CN104524109A - 一种治疗肾阳虚衰型良性前列腺增生症的药物及制备方法 - Google Patents
一种治疗肾阳虚衰型良性前列腺增生症的药物及制备方法 Download PDFInfo
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Abstract
本发明提供了一种治疗肾阳虚衰型良性前列腺增生症的药物，制成该药物有效成分的原料组成为：党参、菟丝子、山茱萸、枸杞子、山药、车前子、蒲公英、白术、茯苓、川牛膝、王不留行，具有补肾益气、滋阴补阳、利水消肿之功效，可有效地减轻病者负担和痛苦，能够达到标本兼治的目的，对肾阳虚衰型良性前列腺增生效果显著。本发明还提供了该药物的制备方法，可制成多种口服剂型，服用方便。
Description
技术领域
本发明属于中药领域，具体涉及一种治疗肾阳虚衰型良性前列腺增生症的药物及其制备方法。
背景技术
良性前列腺增生症，民间称前列腺肥大，中医学无此病名，按其症状当属于中医学中的“癃闭”范畴。良性前列腺增生症是老年男性常见病之一，由于它在泌尿系所造成的梗阻，影响排尿，直接威胁肾功能，对患者的生活与健康带来严重的危害。
从西医角度看，良性前列腺增生症的病因目前尚不完全清楚，估计与老年人性激素平衡失调有关。从中医角度看，良性前列腺增生症“癃闭”虽然病标在膀胱，病本却在肾脏。膀胱的气化功能，取决于肾气的盛衰，肾气有助膀胱气化津液和主宰膀胱开阖以约束尿液的作用。肾气充实，固摄有权，膀胱气化有力，开阖有度，能够维持水液的正常代谢。如果肾气不充，则膀胱气化无力，开阖失度，水道不畅，出现尿频，小便不利等症状。
老年男性之所以容易患此病，原因在于人到老年之后，肾气自衰，阳气不足，气不摄纳。特别是多数老年病人往往兼有其他慢性病，年老体衰，久病体虚，更易导致肾气虚弱。
肾阳虚衰型良性前列腺增生由于肾阳虚衰，则气化无力，气化无力，则小便不利，滴沥不净，甚者尿闭。肾阳不充，气化不及膀胱，则腰以下有冷感。肾阳虚，则舌淡，脉虚弱，腰膝无力。肾开窍于耳，老年人肾气衰弱，故常伴有听力减退或耳聋。根据“治病必求其本”的原则，应采取补益肾气、温补肾阳的治法。
发明内容
发明人依据多年的从医经验以及肾阳虚衰型良性前列腺增生症的病因病机及其治法治则，提供了一种治疗肾阳虚衰型良性前列腺增生症的药物，制成所述药物有效成分的原料组成及重量份数为：党参10-16份、菟丝子15-20份、山茱萸9-13份、枸杞子20-26份、山药8-13份、车前子22-26份、蒲公英16-21份、白术9-15份、茯苓11-16份、川牛膝8-13份、王不留行5-9份。
优选地，上述所述治疗肾阳虚衰型良性前列腺增生症的药物，其原料组成及重量份数为：党参14份、菟丝子17份、山茱萸10份、枸杞子25份、山药11份、车前子25份、蒲公英20份、白术12份、茯苓13份、川牛膝10份、王不留行8份。
解方：方中菟丝子、枸杞子、山茱萸滋补肝肾，菟丝子性温偏于助阳，枸杞子性平偏于补阴，山茱萸酸涩能收，三药配伍既补肾阳，又补肾阴，以奏阴中求阳，滋补肝肾力强，为君药。党参补中益气、健脾益肺，白术健脾益气、燥湿利水，山药补脾养胃，生津益肺，补肾涩精，茯苓利水渗湿，四药共用健脾益气，燥湿利水；车前子、蒲公英清热利尿，渗湿通淋，共为臣药，与君药共奏温阳利水，标本兼治。王不留行活血通经，蒲公英消肿散结，川牛膝逐瘀通经、利尿通淋、阴药下行，配合臣药利水消肿之效佳，为佐使药。诸药合而为之，具有补肾益气、滋阴补阳、利水消肿之功效，对肾阳虚衰型良性前列腺增生效果显著。
