CN105770688A - 一种治疗复发性流产患者抗子宫内膜抗体阳性的中药制剂 - Google Patents
一种治疗复发性流产患者抗子宫内膜抗体阳性的中药制剂 Download PDFInfo
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Abstract
本发明属于中医药技术领域，具体公开了一种治疗复发性流产患者抗子宫内膜抗体阳性的中药制剂及其制备方法。该中药制剂由功劳叶、干地黄、牛尾参、砂仁、虎杖、天葵草、小雪人参、当归、赤芍为药用原料制成，诸药伍用有滋阴清热，凉血解毒，活血祛瘀之功效。本发明药物治疗RSA患者抗子宫内膜抗体阳性症疗效确切，转阴率高，复发率低，明显优于醋酸泼尼松对照组，具有较好的临床疗效。
Description
技术领域
本发明属于中医药技术领域，具体公开了一种治疗复发性流产患者抗子宫内膜抗体阳性的中药制剂及其制备方法。
背景技术
复发性流产(recurrentspontaneousabortion，RSA)是指与同一性伴侣连续遭受2次或2次以上在妊娠20周前的胎儿(体重≤500g)丢失者，是育龄妇女的常见病。近年来，国内外大量临床研究数据表明，复发性流产率呈逐步上升趋势，不仅影响了妇女的身心健康，还影响家庭及社会的和谐，目前己经成为公共卫生问题。
导致复发性流产的原因多种多样，并且比较复杂，但是不同的原因所占的比例有所不同。大量临床研究表明，复发性流产的发生除与内分泌因素、感染因素、免疫因素、遗传因素、子宫及生殖道崎形、男性因素、环境因素、全身疾病、不良生活习惯等原因有关。
抗子宫内膜抗体(Anti-EndometriumAntibody，EmAb)是子宫内膜异位的标志性抗体，其产生与异位子宫内膜的刺激及机体免疫内环境失衡有关，是引起免疫性不孕的主要因素之一，同时也与反复自然流产有一定关系；其以子宫内膜为靶器官，与子宫内膜中的抗原结合，引起子宫内膜病理损伤，干扰和妨碍孕卵着床和胚胎发育导致流产。
复发性流产属中医的“滑胎”、“数堕胎”、“屡孕屡堕”范畴。本病以连续性、自然性和应期而下为特点，祖国医学对本病的认识由来已久，古代文献中对本病的病因病机及辨证论治有很多记载，认为导致滑胎的机理主要为母体冲任损伤及胎元不健，临床常见的病因主要有肾虚、脾肾虚弱、气血两虚、血热及血瘀等。目前治疗复发性流产的方法有很多种，而中医药在治疗滑胎方面的显著效果引起了人们的重视。多数医家认为复发性流产的预防重于治疗，并建立了以未病先防、预培其损立法治疗复发性流产的理论体系。
发明内容
发明人结合古今先贤的理论与自己的临床经验，将现代生理病理与中医病因病机、辨证与辨病有机结合起来，提供了一种治疗复发性流产患者抗子宫内膜抗体阳性的中药制剂，其配伍完善，治疗效果好、无任何毒副作用，消除了异常抗体，为下一次的成功妊娠打下良好的基础。
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患者抗子宫内膜抗体阳性的中药制剂，其由以下药用原料制成：功劳叶、干地黄、牛尾参、砂仁、虎杖、天葵草、小雪人参、当归、赤芍。
为了增加药物中有效活性成分的协同作用，使诸药配合使用以达到一加一大于二的技术效果，本发明人在祖传秘方的基础上，经过长期、大量的筛选组方试验，进一步优选如下技术方案：
一种治疗复发性流产患者抗子宫内膜抗体阳性的中药制剂，其由以下重量分配比的药用原料制成：功劳叶20-25份、干地黄10-15份、牛尾参20-25份、砂仁6-11份、虎杖8-13份、天葵草15-20份、小雪人参8-13份、当归10-15份、赤芍7-12份。
进一步优选地，一种治疗复发性流产患者抗子宫内膜抗体阳性的中药制剂，其由以下重量分配比的药用原料制成：功劳叶20份、干地黄12份、牛尾参25份、砂仁9份、虎杖10份、天葵草18份、小雪人参11份、当归13份、赤芍10份。
