CN101028421A - 一种治疗慢性肾衰的中成药 - Google Patents
一种治疗慢性肾衰的中成药 Download PDFInfo
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- CN101028421A CN101028421A CNA2007100654903A CN200710065490A CN101028421A CN 101028421 A CN101028421 A CN 101028421A CN A2007100654903 A CNA2007100654903 A CN A2007100654903A CN 200710065490 A CN200710065490 A CN 200710065490A CN 101028421 A CN101028421 A CN 101028421A
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Abstract
本发明涉及一种治疗慢性肾衰的中成药，它以生黄芪、三七粉、猪苓、淫羊藿、土鳖虫和桂枝等10余味中草药为原料。本发明具有益气补肾，利水消肿的功效。本发明是在传统的中医辨证治疗的基础上结合现代最新科研成果研制而成的。本发明的目的是提供一种治疗慢性肾衰的中成药，且具有疗效确切、安全方便、副作用小、价格低廉的特点。
Description
技术领域
本发明涉及一种治疗慢性肾衰的中成药，是一种治疗慢性肾衰以中草药为原料的中成药。属于中药领域。
背景技术
慢性肾功能衰竭(慢性肾衰)是由于各种原因引起的肾脏损害和进行性恶化的结果，机体在排泄代谢产物，调节水、电解质、酸碱平衡，以及某些内分泌活性物质的生成和灭活等方面出现紊乱的临床综合征。临床上常见倦怠、恶心、呕吐、贫血、少尿、水肿等症状及肾功能受损、水电解质紊乱等。慢性肾衰在中医属于“癃闭”、“关格”、“水肿”、“虚劳”等范畴。
慢性肾衰可由水肿、淋证、尿血等多种肾脏疾病发展而来。中医认为各种肾病日久，损及各脏腑功能，并以脾肾虚损为主，病情逐步发展而使病情加重，最后导致正气虚衰，浊邪、瘀血壅滞肾络，导致肾脏失去开阖的功能，湿浊尿毒潴留于体内，而引发本病。在其发展过程中，往往由于某些因素而使病程进展加快，病情恶化。常见的诱因如感受外邪、饮食不节、劳倦过度等。中医在临床上分为：脾肾气虚、脾肾阳虚、肝肾阴虚、阴阳两虚等症型辩证治疗，延缓慢性肾衰的进展，疗效显著。
西医治疗本病的方法很多，包括血液透析、腹膜透析和肾移植等，给患者和家人带来很重的精神负担和经济负担，且有不同程度的副作用。
发明内容
本发明是在传统的中医辨证治疗的基础上结合现代最新科研成果研制而成的。本发明的目的是提供一种治疗慢性肾衰的中成药，且具有疗效确切、安全方便、副作用小、价格低廉的特点。
本发明是由下述重量配比的原料制成的：
生黄芪3～12份 三七粉0.1～0.5份 猪苓1.5～6份
淫羊藿1.5～6份 土鳖虫0.1～2份 泽泻1.0～4份
生地黄1.0～4份 生槐花0.1～2份 山药1.0～4份
土茯苓1.5～6份 车前子0.1～2份 桂枝0.1～2份
本发明的优选配方各原料的重量配比是：
生黄芪4～8份 三七粉0.2～0.4份 猪苓2.5～3.5份
淫羊藿2.5～3.5份 土鳖虫0.5～1.5份 泽泻1.5～2.5份
生地黄1.5～2.5份 生槐花0.5～1.5份 山药1.5～2.5份
土茯苓2.5～3.5份 车前子0.5～1.5份 桂枝0.5～1.5份
本发明的最佳配方各原料的重量配比是：
生黄芪6份 三七粉0.3份 猪苓3份
淫羊藿3份 土鳖虫1份 泽泻2份
生地黄2份 生槐花1份 山药2份
土茯苓3份 车前子1份 桂枝1份
本发明中的药物机理如下：
生黄芪 性味甘、温。归肺、脾经。具有益卫固表，利水消肿，托毒，生肌的功效。可治疗内伤劳倦、脾虚泄泻、脱肛、气虚血脱、崩带、自汗、盗汗、血痹、浮肿、痈疽不溃或溃之不敛及一切气衰血虚之症等。(季宇彬主编《抗癌中药药理与应用》黑龙江科学技术出版社1999年版 第1074页)。
