CN116585435A - 一种治疗淋证的药物组合物及其制剂和应用 - Google Patents
一种治疗淋证的药物组合物及其制剂和应用 Download PDFInfo
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Abstract
本发明提供一种治疗淋证的药物组合物及其制剂和应用,该药物组合物由以下重量配比的中药原料制成:茯苓、泽泻、薏苡仁、焦黄柏、炒苍术、车前子、通草、木香、乌药、小蓟、小茴香、白豆蔻、桔梗、甘草。本申请依据中医理论基础—肺的通调、脾的传输、肝的疏泄、肾及膀胱的气化,各脏腑相互协调、配合共同完成水液代谢来组方,利水通淋,理气除湿,利湿清热而不伤正,健脾理气而通水道,用以治疗淋证所见症状,并有效改善症状,体现了中医整体辨证论治的特点。患者服用本申请的利水通淋颗粒后无明显身体不适,证明该方安全、有效、无毒副作用,有广泛的临床应用价值。
Description
技术领域
本发明涉及中医药技术领域,特别涉及一种治疗尿路感染,急、慢性肾盂肾炎,膀胱炎,前列腺炎,前列腺增生,尿路结石,乳糜尿,尿道综合征等的中药混合物。
背景技术
尿路感染,急、慢性肾盂肾炎,膀胱炎,前列腺炎,前列腺增生,尿路结石,乳糜尿,尿道综合征等是以尿频、尿急、尿痛,小便短赤,小腹胀痛为主要表现的临床综合症。
在中医的疾病诊断为淋证,此证以小便频数短涩,淋沥刺痛,小腹拘急引痛为主症。淋证的中医病因主要有外感湿热、饮食不节、情志失调、禀赋不足或劳伤久病等几方面。外感湿热,因下阴不洁,秽浊之邪从下侵入机体,上犯膀胱,发为淋证;饮食不节,多食辛热肥甘之品,或嗜酒太过,脾胃运化失常,积湿生热,下注膀胱,发为淋证;情志失调,肝郁气结,膀胱气滞,或气郁化火,气火郁于膀胱,导致淋证;禀赋不足,肾与膀胱先天畸形,或久病缠身,劳伤过度,房事不节,多产多育,或久淋不愈,耗伤正气,或妊娠、产后脾肾气虚,膀胱易受外邪,而致淋证。
淋证初起多因湿热引起,正气尚未虚损,多为实证,病情尚轻,治疗得当,多易治愈。但淋久湿热伤正,由肾及脾,脾肾两虚,淋证由实转虚,病久不愈,或反复发作,不仅可转为劳淋,甚则转变为水肿、癃闭、关格等。
目前西医治疗尿路感染使用抗生素治疗,缓解症状、消除感染和预防复发,并预防潜在的严重并发症,抗生素类药物的使用会损伤肝脏、胃肠道等,引起各种不良反应,从短期看,现代医学治疗尿路感染具有比较好的临床疗效,但长期来看,抗生素的使用将使更多的细菌产生耐药性,因此难以避免的也将导致淋证的治疗疗效变差、复发率升高、疗程延长。如肾损伤和败血症。前列腺炎治疗方法是:①药物治疗:如前列腺液培养发现致病病原体,则采用抗菌治疗;②对症治疗:抗炎止痛;③物理治疗;④手术治疗:较少采用。前列腺增生未引起明显梗阻的一般不需治疗,可观察;梗阻较轻可采用药物治疗;排尿梗阻症状严重,或反复出现并发症,药物治疗不佳,且能耐受手术,则采取外科手术治疗。乳糜尿的治疗主要为药物治疗和手术治疗,如不接受正规治疗,可引起严重的并发症,导致肾衰竭发生。尿道综合征目前尚无特效治疗药物,针对症状和因素进行治疗,有药物治疗、介入治疗、手术治疗。
发明内容
本发明就是为了提供一种对于中医证属淋证的治疗,具有标本兼治、疗效明显、安全、无毒副作用,且治疗费用较低的中药组合物。
本发明的目的是通过以下技术方案实现的:
