CN115463177A - 一种治疗卵巢功能低下和/或者输卵管堵塞的中药组合物 - Google Patents
一种治疗卵巢功能低下和/或者输卵管堵塞的中药组合物 Download PDFInfo
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- CN115463177A CN115463177A CN202111177024.0A CN202111177024A CN115463177A CN 115463177 A CN115463177 A CN 115463177A CN 202111177024 A CN202111177024 A CN 202111177024A CN 115463177 A CN115463177 A CN 115463177A
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Abstract
本发明公开了一种治疗卵巢功能低下和/或输卵管堵塞的中药组合物，它是由下述重量配比的原料制备而成：菟丝子10～20份、续断片10～20份、寄生15～20份、桂枝5～15份、大枣10～20份、白芍10～20份、甘草4～12份、威灵仙5～10份、王不留行5～10份、丝瓜络5～10份、丹参10～20份、巴戟天5～15份。本发明组合物能够促进输卵管功能的康复，提升卵巢功能，治疗排卵障碍性不孕和输卵管堵塞性不孕，收效良好，具备临床应用价值。
Description
技术领域
本发明具体涉及一种治疗卵巢功能低下和/或者输卵管堵塞的中药组合物。
背景技术
不孕症是妇科疑难疾病，世界卫生组织将不孕症列为仅次于肿瘤和心脑血管病的第三大疾病，据统计我国不孕不育的比例约18.7％,女性不孕因素占40％～45％，其中输卵管堵塞性不孕占25％～30％，排卵障碍性不孕约占25～35％，流行病学调查结果显示，排卵障碍及输卵管堵塞性不孕的发病率均呈逐年显著攀升的趋势。排卵障碍是指卵泡发育障碍或成熟后不能正常排出，目前西医促卵泡生长、发育、成熟的方法很多，临床疗效肯定，但存在诱发成熟卵泡排出的方法单一，且易并发卵泡未破裂黄体综合征、卵巢过度刺激综合征及多胎妊娠等医源性疾病。引起输卵管堵塞的因素主要有盆腔炎性疾病(PID)、子宫内膜异位症、支原体感染、盆腹腔手术史以及先天解剖异常等，这些因素导致输卵管不同程度粘连、梗阻，致其拾卵、受精、运输受精卵等功能受影响而引发不孕。西医主要通过腔镜手术、介入术、物理疗法等方法治疗输卵管堵塞性不孕，该类疗法可提高输卵管通畅率、改善粘粘，但未根本解决输卵管收缩功能和纤毛运动功能受损的问题，加之部分抗炎药会影响卵子发育，不利于精卵结合受孕，故治疗后易复发炎症、堵塞，且妊娠率较低下。
与西药比较，中药方剂在治疗排卵障碍方面，临床疗效确切，具有排卵率、妊娠率高、不良反应少的特点；在治疗输卵管堵塞方面，也具有良好效果，但目前还没有即能用于卵巢功能低下，又能用于输卵管堵塞的中药方剂的研究。
发明内容
为解决上述问题，本发明提供了一种治疗卵巢功能低下和/或者输卵管堵塞的中药组合物，它是由下述重量配比的原料制备而成：菟丝子10～20份、续断片10～20份、桑寄生15～20份、桂枝5～15份、大枣10～20份、白芍10～20份、甘草4～12份、威灵仙5～10份、王不留行5～10份、丝瓜络5～10份、丹参10～20份、巴戟天5～15份。
进一步低，它是由下述重量配比的原料制备而成：
菟丝子15份、续断片15份、桑寄生15份、桂枝10份、大枣15份、白芍15份、甘草8份、威灵仙10份、王不留行10份、丝瓜络10份、丹参15份、巴戟天10份。
更进一步地，所述菟丝子为盐菟丝子；所述甘草为炙甘草。
进一步地，它是由原料药的药粉、或原料药的水或有机溶剂提取物为活性成分，加上药品或食品上可接受的辅料制备而成的外用制剂。
更进一步地，所述外用制剂为颗粒剂、散剂、丸剂或溶液剂。
更进一步地，所述溶液剂为灌肠溶液。
