CN104548055A - 一种治疗雄性勃起功能障碍的中药组合物及其用途 - Google Patents
一种治疗雄性勃起功能障碍的中药组合物及其用途 Download PDFInfo
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- CN104548055A CN104548055A CN201510080025.1A CN201510080025A CN104548055A CN 104548055 A CN104548055 A CN 104548055A CN 201510080025 A CN201510080025 A CN 201510080025A CN 104548055 A CN104548055 A CN 104548055A
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Abstract
本发明涉及一种治疗雄性勃起功能障碍的中药组合物及其用途，属于医药领域。为了解决现有治疗雄性勃起功能障碍的药物存在不良反应及作用时间短或者起效慢的缺陷，发明提供一种能够治疗雄性功能障碍的中药组合物，其主要由以下重量份的原料制得：桂枝8-20份、女贞子5-15份、熟地5-15份、淫羊藿3-10份、山药10-25份、巴戟天5-15份、厚朴10-20份、生姜3-10份、制何首乌10-20份、黄芪8-20份、百合5-12份、茯苓10-20份、肉苁蓉3-10份、当归5-15份、党参3-10份、枸杞子3-10份、酸枣仁5-12份、黄芩10-15份、金银花10-20份、连翘3-10份、白术5-15份、白头翁5-15份、五倍子5-25份、甘草10-20份。其可以显著缩短勃起潜伏期并能够明显延长射精潜伏期，对于神经性ED具有很好的治疗效果。
Description
技术领域
本发明涉及一种治疗雄性勃起功能障碍的中药组合物及其用途，属于医药领域。
背景技术
勃起功能障碍(erectiledysfunction，ED)，是指男子在性刺激下，持续地(3个月以上)不能达到或维持足够硬度的阴茎勃起以完成满意性交。据统计40～70岁的男性中有52％存在着不同程度的ED，估计到2025年，全球将有3.22亿男性存在ED的问题。但勃起功能障碍常常牵涉到全身多系统，且病因复杂，有血管性、神经性、内分泌性、心理性、老年性等多种因素，因此临床疗效并不理想。
目前市场上用于治疗雄性勃起功能障碍的药物主要有三类：第一类为中国传统中药，中药治疗副作用小，但治疗周期长，这主要是由于现有中药的提取方法使药物大部分的有效成分在高温下失去活性，或者提取药物的过程中因没有打破细胞壁的屏障使有效成分的很大一部分还存留在药材内部；第二类为西药——磷酸二酯酶抑制剂，包括伐地那非、他达拉非与西地那非，这类药虽然效果较好，但服用后的不良反应很多，且作用时间短。比如西地那非常见的不良反应有头痛、面部潮红、心绞痛、消化不良和肌肉疼痛，其次为鼻塞、腹泻、头晕和皮疹，其发生率100mg剂量常高于50mg剂量。更严重的，这类药常会使人血压升高，并且服用后对肝脏和肾脏造成损害；第三类为以动物器官所制成的药物，这类药物通过促进血液循环，补充雄性激素来达到治疗目的，服用后也会使血压升高。因此，研究和生产一种安全、有效、廉价、毒副作用低的药物是患者的渴望，具有深远的社会意义。