一种药物组合物,由以下重量配比的中药原料制成:茯苓5-30份、泽泻5-20份、薏苡仁5-30份、焦黄柏5-20份、炒苍术5-20份、车前子5-20份、通草5-15份、木香5-20份、乌药5-20份、小蓟5-20份、小茴香5-20份、白豆蔻5-20份、桔梗10-20份、甘草3-10份。
优选地,由以下重量配比的中药原料制成:茯苓5-20份、泽泻5-15份、薏苡仁5-20份、焦黄柏5-15份、炒苍术5-15份、车前子5-15份、通草5-10份、木香5-15份、乌药5-15份、小蓟5-15份、小茴香5-15份、白豆蔻5-15份、桔梗10-15份、甘草3-8份。
优选地,由以下重量配比的中药原料制成:茯苓5-15份、泽泻5-10份、薏苡仁5-15份、焦黄柏5-10份、炒苍术5-10份、车前子5-10份、通草5-8份、木香5-10份、乌药5-10份、小蓟5-10份、小茴香5-10份、白豆蔻5-10份、桔梗10-10份、甘草3-5份。
本发明所述药物组合物以茯苓为君药,茯苓利水消肿,渗湿,健脾,化痰,宁心。茯苓利水而不伤正气,为利水渗湿要药,故为本方君药。泽泻、薏苡仁、黄柏为臣药,助君药增强利水渗湿、清热通淋之效。本方苍术、车前子、通草、小蓟、白豆蔻、乌药、小茴香、木香为佐药。佐以苍术、车前子、通草以增强健脾化湿、清热利水通淋之功。佐小蓟利尿通淋,治尿血、血淋。佐以木香、乌药、小茴香、白豆蔻等温中健脾、疏肝和胃、理气止痛之药,意在减轻清热利湿药之寒性对胃肠的不良反应,更增加了理气除湿、利水通淋之效。桔梗、甘草为使药。肺为水之上源,桔梗开宣肺气而通利二便。甘草补脾益气,清热解毒,祛痰止咳,缓急止痛,调和诸药。
茯苓:味甘、淡,性平。归心、肺、脾、肾经。功效利水消肿,渗湿,健脾,化痰,宁心。用于治疗小便不利,水肿胀满,痰饮呕吐,脾虚食少,泄泻,心悸不安,失眠健忘,遗精白浊等病症。现代药物研究茯苓煎剂、糖浆剂、醇提取物、乙醚提取物,分别具有利尿、镇静、抗肿瘤、降血糖、增加心肌收缩力的作用。茯苓多糖有增强免疫功能的作用。茯苓有护肝作用,能降低胃液分泌,对胃溃疡有抑制作用。
泽泻:味甘,性寒。归肾、膀胱经。功效利水渗湿,泄热,化浊降脂。用于治疗小便不利,热淋涩痛,水肿胀满,泄泻,痰饮眩晕,遗精等病症。现代药物研究泽泻具有利尿、降血糖血脂及抗动脉粥样硬化、抗结石形成、抗肾炎活性、抗脂肪肝、对心血管系统及免疫调节的作用 。
薏苡仁:味甘、淡,性微寒。归脾、胃、肺经。功效利水渗湿,健脾止泻,除痹,排脓,解毒散结。用于治疗水肿,脚气,小便不利,脾虚泄泻,湿痹拘挛,肺痈,肠痈,赘疣,癌肿等病症。现代药物研究薏苡仁煎剂、醇及丙酮提取物对癌细胞有明显抑制作用,有抗肿瘤、免疫调节、降血糖血钙、降压、抗病毒抑制胰蛋白酶、诱发排卵等方面的药理活性。
黄柏:味苦,性寒。归肾、膀胱经。功效清热燥湿,泻火解毒,除骨蒸。用于治疗湿热泻痢,黄疸尿赤,带下阴痒,热淋涩痛,脚气,骨蒸劳热,盗汗,遗精,疮疡肿毒,湿疹湿疮等病症。现代药物研究本品所含生物碱类,如小檗碱、药根碱、掌叶防己碱等对金黄色葡萄球菌、大肠杆菌、痢疾杆菌、伤寒杆菌、结核杆菌、溶血性链球菌有抑制作用;对白色念珠菌、絮状表皮癣菌、大小孢子菌等皮肤至病性真菌有较强抑制作用。黄柏除有抗细菌作用,对心血管系统有降血压、抗心律失常等作用,对消化系统抗消化道溃疡、收缩或舒张肠管、促进胰腺分泌、降血糖等作用。
