CN105998579A - 一种治疗输卵管炎性不孕症的药物及其制备方法和应用 - Google Patents
一种治疗输卵管炎性不孕症的药物及其制备方法和应用 Download PDFInfo
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Abstract
本发明公开了一种治疗输卵管炎性不孕症的药物及其制备方法和应用，该药物，由以下按照重量份的原料组成：党参20‑40份，炒白术20‑40份，当归10‑20份，赤芍10‑20份，丹参10‑20份，泽兰10‑20份，香附10‑20份，乳香10‑20份，没药10‑20份，王不留行10‑20份，路路通10‑20份，三七6‑15份，穿山甲6‑15份，穿破石20‑40份，薤白10‑20份，茺蔚子10‑20份，甘草5‑10份。本发明的药物具有消炎、疏通输卵管、滋阴、补血、有利于输卵管恢复正常功能的疗效，对因患有输卵管炎性而引发不孕不育症疗效确切，治愈率高、见效快，无毒副作用，降低治疗成本。
Description
技术领域
本发明涉及医药技术领域，具体是一种治疗输卵管炎性不孕症的药物及其制备方法和应用。
背景技术
输卵管炎是盆腔炎症性疾病的主要发病部位，大多发生在性活跃期、有月经的妇女，初潮前、绝经后或者未婚者很少发生。若发生也常是邻近器官炎症的扩散。若未能得到及时正确的治疗，则可由于盆腔粘连、输卵管阻塞而导致不孕、输卵管妊娠、慢性盆腔痛，炎症反复发作等后遗症。,输卵管炎多由于病原体感染引起，主要有葡萄球菌、链球菌、大肠杆菌、淋球菌、变形杆菌、肺炎球菌、衣原体等引起，分为急性输卵管炎和慢性输卵管炎，后者在不孕妇女中较为常见。目前治疗以抗生素药物为主，易耐药，手术可行输卵管成形术或宫腔注药，给患者带来很大痛苦。
发明内容
本发明的目的在于提供一种治愈率高、见效快，无毒副作用的治疗输卵管炎性不孕症的药物及其制备方法和应用，以解决上述背景技术中提出的问题。
为实现上述目的，本发明提供如下技术方案：
一种治疗输卵管炎性不孕症的药物，由以下按照重量份的原料组成：党参20-40份，炒白术20-40份，当归10-20份，赤芍10-20份，丹参10-20份，泽兰10-20份，香附10-20份，乳香10-20份，没药10-20份，王不留行10-20份，路路通10-20份，三七6-15份，穿山甲6-15份，穿破石20-40份，薤白10-20份，茺蔚子10-20份，甘草5-10份。
作为本发明进一步的方案：所述治疗输卵管炎性不孕症的药物，由以下按照重量份的原料组成：党参25-35份，炒白术25-35份，当归12-18份，赤芍12-18份，丹参12-18份，泽兰12-18份，香附12-18份，乳香12-18份，没药12-18份，王不留行12-18份，路路通12-18份，三七9-12份，穿山甲9-12份，穿破石25-35份，薤白12-18份，茺蔚子12-18份，甘草6-9份。
作为本发明进一步的方案：所述治疗输卵管炎性不孕症的药物，由以下按照重量份的原料组成：党参30份，炒白术30份，当归15份，赤芍15份，丹参15份，泽兰15份，香附15份，乳香15份，没药15份，王不留行15份，路路通15份，三七11份，穿山甲11份，穿破石30份，薤白15份，茺蔚子15份，甘草7份。
本发明另一目的是提供一种治疗输卵管炎性不孕症的药物的制备方法，由以下步骤组成：
1)将炒白术、当归、赤芍、丹参、泽兰、香附、乳香、没药粉碎、过100目筛，加入上述几味药总质量13倍的碳酸氢钠水溶液，碳酸氢钠水溶液中碳酸氢钠质量含量为3-5％，在45-48℃下加热搅拌处理2-2.2h，再在68-70℃下加热搅拌1-1.2h，然后在100-105℃下搅拌处理1-1.2h，过滤取滤液；