三七粉 性味甘、微苦、温。归肝、胃、大肠经。具有散瘀止血，消肿定痛的功效。可治疗吐血、咳血、衄血、便血、血痢、崩漏、症瘕、产后血晕、恶露不下，外伤出血、胸腹刺痛、跌扑瘀血、痈肿疼痛、急性咽喉炎、头昏目眩、耳鸣、冠心病、心绞痛、急性坏死性节段小肠炎、蛇咬伤、蜂螫伤、风湿性关节炎病、高血压等。(季宇彬主编《抗癌中药药理与应用》黑龙江科学技术出版社1999年版 第60页)。
猪苓 性味甘、淡、平。归脾、肾、膀胱经。具有利尿渗湿、抗癌的功效。可治疗小便不利，水肿胀满、脚气、泌尿系统感染、腹泻、淋浊、带下等。(季宇彬主编《抗癌中药药理与应用》黑龙江科学技术出版社1999年版 第1122页)。
淫羊藿 性味辛、甘、温。归肝、肾经。具有补肾壮阳、祛风除湿、强筋骨的功效。可治疗阳痿不举、小便淋沥、筋骨挛急、半身不遂、腰膝无力、风湿痹痛、四肢不仁、更年期高血压症、神疲健忘、神经衰弱、骨髓炎等。(季宇彬主编《抗癌中药药理与应用》黑龙江科学技术出版社1999年版 第1143页)。
土鳖虫 性味咸、寒、有小毒。归肝经。具有活血散瘀，通经止痛，消瘕，接骨续筋的功效。可治疗癥瘕积聚，血滞经闭，产后瘀血腹痛，跌打损伤，木舌，重舌，筋骨折伤，肝脾肿大，干血痨，猩红热，丹毒等。(季宇彬主编《抗癌中药药理与应用》黑龙江科学技术出版社1999年版 第91页)。
泽泻 性味甘、寒。归肾、膀胱经。具有利小便，清湿热的功效。可治疗小便不利，水肿胀满，泄泻尿少，痰饮眩晕，热淋涩痛；高血脂等。(国家药典委员会编《中华人民共和国药典》2000年版一部 第184页 化学工业出版社)。
生地黄 性味甘、寒。归心、肝、肾经。具有清热凉血，养阴，生津的功效。可治疗热病舌绛烦渴、阴虚内热、骨蒸劳热、内热消渴、吐血、衄血、发斑发疹等。(季宇彬主编《抗癌中药药理与应用》黑龙江科学技术出版社1999年版 第514页)。
生槐花 性味苦，微寒。归肝、大肠经。具有凉血止血，清肝明目的功效。主治肠风便血，痔疮下血，赤白痢，血淋，崩漏，吐血，衄血，疮疡肿毒等。(《中药大辞典》南京中医药大学 编著上海科学技术出版社 第二版 第3440页)。
山药 性味甘、平。归脾、肺、肾经。具有补脾，养肺，固肾，益精的功效。主治脾虚泄泻，食少浮肿，肺虚咳喘，消渴，遗精，带下。肾虚尿频等。(《中药大辞典》南京中医药大学 编著上海科学技术出版社第二版 第218页)。
土茯苓 性味甘、淡、平。归肝、胃经。具有清热解毒，祛风湿，强筋骨，利关节，抗癌的功效。可治疗湿热疮毒，湿疹，风湿骨痛，肢体拘挛，杨梅恶疮，泌尿系统感染，梅毒，淋浊，淋症白带，消化不良，腹泻，脚气，疔疮，痈肿，瘰疬等。(季宇彬主编《抗癌中药药理与应用》黑龙江科学技术出版社1999年版 第87页)。
车前子 性味甘、微寒。归肝、肾、肺、小肠、膀胱经。具有清热利尿，渗湿止泻，清肝明目，清肺化痰的功效。可治疗肺热咳嗽，泌尿系感染，结石，胃炎，小便不利，肠炎，细菌性痢疾，急性黄疸性肝炎，支气管炎，急性眼结膜炎，淋浊，带下，尿血，水肿，热痢，泄泻，鼻衄，目赤肿痛，喉痹乳蛾，咳嗽，皮肤溃疡等。(季宇彬主编《抗癌中药药理与应用》黑龙江科学技术出版社1999年版 第291页)。
桂枝 性味辛、甘、温。归心、膀胱、肺经。具有发汗解肌，温经通脉，祛风寒湿，行上肢横通肢节，通阳化气，平冲降气的功效。可治疗风寒表证，肩背肢节酸痛、胸痹痰饮、经闭症瘕、风湿痹痛、感冒风寒、咳喘痰饮、经闭腹痛等。(季宇彬主编《抗癌中药药理与应用》黑龙江科学技术出版社1999年版 第980页)。
本发明遵循中医“君臣佐使”的组方原则，用生黄芪、三七粉、猪苓、淫羊藿和土鳖虫为君药，用泽泻、生地黄、山药、生槐花和土茯苓为臣药，用车前子和桂枝为佐使药。诸药相和共具益气补肾，利水消肿的功效，治疗慢性肾衰，具有疗效确切，无毒副作用，服用方便，价格低廉的特点。
本发明的中成药，在制备成药剂时可加入药物可接受的载体，所述药物可接受的载体可以是：淀粉、蔗糖、乳糖、甘露糖醇、硅衍生物、纤维素类及其衍生物、藻酸盐、明胶、聚乙烯吡咯烷酮、甘油、土温80、琼脂、碳酸钙、碳酸氢钙、表面活性剂、聚乙二醇、环糊精、β-环糊精、磷脂类材料、高岭土、滑石粉、硬脂酸钙、硬脂酸镁等。
