CN102188613B - 一种治疗糖尿病的中药制剂 - Google Patents
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Abstract
一种治疗糖尿病的中药制剂，是由下述原料药材制成的药剂：山药、人参、沙参、麦冬、五味子、黄精、石斛、苦瓜、甘草、山茱萸、茯苓、瓜蒌、葛根、生地、苦刺花、黄芩、蛤蚧、昆布、知母、白僵蚕、鳖甲、紫草、鬼箭羽、女贞子、地骨皮、苍术、红景天、元胡、银杏、红皮黄芪、白花蛇舌草、金毛狗。本发明根据传统医学的理论，集众医家所长，广采博收云南各民族地区奇药妙方，基于中医学对糖尿病疾病的发病机理的认识及治疗原则，参考古今药理研究成就，筛选活血祛瘀、平肝熄风、养血通窍的天然中草药，按中医理论组方，提取精华，并经长期诊疗病例的临床实践总结而成。本发明通过调整失衡的阴阳，提高自身对血糖的利用和转化能力，本发明药物标本兼治，对糖尿病有较好的疗效，对重症糖尿病效果明显。本发明采用的原料药为常用的普通中药，制作成本低，基本无毒副作用。
Description
技术领域
本发明涉及一种用中药制备的中药制剂，具体的是一种治疗糖尿病的中药制剂。
背景技术
随着人们生活水平的提高，糖尿病患者人数的迅速增长。糖尿病是由遗传、环境及免疫系统等多种因素引起的、以高血糖为特点的代谢性疾病。主要是体内胰岛素分泌紊乱或胰岛素作用缺陷引起的。随着人们生活水平的提高，生活方式和工作方式的逐渐改变，我国糖尿病患者也在大幅度增加。糖尿病是以持续高血糖为其基本特征的综合征。主要分为胰岛素依赖型1型和胰岛素非依赖型2型，临床所见约90%为2型。其基本生理病理是体内胰岛素相对或绝对不足而引起糖、蛋白质、脂肪、水电解质的代谢紊乱，其特征为高血糖、尿糖、葡萄糖耐量减低及胰岛素释放试验异常。症状为多饮、多食、多尿、烦渴、善饥、消瘦、疲乏无力等。常并发或伴发急性感染、动脉硬化、肾和视网膜微血管病变及神经病变。由于目前尚无根治糖尿病的药物，特别是糖尿病的合并症还不能得到有效控制，全世界都在从不同途径探索新的治疗方法。我国的传统医学认为，糖尿病属“消渴”病,首见于《内经。
发明内容
本发明的目的在于提出一种新的能有效治疗糖尿病的中药制剂，具体的是一种治疗糖尿病的中药制剂的技术方案。
本发明的技术方案为，一种治疗糖尿病的中药制剂，其特征在于，它是由下述重量份配比的原料药材制成的药剂：
山药450-550 人参250-350 沙参100-200 麦冬450-550 五味子150-250
黄精450-550 石斛150-200 苦瓜 450-550 甘草80-120 山株萸150-250
茯苓450-550 瓜蒌150-250 葛根350-450 生地200-300 苦刺花350-450
黄芩250-350 蛤蚧350-450 昆布250-350 知母450-550 白僵蚕400-500
鳖甲350-450 紫草250-350 鬼箭羽450-550 女贞子200-300 地骨皮450-550
苍术150-250 红景天150-250 元胡100-200 银杏330-400 红皮黄芪350-450
白花蛇舌草 200-300 金毛狗脊150-250。
所述的药剂是口服液、散剂、胶囊、冲剂、片剂、丸剂。
中医认为，糖尿病多是由于饮食不节，恣食肥甘酒醴，辛辣香燥，情志过极，郁怒失节，或劳心竭虑，房事不节，劳欲过度，禀赋遗传，感染邪毒，热病之后等因素，致肺、胃、肾受损，郁热内蕴，阴精损耗，气化失常，津液精微失于正常输布，淫溢血脉，或直趋下泄而成。病有上、中、下“三消”之分，肺燥、胃热、肾虚之别肺燥为主，多饮突出者为“上消”；胃热为主，多食突出者为“中消”；肾虚为主，多尿突出者为“下消”。病性初起以实证为主，中期虚实并见，后期以虚损为主。糖尿病，中医辨证论治一般分为肺燥津亏证、胃热津伤证、肾阴亏虚证和阴阳两虚证。本发明主要根据传统医学扶正培本、活血化瘀的理论，集众医家所长，广采博收云南各民族地区奇药妙方，基于中医学对糖尿病疾病的发病机理的认识及治疗原则，参考古今药理研究成就，筛选活血祛瘀、平肝熄风、养血通窍的天然中草药，按中医理论组方，提取精华，并经长期诊疗病例的临床实践总结而成。