苍术:味辛、苦,性温。归脾、胃、肝经。功效燥湿健脾、祛风散寒,明目。用于治疗脘腹胀满,泄泻,水肿,脚气痿躄,风湿痹痛,风寒感冒,夜盲等病症。现代药理研究苍术具有利尿、抗炎、抗缺氧、抗心律失常等作用,促进胃肠运动,保肝、降血糖、抗菌、抗病毒等作用 。
车前子:味甘,性寒。归肝、肾、肺、小肠经。功效清热利尿通淋,渗湿止泻,明目。用于治疗热淋涩痛,水肿胀满,暑湿汇泻,目赤肿痛,痰热咳嗽等病症。现代药理研究车前子有显著利尿作用,对杆菌和葡萄球菌均有抑制作用。车前子提取液有预防肾结石形成的作用。
通草味甘、淡,性微寒。归肺、胃经。功效清热利尿,通气下乳。用于治疗淋证涩痛,小便不利,小便短赤,水肿,黄疸,湿温病,产后乳少,经闭,带下等病症。便现代药理研究通草有利尿作用,并能明显增加尿钾排出量。通草多糖具有一定调节免疫和抗氧化的作用。
木香味辛、苦,性温。归脾、胃、大肠、三焦、胆经。功效行气止痛,健脾消食。用于治疗脘腹腹痛,湿热泻痢,胁痛等病症。现代药理研究证明其在抗心血管疾病、抗炎、抗癌、抗溃疡、抗病原微生物以及其他多方面表现出良好的药理活性。木香还具有抗血管生成、免疫调节、调控中枢神经系统、抗氧化、抗寄生虫等方面的作用。
小蓟味甘、苦,性凉。归心、肝经。功效凉血止血,散瘀消痈。用于治疗吐血,尿血,血淋,便血,崩漏,外伤出血,痈肿疮毒等病症。现代药物研究具有止血、抗菌作用,其水煎剂体外对白喉杆菌、肺炎球菌、金黄色葡萄球菌等均有不同程度的抑制作用。
白豆蔻味辛,性温。归肺、脾、胃经。功效化湿行气,温中止呕,开胃消食。现代药理研究白豆蔻能促进胃液分泌,增进胃肠蠕动,制止肠内异常发酵,祛除胃肠积气,有良好的芳香健胃作用,并能止呕。
乌药味辛,性温。归肺、脾、肾、膀胱经。功效行气止痛,温肾散寒。能治三焦寒凝气滞疼痛,与木香、小茴香配合使用,疗效明显。用于治疗寒凝气滞,胸腹胀痛,气逆喘急,疝气疼痛,经寒腹痛,肾阳不足,膀胱虚冷,遗尿尿频等病症。现代药理研究乌药对胃肠道平滑肌有兴奋和抑制的双向调节作用,能促进消化液的分泌;具有抗病毒、抑菌、抗肿瘤、兴奋心肌、改善中枢神经系统功能、抗炎镇痛、防治糖尿病肾病、保护肝脏、调节凝血功能的药理作用。
小茴香味辛,性温。归肝、肾、脾、胃经。功效散寒止痛,理气和胃。可治疗睾丸胀痛,少腹冷痛,善理脾胃之气而开胃、止呕。现代药理研究发现对家兔在体肠蠕动有促进作用;十二指肠或口服给药对大鼠胃液分泌及应激性溃疡胃液分泌有抑制作用;能促进胆汁分泌,并使胆汁固体成分增加;其挥发油对豚鼠气管平滑肌有松弛作用,并能促进肝组织再生;另有镇痛及乙烯雌酚样作用等。
本发明中木香、乌药、小茴香、白豆蔻等温中健脾、和胃止痛之药,意在减轻清热利湿药之寒性对胃肠的不良反应,更增加了理气除湿、利水通淋之效。
桔梗味苦、辛,性平。归肺经。功效宣肺,祛痰,利咽,排脓。肺为水之上源,桔梗开宣肺气而通利二便。用于治疗咳嗽痰多,咽痛音哑,肺痈吐脓,小便癃闭等病症。现代药物研究桔梗具有祛痰作用、抗炎作用、免疫调节作用、抗肿瘤作用、保肝作用、降血糖作用、利尿作用等。
甘草味甘,性平。归心、肺、脾、胃经。功效补脾益气,清热解毒,祛痰止咳,缓急止痛,调和诸药。用于治疗心悸气短,腹痛便溏,四肢挛急疼痛,咽喉肿痛,痈疮肿痛,药物、食物中毒等病症。现代药物研究甘草具有抗心律失常、抗溃疡、镇咳、抗菌、抗病毒、抗炎、抗过敏、抗利尿、降血脂、保肝的作用。
本发明的有益效果:
中医学在临床诊治疾病过程中讲究整体观念,继而辨证施治,在疾病进程中,牢牢把握住“证”的本质,即疾病变化进程中某一阶段的病理本质,根据疾病本质施以恰当的治疗。淋证,从临床角度分析,除了实证外,也常常表现为虚实夹杂证。本申请治疗中医淋证,能够审其主次缓急,针对病因病机,标本兼治,治疗范围为现代医学中的泌尿系感染(急、慢性肾盂肾炎、膀胱炎),前列腺炎、前列腺增生,尿路结石,泌尿道结核,乳糜尿及尿道综合征等病出现的尿频、尿急、尿痛等膀胱刺激症,小腹及膀胱区、腰部疼痛不适等临床症状,治疗效果明显,无明显毒副作用,临床应用安全可靠,可进一步研究,使其广泛应用于临床。
实施方式
下面结合实施例对本发明作进一步说明,但本发明并不局限于实施例。
一种治疗淋证的药物组合物,包括如下按重量份数计的组分:茯苓5-30份、泽泻5-20份、薏苡仁5-30份、焦黄柏5-20份、炒苍术5-20份、车前子5-20份、通草5-15份、木香5-20份、乌药5-20份、小蓟5-20份、小茴香5-20份、白豆蔻5-20份、桔梗10-20份、甘草3-10份。
包括如下按重量份数计的组分:茯苓5-20份、泽泻5-15份、薏苡仁5-20份、焦黄柏5-15份、炒苍术5-15份、车前子5-15份、通草5-10份、木香5-15份、乌药5-15份、小蓟5-15份、小茴香5-15份、白豆蔻5-15份、桔梗10-15份、甘草3-8份。
包括如下按重量份数计的组分:茯苓5-15份、泽泻5-10份、薏苡仁5-15份、焦黄柏5-10份、炒苍术5-10份、车前子5-10份、通草5-8份、木香5-10份、乌药5-10份、小蓟5-10份、小茴香5-10份、白豆蔻5-10份、桔梗10-10份、甘草3-5份。
所述制剂由所述药物组合物添加药学上可接受的辅料,制成制剂。
所述的制剂的制备方法,包括以下步骤:加水浸泡后,煎煮两次,合并煎液,滤过,浓缩至稠膏,干燥,粉碎成细粉,加入药学上可接受的辅料,混匀,制成制剂。
所述药物组合物用于制备治疗淋证的药物。
所述制剂用于制备治疗淋证的药物。
实施例
一种药物组合物,包括如下组分:茯苓30g、泽泻 20g、薏苡仁20g、焦黄柏10g、炒苍术15g、车前子10g、通草10g 、木香15g 、乌药10g、小蓟 10g、小茴香10g、白豆蔻15g、桔梗10g、甘草5g。
实施例
一种药物组合物,包括如下组分:茯苓20g、泽泻10g、薏苡仁30g、焦黄柏15g、炒苍术20g、车前子15g、通草15g 、木香20g 、乌药15g、小蓟 15g、小茴香15g、白豆蔻 10g、桔梗15g、甘草 10g。
实施例
一种药物组合物,包括如下组分:茯苓10g、泽泻10g、薏苡仁10g、焦黄柏20g、炒苍术10g、车前子20g、通草5g 、木香10g 、乌药5g、小蓟10g、小茴香20g、白豆蔻20g、桔梗20g、甘草3g。
实施例
一种药物组合物,包括如下组分:茯苓5g、泽泻5g、薏苡仁5g、焦黄柏10g、炒苍术5g、车前子5g、通草5g、木香10g、乌药10g、小蓟5g、小茴香5g、白豆蔻5g、桔梗10g、甘草8g。
实施例
一种药物组合物的制剂,取实施例1-4任意一项所述的药物组合物,加水浸泡后,煎煮两次,合并煎液,滤过,浓缩至稠膏,干燥,粉碎成细粉,加入糊精、淀粉或其他适宜的辅料适量,混匀,制成片剂、散剂、丸剂等制剂。
实施例
一种药物组合物的制剂,按照以下步骤制备:
按照实施例1-4任意一项所述的药物组合物的比例称取中药饮片;取车前子粗碎,装入80目单层滤网中,与其余十三味一起,加水煎煮二次,加水量第一次8倍、第二次6倍,每次煎煮1.5小时,煎液200目滤网滤过,滤液减压浓缩至相对密度为1.20-1.24(60 ℃),减压干燥,粉碎,过100目筛,加入糊精适量,置槽型混合机中,搅拌25分钟混匀,加入75 %乙醇适量,搅拌制成软材,摇摆式颗粒机制粒(14目筛),80℃条件下干燥,10目和80目筛整粒,混匀,分装,即得。
应用实施例——观察本发明所述药物组合物治疗淋证的临床疗效和不良反应。
一、研究方法
选取近五年内符合淋证纳入标准的患者,运用本发明所述药物组合物进行治疗,观察其临床疗效及不良反应。
二、诊断标准
参照《中药新药临床研究指导原则》(1993年版)。
淋证中医诊断标准
主症:小便频数短涩、滴沥刺痛、欲出未尽、尿道灼热。
次症:小腹坠胀、拘急疼痛,腰痛,血尿,膀胱压痛,肾区叩击痛,可兼见发热。 舌脉:舌质红,苔黄腻,脉滑或滑数。
(二)中医证候诊断标准 参照《新药(中药)治疗淋证(泌尿系感染)临床研究指导原则》、《中医内科学》 “淋证辨证分型”执行,本证分为热淋、血淋、气淋、劳淋。
三、纳入标准
1、符合淋证的中医证候诊断标准;
2、患者年龄在 18 至 75 周岁;
3、未使用其他药物治疗;
4、患者知情同意并能按要求去配合。
四、排除标准
1、不符合上述纳入标准者;
2、慢性肾衰患者;
3、尿路解剖畸形、尿路梗阻、尿道狭窄者;
4、妊娠或哺乳期妇女、精神病患者等;
5、有严重心、肝、肾等严重原发或继发疾病者;
6、有严重胃炎或消化道溃疡者。
五、服用方法:一次一袋,每日2次。
六、疗效判定标准
1、治愈:临床症状体征消失,尿路感染者尿常规检查正常。
2、有效:临床症状体征减轻,尿路感染者尿常规检查改善。
3、无效:治疗后临床症状未改善,及尿路感染者尿检改善不明显。
十、临床疗效总结
运用本申请(利水通淋方)治疗淋证患者102例,其中治愈14例(13.7%),有效81例(79.4%),无效7例(6.8%)。102例患者的总有效率为 93.2%。
请根据中医的辨证治疗和随症加减以及其它中医理论,对上述的临床数据进行解释说明。说明为何无法一一列举每一例患者的用药,原因是每一例患者均可能出现不同的药方(包括药和量上的不同)。
上述临床疗效的用药和用量是根据不同患者的临床表现在基础方的基础上随症加减:
例如:
尿血显著者,需要在基础方中加大蓟10g、槐花10g;尿急、
尿痛显著者,需要在基础方中加野菊花15g、延胡索10g;
乏力显著者,需要在基础方中加黄芪10g、大枣10g;
五心烦热显著者,需要在基础方中加白芍10g、地骨皮10g;
纳差、胃胀者,需要在基础方中加神曲15g、厚朴10g;
小腹胀满,需要在基础方中小便涩滞不畅者,加青皮10g、乌药10g;
尿中夹砂石,需要在基础方中排尿涩痛,加金钱草15g、海金沙10g、石韦10g;
十一、不良反应
临床应用显示无毒副作用及不良反应。
十二、典型病例
患者张某,女,38岁,患者因尿频、尿急、尿痛伴下腹部疼痛10天就诊。患者10天前无明显诱因出现尿频、尿急、尿痛、排尿不适,伴下腹部酸胀痛,无发热,尿常规检查示,白细胞(+++),自服头孢治疗,上述症状未得明显缓解,饮食可,眠差,大便正常,舌尖红,苔黄腻,脉滑。诊断为淋证(下焦湿热证),予口服本发明所述药物组合物制得的颗粒剂两周后,患者尿频、尿急、尿痛明显缓解,下腹部疼痛减轻,二便正常,舌红,苔薄白,脉细。