近年来，中医男科在继承传统男科经验及学术思想的基础上，以创新为动力，借鉴吸收现代科技成果，在阳痿病的理论和临床研究取得了较大进展。不少学者在阳痿的诊断治疗上逐渐突破了在脏腑定位上以肾为中心，在病因病机上以虚为重点，在治疗上以补肾壮阳为主导的传统观念，开始从多方位考虑阳痿的病因病机，提出阳痿从肝论治、从瘀论治；动脉性阳痿以活血为主，静脉性阳痿宜气血双顾；情志之变已取代房劳损伤成为主要病因，不良生活习惯是不可忽视的因素；在病机学方面，实多虚少是病机转变的普遍规律，脏腑功能改变以肝肾为中心而涉及其他脏腑；在基本病理学方面，最基本的病理变化是肝郁肾虚血瘀湿热，其中湿热是疾病的起始，肝郁是主要病理特点，肾虚是主要病理趋势，血瘀是最终病理结果。许多研究已证明了补肾活血中药能提高去势大鼠对外部刺激兴奋性，阴茎勃起潜伏期明显缩短；可提高今天的耐受力，抗疲劳；对机体网状内皮系统吞噬功能有增强作用；对勃起功能、射精功能均有明显改善作用；淫羊藿的水提物可明显促进精液分泌，同时发现有雄性激素作用或雄激素增强作用，能使去势大鼠的前列腺、精囊、肛提肌重量增加。本发明旨在提供一种起效快，作用时间长，副反应更少的ED治疗的中药组合物。
发明内容
本发明为了解决现有治疗雄性勃起功能障碍的药物存在不良反应，及作用时间短或者起效慢的缺陷，而提供一种起效快，作用时间长，副反应更少的ED治疗药物。
为了实现本发明的目的，
一种治疗雄性功能障碍的中药组合物，其由以下重量份配比的原料制成：桂枝8-20份、女贞子5-15份、熟地5-15份、淫羊藿3-10份、山药10-25份、巴戟天5-15份、厚朴10-20份、生姜3-10份、制何首乌10-20份、黄芪8-20份、百合5-12份、茯苓10-20份、肉苁蓉3-10份、当归5-15份、党参3-10份、枸杞子3-10份、酸枣仁5-12份、黄芩10-15份、金银花10-20份、连翘3-10份、白术5-15份、白头翁5-15份、五倍子5-25份、甘草10-20份；
本发明上述中药均为临床常用中药，其入药部位均为本领域技术人员所熟知，所述的中药组合物经过合理配伍后能够显著减轻雄性功能障碍治疗过程中的毒副作用，并增强疗效。根据中药组合物对雄性功能障碍的治疗效果发明人在上述中药组合物基础上进行了优选，所述的中药组合物由如下重量份配比的原料制成：
(一)桂枝15份、女贞子10份、熟地10份、淫羊藿7份、山药18份、巴戟天10份、厚朴15份、生姜7份、制何首乌15份、黄芪14份、百合9份、茯苓15份、肉苁蓉7份、当归10份、党参7份、枸杞子6份、酸枣仁8份、黄芩13份、金银花15份、连翘7份、白术10份、白头翁10份、五倍子20份、甘草15份。
(二)桂枝8份、女贞子5份、熟地5份、淫羊藿3份、山药10份、巴戟天5份、厚朴10份、生姜3份、制何首乌10份、黄芪8份、百合5份、茯苓10份、肉苁蓉3份、当归5份、党参3份、枸杞子3份、酸枣仁5份、黄芩10份、金银花10份、连翘3份、白术5份、白头翁5份、五倍子5份、甘草10份。
(三)桂枝20份、女贞子15份、熟地15份、淫羊藿10份、山药25份、巴戟天15份、厚朴20份、生姜10份、制何首乌20份、黄芪20份、百合12份、茯苓20份、肉苁蓉10份、当归15份、党参10份、枸杞子10份、酸枣仁12份、黄芩15份、金银花20份、连翘10份、白术15份、白头翁15份、五倍子25份、甘草20份。
(四)桂枝12份、女贞子12份、熟地10份、淫羊藿5份、山药16份、巴戟天18份、厚朴13份、生姜6份、制何首乌20份、黄芪10份、百合8份、茯苓16份、肉苁蓉6份、当归10份、党参5份、枸杞子8份、酸枣仁7份、黄芩8份、金银花14份、连翘10份、白术5份、白头翁15份、五倍子15份、甘草17份。