2)将王不留行、路路通、三七、穿山甲、穿破石、薤白、茺蔚子、甘草粉碎、过80目筛，加入上述几味药总质量5-6倍的80％乙醇溶液浸提2次，浸提温度为70-72℃，浸提时间为2.5-2.8h，合并浸提液，浓缩至原体积的20-22％，制得浓缩液；
3)将党参粉碎、过200目筛，加入其质量1.5-1.6倍的柠檬酸醇溶液，柠檬酸醇溶液中柠檬酸的质量含量为5-6％，在55-56℃下加热搅拌1.5-1.6h，再在88-90℃下搅拌烘干即得党参粉；
4)将滤液与浓缩液混合，在78-80℃下加热搅拌25-30min，然后加入党参粉，继续在该温度下搅拌10-15min，进行微波处理10-12min，其中微波功率为900W，再在84-86℃下搅拌烘干即得药物。
本发明又一目的是提供所述药物在制备治疗输卵管炎性不孕症药物中的应用。
炒白术健脾益气，燥湿利水，止汗，安胎。用于脾虚食少，腹胀泄泻，痰饮眩悸，水肿，自汗，胎动不安。
当归具有补血活血，调经止痛，润肠通便之功效。常用于血虚萎黄，眩晕心悸，月经不调，经闭痛经，虚寒腹痛，风湿痹痛，跌扑损伤，痈疽疮疡，肠燥便秘。酒当归活血通经。用于经闭痛经，风湿痹痛，跌扑损伤。
赤芍清热凉血，散瘀止痛。用于热人营血，温毒发斑，吐血衄血，目赤肿痛，肝郁胁痛，经闭痛经，瘾瘕腹痛，跌扑损伤，痈肿疮疡。
丹参具有活血祛瘀，通经止痛，清心除烦，凉血消痈之功效。用于胸痹心痛，脘腹胁痛，瘕瘕积聚，热痹疼痛，心烦不眠，月经不调，痛经经闭，疮疡肿痛。
泽兰具有活血调经，祛瘀消痈，利水消肿之功效。用于月经不调，经闭，痛经，产后瘀血腹痛，疮痈肿毒，水肿腹水。
香附疏肝解郁，理气宽中，调经止痛。用于肝郁气滞，胸胁胀痛，疝气疼痛，乳房胀痛，脾胃气滞，脘腹痞闷，胀满疼痛，月经不调，经闭痛经。
乳香活血行气止痛，消肿生肌。用于胸痹心痛，胃脘疼痛，痛经经闭，产后瘀阻，症瘕腹痛，风湿痹痛，筋脉拘挛，跌打损伤，痈肿疮疡。
没药具有散瘀定痛，消肿生肌之功效。常用于胸痹心痛，胃脘疼痛，痛经经闭，产后瘀阻，癥瘕腹痛，风湿痹痛，跌打损伤，痈肿疮疡等病症的治疗。
王不留行具有活血通经，下乳消肿，利尿通淋的功效。用于经闭，痛经，乳汁不下，乳痈肿痛，淋证涩痛。
路路通有祛风活络，利水，通经的作用。用于关节痹痛，麻木痉挛，水肿胀满，乳少，经闭。
三七散瘀止血，消肿定痛。用于咯血，吐血，衄血，便血，崩漏，外伤出血，胸腹刺痛，跌扑肿痛。
穿山甲活血散结；通经下乳；消痈溃坚。主血瘀经闭；症瘕；风湿痹痛；乳汁不下；痈肿；瘰疬。用于经闭癓瘕，乳汁不通，痈肿疮毒，关节痹痛，麻木拘挛。
穿破石止咳化痰，祛风利湿，散瘀止痛。用于肺结核，黄疸型肝炎，肝脾肿大，胃、十二指肠溃疡，风湿性腰腿痛；外用治骨折，跌打损伤。
甘草具有补脾益气，清热解毒，祛痰止咳，缓急止痛，调和诸药之功效。常用于脾胃虚弱，倦怠乏力，心悸气短，咳嗽痰多，脘腹、四肢挛急疼痛，痈肿疮毒，缓解药物毒性、烈性。
茺蔚子具有活血调经，清肝明目的功效。用于月经不调，经闭痛经，目赤翳障，头晕胀痛。
薤白通阳散结，行气导滞。主治胸痹心痛，脘腹痞满胀痛，泻痢后重。
党参补中，益气，生津。治脾胃虚弱，气血两亏，体倦无力，食少，口渴，久泻，脱肛。
与现有技术相比，本发明的有益效果是：
本发明在各原料的协同作用下，制得的药物具有消炎、疏通输卵管、滋阴、补血、有利于输卵管恢复正常功能的疗效，对因患有输卵管炎性而引发不孕不育症疗效确切，治愈率高、见效快，无毒副作用，避免了西药给患者带来的各种弊端和毒副作用，本发明在确保疗效的同时，尽量的减少了药物的种类数量，降低了治疗成本。
