CN111329927B - 一种治疗女性特发性水肿的中药 - Google Patents
一种治疗女性特发性水肿的中药 Download PDFInfo
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Abstract
本发明涉及治疗女性特发性水肿的中药，可以有效解决女性特发性水肿的用药问题，其解决的技术方案是，该中药是由以下重量计的原料药物制成：青皮10‑20g、木蝴蝶10‑20g、月季花10‑20g、合欢皮10‑20g、泽兰10‑20g、益母草10‑20g、水红花子10‑20g、三白草10‑20g、枸杞子10‑20g、土炒白术15‑30g和甘草3‑9g，本发明制备方法简单，容易生产，疗效稳定可靠，服用安全，效果和患者的依从性很好，具有疏肝理气利水功效，有效用于女性特发性水肿，是治疗女性特发性水肿药物上的创新。
Description
技术领域
本发明涉及医药领域，特别是一种治疗女性特发性水肿的中药。
背景技术
特发性水肿(Idiopathic Edema)是一种特殊的原因未明的水盐代谢紊乱综合征，多发生于20～50岁的育龄妇女，本病以反复发作的周期性下肢凹陷性水肿为主要临床表现，立位重于卧位，傍晚重于早晨，病因和发病机制至今仍不清楚，可能与内分泌紊乱和直立体位反应异常有关。西医对本病没有特异治疗方法，只能以氢氯噻嗪、螺内酯等利尿剂姑息治之，远期效果很差，且有电解质紊乱等副作用。因此，临床治疗上亟需治疗效果好、无副作用、依从性好的治疗药物。
中药对女性特发性水肿有独特的疗效，可以弥补西医治疗上的不足。中国发明专利授权公告号CN101549073B公开了一种治疗特发性水肿的药物及其制备方法，选用纯天然植物药当归159-240份、柴胡106-160份、茯苓212-322份、泽泻126-192份、白术126-192份、猪苓126-192份、益母草318-482份、泽兰126-192份、白芍126-192份、香附105-159份、桂枝105-159份，具有疏肝健脾，通络利水功效。中国发明专利授权公告号CN104524504B公开了一种治疗女性特发性水肿的中药，制成有效成分的原料重量份组成为桂枝5-10、陈皮10-15、大腹皮5-15、猪苓10-20、茯苓10-15、泽泻10-15、白术10-15、生姜皮5-10、柴胡10-15、瓜蒌15-20、肉苁蓉10-15、牛膝5-10，具有温阳化气，渗湿利水消肿功效。但是，以疏肝行气利水为主要功效，对女性特发性水肿具有满意疗效且无副作用的中药，尚未见报导。
发明内容
针对上述情况，为解决现有技术之缺陷，本发明之目的就是提供一种治疗女性特发性水肿的中药，可以有效解决女性特发性水肿的用药问题。
本发明解决的技术方案是，该中药是由以下重量计的原料药物制成：青皮10-20g、木蝴蝶10-20g、月季花10-20g、合欢皮10-20g、泽兰10-20g、益母草10-20g、水红花子10-20g、三白草10-20g、枸杞子10-20g、土炒白术15-30g和甘草3-9g，将上述原料药物混合在一起，加入原料药物10倍重量的饮用水，浸泡30分钟，用武火煎沸，再用文火煎30分钟，过滤，得第一次滤液；再将药渣加入原料药物8倍重量的饮用水，用武火煎沸，再用文火煎25分钟，过滤，得第二次滤液；将两次滤液合并，中火煎煮浓缩至400mL，即得。
本发明制备方法简单，容易生产，疗效稳定可靠，服用安全，效果和患者的依从性很好，具有疏肝理气利水功效，有效用于女性特发性水肿，是治疗女性特发性水肿药物上的创新。
具体实施方式
以下结合实施例对本发明的具体实施方式作进一步详细说明。
实施例1
本发明在具体实施时，可由以下重量计的原料药物制成：青皮15g、木蝴蝶15g、月季花15g、合欢皮15g、泽兰15g、益母草15g、水红花子15g、三白草15g、枸杞子15g、土炒白术20g和甘草6g，将上述原料药物混合在一起，加入原料药物10倍重量的饮用水，浸泡30分钟，用武火煎沸，再用文火煎30分钟，过滤，得第一次滤液；再将药渣加入原料药物8倍重量的饮用水，用武火煎沸，再用文火煎25分钟，过滤，得第二次滤液；将两次滤液合并，中火煎煮浓缩至400mL，即得。
实施例2