发明人认为：屡屡堕胎耗伤精血，精血不足，肾阴亏虚导致冲任二脉损伤；阴虚则生内热，煎灼阴血，病久致瘀。形成肾虚为本，阴虚内热、血瘀冲任的病理机制。方中：功劳叶苦凉，能补养阴气，清热养阴，平肝益肾；干地黄甘苦微寒，善滋阴清热，凉血补血，二药伍用滋阴补肾，凉血清热为君药。虎杖善活血散瘀，祛风通络，清热利湿，解毒；赤芍清热凉血，活血祛瘀；天葵草清热解毒，消肿散结，三药伍用活血祛瘀，清热凉血，解毒散结为臣药。牛尾参健脾益肾，调畅水道；小雪人参健脾补血，清热利湿，活血调经；当归补血活血，调经止痛、润汤通便；砂仁养胃益肾，理气通滞，四药伍用既补后天助先天，使补而不滞，又补血活血以散瘀滞、清湿热。诸药伍用有滋阴清热，凉血解毒，活血祛瘀之功效，针对肾阴虚血热血瘀型抗子宫内膜抗体阳性患者而研制，效果显著。
本发明各组分药用原料的具体药理研究现状如下：
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。
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。【注意】脾虚泄泻、胃虚食少、胸膈多痰者慎服。
牛尾参：【性味】甘；微辛；平。【归经】脾；肺；肾经。【功能主治】健脾去湿；补肺益肾。主脾虚食少；泄泻；肾虚遗精；消渴；肺劳咳嗽；跌打损伤。【用法用量】内服：煎汤，9-15g；或入丸、散。外用：适量，捣敷。
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。
虎杖：【性味】苦；酸；性微寒。【归经】肝；胆经。【功能主治】活血散瘀；祛风通络；清热利湿；解毒。主妇女经闭；痛经；产后恶露不下；症瘕积聚；跌扑损伤；风湿痹痛；湿热黄疸；淋浊带下；疮疡肿毒；毒蛇咬伤；水火烫伤。【用法用量】内服：煎汤，10-15g；或浸酒；或入丸、散。外用：适量，研末调敷；或煎浓汁湿敷；或熬膏涂擦。
天葵草：【性味】甘、苦，寒。【归经】归肝、胃经。【功能主治】：清热解毒，消肿散结。用于痈肿疔疮，乳痈，瘰疠，毒蛇咬伤。
小雪人参：【性味】甘；微淡；性平。【归经】脾经。【功能主治】健脾补虚；清热利湿；活血调经。主虚劳；血虚头晕；水肿；腹水；痢疾；经闭；痛经。【用法用量】内服：煎汤，15-30g。
当归：【性味】味甘、辛、苦，性温，【归经】入肝、心、脾经，【功能主治】补血活血，调经止痛、润汤通便的作用，用于血虚萎黄、眩晕心悸、月经不调、经闭痛经、虚寒腹痛、肠燥便秘、风湿痹痛、跌扑损伤、痈疽疮疡等证。
赤芍：【性味】苦；微寒。【归经】肝；脾经。【功能主治】清热凉血；活血祛瘀。主温毒发斑；吐血衄血；肠风下血；目赤肿痛；痈肿疮疡；闭经；痛经；崩带淋浊；瘀滞胁痛；疝瘕积聚；跌扑损伤。【用法用量】内服：煎汤，4-10g；或入丸、散。
为了便于使用，本发明的中药制剂可以制成口服剂型，如：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、颗粒剂、冲剂、丸剂、散剂、混悬剂、粉剂。
优选地，上述所述的口服剂型为胶囊剂、片剂、口服液、颗粒剂或丸剂。
最优选地，上述所述的剂型是胶囊剂。
本发明提供的上述所述中药制剂的制备方法，其特征在于包括以下步骤：
(1)按处方取虎杖、赤芍，粉碎、混合，加所述混合物重量份3～8倍的浓度为45～55％的乙醇回流提取2次，每次加热回流的时间为1～2小时，合并提取液，过滤，减压浓缩成稠膏；
(2)按处方称取功劳叶、干地黄、牛尾参、砂仁、天葵草、小雪人参、当归，混合，加所述混合物重量份3～8倍的水煎煮提取2次，每次煎煮时间为1～2小时，合并提取液，过滤，静置，取上层清夜，减压浓缩成稠膏；
(3)将步骤(1)和步骤(2)获得的稠膏混合，干燥后粉碎，与适量的药学上可接受的载体或/和辅料混合均匀，按本领域常规制剂工艺制备即得。
上述所述药学上可接受的载体或/和辅料可选自：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。
本发明是发明人在治疗RSA患者EmAb阳性的过程中，经过反复研究，逐步改进，最后成功的一种疗效较好的中药制剂，并通过临床病例进一步验证了本发明中药制剂疗效，详细资料如下所述：
1资料与方法