具体实施方式
下面将结合本发明实施例，对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。
实施例1
本发明实施例中，一种治疗输卵管炎性不孕症的药物，由以下按照重量份的原料组成：党参20份，炒白术20份，当归10份，赤芍10份，丹参10份，泽兰10份，香附10份，乳香10份，没药10份，王不留行10份，路路通10份，三七6份，穿山甲6份，穿破石20份，薤白10份，茺蔚子10份，甘草5份。
将炒白术、当归、赤芍、丹参、泽兰、香附、乳香、没药粉碎、过100目筛，加入上述几味药总质量13倍的碳酸氢钠水溶液，碳酸氢钠水溶液中碳酸氢钠质量含量为3％，在45℃下加热搅拌处理2h，再在68℃下加热搅拌1h，然后在100℃下搅拌处理1-1.2h，过滤取滤液。将王不留行、路路通、三七、穿山甲、穿破石、薤白、茺蔚子、甘草粉碎、过80目筛，加入上述几味药总质量5倍的80％乙醇溶液浸提2次，浸提温度为70℃，浸提时间为2.5h，合并浸提液，浓缩至原体积的20％，制得浓缩液。将党参粉碎、过200目筛，加入其质量1.5倍的柠檬酸醇溶液，柠檬酸醇溶液中柠檬酸的质量含量为5％，在55℃下加热搅拌1.5h，再在88℃下搅拌烘干即得党参粉。将滤液与浓缩液混合，在78℃下加热搅拌25min，然后加入党参粉，继续在该温度下搅拌10min，进行微波处理10min，其中微波功率为900W，再在84℃下搅拌烘干即得药物。
实施例2
本发明实施例中，一种治疗输卵管炎性不孕症的药物，由以下按照重量份的原料组成：党参40份，炒白术40份，当归20份，赤芍20份，丹参20份，泽兰20份，香附20份，乳香20份，没药20份，王不留行20份，路路通20份，三七15份，穿山甲15份，穿破石40份，薤白20份，茺蔚子20份，甘草10份。
将炒白术、当归、赤芍、丹参、泽兰、香附、乳香、没药粉碎、过100目筛，加入上述几味药总质量13倍的碳酸氢钠水溶液，碳酸氢钠水溶液中碳酸氢钠质量含量为5％，在48℃下加热搅拌处理2.2h，再在70℃下加热搅拌1.2h，然后在105℃下搅拌处理1.2h，过滤取滤液。将王不留行、路路通、三七、穿山甲、穿破石、薤白、茺蔚子、甘草粉碎、过80目筛，加入上述几味药总质量6倍的80％乙醇溶液浸提2次，浸提温度为72℃，浸提时间为2.8h，合并浸提液，浓缩至原体积的22％，制得浓缩液。将党参粉碎、过200目筛，加入其质量1.6倍的柠檬酸醇溶液，柠檬酸醇溶液中柠檬酸的质量含量为6％，在56℃下加热搅拌1.6h，再在90℃下搅拌烘干即得党参粉。将滤液与浓缩液混合，在80℃下加热搅拌30min，然后加入党参粉，继续在该温度下搅拌15min，进行微波处理12min，其中微波功率为900W，再在86℃下搅拌烘干即得药物。
实施例3
本发明实施例中，一种治疗输卵管炎性不孕症的药物，由以下按照重量份的原料组成：党参25份，炒白术25份，当归12份，赤芍12份，丹参12份，泽兰12份，香附12份，乳香12份，没药12份，王不留行12份，路路通12份，三七9份，穿山甲9份，穿破石25份，薤白12份，茺蔚子12份，甘草6份。