本发明的中药组合物可以制备成临床上常用的剂型。优选地，本发明中药组合物按照常规制备工艺制备成散剂、合剂、片剂或胶囊剂。本发明还提供一种上述中药组合物的制备方法，其包括下述步骤：取处方量中药材碎成粗粉，按照粗粉总重量的4～9倍加入体积浓度为40％～95％的乙醇溶液，回流提取三次，回流时间为2～5h，滤过，滤液合并后回收乙醇，冷却过滤，用水洗涤，干燥后即得中药浸膏；本领域技术人员可在该制备方法技术上制备得到临床上常用中药药物剂型，如片剂、胶囊剂等。
本发明还请求保护上述中药组合物在制备治疗雄性勃起功能障碍药物中的用途。本发明实施例7表明，本发明中药组合物明显缩短了正常大鼠勃起潜伏期，延长了正常大鼠的射精潜伏期，其在上述指标改善方面优于阳性药物西地那非。随着用药的时间的延长，其药物效果优势更加明显，且几乎没有任何毒副作用。。本发明中药组合物在提高大鼠勃起功能方面优于现有治疗药物。本发明实施例8表明，西地那非对神经性ED大鼠的治疗效果不明显，很多大鼠在测试过程中射精潜伏期也短，甚至有些大鼠根本不会出现性反应。而本发明中药组合物用药一周后，射精潜伏期和勃起潜伏期均接近正常组。临床试验表明用药时间越长，治疗作用越明显。
本发明中药组合物在治疗雄性功能障碍方面与现有技术相比具有如下优势：
1)与当前雄性功能障碍治疗药物相比，本发明中药组合物为天然纯中药制剂，不良反应和副作用显著降低，且本发明中药组合物作用全面，药物治疗效果更佳，显著提高了雄性功能障碍患者的用药依从性，并提高了患者的生活质量。
2)本发明中药组合物中含有多种药物组分，作用靶点众多，与现有的中药相比起效快，作用时间长；本发明中药组合物用于正常大鼠时，可以明显缩短了大鼠勃起潜伏期，延长了大鼠的射精潜伏期。用于神经性ED时，射精潜伏期和勃起潜伏期均接近正常组。临床试验表明用药时间越长，治疗作用越明显。这表明其在临床上治疗效果十分优异。
3)本发明中药组合物治疗费用不仅不会增加，反而会有下降，使得治疗的效益/费用比有明显提高。因此患者的治疗依从性大大增加，生活质量也就明显改善。
具体实施例
现通过如下实施例进一步说明本发明的组合物及其制备方法以及治疗效果，但本发明的保护范围并不限于实施例。
(一)制剂实施例部分
实施例1本发明中药组合物及制备工艺
处方组成如下：桂枝80g、女贞子50g、熟地50g、淫羊藿30g、山药100g、巴戟天50g、厚朴100g、生姜30g、制何首乌100g、黄芪80g、百合50g、茯苓100g、肉苁蓉30g、当归50g、党参30g、枸杞子30g、酸枣仁50g、黄芩100g、金银花100g、连翘30g、白术50g、白头翁50g、五倍子50g、甘草100g；
制备方法：取处方量中药材碎成粗粉，按照粗粉总重量的4倍加入体积浓度为40％的乙醇溶液，回流提取三次，回流时间为5h，滤过，滤液合并后回收乙醇，冷却过滤，用水洗涤，干燥后即得中药浸膏；将中药浸膏粉碎并加入制剂常用辅料制备成片剂或胶囊剂。
实施例2本发明中药组合物及制备工艺
处方组成如下：桂枝200g、女贞子150g、熟地150g、淫羊藿100g、山药250g、巴戟天150g、厚朴200g、生姜100g、制何首乌200g、黄芪200g、百合120g、茯苓200g、肉苁蓉100g、当归150g、党参100g、枸杞子100g、酸枣仁120g、黄芩150g、金银花200g、连翘100g、白术150g、白头翁150g、五倍子250g、甘草200g；
制备方法：取处方量中药材碎成粗粉，按照粗粉总重量的5倍加入体积浓度为90％的乙醇溶液，回流提取三次，回流时间为3h，滤过，滤液合并后回收乙醇，冷却过滤，用水洗涤，干燥后即得中药浸膏；将中药浸膏粉碎并加入制剂常用辅料制备成片剂或胶囊剂。
实施例3本发明中药组合物及制备工艺
