CN107007686A - 一种治疗糖尿病肾病的中药制剂及其制备、服用方法 - Google Patents
一种治疗糖尿病肾病的中药制剂及其制备、服用方法 Download PDFInfo
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Abstract
本发明涉及一种治疗糖尿病肾病的中药制剂及其制备、服用方法,所述中药制剂由以下原料组成:黄芪、太子参、菟丝子、山芋肉、白术、葛根、芡实份、金樱子份、蝉蜕份、佩兰份、藿香份、大黄份、黄芩份、生地黄、三七粉、丹参。本发明根据中医理论,结合糖尿病肾病发病特点,肾脏损伤的情况,进行辨证施治,拟定中药复方制剂;经长期临床观察,患者临床症状均得到改善,蛋白尿、尿素氮和血肌酐有不同程度降低,延缓了肾病发展,改善了肾功能,起到了标本兼治的效果。
Description
技术领域
本发明涉及中药领域,尤其涉及一种治疗糖尿病肾病的中药制剂及其制备、服用方法。
背景技术
多年来,糖尿病发病率逐年增高,伴随而来的,是糖尿病肾病发病率越来越高。糖尿病肾病是微血管病变并发症,实质上是糖尿病治疗不当、日久损伤所至,糖尿病肾病直接影响人们生存质量,严重则危及生命。
传统中医认为消渴病是久治不愈伤阴耗气,痰热郁瘀互结,阻于脉落形成微型癥瘕。糖尿病肾病是阴液耗损燥热偏盛,以阴虚为主,燥热为标;因此在治疗上采用滋阴固肾法,常以六味地黄丸为主;如阴阳不调,则采用温阳滋阴固肾法,以金贵肾气丸为主。
根据多年来对糖尿病肾病发病机理的研究,借鉴传统中医学的经验,再结合临床糖尿病肾病发病的特点,本人认为糖尿病肾病的发病主要是与虚、湿、瘀、浊四大病理机制有关,并强调虚是构成糖尿病肾病的病理基础。早期肺肾阴液亏损,日久阴伤及气,气损及阳而出现气阴两虚、阴阳两虚及脾肾阳气虚衰的病理改变。病程中又出现因虚至实的病理机制,如气虚阳弱,可导致脾胃运化失职,肾关开阖失常,三焦决渎失职,而出现水湿停聚,以及阴虚血少脉涩,气虚血行无力。阳虚血寒凝滞而出现瘀血病机,湿聚血瘀可化热生毒,病至后期每因脏腑衰败,肾失开阖,而导致浊邪内聚,从而表现为糖尿病肾病虚实错杂,本虚标实之错综复杂的病理特点。
西医认为,糖尿病肾病造成肾损伤主要是患糖尿病多年,血糖控制不理想,而出现微血管病变,结节性肾小球硬化、瀰慢性肾小球硬化型病变。对肾功能影响主要是肾小球滤过率下降,大量尿蛋白丢失,可出现水肿、高血压。继而多数肾单位闭锁,尿白蛋白排泄率(UAER)降低,血肌酐、尿素氮升高,血脂升高、血压升高代谢异常,最后形成尿毒症。目前西医治疗方法不少,如采取血管紧张素转换酶抑制剂(ACEL)药物口服治疗,减轻微量白蛋白尿、降血肌酐、降尿素氮,或服用羟苯磺酸钙、开同及中药制剂海昆肾喜,但效果均不稳定,副作用及不良反应较为严重。若反复发作转化为难治的尿毒症,则需要进行血液透析,腹膜透析或换肾。本人认为这些方法治标不治本。很难想象患者的生活质量。
发明内容
本发明提供了一种治疗糖尿病肾病的中药制剂及其制备、服用方法,根据中医理论,结合糖尿病肾病发病特点及肾脏损伤的情况,进行辨证施治,拟定中药复方制剂;经长期临床观察,患者临床症状均得到改善,蛋白尿、尿素氮和血肌酐有不同程度降低,延缓了肾病发展,改善了肾功能,起到了标本兼治效果。
为了达到上述目的,本发明采用以下技术方案实现:
一种治疗糖尿病肾病的中药制剂,由以下原料按重量份比例组成:黄芪30~60份、太子参20~40份、菟丝子20~40份、山芋肉15~30份、白术20~40份、葛根20~40份、芡实10~30份、金樱子15~30份、蝉蜕10~30份、佩兰20~40份、藿香15~30份、大黄10~30份、黄芩15~30份、生地黄20~40份、三七粉10~30份、丹参20~40份。
一种治疗糖尿病肾病的中药制剂的制备、服用方法,包括:
1)制成煎剂服用;将组成所述中药制剂的原料按配比混合均匀,加入原料6~8倍体积的清水浸泡15~30分钟,分两次煎制;每次煎制时先用武火煮沸,再用文火煎30~40分钟;两次煎液混合后制得煎剂;每日分早、中、晚三次口服,每次各服用100ml;用于糖尿病肾病急性发病期;
2)制成丸剂服用;将组成所述中药制剂的原料按配比混合,粉碎至60~80目;加入浓度为70%~80%的乙醇浸泡10~15小时,乙醇加入量与原料的体积比为8~12:1;回流提取2次,每次1~2小时;醇提液滤过,合并,减压浓缩至相对密度1~1.2,浓缩液按常规方法加辅料做成水丸;每日分两次口服,早晚各服用20粒;用于糖尿病肾病稳定期;
3)制成膏剂服用;将组成所述中药制剂的原料按配比混合均匀,加入原料6~8倍体积的清水,分3次煎制;将3次煎液合并后过滤,浓缩成相对密度1~1.2的清膏,按每袋20克装袋;每日分早晚两次口服,每次服用一袋;用于糖尿病肾病稳定期。
与现有技术相比,本发明的有益效果是:
1)所述中药制剂具有温补肾阳,调补肾阴,固肾涩精,健脾利湿,荡涤胃肠,泄浊祛瘀,祛除中洲秽浊陈腐之气的功能,从而对糖尿病肾病起到标本兼治的作用;
2)所述中药制剂为纯中药复方制剂,副作用小,安全方便,价格低廉;
3)本发明所述中药制剂可制成煎剂、丸剂或膏剂,急性发病期服用煎剂,病情稳定期服用丸剂或膏剂,服用方便。
具体实施方式
本发明所述一种治疗糖尿病肾病的中药制剂,由以下原料按重量份比例组成:黄芪30~60份、太子参20~40份、菟丝子20~40份、山芋肉15~30份、白术20~40份、葛根20~40份、芡实10~30份、金樱子15~30份、蝉蜕10~30份、佩兰20~40份、藿香15~30份、大黄10~30份、黄芩15~30份、生地黄20~40份、三七粉10~30份、丹参20~40份。
一种治疗糖尿病肾病的中药制剂的制备、服用方法,包括:
1)制成煎剂服用;将组成所述中药制剂的原料按配比混合均匀,加入原料6~8倍体积的清水浸泡15~30分钟,分两次煎制;每次煎制时先用武火煮沸,再用文火煎30~40分钟;两次煎液混合后制得煎剂;每日分早、中、晚三次口服,每次各服用100ml;用于糖尿病肾病急性发病期;
2)制成丸剂服用;将组成所述中药制剂的原料按配比混合,粉碎至60~80目;加入浓度为70%~80%的乙醇浸泡10~15小时,乙醇加入量与原料的体积比为8~12:1;回流提取2次,每次1~2小时;醇提液滤过,合并,减压浓缩至相对密度1~1.2,浓缩液按常规方法加辅料做成水丸;每日分两次口服,早晚各服用20粒;用于糖尿病肾病稳定期;
3)制成膏剂服用;将组成所述中药制剂的原料按配比混合均匀,加入原料6~8倍体积的清水,分3次煎制;将3次煎液合并后过滤,浓缩成相对密度1~1.2的清膏,按每袋20克装袋;每日分早晚两次口服,每次服用一袋;用于糖尿病肾病稳定期。
中医学认为肾为先天之本,肾阴肾阳是其他脏腑阴阳的根本,为生命活动之根。正如《素问.上古天真论》云:“肾者主水,受五脏六腑之精而藏之。”肾所藏的精气,是脏腑阴阳之本,它包括“先天之精”和“后天之精”。糖尿病肾病日久,脾肾两虚,肾气肾元亏虚,固涩无权,水谷精微下泄形成蛋白尿,甚则脾肾衰败,湿浊内停,湿阻瘀生。形成肾衰之证。在治疗上应滋阴固肾,温补肾阳,健脾利湿,泄浊祛瘀,才是治疗糖尿病肾病最佳方法。
