CN112933201A - 一种用于治疗糖尿病肾病的中药组合物、中药制剂及其制备方法 - Google Patents
一种用于治疗糖尿病肾病的中药组合物、中药制剂及其制备方法 Download PDFInfo
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Abstract
本发明提供了一种用于治疗糖尿病肾病的中药组合物,包括生黄芪5‑30份,党参5‑20份,制山萸肉5‑20份,泽兰5‑20份,泽泻5‑20份,猫爪草5‑30份,土茯苓10‑40份,海风藤5‑20份,穿山龙5‑20份,天花粉5‑20份,当归5‑20份,莪术5‑20份。本发明还提供了采用所述中药组合物制成的中药制剂及其制备方法。本发明中药组合物君臣佐使俱全,配伍严谨,相辅相成,具有固肾疏风,泄浊和络之功,对改善糖尿病肾病临床证候有显著效果,可降低糖尿病肾病患者的血肌酐、尿素氮及尿蛋白,具有良好的肾脏保护作用,有良好的应用前景。
Description
技术领域
本发明属于医药领域,具体涉及一种用于治疗糖尿病肾病的中药组合物、中药制剂及其制备方法。
背景技术
糖尿病肾病(diabetic nephropathy,DN)是常见的1型和2型糖尿病的慢性并 发症,临床以慢性高血糖、蛋白尿和进行性肾功能损害为主要表现,具有很高的致残 率。糖尿病肾病的发病机制尚未阐述明确,目前认为遗传因素、血流动力学改变、炎 性细胞浸润、糖代谢紊乱及组织缺氧均能导致糖尿病肾病。近年来糖尿病肾病在我国 的发病率不断上升,目前已成为终末期肾脏病的主要原因,仅次于肾小球肾炎。而慢 性肾脏病能导致心血管事件的发生,慢性肾脏病患者的医疗费用是非慢性肾脏病患者 的1.8倍,为患者个人及社会造成了较为沉重的经济负担。
目前糖尿病肾病尚无特效治疗方法,治疗上以控制血糖、血压、血脂及减少蛋白尿为主要原则,并无有效手段阻止DN病情进展。目前血管紧张素转换酶抑制剂(ACEI) 或血管紧张素受体拮抗剂(ARB)为治疗DN首选药,有新的研究表明,盐皮质激素受 体阻断剂(MRB)联合ACEI或ARB使能协助减轻蛋白尿。新型降糖药钠-葡萄糖协同 转运蛋白2(SGLT2)抑制剂,如依帕列净、达格列净等能减少蛋白尿病,减少复合肾 脏结果的发生。GLP-1激动剂对蛋白尿也有有利影响,利拉鲁肽能减少蛋白尿的剂量 依赖性。但上述治疗仍存在局限性及不良反应,治疗DN仍需寻找更有效的治疗方式。
糖尿病的病机以阴虚为本,燥热偏盛,古人多采用上、中、下三消辨证论治。糖 尿病肾病辨证分型和治疗现在没有统一的观点,现代研究表明部分单味药及其提取物 如黄芪、黄精多糖、黄连素等能延缓糖尿病肾病进展,中药复方如益气解毒化瘀小复 方中药、济生肾气丸、肾消汤等可通过不同机制延缓糖尿病肾病的进程。但已上市的 中成药如消渴丸、玉泉丸等均侧重于养阴清热,益气生津,对糖尿病肾病相关证候的 针对性较差,疗效需进一步提高。
发明内容
本发明在于克服现有技术的不足,提供一种用于治疗糖尿病肾病的中药组合物及采用该中药组合物制备而成的中药制剂,显著改善糖尿病肾病临床证候,降低糖尿病 肾病患者的血肌酐、尿素氮及尿蛋白,具有良好的肾脏保护作用。
本发明提供一种用于治疗糖尿病肾病的中药组合物,所述中药组合物由下列重量份数的中药制成:生黄芪5-30份,党参5-20份,制山萸肉5-20份,泽兰5-20份, 泽泻5-20份,猫爪草5-30份,土茯苓10-40份,海风藤5-20份,穿山龙5-20份, 天花粉5-20份,当归5-20份,莪术5-20份。