本发明在具体实施时，还可由以下重量计的原料药物制成：青皮10g、木蝴蝶10g、月季花10g、合欢皮10g、泽兰10g、益母草10g、水红花子10g、三白草10g、枸杞子10g、土炒白术15g和甘草3g，将上述原料药物混合在一起，加入原料药物10倍重量的饮用水，浸泡30分钟，用武火煎沸，再用文火煎30分钟，过滤，得第一次滤液；再将药渣加入原料药物8倍重量的饮用水，用武火煎沸，再用文火煎25分钟，过滤，得第二次滤液；将两次滤液合并，中火煎煮浓缩至400mL，即得。
实施例3
本发明在具体实施时，还可由以下重量计的原料药物制成：青皮20g、木蝴蝶20g、月季花20g、合欢皮20g、泽兰20g、益母草20g、水红花子20g、三白草20g、枸杞子20g、土炒白术30g和甘草9g，将上述原料药物混合在一起，加入原料药物10倍重量的饮用水，浸泡30分钟，用武火煎沸，再用文火煎30分钟，过滤，得第一次滤液；再将药渣加入原料药物8倍重量的饮用水，用武火煎沸，再用文火煎25分钟，过滤，得第二次滤液；将两次滤液合并，中火煎煮浓缩至400mL，即得。
本发明中药也可按照常规方法，制成丸剂、散剂、颗粒剂、片剂、胶囊剂、口服液等。本发明保护的是中药组方，而不在于剂型或制备方法。
本发明发明人在长期的临床实践中，发现女性特发性水肿的发病机理符合“女子以肝为先天”的中医理论，其基本病机为肝郁气滞，气不布津，津停为水，治应疏肝行气利水。通过临床反复验证与反复药物优选，本发明发明人发现了具有上述功效的治疗女性特发性水肿的中药，对女性特发性水肿的治疗效果很好且无副作用。
在上述药物中，青皮，味苦、辛，性温，归肝、胆、胃经，疏肝破气，消积化滞；木蝴蝶，味苦、甘，性凉，归肝、胃、肺经，疏肝和胃，清肺利咽；月季花，味甘，性温，归肝经，活血调经，疏肝解郁；合欢皮，味甘，性平，归心、肝、肺经，解郁安神，活血消肿；泽兰，味苦、辛，性微温，归肝、脾经，活血调经，祛瘀消痈，利水消肿；益母草，味苦、辛，性微寒，归肝、心包、膀胱经，活血调经，利水消肿，清热解毒；水红花子，味咸，性寒，归肝、胃经，散血消癥，消积止痛，利水消肿；三白草，味甘、辛，性寒，归肺、膀胱经，利水消肿，清热解毒；枸杞子，味甘，性平，归肝、肾经，滋补肝肾，益精明目；土炒白术，味苦、甘，性温，归脾、胃经，健脾益气，燥湿利水，止汗，安胎；甘草，味甘，性平，归心、肺、脾、胃经，补益脾气，清热解毒，祛痰止咳，缓急止痛，调和诸药。根据中药君臣佐使的配伍原则和治疗女性特发性水肿的实际，青皮疏肝破气，木蝴蝶疏肝和胃，共为君药；月季花疏肝解郁，合欢皮解郁消肿，共为臣药；泽兰、益母草活血利水，水红花子、三白草利水消肿，枸杞子滋肝阴柔肝体以顺应肝“体阴用阳”生理特性，土炒白术健脾燥湿以“见肝之病，知肝传脾，当先实脾”，共为佐药；甘草调和诸药，为使药。全方组分间配伍严谨，相互支持，共奏疏肝行气利水之效，有效用于治疗女性特发性水肿，并经临床试验得到了充分证明，相关实验资料如下：
1一般资料
68例女性特发性水肿患者，根据就诊时间的先后，按简单随机化方法，随机分为观察组34例和对照组34例。观察组34例中，年龄21～50岁，平均(42.67±3.13)岁；病程最短4个月，最长6年，平均(3.78±0.72)年。对照组34例中，年龄22～49岁，平均(41.46±3.27)岁；病程最短3个月，最长7年，平均(3.96±0.81)年。两组一般资料比较，无统计学差异(P＞0.05)，具有可比性。
2诊断标准
参照《实用水肿病学》诊断标准制定。①有明显的体位性水肿，晚上睡前较早上起床后体重增加1.4kg以上；②站立4小时即出现明显的下肢肿胀；③水肿呈周期性演进，多在月经前期加重；④直立性低血压：立位时血压较卧位时降低1kpa以上；⑤立卧位水负荷试验阳性：早晨空腹排尿后于20分钟内饮水1000mL，然后卧位4小时，每小时排尿1次，记录4小时排尿总量；第2天同样方法饮水1000mL，取立位4小时，记录4小时排尿总量；立位4小时排尿总量少于卧位4小时排尿总量的50％。
3纳入标准
①符合诊断标准；②年龄在20～50岁之间；③不伴有其它器质性疾病。
4剔除标准
①未按时服药者；②改变治疗方案者；③未完成疗程者；④出现明显不良反应者。
5治疗方案
对照组口服氢氯噻嗪片，1日1次，1次12.5mg，早饭后服；螺内酯片，1日1次，1次20mg，早饭后服。观察组口服本发明实施例1制得的中药汤剂，每日1剂，水煎为400mL，早晚饭后各服200mL，两组疗程均为4周，4周后统计疗效。
