CN102357190B - 一种治疗前列腺增生的中药制剂 - Google Patents
一种治疗前列腺增生的中药制剂 Download PDFInfo
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- CN102357190B CN102357190B CN 201110334112 CN201110334112A CN102357190B CN 102357190 B CN102357190 B CN 102357190B CN 201110334112 CN201110334112 CN 201110334112 CN 201110334112 A CN201110334112 A CN 201110334112A CN 102357190 B CN102357190 B CN 102357190B
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Abstract
本发明提供一种治疗前列腺增生症的中药制剂,其活性成分由下列重量配比的原料制成:北沙参10-15,石莲子9-12,赤茯苓10-15,赤芍10-15,炙甘草3-6,生地黄10-20,车前子5-10,麦门冬10-15,毛柴胡3-10,地骨皮6-15,炙黄芪10-15。制备的药物为下列之一的剂型:口服液、胶囊、片剂、丸剂或散剂。本发明不仅能补益元气,清心火,交心肾,通肾水,增强膀胱收缩功能,促进前列腺体积缩小,有效缓解膀胱出口梗阻症状;而且对人体气血及五脏生理功能具有协调平衡作用,调理气机,达到治病求本的目的;且具有剂量轻,疗效确切,疗程短,治愈率高,减少手术治疗概率,副作用小等优点。
Description
技术领域
本发明涉及一种中药制剂,更具体的是涉及一种治疗前列腺增生伴有下尿路梗阻症状的中药制剂,适合于治疗老年前列腺增生症。
背景技术
前列腺增生症系前列腺基质和(/或)腺体增生的特殊病理改变,导致良性前列腺增大,及膀胱出口梗阻,多发生于50岁以上的男性患者,是引起中老年男性排尿障碍原因中最为常见的一种良性疾病。1984年Berry等总结了5组来自不同国家尸检报告,发现组织学前列腺增生的发生率随着年龄增长而逐渐增加,40岁以后其发生率比较明显,40-49岁年龄组约为20%,50-59岁年龄组约为40%,60-69岁年龄组约为70%,70-79岁约为80%,80岁以上年龄组约为90%以上。大约有50%组织学前列腺增生的男性有中~重度下尿路症状。1997年Homma等调查研究表明,在组织学前列腺增生患者中,中~重度下尿路症状的发生率是随着年龄增长而增加:40-49岁年龄组约为18%,50-59岁年龄组约为29%,60-69岁年龄组约为40%,70-79岁约为56%.除此之外,研究还发现亚洲人较美州人更易于长生中~重度下尿路症状。
迄今为止,良性前列腺增生的发生具体机制尚不清楚,可能由于表皮和间质细胞的增殖以及细胞凋亡的平衡性破坏引起。组织病理学证实,良性前列腺增生的特点是在尿道周围的前列腺组织内表皮与间质细胞的增殖。总的说来,良性前列腺增生的因素包括雌雄激素、生长因子、神经递质、环境和遗传导致间质-表皮细胞增殖,最终导致良性前列腺增生。对于良性前列腺增生如果不予治疗,可出现很多并发症,比如急性尿潴留、肾功能不全、尿路感染、肉眼血尿、膀胱功能失代偿等。
