CN111803607B - 一种用于治疗良性前列腺肥大合并肥胖症的药物组合物及其制备方法 - Google Patents
一种用于治疗良性前列腺肥大合并肥胖症的药物组合物及其制备方法 Download PDFInfo
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Abstract
本发明涉及医药领域,尤其涉及一种用于治疗良性前列腺肥大合并肥胖症的药物组合物及其制备方法和应用。所述用于治疗良性前列腺肥大合并肥胖症的药物组合物,是由如下重量份数的成分组成:炙黄芪4‑24份,人参2‑12份,麸炒白术3‑18份,肉苁蓉片1‑6份,山萸肉1‑6份,鹿角霜1‑6份,滑石2‑12份,泽泻2‑12份,夏枯草2‑12份,郁金2‑12份,北柴胡1‑6份,升麻1‑6份,远志2‑12份,生蒲黄1‑6份。本发明提供的药物组合物具有健脾固肾、清热散瘀、理气化痰、通利水道、升清降浊之功效,临床实验结果表明所述的药物组合物能够有效减轻患者症状,提高生存质量,依从性好,不良反应少,价格低廉,其制备方法适合工业化生产,便于开发应用。
Description
技术领域
本发明涉及医药领域,尤其涉及一种用于治疗良性前列腺肥大合并肥胖症的药物组合物及其制备方法和应用。
背景技术
前列腺肥大,又称良性前列腺增生症(BPH),多发生于50岁以上的老年男子,是一种前列腺明显增大而影响老年男性健康的常见病,主要表现为排尿不畅、尿频、尿急、下腹部不适等症状。BPH的发病机制尚不明确,但研究显示与代谢性疾病相关,且年龄呈下降趋势。肥胖症,是指体内脂肪积聚过多和(或)分布异常与体质量增加,是由于遗传、饮食等因素共同作用的慢性代谢性疾病。近年来,国内外研究表明,BPH与肥胖症的发生呈相关性,且有研究表明,肥胖症是导致BPH的独立危险因素之一。中医理论同样支持该研究结果,认为两者均由痰瘀内,生气血瘀阻导致,可从脾论治。
目前市场上用于治疗BPH的中药制剂主要针对50岁以上的老年男子,中医治疗原则主要从肾入手。经检索,能够同时用于治疗肥胖症和BPH的药物专利主要是以雄激素受体调节剂为主的西药化合物,由于经济条件、激素副作用大等多方面因素,因此探索中医药治疗方法有效防治良性前列腺肥大合并肥胖症是目前重要的研究热点,研制一种用于治疗良性前列腺肥大合并肥胖症的药物制剂成为目前亟待解决的问题。
发明内容
针对上述问题,本发明的目的提供一种用于治疗良性前列腺肥大合并肥胖症的药物组合物及其制备方法,本发明提供的药物组合物抓住导致良性前列腺肥大的独立危险因素即肥胖症,并且从中医理论出发,从共同病理因素“痰瘀”入手,从脾论治,抓住导致疾病的根本因素,所述的药物组合物具有健脾固肾、清热散瘀、理气化痰、通利水道、升清降浊之功效,在临床上用于治疗良性前列腺肥大合并肥胖症而出现的排尿不适症等症状,疗效显著。大量临床经验及试验结果表明本发明提供的药物组合物能够有效减轻患者症状、提高生存质量,且所述的药物组合物价格低廉、依从性好、不良反应少,其制备方法适合工业化生产,便于开发应用。
为了实现上述目的,本发明采用以下技术方案。
一种用于治疗良性前列腺肥大合并肥胖症的药物组合物,是由如下重量份数的成分组成:炙黄芪4-24份,人参2-12份,麸炒白术3-18份,肉苁蓉片1-6份,山萸肉1-6份,鹿角霜1-6份,滑石2-12份,泽泻2-12份,夏枯草2-12份,郁金2-12份,北柴胡1-6份,升麻1-6份,远志2-12份,生蒲黄1-6份。