一种治疗肾阳虚衰型良性前列腺增生症的药物的制备方法，包括以下工艺步骤：
(1)将菟丝子、山茱萸洗净，浸入4～6倍量的80％的乙醇溶液浸泡1～2小时，加热提取2小时，回收乙醇，滤过，得滤液，浓缩为稠膏，备用；
(2)将党参、枸杞子、山药、车前子、蒲公英、白术、茯苓、川牛膝洗净，加入8～10倍量的蒸馏水，浸泡3～4小时后，煮沸2～3小时，提取；再次加入6～8倍量蒸馏水，煮沸1.5～2小时，提取；合并提取液，过滤，得滤液，浓缩成稠膏，备用；
(3)将王不留行进行粉碎处理，研末，过180目细粉，备用；
(4)将上述步骤(1)～(3)所制得的稠膏以及细粉混合，按中药制剂常规工艺制成口服剂型，即得本发明所述的治疗肾阳虚衰型良性前列腺增生症的药物。
上述所述口服剂型可为片剂、胶囊剂、颗粒剂等。
本发明所用中药的药性如下：
党参：甘，平。归脾、肺经。功能主治：补中益气，健脾益肺。用于脾肺虚弱，气短心悸，食少便溏，虚喘咳嗽，内热消渴。
菟丝子：甘，温。归肝、肾、脾经。功能主治：滋补肝肾，固精缩尿，安胎，明目，止泻。用于阳痿遗精，尿有余沥，遗尿尿频，腰膝酸软，目昏耳鸣，肾虚胎漏，胎动不安，脾肾虚泻；外治白癜风。
山茱萸：酸、涩，微温。归肝、肾经。功能主治：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。
枸杞子：甘，平。归肝、肾经。功能主治：滋补肝肾，益精明目。用于虚劳精亏，腰膝酸痛，眩晕耳鸣，内热消渴，血虚萎黄，目昏不明。
山药：甘，平。归脾、肺、肾经。功能主治：补脾养胃，生津益肺，补肾涩精。用于脾虚食少，久泻不止，肺虚喘咳，肾虚遗精，带下，尿频，虚热消渴。麸炒山药补脾健胃。用于脾虚食少，泄泻便溏，白带过多。
车前子：甘，微寒。归肝、肾、肺、小肠经。功能主治：清热利尿，渗湿通淋，明目，祛痰。用于水肿胀满，热淋涩痛，暑湿泄泻，目赤肿痛，痰热咳嗽。
白术：苦、甘，温。归脾、胃经。功能主治：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。土白术健脾，和胃，安胎。用于脾虚食少，泄泻便溏，胎动不安。
茯苓：甘、淡，平。归心、肺、脾、肾经。功能主治：利水渗湿，健脾宁心。用于水肿尿少，痰饮眩悸，脾虚食少，便溏泄泻，心神不安，惊悸失眠。
川牛膝：甘、微苦，平。归肝、肾经。功能主治：逐瘀通经，通利关节，利尿通淋。用于经闭症瘕，胞衣不下，关节痹痛，足痿筋挛，尿血血淋，跌扑损伤。
蒲公英：苦、甘，寒。归肝、胃经。功能主治：清热解毒，消肿散结，利尿通淋。用于疔疮肿毒，乳痈，瘰疠，目赤，咽痛，肺痈，肠痈，湿热黄疸，热淋涩痛。
王不留行：苦，平。归肝、胃经。功能主治：活血通经，下乳消肿。用于乳汁不下，经闭，痛经，乳痈肿痛。
本发明药物所选药材配伍相宜，符合中医药学和现代医药学理论，并具有补肾益气、滋阴补阳、利水消肿之功效，对治疗肾阳虚衰型良性前列腺增生症具有显著的疗效，服用方便，治愈后不复发，安全无毒副作用，可有效地减轻病者负担和痛苦，能够达到标本兼治的目的，成本低廉，值得临床上广泛推广应用。
具体实施方式
下面结合具体实施方式及试验例对本发明作进一步的详细描述。但不应将此理解为本发明上述主题的范围仅限于以下的实施例，凡基于本发明内容所实现的技术均属于本发明的范围。
实施例1
处方：原料组成及重量份数为：党参14份、菟丝子17份、山茱萸10份、枸杞子25份、山药11份、车前子25份、蒲公英20份、白术12份、茯苓13份、川牛膝10份、王不留行8份。
