CN103656533B - 一种治疗慢性前列腺炎的中药组合物 - Google Patents
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Abstract
本发明公开了一种治疗慢性前列腺炎的中药组合物，涉及中药技术领域。其由以下重量份原料制成：车前草18-24、红花2-4、巴戟天12-24、淫羊藿12-18、黄芪20-40、莪术12-24、石莲子20-28、沉香3-6、太子参6-12、甘草6-18。本发明中药组合物主要通过调和阴阳，补益肝肾，清热利尿，消肿止痛，利湿通淋，达到治疗慢性前列腺炎的目的。
Description
技术领域
本发明涉及一种治疗前列腺炎的药物，特别是涉及一种以中药为原料药制备的治疗慢性前列腺炎的中药组合物。
背景技术
慢性前列腺炎是男性的常见病和多发病，症状复杂，顽固难愈，容易复发，治疗棘手。慢性前列腺炎发病率较急性为多，多发于青壮年，少部分为急性期转变而来，大多数患者未经急性过程而直接呈慢性炎症状态。本病归于中医学的“精浊”等范畴。病理病机为忍精不泄，败精瘀浊，留于下焦，日久化热生湿而腐；或性交不洁，感染病原体和细菌等淫毒循窍内侵；或肺脾素虚，时宜感冒，病邪不去，引动下焦湿热而成；或湿热久蕴不清，扰乱精室，熏蒸精室而致；或手淫过频，房事大过，导致腺体过份充血，脉络失畅，气血瘀滞而致本病；或久病及肾，肾气亏虚，封藏失职，则精关不固，精浊下泄不已而致。
就目前而言，治疗的方法较多，主要采用药物治疗，而且主要是西药治疗，但西药治疗前列腺炎的效果不是很理想，如常用的西药“前列腺片”，总有效率仅86％，治愈率就更低了。采用“局剖穿刺给药”的治疗前列腺炎的方法，虽然总的有效率高达90％，但增加病人的痛苦，而且引起病人术后尿道出血，诱发前列腺浓肿的事件时有发生，广泛推广有一定的难度。目前治疗前列腺炎的中药很多，但都是见效慢，疗效不近人意，且容易反弹，久治不愈给患者带来内心的痛苦和经济上的负担。
发明内容
本发明的目的是提供一种见效快，疗效显著，疗程短，愈后不复发的中药组合物及药物制剂，主要用于治疗慢性前列腺炎。
本发明解决技术问题所采用如下的技术方案：
本发明一种治疗慢性前列腺炎的中药组合物，由如下重量份的原料制成：车前草18-24份、红花2-4份、巴戟天12-24份、淫羊藿12-18份、黄芪20-40份、莪术12-24份、石莲子20-28份、沉香3-6份、太子参6-12份、甘草6-18份。
经过发明人长期的研究发现，本发明治疗慢性前列腺炎的中药组合物优选由如下重量份的原料制成：车前草20份、红花2.5份、巴戟天22份、淫羊藿16份、黄芪22份、莪术18份、石莲子22份、沉香4份、太子参6份、甘草10份。
本发明中药组合物中：
车前草：为车前科植物车前Plantago asiatica L.或平车前Plantago depressa Willd.的干燥全草；夏季采挖，除去泥沙，晒干；性味：甘，寒。归肝、肾、肺、小肠经；清热利尿，凉血，解毒；主治热结膀胱，小便不利，淋浊带下，暑湿泻痢，衄血，尿血，肝热目赤，咽喉肿痛，痈肿疮毒；
红花：为菊科植物红花Carthamus tinctorius L.的干燥花；夏季花由黄变红时采摘取管状花，注意勿伤基部的子房，除去杂质，阴干或微火烘干，此时质较软，色深红最佳；辛，温。归心、肝经。活血通经，散瘀止痛；用于经闭，痛经，恶露不行，症瘕痞块，跌扑损伤，疮疡肿痛；
巴戟天：为茜草科植物巴戟天Morinda officinalis How 的干燥根；全年均可采挖，洗净，除去须根，晒至六、七成干，轻轻捶扁，晒干；甘，辛，微温。
