CN110841043A - 一种输卵管不孕症膏贴的中药组合物 - Google Patents

一种输卵管不孕症膏贴的中药组合物 Download PDF

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CN110841043A
CN110841043A CN201910846609.3A CN201910846609A CN110841043A CN 110841043 A CN110841043 A CN 110841043A CN 201910846609 A CN201910846609 A CN 201910846609A CN 110841043 A CN110841043 A CN 110841043A
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付艳霞
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Fu Bichi
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Abstract

一种输卵管不孕症膏贴的中药组合物是发明专利，功效是理气清湿疏肝、化瘀通络消徵、调周通管促孕。属于中医药技术领域。是现代化精制提取工艺的外用膏贴，贴于下腹部单侧或双侧归来穴。治疗或辅助治疗输卵管因素不孕症。

Description

一种输卵管不孕症膏贴的中药组合物
技术领域
据国外某些研究报道，输卵管性不孕占不育症的29.9％，我国分析数字是20.0％-32.8％。原因跟性传播性疾病如淋病、沙眼衣原体、支原体感染；子宫腔内操作如人工流产或盆腔结核等有关。由于患者不及时就诊，盆腔X线或B超检查大都正常，临床误诊漏诊率占约70％左右。西医治疗以消炎、激素、理疗为主，很难找到安全准确且保证疗效的方法。共同缺点是治疗目的不明确、机械性损伤、安全性差、副作用大、破坏机体免疫环境。如口服剂的消化道反应、手术多次卵巢过度刺激综合症(OHSS)等。
本发明的目的及达到的技术效果是：提出一种新的中药组合处方，疗效显著、安全性好的外用中药贴剂的中药组合物。
背景技术
古代外用法是纳入阴户和温脐。现代的中药透皮贴剂是将药物做成适当剂型敷于特定部位，以激发经气，疏通经络，促进气血运行、益肾促孕的方法。近40篇文献记载输卵管不孕已有不少于10种外治方公诸于世，也有国内药企或医疗单位进行宫腔通液或输卵管腔内灌注，内服外敷，但可操作性差，用药不安全，影响了临床认知和市场推广。
例如主分类号A61K369066(2006.01)I分类号A61K369066(2006.01)I、A61P15/08(2006.01)I、 A61K9/48(2006.01)N一种治疗女性不孕症的中药组合物及其制剂和制备方法内服外用，包括以下重量份数比的原料：路路通18-20份，地龙13-15份，三棱18-22份，莪术18-22份，桃仁14-16份，红花 14-16份，丹参18-20份，银花28-32份，败酱草28-30份，红藤30-32份，香附18-22份，鸡血藤28-32 份，炙山甲3-5份，薏苡仁28-32份，生甘草9-11份。临床试验证明本发明中药组合物具有解毒化浊、通络散结、消瘀促孕功效，尤其适合治疗由慢性输卵管炎、慢性盆腔炎、阴道炎等引起的不孕症。
又如分类号A61K36/8888(2006.01)I分类号A61K36/8888(2006.01)I、A61P15/08(2006.01)I、 A61K31/045(2006.01)NA61K31/125(2006.01)N公开了一种治疗输卵管阻塞性不孕症的隔药灸脐中药组合物，包括以下原料：透骨草10-15g，血竭10-20g，樟脑10-15g，白芷10-15g，没药10-20g，乳香15-25g，吴茱萸10-15g，生半夏10-15g，皂刺10-20g，冰片4-8g。本药物为外用药，避免了口服药物对胃肠、肝肾的损伤，无毒副作用，并且采用隔药灸脐法进行治疗，具有简、便、验、廉、捷的优点，既有艾灸刺激穴位而产生的作用，也有药物吸收后的直接作用，两者结合，内病外治，治疗输卵管阻塞性不孕症见效快，疗效确切。
另分类号A61K36/716(2006.01)I分类号A61K36/716(2006.01)I、A61K36/9068(2006.01)I、A61P15/08 (2006.01)I、A61K35/36(2006.01)N、A61K35/62(2006.01)NA61K35/64(2006.01)N一种治疗输卵管阻塞性不孕症的药物，它分为内服和外用两种丸剂。内服丸由土元、水蛭、川大黄、皂角刺、川牛膝、小茴香、灵芝、威灵侧、炮山甲制成；外用丸由细辛、干姜、葶苈子、苦丁香、母丁香、花椒、生白附子、炮山甲、皂角肉、川大黄及辅料医用纱布、面糊、大葱白制成。根据整体观念辩证施治的中医药理论之配伍，内服外用二效合一，力专功宏，令药力药效多靶点输布胞宫脉络进行治疗；其有效活性成分促使病灶血管扩张，加速血液循环，并快速整体调理胞宫脉络，疏通输卵管血脉，血脉通，经络通，炎症消，粘连自开，结块自除，输卵管自通。本发明药物见效快，1-2个疗程可治愈，无痛苦，无副作用，治愈率高，较现有技术有很积极的效果。