本发明的中成药可以是任何可药用的剂型，这些剂型包括：片剂、糖衣片剂、薄膜衣片剂、肠溶衣片剂、胶囊剂、硬胶囊剂、软胶囊剂、口服液、口含片、颗粒剂、丸剂、散剂、膏剂、丹剂、混悬剂、粉剂、溶液剂、注射剂、栓剂、软膏剂、硬膏剂、霜剂、喷雾剂、滴剂、贴剂。本发明的制剂，优选的中成药是口服剂型，如：片剂、胶囊剂、口服液、口含片、颗粒剂、丸剂、散剂、混悬剂、粉剂、溶液剂、滴剂、滴丸剂。更优选的中成药是胶囊剂、片剂、颗粒剂。
本发明药物临床使用结果表明，有如下优点：
1、本发明选用的中草药各组份符合中华人民共和国药品管理法之规定，利用各味中药的综合作用治疗慢性肾衰，对人体无毒无害。经动物急性毒性实验表明被实验的动物未见任何毒性反应，其主要脏器也无明显的改变，药物安全可靠。
2、本发明无须煎煮，无苦涩感，药中富含蛋白质，葡萄糖，葡萄糖醛酸，挥发油，果胶，果糖，有机酸，卵磷脂，维生素，氨基酸，还含皂甙，植物甾醇和钙等多种微量元素，利于人体吸收，增强体质，且服用方便。
3、本发明不仅可有效的治疗慢性肾衰，对慢性肾衰的预防也有很好的作用，大大提高了患者的生存质量，有较高的治愈康复效果。
慢性肾衰(癃闭)诊断依据：(戴慎等主编《中医病证诊疗标准与方剂选用》人民卫生出版社 2001年版 第219页)。
1、小便不利，点滴不畅，或小便闭塞不通，尿道无涩痛，小腹胀满。
2、多见于老年男性，或产后妇女及手术后患者。
3、男性直肠指诊检查前列腺肥大，或膀胱区叩诊明显浊音。
4、作膀胱镜、B超、腹部X线等检查，有助诊断。
慢性肾衰(癃闭)疗效评定标准：(戴慎等主编《中医病证诊疗标准与方剂选用》人民卫生出版社 2001年版 第222页)。
1、治愈：小便通畅，症状及体征消失。
2、好转：症状及体征改善。
3、未愈：症状无变化。
下面通过临床应用例进一步说明本发明药物对治疗慢性肾衰的治疗效果
经临床试验结果如下；治疗慢性肾衰患者97例。服用实施例1胶囊剂，每次2-10粒，每日三至四次，温开水送下，饭前半小时服用。两个月为一个疗程，连续服用三个疗程观察疗效。治愈51例占52.58％，好转35例占36.08％，未愈11例占11.34％，总有效率达88.66％。经三个疗程治疗后，患者倦怠、恶心、呕吐、贫血、少尿、水肿等症状均有明显改善。且病人无任何不良反应，三大常规化验及肝肾功能检测未发现异常。
具体实施方式
实施例1 胶囊剂 按下述重量称取原料：
生黄芪6份 三七粉0.3份 猪苓3份
淫羊藿3份 土鳖虫1份 泽泻2份
生地黄2份 生槐花1份 山药2份
土茯苓3份 车前子1份 桂枝1份
制备方法是先取三七粉干燥粉碎至120～200目细粉，再取生黄芪、猪苓、淫羊藿、土鳖虫、泽泻、生地黄、生槐花、山药、土茯苓、车前子和桂枝加水煎煮两次，第一次1.5～2小时，第二次0.5～1小时，合并两次煎液，滤过，滤液浓缩至80度～85度时，相对密度1.08～1.10的清膏，加入乙醇使清膏含醇量达70％，静置24小时，回收乙醇，在50度～55度时浓缩至相对密度1.30～1.32的清膏，再将清膏与三七粉细粉混匀，干燥，粉碎成细粉，装入胶囊。每粒装0.3克，通常饭前半小时口服，温开水送下，一次2～10粒，一日三至四次，一个月为一个疗程。
实施例2 片剂 按下述重量称取原料：
生黄芪6份 三七粉0.3份 猪苓3份
淫羊藿3份 土鳖虫1份 泽泻2份
生地黄2份 生槐花1份 山药2份
土茯苓3份 车前子1份 桂枝1份
制备方法是先取三七粉干燥粉碎至120～200目细粉，再取生黄芪、猪苓、淫羊藿、土鳖虫、泽泻、生地黄、生槐花、山药、土茯苓、车前子和桂枝加水煎煮两次，第一次1.5～2小时，第二次0.5～1小时，合并两次煎液，滤过，滤液浓缩至80度～85度时，相对密度1.08～1.10的清膏，加入乙醇使清膏含醇量达70％，静置24小时，回收乙醇，在50度～55度时浓缩至相对密度1.30～1.32的清膏，再将清膏与三七粉细粉混匀，干燥，粉碎成细粉，加入适量硬脂酸镁，压片，包糖衣即得。通常饭前半小时口服，温开水送下，一次2～10片，一日三至四次，一个月为一个疗程。