处方组成如下：桂枝150g、女贞子100g、熟地100g、淫羊藿70g、山药180g、巴戟天100g、厚朴150g、生姜70g、制何首乌150g、黄芪140g、百合90g、茯苓150g、肉苁蓉70g、当归100g、党参70g、枸杞子60g、酸枣仁80g、黄芩130g、金银花150g、连翘70g、白术100g、白头翁100g、五倍子200g、甘草150g；
制备方法：取处方量中药材碎成粗粉，按照粗粉总重量的5倍加入体积浓度为70％的乙醇溶液，回流提取三次，回流时间为4h，滤过，滤液合并后回收乙醇，冷却过滤，用水洗涤，干燥后即得中药浸膏；将中药浸膏粉碎并加入制剂常用辅料制备成片剂或胶囊剂。
实施例4本发明中药组合物及制备工艺
处方组成如下：桂枝80g、女贞子150g、熟地150g、淫羊藿30g、山药250g、巴戟天150g、厚朴100g、生姜100g、制何首乌100g、黄芪160g、百合120g、茯苓100g、肉苁蓉30g、当归50g、党参100g、枸杞子100g、酸枣仁70g、黄芩100g、金银花150g、连翘30g、白术100g、白头翁100g、五倍子100g、甘草100g；
制备方法：取处方量中药材碎成粗粉，按照粗粉总重量的5倍加入体积浓度为70％的乙醇溶液，回流提取三次，回流时间为4h，滤过，滤液合并后回收乙醇，冷却过滤，用水洗涤，干燥后即得中药浸膏；加入乙醇至含醇量为75％(v/v)，静置24小时，取上清液，回收乙醇浓缩，加水至1000ml，搅匀，分装，流通蒸汽灭菌35min，即得合剂。
实施例5本发明中药组合物及制备工艺
处方组成如下：桂枝120g、女贞子120g、熟地100g、淫羊藿50g、山药160g、巴戟天180g、厚朴130g、生姜60g、制何首乌200g、黄芪100g、百合80g、茯苓160g、肉苁蓉60g、当归100g、党参50g、枸杞子80g、酸枣仁70g、黄芩80g、金银花140g、连翘100g、白术50g、白头翁150g、五倍子150g、甘草170g；
制备方法同实施例4。
实施例6本发明中药组合物及制备工艺
处方组成如下：桂枝140g、女贞子100g、熟地130g、淫羊藿60g、山药200g、巴戟天150g、厚朴200g、生姜30g、制何首乌160g、黄芪110g、百合70g、茯苓160g、肉苁蓉70g、当归110g、党参50g、枸杞子100g、酸枣仁120g、黄芩150g、金银花160g、连翘100g、白术150g、白头翁120g、五倍子180g、甘草170g；
制备工艺同实施例4。
实施例7本发明中药组合物对正常大鼠勃起功能的影响
1.正常大鼠挑选
实验选用动物为8周龄大的SD品系大鼠。雌鼠和雄鼠分开饲养，严格执行驯养计划(早六点到晚六点关灯)。SD大鼠适应环境后即进行实验用鼠挑选。
交配行为测定在聚丙烯透明笼(30cm×40cm×60cm)中进行。聚丙烯透明笼置于安静且光线略暗环境中，记录各行为发生的持续时间及频次。测定时间为30min，每只大鼠测定1次。雌鼠在测试之前36h注射0.75μg/g雌二醇，实验前4～6h再注射15μg/g的黄体酮。雄鼠在整个挑选过程中未服用任何药物。大鼠挑选在四周内完成，每周测试一次，将连续两次在30min内射精2-3次，且射精潜伏期在6min以上的雄鼠作为实验用鼠(N＝144)。
2.分组与给药
将96只大鼠随机分成8组，每组12只。实验中药品均用蒸馏水配制，每组大鼠给予的治疗药物如下所示：
正常组：灌胃给予等体积的蒸馏水
西地那非组：灌胃给予5mg/kg西地那非；
中药组合物一组：灌胃给药实施例1中药组合物200mg/kg；
中药组合物二组：灌胃给药实施例2中药组合物200mg/kg；
