CN116270846B - 一种治疗孕中期胎盘前置症的中药复方组合物及其制备方法与应用 - Google Patents
一种治疗孕中期胎盘前置症的中药复方组合物及其制备方法与应用 Download PDFInfo
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Abstract
本发明公开了一种治疗孕中期胎盘前置症的中药复方组合物及其制备方法与应用，它包括炙黄芪30～60g，党参15～30g，炒白术15～30g，升麻6～12g，柴胡6～12g，熟地黄20～40g，川断15g，菟丝子15～30g，覆盆子15～30g，炙甘草6～12g，陈皮6～12g。本发明提供的中药复方组合物，在中医药理论的指导下应用于治疗孕中期胎盘前置症，临床观察结果表明，该中药复方组合物配比科学合理，不仅可以有效改善胎盘前置状态患者的临床症状，而且能显著升提胎盘位置，使胎盘位置恢复正常，并且毒副作用低，临床用药安全、可靠。
Description
技术领域
本发明涉及一种中药复方组合物，具体涉及一种治疗孕中期胎盘前置症的中药复方组合物及其制备方法与应用。
背景技术
胎盘前置状态(Placenta Previa State)一般定义为：妊娠13-27周胎盘附着于子宫下段，进而胎盘下缘达到甚至覆盖宫颈内口，通常导致腹痛、阴道出血等症状。胎盘前置状态属于前置胎盘的早期阶段，此阶段需要进行积极治疗，否则妊娠晚期阶段则可能进展为前置胎盘并导致严重后果，比如：严重的产后出血、失血性休克、早产及新生儿窒息等，极大地威胁产妇及新生儿生命安全。现代医学对于胎盘前置状态干预措施有限且临床疗效和安全性不够理想，主要采取期待疗法和适时终止妊娠。
妊娠中期胎盘前置状态属中医学的“胎漏”、“胎动不安”等范畴。中医学认为妊娠中期胎盘前置状态的发生多系冲任气血不调、胎元不固、无力摄举胎元所致。胞络系于肾，冲任之本在于肾，肾虚则冲任不固，胎失所系。又气以载胎，血以养胎，若气虚血亏，濡养不足，胎气不固，则胎盘低置而不能附于子宫的位置，出现阴道下血、腰酸腹坠等现象。《景岳全书·妇人规》中云：“气虚则提摄不固，血虚则灌溉不周……善保胎者，必当专顾血虚”。妊娠后，血聚于胞宫以养胎元，肝血偏虚，肝失所养，肝气郁结，肝木过旺克脾土故脾虚，脾主升清，脾虚则清阳不升，中气下陷，故见胎盘低置。胎盘前置辨证多属脾肾亏虚，气虚下陷。胞脉者系于肾，肾气不固，无力固摄而致胞胎下移，则胎盘低置而不能附于子宫的正常位置。遵循“虚者补之、陷者举之”之旨，通过补益脾肾，补虚升提，升阳举陷，加强冲、任、带脉的功能，提高机体气机调理功能，才能更好的促进胎盘“迁移”。
中医药在治疗胎盘前置状态方面具有其独特的优势，因此在现有技术基础上，开发一种临床疗效确切、安全可靠的治疗孕中期胎盘前置症的中药复方组合物。
发明内容
发明目的：本发明的目的是为了解决现有技术的不足，提供一种组方配比科学合理，不仅可以有效改善胎盘前置状态患者的临床症状，而且能显著升提胎盘位置，使胎盘位置恢复正常的中药复方组合物。
技术方案：为了实现以上目的，本发明采取的技术方案为：
一种治疗孕中期胎盘前置症的中药复方组合物，它包括下列重量份数的原料制成：
炙黄芪30～60g，党参15～30g，炒白术15～30g，升麻6～12g，柴胡6～12g，熟地黄20～40g，川断15g，菟丝子15～30g，覆盆子15～30g，炙甘草6～12g，陈皮6～12g。
作为优选方案，所述的治疗孕中期胎盘前置症的中药复方组合物，它包括下列重量份数的原料制成：
炙黄芪30～60g，党参15～30g，炒白术15～30g，升麻6～12g，柴胡6～12g，熟地黄20～40g，川断15g，菟丝子15～30g，覆盆子15～30g，炙甘草6～12g，陈皮6～12g，阿胶珠10～20g，地榆炭10～20g，仙鹤草15～30g。