实施例3 颗粒剂 按下述重量称取原料：
生黄芪6份 三七粉0.3份 猪苓3份
淫羊藿3份 土鳖虫1份 泽泻2份
生地黄2份 生槐花1份 山药2份
土茯苓3份 车前子1份 桂枝1份
制备方法是先取三七粉干燥粉碎至120～200目细粉，再取生黄芪、猪苓、淫羊藿、土鳖虫、泽泻、生地黄、生槐花、山药、土茯苓、车前子和桂枝加水煎煮两次，第一次1.5～2小时，第二次0.5～1小时，合并两次煎液，滤过，滤液浓缩至80度～85度时，相对密度1.08～1.10的清膏，加入乙醇使清膏含醇量达70％，静置24小时，回收乙醇，在50度～55度时浓缩至相对密度1.30～1.32的清膏，再将清膏与三七粉细粉混匀，干燥，粉碎成细粉，加入适量蔗糖和可溶性淀粉，乙醇制粒，干燥后装袋即得。通常饭前半小时温开水冲服，一次1～3袋，一日三至四次，一个月为一个疗程。
Claims (6)
1、一种治疗慢性肾衰的中成药，其特征在于它是由下述重量配比的原料制成的：
生黄芪3～12份 三七粉0.1～0.5份 猪苓1.5～6份
淫羊藿1.5～6份 土鳖虫0.1～2份 泽泻1.0～4份
生地黄1.0～4份 生槐花0.1～2份 山药1.0～4份
土茯苓1.5～6份 车前子0.1～2份 桂枝0.1～2份
2、根据权利要求1所述的一种治疗慢性肾衰的中成药，其中各原料的重量配比是：
生黄芪4～8份 三七粉0.2～0.4份 猪苓2.5～3.5份
淫羊藿2.5～3.5份 土鳖虫0.5～1.5份 泽泻1.5～2.5份
生地黄1.5～2.5份 生槐花0.5～1.5份 山药1.5～2.5份
土茯苓2.5～3.5份 车前子0.5～1.5份 桂枝0.5～1.5份
3、根据权利要求1所述的一种治疗慢性肾衰的中成药，其中各原料的重量配比是：
生黄芪6份 三七粉0.3份 猪苓3份
淫羊藿3份 土鳖虫1份 泽泻2份
生地黄2份 生槐花1份 山药2份
土茯苓3份 车前子1份 桂枝1份
4、权利要求1-3的中成药，是适合药用的各种剂型。
5、权利要求4的中成药是片剂、胶囊剂、口服液、口含片、颗粒剂、丸剂、散剂、混悬剂、粉剂、溶液剂、滴剂、滴丸剂。
6、权利要求4的中成药是胶囊剂、片剂、颗粒剂。
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| CN101785776A (zh) * | 2010-04-02 | 2010-07-28 | 西北大学 | 麦角甾酮在制备治疗慢性肾衰竭药物中的应用 |
| CN101843695B (zh) * | 2009-09-25 | 2011-07-27 | 北京绿源求证科技发展有限责任公司 | 一种治疗慢性肾功能衰竭的中药 |
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| CN1268355A (zh) * | 2000-01-08 | 2000-10-04 | 陈柏林 | 蚁蝉慢肾康 |
| CN1275630C (zh) * | 2003-11-11 | 2006-09-20 | 国家中药现代化工程技术研究中心 | 一种治疗慢性肾衰的药物及其制备方法 |
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| CN101843695B (zh) * | 2009-09-25 | 2011-07-27 | 北京绿源求证科技发展有限责任公司 | 一种治疗慢性肾功能衰竭的中药 |
| CN101785776A (zh) * | 2010-04-02 | 2010-07-28 | 西北大学 | 麦角甾酮在制备治疗慢性肾衰竭药物中的应用 |
| CN101785776B (zh) * | 2010-04-02 | 2011-07-27 | 西北大学 | 麦角甾酮在制备治疗慢性肾功能衰竭药物中的应用 |
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