将炒白术、当归、赤芍、丹参、泽兰、香附、乳香、没药粉碎、过100目筛，加入上述几味药总质量13倍的碳酸氢钠水溶液，碳酸氢钠水溶液中碳酸氢钠质量含量为4％，在46℃下加热搅拌处理2.1h，再在69℃下加热搅拌1.1h，然后在102℃下搅拌处理1.1h，过滤取滤液。将王不留行、路路通、三七、穿山甲、穿破石、薤白、茺蔚子、甘草粉碎、过80目筛，加入上述几味药总质量5.5倍的80％乙醇溶液浸提2次，浸提温度为71℃，浸提时间为2.6h，合并浸提液，浓缩至原体积的21％，制得浓缩液。将党参粉碎、过200目筛，加入其质量1.5倍的柠檬酸醇溶液，柠檬酸醇溶液中柠檬酸的质量含量为5.5％，在55-56℃下加热搅拌1.5h，再在89℃下搅拌烘干即得党参粉。将滤液与浓缩液混合，在79℃下加热搅拌28min，然后加入党参粉，继续在该温度下搅拌12min，进行微波处理11min，其中微波功率为900W，再在85℃下搅拌烘干即得药物。
实施例4
本发明实施例中，一种治疗输卵管炎性不孕症的药物，由以下按照重量份的原料组成：党参35份，炒白术35份，当归18份，赤芍18份，丹参18份，泽兰18份，香附18份，乳香18份，没药18份，王不留行18份，路路通18份，三七12份，穿山甲12份，穿破石35份，薤白18份，茺蔚子18份，甘草9份。
将炒白术、当归、赤芍、丹参、泽兰、香附、乳香、没药粉碎、过100目筛，加入上述几味药总质量13倍的碳酸氢钠水溶液，碳酸氢钠水溶液中碳酸氢钠质量含量为4％，在46℃下加热搅拌处理2.1h，再在69℃下加热搅拌1.1h，然后在102℃下搅拌处理1.1h，过滤取滤液。将王不留行、路路通、三七、穿山甲、穿破石、薤白、茺蔚子、甘草粉碎、过80目筛，加入上述几味药总质量5.5倍的80％乙醇溶液浸提2次，浸提温度为71℃，浸提时间为2.6h，合并浸提液，浓缩至原体积的21％，制得浓缩液。将党参粉碎、过200目筛，加入其质量1.5倍的柠檬酸醇溶液，柠檬酸醇溶液中柠檬酸的质量含量为5.5％，在55-56℃下加热搅拌1.5h，再在89℃下搅拌烘干即得党参粉。将滤液与浓缩液混合，在79℃下加热搅拌28min，然后加入党参粉，继续在该温度下搅拌12min，进行微波处理11min，其中微波功率为900W，再在85℃下搅拌烘干即得药物。
实施例5
本发明实施例中，一种治疗输卵管炎性不孕症的药物，由以下按照重量份的原料组成：党参30份，炒白术30份，当归15份，赤芍15份，丹参15份，泽兰15份，香附15份，乳香15份，没药15份，王不留行15份，路路通15份，三七11份，穿山甲11份，穿破石30份，薤白15份，茺蔚子15份，甘草7份。
将炒白术、当归、赤芍、丹参、泽兰、香附、乳香、没药粉碎、过100目筛，加入上述几味药总质量13倍的碳酸氢钠水溶液，碳酸氢钠水溶液中碳酸氢钠质量含量为4％，在46℃下加热搅拌处理2.1h，再在69℃下加热搅拌1.1h，然后在102℃下搅拌处理1.1h，过滤取滤液。将王不留行、路路通、三七、穿山甲、穿破石、薤白、茺蔚子、甘草粉碎、过80目筛，加入上述几味药总质量5.5倍的80％乙醇溶液浸提2次，浸提温度为71℃，浸提时间为2.6h，合并浸提液，浓缩至原体积的21％，制得浓缩液。将党参粉碎、过200目筛，加入其质量1.5倍的柠檬酸醇溶液，柠檬酸醇溶液中柠檬酸的质量含量为5.5％，在55-56℃下加热搅拌1.5h，再在89℃下搅拌烘干即得党参粉。将滤液与浓缩液混合，在79℃下加热搅拌28min，然后加入党参粉，继续在该温度下搅拌12min，进行微波处理11min，其中微波功率为900W，再在85℃下搅拌烘干即得药物。
对比例1
除不含有王不留行、路路通外，其配方及制备过程与实施例5一致。
对比例2
仅含有王不留行、路路通，其制备过程与实施例5一致。
实施例6急性毒性最大耐受试验