所述的中药组合物由下列重量份数的中药制成:生黄芪15-30份,党参10-20份,制山萸肉8-20份,泽兰8-20份,泽泻5-20份,猫爪草15-30份,土茯苓20-40份, 海风藤8-20份,穿山龙10-20份,天花粉10-20份,当归8-20份,莪术8-20份。
所述的中药组合物由下列重量份数的中药制成:生黄芪30份,党参15份,制山 萸肉10份,泽兰12份,泽泻10份,猫爪草30份,土茯苓40份,海风藤12份,穿 山龙15份,天花粉15份,当归12份,莪术10份。
所述的中药组合物,制备方法:采用水提法进行提取,制备,即得。
具体水提法为:取中药原料,加水8-16倍(重量),煎煮1小时,过滤,滤液备 用;滤渣再加上8-16倍(重量)水,煎煮1小时,过滤,弃去滤渣,合并前次滤液, 浓缩,干燥,制成丸剂、片剂、胶囊剂、液体制剂等。
所述的中药组合物,中药原料提取后添加药学上可接受的辅料制备成中药制剂,剂型为丸剂、片剂、胶囊剂、颗粒剂、软胶囊剂、口服液中的一种。
所述的中药组合物在制备治疗糖尿病肾病药物中的应用。
生黄芪,为豆科植物蒙古黄芪(Astragalus mongholicus Bunge)的干燥根。主 产于中国的内蒙古、山西、黑龙江等地。黄芪性微温,具有补气升阳、固表止汗、托 毒生肌之功效。主治气血虚弱、自汗、久泻脱肛、子宫脱垂、肾炎浮肿、蛋白尿、糖 尿病、慢性溃疡等症。近代研究表明其提取物黄芪甲苷具有增强免疫***、抗氧化、 延缓衰老、改善心功能状态、抗病毒、抗癌等功效。
党参,为桔梗科党参属(Codonopsis pilosula(Franch.)Nannf.),产地中国 北方海拔1560-3100米的山地林边及灌丛中。性平,味甘,具有补中益气、止渴、健 脾益肺,养血生津的功效,主治治脾胃虚弱,气血两亏,体倦无力,食少,口渴,久 泻,脱肛。近代研究表明其主要成分多糖有增强机体免疫力、抗衰老、降血糖等多种 作用。
制山萸肉,为山茱萸科植物山茱萸(Cornus officinalis Sieb.et Zucc.)蒸 透去内核晒干而来,分布于山西、江苏、浙江、安徽、江西、山东、河南、湖南、四 川、陕西、甘肃等地。酸、涩、微温,入肝、肾经。具有补益肝肾,收涩固脱之功效。 常用于眩晕耳鸣,腰膝酸痛,阳痿遗精,遗尿尿频,崩漏带下,大汗虚脱,内热消渴。 现代医学研究表明,山茱萸具有增强免疫***功能、抗炎抑菌、降血糖、抗休克、抗 氧化、抗肿瘤等作用。
泽兰,为唇形科植物毛叶地瓜儿苗(Lycopus lucidus Turcz.vat.hirtus Regel)的干燥地上部分。分布于我国大部分地区。苦、辛,微温。归肝、脾经。具有活血调 经,祛瘀消痈,利水消肿之功效。用于***,经闭,痛经,产后瘀血腹痛,疮痈 肿毒,水肿腹水。现代研究表明泽兰可通过促进HGF及VEGF表达,从而改善肾间质 纤维化,延缓慢性肾脏病的进展。
泽泻,为泽泻科植物泽泻(Alisma orientalis(Sam.)Juzep.)的干燥块茎。甘,寒。归肾、膀胱经,利小便,清湿热,主治小便不利,水肿胀满,泄泻尿少,痰饮眩 晕,热淋涩痛。现代研究表明泽泻水提液能明显抑制乙二醇与活性维生素D3诱导的 大鼠实验性肾结石的形成。