本发明还提供了一种前述组合物的制备方法，它包括以下步骤：
(1)按照前述配比称取原料药；
(2)原料药研为粉末，或原料药的水或有机溶剂提取液，加入药品或食品上常用的辅料或辅助性成分，即得。
本发明还提供了一种前述的组合物在在制备治疗卵巢功能低下的药物中的用途。
本发明还提供了一种前述的组合物在制备治疗输卵管堵塞的药物中的用途。
本发明最后提供了一种前述的组合物在制备益肾固精和/或温阳通络的药物中的用途。
本发明组合物中，菟丝子补肾壮阳、益肾固精；桑寄生、巴戟天补益肝肾，三药共为君药，起补益肝肾，壮阳，固精之效。巴戟天温肾助阳，桂枝温通血脉，助阳行瘀通络；丹参、丝瓜络、王不留行、威灵仙四药相配，以活血化瘀，通络止痛为臣药。大枣配甘草，补中益气，养血安神，意在气旺则血行，瘀去则络通；白芍配甘草，酸甘化阴，养血调经，为佐使之用。诸药相配，共奏益肾固精，温阳通络之效。
本发明组合物制成的灌肠液，通过直肠吸收，避免了肝肠循环，疗效快，副作用少，经临床试验证明，本发明组合物能够促进输卵管功能的康复，提升卵巢功能，治疗排卵障碍性不孕和输卵管堵塞性不孕，收效良好，具备临床应用价值。
显然，根据本发明的上述内容，按照本领域的普通技术知识和惯用手段，在不脱离本发明上述基本技术思想前提下，还可以做出其它多种形式的修改、替换或变更。
以下通过实施例形式的具体实施方式，对本发明的上述内容再作进一步的详细说明。但不应将此理解为本发明上述主题的范围仅限于以下的实例。凡基于本发明上述内容所实现的技术均属于本发明的范围。
具体实施方式
实施例1、本发明药物的制备
配方：盐菟丝子15份、续断片15份、桑寄生15份、桂枝10份、大枣15份、白芍15份、炙甘草8份、威灵仙10份、王不留行10份、丝瓜络10份、丹参15份、巴戟天10份。
制备方法：按配比称取原料，加10倍量水煎煮提取二次，每次提取1小时，煎液过滤，合并滤液，即得。
实施例2、本发明药物的制备
配方：盐菟丝子10份、续断片10份、桑寄生15份、桂枝5份、大枣10份、白芍10份、炙甘草4份、威灵仙5份、王不留行5份、丝瓜络5份、丹参10份、巴戟天5份。
制备方法：按配比称取原料，加8倍量水煎煮提取二次，每次提取1小时，煎液过滤，合并滤液，即得。
实施例3、本发明药物的制备
配方：盐菟丝子20份、续断片20份、桑寄生20份、桂枝15份、大枣20份、白芍20份、炙甘草12份、威灵仙10份、王不留行10份、丝瓜络10份、丹参20份、巴戟天15份。
制备方法：按配比称取原料，加20倍量水煎煮提取二次，每次提取1小时，煎液过滤，合并滤液，即得。
以下通过试验例来说明本发明的有益效果。
试验例1本发明药物组合物治疗排卵障碍性不孕
1资料与方法
1.1一般资料
收集2020年01月01日至2021年06月30日成都中医药大学附属医院妇科诊断为排卵障碍性不孕患者93例，根据随机数字表进行分为3组，试验组30例、对照组31例，对比组32例，三组患者治疗前年龄、性别、病程等方面比较差异无统计学意义(P＞0.05)，具有可比性。
1.2药物及制备
试验药物：盐菟丝子15g、续断片15g、桑寄生15g、桂枝10g、大枣15g、白芍15g、炙甘草8g、威灵仙10g、王不留行10g、丝瓜络10g、丹参15g、巴戟天10g，加水1500ml，浓煎至80～100ml,置于灌肠袋内。
对照组药物：克罗米芬+注射用绒促性素；
对比组：盐菟丝子10份、续断片10份、桑寄生10份、桂枝10份、大枣15份、白芍15份、炙甘草8份、巴戟天10份；制备方法同试验药物。
1.3诊断标准
1.3.1西医诊断标准
(1)生育期女性，性生活正常，月经周期正常，男方生殖功能正常，未避孕一年未孕者；
(2)BBT：呈单向型
(3)宫颈粘液结晶：无椭圆体出现
(4)内膜检查：经前6天或月经来潮后6小时内，内膜检查无典型分泌期变化
(5)卵泡监测：B超连续监测卵泡，有成熟卵泡而无排卵征象，或排卵期优势卵泡平均直径<18mm
(6)血清、尿孕酮值低于黄体期水平