本发明的辩证指南：补气养阴、清火、生津止渴、化瘀固摄。用于气阴两虚、肺脾肾俱虚，久病必瘀，气不布津，阴伤气耗，固摄无能，津伤液燥，困倦乏力，脉虚无力。本发明的处方分析：方中蛤蚧、五味子、山株萸、茯苓、金毛狗脊、山药、人参、白术、红皮黄芪、红景天、女贞子、鬼箭羽及苦刺花等药补中益气，养阴生津，滋阴清火，健脾胃，共为君药；地骨皮、苦瓜、昆布、沙参、鳖甲、麦冬、白僵蚕、紫草、知母等药养阴润肺，补肝肾，降火，凉血，降血糖、软坚化瘀为臣药；黄芩、生地、苍术、银杏、葛根、石斛、黄精、当归、瓜萎、元胡及白花蛇舌草等药利尿，凉心血，温肾阳、补血、降血糖血脂，共为佐药；甘草调理诸药为使。本发明中本发明中采用了云南特有的苦刺花，别名苦刺、狼牙刺、铁马胡烧。是豆科槐属植物白刺花Sophora viciifolia Hance，具有清热解毒、消炎的作用。红景天，景天科植物大花红景天Rhodiola crenulata(Hook.Thoms.)H.Ohba的干燥根及根茎。甘，苦，平。归肺、心经。益气活血，通脉平喘。用于气虚血瘀，胸痹心痛，中风偏瘫，倦怠气喘。苦刺花及红景天在本发明中与诸药协同作用，对治疗糖尿病起到重要的作用。本发明的药理作用：糖尿病是一个复合病因的综合病症，胰岛素是人体能源利用的原动力，又是糖原分解与合成的始动环节。胰岛素缺失可致糖不能利用。本发明通过调整失衡的阴阳，提高自身对血糖的利用和转化能力，本发明药物按君臣佐使的原理有机组合，协同作用，标本兼治，对糖尿病有较好的疗效，对重症糖尿病效果明显。本发明采用的原料药为常用的普通中药，制作成本低，基本无毒副作用。
本发明口服液、片剂、丸剂、散剂、胶囊、冲剂等其中一种，每次含药量1.5-2克，日服3次，各种剂型可交替使用，治疗20天为一疗程，轻症1-3个疗程，重症3-5个疗程。
本发明的临床试验资料：
采用本发明跟踪治疗糖尿病共100例，其中，男性61例，女性39例，年龄40-80岁，发病后1-20年。患者症状，口渴喜饮，消谷善饥，身痒有蚁走感，肢体麻木，肢端发凉，肢体疼痛或刺痛，倦怠乏力，自汗，五心烦热，便秘，舌体胖大、舌质紫暗或有瘀斑，脉象细数或细涩。空腹血糖为9.11-9.83mmol/L，或餐后2小时血糖为12.36-12.711mmol/L。其中Ⅰ型糖尿病患者21例，Ⅱ型糖尿病患者79例。
治疗方法：口服液每次10-20ml, 日服3次，散剂、胶囊、冲剂、丸剂等每次含药量1.5-2克，日服3次饭前温水服下。10天一疗程。通常1-3个疗程，重症4-5个疗程。
观察指标：
症状观察：临床症状基本消失的显效患者为35人，临床症状部份消失的有效患者为60人，临床症状无改善的8人。
空腹血糖：显效患者空腹血糖为6.8-7.83mmol/L，或餐后2小时血糖为11.03-9.711mmol/L。
显效患者空腹血糖为8.3-8.5mmol/L，或餐后2小时血糖为10.63-11.02mmol/L。
无效患者空腹血糖或餐后2小时血糖基本无变化。
服药1-3个疗程，临床症状基本消失的显效患者为34人，总显效率34%。临床症状部份消失的有效患者为57人，总有效率57%。临床症状无改善的9人，总无效率9%。在治疗过程中未见明显药物不良反应和毒副作用，没有发现有肝、肾、肺、脾、胃不适的现象。
具体实施方式
各实施例按表1备原料药，全部药为干品。按常规方法制成为口服液、散剂、胶囊、冲剂、片剂、丸剂。
表1
1、一种治疗糖尿病的中药制剂采用水提法的制备方法，由以下步骤组成：
(1)将表1的原料药按常规方法制为含水量为10%的水提取液，
(2)按常规方法用步骤（1）制得的水提取液制为口服液，
(3)将步骤（1）得到的水提取液干燥、粉碎、过至少200目筛，取筛下物，为药物提取散剂 ，
(4)按常规方法用步骤（3）制得的药物提取散剂制为口服剂中的片剂、丸剂、冲剂或胶囊剂。
2、一种治疗糖尿病的中药制剂采用直接粉碎法的制备方法，按表1备原料药，由以下步骤组成：
（1）表1所述的原料药筛去灰土,粉碎，过至少200目筛，取筛下物，
（2）用高温、紫外线等常规方法消毒灭菌，为生粉散剂，
（3）按常规方法用步骤（2）制得的生粉散剂制为口服剂中的片剂、丸剂、冲剂或胶囊剂。
Claims (1)
1.一种治疗糖尿病的中药制剂，其特征在于，它是由下述重量份配比的原料药材制成的药剂：
山药450-550 人参250-350 沙参100-200 麦冬450-550 五味子150-250
黄精450-550 石斛150-200 苦瓜 450-550 甘草80-120 山茱萸150-250
茯苓450-550 瓜蒌150-250 葛根350-450 生地200-300 苦刺花350-450
黄芩250-350 蛤蚧350-450 昆布250-350 知母450-550 白僵蚕400-500
鳖甲350-450 紫草250-350 鬼箭羽450-550 女贞子200-300 地骨皮450-550
苍术150-250 红景天150-250 元胡100-200 银杏330-400 红皮黄芪350-450
白花蛇舌草 200-300 金毛狗脊150-250。
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