CN100387245C - 一种治疗勃起功能障碍的药物及其制备方法 - Google Patents
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Abstract
本发明公开了一种治疗勃起功能障碍的药物组合物，它是以淫羊藿、蒺藜、漏芦、蛇床子四味药物组成的制剂。本发明处方简单、独特，价格便宜，疗效显著。经临床研究证实，该药能明显增加国际勃起功能指数(问卷)(IIEF-5)评分；明显增加患者勃起硬度、延长阴茎勃起持续时间，无副作用，总有效率为90%，临床治愈率65%。本发明还公开了以上所述药物的制备方法，根据每味中药的不同特性，分别以粉碎或溶剂提取等预处理后，按比例配制而成。
Description
技术领域
本发明涉及一种治疗勃起功能障碍的药物组合物。具体的说是以淫羊藿、蒺藜、蛇床子、漏芦为主要原料制备而成的中成药。本发明还涉及上述药物的制备方法。
背景技术
勃起功能障碍(ED)又称阳痿。一般指在多数情况下阴茎不能勃起，或虽能勃起但不能维持勃起并进行性交，是临床上最常见的男子性功能障碍，据统计40～70岁男子中有52％患有不同程度的ED。其治疗可分为非侵入性和侵入性治疗两类，非侵入性治疗系指心理治疗、药物治疗和真空负压勃起治疗。侵入性治疗包括尿道给药、海绵体活性药物注射、阴茎假体植入和血管性阳痿的手术治疗。侵入性治疗带有一定的创伤性，并发症多，患者不易接受；药物治疗目前主要是以西药为主，多为磷酸二酯酶-5(PDE-5)抑制剂：如西地那非(伟哥，辉瑞公司)、伐地那非(艾力达，拜耳公司)等虽然疗效肯定，但价格昂贵，一般患者难以承受，并可引起如头痛、直立性低血压、心血管不良反应等令人不能接受的副作用。
目前虽研究有一些治疗勃起功能障碍的中成药，但仍不能满足患者的需要，且其处方组成均较复杂，药味较多，价格较高，疗效不佳。
发明内容
本发明的目的在于提供一种治疗勃起功能障碍疗效确切的中药及其相应制剂。其特点有：能较快改善患者的勃起功能、增加勃起的硬度，延长勃起持续时间，且价格便宜、无副作用。
本发明的解决方案是基于祖国医学对ED的发病机理的认识，根据自己多年临床经验，先从众多中药中确定一系列治疗ED有效的中药，再经临床反复验证，筛选出来中药复方制剂。能较快改善患者的勃起功能、增加勃起的硬度，延长勃起持续时间，且价格便宜、无副作用。
本发明是一种治疗勃起功能障碍的药物组合物，其特征在于它包括：淫羊藿10～50％、蒺藜10～50％、蛇床子10～30％、漏芦10～30％。
本发明药物可以是任何一种药剂学上所说剂型的药物。
该药物的制备可以按多种药剂学上的常规方法制备，如：
淫羊藿、蒺藜、蛇床子、漏芦用乙醇或水等按常规方法提取，浓缩，干燥，得提取物，制成所需剂型的药物。
以上制备过程中，如有必要，可加入适量药剂学中常用的辅料，如淀粉、糊精、微晶纤维、可压性淀粉、硬脂酸镁、微粉硅胶、蔗糖、羧甲基淀粉钠等。
本发明药物临床使用结果表明，有下述优点：
(1)治疗ED引起的腰膝酸软、畏寒肢冷、精冷遗精等症状，增加国际勃起功能指数(问卷)(IIEF-5)评分，提高生活质量。
(2)明显增加患者勃起硬度。
(3)明显延长阴茎勃起持续时间。
(4)无副作用。
(5)疗效稳定。
为表明本发明的临床效果，参照《中药新药治疗阳痿的临床研究指导原则》，选择20～60岁、诊断为勃起功能障碍的患者40例，经系统客观临床观察。年龄最小22岁，最大60岁，平均47.24±4.52岁。病程最短6个月，最长162个月，平均43.51±11.20个月。病情轻度6例(15％)，中度23例(57.5％)，重度11例(27.5％)。观察期一个月。分别于服药前及服药后观察：
(1)安全性指标：血压、脉搏、血、尿、粪三大常规及心电图、肝、肾测功能检查
(2)疗效性指标：
(a)IIEF-5评分。
(b)中医证候评分。
(3)不良反应观察
包括胃肠道反应、神经系统异常、皮肤和肌肉异常等。
治疗前后各项指标变化如表1～4所示
表1国际勃起功能指数(问卷)(IIEF-5)评分变化
注：**表示与治疗前比较p＜0.01(下同)。
表2中医证候评分变化
注：p值表示同上。
表3总疗效评价
服药过程中未见明显不良反应，服药前后心电图，肝、肾功能，血、尿常规无明显变化。
具体实施方式
下面结合实施例对本发明作进一步的描述。
本发明药物可以有多种不同成分组成及不同的配比关系，如(用量为重量百分比)：
(1)淫羊藿50蒺藜10漏芦15蛇床子25
(2)淫羊藿45蒺藜20漏芦20蛇床子15
(2)淫羊藿40蒺藜25漏芦20蛇床子15
(3)淫羊藿35蒺藜25漏芦30蛇床子10
(4)淫羊藿35蒺藜30漏芦20蛇床子15
(5)淫羊藿35蒺藜25漏芦20蛇床子20
(6)淫羊藿30蒺藜30漏芦25蛇床子15
(7)淫羊藿25蒺藜35漏芦20蛇床子20
(8)淫羊藿20蒺藜40漏芦20蛇床子20
(9)淫羊藿10蒺藜50漏芦20蛇床子20
本发明药物的制备方法，可参照如下方法：
(1)将淫羊藿、蒺藜、蛇床子、漏芦用乙醇回流提取，回收溶剂，干燥，得提取物，加适量淀粉，制粒，加工成颗粒剂。
(2)将淫羊藿、蒺藜、蛇床子、漏芦用水按煎煮方法提取，浓缩，干燥，制粒，加工成片剂。
(3)将淫羊藿、蒺藜、蛇床子、漏芦用水按煎煮方法提取，浓缩，干燥，制粒，加工成胶囊剂。
Claims (6)
1.一种治疗勃起功能障碍的药物，其特征在于它是由下述重量配比的原料药制成：淫羊藿10～50％、蒺藜10～50％、蛇床子10～30％和漏芦10～30％。
2.根据权利要求1所述的药物，其特征在于原料药中各药物重量配比范围是：淫羊藿20～40％、蒺藜20～40％、蛇床子15～25％和漏芦15～25％。
3.根据权利要求2所述的药物，其特征在于原料药中各药物重量配比范围是：淫羊藿25～35％、蒺藜25～35％、蛇床子15～25％和漏芦15～25％。
4.根据权利要求3所述的药物，其特征在于原料药中各药物重量配比范围是：淫羊藿30％、蒺藜30％、蛇床子15～25％和漏芦15～25％。
5.根据权利要求1至4中任一项所述的药物，其特征在于所说的药物的剂型选自颗粒剂或片剂或胶囊。
6.制备权利要求1至4中任一项所述的药物的方法，其特征在于：将淫羊藿、蒺藜、蛇床子和漏芦用水或不同浓度的乙醇溶液按常规方法提取，然后将各提取物混合均匀，制成所需剂型的药物。
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