1.1临床资料：2013年7月至2014年4月在我院妇科门诊再次就诊的女性RSA患者中EmAb阳性106例，年龄25～37岁，平均(30.7±3.6)岁，流产发生次数2-6次。所有患者经检查无生殖道性病及其他病原体感染，双侧输卵管通畅，生殖内分泌测定在正常范围，排卵功能正常，其配偶精液常规在正常范围。将患者分为治疗组和对照组，治疗组60例，平均年龄(29.7±3.3)岁，流产发生次数(2.5±1.2)次；对照组46例，平均年龄(31.6±3.8)岁，流产发生次数(2.3±1.1)次。两组年龄、流产次数等基线资料比较，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西医诊断标准：复发性自然流产参照乐杰主编的《妇产科学》第7版的诊断标准：连续2次及2次以上的自然流产，表现为妊娠28周前先出现少量阴道出血，无妊娠物排出，随后出现阵发性下腹痛或腰背痛；妇科检查宫颈口未开，子宫大小与停经周数相符；B超检查子宫大小、孕囊或胚胎与孕周相符。
1.2.2中医辨证分型标准：参照《中药新药临床研究指导原则》并结合临床症状：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免疫反应测定方法：采用金标免疫斑点法检测，操作步骤按说明进行，反应板上若出现红色圆斑为阳性。
1.4纳入标准：连续发生2次或2次以上自然流产；抗子宫内膜抗体阳性；符合中医阴虚血热血瘀的辨证分型标准者。
1.5治疗方法：
对照组：给予阿司匹林(阿司匹林肠溶片(50mg/片)，口服，每次1片；泼尼松5mg/片，每晚一次，连续用药三个疗程。
治疗组：口服本发明实施例1制备的胶囊剂，每日早晚2次，每次2-4粒，饭后半小时服用，连续用药三个疗程。
1.6观察指标与方法：
1.6.1一般指标：观察治疗前后相关症状、体征和舌脉的变化，并进行中医症状评分，症状评分标准参照《中药新药临床研究指导原则》2002版相关内容修改制定，根据综合证候积分函盖总分的1/3比例进行病情分级：轻度，0～9分；中度，10～18分；重度，19～27分。
1.6.2测定治疗前、后及治疗后3个月抗子宫内膜抗体情况。
1.7疗效评定标准：
1.7.1临床疗效评定标准：参照本病的临床研究报道资料，拟评定标准如下：治愈：妊娠或血清EmAb转阴，3个月后无复发；有效：血清EmAb转阴但未孕，3个月后复发；无效：血清EmAb未转阴，未孕。
1.7.2中医证候疗效评定标准：参照《中药新药临床研究指导原则》相关内容修改制定。疗效指数(n)计算采用尼莫地群法：n＝(治疗前积分-治疗后积分)/治疗前积分×100％；痊愈：治疗后各症状消失或明显减轻，n≥70％；好转：治疗后各症状有所减轻，70％＞n≥30％；无效：治疗后各症无减轻或有加重，n＜30％。
1.8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
2.1两组临床综合疗效的比较：治疗组与对照组治愈率和总有效率分别为73.3％，95.0％和30.4％，78.3％，两组治愈率、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1两组临床综合疗效的比较
注：与对照组比较，*P＜0.05。
2.2两组中医证候疗效的比较：治疗后治疗组痊愈45例，好转13例，无效2例，总有效率96.7％；对照组痊愈10例，好转18例，无效18例，总有效率60.9％，治疗组与对照组总有效率比较，差异有统计学意义(P＜0.05)，说明治疗组中医证候积分改善明显优于对照组。见表2。
表2两组患者中医证候疗效比较
注：与对照组比较，*P＜0.05。
2.3两组中医证候积分比较：治疗前两组患者的症状积分差异无统计学意义(P＞0.05)，具有可比性。疗程结束后，两组患者中医证候积分较治疗前均有下降，然与对照组比较，治疗组中医证候积分下降幅度更明显，差异均有统计学意义(P＜0.05)。见表3。
表3两组患者治疗前后中医症状积分比较分
注：与治疗前比较：*P＜0.01；治疗后两组间比较：#P＜0.05。
2.4安全性评价：治疗组患者服用后，对血常规，尿常规，肝、肾功能等安全性指标检测未见影响，治疗期间及随访期间均未见不良反应发生。