本发明认为糖尿病肾病早期以虚为病机的主要方面,同时湿和瘀也是其不可忽视的病机关键,并且贯穿糖尿病肾病的整个过程。随着糖尿病肾病病情的发展,其水湿、瘀血的临床表现亦逐渐加重,水湿阻遏与瘀血内停,是导致加重肾功能损害的重要因素。病至后期病机向阴阳两虚和脾肾阳衰惫转化,此时患者水肿加重,出现氮质血症,中医称之为溺浊、湿、瘀、逐成新的至病因素,进一步导致五脏形质的损害,最终出现多脏器受损的严重局面。治疗中应准确辨证,标本兼顾,才使病情长期稳定,延缓疾病进程,以至达到临床治愈。
本发明所述中药制剂的原料选用:黄芪、太子参、菟丝子、山芋肉、白术、葛根、芡实、金樱子、蝉蜕、佩兰、藿香、大黄、黄芩、生地黄、三七粉、丹参;其中:
黄芪:味甘,性温,归脾、肺经。黄芪为补气之要药,具有升举阳气作用;能补脾、肺之气,又能补气生血,生津止渴,利水消肿;适用于气虚不运引起的小便不利,肢体面目浮肿。现代化药理研究其对血清性肾炎的发病有阻抑作用,并能延迟蛋白尿与高胆固醇血症的发生,因此本发明将其作为治疗糖尿病肾病的首选药物。
太子参:味甘,微苦,性微寒;其为清补之品,既能益气,又可养阴;适于气阴不足,神倦食少,津伤口渴,及病后体弱,本发明用其补元气。
菟丝子:既能助阳,又能益精,为平补肝、肾、脾三经良药,且有固精、缩尿、明目、止泻,适用于肝肾不足、泄精、白浊、小便不禁、尿有余沥等症。
山芋肉:既具收敛之性,以秘藏精气固摄下元;又能补益肝肾,以滋养精血而助元阳之不足。故凡肝肾不足,精气失常之证均用此药。《衷中参西录》中记载“山芋肉味酸性温,大能收敛元气,振作精神,固摄滑脱”。
白术:有补脾益气。燥湿利水作用。“肾为先天之本”,“脾为后天之本”,肾的气血津液靠脾的生化之元来滋养。在此方中起到了补益脾气而祛湿,消除痞满祛痰饮。(本草摘要)《别录》:“消痰水,逐皮间风水结肿”在此进一步阐明白术的主要功能。
葛根:味甘、辛,性平。归脾胃经。在此方能鼓舞胃气上行,有生津止渴之效。
芡实:味甘涩,性平。归脾肾精。本品味甘补益,味涩固敛,既能补脾益气,又能益精以固下元。固肾涩精,常与金樱子相须为用,在此方中起到了减少蛋白流失。如《本草纲目》:“止渴益肾,治小便不禁,遗精,白浊,带下。”
金樱子:味酸、涩,性平。归肾、膀胱、大肠经。其性专收敛,固涩下焦为其所长,功能固精、缩尿、止泻。凡肾虚精关不固,下焦虚损之滑脱不禁病症,均有疗效。
蝉蜕:味甘、性寒,归肺、肝经。药理研究含主要成分角蛋白,24种氨基酸和大量的甲壳质,壳聚糖,本品有一定的免疫抑制和抗过敏作用,其对机体免疫功能和变态反应有明显的抑制作用。本发明用其起到消减蛋白尿的作用。
佩兰:药力平和,其气芬芳清香,长于醒脾,宣湿化浊,善能祛除中洲秽浊陈腐之气。
藿香:善于散邪辟恶,理气化湿,芳香化浊。
大黄:苦寒沉降,俊下实热,荡涤胃肠,走而不守,斩关夺门,有将军之号。还有行瘀破积,适用于瘀血阻滞引起的多种病症。正如《本经》所述:“下瘀血,血闭寒热,破癥瘕积聚,荡涤肠胃,推陈致新,通利水谷,调中化食,安和五脏。”因此能有效排除体内毒素。
黄芩:味苦,性寒。归肺、大、小肠、脾、胆诸经。苦能燥湿,寒能清热,善清肺、大、小肠、脾、胆诸经之湿热,尤长于清泄肺与大肠之火,并有泄火解毒之功。
生地黄:入心、肝、肾经。为滋阴凉血之要药。适用于热病伤阴,舌降烦渴,阴亏血虚,心烦内热,骨蒸,消渴。现代化药理研究经动物试验证实,其有显著的降血糖作用。