作为优选方案，以上所述所述的治疗孕中期胎盘前置症的中药复方组合物，它是由下列重量份数的原料制成：
炙黄芪30～60g，党参15～30g，炒白术15～30g，升麻6～12g，柴胡6～12g，熟地黄20～40g，川断15g，菟丝子15～30g，覆盆子15～30g，炙甘草6～12g，陈皮6～12g，阿胶珠10～20g，地榆炭10～20g，仙鹤草15～30g，炒白芍30～90g。
作为另一优选方案，所述所述的治疗孕中期胎盘前置症的中药复方组合物，它是由下列重量份数的原料制成：
炙黄芪30～60g，党参15～30g，炒白术15～30g，升麻6～12g，柴胡6～12g，熟地黄20～40g，川断15g，菟丝子15～30g，覆盆子15～30g，炙甘草6～12g，陈皮6～12g，阿胶珠10～20g，地榆炭10～20g，仙鹤草15～30g，炒白芍30～90g，肉苁蓉10～20g。
作为另一优选方案，所述所述的治疗孕中期胎盘前置症的中药复方组合物，它是由下列重量份数的原料制成：
炙黄芪30～60g，党参15～30g，炒白术15～30g，升麻6～12g，柴胡6～12g，熟地黄20～40g，川断15g，菟丝子15～30g，覆盆子15～30g，炙甘草6～12g，陈皮6～12g，阿胶珠10～20g，地榆炭10～20g，仙鹤草15～30g，炒白芍30～90g，肉苁蓉10～20g，莲子心3～6g。
本发明所述的治疗孕中期胎盘前置症的中药复方组合物的制备方法，包括以下步骤：
(1)按重量份数取各原料药材置多功能提取罐中，加入总药材重量8～12倍量的水浸泡0.5～1.5小时；提取0.5～2小时，过滤，取滤液备用；
(2)再次加入总药材重量5～8倍量的水，提取0.5～1.5小时，过滤，取滤液备用；
(3)合并步骤(1)和步骤(2)两次滤液，减压浓缩、真空干燥后得中药复方的提取物；
(4)将步骤(3)的中药复方的提取物和药学上可接受的载体制备成制剂。
作为优选方案，所述的治疗孕中期胎盘前置症的中药复方组合物的制备方法，所述的提取方法为煎煮、回流或连续回流。
作为优选方案，所述的治疗孕中期胎盘前置症的中药复方组合物的制备方法，步骤(1)按重量份数取各原料药材置多功能提取罐中，加入总药材重量10倍量的水浸泡1小时；提取1.5小时，过滤，取滤液备用；
(2)再次加入总药材重量8倍量的水，提取1小时，过滤，取滤液备用。
以上治疗孕中期胎盘前置症的中药复方组合物的制备方法，将各原料的提取物和药学上可接受的载体制备成颗粒剂、散剂、片剂、胶囊剂、丸剂或合剂。
本发明在制成片剂时，把中药复方组合物的提取物添加药学载体乳糖、微晶纤维素或玉米淀粉，需要时加入润滑剂硬脂酸镁或滑石粉，混合均匀，然后压片制成片剂。
本发明在制成胶囊剂时，把中药复方组合物的提取物添加药学载体乳糖、微晶纤维素或玉米淀粉混合均匀，制粒，干燥，整粒，然后装胶囊制成胶囊剂。
本发明在制成颗粒剂时，把中药复方组合物的提取物和稀释剂乳糖、糊精或玉米淀粉混合均匀，制粒，干燥，整粒，制成颗粒剂。
本发明提供的治疗孕中期胎盘前置症的中药复方组合物的方解规律为：
本发明提供的中药复方组合物补中益气，升阳举陷，主治气虚下陷证。方中黄芪与人参、甘草、白术等配伍补中益气；柴胡、升麻为使药，升阳举陷，共起益气升陷的作用。李东垣认为黄芪“益元气而补中焦”，并认为升麻“升胃中清气，又引甘温之药上升，以补卫气之散而实其表，故元气不足者，用此于阴中升阳”。方中黄芪为君药，补中气，固表气，且升阳举陷。以党参易人参，增强其补气健脾，主脾运化之功效。《本草纲目》曰：“升麻引阳明清气上行，柴胡引少阳清气上行”。诸药合用，既补益中焦脾胃之气，又升提下陷之气。方中菟丝子、川断、覆盆子、熟地黄补肾气、固冲任，通过补肾健脾，益气升提，从而改善胎盘前置状态。随证加减：添加阿胶珠、地榆炭和仙鹤草可增强治疗阴道出血较多等症；增加炒白芍可改善腹痛症状，增加肉苁蓉可改善大便便秘，增加莲子心可改善预期精神紧张。