制备方法:将菟丝子、山茱萸洗净，浸入5倍量的80％的乙醇溶液浸泡1～2小时，加热提取2小时，回收乙醇，滤过，得滤液，浓缩为60℃下相对密度为1.15的稠膏，备用；将党参、枸杞子、山药、车前子、蒲公英、白术、茯苓、川牛膝洗净，加入9倍量的蒸馏水，浸泡3～4小时后，煮沸2～3小时，提取；再次加入7倍量蒸馏水，煮沸1.5～2小时，提取；合并提取液，过滤，得滤液，浓缩成60℃下相对密度为1.07的稠膏，备用；将王不留行进行粉碎处理，研末，过180目细粉，备用；将上述步骤所制得的稠膏以及细粉混合，加入适量辅料，按中药制剂常规工艺制成胶囊。
实施例2
处方：原料组成及重量份数为：党参10份、菟丝子15份、山茱萸9份、枸杞子20份、山药8份、车前子22份、蒲公英16份、白术9份、茯苓11份、川牛膝8份、王不留行5份。
制备方法:将菟丝子、山茱萸洗净，浸入4倍量的80％的乙醇溶液浸泡1～2小时，加热提取2小时，回收乙醇，滤过，得滤液，浓缩为60℃下相对密度为1.10的稠膏，备用；将党参、枸杞子、山药、车前子、蒲公英、白术、茯苓、川牛膝洗净，加入8倍量的蒸馏水，浸泡3～4小时后，煮沸2～3小时，提取；再次加入6倍量蒸馏水，煮沸1.5～2小时，提取；合并提取液，过滤，得滤液，浓缩成60℃下相对密度为1.03的稠膏，备用；将王不留行进行粉碎处理，研末，过180目细粉，备用；将上述步骤所制得的稠膏以及细粉混合，加入适量辅料，按中药制剂常规工艺制成胶囊。
实施例3
处方：原料组成及重量份数为：党参16份、菟丝子20份、山茱萸13份、枸杞子26份、山药13份、车前子26份、蒲公英21份、白术15份、茯苓16份、川牛膝13份、王不留行9份。
制备方法:将菟丝子、山茱萸洗净，浸入6倍量的80％的乙醇溶液浸泡1～2小时，加热提取2小时，回收乙醇，滤过，得滤液，浓缩为60℃下相对密度为1.20的稠膏，备用；将党参、枸杞子、山药、车前子、蒲公英、白术、茯苓、川牛膝洗净，加入10倍量的蒸馏水，浸泡3～4小时后，煮沸2～3小时，提取；再次加入8倍量蒸馏水，煮沸1.5～2小时，提取；合并提取液，过滤，得滤液，浓缩成60℃下相对密度为1.13的稠膏，备用；将王不留行进行粉碎处理，研末，过180目细粉，备用；将上述步骤所制得的稠膏以及细粉混合，加入适量辅料，按中药制剂常规工艺制成胶囊。
实施例4
处方：原料组成及重量份数为：党参13份、菟丝子15份、山茱萸13份、枸杞子25份、山药8份、车前子22份、蒲公英16份、白术9份、茯苓14份、川牛膝10份、王不留行7份。
制备方法:将菟丝子、山茱萸洗净，浸入5倍量的80％的乙醇溶液浸泡1～2小时，加热提取2小时，回收乙醇，滤过，得滤液，浓缩为60℃下相对密度为1.17的稠膏，备用；将党参、枸杞子、山药、车前子、蒲公英、白术、茯苓、川牛膝洗净，加入9倍量的蒸馏水，浸泡3～4小时后，煮沸2～3小时，提取；再次加入6下相对密度为1.08的稠膏，备用；将王不留行进行粉碎处理，研末，过180目细粉，备用；将上述步骤所制得的稠膏以及细粉混合，加入适量辅料，按中药制剂常规工艺制成片剂。
实施例5
处方：原料组成及重量份数为：党参14份、菟丝子20份、山茱萸12份、枸杞子26份、山药13份、车前子22份、蒲公英16份、白术14份、茯苓15份、川牛膝8份、王不留行9份。