猫爪草,为毛茛科植物小毛茛(Ranunculus ternatus Thunb.)的干燥块根。分 布于广西、台湾、江苏、浙江、江西、湖南、安徽、湖北、河南等地。味甘、辛,性 温。归肝、肺经。具有化痰散结,解毒消肿之功效。常用于瘰疬痰核,疔疮肿毒,蛇 虫咬伤。现代研究表明复方猫爪草水提物有抗炎症作用。
土茯苓,为双子叶植物药百合科植物光叶菝葜的干燥根茎(Glabrous GreenbrierRhizome)。味甘、淡,性平,有解毒,除湿,利关节的功效。主治梅毒,淋浊,筋骨 挛痛,脚气,疔疗疮,痈肿,瘰疬。现代研究表明土茯苓有较好的免疫及抗炎功效。
海风藤,为胡椒科植物风藤(Piper kadsura(Choisy)0hwi)的干燥藤茎,味辛、苦,性微温,归肝经。有祛风湿,通经络,止痹痛功效,主治风寒湿痹,肢节疼痛, 筋脉拘挛,屈伸不利。其有效成分胡椒酮有抗炎作用,风藤烯酮可拮抗血小板激活因 子引起的人中性粒细胞聚集和脱颗粒反应,还可阻断激活因子、组胺、缓激肽昕致的 大鼠皮肤血管通透性增强反应
穿山龙,为薯蓣植物穿龙薯蓣Dioscorea nipponica Makino的干燥根茎,主要 分布于辽宁、吉林、黑龙江、河北、内蒙古等地。味甘、苦,性温,归肝,肾、肺经。 有祛风除湿,舒筋通络,活血止痛,止咳平喘的作用,用于风湿痹病,关节麻木,跌 扑损伤,闪腰岔气,咳嗽气喘。研究表明其有效成分总皂甙能显著降低兔血胆甾醇及 血压,延缓心率、增强心收缩振幅、增加尿量、降低β/α脂蛋白比例,改善冠状循 环。
天花粉,为葫芦科植物栝楼或双边栝楼的干燥根。分布于河南等地。味甘、微苦,微寒,归肺、胃经,有清热泻火,生津止渴,消肿排脓的功效,主治热病烦渴,肺热 燥咳,内热消渴,疮疡肿毒。研究表明天花粉分离出的5种聚糖成分能使小鼠血糖下 降。
当归,为伞形科植物当归(Angelica sinensis(Oliv.)Diels)的干燥根。主产 甘肃东南部,以岷县产量多,质量好,其次为云南、四川、陕西、湖北等省。味甘、 辛,性温,归肝、心、脾经。具有补血活血,调经止痛,润肠通便之功效。常用于血 虚萎黄,眩晕心悸,***,经闭痛经,虚寒腹痛,风湿痹痛,跌扑损伤,痈疽疮 疡,肠燥便秘。酒当归活血通经。用于经闭痛经,风湿痹痛,跌扑损伤。其有效成分 阿魏酸有降血脂作用。
莪术,为姜科植物莪术(Curcuma aeruginosa Roxb.[C.zedoaria non Rosc.])、广西莪术(Curcuma kwangsiensis S.G.Lee et C.F.Liang)和温郁金(Curcuma wenyujinY.H.Chen et C.Ling)的根茎,分布于广东、广西、四川、云南等地; 味辛、苦,性温,归肝、脾经。具有行气破血,消积止痛之功效。常用于血气心痛, 饮食积滞,脘腹胀痛,血滞经闭,痛经,癓瘕痞块,跌打损伤。现代研究表明莪术对 肝肾均有保护作用,且其成分温郁金挥发油有一定抗炎作用。
本发明中的中药组合物组分包括生黄芪,党参,制山萸肉,泽兰,泽泻,猫爪草, 土茯苓,海风藤,穿山龙,天花粉,当归,莪术。其中生黄芪益气固表,利水消肿为 君药,党参、山萸肉助生黄芪补益肾气为臣药,泽兰、泽泻、猫爪草、天花粉、土 茯苓。清热利湿,解毒泄浊,海风藤、穿山龙祛风湿,通经络为佐药,莪术、当归活 血化瘀和络为使药,诸药合用共达固肾疏风泄浊和络之功,本发明中药组合物君臣佐 使俱全,配伍严谨,相辅相成,具有固肾疏风,泄浊和络之功,对改善糖尿病肾病临 床症候非常显著,可降低糖尿病肾病患者血肌酐、尿素氮及尿蛋白,具有良好的保护 肾脏作用,具有良好的应用前景。
