1月～2014年5月在本院住院及门诊诊断为先兆流产且查抗心磷脂抗体阳性患者96例，年龄23～39岁，平均年龄30岁；其中46例有自然流产史，自然流产1次34例，自然流产2次8例，自然流产3次以上者4例。采用随机按数字表法以1：1分为治疗组和对照组，其中治疗组48例，脱落3例(中途放弃治疗1例，治疗期间合并用其他治疗措施1例，随访资料不全1例)，最后纳入结果统计者45例，年龄24～38岁，平均年龄(30.5±3.7)岁。对照组48例，脱落2例(随访资料不全1例，未按要求用药1例)，最后纳入结果统计者46例，年龄23～39岁，平均年龄(29.8±3.4)岁。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诊断标注
1.2.1先兆流产的诊断标准参照：张玉珍第7版《中医妇科学》早期先兆流产诊断标准如下：①病史：有停经史和早孕反应；②症状：阴道少量出血，或伴有小腹坠痛或腰酸痛；③妊娠试验：尿妊娠试验阳性；④妇科检查：子宫颈口未开，子宫体软，大小与孕周相符；⑤超声波检查：B型声波检查子宫大小、孕囊或胚胎(胎儿)发育与孕周相符；⑥基础体温测定：保持黄体期水平(维持高温曲线)；⑦血清绒毛膜促性腺激素(β-HCG)、孕酮(P)水平与孕周和B超结果(孕囊大小、胚胎发育)基本相符；⑧血清ACA检测阳性。
1.2.2先兆流产的中医证型分型标准：参考国家药品食品监督局2002年修订的《中药新药临床研究指导原则》制定，主证：①素体虚弱或曾有滑胎病史②孕初少量阴道流血，色淡黯；③腹坠痛，腰酸困；
次证：①腰膝酸软，精神疲倦；②头晕耳鸣，夜尿多；③面色暗淡无光，眼眶黧黑；④舌暗淡或边有瘀斑，脉弦滑或细滑，尺脉弱；
符合以上主证中①、②和③，次证①、②、③、④中任一项者，即可诊断为肾虚血瘀症。
1.3病例纳入标准：参考国家药品食品监督局2002年修订的《中药新药临床研究指导原则》：(1)符合中、西医诊断标准。(2)自愿接受本研究者。(3)年龄在20～40岁之间。
1.4病例排除标准：参考国家药品食品监督局2002年修订的《中药新药临床研究指导原则》(1)年龄＞40岁或＜20岁；(2)不符合本病西医诊断标准及中医症候诊断标准；(3)合并有心、脑、肝、肾和造血系统等严重疾病患者；(4)无法合作者，如合并有神经、精神疾患，或不愿合作者；(5)排除与染色体异常、生殖器解剖因素、内分泌因素、生殖器感染、封闭抗体异常、外界不良因素等导致早期先兆流产的患者。
1.5治疗方法：两组患者均嘱绝对卧床休息，禁止房事及各种重体力活动或劳动，保持心情舒畅。
治疗组：在次基础上，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。
对照组：在基础治疗基础上，对照组口服阿司匹林，75mg/d。
两组患者均连续治疗7天为1个疗程，7天复查ACA1次；共治疗2个疗程。
1.6观察指标：中医症候学观察(症状、舌象、脉象等)，按程度无、轻、中、重分级，其对应分值分别为0、1、2、3分；阴道出血停止时间的观察；检测血ACA转阴情况；B超监测胚胎发育情况，若有宫内积血者，监测积血吸收情况。
1.7疗效评定标准：
1.7.1总疗效判定标准：依据《中医病证诊断疗效标准》及《中药新药临床研究指导原则》先兆流产疗效标准：临床治愈：治疗后阴道出血停止，腹痛腰酸症状消失，子宫大小与孕周相符，B超检查胚胎发育正常。显效：治疗后阴道出血停止，腹痛腰酸症状明显改善，证候积分减少≥70％，子宫大小与孕周相符，B超检查胚胎发育正常。有效：治疗后阴道出血停止，腹痛腰酸症状有所改善，证候积分减少≥30％，子宫大小与孕周相符，B超检查胚胎发育正常。无效：治疗后阴道流血、腹痛腰酸症状同前或加重，最终难免流产。
1.7.2血ACA转阴疗效判定标准：治愈：治疗后血ACA各型抗体全部转阴。有效：治疗后血ACA-IgG和ACA-IgM均阳性者，其中任一项转阴。无效：治疗后血ACA仍为阳性。
2结果
2.1两组临床总疗效的比较：治疗组治愈24例，显效15例，有效2例，无效4例，对照组组治愈11例，显效5例，有效13例，无效17例，治疗组与对照组总有效率分别为91.1％和63.0％，两组总有效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1两组临床总疗效的比较
注：与对照组比较，*P＜0.05。
2.2两组ACA转阴疗效比较：治疗组治愈33例，有效8例，无效4例，对照组组治愈16例，有效12例，无效18例，治疗组与对照组总有效率分别为91.1％和60.9％，两组总有效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2。
表2两组ACA转阴疗效比较
注：与对照组比较，*P＜0.05。所有ACA转阴有效病例均为先兆流产有效病例。
2.3两组治疗前后中医症状积分比较：治疗组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)，对照组与治疗前比较，差异有统计学意义(P＜0.05)；治疗后两组间比较，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3。
表3两组治疗前后中医症状积分比较(分)
注：与治疗前比较，*P＜0.05，**P＜0.01；与对照组同期比较，#P＜0.01。
2.4安全性情况：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。
2.5随访情况：治疗组有效病例45例中，35例足月分娩，2例早产，均母婴健康；8例正在妊娠中，现孕31-35周，均未见异常反应。
总之本发明药物治疗ACA阳性所致先兆流产疗效安全可靠，对母婴未发现有明显毒副作用，显示了中医药在治疗先兆流产方面的巨大优势，并且体现了中医根据个体差异及各种不同的证型辨证施治的灵活性和特点，在目前临床上治疗本病单纯应用西药副作用过大，单纯应用中药疗效不确切的情形下，提供了病因病机的思路和切实有效的方药资料，值得进一步研究应用。
Claims (10)
1.一种治疗抗心磷脂抗体阳性先兆流产的药物制剂，其特征在于由菟丝子、覆盆子、续断、刺五加、牛奶浆根、手掌参、丹参、苎麻根为药用原料制成。
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：菟丝子20-26份、覆盆子8-13份、续断10-15份、刺五加8-13份、牛奶浆根20-25份、手掌参15-20份、丹参7-12份、苎麻根5-8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：菟丝子25份、覆盆子12份、续断15份、刺五加10份、牛奶浆根20份、手掌参18份、丹参10份、苎麻根7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)按处方取刺五加、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)按处方取菟丝子、覆盆子、续断、奶浆根、手掌参、苎麻根，与刺五加、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1.10-1.15(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。
5.如权利要求1-4任一所述的药物制剂，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片剂、胶囊剂或颗粒剂。
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抗心磷脂抗体阳性先兆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先兆流产肾虚血瘀证的药物中的用途。
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