所述用于治疗良性前列腺肥大合并肥胖症的药物组合物的制备方法,具体包括以下步骤:按处方比例称取炙黄芪、人参、麸炒白术、肉苁蓉片、山萸肉、鹿角霜、滑石、泽泻、夏枯草、郁金、北柴胡、升麻、远志、生蒲黄,混合均匀;加水煎煮二次,第一次加相当于药材重量6-10倍的水,煎煮1-3小时,滤过;第二次加相当于药材重量4-8倍的水,煎煮0.5-2.5小时,滤过,合并滤液,滤液浓缩至相对密度为1.2~1.3g/mL(30℃-60℃),加入适量的糊精,混匀,制成颗粒,干燥,制成1000g,分装,即得。
所述用于治疗良性前列腺肥大合并肥胖症的药物组合物中各组成成分的药理作用及功效如下。
黄芪:甘,温。归肺、脾经。具有补气固表,利尿托毒,排脓,敛疮生肌之用。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。
人参:甘、微苦,平。归脾、肺、心经。功能大补元气,复脉固脱,补脾益肺,生津,安神。用于体虚欲脱,肢冷脉微,脾虚食少,肺虚喘咳,津伤口渴,内热消渴,久病虚羸,惊悸失眠,阳痿宫冷;心力衰竭,心原性休克。
白术:苦、甘,温。归脾、胃经。功能健脾益气,燥湿利水,止汗,安胎。用于脾虚食少,腹胀泄泻,痰饮眩悸,水肿,自汗,胎动不安。
肉苁蓉:甘、咸,温。归肾、大肠经。功能补肾阳,益精血,润肠通便。用于阳痿,不孕,腰膝酸软,筋骨无力,肠燥便秘。
山萸肉:酸、涩,微温。归肝、肾经。功能补益肝肾,涩精固脱。用于眩晕耳鸣,腰膝酸痛,阳痿遗精,遗尿尿频,崩漏带下,大汗虚脱。内热消渴。
鹿角霜:甘,平,无毒。补中益气,止痛安胎。治一切血病,吐血下血尿血血崩血闭,疗诸般劳症,益髓长肌,肥身悦颜。淋露折伤之苦,疮痔肿毒之。除赤白之漏下,助阴分而生子。
滑石:甘、淡,寒。归膀胱、肺、胃经。功能利尿通淋,清热解暑,祛湿敛疮。用于热淋,石淋,尿热涩痛,暑湿烦渴,湿热水泻;外治湿疹,湿疮,痱子。
泽泻:甘,寒。归肾、膀胱经。功能利小便,清湿热。用于小便不利,水肿胀满,泄泻尿少,痰饮眩晕,热淋涩痛;高血脂。
夏枯草:辛、苦,寒。归肝、胆经。功能清火,明目,散结,消肿。用于目赤肿痛,目珠夜痛,头痛眩晕,瘰疬,瘿瘤,乳痈肿痛;甲状腺肿大,淋巴结结核,乳腺增生,高血压。
郁金:辛、苦,寒。归肝、心、肺经。功能行气化瘀,清心解郁,利胆退黄。用于经闭痛经,胸腹胀痛、刺痛,热病神昏,癫痫发狂,黄疸尿赤。
柴胡:苦,微寒。归肝、胆经。功能和解表里,疏肝,升阳。用于感冒发热,寒热往来,胸胁胀痛,月经不调,子官脱垂,脱肛。
升麻:辛、微甘,微寒。归肺、脾、胃、大肠经。功能发表透疹,清热解毒,升举阳气。用于风热头痛,齿痛,口疮,咽喉肿痛,麻疹不透,阳毒发斑;脱肛,子宫脱垂。
远志:苦、辛、温。归心、肾、肺经。功能安神益智,祛痰,消肿。用于心肾不交引起的失眠多梦,健忘惊悸,神志恍惚,咳痰不爽,疮疡肿毒,乳房肿痛。
生蒲黄:甘,平。归肝、心包经。功能止血,化瘀,通淋。用于吐血,衄血,咯血,崩漏,外伤出血,经闭痛经,脘腹刺痛,跌扑肿痛,血淋涩痛。
本发明提供的药食组合物配方中黄芪补脾益气,升阳固表,通利血脉;人参、白术健脾和中;茯苓益气健脾渗湿;肉苁蓉、山萸肉温补肾阳,以助气化;鹿角霜为血肉有情之品,用以补肾填精;滑石、泽泻利尿渗湿,通调水道;夏枯草清热散结消肿;郁金祛瘀行气止痛;柴胡、升麻升举清阳;远志、石菖蒲,一升一降,使气自顺而壅自开,痰瘀消散。诸药合用,从脾论治,共奏健脾固肾、清热散瘀、理气化痰、通利水道、升清降浊之功。