具体实施方式
以下结合实例对本发明作进一步的描述,实施例仅用于对本发明进行说明,并不构成对权利要求范围的限制,本领域技术人员可以想到的其他替代手段,均在本发明 权利要求范围内。
实施例1:取生黄芪5g,党参20g,制山萸肉5g,泽兰20g,泽泻5g,猫爪草 30g,土茯苓10g,海风藤20g,穿山龙5g,天花粉20g,当归5g,莪术20g,加药材 重量16倍量的水,煎煮1小时,过滤,药渣再加药材重量8倍量的水,煎煮1小时, 合并两次次水煎液,过滤,将滤液浓缩,真空干燥,得浸膏干粉,加糊精,以80%乙 醇湿法制颗粒,湿颗粒在60℃干燥,即得颗粒剂。
实施例2:取生黄芪30g,党参5g,制山萸肉20g,泽兰5g,泽泻20g,猫爪草 5g,土茯苓40g,海风藤5g,穿山龙20g,天花粉5g,当归20g,莪术5g,加药材重 量16倍量的水,煎煮1小时,过滤,药渣再加药材重量8倍量的水,煎煮1小时, 合并两次水煎液,过滤,将滤液浓缩,真空干燥,得浸膏干粉,加淀粉,制颗粒,压 片,即得片剂。
实施例3:取生黄芪30g,党参15g,制山萸肉10g,泽兰12g,泽泻10g,猫爪 草30g,土茯苓40g,海风藤12g,穿山龙15g,天花粉15g,当归12g,莪术10g,加 药材重量16倍量的水,煎煮1小时,过滤,药渣再加药材重量8倍量的水,煎煮1 小时,合并两次次煎液,过滤,将滤液浓缩,喷雾干燥,得浸膏干粉,加糊精,以制 颗粒,干燥,罐胶囊,即得胶囊剂。
实施例4:取生黄芪30g,党参15g,制山萸肉10g,泽兰12g,泽泻10g,猫爪 草30g,土茯苓40g,海风藤12g,穿山龙15g,天花粉15g,当归12g,莪术10g,加 药材重量16倍量的水,煎煮1小时,过滤,药渣再加药材重量8倍量的水,煎煮1 小时,合并两次水煎液,过滤,将滤液浓缩,制备成口服液剂。
实施例5:取生黄芪30g,党参15g,制山萸肉10g,泽兰12g,泽泻10g,猫爪 草30g,土茯苓40g,海风藤12g,穿山龙15g,天花粉15g,当归12g,莪术10g,加 药材重量16倍量的水,煎煮1小时,过滤,药渣再加药材重量8倍量的水,煎煮1 小时,合并两次次煎液,过滤,将滤液浓缩,喷雾干燥,得浸膏干粉,加辅料,制备 成丸剂。
实施例6:本发明治疗糖尿病肾病的临床观察
1、病例来源:以南京市中医院2018年8月至2020年3月肾病科专科门诊就诊 或住院收治的80例糖尿病肾病患者,治疗组入组患者均符合肾虚湿浊血瘀证,按随 机对照原则将符合纳入标准的患者分为治疗组、对照组,每组40例。
2、糖尿病肾病诊断标准:参照中华医学会内分泌学分会颁发的《中国成人糖尿 病肾脏病临床诊断专家共识2016年版》及改善全球肾脏病预后组织KDIGO颁布的《CKD 评估与管理临床实践指南2012》的糖尿病肾病诊断标准,并按Mogensen分期标准, 属III、IV期DN为观察对象。具体为:①有确切的糖尿病史;②有眼底视网膜病变; ③尿微量白蛋白定量>30mg/24h或尿白蛋白/尿肌酐>30mg/mmol。④eGFR>10ml/min。
3、治疗分组方法:入选前通过限制蛋白摄入、给予优质低蛋白饮食、控制血糖、 降压等治疗,达到基本体征平稳,符合入选条件的病例进入本试验。入选病例按照1: 1随机分成治疗组和对照组。本研究中治疗组脱落2例,治疗组38例,对照组40 例。