归肾、肝经；补肾阳，强筋骨，祛风湿。用于阳痿遗精，宫冷不孕，月经不调，少腹冷痛，风湿痹痛，筋骨痿软；
淫羊藿：为小檗科植物淫羊藿Epimedium brevicornum Maxim.、箭叶淫羊藿Epimedium sagittatum （Sieb.et Zucc.）Maxim. 、柔毛淫羊藿Epimedium pubescens Maxim.、巫山淫羊藿Epimedium wushanense T.S.Ying、或朝鲜淫羊藿Epimedium koreanum Nakai的干燥地上部分；夏、秋季茎叶茂盛时采割，除去粗梗及杂质，晒干或阴干；辛、甘，温。归肝、肾经；补肾阳，强筋骨，祛风湿；用于阳痿遗精，筋骨痿软，风湿痹痛，麻木拘挛；更年期高血压；
黄芪：为豆科植物蒙古黄芪 Astragalus membranaceus （Fisch.） Bge. var. mongholicus （Bge.）Hsiao 或膜荚黄芪 Astragalus membranaceus （Fisch.） Bge.的干燥根；春、秋二季采挖，除去须根及根头，晒干；甘，温；归肺、脾经；
补气固表，利尿托毒，排脓，敛疮生肌；用于气虚乏力，食少便溏，中气下陷，久泻脱肛，便血崩漏，表虚自汗，气虚水肿，痈疽难溃，久溃不敛，血虚痿黄，内热消渴；慢性肾炎蛋白尿，糖尿病；
莪术：为姜科植物蓬莪术 Curcuma phaeocaulis Val.、广西莪术 Curcuma Kwangsiensis S. G.Lee et C. F. Liang或温郁金Curcuma wenyujin Y.H. Chen et C. Ling的干燥根茎。后者习称“温莪术”；冬季茎叶枯萎后采挖，洗净，蒸或煮至透心，晒干或低温干燥后除去须根及杂质；辛、苦，温。归肝、脾经；行气破血，消积止痛；用于燀瘕痞块，瘀血经闭，食积胀痛；早期宫颈癌；
石莲子：为睡莲科植物莲Nelumbo nucifera Gaertn.的老熟果实；10月莲子成熟时，割下莲蓬，取出果实晒干；或拾取落入泥中之莲实，洗净晒干；甘、微苦，平；甘；涩；微苦；寒脾；胃；心；肺经；清湿热；开胃迸食；清心宁神；涩精止泄；主噤口痢；呕吐不食；心烦失眠；遗精；尿浊；带下；
沉香：为瑞香科植物白木香Aquilaria sinensis （Lour.） Gilg 含有树脂的木材；全年均可采收，割取含树脂的木材，除去不含树脂的部分，阴干；性味辛、苦，微温；归经归脾、胃、肾经；功能主治行气止痛，温中止呕，纳气平喘；用于胸腹胀闷疼痛，胃寒呕吐呃逆，肾虚气逆喘急；
太子参：为石竹科植物孩儿参Pseudostellaria heterophylla （Miq.）Pax ex Pax et Hoffm.的干燥块根；夏季茎叶大部分枯萎时采挖，洗净，除去须根，置沸水中略烫后晒干或直接晒干；性味甘、微苦，平。归经归脾、肺经；功能主治益气健脾，生津润肺；用于脾虚体倦，食欲不振，病后虚弱，气阴不足，自汗口渴，肺燥干咳；
甘草：为豆科植物甘草 Glycyrrhiza uralensis Fisch.、胀果甘草 Glycyrrhiza inflata Bat. 或光果甘草 Glycyrrhiza glabra L. 的干燥根；春、秋二季采挖，除去须根，晒干；性味甘，平；归经归心、肺、脾、胃经 ；功能主治补脾益气，清热解毒，祛痰止咳，缓急止痛，调和诸药；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。
本发明还提供了一种治疗慢性前列腺炎药物的制备方法，具体地制备方法如下：