发明内容
药品组成
一种治疗输卵管不孕的中药组合物，由以下重量份的组分组成：必要：王不留行1-2份、当归1-2份、三棱1-2份、莪术1-2份、炒五灵脂1-2份、桃仁1-2份、元胡1-2份、香附1-2份、红花1-2份、丹参1-2份、小茴香1-2份、干姜1-2份、白芥子1-2份、桂枝1-2份、白芷1-2份、忍冬藤2-3份、路路通 2-3份、续断1-2份、肉苁蓉1-2份、菟丝子1-2份。非必要：肉桂1-2份、黄芪1-2份、蜂蜡4-5份。
制备方法
第一步：将肉桂、白芥子水蒸汽法蒸馏，得到结晶物，然后粉碎，过100-120目细筛，待用，作为组分1；
第二步：将其余原料用乙醇萃取，浓缩，作为组分2；
第三步：将组分1和组分2加蜂蜡基质调和，用涂布机定型做膏贴。
用途
用于输卵管因素不孕症。
效果
具有理气清湿疏肝、化瘀通络消癥、调周通管促孕。
原理
对于关联不孕症的因素，无排卵型和黄体功能不全的均以肾虚为主，输卵管阻塞和卵巢囊肿型的则主要在气滞血瘀；子宫内膜异位主要是肾虚血瘀兼有肝郁；免疫性不孕主要是阴阳失调肾虚肝郁。正常输卵管自然受孕是输卵管平滑肌蠕动及上皮细胞纤毛推动，输卵管才能通畅。因炎症或非炎症充血、粘连、结节、结核、包块、钙化、僵硬、管腔内部狭窄、迂曲、疤痕等，都妨碍通畅受孕。所以方中以王不留行、当归、三棱、莪术、炒五灵脂、桃仁、元胡、香附、红花化瘀通络消癥；续断、肉苁蓉、菟丝子温肾益精，白芥子、干姜、肉桂温化祛湿，黄芪、蜂蜡调节免疫，共奏理气清湿、化瘀通管、调周促孕之效。
剂型
膏贴
用法
行输卵管介入再通术前、后外用。揭去防粘层，贴于双侧归来穴，每日一次，每次1贴，每贴6-12小时，临睡前使用较好。月经期禁用。
临床观察
将39例合格受试对象随机分为两组，治疗组20例，对照组19例，两组患者均行输卵管介入再通术。治疗组患者术中予行输卵管腔内灌注、术后加用以中药辨证口服，下腹外敷，连续治疗1-2个疗程(1.5 个月为一疗程)；对照组患者术中行输卵管腔内灌注，术后予西药行宫腔通液，连续治疗1-3月。观察第一、二疗程宫腔通液时输卵管通畅情况，全身症状的改善情况及妊娠率。结果如下：
1.两组患者输卵管再通的临床疗效：两组患者疗效等级分布经统计学检验差别无统计学意义，治疗组痊愈率、有效率均高于对照组，但经卡方检验，差异无统计学意义(P＞0.05)；
2.两组患者慢性盆腔炎临床相关症状的疗效：两组患者疗效等级分布情况经统计学检验差别有统计学意义 (P＜0.01)，治疗组治愈率、有效率均明显高于对照组，差别具有统计学意义(P＜0.01)；
3.随访1年，治疗组妊娠11例，妊娠率55％，对照组妊娠3例，妊娠率20％，差别具有统计学意义(P＜0.05)。
讨论与结论
输卵管介入再通术配合理气清湿疏肝、活血化瘀消癥、益肾调周促孕法能有效改善近段输卵管阻塞性不孕症患者的输卵管不通状况和临床相关症状，特别对下腹疼痛等的作用明显，有效的提高妊娠率，标本兼治，充分发挥了中西医结合在治疗输卵管阻塞性不孕症方面的优点，具有较高的临床价值。
典型病例
1.李XX，女，37岁。2017年3月23日就诊。拟生二胎，输卵管左侧切除，右侧炎症、盆腔少许积液。经用输卵管再通术并贴敷中药调理3个月怀孕，生下女宝宝。
2.刘X，31岁。2017年3月5日就诊。双侧输卵管左侧堵塞、右侧迂曲肿大，月经经间期出血，盆腔积液。经用输卵管通液术，配合中药养阴清热、益气固摄之剂，外贴中药贴治疗3-4个月，第7个月怀孕，生男宝宝。

Claims (1)

1.一种具有理气清湿疏肝、化瘀通络消癥功效、治疗输卵管不孕症的纯中药药物组合物制作为膏贴，其特征在于：由以下成分在制备而成：必要：王不留行1-2份、当归1-2份、三棱1-2份、莪术1-2份、炒五灵脂1-2份、桃仁1-2份、元胡1-2份、香附1-2份、红花1-2份、丹参1-2份、小茴香1-2份、干姜1-2份、白芥子1-2份、桂枝1-2份、白芷1-2份、忍冬藤2-3份、路路通2-3份、续断1-2份、肉苁蓉1-2份、菟丝子1-2份。非必要：肉桂1-2份、黄芪1-2份、蜂蜡4-5份。
CN201910846609.3A 2019-09-09 2019-09-09 一种输卵管不孕症膏贴的中药组合物 Pending CN110841043A (zh)

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