(1)基础治疗:对患者进行相关基础知识宣教;低盐低脂优质低蛋白饮食;给 予口服降糖药或胰岛素控制血糖,用量随具体病情而定,保证血糖达标同时避免低血 糖发生,使空腹血糖≤7.1mmol/L,餐后2h血糖<11.1mmol/L,糖化血红蛋白 <7%。
(2)对照组治疗:在基础治疗同时,根据血压情况,高血压者给予厄贝沙坦 150mg,每日1次。血肌酐>265umol/l的患者选择非ACEI、ARB类降压药物控制血压。
(3)治疗组治疗:在基础治疗中降压选择非ACEI、ARB类药物。并给予实施例 4制成的口服液剂。早晚2次分服,每次服用20ml,疗程8周。
注:与本组治疗前采用配对样本t检验比较,**P<0.01。与对照组治疗后组间 比较,ΔP<0.05,ΔΔP<0.01。
注:与本组治疗前对比较,*P<0.05,**P<0.01。与对照组治疗后组间比较, ΔP<0.05。
上述临床实验显示,本发明能降低Scr(μmol/L)、BUN(mmol/L)、ACR(mg/gCr)、MAlb(mg/L),升高GFR(ml/min*1.73m2),与对照组比较具有显著性差异,说明本发明 对糖尿病肾病具有良好的治疗效果。
实施例7:本发明药效学实验
1、仪器与材料
1.1主要仪器:HEA-230血糖仪(日本OMRON公司),血糖试纸(日本OMRON公 司),5415R型离心机(德国Eppendorf公司),Sartorius电子天平(赛多利斯科学 仪器(北京)有限公司),日立OLYMPUS自动生化分析仪(型号7600,南京三和公司)。
1.2试剂:链脲佐菌素(STZ,SIGMA公司);实施例4制备得到的口服液剂。
1.3实验动物:60只健康雄性Sprague-Dawley(SD)大鼠,清洁级,4-6周龄, 体重约140-220g,购自南通大学,许可证号:SYXK(苏)2017-0040。适应性喂养一 周,无不良反应即进入实验。
2、实验方法
2.1造模:50只SD大鼠按随机数字表分组,其中正常组(N组)10只,造模组 50只,适应性喂养7天后,禁食12h,称重后,制备糖尿病肾病模型,模型组按55mg/kg 的剂量一次性左侧腹腔注射1%链脲佐菌素(STZ)溶液,正常组(N组)用等量生理 盐水左侧腹腔注射,各组均予标准饮食,定期更换垫料,消毒笼具。STZ溶液注射造 模后72h连续测3天随机血糖,血糖值>16.7mmol/L为糖尿病(DM)模型制备成功, 未达标者重复予STZ溶液55mg/kg左侧腹腔注射1次,5天后复测血糖达标者进入后 续糖尿病肾病(DN)造模。DM造模成功后的大鼠喂养1周后测随机血糖>16.7mmol/L, 尿量为正常组(N组)的1.5倍及以上,24h尿蛋白为正常组(N组)的1.5倍及以上, 则为DN模型制备成功,指标未达标准的造模大鼠予以剔除。
2.2分组及给药:DN成模大鼠40只随机分为模型组(DN组)10只、中药复方 低剂量组10只、中药复方中剂量组(GSM组)10只、中药复方高剂量组(GSH组)10 只。大鼠给药剂量按动物与人体每公斤体质量折算(人的6.25倍),中药复方组低中 高剂量组均采用实施例1制得药物成分。N组、DN组均予0.1ml/10g生理盐水灌胃, 中药复方组分别按试验药物低、中、高浓度(分别为10.99、21.98、43.96g/kg)给 药,给药体积均为0.1ml/10g,每天给药1次,连续给药6周。