三七粉:甘缓温通,苦降下泄,功擅散瘀和血,散瘀止血,《本草求真》记载“世人仅知功能止血定痛,殊不知因血瘀则痛作,血因瘀散则痛止,三七气味苦温,能于血分化其血瘀。”
丹参:功能活血通经,凉血消肿,清心除烦。现代药理研究其有效改造外周循环,提高常压和低压条件下机体的耐缺氧力,加快微循环血流速度增加毛细血管网等作用;有持久的降血糖作用。
本发明对所述中药制剂的配方是在经过大量临床摸索总结得出的最佳组方,各组分用量在所述重量份范围随症加减,均具有较好疗效。具体治疗机理如下:
糖尿病肾病虽然错综复杂,但还是以虚为主,本发明用黄芪、太子参、白术,以健脾补气,益精养肾,本发明尤其重用黄芪,因为补其气虚,兼顾其实,是治疗糖尿病肾病的大法。
糖尿病肾病久病伤阴,阴精耗损,阴易损伤阳气,故本发明用山芋肉、菟丝子,以益精固阳,滋养精血,平补肝、肾、脾三经,尤以补肾为主。
糖尿病肾病由于久病脾肾衰败,湿浊内停,湿阻瘀生,本发明用藿香、佩兰,以芳香化浊,祛湿,祛除中洲秽浊陈腐之气。
糖尿病肾病由于肾精不足,固摄失职,导致精微下泄,阴液耗损而出现蛋白尿,对于水肿、氮质血症采用芡实、金樱子、蝉蜕、大黄下瘀血,破癥瘕积聚,荡涤胃肠,有效排除体内毒素;同时又能固肾摄精,补脾益气,减轻蛋白尿、水肿症状。
糖尿病肾病本是阴虚为本,燥热为标,湿浊瘀久化热生毒,因而本发明用黄芩、生地黄、葛根,以滋阴凉血,尤其清泄肺与大肠之火,并有泄火解毒之功。
糖尿病肾病瘀滞贯穿始终,在治疗应用活血化瘀药是必不可少,本发明用丹参、三七粉,以散瘀和血化其血份中的瘀血,还能活血通经,凉血消肿。
综上,本发明中以上诸药合用,有补肾、脾、肺之气,滋养肾阴,固摄肾阳,祛出秽浊陈腐之气,破癥瘕积聚,排出体内毒素的功效。
糖尿病肾病治疗首先要控制好血糖,这是最基础治疗。血糖如控制在理想范围内,糖尿病肾病治疗效果均比较理想。本发明所述中药制剂适合大多数糖尿病肾病患者,亦有少数患者有兼证者,可在本发明所述配方基础上适应增加其它中药材,如血尿严重者可加旱莲草、藕节;水肿重者加猪苓、泽泻;贫血重者加阿胶、熟地黄。
以下实施例在以本发明技术方案为前提下进行实施,给出了详细的实施方式和具体的操作过程,但本发明的保护范围不限于下述的实施例。下述实施例中所用方法如无特别说明均为常规方法。
【实施例】
1.临床资料
将患者随机分为治疗组、对照组各84例,均为住院患者;其中:
治疗组,男性46例,女性38例,男女之比5:4;年龄20~30岁8例;31~40岁12例;41~50岁15例;51~60岁18例;61~70岁20例;71岁以上11例。
对照组,男性45例,女性39例,男女之比5:4;20~30岁10例,31~40岁8例,41~50岁14例,51~60岁17例,61~70岁20例,71岁以上15例。
2.诊断标准
(1)中医诊断标准:参照1987年天津中华中医药学会内科肾病专业委员会“慢性肾衰中医辨证分型诊断专题讨论会”通过的相关标准;
(2)中华医学会糖尿病学分会微血管并发症学组发布的《糖尿病肾病防治专家共识(2014年版)》;
(3)郑筱萸主编的《中华新药临床研究指导原则》“中药新药治疗慢性肾功能衰竭的临床研究指导原则”;
(4)《中医内科学》新版第七版;
(5)《中医内科疾病诊疗常规》;
3.临床症状及分型:
一型糖尿病约5年进展一期,二型糖尿病约3~4年进展一期。
Ⅰ期:肾小球高滤过期,肾小球滤过率增多,血糖控制后可以恢复。