中药组合物三组：灌胃给药实施例3中药组合物200mg/kg；
中药组合物四组：灌胃给药实施例4中药组合物200mg/kg；
中药组合物五组：灌胃给药实施例5中药组合物200mg/kg；
中药组合物六组：灌胃给药实施例6中药组合物200mg/kg；
临床拟用的给药途径为口服，故本试验采用灌胃法给药。各组大鼠给药剂量为0.3ml/100g体重，每天给药1次，给药1周后停止给药。
3.检测指标
给药结束后即刻检测各项指标。雌鼠在测试之前36h注射0.75μg/g雌二醇，实验前4～6h再注射15μg/g的黄体酮。在实验期间，每只刺激雌体仅用一次。雄鼠最后一次给药结束后2-3小时即进行测试，交配行为测定在聚丙烯透明笼(30cm×40cm×60cm)中进行。聚丙烯透明笼置于安静且光线略暗环境中，记录各行为发生的持续时间及频次。测定时间为30min，每只大鼠测定1次。实验过程中记录各组内雄鼠射精频率、勃起潜伏期、射精潜伏期、交配潜伏期。每次测定结束，用自来水和75％酒精冲洗实验箱，以消除混杂和残留气味。
其中勃起潜伏期为通过录像观察从雌雄鼠共处到大鼠阴茎第一次勃起所需的时间，阴茎头充血及末端阴茎体出现计为阴茎勃起；射精潜伏期是指阴茎插入阴道到射精开始的时间；交配潜伏期是指雄鼠阴茎勃起至开始交配的时间；交配次数是指30min测试过程中观测到大鼠的交配次数。
表1不同中药组合物对SD大鼠性能力的影响(Mean±SE)
与正常组比较，￥P＜0.05，￥￥P＜0.01；与西地那非组比较，*P＜0.05，**P＜0.01；
通过上述实验显示，西地那非和本发明中药组合物对正常大鼠的性能力指标均有一定的改善作用。本发明中药组合物明显缩短了正常大鼠勃起潜伏期，延长了正常大鼠的射精潜伏期，其在上述指标改善方面优于阳性药物西地那非。随着用药的时间的延长，其药物效果优势更加明显，且几乎没有任何毒副作用。可见，本发明中药组合物在提高大鼠勃起功能方面优于现有治疗药物。
实施例8本发明中药组合物对神经性ED模型大鼠勃起功能的影响试验
1神经性ED模型的建立
通过对10只废弃SD大鼠的解剖，初步掌握海绵体神经的解剖.将144只实验大鼠用6％水合氯醛腹腔麻醉大鼠(60—80mg/kg)，经碘酒消毒后取下腹正中切口，逐层打开腹腔，在耻骨联合前充分分离肌肉组织，以便充分暴露前列腺的后外侧，在前列腺的后外侧，首先找到盆腔神经节，仔细分离海绵体神经，通过电刺激实验加以证实，然后用血管钳双侧钳夹海绵体神经lmin制作海绵体神经损伤模型。对照组未作任何处理。一个月后，再次通过电刺激实验证实造模是否成功。
2.分组与给药
将96只大鼠随机分成8组，每组12只，设正常组。实验中药品均用蒸馏水配制，每组大鼠注射药物组合如下所述。
模型组：灌胃给予等体积的蒸馏水
西地那非组：灌胃给予5mg/kg西地那非；
中药组合物一组：灌胃给药实施例1中药组合物200mg/kg；
中药组合物二组：灌胃给药实施例2中药组合物200mg/kg；
中药组合物三组：灌胃给药实施例3中药组合物200mg/kg；
中药组合物四组：灌胃给药实施例4中药组合物200mg/kg；
中药组合物五组：灌胃给药实施例5中药组合物200mg/kg；
中药组合物六组：灌胃给药实施例6中药组合物200mg/kg；
临床拟用的给药途径为口服，故本试验采用灌胃法给药。各组大鼠给药剂量为0.3ml/100g体重，每天给药1次，给药1周后停止给药。
3.检测指标
检测指标及检测方法同实施例7中检测指标和检测方法。
表2不同中药组合物对SD大鼠神经性ED的治疗作用(Mean±SE)
与正常组比较，￥P＜0.05，￥￥P＜0.01；与西地那非组比较，*P＜0.05，**P＜0.01；