分别称取车前草、红花、巴戟天、淫羊藿、黄芪、莪术、石莲子、沉香、太子参、甘草，粉碎成细粉，过100目筛，混匀；按每100g粉末加炼蜜30-50g与适量的水，泛丸，干燥，即得。
本发明还可以采用常规的制备方法制成胶囊、片剂、丸药、散剂、糖浆或口服液。
本发明中药组合物可以相互协同，具有调和阴阳，补益肝肾，清热利尿，消肿止痛，利湿通淋的作用，可以起到治疗慢性前列腺炎的目的。
为进一步考察本发明药物的临床疗效和安全性，选择98例慢性前列腺病患者对本发明药物的疗效进行临床观察。
将98例病例随机分为两组，一组为治疗组68人，一组为对照组30人，全部病例均根据《中药新药治疗慢性前列腺炎的临床研究指导原则》确诊为前列腺炎。
前列腺炎进行疗效性观测：（1）相关症状及体征，前列腺触诊；（2）EPS 检查；（3）B 超检查；（4）分段尿测试；（5）精液染色片观测；（6）前列腺液细菌培养，衣原体、鲜尿支原体检查。
疗效评定标准：
参照《中药新药临床研究指导原则》(2002年发布)“中药新药治疗慢性前列腺炎症临床指导原则”中的疗效评价标准，并根据具体观察指标有所变化。
临床痊愈：症状消失，EPS检查连续2次以上正常，肛诊压痛消失，质地正常或接近正常，B超检查大致正常。
显效：症状基本消失，EPS检查连续2次以上WBC值较前减少1∕2或＜15个∕HP，触诊压痛及质地均有改善，B超检查有所改善。
有效：症状减轻，EPS检查较前改善。
无效：症状、体征及EPS检查均无改善或加重。
治疗方法：
治疗组：采用采用本发明实施例1制备的药物，口服，一日2次，一次10g，30天为一疗程，治疗2个疗程。
对照组采用氟哌酸，口服，一日3次，200 mg/次；前列康片，口服，一日3次，一次4片。1个月为1个疗程，共2个疗程。
注：在进行药物治疗的同时允许采用以下治疗措施和注意事项：(1)排尿训练；(2) 每晚睡前按摩前列腺3～5 min；(3)忌辛辣厚腻饮食。
统计学处理：
采用spss13.0 软件对资料信息进行统计学分析,计数资料用χ2检验；计量资料采用t 检验。
两组临床疗效比较：
表1 两组临床疗效比较（例）
注：与西药组比较﹡P<0.05
临床实验结果证明，本发明药物作用明显优于对照组，未见任何不良反应。
具体实施方式
实施例1
称取车前草20g、红花2.5g、巴戟天22g、淫羊藿16g、黄芪22g、莪术18g、石莲子22g、沉香4g、太子参6g、甘草10g，粉碎成细粉，过100目筛，混匀。按每100g粉末加炼蜜40g与适量的水，泛丸，干燥，即得。
实施例2
称取车前草24g、红花4g、巴戟天22g、淫羊藿18g、黄芪22g、莪术20g、石莲子20g、沉香6g、太子参8g、甘草18g，粉碎成细粉，过100目筛，混匀。按每100g粉末加炼蜜40g与适量的水，泛丸，干燥，即得。
Claims (3)
1.一种用于治疗慢性前列腺炎的中药组合物，其特征在于由如下重量份的原料制成：车前草20份、红花2.5份、巴戟天22份、淫羊藿16份、黄芪22份、莪术18份、石莲子22份、沉香4份、太子参6份、甘草10份。
2.一种制备如权利要求1所述治疗慢性前列腺炎的中药组合物的方法，其特征在于包括如下工艺步骤：分别称取车前草、红花、巴戟天、淫羊藿、黄芪、莪术、石莲子、沉香、太子参、甘草，粉碎成细粉，过100目筛，混匀；按每100g粉末加炼蜜30-50g与适量的水，泛丸，干燥，即得。
3.如权利要求1所述治疗慢性前列腺炎的中药组合物，其特征在于：所述中药组合物为胶囊、片剂、丸药、散剂、糖浆或口服液。
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