目前治疗现状:一、对于轻度下尿路症状,以及中度以上下尿路症状同事生活质量尚未受到明显影响的患者,可采取观察等待治疗措施。二、良性前列腺增生药物治疗主要包括α-受体阻滞剂、5α还原酶抑制剂以及中药和植物制剂,缓解了患者下尿路症状,延缓疾病的临床进展及并发症发生。三、但当患者药物治疗效果不佳,下尿路症状已明显影响到患者生活质量的患者,均考虑采取外科手术治疗。
中医药及植物制剂在缓解良性前列腺增生相关下尿路症状方面获得一定临床疗效,在国内外取得了广泛临床应用。
发明内容
本发明的目的是提供一种治疗前列腺增生症的中药制剂, 其活性成分由下列重量配比的原料制成:北沙参10-15,石莲子9-12,赤茯苓10-15,赤芍10-15,炙甘草3-6,生地黄10-20,车前子5-10,麦门冬10-15,毛柴胡3-10, 地骨皮6-15,炙黄芪10-15。
本发明制备的药物为下列之一的剂型:口服液、胶囊、片剂、丸剂或散剂。
上述制剂组中,北沙参含生物碱、淀粉、多糖、多种香豆素类成分,微量挥发油等成分;炙黄芪含有多种黄芪皂甙、黄酮、 黄芪多糖,以及氨基酸、亚油酸、生物碱、胆碱等复杂的化学成分,蜜炙部分增加了黄芪的抗氧化效能;炙甘草含有甘草甜素、甘草次酸、甘草多糖等多种化学成分。北沙参、炙黄芪、炙甘草补益元气,而清虚火作用。地骨皮含甜菜碱、桂皮酸、蜂花酸、亚油酸、亚麻酸、卅一酸、β-谷甾醇、柳杉酚、枸杞酰胺、维生素B1、苦柯胺A、东莨菪内酯等成分;赤芍含芍药甙、芍药内酯甙、羟基芍药甙、苯甲酰芍药甙;生地黄主要含甾醇类(如β-谷甾醇、少量豆甾醇、菜油固醇等多种甾醇类;20多种苷类,以环烯醚萜苷类为主,如梓醇、二氢梓醇、地黄素、桃叶珊瑚苷、胡萝卜苷、密力特苷),多糖类成分(如水苏糖、棉子糖、葡萄糖、蔗糖、果糖、甘露三糖、毛蕊花糖、半乳糖、1,2-基-半乳糖苷),还含甘露醇、维生素A、生物碱、氨基酸等成分。地骨皮、生地黄、赤芍,清肝肾火而凉血作用。柴胡含柴胡皂苷(saikosapoins a、 b、 c、 d 四种),甾醇,挥发油(柴胡醇、丁香酚等),脂肪酸(油酸、亚麻油酸、棕榈酸、硬脂酸等)和多糖等,还含黄酮、多元醇、香豆素和微量元素等成份。柴胡泄肝胆火作用。麦门冬含麦冬皂甙A、B、B’、C、C’、D、D、、麦冬酮A、B、甲基麦冬黄酮A、B、二氢麦冬黄酮A、B。麦门冬清心肺火作用。赤茯苓含含β-茯苓聚糖约占干重93%和三萜类化合物乙酰茯苓酸、茯苓酸、3β-羟基羊毛甾三烯酸,此外,尚含树胶、甲壳质、蛋白质、脂肪、甾醇、卵磷脂、葡萄糖、腺嘌呤、组氨酸、胆碱、β-茯苓聚糖分解酶、脂肪酶、蛋白酶;车前子含有车前子酸、琥珀酸、腺嘌呤、胆碱等、棕榈酸、硬脂酸、花生酸、亚油酸、亚麻酸等及车前子胶。
赤茯苓、车前子清下焦湿热作用。石莲子含多量的淀粉、棉子糖、荷叶碱、N-去甲基荷叶碱、氧化黄心树宁和 N-去甲亚美罂粟碱、蛋白质、脂肪及钙、磷、铁盐。石莲子清肾火而通肾水,从而使尿道通畅,小便清长。
本发明的优点是:不仅能补益元气,清心火,交心肾,通肾水,增强膀胱收缩功能,促进前列腺体积缩小,有效缓解膀胱出口梗阻症状;而且对人体气血及五脏生理功能具有协调平衡作用,调理气机,达到治病求本的目的。本发明能集食疗、药疗、保健于一体的方剂,能改善前列腺增生临床症状,延缓或阻止该病得发生。根据门诊疗效随访,临床不适症状改善或消失达85%,而且剂量轻,疗效确切,疗程短,治愈率高,减少手术治疗概率,副作用小等优点。
具体实施方式
下面结合实施例对本发明作进一步的说明。
实施例1