以上六项中在第一项的基础上，同时符合(2)—(6)项中任意两项即可诊断为排卵障碍性不孕。
1.3.2中医诊断标准
主症：①婚久不孕，②月经不调
次症：月经量少，月经后期，闭经，经色紫暗，有血块，舌黯或有瘀点，苔薄白，脉弦或细涩。
具备两项主症，同时具备兼症中任意一项，即可诊断
1.4入选病例标准
符合排卵障碍性不孕诊断标准，同意接受治疗组、对照组或对比组治疗，并自愿签署知情同意书，配合课题组人员试验者。
1.5治疗方法
月经干净开始至下次月经来潮前、3个月经周期为一疗程、本组治疗一疗程。使用前将药温加热至在37～40℃、临睡前侧卧位、将肛管插入肛门约15～20cm(中位保留灌肠)，打开开关、将药液缓慢注入直肠、保留在直肠内2h以上，每晚一次。月经周期第9天开始监测排卵指导受孕，没有获得妊娠者下次月经干净后重复。
试验组及对比组分别使用相应的药物。
对照组接受常规西药治疗，在月经第5天开始，克罗米芬，口服，50mg/次，1次/天，持续5天，待卵泡成熟，注射用绒促性素8000U，肌肉注射1次。
1.6疗效评价
参照国家卫生部颁布的《中药新药临床研究指导原则》及国家中医药管理局颁布的《中医病证诊断疗效标准》的相关内容拟定。
痊愈：成功妊娠，BBT双向，月经恢复正常，临床症状基本好转。
显效：治疗期间超声检测有成熟卵泡并排卵，患者基础体温在三个月经周期中出现一个或一个以上双向或出现不典型双向，治疗后月经周期基本正常(<40天)，临床症状好转。
有效：超声检测无排卵未见优势卵泡，最大卵泡直径治疗前增大5mm以上或发现有卵泡发育，治疗后月经情况有所改善(3个月内来潮一次)，临床症状有一定程度改善。
无效：治疗后月经周期无改善，或超声检测未见卵泡发育现象，或最大卵泡直径较治疗前无增大，BBT单相，临床症状无明显改善。
1.7统计学方法
采用SPSS17.0统计分析软件，计数资料以[例(％)]表示，数据比较采用x检验，等级资料比较采用秩合检验，计量资料以表示，数据比较采用t检验，P<0.05为差异有统计学意义
2结果
表1.本发明药物组合物的临床疗效结果
| 组别 | 例数 | 痊愈(例) | 显效(例) | 有效(例) | 无效(例) | 有效率(％) |
| 试验组 | 30 | 5 | 14 | 8 | 3 | 90％ |
| 对照组 | 31 | 6 | 13 | 7 | 4 | 87.1％ |
| 对比组 | 32 | 3 | 10 | 14 | 5 | 84％ |
试验结果说明：治疗组与对照组有效率相近，治疗组的痊愈及显效病例数和总有效率均显著高于对比组(P<0.05)，说明本发明药物组合物能有效治疗排卵障碍性不孕。
试验例2本发明药物组合物治疗输卵管堵塞性不孕
1资料与方法
1.1一般资料
收集2019年06月01日至2021年06月30日成都中医药大学附属医院妇科诊断为输卵管堵塞性不孕患者89例，根据随机数字表进行分为3组，试验组30例、对照组29例，对比组30例，三组患者治疗前年龄、性别、病程等方面比较差异无统计学意义(P＞0.05)，具有可比性。
1.2药物及制备
试验药物：盐菟丝子15g、续断片15g、桑寄生15g、桂枝10g、大枣15g、白芍15g、炙甘草8g、威灵仙10g、王不留行10g、丝瓜络10g、丹参15g、巴戟天10g，加水1500ml,浓煎至80～100ml,置于灌肠袋内。
对照组药物：来源于经典名方少腹逐瘀汤：小茴香10g、干姜6克、延胡索15克、没药6克、当归10克、川芎10克、肉桂5克、赤芍10克、蒲黄15克、五灵脂10克；制备方法同试验药物；
对比组：盐菟丝子10份、续断片10份、桑寄生10份、桂枝10份、大枣15份、白芍15份、炙甘草8份、巴戟天10份；制备方法同试验药物。
1.3诊断标准
1.3.1西医诊断标准
(1)生育期女性，性生活正常，月经周期正常，男方生殖功能正常，未避孕一年未孕者；
(2)输卵管造影显示单侧或双侧间质部堵塞，堵塞侧输卵管全部不显影。具备此两项便可成立诊断。