有益效果：
本发明中药组合物积极干预胎盘前置状态，全方脾肾、气血同治，以益冲任之本，不仅能改善患者的临床症状，并能使胎盘位置恢复正常，可以降低孕晚期前置胎盘发生几率，提高母婴存活率，从根本上预防孕晚期前置胎盘导致的产后出血及降低孕产妇死亡率。且治疗组按孕周不同进行干预后疗效有明显差异，提示对于胎盘前置状态应早发现、早治疗。唐代医家孙思邈指出：“消未起之患，治未病之疾，医之于无事之前”。对于胎盘前置状态，同样可以预先采取措施及早干预治疗，减少前置胎盘的发生，而不仅仅是观察、期待。对胎盘前置状态釆取积极治疗具有预防凶险性前置胎盘的治未病之意，也是中医学“未病先防，既病防变”治疗思想的具体体现，同时也体现了中医“治病必求于本”的基本思想。
具体实施方式
根据下述实施例，可以更好地理解本发明。然而，本领域的技术人员容易理解，实施例所描述的具体的物料配比、工艺条件及其结果仅用于说明本发明，而不应当也不会限制权利要求书中所详细描述的本发明。
实施例1
1.一种治疗孕中期胎盘前置症的中药复方组合物，它是由下列重量份数的原料制成：
2、治疗孕中期胎盘前置症的中药复方组合物的制备方法，包括以下步骤：
(1)按上述1的重量份数取各原料药材置多功能提取罐中，加入总药材10倍量的水浸泡1小时；然后煎煮提取1.5小时，过滤，取滤液备用；
(2)取药渣再次加入总药材8倍量的水，煎煮1小时，过滤，取滤液备用；
(3)合并两次滤液，减压浓缩、真空干燥后得中药复方提取物；
(4)将中药复方提取物添加药用辅料乳糖、微晶纤维素混匀，加入润滑剂硬脂酸镁，混合均匀，然后压片制成片剂。
实施例2
1.一种治疗孕中期胎盘前置症的中药复方组合物，它是由下列重量份数的原料制成：
2、治疗孕中期胎盘前置症的中药复方组合物的制备方法，包括以下步骤：
(1)按上述1的重量份数取各原料药材置多功能提取罐中，加入总药材8倍量的水浸泡1小时；然后煎煮提取1.5小时，过滤，取滤液备用；
(2)取滤渣再次加入总药材8倍量的水，煎煮1小时，过滤，取滤液备用；
(3)合并两次滤液，减压浓缩、真空干燥后得中药复方提取物；
(4)将中药复方提取物添加药用辅料乳糖、玉米淀粉混合均匀，制粒，干燥，整粒，然后装胶囊制成胶囊剂。
实施例3
1.一种治疗孕中期胎盘前置症的中药复方组合物，它是由下列重量份数的原料制成：
2、治疗孕中期胎盘前置症的中药复方组合物的制备方法，包括以下步骤：
(1)按上述1的重量份数取各原料药材置多功能提取罐中，加入总药材12倍量的水浸泡0.5小时；然后煎煮提取2小时，过滤，取滤液备用；
(2)取步骤(1)滤渣再次加入总药材8倍量的水，煎煮1.5小时，过滤，取滤液备用；
(3)合并两次滤液，减压浓缩、真空干燥后得中药复方提取物；
(4)将中药复方提取物添加药用辅料糊精、玉米淀粉混合均匀，制粒，干燥，整粒，制成颗粒剂。
实施例4
1.一种治疗孕中期胎盘前置症的中药复方组合物，它是由下列重量份数的原料制成：
2、治疗孕中期胎盘前置症的中药复方组合物的制备方法，包括以下步骤：
(1)按上述1的重量份数取各原料药材置多功能提取罐中，加入总药材12倍量的水浸泡1小时；然后煎煮提取1.5小时，过滤，取滤液备用；
(2)取步骤(1)滤渣再次加入总药材8倍量的水，煎煮1小时，过滤，取滤液备用；
(3)合并两次滤液，减压浓缩、真空干燥后得中药复方提取物；
(4)将中药复方提取物添加药用辅料糊精、玉米淀粉混合均匀，制粒，干燥，整粒，制成颗粒剂。
实施例5
1.临床资料
1.1一般资料