Ⅱ期:正常白蛋白尿期,平常白蛋白尿正常,应激状态下(运动、发热等)尿蛋白排泄增多,出现微量白蛋白尿/肌酐比值达30~300mg/g,或尿白蛋白排泄率达20~200Ug|/min。
Ⅲ期:持续微量白蛋白尿又称早期糖尿病肾病期,呈现持续性微量白蛋白尿,肾小球滤过率开始下降。
Ⅳ期:临床糖尿病肾病期尿常规化验尿蛋白阳性,称为进入此期的标准,常于3~4年内发展至大量蛋白尿(≥3.5g/d)临床出现肾病综合症。此期肾小球滤过率持续下降,血清肌酐开始升高。
Ⅴ期:肾衰竭期,肾小球滤过率<15mmol/min,出现尿毒症症状,但是不少患者在相当长一段时间内仍保持大量蛋白尿及肾病综合症,而且肾脏影像检查肾脏体积无明显萎缩,为此欲及时发现早期糖尿病患者定期检查GFR及尿白蛋白。
4.治疗方法
对照组:血糖>12.5mmol/L时,给与常规胰岛素治疗,将血糖控制在5.2~7.8mmol/L。卡托普利25mg,每日2次口服,羟苯磺酸钙0.5,每日3次口服,海昆肾喜2粒,每日3次口服。
治疗组:血糖>12.5mm0l/L时,给与常规胰岛素治疗.控制血糖在5.2~7.8mmol/L。实施中药治疗,服用本发明所述中药制剂煎剂,每日一剂,分早、中、晚三次口服,一个月为一个疗程,一个月后可口服本发明所述中药制的丸剂或膏剂,连续治疗3个月。
5.疗效评定标准
(1)基本治愈:症状体征消失,尿常规检查3次均为正常,尿微量蛋白定量、血脂、血浆蛋白、尿素氮、肌酐指标均为正常。
(2)显效:症状体征消失,尿蛋白定性±~++,24h尿蛋白定量较治疗前减少1/2以上,血脂明显改善,尿素氮、肌酐指标接近正常。
(3)有效:临床症状有所减轻,尿蛋白定性++~+++,血脂指标下降,尿素氮、肌酐有所好转。
(4)无效:症状与体征,相关实验室检查均无明显改变甚或加重。
6.治疗结果:
治疗组:基本治愈43例,显效21例,有效16例,无效4例,总有效率95.2%。
对照组:基本治愈26例,显效18例,有效20例,无效20总有效率35%。
如下表所示,是治疗组与对照组临床疗效对比数据:
组别 | 例数 | 基本治愈 | 显效 | 有效 | 无效 |
试验组 | 84 | 43(51.1) | 21(25.0) | 16(19.0) | 4(4.76) |
对照组 | 84 | 26(30.9) | (21.4) | 19(22.6) | 21(25.0) |
因此可得出结论:与对照组比较,治疗组的疗效有显著提高(p<0.05)。
【典型病例】
张某,男,61岁,首诊,患者以周身不适全、消瘦、浮肿(双下肢尤甚)两周,在当地对症治疗不见明显好转而来院就诊;既往患糖尿病5年,口服二甲双胍,每次0.5餐后即服,每日三次治疗。平时血糖维持7.5~9.3mmol/L,饮食控制的不理想。收入院治疗。
入院时患者全身乏力,周身肿胀,面色萎黄无华,腹胀纳差,尿少有异味;入院检查结果,尿液分析红细胞++,尿蛋白+++,尿糖+++,血糖16mmol/L,餐后血糖21mmol/L,糖化血红蛋白8.6%/,肝功能正常,肾功能血清肌酐210mmol/L,尿素氮13mmol/L,血脂胆固醇7.8mmol/L,甘油三脂3.8mmol/L,血清蛋白30g/L。
入院诊断:1.糖尿病;2.糖尿病肾病;3.低蛋白血症。
治疗采取先治标的方法,皮下注射短效胰岛素8ug,餐前30分钟,皮下注射,每日3次,三天后血糖降至10mmol/L,其他化验指标没明显变化。
第四天开始施用本发明所述中药制剂,具体由以下原料制成:黄芪50克、太子参20克、菟丝子20克、山芋肉15克、白术20克、葛根25克、芡实15克、金樱子15克、蝉蜕15克、佩兰25克、藿香15克、大黄15克、黄芩15克、生地黄25克、三七粉10克、丹参20克。