组方及各组分重量份比为:北沙参12,石莲子9,赤茯苓12,赤芍15,炙甘草6,生地黄15,车前子9,麦门冬12,毛柴胡6, 地骨皮12,炙黄芪15。
将上述组分按重量份称取后,将原料按常规口服液生产工艺制成口服液。
实施例2
组方及各组分重量份比为:北沙参15,石莲子12,赤茯苓15,赤芍12,炙甘草5,生地黄12,车前子10,麦门冬12,毛柴胡6, 地骨皮12,炙黄芪15。
将上述组分按重量份称取后,将原料按常规蜜丸生产工艺制成蜜丸。
实施例3
组方及各组分重量份比为:北沙参15,石莲子10,赤茯苓12,赤芍115,炙甘草6,生地黄20,车前子10,麦门冬15,毛柴胡9, 地骨皮12,炙黄芪12。
将上述组分按重量份称取后,将原料按常规片剂生产工艺制成片剂。
实施例4
组方及各组分重量份比为:
北沙参15,石莲子,12,赤茯苓12,赤芍12,炙甘草3,生地黄18,车前子10,麦门冬12,毛柴胡9, 地骨皮15,炙黄芪15。
将上述组分按重量份称取后,将原料按常规胶囊生产工艺制成胶囊。
实施例5
组方及各组分重量份比为:
北沙参12,石莲子,12,赤茯苓10,赤芍15,炙甘草6,生地黄20,车前子10,麦门冬12,毛柴胡10, 地骨皮12,炙黄芪15。
将上述组分按重量份称取后,将原料按常规散剂生产工艺制成散剂。
实施例6
取实施例1制备的口服液选择临床诊断为前列腺增生伴膀胱出口梗阻、排尿不畅患者200例,根据年龄及疾病严重程度等变化,服药剂量每日2次,每次10-30ml,每4周为1疗程,随访36-48月。疗效判断:自觉排尿通畅,夜尿为0-1次,尿路感染、血尿消失,停药12月内无复发,为临床治愈;治愈后12月内再次复发,为有效;临床症状减轻但尚未达到治愈为缓解。结果:治愈73例,有效42例,缓解23例,总有效率达79%。
实施例7
取实施例2制备的蜜丸选择临床诊断为前列腺增生伴膀胱出口梗阻、排尿不畅患者100例,根据年龄及疾病严重程度等变化,服药剂量每日3次,每次2g,每4周为1疗程,随访36-48月。疗效判断:自觉排尿通畅,夜尿为0-1次,尿路感染、血尿消失,停药12月内无复发,为临床治愈;治愈后12月内再次复发,为有效;临床症状减轻但尚未达到治愈为缓解。结果:治愈33例,有效18例,缓解22例,总有效率达73%。
实施例8
取实施例5制备的散剂选择临床诊断为前列腺增生伴膀胱出口梗阻、排尿不畅患者100例,根据年龄及疾病严重程度等变化,服药剂量每日3次,每次3g,每4周为1疗程,随访36-48月。疗效判断:自觉排尿通畅,夜尿为0-1次,尿路感染、血尿消失,停药12月内无复发,为临床治愈;治愈后12月内再次复发,为有效;临床症状减轻但尚未达到治愈为缓解。结果:治愈32例,有效17例,缓解26例,总有效率达75%。
无需进一步详细阐述,相信采用前面所公开的内容,本领域技术人员可以最大限度的应用本发明。因此,前面的实施方案应理解为仅为举例说明,而非以任何形式限制本发明的范围。
Claims (2)
1.一种治疗前列腺增生症的中药制剂, 其活性成分由下列重量配比的原料制成:北沙参10-15,石莲子9-12,赤茯苓10-15,赤芍10-15,炙甘草3-6,生地黄10-20,车前子5-10,麦门冬10-15,毛柴胡3-10, 地骨皮6-15,炙黄芪10-15。
2.根据权利要求1所述的一种治疗前列腺增生症的中药制剂, 其特征在于,制备的药物剂型选用口服液、胶囊、片剂、丸剂或散剂。
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