选取自2019年10月至2022年12月于苏州市吴江区中医医院妇产科就诊，并诊断为胎盘前置状态的患者86例，按随机数字原则分为治疗组与对照组。治疗组：年龄(32.39±6.39)周岁，孕次(2.34±1.49)，既往产次(1.26±0.89)，既往剖宫产次(1.33±0.82)，孕周(20.07±4.21)；对照组：年龄(31.72±6.26)周岁，孕次(2.14±1.52)，既往产次(1.37±0.73)，既往剖宫产次(1.27±0.52)，孕周(20.27±3.24)；两组患者一般资料比较，差异无统计学意义(P>0.05)。
1.2诊断标准
1.2.1西医诊断标准：参照《妇产科学》、《超声医学》制定。(1)妊娠13-28周；临床表现有少量的阴道出血，小腹坠胀感或轻微腹痛；(2)彩超显示：胎儿存活，无明显畸形，子宫大小与停经周数相符，宫颈长度正常，存在胎盘前置状态，胎盘下缘与子宫颈内口相距小于2cm；
(3)妇科检查宫口未开大，宫颈未见赘生物，胎膜未破裂，子宫大小与妊娠周数符合；
(4)既往病史，包括有无多次流产、分娩史，子宫、宫颈手术史。
1.2.2中医辩证标准参照《中药新药临床研究指导原则》、《中医妇科学》中的有关脾肾气虚型证候内容制定。
(1)主症：妊娠中期，阴道出血，色淡黯，小腹坠胀或隐痛，腰膝酸软；
(2)次症：1)神疲肢倦；2)头晕耳鸣；3)气短懒言；4)夜尿频多；5)面色少华或萎黄(3)典型舌脉：舌质淡、舌苔薄白、脉沉细滑；
主症必备，次症1项以上，并具有上述舌象及脉象表现者即可诊断。
1.3纳入标准
(1)符合上述西医诊断及中医辩证标准；
(2)孕周在13-27周之间，均为自然受孕，月经周期规律，末次月经时间准确，无物理及化学药品接触史，妊娠期无内、外科合并症，如妊娠期糖尿病、妊娠期高血压等；
(3)单胎妊娠，经产前超声系统筛查胎儿符合正常孕龄且无结构异常；
(4)胎盘形态正常，无副胎盘、膜状胎盘等；
(5)同意参加本研究，并签署知情同意书者。
1.4排除标准
(1)不符合纳入标准者；
(2)彩超提示NT值异常、唐氏筛查异常、排畸检查异常者、宫颈机能不全、宫颈息肉出血、胎膜早破、精神疾病、各种恶性肿瘤、心脑血管、肝、肾及造血系统等严重疾病者；
(3)阴道大出血、宫腔感染、难免流产者；
(4)子宫发育异常、合并子宫肿瘤，如子宫肌瘤或腺肌瘤等；
(5)临床资料不全等影响判断者；
(6)依从性差、不能接受随访者；
(7)过敏体质和/或对多种药物过敏者。
2.治疗方法
选取2019年10月至2022年12月间于我院妇产科就诊，并诊断为胎盘前置状态的患者86例，在孕13-27周行彩超检查提示为胎盘前置状态，将其随机分为治疗组和对照组，每组各43例。
2.1治疗组
按实施例4制备得到的中药复方组合物提取物。药物组成：炙黄芪30g，党参15g，炒白术15g，升麻6g，柴胡6g，熟地黄20g，川断15g，菟丝子15g，覆盆子15g，炙甘草6g，陈皮6g，阿胶珠10g，地榆炭10g，仙鹤草15g，炒白芍30g，肉苁蓉10g和莲子心3g。用法：水煎液150ml，每日一剂，早晚分服，28剂为一疗程。
2.2对照组
予期待疗法。任何一组患者若出现阴道出血、腹痛等症状，给予0.9％氯化钠250mL+卡络磺钠注射液60mg静滴止血；5％葡萄糖500mL+硫酸镁30mL静滴抑制宫缩。治疗期间嘱绝对卧床休息、畅情志、禁房事、忌辛辣刺激饮食，保持大便通畅。
每周评估临床症状及胎心变化，每4周复查一次彩超，分别记录各项观察指标。若胎盘位置转至正常，则停止治疗；反之则继续治疗，直至彩超提示胎盘位置正常，或观察至孕28周。
3.观察指标
3.1疗效性观测
(1)观察阴道出血、小腹隐痛、腰膝酸软、神疲肢倦、头晕耳鸣等症和舌苔、脉象的变化(2)产科检查：胎儿及宫缩情况；
(3)彩超检查：观察胎盘的位置，胎儿发育情况。
3.2安全性观测
观察两组患者治疗期间发生的不良反应情况，如面色潮红、胸闷、头晕、恶心、心悸及膝反射减弱等。
4.疗效标准
4.1综合疗效评定标准
(1)痊愈：治疗1周内阴道出血停止，小腹坠胀或隐痛及腰膝酸软等症状消失，胎心音正常，宫体大小与孕周相符。