制备方法:将菟丝子、山茱萸洗净，浸入6倍量的80％的乙醇溶液浸泡1～2小时，加热提取2小时，回收乙醇，滤过，得滤液，浓缩为60℃下相对密度为1.17的稠膏，备用；将党参、枸杞子、山药、车前子、蒲公英、白术、茯苓、川牛膝洗净，加入8倍量的蒸馏水，浸泡3～4小时后，煮沸2～3小时，提取；再次加入8倍量蒸馏水，煮沸1.5～2小时，提取；合并提取液，过滤，得滤液，浓缩成60℃下相对密度为1.10的稠膏，备用；将王不留行进行粉碎处理，研末，过180目细粉，备用；将上述步骤所制得的稠膏以及细粉混合，加入适量辅料，按中药制剂常规工艺制成颗粒剂。
实施例6
处方：原料组成及重量份数为：党参16份、菟丝子15份、山茱萸9份、枸杞子26份、山药11份、车前子26份、蒲公英18份、白术15份、茯苓11份、川牛膝10份、王不留行7份。
制备方法：参照实施例1进行。
实施例7
处方：原料组成及重量份数为：党参15份、菟丝子15份、山茱萸10份、枸杞子25份、山药12份、车前子25份、蒲公英20份、白术12份、茯苓13份、川牛膝11份、王不留行8份。
制备方法：参照实施例1进行。
以下通过临床试验例来进一步说明本发明。
1.一般资料：选择2011年9月-2012年6月在我院中医门诊就诊的80例BPH(肾阳虚衰型)患者为研究对象，按照随机数字表法随机分为治疗组和对照组，每组30例。治疗组患者年龄为(67.5±4.3)岁,病程为(5.6±1.2)年,治疗前国际前列腺症状评分(I-PSS)为(20.1±6.3)分；对照组患者年龄为(69.1±4.5)岁,病程为(5.8±1.5)年,治疗前I-PSS为(20.4±5.7)分。两组患者一般资料差异无统计学意义(P＞0.05)，具有可比性。
2.诊断及纳入标准：参照陈贵廷《最新国内外疾病诊断标准》拟定。即：50岁以上的男性有进行性排尿困难；排尿后，直肠指诊可触到增大的前列腺表面光滑、质韧、有弹性、中央沟消失或隆起；B型超声检查：检查测量前列腺体积及其内部结构，其中前列腺体积＞20mL；中医辨证为肾阳虚衰型，症见：小便不爽,或频数,夜尿频多、量少,尿末滴沥不尽,或排出无力,或遗尿不能自禁,神疲懒言,会阴或腰部冷痛,伴有阳萎、遗精,舌淡、苔白或白腻,脉沉细。排除其它良性、恶性病变。
3.治疗及护理方法：
治疗组：给予本发明实施例1制备的胶囊剂，每粒0.3g，每次3粒，一日两次；对照组：给予金匮肾气丸(北京同仁堂股份有限公司同仁堂制药厂)一次20-25丸，一日两次；两组均忌生、冷、粘、硬(如：冷饮，粘糕)、烟酒，辛辣等食物，4周为一疗程，两个疗程后进行疗效评价。
4.观察项目与检测方法：
4.1观察治疗前后中医症状(包括夜尿次数、排尿困难、尿后滴沥)改善情况。
4.2观察治疗前后IPSS总分、残余尿量及前列腺体积变化。
4.3安全性评价分别于用药前后进行肝、肾功能测定，并及时记录各种不良反应。
5.疗效标准治愈：症状消失，排尿通畅，残余尿＜20ml，停药以后无复发，前列腺B超检查示腺体大小、质地、形态均恢复正常，I-PSS总分＜7分；有效：排尿症状明显改善,但残余尿仍在20-60ml之间。前列腺B超检查示前列腺大小、形态、质地未恢复正常,但较治疗前有好转，I-PSS总分7-13分；无效:症状以及前列腺B超检查腺体大小、质地、形态均无改善，I-PSS总分无变化。
6.统计学方法：采用SPSS15.0统计分析软件进行计算，组内前后差异采用配对t检验比较，等级资料的比较采用Ridit分析，以P＜0.05为有统计学意义。
7.结果：