与现有技术相比,本发明的有益效果如下。
本发明的药食组合物,抓住导致良性前列腺肥大的独立危险因素,即肥胖症,以良性前列腺肥大合并肥胖症患者为研究对象,与现有对比文件相比,组方用药更具针对性;并且从中医“异病同治”理论出发,认为此部分人群的发病机理为:脾气虚,升清降浊及转输水液功能失常,运化失职,痰浊内生,阻滞气机,痰瘀互结,久而脾虚及肾,肾中阳气不足,气化无权。本发明从两种疾病状态的根本,即“脾虚”入手,从脾论治,益气健脾,使气血生化有源,气机升降出入有序,三焦水道通畅,水液代谢功能正常,膀胱气化功能协调,使痰瘀不生。本发明抓住导致疾病的根本因素,兼顾益肾固本,共奏健脾固肾、清热散瘀、理气化痰、通利水道、升清降浊之功效,临床有效用于治疗良性前列腺肥大合并肥胖症而出现的小腹坠胀,时欲小便而不得出,或量少而不畅等排尿不适,伴见形体肥胖,神疲乏力,食欲不振等症状,在改善患者排尿无力效果尤为突出。
与已有现有技术相比,专利号CN105125911A公开了一种用于调治前列腺增生的中药组合物,虽然与本发明提供的药物组合物中的肉苁蓉、泽泻、夏枯草、升麻4味药物相同,但其组方以祛湿利尿,利水通淋,清热解毒之品为君药,与本发明以益气健脾之品为君药组方思路不同,治疗重点不同;专利号CN107158318A公开一种用于治疗前列腺增生的胶囊剂药物,虽然与本发明提供的药物组合物中的茯苓、泽泻、郁金、夏枯草、肉苁蓉5味药物相同,专利号CN107261074A公开一种治疗前列腺增生的丸剂药物及其制备方法与本发明提供的药物组合物中的茯苓、肉苁蓉、山萸肉、泽泻、郁金5味药物相同,专利号CN109432319A公开了一种治疗前列腺增生的中药药物,与本发明提供的药物组合物中的黄芪、肉苁蓉、泽泻3味药物相同,虽然三篇专利未描述君臣佐使,但根据其组方中其它组成药物可见,该三篇专利提供的药物组合物组方均以清热、祛湿、逐瘀为主,兼以填补肾精,与本发明从脾论治的治疗思路有根本性的区别。
具体实施方式
下面结合具体实施例对本发明进行详细说明。
实施例1用于治疗良性前列腺肥大合并肥胖症的药物组合物的制备方法。
一种用于治疗良性前列腺肥大合并肥胖症的药物组合物,是由如下重量份数的成分组成:炙黄芪12份,人参6份,麸炒白术9份,肉苁蓉片3份,山萸肉3份,鹿角霜3份,滑石6份,泽泻6份,夏枯草6份,郁金6份,北柴胡3份,升麻3份,远志6份,生蒲黄3份。
所述用于治疗良性前列腺肥大合并肥胖症的药物组合物的制备方法,具体包括以下步骤:按处方比例称取炙黄芪、人参、麸炒白术、肉苁蓉片、山萸肉、鹿角霜、滑石、泽泻、夏枯草、郁金、北柴胡、升麻、远志、生蒲黄,混合均匀;加水煎煮二次,第一次加相当于药材重量6-10倍的水,煎煮1-3小时,滤过;第二次加相当于药材重量4-8倍的水,煎煮0.5-2.5小时,滤过,合并滤液,滤液浓缩至相对密度为1.2~1.3g/mL(30℃-60℃),加入适量的糊精,混匀,制成颗粒,干燥,制成1000g,分装,即得。
实施例2临床资料。
材料与方法。
1.受试对象。
1.1诊断标准。
1)西医诊断标准:参考卫生部制定的《中药新药临床研究指导原则(第3辑)》中良性前列腺增生症的诊断标准确立。