6疗效标准
参照《中医病证诊断疗效标准》和《实用中医内科学》中水肿病的疗效标准制定。治愈：水肿消失，伴随症状消失；有效：水肿减轻，伴随症状减轻；无效：水肿无变化或加重，伴随症状不减轻或加重。两组均在疗程结束后即时进行疗效分析，判定近期疗效；疗程结束后6个月进行疗效分析，判定远期疗效。统计学处理方法采用卡方分析。
7结果
7.1两组近期疗效比较
结果见表1，观察组近期有效率与对照组相比，无统计学差异(P>0.05)，提示两组近期疗效无明显差异。
表1两组近期疗效比较例(％)
注：与观察组比较，*P>0.05。
7.2两组远期疗效比较
结果见表2，观察组远期有效率与对照组相比，具有极显著性统计学差异(P＜0.01)，提示观察组远期疗效明显优于对照组。
表2两组远期疗效比较例(％)
注：与观察组比较，*P＜0.01。
7.3两组药物不良反应比较
结果见表3，观察组药物不良反应发生率与对照组相比，具有极显著性统计学差异(P＜0.01)，提示观察组药物不良反应发生率明显低于对照组。
表3两组药物不良反应比较[n,n(％)]
注：与对照组相比，*P＜0.01。
经反复实验，本发明其它实施例制备的中药均与实施例1取得了相同或相似的治疗效果，不再一一详述，防止赘述。
8结论
本发明中药对女性特发性水肿具有显著的治疗作用，并且无明显副作用，本发明中药原料丰富，制备方法简单，容易生产，疗效稳定可靠，服用安全，效果很好，具有疏肝行气利水功效，有效用于治疗女性特发性水肿，是治疗女性特发性水肿药物上的创新，具有实际的临床意义和推广应用价值。
Claims (4)
1.一种治疗女性特发性水肿的中药，其特征在于，该中药是由以下重量计的原料药物制成：青皮10-20g、木蝴蝶10-20g、月季花10-20g、合欢皮10-20g、泽兰10-20g、益母草10-20g、水红花子10-20g、三白草10-20g、枸杞子10-20g、土炒白术15-30g和甘草3-9g，将上述原料药物混合在一起，加入原料药物10倍重量的饮用水，浸泡30分钟，用武火煎沸，再用文火煎30分钟，过滤，得第一次滤液；再将药渣加入原料药物8倍重量的饮用水，用武火煎沸，再用文火煎25分钟，过滤，得第二次滤液；将两次滤液合并，中火煎煮浓缩至400mL，即得。
2.根据权利要求1所述的治疗女性特发性水肿的中药，其特征在于，由以下重量计的原料药物制成：青皮15g、木蝴蝶15g、月季花15g、合欢皮15g、泽兰15g、益母草15g、水红花子15g、三白草15g、枸杞子15g、土炒白术20g和甘草6g，将上述原料药物混合在一起，加入原料药物10倍重量的饮用水，浸泡30分钟，用武火煎沸，再用文火煎30分钟，过滤，得第一次滤液；再将药渣加入原料药物8倍重量的饮用水，用武火煎沸，再用文火煎25分钟，过滤，得第二次滤液；将两次滤液合并，中火煎煮浓缩至400mL，即得。
3.根据权利要求1所述的治疗女性特发性水肿的中药，其特征在于，由以下重量计的原料药物制成：青皮10g、木蝴蝶10g、月季花10g、合欢皮10g、泽兰10g、益母草10g、水红花子10g、三白草10g、枸杞子10g、土炒白术15g和甘草3g，将上述原料药物混合在一起，加入原料药物10倍重量的饮用水，浸泡30分钟，用武火煎沸，再用文火煎30分钟，过滤，得第一次滤液；再将药渣加入原料药物8倍重量的饮用水，用武火煎沸，再用文火煎25分钟，过滤，得第二次滤液；将两次滤液合并，中火煎煮浓缩至400mL，即得。
4.根据权利要求1所述的治疗女性特发性水肿的中药，其特征在于，由以下重量计的原料药物制成：青皮20g、木蝴蝶20g、月季花20g、合欢皮20g、泽兰20g、益母草20g、水红花子20g、三白草20g、枸杞子20g、土炒白术30g和甘草9g，将上述原料药物混合在一起，加入原料药物10倍重量的饮用水，浸泡30分钟，用武火煎沸，再用文火煎30分钟，过滤，得第一次滤液；再将药渣加入原料药物8倍重量的饮用水，用武火煎沸，再用文火煎25分钟，过滤，得第二次滤液；将两次滤液合并，中火煎煮浓缩至400mL，即得。
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