综上所述，本发明治疗RSA患者抗子宫内膜抗体阳性症疗效确切，转阴率高，复发率低，明显优于醋酸泼尼松对照组，具有较好的临床疗效，因此，本发明还请求保护上述中药制剂在制备治疗复发性流产患者抗子宫内膜抗体阳性的药物中的用途，以及在制备抗子宫内膜抗体阳性的药物中的用途。
与现有技术相比，本发明既遵循了中医辨证用药规律，又融入了现代药理，立法全面，组方严谨合理，具有多靶点、多环节、多层次的综合调控作用是治疗抗子宫内膜抗体阳性的理想中药复方；临床疗效确切，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，能够达到标本兼治的目的，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：功劳叶20份、干地黄12份、牛尾参25份、砂仁9份、虎杖10份、天葵草18份、小雪人参11份、当归13份、赤芍10份。
制备方法：(1)按处方取虎杖、赤芍，粉碎、混合，加所述混合物重量份3～8倍的浓度为50％的乙醇回流提取2次，每次加热回流的时间为1～2小时，合并提取液，过滤，减压浓缩成稠膏；
(2)按处方称取功劳叶、干地黄、牛尾参、砂仁、天葵草、小雪人参、当归，混合，加所述混合物重量份3～8倍的水煎煮提取2次，每次煎煮时间为1～2小时，合并提取液，过滤，静置，取上层清夜，减压浓缩成稠膏；
(3)将步骤(1)和步骤(2)获得的稠膏混合，干燥后粉碎，按本领域常规制剂工艺制备即得。本实施例胶囊剂每粒含有生药0.9g。
实施例2胶囊剂
处方：功劳叶25份、干地黄12份、牛尾参20份、砂仁7份、虎杖12份、天葵草15份、小雪人参8份、当归10份、赤芍8份。
制备方法：(1)按处方取虎杖、赤芍，粉碎、混合，加所述混合物重量份5倍的浓度为47％的乙醇回流提取2次，每次加热回流的时间为1～2小时，合并提取液，过滤，减压浓缩成稠膏；
(2)按处方称取功劳叶、干地黄、牛尾参、砂仁、天葵草、小雪人参、当归，混合，加所述混合物重量份3～8倍的水煎煮提取2次，每次煎煮时间为1～2小时，合并提取液，过滤，静置，取上层清夜，减压浓缩成稠膏；
(3)将步骤(1)和步骤(2)获得的稠膏混合，干燥后粉碎，按本领域常规制剂工艺制备即得。
实施例3胶囊剂
处方：功劳叶20份、干地黄15份、牛尾参22份、砂仁6份、虎杖12份、天葵草20份、小雪人参10份、当归10份、赤芍10份。
制备方法：(1)按处方取虎杖、赤芍，粉碎、混合，加所述混合物重量份3～8倍的浓度为53％的乙醇回流提取2次，每次加热回流的时间为1～2小时，合并提取液，过滤，减压浓缩成稠膏；
(2)按处方称取功劳叶、干地黄、牛尾参、砂仁、天葵草、小雪人参、当归，混合，加所述混合物重量份3～8倍的水煎煮提取2次，每次煎煮时间为1～2小时，合并提取液，过滤，静置，取上层清夜，减压浓缩成稠膏；
(3)将步骤(1)和步骤(2)获得的稠膏混合，干燥后粉碎，按本领域常规制剂工艺制备即得。
实施例4胶囊剂
处方：功劳叶22份、干地黄12份、牛尾参24份、砂仁10份、虎杖8份、天葵草20份、小雪人参12份、当归10份、赤芍7份。
制备方法：参照实施例1-3。
实施例5胶囊剂
处方：功劳叶20份、干地黄10份、牛尾参20份、砂仁8份、虎杖8份、天葵草18份、小雪人参8份、当归12份、赤芍10份。
制备方法：参照实施例1-3。
实施例6胶囊剂
处方：功劳叶20份、干地黄15份、牛尾参25份、砂仁10份、虎杖12份、天葵草15份、小雪人参12份、当归15份、赤芍12份。
制备方法：参照实施例1-3。
实施例7片剂
处方：功劳叶20份、干地黄12份、牛尾参25份、砂仁9份、虎杖10份、天葵草18份、小雪人参11份、当归13份、赤芍10份。
制备方法：(1)按处方取虎杖、赤芍，粉碎、混合，加所述混合物重量份3～8倍的浓度为45％的乙醇回流提取2次，每次加热回流的时间为1～2小时，合并提取液，过滤，减压浓缩成稠膏；
(2)按处方称取功劳叶、干地黄、牛尾参、砂仁、天葵草、小雪人参、当归，混合，加所述混合物重量份3～8倍的水煎煮提取2次，每次煎煮时间为1～2小时，合并提取液，过滤，静置，取上层清夜，减压浓缩成稠膏；