2)中医诊断标准:良性前列腺增生症属中医“癃闭”范畴,诊断标准参照《中医内科学》(普通高等教育“十五”国家级规划教材)中“脾气不升”型中医疾病及证候诊断标准。
①小腹坠胀,时欲小便而不得出,或量少而不畅。
②神疲乏力,食欲不振,气短而语声低微。
③舌淡,苔白。
④脉细。
2.2纳入标准。
1)45岁≤年龄≤65岁的成年男性。
2)符合脾气虚型良性前列腺增生的诊断标准。
3)超重或肥胖:体重指数(BMI)≥25.0kg/m2。
2.3排除标准。
1)不符合纳入标准者。
2)患严重精神系统疾病、腰椎间盘突出症、椎管狭窄、下腹或盆腔大手术、严重糖尿病等原因引起的膀胱疾病。
3)合并其他系统性疾病者。
4)患有心血管、脑血管、肝、肾、造血系统等疾病者。
2.4剔除标准。
1)未按规定食用受试物者。
2)资料不全等影响功效或安全性判断者。
2.试验设计及分组。
3.1试验分组。
30例受试者采用随机双盲法分为试食组和安慰剂对照组,每组各15人,一般条件均具有可比性,试验采用自身前后对照方案。
3.2试验方法。
患者服用本品,300ml水煎服,每日早、中、晚各1次,每次100ml,服用时间为90d。
3.3观察指标。
各项指标于试食试验开始前及结束时各测定1次。
观察治疗前及治疗90d后患者IPSS评分并对进行评定。
疗效评价标准:①临床控制:所有临床症状完全消失,IPSS评分改善在60%以上;②显效:所有临床症状基本消失,IPSS评分改善在45%-60%之间;③有效:所有临床症状有所好转,IPSS评分改善在30%~45%之间;④无效:临床症状无明显变化或继续加重,IPSS评分与治疗前相比无变化。治疗总有效率的计算方法为临床控制、显效、有效三者百分比。IPSS评分表,见表1。
表1.IPSS评分表。
3.4数据处理和结果判定。
数据处理用统计软件STSTS6.0计算分析数据,结果判定使用X2检验,p<0.05视为具有统计学差异。
4.结果。
4.1治疗前后临床治疗效果对比。
研究结果显示,临床治疗效果达到临床控制1例,显效10例,有效17例,无效2例,总有效率达93.3%。
表2.治疗前后临床治疗效果对比[例(%)]。
4.2治疗前后IPSS评分变化情况对比。
表3.治疗前后IPSS评分变化情况对比[例(%)]。
注:#与治疗前比较,p<0.05。
二、典型病例。
1、病例1。
王某,男,48岁,公司职员。
患者无明显诱因出现尿频尿急,每次排尿量少,不易排出,排尿无力,小腹坠胀,曾在西医院诊断为前列腺增生,同时血脂检查示高脂血症,经治疗后效果欠佳,遂到我院就诊。刻下症见:排尿困难,尿频而量少,排尿无力,乏力,食欲不振,小腹坠胀,便溏,舌质淡暗,舌苔厚腻,脉沉细而涩。查体见:患者体型配胖,身高168cm,体重102kg,BMI值36.1西医诊断:前列腺增生。中医诊断:癃闭(脾虚痰浊)。治以本发明实施例1提供的药物组合物14剂,每日1剂,300mL水煎服,早中晚各一次。复诊:患者自述症状好转,排尿无力感尤为缓解,乏力,食欲不振,便溏小腹坠胀感减轻。又14剂后复诊,患者排尿困难等症状基本缓解。
2、病例2。
李某,男50岁,软件设计师。
该患者长期伏案工作,体型偏胖,无明显诱因出现尿频尿急,排尿困难,点滴而出,怕冷,便溏,纳差,腹胀,伴见神疲乏力,语声低微,舌质暗淡,有瘀斑,脉沉。西医诊断:前列腺增生。中医诊断:癃闭(脾虚痰浊)。治以发明实施例1提供的药物组合物14剂,每日1剂,300mL水煎服,早中晚各一次。复诊:患者自述排尿困难、腹胀、乏力等症状好转,食欲增加。