2.3观测指标:血糖:造模成功后第0天、21天、42天分别用HEA-230血糖仪 检测大鼠随机血糖。24小时尿蛋白定量:成模后及药物干预结束后分别用代谢笼收集24小时尿液,记录尿量,放免法测定24小时尿蛋白含量。肾功能:血样于南京市中 医院检验科,通过OLYMPUS自动生化分析仪检测Scr、BUN。肾脏病理组织学观察:大 鼠麻醉后脱颈椎处死,取右肾,去除被膜,用生理盐水灌洗肾脏血管以除去血液,滤 纸干燥,沿矢状正中线切开,将其1/2置入4%多聚甲醛固定液,48小时候常规石蜡 包埋,连续4um切片,HE染色,光镜下观察肾脏病理组织学变化。
2.4统计学处理:采用SPSS26.0软件进行统计学分析。计量资料以(X±S)表 示,两两比较采用t检验,多组比较采用单因素方差分析。P<0.05为差异有统计学 意义。
3、实验结果
3.1各组大鼠空腹血糖比较(表3)
表3各组大鼠随机血糖变化比较(mmol/L)(X±S)(n=10)
注:与正常对照组相比,ΔP<0.01,与模型组相比,※P<0.05
与正常对照组比较,其余各组小鼠血糖显著升高(P<0.01),各给药组血糖无显 著差异(P>0.05)。随时间延长,各给药组血糖均较模型组下降,差异有统计学意义 (P<0.05)。
3.2各组大鼠24小时尿蛋白情况(表4)
表4各组大鼠24小时尿蛋白比较(mg/24h)(X±S)(n=10)
注:与正常对照组比较,ΔP<0.01,与模型组比较各组尿蛋白定量均有改善, 以受试中药高剂量组减轻最明显,#P<0.01。
3.3各组大鼠血清Scr、BUN水平比较(表5)
表5各组大鼠血清Scr、BUN水平(X±S)(n=10)
注:与正常组相比,#P<0.01,与模型组比较,ΔP<0.05。
3.4各组大鼠肾脏病理积分比较(表6)
表6各组大鼠肾脏病理积分(X±S)(n=10)
注:与模型组比较,ΔP<0.05。
结论:本发明可有效降低糖尿病肾病大鼠血糖、血肌酐、尿素氮、24小时尿蛋白,并改善肾脏损伤,其疗效与药物剂量有关。
Claims (6)
1.一种用于治疗糖尿病肾病的中药组合物,其特征在于,所述中药组合物由下列重量份数的中药制成:生黄芪5-30份,党参5-20份,制山萸肉5-20份,泽兰5-20份,泽泻5-20份,猫爪草5-30份,土茯苓10-40份,海风藤5-20份,穿山龙5-20份,天花粉5-20份,当归5-20份,莪术5-20份。
2.根据权利要求1中所述的中药组合物,其特征在于,所述中药组合物由下列重量份数的中药制成:生黄芪15-30份,党参10-20份,制山萸肉8-20份,泽兰8-20份,泽泻5-20份,猫爪草15-30份,土茯苓20-40份,海风藤8-20份,穿山龙10-20份,天花粉10-20份,当归8-20份,莪术8-20份。
3.根据权利要求2所述的中药组合物,其特征在于,所述中药组合物由下列重量份数的中药制成:生黄芪30份,党参15份,制山萸肉10份,泽兰12份,泽泻10份,猫爪草30份,土茯苓40份,海风藤12份,穿山龙15份,天花粉15份,当归12份,莪术10份。
4.根据权利要求1-3中任意一项所述的中药组合物,其特征在于,制备方法:采用水提法进行提取,制备,即得。
5.根据权利要求1-3中任意一项所述的中药组合物,其特征在于,中药提取后添加药学上可接受的辅料制备成中药制剂,剂型为丸剂、片剂、胶囊剂、颗粒剂、软胶囊剂、口服液中的一种。
6.根据权利要求1-3中任意一项所述的中药组合物在制备治疗糖尿病肾病药物中的应用。
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