根据本发明实施例1-5制备的药物在动物体内进行急性毒性最大耐受试验，对小鼠灌胃给药的日最大耐受量为成人临床日用量的420倍，在此剂量下未观察到本发明提供的制备方法制成的药物的毒性反应。
实施例7长期毒性试验
根据本发明实施例1-5制备的药物在动物体内进行6个月长期毒性试验，每日给大鼠灌胃给药，剂量分别相当于成人每日临床日服用量的100倍、50倍、25倍。观察项目包括一般性观察和包括血液学检查29项在内的全面检测。结果表明，三个给药剂量皆未出现明显不良反应，表明根据本发明实施例1-5制备的药物用于临床使用是安全的。
实施例8临床试验
应用时自经后3-5天开始，连续服至下次月经来潮停止，每月约服20剂，为一疗程。
下面是患者使用本发明药物的临床资料：
一、一般资料
收治患者共400例，均经妇科检查确诊为输卵管炎性不孕症，其年龄22-51岁，平均32岁。随机分为8组，每组50例，分别为治疗1组、治疗2组、治疗3组、治疗4组、治疗5组以及对照1组、对照2组、对照3组，治疗1-5组分别服用实施例1-5的药物，对照1-2组分别服用对比例1-2的药物，用法用量：一天一次，一次2g。对照3组经期用青霉素钠800万U+0.9％NaS 250ml，0.5％甲硝唑200ml静脉滴注，一日一次，连续3天，经后3～7天行宫腔通液，0.9％NaS 20ml+2％利多卡因5ml，地塞米松5mg，庆大霉素8万U，隔天一次，共2次。
二、诊断标准
1、病史：不孕，盆腔疼痛，有或没有人工流产、药物流产等病史。2、妇科检查：患有输卵管炎性。
三、疗效评定标准
治愈：疗程结束后，临床症状完全消失。
好转：症状基本缓解。
无效：症状缓解不明显。
四、治疗结果
服药两个月后停止服药，随访1年判定疗效结果如表1所示。
表1
| 组别 | 总例数 | 治愈 | 好转 | 无效 | 治愈率％ | 总有效率％ |
| 治疗1组 | 50 | 42 | 7 | 1 | 84 | 98 |
| 治疗2组 | 50 | 45 | 5 | 0 | 90 | 100 |
| 治疗3组 | 50 | 47 | 3 | 0 | 94 | 100 |
| 治疗4组 | 50 | 48 | 2 | 0 | 96 | 100 |
| 治疗5组 | 50 | 50 | 0 | 0 | 100 | 100 |
| 对照1组 | 50 | 4 | 20 | 26 | 8 | 48 |
| 对照2组 | 50 | 0 | 3 | 47 | 0 | 6 |
| 对照3组 | 50 | 5 | 19 | 26 | 10 | 48 |
临床治疗效果显示，本发明实施例1-5优于对照1-3组，本发明实施例1-5提供的药物治疗输卵管炎性不孕症的治愈率在84％以上，其中实施例3-5较好，治愈率在94％以上，实施例5最优，治愈率达100％；总有效率在98％以上。实施例5与对比例1-2相比较，可知，本发明是在各原料的协同作用下发挥功效的。随访1年判定疗效为：输卵管通畅率达98％以上，1年内宫内妊娠率80％。
典型病例：
病例1：张某，33岁，结婚十年。28岁通过吃中药怀过孕，流产未净而清宫，始终未孕，做过各项检查，患有输卵管炎性不孕症，其它检查未见异常。服用本发明药物2个月检查后发现输卵管已畅通，可以停药，准备受孕，现已有宝宝3个月。
病例2：宋某，39岁，婚后多年不孕，在多家医院就医，患有输卵管炎性不孕症，经手术治疗无效，多家医院主张做试管婴儿，或放弃治疗抱养，后经用本发明药物治疗，两个月痊愈怀孕，后生以健康男婴，现在孩子已2岁。
病例3：江某，38岁，之前人工流产两次，以后不再怀孕，诊断为患有输卵管炎性不孕症，经输液抗菌消炎，手术通液无效，患者已丧失信心。服用本发明药物2个月后治愈怀孕，后顺利生下一男婴。