3、病例3。
艾某,男51岁,公交车司机。
该患者长期久坐、憋尿习惯,超重,BMI值35。近日出现尿频尿急,夜尿增多,夜尿3-4次。患者自觉乏力,排尿无力,尿浊,有尿等待,约5分钟,平素腹部坠胀,纳差,大便不成型,舌质暗,舌苔白腻,脉滑。西医诊断:前列腺增生。中医诊断:癃闭(脾虚痰浊)。治以炙黄芪6g,人参3g,麸炒白术6g,肉苁蓉片3g,山萸肉3g,鹿角霜3g,滑石6g,泽泻6g,夏枯草6g,郁金6g,北柴胡3g,升麻3g,远志6g,生蒲黄3g。14剂,每日1剂,300mL水煎服,早中晚各一次。复诊:患者自述尿频尿急,夜尿增多症状略好转,夜尿2-3次,乏力,腹部坠胀,排尿无力,尿浊,尿等待等症状仍存在。调整益气健脾中药数量,予发明实施例1提供的药物组合物14剂,每日1剂,300mL水煎服,早中晚各一次。复诊:患者自述乏力,排尿无力,尿浊,腹部坠胀,纳差等症状明显好转,尿等待时间由5分钟缓解至1-2分钟,夜尿1次。
4、病例4。
熊某,男53岁,公务员。
该患者长期伏案工作,BMI值38,患者以尿频尿急,伴尿浊入院治疗。患者自觉排尿困难,尿线变细排尿无力,尿浊,有尿等待,约3分钟,平素乏力,困倦,腹部坠胀,纳差,大便不成型,舌质淡红,舌苔白腻,脉滑。西医诊断:前列腺增生。中医诊断:癃闭(脾虚痰浊)。治以炙黄芪18g,人参6g,麸炒白术15g,肉苁蓉片3g,山萸肉3g,鹿角霜3g,滑石6g,泽泻6g,夏枯草6g,郁金6g,北柴胡3g,升麻3g,远志6g,生蒲黄3g。14剂,每日1剂,300mL水煎服,早中晚各一次。患者服7剂,自觉症状未见好转,偶有胸闷,腹胀,遂来复诊,调整益气健脾中药剂量,予发明实施例1提供的药物组合物14剂,每日1剂,300mL水煎服,早中晚各一次。复诊:患者自述排尿困难,尿浊,乏力,困倦,腹部坠胀,纳差,大便不成型等症状明显好转,尿等待时长缓解至1分钟。
Claims (3)
1.一种用于治疗良性前列腺肥大合并肥胖症的药物组合物,其特征在于,各原料以重量份计为:炙黄芪4-24份,人参2-12份,麸炒白术3-18份,肉苁蓉片1-6份,山萸肉1-6份,鹿角霜1-6份,滑石2-12份,泽泻2-12份,夏枯草2-12份,郁金2-12份,北柴胡1-6份,升麻1-6份,远志2-12份,生蒲黄1-6份。
2.如权利要求1所述的用于治疗良性前列腺肥大合并肥胖症的药物组合物,各原料以重量份计为:炙黄芪12份,人参6份,麸炒白术9份,肉苁蓉片3份,山萸肉3份,鹿角霜3份,滑石6份,泽泻6份,夏枯草6份,郁金6份,北柴胡3份,升麻3份,远志6份,生蒲黄3份。
3.如权利要求1所述的用于治疗良性前列腺肥大合并肥胖症的药物组合物的制备方法,具体包括以下步骤:按处方比例称取炙黄芪、人参、麸炒白术、肉苁蓉片、山萸肉、鹿角霜、滑石、泽泻、夏枯草、郁金、北柴胡、升麻、远志、生蒲黄,混合均匀;加水煎煮二次,滤过,合并滤液,滤液浓缩至30℃-60℃时相对密度为1.2~1.3g/mL,加入适量的糊精,混匀,制成颗粒,干燥,制成1000g,分装,即得;
所述加水煎煮二次具体操作为第一次加相当于药材重量6-10倍的水,煎煮1-3小时,滤过;第二次加相当于药材重量4-8倍的水,煎煮0.5-2.5小时。
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