(2)有效：治疗1周内阴道出血停止，小腹坠胀或隐痛及腰膝酸软等症状减轻，胎心音正常，宫体大小与孕周相符；
(3)无效：治疗1周内阴道出血未止，小腹坠胀或隐痛及腰膝酸软等症状无减轻或有所加重，胎心音正常，宫体大小与孕周相符。
4.2胎盘位置变化判定标准
参照《超声医学》及相关文献制定。
(1)痊愈：孕28周或28周前，彩超显示胎盘位置正常；
(2)有效：孕28周时，胎盘位置改善，但未转至正常；
(3)无效：孕28周时，胎盘位置无改变。
5.统计学方法
应用SPSS统计软件进行组间比较统计学分析；采用均数±标准差表示，采用t检验比较两组治疗有效率。统计分析均以P<0.05作为差异有统计学意义的界限。
6.治疗结果
6.1综合疗效
治疗组总有效率为93.02％，对照组总有效率为81.40％，治疗组明显高于对照组，两组差异有统计学意义(P<0.05)。表明本发明的中药复方组合物治疗能有效改善胎盘前置状态患者的临床症状，综合疗效优于对照组。详见表1。
表1两组综合疗效比较[例(％)]
6.2胎盘位置
胎盘位置改善方面，治疗组总有效率为90.70％，对照组总有效率为72.09％，两组差异有统计学意义(P<0.05)。表明中药复方组合物加减治疗能显著升提胎盘位置，明显优于对照组。详见表2。
表2两组胎盘位置改善情况比较[例(％)]
6.3不同孕周改善情况
治疗组按孕周不同进行分组比较后发现，在胎盘位置改善方面，孕18周前疗效明显优于孕18周后(P<0.05)。提示对于胎盘前置状态应早发现、早治疗，疗效更佳。详见表3。
表3治疗组不同孕周改善情况比较[例(％)]
以上实施方式只为说明本发明的技术构思及特点，其目的在于让熟悉此项技术的人了解本发明内容并加以实施，并不能以此限制本发明的保护范围，凡根据本发明精神实质所做的等效变化或修饰，都应涵盖在本发明的保护范围内。
Claims (6)
1.一种治疗孕中期胎盘前置症的中药复方组合物，其特征在于，它由下列重量的原料制成：
炙黄芪30~60g，党参15~30g，炒白术15~30g，升麻6~12g，柴胡6~12g，熟地黄20~40g，川断15g，菟丝子15~30g，覆盆子15~30g，炙甘草6~12g，陈皮6~12g，阿胶珠10~20g，地榆炭10~20g，仙鹤草15~30g，炒白芍30~90g ，肉苁蓉10~20g，莲子心3~6g。
2.权利要求1所述的治疗孕中期胎盘前置症的中药复方组合物的制备方法，其特征在于，包括以下步骤：
（1）按重量取各原料药材置多功能提取罐中，加入总药材重量8~12倍量的水先浸泡0.5~1.5小时，然后提取0.5~2小时，过滤，取滤液备用；
（2）再次加入总药材重量5~8倍量的水，提取0.5~1.5小时，过滤，取滤液备用；
（3）合并步骤（1）和步骤（2）两次滤液，减压浓缩、真空干燥后得中药复方的提取物；
（4）将步骤（3）的中药复方的提取物和药学上可接受的载体制备成制剂。
3.根据权利要求2所述的治疗孕中期胎盘前置症的中药复方组合物的制备方法，其特征在于，所述的提取方法为煎煮、回流或连续回流。
4.根据权利要求2所述的治疗孕中期胎盘前置症的中药复方组合物的制备方法，其特征在于，步骤（1）按重量取各原料药材置多功能提取罐中，加入总药材重量10倍量的水浸泡1小时；提取1.5小时，过滤，取滤液备用；
步骤（2）再次加入总药材重量8倍量的水，提取1小时，过滤，取滤液备用。
5.根据权利要求2所述的治疗孕中期胎盘前置症的中药复方组合物的制备方法，其特征在于，将各原料的提取物和药学上可接受的载体制备成颗粒剂、散剂、片剂、胶囊剂、丸剂或合剂。
6.权利要求1所述的中药复方组合物在制备治疗孕中期胎盘前置症药物中的应用。
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