对于本领域技术人员而言，显然本发明不限于上述示范性实施例的细节，而且在不背离本发明的精神或基本特征的情况下，能够以其他的具体形式实现本发明。因此，无论从哪一点来看，均应将实施例看作是示范性的，而且是非限制性的，本发明的范围由所附权利要求而不是上述说明限定，因此旨在将落在权利要求的等同要件的含义和范围内的所有变化囊括在本发明内。
此外，应当理解，虽然本说明书按照实施方式加以描述，但并非每个实施方式仅包含一个独立的技术方案，说明书的这种叙述方式仅仅是为清楚起见，本领域技术人员应当将说明书作为一个整体，各实施例中的技术方案也可以经适当组合，形成本领域技术人员可以理解的其他实施方式。
Claims (5)
1.一种治疗输卵管炎性不孕症的药物，其特征在于，由以下按照重量份的原料组成：党参20-40份，炒白术20-40份，当归10-20份，赤芍10-20份，丹参10-20份，泽兰10-20份，香附10-20份，乳香10-20份，没药10-20份，王不留行10-20份，路路通10-20份，三七6-15份，穿山甲6-15份，穿破石20-40份，薤白10-20份，茺蔚子10-20份，甘草5-10份。
2.根据权利要求1所述的治疗输卵管炎性不孕症的药物，其特征在于，由以下按照重量份的原料组成：党参25-35份，炒白术25-35份，当归12-18份，赤芍12-18份，丹参12-18份，泽兰12-18份，香附12-18份，乳香12-18份，没药12-18份，王不留行12-18份，路路通12-18份，三七9-12份，穿山甲9-12份，穿破石25-35份，薤白12-18份，茺蔚子12-18份，甘草6-9份。
3.根据权利要求2所述的治疗输卵管炎性不孕症的药物，其特征在于，由以下按照重量份的原料组成：党参30份，炒白术30份，当归15份，赤芍15份，丹参15份，泽兰15份，香附15份，乳香15份，没药15份，王不留行15份，路路通15份，三七11份，穿山甲11份，穿破石30份，薤白15份，茺蔚子15份，甘草7份。
4.一种如权利要求1-3任一所述的治疗输卵管炎性不孕症的药物的制备方法，其特征在于，由以下步骤组成：
1)将炒白术、当归、赤芍、丹参、泽兰、香附、乳香、没药粉碎、过100目筛，加入上述几味药总质量13倍的碳酸氢钠水溶液，碳酸氢钠水溶液中碳酸氢钠质量含量为3-5％，在45-48℃下加热搅拌处理2-2.2h，再在68-70℃下加热搅拌1-1.2h，然后在100-105℃下搅拌处理1-1.2h，过滤取滤液；
2)将王不留行、路路通、三七、穿山甲、穿破石、薤白、茺蔚子、甘草粉碎、过80目筛，加入上述几味药总质量5-6倍的80％乙醇溶液浸提2次，浸提温度为70-72℃，浸提时间为2.5-2.8h，合并浸提液，浓缩至原体积的20-22％，制得浓缩液；
3)将党参粉碎、过200目筛，加入其质量1.5-1.6倍的柠檬酸醇溶液，柠檬酸醇溶液中柠檬酸的质量含量为5-6％，在55-56℃下加热搅拌1.5-1.6h，再在88-90℃下搅拌烘干即得党参粉；
4)将滤液与浓缩液混合，在78-80℃下加热搅拌25-30min，然后加入党参粉，继续在该温度下搅拌10-15min，进行微波处理10-12min，其中微波功率为900W，再在84-86℃下搅拌烘干即得药物。
5.如权利要求1-3任一所述的药物在制备治疗输卵管炎性不孕症药物中的应用。
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