以上中药制剂制成煎剂服用;将组成所述中药制剂的原料按配比混合均匀,加水浸泡30分钟,分两次煎制;每次煎制时先用武火煮沸,再用文火煎30分钟;头煎取汁150毫升,二煎取汁150毫升,两次煎液混合后制得煎剂;每日早、中、wan晚各服用一次,每次口服100毫升。
服用本发明所述中药制剂煎剂后,患者两周后全身症状明显好转,化验血糖、血脂、肾功能,血清蛋白等都有明显改善。继续服用两周,各项检验指标均在正常范围。
改服用上述中药制剂的膏剂,每日早晚各服用一次,每次服用20克,连服两个月。随访一年,无复发。
本发明采用应用临床数十例患者,疗效显著,治愈病例数目众多,均取得良好效果,且成本低,无毒副作用,减轻了患者痛苦和经济负担;具有广阔的应用前景。
以上所述,仅为本发明较佳的具体实施方式,但本发明的保护范围并不局限于此,任何熟悉本技术领域的技术人员在本发明揭露的技术范围内,根据本发明的技术方案及其发明构思加以等同替换或改变,都应涵盖在本发明的保护范围之内。
Claims (2)
1.一种治疗糖尿病肾病的中药制剂,其特征在于,由以下原料按重量份比例组成:黄芪30~60份、太子参20~40份、菟丝子20~40份、山芋肉15~30份、白术20~40份、葛根20~40份、芡实10~30份、金樱子15~30份、蝉蜕10~30份、佩兰20~40份、藿香15~30份、大黄10~30份、黄芩15~30份、生地黄20~40份、三七粉10~30份、丹参20~40份。
2.一种如权利要求1所述治疗糖尿病肾病的中药制剂的制备、服用方法,其特征在于,包括:
1)制成煎剂服用;将组成所述中药制剂的原料按配比混合均匀,加入原料6~8倍体积的清水浸泡15~30分钟,分两次煎制;每次煎制时先用武火煮沸,再用文火煎30~40分钟;两次煎液混合后制得煎剂;每日分早、中、晚三次口服,每次各服用100ml;用于糖尿病肾病急性发病期;
2)制成丸剂服用;将组成所述中药制剂的原料按配比混合,粉碎至60~80目;加入浓度为70%~80%的乙醇浸泡10~15小时,乙醇加入量与原料的体积比为8~12:1;回流提取2次,每次1~2小时;醇提液滤过,合并,减压浓缩至相对密度1~1.2,浓缩液按常规方法加辅料做成水丸;每日分两次口服,早晚各服用20粒;用于糖尿病肾病稳定期;
3)制成膏剂服用;将组成所述中药制剂的原料按配比混合均匀,加入原料6~8倍体积的清水,分3次煎制;将3次煎液合并后过滤,浓缩成相对密度1~1.2的清膏,按每袋20克装袋;每日分两次口服,每次服用一袋;用于糖尿病肾病稳定期。
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CN107737279A (zh) * | 2017-11-21 | 2018-02-27 | 武汉大学 | 一种治疗糖尿病肾病的中药配方及其制备方法 |
CN112451618A (zh) * | 2020-11-10 | 2021-03-09 | 青岛大学附属医院 | 一种治疗糖尿病肾病的中药组合物 |
CN115192657A (zh) * | 2022-09-16 | 2022-10-18 | 山东第一医科大学附属省立医院(山东省立医院) | 一种用于治疗2型糖尿病肾脏病的中药制剂及其应用 |
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