患者刘某,女,32岁,患者因尿频,尿急伴外阴瘙痒3天就诊,患者3天前无明显诱因出现尿频,尿急,尿痛并伴外阴瘙痒,腹部稍坠痛,舌质红,苔黄腻,脉滑。无发热,尿常规检查示:白细胞(+++),诊断为淋证(下焦湿热证),予口服本发明所述药物组合物制得的颗粒剂两周后,患者尿频、尿急、外阴瘙痒明显缓解,复诊后患者继服一周后,患者已无尿频、尿急及外阴瘙痒等症状。
患者王某,男,45岁,患者因尿频、尿急伴腰痛1月余,患者1月前无明显诱因出现尿频、尿急、伴腰部疼痛,自服左氧氟沙星治疗,尿频症状稍改善,但腰部仍痛,饮食欠佳,眠差,大便正常。尿常规示:白细胞(+++),予口服本发明所述药物组合物制得的颗粒剂两周后,患者尿频、尿急症状好转,继服一周后,腰痛症状明显缓解。
以上典型病例仅为临床观察的部分病例,所使用的药物组合物也仅是部分药物组合物,在实际临床使用中,根据患者不同的临床症状,对药物组合物中具体药物的用量可在本发明范围内任意选择。
Claims (7)
1.一种治疗淋证的药物组合物,其特征在于,由如下按重量份数计的组分组成:茯苓5-30份、泽泻5-20份、薏苡仁5-30份、焦黄柏5-20份、炒苍术5-20份、车前子5-20份、通草5-15份、木香5-20份、乌药5-20份、小蓟5-20份、小茴香5-20份、白豆蔻5-20份、桔梗10-20份、甘草3-10份。
2.根据权利要求1所述的药物组合物,其特征在于,包括如下按重量份数计的组分:茯苓5-20份、泽泻5-15份、薏苡仁5-20份、焦黄柏5-15份、炒苍术5-15份、车前子5-15份、通草5-10份、木香5-15份、乌药5-15份、小蓟5-15份、小茴香5-15份、白豆蔻5-15份、桔梗10-15份、甘草3-8份。
3.根据权利要求1所述的药物组合物,其特征在于,包括如下按重量份数计的组分:茯苓5-15份、泽泻5-10份、薏苡仁5-15份、焦黄柏5-10份、炒苍术5-10份、车前子5-10份、通草5-8份、木香5-10份、乌药5-10份、小蓟5-10份、小茴香5-10份、白豆蔻5-10份、桔梗10-10份、甘草3-5份。
4.一种权利要求1至3任意一项所述的药物组合物的制剂,其特征在于,所述制剂由所述药物组合物添加药学上可接受的辅料,制成制剂。
5.根据权利要求4所述的制剂的制备方法,其特征在于,包括以下步骤:加水浸泡后,煎煮两次,合并煎液,滤过,浓缩至稠膏,干燥,粉碎成细粉,加入药学上可接受的辅料,混匀,制成制剂。
6.一种权利要求1至3任意一项所述的药物组合物的应用,其特征在于,所述药物组合物在用于制备治疗淋证的药物中的应用。
7.一种权利要求4至5任意一项所述的制剂的应用,其特征在于,所述制剂在用于制备治疗淋证的药物中的应用。
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Non-Patent Citations (2)
Title |
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郭国霞等: "四妙散加味异病同治临床应用举隅", 《亚太传统医药》, vol. 13, no. 14, 31 July 2017 (2017-07-31), pages 101 - 102 * |
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