1.3.2中医诊断标准
主症：婚久不孕，月经周期正常。
次症：经来腹痛，经量多少不一，经色紫暗，有血块，舌黯或有瘀点，苔薄白，脉弦或细涩。
具备主症2项+次症2项，即可诊断。
1.4入选病例标准
符合输卵管阻塞性不孕诊断标准，同意接受治疗组、对照组或对比组治疗，并自愿签署知情同意书，配合课题组人员试验者。
1.5治疗方法
月经干净7天内行宫腹腔镜术，术后7天开始使用中药直肠滴入治疗，经期停药，连续治疗3个月经周期，3个月经周期后开始试孕。
中药灌肠方法：使用前将药温加热至在37～40℃、临睡前侧卧位、将肛管插入肛门约15～20cm(中位保留灌肠)，打开开关、将药液缓慢注入直肠、保留在直肠内2h以上，每晚一次。
试验组、对照组及对比组分别使用相应的药物。
1.6疗效评价
参照《中药新药临床研究指导原则》
痊愈:一年内正常妊娠，临床体征完全消失，或HSG显示输卵管完全通畅有效:一年内未妊娠，患者临床体征好转，或HSG显示输卵管通畅度改善无效:未妊娠，患者临床体征无改善或加重，或HSG显示输卵管无变化1.7统计学方法
采用SPSS17.0统计分析软件，计数资料以[例(％)]表示，数据比较采用χ2检验，等级资料比较采用秩合检验，计量资料以表示，数据比较采用t检验，P<0.05为差异有统计学意义
2结果
表2.本发明药物组合物的临床疗效结果
| 组别 | 例数 | 痊愈(例) | 有效(例) | 无效(例) | 有效率(％) |
| 试验组 | 30 | 15 | 13 | 2 | 93.3％ |
| 对照组 | 29 | 10 | 12 | 7 | 75.9％ |
| 对比组 | 30 | 9 | 14 | 7 | 70％ |
试验结果说明：治疗组的痊愈病例数和总有效率均显著高于对照组及对比组(P<0.05)，说明本发明药物组合物能有效治疗输卵管堵塞性不孕。
综上，本发明组合物制成的灌肠液，通过直肠吸收，避免了肝肠循环，疗效快，副作用少，经临床试验证明，其能够促进输卵管功能的康复，提升卵巢功能，治疗排卵障碍性不孕和输卵管堵塞性不孕，收效良好，具备临床应用价值。
Claims (10)
1.一种治疗卵巢功能低下和/或输卵管堵塞的中药组合物，其特征在于：它是由下述重量配比的原料制备而成：
菟丝子10～20份、续断片10～20份、桑寄生15～20份、桂枝5～15份、大枣10～20份、白芍10～20份、甘草4～12份、威灵仙5～10份、王不留行5～10份、丝瓜络5～10份、丹参10～20份、巴戟天5～15份。
2.根据权利要求1所述的中药组合物，其特征在于：它是由下述重量配比的原料制备而成：
菟丝子15份、续断片15份、桑寄生15份、桂枝10份、大枣15份、白芍15份、甘草8份、威灵仙10份、王不留行10份、丝瓜络10份、丹参15份、巴戟天10份。
3.根据权利要求1或2所述的中药组合物，其特征在于：所述菟丝子为盐菟丝子；所述甘草为炙甘草。
4.根据权利要求1所述的中药组合物，其特征在于：它是由原料药的药粉、或原料药的水或有机溶剂提取物为活性成分，加入药品上可接受的辅料制备而成的外用制剂。
5.根据权利要求4所述的中药组合物，其特征在于：所述外用制剂为颗粒剂、散剂、丸剂或溶液剂，优选溶液剂。
6.根据权利要求5所述的中药组合物，其特征在于：所述溶液剂为灌肠溶液。
7.权利要求1～6任一项所述中药组合物的制备方法，其特征在于：它包括以下步骤：
(1)按照权利要求1所述配比称取原料药；
(2)原料药研为粉末，或原料药的水或有机溶剂提取液，加入药品上常用的辅料或辅助性成分，即得。
8.权利要求1～6任一项所述的组合物在制备治疗卵巢功能低下的药物中的用途。
9.权利要求1～6任一项所述的组合物在制备治疗输卵管堵塞的药物中的用途。
10.权利要求1～6任一项所述的组合物在制备益肾固精和/或温阳通络的药物中的用途。
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