7.1两组中医症状改善情况比较：两组治疗后夜尿次数、排尿困难、尿后滴沥与治疗前比较均有改善，差异均有统计学意义(P＜0.05)，治疗后两组间比较，差异亦有统计学意义(P＜0.05)，见表1。
表1中医症状改善情况比较，分
注：与本组治疗前比较*P＜0.05，与对照组治疗后比较#P＜0.05。
7.2两组治疗前后I-PSS总分、残余尿及前列腺体积比较：与治疗前比较，两组治疗后I-PSS评分、残余尿差异均有统计学意义(P＜0.05)，治疗组与对照组治疗后比较，差异也有统计学意义(P＜0.05)；与治疗前比较，前列腺体积差异有统计学意义(P＜0.05)，治疗组与对照组治疗后比较，差异无有统计学意义(P＞0.05)，见表2。
表2两组治疗前后I-PSS总分、残余尿及前列腺体积比较
注：与本组治疗前比较*P＜0.05，与对照组治疗后比较#P＜0.05。
7.3两组中医证候疗效比较：治疗组：显效25例；有效11；无效4；总有效率为90.0％(36/40)；对照组：显效14例；有效9；无效17；总有效率57.5％(23/40)。两组比较,差异有统计学意义(P＜0.05)。治疗组疗效明显优于对照组。
7.4药物不良反应：本次观察过程中，两治疗组均未见肝、肾功能明显异常，两组治疗期间及门诊随访未发现有急性尿储留发生。治疗组有2例，对照组有3例诉胃部不适、口渴等，均未影响患者继续服药，亦未做纠正治疗。
小结：通过本次临床观察试验，我们可以发现本发明中药制剂与现有药物或现有药物的组合相比，对治疗肾阳虚衰型良性前列腺增生，具有明显的优势和效果，值得推广应用。
Claims (5)
1.一种治疗肾阳虚衰型良性前列腺增生症的药物，其特征在于制成所述药物有效成分的原料组成为：党参、菟丝子、山茱萸、枸杞子、山药、车前子、蒲公英、白术、茯苓、川牛膝、王不留行。
2.如权利要求1所述的治疗肾阳虚衰型良性前列腺增生症的药物，其特征在于制成所述药物有效成分的原料组成及重量份数为：党参10-16份、菟丝子15-20份、山茱萸9-13份、枸杞子20-26份、山药8-13份、车前子22-26份、蒲公英16-21份、白术9-15份、茯苓11-16份、川牛膝8-13份、王不留行5-9份。
3.如权利要求2所述的治疗肾阳虚衰型良性前列腺增生症的药物，其特征在于制成所述药物有效成分的原料组成及重量份数优选为：党参14份、菟丝子17份、山茱萸10份、枸杞子25份、山药11份、车前子25份、蒲公英20份、白术12份、茯苓13份、川牛膝10份、王不留行8份。
4.如权利要求1-3所述的治疗肾阳虚衰型良性前列腺增生症的药物，其特征在于其制备方法包括以下步骤：
(1)将菟丝子、山茱萸洗净，浸入4～6倍量的80％的乙醇溶液浸泡1～2小时，加热提取2小时，回收乙醇，滤过，得滤液，浓缩为稠膏，备用；
(2)将党参、枸杞子、山药、车前子、蒲公英、白术、茯苓、川牛膝洗净，加入8～10倍量的蒸馏水，浸泡3～4小时后，煮沸2～3小时，提取；再次加入6～8倍量蒸馏水，煮沸1.5～2小时，提取；合并提取液，过滤，得滤液，浓缩成稠膏，备用；
(3)将王不留行进行粉碎处理，研末，过180目细粉，备用；
(4)将上述步骤(1)～(3)所制得的稠膏以及细粉混合，按中药制剂常规工艺制成口服剂型，即得本发明所述的治疗肾阳虚衰型良性前列腺增生症的药物。
5.如权利要求4所述的治疗肾阳虚衰型良性前列腺增生症的药物，其特征在于所述的口服剂型优选为片剂、胶囊剂、颗粒剂。
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