(3)将步骤(1)和步骤(2)获得的稠膏混合，干燥后粉碎，与适量的药学上可接受的载体或/和辅料混合均匀，按本领域常规制剂工艺制备即得。
本实施例片剂每片含有生药0.8g。
实施例8颗粒剂
处方：功劳叶20份、干地黄12份、牛尾参25份、砂仁9份、虎杖10份、天葵草18份、小雪人参11份、当归13份、赤芍10份。
制备方法：(1)按处方取虎杖、赤芍，粉碎、混合，加所述混合物重量份3～8倍的浓度为55％的乙醇回流提取2次，每次加热回流的时间为1～2小时，合并提取液，过滤，减压浓缩成稠膏；
(2)按处方称取功劳叶、干地黄、牛尾参、砂仁、天葵草、小雪人参、当归，混合，加所述混合物重量份3～8倍的水煎煮提取2次，每次煎煮时间为1～2小时，合并提取液，过滤，静置，取上层清夜，减压浓缩成稠膏；
(3)将步骤(1)和步骤(2)获得的稠膏混合，干燥后粉碎，与适量的药学上可接受的载体或/和辅料混合均匀，按本领域常规制剂工艺制备即得。
本实施例颗粒剂每袋含有生药3.0g。
实施例9口服液
处方：功劳叶20份、干地黄12份、牛尾参25份、砂仁9份、虎杖10份、天葵草18份、小雪人参11份、当归13份、赤芍10份。
制备方法：(1)按处方取虎杖、赤芍，粉碎、混合，加所述混合物重量份3～8倍的浓度为50％的乙醇回流提取2次，每次加热回流的时间为1～2小时，合并提取液，过滤，减压浓缩成稠膏；
(2)按处方称取功劳叶、干地黄、牛尾参、砂仁、天葵草、小雪人参、当归，混合，加所述混合物重量份3～8倍的水煎煮提取2次，每次煎煮时间为1～2小时，合并提取液，过滤，静置，取上层清夜，减压浓缩成稠膏；
(3)将步骤(1)和步骤(2)获得的稠膏混合，干燥后粉碎，按本领域常规制剂工艺制备即得。
本实施例口服液每瓶含有生药3.0g。
Claims (10)
1.一种治疗复发性流产患者抗子宫内膜抗体阳性的中药制剂，其特征在于由以下药用原料制成：功劳叶、干地黄、牛尾参、砂仁、虎杖、天葵草、小雪人参、当归、赤芍。
2.如权利要求1所述的中药制剂，其特征在于由以下重量分配比的药用原料制成：功劳叶20-25份、干地黄10-15份、牛尾参20-25份、砂仁6-11份、虎杖8-13份、天葵草15-20份、小雪人参8-13份、当归10-15份、赤芍7-12份。
3.如权利要求2所述的中药制剂，其特征在于由以下重量分配比的药用原料制成：功劳叶20份、干地黄12份、牛尾参25份、砂仁9份、虎杖10份、天葵草18份、小雪人参11份、当归13份、赤芍10份。
4.如权利要求1-3任一所述的中药制剂，其特征在于所述中药制剂为口服剂型。
5.如权利要求4所述的中药制剂，其特征在于所述口服剂型优选为片剂、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、颗粒剂、冲剂、丸剂、散剂、混悬剂、粉剂。
6.如权利要求5所述的中药制剂，其特征在于所述口服剂型优选为胶囊剂、片剂、口服液、颗粒剂或丸剂。
7.如权利要求6所述的中药制剂，其特征在于所述口服剂型优选为胶囊剂。
8.如权利要求1-3任一所述的中药制剂，其特征在制备方法包括以下步骤：
(1)按处方取虎杖、赤芍，粉碎、混合，加所述混合物重量份3～8倍的浓度为45～55％的乙醇回流提取2次，每次加热回流的时间为1～2小时，合并提取液，过滤，减压浓缩成稠膏；
(2)按处方称取功劳叶、干地黄、牛尾参、砂仁、天葵草、小雪人参、当归，混合，加所述混合物重量份3～8倍的水煎煮提取2次，每次煎煮时间为1～2小时，合并提取液，过滤，静置，取上层清夜，减压浓缩成稠膏；
(3)将步骤(1)和步骤(2)获得的稠膏混合，干燥后粉碎，与适量的药学上可接受的载体或/和辅料混合均匀，按本领域常规制剂工艺制备即得。
9.权利要求1-3任一所述的中药制剂在制备治疗复发性流产患者抗子宫内膜抗体阳性的药物中的用途。
10.权利要求1-3任一所述的中药制剂在制备治疗抗子宫内膜抗体阳性的药物中的用途。
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