上述实验显示，西地那非和本发明中药组合物对神经性ED大鼠均具有一定的治疗作用，但西地那非对神经性ED大鼠的治疗效果不明显，很多大鼠在测试过程中射精潜伏期也短，甚至有些大鼠根本不会出现性反应。而本发明中药组合物用药一周后，射精潜伏期和勃起潜伏期均接近正常组。临床试验表明用药时间越长，治疗作用越明显。
Claims (9)
1.一种治疗雄性功能障碍的中药组合物，其特征在于，所述的中药组合物主要由以下重量份的原料制得：桂枝8-20份、女贞子5-15份、熟地5-15份、淫羊藿3-10份、山药10-25份、巴戟天5-15份、厚朴10-20份、生姜3-10份、制何首乌10-20份、黄芪8-20份、百合5-12份、茯苓10-20份、肉苁蓉3-10份、当归5-15份、党参3-10份、枸杞子3-10份、酸枣仁5-12份、黄芩10-15份、金银花10-20份、连翘3-10份、白术5-15份、白头翁5-15份、五倍子5-25份、甘草10-20份。
2.如权利要求1所述的中药组合物，其特征在于，所述的中药组合物主要由以下重量份的原料制得：桂枝15份、女贞子10份、熟地10份、淫羊藿7份、山药18份、巴戟天10份、厚朴15份、生姜7份、制何首乌15份、黄芪14份、百合9份、茯苓15份、肉苁蓉7份、当归10份、党参7份、枸杞子6份、酸枣仁8份、黄芩13份、金银花15份、连翘7份、白术10份、白头翁10份、五倍子20份、甘草15份。
3.如权利要求1所述的中药组合物，其特征在于，所述的中药组合物主要由以下重量份的原料制得：桂枝8份、女贞子5份、熟地5份、淫羊藿3份、山药10份、巴戟天5份、厚朴10份、生姜3份、制何首乌10份、黄芪8份、百合5份、茯苓10份、肉苁蓉3份、当归5份、党参3份、枸杞子3份、酸枣仁5份、黄芩10份、金银花10份、连翘3份、白术5份、白头翁5份、五倍子5份、甘草10份。
4.如权利要求1所述的中药组合物，其特征在于，所述的中药组合物主要由以下重量份的原料制得：桂枝20份、女贞子15份、熟地15份、淫羊藿10份、山药25份、巴戟天15份、厚朴20份、生姜10份、制何首乌20份、黄芪20份、百合12份、茯苓20份、肉苁蓉10份、当归15份、党参10份、枸杞子10份、酸枣仁12份、黄芩15份、金银花20份、连翘10份、白术15份、白头翁15份、五倍子25份、甘草20份。
5.如权利要求1所述的中药组合物，其特征在于，所述的中药组合物主要由以下重量份的原料制得：桂枝12份、女贞子12份、熟地10份、淫羊藿5份、山药16份、巴戟天18份、厚朴13份、生姜6份、制何首乌20份、黄芪10份、百合8份、茯苓16份、肉苁蓉6份、当归10份、党参5份、枸杞子8份、酸枣仁7份、黄芩8份、金银花14份、连翘10份、白术5份、白头翁15份、五倍子15份、甘草17份。
6.如权利要求1-5任一所述的中药组合物，其特征在于，所述的中药组合物为散剂、合剂、片剂或胶囊剂。
7.一种制备权利要求1-5任一所述中药组合物的方法，其特征在于，所述制备方法包括如下步骤：取处方量中药材碎成粗粉，按照粗粉总重量的4～9倍加入体积浓度为40％～95％的乙醇溶液，回流提取三次，回流时间为2～5h，滤过，滤液合并后回收乙醇，冷却过滤，用水洗涤，干燥后即得中药浸膏；本领域技术人员可在该制备方法技术上制备得到临床上常用中药药物剂型。
8.如权利要求1-5任一所述的中药组合物在制备治疗雄性功能障碍的药物中的用途。
9.如权利要求8所述的用途，其特征在于，所述的雄性功能障碍为神经性雄性功能障碍。
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